Biological measurement apparatus and method of activation of biological device

Abstract

A biological measurement apparatus comprising at least one biological device that is in physical contact with a patient, and a user apparatus are in a wired or wireless connection for the biological measurement. The user apparatus has a unique workstation identifier, and the user apparatus anonymizes the unique workstation identifier, protects communication between a license server and the user apparatus by a symmetric and / or asymmetric encryption while having the anonymized unique identifier as a key to the encryption, communicates a unique user identification code of each of the at least one biological device ttoo the license server through the protected communication for validation, and receives, from the license server in response to the validation, data for enabling the biological measurement with the at least one biological device and the user apparatus for a predetermined period.

Description

[0001] Biological measurement apparatus and method of activation of biological device

[0002] Field

[0003] The invention relates to a biological measurement apparatus and a method of activation of at least one biological device.

[0004] Background

[0005] A user apparatus for performing biological measurements comprises typically a data processing machine such as a computer and one or more additional devices such as electrodes or needles and their adapter. There is a need to link the biological devices and the data processing device together for proper measurements and data processing. Some biological devices are disposable and may not be used more than once or they may be required to be used within a certain period. The prior art has not fully solved the problems relating to these issues. Hence, an improvement would be welcome.

[0006] Brief description

[0007] The present invention seeks to provide an improvement to activate and enable a biological measurement.

[0008] The invention is defined by the independent claims. Embodiments are defined in the dependent claims.

[0009] If one or more of the embodiments is considered not to fall under the scope of the independent claims, such an embodiment is or such embodiments are still useful for understanding features of the invention.

[0010] List of drawings

[0011] Example embodiments of the present invention are described below, by way of example only, with reference to the accompanying drawings, in which

[0012] Figure 1 illustrates an example of a biological measurement apparatus; Figure 2 illustrates an example of a biological device that comprises one or more sensors;

[0013] Figure 3 illustrates an example of a workstation; and

[0014] Figure 4 illustrates of an example of a flow chart of a measuring method.

[0015] Description of embodiments

[0016] The following embodiments are only examples. Although the specification may refer to “an” embodiment in several locations, this does not necessarily mean that each such reference is to the same embodiment(s), or that the feature only applies to a single embodiment.

[0017] The articles “a” and “an” give a general sense of entities, structures, components, compositions, operations, functions, connections or the like in this document. Note that singular terms may include pluralities.

[0018] Single features of different embodiments may be combined to provide other embodiments. Furthermore, words "comprising" and "including" should be understood as not limiting the described embodiments to consist of only those features that have been mentioned and such embodiments may contain features / structures that have not been specifically mentioned. All combinations of the embodiments are considered possible if their combination does not lead to structural or logical contradiction.

[0019] Fig. 1 illustrates an example of a biological measurement apparatus. In fact, Fig. 1 illustrates the biological apparatus as a system. However, a user 112’ and / or a patient 112 may have at their / his / her disposal at least one biological device 100, a portable handheld device 102 and a workstation 110. The license server 112 may be accessed remotely. In an embodiment, the remote access by be performed over the Internet, for example. A user apparatus 108 may comprise the workstation 110, the portable handheld device 102 and the at least one biological device 100. Alternatively, it can be considered that the user apparatus 108 comprises the workstation 110 and the portable handheld device 102. It can also be considered that the at least one biological device 100 can only be used once. The patient 112 that / who is measured is a mammal such as a human being, a household animal, or a wild animal.

[0020] In an embodiment, an example of which is illustrated in Fig. 2, the one or more biological devices 100 may comprise at least one of sensor 200. The one or more sensors 200 may comprise at least one of the following: electrodes, needles, electrode needles, one or more optical sensors, one or more blood pressure sensor, one or more multi-sensor integrations. A diabetes sensor may in this manner be paired to a mobile application, for example.

[0021] The one or more biological devices 100 may comprise a foil 202 and sensors 200 that are attached or connected together. The one or more biological devices 100 may be attached on the skin of the patient 112 for performing the biological measurement in a non-invasive manner or by penetrating the skin by the needle. The one or more biological devices 100 may be attached to the skin by clue or the one or more biological devices 100 have a shape of a band that can be wound round a limb or torso and attached by a push-pull connection, for example. A person skilled in the art is familiar with these kinds of biological devices 100 that are used to measure and potentially stimulate organs and / or live tissue of a patient 112 for the biological measurement.

