Method for guiding a user through self-application of a medical device via an electronic device application

Abstract

It is disclosed a method for guiding a user through self-application of a medical device via an electronic device application, the electronic device application being at least partially executed by an electronic device comprising a camera. The method comprises the steps of: collecting data about the user's posture; detecting at least a medical device parameter; guiding the user in positioning the medical device onto the user's body; detecting the position of the medical device onto the user's body and verify if this position is within a range of a predetermined position defined as the correct position; collecting data of the medical device for verifying the activation of the medical device.

Description

[0001] METHOD FOR GUIDING A USER THROUGH SELF-APPLICATION OF A MEDICAL DEVICE VIA AN ELECTRONIC DEVICE APPLICATION

[0002] INVENTORS:

[0003] Helmut Lasser, French citizen

[0004] Neuhausweg 1

[0005] CH-8712 Stafa SWITZERLAND

[0006] Lucien Vouillamoz, Swiss citizen Dorfstrasse 31

[0007] CH-8835 Feusisberg SWITZERLAND

[0008] Alain Jaccard, Swiss citizen Chemin des Addreys 3 CH-1450 Ste-Croix SWITZERLAND

[0009] METHOD FOR GUIDING A USER THROUGH SEEF-APPLICATION OF A MEDICAL DEVICE VIA AN ELECTRONIC DEVICE APPLICATION

[0010] Cross Reference to Related Applications

[0011] This application is an International Application, which claims the benefit of U.S. Provisional Application No. 63 / 695,924, filed September 18, 2024, entitled METHOD FOR GUIDING A USER THROUGH SELF-APPLICATION OF A MEDICAL DEVICE VIA AN ELECTRONIC DEVICE APPLICATION, and of U.S. Provisional Application No. 63 / 739,590, filed December 29,2024, entitled METHOD FOR GUIDING A USER THROUGH SELFAPPLICATION OF A MEDICAL DEVICE VIA AN ELECTRONIC DEVICE APPLICATION, the contexts of which are hereby incorporated by reference and relied upon.

[0012] Copyright & Legal Noticed

[0013] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The Applicant has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the respective Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. Further, no references to third party patents or articles made herein is to be construed as an admission that the present invention is not entitled to antedate such material by virtue of prior invention.

[0014] Background of the Invention

[0015] In cases of war or large epidemics, it may become necessary to analyze the body fluids, for example the blood, of a substantial part of a given population, potentially the whole population of a neighborhood, a block or group of blocks, a suburb, a city, a whole country or a continent. In such situations, it may not be possible for medical personnel (also abbreviated as MED, such as a physician or healthcare responsible) to personally attend to the sampling of the body fluids of every patient for several reasons such as confinement obligation, risk of contamination, unsafe areas, travelling distances, lack of transport infrastructures, and / or lack of personnel.

[0016] What is needed therefore is a medical device adapted to be used by any individual on himself / herself without rigorous medical training, and a method to ensure the proper guide for the user / patient that uses the medical device. It is also beneficial to have the proper association between the user / patient - optionally authenticated (previously or during the process) - and the body fluid sample, as well as the intact, safe and sanitary transport of the body fluid sample to an analysis lab.

[0017] Summary of the Invention

[0018] The invention relates to a method for guiding a user through self-application of a medical device via an electronic device application (app) according to claim 1. Preferred embodiments are defined in the appended dependent claims.

[0019] According to the invention, the method, and the related electronic device, medical device and system, advantageously permits to replace a medical personnel ensuring the correct execution of the process. In addition, the method, and the related electronic device, medical device and system, according to the invention advantageously permits to witness that the process was done correctly.

[0020] The electronic device can be, for example, a smartphone, a tablet, a computer, a laptop, a pager, a human-like robot or a dedicated electronic device for the medical device. The electronic device can be a fixed or portable device. Advantageously the electronic device can communicate with a data processing, storage and / or validating unit wherein data are processed, stored or verified, in order to execute the method according to the present invention. The electronic device is configured to receive data input from the patient / user.

[0021] In some embodiments, the electronic device is built-in with the medical device, so that the medical device is integrated with the electronic device.

[0022] Advantageously the method according to the present invention combines computer vision technologies and, eventually, sound event recognition technologies, inside an electronic device application, such as a smartphone app, to interactively guide a user in real-time through the selfapplication of a medical device, such a vaccine injector or a blood-sampler.

[0023] For computer vision technology is intended a technology that uses computer vision algorithms. A computer vision algorithm is an algorithm that uses one or more images, or sequence of images. The images are collected to be used by the computer vision algorithm to provide some analysis of the collected images. An image analysis software can use a computer vision algorithm.

[0024] Advantageously the computer vision algorithm is used for tracking the patient / user. The tracking of the user is made using tracking techniques. A computer vision algorithm implements a tracking technique. For tracking technique is intended any technique used for following the evolution of an object or a person during time.

[0025] In a preferred embodiment of the invention, the computer vision algorithm uses or interacts with an algorithm, as a GPS tracer, so that a GPS detection of the position of the medical device and / or of the patient / user is made during time.

[0026] Advantageously the functions of the electronic device according to the present invention can be split between a first and a second electronic device. Preferably, the second electronic device is separated by the first electronic device.

[0027] Advantageously the medical device interacts with one or more electronic devices, such as wearable devices worn by the user. A wearable device is defined for the purpose of the present invention as a second electronic device. A wearable device is, but not limited to, a smart-watch, a smart-ring, a garment including physiological or postural measurement capabilities (such as posture, pressure, temperature, sweat, . ..) in order to enhance the user monitoring. Such wearable device may be a connectable wearable device already worn by the patient, or a dedicated wearable device made for the purpose of interacting with the electronic device of the present invention.

[0028] Preferably, the second electronic device comprises one or more sensors for collecting some data about the patient position in the space. The second electronic device can be, for example, a smart-watch that can inform the user about the orientation of the medical device. The second electronic device can be, for example, a T-shirt with built-in sensors that can inform the user about his / her body position. The second electronic device can be, for example, an armchair on which the user is sitting or lying equipped with load or pressure sensors and a sound detection / analysis device able to emit some sounds for detecting the user’s position and guiding the user.

[0029] In order to implement the method of the present invention, the electronic device is configured to communicate with a camera. The camera advantageously comprises one or more camera sensors for detecting the user / patient and his / her posture, or data about his / her posture.

[0030] In some embodiments, the camera can be embedded in the electronic device. In some other embodiments the camera is separated by the electronic device, and it can be hosted by the second electronic device.

[0031] Advantageously the method ensures compliance with the instruction of use (IFU) of a medical device and / or validates that usage is authenticated for a specific patient in order to safely and autonomously (i.e. by the patient) administer a vaccine / drug.

[0032] Advantageously some of the steps of the method can be accomplished by a system of artificial intelligence (Al).

[0033] The invention also relates to a system which provides a non-medically trained user with the ability to perform a self-injection or a self-sampling, using an associated medical device.

[0034] In order to do that, the patient / user is guided through an electronic application to correctly positioning the medical device and perform the self-injection and / or the self-sampling.

[0035] In some embodiments, the guiding of the patient is realized by visualizing some instructions on a screen of the electronic device, or on a separate screen. In some other embodiments the guiding of the patient is accompanied, or substituted, by the emission of one or more sounds. For example, the sound can be one or more recorded voice instruction. In this case the electronic device comprises, or is configured to communicate with, one or more speakers for emitting sounds. Optionally, the electronic device comprises, or is configured to communicate with, one or more microphones for recording some predetermined sounds and thus detecting if and / or when the correct position is assumed by the user, so that the sampling or the injection process can start.

[0036] Possible connections for creating a communication between the first and the second electronic device are, for example, radio connections, Wi-Fi, Bluetooth or cabled links. It would be clear to the expert in the field that the user can be guided using any type of optical, tactile, audible, tasting or smelling, signal(s).

[0037] Optionally, the guiding method according to the invention comprises an authentication step, for authenticating the user and associating the user to the medical device, and / or to the fluid sample or the drug to be injected.

[0038] This invention also relates to medical devices allowing for the sampling of body fluids and their transport to an analysis lab without the intervention of medical personnel.

[0039] A fluid sampling device and methods are provided for collecting body fluid samples, such as blood, without the intervention of medically trained personnel. Associated methods are provided for authenticating the user / patient, associating with or ensuring the correspondence between the authenticated user / patient and the sample container, optionally with the sampling device, and using such sampling device to collect a sample of body fluid and to ensure the hermetic, sanitary, intact and safe transport of the collected body fluid sample to an analysis lab.

[0040] In addition, the invention also relates to a vaccine and / or drug injecting device which provides a non-medically trained user with the ability to inject vaccines and / or drugs, optionally auto-injecting.

[0041] Brief Description of the Drawings

[0042] FIG. 1A is a flowchart of a first embodiment of the method of the invention.

[0043] FIG. IB is a flowchart of a second embodiment of the method of the invention.

[0044] FIG. 1C is a flowchart of a third embodiment of the method of the invention.

[0045] FIG. ID is a flowchart of a fourth embodiment of the method of the invention.

[0046] FIG. 2A is a perspective view of the internal mechanism of a sampling device, showing a first embodiment of the cutting blade of the invention before use.

[0047] FIG. 2B is a perspective view of the internal mechanism of a sampling device according to the invention while in use.

[0048] FIG. 2C is a perspective view of the internal mechanism of a sampling device according to the invention after use. FIG. 3A is a side view of the internal mechanism of a sampling device according to the invention before use.

[0049] FIG. 3B is a perspective view showing the internal mechanism of a sampling device according to the invention while in use.

[0050] FIG. 3C is a side view of the internal mechanism of a sampling device according to the invention while in use.

[0051] FIG. 3D is the side view of the internal mechanism of a sampling device according to the invention after use.

[0052] FIG. 4 is a lower perspective view of the contact surface of a sampling device according to the invention with the user’s skin.

[0053] FIG. 5 is a perspective view of the internal fluidic channel of a sampling device according to the invention.

[0054] FIG. 6 is a plan view of a thermal indicator panel according to the invention.

[0055] FIGs. 7A-7B are partial cross-section views of the internal elements of a sampling device according to the invention, showing the extraction of the body fluid sample.

[0056] FIGs. 8A - 8B are cross sectional views showing two stages of movement of the body fluid sampling device of the invention, namely, the step before use (FIG. 8A), and then the step after sampling (FIG.8B).

[0057] FIG. 9 is a perspective view of another embodiment of the body fluid sampling device of the invention for the collection of capillary blood from the ear lobe.

[0058] FIGs. 10A-10B are schematic views of the body fluid sampling device for the collection of capillary blood from the ear lobe.

[0059] FIG. 11 is a flow chart of a fifth embodiment of the method for sampling body fluids of the invention, ensuring the identification of the user-patient.

[0060] FIG. 12, is a side view of an embodiment of capillary blood sampling device according the invention which has a main structure containing the suction interface adapted to be attached to the skin of the user / patient. FIG. 13 is a localized, partial, cross-sectional view of the embodiment of capillary blood sampling device of FIG. 12 showing a second embodiment of the cutting blade of the invention, the device in contact with the user / patient through its suction interface.

[0061] FIGs. 14A to 141 are partial, cross-sectional views showing the functioning of the device of the invention for use with a standard sample container.

[0062] FIG. 15A is a side view of the second embodiment of a cutting blade, or lancet, for use in the invention, in a position ready for release.

[0063] FIG. 15B is side view of the second embodiment of the cutting blade for use in the invention, in a position ready half-way extended.

[0064] FIG. 15C is a top view of the second embodiment of the cutting blade fully extended.

[0065] FIG. 16A is a perspective view of a third embodiment of the cutting blade of the invention, made from a single piece of metal.

[0066] FIG. 16B is a side view of the third embodiment of the cutting blade of the invention.

[0067] FIG. 16C is a front view of the third embodiment of the cutting blade of the invention.

[0068] FIG. 16D is a top view of the third embodiment of the cutting blade of the invention.

[0069] FIG. 16E is a side view of the third embodiment of the cutting blade of the invention, half extended.

[0070] FIG. 16F is a side view of the third embodiment of the cutting blade of the invention, fully extended.

[0071] FIG. 17 is a multitum torsion spring that may be used in the elastic zone in a particular embodiment of the invention.

[0072] FIG. 18A is an upper perspective view of another embodiment of the blood sampling device of the invention.

[0073] FIG. 18B is a lower perspective view of another embodiment of the blood sampling device of the invention.

[0074] FIG. 19 is a perspective view of an injection device of the invention.

[0075] FIGs. 20A to 20P are schematic views illustrating the steps of a sixth embodiment of the method of using the system of the invention. FIGs. 21A to 21D are schematic views with more detail about the specific features of the adhesive integrated dressing included in the capillary blood sampling device.

[0076] FIG. 22A is a perspective view of a fourth embodiment of the cutting blade of a device of the invention is made of a single part.

[0077] FIG. 22B is a side, four-position, shutter view of the fourth embodiment of the cutting blade of a device of the invention.

[0078] FIG. 22C is a side, four-position, shutter view of the fourth embodiment of the cutting blade of a device of the invention showing the retraction thereof.

[0079] FIG. 23A is a perspective view of a fifth embodiment of the cutting blade of the invention.

[0080] FIG. 23B is a front view of the fifth embodiment of the cutting blade of the invention.

[0081] FIG. 24A is a side view of a sixth embodiment the cutting blade of a device of the invention, prior to entry into the epidermal layer of the patient’s body.

[0082] FIG. 24B is a side view of the sixth embodiment the cutting blade of a device of the invention half way through its cycle of motion.

[0083] FIG. 24C is a side view of the sixth embodiment the cutting blade of a device of the invention at the end of its cycle of motion, having returned to its initial position.

[0084] FIG. 25A is a perspective view of a seventh embodiment the cutting blade of a device of the invention showing a standard scalpel blade.

[0085] FIG. 25B is a side view of the seventh embodiment the cutting blade of a device of the invention, prior to entry into the epidermal layer.

[0086] FIG. 25C is a side view of the seventh embodiment of the cutting blade of a device of the invention after entry into the epidermal layer, as it is about to be removed from said layer.

[0087] FIG. 25D is a side view of the epidermal layer showing the cut made by the seventh embodiment of the cutting blade.

[0088] FIG. 26A to FIG. 26C show examples of visible features that can be integrated in a device of the invention to be easily recognized by the human observer, or easily identified by a real-time image analysis software.

[0089] FIG. 27A is an image of the upper arm of a patient with an attached capillary blood sampling device. FIG. 27B is an image of a capillary blood sampling device during the insertion of a vacuum tube.

[0090] FIG. 27C is an image of a capillary blood sampling device with inserted vacuum tube.

[0091] FIG. 28A is a top view of a capillary blood sampling device comprising a thin heating element.

[0092] FIG. 28B is a first side view of a capillary blood sampling device comprising a thin heating element.

[0093] FIG. 28C is a second side view (rear vew of the first) of a capillary blood sampling device comprising a thin heating element.

[0094] FIG. 29 is a drawing of three sample tubes attached to a sampling device showing the subsequent filling of each.

[0095] FIG. 30 is a drawing of a capillary blood sampling device with a larger vacuum tube connected to a smaller sample tube.

[0096] FIG. 31 is a flowchart of a method of the invention, showing subsequent stages of removal and replacement of sample tubes.

[0097] FIG. 32A is an image of a sample tube comprising a cap with a tamper evident feature (TEF).

[0098] FIG. 32B is an image of various forms of sample tubes.

[0099] FIG. 33 is a drawing of a vent mechanism providing release of remaining vacuum after blood sampling.

[0100] FIG. 34 is an image of a patient’s upper arm with incisions for blood sampling.

[0101] FIG. 35A is an image of a capillary blood sampling device with connexion to an external vacuum source.

[0102] FIG. 35B is an image of a capillary blood sampling device with connexion for a vacuum tube that is different from the blood sample tube.

[0103] FIG. 35C is schematic cross-section view of the inside of the sample tube connection when the vacuum source is different from the blood sample tube.

[0104] FIG. 36A is an upper, perspective view of an embodiment of the body fluid sampling device of the invention before use.

[0105] FIG. 36B is a lower, perspective view of an embodiment of the body fluid sampling device of the invention before use. FIG. 36C is a top view of an embodiment of the body fluid sampling device of the invention before use.

[0106] FIG. 36D is a bottom view of an embodiment of the body fluid sampling device of the invention before use.

[0107] FIG. 36E is a left side view of an embodiment of the body fluid sampling device of the invention before use.

[0108] FIG. 36F is a right side view of an embodiment of the body fluid sampling device of the invention before use.

[0109] FIG. 36G is a front side view of an embodiment of the body fluid sampling device of the invention before use.

[0110] FIG. 36H is a back side view of an embodiment of the body fluid sampling device of the invention before use.

[0111] FIG.361 is an upper, perspective view of an embodiment of the body fluid sampling device of the invention while in use.

[0112] FIG. 36 J is a lower, perspective view of an embodiment of the body fluid sampling device of the invention while in use.

[0113] FIG. 36K is a top view of an embodiment of the body fluid sampling device of the invention while in use.

[0114] FIG. 36L is a bottom view of an embodiment of the body fluid sampling device of the invention while in use.

[0115] FIG. 36M is a left side view of an embodiment of the body fluid sampling device of the invention while in use.

[0116] FIG. 36N is a right side view of an embodiment of the body fluid sampling device of the invention while in use.

[0117] FIG. 360 is a front side view of an embodiment of the body fluid sampling device of the invention while in use.

[0118] FIG. 36P is a back side view of an embodiment of the body fluid sampling device of the invention while in use.

[0119] FIG. 37A shows an adhesive pad of the invention before use. FIG. 37B shows an adhesive pad of the invention while in use.

[0120] FIG. 38A illustrates the step of installing the adhesive pad of the invention.

[0121] FIG. 38B illustrates the step of installing the fluid sampling device of the invention.

[0122] FIG. 38C illustrates the step of activating the sampling with the device of the invention.

[0123] FIG. 38D illustrates the step of waiting and monitoring the sampling with the device of the invention.

[0124] FIG. 38E illustrates the step of removing the device of the invention after sampling.

[0125] FIG. 38F illustrates the step of dressing the wound with the adhesive pad of the invention.

[0126] FIG. 39 is a flow sheet of a method for authenticating and guiding a patient through selfapplication of a medical device via an electronic device application according to a preferred embodiment of the present invention.

[0127] FIGs. 40 and 41 are schematic views of the screen of the electronic device in two different configurations of use according to the present invention.

[0128] FIG. 42 represents a flow sheet of a simplified method for guiding a user through selfapplication of a medical device via an electronic device application according to the present invention.

[0129] Those skilled in the art will appreciate that elements in the Figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, dimensions may be exaggerated relative to other elements to help improve understanding of the invention and its embodiments. Furthermore, when the terms 'first' , ' second', and the like are used herein, their use is intended for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. Moreover, relative terms like 'front', 'back', 'top' and 'bottom', and the like in the Description and / or in the claims are not necessarily used for describing exclusive relative position. Those skilled in the art will therefore understand that such terms may be interchangeable with other terms, and that the embodiments described herein are capable of operating in other orientations than those explicitly illustrated or otherwise described. Detailed Description of the Preferred Embodiment

[0130] The following description is not intended to limit the scope of the invention in any way as they are exemplary in nature, serving to describe the best mode of the invention known the inventors as of the filing date hereof. Consequently, changes may be made in the arrangement and / or function of any of the elements described in the exemplary embodiments disclosed herein without departing from the spirit and scope of the invention.

[0131] According to the invention, the medical device is also hereinafter identified such as the body fluid sampling device, the sampling device, the sample device, the capillary blood sampling device, the device for capillary blood sampling, the sampler (also called micro-sampler for remembering the non-invasive dimensions of the sampler) or the vaccine and / or drug injecting device (or simply as the injection device). Examples of these devices are described hereinafter. The expert of the field would appreciate that a different medical device can be used, without departing from the scope of the present invention.

