U.S. patent number 3,583,460 [Application Number 04/844,521] was granted by the patent office on 1971-06-08 for sterile cover for fluid container port.
This patent grant is currently assigned to Union Carbide Corporation. Invention is credited to Clifford Charles Faust, Sheldon Kavesh, Louis Lloyd Winokur.
United States Patent |
3,583,460 |
Faust , et al. |
June 8, 1971 |
STERILE COVER FOR FLUID CONTAINER PORT
Abstract
A sterile cover for a tubular port of a flexible plastic fluid
container consists of a sheath of flexible film material disposed
over the tubular port and peelably sealed to the port. The port is
exposed for use by peeling the sheath off the port and the sheath
is thereafter discarded.
Inventors: |
Faust; Clifford Charles
(Riverside, IL), Kavesh; Sheldon (Homewood, IL), Winokur;
Louis Lloyd (Evanston, IL) |
Assignee: |
Union Carbide Corporation (New
York, NY)
|
Family
ID: |
25292950 |
Appl.
No.: |
04/844,521 |
Filed: |
July 24, 1969 |
Current U.S.
Class: |
138/89; 383/9;
383/906; 604/263; 604/415; 138/96R; 383/80; 493/212; 604/408 |
Current CPC
Class: |
A61J
1/10 (20130101); Y10S 383/906 (20130101) |
Current International
Class: |
A61J
1/05 (20060101); B65d 041/00 () |
Field of
Search: |
;138/89,96 ;150/8,52
;206/46 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Norton; Donald F.
Claims
What I claim is:
1. A sterile cover for a tube of plastic material which comprises a
sheath of flexible film material disposed over and sealed about
said tube by at least one peelable seal closing said sheath about
said tube, said sheath having free end tabs extending about said
tube, the seal being so positioned and the end tabs so constructed
and arranged that when said tabs are pulled said peelable seal is
progressively opened, said sheath is progressively inverted, and
said inverted sheath is removed from said tube.
2. A cover as claimed in claim 1, in which said sheath is peelably
sealed to said tube by a plurality of peelable seals disposed in
spaced relationship with respect to each other, at least one of
said peelable seals being a destructible sterility seal extending
in a plane transverse to the longitudinal axis of said tube and
circumferentially closing said sheath about said tube.
3. A cover as claimed in claim 1, in which said end tabs are sealed
to each other at their extremities.
4. A cover as claimed in claim 1, in which said sheath is a single
folded strip.
5. A cover as claimed in claim 1, in which said sheath is
tubular.
6. A cover as claimed in claim 2, in which the peelable seals
extend in a plane transverse to the longitudinal axis of the
tube.
7. A cover as claimed in claim 2, in which the peelable seals
extend in a plane parallel to the longitudinal axis of the
tube.
8. A cover as claimed in claim 2, in which the tube is made of an
olefin polymer and the thermoplastic film is made of an ionic
ethylene-carboxylic acid copolymer.
9. A cover as claimed in claim 2, in which said sheath is composed
of a film laminate.
10. A cover as claimed in claim 2, in which the tube is made of an
olefin polymer and the sheath is made of a film obtained from a
material selected from the group consisting of ethylene
terephthalate polymer and a vinyl polymer, said film having a
surface thereof in contact with the tube coated with a layer of
ethylene-vinyl acetate copolymer.
11. A cover as claimed in claim 1, in which the sheath is made of a
film strip selected from the group consisting of heat-shrinkable
thermoplastic film and elastic film, said film having edges adhered
to each other around the tube by a peelable seal and said sheath
being peelably and circumferentially sealed to said tube by a
peelable, destructible sterility seal transverse to the tube.
12. A sterile cover for a tube of plastic material which cover
comprises a sheath of flexible film material disposed over and
sealed about said tube by at least one peelable seal closing said
sheath about said tube, said sheath having a free end portion
extending about said tube, the seal being so positioned and the end
portion so constructed and arranged that when said end portion is
pulled said peelable seal is progressively opened, said sheath is
progressively inverted, and said inverted sheath is removed from
said tube.
Description
This invention relates generally to flexible plastic containers
used for collecting, storing and dispensing blood and other viable
fluids, and refers more particularly to a new sterile cover for
entrance or exit ports of such containers.
These flexible, plastic containers are provided with outwardly
projecting fluid collecting and dispensing tubular ports. The
containers and tubular ports, as well as the fluids, must be kept
sterile. While it is relatively easy to maintain the inside of the
containers in sterile condition, it is more difficult to keep the
tubular ports sterile in the handling required in the various
collecting, storing and dispensing operations to which these
containers are subjected.
