Classifications

• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N2035/00465—Separating and mixing arrangements
  • G01N2035/00524—Mixing by agitating sample carrier
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
  • G01N35/04—Details of the conveyor system
  • G01N2035/0401—Sample carriers, cuvettes or reaction vessels
  • G01N2035/0412—Block or rack elements with a single row of samples
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
  • G01N35/026—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations having blocks or racks of reaction cells or cuvettes

Definitions

• the invention is related to a method and device for delivering fluid sample to analyzing apparatus.
• the invention refers to blood samples delivery and blood analysis, such as haematological analysis.
• Haematological analysis has become one of the basic and standard medical tests, aiding diagnosis of numerous diseases and malfunctions of human or animal body.
• the purpose of the analysis is to measure the concentration of different kinds of blood cells (such as: red blood cells, white blood cells etc.) in a sample.
• blood cells such as: red blood cells, white blood cells etc.
• haematological analysis is typically carried out using automated devices (haematological analyzers). Having regard to the fact, that such tests have become very common - they are performed on a mass scale, using analyzers of different construction, different scale and different throughput, from devices suitable for single samples and incidental measurements to devices capable of handling several hundreds samples and delivering several hundreds measurement results per hour, used e.g. in large hospitals or external laboratories.
• the blood is first taken from the human or animal body using know technical means, such as syringes, and stored in a tube. Recently, it is common to take the blood using a disposable needle, to which a disposable tube, usually made of plastics, is attached. The blood is then stored in the tube, usually in lowered temperature, until its analysis is performed. As the key point of the analysis is to measure the concentration of blood cells (i.e. roughly speaking - the number of blood cells in a unit of volume of the sample) - the tube with blood, before analysis, has to carefully mixed, to secure uniform concentration of blood cells in the volume of the sample. Improper or no mixing leads to sedimentation and agglomeration of blood cells in the tube, which makes concentration measurements inaccurate or impossible.
• the mixing step has to be performed without opening of the tube (to preserve the operator from contamination in case of direct contact with the blood (danger of hepatitis, HIV, etc.) as well as to guarantee integrity and purity of the sample) and it cannot be too fast (i.e. no centrifugal process is allowed) - so as to prevent decomposition of the sample into plasma and haematocrit.
• the mixing step is therefore very important and sensitive to its parameters and conditions. Mixing is often done by hand, in particular by swinging or rotating the tube with the sample and repeating this movement. In this process, an air bubble contained inside the tube moves along the tube and is responsible for actual mixing.
• mixers are used.
• One, two or more tubes are placed within the mixer and they are mixed by swinging or by full-rotational movement of the mixer. It is known to those skilled in art that mixing by full rotation is superior to swinging or other kinds of mixing movements.
• the tubes may be placed in racks or may be taken out from the rack, depending on the type of device.
• a blood sample is taken from the tube - usually by aspiration with a needle, which cuts through the closing of the test tube. Again - depending on the type of device - this sampling may be carried out while the tube stays within or is taken out from the mixer and also while the tube stays within or is taken out from rack.
• the blood sample is then delivered to the analyzer, where the haematological analysis is performed.
• EP 0061317 A1 discloses an apparatus for sampling blood from tubes placed in racks, which racks are inserted in a drum-like mixer. For mixing, the racks with tubes are rotated on the mixer drum, so efficient mixing by full rotation is possible. The blood is then sampled directly from the tubes placed in racks, while the racks are still in the mixer by an aspiration needle. For this, the drum-like mixer is rotated until a given tube reaches the aspiration position. This is a time-consuming approach, not suitable for high-throughput devices.
• EP0061317A1 there is a unique rack with a limited number of tubes. The operator has to change manually the unique rack (i.e. he has to remove the rack and put in another one) when analyses are finished. However, in automated, high-throughput analysis, it is desired that the rack in the mixer, once all tubes from this rack have been sampled, is automatically replaced by another one.
