U.S. patent number 3,915,806 [Application Number 05/434,253] was granted by the patent office on 1975-10-28 for specimen holding kit.
This patent grant is currently assigned to Denver Chemical Manufacturing Company. Invention is credited to Heinz Eric Horlach.
United States Patent |
3,915,806 |
Horlach |
October 28, 1975 |
Specimen holding kit
Abstract
A disposable kit for collecting, holding and transporting
biological specimens in a saturated medium environment. A flat
elongated resilient pouch of inert material is formed with two
sterile hermetically sealed compartments. A rupturable transverse
closure across one of the compartments defines a sealed chamber
containing a transport medium. The second compartment contains a
specimen collecting swab having an elongated stem. The pouch is
adapted to be opened at one end to permit the swab to be removed
and, after the specimen has been collected, reinserted, thrust
through the rupturable closure, and immersed in the transport
medium. The pouch is resealable to secure the swab in the medium
containing chamber and to prevent exposure to the atmosphere during
transport and storage.
Inventors: |
Horlach; Heinz Eric (Los
Angeles, CA) |
Assignee: |
Denver Chemical Manufacturing
Company (Stamford, CT)
|
Family
ID: |
23723478 |
Appl.
No.: |
05/434,253 |
Filed: |
January 17, 1974 |
Current U.S.
Class: |
435/307.1;
435/30; 435/810 |
Current CPC
Class: |
A61B
10/02 (20130101); A61B 10/0096 (20130101); G01N
2001/028 (20130101); Y10S 435/81 (20130101) |
Current International
Class: |
A61B
10/00 (20060101); G01N 1/02 (20060101); C12B
001/00 () |
Field of
Search: |
;195/103.5,127,139
;23/259TP ;128/2W |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Monacell; A. Louis
Assistant Examiner: Penland; R. B.
Claims
I claim:
1. A specimen holding kit comprising:
a flat, elongated resilient pouch having first and second
hermetically sealed compartments positioned side-by-side therein,
said first compartment having a rupturable transverse closure
therein defining an hermetically sealed chamber at one end
thereof;
a culture transport medium contained in said chamber;
a specimen collecting swab positioned in said second
compartment;
means for opening the end of the pouch remote from said chamber to
expose both of said compartments, thereby allowing said swab to be
removed from said second compartment and, after collection of the
specimen, to be inserted into said first compartment and thrust
through said transverse closure into said chamber and in contact
with the culture transport medium; and
means for securely closing the opened end of said pouch thereby
closing said first compartment and retaining said swab in said
chamber.
2. The specimen holding kit of claim 1 wherein said pouch comprises
a pair of elongated thin sheets of resilient material joined along
their sides and ends and along a medial line intermediate said
sides to form said first and second sealed compartments.
3. The specimen holding kit of claim 2 wherein said rupturable
closure is formed by joining said pair of sheets in a narrow region
lying transverse to their longer dimension and extending between
said medial line and the joined region at one of their sides.
4. The specimen holding kit of claim 3 wherein the region of
joinder of said sheets at one of the ends thereof is spaced
inwardly of the edges of said sheets at said end, leaving an
unjoined region at said edges whereby said sheets may be grasped
and manually separated.
5. The specimen holding kit of claim 4 wherein said sheets are
joined by releasable means whereby one may be readily stripped from
the other to open one end of said pouch by application of manual
force.
6. The specimen holding kit of claim 5 wherein said sheets are so
joined by means of a cementious material.
7. The specimen holding kit of claim 5 wherein at least one of said
sheets is of thermoplastic material and is so joined to the other
of said sheets by thermofusion.
8. The specimen holding kit of claim 7 wherein said specimen
collecting swab is provided with a frangible elongated handle.
9. The specimen holding kit of claim 8 wherein said handle is
scored to facilitate its fracture after said swab has been thrust
through said closure into said chamber and in contact with said
culture transport medium.
10. The specimen holding kit of claim 9 wherein said means for
closing the opened end of said pouch comprises an adhesive strip
for securing the ends of said sheets doubled over the portion of
said pouch wherein said sheets have not been separated.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to kits for collecing, holding and
transporting biological specimens in a saturated medium
environment, and more particularly to a unitary system wherein a
sterile specimen collector and a transport medium are dispensed in
an unbreakable disposable container.
Over the past decade or more the importance of microbiological
analysis, testing and experimentation in the fields of public
health and clinical medicine, in the food, drug, cosmetics and
chemical industries, and in the realm of pure research has
burgeoned to the point it is estimated that in excess of three
billion microbiological specimens were collected and examined in
the United States alone during 1973. The need for a mass-produced,
inexpensive, easily used disposable system for collecting, holding
and transporting such specimens has become acute.
2. Description of the Prior Art
The traditional method for sample collection is to use a separately
packaged single sterile swab and a glass screw cap vial containing
sterile culture medium. This method is cumbersome in that it
requires the requisition, storage and handling of huge quantities
of individual swabs and vials. Glass vials are notoriously fragile
and require careful handling. Additionally, their initial cost
makes their reuse almost madatory, thereby creating the need for
expensive and time consuming reprocessing. Disposable vials of
plastic have by and large proved to be no more satisfactory.
