U.S. patent number 3,811,591 [Application Number 05/297,810] was granted by the patent office on 1974-05-21 for dually sealable, non-leaking vial for shipping radioactive materials.
This patent grant is currently assigned to New England Nuclear Corporation. Invention is credited to Howard Novitch.
United States Patent |
3,811,591 |
Novitch |
May 21, 1974 |
DUALLY SEALABLE, NON-LEAKING VIAL FOR SHIPPING RADIOACTIVE
MATERIALS
Abstract
A dually sealable, non-leaking vial for shipping liquid
radioactive materials, particularly sterile radioactive materials,
and other sterile liquid materials in which the mouth of the vial,
as shipped, is sealed by a needle pierceable septum seal and in
which a threaded cap is located and held over the septum seal and
mouth with the threads thereby held out of engagement with mating
threads on the vial by the septum seal. However, upon removal of
the septum seal after shipment, the threads of the cap mate with
the threads of the vial whereby the cap can be removably threaded
tightly over the mouth to seal it. The capped and septum-sealed
loaded vial is placed in a heat shrinkable plastic envelope having
a bottom end wall and an upstanding cylindrical wall of greater
height than the capped, septum-sealed vial and of lesser thickness
than the bottom end wall and the envelope is heat shrunk
circumferentially, tightly and sealably around the capped
septum-sealed vial with the upper part of the envelope being shrunk
circumferentially and downwardly tightly over the margin of the
upper surface of the cap to securely seal the capped septum-sealed
vial.
Inventors: |
Novitch; Howard (Walnut Creek,
CA) |
Assignee: |
New England Nuclear Corporation
(Boston, MA)
|
Family
ID: |
26886169 |
Appl.
No.: |
05/297,810 |
Filed: |
October 16, 1972 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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190490 |
Oct 19, 1971 |
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Current U.S.
Class: |
215/246;
215/12.2 |
Current CPC
Class: |
B65D
55/0854 (20130101); B65D 51/002 (20130101) |
Current International
Class: |
B65D
51/00 (20060101); B65D 55/08 (20060101); B65D
55/02 (20060101); B65d 065/28 (); B65d
085/70 () |
Field of
Search: |
;215/12R,38A |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Norton; Donald F.
Attorney, Agent or Firm: Dike, Bronstein, Roberts &
Cushman
Parent Case Text
This is a division of application Ser. No. 190,490, filed on Oct.
19, 1971.
Claims
1. A sealed vial for shipping radioactive materials comprising in
combination a vial having a mouth and a threaded portion, a septum
seal sealably but removably secured over said mouth, a threaded cap
located over said mouth and septum seal and depending there around,
a cylindrical heat shrinkable envelope normally of greater height
than said capped septum-sealed vial and closed at its bottom by a
bottom wall of greater thickness than the envelope cylinder but
open at its top and adapted to snugly receive said capped
septum-sealed vial with the open top end thereof extending upwardly
beyond said cap and the bottom of the vial resting on the bottom
wall of said envelope, said cylindrical wall being heat shrunk
sealably and circumferentially around said capped vial with the
open upper end portion of said heat shrinkable envelope being heat
shrunk inwardly and downwardly and sealably over the marginal
portion of the top of said cap to seal the capped vial and prevent
accidental removal
2. A vial according to claim 1, said envelope having a
circumferential line of weakness extending around the circumference
thereof between the portion thereof surrounding said cap and the
portion thereof surrounding an enlarged body portion, whereby upon
turning of said cap relative to said vial, the heat shrunk envelope
breaks at said line of weakness to thereby
3. A vial according to claim 2, the top portion of said envelope
having a pair of parallel lines of weakness extending
longitudinally from said circumferential line of weakness to the
upper edge of said envelope to permit removal from the cap of the
broken portion of the envelope surrounding said cap after said
circumferential line of weakness has been
4. A vial according to claim 1, said vial having an enlarged body
portion and a reduced neck portion extending upwardly into an
enlarged lip forming said mouth and downwardly into said threaded
portion, the threads of which are external, said cap having a
depending wall depending around said septum seal, said mouth and
said neck, said depending wall having internal threads held out of
mating engagement with said external threads by said septum seal
when said septum seal is located over said mouth but being located
in mating engagement with said external threads when said septum
seal is removed from said mouth, whereby said cap is adapted to be
threaded over said mouth to seal said mouth when said septum seal
is removed.
Description
STATEMENT OF THE INVENTION
The invention relates to a shipping vial for liquid radioactive
materials, particularly sterile radioactive materials, e.g.
solutions or dispersions of radioactive compounds, and other
sterile liquid materials and more particularly to such a vial which
is dually sealable and non-leaking.