The tubular ports of plastic film containers are conventionally
maintained in sterile condition by the use of a cover in the form
of a sheath of thin plastic film completely enclosing the portion
of tubular port which projects out of the container. The sheath is
sealed to the container. It is made either of a tubular film or of
two strips of flat film sealed to each other around the tubular
port. When use of the tubular port is desired, the end of the
sheath is cut away to permit access to the port.
Another sheath has been proposed, which consists of two strips of
plastic film disposed about the tubular port and permanently sealed
to the container walls. The strips are peelably sealed to each
other around the tubular port projecting from the container. Each
of the strips has a terminal portion extending outwardly beyond the
peelable seal around the tubular port and beyond said tubular port
to form an end tab for the sheath. Access to the tubular port is
provided by grasping the end tabs and pulling them apart from each
other until the peelable seal is broken and the tubular port is
exposed. A disadvantage of this sheath is that both hands are
necessary to pull the end tabs apart, which means that another
person or some kind of support must be provided to hold the
container during the pulling operation. Another disadvantage
resides in the fact that, after opening of the sheath, the strips
are no longer sterile, the inside walls of the tabs have been in
contact with the fingers of the operator and there is always a risk
of contact between the tubular port and the end tabs of the strips
since these strips remain attached to the container. The intended
use of the container requires that the tubular port be maintained
in sterile condition before and after opening the sheath.
Accordingly, it is an object of the invention to provide a new
sterile cover for the tubular port of a plastic film container
which may easily be removed from the port by the use of one hand
only.
It is another object of the invention to provide a sterile cover
for a tubular port which is removable in a single operation from
the port and thereafter discarded, thus eliminating the risks of
contamination of the port by the cover.
The invention by means of which these objects are achieved will be
described with reference to the accompanying drawing wherein:
FIG. 1 is a front view of a container having walls of flexible
plastic material and two tubular ports, one of said ports being
provided with a sterile cover according to one embodiment of the
invention;
FIG. 2 is an isometric view of an embodiment of a sheath of
flexible film used to make the cover of the invention;
FIG. 3 is a view similar to that of FIG. 2 of another embodiment of
a sheath of flexible film used to make the cover of the
invention;
FIG. 4 is an enlarged perspective view of the tubular port of FIG.
1 provided with the sterile cover;
FIG. 5 is an enlarged perspective view of another tubular port
provided with a modified embodiment of the sterile cover
illustrated in FIGS. 1 and 4;
FIG. 6 is a view similar to that of FIG. 5 of another tubular port
provided with another modified embodiment of the sterile cover;
and
FIGS. 7 and 8 are enlarged, fragmentary cross-sectional views of a
peelable destructible seal attaching a sterile cover to a port
according to the invention.
According to the invention, there is provided a sterile cover for a
tubular port of a container. The container preferably has walls of
plastic film material and the port is in the form of a tube, also
preferably made of a plastic material. The tube projects outwardly
from the container and is attached to the inner surface of the
walls of the container. The cover of the invention comprises a
sheath of flexible film material disposed over the outwardly
projecting tube and enclosing at least the end portion of the
outwardly projecting tube. The sheath is hermetically sealed about
the tube by at least one peelable circumferential seal to ensure
preservation of the sterility of the end portion of the tube until
removal of the sheath therefrom. The sheath extends beyond the
peelable, circumferential sterility seal to form free end tabs. The
tabs are folded back over the sterility seal and extend over the
sheath beyond the end of the tube and of the sheath. The cover may
be removed by pulling the tabs with only one finger and the thumb
of one hand, in a direction away from the container. In addition to
maintaining the sterility of the portion of the tube enclosed in
the cover, the peelable seal has another, essential function, i.e.,
it is so positioned about the tube that, upon pulling of the tabs,
it initiates inversion of the sheath and further causes the sheath
to be progressively inverted by offering a resistance to the
pulling force during the peeling open operation. Unless the sheath
closely fits the tubing, additional peelable seals may be necessary
to ensure the progressive inversion of the sheath. Once the
inverted sheath has been removed from the tube, it is thrown away.
In this manner, the end portion of the tube is kept sterile even
after its exposure for use since the risk of contact between said
end portion and the cover has been eliminated by progressively
inverting the cover outwardly from the peelable, sterile seal,
instead of pulling it apart, and by removing the cover completely
from the tube and from the container and discarding it.
Referring to the drawing, there is shown in FIG. 1 a container 10
for fluids such as are conventionally used in the storing and
dispensing of blood, for example. The container 10 has two walls,
12 and 14, made of a plastic film material. Holes 16 and 18 are
provided in a sealed edge at one end of the container for
suspending said container. At the other end, the container 10 has
two tubular ports in the form of outwardly projecting tubes 20 and
22. The tubes 20 and 22 are conventionally made of a thermoplastic
material, heat sealed to the inner surface of the walls 12 and 14,
and closed in a manner well known in the art.
