Patent Publication Number: US-2023138274-A1

Title: Body Fluids Sampling Device and Method of using the Same

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 63/002,581, filed Mar. 31, 2020, entitled BODY FLUIDS SAMPLING DEVICE AND METHOD OF USING THE SAME, No. 63/006,337, filed Apr. 7, 2020, entitled BODY FLUIDS SAMPLING DEVICE AND METHOD OF USING THE SAME, No. 63/025,692, filed May 15, 2020, entitled BODY FLUIDS SAMPLING DEVICE AND METHOD OF USING THE SAME, No. 63/011,010, filed Apr. 16, 2020, entitled BODY FLUIDS SAMPLING METHOD WITH AUTOMATIC USER IDENTIFICATION, No. 63/069,112, filed Aug. 23, 2020, entitled CAPILLARY BLOOD SAMPLING DEVICE AND METHOD OF USING THE SAME, No. 63/114,162, filed Nov. 16, 2020, entitled SELF-MADE MEDICAL PROCESS VERIFICATION SYSTEM, No. 63/142,756, filed Jan. 28, 2021, entitled CAPILLARY BLOOD SAMPLING SYSTEM INCLUDING USER/PATIENT AUTHENTICATION, No. 63/150,113, filed Feb. 17, 2021, entitled CAPILLARY BLOOD SAMPLING DEVICE, and No. 63/153,088, filed Feb. 24, 2021, entitled VACCINE AND/OR DRUG INJECTION AND ADMINISTRATION DEVICE. 
    
