WO2021028544A1 - Récipient d'échantillonnage médical comportant un champ d'essai et une unité d'absorption - Google Patents

Récipient d'échantillonnage médical comportant un champ d'essai et une unité d'absorption Download PDF

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Publication number
WO2021028544A1
WO2021028544A1 PCT/EP2020/072788 EP2020072788W WO2021028544A1 WO 2021028544 A1 WO2021028544 A1 WO 2021028544A1 EP 2020072788 W EP2020072788 W EP 2020072788W WO 2021028544 A1 WO2021028544 A1 WO 2021028544A1
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WO
WIPO (PCT)
Prior art keywords
fluid
sample
container
extraction
test
Prior art date
Application number
PCT/EP2020/072788
Other languages
German (de)
English (en)
Inventor
Janik WALDEMAR
Peter MANDRY
Franco Teltow
Anne Zygmanowski
Original Assignee
B. Braun Melsungen Ag
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 B. Braun Melsungen Ag filed Critical B. Braun Melsungen Ag
Publication of WO2021028544A1 publication Critical patent/WO2021028544A1/fr

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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
    • G01N33/4875—Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; 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
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A61J1/12—Bag-type containers with means for holding samples of contents
    • 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
    • B01L3/0289—Apparatus for withdrawing or distributing predetermined quantities of fluid
    • B01L3/0293—Apparatus for withdrawing or distributing predetermined quantities of fluid for liquids
    • B01L3/0296—Apparatus for withdrawing or distributing predetermined quantities of fluid for liquids from piercable tubing, e.g. in extracorporeal blood sampling
    • 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
    • B01L2200/0684—Venting, avoiding backpressure, avoid gas bubbles
    • 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
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/143—Quality control, feedback systems
    • 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
    • B01L2300/069—Absorbents; Gels to retain a fluid
    • 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
    • B01L2400/0481—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure squeezing of channels or chambers

Definitions

  • the present invention relates to a medical fluid sample extraction system with a medical sample / extraction container for receiving a fluid to be examined, in particular a body fluid or a fluid coming into contact with such, from a fluid line and / or fluid collection system, in particular a catheter or a Collection container.
  • body fluids or fluids in contact with them take place.
  • An example of this is examining urine (urinalysis).
  • body fluids are collected in closed containers (e.g. catheters, urine bags).
  • a urinalysis can be carried out, for example, by dipping commercially available test strips into the urine, which is located in a test vessel for this purpose.
  • test strips usually have several test fields that change their color in the presence of the analyte to be examined and its concentration.
  • Common parameters that can be determined with the help of such test strips include
  • Nitrite e.g. formed from nitrate by some germs and therefore indicates a urinary tract infection
  • red blood cells indicating inflammation of the urinary tract
  • white blood cells which may occur when the kidney or bladder is inflamed
  • pH value an alkaline pH value occurs in urinary tract infections, whereas an acidic pH value indicates diabetes
  • glucose incates diabetes and can also occur in some types of cancer
  • a tube leading from the patient to a urine collection bag is clamped for a few minutes so that urine can collect up to the clamped area.
  • the medical staff will use a syringe to remove urine from the extraction point provided for this purpose in the hose, which is preferably located on a stepped cone between the bag hose and the catheter.
  • the syringe has either a cannula or a Luer slip attachment. Then the urine drawn into the syringe is filled into another vessel and sent to a suitably equipped laboratory, where the test strip / field is immersed.
  • the urine is also allowed to drip directly from the tube onto the test strip / test field inside the test vessel.
  • the test liquid eg urine
  • protective measures such as gloves and disinfectants are required and the procedure is prone to errors. Manual steps are therefore necessary in order to get a test result. After a few minutes, the result can be read from a reference color card.
  • the test vessel containing the urine is then emptied and disposed of.
  • Another liquid which does not come directly from the patient, but is at least temporarily in contact with him or at least one component of him, is the so-called dialysis liquid during a dialysis treatment (extracorporeal blood treatment).
  • a parameter that is usually to be examined here is the pH value of the dialysis fluid. Since the dialysis fluid is in contact with the patient's blood via the semipermeable membrane in the dialyzer, a pH value that is set too high or too low can have serious effects on the patient. Regular checks can therefore be useful. Similar to urinalysis, dialysis fluid must be regularly withdrawn for this purpose, for example by passing it into a separate test vessel into which a correspondingly designed test strip or pH indicator paper is then held.
  • test strips are used as follows using the example of urine examinations: First, fresh test liquid is obtained. Then the liquid is transferred to a container with a large opening, the strip is briefly immersed and then excess liquid is wiped off. The exposure time is awaited and then the color change is read off and compared with a specified color scale. The results are documented. Readers are available for reading the color scale. More precise analyzes are carried out using other laboratory methods.
  • test vessels For the use of conventional test fields / strips, open (test) vessels in particular have so far been required, which represent potential sources of infection for the nursing staff. A sufficient volume of urine is also required to immerse the test field. This creates a possible source of error with regard to compliance with the contact time, ie a length of the immersion time and correct wiping of the fluid residue on the strip by personnel.
  • urine can drip onto the floor between the patient and the bag when it is removed from the urine collection bag or the supply tube, which then has to be wiped away and which can affect hygiene in the hospital.
  • Today's urine collection which is common in everyday clinical practice, always represents a certain amount of extra work for the nursing staff.
  • the sample can be contaminated each time it is transferred to another vessel, be it from the ambient air or an incorrectly stored sample vessel.