For many years a recurring problem in shipping radioactive liquids
has been the leakage that can occur if a package is so roughly
handled that the cap works loose or if a cap was improperly sealed
in the plant. This problem is especially serious because the
leakage of radioactive materials can be hazardous and also because
in many cases the radioactive material is sterile for medical
purposes (the vial is also sterile) and the leaking liquid becomes
a source of contamination of the sterile liquid while in the vial
or when removed from the vial. Consequently, this problem receives
greater attention by shippers and customers of radioactive
liquids.
The present invention solves this problem by providing a shipping
vial, the mouth of which is sealed during shipment by a
needle-pierceable septum seal closure removably secured over the
mouth and over which a threaded cap is located for sealing the vial
by the customer upon removal of the septum seal. In most cases, the
vial contains a multidose, i.e. more than one dose, so that the
customer uses only part of the radioactive contents of the vial at
a time. The first part or dose can be removed from the vial by a
syringe (forcing the hypodermic needle of the syringe through the
needle-pierceable septum seal). However, after the septum seal has
been pierced once by a hypodermic needle for partial removal of the
radioactive liquid contents, the integrity of the septum seal may
be broken and it may be safer with respect to possible
contamination of the remaining sterile radioactive materials in the
vial and with respect to subsequent leakage thereof, particularly
when an organic solvent, such as benzene or alcohol, is present, to
remove the septum seal. Thereafter the vial and remaining
radioactive liquid in the vial can be sealed by threading the screw
cap tightly over the mouth of the vial and can be removed in parts
by pipette as desired by removing the screw cap.
The present invention also permits convenient sterilization of the
solutions by autoclaving with the screw cap removed. Conventional
screw caps usually can't be used because the seal thereof will not
stand autoclaving temperatures.
In accordance with the invention, the septum seal, when removably
secured over the mouth, holds internal threads of the cap upwardly,
out of mating relationship with cooperating external threads on the
vial. The screw cap is held over the septum seal and mouth by a
slight friction fit.
The vial has an enlarged diameter body portion and a reduced
diameter neck portion which extends upwardly at one end into an
enlarged diameter lip forming the mouth of the vial and downwardly
at the other end into an enlarged diameter externally threaded
portion having the aforesaid external threads.
The height of the reduced neck portion and thickness of the septum
seal above the lip cooperate with the distance of the internal
threads of the cap from the end wall of the cap to hold such
internal threads out of mating or threading engagement with the
external threads of the vial. In this respect the internal threads
of the cap are located on the inner surface of the cylindrical wall
depending from the end wall of the cap around the mouth, septum
seal and reduced neck portion.
However, when the septum seal is removed the internal threads of
the cap, when placed over the mouth, are located in mating or
threading position with respect to the external threads of the
vial, whereby the cap can be removably threaded tightly over the
mouth to seal the mouth.
In a preferred embodiment the floor of the interior of the vial is
conical-shaped with the apex of the cone located at the bottom of
the interior to thereby concentrate a small volume of highly
concentrated radioactive liquids to facilitate removal.
Another aspect of the invention employes a cylindrical-shaped
envelope of heat shrinkable material, e.g. a resin such as
polyvinyl chloride or polyethylene, which has a bottom end wall of
greater thickness than the cylindrical wall, which is open at its
upper end, which is of greater height than the capped,
septum-sealed vial and which snugly receives the periphery of the
enlarged body portion of the vial and the periphery of the cap with
the bottom of the vial resting on the bottom end wall of the
envelope and with the cylindrical wall of the envelope extending
upwardly beyond the top of the cap. The capped septum-sealed vial
loaded with radioactive liquid is placed in the envelope whereafter
the envelope is heat shrunk circumferentially, tightly and sealably
around the capped, septum-sealed vial with the open upper end
portion of the envelope extending above the cap being heat shrunk
circumferentially, downwardly, tightly and sealable over the
marginal portions of the top of the cap. In this way, the capped
septum-sealed vial is further sealed and the cap is firmly secured
in place over the septum seal, mouth and neck of the bottle.
In a preferred embodiment, the envelope is provided with a
circumferential line of weakness between the cap-enclosing portion
and the enlarged vial body-enclosing portion so that by twisting
the cap relative to the vial the sealing envelope breaks along the
circumferential line of weakness to permit removal of the cap from
the vial.