• French patent application no. 2 812 088 discloses a device in which two tubes are taken out from a rack with grabber. They are then mixed by full rotation outside the rack and sampled inside the rack.
• the French patent application no. 2 730 315 discloses a device, in which tubes are placed in racks and two of such racks a time are taken to a mixer, wherein one of the racks is turned upside down with respect to the other. The mixing process is carried out by full rotation of the mixer.
• the device can be used with or without a grabber and may reach the throughput of 120 samples/hour.
• it is difficult to load and unload the mixer in the embodiments disclosed in FR 2 730 315.
• the invention includes a method for delivering fluid sample to analyzing apparatus, said method comprising the steps of:
• the tube is located in the rack and the rack is located in the mixer and after all the tubes from a given rack in the mixer are sampled, this rack is automatically replaced by another rack by loading means.
• the tubes have linear arrangement in the rack, preferably of five tubes in the rack.
• step b is carried out by essentially horizontal translational movement of at least one rack with tubes.
• step b two racks are loaded to the mixer and one of the racks is turned by 180° with respect to the other one.
• the mixing is carrier out by rotations of the mixer around an essentially horizontal axis.
• the mixing comprises at least 20 full rotations of the mixer.
• the racks with tubes are provided from a repository of racks.
• the racks with tubes are delivered to a parking area of racks.
• the fluid sample is delivered to the analyzing apparatus by movement of the sampling device, preferably by translational movement of the sampling device in the direction essentially parallel to the direction of transporting of racks with tubes after sampling.
• the method according to the invention further comprising a step of sampling the fluid from an additional tube, inserted to an additional tube holder.
• the method according to the invention further comprising a step of sampling the fluid from an additional tube, delivered by hand by an operator.
• said sampling the fluid from the additional tube is carried out with the same sampling device as in the step d.
• the tubes with fluid arranged in a rack are maintained in essentially vertical position, at least in the steps a, b and d, preferably throughout the whole procedure but the step of mixing c.
• said fluid is blood.
• the invention also includes a device for delivering fluid sample to analyzing apparatus, said device comprising:
• a sampling device for sampling the fluid from the tube and delivering the fluid sample to analyzing apparatus
• the sampling device is configured for sampling the fluid from the tube while the tube is located in the rack and the rack is located in the mixer and the means for loading at least one rack with tubes to the mixer is configured to automatically replace a given rack in the mixer by another rack, after all the tubes from the given rack in the mixer are sampled.
• the rack is designed for linear arrangement of tubes in the rack, preferably for linear arrangement of five tubes in the rack.
• said mixer is capable of full rotational movement around an essentially horizontal axis.
• said mixer is capable of holding two racks, one of the racks turned by 180° with respect to the other one.
• said means for loading at least one rack with tubes to the mixer is arranged to carry out the loading by essentially horizontal translational movement of at least one rack with tubes.
• said means for transporting racks is selected from the group comprising: conveyor, belt, chain.
• said sampling device is capable of delivering the fluid sample to analyzing apparatus by movement of the sampling device, preferably by translational movement of the sampling device in the direction essentially parallel to the direction of transporting of racks with tubes after sampling.
• the device according to the invention further comprising an additional tube holder, located such that a tube placed in the additional tube holder is accessible for the sampling device by translational movement of the sampling device.
• the device according to the invention further comprising an additional sampling position, located such that a tube placed in the additional sampling position is accessible for the sampling device by translational movement of the sampling device.
• the device according to the invention further comprising a repository of racks with tubes for sampling.
• the device according to the invention further comprising a parking area for racks with tubes after sampling.
• the device according to the invention further comprising a bar code reader for reading the barcode identification label on the tube.
• said means for transporting racks and preferably also the repository of racks with tubes for sampling and/or the parking area for racks with tubes after sampling are arranged to maintain the tubes in the rack in essentially vertical position.
• said means for transporting racks is arranged such that the racks with tubes are delivered to two or more mixers.