[0022] In an embodiment, the needle may comprise a biopsy needle. In an embodiment, the needle may be non-ferromagnetic. The non-ferromagnetic needle may be used for biopsy during a magnetic resonance and / or computer tomography, for example. In an embodiment, the needle electrode may refer to a electromyography (EMG) needle that is inserted into a muscle for measuring muscle fiber activity, for example. In an embodiment, electrodes may be used to measure a bio-signal such as electrocardiogram (ECG) or electroencephalogram (EEG) signals of electrical activity of the heart or in the brain. In an embodiment, the electrodes may be used to monitor signal propagation in one or more nerves.

[0023] In an embodiment, the one or more biological devices 100 may comprise one or more transdermal patches. In an embodiment, the one or more biological devices 100 may comprise one or more subcutaneous injection means such as a bolus or subcutis, for example. The portable handheld device 102 of the user apparatus 108 and at least one biological device 100 that is in physical contact with a patient 112 are in a wired or wireless connection with each other when the biological measurement is going on. The user apparatus 108 has a unique workstation identifier. The user apparatus 108 anonymizes the unique workstation identifier. Anonymization may also be called de-identification. De-identification refers to removal or concealment of identifiers. Anonymization in turn implies that an outsider cannot link the data to the patient or identify the patient 112. Authorized access to the data is only allowed using valid and secure credentials.

[0024] The user apparatus 108 protects the communication between a license server 112 and the user apparatus 108 together with the license server 112 by asymmetric and / or symmetric encryption while having the anonymized unique identifier as a key to the encryption. In an embodiment, both the asymmetric and symmetric encryption can be utilized for protection. Asymmetric encryption may refer to Rivest-Shamir-Adleman (RSA) encryption, Elliptic Curve Cryptography (ECC) or the like, for example. Symmetric encryption may refer to Advanced Encryption System (AES), Data Encryption Standard (DES) which is an older system, Blowfish, TwoFish, 3DES (Triple DES), or the like, for example. The public key infrastructure (PK1) that can utilize both symmetric and asymmetric encryption is used to authenticate users and devices and manage public-key encryption. A person skilled in the art is familiar with the encryption methods and that is why they do not need to be explained more in detail.

[0025] The biological apparatus 108 then communicates a unique user identification code of each of the at least one biological device 100 to the license server 112 through the protected communication for validation.

[0026] In more details, each workstation 110 running the media access control (MAC) application has a unique ID (unique workstation identifier). Here, MAC refers in general to a part of the data link layer in the OS1 model (Open Systems Interconnection model). The MAC deals with protocols that manage access to the physical transmission medium. It ensures that data packets are successfully sent and received between devices on the same network. In other words, MAC controls the hardware that interacts with the transmission medium in a wired or wireless manner. The ID is generated from known assets of the that workstation 110. The assets may include hardware assets and software assets and additionally network assets, cloud assets and peripherals. The ID may be generated from a combination of the known assets of the that workstation 110. The data that is gathered from the workstation 110 are known assets such as serial numbers of the processor, bios, SSD (solid state drive), HDD (hard disc drive) adapters, or the like. These rarely change. A person skilled in the art is familiar with the assets, perse. The ID is further manipulated to make it anonymous. Namely, from those items of data it is possible to create a unique and irreversible sh256 (hash). The resulting unique ID is used as the key to encrypt data using the encryption methods for secure communication between the workstation 110 and the license server 112. The resulting unique ID is used as the key to encrypt data using either AES or RSA or both AES and RSA, for example, for secure communication between the workstation 100 and a license server 112.

[0027] Finally, the biological apparatus 108 receives, from the license server 112 in response to the validation, data for enabling the biological measurement with the at least one biological device 100 and the user apparatus 108 for a predetermined period. The period may depend on the biological device(s) 100. Disposable electrodes may have a period of one hour, for example. The more technically complex the biological device(s) 100 are and / or the more times the biological device(s) 100 can be used, the longer usable period may be. The length of the period may be a function of or may depend on the product type of the biological device(s) 100. The length of the period may alternatively or additionally depend on the fee paid by the user 112’ or the patient 112. The more money is paid, the longer the period for the use of the biological device(s) 100 may be.

[0028] In an embodiment, the at least one biological device 100 and the portable handheld device 102 may be connected with each other. The portable handheld device 102 may further be connected in a wired or wireless manner with the workstation 110, which may communicate with the license server 112. The workstation 110 may perform data processing relating to the biological measurement and may communicate through a user interface 106 with the user 112. The portable handheld device 102 may be used to control one or more of the biological devices 100. The control may refer to the sensors bias, sensitivity, amplification, stimulation intensity, wavelength, pulsation, duty cycle, sample rate phasing, or the like, for example. Additionally, the portable handheld device 102 may perform conversion from an analog signal to digital signal.