A variety of prior art devices have been introduce employing
compartmentalized containers for microbiological use. U.S. Pat. No.
3,589,983 is illustrative of one such container. In addition to
being difficult and expensive to produce, devices of this type are
much too bulky and cumbersome for convenient use on a mass
scale.
Disposable culturing devices, such as those depicted in U.S. Pat.
Nos. 3,450,129 and 3,308,039, come closer to resolving the need,
but they too suffer from deficiencies which render their use
impracticable.
The object of the subject invention is to provide an inexpensive,
unbreakable, disposable unitary specimen handling kit which
overcomes all of these deficiencies.
SUMMARY OF THE INVENTION
Essentially, this invention comprises a flat elongated resilient
pouch of inert material formed with two sterile hermetically sealed
internal compartments. Preferably, the pouch is formed by joining a
pair of elongated thin sheets of resilient material along their
sides and ends and along a medial line extending between their
ends. A sealed chamber containing a culture transport medium is
formed at the lower end of one of the compartments, preferably by
joining the two sheets along a transverse line extending across the
compartment. The upper end of the sealed chamber is adapted to be
easily ruptured. A specimen collecting swab having an elongated
stem is provided in the second compartment, and both the transport
medium and the swab are sterilized.
The pouch is constructed so that its upper end may be opened
manually to expose the two compartments. In the preferred
embodiment the two resilient sheets are joined along a line spaced
from one end of the pouch to permit them to be grasped and
separated easily.
With the pouch thus opened, the swab is removed to collect the
desired specimen and then is reinserted into the compartment having
the chamber at its lower end and thrust through the rupturable
closure and into the transport medium.
The pouch is resealed by folding the opened end over on itself and
securing it in place by means of an adhesive band or similar
device. Thus folded over, the pouch itself retains the swab fully
immersed in the transport medium and protects both the swab and the
medium from accidental airborne contamination.
In the preferred embodiment, the swab stem is scored to permit it
to be broken after immersion of the swab in the culture medium.
This facilitates the resealing of the pouch and makes for a shorter
and more compact unit for handling, transporting and storing.
The specimen may be recovered without removing the adhesive band by
grasping the pouch near its lower end between the thumb and fingers
of one hand and forcing the swab stem downwardly with the other
hand to thrust the swab through the lower end of the transport
medium-containing chamber.
The details of construction and use of the subject invention will
become more readily apparent from a reading of the following
description of its preferred embodiment, taken in connection with
the appended drawings in which:
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a frontal view of a specimen holding kit embodying the
subject invention with portions of the front facing sheet cut away
for illustrative purposes;
FIG. 2 is a sectional view taken in the direction 2--2 of FIG.
1;
FIG. 3 is a perspective view of the device of FIG. 1 showing the
two resilient sheets forming the pouch separated to expose the
internal compartments and the upper end of the swab stem;
FIG. 4 is a perspective view of the pouch of FIG. 3 after it has
been resealed;
FIG. 5 is an enlarged frontal view of the pouch of FIGS. 3 and 4
illustrating the preferred method for recovering the specimen;
FIG. 6 is an enlarged detailed sectional view of the cavity
containing the transport medium illustrating method of removing the
swab from the pouch; and
FIG. 7 is a sectional view of another embodiment of the subject
invention taken between the two sheets comprising the pouch to
illustrate the manner in which they are joined.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to FIGS. 1 and 2, the specimen holding kit of the subject
invention is a fully self-contained unit comprising a flat,
flexible, light-weight pouch 11, preferably formed of two thin
resilient sheets 12, 13 of flexible, light-weight, substantially
inert hydrophobic plastic material, such as polyethylene, or the
like. In addition to its other characteristics, polyethylene's
transparency makes it particularly satisfactory for this purpose.
For certain applications a backing sheet 12 of polyethylene coated
metallic foil or paper and a facing sheet 13 of translucent
polyethylene have proved to be a nearly ideal combination.
Backing sheet 12 and facing sheet 13 are joined along their lateral
edges and at one end and along a longitudinal medial line to form a
pair of internal compartments 14, 15. Joining may be accomplished
by the use of any appropriate epoxy cement or other cementious
material, but thermoplastic welding has been found preferable for
this purpose.
Using well known thermoplastic welding techniques, the sheets 12,
13 may be welded along one or more lines 16 adjacent their lateral
edges and in their medial region 17. Preferably a single weld 18 is
used to join them at their lower ends.
A suitable bacteriological transport medium 21, such as Stuarts or
Amies-Charcoal solution is introduced into the lower end of the
first compartment 14 and sealed in place by joining the sheets 12,
13 using any of the techniques previously described for joining the
sheets 12, 13. As mentioned earlier, thermoplastic welding has been
found to be the most satisfactory means for this purpose.
Preferably the closure 22 forming the cavity containing transport
medium 21 is formed with a wide V-shaped weld which is
intentionally made somewhat weaker than those joining sheets 12, 13
along their lateral edges. As will be seen presently, the purpose
of this is to allow closure 22 to be ruptured relatively
easily.
