Patent Publication Number: US-2023146889-A1

Title: Sample collection device, system and method for extracting and collecting a sample of a fluid of a user

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. Non-Provisional Patent Application No. 17/096,796, entitled “SAMPLE COLLECTION DEVICE, SYSTEM AND METHOD FOR EXTRACTING AND COLLECTING A SAMPLE OF A FLUID OF A USER,” and filed on Nov. 12, 2020. U.S. Non-Provisional patent application Ser. No. 17/096,796 claims priority to European Patent Application No. 19208831.8 filed on Nov. 13, 2019. The entire contents of each of the above-listed applications are hereby incorporated by reference for all purposes. 
    
    
     TECHNICAL FIELD 
     Embodiments of the subject matter disclosed herein relate to a sample collection device for collecting a sample of a fluid of a user, e.g. blood, in particular capillary blood. Specifically, a system and a method for extracting and collecting this sample. 
     BACKGROUND AND SUMMARY 
     Venipuncture is a blood collection method where the vein is punctured by a hollow needle and blood is collected into a tube. This method allows collection of large and high quality blood samples into tubes. Several tubes can be filled during one blood sampling. Furthermore, these tubes are compatible with highly automated blood analyzers, which can analyze thousands of samples per day. These high throughputs capabilities answer the growing need for fast and clinical grade diagnostics at the lowest cost. 
     However, this method requires a healthcare professional (e.g. a nurse) with a specific qualification and a dedicated infrastructure. Moreover, risks are associated with puncturing the vein: if the vein is fragile or if the gesture is not performed properly, it can result in a hematoma. There is also a risk of a needle-stick injury, which may expose the healthcare professionals to blood-borne diseases. 
     On the other hand, the finger prick method consists of an incision in the skin at the fingertip using a lancet. A drop or a few drops of capillary blood can be collected into capillary tubes or into dedicated analytical devices (e.g. microfluidic devices, lab-on-chip, paper-based diagnostic tools, and the like). While this technique does not require highly trained professional and can be performed by the patient himself, it is very difficult to collect more than 100 μl of blood and to perform many analyses per sample. 
     Moreover, the blood collected into glass capillaries or through other devices, cannot be analyzed by the automated analyzers used by central laboratories, which require a minimum dead volume of blood of 100 μl to 200 μl in a single tube. 
     In some instances, more blood, up to 0.5 ml, can be collected with the finger prick method. However, this requires pressing and squeezing the finger in order to collect more blood. Squeezing too hard may result in haemolysis (damage of the red blood cells) and dilution of the blood sample by the interstitial fluid contained in spaces between the tissue cells. For these reasons, and to keep a good blood quality, the use of finger prick is generally limited to the collection of small volumes of blood. 
     U.S. Pat. No. 6,283,926 describes a method and a device for obtaining samples of blood for diagnostic purposes. The device comprises a vacuum pump, which requires a source of power, and a micro-controller arranged to drive the pump and the lancet based on the signal from a pressure sensor. The lancet of this device moves in a direction perpendicular to the skin of the user. This device is complicated, as it comprises several electronics components. Moreover, it is arranged to draw relatively small blood volumes (1 μl). 
     An aim of the present disclosure is to propose a sample collection device that simplifies the collection of a fluid of a user, e.g. blood, while keeping a high-quality standard for its analysis. 
     Another aim of the present disclosure is to propose a sample collection device which is safer for the user or for an operator (e.g. a nurse), as it minimizes the risk of injury by handling it. 
     Another aim of the present disclosure is to propose a sample collection device that reduces the risk of contamination of the collected sample. 
     Another aim of the present disclosure is to propose a sample collection device that is compatible with standard blood analyzers of central laboratories. 
     Another aim of the present disclosure is to propose a system for extracting and collecting a user fluid sample which can be used without the need of high-skill training, for example which can be used by the user himself (i.e. a patient). 
     Another aim of the present disclosure is to propose a system for extracting and collecting a user fluid sample that requires minimal action from the user. 
     Another aim of the present disclosure is to propose a system for extracting and collecting a user fluid sample that can collect about 0.5 ml to 2 ml of fluid, e.g. 1 ml of fluid. 
     Another aim of the present disclosure is to propose a system for extracting and collecting a user fluid sample that is as painless as possible. 
     Another aim of the present disclosure is to propose a system for extracting and collecting a user fluid sample that avoids and/or prevents cross contamination of the fluid sample. 
     According to the disclosure, these aims are achieved by means of the sample collection device, the system and the method for extracting and collecting a sample of a fluid of a user according to the attached independent claims. 
     In particular, according to the disclosure, a sample collection device for collecting a blood sample of a patient is provided, the sample collection device at least comprising:
         a first partially deformable shell,   a second at least partially pierceable shell, wherein in the mounted state of the collection device a pre-packaged vacuum is sealed between the first shell and the second shell.       

