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EP2349010A1 - Dispositif et procédé pour le diagnostic et le pronostic précoces de processus cicatriciels, en particulier en présence de lésions osseuses - Google Patents

Dispositif et procédé pour le diagnostic et le pronostic précoces de processus cicatriciels, en particulier en présence de lésions osseuses

Info

Publication number
EP2349010A1
EP2349010A1 EP09736171A EP09736171A EP2349010A1 EP 2349010 A1 EP2349010 A1 EP 2349010A1 EP 09736171 A EP09736171 A EP 09736171A EP 09736171 A EP09736171 A EP 09736171A EP 2349010 A1 EP2349010 A1 EP 2349010A1
Authority
EP
European Patent Office
Prior art keywords
analysis
unit
sample
receiving unit
analysis unit
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Withdrawn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
EP09736171A
Other languages
German (de)
English (en)
Inventor
Georg Duda
Ulrike Lehnigk
Ansgar Petersen
Juliane GLÄSER
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.)
Charite Universitaetsmedizin Berlin
Original Assignee
Charite Universitaetsmedizin Berlin
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 Charite Universitaetsmedizin Berlin filed Critical Charite Universitaetsmedizin Berlin
Publication of EP2349010A1 publication Critical patent/EP2349010A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/414—Evaluating particular organs or parts of the immune or lymphatic systems
    • A61B5/415—Evaluating particular organs or parts of the immune or lymphatic systems the glands, e.g. tonsils, adenoids or thymus
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/02—Burettes; Pipettes
    • B01L3/021—Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids
    • B01L3/0217—Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids of the plunger pump type
    • B01L3/0224—Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids of the plunger pump type having mechanical means to set stroke length, e.g. movable stops
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/0064—Devices for taking samples of body liquids for taking sweat or sebum samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/007—Devices for taking samples of body liquids for taking urine samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0096—Casings for storing test samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B2010/0067—Tear or lachrymal fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B2010/0077—Cerebrospinal fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B2010/008—Interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0631—Purification arrangements, e.g. solid phase extraction [SPE]
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0681—Filter
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0478—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure pistons