    
     COPYRIGHT &amp; LEGAL NOTICE 
     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. 
     BACKGROUND OF THE INVENTION 
     This invention relates to devices allowing for the sampling of body fluids and their transport to an analysis lab without the intervention of medical personnel. 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 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. What is needed therefore is a fluid sampling device adapted to be used by any individual on himself without rigorous medical training, and a method to ensure the authentication of the user/patient and the association between the authenticated user/patient and the body fluid sample, as well as the intact, safe and sanitary transport of the body fluid sample to an analysis lab. 
     SUMMARY OF THE INVENTION 
     A fluid sampling device and methods are provided consisting of collecting body fluid samples such as blood without the intervention of medically trained personnel. The body fluid sampling device optionally advantageously includes an insulating cover or sleeve adapted to slide over the sample container so as to extend the possible transport times. In one embodiment, the isolating cover or sleeve is manually set into place by the user via a tab actuated by the user according to written instructions provided with the device, or automatically slid into 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. 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. 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. Advantageously, the body fluid sampling device according the invention is optionally configured to use standard analysis tubes as well-known in the industry, so that the tubes&#39; content can be analyzed on standard automated analysis equipment. 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. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1 A  is a flowchart of a first embodiment of the method of the invention. 
         FIG.  1 B  is a flowchart of a second embodiment of the method of the invention. 
         FIG.  1 C  is a flowchart of a third embodiment of the method of the invention. 
         FIG.  1 D  is a flowchart of a fourth embodiment of the method of the invention. 
         FIG.  2 A  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. 
         FIG.  2 B  is a perspective view of the internal mechanism of a sampling device according to the invention while in use. 
         FIG.  2 C  is a perspective view of the internal mechanism of a sampling device according to the invention after use. 
         FIG.  3 A  is a side view of the internal mechanism of a sampling device according to the invention before use. 
         FIG.  3 B  is a perspective view showing the internal mechanism of a sampling device according to the invention while in use. 
         FIG.  3 C  is a side view of the internal mechanism of a sampling device according to the invention while in use. 
         FIG.  3 D  is the side view of the internal mechanism of a sampling device according to the invention after use. 
         FIG.  4    is a lower perspective view of the contact surface of a sampling device according to the invention with the user&#39;s skin. 
         FIG.  5    is a perspective view of the internal fluidic channel of a sampling device according to the invention. 
         FIG.  6    is a plan view of a thermal indicator panel according to the invention. 
         FIGS.  7 A- 7 B  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. 
         FIGS.  8 A- 8 B  are cross sectional views showing two stages of movement of the body fluid sampling device of the invention, namely, the step before use ( FIG.  8 A ), and then the step after sampling ( FIG.  8 B ). 
         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. 
         FIGS.  10 A- 10 B  are schematic views of the body fluid sampling device for the collection of capillary blood from the ear lobe. 
         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. 
         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. 
         FIGS.  14 A to  14 I  are partial, cross-sectional views showing the functioning of the device of the invention for use with a standard sample container. 
         FIG.  15 A  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. 
         FIG.  15 B  is side view of the second embodiment of the cutting blade for use in the invention, in a position ready half-way extended. 
         FIG.  15 C  is a top view of the second embodiment of the cutting blade fully extended. 
         FIG.  16 A  is a perspective view of a third embodiment of the cutting blade of the invention, made from a single piece of metal. 
         FIG.  16 B  is a side view of the third embodiment of the cutting blade of the invention. 
         FIG.  16 C  is a front view of the third embodiment of the cutting blade of the invention. 
         FIG.  16 D  is a top view of the third embodiment of the cutting blade of the invention. 
         FIG.  16 E  is a side view of the third embodiment of the cutting blade of the invention, half extended. 
         FIG.  16 F  is a side view of the third embodiment of the cutting blade of the invention, fully extended. 
         FIG.  17    is a multiturn torsion spring that may be used in the elastic zone in a particular embodiment of the invention. 
         FIG.  18 A  is an upper, perspective view of another embodiment of the blood sampling device of the invention. 
         FIG.  18 B  is a lower, perspective view of another embodiment of the blood sampling device of the invention. 
         FIG.  19    is a perspective view of an injection device of the invention. 
         FIGS.  20 A to  20 P  are schematic views illustrating the steps of a sixth embodiment of the method of using the system of the invention. 
         FIGS.  21 A to  21 D  are schematic views with more detail about the specific features of the adhesive integrated dressing included in the capillary blood sampling device. 
         FIG.  22 A  is a perspective view of a fourth embodiment of the cutting blade of a device of the invention is made of a single part. 
         FIG.  22 B  is a side, four-position, shutter view of the fourth embodiment of the cutting blade of a device of the invention. 
         FIG.  22 C  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. 
         FIG.  23 A  is a perspective view of a fifth embodiment of the cutting blade of the invention. 
         FIG.  23 B  is a front view of the fifth embodiment of the cutting blade of the invention. 
         FIG.  24 A  in 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&#39;s body. 
         FIG.  24 B  in side view of the sixth embodiment the cutting blade of a device of the invention half way through its cycle of motion. 
         FIG.  24 C  in 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. 
         FIG.  25 A  is a perspective view of a seventh embodiment the cutting blade of a device of the invention showing a standard scalpel blade. 
         FIG.  25 B  is a side view of the seventh embodiment the cutting blade of a device of the invention, prior to entry into the epidermal layer. 
         FIG.  25 C  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. 
         FIG.  25 D  is a side view of the epidermal layer showing the cut made by the seventh embodiment of the cutting blade. 
         FIG.  26 A  to  FIG.  26 C  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. 
     
    
    
     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 
     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. 
     The body fluid sampling device according 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&#39;s fridge to the fridge of the analysis lab with sufficient margin. The transport of the collected sample from the user&#39;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 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. 
     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 anti-tampering 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. 
     Referring now to  FIG.  1 A , 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&#39;s ID;   d) putting the filled micro-sampler into the patient&#39;s refrigerator, optionally before the first step a) orb) 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&#39;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.  1 B , 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&#39;s ID, and sending the same to a specified recipient by SMS, MIMS, or other email, for example;   iv. storing the filled micro-sampler optionally into the patient&#39;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&#39;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.       

     Referring now to  FIG.  1 C , a third embodiment of the method of the invention comprises the steps:
         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&#39;s ID document, or together with the patient&#39;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.   Step  3 : The user applies the sampling device on his skin/mucosa at the appropriate area.   Step  4 : The user triggers the sampling process, optionally after having cooled the device according to the previously described methods,   Step  5 : The sampling process is executed automatically by the sampling device, in the following sub-steps:   Step  5 . 1 : The actuation spring is released.   Step  5 . 2 : The piston starts sucking to create a vacuum between the user&#39;s skin/mucosa and the sampling device&#39;s contact surface, and the optional cutting blade starts cutting.
           Step  5 . 3 : The optional cutting blade cuts the user&#39;s skin/mucosa.   Step  5 . 4 : The micro-wound starts releasing body fluid.   Step  5 . 5 : Body fluid is sucked into the reservoir.   Step  5 . 6 : The optional cutting blade is retracted.   Step  5 . 7 : The piston reaches its end-stop.   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.   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.   
           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&#39;s ID document, or together with the patient&#39;s face.   Step  7 : Optionally before the sample is taken, the user stores the sampling device in his fridge.   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.   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.   Step  10 : The sample collection organization collects the sampling device and brings it to the analysis lab.   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&#39;s smartphone or by any other appropriate communication means.       