[0132] The body fluid sampling device according to the invention may take on different sizes and shapes, depending on the fluid(s) and size of the sample to be collected, and on the area of the body where the sample is to be collected. The sample may be collected on the skin or on a mucosa, but the sample may have to be collected through the skin / mucosa, in such case the sampler may be equipped with a cutting blade to open the skin / mucosa and release the body fluid to be sampled. A reactant may be added by the user on the surface of the skin / mucosa to facilitate the conservation of the sample or to enable specific analyses. Optionally, the thermal inertia of the body fluid sampling device is adapted to the above parameters and to the transport constraints, so that the storage temperature of the body fluid sample is kept optimal from the user’s fridge to the fridge of the analysis lab with sufficient margin. The transport of the collected sample from the user’s location to the analysis lab may be done by the user himself, by postal services, or by a dedicated logistics organization using human transporters or autonomous or remotely controlled unmanned vehicles. Depending on the circumstances, the sampling device may be equipped with geolocalization and long-range communication capabilities so as to be collectable without any further action from the user after the sampling process has been executed. The authentication of the patient and ensuring the correspondence between the authenticated user / patient and the sample, optionally with the sampling device, is optionally accomplished via differing levels of antitampering measures, as the stakes may be very high for the patient, for example, the result may determine whether the patient is placed in quarantine or released from quarantine, authorized to travel, authorized to work, it may serve as confirmation of the efficiency of a treatment, and / or the releasing of payment for a treatment, etc. Such antitampering measures may increase to include filming the entire body fluid sampling process from opening the box containing the sampling device to sealing the box to be mailed to the sample analysis organization, optionally encrypting, and storing the movie for later use, for example to be used as a proof in court in case of legal proceeds. The body fluid sampling device optionally is equipped with a unique identification code, and optionally carries an electronically readable identification tag such as an RFID readable tag.

[0133] Referring now to FIG. 1A, a first embodiment of the method according to the invention includes the steps of: a) disinfecting and moistening the area of the body where the blood sample will be taken; b) taking the sample of blood; c) photographing the filled micro-sampler and optionally the patient’s ID; d) putting the filled micro-sampler into the patient's refrigerator, optionally before the first step a) or b) above, in which the micro-sampler is cooled until the shelf life necessary for its transport is obtained, still further, optionally, sliding an insulating sleeve over the sample reservoir via activating a tab according to instructions provided to the user; e) transporting the micro-sampler from the patient's home to the doctor, pharmacist, hospital or dedicated collection point; f) intermediate storage, optionally in the refrigerator of the doctor, pharmacist, hospital or other collection point before; and g) the blood test itself related with the photo sent by the patient. Referring now to FIG. IB, a second embodiment of the method according to the invention includes the steps of: i. disinfecting and optionally moistening the area of the body where the sample will be taken; ii. taking the fluid sample; iii. at any time, associating the micro sampler with the test subject, such as by photographing the filled micro-sampler, optionally together with the patient’s ID, and sending the same to a specified recipient by SMS, MMS, or other email, for example; iv. storing the filled micro-sampler optionally into the patient's refrigerator, optionally before the step i) or ii) above, in which the micro-sampler is cooled until at least the shelf life necessary for its transport is obtained, still further, optionally, sliding an insulating sleeve over the sample reservoir via activating a tab according to instructions provided to the user; v. taking the sample out of the refrigerator; vi. transporting the micro-sampler optionally from the refrigerator which may be at the patient's home to the doctor, pharmacist, hospital or dedicated collection point; vii. intermediate storage optionally in the refrigerator of the doctor, pharmacist, hospital or other collection point; viii. using the sample in the micro-sampler to take diagnose the pathogen; and ix. informing the appropriate persons of the results of the analysis.

[0134] For the scope of the present invention the micro-sampler is a sampler.

[0135] Referring now to FIG. 1C, a third embodiment of the method of the invention comprises the steps:

[0136] Step 1 : The user captures the unique identification of his sampling device, with a dedication software application (app) (connected to the Internet or to the CLOUD™) on his smartphone capturing a QR code on his sampling device, by collecting an identification tag attached on the device when delivered, or any other appropriate means. Optionally the user associates the sampling device with the patient, for example by photographing the device with its identification visible together with the patient’s ID document, or together with the patient’s face. Step 2: Optionally the user disinfects the skin surface, providing disinfection but optionally also moisturizing the surface, enabling better suction. Optionally the user applies a reactant on his skin / mucosa, such reactant to mix with the body sample to allow / improve the body sample conservation and / or to enable / improve analyses.

[0137] Step 3 : The user applies the sampling device on his skin / mucosa at the appropriate area.

[0138] Step 4: The user triggers the sampling process, optionally after having cooled the device according to the previously described methods,

[0139] Step 5: The sampling process is executed automatically by the sampling device, in the following sub-steps:

[0140] Step 5.1 : The actuation spring is released.

[0141] Step 5.2: The piston starts sucking to create a vacuum between the user’s skin / mucosa and the sampling device’s contact surface, and the optional cutting blade starts cutting.

[0142] Step 5.3 : The optional cutting blade cuts the user’s skin / mucosa.

[0143] Step 5.4: The micro-wound starts releasing body fluid.

[0144] Step 5.5: Body fluid is sucked into the reservoir.

[0145] Step 5.6: The optional cutting blade is retracted.

[0146] Step 5.7: The piston reaches its end-stop.

[0147] Step 5.8: A visible indicator signals the user that the sampling process is complete. Such visible indication may also be provided by the reservoir being transparent so that the user can see the reservoir filled by the body fluid.

[0148] Step 5.9: If the sampling device is equipped with a long-range wireless communication device, information that the sample process has been executed is sent directly to the sample collection organization.

[0149] Step 6: The user detaches the sampling device from his skin / mucosa and closes it so as to protect the integrity of the body fluid sample. The user optionally applies a plaster on the micro-wound, the micro-wound closes itself naturally. Optionally, the user associates the sampling device with the patient, for example by photographing the device with its identification visible together with the patient’s ID document, or together with the patient’s face.

[0150] Step 7: Optionally before the sample is taken, the user stores the sampling device in his fridge.

[0151] Step 8: Optionally before the sample is taken, the user follows instructions to bring the temperature of the sampling device to appropriate temperature, optionally monitoring the evolution of the temperature of the sampling device by observing the temperature display. If the sampling device is equipped with a temperature sensor and with a long-range wireless communication device, information on the sampling device temperature is sent directly to the sample collection organization.

[0152] Step 9: When the instructions are followed, e.g. transport temperature is reached, the user optionally informs the sample collection organization that the sample is ready to be picked up or has the device delivered to the appropriate collection point. If the sampling device is equipped with a long-range wireless communication device, information about the sampling device readiness to be picked up may be sent directly to the sample collection organization.

[0153] Step 10: The sample collection organization collects the sampling device and brings it to the analysis lab.

[0154] Step 11 : The analysis lab runs the sample analysis and informs the user and / or the appropriate authorities of the result by any communication means such as through a dedication software application (app) (connected to the Internet or the CLOUD™) in the user’s smartphone or by any other appropriate communication means.

[0155] Capturing the identification of the sampling device (step 1) may also be done between steps 5 and 6 (after having run the sampling process)

[0156] Referring now to FIG. ID, a fourth embodiment of the method of the invention has all the steps of the third embodiment of the method of the invention but instead of Step 5, a modified Step 5b as follows: Step 5b: The sampling process is executed automatically by the sampling device, in the following sub-steps:

[0157] Step 5b.1 : The actuation spring is released.

[0158] Step 5b.2: The piston starts sucking to create a vacuum between the user’s skin / mucosa and the sampling device’s contact surface, and the cutting blade starts cutting.

[0159] Step 5b.3 : The cutting blade cuts the user’s skin / mucosa.

[0160] Step 5b.4: The cutting blade is retracted.

[0161] Step 5b.5: The micro-wound starts releasing body fluid.

[0162] Step 5b.6: The mechanism optionally includes a device (such as a device including a spring that is unwound via a loaded flywheel connected to a reduction gear drive system) allowing for a waiting time prior to sufficient release of body fluid, for example 0.1 to 10 seconds, or 0.2 to 5 seconds, or 0.5 to 3 seconds as appropriate for the body fluid to be collected.

[0163] Step 5b.7: The mechanism actuates an absorbing pad to collect through absorption the first droplet or a first amount of body fluid and take it away from the collection area.

[0164] Step 5b.8: As the micro-wound continues releasing body fluid, the body fluid is sucked into the reservoir.

[0165] Step 5b.9: The piston reaches its end-stop.

[0166] Step 5b.10: A visible indicator signals the user that the sampling process is complete. Such visible indication may also be provided by the reservoir being transparent so that the user can see the reservoir filled by the body fluid. If the sampling device is equipped with a long-range wireless communication device, information that the sample process has been executed is sent directly to the sample collection organization.

[0167] Referring now to FIGs. 2A-2C, the internal mechanism 10 of the body fluid sampling device contains an energy source 200 that is sufficient to ensure the execution of the entire sampling process, for example a spring. The device includes a rigid reservoir 502 closed by a plunger 504. The mechanism 10 connects the energy source 200 to the plunger 504 via a piston 242 so that the plunger 504 can be retracted in order to create vacuum and suck the body fluid sample. Depending on the type of body fluid to be collected and the skin / mucosa protecting it, optionally the mechanism 10 also connects the energy source 200 to a first embodiment of a cutting blade 302 that is able to cut the user’s skin / mucosa in order to release the body fluid sample to be collected. The mechanism 10 includes a trigger 210 that can be activated by the user to launch the sampling process. The mechanism 10 may include gears, levers, cams, snaps, racks, pinions, springs, and any other mechanic components 220, 222, 224 the selection of a suitable assembly of which is within the skill of a person of ordinary skill in the micromechanics industry so as to ensure the execution of the entire sampling process without any other action from the user after the trigger 210 has been released.

[0168] Referring now to FIG. 2B, the sampling device 10 (also devices 1100, 2010, 2210, 4100, 3100) has a unique identification that can take many forms: a QR code that may be read by the user’s smartphone or a number that the user may write down for reference, etc. The sampling device 10 (and 1100, 2010, 2210, 4100, 3100 as the case may be) optionally contains a long-range wireless communication device in order to be geo-localized and to provide status information directly to the sample collection organization. Sampling device status, geo-localization, user’s name may as well be communicated by the user directly, by his smartphone using a dedication software application (an “app” connected to the Internet or the CLOUD™), or by any other appropriate means. Starting the sampling process may be made on the own initiative of the user, or may be ordered by the health authorities of a given region.

[0169] Referring now to FIGs. 3A-3D, the internal mechanism 10 of the body fluid sampling device is represented with less elements visible, to show in a clearer manner the reservoir 502, the piston 242, the plunger 504, the mechanism elements 220, 222, 224, the cutting blade 302.

[0170] Referring now to FIG. 4, the contact surface 100 of the body fluid sampling device 10 has an appropriate shape 110 so as to correspond to the shape of the area of the user’s body where the sample has to be taken. The contact surface 100 may be made of soft material or include a flexible seal 120 so as to tightly fit, so that a sufficient level of vacuum is established when retracting the plunger 504 via the piston 242 to collect the body fluid sample. Optionally the contact surface 100 is protected by a film that the user removes before using the sampler, the protective film may be re-usable to close the surface 100 after sampling.

[0171] Referring now to FIG. 5, the body fluid sampling device 10 contains a channel 404 connecting at one end 402 an opening 112 in the device’s contact surface 100 and at the other end 406 to the inlet 506 of the reservoir 502.

[0172] Referring now to FIG. 6, the body fluid sampling device includes a temperature monitoring display / indicator 600. Such display / indicator may consist of a printed adhesive strip 600 with several zones of different colors 602, 604, 606, 608, the color of these zones changing so as to indicate when the sampling device has reached the corresponding range of temperature, labelling of these zones may include instructions for the user. Examples of temperature ranges may be:

[0173] - 602: too warm (for example as long as the sampling device’s temperature is above 8°C)

[0174] - 604: soon ready for transport (for example when the sampling device’s temperature is between 5 °C and 7°C).

[0175] - 606: ready for transport (for example when the sampling device’s temperature is between 1°C and 5°C).

[0176] 608: too cold (for example when the sampling device’s temperature is below a certain temperature, such as below 1°C as another temperature range may be more appropriate for the specific fluid sample and the corresponding process and / or instructions to be given to the user.

[0177] Referring now to FIGs. 7A-7B, the extraction of the body fluid sample from the sampling device is accomplished with a needle 944. An access hole 244 is provided through the piston 242, so that the needle 944 can pierce the plunger 504 and suck the body fluid sample contained in the reservoir 502. Optionally, the body fluid sampling device advantageously includes an insulating cover or sleeve adapted to slide over the sample container so as to extend the transport time possibilities. In one embodiment, the isolating cover or sleeve is manually set in place by the user via a tab actuated by the user according to written instructions provided with the device, or automatically slid in place by a second mechanism optionally triggered by thermal contraction of an element after the device has reached a sufficiently low temperature in the refrigerator.

[0178] Any embodiment of the body fluid sampling device such as those described herein is optionally equipped with a unique identification code, and may carry an electronically readable identification tag. Depending on the circumstances, the sampling device is optionally equipped with geo-localization and long-range communication capabilities so as to be collectable without any further action from the user after the sampling process has been executed.

[0179] The body fluid sampling device according to the invention is made to use standard analysis tubes as well-known in the industry, so that the tubes’ content can be analyzed on standard automatized analysis equipment.

[0180] The body fluid sampling device according to the invention thereby provides a non- medically trained user, such as the patients themselves, with the main functionalities of:

[0181] 1. sampling a body fluid (for example blood), optionally auto-sampling (selfadministered sampling);

[0182] 2. optionally dispensing one or more droplet(s) of the sampled fluid for immediate analyses: and

[0183] 3. providing a standard medical analysis tube filled with a sample of body fluid (for example blood) for analysis in a medical lab.

[0184] Referring now to FIG. 8A - 8B, an embodiment of body fluid sampling device 1100 is presented as before use (FIG. 8A), and after the sampling (FIG.8B). The body fluid sampling device 1100 comprises a standard medical analysis tube 1007 with its cover (c) made in standard colors and labelling (e), which preferably remains visible at all times. The device’s structure preferably includes two push buttons 1002 on each side of the device 1100, whose activation, in one embodiment, must be combined with pushing the safety button 1001 in order to launch the sampling process. A combination of levers, stoppers, cams, or any other mechanical elements well known in the art triggers through a sealed sleeve I the movement of a second embodiment of one or more lancet(s) or cutting blade(s) 1004 as well as the movement of the piston pl when the buttons 1001 and 1002 are pressed by the user. It should be mentioned that the device can have one or more cutting blades 1004 (e.g., but not limited to cutting blades 302, 5450, 5456, 3260, 3360, 3460), in principle one cutting blade for up to 500pl, and two or more cutting blades in order to collect 1ml or more over a duration that is acceptable to the patient. Forbackground information, the duration of blood flow is about 30' for 500pl for one incision, so the same time for 1ml with 2 incisions. The movement of the cutting blade 1004 is ensured by a dedicated spring, typically a torsion spring such as shown in FIG. 17 or element 3362 in FIG. 22A), so that it cuts an opening in the patient’s skin to release capillary blood and retracts into the device’s structure / housing 1008. The suction area 1010 is kept air-tight by a skirt 1005 made of flexible material such as silicone or any other appropriate material, which connects the device and the patient’s skin, and a sealed sleeve I. The suction area 1010 is connected to the tube chamber 1011 via a cannula 1006, whose tip ii is similar to that of an injection needle and can pierce the plunger-septum p2 when the piston pl is mobilized to create vacuum in the tube chamber 1011 and aspire the blood from the suction area 1010 into the tube chamber 1011. The plunger- septum p2 provides a cylindrical recess clearance i to minimize friction with the cannula during operation, a sealing lip v and a closing zone iii, that is pierced by the needle tip ii to allow the suction of the body fluid, and closes when the cannula tip ii is disengaged when the tube 1007 is removed from the device structure 1008. After the sampling, a button 1003 provides the possibility to push back the piston pl on a short distance so as to expel a small amount of the collected blood sample back through the cannula 6 to dispense one or more droplets from the protruding end 1009 of the cannula 1006 for an immediate analysis using a home testing kit, for example. Button 1003 provides for an access to disengage the piston pl from the plunger-septum p2, so that the plunger- septum p2 can remain engaged in the tube 1007 and keep it tightly closed when it will be released from the device’s structure 8. The standard medical analysis tube 1007 is held within the devices’ structure 1008 for the sampling process and the optional droplet dispensing process. The devices’ structure 1008 may be made of several parts, and may contain elements that can be broken or disassembled to release the standard medical analysis tube 1007, so that it can be delivered to a lab for processing by standard medical lab analysis equipment. Before releasing the standard medical analysis tube 1007, the piston pl must be separated from the plunger- septum p2, by, for example, turning the button 1003 to rotate the piston pl so that it disengages from the plunger p2 via, for example, unthreading at threads x. The actuation spring 1012 is maintained within the device’s structure by a washer 1013. Note that the end of the piston shaft engages with the button so as to rotate therewith when it reaches the end of the suction cycle, allowing for removal of the shaft from the plunger.

[0185] The use or operation of the device can be described as follows:

[0186] 1. Typically the user holds the device between his thumb and major finger, placed on the two buttons 2, and applies his index on the safety button 1001.

[0187] 2. A combination of levers, stoppers, cams, or any other mechanical elements such as well-known in the micro-mechanics art triggers the movement of the piston pl when the buttons 1001 and 1002 are pressed by the user. At the same time, it triggers the movement of the cutting blade 1004.

[0188] 3. The spring 1012 actuates the piston pl, to which the plunger- septum p2 is attached, so that the plunger impales on the needle tip ii, the tip ii piercing through the plunger, and opens the connection between the suction area 1010 and the tube chamber 1011. The cutting blade moves and cuts the skin of the patient.

[0189] 4. The spring continues to pull the piston pl, so that a vacuum is created within the chamber 1011 of the medical analysis tube 1007. The patient starts bleeding, the blood is aspired through the cannula 1006 into the tube chamber 1011. The cutting blade 1004 continues its movement and retracts within the device’s structure.

[0190] 5. The piston pl reaches the end of its stroke against button 1003, the suction stops, the sample is contained within the tube chamber 1011. Typically the volume of the sample is 500 pL. with one cutting blade, 1ml with two cutting blades.

[0191] 6. The user removes the device from the patient’s skin, cleans the wound, applies a Band- Aid if necessary. 7. Optionally, the user uses button 1003 to expel a small part of the sample, typically 1025 pL, and uses it on an immediate test as available on the market.

[0192] 8. User uses button 1003 to disconnect piston p 1 from plunger-septum p2, so that plungerseptum p2 remains in the tube 1007 to keep it tightly sealed.

[0193] 9. User releases the tube 1007 from the device’s structure, upon removing the tube the plunger-septum p2 disengages from the cannula 1006 and closes.

[0194] 10. User sends or brings the tube to a medical analyses lab to be analyzed.

[0195] 11. The analysis lab analyses the blood sample and communicates the test results to the patient and / or to the relevant authorities.

[0196] 12. Optionally, treatment and / or quarantine protocol is initiated to ensure that a test subject having a positive test is handled in a manner to minimize the spread of the pathogen.

[0197] In another embodiment, the body fluid sampling device according to the invention may include integrated analysis functions. The sample may be collected on the skin or on a mucosa, but the sample may have to be collected through the skin / mucosa, in such case the sampler is optionally equipped with a cutting blade to open the skin / mucosa and release the body fluid to be sampled. A reactant is optionally added by the user on the surface of the skin / mucosa to facilitate the conservation of the sample or to enable specific analyses.