Definitions

  • the present invention achieves this object by providing a device comprising: i) a sample receiving unit, wherein the sample receiving unit has a cavity for receiving sample material, means for the controlled and / or controllable exertion of pressure on cavity located in the cavity
  • Sample receiving unit can be fed directly to the analysis unit, wherein the first filter between the inlet and the reservoir is arranged so that in Substantially liquid constituents of the sample material can be transferred from the inlet through the filter into the reservoir, and wherein the reservoir and analyzer rail are arranged and configured such that filtrate can be transferred from the reservoir into the analysis rail; wherein the outlet of the sampling unit is connected in a fluid-tight manner directly to the inlet of the analysis unit.
  • a sample material located in the cavity is pressurized and one, several or all components of the sample material are moved from the cavity in the direction of the outlet.
  • constituents of the sample material can be transferred via the outlet to the inlet of an analysis unit which is connected directly to the sample receiving unit in a liquid-tight manner.
  • constituents of the sample material are pressed against the first filter from the inlet of the analysis unit, wherein the first filter permits the passage of substantially liquid constituents of the sample material into the adjoining reservoir, while substantially solid Components do not pass the first filter and thus can not pass into the reservoir.
  • the first filter of the analysis unit thus takes place a separation of substantially solid and liquid components of the sample material, wherein the separation driven by actuation of the means for regulating and / or controllable exertion of pressure of the sample receiving unit and determined by the nature and design of the first filter becomes.
  • the filtrate now in the reservoir can be fed to the subsequent analysis rail.
  • the supply of filtrate from the reservoir into the analysis rail can passively, for example by diffusion events, or actively, for example by the means for regulating and / or controllable exertion of pressure of the sample receiving unit, take place.
  • the filtrate is fed to a detection reaction, the result of which may then be read on or off the analysis rail.
  • An advantage of the device according to the invention is that, irrespective of the consistency of the sample matehal, which is to be supplied to a parameter analysis, an analysis of substantially liquid constituents of the sample material can be carried out quickly and easily, without the need for elaborate sample processing steps.
  • sample receiving unit and analysis unit are connected to one another directly and in a liquid-tight manner, it is possible in one step to extract essentially liquid constituents of a sample material and to supply them specifically and directly to an analysis.
  • both the extraction of the sample material as well as their extraction and analysis can be done on site. It is no longer necessary to use a plurality of optionally spatially separate methods and / or devices.
  • the device according to the invention can be made of sterile or sterilizable material, in particular steam and / or pressure-stealable material, such as e.g. of metals, alloys or plastics, so that the device according to the invention can also be used directly in a sterile environment, e.g. an operating room can be used.
  • sterile or sterilizable material in particular steam and / or pressure-stealable material, such as e.g. of metals, alloys or plastics, so that the device according to the invention can also be used directly in a sterile environment, e.g. an operating room can be used.
  • the device according to the invention, the sample receiving unit and / or the analysis unit can be realized in each case or together as a structural unit.
  • a structural unit is understood to mean an arrangement of one or more elements which, for the purpose of intended use, are permanently, possibly irreversibly, connected to one another.
  • a structural unit can for this purpose have a housing surrounding the structural unit.
  • the device according to the invention is preferably configured and dimensioned in such a way that the device can be carried, and the device according to the invention is particularly preferably portable with one hand.
  • the sample receiving unit according to the invention has at least one cavity for receiving sample material, an outlet and means for the controllable and controllable exertion of pressure on sample material located in the cavity.
  • the elements of the sample receiving unit are configured and arranged such that components of the sample material can be transferred from the cavity by actuation of the means for regulating and / or controllable application of pressure via the outlet directly to an analysis unit which can be connected to or connected to the outlet.
  • sample material biological material which can be taken from an organism or material containing such biological material, e.g. a tamponade loaded with tissue, cells and / or body fluid.
