EP0494845A1 - Durchstechbarer Verschluss für evakuierte Proberöhrchen - Google Patents

Durchstechbarer Verschluss für evakuierte Proberöhrchen Download PDF

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Publication number
EP0494845A1
EP0494845A1 EP92830002A EP92830002A EP0494845A1 EP 0494845 A1 EP0494845 A1 EP 0494845A1 EP 92830002 A EP92830002 A EP 92830002A EP 92830002 A EP92830002 A EP 92830002A EP 0494845 A1 EP0494845 A1 EP 0494845A1
Authority
EP
European Patent Office
Prior art keywords
test tube
stopper
needle
extension
external
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.)
Granted
Application number
EP92830002A
Other languages
English (en)
French (fr)
Other versions
EP0494845B1 (de
Inventor
Gabriele Monciatti
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.)
Diesse Diagnostica Senese SRL
Original Assignee
Diesse Diagnostica Senese SRL
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 Diesse Diagnostica Senese SRL filed Critical Diesse Diagnostica Senese SRL
Publication of EP0494845A1 publication Critical patent/EP0494845A1/de
Application granted granted Critical
Publication of EP0494845B1 publication Critical patent/EP0494845B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes

Definitions

  • Blood-sampling systems which are well known and widely used, comprise (see Fig.1) a device 1 with a cylindrical guide structure 1A on the base 1B of which there are connected an external needle 3 for insertion into the vein and an internal needle 5 intended to perforate the rubber stopper T0 of an evacuated test tube P0; the rubber stopper T0 has a diaphragm which is perforable by the needle 5 and a flange expansion (projecting over the rim of the test tube P0) to guide it into the cavity of the cylinder 1A toward the needle 5.
  • the needle 5 is covered in a slidable perforable elastic sheath 7 which forms a sealing valve for the needle 5 and is made to slide back by the diaphragm of the stopper P0 when the test tube with said stopper is inserted in the direction of the arrow fo into the cavity of the cylinder 1A, in order to take the sample; inside the test tube P0 a predetermined vacuum is created, as a result of which - with the insertion of the test tube P0 and the perforation of the diaphragm of the stopper T0 by the needle 5 after the cap 7 has been slid back - blood is brought from the vein through the needles 3 and 7 toward the test tube P0 to obtain the sample of a desired quantity of blood, which depends on the venous pressure, the capacity of the test tube P0 and the degree of vacuum established inside the latter.
  • sampling systems make it possible to take many samples while the device 1 is kept with the needle 3 in the vein and with no danger to the patient, since the only operation needed for taking a sample is that of inserting the evacuated test tube into the cavity of the cylinder 1A with a gentle axial thrust to perforate the diaphragm and a gentle axial pull to withdraw it. This operation may be repeated many times with new test tubes, while the needle 3 remains in the vein.
  • the double-needle device 11 has an external needle 13 for insertion into the vein and an internal needle contained within a cavity 11A formed by the body of the device 11; here too, the needle 15 has a slidable elastic sheath 17 which is pushed back on perforation and slips forward again to close off the channel formed by the two needles 13 and 15, once the sample has been taken.
  • a test tube P1 is provided, forming a cylinder-plunger system in which the plunger P2 is operated by a rod P3 to draw in the liquid (blood) after the head T1 of the test tube P1 has been inserted into the cavity 11A in such a way as to perforate the diaphragm T6 with the needle 5, the sheath 17 having been slid elastically back up the needle 15;
  • the head T1 is provided with pins T3 and the body 11 forming the cavity 11A has L-shaped clefts 11B running in from the rim, to allow bayonet connection of the head T1 after its insertion into the cavity 11A, by means of an angular movement which engages the pins P3 in the innermost extremities of the Ls of the clefts 11B; a reverse angular movement must be made to withdraw the head T1 of the teat tube P1 out of the cavity 11A, whereupon the sheath 17 slips forward
  • This arrangement has a number of disadvantages due chiefly to the need to make repeated operations - which require much skill - to repeat the functions of connecting and disconnecting the bayonet by rotating the successive test tubes inside the cavity 11A, while the device 11 is kept with the needle 13 in the vein; in particular, there is the danger that the needle 13 may slip out of the vein, or that the vein itself may be traumatized by sudden movements as the test tubes are changed over.
