Diagnostic specimen collector

A device for taking specimens for laboratory analysis, specimens being of a fluid type such as body liquids or may be liquids of a different source. The device comprises a hollow body member with a closed end and an open end. The closed end has orifice therethrough which orifice is eccentric with respect to the longitudinal axis of the body member. A plunger having a plunger tip means is inserted into the body member for the purpose of accurately varying the internal volume of the device. The closed end is provided with an exteriorly mounted closure which may be of a rotatable type or a sliding plate type. The closure contains an orifice which may be aligned with the orifice in the closed end to take specimens into the device and then the closure may be moved with reference to the body member to misalign the orifices so that the orifice in the body member is closed and the specimen cannot be ejected from the device. Sealing means are provided between the closure interior and the exterior of the closed end around the orifice in the body member. The present embodiment of the invention includes the presence of an agent which is applied to the collected specimen for the purpose of maintaining it, culturing it, or defining the composition of the specimen. The agent may be placed on the interior of the hollow body member in which configuration it contacts the specimen immediatedly upon the entry of the specimen into the hollow body. The agent may be placed in a recess on the interior of the closure which recess is brought into registration with the orifice in the closed end only by movement of the closure so there is subsequent contact between the agent and the specimen. This avoids any communication between the specimen source and the specimen agent or specimen after its contact with the agent. There is also disclosed a novel plunger having a pivotal member on the stem of the plunger which engages the open end of the hollow body member of any type of syringe to prevent accidental ejection of a collected specimen.

FIELD OF THE INVENTION 
The present invention is in the field of medical diagnostic devices, and 
more particularly, in that portion of this field in which fluid specimens 
are collected for subsequent analysis in a laboratory. 
BACKGROUND OF THE INVENTION AND PRIOR ART 
The taking of fluid specimens for laboratory analysis is an important 
diagnostic tool in the treatment of medical diseases and ailments. It is 
clearly evident that specimens should be as free as possible from any 
possible secondary contamination, be it from the area from which the 
specimen is taken or the ambient conditions external to the subject but 
through which the specimen collecting device must be moved. 
Conventionally, fluid specimens are withdrawn from a subject by syringe, 
having generally a hypodermic needle attached thereto for penetration of 
the subject. Often there is a need to introduce the collected specimen to 
a specimen maintenance agent, reagent, or culture media to induce specimen 
growth, specimen identification, or sustain the collected specimen's 
values constant and viable for subsequent laboratory procedures. It is not 
generally desired to introduce the specimen agent, reagent, or culture 
media, nor a specimen to which any of these media have been applied to a 
patient, the matter of toxicity being the question. Specimens may be body 
liquids such as blood or urine, or other tissue fluids, or may be 
anaerobic specimens collected from various organs within the body, or may 
consist of water or other non-body fluids. 
In some institutions, the practice has been to place a cork or stopper over 
the end of the needle after it is withdrawn from the subject in order to 
seal and protect the collected specimen, and then the syringe is carried 
to the laboratory. In other situations, the syringe collected specimen is 
injected through a rubber stopper into an otherwise sealed vial or tube. 
These vials and tubes often containing a specimen agent are then sent to 
the laboratory. 
Sometimes, a specimen is ejected from the syringe into a tube containing 
specimen maintenance media which tube is then closed and taken to the 
laboratory, sealing and maintenance of the specimen being of primary 
importance in preserving the viability of the specimen and its 
quantitative values. 