  • a well-known system for taking urine samples is the Monovette available on the market.
  • This system has a sample collection container, which has a suction tip for taking urine directly from a catheter, for example, is filled like a syringe and is then suitable for further testing in the laboratory, for example for centrifugation.
  • a chemical urine analysis however, it is intended to open the sample / collection container and immerse a test strip in it.
  • One of the problems with this system is that for such a urinalysis it is necessary to handle an open sample collection container, as a result of which the hazards and inadequacies already described above occur. This also applies if you want to transfer urine that was taken using this system to a test field.
  • test vessel which reduces or eliminates the disadvantages of the prior art.
  • a test vessel is to be provided which allows the samples to be handled safely and quickly. It should also be ensured that the samples taken provide the most accurate measurement results possible. In particular, the wetting and reading of the test strips should take place in a closed system so that no handling with open liquid has to take place.
  • the essence of the present invention for solving the problem is, in principle, that the applicant of the present invention has recognized that for the previous sequence of sampling known from the prior art and transferring into a test vessel, transport and final analysis in the laboratory, an inaccuracy in the measurement result is to be expected.
  • the content of the sample can change chemically every minute.
  • By-products can arise through oxidation (e.g. conversion of bilinogen to urobilinogen) and, through waiting times, bacteria also have the opportunity to penetrate the sample and change it.
  • the sample container must always be opened for the commissioned measurement series.
  • the contact time ie a length of the immersion time and correct wiping of the fluid residue on the strip by personnel, must be observed. This is bad for the sample itself but also for the personnel who have to handle the opened sample containers.
  • the present invention offers the measure of using a sampling container (for short: container) of a sampling system (e.g.
  • Syringe or tube at the same time as a device for storing / receiving one or more test strips / test field (s) within the withdrawal container (tube or syringe cylinder) for the analysis of fluids originating from the body or fluids in contact with them , so that in the extraction device / extraction system itself (i.e. with the extraction process) without further additional measures such as removing the extraction container, opening the extraction container and dipping a test strip, etc. a fast, clean and safe analysis of the extracted liquid in a quasi closed system (without opening and decanting). In addition, it is avoided that excess liquid has to be let out of the container again without risking an excessive exposure time, by providing a pre-integrated absorber unit in the container.
  • the sample / removal container of the sampling system is already provided with at least one test strip / test field / etc. and an absorber unit equipped or equipped and preferably tightly closed (not openable - with the exception of the connector for withdrawing fluid from the patient / reservoir).
  • the fluid / liquid sample is taken from the patient or a reservoir to be examined sucked in / introduced by means of the sampling system (syringe) and thus the withdrawal container is filled, the test strip / test field or test fields already in it (integrated with the withdrawal container) is simultaneously wetted with the liquid. An excessively long exposure time is avoided by absorbing excess liquid.
  • a medical fluid sampling system with a sample / withdrawal container for receiving a fluid to be examined, in particular a body fluid or a liquid coming into contact with such a fluid, with at least one test field in the sampling container for displaying Analytes (ie to indicate the presence or absence of the analyte (s)) and an absorber unit (provided separately for the test field) are integrated, which is designed to absorb the fluid to be examined.
  • a fluid to be examined in particular a body fluid or a liquid coming into contact with such a fluid
  • Analytes ie to indicate the presence or absence of the analyte (s)
  • an absorber unit provided separately for the test field
  • a simple (in particular transparent) sample collection container which is equipped with a test strip or a test field that allows the presence of certain substances in a fluid to be examined to be identified, as well as with a unit made of absorbent material which can absorb or soak up excess fluid.
  • the absorber unit sucks up the (excess) fluid so slowly (requires so much time to suck up) that the fluid, before it is absorbed by the absorber unit, comes into contact with the test strip for a long enough time that the test strip is present or absent Can display analytes.
  • this prevents excess fluid from leaking out when the sample collection container is opened.
  • a medical fluid extraction system is provided with a medical sample Z collection container, which enables a fluid to be examined, for example, to be removed from an associated line Z collection system, to soak or wet a test strip Z test field (s) with it and to examine this test strip Z test field (s) in particular together with the sample collection container without the fluid ever having to be handled openly.
  • test strip (s) can optionally be applied separately and thus possibly exchangeable, in particular on a separate carrier element and further preferably in the form of a ring or a cartridge, which is inserted into the sample collection container and through the
  • the carrier can be mounted directly in the container directly or via a component attached to it, or it can be loosely received therein.
  • the absorber unit can in particular be arranged on the same carrier, for example on the back or next to the test strip.
  • the absorber unit can be provided on a separate, correspondingly designed carrier.
  • the test strip ZT test field (s) can be held on the inside of the sample collection container, for example by gluing.
  • the particular separate carrier has the advantage that it can be designed to have the sample collection container and the suction mechanism independently of the collection system and can be inserted into the sample collection container like a cartridge together with or in addition to the absorber unit.
  • the carrier can, for example, be a (frontal) closure or similar of the sample / Withdrawal container. If necessary, a set of carrier plates with different test strips / test field (s) can be provided. Alternatively, the test strip / test field and / or the absorber unit can also be loosely accommodated in the sample / removal container.
  • the absorber unit can preferably be arranged inside the sample / removal container on a rear side of the at least one test field which is opposite to a side provided for the display for analytes. This ensures that the test field is not covered by the absorber unit and is therefore also visible and readable from the outside, through a (transparent) wall of the sample collection container.