  • the invention accordingly relates to a stopper made of rubber - or similar material - for test tubes intended for the taking of blood samples by vacuum suction through a double-needle device 11 having an external needle 13 for insertion into the vein while the other or internal needle 15 is coaxial with and opposed to the first and fitted with a sheath forming a slidable elastic cap 17, and able to perforate the diaphragm of said stopper.
  • the stopper has an external extension, with axial cavity, which projects from inside the test tube to end in the perforable diaphragm at the extremity of the extension; said external extension can be inserted into the recess of the internal needle 15 of the sampling device 11, without the need for bayonet-type connection and disconnection.
  • said external extension is more or less cylindrical, advantageously frustoconical, with a slight gradual narrowing.
  • the tip of the extension which defines externally the perforable diaphragm, is advantageously concave in order to hold any microdrop of blood which might form on withdrawal from the internal needle after sampling.
  • the rubber stopper of the invention comprises a body capable of entering the test tube in order to close it; in said body there may, or equally well may not, be one or more external recesses to enable the vacuum to be established with the body of the stopper partly inserted in the test tube; there also must be a stop flange which remains outside the test tube.
  • a test tube P10 - in which a particular degree of vacuum can be pre-established - is fitted with a stopper T10 made of rubber or other equivalent material.
  • This stopper T10 has a body T12 capable of entering the top of the test tube in order to close the test tube (with the help also of the vacuum created in the test tube) and a flange T14 by which it rests against the test tube rim.
  • the body T12 has a slightly frustoconical portion T16 to ensure that it grips with a certain force on the test tube walls and an end section T18 to encourage its insertion into the mouth of the test tube P10; recesses T20 may be made in said section T18 in order that in the production stage the vacuum can be established inside the test tube with the section T18 of the stopper T10 only just inserted into the mouth of said test tube; the final forcible insertion of the section T16 of the stopper T10 into the test tube seals in and maintains the vacuum that has been pre-established in the cavity of the test tube.
  • the stopper T10 projects beyond the flange T14 with an extension T22 which is typically shaped in a frustoconical or more or less slightly narrowing form to enable its insertion into the cavity 11A in the same way as with the extension T1 of the conventional test tube P1, T1.
  • the extension T22 has no projections like those of T3, the bayonet connection of the test tube onto the device 11 being avoided because the test tube T10 contains a vacuum, and no axial movements of a plunger, which would necessitate an axial link between the body 11 and the test tube P1 of the conventional system of Figs 2 and 3, are therefore necessary.
  • An axial cavity 24 extends from the inward extremity of the body T12, which forms the real stopper, into the extension T22 and as far as the extremity thereof where a perforable diaphragm T26 is present, analogous to the diaphragm T6 of the test tube P1, T1; the outward extremity of the extension T22 is concave, T28, in order to hold any microdrop of blood which might form on withdrawal of the test tube P10, T10 from the needle 15 of the device 11.
  • test tube P10, T10 As described, it is possible to use the device 11 - already known for use with plunger test tubes P1 - with a test tube containing a particular calibrated degree of vacuum for drawing in a predefined volume of blood; such a test tube P10, T10 simply requires the extension T22 to be inserted into the cavity 11A, with no need for angular operations to achieve a bayonet connection, nor for suction operations with the rod of a plunger, but simply the operation of inserting and perforating the diaphragm T26 by means of the needle 15, with the sliding back and temporary puckering up of the elastic sheath 17, which reseals the needle 15 as it slips forward once more when the test tube is withdrawn.
  • test tube P10, T10 fitted with the extension T22 is that it can also be used with the device 1 of known type and already described with reference to Fig. 1.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Devices For Use In Laboratory Experiments (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
EP92830002A 1991-01-10 1992-01-03 Durchstechbarer Verschluss für evakuierte Proberöhrchen Expired - Lifetime EP0494845B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITFI910006 1991-01-10
ITFI910006A IT1246994B (it) 1991-01-10 1991-01-10 Tappo perforabile atto al prelievo del sangue con dispositivi a doppio ago in provette sotto vuoto

