Method and apparatus for automated pre-treatment and processing of biological samples

• US 20060148063A1
• Filed: 09/16/2005
• Published: 07/06/2006
• Est. Priority Date: 05/14/2003
• Status: Active Grant

• Current Assignee: Agilent Technologies, Inc.
• Original Assignee: Dako Denmark A/S (Agilent Technologies, Inc.)
• Inventors: Fauzzi, John A., Feingold, Gordon A., Key, Marc E., Lathrop, Robert L.
• Granted Patent: US 7,850,912 B2
• Time in Patent Office: Days
• US Class Current: 435/286.400
• CPC Class Codes: G01N 1/31 Apparatus therefor
• CPC Class Codes: G01N 35/00871 Communications between instruments or with remote terminals
• CPC Class Codes: G01N 35/0092 Scheduling
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A method and apparatus for continuous workflow processing of biological samples. In one embodiment, the appratus includes a probe for dispensing one or more reagents from one or more reagent containers onto one or more biological sample carriers. The method and apparatus includes processing each biological sample according to a respective sequence of protocol steps which may be ordered by a scheduler protocol. The method and apparatus also includes network capability for connectivity with additional equipment for receiving or transmitting pertinent data via the network.

Claims

1. An apparatus for automated processing of a plurality of biological samples, said apparatus comprising:

a plurality of independently accessible reagent holders;

a plurality of independently accessible biological sample holders;

at least one probe for dispensing at least one reagent;

at least one reagent mixer;

at least one fluid supply for supplying fluids to either the at least one probe or the at least one processing tank;

at least one temperature controller;

at least one distributed controller; and

at least one computer comprising a scheduler for scheduling tasks; and

wherein the apparatus communicates with a network comprising at least one element chosen from servers, clients, and additional apparatus;

and wherein the network is optionally connected to a proprietary network;

and wherein processing of each biological sample is conducted according to a respective sequence of protocol steps;

wherein a first biological sample, on a first sample holder, for which the processing is completed may be removed from the apparatus simultaneous with the processing of a second biological sample on a second sample holder;

and wherein a first reagent container may be removed or replaced simultaneous with the processing of the at least one biological sample.

2. An apparatus according to claim 1, wherein the apparatus further comprises at least one processing tank.

3. An apparatus according to claim 1, wherein each independently accessible reagent holder comprises a plurality of individual reagent holders.

4. An apparatus according to claim 1, wherein each independently accessible biological sample holder comprises a plurality of individual sample holders.

5. An apparatus according to claim 1, wherein the biological sample holder is a microscope slide holder.

6. An apparatus according to claim 1, wherein the microscope slide holder is a slide clip.

7. An apparatus according to claim 3, wherein each independently accessible biological sample holder is chosen from slide racks and slide carrousels.

8. An apparatus according to claim 2, wherein each independently accessible reagent holder is chosen from reagent racks and reagent carrousels.

9. An apparatus according to claim 3, further comprising at least one drawer, wherein each drawer comprises at least one slide rack.

10. An apparatus according to claim 2, wherein each independently accessible reagent holder is chosen from reagent racks and reagent carrousels.

11. An apparatus according to claim 1, wherein the at least one probe is connected to a robotic head.

12. An apparatus according to claim 1, wherein the independently accessible biological sample holders are transported to the at least one probe.

13. An apparatus according to claim 1, wherein the at least one probe comprises a syringe pump.

14. An apparatus according to claim 1, wherein the biological sample on each biological sample holder my be immersed in the at least one processing tank.

15. An apparatus according to claim 1, wherein the at least one temperature controller is a Peltier device.

16. An apparatus according to claim 1, wherein the at least one distributed controller comprises a controller that communicates with at least one other controller that controls at least one element chosen from the at least one independently accessible reagent holder;

at least one independently accessible biological sample holder;

at least one probe;

at least one reagent mixer;

at least one fluid supply; and

at least one temperature controller;

17. An apparatus according to claim 1, wherein the at least one scheduler is an adaptive scheduler.

18. The apparatus according to claim 1, wherein the at least one processing tank pretreats the biological sample.

19. The apparatus according to claim 17, wherein the pre-treatment is deparaffinization.

20. The apparatus according to claim 1, wherein the apparatus further controls the temperature of at least one biological sample according to a sequence of steps in a first protocol.

21. The apparatus according to claim 1, wherein at least one reagent is dispensed on the at least one biological sample according to a sequence of steps in a first protocol.