     In some aspects, the second shell holds, in the mounted state, a sample container and an automatic mechanical cutting mechanism comprising a rotatable cutting blade and an actuator spring, the actuator spring being directly and/or indirectly actuatable by pressing the first shell, thereby releasing and rotating the cutting blade. In some aspects, by pressing the first shell the pre-packaged vacuum is released to a collection opening of the second shell such that the vacuum effects a suction effect such that blood coming out of the incision created by the rotatable cutting blade leaks into the sample container. 
     The invention is based on the basic idea that by using a minimal cut into the skin of a patient by using a cutting blade that is automatically actuated, the collection of blood can be performed more or less painlessly for the patient. The pain can be further reduced by effecting a tangential cut. By having the prepackaged vacuum between the first and the second shell, wherein these two shells form in the mounted state a vacuum housing, a sufficient suction force or mechanism is provided, by means of which the blood coming out of the incision created by the rotatable cutting blade is leaked and/or flowing into the sample container. In particular, the vacuum can and/or will create a skin deformation, which generates a concentrated vasodilation. Vasodilation then allows an excessive amount of blood to be extracted from the wound created by the blade. 
     By using a cutting blade (which is to be understood to also cover blade-like elements) an incision into the skin of the patient can be made. Unlike a needle or a lancet or any sharps tips, the use of a cutting blade provides, according to the experience of the inventors, a more accurate and less painful creation of an opening into the skin of the patient for collecting blood. In particular, the blade allows a soft diving and cutting into the skin with less pressure, thereby not creating too much pain. In some cases, no pain was felt by the patients. This concept is inspired by the experience that cuts created e.g. by a sharp knife or even by a sheet of paper are not felt in the first moment, but nevertheless creating enough of an opening to produce blood in the amount needed for analysis. 
     Additionally, another effect that makes the cut painless is the fact that the skin is stretched when the device is performing the cut. When the skin is pinched before puncturing, there will be also less pain felt. Here, by first stretching the skin then cutting it, the cut is less painful. The skin is stretched, which triggers the spring and blade that cuts the skin. This mechanism ensures that the skin is first stretched before being cut. 
     The actuator spring can be released for example directly by pressing e.g. a button. However, it is also possible that the actuator spring can be actuated indirectly. This can happen that by pressing the shell, the pierceable shell is punctured, thereby transferring vacuum into the second shell, which has the effect of sucking and stretching the skin. Then, the stretched skin presses against a movable part of the cap, which then releases the spring. 
     The second shell can be at least partially pierceable. It can be e.g. realized by having a part of the second shell formed by a membrane, which is pierceable. The membrane can be e.g. made of aluminum or any other suitable material, e.g. a polymer or plastic material. 
     Alternatively, the whole may be pierceable, e.g. made of a pierceable material. 
     Furthermore, it is possible that the cutting blade is mounted on and/or part of a rotatable plunger. 
     The plunger may be a rotatable, more or less cylindrical element configured to hold and/or carry the cutting blade. The plunger and the cutting blade may be connected by form-fit or snap-fit only. Also, the form-fit may be used for correct placement during manufacturing only. Then, a connection can be established by gluing or welding. 
     In particular, it is possible that the blade has one or two recesses (or other specially formed portions), which fit into respective counterparts of the plunger. 
     The plunger may further comprise a seal portion, the seal portion being arranged and configured such that after the collection of blood the sample container is and/or may be sealed by the seal portion such that the sample container is closed by the plunger and its seal. By this, the plunger may be used as a closure for the sample container. It may be pressed into the sample container as closure means after the blood collection. In particular, it may be pressed into the opening of the sample container by a finger, e.g. the thumb of the user, thereby closing and sealing the sample container and its opening. 
     Moreover, the plunger further comprises a septum. The septum may be used to create an opening when the collected blood in the sample container shall be analyzed. The septum can be pierceable. It is possible that a standard syringe needle can be used to pierce the septum and to remove the blood from the sample container. Also, the septum may be used by automatic analyzing machines and their analyte collectors, probes, or sample takers. 
     In connection with the septum, it is possible that the plunger and also the cap and the trigger allow access to the septum. Such access may be formed as a conical hole for guiding the probe for blood analysis. The diameter of the conical hole at the largest opening should be approx. 4.5 mm so as to comply and allow compatibility with standard probes (of e.g. analyzing machines). 
     Additionally, in a further possible embodiment, the cutting blade may comprise a cutting edge, wherein the cutting edge has an acute end and a rounded end. The acute end may be used to dive into the skin of the patient, while doing the rotation and incision movement. The rounded end is provided to create more handling safety of the blade and also to facilitate the rotation movement of the blade, further reducing the needed space of the blade. 
     Furthermore it is possible that the cutting edge of the cutting blade has an angle chosen in the range of 15°-25°, especially approx. 19°-21°, in other aspects approx. 20°. This angle has been found to create a very sharp incision due to its smooth but nevertheless sharp diving and cutting into the skin that is less painful than other incision or skin-opening or skin-piercing methods. 
     Additionally, the acute end of the cutting blade has an angle chosen in the range of 45°-55°, especially approx. 47°-53°, in other aspects approx. 50°. This angle forms at the acute end a sharp tip, which will create the first contact with the skin and start the incision. 
     It is also possible that the rounded end of the cutting blade may have the same radius as the outer edge of the cutting blade on the side of the rounded end. This facilitates the rotational movement of the cutting blade. Further, the handling safety is enhanced. 
     It should be understood that the summary above is provided to introduce in simplified form a selection of concepts that are further described in the detailed description. It is not meant to identify key or essential features of the claimed subject matter, the scope of which is defined uniquely by the claims that follow the detailed description. Furthermore, the claimed subject matter is not limited to implementations that solve any disadvantages noted above or in any part of this disclosure. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       The invention will be better understood with the aid of the description of an embodiment given by way of example and illustrated by the figures, in which: 
         FIG.  1    shows a perspective view of a part of the sample collection device according to one embodiment of the invention; 
         FIG.  2    shows a perspective view of the system for extracting and collecting a sample of a fluid of a user according to one embodiment of the invention; 
         FIG.  3    shows a perspective view of the system of  FIG.  2   , and in particular the removing of its lid; 
         FIG.  4    shows a perspective view of the system of  FIGS.  2  and  3   , without the lid; 
         FIG.  5    shows a perspective view of the system of  FIG.  4   , wherein its vacuum creation mechanism is in a first position; 
         FIG.  6    shows a perspective view of the system of  FIG.  4   , wherein its vacuum creation mechanism is in a second position; 
         FIG.  7    shows a perspective view of one embodiment of the system according to the invention, placed on an arm of a user; 
         FIG.  8    shows a perspective view of a part of an embodiment of the system according to the invention, wherein the incision mechanism is in the first incision mechanism position; 
         FIG.  9    shows a perspective view of a part of the embodiment of the system of  FIG.  8   , wherein the incision mechanism is in the second incision mechanism position; 
         FIG.  10 A  shows a perspective view of one embodiment of a part of the sample collection device according to one embodiment of the invention, wherein the cap is in the first cap position; 
         FIG.  10 B  shows a perspective view of one embodiment of the part of the sample collection device of  FIG.  10 A , wherein the cap is in the second cap position; 
         FIG.  11 A  shows a cross-section view of one embodiment of the sample extraction device of the system for extracting and collecting a sample of a fluid of a user according to the invention; 
         FIG.  11 B  shows a cross-section view of one embodiment of the sample collection device according to the invention; 
         FIG.  11 C  shows a front view of the embodiment of the sample collection device of  FIG.  11 B ; 
         FIG.  12    shows a cross-section view of one embodiment of the system for extracting and collecting a sample of a fluid of a user according to the invention, wherein the sample collection device is inserted inside the sample extraction device; 
         FIG.  13    shows a cross-section view of the embodiment of the system of  FIG.  12   , wherein the lid of the sample collection device is removed; 
         FIG.  14    shows a cross-section view of the embodiment of the system of  FIG.  13   , approaching a user, e.g. an arm of the user; 
         FIG.  15    shows a cross-section view of the embodiment of the system of  FIG.  14   , wherein the system is placed on the user; 
         FIG.  16    shows a cross-section view of the embodiment of the system of  FIG.  15   , wherein the valve control mechanism is activated; 
         FIG.  17    shows a cross-section view of the embodiment of the system of  FIG.  16   , wherein the suction created by the vacuum stretches and deforms the user&#39;s skin; 
         FIG.  18    shows a cross-section view of the embodiment of the system of  FIG.  17   , wherein the incision mechanism is in the second incision mechanism position and the user&#39;s skin has been incised by the incision mechanism; 
         FIG.  19    shows a cross-section view of the embodiment of the system of  FIG.  18   , wherein the blood is flowing from the incision created by the incision mechanism; 
         FIG.  20    shows a cross-section view of the embodiment of the system of  FIG.  19   , wherein according to one embodiment at least one sensor of the system announces the user once the volume of the sample in the sample container has reached a predetermined value; 
         FIG.  21    shows a cross-section view of the embodiment of the system of  FIG.  20   , wherein according to one embodiment the valve control mechanism is pressed to re-equilibrate the system to atmospheric pressure; 
         FIG.  22    shows a cross-section view of the embodiment of the system of  FIG.  21   , wherein the system is removed from the user; 
         FIG.  23    shows a cross-section view of the embodiment of the system of  FIG.  22   , wherein the cap is moved to the second cap position; 
         FIG.  24    shows a cross-section view of the embodiment of the system of  FIG.  23   , wherein the cap is in the second cap position and seals the sample container; 
         FIG.  25    shows a cross-section view of the embodiment of the system of  FIG.  24   , wherein the sealed sample container is removed from the suction pack; 
         FIG.  26    shows a cross-section view of the embodiment of the system of  FIG.  25   , wherein the suction pack is removed from the sample extraction device; 
         FIG.  27 A  shows a front view of a part of the sample collection device according to one embodiment of the invention; 
         FIG.  27 B  shows one embodiment of a section view of the part of the sample collection device of  FIG.  27 A ; 
         FIG.  27 C  shows another embodiment of a section view of the part of the sample collection device of  FIG.  27 A ; 
         FIG.  28    shows another embodiment of a cross-section view of the sample extraction device; 
         FIG.  29    shows another embodiment of a front view of the sample collection device; 
         FIG.  30    shows a perspective view of another embodiment of the sample collection device according to the invention; 
         FIG.  31    shows a cross-section view of the embodiment of the sample collection device of  FIG.  30   ; 
         FIG.  32    shows a perspective view of another embodiment of the sample collection device according to the invention; 
         FIG.  33    shows a cross-section view of the embodiment of the sample collection device of  FIG.  32   ; 
         FIG.  34    shows another cross-section view of the embodiment of the sample collection device of  FIG.  32   ; 
         FIG.  35 A  shows a cross-section view a part of another embodiment of the sample collection device according to the invention; 
         FIG.  35 B  shows another cross-section view of the embodiment of the sample collection device of  FIG.  35 A ; 
         FIG.  36    shows a perspective view of another embodiment of the system for extracting and collecting a sample of a fluid of a user according to the invention; 
         FIG.  37    shows an exploded view of the embodiment of the system of  FIG.  36   ; 
         FIG.  38    shows a part of a cross-section view of the embodiment of the system of  FIG.  36   ; 
         FIG.  39    shows another part of another cross-section view of the embodiment of the system of  FIG.  36   ; 
         FIG.  40    shows a perspective view of one embodiment the triggering and incision mechanisms of system of  FIG.  36   ; 
         FIG.  41 A  shows a perspective view (front side) of one embodiment of the sample collection device of the system of  FIG.  36   ; 
         FIG.  41 B  shows a perspective view (rear side) of the embodiment of the sample collection device of  FIG.  41 A ; 
         FIG.  42    shows a top view of the system according to the invention, once placed near a user&#39;s member as an arm; 
         FIG.  43    shows an exploded view of a further embodiment of a sample collection device for collecting a blood sample of a patient of the present invention; 
         FIG.  44 A-C  show details of the embodiment shown in  FIG.  43   , the details being related to the functionality of the device; 
         FIG.  45 A-E  different view of the device of  FIG.  43   ; 
         FIG.  46 A-E  different views of the sample container of the embodiment shown in  FIG.  43   ; 
         FIG.  47 A-F  different views of the plunger and the cutting blade of the embodiment shown in  FIG.  43   ; 
         FIG.  48 A-B  different views of the cutting blade of the embodiment shown in  FIG.  43   ; and 
         FIG.  49 A-B  different views of the torsion spring of the embodiment shown in  FIG.  43   . 
     
    
    
     DETAILED DESCRIPTION 
     In the following description provided by way of example, reference will be made, for reasons of simplicity, to a system for collecting and extracting the blood of a user, comprising a blood collection device and a blood extraction device. However, it must be understood that the invention is not limited to such a fluid, but includes also collection devices and extraction devices, both being arranged to collect respectively extract other kinds of fluid, in particular bodily fluids. 
     In the following description provided by way of example, reference will be made, for reasons of simplicity, to “sample collection device” and “sample extraction device”. However, it must be understood that the “sample” indicated in those expressions is a sample of a fluid, in particular a bodily fluid, e.g. blood, in particular capillary blood. 
       FIGS.  1 - 49    show example configurations with relative positioning of the various components. If shown directly contacting each other, or directly coupled, then such elements may be referred to as directly contacting or directly coupled, respectively, at least in one example. Similarly, elements shown contiguous or adjacent to one another may be contiguous or adjacent to each other, respectively, at least in one example. As an example, components laying in face-sharing contact with each other may be referred to as in face-sharing contact. As another example, elements positioned apart from each other with only a space there-between and no other components may be referred to as such, in at least one example. As yet another example, elements shown above/below one another, at opposite sides to one another, or to the left/right of one another may be referred to as such, relative to one another. Further, as shown in the figures, a topmost element or point of element may be referred to as a “top” of the component and a bottommost element or point of the element may be referred to as a “bottom” of the component, in at least one example. As used herein, top/bottom, upper/lower, above/below, may be relative to a vertical axis of the figures and used to describe positioning of elements of the figures relative to one another. As such, elements shown above other elements are positioned vertically above the other elements, in one example. As yet another example, shapes of the elements depicted within the figures may be referred to as having those shapes (e.g., such as being circular, straight, planar, curved, rounded, chamfered, angled, or the like). Further, elements shown intersecting one another may be referred to as intersecting elements or intersecting one another, in at least one example. Further still, an element shown within another element or shown outside of another element may be referred as such, in one example. 
     The system  300  for extracting and collecting a sample of a fluid of a user according to the invention comprises two parts:
         a sample collection device  200 ; and   a sample extraction device  100 .       

     In one advantageous embodiment, the sample collection device  200  is consumable and the sample extraction device  100  is reusable. In another embodiment, the sample extraction device  100  is also a consumable. In this case, the sample collection device  200  and the sample extraction device  100  can form one single system  300  that is consumable. An example of such consumable system  300  will be discussed with reference to  FIG.  36   . 
     We will describe first the features of sample collection device  200 , secondly the features of sample extraction device  100  and at the end the method and system of collecting and extracting such a sample. 
       FIG.  1    shows a perspective view of a part of the sample collection device  200  according to one embodiment of the invention. 
     The sample collection device  200  according to one embodiment of the invention comprises:
         a sample container  212  arranged to receive the sample and comprising an open end  2121 ;   a cap  202  arranged to cooperate with the sample container  212  so as to close the open end  2121 .       

