EP3697534A1 - Récipient pour la réalisation de procédures médicales ou vétérinaires et procédé d'étalonnage associé - Google Patents

Récipient pour la réalisation de procédures médicales ou vétérinaires et procédé d'étalonnage associé

Info

Publication number
EP3697534A1
EP3697534A1 EP18797107.2A EP18797107A EP3697534A1 EP 3697534 A1 EP3697534 A1 EP 3697534A1 EP 18797107 A EP18797107 A EP 18797107A EP 3697534 A1 EP3697534 A1 EP 3697534A1
Authority
EP
European Patent Office
Prior art keywords
reservoir
stopper
container
internal pressure
pressure value
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.)
Withdrawn
Application number
EP18797107.2A
Other languages
German (de)
English (en)
Inventor
Gian Cesare GUIDI
Gabriel LIMA OLIVEIRA
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.)
Universita degli Studi di Verona
Original Assignee
Universita degli Studi di Verona
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 Universita degli Studi di Verona filed Critical Universita degli Studi di Verona
Publication of EP3697534A1 publication Critical patent/EP3697534A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082Test tubes per se
    • B01L3/50825Closing or opening means, corks, bungs
    • 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
    • A61B5/150351Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • 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
    • A61B5/150946Means for varying, regulating, indicating or limiting the speed or time of blood collection
    • 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
    • A61B5/154Devices using pre-evacuated 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
    • A61B5/150755Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14Process control and prevention of errors
    • B01L2200/148Specific details about calibrations
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/041Connecting closures to device or container
    • B01L2300/042Caps; Plugs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/046Function or devices integrated in the closure
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/14Means for pressure control