Publications (2)

Publication Number Publication Date
EP0494845A1 true EP0494845A1 (de) 1992-07-15
EP0494845B1 EP0494845B1 (de) 1996-04-10

Family

ID=11349420

Family Applications (1)

Application Number Title Priority Date Filing Date
EP92830002A Expired - Lifetime EP0494845B1 (de) 1991-01-10 1992-01-03 Durchstechbarer Verschluss für evakuierte Proberöhrchen

Country Status (5)

Country Link
EP (1) EP0494845B1 (de)
AT (1) ATE136446T1 (de)
CA (1) CA2059073A1 (de)
DE (1) DE69209667T2 (de)
IT (1) IT1246994B (de)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITUD20100096A1 (it) * 2010-05-18 2011-11-19 Alifax Holding S P A Dispositivo medicale pre-analitico per la raccolta di un campione biologico di feci
US11697114B2 (en) * 2015-12-11 2023-07-11 Babson Diagnostics, Inc. Centrifugation method separating serum or plasma from whole blood using a specimen container having a cap to retain blood cells
US12025629B2 (en) 2022-04-06 2024-07-02 Babson Diagnostics, Inc. Automated centrifuge loader
US12050052B1 (en) 2021-08-06 2024-07-30 Babson Diagnostics, Inc. Refrigerated carrier device for biological samples

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1818046B1 (de) * 1967-12-05 1980-03-13 Ims Ltd Blutentnahmevorrichtung
CA1107245A (en) * 1979-06-06 1981-08-18 Gabor Zellerman Device for connecting a tube to the neck of a container
US4295572A (en) * 1976-03-04 1981-10-20 Becton, Dickinson And Company Cannula pierceable self-sealing closure

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1818046B1 (de) * 1967-12-05 1980-03-13 Ims Ltd Blutentnahmevorrichtung
US4295572A (en) * 1976-03-04 1981-10-20 Becton, Dickinson And Company Cannula pierceable self-sealing closure
CA1107245A (en) * 1979-06-06 1981-08-18 Gabor Zellerman Device for connecting a tube to the neck of a container

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITUD20100096A1 (it) * 2010-05-18 2011-11-19 Alifax Holding S P A Dispositivo medicale pre-analitico per la raccolta di un campione biologico di feci
WO2011144985A1 (en) 2010-05-18 2011-11-24 Alifax Holding Spa Pre-analytical medical device to collect a biological sample of feces
US11697114B2 (en) * 2015-12-11 2023-07-11 Babson Diagnostics, Inc. Centrifugation method separating serum or plasma from whole blood using a specimen container having a cap to retain blood cells
US12059676B1 (en) 2015-12-11 2024-08-13 Babson Diagnostics, Inc. Device and method for testing serum and plasma separated from blood cells in whole blood samples
US12050052B1 (en) 2021-08-06 2024-07-30 Babson Diagnostics, Inc. Refrigerated carrier device for biological samples
US12025629B2 (en) 2022-04-06 2024-07-02 Babson Diagnostics, Inc. Automated centrifuge loader

Also Published As

Publication number Publication date
IT1246994B (it) 1994-12-12
ITFI910006A0 (it) 1991-01-10
EP0494845B1 (de) 1996-04-10
DE69209667T2 (de) 1996-09-12
CA2059073A1 (en) 1992-07-11
ITFI910006A1 (it) 1992-07-10
DE69209667D1 (de) 1996-05-15
ATE136446T1 (de) 1996-04-15

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