Abstract:
The invention provides an apparatus for obtaining a stool specimen. The apparatus comprises a housing, a collection bag, a slider to close the collection bag and a draw string to move the slider. A user places the apparatus on a toilet, deposits a first stool into the collection bag, then pulls the draw string to move the slider to close the collection bag thereby allowing the user to urinate or further defecate.

Description:
RELATED APPLICATIONS  
       [0001]    This application is a continuation in part of U.S. Ser. No. 09/303,988 filed on May 3, 1999. 
     
    
     
       TECHNICAL FIELD  
         [0002]    This invention relates generally to an apparatus for collecting biological specimens. More particularly, the invention relates to an apparatus for the collection and transportation of stool specimens.  
         BACKGROUND OF THE INVENTION  
         [0003]    Stool specimens are used with increasing frequency for the screening and diagnosis of disease. Evidence of parasitic, infectious, or inherited disease may be found in stool. For example, the presence of carcinoembryonic antigen or blood in stool is indicative of colorectal cancer. Stool-based assays for parasitic organisms are also widely available.  
           [0004]    A significant problem with using stool specimens in screening or diagnosis arises in the collection of the specimen. Depending on its physical state, the specimen may be difficult to collect into a container. Moreover, the handling of a specimen raises sanitary concerns. Merely obtaining a specimen may increase the risk of disease transmission, especially if sanitary procedures are not followed. This is especially true if the patient is responsible for obtaining the specimen. The odor often associated with a stool specimen, and the frequent need to transport the specimen also contribute to the problems associated with sample collection.  
           [0005]    Attempts have been made to solve these problems. For example, Aslam, U.S. Pat. No. 4,101,279, reports a disposable bowl adapted to fit onto a toilet for collection of stool. Such a device eliminates the need for the patient to handle the specimen directly. However, the patient (or technician) is still exposed to the sample, resulting in possible contamination and the presence of odor. Moreover, the Aslam device contains blades for homogenization that may present a danger to the patient.  
           [0006]    Paulin, U.S. Pat. No. 4,309,782, also reports a bag adapted to fit onto a toilet for collection of stool. The device reported by Paulin also provides for scraping excess stool out of the bag after use.  
           [0007]    While these and other devices of the art have attempted to solve the problems associated with collection of stool, none have provided a solution that minimizes handling of the specimen, minimizes odor and contamination, and provides for easy transport of the specimen. Accordingly, there remains a need in the art for a device for safe and secure collection of stool.  
         SUMMARY OF THE INVENTION  
         [0008]    The present invention provides an apparatus for a collecting, storing, and/or shipping a stool specimen. Generally, the invention provides a housing having attached thereto a retractable bag for collecting the specimen. The bag is retracted by a draw string or cord (e.g., a lanyard) attached thereto, or preferably by a slider attached to the housing and to which the draw string is attached for moving the slider. In use, the patient places a device of the invention on a toilet, deposits stool into the bag, and pulls the draw string thereby to engage the slider to retract the bag. The patient may then urinate or further defecate. In a preferred embodiment, the bag is retracted into a portion of the housing. An advantage of a device of the invention is that the bag can be closed by the patient while the patient is still seated on the device.  
           [0009]    Also in a preferred embodiment, the housing is shaped to fit onto a toilet seat. A preferred housing releasably attaches to the toilet seat or may comprise a non-slip surface for contacting the toilet. The housing may comprise padding to increase patient comfort. A preferred housing is preferably constructed of cardboard or plastic but may be constructed of any useful material. The housing may comprise supports for resting the apparatus on a toilet seat. The supports may be folded over the housing for compact transportation of the apparatus.  
           [0010]    A stool specimen collector of the invention comprises a bag for collection, storage, and/or transport of the specimen. Preferably, a bag for use in an apparatus of the invention is releasably attached to the housing, preferably on the underside of the housing. In a preferred embodiment, the bag may be movably attached in a groove in the housing in order to facilitate closure of the bag. However, the bag may be fixedly attached to the housing at the convenience of the manufacturer or the technician. The bag is constructed of any suitable material such as polyethylene or PVC, and is preferably opaque. In a preferred embodiment, the bag may contain a buffer, or other additives to retard degradation of the specimen, and to optionally reduce odor.  
           [0011]    A preferred apparatus comprises a slider attached to a draw string for closing the bag. In a preferred embodiment, the bag comprises a spring beam holding the bag in an open position. The spring beam deforms to a closed position under the housing when the bag is closed. The slider is preferably engaged on the underside of the housing, such that when the draw string is pulled the slider sweeps the underside of the housing, thereby gathering the perimeter of the bag and causing the bag to close. In an alternative embodiment, the draw string itself is attached to the bag for closure and no separate slider is used. Thus, the draw string may be any material or configuration that is capable of closing the bag. It is not necessary for the draw string to remain attached to the bag after closure. Thus, the draw string may be detachable. A preferred draw string is constructed of nylon, and may be a loop, straight chord, braided, or any other configuration capable of closing the bag. Preferred bag closure mechanisms include a flexible tongue and groove assembly, a zipper, a thermal seal, an adhesive, a “zip-lock” assembly and others known in the art to effect closure of the open perimeter of a collection bag.  
           [0012]    Also in a preferred embodiment, instructions for using the apparatus are attached to or printed on the housing.  
           [0013]    Another embodiment of the invention provides methods for obtaining a stool specimen. In one embodiment, methods comprise placing a stool collector apparatus over a toilet, sitting over or on the apparatus, evacuating a stool into the collection bag, pulling the draw string to close the collection bag, and retracting the collection bag under the housing or bracket. A particular advantage of this embodiment is the collection bag is closed while the patient is still seated. 
       