Definitions

  • the present invention relates to a container for carrying out medical or veterinary procedures.
  • the invention fits into the technical field of medical devices for collecting 5 liquid biological samples, for example vacuum test tubes, and more precisely it relates to a container capable of maintaining the amount of a liquid biological sample collected at any altitude substantially constant or, at the same elevation, increasing the amount of the liquid biological sample collected, where this becomes necessary.
  • test tubes also commonly called test tubes, have different dimensions 15 so as to be able to contain different amounts of liquid biological sample (3 imL, 8 ml ).
  • Vacuum test tubes are sold sealed in order to avoid contamination by external contaminating agents and to preserve the specific degree of vacuum created inside them.
  • test tubes 20 The distinctive feature of this type of test tubes, in fact, is the ability to enable the collection of a liquid biological sample, typically blood, thanks to the difference in pressure between the pressure inside the test tube and the patient's internal pressure, which coincides substantially with the atmospheric pressure of the place where the sample is collected.
  • the liquid biological sample typically blood
  • the degree of vacuum set inside test tubes in order to bring about a pressure differential (between the inside of the test tube and the patient's body) such as to enable the collection of a given amount of a liquid biological sample is calculated at the standard atmospheric pressure (1013.25 hPa).
  • test tubes made according to the prior art have a further relevant drawback, as explained in the paragraphs that follow.
  • the vacuum test tubes present on the market contain additives, for example blood thinners, procoagulants and various inhibitors suitable for mixing with the amount of the liquid biological product collected.
  • the amount of additives present in a vacuum container is precisely calibrated based on the amount of liquid biological sample it is planned to collect. Disadvantageously, therefore, a decrease in the amount of the liquid biological sample collected brings about a variation in the quantitative ratio between additives and the biological sample itself with the consequent alteration of the results of the analyses it is intended to perform.
  • the technical task of the present invention is to propose a container for carrying out medical or veterinary procedures that overcomes the above-mentioned drawbacks of the prior art.
  • Another object of the present invention is to provide a container that is capable of maintaining a constant quantitative ratio between the liquid biological sample collected and the additives present inside the test tube itself.
  • Another object of the present invention is to provide a container that is capable of enabling, at the same elevation, the collection of a greater amount of a liquid biological sample, where this becomes necessary.
  • the invention relates to a container for carrying out medical or veterinary procedures which comprises: a reservoir having a closed end and an open end; a stopper at least partially inserted sealingly in the reservoir at the open end to maintain a pre-established initial pressure value of a gaseous fluid present inside the reservoir.
  • the stopper delimits an initial volume inside the reservoir and is shaped in such a manner that a conduit can pass through it so as to enable the reservoir to be filled with a liquid biological sample.
  • the container comprises a movement member that is associated with the reservoir and operatively active on the stopper so as to move the latter between at least a first operative position, in which it delimits said initial volume, and at least a second stable operative position, in which the stopper delimits a final volume that is larger or smaller than the initial volume so as to decrease or increase the pressure value of the gaseous fluid present inside the reservoir, respectively.
  • the movement member is solidly constrained to the stopper and is slidably movable along a direction of extension of the reservoir at least between two operative configurations corresponding, respectively, to the first and second operative positions assumed by the stopper to delimit the initial and final volumes.
  • the movement member comprises a hollow body, having a housing seat suitable for receiving a portion of the stopper, and a first coupling means fashioned on a portion of the hollow body and suitable for engagement in a corresponding second coupling means fashioned on a portion of the reservoir.
  • the first coupling means preferably comprises a thread fashioned on the hollow body
  • the second coupling means comprises a counter- thread fashioned on the reservoir and that at least partially faces the thread present on the hollow body, whereby the hollow body is screwed and unscrewed in such a manner as to be slidably movable along a direction of extension of the reservoir.
  • the reservoir has a plurality of marks, each of which referring to positions in which the stopper stops so as to delimit volumes inside the reservoir.
  • the marks present on the reservoir provide a visual point of reference for identifying exactly where the stopper is positioned following its movement.
  • the first mark refers - preferably - to the position in which the stopper delimits the initial volume
  • knowing the number of marks comprised between the first one and the one in which the stopper stops makes it possible to verify how much the internal volume of the reservoir has increased and thus to estimate how much the degree of vacuum has increased (that is, how much the internal pressure has decreased).
  • having initially pre- established a correlation between the usable internal volume and the degree of vacuum set inside the test tube it is possible to estimate the pressure inside the container starting from the position assumed by the stopper.
  • the reservoir is preferably made of a transparent material so as to enable the position in which the stopper stops inside the reservoir to be seen directly with respect to the plurality of marks.
  • each mark of said plurality of marks corresponds to a position in which a reference portion of the movement member stops during movement of the stopper.
  • the stopper has a section that is perforable and of reduced thickness so as to enable a conduit that can be associated therewith to penetrate into the volume delimited by the stopper when it is stopped in a specific position to enable the reservoir to be filled with the liquid biological sample.
  • the stopper preferably has a section that, in the direction of extension of the reservoir, is substantially H-shaped, so as to define two cavities of the stopper arranged along the direction of extension of the reservoir.