22. The apparatus according to claim 1, wherein the apparatus further comprises at least one sample detector that detects the presence or absence of at least one sample.

23. The apparatus according to claim 1, wherein the apparatus further comprises at least one reagent detector that detects the presence or absence of at least one reagent.

24. The apparatus according to claim 1, wherein the apparatus further comprises at least one fluid detector that detects the presence or absence of at least one fluid.

25. The apparatus according to claim 1, wherein the apparatus provides continuous workflow processing of the at least one biological sample.

26. An apparatus for automated processing of a plurality of biological samples, said apparatus comprising the following elements:

a plurality of independently accessible reagent holders;

a plurality of independently accessible biological sample holders;

a means for dispensing at least one reagent onto at least one biological sample holder;

a means for mixing at least one reagent;

a means for at least one pre-treatment of at least one biological sample;

means for delivering fluid to the at least one probe and a means for delivering fluid to the means for the at least one pre-treatment; and

at least one temperature controller;

wherein at least one element comprises a individual controller that receives instructions from a controller; and

wherein the apparatus further comprises a means for scheduling tasks; and

wherein the apparatus communicates with a network comprising at least one element chosen from servers, clients, and additional apparatus;

and wherein the network is optionally connected to a proprietary network.

27. The apparatus according to claim 26, wherein the means for at least one pre-treatment comprises transporting at least one biological sample holder to at least one at least one processing tank.

28. The apparatus according to claim 26, wherein at least one biological sample holder is transported to the means for dispensing at least one reagent.

29. An automated method of processing a plurality of biological samples in an apparatus comprising:

applying at least one reagent from a plurality of reagents to at least one first biological sample according to a sequence of steps in a first protocol;

wherein at least one second biological sample can be added or removed from the apparatus prior to completion of the first protocol; and

wherein at least one second reagent can be added or removed from the apparatus prior to completion of the first protocol;

wherein the apparatus comprises

a plurality of independently accessible reagent holders;

a plurality of independently accessible biological sample holders;

at least one probe for dispensing at least one reagent;

at least one reagent mixer;

at least one processing tank for at least one biological sample;

at least one fluid supply for supplying fluids to either the at least one probe or the at least one processing tank;

at least one temperature controller;

at least one distributed controller; and

at least one computer comprising a scheduler for scheduling tasks; and

wherein the apparatus communicates with a network comprising at least one element chosen from servers, clients, and additional apparatus;

and wherein the network is optionally connected to a proprietary network.

30. The automated method of claim 29, wherein the apparatus further controls the temperature of the at least one first biological sample according to a sequence of steps in a first protocol.

31. The automated method of claim 29, wherein the processing includes deparaffinization.

32. The automated method of claim 29, wherein the processing includes biological staining.

33. The automated method of claim 29, wherein the processing includes in-situ hybridization.

34. A laboratory instrument information management and control apparatus, comprising:

a Laboratory Information System (LIS) configured to manage patient and laboratory information;

at least one laboratory instrument configured to run anatomical pathology tests relating to at least one patient;

at least one host computer in communication with said at least one laboratory instrument;

an interface point server (IPS) in communication with said host computer and said LIS, said interface point server configured to function as a communication interface between said host computer and said hospital laboratory information system in a manner responsive to a predetermined communication protocol, and said IPS comprising a first level interface for data communication and control between said LIS and said IPS, and said IPS comprising a second level interface for data communication and control between said at least one laboratory instrument and said IPS.

35. The laboratory instrument information management and control apparatus of claim 34 wherein said at least one laboratory instrument comprises at least two automated slide staining systems, and said second level interface of said IPS controls data communication and control between said at least two automated slide staining systems and said IPS, and said second level interface of said IPS controls data communication and control among said at least two automated slide staining systems.

36. The laboratory instrument information management and control apparatus of claim 34 wherein said at least one laboratory instrument configured to run tests relating to at least one patient includes said at least one host computer in communication with said at least one laboratory instrument as an integral part of said at least one laboratory instrument.

37. The laboratory instrument information management and control apparatus of claim 34 wherein said predetermined communication protocol governs data exchange, data management and integration of data in accordance with one of Health Level Seven (HL7) protocol, or IEEE 1073 standard for Medical Device Communications.

38. The laboratory instrument information management and control apparatus of claim 34 wherein said at least one host computer is in communication with said at least one laboratory instrument via at least one of a wireless connection, a serial connection, a parallel connection and an Ethernet connection.

