[0001] The present invention refers to a device and the related procedure for photometric
and spectrophotometric determinations on liquids of any type, such as, for example,
sampling and measurement of blood levels of bilirubin in pediatrics, as well as chemical
microreactions.
[0002] Measurement of bilirubin in the plasma of newborns is done essentially by photometric
methods, i.e. by illuminating the plasma container, which must be transparent to the
radiation used and is generally made of glass, with a photometric lamp.
[0003] Devices are already known that allow small amounts of blood to be drawn from the
patient, based essentially on the use of a glass capillary tube the bottom end of
which is brought into contact with a drop of blood from the newborn. The blood is
drawn up into the tube, which has an internal diameter of approximately 1,6 mm., by
capillarity. The bottom end of the tube filled with blood is then pressed down on
a piece of a substance such as plasticine, about 10 mm thick, so that the plasticine
that enters the opening forms a stopper for the capillary tube.
[0004] The plasma is subsequently separated from the corpuscular part of the blood by placing
the stopped capillary, with its axis horizontal and the plasticine stopper facing
outwards, in a centrifuge. In this manner, the corpuscular part of the blood collects
near the plasticine stopper, while the plasma phase collects at the opposite end.
[0005] At this point the capillary, according to the known method, is disposed vertically,
with the plasma in the upper part, and is placed directly on the optical axis of the
bilirubinometer, thus acting as a phtometric cell.
[0006] This method has considerable drawbacks:
a) the curve of the cylindrical wall of the capillary tube, together with the inevitable
imperfections associated with glass drawing, causes such substantial inaccuracy in
the results of the analysis as to be superimposable with biological variability;
b) the excessive thickness of the liquid to be analyzed, which is five times the optimum
thickness for the test (0,25 mm), also contributes to errors in the results;
c) the considerable thickness mentioned under point b) means that the photometric
lamps must have considerable light intensity, which can be obtained by increasing
the voltage thus reducing the average lamp life to about 100 h.
[0007] A second known device also entails drawing the blood with a glass capillary tube,
which is then stopped and centrifuged in a similar way to that indicated above. The
capillary tube with the separated plasma and corpuscular part of the blood is then
cut with an injection vial saw to divide the two sections, one containing the plasma
and the other the corpuscular part. The plasma is then poured into an optical glass
microcell with flat parallel sides 0,25 mm apart, so that an optically perfect layer
is obtained and the bilirubin can be measured without photometric or methodological
errors. The optical system does not require excessive light intensities and thus its
life can be up to a hundredfold that of the preceding system.
[0008] However this second device too holds some serious drawbacks:
1) it is not always easy to break the capillary and a certain ability and experience
are necessary;
2) during this operation the operator could cut himself with glass splinters or the
vial saw and thus possibly become infected by the newborn's blood;
3) horizontal balancing of the section of capillary tube containing the plasma and
subsequent pouring into the microcell also require considerable manual ability.
[0009] The purpose of the present invention is to provide a sampling device for photometric
and spectrophotometric analysis on any type of liquid, such as, for example, analysis
of blood bilirubin, capable of overcoming the above problems, i.e. that permits simple,
safe drawing of the liquid for analysis, separation of the phases making up the liquid
if necessary and accurate analysis.
[0010] A further purpose is to provide a device that also permits other analyses on the
liquid, involving chemical microreactions, using suitable reagents.
[0011] A further purpose is to be able to identify the sampling and analysis device with
a suitable code that can be read by a scanner attached to the analyzer, containing,
as well as identification of the sample to be analyzed, any information on characteristic
analysis parmeters so that this code serves to control all the working parameters
of the analyzer (wave length of the light radiation, conversion factors, temperature,
duration and intensity of shaking, incubation, times etc.). This means that clinical
analyses can easily be carried out not only by specialized analysts, but also by doctors
and medical workers who are not experts in laboratory practice.
[0012] The main purpose has been achieved by providing a device for sampling liquids, particularly
blood, for photometric and spectrophotometric analysis and a related sampling and
analysis process as stated in the attached claims 1 and 8.
[0013] Further advantageous arrangements, suitable for clinical analyses including chemical
microreactions, have been described in claims 2 to 7, 9 and 10.
[0014] The present invention will now be better described with reference to the accompanying
drawings, in which:
fig. 1 is a vertical cross section along line 1-1 in fig. 2 showing a first embodiment;
fig. 2 is a horizontal cross section along line 2-2 in fig. 1;
fig. 3 is a vertical cross section of a second embodiment of the invention in the
first working stage;
fig. 4 is a view of the device according to fig. 3 in a later working stage;
fig. 5 is an exploded perspective view of the embodiment in figs. 3 and 4.
[0015] With reference to figures 1 and 2, they show the device 1 consisting of a capillary
tube 2 and a microcell 3 set above said capillary and integral with it. The microcell
3 has flat parallel surfaces, preferably set 0,25 mm apart. In the bottom part of
the capillary tube 2 a micropiston 4 is shown, which can be pushed up inside the capillary
tube to the desired height.
[0016] The device is operated as follows: the base of the capillary tube 2 is brought into
contact with a drop of blood from the patient, which is sucked up by capillarity and
reaches a certain height inside the capillary tube. The capillary tube 2 is then pressed
down on a 10 mm thick piece of plasticine so that the plasticine enters the bottom
opening forming a stopper. The device is then placed with its axis horizontal, with
the plasticine stopper facing towards the outside of the centrifuge rotor, and centrifuged,
so that the corpuscular part of the blood is separated from the plasma phase. If centrifuging
is not necessary, the next step can be performed immediately.