  • the test strip / test field (s) is held directly or via a carrier plate on an inner wall of the syringe cylinder, the inner wall being made of a translucent or transparent material that allows for visual monitoring of the test strip / test field (it ) allowed from outside.
  • the absorber unit does not cover the test field because it is attached next to or behind the test field, preferably on the same carrier.
  • the absorber unit can have an absorbent material such as core-crosslinked polyacrylamide, polyvinylpyrrolidone, amylopecting, gelatin, cellulose, etc.
  • an expansion mechanism which is expandable at least in the radial direction is preferably provided which is designed to expand when the fluid to be examined is absorbed and to press the at least one test field against an inner wall of the sample collection container. This further improves the readability from the outside and any optical distortions that may be present due to the container wall are reduced. This also displaces excess liquid from the test strip.
  • the absorber unit forms the expansion mechanism. In principle, however, this can also be a separately provided component. It is advantageous if the test strip / test field (s) lies directly against the wall of the sample / removal container in order to ensure good visual readability of the test strip / test field (s) from the outside through the wall of the sample / removal container to ensure.
  • test strip were to lie directly on the wall from the start, this would have the disadvantage that the test strip / test field (s) would not be optimally wetted by the fluid that has been sucked in.
  • expansion mechanism acting at least in the radial direction (possibly with the absorber unit
  • the carrier is, for example, elastic (as an expandable ring or a leaf spring that can be pressed against the container wall, for example slightly inwardly bent in the relaxed state) or is held loosely in the container with play.
  • An alternative to this would be to design the carrier with radial spacer elements (knobs or similar spacers), which keep the test strip / test field (s) at a radial distance from the container wall and, when they come into contact with the fluid that is sucked in, resorb (dissolve, whereby the T test strip / test field (s) is / are pressed against the container wall by the inherent elasticity of the carrier.
  • This means that the provision of the expansion mechanism has two effects: excess liquid is displaced from the test strip and the readability of the test strip is improved.
  • the absorber unit serves as the expansion mechanism, it also fulfills the additional function of sucking up excess fluid and thus preventing it from being left out (unnecessary handling). After the prescribed exposure time, the result must be read off and documented.
  • the sample Z collection container has a container-side extraction connector for extracting the fluid to be examined directly from a fluid line and / or fluid collection system, in particular a catheter or a collection container.
  • an inlet pressure (inside or outside) of the sample Z collection container is / can be made available in order to flow it through with the fluid upon actuation of a removal mechanism which is formed integrally with the sample / removal container or which can be directly and adaptively attached to it to fill the container-side extraction connector if it is connected to the fluid line and / or fluid collection system during the actuation of the extraction mechanism.
  • the object on which the invention is based is achieved by a medical sample extraction system (e.g. syringe) with a sample / extraction container which has a connector (e.g. syringe needle, Luer lock, etc.) for extracting a fluid to be examined, in particular a body fluid or a liquid coming into contact with such, from a patient or a fluid line and / or fluid collection system, in particular a catheter or a collection container.
  • a medical sample extraction system e.g. syringe
  • a sample / extraction container which has a connector (e.g. syringe needle, Luer lock, etc.) for extracting a fluid to be examined, in particular a body fluid or a liquid coming into contact with such, from a patient or a fluid line and / or fluid collection system, in particular a catheter or a collection container.
  • a medical sample extraction system e.g. syringe
  • a sample / extraction container which has a connector (e
  • the sample Z collection container is designed integrally with the extraction system, in particular a syringe, or can be attached directly to it (in the form of an adapter) in such a way that a removal pressure, preferably negative pressure, can be built up in the sample Z collection container by actuating the extraction system to fill the connector connected to the fluid line and / or fluid collection system with the fluid during the actuation of the extraction system.
  • the extraction mechanism has a piston, preferably in the form of a syringe piston, received in the sample extraction container, in order to provide a negative pressure within the sample extraction container as the introduction pressure during actuation of the extraction mechanism.
  • the sample Z collection container already has the test strip ZT test field (s) inserted therein, for example for the detection of substances in the sample, whereby the sample Z collection container or the Withdrawal system has a spacer arrangement or a separating element which / s the test strip / test field (s) to (relative to each other movable) components of the withdrawal system, in particular a syringe plunger and / or a syringe cylinder, which when the withdrawal system is actuated relative to the T test strips / test field (s) can be moved.
  • the test strip / test field (s) can be placed at any point in the sample collection container without it being damaged by a component that is movable relative to it, for example as a result of pressure and the resulting kinking .
  • the medical fluid extraction system with the sample / extraction container is designed as a syringe, or in other words, is designed integrally therewith.
  • a fluid receiving space is defined by the syringe cylinder and a pressure element of the syringe plunger, in which the carrier for the test strip / test field (s) or the test strip / test field (s) is directly inserted, with the wall of the sample / Removal container itself serves as a carrier or holder for the test strip / test field (s).
  • the pressure element has, for example, a rubber disc (plunger plate) and is accommodated in the syringe cylinder in a sealing and longitudinally displaceable manner.
  • a syringe is a particularly easy-to-use device that is known to every medical user and does not require any special handling or training. Furthermore, a syringe is simple and inexpensive to manufacture and a number of lost individual parts is reduced. Preferably, the fluid extraction system or the syringe can be dismantled, for example for cleaning or handling purposes.
  • the sample extraction container is formed / arranged at least in sections upstream of a fluid suction mechanism (preferably suction piston) of the fluid sample extraction system, the sample extraction container optionally (spatially) spaced apart (and thus not able to be brought into mechanical contact with it) T est strips / test fields-receiving space forms upstream of the fluid suction mechanism.