  • biological material may be tissue, bone, cartilage, tendons and / or cells and / or body fluids such as blood, plasma, serum, synovial fluid, urine, stool, interstitial fluid, lymph, saliva, sweat, spinal fluid and / or tear fluid.
  • the sample receiving unit may have a basic body, preferably a substantially cylindrical basic body, which encloses the cavity or into which the cavity is formed.
  • the sample receiving unit preferably has means at a first end of the main body for the controlled and / or controllable exertion of pressure on sample material located in the cavity and an outlet at an end opposite the first end.
  • the cavity between the means for regulating and / or controllable exertion of pressure and the outlet is arranged, so that upon actuation of the means for regulating and / or controllable exertion of pressure, components of the sample material from the cavity to the outlet are movable.
  • the means for the controlled and / or controllable exertion of pressure on sample material located in the cavity is in particular designed such that a directed pressure can be exerted, so that components of the Sample material are preferably movable in a particular direction, in particular in the direction of the outlet of the sample receiving unit.
  • the means for the regular and / or controllable exertion of pressure can comprise a piston which can be pressed into the cavity.
  • the sample receiving unit according to the invention can be designed in such a way that, if necessary, sample material already obtained in advance (for example a tamponade impregnated with body fluid) can be introduced into the cavity from the outside.
  • sample material already obtained in advance for example a tamponade impregnated with body fluid
  • the sample receiving unit may have an additional, possibly closable, access to the cavity.
  • the sample receiving unit according to the invention can be designed as a squeezing unit.
  • the sample receiving unit has on its base body an opening for loading the cavity with sample material, a means for the controlled and / or controllable exertion of pressure, e.g. in the form of a piston, and an outlet opposite the means for the regular and / or controllable exertion of pressure.
  • a means for the controlled and / or controllable exertion of pressure e.g. in the form of a piston
  • an outlet opposite the means for the regular and / or controllable exertion of pressure e.g. in the form of a piston
  • such Auspresstechniken are suitable for the use of sample material in the form of a tamponade, the tamponade was previously introduced into the wound and there has absorbed liquid ingredients.
  • the tamponade is heparanized for sampling.
  • the tamponade loaded with the sample may then be transferred to a sample receiving unit, e.g. be supplied in the form of a squeezing unit, which allows, e.g. by extruding the tamponade, to provide constituents of the sample material of an analysis device according to the invention.
  • a sample receiving unit e.g. be supplied in the form of a squeezing unit, which allows, e.g. by extruding the tamponade, to provide constituents of the sample material of an analysis device according to the invention.
  • the sample receiving unit can also be designed, for example, as a syringe or as a suction punch.
  • Preferred sampling devices such as e.g.
  • Syringes or suction punches allow to take sample material directly from the human or animal body in one way, so that components of the sample material can be analyzed immediately after the removal in a directly connected to the sample receiving unit liquid-tightly connected or connectable analysis unit, without further sample preparation steps may be necessary in other containers.
  • the sampling unit is designed so that it allows the removal of a sample at the point of interest, that is, for example, at the site of injury and / or healing.
  • Sampling units suitable for this purpose are, for example, syringes and / or punch biopsy devices with / without a vacuum device, e.g. a suction punch.
  • the analysis unit for use in the device according to the invention has at least one inlet, a first filter, a reservoir and an analysis rail.
  • the inlet is designed such that it can be connected to an outlet of the sample receiving unit such that constituents of the sample material from the sample receiving unit can be fed directly to the analysis unit.
  • the term "immediate” is understood to mean that the outlet of the sample receiving unit and the inlet of the analysis unit are in direct contact with each other, without such means or devices between outlet and inlet, which are provided by means for direct, liquid-tight connection, such as For example, tubular bodies, tubular bodies and / or annular bodies differ.
  • the first filter is arranged between inlet and reservoir, so that substantially liquid components of the sample material can be transferred from the inlet through the filter into the reservoir.
  • the analysis unit is designed such that a transfer of sample material from the inlet into the reservoir is possible only through the first filter.
