Automatic Method of Preparing Samples of Total Blood For Analysis, and an Automatic Device For Implementing the Method

• US 20090142844A1
• Filed: 07/04/2006
• Published: 06/04/2009
• Est. Priority Date: 07/08/2005
• Status: Active Grant

• Current Assignee: Horiba Abx SAS (Horiba Limited)
• Original Assignee: Horiba Abx SAS (Horiba Limited)
• Inventors: Le Comte, Roger
• Granted Patent: US 9,952,238 B2
• Time in Patent Office: Days
• US Class Current: 436/8
• CPC Class Codes: G01N 2035/00524 Mixing by agitating sample carrier
• CPC Class Codes: G01N 2035/0406 Individual bottles or tubes
• CPC Class Codes: G01N 35/00584 Control arrangements for automatic analysers
• CPC Class Codes: G01N 35/00594 Quality control, including calibration or testing of components of the analyser
• CPC Class Codes: G01N 35/00712 Automatic status testing, e.g. at start-up or periodic
• CPC Class Codes: G01N 35/0092 Scheduling
• CPC Class Codes: G01N 35/0099 comprising robots or similar manipulators robots per se B25J
• CPC Class Codes: G01N 35/04 Details of the conveyor system G01N35/021 - G01N35/028 take precedence
• CPC Class Codes: G01N 35/1097 characterised by the valves valves in general F16K
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/114165 with step of insertion or removal from test line

Abstract

The present invention relates to a method of preparing analyses of total blood samples and to a device that is useful for implementing the method, said samples being conserved in tubes including at least one identification means for identifying the sample, the device comprising:

• • at least one compartment constituting a said storage zone for storing said tubes before and after analysis; and
  • at least one said read means for reading said identification means of said tubes; and
  • at least one preparation zone for preparing said blood samples prior to analysis and including means for verifying and/or treating said tubes containing said samples, and in particular at least one agitator means for agitating said tubes; and
  • at least one access zone giving access to at least one automatic analyzer of total blood, said access zone enabling a said tube to be placed in said analyzer; and
  • robotic gripper and displacement means controlled by an automatic controller and suitable for taking hold of and replacing said tubes individually in said storage zone and for conveying them in at least three directions XYZ between said storage zone, said preparation zone and said access zone giving access to said analyzer, said analyzer preferably being connected to and/or controlled by said automatic controller.

Claims

1. A method of preparing analyses of samples of total blood, said samples being conserved in tubes including identification means for identifying the samples and preferably hermetically closed by plugs, the method being characterized by the following successive steps:

a) placing a said tube in a storage zone and identifying said tube of blood by reading its said identification means with the help of reader means and recording the information read in an automatic controller in order to know the identity of the patient, the type of analysis to be performed on the sample of blood contained in said tube, and to determine automatically therefrom the type of preparation to which each tube is to subjected before analysis; and

b) taking and moving said tube individually with the help of robotic gripper and displacement means controlled by said automatic controller from said storage zone to at least one preparation zone for preparing the tube and the blood sample; and

c) preparing said tube and said sample in said preparation zone in application of a preparation sequence that is determined as a function of the information read from said sample identification means and/or information input into said automatic controller by an operator, said sequence including at least agitating the tube so as to mix together all of the components of the blood contained therein; and

d) individually displacing said tube immediately after preparation with the help of said robotic gripper and displacement means to at least one access zone giving access to an automatic analyzer of total blood to analyze the blood sample contained in said tube as a function of the information read from said identification means of said tube; and

e) extracting said tube from said analyzer from a said access zone after analysis and replacing it in said storage zone with the help of said robotic gripper and displacement means; and

preferably

f) reiterating operations a) to e) for the other samples.

2. A method according to claim 1, wherein in step a) said tubes are placed and held vertically in supports, each having a plurality of individual housings of format suitable for receiving a said tube and organized in rows of adjacent housings, said supports being positioned in said storage zone suitable for receiving a plurality of said supports and accessible to said robotic gripper and displacement means.

3. A method according to claim 1, wherein in step a), a plurality of tubes is placed in said storage zone and information relating to the samples contained in said tube is identified and recorded in said automatic controller, together with the positions of said tubes so as to establish an electronic map of the tubes in said storage zone prior to proceeding with the steps b) to e) of individually treating the tubes.

4. A method according to claim 1, wherein in step c), at least one of the following additional operations is performed:

causing the tube to be aerated; and

verifying the level of said sample of blood in said tube; and

determining whether any blood clots exist in said sample; and

verifying the depth to which the plug closing said tube has been engaged in said tube.

5. A method according to claim 4, wherein in step c) the temperature of said sample is set, preferably by heating.

6. A method according to claim 1, wherein in step a) a tube is placed in an emergency treatment zone and said automatic controller is programmed so that the preparation and analysis of said tube is performed with priority over that of the tube(s) present in said storage zone.

7. A method according to claim 2, wherein in step e), the tubes are sorted and stored in different said supports with the help of said robotic gripper and displacement means as a function of the results of the analyses performed on the samples contained in said tubes and/or as a function of any additional operations that are to be performed on said samples.

8. A method according to claim 1, wherein prior to preparing and analyzing said samples of total blood, quality control is performed using tubes containing control samples of blood, said control sample tubes being conserved in a refrigerated conservation zone accessible to said robotic gripper and displacement means, said control sample tubes being heated and prepared like tubes of unknown total blood, and then successively introduced into said analyzer and recovered automatically in order to be replaced in their starting locations in said refrigerated zone by said robotic gripper and displacement means.