     Capturing the identification of the sampling device (step  1 ) may also be done between steps  5  and  6  (after having run the sampling process) 
     Referring now to  FIG.  1 D , 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  5   b  as follows:
         Step  5   b : The sampling process is executed automatically by the sampling device, in the following sub-steps:
           Step  5   b . 1 : The actuation spring is released.   Step  5   b . 2 : The piston starts sucking to create a vacuum between the user&#39;s skin/mucosa and the sampling device&#39;s contact surface, and the cutting blade starts cutting.   Step  5   b . 3 : The cutting blade cuts the user&#39;s skin/mucosa.   Step  5   b . 4 : The cutting blade is retracted.   Step  5   b . 5 : The micro-wound starts releasing body fluid.   Step  5   b . 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.   Step  5   b . 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.   Step  5   b . 8 : As the micro-wound continues releasing body fluid, the body fluid is sucked into the reservoir.   Step  5   b . 9 : The piston reaches its end-stop.   Step  5   b . 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.   
               

     Referring now to  FIGS.  2 A- 2 C , 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&#39;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. 
     Referring now to  FIG.  2 B , 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&#39;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&#39;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. 
     Referring now to  FIGS.  3 A- 3 D , 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 . 
     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&#39;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. 
     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&#39;s contact surface  100  and at the other end  406  to the inlet  506  of the reservoir  502 . 
     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:
           602 : too warm (for example as long as the sampling device&#39;s temperature is above 8° C.)     604 : soon ready for transport (for example when the sampling device&#39;s temperature is between 5° C. and 7° C.).     606 : ready for transport (for example when the sampling device&#39;s temperature is between 1° C. and 5° C.).     608 : too cold (for example when the sampling device&#39;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.       

     Referring now to  FIGS.  7 A- 7 B , 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. 
     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. 
     The body fluid sampling device according the invention is made to use standard analysis tubes as well-known in the industry, so that the tubes&#39; content can be analyzed on standard automatized analysis equipment. 
     The body fluid sampling device according the invention thereby provides a non-medically trained user, such as the patients themselves, with the main functionalities of: 
     1. sampling a body fluid (for example blood), optionally auto-sampling (self-administered sampling); 
     2. optionally dispensing one or more droplet(s) of the sampled fluid for immediate analyses: and 
     3. providing a standard medical analysis tube filled with a sample of body fluid (for example blood) for analysis in a medical lab. 
     Referring now to  FIG.  8 A- 8 B , an embodiment of body fluid sampling device  1100  is presented as before use ( FIG.  8 A ), and after the sampling ( FIG.  8 B ). 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&#39;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 p 1  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 500 μl, and two or more cutting blades in order to collect 1 ml or more over a duration that is acceptable to the patient. For background information, the duration of blood flow is about 30′ for 500 μl for one incision, so the same time for 1 ml 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.  22 A ), so that it cuts an opening in the patient&#39;s skin to release capillary blood and retracts into the device&#39;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&#39;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 p 2  when the piston p 1  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 p 2  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 p 1  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 p 1  from the plunger-septum p 2 , so that the plunger-septum p 2  can remain engaged in the tube  1007  and keep it tightly closed when it will be released from the device&#39;s structure  8 . The standard medical analysis tube  1007  is held within the devices&#39; structure  1008  for the sampling process and the optional droplet dispensing process. The devices&#39; 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 p 1  must be separated from the plunger-septum p 2 , by, for example, turning the button  1003  to rotate the piston p 1  so that it disengages from the plunger p 2  via, for example, unthreading at threads x. The actuation spring  1012  is maintained within the device&#39;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. 
     The use or operation of the device can be described as follows:
         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 .   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 p 1  when the buttons  1001  and  1002  are pressed by the user. At the same time, it triggers the movement of the cutting blade  1004 .   3. The spring  1012  actuates the piston p 1 , to which the plunger-septum p 2  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.   4. The spring continues to pull the piston p 1 , 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&#39;s structure.   5. The piston p 1  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 μL. with one cutting blade, 1 ml with two cutting blades.   6. The user removes the device from the patient&#39;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 μL, and uses it on an immediate test as available on the market.   8. User uses button  1003  to disconnect piston p 1  from plunger-septum p 2 , so that plunger-septum p 2  remains in the tube  1007  to keep it tightly sealed.   9. User releases the tube  1007  from the device&#39;s structure, upon removing the tube the plunger-septum p 2  disengages from the cannula  1006  and closes.   10. User sends or brings the tube to a medical analyses lab to be analyzed.   11. The analysis lab analyses the blood sample and communicates the test results to the patient and/or to the relevant authorities.   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.       