  • a fluid suction mechanism preferably suction piston
  • spacing is to be understood in such a way that a main area of the test field / test strip, which is necessary for displaying analytes, is spaced from the corresponding components, e.g. to prevent them from kinking. It should not be ruled out that a (circumferential) edge of the test field / test strip can possibly touch the corresponding components, since damage to the same is negligible in the context of the intended application.
  • a movement of the piston within the sample / removal container is preferably limited by a stop between the piston and the sample / removal container or a carrier holding the at least one test field.
  • a separate carrier is provided for the test strip / field, it is possible, for example, to equip / retrofit commercially available syringes with such a carrier, wherein the carrier can preferably be designed with such a rigidity that it also serves as an axial stop for the syringe plunger for pressing -Limitation is used and thus prevents damage to the test strip / test field (s).
  • a length of the sample / removal container is preferably greater than a length of the syringe plunger (stroke length) and the spacer arrangement or the separating element is provided via a stop between the syringe cylinder and the syringe plunger in order to define a minimum fluid receiving space volume, which is completely the piston pushed into the cylinder.
  • the stop can be formed, for example, by a change in diameter, in particular a step or an end surface, of the syringe cylinder and / or the syringe piston.
  • the stop can be provided by proximal actuating and holding elements or grip elements, as are also provided in commercially available syringes are what corresponds to a standardized system and is particularly inexpensive and easy to manufacture.
  • the actuating shaft / syringe plunger is shortened compared to the syringe cylinder or the pressure element is arranged further proximally, so that a (predetermined) gap / distance remains between a distal end of the syringe cylinder and the plunger plate, in which the test strip / test field (s) is arranged.
  • the size of the gap in which the test strip / test field (s) is received is particularly easy to set in terms of construction, for example by displacing an axial stop on the syringe plunger in its longitudinal direction. It is also conceivable to make the stop adjustable for the user (sliding ring on the syringe plunger) in order, for example, to be able to insert differently sized test strips / test field (s) into the syringe cylinder in advance. Alternatively or in addition, a part of the syringe plunger can serve as the spacer or the separating element, which protrudes beyond the pressure element in order to be supported distally on a connector end of the syringe cylinder.
  • test strip / test field (s) is attached to a distal end or the connector end of the syringe cylinder so that the test strip / test field (s) is securely in the gap provided by the spacer arrangement between the syringe plunger and the connector end / the distal end finds space.
  • the medical sample / collection container can be designed as a syringe attachment defining a closed fluid receiving space which, in addition to the connector, has a syringe connector through which a syringe nozzle (ie, a connector of a syringe) can be connected to the syringe attachment.
  • a syringe nozzle ie, a connector of a syringe
  • an adapter-shaped, medical sample / collection container (receiving cylinder) is provided for a commercially available syringe, on one end wall of which a connector is formed which, as it were, simulates the syringe connector of the commercially available syringe and on its other end wall a connection for the syringe connector of the commercially available syringe is designed.
  • the medical sample collection container in the form of an adapter is an axial extension of the Syringe cylinder, which is integrated in the suction stroke of the syringe and is thus filled with a fluid sample when the syringe plunger is pulled out of the syringe cylinder (suction stroke).
  • sample / removal container as an adapter is particularly advantageous, since in this way the sample / removal container can be used with any syringe. That is to say, the sample collection container itself has a very simple structure and is therefore cheaper to manufacture and there is no risk of confusion with conventional syringes with regard to the syringe to be used.
  • the sampling container can be designed to be particularly small, space-saving and light and is easy to handle, in particular individually and without the syringe.
  • the removal mechanism has an elastic housing section of the sampling container, which can be compressed to actuate the removal mechanism and, through its elastic restoring force, provides a negative pressure within the sampling container as the inlet pressure when the compression is released.
  • the sampling container can also be connected to it before it is compressed.
  • a valve on the container through which the air / gas can escape into the environment, and, if necessary, an additional valve on the Connector that prevents the air / gas from entering the fluid line and / or fluid collection system.
  • the housing of the test device is formed from a flexible material, preferably from a hose material.
  • One side is provided with a detachable connection (e.g. Luer) or a tapered tip (as a connector). The other side is locked.
  • the test strip is located in the housing.
  • a flexible sponge-like and absorbent material i.e., absorbent material, e.g. cellulose, etc.
  • absorbent material e.g. cellulose, etc.
  • the user In order to displace the air and suck in the test liquid, the user has to squeeze the flexible housing together and release it (pump) until the test strip is completely wetted. Depending on the geometry and elasticity of the housing, a single pump stroke (squeeze once and release) may be sufficient to suck in sufficient liquid, or several pump strokes may have to be carried out.
  • the test device must then be separated from the hose and, if necessary, a cap must be placed on the connection / tip. After the prescribed exposure time, the result must be read off and documented.
  • This embodiment of the container has a special structure and is particularly inexpensive to manufacture compared to the design as a syringe.
  • the extraction mechanism has a pre-set negative pressure in the sample / extraction container as the inlet pressure and a closure of the extraction connector, which is actuated and opened by connecting the extraction connector to the fluid line and / or fluid collection system, so that the Fluid flows into the sample Z collection container due to the preset negative pressure. That is, a fluid connection between the sample / removal container and the fluid line and / or collection system is automatically established in that the connector is connected to it, so that a user can remove the fluid and the wetting the test strip only needs to perform one action - connecting the connector to the fluid line and / or collection system.