39. The laboratory instrument information management and control apparatus of claim 34 wherein said hospital laboratory information system is in communication with the interface point server via at least one of an Ethernet connection and an Internet connection.

40. The laboratory instrument information management and control apparatus of claim 34 wherein said at least one laboratory instrument comprises at least two automated slide staining systems, and said second level interface controls data sharing among said at least two automated slide staining systems.

41. The laboratory instrument information management and control apparatus of claim 40 wherein said data sharing among said at least two automated slide staining systems includes data comprising staining protocols;

user passwords and privileges;

reagent dispensers;

reagent vials;

cases;

keycodes;

templates;

panels; and

3^rd party reagents.

42. The laboratory instrument information management and control apparatus of claim 34 wherein said laboratory information system manages the workflow for anatomical pathology in a laboratory, including at least one of pathology order placement;

slide processing optimization on multiple instruments;

slide identification through the process;

bar code use;

reagent use and supply;

reagent sharing between laboratory instruments; and

operator in-service qualification.

43. The laboratory instrument information management and control apparatus of claim 34 wherein said laboratory information system is a hospital laboratory information system.

44. A method for communication between a laboratory information system and at least one host computer comprising the steps of:

configuring an Interface point network including an interface point server (IPS) in communication with a laboratory information system and at least one host computer managing data and control for at least one anatomical pathology laboratory instrument, said at least one host computer including host data and being in communication with said at least one laboratory instrument;

operating said interface point server to broadcast a message across said interface point network, wherein said message includes information responsive to data present on said IPS;

determining if differences exist between said host data and said data present on said IPS; and

updating at least one of said IPS and said at least one host computer in a manner responsive to at least one of said host data and said data present on said IPS.

45. The method of claim 44 wherein said at least one host computer comprises more than one host computer and the method further includes the step of sharing of data among said more than one host computer.

46. The method of claim 45 wherein said sharing of data among said more than one host computer includes data comprising staining protocols;

user passwords and privileges;

reagent dispensers;

reagent vials;

cases;

keycodes;

templates;

panels; and

3^rd party reagents.

47. The method of claim 44 wherein said laboratory information system manages the workflow for anatomical pathology in a laboratory, including at least one of pathology order placement;

slide processing optimization on multiple Instruments;

slide identification through the process;

bar code use;

reagent use and supply;

reagent sharing between laboratory instruments; and

operator in-service qualification.

48. The method of claim 44 wherein said at least one host computer managing data and control for at least one anatomical pathology laboratory instrument is an integral part of said at least one laboratory instrument.

49. The method of claim 44 wherein said interface point server (IPS) in communication with said laboratory information system communicates via a predetermined communication protocol that governs data exchange, data management and integration of data in accordance with one of Health Level Seven (HL7) protocol, or IEEE 1073 standard for Medical Device Communications.

50. A method for laboratory instrument information management and control, comprising the steps of:

configuring a Laboratory Information System (LIS) to manage patient and laboratory information in accordance with Health Level Seven protocol;

configuring at least two automated slide staining laboratory instruments to run anatomical pathology tests relating to at least one patient;

configuring at least one host computer in communication with said at least two slide staining laboratory instruments;

configuring a server in communication with said at least one host computer and said LIS, said server comprising a first level Interface for data communication and control between said LIS and said server, and said server comprising a second level interface for data communication and control between said at least two automated slide staining laboratory instruments and said server, wherein said server is further configured for data sharing among said at least one host computer and said at least two automated slide staining laboratory instruments.

51. The method for laboratory instrument information management and control of claim 50 wherein said data sharing among said at least two automated slide staining laboratory instruments includes data comprising staining protocols;

user passwords and privileges;

reagent dispensers;

reagent vials;

cases;

keycodes;

templates;

panels; and

3^rd party reagents.

52. The method for laboratory instrument information management and control of claim 50 wherein said laboratory Information system manages the workflow for anatomical pathology in a laboratory, including at least one of pathology order placement;

slide processing optimization on multiple instruments;

slide identification through the process;

bar code use;

reagent use and supply;

reagent sharing between laboratory instruments; and

operator In-service qualification.

53. The method of claim 50 wherein said server In communication with said laboratory information system communicates via a predetermined communication protocol that governs data exchange, data management and integration of data in accordance with one of Health Level Seven (HL7) protocol, or IEEE 1073 standard for Medical Device Communications.