9. A method according to claim 8, wherein the analysis of at least one control sample tube is prepared periodically after preparing and analyzing a determined number of total blood tubes in a said analyzer, said control sample tube being taken, prepared, and introduced into the analyzer and then recovered and stored by said robotic gripper and displacement means.

10. A method according to claim 8, characterized by the following steps:

taking an average of each of the parameters analyzed on a series of a determined number of unknown total blood samples; and

comparing the average values of the analyzed parameters with ranges of nominal values for said parameters corresponding to healthy patients and recorded in said controller; and

if one of said mean values lies outside the range of nominal values for the corresponding parameter, preparing a control sample of blood and analyzing the same parameter on the control sample; and

if the value of the parameter as analyzed on the control sample lies in a range of nominal values for said parameter, continuing analysis on a new series of unknown total blood samples, the mean value(s) situated outside the range(s) of corresponding nominal values indicating that at least one sample of pathological blood is present in the preceding series; and

if the value of the parameter analyzed on the control sample lies outside the range of nominal values for said parameter, then said analyzer is calibrated prior to analyzing a new series of unknown total blood samples.

11. A device suitable for preparing analyses of samples of total blood in accordance with a method according to claim 1, said samples being conserved in tubes each having at least one identification means for identifying the tube and preferably being closed hermetically by a plug, the device comprising:

at least one compartment constituting a said storage zone for storing said tubes before and after analysis; and

at least one said read means for reading said identification means of said tubes; and

sorter means for sorting tubes before and/or after analyses in said storage zone; and

at least one preparation zone for preparing said blood samples prior to analysis and including means for verifying and/or treating said tubes containing said samples, and in particular at least one agitator means for agitating said tubes; and

at least one access zone giving access to at least one automatic analyzer of total blood, said access zone enabling a said tube to be placed in said analyzer; and

robotic gripper and displacement means controlled by an automatic controller and suitable for taking hold of and replacing said tubes individually in said storage zone and for conveying them in at least three directions XYZ between said storage zone, said preparation zone and said access zone giving access to said analyzer, said analyzer preferably being connected to and/or controlled by said automatic controller.

12. A device according to claim 11, including supports including individual housings in which said tubes are placed by an operator, said supports being positioned in said storage zone and being manually removable therefrom, said storage zone being suitable for receiving a plurality of said supports and being accessible by said robotic gripper and displacement means so as to enable the tubes containing the samples of total blood for analysis to be taken therefrom and replaced therein.

13. A device according to claim 11, including an emergency treatment compartment that is manually accessible to an operator from outside the device, said emergency treatment compartment also being accessible to said robotic gripper and displacement means and including at least one tube support element including at least one housing suitable for receiving a tube of blood.

14. A device according to claim 11, wherein said verification and/or treatment means including a device for aerating said tubes.

15. A device according to claim 11, including a compartment for storing and conserving tubes of control samples of blood to enable said analyzers to be verified, said compartment including means for cooling said tubes.

16. A device according to claim 11, wherein said control sample tubes are positioned and held in said conservation compartment in individual housings of a support, said cooling means being constituted by thermoelectric cells preferably placed in said housings or at the periphery thereof.

17. A device according to claim 11, wherein said verification and/or treatment means include a selection of:

means for detecting the level of blood in a said tube and the presence of clots, if any, in said blood; and

/or

means for verifying the level to which the plug is put into a said tube of blood; and

/or

means for heating said tubes, preferably constituted by thermoelectrical cells.

18. A device according to claim 11, wherein said robotic gripper and displacement means comprise a hinged clamp adapted to take hold of said tubes, preferably under the base of the plug, said clamp being movable vertically and horizontally in translation along three orthogonal XYZ axes by means of a transporter device having at least three guide rails directed along said XYZ axes and connected together in pairs, comprising a first rail that is horizontal and stationary, supporting a second rail that is horizontal and perpendicular to said first rail, being movable in translation thereon, and a third rail that is vertical, being secured to said second rail and being movable in translation thereon and perpendicularly thereto, said clamp being secured to said third rail.

19. A device according to claim 11, wherein said robotic gripper and displacement means comprise an articulated arm provided at one of its ends with a clamp for gripping said tubes of blood.

20. A device according to claim 11, the device being confined in a protective enclosure including at least one access opening giving access to at least one said analyzer, and a second access opening giving access to an emergency treatment compartment.

21. A device according to claim 11, wherein said access zone(s) giving access to said analyzer(s) includes respective moving carriages suitable for moving between said device and a said analyzer, each said carriage being controlled by said automatic controller and including at least one housing suitable for receiving a said tube of blood from said robotic gripper and displacement means.

22. A device according to claim 18, wherein said robotic gripper and displacement means include means for detecting and/or viewing said tubes containing said samples of blood and said tubes containing control samples in said storage zones, said preparation zone, said zone(s) giving access to said analyzer(s), in said emergency treatment compartment, and in said compartment for storing and conserving tubes of control samples.

23. A device according to claim 12, wherein said supports disposed in said storage zone and/or in said compartment for conserving tubes of control samples also include identification means suitable for being read by a said read means.

24. An automatic device for analyzing total blood comprising at least one automatic analyzer of total blood, said analyzer including means, in particular, a needle for taking blood from a sample to be analyzed that is contained in a tube, which tube is preferably hermetically closed by a plug, the device including at least one device suitable for preparing analyses of samples of total blood according to claim 11 coupled to said analyzer and communicating therewith via at least one said access zone of said preparation device giving access to said analyzer.