WO2020163137A1 - Instrument de laboratoire, réseau et procédé de communication de données - Google Patents

Instrument de laboratoire, réseau et procédé de communication de données Download PDF

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Publication number
WO2020163137A1
WO2020163137A1 PCT/US2020/015656 US2020015656W WO2020163137A1 WO 2020163137 A1 WO2020163137 A1 WO 2020163137A1 US 2020015656 W US2020015656 W US 2020015656W WO 2020163137 A1 WO2020163137 A1 WO 2020163137A1
Authority
WO
WIPO (PCT)
Prior art keywords
instrument
central server
operational state
sub
data
Prior art date
Application number
PCT/US2020/015656
Other languages
English (en)
Inventor
Santosh VIJAY
Original Assignee
Beckman Coulter, Inc.
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 Beckman Coulter, Inc. filed Critical Beckman Coulter, Inc.
Publication of WO2020163137A1 publication Critical patent/WO2020163137A1/fr

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Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L63/00—Network architectures or network communication protocols for network security
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L9/00—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols
    • H04L9/32—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols including means for verifying the identity or authority of a user of the system or for message authentication, e.g. authorization, entity authentication, data integrity or data verification, non-repudiation, key authentication or verification of credentials
    • H04L9/3236—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols including means for verifying the identity or authority of a user of the system or for message authentication, e.g. authorization, entity authentication, data integrity or data verification, non-repudiation, key authentication or verification of credentials using cryptographic hash functions
    • H04L9/3239—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols including means for verifying the identity or authority of a user of the system or for message authentication, e.g. authorization, entity authentication, data integrity or data verification, non-repudiation, key authentication or verification of credentials using cryptographic hash functions involving non-keyed hash functions, e.g. modification detection codes [MDCs], MD5, SHA or RIPEMD
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L9/00—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols
    • H04L9/50—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols using hash chains, e.g. blockchains or hash trees
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L2209/00—Additional information or applications relating to cryptographic mechanisms or cryptographic arrangements for secret or secure communication H04L9/00
    • H04L2209/88—Medical equipments