  • the first filter is configured to separate solid from liquid sample components and preferably to allow the passage of substantially liquid components of the sample material and solutes therein, such as Eg proteins and hormones, allowed.
  • the first filter is preferably selected so that it has a pore size that allows at least the passage of such substances whose presence is to be determined later in the analysis bar in a detection reaction.
  • the choice of the first filter thus depends on the nature and nature of the parameters to be determined in the analysis rail and can be determined and determined by the skilled person without undue burden.
  • the first filter preferably has a pore size of, for example, ⁇ 10 .mu.m, particularly preferably ⁇ 5 .mu.m, very particularly preferably ⁇ 1 .mu.m.
  • the filter is preferably configured to withstand the pressure that must be expended to release a substantial amount of substantially liquid constituents of the sample material from the sample and to move through the first filter into the reservoir.
  • the analysis unit according to the invention may have one or more further filters which are arranged between inlet and first filter.
  • These additional second filters can serve to prepare, comminute and / or digest the sample material so that the most effective possible transfer of substantially liquid constituents of the sample material is made possible at the first filter.
  • These further, second filters preferably have a pore size which is ⁇ 200 ⁇ m, preferably ⁇ 150 ⁇ m, particularly preferably ⁇ 75 ⁇ m.
  • the first and / or each additional filter is heparinized.
  • the analysis unit In the analysis unit according to the invention reservoir and analysis rail are arranged and configured such that filtrate from the reservoir into the analysis rail can be transferred.
  • the reservoir is positioned in the direction of flow of the substantially liquid constituents of the sample material between the first filter and the analysis rail.
  • the analysis unit is functionally connected to a sampling unit in such a way that the essentially liquid constituents of the sample material contained in the cavity of the sample receiving unit are separated by the first filter the reservoir of the analysis unit are transferable, wherein the solid components of the Probenmatehals are retained by the filter and not supplied to the analysis unit.
  • the selection of the first filter limits the size of substances present in the filtrate of the sample material.
  • the filter is mounted in the analysis unit so as to preferably allow passage of substantially liquid components of the sample from the sampling device into the reservoir.
  • the reservoir is designed to receive the filtrate after it has passed through the filter and to make the analysis bar accessible in such a way that detection of the parameters and / or factors in the filtrate in the analysis bar is possible. Possibly. the reservoir has a venting device.
  • the passage of substantially liquid constituents through the first filter can be effected, for example, by actuation of means for the controllable and controllable exertion of pressure on the sample material in the sample receiving unit.
  • the reservoir is adjoined by a reservoir such that this reservoir receives as the filtrate the substantially liquid constituents of the sample material which have passed through the first filter.
  • the reservoir may have an additional opening.
  • This optional opening is provided in addition to the opening for connection to the first filter and the opening for connection to the analysis rail.
  • the additional opening may be provided to avoid, for example, an overpressure situation in the reservoir during the intake of filtrate into the reservoir or to provide the possibility to supply the filtrate more liquids or reagents before the filtrate enters the analysis rail.
  • This additional opening may be designed to be closable, preferably this additional opening is reversibly or irreversibly closed or closed.
  • the opening may be provided, for example, with a membrane, a lid and / or a bursting device.
  • the reservoir is located between the first filter of the analysis unit and the analysis rail.
  • the reservoir is connected to the analysis rail, that a transfer of filtrate from the reservoir is made possible in the analysis rail.
  • This transfer can be done, for example, by passive means, such as diffusion mechanisms and / or capillary forces.
  • the transfer can also be actively mediated, for example, by the means for the controlled and / or controllable exertion of pressure of the sample receiving unit.
  • the analysis rail adjoins the reservoir in such a way that filtrate can be transferred from the reservoir into the analysis rail and examined there for the presence of one or more specific, previously defined parameters and / or factors.
  • the analysis bar is designed to enable detection of one or more selected, predetermined parameters in the filtrate from the reservoir.
  • the analysis rail can have a region which serves to receive filtrate from the reservoir and a region which is functionally connected thereto, optionally separated, and which serves to carry out a detection reaction. Depending on the intended detection reaction, selected parameters and / or factors can be determined.