    
    
       [0014]    Additional aspects and advantages of the invention are apparent upon consideration of the following detailed description thereof.  
       BRIEF DESCRIPTION OF THE DRAWINGS  
       [0015]    In the drawings, like reference characters generally refer to the same part throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead being place upon illustrating the principles of the invention.  
         [0016]    [0016]FIG. 1A is a bottom view of the stool specimen collector apparatus.  
         [0017]    [0017]FIG. 1B is a front view of the stool specimen collector apparatus.  
         [0018]    [0018]FIG. 2A is a side view of the collection bag.  
         [0019]    [0019]FIG. 2B is a side view of the integral assembly of the collection bag, zipper and spring beam.  
         [0020]    [0020]FIG. 3 is a schematic diagram illustrating the method of using the stool specimen collection apparatus.  
         [0021]    [0021]FIG. 4A is a side view of the slider.  
         [0022]    [0022]FIG. 4B is a front view of the slider.  
         [0023]    [0023]FIG. 4C is a perspective view of the slider.  
         [0024]    [0024]FIG. 4D is a perspective view of the slider showing the slider closure area.  
         [0025]    [0025]FIG. 4E is a perspective view of the slider, zipper, collection bag and draw string.  
         [0026]    [0026]FIG. 5 is a perspective view of the slider, adhesive, collection bag and draw string. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0027]    Referring to FIGS. 1A and 1B, shown is a bottom view ( 1 A) and a side view ( 1 B) of a preferred stool specimen collector apparatus  10 . The stool specimen collector apparatus  10  comprises a housing  12  which comprises a center U-shaped support  14  which is connected to two side supports  16  and  18 . The side supports  16  and  18  are hinged to center support  14  in such a way as to support the stool specimen collector apparatus  10  when it is placed on a toilet (not shown), and to allow the side supports  16  and  18  to be folded under the center support  14  when the stool specimen collector apparatus  10  is not being used.  
         [0028]    At least a portion of a collection bag  20  is attached to the center support  14 . Preferably, the collection bag  20  is removably attached to the center support  14 . In FIG. 1A and FIG. 4E, the rear portion of the collection bag  20  is attached by rivets  22  through holes  21  in a zipper flange  26 C of a zipper  26  which is attached to the collection bag  20 . The rivets  22  then pass into holes  14 C located in the center support  14 . Alternatively, attachment of the collection bag  20  is accomplished by other known methods, such as heat staking. FIG. 2A is a side view of the collection bag  20 , and FIG. 2B is a side view of the integral assembly of the collection bag, zipper  26  and spring beam  24 .  
         [0029]    As shown in FIGS. 1A and 1B, the front of the collection bag  20  also includes a spring beam  24  which is preferably an integral part of the collection bag  20 . The spring beam  24  is a narrow strip of resiliently biased material but has sufficient vertical height to prevent vertical deflection of the collection bag  20  away from the center support  14 . The spring beam  24  is initially flexed outward toward the front of the toilet bowl when the apparatus is in use, and provides support for the collection bag  20  in the open position.  
         [0030]    A preferred collection bag  20  comprises a thin flexible plastic film or any other material known to those skilled in the art for containing a biological sample. The collection bag  20  may be opaque to prevent the individual from viewing the contents, or the collection bag  20  may be clear to allow visual analysis by technicians.  
         [0031]    As shown in FIG. 1A, FIG. 2A, FIG. 2B, and FIG. 4E, the top edges of the collection bag  20  preferably have a zipper  26 , in which the front portion of the collection bag  20  contains a first portion of the zipper  26 A, and the back portion of the collection bag  20 , which is attached to center support  14 , contains a second portion of the zipper  26 B. In one embodiment of the first portion of the zipper  26 A is the male portion of the zipper  26  and the second portion of the zipper  26 B is the female portion of the zipper  26 . In another embodiment the zipper  26  runs the entire length of the open perimeter of the collection bag  20 . A preferred zipper is an ITW Maxgrip UX202T. The collection bag  20  may have alternative closures, such as an adhesive closure, or others known in the art.  
         [0032]    Mounted to the underside of the center support  14  is a slider  28  that runs along slider track  30 . The slider  28  is attached to the zipper  26  of collection bag  20 . The slider  28  is attached to a draw string  32 . The draw string  32  extends from the slider  28 , around the center support  14 , under side support  16 , and extends through an opening  34  in side support  16 . A handle  36  is attached to the end of the draw string  32  as shown in FIG. 1A.  
