Note: Descriptions are shown in the official language in which they were submitted.
E~'RESS M~IL ~: RB822402636
,, ~ ~E OE' DE~T: 7--22--92
NST 210027~
P-25 18
29 58P
FOR: BLOOD COLLECTION ASSEMBLY
BACKGROUND OF THE I~YE~TION
1. Field of the In~ention
This invention relates to barrier coatings and
barrier labels for providing an effective barrier
against gas and water permeability for containers,
especially plastic evacuated blood collection tubes.
2. Description of the Related Art
With the increased emphasis on the use of plastic
medical products, a special need exists for improving
the barrier properties of articles made of polymers.
Such medical products that would derive a
considerable benefit from improving their barrier
properties include, but are not limited to, collection
tubes and particularly those used for blood collection.
Blood collection tubes require certain pérformance
standards to be acceptable for use in medical
applications. Such performance standards include the
ability to maintain greater than about 90% original draw
volume over a one year period, to be radiation
sterilizable and to be noninterfering in tests and
analysis.
A critical performance standard of the blood
collection tube is the draw volume retention. Draw
volume retention depends on the existence of a partial
- . , . . ~
- . . : , - :
. .
P-2518
210027~
vacuum, or reduced pressure, inside the tube. The draw
volume changes in direct proportion to the change in
vacuum (reduced pressure~. Therefore, draw volume
retention is dependent on good vacuum retention.
For example, it is important to maintain the
vacuum over a period of time in order to provide
appropriate storage life for those tubes prior to their
being used. That is, it is important for the vacuum
level to be maintained for a period of time prior to the
time when a technician or a nurse uses the tube for
collecting a blood sample.
Radiation sterilizable means that after the tube
is exposed to certain levels of radiation in the
sterilization process, there is substantially no change
in optical or mechanical and functional properties.
Noninterference in performance of a tube's
specifications means that the materials of the tube,
such as glass or plastic materials do not interfere with
testing and analysis that is typically performed on
blood in the tube. Such tests include but are not
limited to, hematology, blood chemistry, blood typing,
toxicology analysis ~nd therapeutic drug monitoring.
Furthermore, the tube must be capable of being subjected
to automated machinery such as centrifuges.
Therefore, a need exists to improve the barrier
properties of articles made of polymers and in
particular plastic evacuated blood collection tubes
wherein such improvement does not obscure the contents
;~ of the articles, certain performance standards would be
able to be met and the article would be effective and
usable in medical applications.
,
- ' . .'. . ' , . .. . .
. , ', -,:
. : . . ' ' - ' '
P-2518 21002~
SUMMARY O~ IE INV~TION
The present invention is a plastic composite
container coated with a barrier composition or barrier
label disposed over an outer surface of the composite
container. That is, a barrier composition is coated
over the previously formed plastic container or a
barrier label coated with a barrier composition is
disposed over the outer surface of the composite
container. Such a barrier composition or barrier label
improves the barrier properties of plastic containers,
does not obscure the contents of the plastic containers
and extends the shelf-life of plastic containers,
especially plastic evacuated blood collection devices.
A desirable barrier composition which can be
disposed over a plastic container or a barrier label,
preferably comprises a diamond composition. A diamond
composition may be applied either to an interior surface
portion or to an exterior surface portion of the
container or label.
Desirably, the barrier label may be placed or
formed around the container and then adhered to the
container by methods such as, but not limited to, an
adhesive layer, heating the barrier label and container
to a temperature sufficient to cause the barrier label
to heat-shrink onto the container or by expanding the
container into the barrier label by blow molding.
Desirably the barrier label of the present invention is
a polymer film with a diamond composition coating.
Preferably, the diamond composition provides a
transparent, translucent or colorless appearance and may
have printed matter applied thereon.
-3-
- .
.
