Information
-
Patent Grant
-
6170719
-
Patent Number
6,170,719
-
Date Filed
Friday, August 6, 199924 years ago
-
Date Issued
Tuesday, January 9, 200123 years ago
-
Inventors
-
Original Assignees
-
Examiners
-
CPC
-
US Classifications
Field of Search
US
- 222 4815
- 222 484
- 222 479
- 222 556
- 215 237
- 215 235
- 215 307
- 215 309
- 215 354
- 220 254
- 220 3671
-
International Classifications
-
Abstract
A specimen safety closure is provided for sealing an open top of a test tube during the collection, transfer, and shipment of specimens to analytical laboratories. The closure includes an oblong transfer port for allowing transfer of the liquid specimen from a male reservoir outlet into the tube. A barrier wall and annular skirt provide leakage protection from the test tube connection. Also included is a cylindrical vent tube extending from the bottom of the safety closure. The vent tube has a supporting disk which has a very small hole in its bottom to provide venting. The vent tube also performs the function of filling the tube passively while stopping the liquid specimen from filling at a predetermined volume. Both the transfer port and vent tube are located off the center axis for providing maximum filling speed. The transfer port and vent tube are positioned in opposite directions for providing uninterrupted transfer of the liquid specimen. The safety closure further includes a snap lid. The snap lid has an annular snap ring, a portal mating plug, and a frangible tab. The annular snap ring and the portal mating plug seals the cap to allow liquid-tight transportation of the specimen within the test tube for shipment to a testing facility. The annular snap on the snap lid is a one-time operation and removal of the cap is only facilitated by twisting off the cap. Thus, safety from the spray of the specimen by removal of the snap lid is avoided. The frangible tab on the snap lid provides tamper resistance and further protection from specimen spray by breaking off when excessive force is applied to the tab in attempts to defeat the lock of the annular snap ring.
Description
BACKGROUND OF THE INVENTION
1. Field of Invention
The present invention relates to a medical safety closure for sealing an open top of a specimen collection tube. More particularly, the present invention relates to a medical specimen safety closure used during the collection and shipment of biological specimens, such as urine, to analytical laboratories.
2. Background Description
Biological specimen collections are frequently performed in physicians' offices, hospitals and clinics. It is then sent out to the laboratory for diagnostic testing. Urine collection is one of the most notable. The usual procedure to carry out a urine test is to have one's urine collected and then shipped to an analytical laboratory. The specimen is usually collected in a physician's office where the patient is asked to fill some type of container and then return it to the healthcare provider. The specimen is then transferred from the reservoir container into some shipping container and mailed out to an analytical laboratory for diagnostic analysis.
A problem with current devices that are utilized to carry out this specimen collection is that during the transfer of the specimen from the primary collection device to the transport device, the healthcare provider can be exposed to the specimen. There is a current need to provide safe transfer of the specimen from the reservoir to the shipping container. In addition, there is a need to provide a closure which has a liquid-tight seal so that the specimen does not leak out during transport to the analytical laboratory.
It is also important to provide a safety feature to the closure so that the laboratory technician cannot defeat the medical safety closure's lid and potentially become exposed to the specimen by splatter or spray when the lid is re-opened.
Furthermore, it is desirable to have these above features and advantages with a closure that provides passive filling of the specimen which also stops the liquid specimen from filling at a pre-determined volume. As those skilled in the field of specimen collection are aware, safety is becoming more important due to the exposure to the specimen and the possible infectious disease it may carry. Therefore, there is an ever-increasing need for a specimen closure that minimizes exposure of the specimen to the healthcare provider during collection and transfer of the specimen from a reservoir to a container. In addition, there is a need for a closure to be fluid-tight during shipping of the specimen and a feature to prevent tampering of the closure's lid that could lead to exposure of the specimen from spray or splatter caused by the re-opening of the lid. Currently, stoppers are used that must be pulled out of the containers which can cause splatter or spray of the specimen out of the container. Closures which have a permanent snap fit and only allow removal of the closure by twisting off of the container may be defeated if enough force is applied to the lid of the closure.