  • the filter may be the presence or absence of certain one or more substances, such as proteins, hormones, nucleic acids, and / or other filtrate-insoluble substances not precluded by the filter.
  • ELISA enzyme-linked immunosorbent assay
  • the analysis bar also contains control mechanisms which make it possible to ascertain whether the detection reaction has also proceeded properly and specifically.
  • the analysis rail can be designed so that the result of the measurement is directly readable. Preferably, no further steps are necessary to be able to read the result of the measurement from the outside.
  • the representation of the measurement result can be configured as a color reaction.
  • the absorption of filtrate from the reservoir into the analysis rail can take place actively or passively.
  • the sample receiving unit according to the invention and / or the analysis unit according to the invention can be configured such that filtrate from the reservoir can be passively and / or actively transferred into the analysis rail.
  • This shot may e.g. by passive means, such as means for utilizing diffusion mechanisms, e.g. along a membrane or test strip, and / or by means of capillary action or the like. respectively.
  • the recording can also be actively mediated, for example, by the means for regulating and / or controllable application of pressure to the sample receiving unit.
  • the analysis bar of the analysis unit according to the invention preferably has a test strip which is configured and arranged such that filtrate can be passively removed from the reservoir by means of the test strip and fed to a detection reaction arranged on the test strip.
  • the test strip may comprise means for a detection reaction in ELISA format.
  • sample receiving unit and the analyzing unit are directly connected to one another in a fluid-tight manner.
  • a liquid-tight connection is understood here to mean any connection which, when the device according to the invention is in operation, permits substantially no leakage of liquid at the connection between the sampling unit and the analysis unit.
  • sample receiving unit and analysis unit may be irreversibly connected to one another, eg as a structural unit.
  • Sample receiving unit and analysis unit can be reversibly connected or connectable connected. Under a reversible connection is understood a compound that can be restored liquid-tight after a separation.
  • sample receiving unit and / or analysis unit may comprise means for reversible, liquid-tight connection, so that the outlet of the sample receiving unit is liquid-tight connectable to the inlet of the analysis unit.
  • Such means may comprise means for liquid-tight screw and / or plug connections as well as combinations thereof.
  • the means comprises means for a liquid-tight screw connection, for example a combination of complementary inner and outer threads with or without additional intervening seal (s).
  • the sample receiving unit may have an internal thread and the analysis unit an external thread, which are complementary to each other and allow the formation of a liquid-tight connection.
  • the sample receiving unit may have an external thread and the analysis unit an internal thread which are complementary to one another and allow the formation of a liquid-tight connection.
  • the invention additionally discloses a method for the early analysis of sample material comprising the steps of: a) obtaining sample material; b) transfer of recovered sample material into a cavity of a sample receiving unit according to the invention; c) direct transfer of liquid components of the sample material from the sample receiving unit into a reservoir of an analysis unit according to the invention; d) direct transfer of liquid components of the sample material from the reservoir into the analysis bar of the analysis unit by means of passive and / or active means; and e) reading the analysis result from the analysis bar of the analysis unit.
  • the invention also relates to a method for generating a prognosis for an expected healing process, comprising the steps: a) obtaining a sample from the tissue of interest, b) transferring liquid constituents of the sample into an analysis unit according to the invention, c) carrying out the measurement by means of the analysis unit according to the invention, d) reading the results of the measurement.
  • the method is suitable for generating a prognosis for an anticipated healing process in the case of bone injuries, wherein the analysis unit according to the invention is designed such that the presence of factors, e.g. of pro- and anti-inflammatory cytokines or proteases, respectively, in which liquid sample components are measured.
  • factors e.g. of pro- and anti-inflammatory cytokines or proteases, respectively, in which liquid sample components are measured.
  • the present invention also relates to a sample receiving unit described above and / or to an analysis unit described above, each for use in a device according to the invention.