BRIEF DESCRIPTION OF DRAWINGS
Further advantages of the invention will be apparent from the
following description for illustrative purposes of preferred
embodiments of the invention and from the accompanying drawings in
which:
FIG. 1 is a front view in elevation with sections broken away of a
vial embodying the present invention, as shipped, with the envelope
removed, with the septum seal in place over the mouth and with the
screw cap located over the septum seal;
FIG. 2 is a top view in plan with section broken away of the vial
of FIG. 2;
FIG. 3 is a bottom plan view of the vial of FIG. 1;
FIG. 4 is an exploded view in perspective of the vial of FIG. 1
with the screw cap removed and the septum seal being removed;
FIG. 4A is an exploded view in perspective of the three parts of
the septum seal of FIG. 1;
FIG. 5 is a view like FIG. 1 of the vial of FIG. 1 with the septum
seal removed and the screw cap screwed over the vial mouth to seal
the vial;
FIG. 6 is a view like FIG. 1 disclosing another embodiment of the
invention in which the interior of the vial is not conical shaped
at its bottom as in FIG. 1;
FIG. 7 is a view like FIG. 1 of the vial of FIG. 1 placed in the
heat shrinkable envelope but before heat shrinkage;
FIG. 8 is a view like FIG. 7, with the heat shrinkable envelope
shrunk around the capped septum-sealed vial;
FIG. 9 is a view like FIG. 8 but in which the cap has been removed
from the septum-sealed vial by breaking the heat shrunk envelope
along a circumferential line of weakness by twisting the cap
relative to the vial.
With reference to the figures, 2 represents the capped,
septum-sealed vial made up of a glass or plastic vial 4, a plastic
cap 5 and a septum seal 6.
The glass vial 4 consists of an enlarged diameter body portion 7, a
reduced neck portion 8 extending upwardly into an enlarged diameter
lip 10, which has a slight upstanding circular ridge 11 at its
inner margin and which forms the mouth 12 of the vial, and
downwardly into an enlarged diameter externally threaded portion 14
having external threads 16. Threaded portion 14 is of smaller
diameter than body portion 7.
The hollow interior 18 of the vial has a conical shaped floor 20
containing a sterile radioactive liquid 22.
The outer bottom surface of the vial is dished centrally inwardly
at 24 to form a marginal rim 26 which rests against the supporting
surface for the vial and which is stippled or corrugated to reduce
risk of toppling or sliding.
The septum seal 6 is conventional and is made up of (a) a needle
pierceable circular rubber disc 28 having secured to its lower
surface a thin layer 30 of teflon, (b) a cylindrical-shaped
malleable aluminum holder 32 for the disc 28 and having an
apertured end wall 34 located over the top of the disc 28 and a
depending cylindrical wall 36 which snugly receives the periphery
of disc 28, and (c) a cylindrical shaped aluminum securing member
38 having an apertured end wall 40 located over the top of disc 28
and over the end wall 34 of holding member 32 and a depending
cylindrical 41, which snugly receives the periphery of holder 32
and which extends downwardly beyond the lower edge of holder 32 and
is crimped at 43 under the lip 10, as shown, to urge the teflon
coated layer 30 of resilient disc 28 snugly and sealably against
the upper surface 60 and upstanding ridge 11 of the lip 10, the
ridge 11 becoming embedded in the resilient teflon coated layer 30,
as shown, to provide an excellent seal.
The upper end wall 40 has a semi-circular cut line 42 the ends of
which extend into score lines 44 which extend radially to the outer
edge of end wall 40 and downwardly in parallel relation a
substantial distance along the depending wall 41. The semi-circular
cut line 42 forms a tab 46 which, when cap 5 is removed, can be
lifted as shown in FIG. 4 and pulled or peeled back to break the
securing member 38 by tearing the end wall 40 and cylindrical wall
41 along one or both of the score lines 44. Upon breaking the
securing member, the whole septum seal is removed.
The axially aligned apertures 48 in the end walls of holding member
32 and securing member 38 expose the rubber disc 28 for piercing by
the hypodermic needle of a syringe.
The end wall 40 of the securing member has a circular upstanding
rib 50 stamped into it between the aperture 48 and semi-circular
cut line 42.
The rigid plastic cap 5 has an end wall 52 and a cylindrical wall
34 depending downwardly therefrom around the septum seal 6, the
mouth 30, the neck 8 and the upper part of threaded portion 14, as
shown.
The inner surface of end wall 52 is provided with a sealing disc 56
of flexible material, such as mylar lined pulp (cardboard) or
teflon or cork or rubber, and the inner surface of depending wall
54 has internal threads 58 for cooperating with the external
threads 16 of the vial to thread the cap 5 tightly over the mouth
12 and neck 8 of the bottle and thereby urge the sealing disc 56
tightly and sealably against the upper annular surface 60 and
upstanding ridge 11 of lip 10 to seal the vial after the septum
seal 6 has been removed, as aforesaid, the ridge 11 becoming
embedded in the flexible disc 56 to increase the sealing
effect.
However, when the septum seal is secured to the mouth of the vial,
the thickness of such seal above the lip 10 together with the
height of neck 8 and the distance of the internal threads 58 from
the lower inner surface of sealing disc 56 of the cap holds such
internal threads 58 upwardly out of threading or mating engagement
with external threads 16, thereby preventing threading of the cap
on the vial. In this respect, when the cap 5 is placed on the
septum-sealed mouth of the vial it is pushed downwardly over the
septum seal and mouth until the inner surface of sealing disc 56 of
cap 5 rests against the top of the septum seal, as shown in FIG. 1.