SUMMARY OF THE INVENTION
The present invention overcomes the problems identified in the background material. The preferred embodiment of the safety specimen closure comprises a base having an open upper portion, a lower portion and side walls therebetween. The side walls have at least one detent. The lower portion has an annular skirt and a barrier wall extending distally. The annular skirt is attached to the tube by having at least one internal protrusion and the tube having at least one external protrusion. The tube is secured between the annular skirt and barrier wall to provide leakage protection from the tube and closure connection. A transfer port for internally receiving the male reservoir outlet is attached to the lower portion and extends towards the open upper portion. The transfer port is offset from the center of the lower portion and has a hole that is oblong in shape for maximum filling speed. The oblong transfer port where a male reservoir outlet is received inside the transfer port assists in avoiding any spillage or leakage that may occur by having the specimen from the container directly poured into the transport container or tube, instead of having a male receptacle over the transfer port of the closure which may result in leakage of the specimen.
A vent tube is mounted on the lower portion between the transfer port and side walls. The vent tube extends adjacent to the annular skirt and has a conduit therethrough such that the diameter of the conduit is larger at the lower portion than at the distal end of the vent tube adjacent to the annular skirt.
The closure further includes a snap lid hingedly connected to the base. The snap lid has at least one coupler or annular ring and a portal mating plug such that when the snap lid is rotated onto the open upper portion of the closure, the portal mating plug securely attaches into the transfer port and the coupler permanently attaches to the detent on the side walls. This feature provides a liquid-tight seal suitable for shipment and prevents the snap lid from being re-opened. Further prevention of re-opening the snap lid is provided by a tab being frangibly and flexibly mounted on the snap lid which detaches when force is applied to re-open the snap lid. This frangible tab is strong enough to press the snap lid onto the open upper portion but breaks off making it unusable when attempts are made to re-open the lid. A plurality of vertical ribs mounted on the side walls of the closure further provide safety by allowing secure gripping of the closure.
The closure further includes a supporting disk attached to the distal end of the vent tube. The supporting disk has an aperture therethrough that has a diameter smaller than the diameter of the conduit of the vent tube adjacent to the annular skirt. The supporting disk provides for passive filling of the specimen into the specimen collection tube. The supporting disk also provides for the specimen to stop filling at a certain predetermined volume based on the height of the supporting disk from the bottom of the specimen collection tube.
These and other aspects, features and advantages of the present invention is apparent from the following detailed description taken in conjunction with the accompanying drawings and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1
is a perspective view of the medical safety closure in accordance with the subject invention.
FIG. 2
is a bottom perspective view of the closure shown in FIG.
1
.
FIG. 3
is a top plan view of the closure shown in FIG.
1
.
FIG. 4
is a side view of the closure shown in FIG.
1
.
FIG. 5
is a cross-sectional view taken along line
5
—
5
in FIG.
3
.
FIG. 6
is an enlarged cross-sectional view of FIG.
5
.
FIG. 7
is an exploded perspective view of the closure shown in
FIG. 1
attached to a specimen collection tube and a male reservoir outlet.
FIG. 8
is a side elevational view of the closure mounted to the male reservoir outlet in FIG.
7
.
FIG. 9
is a cross-sectional view taken along line
9
—
9
in FIG.
8
.
FIG. 10
is an enlarged cross-sectional view of FIG.
9
.
FIG. 11
is an enlarged side elevational view of the closure in
FIG. 1
attached to a tube with a snap lid in the closed position.
DETAILED DESCRIPTION
While this invention is satisfied by embodiments in many different forms, there is herein described in detail preferred embodiments of the invention with the understanding that the present disclosure is to be considered as exemplary of the principles of the invention and is not intended to limit the invention to the embodiments illustrated and described. The scope of the invention is measured by the appended claims and their equivalents.
A medical safety closure
10
and a medical safety closure collection system
82
in accordance with the subject invention is identified generally in FIGS.
1
-
11
. Closure
10
as shown in FIGS.
1
-
5
, includes a base
20
having an open upper portion
22
, a lower portion
24
, and side walls
30
therebetween. Side walls
30
have a length “F”. Base
20
is preferably cylindrical in shape, however, other shapes could be provided such as polygonal, elliptical, and/or orthogonal for providing maximum gripping area. Side walls
30
could be similarly shaped in different structures as base
20
. Lower portion
24
includes an annular skirt
32
and a barrier wall
36
both extending distally from lower portion
24
. Annular skirt
32
has a length “H”. Barrier wall
36
has a length “J. Side walls
30
include at least one detent
34
. Detent
34
is preferably positioned inside side walls
30
. However, detent
34
may be placed on the outside of side walls
30
.