     In the embodiment of  FIG.  1   , the sample container  212  is a tube, having substantially a cylindrical shape and comprising the open end  2121  and a closed end  2122  with a substantially spherical shape. 
     In a particular embodiment, the tube is a “standard” tube, i.e. a tube compatible with standard blood analyzers of central laboratories. For example, the diameter of the standard tube belongs to the range 12 mm-16 mm, e.g. it is equal to 13 mm. 
     In another embodiment, the length of the tube is less than a standard length, i.e. a length compatible with standard blood analyzers of central laboratories. In such a case, the tube can comprise connection means so as to connect it with an extension tube, so that the total length of the set comprising the tube and the extension tube is a standard length, for example a length ranging from 50 mm to 120 mm, e.g. equal to 75 mm. In another embodiment, this extension tube could also correct the final diameter of the tube. The diameter of the tube could be smaller than the standard diameter, but it could be adjusted with a larger extension tube, so as to be compatible with standard blood analyzers of central laboratories. 
     In one embodiment, those connection means for connecting the tube with the extension tube are arranged such that they allow an easy connection of the tube with the extension tube, but they prevent or render difficult the disconnection of the extension tube from the tube. This feature is useful in particular if a label identifying the fluid sample is placed on the outer surface of the extension tube, so as to prevent a user from detaching the extension tube from the tube: the traceability of the fluid sample is then guaranteed. In one embodiment, those connection means comprise clip means and/or screwing means. 
     In a particular embodiment, the tube is arranged for receiving at least 0.5 ml, and preferably 1 ml, of fluid sample, as will be discussed. 
     In the embodiment of  FIG.  1   , the sample container  212  may be (at least partially) transparent, so as to directly see its content. 
     In the embodiment of  FIG.  1   , the cap  202  is also a “standard” cap i.e. a cap compatible with standard blood analyzers of central laboratories. For example, the diameter of the outer part of the standard cap is 15 mm. 
     In the embodiment of  FIG.  1   , the sample container  212  and its cap  202  are placed in a suction pack  201 . The size and the shape of the suction pack  201  are therefore arranged to receive the sample container  212  and the cap  202 . In one embodiment, the suction pack  201  is made, at least in part, of a flexible material. 
     The suction pack  201  has two main functions: 1) it is used as a packaging for the sample container  212  and its cap  202 ; 2) it serves as a suction cup in which vacuum is applied to the user&#39;s skin for dsuction and fluid collection, as will be discussed. 
     In the embodiment of  FIG.  1   , the suction pack  201  comprises a lid  207 , so as to guarantee the sterilization of its content and/or a barrier from moisture. This lid  207  is removable. In one embodiment, it is a semi-permeable membrane that allows the maintenance of the inside of the suction pack  201  as sterilized, for example Tyvek®. In another embodiment, the lid  207  is non-permeable: this allows an airtight environment during storage and/or transport to be maintained so as to prevent humidity from entering the suction pack  201  and/or the sample container  212 . In fact, humidity could affect the stability of the additives present in the sample container  212 . 
     In the embodiment of  FIG.  1   , the suction pack  201  is also (at least partially) transparent, so as to provide a good visual indication of the integrity of its content. Before the use, the user (or an operator, e.g. a nurse) can indeed check that the lid  207  of the suction pack  201  has not been open yet, as an indication that its content is still sterilized and safe to be used. 
     In one example, the suction pack  201  is made for instance of polycarbonate, PET-G, etc. so that a user or an operator can track the progress of the fluid collection by optically monitoring the level of the fluid sample in the sample container  212 . 
     As will be discussed, in one embodiment the suction pack  201  comprises a semi-permeable membrane allowing the vacuum to enter the suction pack. 
     In one embodiment, the suction pack  201  comprises or is made (at least partially) of materials enhancing the sealing between the suction pack  201  and the skin of the user, so as to guarantee a good sealing between the skin and the suction pack  201 . 
     In one embodiment, the suction pack  201  is a blister pack. 
     Consumables or so-called disposables in blister packs are common practice in healthcare. 
     The advantage of a blister packaging is that it is cost-effective, it can be closed by a removable lid  207 , and can be transported and handled while preserving the sterile condition of its content. 
     According to the invention, the cap  212  comprises: 
     a collection window  205 , visible e.g. in  FIGS.  8 ,  11 B and  11 C  and arranged to enter in contact with the area or part of the user to be incised; 
     a triggering mechanism; and an incision mechanism movable in the cap  202  by the triggering mechanism from a first incision mechanism position (illustrated for example in  FIG.  8   ) to a second incision mechanism position (illustrated for example in  FIG.  9   ). 
     Advantageously, when moving from the first incision mechanism position to the second incision mechanism position, the incision mechanism is arranged to incise the user at the collection window  205  so as to withdraw the sample from the user. During the movement from the first incision mechanism position to the second incision mechanism, the cap  202  is always in a first cap position, illustrated for example in  FIGS.  1 ,  8 ,  9  and  10 A . 
     In fact, according to the disclosure, the cap  202  itself is arranged to be moved on the sample container  212  from a first cap position (illustrated for example in  FIG.  1 ,  8 ,  9  or  10 A ) to a second cap position (illustrated for example in  FIG.  10 B ), wherein, in both the first and in the second cap positions, the open end  2121  of the sample container  212  is at least partially in contact with the sample container  212  so as to guide the movement of the cap  202  from the first cap position to the second cap position. In the illustrated embodiment, which is not limitative, in both the first and in the second cap positions the open end  2121  of the sample container  212  is closed by the cap  202 . 
     According to the disclosure, the cap  202  also includes a sealing mechanism (not illustrated), so as so seal the sample container when the cap is in the second cap position (illustrated for example in  FIG.  10 B ), so as to safely transport the sample. 
     Since the fluid is collected with a sufficient amount (about 1 ml), conditioned into a sample container  212  with a cap  202 , in which both the sample container and the cap match standards (container size, cap format, and/or additives required for the different types of analyses) used for standard blood analyzers, and safely transported, several analyses can be performed from one sample of fluid collected with the device according to the disclosure. 
     The collection device according to the invention has therefore the following advantages:
         the cap  202  integrates the incision mechanism;   the same cap seals the sample container  212  after that the fluid sample has been collected, so as to safely transport this fluid sample;   the fluid, e.g. blood, is directly collected into the sample container  212  used for its transport and analysis, as the fluid falls down directly into the sample container  212 .       

     It must be noted that the movement of the incision mechanism requires no active actions from the user: in fact, it is triggered by a triggering mechanism in an automatic way, as will be described. 
     In a particular embodiment, the movement of the cap  202  is manually performed by the user or by an operator. However, in another embodiment, it is automatically performed as well. 
     In one preferred embodiment, visible for example in  FIGS.  8  and  9   , the cap  202  includes a first cap portion  2021  and a second cap portion  2022 . The two portions  2021 ,  2022  can be two distinct parts connected together by connecting means (not illustrated). In another embodiment, the cap  202  is a monobloc, i.e. it is made by a single piece comprising those two portions  2021 ,  2022 . 
     In one embodiment, the first cap portion  2021  comprises the collection window  205 . 
     As visible in  FIGS.  8  and  9   , the first cap portion  2021  comprises an opening  215  along the main direction of the first cap portion  2021 . In other words, since this opening  215  is present, the first cap portion  2021  has a cross section with a substantially C shape. 
     In the illustrated embodiment, at least a part  2021 ′ of this first cap portion  2021  is inserted during the working of the system  300  into the sample container  212 , so as to close the open end  2121  of the sample container  212  during the moving of the incision mechanism. 
     Another part  2021 ″ of this first cap portion  2021  is outside of the sample container  212 , when the cap  202  is in its first position, as illustrated in  FIG.  8   . 
     In one embodiment, the second cup portion  2022  is larger than the first cup portion  2021 . It is not adapted to enter into the sample container  212 , but rather to seal it. 
     In one embodiment, the second cup portion  2022  comprises the above-mentioned sealing mechanism. 
     In one embodiment, the second cup portion  2022  comprises a cavity  216 , visible in  FIGS.  8  and  9   , for receiving the incision mechanism, and in particular the cutting element  206 , once the incision mechanism is in the second incision mechanism position (illustrated in  FIG.  9   ), so that the incision mechanism is irreversibly and safely retracted in this cavity  216  so that it can no longer incise the user. 
     In one embodiment, at least a part of the cap  202  is accessible by the user or by an operator, so as to manually extract the fluid sample from the sample container  212 , without detaching the cap  202  from the sample container  212 . 
     In one embodiment, the incision mechanism comprises:
         a support element  203 ; and   an elastic element  204 .       

     In one preferred embodiment, the support element  203  is a piston, which is for example visible in  FIGS.  8  and  11 B . This support element is connected, preferably directly connected, to a cutting element  206 , so that once the support element  203  is moved, the cutting element  206  is moved as well. 
     The cutting element  206  may be a blade, or any other blade-like element capable of forming an opening in the skin of a user. 
     In one preferred embodiment, the elastic element  204  is a spring, which is for example visible in  FIGS.  8  and  11 B ; this elastic element  204  is blocked before the use of the system according to the invention, for example in a compressed position. 
     Once the incision mechanism is triggered, the elastic element  204  is free to be decompressed, and this decompression moves the support element  203  and then the cutting element  206  from the first incision mechanism position (visible e.g. in  FIG.  8   ) to the second incision mechanism position (visible e.g. in  FIG.  9   ). 
     It must be understood that the present invention is not limited to a compression elastic element only, i.e. an elastic element (e.g. a spring) that can be compressed and decompressed, but it also includes other elastic elements, e.g. torsion and/or traction elastic elements, i.e. elastic elements (e.g. springs) that can perform a movement of torsion and/or traction. 
     As visible in  FIG.  8   , when the incision mechanism is in the first incision mechanism position, the cutting element  206  is in the sample container  212 , so as to ensure the safety of the user and/or of an operator. 
     In the embodiment of  FIGS.  8  and  9   , the movement of the incision mechanism from the first incision mechanism position to the second incision mechanism position is a linear movement (i.e. a translation) performed in a direction parallel to a surface of the user to be incised, as illustrated in  FIG.  27 B . 
     However, in another alternative embodiment, the movement of the incision mechanism from the first incision mechanism position to the second incision mechanism position is a circular movement (i.e. a rotation), as illustrated in  FIG.  27 C , wherein the axis of rotation of this circular movement is preferably a main axis of the sample container  212 . 
     For example, this circular movement is possible if the elastic element  204  is a torsion elastic element  204 . Another example of such circular movement will be discussed with reference to the embodiment of  FIG.  36   . 
     The triggering mechanism of the sample collection device includes a triggering element, which is visible in for example  FIGS.  11 B and  11 C . 
     This triggering mechanism includes a triggering element  209 , which in the illustrated embodiment is a half-ring surrounding at least a part of the support element  203 . 
     In particular, the triggering element  209  includes a protrusion  210 , e.g. a finger, which is arranged to be received by a corresponding cavity  211  in the support element  203 , so as to hold the triggering element  209  in the first triggering element position visible in for example  FIG.  11 B . 
     In the illustrated embodiment, the cap  202  includes the triggering mechanism, in particular the triggering element  209 . In another alternative embodiment, not illustrated, the support element  203  includes the triggering mechanism, in particular the triggering element  209 . 
     As will be discussed, once the system  300  is placed on the user&#39;s skin, it deforms and/or stretches a part of the user&#39;s skin so that this deformed and/or stretched part will move the triggering element  209  from a first triggering element position (visible e.g. in  FIG.  17   ), wherein it holds the elastic element  204  in a compressed position and the support element  203  in a fixed position in the sample container  212 , to a second triggering element position (visible e.g. in  FIG.  18   ), wherein the triggering element  209  no longer holds the elastic element  204  nor the support element  203 . 
     We describe now the sample extraction device. As is visible for example in  FIG.  11 A , it comprises:
         a port  107  (e.g. a cavity or a recess) arranged to receive at least a part of the sample collection device  200 ;   a vacuum chamber  101 ;   a vacuum creation mechanism  108  arranged to create vacuum in the vacuum chamber  101 ; a non-limitative example of such vacuum creation mechanism is illustrated in  FIGS.  5  and  6   ; the vacuum creation mechanism is preferably completely mechanical and devoid of electronics component;   a valve (or an assembly of valves)  104  arranged to close and/or open the vacuum chamber  101  and/or to release the sample collection device ( 200 ) to atmospheric pressure; and   a valve control mechanism  102  arranged to command the valve  104  (or the assembly of valves) so as to transfer the vacuum from the vacuum chamber  101  to the sample collection device  200 , but also to release the sample collection device  200  to atmospheric pressure, in particular after collection.       