Definitions

  • the present disclosure relates in general to laboratory instruments for testing patient samples.
  • instruments laboratory instruments or diagnostic instruments (hereinafter broadly referred to as instruments) like immunoassay analyzers may be used for testing a patient sample.
  • diagnostic instruments may be connected to a central server.
  • such instruments may be configured to transmit data to the central server.
  • data may include for example, instrument parameters, instrument operation status, parameters associated with sub-modules of the instrument, and the like.
  • data is regularly monitored by the central server to have traceability and to ensure accurate working of the instruments.
  • data to be transmitted may be secured, for example by encrypting, by using various proprietary techniques and tools.
  • existing data security techniques used in medical instmments may not be reliable as the data can be hacked or tapped.
  • hackers may be taking advantage of security holes on medical devices/medical instruments, causing a concern on multiple levels, and wherein there may arise a need to protect patients from being hacked on their device that could put their life in jeopardy, as well as medical devices/medical instmments that connect to a wide array of sensors and monitors, which may make them vulnerable points of entry to hospital networks. The latter may lead to massive ransomware attacks and theft of personal health information.
  • servers which usually may be physically protected behind doors or even cages
  • medical devices/medical instruments are usually right out there in the open. Therefore, data transmitted by existing medical instmments may not be secure.
  • the present disclosure discloses a laboratory instrument (diagnostic instrument, which is hereinafter referred to as an instrument) (for example an immunoassay analyzer) for performing tests on patient samples.
  • the instrument may include a plurality of sub-modules.
  • each sub-module may have an operational state.
  • the instrument as a whole may have an operational state.
  • the instrument and each sub-module of the instrument may transmit respective operational states to a central server.
  • a plurality of operational parameters may be associated with each operational state of the instrument and the sub-modules.
  • a transition from a first operational state to a second operational state may be recorded.
  • the operational parameters and the transition in operational state may be transmitted to the central server.
  • the operational state, the operational parameters and the transition in operational state may be transmitted to the central server using blockchain technique to secure data.
  • Figure 1 illustrates an exemplary diagram of a laboratory set-up communicating with a server, in accordance with embodiments of the present disclosure
  • Figure 2 illustrates simplified diagram of a network comprising a laboratory instrument, a central server and blockchain generators for securing communication of data in the network, in accordance with an exemplary embodiment of the present disclosure
  • Figure 3 and Figure 4 illustrate exemplary block diagrams of an instrument configured to perform tests on patient samples, in accordance with embodiments of the present disclosure
  • Figure 5 shows an exemplary flowchart illustrating secure communication between an instrument and a server, in accordance with an embodiment of the present disclosure.
  • Figure 6 shows an exemplary block diagram of multiple instruments connected to a cloud server, in accordance with embodiments of the present disclosure.
  • an instrument for testing patient samples may comprise a plurality of sub-systems, each sub-system operated in one or more operational states, wherein each operational state is associated with a plurality of operational parameters.
  • each sub-system may comprise one or more blockchain generators configured to identify an operational state of corresponding sub-system, the plurality of operational parameters associated with the identified operational state, and a transition from a first operational state to a second operational state in the instrument; and to generate a blockchain code for corresponding sub-system from the identified operational state, the plurality of operational parameters and the transition of the operational state of the respective sub-system.
  • Such an instrument may comprise a communication module configured to transmit data comprising the identified operational state of each sub-system, the plurality of parameters associated with the identified operational state and transition from one operational state to another operational state to a central server associated with the instrument.
  • the transmitted data may be used for performing instrument analysis.
  • the communication module upon determination of the data not being transmitted to the central server successfully, is configured to receive a request for retransmitting the data to the central server.
  • the communication module upon receiving the request to retransmit data, is configured to retransmit the data to the central server.
  • the communication module may be associated with the one or more blockchain generators, wherein each blockchain code generated is validated by the central server.
  • the data may be transmitted to the central server indirectly through middleware.
  • an instrument for performing tests on patient samples is disclosed.
  • the instrument is also referred as a laboratory instrument or a diagnostic instrument in the present disclosure and also in general.
  • the laboratory instrument is an immune assay analyzer, that includes a reagent carousel for holding a plurality of containers (generally referred as reagent packs), wherein the containers include reagents that are generally chemical substances used in testing the patient sample on the instrument.
  • the reagent packs include compartments (a typical reagent pack may include five compartments).
  • each compartment comprises a unique chemical substance.
  • each compartment of the reagent pack has an opening provided for aspirating the chemical substance from the container into a reaction vessel in the instrument.
  • the laboratory instrument includes a sample carousel for holding one or more patient samples.
  • the one or more patient samples are placed in one or more containers (generally referred as test tubes) in the sample carousel and labelled accordingly.