A transfer port
40
is further included in closure
10
. Port
40
has a distal end
46
, a proximal end
48
, and a length “E”. Proximal end
48
of transfer port
40
is attached to lower portion
24
and distal end
46
extends toward open upper portion
22
. Transfer port
40
is offset from the center of lower portion
24
for providing maximum filling speed and minimizing interference during transfer of the specimen. As shown in
FIG. 3
, transfer port
40
is offset from the center of lower portion
24
by a distance “G”. Transfer port
40
includes a hole
42
for internally receiving a male reservoir outlet
14
and allowing the specimen to safely transfer into a specimen collection tube
12
. Tube
12
has an open top
94
, a closed bottom
96
and cylindrical side walls
98
. Preferably, transfer port
40
is oblong shaped for providing maximum filling speed of the specimen in tube
12
. However, other shapes can be provided, such as circular or elliptical. As shown in
FIG. 3
, transfer port
40
further includes an array of supporting ribs
102
disposed circumferentially around transfer port
40
and attached to side walls
30
. Ribs
102
minimizes the amount of deflection of transfer port
40
from the insertion of male reservoir outlet
14
during transfer of the speciman. Thus, ribs
102
reduce the potential of the specimen leaking out. As shown in FIGS.
5
-
6
, closure
10
further includes a vent tube
44
having a proximal end
78
and a distal end
76
. Proximal end
78
is mounted on lower portion
24
between transfer port
40
and side walls
30
. Vent tube
44
extends adjacent to annular skirt
32
. Vent tube
44
is preferably cylindrical in shape but does not have to be so shaped to function. Vent tube
44
further includes a conduit
50
therethrough. Conduit
50
has a diameter “A” located at lower portion
24
and a diameter “B” at annular skirt
32
. Diameter A is larger than diameter B. Vent tube
44
further includes a supporting disk
74
attached to distal end
76
. Supporting disk
74
has an aperture
80
therethrough that has a diameter “C”. Diameter “C” is smaller than diameter “B” of conduit
50
. Vent tube
44
has a length “D”. Length “D” and the position of supporting disk
74
determines the amount of specimen that enters tube
12
. Conduit
50
at distal end
76
has a diameter “I”.
The vent tube
44
preferably protrudes distally beyond annular skirt
32
. Length “D” is greater than length “E”. Preferably, length “F” of side walls
30
is greater than length “E” of port
40
and length “H” of annular skirt
32
is smaller than length “D” of vent tube
44
. However, these size relationships can be reversed and the length “E” of port
40
can be greater than length “F” of side wall
30
. In addition, length “H” of annular skirt
32
can be greater than length “D” of vent tube
44
. Aperture
80
having diameter “C” is sized to prevent the passage of fluid, but allow the passage of air to vent through. Length “D” and the position of supporting disk
74
determines the amount of specimen that enters tube
12
. Vent tube
44
allows passive filling and length “D” and the position of supporting disk
74
from closed bottom
96
of tube
12
predetermines the volume to be transferred in tube
12
.
Vent tube
44
is further characterized by a method to manufacture vent tube
44
. Vent tube
44
can be an extruded tube with a small inside diameter equivalent in size to diameter “C”. This alternate embodiment utilizes a press fit on the extruded tube to attach vent tube
44
on lower portion
24
. This embodiment allows the simple cutting of the extrusion to vary the volume in tube
12
. The advantage of this embodiment is efficiency in manufacturing and flexibility associated with the ease in variation of specimen volume by simply changing the cut length of vent tube
44
.
Closure
10
further includes a snap lid
52
hingedly connected by a hinge
54
to base
20
. Snap lid
52
includes at least one annular snap ring
60
and a portal mating plug
62
. Annular snap ring
60
is positioned on snap lid
52
to correspond with detent
34
on side walls
30
when snap lid
52
is rotated onto open upper portion
22
of closure
10
. Portal mating plug
62
is positioned on snap lid
52
to correspond with and enter hole
42
of transfer port
40
when snap lid
52
is rotated onto open upper portion
22
.