  • the invention also relates to a kit comprising an analysis unit according to the invention, a sample receiving unit according to the invention and / or a device according to the invention.
  • the analysis unit, sample receiving unit or device according to the invention can be used to generate a prognosis for an expected healing process.
  • the assay unit of the present invention can be used to determine the presence of factors in healing tissue, particularly pro-and anti-inflammatory cytokines or proteases.
  • the healing tissue is preferably tissue which has been obtained during a bone operation, for example for the treatment of a bone fracture or for the use of an endoprosthesis.
  • the invention makes it possible for the first time in bone injuries to decide on a therapy with BMP-2 administration early, even during the operation, and not only after an otherwise usual 6-month follow-up period.
  • the invention makes it possible to take a suitable sample already in the operating room and, by determining the presence of suitable factors, such as BMP-2, MMP-2 and / or VEGF in this sample, to produce a prognosis for an expected healing process and thus a decision-making aid to provide for early initiation of appropriate therapy, possibly therapy with BMP-2 administration.
  • suitable factors such as BMP-2, MMP-2 and / or VEGF
  • the new procedure allows prognosis already during the first operation, so that a corresponding treatment can be connected directly. A second operation for treatment can thus be avoided.
  • a particular advantage of devices comprising an analysis unit according to the invention and a sampling device, wherein the analysis unit is operatively connected to the sampling device so that liquid sample components from the sampling device can be transferred to the analysis unit, is that the sample is removed after removal and until the delivery of the sample Result does not need to be transferred to another container.
  • the present invention also relates to:
  • An analysis unit which is adapted to a sampling devices or designed to be operatively connected, comprising at least one filter, a reservoir and an analysis rail.
  • a device comprising said analysis unit and a sampling device, wherein the analysis unit is operatively connected to the sampling device such that liquid Sample components from the sampling device in the analysis unit can be transferred.
  • a method for generating a prognosis for an expected healing process comprising the steps of: a) obtaining a sample from the tissue of interest, b) transferring the liquid constituents of the sample into such an analysis unit, c) carrying out the measurement by means of such an analysis unit, d) Reading the results of the measurement.
  • FIG. 1 shows a schematic representation of a device according to the invention
  • Device in the sample receiving unit and analysis unit are irreversibly connected to each other.
  • FIG. 2 schematically shows the mode of operation of the device from FIG. 1 in FIGS. 2 A, B and C.
  • FIG. 3 shows a schematic representation of an embodiment of a
  • Sample receiving unit in the form of a squeezing unit.
  • FIG. 4 shows in A a sample receiving unit in the form of a suction punch and in B a recording of sample material in the suction punch is shown schematically.
  • FIG. FIG. 5 schematically shows the mode of operation of FIG. 5 A, B and C
  • a sample receiving unit of Fig. 4 consisting of a sample receiving unit of Fig. 4 and an analysis unit.
  • FIG. 6 shows a sample receiving unit in the form of a suction punch in FIG.
  • 1 device comprising sample receiving unit and analysis unit
  • Example 1 First embodiment of a device according to the invention
  • FIG. 1 schematically shows a first embodiment of a device according to the invention with sample material arranged in the cavity.
  • This is a device 1, in which sample receiving unit 20 and analysis unit 30 are irreversibly connected to one another, as a structural unit.
  • the sample receiving unit 20 has a substantially cylindrical base body 21 in which a cavity 24 for receiving sample material 40 is accessible via an opening 23.
  • the sample receiving unit 20 has a piston 22 for the regular and / or controllable exertion of pressure on the sample material 40 located in the cavity 24.
  • the sample receiving unit 20 has an outlet 25, which is connected directly and in a liquid-tight manner to the analysis unit 30.
  • the inlet 31 of the analysis unit 30 is immediately and irreversibly connected to the outlet 25, liquid-tightly connected. Between the inlet 31 and reservoir 33 of the analysis unit 30, the first filter 32 is arranged, so that sample material can only pass through the first filter 32 from the inlet 31 into the reservoir 33.
  • the reservoir 33 has an additional opening 34. To the reservoir 33, the analysis rail 35 connects.
  • Fig. 2 A, B and C The operation of the device 1 is shown in an overview in Fig. 2 A, B and C.
  • a pressure is exerted on sample material 40 by pressing in piston 22.
  • FIG. 2A by injecting the piston 22, the sample material 40 is conveyed out of the cavity 24 via the outlet 25 from the sample receiving unit 20 and via the inlet 31 the analysis unit 30 supplied.