• the main advantage of the presented invention is the realization of the mixer that is particularly easy to load and to unload with racks coming from an attached autoloader or from a conveyor. In both cases, loading and unloading is done by automatically operated mechanical means - a rack carriage.
• the position of the mixer allows to have only one sampling device (with an aspiration needle) to sample from a selected tube in the rack, from a closed or an open tube in the emergency tube holder and from an open tube, manually held by the operator in the additional sampling position. Therefore, all tubes to be sampled can be arranged along the same axis. Further, a barcode reader can be included on this axis, to provide proper and easy distinction between individual tubes, racks etc.
• one and the same aspiration needle is used for all three sampling positions (i.e. from the rack, from the additional tube holder and from the open contained, delivered by hand to the additional sampling position). Consequently, there is no need to calibrate analytical precision of each type for each type of measurement.
• the possibility of sampling from manually delivers open or closed tube is also unique and characterizing for the present invention.
• the proposed construction brings simplicity and optimization, both in rack transport and in sampling.
• Fig. 1 presents a preferred device for delivering fluid sample to analyzing apparatus according to the invention in a perspective view
• Fig. 2 shows the device of fig. 1 in top view
• Fig. 3 presents the loading module of the device of fig.1 taken alone
• Fig. 4 shows a detail of the loading module of fig. 3 (perspective view)
• Fig. 5 presents a preferred system of two devices for delivering fluid samples to analyzing apparatus according to the invention in a perspective view
• Fig. 6 presents a top view of the system of fig. 5 and
• Fig. 7 shows a detail of the system of fig. 5 (perspective view).
• the following numerals are used: 1 - loading module, 2 - ramp for racks with tubes, 2a - mechanism with two pushers to push the rack on each side, 3 - rack, 4 - tube with blood sample, 5 - rack carriage, 6 - mixer, 7 - analyzing apparatus, 8 - sampling device (with aspiration needle), 9 - additional tube holder (in a closed position), 10 - additional sampling position (for probes delivered by hand), 1 1 - conveyor, 12 - repository slots (holes) for deposition of samples to be analyzed, 13 - second rack carriage, 14 - second analyzer, 15 - parking space for racks with tubes after sampling.
• Example 1 - a device according to the invention
• a device according to the present invention in a preferred embodiment is shown in figs. 1 -4.
• the device comprises a repository area, for storing racks 3 with tubes 4 to be processes.
• the repository area is equipped with ramps 2, 15 for arranging racks 3 with tubes 4.
• ramps 2, 15 for arranging racks 3 with tubes 4.
• standard racks 3 made of plastics and holding five tubes 4 each are used.
• one ramp 2 is used as a repository of racks 3 with tubes 4 to be sampled, while the other ramp 15 is used as parking space for racks 3 with tubes 4 after sampling.
• the racks 3 and the tubes 4 in the racks 3 are generally inserted in the repository area in a vertical ("upright") position.
• the racks 3 loaded in ramp 2 are pushed against the rack carriage 5 and then pushed again inside the mixer 6 with pushers 2a.
• other arranging means such as grabbers, hooks, chains, conveyors, positioning obstacles etc.
• the carriage 5 can move along the lower end of the ramps 2, 15.
• the carriage 5 can take on a racks 3 with tubes 4 from the ramp 2, move it to the mixer 6 and insert it to the mixer 6, while maintaining generally vertical position of the racks 3 with the tubes 4.
• the mixer 6 resembles a cage, in a form of a cuboid, and able to rotate around a rotation axis going through the centers of two opposite walls of the cuboid.
• the mixer 6 can be a part of the analyzer 7, but in the preferred embodiment, the mixer 6 is a part of the loading module 1 . Such preferred embodiment is well visible in figs. 3 and 4.
• the configuration in which the mixer 6 is a part of the loading module 1 is very convenient, because it can be easily aggregated to serve existing analyzers.