[0029] In an embodiment an example of which is illustrated in Fig. 3, the workstation 110 may comprise a data processing part that includes one or more processors 300 and one or more memories 302 including computer program code, the one or more memories 302 and the computer program code are configured to, with the one or more processors 300, cause the workstation 106 at least to perform the anonymization, protection of communication, reception of data from the license server 112 and data processing of the biological measurement.

[0030] The term “computer” includes a computational device that performs logical and arithmetic operations. For example, a “computer” may comprise an electronic computational device, such as an integrated circuit, a microprocessor, a mobile computing device, a laptop computer, a tablet computer, a personal computer, or a mainframe computer. A “computer” may comprise a central processing unit, an ALU (arithmetic logic unit), a memory unit, and a control unit that controls actions of other components of the computer so that steps of a computer program are executed in a desired sequence. Additionally, a “computer” may include at least one peripheral unit that may include an auxiliary storage memory (such as a disk drive, flash memory or solid-state drive (SSDJ), and / or may include data processing circuitry.

[0031] A user interface 106 means an input / output device and / or unit. Nonlimiting examples of a user interface include a touch screen, other electronic display screen, keyboard, mouse, microphone, handheld electronic controller, digital stylus, display screen, speaker, and / or projector for projecting a visual display. In an embodiment, in response to a failure of the validation, the user apparatus 108 may receive no data or receive data disproving the use of the biological device 100 with the user apparatus 108.

[0032] In an embodiment, the user apparatus 108 may disable the biological measurement with the at least one biological device 100 in response to a failure of the validation.

[0033] In an embodiment, the user apparatus 108 may present the patient 112 or a user 112’ guidance through the user interface 106 for the biological measurement prior to and / or during the biological measurement. The guidance may be shown with images, video and / or text on a screen of the user interface 106 of the workstation 110.

[0034] In an embodiment an example of which is illustrated in Fig. 3, the user apparatus 108 may comprise an imaging device 304 of a user interface 106. The imaging device 304, which may also be called image sensor, may comprise a digital camera or a hyperspectral imaging device. The imaging device 304 may capture one or more images and / or a video of the one or more biological devices 100 in physical contact with the patient 112. The user apparatus 108 may determine a position of the one or more biological devices 100 with respect to an optimum position of the physical contact with the patient 112 based on the one or more images and / or the video. The image processing and the position analysis may be based on image processing program and / or machine vision program. Additionally or alternatively, artificial intelligence may be utilized.

[0035] In an embodiment, the user interface 106 of the user apparatus 108 may indicate an optimal position of the one or more biological devices 100 for the physical contact with the patient 112. In an embodiment, the optimal position may be based on tests made prior to the actual measurements. In an embodiment, the license server 112 gather information on the measurements and positions of the one or more biological devices 100, the gathered information is processed by the license server 112 and / or by some other data processing means for determining the optimal location for each of the one or more biological devices 100. In an embodiment, the one or more biological devices 100 comprise position indicators for the physical contact with the patient 118. The position indicators maybe symbols, drawings, marks, or alphanumerical writing characters that illustrate or define an optimal location of them on the skin of the patient 112.

[0036] In an embodiment, the one or more biological devices 100 may comprise at least one of the following sensors that are configured to measure: airflow, brain function, oxygen level of blood, blood pressure, heartbeat, temperature, chemical compound in blood glucose. The license server 112 may collect the information from all measurements and patients 112. The information may be utilized for improving the guidance. The improvement of guidance may refer to the position of the at least one biological devices 110 and / or the biological devices 100 as such. It may happen that some biological devices 100 provide more accurate information than others. The information may help the manufacturers of the biological devices 100 such as patch electrodes improve their products.

[0037] In an embodiment, the biological measurement apparatus comprises the license server 112, which includes reference unique user identification codes pre-registered in the license server 112 by a vendor of the user apparatus 108. Each of the reference unique user identification codes of the license server 112 may have one to one correspondence with or each of the reference unique user identification codes of the license server 112 maybe the same as each of the unique user identification codes the user has.