  • the handling of the sample collection container according to this embodiment is consequently particularly simple and safe.
  • the negative pressure is preferably set in such a way that an amount of fluid sufficient to wet the fluid strip is sucked in, but only so much that the absorption capacity of the absorber unit is sufficient to suck up the excess fluid. This prevents too much or too little fluid from being introduced into the container by a user.
  • the removal mechanism has a venting device on the sample / removal container, preferably in the form of a hydrophobic membrane, and a filling connection, in particular the removal connector.
  • the filling connection can be filled with the fluid through an outlet connection arranged on the fluid line and / or fluid collection system, preferably in the form of a fluid switch, in particular a multi-way valve.
  • the outlet connection When actuated, the outlet connection also provides a fluid pressure external to the sample / extraction container in the fluid line and / or fluid collection system as the introduction pressure, so that when a fluid connection between the fluid line and / or fluid collection system and the filling connection of the sample extraction container is opened, this can be filled with the fluid by the fluid pressure that is external to the sample / withdrawal container.
  • a fluid pressure mechanism which conveys the fluid into the sample extraction container which is now located downstream of the fluid pressure mechanism, in which case the sample extraction container is provided or designed with a venting device to allow air to escape when the fluid sample is introduced.
  • the test device (sample / removal container) has a housing adapted to the test strip with a detachable connection (eg Luer) on one side and a hydrophobic membrane on the other.
  • the test strip is located in the housing. Under the test strip there is material that has super adsorbent properties (e.g.
  • the test device works by being connected to the urine tube via a three-way stopcock or similar.
  • the three-way cock is held in the blocking direction until enough fresh test liquid has accumulated in the hose, but not until it has expired.
  • the tap is turned so that the liquid to be tested flows into the test device.
  • the air inside escapes through the hydrophobic membrane.
  • the test device can now be unscrewed and closed with a cap. The excess liquid is sucked off by the adsorber.
  • the volume expansion of the absorber presses the test strip against the housing wall.
  • a reference field carrier is provided, which is preferably held in the form of a rotatably mounted sleeve on the outside of the sample collection container and allows a visual comparison with the at least one test field inside the sample collection container through a transparent container wall .
  • the outer carrier for reference fields is connected or can be connected to the sample Z collection container in order to be able to adjust (color) changes in the test strip ZT test field (s).
  • this outer carrier can be designed in the form of a ring which can be pushed over the preferably cylindrical sample collection container and rotated thereon. This means that there is no need to use a separate reference color card and the color comparison is particularly easy for the user, since the ring cannot fall and is always optimally held right next to the test strip.
  • Fig. 1 shows schematically a medical sample extraction system according to a first embodiment of the invention in an exploded view.
  • FIG. 2 schematically shows a medical sample Z collection container of the collection system according to a first modification of the first embodiment of the invention.
  • FIG 3 shows schematically a carrier with test and reference fields according to a second modification of the first embodiment.
  • Fig. 4 shows schematically the sampling system of the first embodiment in the fully assembled state.
  • Fig. 5 shows schematically an outer carrier with reference fields.
  • Fig. 6 shows schematically the sampling system of a second embodiment in the fully assembled state.
  • FIG. 7 schematically shows a medical sample extraction system according to the second embodiment of the invention in operation or in an exploded view.
  • FIG. 8 schematically shows a medical sample collection system according to a third embodiment of the invention.
  • FIG. 9 shows schematically a medical sample extraction system according to a fourth embodiment of the invention.
  • Fig. 10 shows schematically connections of a urine tube for connecting the medical sample collection system according to one of the embodiments of the invention.
  • 1 shows a schematic representation of a medical sample extraction system, preferably designed as a syringe, with a sample / extraction container 1 according to a first embodiment of the invention.
  • the sampling container 1 of the sampling system has a syringe nozzle (extraction connector), which is designed, for example, as a Luer connector or a syringe needle and as a connector 7 for extracting a fluid to be examined from a patient or a patient Fluid line and / or fluid collection system is used.
  • a syringe nozzle extraction connector
  • the connector 7 can also be a lowered cannula which forms an inner cannula 8 and an axially extending hollow cylinder 9 surrounding it.
  • the syringe nozzle / the connector 7 is connected to a syringe cylinder 6 of the sampling system (formed with this), which preferably has a larger diameter than the syringe nozzle / the connector 7.
  • the syringe cylinder 6 is open at a proximal end (proximal end face) and has a plate-shaped, radially circumferentially outwardly extending projection Z, a plate ring or holding plate through which the syringe can be easily finger-gripped and operated.
  • a syringe piston 2 of the sample extraction system is guided within the syringe cylinder 6 in a sealing and longitudinally displaceable manner.
  • the syringe plunger 2 has a pressure element / plunger disk / plunger plate 3, for example an elastomer / plastic disc, which seals off a fluid space formed distally in the syringe cylinder 6.
  • the syringe plunger 2 has an actuation shaft 2a which is attached to the pressure element 3 and extends in the proximal direction through the syringe cylinder 6.
  • the actuating shaft 2a has a cross-shaped cross-section due to improved guidance within the syringe cylinder 6 and for reasons of stability, the resulting free longitudinal edges of the shaft possibly slidingly resting on the syringe cylinder.
  • the syringe plunger 2 has an actuation plate on which a user can pull or push to actuate the syringe in order to operate the syringe To displace the pressure element 3 longitudinally within the syringe cylinder 6 and thereby suck a fluid into the syringe or press it out of it.