     In another embodiment, the body fluid sampling device according 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. 
     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 user-patient&#39;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 U.S. 63/002,581 or U.S. 63/006,337 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.  10 A- 10 B , 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&#39;s smartphone  2250  together with the patient&#39;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-patent&#39;s smartphone  2250  may capture and that the application running the user-patent&#39;s smartphone  2250  may analyze and use for reinforcing the device&#39;s identification. The device  2210  includes a wireless communication system to communicate information with the user-patient&#39;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&#39;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&#39;s smartphone  2250 , as well as the communication between the user-patient&#39;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&#39;s identification are communicated to the relevant authority for further processing. 
     Referring now to  FIG.  11   , a fifth method for sampling body fluids and ensuring the identification of the user-patient includes the steps of:
         1. User installing a specific application on his or her smartphone (for the first use);   2. Optionally, user disinfecting skin surface—optionally user applying a reactant on skin/mucosa;   3. User installing sampling device on his skin/mucosa;   4. User launching the specific application on his smartphone;   5. The application communicating with the sampling device and identifying it;   6. The application switching the smartphone&#39;s camera on, inviting user to orient it so that both his face and the device are visible on the smartphone&#39;s screen;   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;   
           8. The application communicating with the sampling device and launching the sampling process:   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;   
           10. The sampling device communicating to the application when the sampling process is complete; and   11. The application storing information on sampling device identification, sampling time and user identification on the cloud and/or in its internal memory.       

     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. 
     The device&#39;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&#39;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. 
     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&#39;s skin a temporary adhesive glue  5130  adapted to hold the device  4100  unto the user/patient&#39;s skin at least for the duration of the sampling process. The temporary adhesive glue  5130  is protected before the device&#39;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&#39;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&#39;s skin. 
     The suction chamber  5400  contains 1 or more cutting blade(s) 5450 of a second embodiment, in principle 1 for up to 500 μl, and 2 if 1 ml need be collected, as required depending on the sample size to be collected. For the reader&#39;s information, the duration of blood flow is about 30′ for 500 μl for one incision, and so about the same time for 1 ml 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&#39;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&#39;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&#39;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. 
     Referring now to  FIGS.  14 A to  14 I , the functioning of the device can be described as follows:
         1. See  FIG.  14 A : 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.   2. See  FIG.  14 B : 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 .   3. See  FIG.  14 C : 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.   4. See  FIG.  14 D : 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&#39;s skin  9000  thanks to the bandage  5120  and the glue  5110  and  5130 .   5. See  FIG.  14 E : 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&#39;s skin  9000 , lacerating through several capillaries in the patient&#39;s skin  9000 , and allowing the vacuum to access the user/patient&#39;s skin  9000 .   6. See  FIG.  14 F : After having lacerated the membrane  5420  and the user/patient&#39;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&#39;s blood  10000 .   7. See  FIG.  14 G : 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 .   8. See  FIG.  14 H : 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 .   9. See  FIG.  14 I : 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.   10. User sends or brings the tube  8000  to a medical analysis lab or to a point of care to be analyzed. The user/patient&#39;s own refrigerator and, optionally, a container with high thermal inertia such as that described in US application no. U.S. 63/002,581, or U.S. 63/006,337, 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.   11. The analysis lab analyzes the blood sample and communicates the test results to the patient and/or to the relevant authorities.   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.       