[0038] The user may have received the at least one unique user identification codes of the at least one biological device 100 in conjunction with purchase of the at least one biological device 100. A single unique user identification code may be a unique product code, for example. The unique code may comprise a bar code, a QR-code or a serial symbol sequence of the product. When the user 112’ or the patient 112 makes the workstation 110 to connect with the license server 112, he or she can activate the use of each of the one or more biological devices 100 with the unique user identification code based on a comparison test in the license server 112. When the user identification code is activated to a certain biological device 100 by a signal from the license server 112 to the workstation 110, the license server 112 makes the reference user identification code be out-of-use thereafter. In that manner, any user identification code can be activated and used only once. The license server 112 sends activation data to the workstation 110 in response to detection that a reference unique user identification code corresponds to the unique user identification code that is received from the workstation 110. The activation data, in turn, enables the workstation 110 to process signals and / or data coming from the at least one biological device 100 through the portable handheld device 102.

[0039] In more detail, the license server 112 receives at least one unique user identification code each associated with the at least one biological device 100 from the workstation 110 of the user apparatus 108. The license server 112 then compares each unique user identification code of the at least one biological device 100 with the reference unique user identification codes pre-registered in the license server 112. In response to a match between the pre-registered reference unique user identification codes and the unique user identification codes, the license server 112 sends an activation message to the workstation 110, which enables the biological measurement with the at least one biological device 100. The number of reference unique identification codes that are used in the comparison is equal to the number of the unique user identification codes each associated with the at least one biological device 100.

[0040] That can further be explained as follows. Each use of the biological device 100 shall be activated by a prior generated universally unique identifier (UUID). This activation UUID is known and pre-registered in a database of the license server 112. The biological device lOOare distributed to suppliers and finally to end users. Third party approved biological device 100 may be used and the UUIDs purchased separately. The UUID must be scanned / entered in to the MAC application prior to the use of the biological device 100 or any measurement performed by them. The workstation connects to the license server 112 to which the UUID is securely sent. The license server 112 checks the validity of the UUID. The validated UUID is now registered for that user apparatus 108 and patient and is available for use for a predetermined length of time. The license server 112 will act as a secure bank for other distributors of the biological device 100. Distributors may order a batch of license keys for redistribution to customers. Customers may credit unused licenses back to the distributor for use by other members of their customer group. This ensures the managed and controlled use and activation of passive disposable components i.e. the biological device 100 such as electrodes for measurements.

[0041] To ensure a proper use of the time for measurement with the biological device 100, the user apparatus 108 may assist the user with automated and intelligent control of the biological device 100. Regarding electrodes, it may be ensured that the correct level of electrical stimulation is provided. Assisted control may indicate if the positioning of the biological device 100 such as electrode(s) requires adjustment by indicating the optimal positioning on the patient through the use of an imaging device of the user interface 106. Each the biological device 100 may be clearly marked. The imaging device 304 of the user interface 106 may determine where the biological device 100 has been placed. The biological apparatus 108 may then, using prior knowledge, indicate where the biological device 100 should be placed on the patient in order to improve and get the optimal measurements. The final position of the biological device 100 may be stored along with the patient data for further analysis. The reuse of the same UU1D after the expiry time will be rejected by the license server 112.

[0042] The techniques described in this document may be considered to be a part of a bio-cyber-physical system that combines computational elements to monitor and / or control living bodies at least to a certain extent. A mobile bio-cyber physical system may have mobility, and because of that a human being or an animal may carry the mobile bio-physical systems, and the biological devices of the biophysical systems may include mechanics, robotics, electronics and optics, for example.

[0043] Fig. 4 is a flow chart of a method of activation of at least one biological device. At least one biological device 100 is configured to be in physical contact with a patient 112. The user apparatus 108 and the biological device 100 are in a wired or wireless connection for the biological measurement. The user apparatus 108 has a unique workstation identifier. In step 400, the unique workstation identifier is anonymized. In step 402, communication between a license server 112 and the user apparatus 108 protected by both a symmetric and asymmetric encryption while having the anonymized unique identifier as a key to the encryption. In step 404, a unique user identification code of each of the at least one biological device 100 is communicated to the license server 112 through the protected communication for validation. In step 406, data for enabling the biological measurement with the at least one biological device 100 and the user apparatus 108 is received from the license server 112 in response to the validation, the enablement lasting for a predetermined period.

[0044] The method shown in Figure 4 may be implemented as a logic circuit solution or computer program. The computer program may be placed on a computer program distribution means for the distribution thereof. The computer program distribution means is readable by a data processing device, and it encodes the computer program commands, carries out the measurements and optionally controls the processes on the basis of the measurements.