     In the present context the term “vacuum” indicates an area with a gaseous pressure much less than the atmospheric pressure, e.g. with a gaseous pressure between −70 kPa and −20 kPa compared to the atmospheric pressure, e.g. of about −40 kPa. 
     In one preferred embodiment, the valve control mechanism  102  is a button, e.g. a push button, or an assembly of buttons. In one preferred embodiment, it is arranged to control three modes of the valve  104 , i.e. open, closed, release. 
     In one preferred embodiment, the sample extraction device comprising an electronic module  105 , visible e.g. on  FIG.  11 A , comprising a communication module (not illustrated) and a power supply (not illustrated). 
     In another preferred embodiment, visible e.g. on  FIG.  11 A , the sample extraction device comprises at least a sensor  106 , e.g. an optic sensor, for detecting a predetermined sample volume in the sample container. 
     In another preferred embodiment, the sample extraction device comprises an alerting mechanism (not illustrated), indicating to the user the end of the sample extraction, e.g. by an audio and/or visible signal. 
     In another preferred embodiment, the sample extraction device comprises a gasket  103 , visible e.g. on  FIG.  11 A , cooperating with the area of the sample collection device  200  comprising a membrane  208 . 
     In one variant, the membrane  208  is semi-permeable. In another variant, the membrane  208  is non-permeable: maintaining an airtight environment during storage and/or transport so as to prevent humidity from entering the suction pack  201  and/or the sample container  212 . In fact, humidity could affect the stability of the additives present in the sample container  212 . 
     We describe now the method for collecting and extracting a sample of a fluid of the user, with the system according to the invention. 
     In one embodiment, the cap  202  is placed in and/or on the sample container  212 , so as to close its open end  2121 , as illustrated in  FIG.  1   . 
     Then, the sample container  212  and the cap  202  are packaged in the suction pack  201 , the suction pack  201  is closed by a lid  207  and the closed suction pack  201 , comprising the sample container  212  and the cap  202 , is sterilized. 
     In an embodiment, the sample collection device  200  is consumable and the sample extraction device  100  is not consumable, that is, it is reusable. A new sample collection device  200  is then placed on or in the sample extraction device  100 , in particular in a port  107  of the sample extraction device  100 , visible in  FIG.  11 A . 
     The sample collection device  200  is then mechanically connected to the sample extraction device  100 , e.g. by using first and second connection means  120  respectively  220 , illustrated in  FIGS.  11 A and  11 B . 
     Those means guarantee a connection by clip or a snap-fit means, but of course any other kind of means guarantying a mechanical connection between the sample collection device  200  and the sample extraction device  100  can be used, e.g. and in a non-limiting way a magnet on a device and a ferromagnetic area on the other device, a screw or a rivet in a device and a hole in the other device, docking means, etc. 
       FIG.  12    shows a cross section view of one embodiment of the system for  300  extracting and collecting a sample of a fluid of a user according to the invention, before that the sample collection device  200  is inserted in the port  107  of the sample extraction device  100 . The arrow F 1  indicates the movement of the sample collection device  200  to the sample extraction device  100 . 
     The sample collection device  200  and the sample extraction device  100  form the system  300  according to the invention. 
     Although  FIG.  12    illustrates an embodiment in which the sample collection device  200  is moved to the extraction device  100  in the direction of the arrow F 1 , this embodiment is not limitative and other possibilities can be imagined by the skilled person. For example, and in a non-limitative way, the sample collection device  200  could be slid in some (not illustrated) rails of the extraction device  100  in a direction perpendicular to the direction of the arrow F 1 . In such a case, the illustrated first and second connection means  120  respectively  220  will be modified accordingly. 
       FIG.  2    shows a perspective view of this system  300  according to one embodiment of the invention. In this case, the arrow F 1  indicates the movement of the sample collection device  200  to the sample extraction device  100 . 
     It must be noted that the sample collection device  200  and the sample extraction device  100  are arranged so that, when connected, the valve  104  and the possible gasket  103  of the sample extraction device  100  are placed in correspondence of the membrane  208  of the sample collection device  200 ; moreover, where present, the sensor(s)  106  of the sample extraction device  100  is(are) placed in correspondence of the sample container  212  of the sample extraction device  100 . 
     The system  300  according to the invention is portable. Its size allows it to be easily handled by a hand of a user. In the embodiment of  FIG.  2   , it is substantially a parallelepiped. However, other shapes are possible, e.g. a cylindrical shape. In another embodiment, its length is in the range of 5 cm to 20 cm, e.g. 10 cm. 
     Then, the user (or an operator) removes the lid  207  of the suction pack  201 , as illustrated in  FIGS.  3    (arrow F 2 ) or  13  (arrow F 6 ). The lid  207  guarantees the sterility of its content. As will be discussed, a membrane  208  of the sample collection device  200  contributes as well to prevent cross contamination of the fluid sample. 
     An embodiment of the system  300  without the lid  207  is illustrated in  FIG.  4   . In this embodiment, the suction pack  201  is (at least partially transparent) so that its content is visible. 
     As illustrated in  FIGS.  5  and  6   , then the user (or an operator) activates a vacuum creation mechanism  108  (a piston in this case, comprising a rod  109 , which is moved in a direction F 3  and then in the opposite direction F 4 ) in the sample extraction device  100  so as to load vacuum into the vacuum chamber  101 . 
     It must be noted that the creation of the vacuum in the vacuum chamber  101  can be performed also before the removing of the lid  207 . In another embodiment, the vacuum does not need to be created by a user, e.g. by activating the vacuum creation mechanism  108 , but it is already pre-packaged in the system  300  according to the invention. In other words, the system  300  comprises a chamber that is placed under vacuum in the manufacturing assembly line or in a healthcare facility. An example of this embodiment will be discussed with reference to  FIG.  36   . 
     Then, the system  300  approaches the user  400  (as illustrated in  FIG.  14   ) and it is placed on the user  400 , as illustrated in  FIGS.  7  and  15   . 
     It must be noted that in one embodiment, the system  300  according to the invention is placed on the user arm, in particular an arm kept vertical, in particular with an orientation so that the cap  202  is on top and the bottom of the sample container  212  is at the bottom with respect to the vertical. However, it could be placed also on other parts of the user (e.g. legs, body, etc.), as long as this part is kept substantially vertical (i.e. substantially parallel to the direction z of the force of gravity g) or forms a predetermined angle θ in the direction z. In particular, in one embodiment, the angle θ formed by the direction a of the main axis of the system  300  according to the invention and the direction z of the force of gravity g is comprised in the range 0°-45°. In fact, the system  300  advantageously exploits also the gravity force (in combination with the vacuum) for extracting the desired volume of the fluid sample. 
     The user (or the operator) then actuates a valve control mechanism  102 , which in the example of  FIG.  16    is a push-button that is pushed in the direction of the arrow F 8 . Of course, other kinds of valve control mechanism  102  can be used instead of a push button, e.g. a rotatory button, etc. 
     The valve control mechanism  102  permits the opening of the valve  104  so as to transfer the vacuum from the vacuum chamber  101  of the sample extraction device  100  to the suction pack  201 . 
     In a particular embodiment, this transfer is performed through an opening  218  in the suction pack  201 , which is covered by a membrane  208  located in the suction pack  201 . In one preferred embodiment, the membrane  208  is made of the same material as the lid  207  (e.g. Tyvek®). 
     This membrane  208  may protect the system  300  from blood contamination that could result in the growth of bacteria and cross-contamination between patients. In one embodiment, the membrane  208 , while letting air go through, prevents bodily fluids like blood permeation. 
     The vacuum created in the suction pack  201  permits also to maintain the whole system  300  against the skin of the user. 
     It also stretches and/or deforms the user&#39;s parts  401  and  402 , visible in  FIG.  17   , among which there is the user&#39;s part to be cut  401 . The user&#39;s part to be cut  401  is the user&#39;s part which enters into contact with the collection window  205  of the sample collection device. The user&#39;s part to be cut  401 , as stretched and/or deformed by the vacuum transferred in the suction pack  201 , actuates the triggering mechanism that in turn triggers the incision mechanism. 
     In fact, as is visible in  FIG.  17   , the stretching and/or the deformation of the skin in the collection window  205  (i.e. the user&#39;s part to be cut  401 ) displaces the triggering element  209 , which in the embodiment of  FIG.  17    is a half-ring surrounding at least a part of the support element  23  (the piston in  FIG.  17   ), so as to liberate the support element  23 . 
     In fact, the movement of the triggering element  209  in the direction of the arrow F 9  in  FIG.  17    disengages the finger  209  from the cavity of notch  211  in the triggering element  209 . 
     Therefore, as illustrated in  FIG.  18   , the loaded elastic element  204  will displace the support element  203  of the incision mechanism inside the cap  202 . In other words, the incision mechanism will be moved from a first incision mechanism position in the cap  202  (illustrated e.g. in  FIG.  8  or  17   ) to a second incision mechanism position in the cap  202  (illustrated e.g. in  FIGS.  9    respectively  18 ). As the support element  203  of the incision mechanism is connected to the cutting element  206 , during this displacement, this cutting element  206  will section a localized part  401  of the stretched and/or deformed skin in the collection window  205 . 
     In other words, the incision is triggered by skin stretching and/or deformation upon applying vacuum in the suction pack  201 : no user action is needed to trigger the incision. The system  300  ensures that the skin is sufficiently stretched and/or deformed before triggering the incision mechanism. The skin, when stretched and/or deformed, presses against the triggering element  209  which, when pushed, displaced or deformed, releases the support element  203  onto which the cutting element  206  is connected. 
     When released, the cutting element  206  moves along the (linear or circular) trajectory of the elastic element  204  to which it is attached and incises the skin on its trajectory. 
     In the embodiment of  FIGS.  8  and  9   , advantageously the movement of the incision mechanism from the first incision mechanism position to the second incision mechanism position is a linear movement (i.e. a translation) performed in a direction parallel to a surface of the user to be incised. 
     The incision into the skin is relatively shallow (less than 5 mm, in particular less than 3 mm into the skin, in length; the depth varies between 1 mm and 2 mm). The cutting element  206  makes a sharp cut into the skin. Moreover, the incision is advantageously made while applying vacuum and/or after vacuum is applied: the skin is deformed and/or stretched and/or pinched into the sample collection device  200  before performing the incision, which reduces the feeling of the pain of the incision. 
     In one embodiment, illustrated in  FIGS.  17  to  19   , at least a part of the edge  219  of the sample container  212  is in contact with the user  400  at a contact point or region P, at or under the incision on the user  400  made by the incision mechanism of the system  300 . This contact point or region P guarantees that there is no space between the user  400  and the sample container  212 , so that the fluid sample can fall down into the sample container  212 . In other words, at least a part of the edge  219  is an edge of the collection window. 
     Advantageously, after the skin incision, the cutting element  206  is retracted into the cap  202 , in particular into a cavity  216  visible in  FIGS.  8  and  9   , with no risk of injury or contamination to anyone handling the sample collection device  200 . 
     In one preferred embodiment, the cutting element  206  is placed at an angle a (illustrated for example in  FIG.  34   ) to maximize the surface cut, without increasing the incision depth. For example, the cutting element  206  can be positioned at a 90° angle with the skin, or it can be placed at a 45° angle with regard to the normal axis of the skin, maximizing the surface of the incision without increasing depth of the incision. In general, the plane containing the cutting element  206  can be positioned anywhere between 45° and 90° with regard to the plane of the skin of the user. 
     In one embodiment, the length of the trajectory of the cutting element  206  allows the cutting of more capillaries so as to maximize the blood flow. 
     The vacuum in the system  300  according to the invention has therefore three main functions: 1) it maintains the system 300 on the user during fluid sample collection; 2) it stretches and/or deforms the skin of the user creating a localized vasodilation of capillaries of the user; and 3) it extracts bodily fluid, e.g. blood from capillaries after the incision has been made. 
     To guarantee a good sealing between the skin of the user and the suction pack  201 , and to maintain vacuum in the suction pack  201 , two elements enter into play: first the better the skin stretches and/or deforms into the suction pack  201 , the higher the surface between the skin and the edge of the suction pack  201  and the better the seal. 
     In order to favor a good stretching and/or deformation of the skin into the blister, the frictional forces between the skin and the suction pack  201  have to be minimized. This can be done e.g. by using the right surface properties of the suction pack  201  and materials inside the suction pack  201  and/or the coating of the suction pack  201  and materials inside the suction pack  201  and/or coating of the skin with a silicone gel, a silicone spray or any other lubricant. 
     Second, the seal between the skin and the suction pack  201  can be enhanced and better guaranteed if no air can penetrate between the skin and the suction pack  201 . In one preferred embodiment, a silicone gel, a silicone spray, or any other lubricant placed between the suction pack  201  and the skin can play the role of a sealing agent. In other words, the materials chosen and the use of a lubricant on the suction pack  201  or on the skin will be used to enhance the vacuum. 
     As illustrated in  FIG.  19   , the fluid (e.g. the blood) flows from the incision created in the deformation window  205 . A sealing edge (illustrated for example in  FIGS.  31  and  33   , reference number  219 ′) ensures that fluid does not flow out of the sample container  212 , the edge of the sample container  212  being positioned near the incision  401 . The drops of fluid  500  formed at the incision point fall into the sample container  212  by exploiting the gravity force g. 
     Since the gravity force g, along with the vacuum, are both used for collecting the fluid sample  500 , the system  500  according to the invention is designed to collect about  1  ml of fluid sample  500 . Moreover, the sample container  212  has a size similar to the tubes used for venipuncture (e.g. diameter 13 mm), making it compatible with known blood analyzers. 
     In the embodiment of  FIG.  21   , the blood extraction device  100  comprises at least a sensor  106 , e.g. an optical sensor in correspondence of the closed end  2121  of the sample container  212 , so as to detect the fluid sample volume. In another embodiment (not illustrated), the sensor(s)  106  are placed in alternative or also on the sample collection device  200 . 
     In one embodiment, once the fluid sample volume has reached a pre-determined value, the system  300  according to the invention indicates to the user (or the operator) the end of fluid sampling, e.g. by a light, a sound or any other appropriated signals. 
     After a sufficient amount of sample fluid has been collected, as shown in the embodiment of  FIG.  21   , the user (or the operator) presses the valve control mechanism  102  (or another valve control mechanism) to put back the system  300 , and in particular the suction pack  201 , at atmospheric pressure. 
     As indicated by the arrow F 11  in  FIG.  22   , the user (or the operator) removes the system  300  from the skin of the user  400 . 
     It is therefore clear that the system  300  according to the invention is arranged to collect a bodily fluid without the need for high-skill training. It could be used by doctors, nurses, non- trained personnel, or by the user (i.e. the patient) himself. The system  300  is designed to require minimal action from the user. The system  300  is positioned on the user, preferably on his arm, kept vertical and pressed against the skin. 
     The user only actuates the valve control mechanism  102  to trigger a vacuum. The vacuum stretches and/or deforms the skin into the suction pack  201 , maintaining it in place against the user. The user does not need to hold the system  300 , he waits for the blood to be collected. 
     Once the required volume is collected, the user is informed by the system  300  and then actuates again the valve control mechanism  102  to return the system  300  to atmospheric pressure. 
     In one preferred embodiment, the time for collecting about 1 mL of bodily fluid is in the range of 1 min to 8 min, in particular 5 min. 
     In one embodiment, the rate with which the fluid, in particular blood, exits from the user once cut by the cutting element  206  of the system  300  is in the range 4 mg/s to 11 mg/s. 
     Then, as illustrated in  FIG.  23   , the user (or the operator) moves the cap  202  onto the sample container  212  to seal it. In the illustrated embodiment, the cap  202  is moved when it is still in the suction pack  201 , to avoid any spillage. In another embodiment, not illustrated, the cap  202  and the sample container  212  are taken out of the suction pack  201  and then the sample container  212  is sealed by the cap  202 . 
     In the embodiment of  FIGS.  23 - 24    (or  FIGS.  10 A- 10 B ), the movement of the cap  202  from the first cap position to the second cap position is a linear movement, the cap  202  sliding onto (the outer surface of) the sample container  212  during this linear movement, as illustrated by the arrow F 12  in  FIG.  23   . 
     However, in another embodiment (not illustrated), the movement of the cap from the first cap position to the second cap position is in complement or in alternative a circular movement. For example, the cap  202  can be screwed onto (the outer surface of) the sample container  212 . 
     As illustrated in  FIG.  25   , the sealed sample container  212  can be removed from the suction pack  201  and it is ready for transport and for sample analysis. 
     As illustrated in  FIG.  26   , the suction pack  201  can then be removed from the sample extraction device  100 . 
     In another embodiment, not illustrated, the suction pack  201  is first removed from the sample extraction device  100 , and them the sample container  212  with the cap  202  are removed from the suction pack  201 . 
     In the embodiment of  FIG.  28   , the sample collection device  100  may be used for combining sample collection and testing. In this case, the sample container  212  located in the sample collection device  100  may contain one or several biomarkers pads  214  reacting with the fluid sample, allowing a direct analysis of the fluid sample by the system  300 . The chemical reaction will produce a signal, e.g. a visible signal (light, color, etc.) which is proportional to the concentration of the target to the measuring in the fluid sample (non-exhaustive list: e.g. fluorescence, reflectance photometry, etc.). The change in color is captured by the sensor(s)  106  of the sample extraction device and converted into a concentration. 
     In the embodiment of  FIG.  29   , the sample collection device  200 , in particular the sample container  212 , comprises an ID element  217 , e.g. a QR code, a barcode, a number, a RF tag etc. 
     In another embodiment, the sample collection device  200  and/or the sample extraction device  100  is (are) arranged so as to store data e.g. blood collection data (such as time of blood collection, level of blood collected, etc.), patient information, sample container barcodes, doctor&#39;s prescription data, and the like. 
     In another embodiment, the sample collection device  200  and/or the sample extraction device  100  is (are) arranged so as to communicate with external devices, in particular portable devices (e.g. smartphones, tablets, etc.) or also to cloud services to which the data can be transferred. 
     It must be noted that the different features illustrated in the embodiments of  FIGS.  1  to  29    (e.g. the trigger element  209  being a half-ring surrounding at least a part of the support element  203 , the sample container  212  entering into the cap  202 , the linear movement of the incision mechanism, etc.) are not necessarily all present. In other words, different embodiments can be imagined by the skilled person, in which not all the illustrated features are together present. 
       FIGS.  30  and  31    show a perspective view respectively of a cross-section view of another embodiment of the sample collection device  200  according to the invention. In the illustrated embodiment, the trigger element  209  is a demi-ring over the cap  202 . In this embodiment, the blade  206  is inclined at an angle β with regard to the normal axis of the skin (which correspond to the normal axis of the piston  203  when the system  300  is placed on the user&#39;s skin), this angle being different than 90°. This allows the cutting element to enter more tangentially into the user&#39;s skin. In this embodiment, moreover, the cap  202  is over a part of the sample container  212 . In other words, the cap  202  does not enter into the sample container  212 , but rather the sample container  212 , in particular at least its end  2121 , enters into the cap  202 . Finally, in this embodiment, the sample container  212  comprises at least two portions  2123 ,  2124 , having different diameters d 1  and respectively d 2 . In one particular embodiment, the diameter dl is a standard diameter according to the definition given above. 
     It must be noted that the different features illustrated in the embodiment of  FIGS.  30 ,  31    (e.g. the trigger element  209  being a demi-ring over the cap  202 , the sample container  212  entering into the cap  202 , the sample container  212  comprising two portions  2123 ,  2124 , the inclined blade  206 , etc.) are not necessarily together present. In other words, different embodiments can be imagined by the skilled person, in which not all the illustrated features are together present. 
     For example, it is possible to imagine a sample collection device  200  in which the trigger element  209  is a demi-ring over the cap  202 , the sample container  212  enters into the cap  202 , the blade  206  is inclined but the sample container  212  comprises a single portion. Moreover, the embodiment of  FIGS.  30 ,  31    can be combined with any of the other previously or later described embodiments. 
       FIGS.  32 ,  33  and  34    show a perspective view respectively cross-section views of another embodiment of the sample collection device  100  according to the invention. In the illustrated embodiment, the trigger element  209  is not a demi-ring over the cap  202 , as in  FIGS.  30  and  31   . 
     In this embodiment, the trigger element  209  is a tab  209 ′ in the cap  202 , which is held in place by the finger  210 ′. The skin of the user, once deformed by the vacuum, will move the tab  209 ′ in the direction of the arrow F 14 , by liberating the tab  209 ′ from the finger  210 ′ so as to liberate the elastic element  204  and therefor the piston  203  with the cutting element  206 . 
     In the embodiment of  FIGS.  32 ,  33 , and  34   , the blade  206  is inclined at an angle β with regard to the normal axis of the skin, this angle being different from 90°, as in  FIGS.  30  and  31   . In this embodiment, the cap  202  is over a part of the sample container  212 , as in  FIGS.  30  and  31   . Finally, in this embodiment, the sample container  212  comprises two portions  2123 ,  2124 , having different diameters d 1  and respectively d 2  as in  FIGS.  30  and  31   . Again, the features illustrated in the embodiment of  FIGS.  32 ,  33  and  34    are not necessarily all present. Moreover, the embodiment of  FIGS.  32 ,  33    can be combined with any of the other previously or later described embodiments. 
       FIGS.  35 A and  35 B  show cross-sectional views of another embodiment of the sample collection device  200  according to the invention. In this embodiment, the support element  203  comprises a protrusion  230 , which, once the support element is moved in the direction of the arrow F 15  by the triggering mechanism, will enter into contact with the finger  232  of the cap  202 : this will cause a mechanical movement of all of the support element  203 , and then of the cutting element  206 , toward the user&#39;s skin, so that the cutting element will move toward the user&#39;s skin while cutting it. In such a way, a deeper cut could be realized in the user&#39;s skin. The shape and the size of the protrusion  230  and/or of the finger  232  are selected so that the movement of the cutting element  206  toward the user&#39;s skin is performed while the cutting element  206  is cutting the user&#39;s skin. Other means can be imagined in order to move the cutting element  206  toward the user&#39;s skin while it cuts the skin. This embodiment can be combined with any of the other previously or later described embodiments. 
       FIG.  36    shows a perspective view of another embodiment of the system  300  for extracting and collecting a sample of a fluid of a user according to the invention. 
     In this embodiment:
         the system  300  is fully consumable/disposable;   the vacuum is already pre-packaged in the system  300 ;   the triggering mechanism is configured so as to perform a circular movement;   the incision mechanism is configured so as to perform a circular movement;   the suction pack comprises an opening which is narrow near or at the collection window;   the lid is not permeable; and   the part(s) in contact with the skin is(are) adapted so as to fit to the shape of the user contacting part;—etc.       