[0198] Referring now to FIG. 9, a body fluid sampling device 2010 for the collection of capillary blood from the ear lobe has a main body part 2100 and a mobile part 2200 to pinch the userpatient’s ear lobe, so that the device 2010 may remain in place for the sampling process without the need of the user-patient to hold it. The body fluid sampling device 2010 contains an internal mechanism such as disclosed in US63 / 002,581 or US63 / 006,337 of the same applicant (the contents of which applications are incorporated by reference herein and relied upon) or any other appropriate mechanism which ensures a complete execution of the body fluids sampling process without any intervention other than triggering. Automatic analysis features and / or systems may be integrated in the device. Referring now to FIGs. 10A-10B, the body fluid sampling device 2210 for the collection of capillary blood from the ear lobe 2230 of the user-patient 2200 is made with an appropriate shape, size and weight to hold by itself at the collection site 2230 and to be visible by the camera of the user-patient’s smartphone 2250 together with the patient’s face. An optical feature 2212 such as a QR code, a visual symbol on the device 2210 is provided to help in identifying and localizing the device and may also include a display showing the readiness, the progress and the completion of the sampling process or any other visual communication elements that the camera of the user-patient’s smartphone 2250 may capture and that the application running the userpatent’s smartphone 2250 may analyze and use for reinforcing the device’s identification. The device 2210 includes a wireless communication system to communicate information with the userpatient’s smartphone, to trigger the body fluid sampling process, and optionally to launch a sample analysis process after the sampling is completed. Information communicated between the device 2210 and the user-patient’s smartphone 2250 include: device unique identification, sampling triggering, sampling process progress, sampling process completion, and / or error messages. The communication between the device 2210 and the user-patient’s smartphone 2250, as well as the communication between the user-patient’s smartphone and the cloud are encrypted, and may use blockchain technologies to make tampering, misuse or hacking difficult or impossible. The sampling information together with the user-patient’s identification are communicated to the relevant authority for further processing.

[0199] Referring now to FIG. 11, a fifth method for sampling body fluids and ensuring the identification of the user-patient includes the steps of:

[0200] 1. User installing a specific application on his or her smartphone (for the first use);

[0201] 2. Optionally, user disinfecting skin surface - optionally user applying a reactant on skin / mucosa;

[0202] 3. User installing sampling device on his skin / mucosa;

[0203] 4. User launching the specific application on his smartphone;

[0204] 5. The application communicating with the sampling device and identifying it; 6. The application switching the smartphone's camera on, inviting user to orient it so that both his face and the device are visible on the smartphone’s screen;

[0205] 7. In parallel: a. The application running a face identification software and identifies user; b. The application running an image analysis software and recognizing the identification of the sampling device;

[0206] 8. The application communicating with the sampling device and launching the sampling process:

[0207] 9. In parallel: a. The application storing a time-lapse video as a witness to the sampling process; b. The sampling device executing the sampling process;

[0208] 10. The sampling device communicating to the application when the sampling process is complete; and

[0209] 11. The application storing information on sampling device identification, sampling time and user identification on the cloud and / or in its internal memory.

[0210] Referring now to FIG. 12, an embodiment of capillary blood sampling device 4100 according the invention has a main structure 5000 containing the suction interface 5100 adapted to be attached to the skin of the user / patient, one or more push-button(s) 5200 for the user / patient to actuate the device 4100, and a tube holder 6000 configured to receive vacuum sampling tubes such as the vacuum sampling tubes well-known in the industry for venous blood sampling. Inside of the main structure 5000 are located a suction chamber 5400, connected to the inside 6100 of the tube holder 6000 via a channel 7000, an actuation mechanism 5300 to convert the action of the user / patient pushing on the one or more buttons 5200 into actuation of the device 4100, and optional electronic and / or connectivity features such as GPS or geo-localization system, identification tag, wireless communication system, or countdown with audible feedback, etc.

[0211] The device’s structure 5000 preferably includes two or more push buttons 5200 and the mechanism 5300 is configured to ensure that only the activation of all push-buttons 5200 launches the sampling process so that the risk of inadvertent launching is minimized. The mechanism 5300 may include a combination of levers, stoppers, cams, or any other mechanical elements well known in the micro-mechanics art, or may preferably be made of flexible elements that can release the sampling just by being deformed when the user / patient presses the push-button(s) 5200. The device’s structure 5000 optionally includes means to expel a small quantity of the blood from the device 4100 for quick on-site analysis. A second embodiment of the cutting blade 5450 is shown in these figures, but of course, any version could be used.

[0212] Referring now to FIG. 13, an embodiment of capillary blood sampling device 4100 according the invention is in contact with the user / patient through its suction interface 5100, the suction interface 5100 being attached to a bandage 5120 with a suitable permanent adhesive glue 5110, the bandage 5120 having on its surface facing the user / patient’ s skin a temporary adhesive glue 5130 adapted to hold the device 4100 unto the user / patient’ s skin at least for the duration of the sampling process. The temporary adhesive glue 5130 is protected before the device’s use by a removable protective film 5140. The glues 5110, 5130 and bandage 5120 expose a passage 5150 to allow for blood sampling, and are air-tight on their periphery in order to ensure the build-up of vacuum between the user / patient’ s skin and the suction chamber 5400 for the sampling process. The bandage 5120 may have a relatively large surface compared to the surface of the suction interface, in order to ensure sufficient air-tightness with the user / patient’ s skin.

[0213] The suction chamber 5400 contains 1 or more cutting blade(s) 5450 of a second embodiment, in principle 1 for up to 500pl, and 2 if 1ml need be collected, as required depending on the sample size to be collected. For the reader’s information, the duration of blood flow is about 30' for 500pl for one incision, and so about the same time for 1ml using two incisions. The cutting blade 5450 has an elastic or spring portion 5458 which has been loaded at the assembly of the device 4100, and is held under tension by a mechanical finger 5350. The mechanical finger 5350 is linked to the mechanism 5300 so that the mechanism 5300 can release the cutting blade 5450 when actuated. The cutting blade is positioned so as to lacerate the user / patient’ s skin through the passage 5150 when released. The suction chamber is closed by an air-tight membrane 5420 made of an air-tight material that can be lacerated by the cutting blade 5450 while at the same time cutting the user / patient’ s skin without tearing. Optionally, the suction chamber 5400 contains an air-tight elastic lining 5410 which allows the mechanism 5300 to actuate the mechanical finger 5350 in an air-tight manner, and optionally includes means to expel a small quantity of blood for quick on-site analyses. Appropriate materials for the membrane 5420 and the optional elastic lining 5410 are well-known in the art and may include silicone, rubber, and other elastomers and / or plastics in one or more layers. The suction chamber 5400 is made so as to minimize its volume, so that the majority of the collected blood doesn’t remain in the suction chamber 5400 and can be fed into the vacuum tube, and a minimal part of the vacuum provided by the tube is used to establish vacuum in the suction chamber 5400. The channel 7000 connecting the suction chamber 5400 to the inside 6100 of the tube holder 6000 may be a needle 7200 with the suction end 7100 of the needle connected to the suction chamber 5400 and the dispensing end 7300 of the needle adapted to enter the vacuum tube and bring the collected blood into the tube. Typically, the needle 7200 may be made of stainless steel, but other materials available nowadays in the industry such as other metals, composites and / or plastics may be used.

[0214] Referring now to FIGs. 14A to 141, the functioning of the device can be described as follows:

[0215] 1. See FIG. 14A: The sampling device 4100 and the vacuum tube 8000 are delivered separately to the user / patient in sterile packaging. The dispensing end 7300 of the needle is sharp so as to be able to pierce the septum 8100 (also sometimes called “rubber stopper”) of the vacuum tube 8000, and is protected by an elastic (preferably silicon or rubber) sleeve 7400. Optionally, the tube holder 6000 is closed by a removable protective film 6110. Optionally, the tube holder 6000 is made of transparent material. Alternatively, optionally, the tube holder 6000 contains a transparent window 6200 for the user / patient to see the inside 6100 of the tube holder 2000. Optionally, the rubber sleeve 7400 is made of a “self-healing” material such as well-known in the industry so that it automatically closes the dispensing end of the needle 7300 after use.

[0216] 2. See FIG. 14B: The user / patient removes the optional protective film 6110, and inserts the vacuum tube 8000 in the tube holder 6000, the septum 8100 of the vacuum tube 8000 facing the dispensing end 7300 of the needle, until reaching the bottom 2120 of the inside 6100 of the tube holder 6000. See FIG. 14C: When reaching the bottom 6120 of the inside 6100 of the tube holder 6000, the vacuum tube 8000 compresses the rubber sleeve 7400, stripping the dispensing end of the needle 7300, allowing the dispensing end of the needle 7300 to pierce the septum 8100 of the vacuum tube 8000 and establishing an airtight connection from the vacuum tube 8000 to the suction chamber 5400 via the needle 7200. As a result, the suction chamber 5400 is placed under vacuum. See FIG. 14D: The user / patient disinfects the area of skin 9000 where the blood collection is to be made, removes the protective film 5140 and applies the device 4100 on the area where the blood collection is to be made. As a result, the device holds and seals against the user / patient’ s skin 9000 thanks to the bandage 5120 and the glue 5110 and 5130. See FIG. 14E: The user / patient actuates the mechanism 5300 by pushing the one or more push-button(s) 5200. The mechanism then actuates the mechanical finger 5350 and releases the one or more cutting blade(s) 5450. The one or more cutting blade(s) 5450 cut(s) through the membrane 5420 and the user / patient’ s skin 9000, lacerating through several capillaries in the patient’s skin 9000, and allowing the vacuum to access the user / patient’ s skin 9000. See FIG. 14F: After having lacerated the membrane 5420 and the user / patient’ s skin 9000, the one or more cutting blade(s) 5450 terminate(s) its / their movement in a recessed area of the suction chamber 5400 out of the wound area 9100, its / their sharp edges out of the reach of the user / patient. As the wound 9100 starts bleeding, the suction chamber 5400 is progressively filled with the user / patient’ s blood 10000. See FIG. 14G: The blood 10000 fills the vacuum tube 8000 through the suction end 7100 of the needle 7200, through the needle 7200, through the dispensing end of the needle 7300. See FIG. 14H: When the vacuum tube 8000 is sufficiently filled with blood 10000, the user / patient removes the vacuum tube 8000 from the device. Indication that the vacuum tube is sufficiently filled may be provided through an electronic or mechanical timer integrated in the mechanism 5300, through a graduation on the vacuum tube which the user / patient can see through the transparent tube holder 6000, through a magnetic or capacitance-sensitive strip that is in contact with the blood, or through the transparent window 6200, or by the observation of the stopping of the blood flow when the vacuum has been exhausted, or by any other appropriate means. As the vacuum tube is removed from the tube holder 6000, the elastic sleeve 7400 is free to extend and cover the dispensing end of the needle 7300, closing the path for the blood 10000. Optionally, the user / patient inserts a further vacuum tube to collect a further blood sample, repeating steps 7 and 8. See FIG. 141: The user / patient removes the device 4100 and applies a typically separately purchased, small-wounds bandage 9200 on the wound 9100. The blood remaining in the suction chamber 5400 is retained in the suction chamber 5400 by the membrane 5420. In case of the need for a quick on-site analysis, a few drops of the blood contained in the suction chamber 5400 can be obtained by pressing on the membrane 5420. Optionally, a second mechanism (not represented) integrated in the structure 5000 provides the means to expel a small quantity of blood by squeezing the elastic lining 5410 upon pressing a push-button. User sends or brings the tube 8000 to a medical analysis lab or to a point of care to be analyzed. The user / patient’ s own refrigerator and, optionally, a container with high thermal inertia such as that described in US application no. US63 / 002,581, or US63 / 006,337, the contents of which are incorporated herein by reference and relied upon, or a container with high thermal inertia and / or thermal insulation optionally equipped with temperature monitoring and / or signaling, may also be used to facilitate the delivery of a suitable sample to a laboratory. The analysis lab analyzes the blood sample and communicates the test results to the patient and / or to the relevant authorities. Optionally, treatment and / or quarantine protocol is initiated to ensure that a test subject having a positive test is handled in a manner to minimize the spread of the pathogen. Referring now to FIGs. 15A-15C, a second embodiment of the cutting blade(s) 5450 is made of a single part, typically out of stamped sheet metal or spring steel, but may be also made of other materials, including composite materials presenting the appropriate mechanical properties. The cutting blade has an end 5460 facing the sampling device structure 5000 so that it can be attached to it, followed by an elastic zone 5458 which is bent elastically when the cutting blade is ready to be used. In this way, the cutting blade 5450 contains all the energy necessary for its movement. The elastic zone 5458 has an appropriate, preferably flat cross-section so as to provide a preferred release trajectory perpendicular to its attachment end 5460.

[0217] Referring now to FIGs. 16A to 16F, a third embodiment of the cutting blade 5456, formed so as to be made in a different and advantageous manner, is shown. In the above two embodiments of the cutting blade 302, 5456, the release trajectory is illustrated by a bent arrow in FIG. 15B and FIG.16E. In one embodiment, after the elastic zone 5458, the cutting blade is twisted by 90° in the area 5456 so as to provide a blade 5452 which is in the same plane as the release trajectory.

[0218] Referring now to FIG. 17, in another embodiment, the elastic zone may take the form of a multitum torsion spring, such as can be found in pegs. In such case, the cross-section of the blade is round and the varying stiffnesses necessary for the function are obtained by variation of the thermal treatments of the different zones of the blade. The blade 5452 has a high rigidity in the direction of the release trajectory. Towards the end of the blade 5452, a cutting edge 5454 is provided so as to lacerate the membrane 5420 and the user / pati ent’s skin 9000. After completion of the movement of the cutting blade 5450, the cutting edge 5454 faces the same side as the attachment end 5460, away from the user / pati ent’s reach.

[0219] In another embodiment, the device 4100 may be remotely triggered via a smartphone, optionally, following a face recognition or recognition of a QR code visible on the device. Given the device is glued on the arm, the patient has a hand free to control such remote triggering.

[0220] In still another embodiment, the capillary blood sampling system according the invention includes a patient biometric based authentication system, a device authentication system and a disposable capillary blood sampling device providing a non-medically trained user with the ability to (a) sample a capillary blood, optionally auto-sampling; (b) optionally, using one or more droplet(s) of the sampled capillary blood, to immediately analyze blood; and (c) to provide a standard medical analysis tube filled with a sample of capillary blood for analysis in a point of care or in a medical lab, the device including an interface for a vacuum tube, the vacuum tube providing suction necessary to fill the vacuum tube with the blood.

[0221] Referring now to FIG. 18A and FIG. 18B, the main features of a blood sampling device of the invention are shown. The blood sampling device comprises on its top side a grip 3122, a draw blood button 3120, a collect blood button 3126, a flash window 3130 indicating readiness for collecting blood, a blood collection tube 3132, and wing tabs 3134 for device removal as well as dressing 3136 with backer thereon. The blood sampling device 3100 further comprises blood draw reservoir 3140 with wound seal, removal wing tab 3142 with adhesive backing on and machine-readable codes 3144.

[0222] Referring now to FIG. 19, the body 3110 of the injecting device 3100 contains a mechanism (not shown) that actuates the needle of the invention in the area of the injection location 3125 when the user / patient depresses the “inject” button 3120. Such mechanism is well known in the micromechanics arts, and can contain levers, clips, springs, flexible elements, sliders, gears, cams, etc. The injecting device 3100 may further comprise a safety button 3123.

[0223] The injection device can be any suitable injection device such as those depicted in US patent applications nos. 63 / 114,162, 62 / 864,572, 62 / 511,361, 15 / 524,748, 31 / 040,459, 14 / 235,107, and 16 / 930,383, the contents of which are incorporated by reference and relied upon as important disclosure in the present application.

[0224] Referring now to FIGs. 20A to 20P, a sixth embodiment of the method of using the system of the invention is shown, and the specific features of the user authentication system 1900, of the device authentication system 1902, of the capillary blood sampling device 3100, 4100 and of the adhesive integrated dressing 3174 included in the capillary blood sampling device 3100, 4100 can be deducted.

[0225] FIG. 20A shows step 1 of the sixth embodiment of the method of using the system of the invention. Step 1 comprises: a) loading a dedicated App for use with the invention via scan website or prescription; b) executing a consent form; c) entering demographics information; d) photographing government issued ID or another identification means; and e) taking a selfie for association with the patient and the device as well as the sample taken.

[0226] FIG. 20B shows step 2 of the sixth embodiment of the method of using the system of the invention. Step 2 comprises: a) opening package; b) reading instructions; c) removing contents from package; d) scanning QR code on kit box to launch App and guide; e) checking contents; and f) cleaning phone with sanitary wipe included in kit.

[0227] FIG. 20C shows step 3 of the sixth embodiment of the method of using the system of the invention. The step 3 comprises: a) deploying integrated phone stand in box; b) wiping down phone with included sanitary towelette; and c) washing hands.

[0228] FIG. 20D shows the step 4 of the sixth embodiment of the method of using the system of the invention. Step 4 comprises: a) taking a selfie with phone on stand; b) starting video of self with face and arm in the frame.

[0229] FIG. 20E shows the step 5 of the sixth embodiment of the method of using the system of the invention. Step 5 comprises: a) following App guide (reading text / reviewing figures); b) preparing arm with a warm towel; c) opening alcohol towelette from kit; and d) wiping site on upper arm with alcohol, then letting dry.

[0230] FIG. 20F shows step 6 of the sixth embodiment of the method of using the system of the invention, step 6 comprises: a) removing device from kit packaging; and b) presenting QR code on device and tube to camera on stand.

[0231] FIG. 20G shows step 7 of the sixth embodiment of the method of using the system of the invention. Step 7 comprises: a) removing adhesive backing; and b) adhering device to upper arm.

[0232] FIG. 20H shows step 8 of the sixth embodiment of the method of using the system of the invention. Step 8 comprises: confirming video of self with face device are in the frame.

[0233] FIG. 201 shows the step 9 of the sixth embodiment of the method of using the system of the invention. Step 9 comprises: a) pushing a first button; b) waiting until in flash window an indication is indicated; c) confirm the indication; and d) if no indication is indicated in prescribed time, follow guide to return kit. FIG. 20 J shows the step 10 of the sixth embodiment of the method of using the system of the invention. Step 10 comprises: a) pushing a second button; and b) waiting for timer on App to indicate tube is full with a means of communication progression.

[0234] FIG. 20K shows the step 11 of the sixth embodiment of the method of using the system of the invention. Step 11 comprises: a) pulling on wing tabs to peel the device off the arm; b) leaving dressing on arm; and c) returning device to kit box.

[0235] FIG. 20L shows the step 12 of the sixth embodiment of the method of using the system of the invention. Step 12 comprises: a) removing dressing backer revealing gauze pad and adhesive; and b) folding gauze dressing down over wound.

[0236] FIG. 20M shows the step 13 of the sixth embodiment of the method of using the system of the invention. Step 13 comprises: a) popping out end of vial from device; and b) pulling vial out of device.

[0237] FIG. 20N shows the step 14 of the sixth embodiment of the method of using the system of the invention. Step 14 comprises: a) securing sample vial in biohazard pouch from kit; and b) securing device in separate biohazard pouch from kit.

[0238] FIG. 200 shows the step 15 of the sixth embodiment of the method of using the system of the invention. Step 15 comprises: a) stopping video; b) removing phone from kit stand; c) collapsing phone stand; and d) securing both biohazard pouches in kit box.

[0239] FIG. 20P shows the step 16 of the sixth embodiment of the method of using the system of the invention. Step 16 comprises: a) sealing kit box in return shipping pouch; b) scanning QR code on shipment package; c) mailing package; d) confirming shipment; e) App notifies patient with test results.

[0240] Referring now to FIGs. 21A to 21D, more details about the specific features of the adhesive integrated dressing 3174 included in the capillary blood sampling device 3100 of the invention are shown. The blood sampling device 3100 comprises an adhesive 3150 around wound site separate from the adhesive 3152 on the bottom of the device. The blood sampling device further comprises an adhesive backing 3154 which is removably located on the adhesive 3150, 3152, the adhesive backing 3154 is removed prior to the device being applied to a patient's body. Once the device is placed on a patient's arm, the device may be pulled up 3157 on a wing tab 3156 to peel the device off of the patient's skin after tube 3132 is filled. The adhesive 3150 surrounding the wound site 3162 remains behind on skin with an encompassing features to restrain the blood from flowing out of the exposed site area temporarily. Then, a dressing backer 3164 is peeled off 3165 so as to reveal gauze pad 3166 surrounded by adhesive 3170. The dressing 3174 comprise a dressing tab 3172 without adhesive. The dressing tab 3172 is pullable 3173 to fold the gauze pad onto the wound site and may be affixed to cover the wound.

