CA1131310A - Device for performing measurements on fluids directly in the sample container - Google Patents

Device for performing measurements on fluids directly in the sample container

Info

Publication number
CA1131310A
CA1131310A CA331,138A CA331138A CA1131310A CA 1131310 A CA1131310 A CA 1131310A CA 331138 A CA331138 A CA 331138A CA 1131310 A CA1131310 A CA 1131310A
Authority
CA
Canada
Prior art keywords
syringe
electrode
measuring
rality
plu
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA331,138A
Other languages
French (fr)
Inventor
Franco Meiattini
Paolo Neri
Giorgio Papeschi
Paolo Tarli
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ISTITUTO SIEROTERAPICO E VACCINOGENO TOSCANO "SCLAVO" SpA
Original Assignee
ISTITUTO SIEROTERAPICO E VACCINOGENO TOSCANO "SCLAVO" SpA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ISTITUTO SIEROTERAPICO E VACCINOGENO TOSCANO "SCLAVO" SpA filed Critical ISTITUTO SIEROTERAPICO E VACCINOGENO TOSCANO "SCLAVO" SpA
Application granted granted Critical
Publication of CA1131310A publication Critical patent/CA1131310A/en
Expired legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/157Devices characterised by integrated means for measuring characteristics of blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14539Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring pH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14542Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring blood gases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150221Valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150236Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150389Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150503Single-ended needles

Abstract

ABSTRACT OF THE DISCLOSURE
For taking measurements on fluids, such as bio-logical fluids (e.g. blood and the like), a device is disclosed which is a cylindrical body insertable in a syringe or a similar sampling container and has on the exposed face a set of electrodes or probes which are connected via appropriate electric leads to process-ing and displaying devices which permit to take imme-diate readings of important parameters such as pH, temperature, partial pressures of gases and so on.

Description

- CASE _1172 DEVICE FOR PERFOR~IING MEASUREMENTS ON
FLUIDS DIRECTLY IN THE SAMPI,E CONTAINER . -_ 3 _ . __ This invention relates to a device adapted toperform analytical check-up operations on samples of - various origin.
A typical example is the check of the environ-mental pollution, which requires, as a rule, a specialsensitivi*y and, concurrently, a simple performance of the analytical operations.
Another field of application is that of clinic-al tests in which there is the necessity of continuously 0 monitoring the trend of cer-tain analytical parameters, such as for example~ during progress of certain surgical operations, or in reanimation centers.
The samples of the material to be analyzed must very often be transferred into specially provided con-tainers for being sent to the analysis laboratory. Theshortcomings which are generally experienced in such procedures are as follows :
- increased occurrence of contamination and/or errors~ such as sample-swapping~ errors in copy-ing down the sample identification codes and the like.
- time waste - increased use up of laboratory vessels - a few particular cases, such as for example the case of analysis of c~ases in the blood, with attendant risk of alteration of~ the values of the substances to be measuredr due to diffusion from and into the environment. This drawback is particularly significant in the case, mentioned above, of the operating rooms and the reanima-tion centers where, on the basis of the analytical results which are obtained, decisions of vi-tal importance shall be taken.
It becomes thus imperative to be able to use a device which permits that these analysis may be performedl if and when possible, without transferring the samples and, preferably, at the very sampling spot.
The subject matter of this invention is a device which permits to taking of readings directly in the sampling container. ' - More specifically and in accordance with the broad concept of the invention, there is provided and claimed herein a device for performing analytical measurements on body fluids, such as blood, comprising: a disposable syringe having opposing ends with a disposable needle at one end for drawing the body fluids within the syringe, and a reusable cylindrical body slidably insertable into and movable in said syringe from and through the other syringe end, wherein said body is shaped relative to the walls of the syringe between the ends thereof so as to act like a piston therein for withdrawing said body fluids, and wherein said body includes a plurality of sensors at the end thereof adjacent s~id needle for contacting body fluids drawn within said syringe, and means connected to said sensors and at the other end of said body for connection to instruments for detection and display of data.