     Referring now to  FIGS.  15 A- 15 C , 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 . 
     Referring now to  FIGS.  16 A to  16 F , 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.  15 B  and  FIG.  16 E . 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. 
     Referring now to  FIG.  17   , in another embodiment, the elastic zone may take the form of a multiturn 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/patient&#39;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/patient&#39;s reach. 
     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. 
     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. 
     Referring now to  FIG.  18 A  and  FIG.  18 B , 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 . 
     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 . 
     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, Ser. Nos. 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. 
     Referring now to  FIGS.  20 A to  20 P , 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. 
       FIG.  20 A  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. 
       FIG.  20 B  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. 
       FIG.  20 C  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. 
       FIG.  20 D  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. 
       FIG.  20 E  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. 
       FIG.  20 F  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. 
       FIG.  20 G  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. 
       FIG.  2011    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. 
       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. 
       FIG.  20 K  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. 
       FIG.  20 L  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. 
       FIG.  20 M  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. 
       FIG.  20 N  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. 
       FIG.  20 O  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. 
       FIG.  20 P  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. 
     Referring now to  FIGS.  21 A to  21 D , 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&#39;s body. Once the device is placed on a patient&#39;s arm, the device may be pulled up  3157  on a wing tab  3156  to peel the device off of the patient&#39;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. 
     As a result, the adhesive integrated dressing  3174  is adapted to ensure the attachment of the blood sampling device  3100  to the patient&#39;s skin, the air-tightness between the patient&#39;s skin and the blood sampling device  3100  during the sampling process, and the dressing of the wound after the sampling process. 
     In another embodiment, 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 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. 
     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. 
     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&#39;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. 
     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: 
     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). 
     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. 
     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. 
     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. 
     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, Ser. Nos. 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. 
     Capillary blood sampling devices for non-medically trained users of the current art usually create the wound in the patient&#39;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 150 μl in 5-10 minutes. 
     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 500 μl, preferably 1 ml 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&#39;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/patient&#39;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&#39;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 1 mm and 2 mm. 
     Referring now to  FIG.  22 A  to  FIG.  22 C , 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. 
     Referring now to  FIG.  17   , the elastic zone may take the form of a multiturn 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&#39;s skin  3290 . After completion of the movement of the cutting, edge  3265  faces away from the user/patient&#39;s reach. Optionally the cutting blade  3260  includes a finger  3270  that interacts with the device&#39;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&#39;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&#39;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&#39;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. 
     Referring now to  FIG.  22 B , as an example, the element of the device&#39;s structure  3242  is made to locally extend the radius of natural release trajectory  3250 , and the element of the device&#39;s structure  3244  is made to locally shrink the radius of the natural release trajectory  3250 . 
     Referring now to  FIG.  22 C , a further example the element of the device&#39;s structure  3246  is made to locally shrink the radius of natural release trajectory  3250 . 
     Referring now to  FIG.  23 A  to  FIG.  23 B , 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&#39;s skin (not represented). After completion of the movement, the cutting edge  3365  faces away from the user/patient&#39;s reach. Optionally, the cutting blade  3360  includes a finger  3370  that interacts with the device&#39;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 . 
     Typically the natural release trajectory  3350  of the cutting blade  3360  is substantially circular or spiral. As a result, the laceration in the patient&#39;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&#39;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&#39;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&#39;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&#39;s structure  3342  can be made with a more complex shape so as to provide a more elaborated modified trajectory  3340 . 
     Referring now to  FIG.  24 A  to  FIG.  24 C , 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.  24 A , the cutting blade  3460  has a rotative attachment  3466  to the device&#39;s structure and a cutting edge  3465 , which is kept in retracted position prior to the cutting process. 
     Referring now to  FIG.  24 B , when actuated the cutting blade  3460  engages into the patient&#39;s skin  3490  in a rotative movement, but the rotative movement is limited by the structure so that the patient&#39;s skin is not completely lacerated. 
     Referring now to  FIG.  24 C , after the laceration the cutting blade  3460  is retracted in reverse rotative movement, leaving a wound under the patient&#39;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&#39;s skin  490 , the opening is smaller, favoring a quicker healing of the wound after the blood collection. 
     Referring now to  FIG.  25 A  to  FIG.  25 D , 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&#39;s mechanism (not shown) in order to penetrate the user/patient&#39;s skin at a substantially non-orthogonal angle ( FIG.  25 B ). 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&#39;s skin ( FIG.  25 C ). When the cutting blade is retracted ( FIG.  25 D ), the flap generated by the non-orthogonal wound closes naturally the wound&#39;s entrance, favoring a quicker healing of the wound after the blood collection. 
     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.
           What may be at stake here is:   For blood sampling
               Reliable blood sampling;   Authorization to work, to travel, to be in contact with family in times of epidemics;   Authorization to use a certain treatment;   Automatized detection of epidemics by large-scale sampling programs;   Verification of the efficiency of a given treatment (payment subject to treatment success);   
               
