Diagnostic device for rapid tests of diseases

Abstract

A diagnostic device for detecting diseases of the human body, designed to detect the presence of a specific disease in a non-contact manner using sensors and electronic components, characterized in that it has electronic components that receive information from other components and sensors of the device, process it, send it via radio or cable to an external central unit, and use the information returned by the central unit to perform the test or authorize the performance of the test.

Description

[0001] To prevent the spread of dangerous infectious diseases, it is crucial to test a large proportion of the population and isolate those who test positive and their contacts. Failure to do so will result in "only extreme measures preventing large numbers of infections and deaths" (Bill Gates: How to prevent the next pandemic, 2022).

[0002] Therefore, it is important that, in the event of an impending outbreak, high-performance testing devices that are easy to operate even by laypeople are available quickly and in large numbers. Suitable devices for this purpose are most effective when based on non-contact testing methods that detect electromagnetic waves, sound waves, or olfactory molecules to identify disease in the body.

[0003] Devices of this type require not only a reliable and highly efficient testing procedure, but also user guidance that allows even untrained personnel to conduct tests flawlessly. The device should also allow for determining whether the test was performed validly, and for documenting and certifying the test and its implementation. Ensuring the reliability of the tests in this way would be an important prerequisite for the acceptance and maximum dissemination of the devices among the population. Above all, it is essential to prevent false negative test results, i.e., to prevent, if possible, the undetected diagnosis of an actual disease.

[0004] Another important prerequisite for ensuring the reliability of the tests enabled by the device would be to prevent tests from being carried out if the device is not able to carry out the tests validly, for example if the test no longer responds to the specific conditions of a mutated pathogen or if the device is aimed at the wrong body region when carrying out the test.

[0005] The commercial usability of the device is also crucial for its widespread adoption among the population, as both the manufacturer and the provider of the device must have a financial interest in the development and distribution of the device and in the associated testing services. The commercial usability of the device must therefore be guaranteed.

[0006] What is proposed is a testing device that ensures fast, reliable and valid test results in non-contact testing procedures and prevents false negative test results, as well as allowing the commercial use of the device and the test procedure.

[0007] The following application example is suggested: The patent category "Detection of tissue fluorescence not resulting in an image A61B 5 / 0059 - A61B 5 / 0071" describes inventions that allow the diagnosis of human diseases by irradiating tissue with electromagnetic waves of a defined wavelength and detecting the disease-specific autofluorescence they cause. This technology enables rapid testing and timely results. Examination of the throat is particularly suitable for testing for coronavirus infections, as the viral load is particularly high there and this area is easily accessible. Visible light or light from the infrared and near-infrared range with wavelengths between 300 and 900 nm is generally used to examine body tissue. Although perhaps also interesting, wavelengths below 300 nm have two problems: they are absorbed by optical systems and they destroy tissue.In addition to the detection of light of specific wavelengths, the lifetime characteristics of fluorescence, i.e. the temporal course of the emission of the excited wavelength, can also be used for diagnosis.

[0008] Another detection option is offered by natural chromophores that absorb in the UV, NIR and visible light range.

[0009] Another approach to non-contact testing for disease diagnosis is based on the olfactory identification of molecules released by the human body during a disease. For example, some people can detect Parkinson's disease by the smell of the sebum of patients (ACS Cent. Sci. 2019, 5, 4, 599-606, Publication Date: March 20, 2019). The olfactory molecules characteristic of the disease can be identified using sensors. For example, Yesse Technologies, with support from the U.S. National Science Foundation, is currently working on a technological platform designed to detect Parkinson's disease in its early stages.

[0010] Another possibility for conducting non-contact tests is the diagnosis of skin diseases using photographs of the affected skin areas, which are examined by special algorithms using artificial intelligence.

[0011] Another way to conduct the above-mentioned non-contact tests is to evaluate acoustic signals from the human body using artificial intelligence - such as the evaluation of coughing sounds, breathing sounds and changes in the voice or the sound waves reflected from certain areas of the body.