  • the cavities are interspaced by the perforable section of reduced thickness.
  • the H-shaped section which defines the two cavities, together with the perforable section of reduced thickness enables easy perforation by means of an external needle of standard length.
  • the presence of the two cavities reduces the thickness of the stopper along the longitudinal direction of extension thereof and enables the needle tip to be introduced into the volume of the reservoir and thus to convey the liquid biological sample collected.
  • the H-shaped section of the stopper provides the further advantage of facilitating the deformation of the portion of the stopper that presses against the walls of the reservoir, thereby facilitating its movement.
  • the stopper has, on at least one portion of a side surface thereof facing the reservoir, a pattern in relief for reducing the contact zones between said side surface and the reservoir, so as to reduce friction during movement of the stopper and thus enable better sliding thereof during displacement in order to establish the desired pressure gradient.
  • the pattern in relief preferably comprises a plurality of lines in relief with different orientations and that are incident with respect to each other, preferably with a mesh-type pattern.
  • the mesh pattern that is, the overlapping of a first plurality of lines in relief parallel to one another and having a specific first orientation with a second plurality of lines in relief, similarly parallel to one another and having a second orientation opposite the first orientation, has shown to be the preferable one, as it is capable of providing an excellent result.
  • the thread present on the hollow body extends over a reduced length compared to the length over which the corresponding counter-thread present on the reservoir extends.
  • this feature makes it possible to prevent the stopper from accidentally slipping off the reservoir during movement of the stopper itself.
  • the thread at the open end of the reservoir and the counter-thread present on the movement member enable the operation of moving the stopper to be simplified. Furthermore, considering that, as already mentioned, the counter-thread of the movement member preferably extends for a smaller length than the length over which the thread of the reservoir extends, the possibility of an accidental opening of the container and thus the consequent risk of dispersing the liquid biological sample collected is considerably reduced. In fact, a portion of the stopper inserted sealingly in the reservoir will maintain the stopper itself connected to the container and thus in the configuration of closure of the open end of the reservoir.
  • the present invention further relates to a closure device for a container for carrying out medical procedures which comprises a stopper that can be sealingly coupled with a reservoir of a container so as to delimit an initial volume inside the reservoir itself.
  • the stopper is shaped in such a manner that a conduit can pass through it so as to enable the reservoir to be filled with a liquid biological sample.
  • the closure device comprises a hollow body solidly constrained to the stopper and that can be slidably coupled to the container along a direction of extension of the reservoir to move the stopper between at least a first operative position, in which the latter delimits an initial volume inside the reservoir, and at least a second stable operative position, in which the stopper delimits a final volume that is larger or smaller than the initial volume inside the reservoir.
  • the closure device further comprises a first coupling means fashioned on a portion of the hollow body and capable of engaging in a corresponding second coupling means present on a portion of the container.
  • the first coupling means comprises a thread fashioned on the hollow body and that is suitable for engagement with a counter-thread present on a portion of the container, whereby the hollow body, when in use on the container, can be screwed and unscrewed so as to be slidably movable along a direction of extension of the reservoir.
  • the stopper has a perforable section of reduced thickness suitable for having a conduit that can pass through it so as to enable the reservoir to be filled with the liquid biological sample.
  • the stopper has a section that, in the longitudinal direction of extension of the reservoir, is substantially H-shaped so that a first cavity and a second cavity of the stopper are arranged at opposite ends with respect to said perforable section of reduced thickness.
  • the stopper has, on at least one portion of a side surface thereof that can face the reservoir, a pattern in relief for reducing the contact zones between said side surface and a surface of the reservoir so as to reduce friction during movement of the stopper itself.
  • the pattern in relief preferably comprises a plurality of lines in relief with different orientations and that are incident with respect to each other, preferably with a mesh-type pattern.
  • the present invention also relates to a method for calibrating a container of the above-described type.
  • the calibration method comprises the steps of:
  • the steps of detecting the value of atmospheric pressure and of detecting the internal pressure value of the gaseous fluid present inside the initial volume of the reservoir are repeated at pre-established altitudes so as to correlate the internal pressure of the fluid to at least one mark that visually signals that the final volume has been reached, at which the internal pressure value achieves the desired pressure gradient value.
  • FIG. 1 illustrates an exploded perspective view of a container for carrying out medical procedures
  • FIG. 2 illustrates a perspective view of the various components of the closure device for a container
  • FIG. 3 illustrates a perspective view of the closure device in use on a container
  • FIG. 4 illustrates an exploded longitudinal-section view of a container
  • FIG. 5 illustrates an overall perspective view of the container in an assembled configuration.
  • the present invention relates to a container 1 for carrying out medical or veterinary procedures, which comprises a device that is capable of maintaining the amount of a collected liquid biological sample substantially constant irrespective of the altitude at which it is used.
  • a container according to the present invention is likewise capable of enabling, at the same elevation, the collection of a larger amount of a liquid biological sample, where this becomes necessary.
  • a container 1 for carrying out medical or veterinary procedures has been generically denoted with the number 1 .
  • figure 5 it is possible to observe the container 1 in an assembled condition.
  • the other numerical references refer to technical features of the invention which, except for various indications or evident structural incompatibilities, the person skilled in the art will know how to apply to all the variant embodiments described.