The tube 20 has been provided with a sterile cover according to one
embodiment of the invention. As more clearly shown in FIGS. 2 and
4, the cover generally indicated at 24, comprises a single sheet 26
of flexible, thermoplastic film. The sheet 26 is folded over
itself, as shown in FIG. 2. The contacting edges of the folded
sheet are permanently heat sealed to each other by seals 28 and 30,
to form a sheath 32 terminating in two free end tabs 34 and 36,
shown The inner wall of the sheath is sterile. As shown in FIG. 4,
the sheath 32 has been disposed over the end portion of the tube
20. The sheath 32 is sealed to the tube 20 by a plurality of
peelable, heat seals 38, 39 and 40, extending transversely of the
tube 20 and of the sheath 32. The same peelable seals 38, 39 and 40
extend on the reverse side (not shown) of the cover and tube. The
seal 38 is the sterility seal, hermetically and circumferentially
sealing the sheath 32 about the tube 20. The seals 39 and 40 ensure
the progressive inversion of the sheath which fits rather loosely
over the tube 20. When the user pulls the end tabs 34 and 36 away
from the tube 20 to remove the cover, easily with thumb and finger
of the same hand, the seal 38 is first peeled open by the pulling
action. Then, progressively, the sheath 32 is inverted, its inner
sterile wall is progressively exposed, the seals 39 and 40 are in
turn peeled open and finally the further inverted sheath 32 is
completely removed from the end of the tube 20. In this manner, the
outer end of the tube, which is the most critical part as far as
sterility is concerned, is the last to be uncovered. Furthermore,
the progressive inversion of the sheath prevents any contact, not
only between the tube and the end tabs, but also between the tube
and the peeled off sheath. Complete inversion of the sheath is not
necessary but at least most of the sheath should invert prior to
its removal from the tube.
In a preferred embodiment of the invention, the peelable, sterility
seal 38 is also a destructible seal. As used herein, the term
"peelable seal" means a seal between two elements, for instance,
sheath and tube, which can be progressively broken or separated
without affecting the integrity of the elements and which
preferably cannot be reformed. A "destructible seal" as used herein
means a seal which in addition to being incapable of being reformed
displays visible and/or tactile evidence of having been broken. The
combined characteristics of these two types of seal are important
in the cover of the invention which is employed to maintain and
ensure the sterility of a tube until it is ready for use.
Of course, in accordance with the invention, one or more of the
other peelable seals may be sterility seals or destructible seals
if desired. For example, in the embodiment illustrated in FIG. 4,
the peelable seals 39 and/or 40 may be destructible. The manner of
producing peelable, destructible heat seals is referred to
below.
FIG. 3 illustrates another embodiment of the sheath 32 of the
invention, wherein said sheath is made of two separate sheets of a
flexible film which are sealed to each other along their edges by a
permanent seal 29. Alternatively, the sheath 32 could be formed of
a flexible tube with one end of said tube closed by a permanent
seal, or in any other manner known to those skilled in the art,
starting either from a tubular film or from a flat film.
There is shown in FIG. 5 a modified embodiment of the closure 24
illustrated in FIG. 4. In this embodiment, the sheath 32 is sealed
to the tube 20 by a peelable, destructible, circumferential
sterility seal 38 and by a plurality of transverse, closely spaced,
peelable seals 41, 42 and 43, similar peelable seals optionally
extending on the opposite side of the cover in juxtaposed or
staggered relationship with respect to the seals 41, 42 and 43. The
end tabs 36 and 34 are sealed to each other at their extremities,
to facilitate gripping thereof by the user. This last feature is
also optional. The number of peelable seals varies according to the
length and width of the sheath and the size and length of the tube
protected by said sheath. For example, there could be only one very
broad, circumferential seal, or a multiplicity of circumferential
seals distributed over the length of the sheath. The number and
position of the peelable seals are not critical as long as they
provide for the essential characteristics of the invention, i.e., a
sterile seal between the sheath and the tube, and a progressive
inversion of the sheath while said seal is peeled open and
destroyed during removal of the sterile cover from the tube.
For example, FIG. 6 shows a further modified embodiment of the
cover of the invention, wherein the sheath 32 is attached to the
tube by a peelable, destructible, circumferential sterility seal 38
and is peelably attached to the tube 20 by a longitudinal, peelable
seal 44 and by another similar seal on the opposite side of the
sheath and tube (not shown).