P-2518 21~0~
Plastic tubes or barrier labels coated with the
diamond composition are able to maintain far better
vacuum retention and draw volume retention than previous
tubes comprised of polymer compositions and blends
thereof without a barrier coating or label. In
addition, the coated or labeled tube's water barrier
properties would be significantly improved since diamond
coatings are substantially non-polar. Notably is the
clarity of the diamond composition, its durability to
substantially withstand resistance to impact, abrasion
and scratches.
Suitable films to be coated for use as barrier
labels according to the present invention include, but
are not limited to polypropylene films, low and high
density polyethylene films and polyvinylchloride films.
Printing may be placed on the barrier composition
or label which is to be used on the container of
~ interest. For example, a product identification, bar
code, brand name, company logo, lot number, expiration
date and other data and information may all be included
on the label surface. Moreover, a matte finish or a
corona discharged surface may be developed on the outer
surface of the barrier composition so as to make the
surface appropriate for writing additional information
on the label. Furthermore, another pressure sensitive
adhesive label may be placed over the outer surface of
the barrier label so as to accommodate various hospital
over-labels, for example.
DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a typical blood
collection tube with a stopper.
P-2518
FIG. 2 is a longitudi ~ 2t~i~nal view Or the
tube of FIG. 1 taken along line 2-2.
FIG. 3 is a longitudinal sectional view of a
tube-shaped container similar to the tube of FIG.
without a stopper.
FIG. 4 is a longitudinal sectional view of a
tube-shaped container similar to the tube of FIG. 1 with
a stopper.
DETAILED DESCRIPTION
Referring to the drawings in which like reference
characters refer to like parts throughout the several
views thereof, FIGS. 1 and 2 show a typical blood
collection tube 10, having an open end 16, a closed
end 18 and stopper 14 which includes a lower annular
portion or skirt 15 which extends into and presses
against the inside walls 12 of the tube for
maintaining stopper 14 in place. FIG. 2 schematically
illustrates that there are three mechanisms for a change
in vacuum in a blood collection tube: ~A) gas permeation
through the stopper material; (B) gas permeation through
the tube material and (C) leak at the closure-tube
interface. Therefore, when there is substantially no
gas permeation and no leak, there is good vacuum
retention and good draw volume retention.
FIG. 3 shows the preferred embodiment of the
invention, a plastic tube coated with a diamond
composition or covered by a diamond coated barrier
label. The preferred embodiment includes many
components which are substantially identical to the
components of FIGS. 1 and 2. Accordingly, similar
-5-
- . . .
- - - . -
P-2518 210~27~
components performing similar functions will be numbered
identically to those components of FIGS. 1 and 2, except
that a suffix "a" will be used to identify those
components in FIG. 3.
Referring now to FIG. 3, the preferred embodiment
of the invention, collection tube assembly 20
comprises a plastic tube lOa, having an open end 16a
and a closed end 18a. A coating comprising a diamond
composition or diamond coated barrier label 25 extends
over a substantial portion of the length of the tube
which is upon the outer surface of the tube with the
exception of open end 16a and closed end 18a thereof.
FIG. 4 illustrates an alternate embodiment of the
invention, wherein collection tube assembly 40
comprises stopper 48 in place for closing open end
41 of tube 42. As can be seen, stopper 48
includes an annular upper portion 50 which extends
over the top edge of tube 42. Stopper 48 includes a
lower annular portion or skirt 49 which extends into
and presses against the inside walls of tube 42 for
maintaining stopper 48 in place and also, defines a
well 52 which, in turn, defines a septum portion 53
~5 for receiving a cannula therethrough. Thus, the user,
once receiving a container such as that shown in FIG. 4
with a sample contained therein, may insert a cannula
through septum 53 for receiving part or all of the
contents in tube 42 to perform various tests on a
sample.
.
