U.S. patent application number 09/804861 was filed with the patent office on 2001-11-22 for stool specimen collector.
Invention is credited to Lapidus, Stanley N., Sloan, Walker M. III.
Application Number | 20010042264 09/804861 |
Document ID | / |
Family ID | 23174549 |
Filed Date | 2001-11-22 |
United States Patent
Application |
20010042264 |
Kind Code |
A1 |
Sloan, Walker M. III ; et
al. |
November 22, 2001 |
Stool specimen collector
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.
Inventors: |
Sloan, Walker M. III;
(Berlin, MA) ; Lapidus, Stanley N.; (Bedford,
NH) |
Correspondence
Address: |
TESTA, HURWITZ & THIBEAULT, LLP
HIGH STREET TOWER
125 HIGH STREET
BOSTON
MA
02110
US
|
Family ID: |
23174549 |
Appl. No.: |
09/804861 |
Filed: |
March 13, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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09804861 |
Mar 13, 2001 |
|
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09303988 |
May 3, 1999 |
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Current U.S.
Class: |
4/315 |
Current CPC
Class: |
A47K 11/105 20130101;
A61B 10/0038 20130101 |
Class at
Publication: |
4/315 |
International
Class: |
E03D 009/10 |
Claims
What is claimed is:
1. An apparatus for collecting a stool specimen, the apparatus
comprising: a housing; a collection bag attached to said housing;
and, a draw string attached to said bag for use in closing said
bag
2. An apparatus for collecting a stool specimen, the apparatus
comprising: a housing; a collection bag attached to said housing; a
slider movably attached to said housing and capable of engagement
with said collection bag; and, a draw string attached to said
slider.
3. The apparatus of claim 1, further comprising a center
support.
4. The apparatus of claim 3 wherein said apparatus further
comprises two side supports foldably attached to said center
support, thereby to enable said side supports to fold under said
housing when said apparatus is not in use.
5. The apparatus of claim 4 wherein said housing is shaped to
conform to a standard toilet seat.
6. The apparatus of claim 1 wherein said housing has instruction
printed thereon or enclosed therewith.
7. The apparatus of claim 1 wherein said collection bag is
opaque.
8. The apparatus of claim 1 wherein said collection bag is
closeable.
9. The apparatus of claim 1 wherein said collection bag further
comprises a spring beam.
10. The apparatus of claim 9 wherein said collection bag is
retractable under said housing.
11. The apparatus of claim 10 wherein said collection bag comprises
a zipper.
12. The apparatus of claim 10 wherein said collection bag comprises
an adhesive.
13. The apparatus of claim 1 wherein said collection bag is
removable from said housing.
14. The apparatus of claim 2 wherein said slider is slideable along
an opening of said collection bag.
15. The apparatus of claim 1 wherein said draw string comprises a
handle.
16. The apparatus of claim 1 further comprising a drape, wherein
said drape is attached to said housing.
17. The apparatus of claim 16 wherein said drape is removable.
18. The apparatus of claim 2 wherein said housing, said slider and
said draw string are reusable.
19. A method of obtaining a stool sample comprising: evacuating a
stool into said collection bag; and, pulling said draw string to
close said collection bag and retracting said collection bag under
said housing.
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] FIG. 1A is a bottom view of the stool specimen collector
apparatus.
[0017] FIG. 1B is a front view of the stool specimen collector
apparatus.
[0018] FIG. 2A is a side view of the collection bag.
[0019] FIG. 2B is a side view of the integral assembly of the
collection bag, zipper and spring beam.
[0020] FIG. 3 is a schematic diagram illustrating the method of
using the stool specimen collection apparatus.
[0021] FIG. 4A is a side view of the slider.
[0022] FIG. 4B is a front view of the slider.
[0023] FIG. 4C is a perspective view of the slider.
[0024] FIG. 4D is a perspective view of the slider showing the
slider closure area.
[0025] FIG. 4E is a perspective view of the slider, zipper,
collection bag and draw string.
[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 (1A)
and a side view (1B) 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 26C of a zipper 26 which is attached to
the collection bag 20. The rivets 22 then pass into holes 14C
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 26A, and the back portion of the collection
bag 20, which is attached to center support 14, contains a second
portion of the zipper 26B. In one embodiment of the first portion
of the zipper 26A is the male portion of the zipper 26 and the
second portion of the zipper 26B 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 28A and 28B
on its top edge as shown in FIG. 4A which also shows the draw
string 32 is attached to block 28A. 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 32A, where the diameter of the helix
32A 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 14B. Blocks 28A and 28B 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 26B and the
male portion of the zipper 26A being brought together and engaged
in the closure area 28C of the slider 28.
[0034] The collection bag 20 is bonded together to both flanges of
the zipper 26. The collection bag bond area 20B is above the holes
21 in the zipper flange 26C on the female portion 26B of the zipper
26, allowing rivets 22 to enter those holes 21 in the zipper flange
26C in the space between the body of the collection bag 20 and the
zipper flange 26C, and then into the holes 14C 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 24A 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 28D
(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 14D of the center support
14. The collection bag 20 in the closed position is stored under
the center support 14.
[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 28D, and
onto an adhesive area 27A 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 14B. The
release paper strip 42 on the adhesive area 27A 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 28C then pushes the adhesive area 27A, with the exposed
adhesive 44, together with an opposite top side of the collection
bag 27B, 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.
* * * * *