A swab 23, preferably of Dacron polyester or some other non-toxic
absorbtive material and having an elongated stem 24 is positioned
in the second compartment 15.
Sheets 12, 13 are joined across the width of pouch 11, as along
line 25, by any of the means previously mentioned, again
thermoplastic welding being the preferable one, thereby
hermetically sealing compartments 14 and 15 and their contents. The
portions of sheets 12, 13 extending above the joinder line 25 are
intentionally left unjoined.
Sterile materials and techniques may be used in the formation and
filling of pouch 11 to insure the sterility of transport medium 21
and swab 23 or, in the alternative, the entire pouch 11 with its
contents may be sterilized by conventional autoclaving or
irradiation techniques as one of the last steps in the
manufacturing process. Whichever method is used, the medium 21,
swab 23 and stem 24 will remain sterile until pouch 11 is opened at
the time of use.
When a specimen is to be taken, backing sheet 12 and facing sheet
13 are grasped firmly between the fingers and peeled downwardly and
apart. To facilitate this operation backing sheet 12 may be made
slightly longer than facing sheet 13 to enable the user to grasp a
corner 31 of facing sheet 13.
As illustrated in FIG. 3, sheets 12, 13 are pulled apart with
sufficient force to open the welds 16 and 25, thereby exposing the
upper ends of compartments 14, 15 and the upper end of swab stem
24. A "tear line" 32 with an appropriate legend may be printed on
facing sheet 13 to advise the user when the pouch 11 has been
opened sufficiently. In a preferred embodiment of the invention a
removeable adhesive strip 33, which may have a label printed on its
reverse side for entry of information concerning the specimen, is
wrapped around pouch 11 and, in addition to the purpose which will
be described subsequently, may be used to provide a mechanical stop
to prevent the sheets 12, 13 from being separated over a greater
length than necessary.
By grasping the exposed end of swab stem 24, the swab 23 may be
withdrawn from pouch 11 and used in a conventional manner to
collect the microbiological specimen. Therafter, with the separated
upper ends of sheets 12, 13 apart, the swab 23 with the specimen in
place is inserted and slipped downwardly into compartment 14 until
the swab 23 contacts rupturable closure 22. With pouch 11 grasped
firmly, a sharp downward thrust of stem 24 will rupture closure 22
and immerse swab 23 and the specimen in transport medium 21.
By grasping stem 24 through pouch 11 near its lower end and bending
its upper end sharply, the upper end of stem 24 is broken off and
discarded. To facilitate this step a notch 36 may be provided near
its midpoint.
To reseal pouch 11 and secure the swab 23 in place fully immersed
in transport medium 21, sheets 12, 13 are once again brought
together and folded downwardly, preferably in a double fold, over
facing sheet 13. A "fold line" with an appropriate legend may be
provided as shown at numeral 37 to assist the user.
As shown in FIGS. 4 and 5, the adhesive strip 33 mentioned earlier
is preferably made with its ends folded over one another on facing
sheet 13. These ends are separated prior to folding the upper ends
of sheets 12, 13 downwardly, and are refolded over the doubled
upper portion of pouch 11 to prevent it from unfolding. This
reseals pouch 11 and protects transport medium 21, swab 23 and the
fully immersed specimen from accidental airborne contamination.
Additionally, as long strip 33 remains secured around the doubled
portion of pouch 11, swab 23 and its contents will remain saturated
until removed and little if any evaporation, oxidation or
deterioration will occur.
Sealed in this fashion, pouch 11 and its contents may readily be
stored for as long as desired and transported at will without fear
of external contamination or breakage. Furthermore, because of
their compact size and extremely light-weight, a number of these
units may be handled simultaneously with ease.
When the specimen is to be utilized for analysis, testing or
experimentation, swab 23 may be removed from pouch 11 by either of
two methods. If desired, the adhesive strip 33 may be removed, the
upper end of pouch 11 unfolded, and swab 23 withdrawn from
compartment 14 by means of stem 24. FIGS. 5 and 6 illustrate the
second method, wherein the pouch 11 is grasped firmly between the
thumb and forefingers of one hand and the upper end of stem 24 is
forced sharply downwardly with the other hand causing swab 23 to
rupture the weld 18 joining the lower ends of backing sheet 12 and
facing sheet 13. With this method, the pouch 11 itself serves as an
enlarged holder for stem 24. Regardless of the removal method used,
when the kit has served its purpose it may be discarded without
concern for breakage and without the taking of a great deal of
space.
FIG. 7 depicts a slightly varied alternative method of sealing
pouch 11 to form the cavity for transport medium 21. In this
method, rupturable closure 22 is formed by joining sheets 12, 13
transversely across their entire width, rather than merely across
the width of compartment 14 as in the embodiment of FIG. 1. It will
be noted that in this illustration sheets 12, 13 are joined at
their lateral edges by a single weld 16, rather than by the
plurality of welds shown in FIG. 1.
While the foregoing description is illustrative of two preferred
embodiments of the subject invention, it will be apparent to those
skilled in the art that many other variations and modifications may
be embodied within the scope of the invention as hereinafter
claimed.
* * * * *