[0241] As a result, the adhesive integrated dressing 3174 is adapted to ensure the attachment of the blood sampling device 3100 to the patient’s skin, the air-tightness between the patient’s skin and the blood sampling device 3100 during the sampling process, and the dressing of the wound after the sampling process.

[0242] In another embodiment, the vaccine and / or drug injecting device according the invention provides a non-medically trained user with the ability to (a) inj ect vaccines and / or drugs, optionally auto-injecting; (b) a data processing and validating system which is configured to receive data related to the vaccine and / or drug entered by the user / patient through the app, or by the HMO who received it previously (whereby the entry of the data may be performed e.g. manually or by scanning a QR-code); and (c) a system configured for sending to and, optionally, receiving from a network (such as the Internet) data.

[0243] Self-administration may be accomplished with the help of devices such as those described in PCT / US2012 / 048044, PCT / IB2018 / 000559; PCT / IB2013 / 000659; and PCT / IB2020 / 055874, the contents of which is incorporated herein by reference thereto and relied upon.

[0244] As emphasized earlier, the present invention provides means for the injection and administration of vaccines and / or drug by a non-medically trained user, the means being implemented in a vaccine and / or drug injection device. The vaccine and / or drug injection device of the invention may use one or more needle(s) as means to inject the vaccine and / or drug into the user / patient' s body. For the purpose of the present disclosure, the functioning of the vaccine and / or drug injection device of the invention is described as if containing one needle, but it must be understood that the injecting device of the invention may contain more than one needles in order to increase the amount of vaccine and / or drug injected and / or to decrease the injection time. The vaccine and / or drug injecting device according the invention provides a non-medically trained user with the ability to (a) inject vaccines and / or drugs, optionally self-injecting; (b) a data processing and validating system which is configured to receive data related to the vaccine and / or drug entered by the user / patient through the app, or by the HMO who received it previously (whereat the entry of the data may be performed e.g. manually or by scanning a QR-code); and (c) a system configured for sending to and, optionally, receiving from a network (such as the Internet) data.

[0245] The device according to the present invention allows authentication for vaccines and / or drug administration. Therefore, the device according to the present invention comprises means to allow the verification of one or more of the following items:

[0246] 1. The data of the physician or healthcare responsible (MED) for the vaccines / drug administration and his / her (MED) specific approval for the use of the vaccines and / or drug administration to the user / patient. The device according to the present invention is adapted to receive data related to the vaccine and / or drug entered by the user / patient through the app, or by the HMO who received it previously (whereby the entry of the data may be performed e.g. manually or by scanning a QR-code).

[0247] 2. The temperature of the vaccines and / or drug administration from shipment to injection (if required). The device according to the present invention is adapted to handle information from a temperature tracer or reagent paper (typically placed in a shipment box during shipment), optionally GPS tracer (also typically placed in a shipment box during shipment). Optionally, the tracers can be returned to the vaccine and / or drug producer. Related to the device, a timer must be switched on in the app when the user / patient takes the device out of its thermal protection. Warnings have to be given by the system (app and / or device) to the user / patient related with this event.

[0248] 3. Patient safety in case of patient reaction a) immediately at the time of injection (e.g. fainting); and b) after the vaccine (e.g. 15 minutes after the injection). For the aforementioned situation a), the device according to the present invention is adapted to receive from the user / patient an input (e.g. by pushing a physical button or a button in the app), so as to validate that the injection has been given. If there is no validation after a certain time after the patient has initiated the injection, an alarm is triggered to alert the MED, and, optionally, trigger an emergency procedure. For the aforementioned situation b), the system of the present invention is configured to allow the user / patient to confirm (e.g. by pushing a physical button or a button in the app) to the MED that he or she is not in need of emergency aid.

[0249] The main features of a vaccine and / or drug injecting device of the above embodiment of the invention are that the body of the injecting device contains a mechanism that actuates the needle of the invention when the user / patient depresses the “inject” button. Such mechanism is well known in the micromechanics arts, and can contain levers, clips, springs, flexible elements, sliders, gears, cams, etc.

[0250] The injection device can be any suitable injection device such as those depicted in US patent applications nos. 63 / 114,162, 62 / 864,572, 62 / 511,361, 15 / 524,748, 31 / 040,459, 14 / 235,107, and 16 / 930,383, the content of which is incorporated by reference and relied upon as critical disclosure in the present application.

[0251] Capillary blood sampling devices for non-medically trained users of the current art usually create the wound in the patient’s skin by perforation with one or more needles, or even without perforation, which only allows for the collection of relatively small volumes of fluid, typically less than 150pl in 5-10minutes.

[0252] In another embodiment, the present invention provides means for the capillary blood sampling device 10, 1100, 2010, 2210, 3100, 4100 to make a significantly larger cut than what is usually known in existing capillary blood sampling devices, so that a significantly larger amount of blood, typically more than 500pl, preferably 1ml can be collected over a reasonable period of time, typically less than 15 minutes, preferably less than 10 minutes. The capillary blood sampling device of the invention uses one or more cutting blade(s) 1004 (e.g., but not limited to cutting blades 302, 5450, 5456, 3260, 3360, 3460), instead of one or more needle(s), so that the user / patient’ s skin is lacerated instead of punctured. For the purpose of the present disclosure, the functioning of the sampling device of the invention is described assuming it contains one cutting blade, but it must be understood that the sampling device of the invention may contain more than one cutting blade in order to increase the amount of blood collected and / or to decrease the blood collection time. Moreover, the current invention provides cutting solutions that favor a quick healing of the wound after the blood sampling is complete. The purpose of the invention is therefore to create a wound in the user / pati ent’s skin that has an optimal depth for cutting as many capillaries as possible, while avoiding unnecessary wound width and length so that the natural healing of the wound can happen as fast as possible after the blood collection. The ideal cutting depth may vary as function of the patient’s age, gender, ethnical group and / or health condition, as a result several adapted versions of sampling devices may be provided. Typically ideal cutting depth is between 1mm and 2mm.

[0253] Referring now to FIGs. 22A to FIG. 22C, in a fourth embodiment the cutting blade 3260 of a device of the invention is made of a single part, typically out of sheet metal or spring steel, but may be also made of other materials, including composite materials presenting the appropriate mechanical properties. The cutting blade 3260 has an end 3261 facing the sampling device structure so that it can be attached to it, followed by an elastic zone 3262 which is bent elastically when the cutting blade is ready to be used. In this way, the cutting blade 3260 contains all the energy necessary for its movement, and the user / patient only needs to release it by depressing the draw blood button 3120. The elastic zone 3262 has an appropriate, preferably flat cross-section so as to provide a preferred release trajectory perpendicular to its attachment end 3261. In one embodiment, after the elastic zone 3262, the cutting blade is twisted by 90° in the area 3263 so as to provide a blade section 3264 which is in the same plane as the release trajectory. The blade section 3264 has a high rigidity in the direction of the release trajectory.

[0254] Referring now to FIG. 17, the elastic zone may take the form of a multitum torsion spring, such as can be found in clothes pins, in such case the cross-section of the blade is round and the varying stiffnesses necessary for the function are obtained by variation of the thermal treatments of the different zones of the blade. Towards the end of the blade section 3264, a cutting edge 3265 is provided so as the lacerate the user / patient’ s skin 3290. After completion of the movement of the cutting, edge 3265 faces away from the user / patient’ s reach. Optionally the cutting blade 3260 includes a finger 3270 that interacts with the device’s structure elements 3242, 3244, 3246 in order to bias the natural release trajectory 3250 of the cutting blade 3260 when released to obtain a modified trajectory 3240. Typically, the natural release trajectory 3250 of the cutting blade 3260 is substantially circular, elliptical or spiral. As a result, the laceration in the patient’s skin 3290 is substantially circular and with a relatively large radius, and the wound length 3296 is relatively long for a small portion at the desired depth 3292. When elements of the device’s structure 3242, 3244, 3246 interact with the finger 3270 of the cutting blade 3260, the resulting trajectory 3240 of the cutting blade 3260 is modified so that the resulting laceration of the patient’s skin 3290 has a steeper dive and retraction path, resulting in a shorter wound length 3294 for a longer proportion of the wound at the desired depth 3292. The modified trajectory 3240 allows for a larger volume of capillary blood to be collected, for a globally smaller wound, favoring a quicker healing of the wound after the blood collection.

[0255] Referring now to FIG. 22B, as an example, the element of the device’s structure 3242 is made to locally extend the radius of natural release trajectory 3250, and the element of the device’s structure 3244 is made to locally shrink the radius of the natural release trajectory 3250.

[0256] Referring now to FIG. 22C, a further example the element of the device’s structure 3246 is made to locally shrink the radius of natural release trajectory 3250.

[0257] Referring now to FIGs. 23A to FIG. 23B, in a fifth embodiment the cutting blade 3360 of a device of the invention is made of a single part, typically out of sheet metal, but may be also made of other materials, including composite materials presenting the appropriate mechanical properties. The cutting blade 3360 has an end 3361 facing the sampling device structure so that it can be attached to it, followed by an elastic zone 3362 which is twisted elastically when the cutting blade 3360 is ready to be used. In this way, the cutting blade 3360 contains all the energy necessary for its movement, and the user / patient only needs to release it by depressing the draw blood button 3120. The elastic zone 3362 has an appropriate, preferably flat cross-section so as to provide a preferred, planar natural release trajectory 3350. In one embodiment, after the elastic zone 3362, the cutting blade is twisted by 90° in the area 3363 so as to provide a blade section 3364 which is in the same plane as the release trajectory. The blade section 3364 has a high rigidity in the direction of the release trajectory. Towards the end of the blade section 3364, a cutting edge 3365 is provided so as to lacerate the user / patient’ s skin (not represented). After completion of the movement, the cutting edge 3365 faces away from the user / patient’ s reach. Optionally, the cutting blade 3360 includes a finger 3370 that interacts with the device’s structure element 3342, in order to bias the natural release trajectory 3350 of the cutting blade 3360 when released, generating a modified release trajectory 3340.

[0258] Typically the natural release trajectory 3350 of the cutting blade 3360 is substantially circular or spiral. As a result, the laceration in the patient’s skin is substantially circular and with a relatively large radius, and the wound length is relatively long for a relatively small portion at the desired depth. When an element of the device’s structure 3342 interacts with the finger 3370, the resulting trajectory 3340 of the cutting blade 3360 can be modified so that the resulting laceration of the patient’s skin has a steeper dive and retraction path, resulting in a shorter wound length, and a longer proportion of the wound at the desired depth. The modified trajectory 3340 allows for a larger amount of blood volume to be collected, for a generally smaller wound, favoring a quicker healing of the wound after the blood collection. As an example, the element of the device’s structure 3342 is made to shrink locally the radius 3352 of the natural release trajectory 3350 by an offset 3341 on a part of the release trajectory 3340. In addition, the element of the device’s structure 3342 can be made with a more complex shape so as to provide a more elaborated modified trajectory 3340.

[0259] Referring now to FIGs. 24A to FIG. 24C, in a sixth embodiment the cutting blade 3460 of a device of the invention is made of a single part, typically out of sheet metal, but may be also made of other materials, including composite materials presenting the appropriate mechanical properties. Referring now to FIG. 24A, the cutting blade 3460 has a rotative attachment 3466 to the device’s structure and a cutting edge 3465, which is kept in retracted position prior to the cutting process.

[0260] Referring now to FIG. 24B, when actuated the cutting blade 3460 engages into the patient’s skin 3490 in a rotative movement, but the rotative movement is limited by the structure so that the patient’s skin is not completely lacerated.

[0261] Referring now to FIG. 24C, after the laceration the cutting blade 3460 is retracted in reverse rotative movement, leaving a wound under the patient’s skin that is much smaller than if the laceration had been made completely. As a result, a larger amount of blood volume can be collected thanks to the deep laceration, but at the surface of the patient’s skin 490, the opening is smaller, favoring a quicker healing of the wound after the blood collection.

[0262] Referring now to FIG. 25A to FIG. 25D, in a fifth embodiment the cutting blade 3660 of a device of the invention may be a standard scalpel blade or any other rigid blade, typically out of sheet metal, but may be also made of other materials, including composite materials presenting the appropriate mechanical properties. The cutting blade 3660 has a cutting edge 3665, positioned substantially parallel to the skin of the user / patient 3690. The cutting blade is guided in a linear movement by the device’s mechanism (not shown) in order to penetrate the user / patient’ s skin at a substantially non-orthogonal angle (FIG. 25B). In this way, the cutting edge 3665 penetrates completely in the skin of the user / patient, reaching a substantially uniform depth along all its length, creating a substantially rectangular wound, oriented non-orthogonally in the user / patient’ s skin (FIG. 25C). When the cutting blade is retracted (FIG. 25D), the flap generated by the non- orthogonal wound closes naturally the wound’s entrance, favoring a quicker healing of the wound after the blood collection.

[0263] In another embodiment, the invention provides for verification of self-administered medical processes. An objective of this embodiment is to make sure the user / patient is identified: - For blood sampling: to make sure the blood in the sampling tube(s) is the blood of this patient -For injection: to make sure the injection is made in this patient.

[0264] What may be at stake here is:

[0265] For blood sampling

[0266] • Reliable blood sampling;

[0267] • Authorization to work, to travel, to be in contact with family in times of epidemics;

[0268] • Authorization to use a certain treatment;

[0269] • Automatized detection of epidemics by large-scale sampling programs;

[0270] • Verification of the efficiency of a given treatment (payment subject to treatment success);

[0271] For Injections: authorization to work, to travel, to be in contact with family after a vaccine / treatment has been taken may be at stake. In addition, keeping personal immunization record up to date and automatized monitoring of large-scale vaccination programs is at stake. Still further, payment of a treatment may be at stake, contingent on vaccination and only if fully administered. Therefore, making a secure patient & process verification is crucial.

[0272] In another aspect, verification of self-administered medical processes is important. For example, use of a smartphone application may be made in order to make a video (or a time-lapse) where the patient's face as well as the process itself are visible in the video all along the process duration. A comparison of the patient's ID with the patient's face may be made. The patient's face recognition and whole process may be observed. The system could be configured to launch the process only when all ID's are confirmed. Automatized handling of the logistics (sampling tube collection & transport, treatment re-supply, etc.) may be implemented. In the case that the smartphone app is configured to analyze the video in real-time, step-by-step instructions may be provided to the patient in real-time, while the process is being executed. Other features could be included such as automated monitoring of process performance. Despite the potential, there will always be challenges to deal with, particularly in degraded conditions, when dealing with insufficient network coverage at the moment of running the process. Optionally, temporary network coverage may be provided via drones / balloons for the duration of the treatment campaign. It would be best however, if the App is able to run independently of network coverage. Saving all data on the smartphone and making verifications at a later stage may also be desirable. Respecting private data regulations is an issue of course. The App may be configured to run a first analysis and then an encryption routine to make private data unreadable, with full video optionally saved for later use in case of need ( e.g. formal proof in a court).

[0273] All of these aspects are also appliable to the method described hereinafter in FIGs. 39-41.

[0274] Main components of the system include a smartphone or laptop / computer or similar and camera (may be included in the smartphone / laptop / computer), the application to be run by the smartphone or laptop / computer; the device for running the injection / sampling process, which may be re-usable. In addition, the treatment to be injected I one or more empty tubes / vials to contain the collected blood sample(s) (may be under vacuum). As for some key features of the system of the invention, the app must be able to read treatment container / sampling tube's unique ID using for example a standard bar-code / QR-code. The App must be able to identify key process steps. The device may need to include automatized wireless signal emission (information: ID / process started I process ongoing / process finished / error). Such signal may be visible (e.g. blinking / colored LEDs) for easy interpretation in the video. The device of the invention may optionally include visible features / landmarks for easier orientation verification in the video. The App should be able to launch the treatment process. The device is optionally equipped with remote triggering feature and advantageously includes a unique ID. All of these aspects are also appliable to the method described hereinafter in FIGs. 39-42.

[0275] Referring now to FIG. 26A to FIG. 26C, visible features 2600 integrated in the device 2610 of the invention that can be recognized easily may optionally take the form of the combination of different high-contrast patterns 2620, 2630 applied on a mobile part (in this example a button 2650) and visible through a window 2612 only one at a time. As a result, predefined positions of the mobile part (button 2650 in high position in FIG.26B, button 2650 in low position in FIG.26D) can be easily recognized by the human observer, or easily identified by an image analysis software. Colored parts and / or features may also protrude and / or disappear from / in the device at specific steps of the process so as to materialize the completion of the step and be easily recognized by the human observer, or easily identified by an image analysis software.

[0276] The invention also relates to devices allowing for the sampling of capillary blood. In many cases it is preferable to avoid venipuncture to sample blood, be it because the patient’s veins are too fragile, or for comfort reasons, or because trained personnel for phlebotomy are not available in sufficient numbers. In the present disclosure the description of the body fluid sampling device is described in particular for the case of sampling capillary blood, but the same invention can also be used for the sampling of other body fluids, such as puss or venom.

[0277] The capillary fluid sampling device according to the invention is adapted to be used safely and able to provide the necessary blood samples for analysis devices or analysis systems at the point of care or at a medical laboratory. The capillary blood collection device can, using a single laceration or puncture system at a single location, collect one or ideally successively multiple blood samples of at least 500pl per sample per tube, in one or ideally in multiple standard tubes for the purpose of performing blood tests, using vacuum from a vacuum tube or several vacuum tubes or from an external vacuum source.

[0278] In a further embodiment, the fluid sampling device includes an analysis arrangement, whereby the analysis arrangement is adapted to analyze the body fluid. Optionally the tube interface is connectable to the analysis arrangement.

[0279] A further embodiment of the fluid sampling device comprises a heating element which is attachable to the skin in the vicinity of an area, wherein the body fluid is drawn from the body. This simplifies the operability of the disposable fluid sampling device. Therefore, the skin of the patient around the position where the body fluid, especially blood, is drawn from the body of the patient, can be heated. That heating widens the blood capillaries in the immediate vicinity of the mentioned position, leading to a higher rate of blood drawable from the body of the person. The heating element may be thin enough to be located between the blood collecting device and the patient’s skin during the blood collection process, preferably between 0.5 mm and 4 mm, more preferably between 1 mm and 3 mm thick.

[0280] Note that the terms body fluid reservoir, fluid reservoir, vacuum tube, sample tube and analysis tube may refer to the same object, depending on the details of the body fluid sampling device of the invention.

[0281] As the sampling device may be used by non-trained users, even in some cases for autosampling, the main parts to be manipulated by the user may be color-coded for easier instructions dispensing and recognition, as mentioned below.

[0282] Referring now to FIGs. 27A to 27C, a first embodiment of a capillary body fluid sampling device comprises (a) a capillary blood sampling device 10 according, for example, to PCT / IB2021 / 000187 and / or PCT / IB2021 / 000580, the contents of which are incorporated herein by reference and relied upon, the capillary blood sampling device 10 being shown mounted against the skin 12 of a patient 14. A flexible tube 16 is disposed between the blood sampling device 10 and a vacuum tube 20, which in operation is inserted in a vacuum tube connector 20’ or an external vacuum source, thereby providing a watertight extraction passage or conduit between the patient’s wound 100 and the sample tube (vacuum tube 20). This arrangement allows for easy insertion / removal of one or more vacuum tubes in a row without risking destabilizing or detaching the blood sampler from the patient’s skin 12.

[0283] The level of vacuum in the vacuum tube or in the external vacuum source is adapted to the need of capillary sampling.

[0284] Referring now to FIG. 28A, a second embodiment of the fluid sampling device 10, which is optionally disposable, optionally includes a heating element 22. Preferably, the heating element 22 has a thickness in a range of about 0.5 to 4 mm, or even more preferably about 1 to 3 mm. The fluid sampling device 10 with the heating element 22 as shown here in a top view. The heating element 22 is disposed to provide heating of the area around the patient’s wound from which the body fluid, preferably blood, is to be drawn. The fluid sampling device is attachable to the skin 12 and so when the skin 12 is heated with the help of the heating element 22, the capillaries are widened, so that more body fluid can be drawn from the body. Note that here, the vacuum source 20 or external vacuum source is optionally directly connected to the fluid sampling device 10 and not via a flexible tube 16.

