EP1714149A1 - Dispositif de passage destine a la mesure de la fonction plaquettaire de l'hemostase primaire, de l'agregation et/ou de la coagulation et/ou de la viscosite du sang - Google Patents

Dispositif de passage destine a la mesure de la fonction plaquettaire de l'hemostase primaire, de l'agregation et/ou de la coagulation et/ou de la viscosite du sang

Info

Publication number
EP1714149A1
EP1714149A1 EP05714946A EP05714946A EP1714149A1 EP 1714149 A1 EP1714149 A1 EP 1714149A1 EP 05714946 A EP05714946 A EP 05714946A EP 05714946 A EP05714946 A EP 05714946A EP 1714149 A1 EP1714149 A1 EP 1714149A1
Authority
EP
European Patent Office
Prior art keywords
housing
blood
storage space
stirring
piston
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Withdrawn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
EP05714946A
Other languages
German (de)
English (en)
Inventor
Michael Kratzer
Volker Von Der Goltz
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.)
Kratzer Michael Dr
VDG-Von Der Goltz GmbH
Original Assignee
Kratzer Michael Dr
VDG-Von Der Goltz GmbH
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 Kratzer Michael Dr, VDG-Von Der Goltz GmbH filed Critical Kratzer Michael Dr
Publication of EP1714149A1 publication Critical patent/EP1714149A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/4905—Determining clotting time of blood