Covering a substantial portion of the length of
the tube is a coating comprising a diamond composition
or diamond coated barrier label 45. The coating or
barrier label 45 covers substantially most of the tube
-6-
~ r
P-2518 2~Q027~
with the exception of open end 41 thereof. FIG. 4
differs from the embodiment in FIG. 3 in that the tube
may be evacuated with the simultaneous placement of
stopper 48 therein after the application of a diamond
coating or diamond coated barrier label 45 thereover
the tube. Alternatively, the diamond coating or diamond
coated barrier label may be applied to the tube before
it has been evacuated.
10An alternate embodiment of the invention also
includes a coating or label incorporating both the upper
portion of the stopper, as well as the entire container
- tube. Such an embodiment may be utilized, for example,
for sealing the container with the stopper in place.
Once a sample has been placed in the tube, the sample
cannot be tampered with by removal of the stopper.
Additionally, serrations could be included at the tube,
stopper interface. The serrations may be registered so
that it can be determined if the sealed container has
been tampered with.
It will be understood by practitioners-in-the-art,
such tubes may contain reagents in the form of additives
or coatings on the inner wall of the tube.
A coating comprising a diamond composition forms a
clear or translucent barrier. Therefore, the contents
of a plastic tube coated with a coating comprising a
diamond composition are visable to the observer at the
same time identifying information may be displayed o~er
the diamond film after it is applied to the plastic tube.
A coating comprising a diamond composition may be
formed on a substrate by radio frequency discharge,
direct or dual ion beam depos~tion, sputtering or plasma
.
'' : ' ,: .. .. -
. .:. - ~ . , . -' ~. ~
. ..
P-25l8 2~00275
chemical vapor deposition, as described in U.S. Patent
Nos. 4,698,256, 4,809,876, 4,992,298 and 5,055,318, the
disclosures of which are herein incorporated by
reference.
The coating of the present invention is preferably
a diamond composition comprising carbon having a major
proportion of sp3 tetrahedral bonding and a minor
proportion of sp2 bonds. In general, the diamond
compositions of the present invention may consist of
carbon atoms bonded in a dense chemical structure
similar to that in a diamond, but without a long range
crystal order.
Desirably, the diamond coating is applied to the
plastic container or to a barrier film by a dual ion
beam ballistic alloy process.
A plastic blood collection tube coated with the
diamond composition or covered with a diamond coated
barrier label may effectively be used in such
applications as routine chemical analysis, biological
inertness, hematology, blood chemistry, blood typing,
toxicology analysis or therapeutic drug monitoring and
2s other clinical tests involving body fluids.
If the diamond composition is also coated on the
inner surface of the plastic blood collection tube, the
diamond coatin~ may be hemorepellent and/or have
characteristics of a clot activator.
It will be understood that it makes no difference
whether the plastic composite container is evacuated or
not evacuated in accordance with this invention. The
presence of a barrier composition or barrier label on
210027~
P-2518
the outer surface of the container has the effect of
maintaining the general integrity of the container
holding a sample so that it may be properly disposed of
without any contamination to the user. Notably is the
clarity of the barrier composition or barrier label and
their abrasion and scratch resistance.
The diamond coatings or blends thereof used in
accordance with this disclosure, may contain
conventional additives and ingredients which do not
adversely affect the properties of articles made
therefrom.
The barrier label is desirably a film coated with
lS a high barrier performance material such as a diamond
composition. Preferred film materials include, but are
not limited to, polymeric substrate resins. Polymeric
substrate resins include, but are not limited to
polyamide, polyolefin and polyester. Polyamide includes
but is not limited to, biaxial oriented nylon, aromatic
amorphous polyamide, polyvinyl chloride and mixtures
thereof. Polyolefin includes, but is not limited to
biaxial oriented polypropylene, low density
polyethylene, polychlorotrifluoroethylene and mixtures
thereof. Polyester includes, but is not limited to,
polyethylene terephthalate, polyethylene naphthalate,
polyethylene isophthalate and mixtures thereof.
.~
_g _ ,
.. ., .~ '` ' ' : .
- : , .. . .
. . ~ . . ~ - - --- , :
- .: . , . . - , . ~ -
, , :. ~' - : :