  • the container 1 for carrying out medical or veterinary procedures comprises a reservoir 2 having a first closed end 2a and a second open end 2b.
  • the reservoir 2 generally for use in the medical or veterinary field, has a cylindrical or slightly conical shape with the closed end 2a in the shape of a hemisphere; however, the possibility of producing a reservoir 2 with different shapes is not ruled out.
  • the container 1 further comprises a stopper 3 partially inserted sealingly in the reservoir 2 at the open end 2b to maintain a given pressure value inside the reservoir 2 itself, as will become clear below.
  • the stopper 3 is preferably substantially a plug having a circular section suitable for inserting it through the open end 2b into the reservoir 2 and maintaining it in a stable position.
  • the stopper 3 has a transversal dimension substantially equal to the dimension of the passage section of the open end 2b of the reservoir 2. In this manner, the side surface 3a of the stopper 3 and the internal side surface of the reservoir 2 are always in contact, thus preventing the exchange of substances with the surrounding environment.
  • the stopper 3 When coupled to the reservoir 2, the stopper 3 delimits an initial volume inside the reservoir 2 itself which is suitable for containing a gaseous fluid having a predefined pressure value, generally lower than the standard atmospheric pressure at sea level.
  • the gaseous fluid is preferably sterile air and the pressure thereof inside the reservoir 2 is set during production of the container.
  • the stopper 3 is of the perforable type, for example by an external needle or conduit.
  • the stopper 3 has a perforable section of reduced thickness, typically a membrane 7 of millimetric thickness, interposed between two cavities 7a, 7b.
  • the stopper 3 is preferably made of a bio-silicone material.
  • the cavities 7a, 7b have - preferably - an identical shape and are arranged along the same direction of extension L of the reservoir 2.
  • the first cavity 7a extends from one end of the stopper 3 outside the reservoir 2 for a length that is less than the length of the needles normally used for collecting samples, whereas the second cavity 7b extends from the end of the stopper 3 inserted in the reservoir 2.
  • the length of the second cavity 7b, extending towards the cavity 7a, is such as to define the millimetric thickness of the perforable membrane 7.
  • the stopper 3 has a section which, along the direction of extension L of the reservoir 2, is substantially H-shaped, as shown in figure 4.
  • the container 1 comprises a movement member 4, preferably in the form of a plug cover element, solidly constrained to the stopper 3 and operatively active on the latter so as to move it between at least a first operative position, in which the stopper 3 delimits the initial volume, and at least a second stable operative position, in which the stopper 3 delimits a final volume that is larger or smaller than the initial volume so as to decrease or increase the pressure value of the gaseous fluid present inside the reservoir 2, respectively.
  • a movement member 4 preferably in the form of a plug cover element, solidly constrained to the stopper 3 and operatively active on the latter so as to move it between at least a first operative position, in which the stopper 3 delimits the initial volume, and at least a second stable operative position, in which the stopper 3 delimits a final volume that is larger or smaller than the initial volume so as to decrease or increase the pressure value of the gaseous fluid present inside the reservoir 2, respectively.
  • the invention achieves a further important advantage.
  • it will be possible to move the stopper so as to increase the final volume inside the reservoir, thereby decreasing the pressure of the gaseous fluid, and thus establishing a higher pressure gradient, which facilitates the collection of larger sample amounts.
  • polycythemia which result in a decrease in the ratio between the liquid part and the cellular part of blood, and in which it becomes necessary to maintain an accurate ratio of volumes between the liquid part of the blood and the additive-anticoagulant.
  • This can be obtained, precisely, by increasing the amount of blood aspirated through the container according to the present invention, instead of manually decreasing the amount of additive- anticoagulant, as presently occurs in the prior art, which is disadvantageously inaccurate, slow and not under vacuum.
  • the movement member 4 and the stopper 3 constitute a closure device 100 for the container 1 .
  • the movement member 4 comprises a hollow body 4a that can be slidably coupled to the container 1 along the direction of extension L thereof to move the stopper 3 itself between at least the first operative position, in which it delimits the initial volume, and at least a second stable operative position, in which it delimits a final volume that is larger or smaller than the previous one in order to vary the internal pressure value of the gaseous fluid present in the reservoir 2.
  • the movement member further comprises a first coupling means 5a capable of engagement in a corresponding second coupling means 5b present on a portion of the reservoir 2.
  • these first and second coupling means 5a, 5b comprise a thread and counter-thread system such that the hollow body 4a can be screwed and unscrewed so as to be slidably movable along a direction of extension L of the reservoir 2 in order to move the stopper 3 in such a way that the latter can assume a stable position defining the volume inside the reservoir 2 and comprised between the above-mentioned first and second operative positions.
  • the thread present on the hollow body 4a extends for a smaller length than the length along which the corresponding counter-thread present on the reservoir 2 extends.
  • the counter-thread on the reservoir 2 extends from the open end 2b for a length of, for example, 10 millimetres
  • the corresponding thread of the hollow body 4a extends for a smaller length beginning at a distance, for example, of about 5 millimetres from the open end of the movement member 4 facing the reservoir 2.
  • the first and second coupling means 5a, 5b can comprise a positioning system defined by a plurality of protrusions disposed on the reservoir 2 along the direction of extension L thereof, preferably equidistant, and by a specific seat present on the hollow body 4a and suitable for receiving and mechanically engaging, by interference, a protrusion so as to define a stable position of the hollow body 4a relative to the reservoir 2.
  • the position is modifiable over time following the application of an external force by an operator on the hollow body 4a, so as to make it slide along the reservoir in discrete steps.