[0285] Referring now to FIGs. 28B and 28C the fluid sampling device 10 of the second embodiment, which is optionally disposable and comprises the optional heating element 22, is shown in two side views. The heating element 22 is locatable in direct contact to the skin of the patient, i.e. on the side of the patient’s skin. In other words, the heating element 22 is thin enough to be located between the blood collecting device and the patient’s skin during the blood collection process. Such a heating element 22 may contain Capsicum extract, which is derived from chili peppers and helps to increase blood flow by lowering blood pressure and stimulating the release of nitric oxide and other substances that relax and widen the blood vessels, leading to a higher rate of blood drawable from the body of the person. When attached to the skin 12 and heated, the capillaries are widened, so more blood can be drawn from the body. In an aspect of the embodiment, rather than containing any reactive agents which stimulate the skin, a heating element 22 may provide direct external heat for example by means of an exothermic chemical reaction. Such a reaction may be initiated for example by exposing the reactive agent(s) to air. The reactive agent(s) may for example contain iron powder or any other easily oxidizable substance which upon the exposure to air are oxidized and thereby produce heat. The oxidation of the oxidizable substance and hence the initiation of the heating may optionally be initiated by lifting a flap 24 on heating element 22, thereby letting air penetrate into the oxidizable substance.

[0286] In another aspect of the embodiment a heating element 22 may consist of at least two compartments the oxidizable substances in which can separately be exposed to air by successively drawing flaps 24 in order to keep a patient’s skin at an optimal temperature for an extended time in which blood can be drawn during a sampling process. Other exothermic chemical reactions may be used, such as Calcium chloride or Magnesium sulfate dissolution in water, or Sodium Acetate crystallization.

[0287] As mentioned above, the main parts to be manipulated by the user may be color-coded for easier instructions dispensing and recognition. For example, the lever 11 may be colored in yellow and the push-button 9 may be colored in green, while the sampling device itself may be essentially white. It should be understood however that other color codes providing sufficient contrast for the same purpose may be used.

[0288] Referring now to FIG. 29, in a third embodiment of the fluid sampling device 10 for example three body fluid reservoirs 30, 32, 34 are connected to a valve 40 communicating with the wound 100 in the patient’s skin 12 from which the body fluid is to be drawn. The valve 40 may consist of a stopcock. The body fluid 50 drawn from the wound 100 in the patient’s skin 12 can flow into one of the body fluid reservoirs 30, 32, 34 at a time. To control which body fluid reservoir 30, 32, 34 is fed, the valve 40 can be turned. On the left of FIG. 29, the valve is in a position 42, such that only the first fluid reservoir 30 is filled. In the middle of FIG. 29 the valve 40 has been turned to a position 44, such that the second fluid reservoirs 32 is filled. Finally, on the right of FIG. 29 all three reservoirs 30, 32, 34 are filled, after the valve 40 has been turned into position 46. The body fluid reservoirs 30, 32, 34 described in all embodiments here need not be identical and so they may be of different sizes and / or colors. The identifiable first receptacle may contain specific reactants different from the reactants in the other receptacles, permitting certain tests to be carried out on the contents of the first receptacle.

[0289] Referring to FIG. 30, a fourth embodiment of a fluid sampling device 10 comprises two optionally different receptacles. A first receptacle 20 may be smaller receptacle already validated by the FDA for capillary blood sampling, and so is expected to be easier to get through FDA approval. A larger second receptacle 60, connected via a flexible tube 62 adapted to pass through the septum 23 of the first receptacle 20, creates vacuum in the device and in the smaller first receptacle and thereby helps filling the smaller first receptacle 20.

[0290] In all four embodiments of the fluid sampling device 10, the incision or laceration of the skin made for blood sampling is preferably made in a direction parallel to a sample receptacle 20, or parallel to the main length of the conduit 16 or main fluidic passage leading the body fluid to the receptacle. This favors multiple incisions to be made for faster capillary blood sampling.

[0291] Referring now to FIG. 31, steps of a method 700 for sample receptacle 20 removal and / or replacement are shown. In a first step 70, the user presses a color-coded flag actuator such as a green flag 9 of the fluid sampling device 10 to lift up the lever 11 fixing receptacle 20. Pushing the green button 9 disengages the tube 20 from the hollow needle (so that the septum closes) and lifts the lever 11, so that the tube 20 can be removed and replaced by the next tube. The "color- coded flag" aspect of the actuator helps make it easier to spot by the user / patient in case of selfsampling, such as by authentification software such as mentioned in the present invention. In a second step 72, the user removes the receptacle 20. In a third step 74, the user seeks a second receptacle 20. In a fourth step 76, the user installs the next receptacle 20. In a fifth step 78, the user optionally closes the lever 11, thereby fixing the receptacle 20 and pushing out the color- coded flag actuator 9, and so continues the sampling process.

[0292] Referring now to FIG. 32A, an embodiment of a sample receptacle 80 optionally has a size about twice as large as the volume of body fluid, preferably blood, to be collected (e.g. 4 ml tube volume to collect 2 ml of blood). Optionally, the sample receptacle 80 of the embodiment provides a excess vacuum beyond the vacuum level needed to fill the sample receptacle 80 in order to speed up the blood collection process (for example from -0.85 bar to -0.30 bar). The size of the sample receptacle 80 and the amount of excess vacuum are particularly adapted for drawing blood from the capillaries in a patient’s skin, as blood drawn from skin capillaries does not flow as fast as blood drawn from a punctured vein. The vacuum level in the sample receptacle 80 may differ from the standard phlebotomy norm, given its larger volume, depending on the volume of blood to be collected and / or on the sensitivity of a patient to suction pressure.

[0293] Optionally, the interior of the sample receptacle 80 has a coating 82 to avoid blood coagulation (for example a heparin coating or or a similar coating). The sample receptacle 80 may also contain additives 84 and / or a separation gel 86 for the conservation / transport of blood cells separate from the plasma.

[0294] Referring now again to FIG. 32A the sample receptacle 80 is typically closed by a cap or stopper 88. Optionally the cap 88 may be provided with a tamper evident feature (TEF) 89 (additional feature to ensure blood is the one of the user) may advantageously be provided. With such a feature 89, only a laboratory may open the sample receptacle. The laboratory can check if the tube was tampered with prior to testing its contents. The TEF 89 also marks the tube 80 with a mark 87 during blood collection process, which shows that this tube has already been in use.

[0295] Referring now to FIG. 32B, various anti -tampering features are useful for blood collection or body fluid collection at home. Such anti-tampering features include, for example, a plastic covering of the tube cap or a tape on the tube to cap junction. In an aspect of the embodiment the body fluid reservoir 20, 80 may include a body 87 made of color changing and / or translucent and / or opaque, and / or thermocromic material such as glass, colored glass, PET, colored PET, PET charged with thermochromic dyes. Therefore, the color of the body fluid seen by the user may be different or even very different from the original color of the body fluid. The user may therefor see that the body fluid reservoir is filling, but because the color is no longer dark red, the non-dark-red color decreases the visual discomfort for people with blood phobia (a.k.a. hemophobia or hematophobia). Alternatively or additionally, the body fluid sampling device may contain an additive adapted to get in contact with the body fluid to be stored within the body fluid reservoirs so as to change the color of the body fluid without affecting its parameters or characteristics which are measured later on. Furthermore, instead of containing an additive which changes the color of the body fluid, the body fluid sampling device may comprise means present on the outside of the body fluid reservoirs which just seem to change the color of the body fluid without really changing it. Such a means may for example consist of a layer of cholesteric liquid crystal on the outside of the fluid reservoir, such liquid crystal changing color upon the filling of the fluid reservoir with warm body fluid.

[0296] The amount of any eventual additives present in the body fluid reservoir for capillary sampling is adapted to the amount of body fluid 50 to be collected (0.5-1.5ml).

[0297] Referring now to FIG. 33, in an aspect of the embodiment of a sample receptacle 80, a vent 90 may optionally provide to release any remaining vacuum after blood sampling, thereby reducing the risk of hemolysis during conservation or transport. The vent 90 can be pulled axially away from the cap 88’, such as to separate a vent surface 92 from a corresponding cap surface 94, thereby releasing any remaining vacuum through a passageway 96 in the vent 90. A knob 91 can be grasped by the user with her / his fingers in order to pull the vent 90, separating surfaces 92, 94 and thereby release the remaining vacuum. Referring now to FIG. 34, a wound 100 for blood collection example in a patient’s upper arm 12 may consist of at least one incision or laceration 102, 104 formed parallel to the direction of blood collection / sample receptacle, or parallel to the main length of the conduit 16 or main fluidic passage leading the body fluid to the receptacle. The laceration in the direction of blood collection is particularly advantageous when more than one incision 102, 104 is to be made for faster capillary blood flow, because in case of laceration perpendicular to the direction of the blood flow, blood flowing from the upper incision would flow over the lower incision.

[0298] Method of use

[0299] 1. FIG.27A: The user installs the fluid sampling device 10 on the patient’s skin 12 with an adhesive pad (such as a a thin heating element 22 but one which does not need to be heated). Any other appropriate means known in the industry may be used to install the fluid sampling device 10. It may for example simply be held or pressed against the skin by the patient himself or by a third person)

[0300] 2. The user triggers the skin incision or laceration

[0301] 3. FIG.27B: The user inserts a vacuum source 20 into the connector 20’ (irrespective of being connected to the device via a flexible tube 16) (N.B: steps 2 and 3 may also be executed in the reverse order)

[0302] 4. FIG.27C: The vacuum tube 20 is filling with the body fluid 50, typically with blood.

[0303] 5. The user removes the vacuum source 20

[0304] 6. Optionally the user inserts a second vacuum source 20, repeating steps 4 to 6 as many times as necessary

[0305] 7. The user removes the device 10 from the patient’s skin 12, and cleans and dresses the wound

[0306] 8. The user sends the sample tube(s) 20 to the laboratory for analyses

[0307] In any of the embodiments mentioned herein, where the sample tube 20 is different from the vacuum tube 60 (FIG.30), the user also changes the sample tube when he changes the vacuum tube. In any of the embodiments mentioned herein, where there is more than one sample tube 30, 32, 34 connected to the sampling device 10 and the vacuum source is more than one vacuum tube (a combination of FIG.29 and FIG.30), the user may change the vacuum tube 60 to have a fresh vacuum tube to fill each sample tubes (30, 32, 34), even without the need of a valve when the tubes are swapped in a certain order. If a valve were to be used, it would be advantageously placed at the T-junction between tubes 112 and 116.

[0308] Referring now to FIGs. 35A, the fluid sampling device 10 includes a connector 114 connected to the device 10 via a flexible tube 112 to receive the blood collection / sample receptacle, and a conduit 116 to connect the receptacle to a vacuum source, as usually available in medical centers. In such configurations, the user can connect sequentially several receptacles to the connector 114, thereby providing more than one receptacle containing a blood sample.

[0309] Referring now to FIGs. 35B, the fluid sampling device 10 includes a connector 114 connected to the device 10 via a flexible tube 112 to receive the blood collection / sample receptacle, and a second connector 118 connected to the receptacle via a conduit 116 to connect to a vacuum tube 20. In such configurations, after the fluid sampling device 10 has been installed on the patient’s skin 12, the user executes the following steps:

[0310] 1. In a first step, connecting a first receptacle to the connector 114

[0311] 2. In a second step, connecting a first vacuum tube to the second connector 118.

[0312] 3. In a third step, triggering the skin incision or laceration

[0313] (step 3 may also be executed before the first step or before the second step)

[0314] 4. In a fourth step, waiting for the first receptacle to be filled with blood

[0315] 5. In a fifth step, disconnecting the first vacuum tube from the second connector 118

[0316] 6. In a sixth step, disconnecting the first receptacle from the connector 114

[0317] 7. In a seventh step, connecting a second receptacle to the connector 114

[0318] 8. In an eighth step, connecting a second vacuum tube to the second connector 118 9. In a ninth step, repeating steps 4 to 8, respectively steps 4 to 6 until having obtained a sufficient number of receptacles filled with a blood sample.

[0319] Of course a configuration in which a valve is used to connect several receptacles, respectively several vacuum tubes, in a row similar to the configuration described in FIG. 29 may also be used.

[0320] Referring now to FIG. 35C, for both configurations shown in FIG.35A and FIG.35B, the junction between tubes 112 and 116 may resemble externally a T-junction, but the internal configuration details are provided here. Functionally, the junction between tubes 112 and 116 is advantageously made in the connector 114 through the blood sample tube. The connector 114 provides a first connection for the device 10 through the flexible tube 112 into the sample tube 120 via a hollow needle 112.1 able to pierce the septum 124, held in the cap 122 that closes the sample tube 120. The connector 114 also provides a second connection for the vacuum source through the conduit 116 via a hollow needle 116.1 able to pierce the septum 124, held in the cap 122 that closes the sample tube 120. Therefore, when a fresh vacuum tube is inserted into the connector 118, or when the vaccum source is activated directly or via the opening of a valve, the vacuum is established first within the sample tube 120, and then progresses through the flexible tube 112 until the sampling device 10 to provide the necessary suction for collecting the blood into the sample tube 120.

[0321] Specific embodiments of the invention can be summarized belonging to at least one of the following feature sets:

[0322] 1. A disposable fluid sampling device including:

[0323] (a) body fluid sampling means, optionally body fluid sampling means for auto-sampling;

[0324] (b) optionally, analysis means using one or more droplet(s) of the sampled fluid to analyze the fluid; and (c) a means for at least one medical body fluid reservoir, body fluid sample tube or analysis tube, the at least one tube adapted to be filled with a sample of fluid for analysis in a point of care or medical lab, wherein the means includes an interface for at least one vacuum tube or external vacuum source, the vacuum tube or external vacuum source being adapted for providing suction necessary to fill the at least one body fluid sample tube with the fluid.

[0325] 2. The disposable fluid sampling device of feature set 1, wherein a watertight fluid extraction passage or conduit from the patient’s wound to the body fluid sample tube comprises a flexible tube.

[0326] 3. The disposable fluid sampling device of feature set 1, wherein a thin heating element is disposed to provide heating around the area around the patient’s wound from which blood is to be drawn. The thin heating element may have a thickness in a range of about 0.5 to 4 mm, or preferably about 1 to 3 mm. When the sampling device is attached to the skin and heated, the capillaries are therefore widened, so that more blood can be drawn from the body. The vacuum tube or external vacuum source may either directly be connected to the sampling device or via a flexible tube, both providing a watertight fluid extraction passage or conduit from the patient’s wound to the body fluid sample tube.

[0327] 4. The thin heating element of feature set 3, wherein said heating element contains at least one of the following ingredients:

[0328] (a) A Capsicum extract, which is derived from chili peppers and helps to increase blood flow by lowering blood pressure and stimulating the release of nitric oxide and other substances that relax and widen the blood vessels, leading to a higher rate of blood drawable from the body of the person,

[0329] (b) An reactive agent providing an exothermic chemical reaction. The reactive agent may for example contain iron powder or any other easily oxidizable substances which upon the exposure to air are oxidized and thereby produce heat. Other exothermic chemical reactions may be used, such as Calcium chloride or Magnesium sulfate dissolution in water, or Sodium Acetate Crystallization. The exothermic reaction may for example be initiated by pulling a flap by means of which the reactive agent is no longer isolated from the ambient air.

[0330] 5. The disposable fluid sampling device of feature set 1, wherein more than one, for example three tubes are connected to a valve communicating with the patient’s skin from which blood is to be drawn. The valve may consist of a stopcock. The body fluid drawn from the patient’s skin can flow into at least one of the body fluid reservoirs at a time. To control which body fluid reservoir is fed, the valve can be turned. The body fluid reservoirs need not be identical, they may have different sizes and / or colors. The identifiable first tube may contain specific reactants different from the reactants in the other tubes, permitting certain tests to be carried out on the contents of the first tube.

[0331] 6. The disposable fluid sampling device of feature set 1, wherein for example two optionally different tubes are used. A first tube may be a smaller tube already validated by the FDA for capillary blood sampling, and so is expected to be easier to get through FDA approval. A larger tube, connected via a flexible tube adapted to pass through the septum of the first tube, creates vacuum in the device and in the small tube and thereby helps filling the small tube.

[0332] 7. The disposable fluid sampling device of feature set 1, wherein a sample tube optionally has a size about twice as large as the volume of blood to be collected (e.g. 4 ml tube volume to collect 2 ml of blood). Optionally, this sample tube provides a excess vacuum beyond the vacuum level needed for it to be filled in order to speed up the blood collection process (for example from -0.85 bar to -0.30 bar). The size of the sample tube and the amount of excess vacuum are particularly adapted for drawing blood from the capillaries in a patient’s skin, as blood drawn from skin capillaries does not flow as fast as blood drawn from a punctured vein. The vacuum level in the sample tube may differ from the standard phlebotomy norm, given its larger volume, depending on the volume of blood to be collected and / or on the sensitivity of a patient to suction pressure.

[0333] Optionally, the interior of the sample tube has a coating to avoid blood coagulation (for example a heparin coating or or a similar coating). The sample tube may also contain additives and / or a separation gel for the conservation / transport of blood cells separate from the plasma.

[0334] The sample tube is typically closed by a cap or stopper. Optionally the cap may be provided with a tamper evident feature (TEF) (additional feature to ensure blood is the one of the user) may advantageously be provided. With such a feature, only a laboratory may open the sample tube. The laboratory can check if the tube was tampered with prior to testing its contents. The TEF also marks the tube with a mark during blood collection process, which shows that this tube has already been in use. Various anti -tampering features are useful for blood collection or body fluid collection at home. Such anti -tamp ering features include for example a plastic covering of the tube cap or a tape on the tube to cap junction.

[0335] 8. The disposable fluid sampling device of feature set 1, wherein the body fluid reservoir includes a body made of color changing and / or translucent and / or opaque, and / or thermocromic material such as glass, colored glass, PET, colored PET, PET charged with thermocromic dyes. Therefore, the color of the body fluid seen by the user may be different or even very different from the original color of the body fluid. The user may therefor see that the body fluid reservoir is filling, but because the color is no longer dark red, the non-dark-red color decreases the visual discomfort for people with blood phobia (a.k.a. hemophobia or hematophobia). Alternatively or additionally, the body fluid sampling device may contain an additive adapted to get in contact with the body fluid to be stored within the body fluid reservoirs so as to change the color of the body fluid without affecting its parameters or characteristics which are measured later on. Furthermore, instead of containing an additive which changes the color of the body fluid, the body fluid sampling device may comprise means present on the outside of the body fluid reservoirs which just seem to change the color of the body fluid without really changing it. Such a means may for example consist of a layer of cholesteric liquid crystal on the outside of the fluid reservoir, such liquid crystal changing color upon the filling of the fluid reservoir with warm body fluid.

[0336] The amount of any eventual additives present in the body fluid reservoir for capillary sampling is adapted to the amount of body fluid to be collected (0.5-1.5ml).

[0337] 9. The disposable fluid sampling device of feature set 1, wherein a vent provides the release of any remaining vacuum after blood sampling, thereby reducing the risk of hemolysis during conservation or transport. The vent can be pulled axially away from the cap of sample tube, such as to separate a vent surface from a corresponding cap surface, thereby releasing any remaining vacuum through a passageway in the vent. A knob can be grasped by the user with her / his fingers in order to pull the vent, separating vent and cap surfaces and thereby releasing the remaining vacuum.

[0338] 10. A method of capillary blood sampling, optionally self sampling, the method including at least the steps of: a) In a first step, preparing the area of the patient’s arm where the blood sample will be taken, according to the standards of the profession (preheating, shaving, disinfection, etc.) b) In a second step, installing the device on the patient’s arm c) In a third step, triggering the skin laceration d) In a fourth step, inserting a vacuum tube in the connector e) In a fifth step, filling a body fluid sample tube with blood f) In a sixth step, removing the body fluid sample tube g) In a seventh step, removing the device from the patient’s arm h) In an eighth step, cleaning and dressing the wound.

