COMMUNICATING DATA

RELATED APPLICATIONS

[0001] This application is related to previously filed provisional application number 62/800,788 titled Laboratory Instrument, Network and Method for Communicating Data filed at the USPTO. The contents of that application is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

[0002] The present disclosure relates in general to laboratory instruments for testing patient samples.

BACKGROUND

[0003] Generally, laboratory instruments or diagnostic instruments (hereinafter broadly referred to as instruments) like immunoassay analyzers may be used for testing a patient sample. Usually, such diagnostic instruments may be connected to a central server. Typically, such instruments may be configured to transmit data to the central server. Usually, data may include for example, instrument parameters, instrument operation status, parameters associated with sub-modules of the instrument, and the like. Usually, data is regularly monitored by the central server to have traceability and to ensure accurate working of the instruments.

[0004] Usually, data to be transmitted may be secured, for example by encrypting, by using various proprietary techniques and tools. However, existing data security techniques used in medical instmments may not be reliable as the data can be hacked or tapped. For example, 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. Unlike 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.

SUMMARY

[0005] In an embodiment, 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. In an embodiment, each sub-module may have an operational state. In one embodiment, the instrument as a whole may have an operational state. In one embodiment, the instrument and each sub-module of the instrument may transmit respective operational states to a central server. In a further embodiment, a plurality of operational parameters may be associated with each operational state of the instrument and the sub-modules. In a further embodiment, a transition from a first operational state to a second operational state may be recorded. In a further embodiment, the operational parameters and the transition in operational state may be transmitted to the central server. In one embodiment, 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.

[0006] The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

[0007] Features and characteristic of the disclosure are set forth in the appended claims. The disclosure itself, however, as well as a preferred mode of use, further objectives and advantages thereof, may best be understood by reference to the following detailed description of an illustrative embodiment when read in conjunction with the accompanying figures. One or more embodiments may be described, by way of example only, with reference to the accompanying figures wherein like reference numerals represent like elements and in which:

[0008] Figure 1 illustrates an exemplary diagram of a laboratory set-up communicating with a server, in accordance with embodiments of the present disclosure; [0009] 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;

[0010] 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;

[0011] Figure 5 shows an exemplary flowchart illustrating secure communication between an instrument and a server, in accordance with an embodiment of the present disclosure; and

[0012] Figure 6 shows an exemplary block diagram of multiple instruments connected to a cloud server, in accordance with embodiments of the present disclosure.

[0013] It should be appreciated by those skilled in the art that any block diagrams herein represent conceptual views of illustrative systems embodying the principles of the present disclosure. Similarly, it will be appreciated that any flow charts, flow diagrams, state transition diagrams, pseudo code, and the like represent various processes which may be substantially represented in computer readable medium and executed by a computer or processor, whether or not such computer or processor is explicitly shown.

DETAILED DESCRIPTION

[0014] In the present document, the word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment or implementation of the present subject matter described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.

[0015] While the disclosure may be susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and will be described in detail below. It should be understood, however that this is not intended to limit the disclosure to the particular forms disclosed, but on the contrary, the disclosure is to cover modifications, equivalents, and alternative falling within the scope of the disclosure.

[0016] The terms“comprises”,“comprising”, or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a setup, device or method that comprises a list of components or steps does not include only those components or steps but may include other components or steps not expressly listed or inherent to such setup or device or method. In other words, one or more elements in a system or apparatus proceeded by“comprises... a” does not, without more constraints, preclude the existence of other elements or additional elements in the system or apparatus.

[0017] The terms "an embodiment", "embodiment", "embodiments", "the embodiment", "the embodiments", "one or more embodiments", "some embodiments", and "one embodiment" mean "one or more (but not all) embodiments of the disclosure(s)" unless expressly specified otherwise.

[0018] The terms "including", "comprising",“having” and variations thereof mean "including but not limited to", unless expressly specified otherwise.

[0019] The enumerated listing of items does not imply that any or all of the items are mutually exclusive, unless expressly specified otherwise. The terms "a", "an" and "the" mean "one or more", unless expressly specified otherwise.

[0020] A description of an embodiment with several components in communication with each other does not imply that all such components are required. On the contrary a variety of optional components are described to illustrate the wide variety of possible embodiments of the disclosure.

[0021] When a single device or article is described herein, it will be readily apparent that more than one device/article (whether or not they cooperate) may be used in place of a single device/article. Similarly, where more than one device or article is described herein (whether or not they cooperate), it will be readily apparent that a single device/article may be used in place of, more than one device or article or a different number of devices/articles may be used instead of the shown number of devices or programs. The functionality and/or features of a device may be alternatively embodied by one or more other devices which are not explicitly described as having such functionality /features. Thus, other embodiments of the disclosure need not include the device itself.

[0022] According to one embodiment, an instrument for testing patient samples is provided. Such an instrument 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. In such an instrument, 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.

[0023] According to another embodiment, the transmitted data may be used for performing instrument analysis.

[0024] According to another embodiment, upon determination of the data not being transmitted to the central server successfully, the communication module is configured to receive a request for retransmitting the data to the central server.

[0025] According to another embodiment, upon receiving the request to retransmit data, the communication module is configured to retransmit the data to the central server.

[0026] According to another embodiment, the communication module may be associated with the one or more blockchain generators, wherein each blockchain code generated is validated by the central server.

[0027] According to another embodiment, the data may be transmitted to the central server indirectly through middleware.

[0028] According to a further embodiment, methods and networks corresponding to any of the above described methods may be provided. [0029] In one embodiment, 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. In an example embodiment, 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. In an example embodiment, the reagent packs include compartments (a typical reagent pack may include five compartments). In a further embodiment, each compartment comprises a unique chemical substance. In a further embodiment, 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.

[0030] In one embodiment, 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.