In attempts to increase the viability of the specimen and further minimize 
secondary contamination, there has been developed a vacuum operated system 
for taking liquid samples. The system comprises a bottle often containing 
a specimen maintenance or culture medium which is evacuated and then 
sealed with a rubber diaphragm to maintain the negative pressure within 
the container. To use such a device, use is made of a special hypodermic 
needle which may be considered as double ended. One of the needles is 
inserted into the subject and the other end of the needle is then inserted 
through the rubber diaphragm. The negative pressure in the container 
automatically draws fluid into the container. The draw is sudden and 
uncontrollable, and has been known to cause veins to collapse. Also, the 
vacuum within the container may be less than necessary to withdraw the 
desired amount of fluid. Because the interior volume of such containers 
cannot be variably controlled, such containers are made available in many 
capacity sizes such as 5, 7, 10, 15, and 20 cc capacities, resulting in 
the need to stock many sizes of the containers to meet varying 
requirements. Many of these types of containers are sold in a non-sterile 
state, and thus the institutions utilizing them must subject them to 
sterilization or run the risk of contaminated cultures. It has been noted 
that in many instances the autoclaving for sterilization reduces the 
amount of negative pressure within the container, and such containers do 
not provide the means to expel the fluid within them. 
In the recent developments in the field of collecting devices, is a syringe 
type device which is shown in U.S. Pat. No. 4,043,336. This patent is a 
hollow body member with a plunger therein. The so-called closed end of the 
end portion of the body member has a circular disk adhesively secured near 
the closed end, but providing space for another disk between the secured 
disk and the interior surface of the closed end. The second disk contains 
a nipple which extends outwardly through a slot in the closed end. Both 
disks have an orifice in each, and each movement of the disk with the 
nipple in the slot and the closed end of the syringe brings the two 
orifices into communication or out of communication. This device may 
contain an exterior protrusion on the side of the body member into which 
may be placed some form of medium for automatic and instant application to 
the specimen as it is being collected. The design of this device does not 
provide for the separation of the self-contained specimen agent from the 
fluid in the chamber of the syringe. 
SUMMARY OF THE PRESENT INVENTION 
The present invention is an elongated hollow body open at one end and 
closed at the opposite end with an orifice in the closed end. A plunger 
with sealing means on one end is slidably inserted into the body to 
variate the interior volume while maintaining a sealing of the interior of 
the body. Movable one piece closure means are exteriorly mounted on the 
closed end of said body. The closure has an outwardly extending fitting, 
with an orifice therethrough, adapted to receive compatible fittings or 
medical collection devices such as needles or multiple specimen collecting 
devices or adaptors used on diagnostic equipment. The closure means can be 
moved from a position in which both the orifices are in communication so 
that a specimen can be drawn into the body and the closure means orifice, 
then moved out of communication so that the orifice in the closed end of 
the body is sealed. Sealing means for the orifice in the closed end are 
positioned around the orifice between the closed end of the body and the 
closure means to create a friction-free space between the closed end and 
the inner surface of the closure. 
The invention also includes an agent or contacting the collected specimen 
which is placed in the closure member and brought into communication with 
the specimen that has been collected when the closure means has been moved 
to place the two orifices out of communication and bring the agent into 
communication with the orifice in the closed end of the body after the 
device is removed from the specimen source. This precludes any possibility 
of specimen with an agent being injected into a patient. 
There also is included a novel plunger having a pivotal vertical member on 
the stem of the plunger which engages the open end of a body member of any 
type syringe after a specimen has been drawn into the body member. 
The wall sections of the body member and the closure means can be of 
specially selected materials in a thickness to provide maximum protection 
from any possible oxygen gas permeation while the device is exposed to 
ambient conditions. The embodiments of the device of the present invention 
provide: 
Devices of practical design and structure for the reasonable cost 
manufacture and assembly required of a disposable syringe. 
Syringes have self-contained specimen agents for application to the 
specimen. 
Syringes having self-contained specimen agents and providing protection to 
the patient or specimen source from cross-contamination with the 
self-contained specimen agent by preventing mixing of the specimen and the 
specimen agent until the syringe has been removed from communication with 
the specimen source. 
A syringe having self-contained specimen agents and a plunger with 
graduated protective check-stops to minimize changes of patient or 
specimen source being reinjected with fluid that has already come in 
contact with the specimen agents. This novel plunger also provides volume 
indices. 