[0012] However, since the existing contactless tests do not provide for the control of all factors required for conducting a valid test, they are not suitable for the necessary rapid and uncomplicated application and proliferation in the population: Without control of the test conditions, the presence of a disease cannot be ruled out with sufficient probability in the case of a negative test result.

[0013] Furthermore, the currently known devices with non-contact testing methods without any control options prevent their widespread distribution and use, as manufacturers and test providers lack interest in widespread use without the possibility of commercial exploitation. Non-contact methods, in particular, offer the opportunity for widespread distribution and frequent use.

[0014] The invention defined in claim 1 addresses the problem of controlling the conditions required for testing for a disease using the detection of electromagnetic radiation of specific wavelengths (emitted by tissue autofluorescence) in such a way that a valid test result is guaranteed. Furthermore, controlling the test conditions significantly improves the commercialization of the tests, as it offers the possibility of releasing a test procedure only when defined requirements, such as payment of a test fee or the provider's access to a user account, are met.

[0015] To irradiate the tissue selected for disease detection with light of the appropriate wavelength and to determine whether the tissue emits light at the wavelength specific for the presence of the disease through autofluorescence, the device is equipped with a monochromatic light source and a sensor that detects the emission of light of the specific wavelength. Since the device is intended to be suitable for testing different diseases or different variants of the disease (e.g., in the case of a mutation of the pathogen), both the light source and the sensor are interchangeable.

[0016] To determine whether the appropriate body area has been selected for the test, the device is equipped with a second light source / sensor pair. This pair emits a light suitable for detecting the tissue type and stimulates the tissue to autofluoresce light at a tissue-specific wavelength, which is then detected by the sensor. Because the device is designed to be suitable for testing various tissues, both the light source and the sensor are interchangeable.

[0017] To determine whether the device is at a suitable distance from the tissue during the test procedure, the device is equipped with a distance measuring element, for example based on ultrasound.

[0018] To monitor and document the test procedure, identify the test subject (e.g., using documents), and provide assistance to the user during the test, the device is equipped with a camera element. The camera element also allows the device to record information from barcodes and other optical information carriers.

[0019] In order to inform the user about the test procedure, give instructions and communicate results during the test, the device is equipped with a display that is controlled by the device's microprocessor.

[0020] In order to clearly signal the operating status of the device and also to convey instructions acoustically and visually, the device is equipped with a loudspeaker unit and a signal lamp.

[0021] To ensure controlled test release, the device is equipped with a bidirectional online connection that transmits all the information required for test release from the device via the internet to a central evaluation unit. The connection to the central evaluation unit can also be established via a cable connection. The central evaluation unit decides whether to release the test based on, among other things, data from the user account (e.g., whether the user has paid the test fee or is otherwise authorized to perform the test) and the data transmitted by the device to check the test conditions. The release is then sent to the device. Only then can the device perform the test.

[0022] To protect test subjects and test administrators from infection, the device features a form-fitting design and is easy to clean. The device also features an antibacterial / antiviral surface and is waterproof.

[0023] The device consists of a handpiece and a reading unit that merge seamlessly and seamlessly into one another.

[0024] The device is equipped with a button to initiate the authorized test procedure or other processes. To identify and authenticate the test performer, the device is equipped with a fingerprint sensor.

[0025] To control the functions of the device, the device is equipped with a microprocessor unit.

[0026] The device's functions can also be performed by a removable smartphone module combined with a smartphone app, which contains the two light source / sensor units. The smartphone handles the other features, such as switches, speakers, cameras, fingerprint sensors, etc.