Definitions

  • Flow device for measuring the platelet function of the primary hemostasis, the aggregation and / or the coagulation and / or the viscosity of the blood
  • the present invention relates to a flow device for measuring the platelet function of the primary hemostasis, the aggregation and / or the coagulation and / or the viscosity of the blood, wherein blood is sucked through an aperture from a blood storage space with the aid of a piston which can be moved in a cylinder and the pressure in the space between the piston and the blood drawn in is measured.
  • the piston is moved by a drive, for example, in such a way that a setpoint pressure value is kept in the room.
  • the movement of the piston then serves as a measure of the amount of blood flow through the aperture.
  • a drive for example, in such a way that a setpoint pressure value is kept in the room.
  • the movement of the piston then serves as a measure of the amount of blood flow through the aperture.
  • Such a device is shown in EP 0 223 044 B1.
  • the object of the present invention is to design such a device in such a way that extremely simple measurements can be carried out without the risk of contamination.
  • the main advantage of the present invention is that extremely simple measurements of the amount of blood flow flowing through an aperture of the present device are possible because the device according to the invention has the form of a disposable or disposable part, with which only a single measurement is carried out in each case. There is therefore no risk of contamination. On such REPLACEMENT SHEET Measurement errors due to contamination can therefore be avoided.
  • the present device which is designed as a one-off part, can also be arranged extremely simply in a measuring arrangement, with blood being able to be filled into the storage space of the device in an extremely simple and quick manner in order to carry out the measurement, and the necessary measuring operations for actuating the piston of the device present device and the stirring rod of the same, as well as the positioning of the pressure sensor, are possible by simply and automatically connecting corresponding drives to the device.
  • Another important advantage of the present invention is that there is only a very small dead volume between the piston and the cylinder of the present device, so that measurements are possible even with very small amounts of blood.
  • FIG. 1 partly in section, the side view of a preferred embodiment of the device according to the invention for examining the aggregation and / or the coagulation and / or the viscosity of the blood;
  • Figure 2 shows a section through the device according to the invention along the line II-II of Figure 1;
  • FIG. 3 shows a section through the device according to the invention along the line III-III of Figure 1;
  • the measuring arrangement comprising a drive for moving the tension rod of the piston, a drive for moving the stirring rod, a drive for positioning the pressure sensor and a drive for locking and releasing the device according to the invention in the measuring arrangement by moving a slide part in a measuring position or in a release position;
  • FIG. 7a shows a view of the fork part of the slide part from above, the fork part being in the release position and the measurement position being indicated schematically by a broken line;
  • FIGS. 8a and 8b show a preferred embodiment of the coupling of the tension rod to the piston of the device according to the invention
  • FIGS. 9a and 9b show a further preferred embodiment of the coupling of the tension rod to the piston of the device according to the invention.
  • Figure 10 shows another preferred embodiment of the piston / cylinder arrangement of the device according to the invention.
  • the device according to the invention for measuring the aggregation of the platelets or the coagulation of the blood or the viscosity of the blood is designated by 1 in FIG.
  • This essentially comprises a housing 2, a piston 5, a cylinder 4 and a stirring device 10, 11, 12 and 13.
  • the housing 2 is essentially tubular, as is also shown in FIGS. 2 and 3, wherein it is closed at its lower end by a bottom wall 60 and is open at its upper end.
  • the side wall of the housing 2 is designated 61.
  • This side wall 61 has at its upper end a radially outwardly projecting flange 15 surrounding the upper opening of the housing 2.
  • the side wall 61 of the housing 2 has a further, preferably rectangular bulge, which is formed by side wall areas 63, 64 and 65 is formed, as shown in Figures 1, 2 and 3.
  • the side wall region 63 has a slot-shaped opening 14 which runs in the longitudinal direction of the housing 2 and extends approximately over the length of the upper third of the housing 2. The function of this further bulge 63 to 65 and the slot-shaped opening 14 will be explained in more detail later.
  • a tubular cylinder 4 which has at its upper, open end an annular, radially outwardly projecting flange 17 which rests on the upper edge of the tubular housing 2.
  • the cylinder 4 and the housing preferably each have an annular cross section.
  • the cylinder 4 is closed by a bottom wall 66 which is connected in a manner known per se to a suction tube 6 which projects into the storage space 8 and ends shortly before the bottom wall 60 of the housing 2.
  • the suction tube 6 is operatively connected to an opening 67 arranged in the bottom wall 66 of the cylinder 4, which in turn is connected to the interior of the cylinder 4 via an aperture 7.
  • the aperture 7 can be arranged in an aperture holder 71 which is inserted tightly into the opening 67.
  • the bottom wall 66 preferably has an annular projection 68 adjoining the opening 67, which forms an extension of the opening 67 and into which the end of the suction tube 6 facing away from the bottom wall 60 is inserted in a sealed manner.
  • the suction tube 6 can also have a very small diameter for certain measurement purposes, so that it forms a capillary similar to a blood vessel.
  • the piston 5 which is in the direction of the arrow 70, that is to say in the longitudinal direction of the vessel 2, is movable, the outer wall of the piston 5, which preferably also has an annular cross section, being sealed with respect to the inner wall of the cylinder 7.
  • the diameter of the piston 5 is dimensioned such that there is a relatively small gap 72 between its outer wall and the inner wall of the cylinder 17.
  • the piston 5 is preferably hollow and closed at its lower end by a bottom wall 73.