As shown in
FIGS. 1
,
4
and
11
, snap lid
52
further includes a tab
64
for pressing snap lid
52
onto open upper portion
22
. Tab
64
is frangibly and flexibly mounted on snap lid
52
which provides for detachment of tab
64
when force is applied to re-open snap lid
52
. Closure
10
further comprises a plurality of vertical ribs
70
mounted on side walls
30
for securely gripping closure
10
. Tab
64
includes a frangible zone
66
for detaching tabs
64
when force is applied to re-open snap lid
52
. Frangible zone
66
preferably has a score line
68
. There are other methods well known to those skilled in the art to make such a frangible zone. Such methods include but are not limited to using frangible or brittle material such as styrene, using a reduced thickness area and using stress concentrations such as sharp edges or non-radiused corners. Annular skirt
32
further comprises at least one internal protrusion
72
for attachment of closure
10
onto tube
12
. Barrier wall
36
provides leakage protection from the attachment of closure
10
onto tube
12
.
Medical safety closure collection system
82
includes closure
10
and tube
12
as shown in FIG.
7
. Tube
12
has an open top
94
, a closed bottom
96
and cylindrical side walls
98
. Tube
12
further includes an external thread
100
. External thread
100
is used to attach test tube
12
to at least one internal protrusion
72
of closure
10
. External thread
100
is the preferred geometry of the subject invention. However, threads can be mounted on the inside of tube
12
and detents can be mounted on the outside of closure
10
to facilitate attachment of closure
10
to tube
12
.
As shown in
FIG. 7
, medical safety closure collection system
82
includes closure
10
and tube
12
. Preferably, closure
10
is threadedly mounted to tube
12
as shown in FIG.
9
. Barrier wall
36
is positioned inside tube
12
when closure
10
is mounted onto tube
12
. Thus, cylindrical side walls
98
of tube
12
is between annular skirt
32
and barrier wall
36
to prevent leakage from the tube connection. Barrier wall
36
prevents the specimen from leaking out of tube
12
and onto the annular skirt
32
. External thread
100
and protrusion
72
are both preferably matching threads. However, it is within the scope of the invention that external thread
100
and protrusion
72
could be any type of removable fastener known to one skilled in the art such as removable snap fits, slip fits or frictional fittings and sleeve locks. Closure
10
is preferably made from a polymeric material such as polyethylene or polypropylene. Test tube
12
is preferably glass. However, test tube
12
can also be made of a polymeric material such as polystyrene, polyethylene terephthalate, polycarbonate or any blends thereof.
After a sufficient volume of liquid specimen has been collected such as in a collection container
104
shown in
FIG. 7
, the male reservoir outlet
14
attached to collection container
104
is mounted inside transfer port
40
. By mounting male reservoir outlet
14
inside transfer port
40
spillage and leakage is minimized. Transfer port
40
is stabilized by supporting ribs
102
as shown in FIG.
1
. Ribs
102
minimizes the amount of deflection of transfer port
40
during transfer of the specimen from the collection container
104
to the specimen collection tube
12
which is later shipped to a lab for analysis. Length “D” of vent tube
44
and the position of disk
80
relative to bottom
96
determines the amount of fluid specimen that is deposited in test tube
12
. Also a factor in the amount of fluid specimen deposited in tube
12
is a length “Z” which is the distance from bottom
96
to disk
80
, and represents the total volume of the specimen to be filled in tube
12
. Distal end
76
of vent tube
44
and aperture
80
is blocked to inhibit further flow of the specimen into test tube
12
.
Once transfer of the liquid specimen from the reservoir or collection container
104
to the specimen collection tube
12
is completed, medical safety closure system
82
is removed from male reservoir outlet
14
. Snap lid
52
is rotated about hinge
54
to cover open upper portion
22
. Portal mating plug
62
mates with hole
42
in transfer port
40
to provide a liquid-tight seal. Annular snap ring
60
mates with inner detent
34
of side walls
30
to permanently secure snap lid
52
onto open upper portion
22
. Annular snap ring
60
also provides additional liquid-tight sealing of the specimen in tube
12
. This additional protection is provided since the snap ring completely surrounds open upper portion
22
and creates a complete seal around open upper portion
22
. Preferably, annular snap ring
60
and inner detent
34
are inside side walls
30
. However, annular snap ring
60
could be configured to seal on the outside of side walls
30
. The filled and sealed test tube may be then transported to a laboratory for analysis without risk of spillage or contamination of the specimen or nearby personnel.