[0045] The computer program may be distributed using a distribution medium which may be any medium readable by the controller. The medium may be a program storage medium, a memory, a software distribution package, or a compressed software package. In some cases, the distribution may be performed using at least one of the following: a near field communication signal, a short distance signal, and a telecommunications signal.

[0046] It will be obvious to a person skilled in the art that, as technology advances, the inventive concept can be implemented in various ways. The invention and its embodiments are not limited to the example embodiments described above but may vary within the scope of the claims.

Claims

What is claimed is:

1. A biological measurement apparatus, wherein the biological measurement apparatus comprises at least one biological device that is configured to be in physical contact with a patient, and a user apparatus are configured be in a wired or wireless connection for the biological measurement, the user apparatus has a unique workstation identifier, and the user apparatus is configured to anonymize the unique workstation identifier; protect communication between a license server and the user apparatus by a symmetric and / or asymmetric encryption while having the anonymized unique identifier as a key to the encryption; communicate a unique user identification code of each of the at least one biological device to the license server through the protected communication for validation; and receive, from the license server in response to the validation, data for enabling the biological measurement with the at least one biological device and the user apparatus for a predetermined period.

2. The apparatus of claim 1, wherein the user apparatus comprises a portable handheld device and a workstation, the at least one biological device and the portable handheld device being configured to be connected with each other, and the portable handheld device being further connected in a wired or wireless manner with the workstation, which is configured to communicate with the license server, perform data processing relating to the biological measurement and communicate with a user.

3. The apparatus of claim 1, wherein the workstation comprises a one or more processors and one or more memories including computer program code, the one or more memories and the computer program code configured to, with the one or more processors, cause workstation at least to perform the anonymization, protection of communication, reception of data from the license server and data processing of the biological measurement.

4. The apparatus of claim 1, wherein, in response to a failure of the validation, no data is received or data disproving the use of the biological device with the workstation is received by the user apparatus.

5. The apparatus of claim 4, wherein the workstation is configured to disable the biological measurement with the at least one biological device in response to a failure of the validation.

6. The apparatus of claim 1, wherein the workstation is configured to present guidance through the user interface to the patient or a user for the biological measurement in conjunction with the biological measurement.

7. The apparatus of claim 6, wherein the user apparatus comprises a camera in a user interface, and the camera is configured to capture one or more images and / or a video of the one or more biological devices in physical contact with a patient, and the user workstation is configured to determine a position of the one or more biological devices with respect to an optimum position of the physical contact with the patient based on the one or more images and / or the video.

8. The apparatus of claim 6, wherein the user interface of the workstation is configured to indicate an optimal position of the one or more biological devices for the physical contact with the patient.

9. The apparatus of claim 1, wherein the one or more biological devices comprise position indicators for the physical contact with the patient.

10. The apparatus of claim 1, wherein the one or more biological devices comprise at least one of the following sensors that are configured to measure: airflow, brain function, oxygen level of blood, blood pressure, heartbeat, temperature, chemical compound in blood.

11. The apparatus of claim 1, wherein the one or more biological devices comprise at least one of the following: electrodes, needles, electrode needles, oneor more optical sensors, one or more blood pressure sensor, one or more multisensor integrations.

12. The apparatus of claim 1, wherein the biological measurement apparatus comprises the license server, which includes reference unique user identification codes pre-registered in the license server for use activations of the least one biological device, and the license server is configured to receive a number of the unique user identification codes each associated with the at least one biological device from the user apparatus, compare the unique user identification code of each of the at least one biological device with the reference unique user identification codes pre-registered in the license server, and send data enabling the use of the at least one biological device with the user apparatus for the biological measurement in response to a match between the pre-registered reference unique user identification codes and the unique user identification codes, the number of which is equal to the number of the reference unique user identification codes each associated with the at least one biological device.

13. A method of activation of at least one biological device for a biological measurement, at least one biological device being configured to be in physical contact with a patient, a user apparatus being configured be in a wired or wireless connection for the biological measurement, and the user apparatus having a unique workstation identifier, the method comprising anonymizing the unique workstation identifier; protecting communication between a license server and the user apparatus by a symmetric and / or asymmetric encryption while having the anonymized unique identifier as a key to the encryption; communicating a unique user identification code of each of the at least one biological device to the license server through the protected communication for validation; andreceiving, from the license server in response to the validation, data for enabling the biological measurement with the at least one biological device and the user apparatus for a predetermined period.

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