  • the one or more test tubes are placed in the laboratory instrument by a laboratory technician.
  • the reagent carousel and the sample carousel may be referred as sub- modules of the instrument.
  • the instrument may include a plurality of sub-modules.
  • a person skilled in the art will appreciate that individual units of the laboratory instrument can be referred as sub-modules of the laboratory instrument.
  • each sub-module may be configured to perform specific tasks.
  • the reagent carousel may be configured to hold a plurality of reagents.
  • the reagent carousel may have one or more sensors to detect the amount of reagents or type of reagent in the carousel.
  • the reagent carousel may provide information to a central server/ computer associated with the instrument regarding presence or absence of reagents in the reagent carousel.
  • the information may be provided to the computer in the lab for the technician to take appropriate measures.
  • the information may be provided to a central server for analysing the information.
  • the present disclosure discloses a laboratory instrument (diagnostic instrument, which is hereinafter referred to as an instrument) (for example an immunoassay analyzer) for performing tests on patient samples.
  • the instrument may include a plurality of sub-modules.
  • each sub-module may have an operational state.
  • the instrument as a whole may have an operational state.
  • the instrument and each sub-module of the instrument may transmit respective operational states to a central server.
  • a plurality of operational parameters may be associated with each operational state of the instrument and the sub-modules.
  • a transition from a first operational state to a second operational state may be recorded.
  • the operational parameters and the transition in operational state may be transmitted to the central server.
  • the operational state, the operational parameters and the transition in operational state may be transmitted to the central server using blockchain technique to secure data.
  • the instrument may include a module (for example a communication module) to transmit data to the central server.
  • the module is referred as communication module hereafter in the description.
  • the central server may be configured to request the communication module of the instrument to retransmit the data.
  • the communication module transmits the data to the central server upon receiving the request.
  • the communication module transmits the data from the instrument to the central server using blockchain technology.
  • the communication module is associated with a plurality of blockchain generators (also referred as blockchain nodes). The blockchain generators are configured to validate the data transmitted by the communication module.
  • a method for establishing secure communication between an instrument and a central server.
  • the method comprises communicating data related to the instrument to the one or more severs using blockchain technology.
  • a network comprises an instrument and central server.
  • the instrument may be configured to communicate data to the central server using blockchain technology to secure the data communicated.
  • Figure 1 illustrates exemplary diagram of a typical laboratory set-up (100).
  • Figure 1 shows instrument (101) and central server (102)/ cloud server.
  • the central server and the cloud server are used interchangeably in the present disclosure.
  • one or more servers can be used as per need.
  • instrument (101) can be an immunoassay analyzer.
  • Central server/ cloud server (102) is used to analyse the data related to instrument (101).
  • the manufacturer of instrument (101) may establish central server/ cloud server (102) to receive the information/ data related to instrument (101). The manufacturer may timely monitor instrument (101) using data.
  • laboratory instrument (101) is connected to the central server (102) via a wired/ wireless network.
  • the central server (102) can be located in a premise comprising the instrument (101).
  • the central server (102) and the instrument (101) can be located in the laboratory (100).
  • the central server (102) can be located remotely to the instrument (101).
  • the central server (102) can be located in a manufacturing/ maintenance premise whereas the instrument (101) can be located in a laboratory (100)/ medical institution.
  • the network may employ connection protocols including, without limitation, direct connect, Ethernet (e.g., twisted pair 10/100/1000 Base T), transmission control protocol/Internet protocol (TCP/IP), token ring, IEEE 802.11a/b/g/n/x, etc.
  • communication network may include, without limitation, a direct interconnection, wired connection, e-commerce network, a peer to peer (P2P) network, Local Area Network (LAN), Wide Area Network (WAN), wireless network (e.g., using Wireless Application Protocol (WAP)), the Internet, Wireless Fidelity (Wi-Fi), etc.
  • FIG. 2 shows an exemplary diagram of a network (201) connected to instrument (101), central server (102) and plurality of blockchain generators (also referred as blockchain nodes) (202A ...., 202N) configured in instrument (101).
  • instrument (101) transmits data to central server/ cloud server (102) using blockchain technology.
  • the blockchain technology can be implemented by generating a digital ledger storing each data communicated by instrument (101) to central server (102).
  • the digital ledger is implemented in central server/ cloud server (102).
  • plurality of blockchain nodes (202A ...., 202N) are configured in instrument (101) to generate blockchain codes using the data to be transmitted by instrument (101) to central server (102).
  • the blockchain codes may be generated using hash techniques.
  • central server (102) includes the digital ledger to validate the data transmitted by instrument (101). The validation of the data enables secure data transmission.
  • the blockchain technology can be used to detect an intrusion in network (201) or detect if data is not completely transmitted to central server (102). If the data is not received by central server (102), central server (102) may request instrument (101) to re-transmit the data.
  • data may be transmitted in defined time intervals.
  • central server (102) may request to transmit the data in the specific interval.
  • FIG 3 illustrates a block diagram of internal structure of instrument (101).