During the transfer of the liquid specimen from the reservoir or collection container
104
to the specimen collection tube
12
, the oblong shape of transfer port
40
and the off-center position of transfer port
40
and vent tube
44
allows a maximum transfer speed of the liquid specimen from the reservoir or collection container
104
to specimen collection tube
12
. Once snap lid
52
is securely mounted on open upper portion
22
the liquid specimen can only be reached by unscrewing closure
10
from tube
12
. If snap lid
52
is attempted to be re-opened, tab
64
breaks along score line
68
thereby preventing the re-opening of snap lid
52
. Once tab
64
has been detached, snap lid
52
has no gripping surface to assist in its re-opening. Vertical ribs
70
on side walls
30
allow for securely gripping closure
10
while unscrewing closure
10
from test tube
12
. This feature further reduces the risk of spillage or contamination of the specimen on nearby personnel.
The embodiments depicted in FIGS.
1
-
11
are intended to merely be exemplary, and are not intended to depict all possible collection containers that may be used with closure
10
and medical safety closure system
82
. Rather, closure
10
and medical safety closure system
82
can be used with any container having an appropriately dimensioned male outlet. The ability to transfer a specimen sample from a reservoir to a specimen collection tube by having a male outlet inside transfer port
34
of closure
10
minimizes the potential for leakages or spills. Furthermore, the volume of the specimen collected can be easily varied by adjusting length “D” of vent tube
44
. The incorporation of portal mating plug
62
and annular snap ring
60
on closure
10
provides prevention for potential leakages or spills during shipping by permanently attaching snap lid
52
on open upper portion
22
and providing a liquid-tight seal. Tabs
64
being frangibly and flexibly mounted on snap lid
54
provides for tamper resistance and protection against potential leakages and spills of the specimen during re-opening of closure
10
. As shown in
FIG. 11
, this protection is provided by tab
64
detaching when force is applied to reopen snap lid
54
after closure. The geometry and position of transfer port
40
and hole
42
as well as the position of vent tube
44
allows minimal interference during transfer of the specimen from the reservoir or collection container
104
to tube
12
. Transfer port
40
and vent tube
44
are positioned in opposite directions for providing uninterrupted transfer of the liquid specimen. These geometries and positions also provide for maximum filling speed between the reservoir or collection container
104
and the specimen collection tube
12
.
Claims
- 1. A medical safety closure for use with a specimen collection tube and a male reservoir outlet, comprising:a base having an open upper portion, a lower portion, and a side wall therebetween, said lower portion having an annular skirt and a barrier wall extending distally therefrom, said side walls having at least one detent, said annular skirt attachable to the tube such that the tube is being secured between said annular skirt and said barrier wall; a transfer port attached to said lower portion and extending toward said open upper portion, said transfer port offset from the center of said lower portion and having a hole therethrough for internally receiving the male reservoir outlet and allowing liquid transfer into the tube, said transfer port further including an array of supporting ribs disposed circumferentially around said transfer port and attached to said wall; and a vent tube having proximal and distal ends mounted on said lower portion between said transfer port and said side walls, said vent tube extending adjacent to said annular skirt and having a conduit therethrough such that the diameter of said conduit is larger at said lower portion than at said distal end of said vent tube adjacent to said annular skirt.
- 2. The closure of claim 1, further comprising a snap lid hingedly connected to said base, said snap lid having at least one annular snap ring and a portal mating plug such that when said snap lid is rotated onto said open upper portion said portal mating plug securely attaches into said transfer port and said annular snap ring permanently attaches to said detent for providing a liquid-tight seal and preventing said snap lid from re-opening.
- 3. The closure of claim 2, wherein said snap lid further includes a tab for pressing said snap lid onto said open upper portion, said tab frangibly and flexibly mounted on said snap lid for detaching said tab when force applied to open said snap lid.