[0017] Once separation has been achieved, the device 1 is placed with its axis vertical
again, then the liquid contained in the capillary tube 2 is pushed upward by pressing
the capillary down repeatedly on a piece of plasticine, which forms successive stoppers
that gradually reach up higher into the capillary 2, or by inserting at the base of
the capillary tube a micropiston 4 of plastic material connected to an electronically
controlled motor, said piston being inserted to the desired height.
[0018] The plasma, stratified in the top part of the capillary tube 2 and pushed by the
micropiston 4, thus enters the microcell 3, which can be subjected to photometric
analysis with low intensity lamps, giving highly accurate results thanks to the reduced
thickness and perfect flatness of the walls 3a and 3b of the microcell 3.
[0019] Figure 3 shows a similar device to the one in the preceding figures, in which analogous
components to those already described have been designated by primed numbers, with
the sole difference that a piercing element 5 is inserted in the microcell 3′, preferably
positioned centrally with respect to the hole in the base of the microcell, which
connects the microcell to the capillary tube 2′. The capillary tube 2′, the bottom
end of which can be inserted into a container 30 of any shape containing the liquid
to be drawn, is connected at its top end to the microcell 3′.
[0020] This consists of two superimposed communicating cubic areas. The lower one 31, smaller
in volume, will have thin transparent walls, parallel and facing each other, allowing
optical measurements to be made perferctly. The upper area 32, larger in section,
demarcates an upper chamber 32, symmetrical with the lower chamber 31. The lower chamber
31 ends in a cylindrical narrowing forming a neck 33 into which the capillary tube
2′ is inserted. The connection and seal between the neck and the capillary tube are
guaranteed by an elastic sheath 34, having a clindrical shape and variable diameter,
the top of wich encloses the neck 33 and the bottom the capillary tube 2′. This elastic
sheath 34 serves as the connection for the arm of a mechanical shaker designed to
shake the liquids inside.
[0021] At the bottom of the upper chamber 32 is set a piercing element 5 consisting, for
example, of a cylindrical element 11 the top edge of which is cut slantwise 35.
[0022] A container 37 can be inserted into the upper chamber 32 from above, the base 39
of said container already being prepared for cutting and piercing; the outside diameter
of the container 37 is slightly smaller than the inside diameter of the upper chamber
32. The desired chemical reagent in the desired physical state (liquid, solid) can
be placed inside the container 37. The container 37 is provided with a stopper 38
and a vent-hole 40, initially closed by a tear-off seal 41. The circumference of this
seal extends beyond the vent-hole 40 and rests on a ledge formed by a further projection
36 of the upper chamber 32. The tear-off seal 41 also has a tab 42 bearing codes that
can be read by a scanner belonging to the analyzer and contain identification of the
specimen for analysis, as well as all information concerning the parameters that the
scanner must read for the analysis to be performed correctly.
[0023] Once the liquid to be analyzed has been pushed up inside the capillary tube 2′ to
the desired height, by one of the methods described earlier, and the chemical reaction
is to be started, the tear-off seal 41 is removed, upon which air can enter the container
37. This container can be pushed downward, manually or automatically, until its base
39 is pierced by the cutting edge 35 and the walls of the container 37 descend to
occupy space 36. The chemical reagent is thus mixed with the liquid to be analyzed
contained in the cell 3′ and reacts. By resting on the top edge of the upper chamber
32, the tear-off seal 41 prevents the container from being accidentally inserted into
the microcell during transport or handling and its base 39 thus being cut. The arm
of a shaker sets the elastic neck 34 in vibration to mix the reagent and the specimen,
so that after the time required for the reaction, measurement can be carried out in
the cell 31.
1. A device for carrying out photometric and spectrophotometric determinations as
well as chemical microreactions in liquids of any type, comprising a capillary tube
(2, 2′) for drawing the liquid to be analyzed, characterized in that one end (2a)
of said capillary tube is sealed to a microcell (3, 3′) having at least two flat transparent
parallel surfaces (3a, 3b).
2. A device according to claim 1, characterized in that the capillary tube (2, 2′)
is equipped with a micropiston (4) of plastic material that can be inserted into said
capillary tube to the desired height.
3. A device according to any of the preceding claims, characterized in that a breakable
container (37) containing a suitable chemical reagent is inserted into the microcell
(3, 3′).
4. A device according to any of claims 1, 2 and 3, characterized in that the microcell
(3′) is divided into two chambers, an upper chamber and a lower chamber.
5. A device according to claim 3 or 4, characterized in that the microcell (3′) is
equipped with means (35) for breaking said container (37).
6. A device according to any of the preceding claims, characterized in that a tab
(42) is connected to the microcell (3, 3′), bearing a code that can be read by a scanner
attached to the analyzer that identifies the microcell and can contain information
regarding the analysis parameters.
7. A device according to claim 6, characterized in that the tab (42) is connected
to the microcell by means of a breakable tear-off system.
8. A sampling procedure for liquid, in particular blood, for photometric and spectrophotmetric
analyses, that provides for the liquid to be drawn by capillarity into a capillary
tube (2, 2′) which is then stopped and, if necessary, centrifuged, characterized in
that the capillary tube is made fast with a microcell, that the liquid, possibly separated
into phases, is pushed upwards in the capillary tube until a sufficient amount of
liquid or phase of the liquid has entered said microcell (3, 3′).
9. A procedure according to claim 8, characterized in that the chemical reagent is
put into a container (37) set inside the microcell (3′, 3˝) and that this reagent
is brought into contact with the liquid to be analyzed by breaking the container (37).
10. A procedure according to claim 8 or 9, characterized in that the specimen to be
analyzed is identified by a code that can be read by a scanner attached to the analyzer,
it being possible for said code to carry information regarding the analysis parameters.