  • the space corresponding to the gap 72 between the piston 5 and the cylinder 4 is connected at the upper end of the cylinder 4 to an opening 16, which is preferably arranged in the region of the flange 17 of the cylinder 2 and for measurement in the manner explained in more detail later of the pressure prevailing in the space mentioned.
  • stirring device 10, 11, 12 and 13 which essentially consists of a lower, preferably annular disc-shaped stirring part 11 and a rudder rod 10, which in the longitudinal direction of the housing 2 in the bulge 63, 64 and 65 runs, and has at its upper end a through the slot-shaped opening 14 radially outwardly beyond the side wall region 63 extension 13 with which the rudder rod 10 can be moved parallel to the arrow 70 up and down.
  • the Ruhr part 11 preferably extends perpendicular to the longitudinal direction of the housing 2 and has a through opening 12 approximately in the center through which the capillary 6 extends. extends. In this way, by moving the stirring rod 10, the stirring part 11 can be moved up and down in the direction of the arrow 70 in the storage space 8 to mix the blood contained in the storage space 8, as will be explained in more detail later.
  • the cylinder 4 sits with the edge region of its bottom wall 76 on a shoulder 75 formed in the housing 2 and is firmly connected to the housing 2.
  • webs 76 which are distributed uniformly over the circumference of the inner wall of the cylinder 4 and each extend in the longitudinal direction, are provided, which extend from the inner wall of the cylinder 4 in the direction of the outer wall of the piston 5, each web 76 preferably forming a tip 77 which is supported on the outer wall of the piston 5.
  • the webs can also be provided on the piston and then supported on the cylinder.
  • the sealing arrangement 18-1 has the shape of an O-ring seal, which is arranged in an inner groove 17-1 of the flange 17 or the upper edge of the piston 4.
  • FIG. 5 shows an embodiment in which the sealing arrangement 18-2 is a so-called duplex Method on the upper surface of the flange 17 made of a comparatively hard material or of the upper edge of the piston 4, which is formed from a soft material and which, for example, consists of a silicon material mixed with graphite.
  • the piston 4 with the flange 17 and the sealing arrangement 18-2 are produced in one and the same pressing operation.
  • the sealing arrangement 18-3 has the shape of an annular sealing lip which is formed on the inside of the flange 17 and which consists of the material of the piston 4 or of the flange 17.
  • the device 1 explained so far has the form of a disposable or disposable part. This has the advantage that no cleaning operations are required when carrying out measurements, because each device is used only once to carry out a measurement. Contamination and measurement errors due to defective cleaning operations can therefore be avoided.
  • Polyethylene is particularly suitable as the material for the device 1, which is preferably produced by an injection molding process.
  • a measuring arrangement 80 for carrying out a measurement with a device 1 is now explained in more detail below.
  • the measuring arrangement 80 has a receiving space 21 for receiving a device 1, the receiving space 21 preferably being complementary to the outer contour of the device 1 is, so that it can only be used in the correct position in the receiving space 21. Accordingly, the receiving space 21 also has receiving areas for the bulges 28 and 63, 64, 65.
  • the measuring arrangement 80 comprises four different drives, namely a first drive 33 for moving a pull rod 32 which can be connected to the piston 5, a second drive 23 for moving the stirring device 10 to 13, a third drive 25 for moving or positioning a pressure sensor S and one fourth drive 27 for moving a slide part 26.
  • the slide part 26 and the first drive 33 and the pull rod 32 which can be actuated by the fourth drive 27 are in a measuring position in which the pull rod 32 can be mechanically connected to the piston 5 and one Release position in which the piston 5 and the pull rod 32 are moved upward and separated from one another and the device 1 can be removed from the receiving space 21, movable.
  • the slide part 26 can preferably be displaced horizontally in the direction of arrow 28 between said measurement position and the release position by the fourth drive 27.
  • the slide part 26 has a fork-shaped part 30 which is pushed in the measuring position over the device 1 located in the receiving space 21 in such a way that the inner edges of the fork parts 82, which can be seen particularly in FIG. 7a, are supported on the upper side of the flange 17 of the cylinder 4, so that the upward movement of the cylinder 4 is effectively avoided if, in the measuring position, the piston 5 is pulled upward by moving the pull rod 32 through the recess enclosed by the fork parts 82, as will be explained in more detail later.
  • the axes of the pull rod 32 and the piston 5 are aligned with one another, so that the pull rod 32 is automatically coupled to the piston 5 by a downward movement of the pull rod 32 can take place in the coupling device 34, as will be explained in more detail later.
  • the device 1 is fixed against rotation when inserted into the receiving space 21 such that the above-mentioned opening 16 is automatically aligned with the direction of movement indicated by the arrow 83 of a pressure sensor S moved by the drive 25, so that the sensor S is complete with the drive 25 is tightly movable into the opening 16 for measuring the pressure prevailing in the space between the cylinder 4 and the piston 5.
  • a holding part 84 on the slide 26 which has a stepping motor 33 as drive 33 for moving the pull rod 32, which pull rod 32 is preferably guided through a bore 85 of the holding part 84 in the direction of arrow 86 can move upwards and downwards, the lower end of the tension rod 32 being mechanically connectable to or separable from the piston 5 in the measuring position by the coupling device 34 shown schematically in FIG.
  • FIGS 8a, 8b and 9a, 9b show preferred embodiments of this coupling device.
  • an internally hollow, hood-like coupling part 50 is formed on the lower end of the pull rod 32, which is divided into two halves on its lower side by a slot running in the longitudinal direction.
  • the cavity surrounded by the hood-like coupling part 50 has at its lower end an inwardly tapering region 90 which serves as a run-in slope for a further coupling part 56 which is attached to the piston 5.
  • the conical region 90 which tapers inwards obliquely inwards, merges into a cylindrical region 91 which extends approximately over the length of the Slit 52 extends, wherein in the transition area between the conically tapering area 90 and the cylindrical area 91, an inner groove 51 is provided in the inner wall of the hood-shaped coupling part 50, which preferably has a semicircular shape.