[0027] Similar devices are already known from the prior art, for example as described in DE 10 2013 201 917 A1, US 2018 / 0 042 481 A1, DE 10 2020 118 756 A1, DE 199 34 038 A1 and EP 2 946 722 A1, which have comparable features and functions. List of reference symbols 1 reading head 2 signal lamps 3 speakers 4 Display 5 On / Off button 6 Shutter button 7 Fingerprint sensor 8 Handle 9 Control unit 10 WLAN / cellular unit 11 Battery 12 USB port 13 Closing flap 14 Light / Sensor Module 1 15 Light / Sensor Module 2 16 Lighting / Camera Module

Claims

[1] Diagnostic device for detecting diseases of the human body, designed to detect the presence of a specific disease without contact using sensors and electronic components, characterized by that it has electronic components that receive information from other components and sensors of the device, process it, send it wirelessly or via cable to an external central unit, and use the information sent back by the central unit to carry out the test or authorise the test to be carried out. [2] Diagnostic device according to claim 1, characterized by that the diagnosis is carried out by means of the detection or the detection and analysis of electromagnetic waves emanating or reflected from parts of the body or generated by the excitation of autofluorescence or biofluorescence from parts of the body. [3] Diagnostic device according to one of the preceding claims, characterized by that the diagnosis is made by detecting or detecting and analyzing sound waves emitted or reflected from parts of the body. [4] Diagnostic device according to one of the preceding claims, characterized by that the diagnosis is made by detecting olfactory molecules released by the human body into the ambient air. [5] Diagnostic device according to one of the preceding claims, characterized by that the housing of the device is designed so that the device can be held and operated by the user with one hand. [6] Diagnostic device according to one of the preceding claims, characterized by that it is designed as an additional device for a smartphone using a corresponding smartphone app. [7] Diagnostic device according to one of the preceding claims, characterized bythat it contains one or more light sources (14, 15, 16) for emitting light of one or more specific wavelengths and one or more sensors (14, 15) for detecting light of one or more wavelengths. [8] Diagnostic device according to one of the preceding claims, characterized by that the emitted light has a wavelength from the wavelength range between 300 and 900 nm. [9] Diagnostic device according to one of the preceding claims, characterized by that the absorption capacity of the tissue for electromagnetic waves of specific wavelengths from the wavelength range between 300 and 900 nm is used for the diagnosis. [10] Diagnostic device according to one of the preceding claims, characterized by that it uses the lifetime characteristics of fluorescence, i.e. the temporal course of the emission of the excited wavelengths, for diagnosis. [11] Diagnostic device according to one of the preceding claims, characterized by that it contains a display (4) connected to the information processing components of the device. [12] Diagnostic device according to one of the preceding claims, characterized by that it contains a signal lamp (2) connected to the information processing components of the device. [13] Diagnostic device according to one of the preceding claims, characterized by that it contains a non-contact distance meter. [14] Diagnostic device according to one of the preceding claims, characterized by that it contains a microphone. [15] Diagnostic device according to one of the preceding claims, characterized by that it contains a loudspeaker element (3). [16] Diagnostic device according to one of the preceding claims, characterized by that it contains an on / off button (5). [17] Diagnostic device according to one of the preceding claims, characterized by that it contains a signal lamp (2). [18] Diagnostic device according to one of the preceding claims, characterized by that it contains a camera module (16). [19] Diagnostic device according to one of the preceding claims, characterized by that it contains a light source (14, 15, 16). [20] Diagnostic device according to one of the preceding claims, characterized by that it contains an accumulator (11) as an energy source. [21] Diagnostic device according to one of the preceding claims, characterized by that it contains a fingerprint sensor (7). [22] Diagnostic device according to one of the preceding claims, characterized by that it is designed as a device with a form-fitting and waterproof housing. [23] Diagnostic device according to one of the preceding claims, characterized by that it contains a mobile radio module (10) for the data connection. [24] Diagnostic device according to one of the preceding claims, characterized by that it contains a WiFi module (10) for the data connection. [25] Diagnostic device according to one of the preceding claims, characterized by that it contains a connection (12) for charging the battery (11). [26] Diagnostic device according to one of the preceding claims, characterized by that it contains a connector (12) for the data connection via cable. [27] Diagnostic device according to one of the preceding claims, characterized by that the body region examined is the throat.

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