     However, it must be noted that the features illustrated in the embodiments of  FIG.  36    are not necessarily all present. In other words, different embodiments can be imagined by the skilled person, in which not all of the illustrated features are present. Moreover, the embodiment of  FIG.  36    can be combined with any of the other previously described embodiments. 
       FIG.  37    shows an exploded view of the embodiment of the system  300  of  FIG.  36   . In this figure, the suction pack  201  present in the previously described embodiments is a first suction pack  201  (or inner suction pack  201 ), and the system  300  comprises a second suction pack  110  (or outer suction pack  110 ). 
     The first suction pack  201  comprises a cavity  2010  arranged to receive the sample container  212  and the cap  202  and having a first thickness. The second suction pack  110  comprises a cavity  1100  having a second thickness, which is greater than the first thickness. The first suction pack  201  is arranged to be received by the second suction pack  110 , so that the difference between the two thicknesses creates a chamber that is placed under vacuum in the manufacturing assembly line or in a healthcare facility. In other words, the pre-packaged vacuum is made by adding a second suction pack  110  on top of the first suction pack  201  so to create this chamber. 
     The first and second suction packs are arranged so that, once the second suction pack  110  receives the first suction pack  201 , they can be permanently sealed together. 
     The system  300  of the embodiment of  FIG.  37    comprises also means for transferring the vacuum from the chamber placed under vacuum in the manufacturing assembly line or in a healthcare facility (in the following, second vacuum chamber) to the first vacuum chamber  101 , once a user wished to activate the system  300 . 
     In one embodiment, the second suction pack  110  comprises a bistable element (as a button) on one of its outer surfaces. An example of such bistable element is visible in  FIG.  38   , which shows a part of a cross-section view of the embodiment of the system of  FIGS.  36 ,  37   . 
     In this embodiment, the first suction pack  201  comprises also a piercing protrusion (reference  2014  in  FIG.  34   ). Once a user activates the bistable element  2012 , e.g. pressing on the second suction pack  110 , the piercing protrusion  2014  will pierce a membrane  208  placed on the first suction pack  201 , thereby transferring the vacuum in the first vacuum chamber or collection chamber. This will start the collection of the liquid sample. In one preferred embodiment, this membrane is non-permeable, so as to avoid a vacuum transfer before the use of the system  300 . 
     In one embodiment, the second suction pack  110  comprises also one or more holes  2010 , completely covered by a removable cap  140 , e.g. a rubber removable cap  140 . In order to stop the collection of the liquid sample, the user can remove, e.g. by pulling, the removable cap  140  so as to lower the pressure in the collection chamber to the atmospheric pressure, thereby stopping the start of the collection of the liquid sample. 
     In the example of  FIG.  36   , a (removable) label  130  can cover the back of the second suction pack  110 . 
       FIG.  39    shows another part of another cross-section view of the embodiment of the system of  FIG.  36   . In the illustrated embodiment, the cutting element  206  makes an incision in the skin of the user by moving into a rotational movement around the main central axis of the tube (and cap  202 ). This rotational movement allows a more compact triggering and incision mechanism. In fact, by choosing a rotational movement of the cutting element  206 , the overall length of the triggering mechanism is reduced, allowing for a smaller dimension of the cap  202  and a smaller overall system  300 . 
     In one embodiment, the cap  202  comprises on its top one or more deformable elements  2020 , visible in  FIG.  39   , which is(are) arranged to be deformed in the direction of the arrow F 16 . The deformable element(s)  2020  is(are) part of the triggering mechanism. Upon applying vacuum, the skin is sucked into the chamber and presses against the deformable element(s)  2020  on the cap  202 . By pushing the deformable element(s)  2020 , the deformable element(s)  2020  free the rotational piston  203  previously loaded with a (torsion) spring  204 . 
       FIG.  41 A  shows a perspective view (front side) of one embodiment of the sample collection device of the system of  FIG.  36   .  FIG.  41 B  shows a perspective view (rear side) of the embodiment of the sample collection device of  FIG.  41 A . In the illustrated embodiment, the triggering element is part of the cap  202 . In another embodiment the deformable elements  2020  belong to a supplementary piece, fixed (in a movable or unmovable way) to the cap  202 . The deformable elements  2020  are larger than in previous variants, for a wider area of contact between the skin and the triggering mechanism permitting to have more reliability in the triggering mechanism. 
     In this embodiment, the cap  202  comprises a liberation notch  2021 . When vacuum is released, the skin will press the triggering surface  2022  of the cap  202 , by pushing the notch  2021  and setting the piston  203  free. 
     Increasing the length of the collection window  205 , allows an improvement in the skin stretching. Having a rotational movement of the cutting element  206  allows that the length of the incision is not dependent on the length of the collection window  205  (proportional the window&#39;s width), as it is the case with a translational movement of the cutting element  206 . 
     By resuming, having a rotational movement of the cutting element  206  provides the following advantages:
         a more compact system  300 ;   a more reliable triggering mechanism;   a more controlled and defined skin stretching.       