  • the analysis unit 30 the sample material 40 abuts the filter 32 and by the pressure exerted by the pressing of the piston 22 on the sample material 40, substantially liquid components of the sample material 40 are now pressed as a filtrate 41 through the filter 32.
  • the filtrate 41 collects in the reservoir 33 of the analysis unit, so that the sample receiving area of the analysis rail 35 is now in contact with and can receive filtrate 41.
  • filtrate 41 is taken up from the reservoir 33 from the analysis rail 35 and reaches a portion of the analysis rail in which a detection reaction in ELISA format is applied.
  • the detection reaction is triggered and the test result can be read from the outside as color marking on the analysis rail 35 after the detection reaction has been carried out.
  • Example 2 Sample receiving unit in the form of a squeezing unit
  • FIG. 3 schematically shows an embodiment of a sample receiving unit 20 in the form of a squeezing unit.
  • the extrusion unit 20 has an im
  • Substantially cylindrical base body 21 with an opening 23 through which a cavity 24 for receiving sample material is accessible.
  • the ejection unit 20 has means for the controlled and / or controllable exertion of pressure on sample material located in the cavity 24 in the form of a piston 22 which can be pressed into the cavity 24.
  • the ejection unit 20 has means for the controlled and / or controllable exertion of pressure on sample material located in the cavity 24 in the form of a piston 22 which can be pressed into the cavity 24.
  • the opposite end of the first end of the base body 21 has the
  • Outlet 25 can be transferred directly to a connectable to the outlet 25 analysis unit.
  • the extrusion unit 20 has means for reversible, liquid-tight connection with an analysis unit in the form of a thread 26 for a screw connection.
  • the squeezing unit 20 can serve, for example, to squeeze out a tamponade laden with body fluid and to supply components of the sample material directly to an analysis unit connected to the squeezing unit 20.
  • Example 3 Second embodiment of a device according to the invention
  • a sample receiving unit 20 is shown in the form of a suction punch and the recording of sample material is presented schematically.
  • the sample receiving unit 20 in the form of a suction punch has a substantially cylindrical base body 21, a cavity 24 for receiving sample material, a piston 22, which is driven by a prestressed, lockable return spring 29, a thread 26 and an outlet opening 25 at its End 27 has cut edges.
  • the sample receiving unit 20 in the form of a suction punch can be loaded with sample material by inserting the outlet end 27 into the biological material of interest and releasing the piston 22 by releasing the locked return spring 29. As a result, the piston is moved away from the outlet end and generates a negative pressure, is absorbed through the sample material via the outlet 25 into the cavity 24 of the suction punch.
  • the sample receiving unit 20 in the form of a suction punch is now loaded with sample material 40.
  • the device 1 according to the invention is now assembled from the sample receiving unit 20 in the form of a suction punch and an analysis unit 30 by reversible, liquid-tight, direct screw connection via the complementary threaded parts 26 of the sample receiving unit and 37 of the analysis unit.
  • the sample material 40 is transferred to the analysis unit 30 and, as shown in FIG. 5B, the filtrate 41 enters the reservoir 33.
  • the filtrate 41 is introduced into the analysis rail 35 and after the detection reaction, the measurement result on the analysis rail 35 as a color reaction is read (see Fig. 5 C).
  • Example 4 Sample receiving unit in the form of a suction punch
  • FIG. 6 an embodiment of a sample receiving unit 20 in the form of a suction punch is shown schematically, in Fig. 6 A in general view, in Fig. 6 B in sectional view, in Fig. 6 C in detail view.
  • the sample receiving unit 20 in the form of a suction punch has a substantially cylindrical base body 21. At a first end of the main body 21, the sample receiving unit 20 in the form of a suction punch a piston 22 with a return spring 29 (not shown here) and a trigger 28, wherein the trigger locked to a grid 28a and a spring or a cylinder elastic material 29 is biased. At the end of the main body 21 opposite the first end, the sample receiving unit 20 in the form of a suction punch has an outlet with an outlet end 27 with a cutting edge.
  • the sample receiving unit 20 in the form of a suction punch means for reversible, liquid-tight connection with an analysis unit in the form of a thread 26 for a screw connection.
  • the return spring 29 causes the piston 22 to be moved away from the outlet end 27. The result is a negative pressure and there is a recording of sample material in the cavity 24 of the suction punch. If the suction punch has been connected to an analysis unit via the thread 26 directly and in a liquid-tight manner, sample material from the suction punch can be transferred into the analysis unit by pressing in the piston 22.