  • Instrument (101) may include communication module (301) and plurality of sub-modules (302). Each sub- module (302) is specified to perform a function.
  • Reference is now made to Figure 4 which is an exemplary illustration of instrument (101) having plurality of sub-modules (302).
  • sub-modules (302) can include for example, reagent carousel (401), sample carousel (402), pipette unit (403), communication module (301), conveyor belt (405) and reaction vessel (404).
  • Figure 4 is an exemplary illustration of an immune assay instrument.
  • sub-modules (302) of instrument (101) can vary and may depend on the type of instrument (101).
  • Sub-modules (302) disclosed in Figure 4 are only exemplary for an immune assay analyzer and should not be considered as a limitation.
  • each sub-module (302) includes blockchain generator (201A- 20 IN) as shown in Figure 4.
  • common blockchain generator (201) may be present in instrument (101) and is common for all sub-modules present in instrument (101).
  • Common blockchain generator (201) may generate unique blockchain codes for each sub-module (302).
  • Reagent carousel (401) may be configured to hold reagent packs. Parameters associated with the reagent carousel can include number of reagent packs, proper insertion of reagent packs, and weight of reagent packs.
  • the parameters related to the reagent carousel may be converted to blockchain codes by blockchain generator (201A). Further, the blockchain codes related to the reagent carousel are transmitted to central server (102) at specific time periods, for example every minute, during testing of a patient sample.
  • a status is associated with reagent carousel (401) (for example, carousel empty, carousel full). The status of reagent carousel (401) and a transition of status (for example, carousel empty to carousel full) are also converted to blockchain codes.
  • the blockchain codes including the status of reagent carousel (401) and transition of status are also transmitted to central server (102).
  • each submodule (302) comprises a functionality, and a status.
  • the functionality may be associated with a plurality of parameters.
  • Each parameter, the status and a change/ transition in status are converted to blockchain codes by respective blockchain generators (201 A... 20 IN).
  • the resulting blockchain codes from respective blockchain generators (201A... 201N) are transmitted by communication module (301) of instrument (101) to central server (102).
  • blockchain generators can use hashing technique to encrypt data to be transmitted.
  • central server (102) receives the hashed data validates the hashed data.
  • Central server (102) may use mapping technique to decrypt the hashed data.
  • central server (102) may include reference hash codes or a method to generate reference has codes.
  • test results generated from in the instrument (101) are also communicated to the central server (102) as blockchain codes.
  • FIG. 5 shows a flow chart illustrating a method for securing communication between instrument (101) and central server (102), in accordance with some embodiments of the present disclosure.
  • method 500 may comprise one or more steps for securing communication between the instrument (101) and central server (102), in accordance with some embodiments of the present disclosure.
  • Method 500 may be described in the general context of computer executable instructions.
  • computer executable instructions can include routines, programs, objects, components, data structures, procedures, modules, and functions, which perform particular functions or implement particular abstract data types.
  • method 500 is described is not intended to be construed as a limitation, and any number of the described method blocks can be combined in any order to implement the method. Additionally, individual blocks may be deleted from the methods without departing from the spirit and scope of the subject matter described herein. Furthermore, the method can be implemented in any suitable hardware, software, firmware, or combination thereof.
  • the common blockchain generator (201)/ respective blockchain generator (201 A... 201N) of instrument (101) identifies operational state of each sub-module (302), operational parameters associated with each sub-module (302) and a transition in state of each sub-module. Further, a state of instrument (101) as a whole may also be identified by common blockchain generator (201. Further, common blockchain generator (201)/ respective blockchain generators (201A... 201N) generate a blockchain code for each sub-module (302) using the data related to respective sub-module (302). The blockchain codes of each sub- module (302) are provided to communication module (301).
  • communication module (301) transmits each blockchain code to central server (102).
  • Figure 6 shows an exemplary block diagram of plurality of instmments connected to a cloud server, in some cases indirectly through middleware (601), in accordance with embodiments of the present disclosure.
  • the plurality of instruments (101A, 101B, 101C) set up in respective laboratories (100A, 100B and lOOC) are connected to central server (102), in some cases (101A) directly and in some cases (101B, 101C) indirectly through middleware (601).
  • central server (102) can include a digital ledger storing data related to each instrument.
  • middleware (601) may receive information from instruments (10 IB, 101C) in any form and may use such information to generate blockchain codes as described previously.
  • instruments communicating with middleware (601) may create blockchain codes as described previously and send them to middleware (601) for communication to the central server (102) without middleware (601) generating blockchain codes.
  • an operator monitoring plurality of instruments (101A, 101B, 101C) can take decisions regarding maintenance of the instruments upon determining that at least one of plurality of instruments (101A, 101B, 101C) is not performing as expected.
  • any message transmitted from each instrument is sent as blockchain codes, and the blockchain codes are validated by the central server.
  • the use of blockchain technology in instrument (101) secures the communication between the instrument and central server (102).
  • the blockchain technology can be implemented in central server (102) as well.
  • incomplete transmission of data can be easily detected using the blockchain technology and such missing data can be requested to be re-transmitted.