• the only condition the analyzer has to fulfill to be supplemented and served with the loading module 1 according to the invention is that the sampling device of the analyzer must be able to sample from the position above the mixer 6.
• the analyzing apparatus 7 is capable of such sampling.
• the mixer 6 is thus of a completely different construction than the drumlike mixer, disclosed in EP 0061317 A1 and it rather resembles the one known from FR 2 730 315.
• the mixer 6 has the capacity of two racks 3, wherein one of the racks 3 is loaded to the mixer 6 in a generally vertical position on one side of the rotation axis and the other rack 3 is loaded to the mixer 6 in a generally vertical position on the other side of the rotation axis.
• the rack carriage 5 inserts the rack 3 into the mixer 6 by movement generally parallel to the direction of the rotational axis of the mixer 6.
• the mixer 6 When in operation, once the first rack 3 has been loaded to the mixer 6 - the mixer 6 is rotated by 180° ("turns upside down") - so that after this rotation another space for loading a rack 3 with tubes 4 is provided for the rack carriage 5. The rack carriage 5 then inserts another rack 3 with tubes 4 to the mixer 6. Therefore, after full loading, the mixer 6 contains two racks 3 with tubes 4, arranged essentially parallel to each other, but one of the racks being turned upside down with respect to the other.
• it is easy to modify the mixer 6 construction such that two or more racks 3 with tubes 4 can be inserted to the mixer 6 on each side of its rotation axis.
• Such racks 3 may be placed in the mixer 6 in series, along the rotational axis (by making the mixer 6 longer), or in parallel, in the direction perpendicular to the rotation axis (by making the mixer 6 "thicker"), or both.
• the mixer 6 performs mixing operation, by full rotations around its rotation axis. Minimum 20 such full rotations are performed before sampling from the tubes 4 by a sampling device 8. Preferably, the mixing is constant, with the only exceptions of the moments of sampling from a tube 4 or loading/unloading of the mixer 6 by the rack carriage 5.
• sampling is performed with a sampling device 8, equipped with a suction needle.
• the mixer 6 is stopped, while one of the racks 3 with the tubes 4, inserted in the mixer 6, is in the upright position, with closing of tubes 4 directed upwards.
• the sampling device 8 arrived from above, in the essentially vertical direction and the suction needle perforates closing of one of the tubes 4 and aspirates a sample from the tube 4.
• the needle is then removed from the tube 4 and the sampling device 8 moves upwards.
• the sampling device 8 with the aspirated sample moves in essentially horizontal direction (towards the left-hand side of the devices shown in figs.
• the mixer 6 continues the mixing process, as described above.
• the sampling device 8 returns to the sampling position above the mixer 6 and is ready for another sampling act. It is worth noticing, that the aforementioned sampling is done directly from the tube 4, while the tube 4 rests in the rack 3 and the rack 3 rests in the mixer 6. This saves time and therefore the inventive device can provide the throughput of 120 samples/hour without or with autoloader.
• the mixer belongs to the autoloader 1 and it is not delivered with the analyzer 7 alone. In case a tube 4 has to be delivered manually to the analyzer 7, the operator has to use the small "one tube holder" 10 (mix manually the tube, place it inside the holder 10 and close the holder 10 to start the analysis cycle) or the open tube position
• the sampling device 8 On its way between the sampling position above the mixer 6 and the repository slots 12, the sampling device 8 passes over an additional tube holder 9.
• This holder 9 can be used to insert therein a tube 4 with a cito sample, which has to be done on priority basis.
• the sampling device 8 may suspend its routine operation of sampling from the mixer 6 and make the next sampling from the additional tube holder 9. This can be triggered automatically when a tube 4 is inserted to the additional tube holder 9 or triggered by hand by the operator.
• the sampling device 8 On its way between the sampling position above the mixer 6 and the repository slots 12, the sampling device 8 passes over an additional sampling position 10, for probes delivered by hand.