Syringes having connector fittings compatible with what are commonly called 
"luer" fittings but not necessarily limited to such. It will be recognized 
that such a fitting could be used directly as the dispensing nozzle 
without additional nozzle means. 
Syringes for containing a reconstitutable substrate in the recessed 
compartment of the cap (such as some antibiotics that are unstable in 
liquid form). That could be mixed with a proper liquid in the chamber of 
the syringe just prior to injection to the subject.

DETAILED DESCRIPTION OF THE INVENTION 
Referring now to FIG. 1, the invention is seen to comprise a generally 
well-known type of syringe having a hollow cylindrical body 11 open at one 
end to receive a plunger 24 and having a substantially closed end 12 
opposite the open end. The closed end 12 has an orifice 13 around which 
there is an annular recess 14 to receive an O-ring 15. Adjacent the closed 
end 12 is an annular recess 16 which receives an internal inwardly 
extending bead 17 in a one piece cap 18. It will be apparent that other 
concepts of movably retaining the closure on the closed end such as 
threads, bayonet mount and the like may be employed. The cap 18 has a 
skirt extension which forms an open end to be fitted over the closed end 
body 11 and rotate thereabout. The cap also has a closed end 19 from which 
there extends outwardly a cannula receiving member 20 having an orifice 21 
therethrough. The cannula receiving member 20, hereinafter referred to as 
a nipple, is of a configuration which will receive a cannula of the 
conventional type and also will receive adaptors, known in the medical 
art, which will permit the use of a single venal puncture by cannula and 
the successive application of the syringes of the present invention for 
the purposes of taking a plurality of samples. These adaptors are normally 
configured with means therein to permit closure thereof after a sample has 
been taken so as to prevent exodus of any body fluid due to the pressure 
of the fluid within the human body. Fitted into hollow body member 11 is a 
plunger 24 of the type which is well known in the medical arts. Generally, 
it is configured with a plunger tip having a conical end surface 25 
although the end surface may be flat 26 as shown in FIG. 9. The plunger 
tip is positioned on one end of a stem shown to consist of a pair of 
longitudinal members 27 and 28 arranged at right angles to each other 
along the axis of the plunger and along which are a plurality of circular 
disks 29. The plunger stem terminates in a thumb ring (not shown) or 
finger plate 30 opposite the plunger tip. In addition to the end surface 
25 or 26, the plunger tip includes at least one annular ring 31, generally 
of a resilient material, which provides a sealing relationship with the 
interior wall of the hollow body member 11 to insure that the movement of 
the plunger 24 would not result in any fluid medium escaping by the 
plunger. These annular rings may be considered seals. 
Referring now to FIG. 2, there is a showing of one embodiment of the 
invention preparatory to extracting a specimen. The plunger 24 has been 
partially withdrawn within the hollow body member 11 to collect the fluid 
specimen 33 which will come from a specimen source 34 via a conventional 
type cannula 35. In this figure it will be noted that the O-ring 15 seated 
in recess 16 has a portion extending outwardly from the closed end surface 
12 into contact with the inner surface 36 of closed end 19 of cap 18, the 
extension thus preventing contact between closed end 12 and this inner 
surface. This extending portion of O-ring 15 forms a seal with the inner 
surface 36 of the cap 18, thus insuring that the fluid specimen enters 
only the interior of the hollow body member 11. Study of FIGS. 2 and 5 
discloses that the extending portion of O-ring 15 in contact with inner 
surface 36 functions as a sealed bearing surface about which cap 18 
rotates. 
The cross-sectional view of FIG. 4 of the plunger 24 principally 
illustrates that the right angle position of the members 27 and 28 not 
only provides resistance to vertical and lateral flexing of the plunger, 
but the outer surfaces of these members also serve to provide bearing or 
guide surfaces for the plunger so that it is not displaced from its 
central axis sufficiently to destroy the vacuum created by the inner 
sealing members 31. 