     In one embodiment, as visible e.g. on  FIG.  36   , the cavity  2010  of the suction pack  201 , arranged to receive the collection container  212 , has a waisted shape, which is narrower at or near the collection window  205 , in particular at or near the incision area, so as to allow for a better stretching of the skin. The applicant has noticed that the skin deforms well along the edges  2011  of the cavity  2010  of the suction pack  201 . To maximize the skin deformation at or near the incision area, the edges of the cavity  2010  of the suction pack  201  are arranged closer to the incision area, by making it narrower. 
       FIG.  42    shows a top view of the system  300  according to the invention, once placed near a user&#39;s member as an arm. In this embodiment, the suction pack  201 , in contact with the skin, has a shape and/or a curvature  2013  to fit the shape and/or the curvature of the arm of the user  400  to ensure a better seal between the skin and the suction pack  201 . In another embodiment (not illustrated), this shape and/or this curvature can be adapted or changed by the user, so as to better fit with the user, in particular with young users. 
       FIG.  43    to  FIG.  49 B  show a further embodiment of a sample collection device  3200  for collecting a blood sample  3500  of a patient of the present invention. The sample collection device  3200  comprises the same structural and functional features and capabilities as the embodiments described above. It can be combined with one or several of the above-described features of the already described sample collection devices. 
     Similar or identical features are denoted with the same (or similar) reference numbers, whereas the value is increased by  3000  or in case of the embodiment shown in  FIG.  36    to  FIG.  42    increased by the value  2000 . 
       FIG.  43    shows an exploded view of a further embodiment of a sample collection device  3200  for collecting a blood sample of a patient of the present invention. The sample collection device  3200  comprises a first shell  3110  and a second shell  3201 . The first shell  3110  is a partially deformable shell  3110 . The shell  3110  comprises a deformable button  3224 . The deformable button is integrally formed within the shell  3110 . In this area, the shell is deformable in a predefined manner, i.e. such that it allows an elastic or plastic deformation by pressing in this section. The button  3224  has a size that is oriented on the size of human thumbprint. The diameter of the button  3224  in the shown embodiment is approx. 30 mm. Further, the shell  3110  has an electronic module port  3226 . The electronic module port  3226  is formed integrally in the shell  3110 . In particular, the electronic module port  3226  is formed by means of a recess. The electronic module port  3226  is configured for receiving and holding an electronic module  3220 . The electronic module  3220  is an optional element. It can be reusable, whereas the rest of the sample collection device  3200  can be a disposable. The electronic module  3220  can comprise the sensors described in this disclosure (cf. especially description parts above). 
     The electronic module  3220  can comprise electronic components configured to execute computer-readable instructions for measuring blood volume, but also may be used for in-situ diagnostics. It can comprise at least one of the following elements, e.g. one or more sensors (of any kind such as temperature sensor, pH-sensor, pressure sensor etc.), one or more power storage units such as a battery, an electronic circuit, at least one communication module, at least one controller, at least one processor, at least one telemetry unit etc. 
     The second shell  3201  is a partially pierceable shell  3201 . The partial pierceable portion is, however, provided by the membrane  3208 , which is placed in the pierceable membrane position  3238 . In this position, the membrane  3208  is firmly welded to the second shell  3201 . 
     In the mounted state of the collection device  3200  there is a pre-packaged vacuum sealed between the first shell  3110  and the second shell  3201 . Again, there is also a pierceable membrane  3208  as already describe above. 
     The second shell  3201  is configured such that in the mounted state a sample container  3212  and an automatic mechanical cutting mechanism are held by the second shell  3201 . The second shell  3201  comprises a base plate  3230  with stabilization ribs  3228  and a main holder recess  3229 . The ribs  3228  prevent collapsing of the first shell  3110  under vacuum. 
     There can be also different arrangements and designs of the ribs. In particular, there can be also a rib design having e.g. at least one circumferential rib encircling the main holder recess  3229 . Then the rib can encircle the main holder recess  3229  with the form of an oval. The rib(s)  3228  can be positioned vertical to the base plate  3230 . 
     In the base plate  3230 , there is a collection opening  3231 . As already described, the collection opening comprises a narrow portion in the area of the cutting mechanism. The narrow portion is formed by rounded protrusions  3230   a  of the base plate  3230 . The function of this narrow portion is already explained above in greater detail. It facilitates the blood collection and incision process. 
     As can be seen e.g. in  FIG.  45 C  and  FIG.  45 E , the base plate  3230  is curved to better fit and adjust to the skin surface of e.g. a human arm. The base plate  3230  can be made of a rigid plastic material (medical grade). All elements of the device  3200  are made of plastic (except the electronic module  3220  and the spring  3204  and the cutting blade  3206 ). On the outside of the main holder recess  3229 , there is vacuum unlocking element  3234  in the form of a bendable arm carrying a piercing portion of vacuum unlocking element  3236 . Further, as a part of the wall of the main holder recess  3229 , there is a pierceable membrane  3208  placed in position  3208 , welded firmly to the second shell  3201 . It is made here in this embodiment of aluminum but can be any other suitable material. The membrane  3208  is arranged such that it can be pierced by means of the vacuum unlocking element  3236 . The base plate  3230  also comprises a handle portion  3232 . With the handle portion, the sample collection device  3200  can be removed from the sample collection side when the collection process is finished. The handle portion  3232  or tab  3232  can be also formed on the first shell  3110  or on both the first shell  3110  and the second shell  3201 . 
     To enclose and to ensure sterility of the automatic mechanical cutting mechanism and the sample container within the main holder recess  3229  of the second shell  3201 , there is a lid  3207  (as already described above in connection with lid  207 ). 
     The automatic mechanical cutting mechanism comprises a trigger  3209 , an actuator spring  3204  (here a torsion spring  3204 ), a plunger  3203  holding a cutting blade  3206 , a cap  3202  and a sample container  3212 . 
     The sample container  3212  is formed as a cylindrical tube with a closed and an open end, the open end being oriented to the cap and plunger  3203 . The plunger  3203  further comprises a seal  3203   a  and a septum  3203   b.  The seal  3203   a  is formed as an O-Ring on the radial outside of the plunger  3203 . 
       FIG.  44 A-C  show details of the device  3200  shown in  FIG.  43   , the details being related to the functionality of the device  3200 . 
     In step S 1 , the user deforms the button  3224  of the blister  3110  (i.e. the first shell  3110 ), after he has put the device  3200  on the collection site, e.g. being located in the arm of the patient. 
     In step S 2 , the deformable arm  3234  (also deformable beam  3234 ) is deflected by this and pierces the aluminum membrane  3208  (placed in position  3238 ). 
     In step S 3 , the vacuum is liberated. 
     In step S 4 , the skin is stretched and pressed on the trigger  3209 . 
     In step S 5 , the trigger  3209  liberates the spring-loaded plunger  3203 , whereas the spring load is created by the torsion spring  3204  (cf. also  FIG.  49 A  and  FIG.  49 B ). 
     In step S 6 , the cutting blade  3206  firmly mounted to the released plunger  3203  rotates and creates an incision in the stretched skin. 
     In step S 7 , blood is flowing into the tube  3212  and is collected there. 
     In step S 8 , the user pulls the handle  3232  to stop the blood collection, thereby releasing the device  3200  from the skin. The closure of the tube  3212  is described below. 
     As shown in  FIG.  46 E , with the trigger  3209 , the plunger  3203 , the seal  3203   a  being engaged with the outer radial wall (radial outside) of the plunger  3203  and the inner wall of the tube  3212 , the tube  3212  carrying blood  3500  can be closed and sealed. 
     Closing of the tube  3212  can be effected by simply putting a finger into the interspace  3240  (cf.  FIG.  44 C ), then pressing all parts together and thereby closing and sealing the sample container. 
       FIG.  45 A-E  show different views of the device  3200  of  FIG.  43   . 
       FIG.  46 A-E  show different views of the sample container of the embodiment shown in  FIG.  43    in connection with extension tubes  3250  (as already described above). 
       FIG.  47 A-F  show different views of the plunger  3203  and the cutting blade  3206  of the embodiment shown in  FIG.  43   . 
       FIG.  48 A-B  show different views of the metal cutting blade of the embodiment shown in  FIG.  43   . 
     As shown, the cutting blade  3206  comprises a cutting edge  3206   a,  wherein the cutting edge  3206   a  has an acute end  3206   b  and a rounded end  3206   c.  The cutting edge  3206   a  of the cutting blade  3206  can have an angle γ chosen in the range of 15°-25°, especially approx. 19°-21°, here of 20°. A deviation of ±1° is not problematic and will be tolerated in this embodiment. 
     The acute end  3206   b  of the cutting blade  3206  can have an angle δ chosen in the range of 45°-55°, especially approx. 47°-53°, here of approx. 50°. 
     The rounded end  3206   c  of the cutting blade  3206  has the same radius R as the outer edge of the cutting blade  3206  on the side of the rounded end  3206   c.    
     For form-fit attachment to the plunger  3203 , there is a holder opening  3206   d,  having fixation recesses  3206   e.    
     For easier manufacturing, there is a break line  3206   f.    
     On this break line, the two blades could be jointly manufactured and then are broken into separate blades. Alternatively, also a manufacturing portion or a carrier could be there during manufacturing, which allows easier handling. 
       FIG.  49 A-B  are different views of the metal torsion spring  3204  of the embodiment shown in  FIG.  43   . 
     The torsion spring  3204  is shown it the loaded position C 1  and the unloaded position C 3 . 
     The following aspects are in the following explicitly disclosed in connection with the present invention as described above: 
     Aspect 1: A sample collection device ( 200 ) for collecting a sample ( 500 ) of a fluid of a user, e.g. blood, the sample collection device ( 200 ) comprising:
         a sample container ( 212 ) arranged to receive said sample ( 500 ) and comprising an open end ( 2121 );   a triggering mechanism ( 209 ,  210 ,  209 ′,  210 ′,  211 );   a cap ( 202 ) arranged to cooperate with said sample container ( 212 ) so as to close said open end ( 2121 ), said cap ( 202 ) being arranged to be moved in and/or on the sample container ( 212 ) from a first cap position to a second cap position, wherein in the first and in the second cap positions said cap ( 202 ) is at least partially in contact with said sample container ( 212 ) so as to guide the movement of the cap ( 202 ) from the first cap position to the second cap position, said cap ( 202 ) comprising:
           a collection window ( 205 ) arranged to enter in contact with an area of the user to be incised;   an incision mechanism ( 203 ,  204 ,  206 ) movable in the cap ( 202 ) by said triggering mechanism ( 209 ,  210 ,  209 ′,  210 ′,  211 ) from a first incision mechanism position to a second incision mechanism position, wherein during said moving the incision mechanism ( 203 ,  204 ,  206 ) is arranged to incise at the collection window ( 205 ) the area of the user so as to exit the sample ( 500 ) from the user, said sample being received by said sample container ( 212 ), and wherein during the moving from the first incision mechanism position to the second incision mechanism the cap ( 202 ) is in the first cap position;   a sealing mechanism, so as to seal said sample container ( 212 ) when the cap ( 202 ) is in the second cap position, so as to safely transport said sample ( 500 ).   
               