               

     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 &amp; process verification is crucial. 
     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&#39;s face as well as the process itself are visible in the video all along the process duration. A comparison of the patient&#39;s ID with the patient&#39;s face may be made. The patient&#39;s face recognition and whole process may be observed. The system could be configured to launch the process only when all ID&#39;s are confirmed. Automatized handling of the logistics (sampling tube collection &amp; 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). 
     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/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&#39;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/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. 
     Referring now to  FIG.  26 A  to  FIG.  26 C , 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.  26 B , button  2650  in low position in  FIG.  26 D ) can be easily recognized by the human observer, or easily identified by an image analysis software. 
     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&#39;s ID during a teleconference, or taking a remote exam. 
     The invention can be summarized as including the following feature sets: 
     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.
 
2. The disposable body fluid sampling device of feature set 1, wherein the sample containment chamber is a standard medical analysis tube.
 
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.
 
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.
 
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.
 
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.
 
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.
 
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.
 
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.
 
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.
 
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.
 
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-injection 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&#39;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. 
     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.
 
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.
 
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.
 
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.
 
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:
 
(a) a sampling mechanism for sampling capillary blood, optionally auto-sampling;
 
(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
 
(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.
 
20. A device according to one of feature sets 1-11 or 19, containing one or more cutting blades for lacerating the user/patient&#39;s skin.
 
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&#39;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&#39;s skin, providing a wound shape that optimizes the number of capillaries cut and favoring the quick healing of the wound after blood collection.
 
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.
 
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/patient&#39;s skin.
 
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:
 
(a) using the device of any one of feature sets 1, 4-11, 13-14, sampling capillary blood, optionally auto-sampling the blood;
 
(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
 
(c) filling a sample containment chamber with a sample of capillary blood for analysis in a point of care or medical lab.
 
26. The method of feature set 25, wherein the sample containment chamber is a standard medical analysis tube.
 
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.
 
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.
 
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.
 
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&#39;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.
 
31. A method of mass collection and analysis of an organic sample of feature set 30, the method including the steps of:
         providing instructions, the instructions including instructions for to taking a blood or other sample;   taking the sample and associating the sample device&#39;s unique identifier with the test subject;   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.
 
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&#39;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.
 
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&#39;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.
 
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.
 
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.
 
37. The system of feature set 36 in combination with an app running on a smartphone.
 
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.
 
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/injection device.
 
40. The system of feature set 39 including a device identification module adapted to, in real-time, dispense audible and/or visual instructions for the user/patient to run the process correctly.
 
41. The system of feature set 39 including a triggering module configured to wirelessly trigger parts or whole of the sampling or injection process.
 
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.
 
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
 
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.
 
45. The system of feature set 33 where the proof provided is adapted for use to release the payment of a treatment.
 
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.
 
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.
 
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.
 
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.
 
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&#39;s skin, (ii) ensure the air-tightness between the patient&#39;s skin and the blood sampling device during the sampling process, and (iii) the dressing of the wound after the sampling process.
       

     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. 
     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. 
     Moreover, the system contemplates the use, sale and/or distribution of any goods, services or information having similar functionality described herein. 
     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. 
     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. 
     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 above-described 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. 
     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. 
     Other characteristics and modes of execution of the invention are described in the appended claims. 
     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. 
     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. 
     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.