  • the stopper 3 has, at the top thereof outside the reservoir 2, an edge 33 suitable for defining a stop element to prevent an excessive insertion of the stopper 3 into the reservoir 2.
  • the edge 33 engages in a housing seat 4b of the hollow body 4a so that the latter is able to move the stopper 3.
  • the housing seat 4b is a recess present along the inner wall of the movement member 4 and shaped so as to fittingly receive the edge 33 of the stopper 3.
  • the housing seat 4b is a projecting abutment extending along a perimeter of the inner wall of the movement member 4 so as to define a rest surface for the edge 33 of the stopper 3 and ensure the correct positioning of the stopper 3 inside the movement member 4 and the necessary constraint for the stopper 3 along the direction L upwards.
  • the closure device 100 (figure 3) comprises a cap 9 placed on top of the stopper 3 in such a way as to fittingly close the hollow body 4a.
  • the movement member 4 is able to apply a translation force on the stopper 3 as a result of the screwing/unscrewing or in any case sliding action along the direction of extension L of the reservoir 2 exerted by an operator on the hollow body 4a.
  • the cap 9 has a hole at the first cavity 7a of the stopper 3, said hole having a transversal dimension that is preferably equal to that of the cavity, so as to enable the passage of a needle or a conduit for collecting the liquid biological sample.
  • the pattern in relief 8 decreases the contact zones between the side surface 3a of the stopper 3 and the inner side wall of the reservoir 2 and, consequently, it decreases the sliding friction that is generated during the sliding of the stopper 3.
  • the plurality of marks 6 each one referring to the positions in which the stopper 3, or the movement member 4 (solidly constrained to the stopper 3), stops to delimit the internal volume of the reservoir, between the first operative position (initial volume) and the second stable operative position, useful for maintaining the pre-selected pressure gradient.
  • the plurality of marks 6 consists in a plurality of lines parallel to each other, preferably equidistant, arranged in proximity to the open end 2b of the reservoir 2 according to a direction transversal to the direction of extension L of the reservoir 2 itself.
  • a first mark 6 is the visual reference of the initial operative position in which the stopper 3, or the movement member 4, stops in defining the initial volume, and thus the initial pressure of the gaseous fluid present inside the container 1 , whereas the remaining marks 6 refer to different positions in which the stopper 3, or the movement member 4, is able to stop in defining different volumes inside the reservoir 2 in order to maintain the pre-selected pressure gradient.
  • the reservoir 2 is preferably produced with a transparent material, for example plastic or glass, to enable at least a portion of the stopper 3 to be seen for precise collimation with the corresponding mark 6.
  • a portion of the movement member 4, solidly constrained to the stopper 3 is taken as a reference with respect to the marks and can be used to indirectly verify the position/movement of the stopper 3 inside the reservoir 2 and thus monitor the variation in the internal volume of the container 1 .
  • the marks 6 are visual references that can be used by the operator to correlate the internal pressure of the container 1 with a specific position of the stopper 3, or a specific volume inside the container 1 .
  • the operator applies a movement of the stopper 3 along the direction of extension L of the reservoir 2, respectively, inserting or extracting the stopper from the reservoir itself.
  • the operator Being able to verify the position of the stopper and/or movement member with respect to the marks, the operator is able to monitor the variation in the internal volume of the container 1 and stop the movement of the stopper at a pre- established internal volume.
  • a closure device 100 for a container 1 for carrying out medical procedures comprising
  • a stopper 3 that can be sealingly coupled with a reservoir 2 of a container 1 to delimit an initial volume inside the reservoir 2 itself, said stopper being shaped in such a manner that a conduit can pass through it so as to enable the reservoir to be filled with a liquid biological sample; a hollow body 4a solidly constrained to the stopper 3 and that can be slidably coupled to the container 1 along a direction of extension L of the reservoir 2 to move the stopper 3 between at least a first operative position, in which it delimits an initial volume inside the reservoir 2, and at least a second stable operative position, in which the stopper 3 delimits a final volume that is larger or smaller than the initial volume inside the reservoir;
  • a first coupling means 5a fashioned on a portion of said hollow body 4a and capable of engagement in a corresponding second coupling means 5b present on a portion of the container 1 .
  • Clause 2 The closure device 100 according to clause 1 , wherein said first coupling means 5a comprises a thread fashioned on said hollow body 4a and that is suitable for engagement with a counter-thread present on a portion of the container 1 , whereby said hollow body 4a, when in use on the container, can be screwed and unscrewed so as to be slidably movable along a direction of extension L of the reservoir 2.
  • Clause 5 The closure device 100 according to any one of clauses 1 to 4, wherein said stopper 3 has, on at least one portion of a side surface 3a thereof that can face the reservoir 2, a pattern in relief 8 for reducing the contact zones between said side surface 3a and a surface of the reservoir 2 so as to reduce friction during movement of the stopper 3 itself.
  • the subject matter of the present invention also relates to a calibration method for associating a specific internal pressure of the gaseous fluid present inside the container 1 with one or more marks 6 present on the reservoir 2.
  • the method for calibrating a container 1 for carrying out medical procedures comprises the operative steps of:
  • the patient's internal pressure is substantially equal to the atmospheric pressure of the place where the patient is located.
  • steps a) to i) listed above are repeated at pre-established altitudes.
  • steps a) to i) can be repeated in an environment that simulates the variation of atmospheric pressure with elevation.
  • a vacuum gauge is preferably used.
  • the vacuum gauge is prepared in accordance with the following procedure:
  • determining the dead volume of the system by calculating the difference between said first pressure value and said second pressure value.
  • the aforesaid procedure enables a precise calibration of the vacuum gauge to be obtained.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