FIGS. 7 and 8 illustrate in enlarged section an example of a
peelable, destructible seal according to the invention. In this
embodiment, the tube 20 is a polyethylene tube, the sheath 32 is a
laminate made of a polyethylene terephthalate film having one
surface thereof coated with a layer 33 of ethylene-vinyl acetate
copolymer, the coated surface of the sheath being in contact with
the tube 20. The sheath 32 is attached to the tube 20 by a
peelable, destructible seal 35 obtained by heat sealing the sheath
32 and its coating 33 to the tube 20. The ethylene-vinyl acetate
intermediate layer being peelably heat-sealable to both the
polyethylene tube and the polyethylene terephthalate film provides
a particularly suitable material for the destructible seal of the
invention. As shown in FIG. 8, when the sterile cover 24 is peeled
from the tube 20 as previously described, the peelable seal 35 is
broken apart and destroyed, while the polyethylene terephthalate
film from which the sheath is made retains its integrity. This
destruction of the peelable seal, together with the inversion of
the intact sheath, guarantee that the cover of the invention will
not be inadvertently reused and that the sterility of the tube will
not be impaired as it would if torn fragments of the sheath
remained attached to the tube at places where the seal was
made.
The use of an intermediate layer as above described is not always
necessary to produce the peelable, destructible seal of the
invention if a film incompatible with the material from which the
tube is made is selected as the sheath material. The combined
peelable, destructible seal feature depends on the materials from
which the sheath and the tube are made. For example, a peelable,
destructible seal may be obtained by using a sheath made of an
ionic cross-linked polymer film such as the ethylene-monocarboxylic
acid copolymer films described in U.S. Pat. No. 3,264,272 and heat
sealing said sheath to a tube made of an olefin polymer such as
polyethylene or polypropylene. Also, satisfactory peelable,
destructible seals may be obtained by heat-sealing a sheath made of
a low density polyethylene to a tube made of a high density
polyethylene.
The production of peelable heat seals is well known to those
skilled in the art. The selection of specific sheath film and tube
materials, of sealing member configurations, heat, pressure and
time necessary for sealing such materials to obtain seals having
both characteristics of peelability and destructibility may be
readily determined by those skilled in the art.
In all the preceding embodiments of the sterile cover of the
invention, the sheath 32 is made of dimensionally stable
thermoplastic film. According to further embodiments of the
invention, the sheath may also be a tight fitting sheath made by
heat shrinking a thermoplastic film about the tube, or made from an
elastic film. Examples of heat-shrinkable thermoplastic films are
polyethylene, polypropylene, vinyl chloride-vinyl acetate copolymer
films which have been suitably oriented. Examples of elastic films
are polyurethane, polybutadiene, polyisoprene, butadiene-styrene
copolymers and ethylene-propylene copolymer films. These examples
are only illustrative since heat-shrinkable and elastic films are
well known to those skilled in the art.
When the sterile cover of the invention is made of a tightly
fitting sheath of heat-shrinkable or of elastic film, the seals
along the edges of the sheath 32, such as, for example, the seals
28 and 30 of the sheath shown in FIG. 2, or the seal 29 of the
sheath shown in FIG. 3, are not permanent seals, but should be
peelable and, if desired, destructible seals because of the nature
of the material from which the sheath is made, in order to obtain
progressive inversion and destruction of the sheath during removal
of the cover from the tube. Thus, the apparent structure of the
sterile cover of these further embodiments is very similar to that
of the cover of the preceding embodiments, with the difference that
only one circumferential, peelable, destructible seal is necessary
to seal the sheath about the tube, such as seal 38 of FIGS. 4 to 6,
in order to preserve the sterility of the cover.
Although the sterile cover of the invention has been more
particularly described in connection with certain specific
materials, the invention is not limited thereto. Any flexible film
material may be used to make the sterile cover of the invention as
long as it permits the production of a sheath peelably sealed about
a sterile tube by peelable seals which bring about the progressive
inversion of the sheath during its removal from the tube. For
example, when used with a vinyl tube, the cover of the invention
may be made of a vinyl film and heat sealed to the tube with
peelable and, if desired, destructible seals. The expression
"vinyl" used herein refers to the vinyl and vinylidene film-forming
polymers and copolymers containing at least 50 percent by weight of
poly(vinyl chloride) or poly(vinylidene chloride). Particularly
effective peelable, destructible seals in the case of a vinyl tube
provided with a vinyl cover according to the invention have been
obtained by coating a vinyl chloride-vinyl acetate film with a
layer of ethylene-vinyl acetate copolymer and heat sealing a sheath
made of said film to the vinyl tube as shown in FIG. 7.
Satisfactory peelable, destructible seals could also be obtained by
use of suitable adhesives. It is also possible to provide a
polyethylene tube with a sterile cover made of a vinyl film coated
with a layer of ethylene-vinyl acetate copolymer, or to provide a
vinyl tube with a sterile cover made of a polyethylene film coated
with a layer of ethylene-vinyl acetate copolymer, for example.
* * * * *