  • a test strip / test field (s) 5 is pre-exposed in the sample Z collection container 1 according to the invention within the fluid space.
  • a preferably separate carrier 4 for example in the form of a sleeve or a plate, is provided on which at least one parameter-specific test field 5a-e is attached, which changes its color in the presence of an analyte to be examined and possibly its concentration.
  • Such a test field is used in the present case to determine, for example, the pH value, to determine nitrite, urobilinogen, erythrocytes, leukocytes, proteins, ketones, glucose, ascorbic acid, blood and / or the density.
  • test fields The number of parameters, i.e. test fields, is not limited to these substances or sizes. Likewise, only a subset of these test fields on the carrier 4 or a redundant design is conceivable.
  • the test fields can be arranged in matrix form or strip form, in which the fields are arranged both next to one another and one above the other.
  • an absorber unit 12 with an absorber material such as cellulose, which absorbs excess fluid is preferably provided behind or next to the test strip / test field 5, possibly on the back of the carrier.
  • the at least one test field 5 and possibly the absorber material 12 is / are attached directly to the carrier 4 or the at least one test field 5 is located on an additional test strip which is located on the carrier or is mounted on it.
  • form-fitting, force-fitting or material-fitting fastening mechanisms are possible.
  • the test strip with the test field 5 can, for example, lie loosely in the syringe cylinder 6 and by means of the carrier 4 as a spacer between the syringe plunger 2 and a distal syringe end before it kinks be protected upon actuation of the syringe.
  • the test field 5 can rest loosely on an inner side of the syringe cylinder 6 or can be fixedly attached.
  • the absorber unit 12 can also be attached to the inside of the syringe cylinder 6, to the syringe plunger 2 or to an additional carrier inserted or insertable into the fluid space.
  • a reference color card can be used, with which it can be compared whether and, if applicable, in what concentration an analyte is present in the liquid to be examined. The same applies to the pH value and the density.
  • the reference color card is preferably located in the vicinity of the test field.
  • FIG. 3 shows an embodiment of a carrier 4 in the present case in the form of a ring with a test field 5 applied to it.
  • the reference color field 10a for the parameter “nitrite” can stand for “no nitrite present”
  • the field 10b can stand for “nitrite present”.
  • the color of the test field 5 is then compared with the reference color fields 10a and 10b after a sample has been taken. This is particularly advantageous when only a small number of analytes have to be analyzed and a limited number of possible color reactions (here: two) can occur.
  • two further test fields can be provided instead of the reference color fields 10a, 10b.
  • this ring-shaped carrier 4 is described below by way of example for a sample / removal container designed as a syringe. It is clear, however, that this form of carrier can be used in any cylindrical container such as the tubes or containers 1 described later with reference to Figs.
  • the annular carrier 4 with the display field or test field 5 and the reference fields 10a, 10b is in the syringe cylinder 6 in In the area of the sample receiving space / fluid space, the receiving space / fluid space subsequently being used by means of the piston 2 is sealed at the front. Since the cylinder wall of the syringe cylinder 6 is translucent or transparent, the fields on the carrier 4 can be read from the outside. Since the carrier 4 consists of a comparatively stiff material, it can also serve as a spacer between the plunger 2 and the fields so that they are not damaged when the plunger 2 is pressed into the syringe cylinder 6.
  • the invention provides an alternative or additional external reference field support or ring 11, as is shown schematically in FIGS. 4 to 6.
  • This ring 11 is rotatably mounted on the outside of the syringe cylinder 6 and has several reference color fields 10.
  • the outer ring 11 By turning the outer ring 11 (outer carrier 11), the color of the test field 5 can be compared more easily with the colors of the reference color fields 10.
  • Such a rotatable reference ring 11 is shown schematically.
  • the reference color fields 10 are fixedly attached to the outside of the syringe cylinder 6.
  • the carrier 4 is connected to the plunger rod 2, for example on the distal end of the plunger plate 3, an adjustment can be made by turning the plunger rod 2 and holding the syringe cylinder 6 or by holding the plunger rod 2 and turning the syringe cylinder 6. This process is described in detail below:
  • the syringe plunger 2 is preferably made shorter than the syringe cylinder 6. That is, when the syringe plunger 2 is completely pushed into the syringe cylinder 6 so that the actuating plate of the plunger 2 rests against the holding plate of the cylinder 6, a predetermined gap remains between a distal end (distal end wall) of the syringe cylinder 6 and the plunger plate 3 Gap width that is sufficient to accommodate the test field or the carrier 4.
  • the retaining plate and the actuating plate serve as an axial stop and thus as a spacing arrangement or a separating element to protect the nutrient medium / test field 5 from contact with the syringe plunger 2 and damage to the test field 5 resulting therefrom.
  • the carrier 4 of the test field 5 itself acts as a spacer.
  • FIG. 4 shows schematically the medical fluid sampling / removal system with a medical sample / collection container 1 according to the first embodiment of the invention in the assembled state.
  • no ring is provided as the carrier 4, as shown in FIG. 3, but a carrier sleeve or a carrier plate 4 on which a plurality of test fields or test strips receiving them are mounted. That is to say that in this embodiment several carrier systems can be used or that a set of exchangeable carriers can be provided.
  • a first carrier system can be provided with a test field for nitrite and a further carrier system with a test field for any further parameter.
  • the parameters to be examined can thus be freely selected and compiled before the sample is taken, which enables an examination that is individually tailored to the patient.