[0339] 11. The method of features set 10 further including the repetition of steps (d), (e), (f) to obtain more than one body fluid sample tube filled with a blood sample. Referring now to FIGs. 36A to 36P, the third embodiment of the device 14000 relies on cutting the user / pati ent’s skin with a separate lacerator and the method follows the schematics of FIG. 35, with a lever 14120 at step I lf. In the third embodiment of the fluid sampling device 14000, the device’s body 14100 contains a mechanism 14200 actuated by the user / patient via a lever 14120, The mechanism 14200 holds the vacuum tube 14400 by a mechanical feature 14420, for example the mechanical feature is the lid of the vacuum tube 14400. The vacuum tube 14400 carries a unique identification tag 14430 that can be read by humans and / or by machine means. The lever 14120 is equipped with a safety feature 14130 to avoid accidental activation, so the device 14000 is provided with the vacuum tube 14400 already in place in the device and step 35a) of the method of FIG. 35 is not necessary. FIGs. 36A to 36H show the fluid sampling device 14000 before use, so the lever 14120 is in open position. After the user / patient has followed the steps until having created the wound, the user / patient sticks the fluid sampling device 14000 over the wound so that the suction opening 14110 of the fluid sampling device 14000 is placed over the wound. In the case of blood sampling the user / patient uses the mechanical features provided by the adhesive pad for accurate positioning, but in case of other usages such as for collecting puss or venom the user / patient places the fluid sampling device 14000 visually. The user / patient can see that the suction opening 14110 of the fluid sampling device 14000 is filling with fluid by looking through the fluid sampling device’s body 14100 that is made of transparent material, or by looking through a transparent window (not shown) provided in the fluid sampling device’s body 14100, or by waiting a predefined duration, this duration may last from a few seconds to several minutes, and may be ensured by a timer integrated in the fluid sampling device 14100, by a timer provided by any electronic device and launched by the user / patient, by a timer included in an app running on the user / patient’ s smartphone monitoring the fluid sampling process. At this point in time the user / patient releases the safety feature 14130 and actuates the lever 14120, mobilizing the mechanism 14200. The mechanism 14200 moves the vacuum tube 14400 towards the fluid sampling device body 14100, impaling the septum 14110 (not shown) of the vacuum tube 14400 on the conduct, connecting the vacuum tube 14000 to the patient’s wound, thereby allowing the collected fluid to flow from the wound to the vacuum tube 14400. Alternatively the mechanism 14200 moves the conduct towards the tube 14400 and pierces the septum 14110 (not shown) of the vacuum tube 14400, connecting the vacuum tube 14000 to the patient’s wound, thereby allowing the collected fluid to flow from the wound to the vacuum tube 14400. The configuration of the fluid sampling device 14000 is made so that the user / patient pushes on the lever 14120 over the localization of the wound so as to not risk unsticking the fluid sampling device 14000 from the patient’s skin. FIGs. 361 to 36P show the fluid sampling device 14000 after the lever 14120 has been pushed.

[0340] Referring now to FIGs. 37A to 37B, an adhesive pad 15000 is provided with at least one mechanical feature that allows for the precise placement of the lacerator and of the fluid sampling device. The adhesive pad 15000 includes an adhesive zone 15100 for its attachment to the patient’s skin, one or more visual target and mechanical features 15200 allowing the precise positioning of the lacerator and of the fluid sampling device, and a dressing part 15300 for covering the wound after the fluid sampling process. The target and mechanical feature(s) 15200 may have the shape of a ridge against which the user / patient can push the lacerator and the fluid sampling device. Before the fluid sampling process starts, the adhesive zone 15100 is covered with backers 15110, the target and mechanical positioning feature(s) 15200 is covered with backers 15210 and the dressing part 15300 with backer 15310. The user / patient removes the respective backers as appropriate in order to follow the fluid sampling process.

[0341] Referring now to FIGs. 38A to 38F, some key steps of the method using the adhesive pad 16100, a lacerator and the fluid sampling device 16200 of the invention to sample blood on the arm 16300 of a patient are shown.

[0342] FIG. 38A illustrates the step of installing the adhesive pad 16100 on the arm 16300 of the patient and exposing the target and mechanical feature 16110.

[0343] FIG. 38B illustrates the step of installing the fluid sampling device 16200 using the target and mechanical feature 16110 over the wound 16310 after it has been cut open with the lacerator.

[0344] FIG. 38C illustrates the step of activating the sampling with the fluid sampling device 16200 by pushing the safety button 16230 and then closing the lever 16240. FIG. 38D illustrates the step of waiting and monitoring the fluid 16400 flowing into the vacuum tube 16250 of the fluid sampling device.

[0345] FIG. 38E illustrates the step of removing the fluid sampling device 16200 after sampling.

[0346] FIG. 38F illustrates the step of dressing the wound 16310 with the adhesive pad 16100.

[0347] A method for sampling body fluid, optionally self sampling, including the following steps: a) in a first step, installing the fluid sampling device on the patient’s arm, the disposable fluid sampling device including a first vacuum source insertable into a vacuum interface; b) in a second step, triggering the skin laceration or incision respectively for lacerating the skin; c) in a third step, inserting a first vacuum source into the vacuum interface; d) in a fourth step, filling a receptacle of the fluid sampling device with a body fluid; and e) in a fifth step, removing the first vacuum source.

[0348] A further embodiment of the method includes a repetition of steps (c), (d), (e) executed for activating a second vacuum source of the fluid sampling device and optionally to fill a second receptacle with a sample of the body fluid.

[0349] Within a further embodiment of the method, a heating element of the body fluid sampling device is activated for a period of time, to keep the patient’s skin at an elevated temperature in order to increase body fluid draw during the sampling process. Preferably the heating element remains activated during the entire sampling process.

[0350] A method of capillary blood sampling, optionally self sampling, the method includes at least the steps of: a) placing an adhesive pad at the intended location for the capillary blood sampling, the adhesive pad including at least one mechanical localization feature and optionally visual indications; b) lacerating the user / pati ent’s skin with a lacerator, thereby opening at least one wound in the user / pati ent’s skin, the lacerator being positioned using the at least one mechanical localization feature of the adhesive pad; c) collecting the patient’s capillary blood with a fluid sampling device, the device being positioned on the at least one wound using the at least one mechanical localization feature of the adhesive pad and the device using vacuum to collect blood from the at least one wound and to fill a sample analysis tube; and d) dressing the at least one wound using a foldable part of the adhesive pad.

[0351] A method of using the fluid sampling device, wherein, in a first step, a test subject is tested for a pathogen, and, if tested positive, in a second step, a treatment and / or quarantine protocol is initiated to ensure that a test subject having a positive test is handled in a manner which helps minimize the spread of the pathogen.

[0352] It is also part of the present invention a method for guiding a user through self-application of a medical device. The method is implemented in an electronic device.

[0353] In some embodiments the electronic device is configured to running, at least partially, a list of instructions. Preferably, the method for guiding a user according to the present invention is processed, at least partially, via a smartphone app or implemented in a smartphone app. The list of instructions, in some embodiments, are recorded on a memory or a database.

[0354] In some other embodiments, not represented, the list of instructions can be stored in a cloud, or a browser, and only partially executed on the electronic device. In this case, the electronic device application is a web-application (web-app).

[0355] In some other embodiments the electronic device application can be integrated into a wearable device, such as a smartphone or a wristband.

[0356] In order to implement the interactive guidance procedure, the following steps are combined into a finite state machine. Each step, depending on its execution status, may trigger the next state of the workflow. At each state, a dedicated set of computer vision algorithms are loaded into a memory and executed onto the video-stream provided by the camera sensor of a smartphone, or an electronic device. In some embodiments the electronic device is an electronic device specifically dedicated to the purposes of the present invention.

[0357] Typically, the smartphone, or the electronic device, is first placed by the user into a stand, on a table in front of the user, at the beginning of the procedure, allowing the positioning in such a way in which the front-camera can view the user’ s face and body parts on which the device needs to be applied and can view the medical device itself. In this way the user and the medical device are within the view of the camera to be captured in one or more image(s).

[0358] Also, in this way the user is able to use both hands to manipulate the medical device.

[0359] And finally, the user can see and hear the visual and audio feedback from the electronic device application (app), to be guided during the positioning of the medical device and the subsequent injection of a drug, or sampling of a body fluid. In fact, according to the invention, real-time instructions and corrective feedback are provided by the app to the user. Real-time instructions and / or corrective feedback are, for example, provided to the user over a screen and / or the built-in speakers of the smartphone.

[0360] Referring now to FIG. 39, a preferred workflow of the method for authenticating and guiding a user through self-application of a medical device, according to the present invention, is represented.

[0361] In a first step the user is authenticated. In particular, during this step it is verified that the patient on the video stream matches the picture provided, for example, on the government-issued identification scanned during patient registration. The biometric recognition of the patient is made for example, by scanning one or more physical properties or behavioral traits of the patient / user.

[0362] Biometric data are, for example, fingerprints, facial scans, voice recognition, iris scans, palm prints, and hand or body parts’ geometry.

[0363] In order to implement such a biometric recognition of the patient (i.e. using some biometric data of the patient) an Al-based recognition model can be advantageously used. Advantageously the Al-based recognition model is an Al-based facial recognition model.

[0364] In preferred embodiments, the Al-based recognition model is adapted for mobile, or smartphone, processor in order to allow a fast execution of the model.

[0365] In some embodiments the Al-based recognition model is a mobile convolutional neural network (CNN) model.

[0366] In some other embodiments, the Al-based recognition model is a biometric recognition model which uses ghost modules for improving the recognition. Ghost modules use a series of inexpensive linear transformations to extract additional feature maps from a set of intrinsic features, allowing for a more comprehensive representation of the underlying information. In some preferred embodiments, the patient / user authentication is performed as a biometrical authentication, preferably as a facial authentication. A preferred algorithm for facial biometrical authentication is GhostFaceNetV2.1. This algorithm provides an accuracy of 0.998667 on the LWF-Dataset reference dataset and is fast enough to allow execution on mobile processor.

[0367] If the biometric authentication of the patient is not successful, the authentication step is performed again, otherwise the tracking of the user is enabled.

[0368] Before or after the authentication of the user, the medical device, or its components, is also authenticated. In this way it is possible to verify the validity, and the integrity, of these components.

[0369] In some embodiments, the authentication of the medical device and / or its components is made by reading or scanning a code - such as a barcode, a QR-code, a micro QR-code, a Unique Device Identifier (UID), or a hologram. Advantageously the code is applied on the medical device and / or its components. Advantageously the camera of the electronic device is used to scan this / those code(s).

[0370] In a preferred embodiment, the Medical Device and its relevant sub-part are authenticated using a ID (GS1-128) and 2D-Barcode Reader (Matrix - ISO / IEC 16022) SDK. This algorithm can be used by the electronic device to scan the UID (Unique Device Identifier) bar-codes printed onto the medical device and / or its relevant sub-parts, such as blood collection tubes or drug holding tubes (in case of an injector). Using the UID, the app (i.e. the electronic device application) can authenticate the device and / or its relevant sub-parts and verify the validity of these components. An example of the algorithm for the device authentication is provided here: https: / / scanbot.io / de / products / barcode-software / 2d-barcode-scanner / udi / .

[0371] If the authentication is not successful, the authentication step is performed again, otherwise the tracking of the device is enabled.

[0372] When the tracking of the user is enabled, it is possible to verify that the patient / user remains positioned within the line of sight of the camera, preferably after having been authenticated.

[0373] Advantageously the tracking of the user is made using an Al-based single Human Pose Estimation algorithm. The output of the pose estimation algorithm is a set of coordinates defining a model of the skeleton of the user. Advantageously the model of the skeleton of the user is displayed on the screen of the electronic device. In a preferred embodiment, the pose estimation algorithm provides the coordinates of some predetermined points of the skeleton of a human, recognized on the user’s images during the real time interaction between the user and the medical device. In this way it is possible to collect data for identifying the posture of the user.

[0374] For example, the pose estimation algorithm can identify the center of the user face and some points of articulation of the arms, such as shoulders, elbows and wrists and connects these points with lines onto the video stream. A representation of the output of a pose estimation algorithm can be seen in FIGs. 40 and 41.

[0375] In some embodiments, for example when the screen of a smartphone is positioned horizontally, the posture of the user is targeted as “correct posture” when the center of the head of the user is in the middle of the screen, and the distance between the shoulders covers between 50% and 75% of the width of the video stream.

[0376] In some embodiments, for example when the screen of a smartphone is positioned vertically, the method according to the present invention may guide the user until the point representing the center of his / her face is on the upper third of the screen’ s height, as shown in FIG. 40.

[0377] In the present invention for “position” and “positioning” must be considered the position in the space of the related object / person. In this regard the orientation of the object is to be considered as an information about the position’s determination of the object. In the case of the patient / user the term “position” can stand also for “posture” and / or for “pose” and viceversa, according to the context.

[0378] In some other embodiments the correct positioning of the patient in front of the camera for having a proper tracking of the patient / user may vary. For example, the pose estimation algorithm can be based on a 2D pose estimation framework. The 2D pose estimation framework can be preferred for a mobile application, in term of speed, size and accuracy. By using a pose estimation algorithm, it is possible to track in real-time the movements of the user and then verify if the instructions are followed by the user in accordance with a predetermined parameter. In a preferred embodiment the algorithm used for the user pose tracking is MobilePose (https: / / github.com / YuliangXiu / MobilePose). The output of the pose estimation is a set of coordinates defining a skeleton of the user on the video stream delivered by the camera sensor. The algorithm model satisfies the requirements in terms of speed, size and accuracy for mobile device execution.

[0379] For example, in certain embodiments, the upper arm needs to be positioned vertically to avoid contraction of the muscles of the shoulder. The tracking of the posture of the user can detect if the arm is positioned vertically within the framework of the camera, or in the real-time captured images.

[0380] If the patient / user is not visible for the camera and / or within the framework defined by the screen of the electronic device, in order to track the user, the method is interrupted and the authentication step of the user is performed again, otherwise the guided positioning of the device is enabled.

[0381] The medical device and components detection and tracking may be implemented using an Al-based Real-Time Object-Detector algorithm (tracking algorithm). The training of the medical device is made using annotated images of the medical device, and or its relevant components, in its state of use.

[0382] The output of the Real-Time Object-Detector algorithm is, for example, represented by a set of coordinates of the smallest possible bounding box that can encapsulate the medical device or its relevant components. This information is used to ensure that the medical device or its relevant components remain in the sight of camera, preferably after authentication. A representation of the output of a Real-Time Object-Detector algorithm is shown in FIG. 41.

[0383] If the medical device, or its relevant components, is no longer detected, no coordinates are returned by tracking techniques.

[0384] If the medical device, or its components, is not visible for the camera and within the framework defined by the screen of the electronic device or are no longer detected, in order to track the medical device or its components, the method is interrupted, and the authentication step of the medical device is performed again. If the coordinates of the medical device or its components are provided, i.e. the output is generated by the Al-based Real-Time Object-Detector algorithm, the guided positioning of the device is enabled.

[0385] In a preferred embodiment the medical device and / or its parts are tracked using an AI- based Object-Detector algorithm. Preferably an Al based Object-Detector algorithm is a YOLO model. The YOLO model is advantageously trained using annotated images of the medical device, and / or its relevant sub-parts, in used state. An example of the YOLO model can be found here: https: / / github.com / Megvii-BaseDetection / YOLOX. The output of this algorithm provides the coordinates of the smallest bounding box surrounding the medical device or its relevant sub-parts. This information is used by the electronic device application (app) to ensure that the medical device, or its relevant sub-parts, remains in the sight of camera after authentication. If the device or its relevant sub-parts get invisible (no coordinate returned by tracker), the app requests the reidentification of the medical device or the relevant sub-part.

[0386] In a preferred embodiment, for the purpose of identifying the detection of the states of the medical device, it is used a trained YOLO model. An example is provided here: https: / / github.com / Megvii-BaseDetection / YOLOX. Training images of the medical device in each state are used to teach the YOLO model to recognize each state. According to the medical devices here described, they display a green colored flag at the top of the device when properly activated. This visual change of the device is detected by the YOLO model during activation.

[0387] The step of guiding the user in positioning the device is advantageously made by comparing the relative position of the medical device as reported by the tracking algorithm and the position of the user skeleton as reported by the human pose estimation algorithm.

[0388] For example, when it is used a vaccine / drug injector, as represented in figures of the present application, the device needs to be placed in the upper third of the upper arm (measured as the distance between the shoulder and the elbow). When it is used a blood sampler as a medical device, the medical device needs to be placed in the middle of the upper arm, between the shoulder and the elbow. By detecting at least one medical device parameter it is possible, for the user, positioning the medical device properly. Advantageously one of the medical device parameters detected is the position of the medical device in the space. The position of the medical device is preferably defined using a reference framework. A reference framework can be represented by the screen of the electronic device or by the position of the patient / user.

[0389] Some feedback are provided to the user in the case the user and / or the medical device is not visible to the camera (i.e. the detection of the patient and the medical device cannot be properly provided). If the patient is not visible by the camera of the electronic device, it is again required the authentication of the user. If the medical device, or its components, is not visible by the camera of the electronic device it is implemented again the authentication of the medical device or its components.

[0390] The resulting geometrical construction of the skeleton of the user and of the medical device, when it is in accordance with a set of predetermined parameters, defines the readiness for injection / sampling, as schematically represented in FIG. 41. Some feedback are provided to the user in the case the position of the device, or of the user itself, is not within a predetermined range of value considered as acceptable for the electronic device application for proceeding further. In this way the position of the patient and / or the medical device is corrected. If the position of the user, or of the medical device, is not correct, the guide positioning step is implemented again, until the user has properly positioned the medical device on his / her body. On this regard, the authentication method comprises the step of detecting the position of the medical device onto the user’s body and verify if this position is within a range of a predetermined positions defined as the “correct positions”.

[0391] Once the correct positioning of the medical device and / or of the user is detected by the electronic device application, the method implemented by the electronic device application requests activation of the medical device by the user. In order to verify this step, the electronic device collects data of the medical device. The procedure for activation varies between medical device types. For example, the activation may be done by pressing a button on the medical device or on the electronic device. In certain embodiments, the electronic device application displays a dedicated visual and / or text instruction to guide the user through the appropriate activation. This instruction may be combined or replaced with recorded voice instructions.

[0392] The electronic device application then enters into the activation detection state. If the position of the medical device or of the user is not within a predetermined range of parameters, the patient is guided again to correct the position of the device or his / her position.

[0393] If the position of the medical device and user are in line with the predetermined range of parameters, it is detected by the electronic device application if the activation of the medical device happened. The correct activation of the medical device may be represented by the recognition of a flag or a hidden part of the medical device that becomes visible only after activation. In this case an Al-based Real-Time Object Detection algorithm can be used to recognize that flag. For example, the algorithm may be trained with annotated images of the medical device in the active state. This supposes that the medical device has moving parts signaling the state change to the user. For example, the medical device may display a green colored flag at the top of the device when properly activated. An example can be represented by the visible features 2600 of FIG. 26A to FIG. 26C. This visual change of the device is detected by the Al-based Real-Time Object Detection algorithm. In other embodiments, a signal or a communication between the medical device and the electronic device can be recognized as a proper flag for confirming the correct activation of the medical device. In this case a Sound Event Detection (SED) algorithm can be used to recognize the flag. In these embodiments the flag is represented by a sound or, otherwise, by a visual and a sound flag together. In a preferred embodiment an AT ST- SED algorithm is used in order to recognize the assembly click delivered by the electronic device’s microphone and produced by the blood-sampling tube when correctly inserted into the medical device. Preferably a machine learning and deep-learning algorithm, or more preferably a convolutional neural networks (CNNs) can be trained and used for detecting the sound event.

[0394] Once the activation state is detected, it is marked the medical procedure as being completed by the user. Because both the medical device and / or its relevant components and the user are still in authenticated states and did not leave the viewing area of the camera, the procedure is considered as authenticated. In this way, this mechanism implements a robust fraud control. An attempt by a user to swap multiple devices or relevant components, or an attempt to swap the user during the procedure, would trigger a re-identification and so a successful fraud attempt can be avoided.

[0395] If the flag is not detected, then the step of request the medical device activation is performed again. If the flag is detected the correct activation of the medical device is confirmed.

[0396] For each task that requests it, a computer vision algorithm, preferably available for mobile architecture, is used.

