CLOSURE STRUCTURE FOR VACUUM SPECIMEN COLLECTION CONTAINER,...

Details CLOSURE STRUCTURE FOR VACUUM SPECIMEN COLLECTION CONTAINER,... CLOSURE STRUCTURE FOR VACUUM SPECIMEN COLLECTION CONTAINER,...

2000-08-30

2003-05-20

Soderquist, Arlen (Department: 1743)

Chemical apparatus and process disinfecting, deodorizing, preser

Control element responsive to a sensed operating condition

C422S091000

Reexamination Certificate

active

06565814

ABSTRACT:

TECHNICAL FIELD
The present invention relates to a closure structure for a vacuum specimen collection container, a vacuum specimen collection container incorporating the closure structure, a vacuum specimen collection system and a holder for a vacuum specimen collection device, which are employed in conducting analytical tests of liquid specimens such as blood and urine or gaseous specimens such as expired gas and working atmosphere, and further to a thermoplastic elastomer composition for forming the closure structure.
BACKGROUND ART
A typical specimen collected by vacuum specimen collection systems is blood. Accordingly, a vacuum blood collection container, as illustrative of vacuum specimen collection containers, is explained below.
A typical conventional vacuum blood collection system is disclosed in Japanese Patent Laying-open No. 62-227316 (1987).
FIG. 18
illustrates a basic construction of such a conventional vacuum blood collection system. FIG.
18
(
a
) shows a vacuum blood collection tube
30
including a blood collection tube
32
sealed at its open end by attachment of a closure structure
31
having good needle hole sealability and gas barrier properties. FIG.
18
(
b
) shows a holder
33
for vacuum blood collection device, into which the vacuum blood collection tube
30
can be inserted. The holder
33
has a blood collection needle retaining bore
34
at its one end. The blood collection needle retaining bore
34
carries an internal thread. FIG.
18
(
c
) shows a vacuum blood collection needle
35
which includes a hub
36
having an external thread and needle tips
37
,
38
positioned on opposite sides of the hub. The external thread on the hub
36
is configured to screw into the internal thread on the blood collection needle retaining bore
34
of the holder
33
shown in FIG.
18
(
b
).
FIG. 20
is a perspective view, showing the vacuum blood collection system of
FIG. 18
while in use for blood collection. When in use for blood collection, the vacuum blood collection needle
35
is screwed into the blood collection needle retaining bore
34
. Then, the vacuum blood collection container
30
is inserted in the holder
33
such that the needle tip
37
of the blood collection needle
35
is forced to penetrate the closure structure
31
to a depth of less than its thickness, whereby the needle tip
37
is kept sealed. This is to prevent the blood from leaking through the needle tip
37
when the needle tip
38
is inserted in a blood vessel.
As shown in
FIG. 20
, an operator holds a whole assembly of blood collection needle
35
, holder
33
and blood collection container
30
in an slanted orientation along an axial direction of blood vessel of a subject and then inserts the exposed needle tip
38
in the blood vessel. When the blood collection container
30
is pushed further inside the holder
33
, the needle tip
37
is forced to penetrate through the closure structure
31
and the pressure differential between the blood collection container side and the blood vessel side causes the blood to flow into the blood collection container
30
. When the pressure differential decreases to zero, the blood ceases to flow. Then, the whole assembly is drawn from the blood vessel to end the blood collection procedure.
The above-described blood collection needle
35
is a so-called single blood collection needle for use in introducing blood into a single vacuum blood collection container. In distributing blood into plural vacuum blood collection containers, the needle tip must be kept in a position within the blood vessel while one blood collection container is replaced by another. Such use of single blood collection needle possibly leads to the leakage of blood from the needle tip
37
. Accordingly, a multiple blood collection needle
39
as shown in
FIG. 19
has come into use. The multiple blood collection needle
39
has an elastic sheath
40
which encloses the needle tip
37
for insertion into the closure structure in an airtight manner to prevent blood leakage therefrom. Where such a multiple blood collection needle
39
is used, the blood collection needle
39
assembled to the holder
33
is operated to penetrate in the blood vessel. Subsequently, the blood collection container
30
is assembled to the holder
33
so that it is brought into communication with the blood vessel. This results in collecting the blood in the blood collection container
30
.
Key qualities sought for elastic materials used to form the closure structure
31
as shown in FIG.
18
(
a
) include gas barrier properties sufficient to maintain a vacuum pressure within the blood collection container and the ability to seal a needle hole left after the needle tip has been retracted. This has led to the widespread use of crosslinked isobutylene-isoprene rubbers (crosslinked IIR, crosslinked butyl rubber).
The closure structure
31
shown in FIG.
18
(
a
) has a configuration most widely adopted in the art. Subsequent to collection of blood, the closure structure
31
is detached to dispense the blood from the blood collection container
30
. It has been reported, however, that the blood is likely caused to splash the moment the closure structure
31
is detached. This is attributed to the configuration of closure structure adopted to provide the improved seal for better maintaining the interior vacuum pressure of the blood collection container
30
. In order to obviate such problems, the use of composite structural closures incorporating a cover disposed to cover a crosslinked butyl rubber closure and prevent splashing of blood has been proposed, for example, by Japanese Patent Laying-Open Nos. Hei 5-168611, Hei 4-215961, Sho 59-228831, Sho 60-242367, Sho 61-170437, Sho 59-230539 and Hei 3-505320.
As stated above, crosslinked butyl rubber has been widely used in the manufacture of closure structures. The use of such crosslinked butyl rubber is however reported to accompany problems, such as the requirements to undergo a prolonged vulcanizing period and subject to washing with water to remove elutable contents thereof, resulting in the reduced productivity.
The crosslinked butyl rubber, because of its inability to be chemically or thermally adhered to a cover member, is physically assembled with the cover member. Such a built-in construction however suffers from a problem of easy separation of the closure structure. For the purpose of preventing such separation, a construction has been proposed which utilizes a generally double-walled tubular cover member having an inner tubular portion fittingly embedded into the crosslinked butyl rubber member. However, the excellent sealing performance of the crosslinked butyl rubber closure structure relies not only upon the properties intrinsic to the material but also upon the pressure that is exerted on the closure structure when it is fitted in a blood collection tube and acts to close a hole pierced by a needle. Accordingly, the use of the generally double-walled tubular cover member may result in the reduced needle hole sealability.
Japanese Patent Laying-Open No. Sho 57-59536 proposes a closure structure wherein a superior gas barrier film is adhered to or embedded in an inferior gas barrier closure body formed of thermoplastic elastomer. The requirement to add an adhering or embedding process, however, results in sacrificing the high productivity that is a key advantage obtained with the use of thermoplastic elastomer.
Closure structures which can be injection molded in a highly productive fashion are disclosed, for example, in Japanese Patent Laying-Open Nos. Sho 58-58057, Sho 61-64253 and Sho 59-28965. These references describe the use of thermoplastic resins and elastomers, as injection moldable materials, which incorporate uncrosslinked butyl rubbers or flake-form inorganic fillers to assure increased elasticity and gas barrier properties. However, the loading of such additives results in the reduced needle hole sealability, which necessitates incorporation of another thermoplastic elastomer member into a needle cannula pierceable site,

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