• the sampling device 8 In this position 10, it is possible to perform sampling with the sampling device 8 from a container of any shape, in particular from a non-standard tube, which cannot be inserted into any rack 3 or into the additional tube holder 9. Such a container is then delivered by hand to the additional sampling position 10 and the sampling procedure therein is triggered manually by the operator.
• the additional sampling position 10 may as well serve cito samples.
• the contents of the additional tube 4 or container has to be mixed, e.g. manually, before sampling.
• the inventive device can operate with only one rack 3 with tubes 4 inserted to the mixer 6 (the other rack 3 being empty of not being inserted to the mixer 6 at all).
• the racks 3 are top-loaded and their vertical arrangement makes them accessible from above - it is quite easy (and very common in the field) to label each tube 4 with a bar code.
• the rack 3 or some part of the inventive device (such as the mixer 6) can be equipped with its own bar code.
• By applying a well-known bar code scanner one can identify a particular tube 4 and - after sampling - apply the analysis program dedicated for this tube 4.
• the mixer 6 etc. one can also easily distinguish between illegible bar code labels on tubes 4 and empty positions in the rack 3.
• the rack 3 with those tubes 4 is removed from the mixer 6 by the rack carriage 5 and it is taken away to the parking space 15 for processed racks 3.
• the racks 3 with the sampled tubes 4 are also maintained in a generally vertical position and they can be moved in the direction generally parallel to the direction of horizontal movement of the sampling device 8 between the sampling position above the mixer 6 and the repository slots 12.
• conveyors 1 1 have been described here as primary means for moving the racks 3 with tubes 4, it is obvious for those skilled in art that other well-known mechanical means can be applied instead of them or in addition to them, without departing from the scope of the present invention.
• Such means include for example: chains, hooks, belts etc.
• Example 2 a system of two inventive devices, serving two mixers and two analyzers
• a set of devices according to the present invention, serving two mixers 6 and two analyzers 7, 14, in a preferred embodiment is shown in figs. 5-7.
• the racks 3 with tubes 4 to be processed are put in the repository area, shown in the right-hand side of the figures. In this case, all ramps 2 in the repository area are used for storing racks 3 with tubes 4 to be processed.
• Racks 3 are transported by conveyors 1 1 towards the first analyzer 7 or the second analyzer 14 and inserted into the first 6 or the second mixer with mechanisms 5 or 13 that first extract the rack from the conveyor 1 1 and then insert it inside the mixer 6.
• the racks 3 and the tubes 4 in the racks 3 maintain essentially vertical position.
• the general direction of transport of the racks 3 with tubes 4 is from the repository area on one side of the first analyzer 7 (the right-hand side in figs. 5-7), along the first 7 and the second 14 analyzer, towards the parking area 15 on another side of the second analyzer 14 (the left- hand side in figs. 5-6).
• the direction of transport of the racks 3 may be designed in a different way, if needed.
• the racks 3 may be transported in the direction essentially perpendicular to the analyzers 7, 14 ("to and from" the analyzers 7, 14), etc.
• conveyors 1 1 have been described here as primary means for moving the racks 3 with the tubes 4, it is obvious for those skilled in art that other well-known mechanical means can be applied instead of them or in addition to them, without departing from the scope of the present invention.
• Such means include for example: chains, hooks, belts etc.

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• Physics & Mathematics (AREA)
• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Analytical Chemistry (AREA)
• Biochemistry (AREA)
• General Health & Medical Sciences (AREA)
• General Physics & Mathematics (AREA)
• Immunology (AREA)
• Pathology (AREA)
• Automatic Analysis And Handling Materials Therefor (AREA)
• Sampling And Sample Adjustment (AREA)

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• 2012
  • 2012-09-27 WO PCT/EP2012/069060 patent/WO2014048473A1/en active Application Filing
  • 2012-09-27 EP EP12778637.4A patent/EP2901164A1/de not_active Withdrawn

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