  • an outer ring 11 is pulled onto the syringe cylinder 6 and carries a large number of reference fields 10 that can be compared with the test field strips 5 on the (inner) carrier 4.
  • the inner carrier 4 with the test fields Z-strips 5 is held on the syringe cylinder 6 in FIG. 4, it is also possible to mount the carrier 4 on the plunger 2 so that the carrier 4 can be rotated by means of the plunger 2, whereas the outer ring 11 must be held in this case.
  • containers are also conceivable in which there is negative pressure, which ensures suction of the fluid sample to be examined when the extraction system is attached to a corresponding extraction point in a fluid-carrying line system.
  • Another alternative in this respect is the use of an elastic sample container. If this is compressed before the sample is taken, and in this attached to the sampling point in the closed state, and then returned to the initial shape (elastic) for sampling, the fluid sample to be examined is sucked into the sample container.
  • FIG. 6 shows an adaptive fluid sampling system, in particular a sampling vessel 1 with a sleeve-shaped or tubular hollow body as the housing 6.
  • the sampling vessel 1 can be flowed through and has a removal connector 7, preferably in the form of a Luer slip connection, on one of its distal end faces and on its other proximal end face a syringe connector 40, preferably in the form of a (female) Luer lock / slip connector.
  • a removal connector 7 preferably in the form of a Luer slip connection
  • a syringe connector 40 preferably in the form of a (female) Luer lock / slip connector.
  • the withdrawal vessel 1 there is at least one carrier 4 on which at least one parameter-specific test field 5a-c is applied.
  • the at least one test field or test fields 5a-f can be located, for example, on a strip 5 that is mounted on the carrier 4.
  • the cross section of the hollow body (the housing) 6 is either round or ellipsoidal, or at least triangular, preferably square.
  • the dimensions of the hollow body 6 are only dependent on the size of the at least one test field 5a-f or the strip 5 on which test fields are arranged.
  • a cannula or a lowered cannula 8, 9, as shown in FIG. 2 can also be used.
  • a check valve either to the withdrawal connector 7 or to the syringe connector 40 or to both connectors so that liquid can flow through the hollow body in only one direction.
  • the carrier 4 is preferably designed as a separate component.
  • the inside of the hollow body / housing 6 can also be used as a receiving unit (Fastening unit) act for the at least one parameter-specific test field 5a-c.
  • the carrier 4 can be designed as part of a distal or proximal closure, for example the removal connector 7 or the syringe connector 40, which can also be provided in the other described embodiments.
  • the carrier 4 for the test fields 5 is designed with a distal stopper, in particular integrally with the removal connector 7 or a distal housing section.
  • test field 5a-c is attached to the carrier 4 or to the test strip 5, which test field changes its color in the presence of an analyte to be examined and, if necessary, its concentration.
  • a test field is used to determine, for example, the p Fl value, to determine the presence of nitrite, urobilinogen, erythrocytes, leukocytes, proteins, ketones, glucose, ascorbic acid, blood and / or the density.
  • test fields are not limited to these substances or sizes. Likewise, only a subset of these test fields on the carrier 4, 5 or a redundant design is conceivable.
  • the test fields can be arranged in matrix form, in which the fields are arranged both next to one another and one above the other. It is also possible to design the test fields in the form of a ring.
  • the at least one test field 5 is attached directly to the carrier unit 4 or the at least one test field 5 is located on the test strip 5, which is located on the carrier 4.
  • the test field 5 is attached directly to the carrier unit 4 or the at least one test field 5 is located on the test strip 5, which is located on the carrier 4.
  • a reference color card 10 can be used for a test field 5 with an in particular ring-shaped carrier 4 provided inside the container, with which it can be compared whether and, if necessary, in which concentration an analyte in the to be examined Liquid is present.
  • concentration an analyte in the to be examined Liquid is present.
  • the invention also provides an outer ring 11 in this exemplary embodiment. This is rotatably attached to the outside of the (adaptive) hollow body / housing 6 and has several reference color fields 10. This is shown in more detail in FIG.
  • the colors of the test field 5 can be compared more easily with the colors of the reference color fields 10.
  • an annular reference field carrier attached to the outside of the container is provided.
  • the reference color fields 10 are fixedly attached to the hollow body or housing 6.
  • a tube 14 is shown which connects a bag (not shown) (for example a urine bag) to a catheter 200 (or urinal condom). Normally the end of the catheter would be in the patient and thus not be seen in FIG. The catheter does not have to be withdrawn from the patient to take a sample.
  • a clamp 102 is attached to the hose for damming the liquid.
  • An outlet connection or an extraction point 101 is located on a stepped cone (connector between the tube 14 and the catheter 200). The test vessel 1 is inserted into this extraction point 101.
  • the removal system or suction mechanism 300 preferably in the form of a commercially available syringe, can then be inserted at the other end of the test vessel 1, with which a fluid sample can be sucked through or into the test vessel 1 for analysis.
  • the test vessel 1 represents an adapter which is interposed between the fluid reservoir and the syringe and can be filled through the suction stroke of the syringe.
  • this can be adapted in such a way that the connector 7 in each case the removal point 101 is connected and the container 1 is filled when the respective removal mechanism is actuated.
  • the sample / removal container (test vessel) 1 is therefore not designed integrally with the syringe but as an attachment and can be connected distally to a syringe nozzle (removal connector) of a syringe.
  • a conventional syringe can be used, the syringe nozzle (extraction connector) of which is compatible with the syringe connector (syringe connector) 40 on the proximal end wall of the sample / extraction container 1.