  • the cavity of the hood-shaped coupling part 50 ends in a central recess 54, into which a central projection 55 of the coupling part 56 of the piston 5 can engage.
  • the transition region between the cylindrical region 91 and the central recess 54 there is a region 53 which tapers conically towards the central region 54 and is complementary to a conical region 57 of the second coupling part 56 of the piston 5.
  • the projection 55 and the conical region 57 of the second coupling part 56 first engage in the cavity of the first coupling part 50 until an annular projection 58, which is radial protrudes beyond the cylindrical region of the second coupling part 56, reaches the region of the conical region 90 which serves as a ramp.
  • the central projection 55 then in the central recess 54 is arranged and the conical areas 53 and 57 abut each other.
  • the hood-shaped first coupling part 50 widens because of the slot 52 to such an extent that the annular projection 58 is pulled out of the inner groove 51.
  • the coupling parts 50 and 56 are then separated from one another.
  • a further embodiment of the piston / cylinder arrangement of the present device 1 is explained in more detail below in connection with FIG. 10, the cylinder 50, the aperture holder 52 and the suction tube 53 being designed in accordance with the embodiment of FIG. 1.
  • a piston 54 is movable, which essentially consists of a piston part 51 with an integrated sealing lip 55 on the periphery of the piston part 51, an extension 80 being integrally formed on the piston part 51 on the side of the piston 54 facing away from the aperture 52 which can be connected to the pull rod 32 via the schematically illustrated coupling device 34.
  • An advantage of this embodiment is the particularly simple design of the piston 54 with the integrated sealing lip 55.
  • a bore 82 which is represented by broken lines in FIG. 10 and ends in an opening 53, which can be connected tightly to a pressure sensor.
  • a coupling device 34 which is particularly suitable for the embodiment of the piston / cylinder arrangement of FIG. 10 will now be explained in connection with FIGS. 8a and 8b.
  • a cylindrical cavity 39 is arranged in the extension 80, the extension 80 in its end region being preferably divided into two halves by a longitudinally extending slot 40.
  • the cylindrical cavity 39 merges at its end facing the rod part 32 into a conically widened opening area 42, an annular inner groove 41 being provided in front of it, which preferably has a semicircular cross section.
  • a projection part 35 is provided, which has a conically tapering end 37 on its end area facing the extension 80 of the piston 54, which end serves as an entry slope.
  • An annular seal 36 is arranged behind the conically tapering region 37, which is preferably seated in an annular recess of the projection part 35.
  • an annular projection 44 on the projection part 35 Spaced in the longitudinal direction from the sealing arrangement 36 is an annular projection 44 on the projection part 35, which is complementary to the inner groove 41 of the extension 80.
  • the projection part 35 is inserted into the cylindrical cavity 39 until the annular Vo 44 reaches the cylindrical cavity 39 via the area 42 serving as a drive-in slope, the end region of the extension 80 divided by the slot 40 being resilient expands until the annular projection 44 engages in the inner groove 41.
  • the seal 36 then creates a tight connection between the projection part 35 and the shoulder 38.
  • the drive 27 is then actuated in such a way that the slide part 26 in the direction of the arrow 28 into the measuring position, i.e. 7, 7a is moved to the right in such a way that the cylinder 4 of the device 1 is prevented from moving in the longitudinal direction, i.e. by the fork arms 82. so upwards, is fixed. This is represented by the broken lines L in FIG. 7a.
  • the pressure sensor S By actuating the drive 25, the pressure sensor S is tightly connected to the opening 16 for measuring the pressure prevailing in the space between the piston 5 and the cylinder 4.
  • the drive rod 32 is moved downward by the drive 33 until the coupling device 34 automatically establishes a mechanical connection between the pull rod 32 and the piston 5.
  • the pull rod 32 is then moved upward by actuating the drive 33 to carry out the measurement, with blood being sucked out of the storage space 8 through the aperture 7 via the suction tube 6.
  • the pressure prevailing in the space between the piston 5 and the cylinder 4 is continuously measured as a measure of the blockage or clogging of the aperture 7 with the aid of the sensor S.
  • the stirring rod 10 By actuating the drive 23, the stirring rod 10 is continuously moved back and forth in the direction of the arrow 24 in the longitudinal direction of the device 1, the blood in the storage space 8 being continuously mixed and kept in motion by the movement of the stirring part 11. It is pointed out that a temperature control device is provided in the housing body 20, which in the storage space during the entire measurement. 8 blood is kept at a predetermined temperature.
  • the piston 5 is moved upwards by actuation of the drive 33 by the pull rod 32 until it comes to rest against the stop part 31 of the slide part 2, the coupling device 34 opening when the pull rod 32 moves upward. so that the piston 5 is automatically separated from the pull rod 32.
  • the present invention relates to a flow device for measuring the platelet function of the primary hemostasis, the aggregation and / or the coagulation and / or the viscosity of the blood, wherein a storage space 8 for blood is arranged in a housing 2, the blood can be removed for measurement and is conveyable through an aperture 7.
  • a stirring device is provided in the storage space 8 and can be moved such that a stirring part 11 of the stirring device mixes the blood in the storage space 8 during the measurement and keeps it moving.
  • the stirring part 11 in the area of the blood supply i.e. So in the storage room 8 has no contact with existing surfaces of wall enclosures or the like. This can prevent blood cells or other components of the blood from being damaged or crushed. This could lead to undesirable distributions of substances, which could lead to falsification of the measurement results.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Urology & Nephrology (AREA)
  • Ecology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