Referring now to FIG. 5, it will be seen that the cap 18 has been rotated 
through a given number of degrees in accordance with the length of the 
slot 22 in cap 18 as controlled by the stop member 23 on the outer surface 
of hollow body member 1 (see FIG. 11). This means for orienting the cap 
relative to the hollow member is configured so that the slot 22 permits 
movement of the cap 18 from the specimen collecting position shown in FIG. 
2 to the position shown in FIG. 4 by a clockwise rotation of the body 
member 11 with respect to cap 18 when cap 18 is held. By such rotation, 
the portion of the inner surface 36 of cap 18 which does not contain the 
orifice 21 is placed over the passageway 13 in hollow body member 11, thus 
sealing it effectively. Other external and/or internal means may be 
substituted to indicate the orientation of the cap relative to the hollow 
member. 
FIG. 2 shows that in the inner surface of closed end 12 of the hollow body 
member 11 there is a recess 37, shown in FIG. 7 to be circular, but which 
may have a rectilinear form into which is placed a substance 38 which is 
considered generally as an agent which reacts with the specimen being 
collected to maintain it or react with the fluid to develop a culture of 
the specimen or to react with the specimen to identify various substances 
in the specimen. The agent may be in the form of a liquid, solid, or a 
semi-solid such as a firm gel and can be of a composition well known in 
the art. 
In FIG. 8 there is seen a modification of the embodiment of the invention 
shown in FIG. 2 in that the agent 39 has been formed as a layer on the 
interior surface of the end wall 12 of the hollow body member. 
Referring now to FIG. 9, there is seen another variation of the embodiment 
of the invention shown in FIG. 2 in that the interior wall of the closed 
end 12 of the hollow body member 11 now has a flat surface and the 
passageway 13 now extends through an inwardly extending tubular member 40 
to form an annular recess in which the agent 41 is placed. In this 
embodiment, it will be noted that the end surface 26 of the plunger 24 has 
a flat surface which matches the interior surface of the closed end 12. 
FIG. 10 shows a novel plunger which selectively may be incorporated with 
the hollow body chamber of the present invention, or which may be used 
with other hollow body members unrelated to the present invention. A novel 
plunger 62 resembles to a great extent the plunger 24 shown in FIG. 1 in 
that it has a plunger tip having a tapered inner face 63 which contacts 
the matching tapered interior of a body chamber just as surface 25 in FIG. 
1. It is provided with at least one annular resilient bead 64 providing 
sealing with an inner wall of a body chamber. It is also provided at the 
end opposite the tapered surface 63 with a gripping disk 30. Lying between 
the gripping disk 30 and the sealing ring 64 is a horizontal member 65 
serving the same purpose as surface 28 in FIG. 1. Perpendicular to surface 
63 is a vertical surface 66 which provides stability in the plunger 
against flexing. A plurality of disks 29 are provided as bearing surfaces 
for the plunger during its travel within a hollow body chamber. A 
semi-circular disk 67 is interposed on member 66 between the two disks 29. 
A short vertical member 68 is inserted between the sealing ring 64 and the 
first circular disk 29. Interposed between the two circular disks 29 is a 
vertically-pivotal member 69 which has a hinging action at its juncture 
with disk 29 to allow the member 69 to be depressed toward the horizontal 
member 65 for insertion of the plunger into a hollow body chamber. A 
plurality of notches or stepped surfaces 71 are provided on the outer 
surface of the member 69. The purpose of the notched surfaces is to 
provide a means on the plunger whereby after it has been withdrawn, thus 
drawing a specimen into the chamber, the notch will engage the outer ring 
72 of the body chamber 11 and will hold the plunger against being pushed 
back towards the closed end of the chamber thus expelling the fluid. To 
permit the plunger to be pushed down into the hollow chamber, it would be 
necessary to depress member 69 towards horizontal member 65, thus 
disengaging the stepped surface 71 from contact with the holding ring 72. 
The stepped surfaces 71 may also have a length which by calibration would 
be an indication of a volume of specimen which has been withdrawn into the 
hollow body chamber.