[0031] In an embodiment, the reagent carousel and the sample carousel may be referred as sub- modules of the instrument. In a further embodiment, 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. In an embodiment, each sub-module may be configured to perform specific tasks. In an example embodiment, the reagent carousel may be configured to hold a plurality of reagents. In a further example embodiment, 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. In one embodiment, the information may be provided to the computer in the lab for the technician to take appropriate measures. In a further embodiment, the information may be provided to a central server for analysing the information.

[0032] In an embodiment, 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. In an embodiment, each sub-module may have an operational state. In one embodiment, the instrument as a whole may have an operational state. In one embodiment, the instrument and each sub-module of the instrument may transmit respective operational states to a central server. In a further embodiment, a plurality of operational parameters may be associated with each operational state of the instrument and the sub-modules. In a further embodiment, a transition from a first operational state to a second operational state may be recorded. In a further embodiment, the operational parameters and the transition in operational state may be transmitted to the central server. In one embodiment, 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.

[0033] In one embodiment, 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. In an embodiment, upon the central server determining that the data is not successfully received, the central server may be configured to request the communication module of the instrument to retransmit the data. In a further embodiment, the communication module transmits the data to the central server upon receiving the request.

[0034] In an embodiment, the communication module transmits the data from the instrument to the central server using blockchain technology. In one embodiment, 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.

[0035] In an embodiment, a method is provided 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.

[0036] In an embodiment, a network is provided. The 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.

[0037] Reference is now made to Figure 1, which illustrates exemplary diagram of a typical laboratory set-up (100). Figure 1 shows instrument (101) and central server (102)/ cloud server. In an embodiment, the central server and the cloud server are used interchangeably in the present disclosure. In one embodiment, one or more servers can be used as per need. As mentioned above, instrument (101) can be an immunoassay analyzer. Central server/ cloud server (102) is used to analyse the data related to instrument (101). In one embodiment, 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.

[0038] In one embodiment, laboratory instrument (101) is connected to the central server (102) via a wired/ wireless network. In a further embodiment, the central server (102) can be located in a premise comprising the instrument (101). For example, the central server (102) and the instrument (101) can be located in the laboratory (100). In an alternate embodiment, the central server (102) can be located remotely to the instrument (101). For example, 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. In a further embodiment, 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. In a further embodiment, 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.

[0039] Figure 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). In one embodiment, instrument (101) transmits data to central server/ cloud server (102) using blockchain technology. In a further embodiment, the blockchain technology can be implemented by generating a digital ledger storing each data communicated by instrument (101) to central server (102). In a further embodiment, the digital ledger is implemented in central server/ cloud server (102). In a further embodiment, 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). In one embodiment, the blockchain codes may be generated using hash techniques. A person skilled in the art will appreciate that any other technique may be used to generate the blockchain codes and the present disclosure is not limited by the technique used for generating the blockchain code. In a further embodiment, 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.

[0040] In one embodiment, data may be transmitted in defined time intervals. In a further embodiment, if central server (102) does not receive the data at a specific defined time interval, central server (102) may request to transmit the data in the specific interval.

[0041] Figure 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). As shown in exemplary Figure 4, 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. However, a person skilled in the art should appreciate that 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. In one embodiment, each sub-module (302) includes blockchain generator (201A- 20 IN) as shown in Figure 4. In an alternate embodiment, 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. In one embodiment, 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. In a further embodiment, 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). Likewise, 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).

[0042] In one embodiment, blockchain generators (201A..., 201N) can use hashing technique to encrypt data to be transmitted. In a further embodiment, central server (102) receives the hashed data validates the hashed data. Central server (102) may use mapping technique to decrypt the hashed data. For example, central server (102) may include reference hash codes or a method to generate reference has codes. Once the blockchain codes are received from instrument (101), the blockchain codes are compared with respective hash codes. If the blockchain code is matched with the hash code, central server (102) considers a successful validation. If the blockchain code does not match with the hash code, central server (102) considers as unsuccessful validation. In an embodiment, decrypted data is used to monitor instrument (101) and perform analysis of instrument (101). A person skilled in the art will appreciate that various techniques can be used to implement the encryption and decryption of the data for blockchain implementation.

[0043] In one embodiment, test results generated from in the instrument (101) are also communicated to the central server (102) as blockchain codes.

[0044] In one embodiment, only upon the data being validated by central server (102), is the data considered to be secure. In one instance, if the data is not received within 10 seconds from transmission, the validity of the data can be checked, and retransmission of the data can be requested. [0045] Figure 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.

[0046] As illustrated in Figure 5, 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. Generally, 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.

[0047] The order in which 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.

[0048] At step 501, 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).

[0049] At step 502, 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. As shown in Figure 6, 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). In one embodiment, central server (102) can include a digital ledger storing data related to each instrument. In some embodiments, 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. In some embodiments, 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. In a further embodiment, 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.

[0050] In an embodiment, any message transmitted from each instrument (101A, 101B, 101C) is sent as blockchain codes, and the blockchain codes are validated by the central server.

[0051] In an embodiment, the use of blockchain technology in instrument (101) secures the communication between the instrument and central server (102). In one embodiment, the blockchain technology can be implemented in central server (102) as well.

[0052] In one embodiment, incomplete transmission of data can be easily detected using the blockchain technology and such missing data can be requested to be re-transmitted.

[0053] Finally, the language used in the specification has been principally selected for readability and instructional purposes, and it may not have been selected to delineate or circumscribe the inventive subject matter. It is therefore intended that the scope of the disclosure be limited not by this detailed description, but rather by any claims that issue on an application based here on. Accordingly, the disclosure of the embodiments of the disclosure is intended to be illustrative, but not limiting, of the scope of the disclosure, which is set forth in the following claims.

[0054] While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.