[0397] In some embodiments, the method according to the present invention comprises a postprocessing step. The post-processing step may comprise the guiding of the user / patient through some medical device-specific post processing sub-steps. This may include the display of the procedure to disassemble the medical device. In the case the medical device is a blood sampler, the post-processing step may comprise the sub-steps of shipping procedure of the medical device or its components to a lab for being analyzed.

[0398] In some embodiments, the medical device can present one or more temperature sensors, to detect the temperature of the medical device, its components, or for detecting the temperature of the drug or the sampled blood, in order to properly implement the method of sample collection or vaccine / drug injection. The data about the temperature of the medical device, its components, and / or the drug or the sampled blood, may be shared with the electronic device and / or the electronic device application, in order to proper guiding the patient / user through the method according to the present invention. For example, as disclosed in connection with the method depicted in FIG. 1C, the medical device is cooled before and / or after use.

[0399] In some embodiments, when the activation of the medical device is confirmed, the sampling and / or injecting process can be automatically executed by the medical device.

[0400] In some embodiments the medical device and / or the electronic device display a timer to enforce the blood drawn time.

[0401] In some embodiments, the data collected by the electronic device, via the electronic device application, may be shared with a health organization in order to verify or trigger further actions of the user or other steps of the method according to the present invention. In this case data shared with the health organization can comprise data associated to a geo-localization of the patient and / or of the sample / drug.

[0402] In some embodiments, the authentication step can be omitted or performed by other devices or processes, as it is represented in FIG. 42. In this case the method according to the present invention is focused on collecting user’s data about his / her posture and guiding him / her through the positioning the medical device onto his / her body until the activation of the medical device is confirmed, so that the sampling or injection process can start.

[0403] The embodiment wherein the authentication step is omitted can be used, for example, for training purposes. In this case authentication is not required. In this embodiment, the camera sensors advantageously can detect the presence of the user, preferably blurring the face of the user in order to keep only a documentation of usage without being able to recognize the user.

[0404] Referring now to FIG. 40, it is shown the screen, for example of an electronic device, in a first configuration of use. The screen represented in the figure shown the capture of an image of the patient 2200 and the model of the skeleton of the patient elaborated by the tracking algorithm. If some parameters fit with some predetermined values, then the position of the patient is considered “correct”, and the other steps of the method can be enabled. In FIG. 40, these parameters are considered the distance between the shoulders of the patient and the position of the face (such as the tip of the note) within the framework of the screen of the electronic device. In particular, it is determined whether the distance between the shoulders of the patient is within a range of a predetermined values, and whether the estimated center of the face is within a predetermined range of values, for example, around the upper third of the video stream. The position of the patient 2200 in front of the camera of the smartphone as shown in FIG. 40 is the “correct” one (i.e. labelled as correct), because it fits those predetermined range of values. Clearly it is just an example of use.

[0405] Referring now to FIG. 41, it shows the tracking of the patient and of the medical device, in order to guide the patient in the correct positioning of the medical device. The position of the medical device is made taking into consideration the model of the skeleton of the patient 2200. A predetermined relative position of the medical device (for example shown as a box or squared line) in respect to the model of the skeleton of the patient defines the correct positioning of the medical device. The patient is guided, with some feedback, to fit the predetermined position of the medical device over his body. The invention may have other uses. For example, it may be applied to another medical treatment other than an injection (the device may be a pills distributor). It may be applied to filling a voting form at home, signing documents, proving one's ID during a teleconference, or taking a remote exam or before being authorized to drive a rental car.

[0406] The invention can be summarized as including the following feature sets:

[0407] 1. A disposable body fluid sampling device providing a non-medically trained user with the functionalities of (a) sampling a body fluid (for example blood), optionally auto-sampling; (b) optionally dispensing one or more droplet(s) of the sampled fluid for immediate analyses; and (c) providing a sample containment chamber filled with a sample of body fluid (for example blood) for analysis in a medical lab.

[0408] 2. The disposable body fluid sampling device of feature set 1, wherein the sample containment chamber is a standard medical analysis tube.

[0409] 3. A method using the body fluid sampling device of feature set 1, wherein, if the test subject tests positive for a pathogen, treatment and / or quarantine protocol is initiated to ensure that a test subject having a positive test is handled in a manner to minimize the spread of the pathogen.

[0410] 4. A method for using the device of feature set 1 to collect and potentially analyze a sample of body fluids, for example blood, while ensuring the identification of the individual from whom the body fluid(s) have been sampled.

[0411] 5. A disposable body fluid sampling device of one of the feature sets 1 or 2, having a sample containment chamber made of a material having a thermal inertia permitting the maintenance of sample temperature over a known period of time. 6. The disposable body fluid sampling device of feature set 5, wherein the thermal inertia is selected to provide a known period of time of storage in an ambient environment sufficient to allow non-refrigerated transport to a collection point.

[0412] 7. The device of the above feature set wherein the known period of time is within a range of 1 hour to 2 hours under normal ambient conditions, and preferably within a range of 1 hour to 6 hours, and more preferably within a range of 1 hour to 8 hours.

[0413] 8. A disposable body fluid sampling device of feature set 5 including a thermally insulating sleeve configured to be manually or automatically triggered to slide over the sample container chamber.

[0414] 9. The disposable body fluid sampling device of the above feature set wherein the thermal inertia is selected to provide a known period of time sufficient to allow non-refrigerated transport to a collection point.

[0415] 10. The device of the above feature set wherein the known period of time is within a range of 1 hour to 2 hours under normal ambient conditions, and preferably within a range of 1 hour to 6 hours, and more preferably within a range of 1 hour to 8 hours.

[0416] 11. A disposable capillary blood sampling device of feature set 1, the device including an interface for and a vacuum tube, the vacuum tube providing suction necessary to fill the vacuum tube with the blood.

[0417] 12. A cutting blade made for making a laceration in the skin of a user / patient for a disposable capillary blood sampling device of feature set 11, wherein the cutting blade construction is made in one piece of material and provides the energy and the guiding for its movement.

[0418] 13. A device and app combination for drug or vaccine injection which provides a non-medically trained user with the ability to perform a self-inj ection adapted to interact with the app connected, preferably in a wireless manner, to the Internet optionally via the Cloud, the app including means to allow for verification of the patient’s ID and / or the particular device used , the combination including at least the following: a) access to data storage adapted to store data of the physician or healthcare responsible (MED) for the vaccines / drug administration and his / her specific approval for the use of the vaccines and / or drug administration to the user / patient, wherein the combination is adapted to receive data related to the vaccine and / or drug entered by the user / patient, or by the HMO who received it previously (whereby the entry of the data may be performed e.g. manually or by scanning a QR-code); b) a recording means adapted to record temperature of the vaccines and / or drug administration from shipment to substantially the time of injection as required; c) patient safety means adapted to be activated in case of patient reaction i) immediately at the time of injection (e.g. fainting); and / or ii) after the vaccine (e.g. 15 minutes after the injection), wherein, for aforementioned situation i), the combination according to the present invention is adapted to receive from the user / patient an input, wherein further, the device is adapted to be shipped in thermal protection and the combination optionally including a temperature tracer or reagent paper (typically placed in a shipment box during shipment), and a GPS tracer (also typically placed in a shipment box during shipment) which tracks storage temperature during shipment.

[0419] 14. The system of feature set 13, wherein the system is adapted to receive input by a user pushing a physical button or a button in the app, such to validate that the injection has been given.

[0420] 15. The system of the above feature set, wherein, if there is no validation after a certain time after the patient has initiated the injection, the system is adapted to trigger an alarm to alert the MED, and, optionally, trigger an emergency procedure. 16. The system of feature set 13, wherein, for the aforementioned situation ii), the system of the present invention is configured to allow the user / patient to confirm (e.g. by pushing a physical button or a button in the app) to the MED that he or she is fine.

[0421] 17. The system of any one of the feature sets 13 - 16, wherein the tracers are adapted to be returned to the vaccine and / or drug producer.

[0422] 18. The system of feature set 13, wherein a timer is provided in the app which is configured to be switched on in the app when the user / patient takes the device out of its thermal protection, wherein warnings have to be given by the combination to the user / patient related with this event.

[0423] 19. A device for capillary blood sampling provides a non-medically trained user with the ability to sample capillary blood, optionally analyze blood using an analysis device, and fill a sample tube with the blood, the device including:

[0424] (a) a sampling mechanism for sampling capillary blood, optionally auto-sampling;

[0425] (b) optionally, the analysis device, which using one or more droplet(s) of the sampled capillary blood, is configured to immediately analyze the blood; and

[0426] (c) a filling mechanism which is configured to fill a standard medical analysis tube with a sample of capillary blood for analysis in a point of care or medical lab, wherein the device including a vacuum tube and an interface therefor, the vacuum tube providing suction necessary to fill the vacuum tube with the blood.

[0427] 20. A device according to one of feature sets 1-11 or 19, containing one or more cutting blades for lacerating the user / patient’ s skin.

[0428] 21. A device according to the feature set 20, wherein the one or more cutting blades are cutting blades wherein the trajectory of which is configured to be substantially non-circular as it passes through the patient’s skin, providing a wound shape that optimizes the number of capillaries cut and favoring the quick healing of the wound after blood collection. 22. A device according to one of the feature sets 19 - 21, containing one or more cutting blades where the trajectory of the one or more cutting blades is configured to be substantially non- orthogonal in the patient’s skin, providing a wound shape that optimizes the number of capillaries cut and favoring the quick healing of the wound after blood collection.

[0429] 23. A device according to the feature set 22, where the trajectory of the one or more cutting blades is configured to have a limited rotation, cutting the skin essentially below its surface.

[0430] 24. A device according to the feature set 22, where the trajectory of the one or more cutting blades is configured to have a substantially linear movement, substantially non-orthogonal to the user / pati ent’s skin.

[0431] 25. A method for capillary blood sampling providing a non-medically trained user with the ability to sample capillary blood, analyze blood and fill a sample tube with the blood, the method including the steps of:

[0432] (a) using the device of any one of feature sets 1, 4-11, 13-14, sampling capillary blood, optionally auto-sampling the blood;

[0433] (b) optionally, using one or more droplet(s) of the sampled capillary blood, immediately analyzing the blood and reading characteristics such as blood type; and

[0434] (c) filling a sample containment chamber with a sample of capillary blood for analysis in a point of care or medical lab.

[0435] 26. The method of feature set 25, wherein the sample containment chamber is a standard medical analysis tube.

[0436] 27. A method using the capillary blood sampling device of any one of feature sets 1 to 7, wherein, if the test subject tests positive for a pathogen, a treatment and / or quarantine protocol is initiated to ensure that a test subject having a positive test is handled in a manner to minimize the spread of the pathogen.

[0437] 28. A method of feature set 25 wherein further the method includes the step of providing the result of the blood sample analysis and wherein the proof provided to the authorities to be used by the authorities to deliver an authorization for the user / patient for certain activities.

[0438] 29. A method of feature set 25, wherein the method includes the step of using the result of the blood sample analysis and the proof provided to release the payment of a treatment.

[0439] 30. A method of mass collection and analysis of an organic sample, the method consisting of collecting organic samples such as body fluid samples without the intervention of medically trained personnel, the method including at least the steps of : a) providing the test subject with a sample device of any one of feature sets 1, 5-11, 13-24 having a unique identifier and instructions; b) providing instructions, the instructions including instructions for placing the device in a refrigerator, to cool the device prior to and / or after taking a blood or other sample; c) taking the sample and associating the sample device’s unique identifier with the test subject; d) transporting the sample to a collection site; e) analyzing the sample to determine a pathogen and the test subject informed of the result.

[0440] 31. A method of mass collection and analysis of an organic sample of feature set 30, the method including the steps of:

[0441] - providing instructions, the instructions including instructions for to taking a blood or other sample;

[0442] - taking the sample and associating the sample device’s unique identifier with the test subject;

[0443] - providing additional instructions, the instructions including optional instructions for placing the device in a refrigerator to cool the device. 32. The method of the above feature set, including the additional step of, if the test subject tests positive for a pathogen indicating a treatment and / or quarantine protocol, to ensure that a test subject having a positive test is handled in a manner to minimize the spread of the pathogen.

[0444] 33. A method of mass collection and analysis of an organic sample, the method consisting of collecting organic samples such as body fluid samples without the intervention of medically trained personnel, the method including at least the steps of: a) providing the test subject with a sample device of any one of feature sets 1, 5-11, 13-24 having a unique identifier and instructions; b) providing the instructions including instructions for to taking a blood or other sample; c) taking the sample and associating the sample device’s unique identifier with the test subject; d) providing further instructions, optionally, the instructions including instructions for placing the device in a refrigerator to cool the device, optionally before step c) when the sample is taken, and further optionally including instructions for sliding an insulating sleeve over a sample containment chamber in the device after the device has reached a temperature within an acceptable temperature range, thus prolonging the time which the sample can be safely stored during transport and before sample analysis of step f); e) transporting the sample to a collection site; f) analyzing the sample to determine a pathogen and the test subject informed of the result.

[0445] 34. A method of mass collection and analysis of an organic sample, the method consisting of collecting organic samples such as body fluid samples without the intervention of medically trained personnel, the method including at least the steps of a) providing the test subject with a sample device of any one of feature sets 1, 5-11, 13-24 having a unique identifier and instructions; b) providing the instructions, optionally, the instructions including instructions for placing the device in a refrigerator, to optionally cool the device prior to and / or after taking a blood or other sample; c) optionally placing the sample device in a refrigerator for an instructed time and following the instructions optionally after step d) when the sample is taken, and further optionally including instructions for sliding an insulating sleeve over a sample containment chamber in the device after the device has reached a temperature within an acceptable temperature range, thus prolonging the time which the sample can be safely stored during transport and before sample analysis of step f); d) taking the sample and associating the sample device’s unique identifier with the test subject; e) transporting the sample to a collection site; f) analyzing the sample to determine a pathogen and the test subject informed of the result.

[0446] 35. The method of the above feature set, including the further step of, if the test subject tests positive for a pathogen, initiating treatment and / or quarantine protocol to ensure that a test subject having a positive test is handled in a manner to minimize the spread of the pathogen, such as by following a quarantine protocol.

[0447] 36. A system able to verify the proper execution of self-administered medical processes such as blood sampling or injection, the system using one of the devices of any one of feature sets 1, 5- 11, or 23-24 including a biometric scanner configured to recognize unique biometric characteristics of the user / patient such as face, scalp, eyes, fingerprints, and a video recorder for recording a video or time-lapse of the process execution.

[0448] 37. The system of feature set 36 in combination with an app running on a smartphone.

[0449] 38. The system of feature set 36 a device identification module adapted to, in real-time, recognize the device executing the blood sampling or injection process.

[0450] 39. The system of feature set 38 a device identification module adapted to, in real-time, analyze the execution of the process by the user / patient and / or by the sampling / inj ection device. 40. The system of feature set 39 including a device identification module adapted to, in realtime, dispense audible and / or visual instructions for the user / patient to run the process correctly.

[0451] 41. The system of feature set 39 including a triggering module configured to wirelessly trigger parts or whole of the sampling or injection process.

[0452] 42. The system of any one of the preceding feature sets 36-41 including a connection mechanism adapted to provide appropriate connectivity to communicate in real-time with health authorities while the process is being run.

[0453] 43. The system of any one of the preceding feature sets 36-42 including a self-contained application running on a smartphone, including the storage of the process execution video or time-lapse in a secure manner in the smartphone for later usage as a proof.

[0454] 44. The system of feature set 33 where the proof provided is adapted for use by the authorities to deliver an authorization for the user / patient for certain activities.

[0455] 45. The system of feature set 33 where the proof provided is adapted for use to release the payment of a treatment.

[0456] 46. A system for capillary blood sampling of any one of feature sets 36-45 includes a patient biometric based authentication system, a device authentication system and a disposable capillary blood sampling device providing a non-medically trained user with the ability to (a) sample a capillary blood, optionally auto-sampling; (b) optionally, using one or more droplet(s) of the sampled capillary blood, to immediately analyze blood; and (c) provide a standard medical analysis tube filled with a sample of capillary blood for analysis in a point of care or medical lab, the device including an interface for and a vacuum tube, the vacuum tube adapted to provide suction necessary to fill the vacuum tube with the blood. 47. A capillary blood sampling system according to feature set 46, wherein the authentication system is adapted to provide real-time recognition of the user / patient and of the device executing the blood sampling process.

[0457] 48. A capillary blood sampling system according to feature set 46, wherein the authentication system includes storage means to store the sampling process execution video or time-lapse in a secure manner for later use as a proof.

[0458] 49. A method using the capillary blood sampling system of any one of the feature sets 36-48, wherein the result of the blood sample analysis and the proof provided are used by the authorities to deliver an authorization for the user / patient for certain activities.

[0459] 50. A method using the capillary blood sampling system of any one of the feature sets 36-48, wherein the result of the blood sample analysis and the proof provided are used to release the payment of a treatment.

[0460] 51. The disposable body fluid sampling device of feature set 1, wherein the device includes an adhesive integrated dressing adapted to (i) ensure the attachment of the blood sampling device to the patient’s skin, (ii) ensure the air-tightness between the patient’s skin and the blood sampling device during the sampling process, and (iii) the dressing of the wound after the sampling process.