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

Abstract

L'invention porte sur un dispositif comprenant : i) une unité réceptrice d'échantillon (20), l'unité réceptrice d'échantillon (20) comportant une cavité (24) destinée à recevoir un matériau échantillon, des moyens (22) pour exercer d'une manière réglable et/ou pilotable une pression sur le matériau échantillon se trouvant dans la cavité, et un orifice de sortie (25), l'orifice de sortie (25) étant disposé et configuré de telle sorte que des constituants du matériau échantillon puissent, à partir de la cavité (24), et par manœuvre des moyens (22) pour exercer d'une manière réglable et/ou pilotable une pression, être envoyés directement, à travers l'orifice de sortie (25), à une unité d'analyse (30) pouvant être reliée à l'orifice de sortie (25); et ii) une unité d'analyse (30), l'unité d'analyse (30) comportant un orifice d'entrée (31), un premier filtre (32), un réservoir (33) et un rail d'analyse (35), l'orifice d'entrée (31) étant configuré de façon à pouvoir être relié à un orifice de sortie (25) de l'unité réceptrice d'échantillon (20) de telle sorte que des constituants du matériau échantillon puissent être directement envoyés de l'unité réceptrice d'échantillon (20) à l'unité d'analyse (30), le premier filtre (32) étant disposé entre l'orifice d'entrée (31) et le réservoir (33), de telle sorte que des constituants sensiblement liquides du matériau échantillon puissent être envoyés, à partir de l'orifice d'entrée (31) et en passant par le filtre (32), dans le réservoir (33), le réservoir (33) et le rail d'analyse (35) étant disposés et configurés de telle sorte que le filtrat puisse être évacué du réservoir (33) pour pénétrer dans le rail d'analyse (35); l'orifice de sortie (25) de l'unité réceptrice d'échantillon (20) étant directement relié, d'une manière étanche aux liquides, à l'orifice d'entrée (31) de l'unité d'analyse (30).
EP09736171A 2008-10-01 2009-10-01 Dispositif et procédé pour le diagnostic et le pronostic précoces de processus cicatriciels, en particulier en présence de lésions osseuses Withdrawn EP2349010A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10171608P 2008-10-01 2008-10-01
PCT/EP2009/062759 WO2010037816A1 (fr) 2008-10-01 2009-10-01 Dispositif et procédé pour le diagnostic et le pronostic précoces de processus cicatriciels, en particulier en présence de lésions osseuses

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EP2349010A1 true EP2349010A1 (fr) 2011-08-03

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EP09736171A Withdrawn EP2349010A1 (fr) 2008-10-01 2009-10-01 Dispositif et procédé pour le diagnostic et le pronostic précoces de processus cicatriciels, en particulier en présence de lésions osseuses

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US (1) US20110230737A1 (fr)
EP (1) EP2349010A1 (fr)
WO (1) WO2010037816A1 (fr)

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Publication number Priority date Publication date Assignee Title
EP3608664B1 (fr) * 2013-05-24 2025-10-29 Premier Biotech, LLC Dispositif de test de fluide buccal à multiples stades
US11008631B2 (en) 2013-10-22 2021-05-18 Ilex Medical Ltd. Kit and method for collecting body fluid for medical diagnosis
EP3600669A4 (fr) * 2017-03-24 2020-12-23 Universal Biosensors, Pty. Ltd. Dispositifs et procédés de pré-traitement d'échantillon
GB2605429A (en) * 2021-03-31 2022-10-05 Mint Diagnostics Ltd Collection device for bodily fluids

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US4418702A (en) * 1981-01-12 1983-12-06 Metpath Inc. Method and apparatus for collecting saliva
US20020015663A1 (en) * 1989-09-21 2002-02-07 Andrew S. Goldstein Oral collection device and kit
DE19809702A1 (de) * 1998-03-06 1999-09-16 Hesch Rolf Dieter Vorrichtung zur Bestimmung von Testosteron
EP1414345A2 (fr) * 2001-02-26 2004-05-06 Ben-Ami Ballin Seringue et procede d'utilisation de cette derniere lors des analyses de sang
US20050059165A9 (en) * 2002-01-31 2005-03-17 Davis James O. Universal sample collection and testing system
AU2005216692B2 (en) * 2004-02-23 2010-04-22 Systagenix Wound Management Ip Co. B.V. Diagnostic swab and biopsy punch systems, and diagnostic caps for use in such systems
US20070128070A1 (en) * 2005-12-01 2007-06-07 Yuzhang Wu Devices and methods for detecting analytes in fluid samples

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US20110230737A1 (en) 2011-09-22

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