- 4. The closure of claim 1, further comprising a plurality of vertical ribs mounted on said side walls for securely gripping the closure.
- 5. The closure of claim 1, further comprising at least one internal protrusion on said annular skirt for attachment of the closure onto the tube.
- 6. The closure of claim 1, wherein said transfer port is oblong in shape.
- 7. The closure of claim 1, wherein said vent tube further includes a supporting disk attached to the distal end of said vent tube, said supporting disk having an aperture therethrough that has a diameter smaller than the diameter of said conduit of said vent tube adjacent to said annular skirt.
- 8. The closure of claim 1, wherein said vent tube protrudes distally beyond said annular skirt.
- 9. A medical safety closure collection system for use with a male reservoir outlet, comprising:a cylindrical base having an open upper portion, a lower portion, and side walls therebetween, said lower portion having an annular skirt and a barrier wall extending distally therefrom, said side walls having at least one inner detent, and said annular skirt having at least one internal thread; a test tube having an open top, a closed bottom, and cylindrical side walls therebetween, said open top having at least one external thread for attaching to said internal thread of said annular skirt such that said tube being secured between said annular skirt and said barrier wall; an oblong transfer port attached to said lower portion and extending toward said open upper portion to a distance below said open upper portion, said transfer port offset from the center of said lower portion and having a hole therethrough for internally receiving the male reservoir outlet and allowing liquid transfer into said test tube, said transfer port further including an array of supporting ribs disposed circumferentially around said transfer port and attached to said side walls; a cylindrical vent tube having proximal and distal ends and mounted on said lower portion between said transfer port and said side walls, said vent tube extending beyond said annular skirt and having a conduit therethrough, said vent tube further including a support disk at said distal end of said vent tube, said support disk having an aperture such that the diameter of said aperture is smaller than the diameter of said conduit at said distal end of the vent tube; and a snap lid hingedly connected to said side walls, said snap lid having an annular snap ring, a portal mating plug, and a tab frangibly and flexibly mounted on said snap lid for pressing said snap lid onto said open upper portion, said portal plug securely attaching into said transfer port and said snap ring permanently attaching to said inner detent on said side walls when said snap lid rotates onto said open upper portion, said tab detaching when force applied to open said snap lid.
- 10. A medical safety closure for use with a specimen collection tube and a male reservoir outlet, comprising:a cylindrical base having an open upper portion, a lower portion, and side walls therebetween, said lower portion having an annular skirt and a barrier wall extending distally therefrom, said side walls having at least one inner detent, and said annular skirt having at least one internal thread for attaching to the tube such that the tube being secured between said annular skirt and said barrier wall; a transfer port attached to said lower portion and extending toward said open upper portion to a distance below said open upper portion, said transfer port offset from the center of said lower portion and having a hole therethrough for internally receiving the male reservoir outlet and allowing liquid transfer into the tube; a cylindrical vent tube having proximal and distal ends and mounted on said lower portion between said transfer port and said side walls, said vent tube extending beyond said annular skirt and having a conduit therethrough such that the diameter of said conduit is larger at said lower portion than at said distal end of said vent tube beyond said annular skirt; and a snap lid hingedly connected to said side walls, said snap lid having an annular snap ring and a portal mating plug such that when said snap lid is rotated onto said open upper portion said portal mating plug securely attaches into said transfer port and said annular snap rings permanently attaches to said inner detent.
- 11. The closure of claim 10, wherein the transfer port is oblong in shape.
- 12. The closure of claim 10, further comprising a plurality of vertical ribs mounted on said side walls for securely gripping the closure.
- 13. The closure of claim 10, wherein said snap lid further includes a tab frangibly and flexibly mounted on said snap lid for pressing said snap lid onto said open upper portion, said tab detaching when force applied to open said snap lid.
- 14. The closure of claim 10, wherein said cylindrical vent tube further, includes a supporting disk attached to said distal end of said cylindrical vent tube, said supporting disk having an aperture therethrough that has a diameter smaller than the diameter of said conduit of said cylindrical vent tube extending beyond said annular skirt.
- 15. The closure of claim 10, wherein said transfer port further includes an array of supporting ribs disposed circumferentially around said transfer port and attached to said side walls.
US Referenced Citations (19)