  • the sample collection container 1 can be connected to a syringe nozzle of the syringe via the syringe connector 40 in the manner of a syringe attachment.
  • the connector 7, that is, the syringe nozzle formed by the sampling container 1 can then be connected to a fluid line and / or fluid collection system, so that a (single) actuation of the syringe 300 (suction stroke) transfers a fluid contained in the collection system to the sampling container 1 and, if necessary, additionally sucked into the syringe 300 through the syringe connector 40, the test field 5 being wetted.
  • a proximal end serves as the spacer arrangement or the separating element, which separates or spaced the test field 5 within the sample collection container 1 from an interior of the syringe 300 and thus prevents damage to the test field 5 from contacting through the actuation shaft of the syringe .
  • the sample collection container (or possibly consists of) a preferably cylindrical tubular housing 6 adapted to the test strips 5a-c with a detachable connection 7 (extraction connector, e.g. Luer connector) on one end and a hydrophobic membrane 13 on the other end of the housing.
  • the test strip 5a-c is located in the housing 6 and is attached as described above or lies loosely therein.
  • a material which has super adsorption properties for example core-crosslinked polyacrylamide, polyvinylpyrrolidone, amylopectin, gelatin, cellulose, etc.
  • This absorber unit 12 absorbs excess test liquid introduced into the housing.
  • the absorber unit is designed such that it also expands in the process.
  • the absorber unit 12 simultaneously functions as an expansion mechanism which, when absorbing liquid and expanding, presses the test strip 5 with the test fields 5a-c directed outwards against a transparent inner wall of the housing 6. As a result, excess test liquid is displaced from the test fields 5a-c and the readability is improved through the housing wall.
  • sample / removal container thus follows the adaptive removal principle of the second embodiment described above, but the syringe used there as a vacuum / suction pump is replaced by a different mechanism as described below:
  • the sample / removal container 1 according to FIG. 8 is connected to a urine tube 14 via a three-way stopcock 15 (see FIG. 10, above) or the like.
  • the three-way tap 15 (short: tap) has an inlet to which an upstream urine tube section is connected, an outlet to which a downstream urine tube section is connected, and a branch 16 to which the sample / removal container 1 according to FIG 8 can be connected.
  • the tap 15, which functions as a fluid switch has a blocking element, which makes it possible to interconnect the input, output and branch with one another so as to conduct or block fluid differently.
  • the sampling container 1 In order to fill the sampling container 1, it is connected to the branch via the connector 7 and the valve 15 is held in its blocking direction / blocking position in which a fluid connection between the inlet and the outlet and the branch is closed until there is enough fresh water Test liquid has accumulated in the hose - but not until it has expired.
  • the tap 15 or its blocking element is turned so that the liquid to be tested flows into the container 1 (i.e. a fluid connection is opened between the inlet and the branch and a connection to the outlet remains blocked).
  • the air / gas in the container 1 escapes through the hydrophobic membrane 13 on the side of the container 1 opposite the connector 7.
  • the sample / removal container 1 can now be unscrewed or separated / uncoupled and, if necessary, closed with a cap or is automatically closed via a valve or the like when separated.
  • the readability of the test strip 5 through the housing wall is improved.
  • the housing 6 of the sample / removal container 1 according to FIG. 9 can consist of a flexible / elastic material, preferably a hose material, or can have an elastic housing section 6b comprising a corresponding material.
  • One side is designed with a detachable connection or with a tapering tip as a connector 7.
  • the other end face is tightly closed in this case, for example by a stopper, a cap or by the fact that the housing 6 is made in one piece and integrally with a base.
  • the test strip 5 is located in the housing of the sample / removal container 1, corresponding to the above embodiment according to FIG. 8. Below the test strip is the above-described, flexible, sponge-like and absorbent material (for example cellulose) arranged.
  • the sample collection container 1 is connected to the hose in which the test liquid is located either via the detachable closure or fluid switch 15 (e.g. via a three-way stopcock described above) (see FIG. 10, above), or connected via the tapering tip 7 to a port 17 in the urine tube 14 (see FIG. 10, below).
  • the user In order to displace the air inside the container 1 and to suck in test liquid, the user has to compress the flexible / elastic housing section 6b and let go / expand again (pump stroke) until the test strip 5 is completely wetted. Then the container 1 is to be separated from the hose 14 and, if necessary, put on a cap. Supernatant liquid is absorbed by the absorbent material / the absorber unit 12, which simultaneously presses the test strip 5 or the test field 5a-5c attached to it against the inside of the housing wall of the container 1.
  • connection options shown in FIG. 10 can be adapted for the embodiments described above.

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Abstract

La présente invention concerne un système d'échantillonnage de fluide médical comprenant un récipient d'échantillon/prélèvement (1) destiné à recevoir un fluide à examiner, en particulier un fluide corporel ou un fluide entrant en contact avec le fluide corporel, au moins un champ d'essai (5a-f) pour l'affichage d'analytes et une unité d'absorption (12) étant préintégrées dans le récipient d'échantillon/prélèvement (1), ladite unité d'absorption étant conçue pour absorber le fluide à examiner.
PCT/EP2020/072788 2019-08-13 2020-08-13 Récipient d'échantillonnage médical comportant un champ d'essai et une unité d'absorption WO2021028544A1 (fr)

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CN113075394A (zh) * 2021-03-19 2021-07-06 北京少多科技有限公司 一种小便斗升级改造方法

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