Chemistry: analytical and immunological testing – Hemoglobin – myoglobin – or occult blood
Reexamination Certificate
2002-02-22
2004-11-23
Alexander, Lyle A. (Department: 1743)
Chemistry: analytical and immunological testing
Hemoglobin, myoglobin, or occult blood
C422S105000, C422S105000, C604S232000, C604S403000, C604S412000
Reexamination Certificate
active
06821785
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a vacuum sampling tube to be used in the so-called vacuum sampling system for collection of specimens which are aspiratable by utilizing a pressure difference between the inside and outside of the tube and a vacuum sampling method using said vacuum sampling tube. Above all else, the invention relates to a vacuum blood collecting tube for use in clinical examinations to be performed on blood specimens and a vacuum blood collecting method using said blood collecting tube.
BACKGROUND ART
While a typical vacuum blood collecting system is described in Japanese Kokai Publication Sho-62-227316, the fundamental construction of the system comprises:
1) as illustrated in
FIG. 12
, a vacuum blood collecting tube
30
comprising a bottomed tubular casing
32
and a plug
31
having needle hole-sealable, gas-barrier properties as sealing the open end of said casing gas-tight to thereby keep a negative pressure within said casing;
2) as illustrated in
FIG. 13
, a vacuum blood collecting needle
40
comprising a hollow needle of metal having needle tips
41
and
42
at both ends and a hub
43
provided with a male thread
44
on the plug-piercing side; and
3) as illustrated in
FIG. 14
, a holder for vacuum blood collection
50
having a blood collecting needle-retaining aperture
51
provided with a female thread engageable with the male thread of said hub
43
so that said vacuum blood collecting tube
30
may be accepted into an internal cavity
52
.
In blood collecting, the vacuum blood collecting needle
40
is threaded onto the blood collecting needle-retaining aperture
51
of the holder for vacuum blood collection
50
. Then, the vacuum blood collecting tube
30
is inserted into said holder
50
and forced against the needle tip
42
of the vacuum blood collecting needle
40
to the extent that the plug
31
is not completely pierced through so as to temporarily seal the needle tip
42
. This is done to prevent the blood from leaking out of the needle tip
42
when the needle tip
41
is inserted into a blood vessel.
The person in charge of blood collection holds the whole of said blood collecting needle/said holder/said blood collecting tube assembly by hand in an incumbent position along the axis of the subject's blood vessel and sticks the needle tip
41
on the blood vessel piercing side into the blood vessel. Then, as he or she advances said blood collecting tube
30
farther into said holder
50
, the needle tip
42
on the plug piercing side penetrates through the plug
31
, with the result that the blood flows into said blood collecting tube due to the pressure difference between the blood collecting tube side and the blood vessel side. Then, as the pressure difference is abolished, the blood inflow stops. Therefore, the whole assembly is withdrawn from the blood vessel to complete a blood collecting work.
Usually, depending on the object of an examination, said blood collecting tube involves a coagulation accelerator, an anticoagulant, a deproteinizing agent, a blood component stabilizer, and/or the like for the pretreatment of a blood specimen in its inside. However, since these drugs denature the blood into a nonphysiological state different from its state in vivo, the risk of these chemicals finding their way into the subject's body in the event of a backflow by mistake during blood collecting has been pointed out.
For the prevention of such a backflow, Japanese Kokai Publication Sho-49-51784 and Japanese Kokai Publication Sho-50-12892 each proposes a vacuum blood collecting needle provided with an elastic backflow prevention valve and Japanese Kokai Publication Sho-54-4191 proposes a vacuum blood collecting tube plug which is provided with a similar elastic backflow prevention valve. The underlying principle of these proposals is that as long as a pressure difference exists between the blood vessel side and the blood collecting tube side, the elastic valve is forced open by the hurriedly incoming blood flow, thus allowing blood collection, but as the pressure difference is abolished, the valve closes to arrest the backflow. However, partly because of the inevitably complicated structures of the blood collecting needle and plug and partly because said pressure difference is inherently small when the blood collecting size setting is small relative to the capacity of the blood collecting tube, the variation in the actual blood collecting size becomes remarkable when a variation occurs in the opening or closing force of the elastic valve.
SUMMARY OF THE INVENTION
The present invention, developed to overcome the above-mentioned disadvantages, has for its object to provide a vacuum sampling tube which is capable of preventing a pretreating reagent accommodated in the vacuum sampling tube from entering the blood vessel and the like even in the event of a backflow of a specimen, such as blood, during vacuum sampling, such as vacuum blood collecting, and a vacuum sampling method using said vacuum sampling tube.
A vacuum sampling tube according to the first aspect of the present invention is a sampling vessel comprising
two tubular casings differing in size and each having a closed bottom and an opening at the other end as assembled together in the manner of a nest of boxes,
wherein
1) the inner casing of the nest of boxes is sealed gas-tight at its open end by a gas-barrier, needle hole-sealable plug, whereby a negative pressure state is kept within said casing,
2) the outer casing of the nest of boxes is substantially not in contact with an outer bottom surface of said inner casing of the nest of boxes but is detachably associated at the open end of said outer casing with an outer peripheral surface of said inner casing in the vicinity of its open end in substantially liquid-tight relation, and
3) a specimen-pretreating reagent is accommodated in a space between said inner casing and said outer casing.
A vacuum sampling tube according to the second aspect of the invention is a sampling vessel comprising
a tubular casing having a closed bottom and an opening at the other end and
a cylinder having openings at both ends as assembled in said casing in the manner of a nest of boxes,
wherein
1) the open top end of the inner cylinder of the nest of boxes is sealed gas-tight by a gas-barrier, needle hole-sealable plug,
2) said cylinder is detachably associated, respectively, with the open end of said tubular casing in the vicinity of its open top end in substantially liquid-tight relation and with a plug means of said tubular casing in the vicinity of cylinder's open bottom end in substantially gas-tight relation,
3) a negative pressure state is kept with in said cylinder, and
4) a specimen-pretreating reagent is accommodated in a space between said cylinder and said tubular casing.
A vacuum sampling tube according to the third aspect of the invention is a sampling vessel comprising
a tubular casing having a closed bottom and an opening at the other end and
a cylinder having openings at both ends as assembled in said casing in the manner of a nest of boxes,
wherein
1) the open top end of the inner cylinder of the nest of boxes is sealed gas-tight by a gas-barrier, needle hole-sealable plug,
2) said cylinder is detachably associated, respectively, with the open end of said tubular casing in the vicinity of its open top end in substantially liquid-tight relation and with a plug means of said tubular casing in the vicinity of cylinder's open bottom end in substantially gas-tight relation,
3) said open bottom end of the cylinder and said plug means of the tubular casing are provided with complementary notches and, by bringing said cylinder into sliding rotation about its axis, internal spaces of said cylinder and said casing are reversibly brought into communication or out of communication,
4) a negative pressure state is kept within said cylinder, and
5) a specimen-pretreating reagent is accommodated in a space between outer surface of said cylinder and inner surface of said casing.
A vacuum sampling tube according t
Anraku Hideo
Okamoto Ryusuke
Alexander Lyle A.
Sekisui Chemical Co. Ltd.
Sughrue & Mion, PLLC
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