In this position the cap is held on the septum-sealed vial by light
friction but cannot be threaded on the vial, as aforesaid. It can
be threaded to the vial to form a seal only after removal of the
septum seal.
The capped septum-sealed vial of FIG. 1 is preferably shipped in a
cylindrical envelope 64 (FIGS. 7-9) made of a thin film of flexible
heat-shrinkable resin, such as heat shrinkable polyvinyl chloride
or polyethylene, which is closed at its bottom by an end wall 66
substantially thicker by four or five times and more rigid than the
cylindrical wall 68 of the envelope, which is greater in height
than the height of the capped, septum-sealed vial so that the open
end portion 69 thereof extends above the top of cap 5, and which
snugly but slidably receives the enlarged diameter body portion 7
of the vial and the outer periphery of cap 5, which in the drawings
is the same in diameter as the enlarged body portion 7 of the vial,
all as shown in FIG. 7. The cylindrical wall 68 of the envelope has
a circumferential line of weakness 70, in this case a perforated
line 70, extending around the circumference thereof between the
portion thereof enclosing cap 5 and the portion thereof enclosing
body portion 7, and a pair of closely spaced, parallel lines of
weakness 72, i.e. perforated or score lines, extending
longitudinally between circumferential score line 70 and the upper
open end 74 of the envelope 64.
The capped, septum-sealed vial of FIG. 1, loaded with sterile
radioactive liquid, is placed in the envelope 64, as shown in FIG.
7, with the bottom of the vial resting on the lower end wall 66 of
the envelope, after which the envelope is heat shrunk
circumferentially, tightly and sealably around the periphery of the
capped septum-sealed vial with the portion 69 of the envelope being
heat shrunk circumferentially and downwardly tightly and sealably
against the outer margin of the top surface of cap 5, as shown in
FIG. 8, to seal the capped septum-sealed vial and to secure and
seal the cap 5 to the vial.
In this way, a plural seal is provided, the cap is firmly secured
to the vial and the envelope protects the label applied to the
outside of the vial and also seals within it any radioactive
contamination on the outside of the vial and/or cap caused by
handling.
By twisting the cap 5 relative to vial 4, the adhesion of the
envelope to the cap 5 and body portion 7 of the vial causes the
upper part of the envelope above score line 70 to twist relative to
the lower part thereof below such score line to thereby cause the
envelope to break at 70, whereupon the cap with the envelope still
adhered thereto can be lifted off the septum-sealed vial with the
envelope still adhered thereto, as shown in FIG. 9, whereafter the
envelope can be aspectically removed from the cap by pulling off
the strip of envelope formed by the score lines 72. This can be
done by grasping the strip at its lower end and pulling it up to
break the envelope at the score lines.
The thicker end wall 66 of the envelope prevents it from buckling
and wrinkling because of heat shrinkage during heat shrinking of
the envelope about the vial. Buckling and wrinkling of this end
wall which supports the vial would reduce the stability of the vial
on supporting surfaces.
The embodiment shown in FIG. 6 is the same as that shown in FIGS.
1-5 except for the conical-shaped interior floor and except that
there is a second neck 76 of reduced diameter between the
externally threaded portion 14 and body portion 7 of the vial.
When the internally sterile vial package is received by the
customer, the cap is aseptically removed from the sterile
septum-sealed vial, as aforesaid. The first dose of the sterile
radioactive liquid in the internally sterile vial can be removed
aseptically by a sterile syringe by piercing the sterile
septum-seal with the needle of the syringe or the septum-seal can
be aseptically removed, as aforesaid, and the first dose removed
aseptically by a sterilized pipette. If the first dose is taken by
syringe, the septum-seal is then removed aseptically and the cap,
after removal of the envelope 64 therefrom, is threaded tightly
over the mouth of the vial to seal the vial, whereafter further
doses can be aseptically removed as desired by pipette after first
aseptically unscrewing the cap.
The vial may be sterilized before being aseptically loaded with the
sterile liquid radioactive material and aseptically sealed by the
aseptic septum seal or may be sterilized after loading and either
before or after sealing by the septum seal but before the screw cap
is applied, followed by placing the sterile screw cap over the
sterile septum seal and aseptically sealing with the sterile
envelope. A preferred manner of sterilizing is by autoclaving.
The aforesaid description and accompanying drawings are for
purposes of illustration only, and it is not intended that the
invention be limited thereby or thereto, the invention being
limited only to the products and methods claimed in the aforesaid
claims and their equivalents.
* * * * *