     Aspect 2: The sample collection device ( 200 ) of aspect 1, wherein said cap ( 202 ) comprises a first cap portion ( 2021 ) and a second cap portion ( 2022 ), wherein the first cap portion ( 2021 ) comprises the collection window ( 205 ) arranged to enter into contact with the user. 
     Aspect 3: The sample collection device ( 200 ) of aspect 2, wherein said cap ( 202 ) comprises an opening ( 215 ), the collection window ( 205 ) comprising a part of said opening ( 215 ). 
     Aspect 4: The sample collection device ( 200 ) of one of aspects 2 or 3, wherein at least a part ( 2021 ′) of said first cap portion ( 2021 ) is inserted into the sample container ( 212 ). 
     Aspect 5: The sample collection device ( 200 ) of one of aspects 2 to 4, wherein the second cup portion ( 2022 ) comprises a cavity ( 216 ) for receiving the incision mechanism ( 203 ,  204 ,  206 ) once it is in said second incision mechanism position, the incision mechanism ( 203 ,  204 ,  206 ) is irreversibly and safely retracted in this cavity ( 216 ) so that it can no longer incise the user. 
     Aspect 6: The sample collection device ( 200 ) of one of aspects 1 to 5, said incision mechanism ( 203 ,  204 ,  206 ) comprising: —a support element ( 203 ), e.g. a piston, comprising a cutting element ( 206 ), e.g. a blade or blade-like element; —an elastic element ( 204 ), e.g. a spring, being blocked in a compressed position, said elastic element ( 204 ), once the incision mechanism is triggered, being free to be decompressed, said decompression moving the support element ( 203 ) and then the cutting element ( 206 ) from the first incision mechanism position to the second incision mechanism position. 
     Aspect 7: The sample collection device ( 200 ) of aspect 6, wherein when in the first incision mechanism position, the cutting element ( 206 ) is in the sample container ( 212 ), so as to ensure the safety of the user and/or of an operator. 
     Aspect 8: The sample collection device ( 200 ) of one of aspects 1 to 7, wherein the movement of the incision mechanism ( 203 ,  204 ,  206 ) from the first incision mechanism position to the second incision mechanism position is a linear movement performed in a direction parallel to the area of the user to be incised. 
     Aspect 9: The sample collection device ( 200 ) of one of aspects 1 to 7, wherein the movement of the incision mechanism ( 203 ,  204 ,  206 ) from the first incision mechanism position to the second incision mechanism position is a circular movement, wherein the axis of rotation of this circular movement is preferably a main axis of the sample container ( 212 ). 
     Aspect 10: The sample collection device ( 200 ) of one of aspects 1 to 9, wherein the support element comprises a protrusion ( 230 ) cooperating with a finger ( 232 ) of the cap ( 202 ) so that the movement of the incision mechanism ( 203 ,  204 ,  206 ) from the first incision mechanism position to the second incision mechanism position is toward the user&#39;s skin while the incision mechanism ( 203 ,  204 ,  206 ) cuts the skin. 
     Aspect 11: The sample collection device ( 200 ) of one of aspects 1 to 10, wherein the movement of the cap ( 202 ) from the first cap position to the second cap position is a linear movement, the cap sliding onto the sample container ( 212 ) during said linear movement. 
     Aspect 12: The sample collection device ( 200 ) of one of aspects 1 to 10, wherein the movement of the cap ( 202 ) from the first cap position to the second cap position is a circular movement. 
     Aspect 13: The sample collection device ( 200 ) of one of aspects 1 to 12, comprising a suction pack ( 201 ) arranged to receive the sample container ( 212 ) and the cap ( 202 ), and to be sterilized, the suction pack ( 201 ) comprising a membrane ( 208 ) allowing the vacuum to enter in the suction pack ( 201 ). 
     Aspect 14: The sample collection device ( 200 ) of aspect 13, the suction pack ( 201 ) comprising a removable lid ( 207 ), in particular a non-permeable removable lid ( 207 ), so as to guarantee a barrier from moisture and ensure sterilization of its content. 
     Aspect 15: The sample collection device ( 200 ) of one of aspects 13 or 14, the suction pack ( 201 ) being at least partially transparent. 
     Aspect  16 : The sample collection device ( 200 ) of one of aspects 13 to 15, comprising lubricant materials inside the suction pack ( 201 ) and/or on the suction pack ( 201 ) so as to enhance the sealing between the suction pack ( 201 ) and the user. 
     Aspect 17: The sample collection device ( 200 ) of one of aspects 6 to 16, said triggering mechanism ( 209 ,  210 ,  209 ′,  210 ′,  211 ) comprises a triggering element ( 209 ) arranged to be moved from a first triggering element position, wherein it holds the elastic element ( 204 ) in a blocked position, e.g. in a compressed position, and the support element ( 203 ) in a fixed position, to a second triggering element position wherein the triggering element ( 209 ) no longer holds the elastic element ( 204 ) nor the support element ( 203 ). 
     Aspect 18: The sample collection device ( 200 ) of aspects 17, the cap ( 202 ) comprising the triggering element ( 209 ), which for example is a half-ring surrounding at least a part of the support element ( 203 ), or a tab ( 209 ′) in the cap ( 202 ). 
     Aspect 19: The sample collection device ( 200 ) of one of aspects 17 to 18, the triggering element comprising a protrusion ( 211 ), e.g. a finger, the support element comprising a cavity ( 210 ) arranged to receive said protrusion ( 211 ) so as to hold the triggering element ( 209 ) in the first triggering element position. 
     Aspect 20: The sample collection device ( 200 ) of one of aspects 1 to 19, said cap ( 202 ) being a standard cap arranged to be automatically opened by a blood analysis apparatus. 
     Aspect 21: The sample collection device ( 200 ) of the previous aspect, the diameter of the second portion ( 2022 ) of the standard cap being 15 mm. 
     Aspect 22: The sample collection device ( 200 ) of one of aspects 1 to 21, said sample container ( 212 ) being a tube, in particular a standard tube being arranged to be entered in a blood analysis apparatus. 
     Aspect 23: The sample collection device ( 200 ) of the previous aspect, a diameter (dl) of the standard tube being comprised in the range 12 mm to 16 mm, e.g. 13 mm. 
     Aspect 24: The sample collection device ( 200 ) of one of aspects 1 to 23, said sample container ( 212 ) being arranged for receiving at least 0.5 ml, and preferably 1 ml, of fluid sample ( 500 ). 
     Aspect 25: The sample collection device ( 200 ) of one of aspects 1 to 24, said sample container ( 212 ) being at least partially transparent. 
     Aspect 26: The sample collection device ( 200 ) of one of aspects 1 to 25, said sample collection device ( 100 ) being consumable. 
     Aspect 27: The sample collection device ( 200 ) of one of aspects 1 to 26, the sample container ( 212 ) comprising one or several biomarker pads ( 214 ) reacting with the fluid sample, allowing a direct analysis of the fluid sample. 
     Aspect 28: The sample collection device ( 200 ) of one of aspects 1 to 27, said cap ( 202 ) comprising said triggering mechanism ( 209 ,  210 ,  209 ′,  210 ′,  211 ), in particular wherein said triggering mechanism comprises at least one deformable element ( 2020 ). 
     Aspect 29: The sample collection device ( 200 ) of one of aspects 1 to 28, said cap ( 202 ), the suction pack ( 201 ) being a first suction pack ( 201 ), the sample collection device ( 200 ) comprising a second suction pack ( 110 ), wherein the first suction pack ( 201 ) comprises a cavity ( 2010 ) arranged to receive the sample container ( 212 ) and the cap ( 202 ), and having a first thickness, wherein the second suction pack ( 110 ) comprises a cavity ( 1100 ), having a second thickness, which is greater than the first thickness, wherein the first suction pack ( 201 ) is arranged to be received by the second suction pack ( 110 ), so that the difference between the two thicknesses creates a chamber arranged to be placed under vacuum in the manufacturing assembly line or in a healthcare facility. 
     Aspect 30: The sample collection device ( 200 ) of aspect 29, wherein, the second suction pack ( 110 ) comprises a bistable element, wherein the first suction pack ( 201 ) comprises a piercing protrusion ( 2014 ), wherein once a user activates the bistable element ( 2012 ), the piercing protrusion ( 2014 ) pierces a membrane ( 208 ) on the first suction pack ( 201 ), thereby transferring the vacuum in the collection chamber. 
     Aspect 31: The sample collection device ( 200 ) of one of aspects 28 or 29, wherein the second suction pack ( 110 ) comprises also one or more holes ( 2010 ), completely covered by a removable cap ( 140 ). 
     Aspect 32: The sample collection device ( 200 ) of one of aspects 1 to 31, wherein the part of the suction pack ( 201 ) arranged to be placed in contact with a user has a curvature ( 2013 ) to fit the shape and/or the curvature of the user, so as to ensure a better seal between the user and the suction pack ( 201 ). 
     Aspect 33: A system ( 300 ) for extracting and collecting a sample ( 500 ) of a fluid of a user, comprising:
         the sample collection device ( 200 ) according to one of the aspects 1 to 32;   a sample extraction device ( 100 ), comprising:
           a port ( 107 ) arranged to receive at least a part of said sample collection device ( 200 );   a vacuum chamber ( 101 );   a vacuum creation mechanism ( 108 ) arranged to create vacuum in the vacuum chamber ( 101 );   a valve ( 104 ) arranged to close and/or open the vacuum chamber ( 101 ), and/or to release the sample collection device ( 200 ) to atmospheric pressure;   a valve control mechanism ( 102 ) arranged to command the valve ( 104 ) so as to release the vacuum from the vacuum chamber ( 101 ) to the sample collection device ( 200 ), and/or to release the sample collection device ( 200 ) to atmospheric pressure.   
               