In the drawing, Figure 1 is a perspective view of a cylinder according to the invention and Figure 2, the cylinder of Figure 1 mounted in a syringe, shown in cross-section.
The device is composed, as shown in Figure 1, by a cylinder of an appropriate material 1, which is not prone to attack by the 1uids to be analyzed and which can be sterilized if so required, appropriate sensors 3, 4, 5 and 6 being inserted in said conta.iner so as to confront the si.de 2 of the cylinder which contacts the sample. The cylinder is so shaped as to be capable of actin.g like a piston in the hollow cylindrical space of the sampling container. The sensors are connected, via appropriate leads, to one or more detecting ,. instrument(s) which serve for the processing and display of the readings.
Figure 2 of the accompanying drawings offers an e.:ample ot a piston of the k i nd referred to abov=, ~n 7 /

.. ~
- 2a -.~ , serted in a hypodermic syringe for taking blood samples.
In such a syringe (hypodermic) the sample of the blood which is drawn contacts, at very instant of sampling, the sensors housed in the head of the piston and which are specific for measurements of pH, P02, P~02 and temperature.
The sensors deliver their signals to the process-ing instruments which provide to process them and to dis-play the readings on appropria~e display screens and/or printed charts. By so doing, the results of the tests are made immediately available. The example given is by no means a limitation and does not exclude the use for different measurements and on sample other than those exemplified herein. An outstanding asset of the invention is that it becomes possible to effect the read-ings on reduced volumes of samRle since it is by no way necessary to fill the cylindrical space completely, it being necessary and sufficient that the sensors project-ing from the piston head are wetted. This fact also faci-litates the performance of tests in a rapid sequentialorder by using a plural-way cock such as in FIGURE 2.
As a matter of fact, once the hypodermic needle l~
has been inserted in the artery or the vein, the sample is drawn and, once the measurement has been taken, the sample itself can be discharged without removing the needle upon shifting the stream to the discharge 2 by the two-way cock 3 which is inserted between the needle and the body of the syringe 4. By rotating the cock handle again, the device is in readiness for the next sampling and so forth~ In the case in which there is the neces-sity of introducing in the sample a clot-preventing 3 ~0 4.
agent such as heparin, the clevice can be equipped with a 3-way cock, one way hein ~ ntended to draw the clot~
preventing agent.
A model of the device has been embodied by way 5 of example only by combining in a singie piston-cylinder assembly of a plastics material, a microelectrode of iridium and iridium oxide for measuring the pH, a micro-electrode for measuring PC0~, a polagraphic-type micro-electrode for measuring P02 and a thermosensitive probe for taking sample temperature readings. This model of pistons can be inserted in a syringe, the latter being possibly surrounded by a thermostatic liner.
As a rule, the electrodes used in the analysis of blood gases are based on the following operating principles :
PC02 electrode : This is composed by an electrode which is normally made of glass and is responsive to the proto-nic activity~ and is immersed in a solution of NaHC03 in contact with a membrane through which diffusion of C02 can take place. When the C02 which is diffused through the membrane is solubilized (I) in the solution held between the electrode surface and the membrane, it shifts the equilibrium (II) towards the right, the pro-tonic activity being consequently increased :
C2 ~ H20 H2C03 (I) H2C~3 H+ ~ CH03 (II) Under equilibrium conditions, the partial pres-sure of C02 will be the same on both faces of the mem-brane. Thus~ variations of PC02 outside the membrane will originate equal variations of PC02 in the film of solution enclosed between the membrane and the electrode.

The potential of thc glass electrode is measured relati~e to a reference electrode AgtAgCl which finds the Cl ions in the internal solution which contains also the bicarbonate (typical composition NaHC03 : 0.05 M +
NaCl : 0.1 M).
The cell is thus constituted as follows :
Ag-AgCl NaHC03 0~05 M pH electrode NaCl 0.1 M
and its potential will be a Eunction of the partial pres-sure of the C02 in the sample.
Therefore :E = E' ~ 2030~ RT log aH+ = E" + 2.303 RT log PC02 P02 electrode . The P02 electrodes are of two types, viz.:
galvanic or polarographic.
Galvanic electrodes are formed by two different metals which evolve, when immersed in an appropriate solution, a potential difference which is sufficient to reduce oxygen. The polarographic electrodes (Clark type)~
conversely, are composed by a platinum of a gold cathode which is biased to a potential value of from -500 mV and -800 mV relative to a reference electrode having satura-ted calomel.
A membrane, for example of Teflon (R.T.M.) sepa-rates the sample being tested from an internal solution which can be potassium chloride, or a pH 7 buffer. This solution must be present as a very thin layer between the membrane and the platinum cathode and must contain ions which fix the potential of the reference Ag~AgCl electrode. The oxygen diffused through the membrane is 3o reduced to OH- on the cathocle and the intensity of cur-rent which accompanies the reaction is proportional to L3 ~0 the partial pressure of the o~ygen in the sample.
pH electro~es : The electrodes for measuring the proto-nic activity or pH are essentially glass membrane electro-des. This thin glass membrane separates the solution being tested from an internal buffer solution in which an Ag/AgCl electrode~ or an Hg/Hg2C12 electrode is im-mersed. The potential of this element is measured re-lative to a reference half-cell and varies according to the relationship :
E = E' + 2.303 RT log H = E~ - 2.303 RT pH
F F
The glass electrodes can take dif~erent shapes (capillary tu~e, planar or spherical head) but it is dif-ficult to combine the small sizc with an adeq~ate mecha-nical robustness, a low electric impedance and a high 5 response velocity.
The electrodes described above, of the kind nor-mally used in the measurements of pH, PC02 and P02 can permit that the present invention may be reduced to practice only if their physical dimensions permit the 0 simultaneous insertion of such electrodes in the piston.
A nonlimiting example of embodiment of the in-vention is a piston comprising the following minia-turized sensors : -~. Ir/IrO2 electrode for measuring the pH
25 2. PC02 electrode composed by an Ir/IrO2 micro-electrode surrounded by a Au and Pt guard of the diameter of 3 mm, immsersed in an appropriate so-lution and coated by a C02-pervious membrane 3. Voltameter type microelectrode with a cathode of 3o Pt (or Au) immersed :in an appropriate solution and coated by an oxygen-previous membrane.