[0461] The method for guiding a user through self-application of a medical device according to the invention can be summarized as including the following feature sets:

[0462] 1. A method for guiding a user (2200) through self-application of a medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) via an electronic device application, the electronic device application being at least partially executed by an electronic device (2250) configured to communicate with a camera, the method comprising the following steps: b) collecting data about the user’s posture, wherein the user’s posture is determined by analyzing at least one or more images of the user (2200) using one of the electronic device camera’s sensors; c) detecting at least a medical device parameter, wherein one of the at least a medical device parameter is the position of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) in the space; d) guiding the user (2200) in positioning the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) onto the user’s body; e) detecting the position of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) onto the user’s body and verify if this position is within a range of a predetermined position defined as the correct position; f) collecting data of the medical device (10; 2010; 2210; 3100; 4100; 14000; 16200) for verifying the activation of the medical device (10; 2010; 2210; 3100; 4100;

[0463] 14000; 16200). The method according to feature 1 further comprising step a) of receiving input data for a biometric authentication of the user (2200), preferably step a) is performed before step b) of collecting data. The method according to the previous feature, wherein the biometric authentication of step a) is based on the comparison between an image of the user taken in real-time by the camera of the electronic device (2250) and a different image of the same user. The method according to any one of the previous features, wherein step b) of collecting data about the user’s posture uses a sequence of images captured in real-time. The method according to any one of the previous features, wherein step b) of collecting data about the user’s posture comprising the usage of an algorithm that, using one or more images captured by the camera of the electronic device (2250), estimates a set of coordinates defining a model of the user’s skeleton. The method according to any one of the previous features, wherein step b) of collecting data about the user’s posture is made using tracking techniques. The method according to the previous feature, wherein the tracking technique comprises at least a computer vision algorithm, preferably configured for mobile architecture. The method according to the previous feature wherein the computer vision algorithm is based on a 2D user’s posture estimation. The method according to any one of the previous features, wherein step b) of collecting data about the user’s posture comprises the sub-step of confirming the position of the user in front of the camera when predetermined parameters are matched. The method according to any one of the previous features, wherein step c) of detecting at least a medical device parameter comprising further the sub-step of:

[0464] - authenticating one or more components of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200). The method according to the preceding feature further comprising the step of:

[0465] - guiding the user (2200) for assembling the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200). The method according to any one of the previous features further comprising the steps of: - informing the user (2200) as how activating the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), and / or

[0466] - guiding the user (2200) in handling the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) after activation. The method according to feature 1, 11 or 12 wherein the step of guiding comprising the sub -steps of:

[0467] - showing one or more instructions to be followed by the user (2200);

[0468] - detecting in real-time if the instruction is accomplished by the user (2200);

[0469] - providing one or more feedback to the user signaling if the instruction is accomplished or not. The method according to the previous feature wherein the sub-step of detecting in realtime if the instruction is accomplished by the user (2200) comprising the phases of:

[0470] - comparing the relative position of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) as recorded during step e) of detecting the position of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) and the position of the user (2200), preferably as estimated by an algorithm that estimates a set of coordinates defining a model of the user’s skeleton. The method according to feature 13 wherein the one or more feedback is:

[0471] - an information displayed over the electronic device (2250) and / or a sound emitted by the electronic device (2250), and / or

[0472] - an information displayed over the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) and / or a sound emitted by the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200). The method according to feature 12 wherein the step of guiding the user (2200) in handling the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) after activation comprising the sub-steps of:

[0473] - detecting the position of the user (2200), the position of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) and / or its components in relation to the position of the user (2200);

[0474] - identifying the user (2200), the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) and / or its components through the capture of one or more images;

[0475] - verifying if the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), and / or its components, and user (2200) are present in at least one image of the one or more images captured in the previous sub-steps. The method according to any one of the previous features further comprising the steps of:

[0476] - automatically activating the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), and / or

[0477] - automatically managing the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) after activation, and / or

[0478] - automatically analyzing a human body fluid collected by the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), preferably immediately after collection of the human body fluid, wherein the human body fluid is preferably blood. The method according to any one of the previous features further comprising the step of:

[0479] - verifying the compatibility of a drug for the user (2200) comparing the drug or its components with at least a predetermined data or parameter associated with the user (2200), and / or - verifying the compatibility of the drug for the user (2200) comparing one or more physical properties of the drug with at least a predetermined data or parameter associated with the drug, and / or

[0480] - verifying the duration of a period of time during two different steps to determine or predict the temperature of the drug and if this temperature is within a predetermined range of value of temperatures. The method according to any one of the previous features further comprising the step of post-processing, after the activation of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), wherein the step of post-processing comprising the sub-steps of:

[0481] - defining a predetermined period for the recovery of the user (2200), and / or

[0482] - guiding the user (2200) to the disassembling procedure of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), and / or

[0483] - showing a list of instructions for preparing a sample of human fluid collected with the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), preferably the instructions are for preparing a sample of human fluid for shipping, transporting and / or storing the sample of human fluid, and / or

[0484] - receiving and showing the result of a lab analysis of a collected human body fluid sample, wherein the human body fluid is preferably blood. The method according to any one of the previous features 2 or 3, wherein the biometric authentication of the user is made using an Al-based recognition model, preferably the biometric authentication of the user is a facial recognition of the user. The method according to the previous feature wherein the Al-based recognition model is a mobile convolutional neural network (CNN) model, and more preferably the Al-based recognition model uses ghost modules. The method of feature 10 wherein the sub-step of authenticating one or more components of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) comprises the step of reading or scanning a code, preferably applied on the medical device or on its components. The method according to any one of the previous features, wherein step e) of detecting the position of the medical device onto the user’s body is made by using an Al-based algorithm, the Al-based algorithm is trained using predefined images of the medical device and / or its components. The method of the previous feature, wherein the training of the Al-based algorithm is made using images of the medical device and / or its components in different states of use. The method according to any one of the previous features, wherein the functions of the electronic device (2250) are split between a first and a second electronic device, and wherein the second electronic device is a wearable device. An electronic device (2250) comprising a camera wherein the electronic device is configured to carry out the method according to any one of the previous features 1-25. A system which provides a non-medically trained user with the ability to perform a selfinjection or a self-sampling, the system comprising:

[0485] - a medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) configured for self-injection of a vaccine or drug, or for self-collection of a human fluid sampling, preferably blood sampling;

[0486] - an electronic device (2250) configured to be put in communication with the medical device (3100), wherein the electronic device (2250) carries out the method according to any one of the previous features 1-25;

[0487] - optionally, an adhesive pad (15000) configured to be attached to the user’s skin and to interact with the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) for signaling at least the proper positioning of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200);

[0488] - optionally, a lacerator configured for lacerating the user’ s skin for the collection of a human body fluid sample.

[0489] 28. A medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) comprising an electronic device (2250) configured to carry out the method according to any one of the previous features 1-25.

[0490] 29. The medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) according to the preceding feature 27 or 28 wherein the medical device (10; 1100; 2010; 2210; 3100;

[0491] 4100; 14000; 16200) comprises: a temperature sensor for detecting the temperature of the medical device or of an injected drug or of a collected sample of human body fluid, and

[0492] - a long-range wireless communication device for sending data about the temperature of the medical device or of an injected drug or of a collected sample of human body fluid to a sample collection organization,

[0493] - optionally, an analysis arrangement adapted to analyze the human body fluid.

[0494] Further, the invention should be considered as comprising all possible combinations of every feature described in the instant specification, appended claims, and / or drawing figures which may be considered new, inventive and industrially applicable.

[0495] It should be appreciated that the particular implementations shown and herein described are representative of the invention and its best mode and are not intended to limit the scope of the present invention in any way. As will be appreciated by skilled artisans, the present invention may be embodied as a system, a device, or a method.

[0496] Moreover, the system contemplates the use, sale and / or distribution of any goods, services or information having similar functionality described herein.

[0497] The specification and figures should be considered in an illustrative manner, rather than a restrictive one and all modifications described herein are intended to be included within the scope of the invention claimed. Accordingly, the scope of the invention should be determined by the appended claims (as they currently exist or as later amended or added, and their legal equivalents) rather than by merely the examples described above. Steps recited in any method or process claims, unless otherwise expressly stated, may be executed in any order and are not limited to the specific order presented in any claim. Further, the elements and / or components recited in apparatus claims may be assembled or otherwise functionally configured in a variety of permutations to produce substantially the same result as the present invention. Consequently, the invention should not be interpreted as being limited to the specific configuration recited in the claims.

[0498] Benefits, other advantages and solutions mentioned herein are not to be construed as critical, required or essential features or components of any or all the claims.

[0499] As used herein, the terms "comprises", "comprising", or variations thereof, are intended to refer to a non-exclusive listing of elements, such that any apparatus, process, method, article, or composition of the invention that comprises a list of elements, that does not include only those elements recited, but may also include other elements described in the instant specification. Unless otherwise explicitly stated, the use of the term “consisting” or “consisting of’ or “consisting essentially of’ is not intended to limit the scope of the invention to the enumerated elements named thereafter, unless otherwise indicated. Other combinations and / or modifications of the abovedescribed elements, materials or structures used in the practice of the present invention may be varied or adapted by the skilled artisan to other designs without departing from the general principles of the invention.

[0500] The patents and articles mentioned above are hereby incorporated by reference herein, unless otherwise noted, to the extent that the same are not inconsistent with this disclosure.

[0501] Other characteristics and modes of execution of the invention are described in the appended claims.

[0502] Further, the invention should be considered as comprising all possible combinations of every feature described in the instant specification, appended claims, and / or drawing figures which may be considered new, inventive and industrially applicable.

[0503] Additional features and functionality of the invention are described in the claims appended hereto. Such claims are hereby incorporated in their entirety by reference thereto in this specification and should be considered as part of the application as filed.

[0504] Multiple variations and modification are possible in the embodiments of the invention described here. For example, the cutting blades 1004 can take on any form, not limited to cutting blades 302, 5450, 5456, 3260, 3360, 3460 herein disclosed. Although certain illustrative embodiments of the invention have been shown and described here, a wide range of changes, modifications, and substitutions is contemplated in the foregoing disclosure. While the above description contains many specific details, these should not be construed as limitations on the scope of the invention, but rather exemplify one or another preferred embodiment thereof. In some instances, some features of the present invention may be employed without a corresponding use of the other features. Accordingly, it is appropriate that the foregoing description be construed broadly and understood as being illustrative only, the spirit and scope of the invention being limited only by the claims which ultimately issue in this application.

Claims

What is claimed is:

1. A method for guiding a user (2200) through self-application of a medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) via an electronic device application, the electronic device application being at least partially executed by an electronic device (2250) configured to communicate with a camera, the method comprising the following steps: b) collecting data about the user’s posture, wherein the user’s posture is determined by analyzing at least one or more images of the user (2200) using one of the electronic device camera’s sensors; c) detecting at least a medical device parameter, wherein one of the at least a medical device parameter is the position of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) in the space; d) guiding the user (2200) in positioning the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) onto the user’s body; e) detecting the position of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) onto the user’s body and verify if this position is within a range of a predetermined positions defined as the correct positions; f) collecting data of the medical device (10; 2010; 2210; 3100; 4100; 14000; 16200) for verifying the activation of the medical device (10; 2010; 2210; 3100; 4100; 14000; 16200).

2. The method according to claim 1 further comprising step a) of receiving input data for a biometric authentication of the user (2200), preferably step a) is performed before step b) of collecting data.

3. The method according to the previous claim wherein the biometric authentication of step a) is based on the comparison between an image of the user taken in real-time by the camera of the electronic device (2250) and a different image of the same user.

4. The method according to claim 1 wherein step b) of collecting data about the user’s posture uses a sequence of images captured in real-time.

5. The method according to claim 1 wherein step b) of collecting data about the user’s posture comprising the usage of an algorithm that, using one or more images captured by the camera of the electronic device (2250), estimates a set of coordinates defining a model of the user’s skeleton.

6. The method according to claim 1 wherein step b) of collecting data about the user’s posture is made using tracking techniques.

7. The method according to the previous claim wherein the tracking technique comprises at least a computer vision algorithm, preferably configured for mobile architecture.

8. The method according to the previous claim wherein the computer vision algorithm is based on a 2D user’s posture estimation.

9. The method according to claim 1 wherein step b) of collecting data about the user’s posture comprises the sub-step of confirming the position of the user in front of the camera when predetermined parameters are matched.

10. The method according to claim 1 wherein step c) of detecting at least a medical device parameter comprising further the sub-step of:- authenticating one or more components of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200).

11. The method according to the preceding claim further comprising the step of:- guiding the user (2200) for assembling the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200).

12. The method according to claim 1 further comprising the steps of:- informing the user (2200) as how activating the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), and / or- guiding the user (2200) in handling the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) after activation.

13. The method according to claim 1, 11 or 12 wherein the step of guiding comprising the sub -steps of:- showing one or more instructions to be followed by the user (2200);- detecting in real-time if the instruction is accomplished by the user (2200);- providing one or more feedback to the user signaling if the instruction is accomplished or not.

14. The method according to the previous claim wherein the sub-step of detecting in realtime if the instruction is accomplished by the user (2200) comprising the phases of:- comparing the relative position of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) as recorded during step e) of detecting the position of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) and the position of the user (2200), preferably as estimated by an algorithm that estimates a set of coordinates defining a model of the user’s skeleton.

15. The method according to claim 13 wherein the one or more feedback is:- an information displayed over the electronic device (2250) and / or a sound emitted by the electronic device (2250), and / or- an information displayed over the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) and / or a sound emitted by the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200).

16. The method according to claim 12 wherein the step of guiding the user (2200) in handling the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) after activation comprising the sub-steps of:- detecting the position of the user (2200), the position of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) and / or its components in relation to the position of the user (2200);- identifying the user (2200), the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) and / or its components through the capture of one or more images;- verifying if the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), and / or its components, and user (2200) are present in at least one image of the one or more images captured in the previous sub-steps.

17. The method according to claim 1 further comprising the steps of:- automatically activating the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), and / or- automatically managing the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) after activation, and / or- automatically analyzing a human body fluid collected by the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), preferably immediately after collection of the human body fluid, wherein the human body fluid is preferably blood.

18. The method according to claim 1 further comprising the step of:- verifying the compatibility of a drug for the user (2200) comparing the drug or its components with at least a predetermined data or parameter associated with the user (2200), and / or- verifying the compatibility of the drug for the user (2200) comparing one or more physical properties of the drug with at least a predetermined data or parameter associated with the drug, and / or- verifying the duration of a period of time during two different steps to determine or predict the temperature of the drug and if this temperature is within a predetermined range of value of temperatures.

19. The method according to claim 1 further comprising the step of post-processing, after the activation of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), wherein the step of post-processing comprising the sub-steps of:- defining a predetermined period for the recovery of the user (2200), and / or- guiding the user (2200) to the disassembling procedure of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), and / or- showing a list of instructions for preparing a sample of human fluid collected with the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), preferably the instructions are for preparing a sample of human fluid for shipping, transporting and / or storing the sample of human fluid, and / or- receiving and showing the result of a lab analysis of a collected human body fluid sample, wherein the human body fluid is preferably blood.

20. The method according to claim 2, wherein the biometric authentication of the user is made using an Al-based recognition model, preferably the biometric authentication of the user is a facial recognition of the user.

21. The method according to the previous claim wherein the Al-based recognition model is a mobile convolutional neural network (CNN) model, and more preferably the Al-based recognition model uses ghost modules.

22. The method of claim 10 wherein the sub-step of authenticating one or more components of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) comprises the step of reading or scanning a code, preferably applied on the medical device or on its components.

23. The method of claim 1 wherein step e) of detecting the position of the medical device onto the user’s body is made by using an Al-based algorithm, the Al-based algorithm is trained using predefined images of the medical device and / or its components.

24. The method of the previous claim wherein the training of the Al-based algorithm is made using images of the medical device and / or its components in different states of use.

25. The method of claim 1 wherein the functions of the electronic device (2250) are split between a first and a second electronic device, and wherein the second electronic device is a wearable device.

26. An electronic device (2250) comprising a camera wherein the electronic device is configured to carry out the method according to claim 1.

27. A system which provides a non-medically trained user with the ability to perform a selfinjection or a self-sampling, the system comprising:- a medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) configured for self-injection of a vaccine or drug, or for self-collection of a human fluid sampling, preferably blood sampling;- an electronic device (2250) configured to be put in communication with the medical device (3100), wherein the electronic device (2250) carries out the method according to claim 1;- optionally, an adhesive pad (15000) configured to be attached to the user’s skin and to interact with the medical device (10; 1100; 2010; 2210; 3100; 4100;14000; 16200) for signaling at least the proper positioning of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200);- optionally, a lacerator configured for lacerating the user’ s skin for the collection of a human body fluid sample.

28. A medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) comprising an electronic device (2250) configured to carry out the method according to claim 1.

29. The medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) according to the preceding claim 27 or 28 wherein the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) comprises: a temperature sensor for detecting the temperature of the medical device or of an injected drug or of a collected sample of human body fluid, and- a long-range wireless communication device for sending data about the temperature of the medical device or of an injected drug or of a collected sample of human body fluid to a sample collection organization,- optionally, an analysis arrangement adapted to analyze the human body fluid.

30. A method for authenticating and guiding a patient (2200) through self-application of a medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) via an electronic device application, the electronic device application being at least partially executed by an electronic device (2250) comprising a camera, the method comprising the following steps: a) receiving input data for a biometric authentication of the patient (2200);b) collecting data about the patient posture, wherein the patient posture is determined by analyzing at least one or more images of the patient (2200) using one of the electronic device camera’s sensors; c) detecting at least a medical device parameter, wherein one of the at least a medical device parameter is the position of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) in the space; d) guiding the patient (2200) in positioning the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) onto the patient’s body; e) detecting the position of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) onto the patient’s body and verify if this position is within a range of a predetermined position defined as the correct position; f) collecting data of the medical device (10; 2010; 2210; 3100; 4100; 14000; 16200) for verifying the activation of the medical device (10; 2010; 2210; 3100; 4100; 14000; 16200).

31. The method according to claim 1 wherein the biometric authentication of step a) is based on the comparison between an image of the patient taken in real-time by the camera of the electronic device (2250) and a different image of the same patient.

32. The method according to claim 1 wherein the step b) of collecting data about the patient posture uses a sequence of images captured in real-time.

33. The method according to claim 1 wherein the step b) of collecting data about the patient posture comprising the usage of an algorithm that, using one or more images captured by the camera of the electronic device (2250), estimates a set of coordinates defining a model of the patient’s skeleton.

34. The method according to claim 1 wherein the step b) of collecting data about the patient posture is made using tracking techniques.

35. The method according to the previous claim wherein the tracking technique comprises at least a computer vision algorithm, preferably configured for mobile architecture.

36. The method according to claim 1 wherein the step b) of collecting data about the patient posture comprising the sub-step of confirming the position of the patient in front of the camera when predetermined parameters are matched.

37. The method according to claim 1 wherein the step c) of detecting at least a medical device parameter comprising further the sub-step of:- authenticating one or more components of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200).

38. The method according to the preceding claim further comprising the step of- guiding the patient (2200) for assembling of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200).

39. The method according to claim 1 further comprising the steps of:- informing the patient (2200) as how activating the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), and / or- guiding the patient (2200) in handling the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) after activation.

40. The method according to claim 1, 9 or 10 wherein the step of guiding comprising the substeps of:- showing one or more instructions to be followed by the patient (2200);- detecting in real-time if the instruction is accomplished by the patient (2200);- providing one or more feedback to the patient signaling if the instruction is accomplished or not.

41. The method according to the previous claim wherein the sub-step of detecting in realtime if the instruction is accomplished by the patient (2200) comprising the phases of:- comparing the relative position of the medical device (10; 1100; 2010; 2210;3100; 4100; 14000; 16200) as recorded during the step e) of detecting the position ofthe medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) and the position of the patient (2200), preferably as estimated by an algorithm that estimates a set of coordinates defining a model of the patient’s skeleton.

42. The method according to claim 11 wherein the one or more feedback is an information displayed over the electronic device (2250) and / or a sound emitted by the electronic device (2250).

43. The method according to claim 10 wherein the step of guiding the patient (2200) in handling the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) after activation comprising the sub-steps of:- detecting the position of the patient (2200), the position of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) and / or its components in relation to the position of the patient (2200);- identifying the patient (2200), the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) and / or its components through the capture of one or more images;- verifying if the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000;16200), and / or its components, and patient (2200) are present in at least one image of the one or more images captured in the previous sub-steps.

44. The method according to claim 1 further comprising the steps of:- automatically activating the medical device (10; 1100; 2010; 2210; 3100; 4100;14000; 16200), and / or- automatically managing the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) after activation, and / or- automatically analyzing a human body fluid collected by the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), preferably immediately after collection of the human body fluid, wherein the human body fluid is preferably blood.

45. The method according to claim 1 further comprising the step of:- verifying the compatibility of a drug for the patient (2200) comparing the drug or its components with at least a predetermined data or parameter associated to the patient (2200), and / or- verifying the compatibility of the drug for the patient (2200) comparing one or more physical properties of the drug with at least a predetermined data or parameter associated to the drug, and / or- verifying the duration of a period of time during two different steps to determine or predict the temperature of the drug and if this temperature is within a predetermined range of value of temperatures.

46. The method according to claim 1 further comprising the step of post-processing, after the activation of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), wherein the step of post-processing comprising the sub-steps of:- defining a predetermined period for the recovery of the patient (2200), and / or- guiding the patient (2200) to the disassembling procedure of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), and / or- showing a list of instructions for preparing a sample of human fluid collected with the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200), preferably the instructions are for preparing a sample of human fluid for shipping, transporting and / or storing the sample of human fluid, and / or- receiving and showing the result of a lab analysis of a collected human body fluid sample, wherein the human body fluid is preferably blood.

47. An electronic device (2250) comprising a camera configured to carry out the method according to claim 1.

48. A system which provides a non-medically trained user with the ability to perform a selfinjection or a self-sampling, the system comprising:- a medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) configured for self-inj ection of a vaccine or drug, or for self-collection of a human fluid sampling, preferably blood sampling;- an electronic device (2250) configured to be put in communication with the medical device (3100), wherein the electronic device (2250) carries out the method according to claim 1;- optionally, an adhesive pad (15000) configured to be attached to the user’s skin and to interact with the medical device (10; 1100; 2010; 2210; 3100; 4100;14000; 16200) for signaling at least the proper positioning of the medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200);- optionally, a lacerator configured for lacerating the user’ s skin for the collection of a human body fluid sample.

49. A medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) comprising an electronic device (2250) configured to carry out the method according to claim 1.

50. The medical device (10; 1100; 2010; 2210; 3100; 4100; 14000; 16200) according to claim 19 wherein the medical device comprises: a temperature sensor for detecting the temperature of the medical device or of an injected drug or of a collected sample of human body fluid, and- a long-range wireless communication device for sending data about the temperature of the medical device or of an injected drug or of a collected sample of human body fluid to a sample collection organization,- optionally, an analysis arrangement adapted to analyze the human body fluid.

Images