L'invention concerne un dispositif de passage destiné à la mesure de la fonction plaquettaire de l'hémostase primaire, de l'agrégation et/ou de la coagulation et/ou de la viscosité du sang. Ledit dispositif comporte un boîtier (2) contenant un réservoir (8) dans lequel du sang peut être prélevé pour la mesure et transporté au travers d'une ouverture (7). Ledit réservoir (8) contient un mélangeur (10, 11, 12, 13) pouvant être mû de telle manière qu'un élément (11) du mélangeur (10, 11, 12, 13) mélange et maintient en mouvement le sang contenu dans le réservoir (8) lors de la mesure.
EP05714946A 2004-02-09 2005-02-04 Dispositif de passage destine a la mesure de la fonction plaquettaire de l'hemostase primaire, de l'agregation et/ou de la coagulation et/ou de la viscosite du sang Withdrawn EP1714149A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102004006316A DE102004006316A1 (de) 2004-02-09 2004-02-09 Einrichtung zur Messung der Aggregation und/oder der Koagulation und/oder der Viskosität des Blutes
PCT/DE2005/000196 WO2005075985A1 (fr) 2004-02-09 2005-02-04 Dispositif de passage destine a la mesure de la fonction plaquettaire de l'hemostase primaire, de l'agregation et/ou de la coagulation et/ou de la viscosite du sang