Claims (10)

The embodiments of the invention in which an exclu-sive property or privilege is claimed are defined as follows:
1. A device for performing analytical measurements on body fluids, such as blood, comprising:
a disposable syringe having opposing ends with a disposable needle at one end for drawing the body fluids within the syringe, and a reusable cylindrical body slidably inserable into and movable in said syringe from and through the other syringe end, wherein said body is shaped relative to the walls of the syringe between the ends thereof so as to act like a piston therein for with drawing said body fluids, and wherein said body includes a plurality of sensors at the end thereof adjacent said needle for contacting body fluids drawn within said syringe, and means connected to said sensors and at the other end of said body for connection to instruments for detection and display of data.
2. A device according to claim 1, wherein said one end of said syringe is formed with a neck having therein a plural-way cock.
3. A device according to claim 1, wherein the plurality of the sensors comprises an electrode for measuring the pH.
4. A device according to claim 1, wherein the plu-rality of the sensors comprises an electrode for measuring the PCO2.
5. A device according to claim 1, wherein the plu-rality of the sensors comprises an electrode for measuring the PO2.
6. A device according to claim 1, wherein the plu-rality of the sensors comprises an electrode for measuring the pCa.
7. A device according to claim 1, wherein the plu-rality of the sensors comprises an electrode for measuring the PCl.
8. A device according to claim 1, wherein the plu-rality of the sensors comprises an electrode for measuring the pNO3.
9. A device according to claim 1, wherein the plu-rality of the sensors comprises a thermosensitive probe.
10. A device according to claim 1, further compris-ing a thermostatic control system.
CA331,138A 1978-07-05 1979-07-04 Device for performing measurements on fluids directly in the sample container Expired CA1131310A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT25351A/78 1978-07-05
IT25351/78A IT1158880B (en) 1978-07-05 1978-07-05 DEVICE FOR PERFORMING MEASUREMENTS ON FLUIDS DIRECTLY IN THE SAMPLE COLLECTION CONTAINER

Publications (1)

Publication Number Publication Date
CA1131310A true CA1131310A (en) 1982-09-07

Family

ID=11216439

Family Applications (1)

Application Number Title Priority Date Filing Date
CA331,138A Expired CA1131310A (en) 1978-07-05 1979-07-04 Device for performing measurements on fluids directly in the sample container

Country Status (7)

Country Link
US (1) US4339317A (en)
JP (2) JPS5512491A (en)
CA (1) CA1131310A (en)
DE (1) DE2927048C2 (en)
FR (1) FR2430605A1 (en)
GB (1) GB2025065B (en)
IT (1) IT1158880B (en)

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Also Published As

Publication number Publication date
JPS63145161U (en) 1988-09-26
IT7825351A0 (en) 1978-07-05
GB2025065A (en) 1980-01-16
IT1158880B (en) 1987-02-25
GB2025065B (en) 1983-04-27
FR2430605B1 (en) 1984-04-27
DE2927048C2 (en) 1982-04-08
US4339317A (en) 1982-07-13
DE2927048A1 (en) 1980-02-07
FR2430605A1 (en) 1980-02-01
JPS5512491A (en) 1980-01-29

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