         [0033]    In further detail, the slider  28  has two blocks  28 A and  28 B on its top edge as shown in FIG. 4A which also shows the draw string  32  is attached to block  28 A. As shown in FIG. 4E, the draw string  32  is a heavy nylon monofilament which is molded by using heat into a high pitch helix  32 A, where the diameter of the helix  32 A is equal to the width of the slider track  30 , and is sufficiently large to prevent the draw string  32  from falling out of the slider track  30  through the gap between the center support  14  and a slider track plate  14 B. Blocks  28 A and  28 B run in the slider track  30 . A beginning portion of the zipper  26  is zipped together while the collection bag  20  is open by sliding the slider  28  over the beginning portion of zipper  26 . As a user pulls handle  36  and draw string  32 , the slider  28  moves along the slider track  30  which results in the female portion of the zipper  26 B and the male portion of the zipper  26 A being brought together and engaged in the closure area  28 C of the slider  28 .  
         [0034]    The collection bag  20  is bonded together to both flanges of the zipper  26 . The collection bag bond area  20 B is above the holes  21  in the zipper flange  26 C on the female portion  26 B of the zipper  26 , allowing rivets  22  to enter those holes  21  in the zipper flange  26 C in the space between the body of the collection bag  20  and the zipper flange  26 C, and then into the holes  14 C in the center support  14 . This arrangement permits the bag assembly of the bag  20 , the zipper  26  and the spring beam  24  to be removably affixed to the center support  14  without penetrating the wall of the collection bag  20 . FIG. 2B shows the spring beam  24  is creased near both ends of the beam at  24 A to permit the spring beam  24  to assume either the open state shown in FIG. 1A, or the closed U shape when the collection bag  20  is closed. A front edge of the slider  28 D (FIG. 4D) deflects the spring beam  24 , first into an S shape while the zipper  26  is being closed. Then when the slider  28  has reached the far end of the slider track  30 , the spring beam  24  has become a U shape in close proximity to the flange  14 D of the center support  14 . The collection bag  20  in the closed position is stored under the center support  14 .  
         [0035]    [0035]FIG. 5 illustrates an embodiment of the invention that uses an adhesive seal instead of a zipper to seal the collection bag  20  closed. FIG. 5 illustrates how a release paper strip  42  passes from the center support  14  (not shown), through a slider slot  28 D, and onto an adhesive area  27 A on a top side of the collection bag  20 . An end of the release paper strip is attached to the center support  14  above the starting position of the slider  28  when the collection bag  20  is in the open position. In one embodiment, the end of the release paper strip can be attached to the center support  14  by using a small clamp plate held down by a screw. In another embodiment, the end of the release paper strip can be captured between the center support  14  and the slider track plate  14 B. The release paper strip  42  on the adhesive area  27 A covers an adhesive  44 . As the slider  28  moves along the slider track  30 , the release paper strip  42  is lifted off the adhesive  44 . The slider closure area  28 C then pushes the adhesive area  27 A, with the exposed adhesive  44 , together with an opposite top side of the collection bag  27 B, to seal the collection bag  20  together forming an adhesive seal in a manner similar to the closure of zipper  26 .  
         [0036]    A method for using a stool specimen collector apparatus  10  is illustrated in FIG. 3. An individual places the stool specimen collector apparatus  10  on a toilet  8 . The user then sits on or over the stool specimen collector apparatus  10  and evacuates a stool sample  6  into collection bag  20 . The user then pulls draw string  32  via handle  36  which closes the collection bag  20  by pulling the slider  28  which zips zipper  26  closed. As the collection bag  20  is being closed, the spring beam  24  at the front of collection bag  20  begins to deflect backwards in response to the zipper  26  closure which moves the closing collection bag  20  under center support  14 .  
         [0037]    In addition, the stool specimen collector apparatus device  10  may have a drape  40  which covers the front of the collection bag  20 . The drape  40  has an opening  38  in the top of the drape  40  to allow stool to pass into collection bag  20 . After a stool has been evacuated into the collection bag  20 , and as the collection bag  20  is being closed, the drape  36  falls in to cover the collection bag  20  to protect the collection bag  20  during the rest of the toileting process. After toileting, the drape  40  can be detached and disposed.  
         [0038]    A shipping container (not shown) may be used to ship the stool specimen collector apparatus, both prior to use, and after use toward a laboratory for analysis. The shipping container may contain one or more over-bags (not shown) to contain the used stool specimen collector apparatus  10  prior to placing the stool specimen collector apparatus  10  into the shipping container. Alternatively, the side supports  16  and  18  may fold over the housing  12  in order to form a shipping container.  
         [0039]    It is envisioned that components of the stool specimen collector apparatus are reusable. In one embodiment the support bracket  12 , slider  28  and draw string  32  are reusable.  
         [0040]    Other aspects and advantages of the invention are apparent upon consideration of the disclosure herein.