Publications (1)

Publication Number Publication Date
EP1714149A1 true EP1714149A1 (fr) 2006-10-25

Family

ID=34801795

Family Applications (1)

Application Number Title Priority Date Filing Date
EP05714946A Withdrawn EP1714149A1 (fr) 2004-02-09 2005-02-04 Dispositif de passage destine a la mesure de la fonction plaquettaire de l'hemostase primaire, de l'agregation et/ou de la coagulation et/ou de la viscosite du sang

Country Status (5)

Country Link
US (1) US7763207B2 (fr)
EP (1) EP1714149A1 (fr)
JP (1) JP4769731B2 (fr)
DE (1) DE102004006316A1 (fr)
WO (1) WO2005075985A1 (fr)

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Publication number Priority date Publication date Assignee Title
US8448499B2 (en) 2008-12-23 2013-05-28 C A Casyso Ag Cartridge device for a measuring system for measuring viscoelastic characteristics of a sample liquid, a corresponding measuring system, and a corresponding method
US10175225B2 (en) 2014-09-29 2019-01-08 C A Casyso Ag Blood testing system and method
US10816559B2 (en) 2014-09-29 2020-10-27 Ca Casyso Ag Blood testing system and method
US10539579B2 (en) 2014-09-29 2020-01-21 C A Casyso Gmbh Blood testing system and method
US10288630B2 (en) 2014-09-29 2019-05-14 C A Casyso Gmbh Blood testing system and method
US11243958B2 (en) 2015-12-31 2022-02-08 Teradata Us, Inc. Implementing contract-based polymorphic and parallelizable SQL user-defined scalar and aggregate functions
US10473674B2 (en) 2016-08-31 2019-11-12 C A Casyso Gmbh Controlled blood delivery to mixing chamber of a blood testing cartridge
US10843185B2 (en) 2017-07-12 2020-11-24 Ca Casyso Gmbh Autoplatelet cartridge device
CN116930517A (zh) * 2023-07-19 2023-10-24 北京汇文源美生物科技有限公司 一种退杯盖机构以及血栓弹力图仪

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JPS5492392A (en) * 1977-12-29 1979-07-21 Toa Medical Electronics Apparatus for measuring osmotic pressure resistance of blood corpuscle
DE3540862A1 (de) 1985-11-18 1987-05-21 Hoopman Onderzoek Ontwikkeling Verfahrbares zerkleinerungs- und austragsgeraet fuer silagebloecke
IL106330A (en) 1993-07-14 1998-01-04 Univ Ramot Method and instrument for determining the activity of their plaques in the initial coagulation system
US5602037A (en) * 1994-06-30 1997-02-11 Dade International, Inc. Combination reagent holding and test device
DE19617407A1 (de) * 1996-04-30 1997-11-06 Michael Kratzer Gmbh Dr Verfahren und Vorrichtung zur Messung der Aggregation der Blutplättchen bzw. der Koagulation des Blutes
US6002475A (en) 1998-01-28 1999-12-14 Careside, Inc. Spectrophotometric analytical cartridge
ES2234349B1 (es) * 2002-04-18 2006-11-01 Servicio De Instrumentacion Hospitalaria, S.L. Dispositivo de medicion de tiempo de coagulacion y actividad plaquetaria y, procedimiento del mismo.
DE20212149U1 (de) 2002-08-07 2003-12-18 Goltz, Volker, Freiherr von der Vorrichtung zur Untersuchung von Eigenschaften der globalen, insbesondere der primären Hämostasefunktionen

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Also Published As

Publication number Publication date
DE102004006316A1 (de) 2005-08-25
JP4769731B2 (ja) 2011-09-07
US20070243105A1 (en) 2007-10-18
US7763207B2 (en) 2010-07-27
JP2007522460A (ja) 2007-08-09
WO2005075985A1 (fr) 2005-08-18

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