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  • Engineering & Computer Science (AREA)
  • Computer Security & Cryptography (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Signal Processing (AREA)
  • Health & Medical Sciences (AREA)
  • Business, Economics & Management (AREA)
  • Biomedical Technology (AREA)
  • General Business, Economics & Management (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Primary Health Care (AREA)
  • Public Health (AREA)
  • Computer Hardware Design (AREA)
  • Computing Systems (AREA)
  • General Engineering & Computer Science (AREA)
  • Medical Treatment And Welfare Office Work (AREA)

Abstract

La présente invention concerne un instrument de laboratoire pour effectuer des tests sur des échantillons de patient. L'instrument de laboratoire comprend une pluralité de sous-modules. Chaque sous-module peut avoir un état opérationnel. L'instrument de laboratoire dans son ensemble peut avoir un état opérationnel. L'instrument de laboratoire et chaque sous-module de l'instrument de laboratoire peuvent transmettre un état opérationnel respectif à un serveur central. Une pluralité de paramètres opérationnels peuvent être associés à chaque état opérationnel de l'instrument de laboratoire et des sous-modules. Une transition d'un état opérationnel à un autre état opérationnel peut être enregistrée. Les paramètres opérationnels et la transition dans l'état opérationnel peuvent être transmis au serveur central à l'aide d'une technique de chaîne de blocs pour sécuriser des données.
PCT/US2020/015656 2019-02-04 2020-01-29 Instrument de laboratoire, réseau et procédé de communication de données WO2020163137A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962800788P 2019-02-04 2019-02-04
US62/800,788 2019-02-04

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WO2020163137A1 true WO2020163137A1 (fr) 2020-08-13

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030088657A1 (en) * 2001-11-07 2003-05-08 Eggers Mitchell D Archive and analysis system and method
US20080033361A1 (en) * 2006-08-03 2008-02-07 Smiths Medical Md, Inc. Interface for medical infusion pump
US20140129172A1 (en) * 2012-11-07 2014-05-08 Beckman Coulter, Inc. Automated sample processing system
US20170312462A1 (en) * 2011-11-02 2017-11-02 Vyaire Medical Capital Llc Ventilation system
US20190017008A1 (en) * 2017-07-17 2019-01-17 Amino Labs North Incorporated Personal Laboratory for Genetic Engineering, Culturing and Analysis of Microorganisms and Biochemicals

Patent Citations (5)

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US20030088657A1 (en) * 2001-11-07 2003-05-08 Eggers Mitchell D Archive and analysis system and method
US20080033361A1 (en) * 2006-08-03 2008-02-07 Smiths Medical Md, Inc. Interface for medical infusion pump
US20170312462A1 (en) * 2011-11-02 2017-11-02 Vyaire Medical Capital Llc Ventilation system
US20140129172A1 (en) * 2012-11-07 2014-05-08 Beckman Coulter, Inc. Automated sample processing system
US20190017008A1 (en) * 2017-07-17 2019-01-17 Amino Labs North Incorporated Personal Laboratory for Genetic Engineering, Culturing and Analysis of Microorganisms and Biochemicals

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Title
WIKIPEDIA: "File verification", 25 July 2018 (2018-07-25), XP055682280, Retrieved from the Internet <URL:https://en.wikipedia.org/w/index.php?title=File_verification&oldid=851885143> [retrieved on 20200402] *
WIKIPEDIA: "Retransmission (data networks)", 14 April 2018 (2018-04-14), XP055682279, Retrieved from the Internet <URL:https://en.wikipedia.org/w/index.php?title=Retransmission_(data_networks)&oldid=836376343> [retrieved on 20200402] *

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