Un récipient (1) pour la réalisation de procédures médicales ou vétérinaires, comprenant : un réservoir (2) ayant une extrémité fermée (2a) et une extrémité ouverte (2b); un bouchon (3) au moins partiellement inséré de manière étanche dans le réservoir (2) à l'extrémité ouverte (2b) pour maintenir une valeur de pression initiale pré-établie d'un fluide gazeux présent à l'intérieur du réservoir (2). Le bouchon (3) délimite un volume initial à l'intérieur du réservoir (2) et est conformé de telle sorte qu'un conduit puisse le traverser de manière à permettre le remplissage du réservoir (2) avec un échantillon biologique liquide. Le récipient (1) comprend un élément de mouvement (4) qui est associé au réservoir (2) et fonctionnellement actif sur le bouchon (3) de manière à déplacer ce dernier entre au moins une première position fonctionnelle, dans laquelle elle délimite le volume initial, et au moins une seconde position fonctionnelle stable, dans laquelle le bouchon (3) délimite un volume final qui est plus grand ou plus petit que le volume initial de façon à diminuer ou augmenter la valeur de pression du fluide gazeux présent à l'intérieur du réservoir (2), respectivement.
EP18797107.2A 2017-10-18 2018-10-11 Récipient pour la réalisation de procédures médicales ou vétérinaires et procédé d'étalonnage associé Withdrawn EP3697534A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102017000117934A IT201700117934A1 (it) 2017-10-18 2017-10-18 Contenitore per l’esecuzione di procedure mediche o veterinarie e relativo metodo di calibrazione
PCT/IB2018/057888 WO2019077448A1 (fr) 2017-10-18 2018-10-11 Récipient pour la réalisation de procédures médicales ou vétérinaires et procédé d'étalonnage associé

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EP3697534A1 true EP3697534A1 (fr) 2020-08-26

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EP18797107.2A Withdrawn EP3697534A1 (fr) 2017-10-18 2018-10-11 Récipient pour la réalisation de procédures médicales ou vétérinaires et procédé d'étalonnage associé

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EP (1) EP3697534A1 (fr)
IT (1) IT201700117934A1 (fr)
WO (1) WO2019077448A1 (fr)

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CN116421302B (zh) * 2023-06-13 2023-09-01 杭州好克光电仪器有限公司 一种电切镜

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DE2438892A1 (de) * 1973-08-15 1975-02-20 Donald Albert Ham Verschliessbarer behaelter
FR2357885A1 (fr) * 1976-07-06 1978-02-03 Charvin Guy Tube a depression pour prelevement de sang
US6431476B1 (en) * 1999-12-21 2002-08-13 Cepheid Apparatus and method for rapid ultrasonic disruption of cells or viruses
ES2593042B1 (es) * 2015-06-03 2017-10-03 Biotechnology Institute, I Mas D, S.L. Dispositivo de recolección de sangre o de un compuesto sanguíneo

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IT201700117934A1 (it) 2019-04-18
WO2019077448A1 (fr) 2019-04-25

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