     Aspect 34: The system ( 300 ) of the aspect 33, wherein the sample extraction device  100  comprises first connection means ( 120 ), the sample collection device  200  comprises second connection means ( 220 ) so as to perform a mechanical connection between the sample extraction device ( 100 ) and the sample collection device ( 200 ). 
     Aspect 35: The system ( 300 ) of one of the aspects 33 or 34, wherein the sample extraction device ( 100 ) comprises an electronic module ( 105 ) comprising a communication module and a power supply. 
     Aspect 36: The system ( 300 ) of one of the aspects 33 to 35, wherein the sample extraction device ( 100 ) comprises at least a sensor ( 106 ), e.g. an optic sensor, for detecting a predetermined sample volume in the sample container ( 212 ). 
     Aspect 37: The system ( 300 ) of one of the aspects 33 to 36, wherein the sample extraction device ( 100 ) comprises an alerting mechanism, indicating to the user the end of the sample extraction, e.g. by an audio and/or visible signal. 
     Aspect 38: The system ( 300 ) of one of the aspects 33 to 37, wherein extraction device comprising a gasket ( 103 ) cooperating with the area of the sample collection device ( 200 ) comprising the membrane ( 208 ). 
     Aspect 39: The system ( 300 ) of one of the aspects 33 to 38, wherein the sample collection device ( 200 ) and the sample extraction device ( 100 ) are arranged so that, when connected, the valve ( 104 ) of the sample extraction device ( 100 ) is placed in correspondence with the membrane ( 208 ) of the sample collection device ( 200 ) and/or the sensor(s) ( 106 ) of the sample extraction device ( 100 ) is(are) placed in correspondence with the sample container ( 212 ) of the sample extraction device ( 100 ). 
     Aspect 40: The system ( 300 ) of one of the aspects 33 to 39, wherein the sample extraction device ( 100 ) is consumable. 
     Aspect 41: The system ( 300 ) of aspect 40, wherein the sample collection device ( 200 ) and the sample extraction device ( 100 ) form a single consumable system ( 300 ). 
     Aspect 42: A method for extracting and collecting a sample ( 500 ) of a fluid of a user by using the system ( 300 ) according to aspects 33 to 40, comprising the following steps:
         placing the system ( 300 ) on an area of the user ( 400 ) kept substantially vertical so that the angle (θ) formed by the direction (a) of the main axis of the system ( 300 ) and the direction (z) of the force of gravity (g) is comprised in the range 0°-45°;   actuating the valve control mechanism ( 102 ), so as to open the valve ( 104 ) so as to transfer the vacuum from the vacuum chamber ( 101 ) of the sample extraction device ( 100 ) to the suction pack ( 201 ) of the sample collection device ( 200 ) through an opening ( 218 ) in the suction pack ( 202 ), said opening ( 218 ) being covered by a membrane ( 208 ) located in the suction pack ( 202 );   stretching and/or deforming a user&#39;s part to be cut ( 401 ) by the vacuum in the suction pack ( 201 );   actuating by the stretched and/or deformed user&#39;s part to be cut ( 401 ) the triggering mechanism ( 209 ,  210 ,  209 ′,  210 ′,  211 ) which in turn triggers the incision mechanism ( 203 ,  204 ,  206 );   moving the incision mechanism ( 203 ,  204 ,  206 ) from a first incision mechanism position in the cap ( 202 ) to a second incision mechanism position in the cap ( 202 ) so that, as the support element ( 203 ) of the incision mechanism is connected to the cutting element ( 206 ), the cutting element ( 206 ) will section the stretched and deformed user&#39;s part to be cut ( 401 ); collecting a volume of fluid sample in the sample container ( 212 ); moving the cap ( 202 ) onto the sample container ( 212 ) from the first cap position to the second cap position to seal the sample container ( 212 ).       

     Aspect 43: The method of aspect 42, further comprising:
         after the skin incision, retracting the cutting element ( 206 ) into the cap ( 202 ), with no risk of injury or contamination to anyone handling the sample collection device ( 200 ).       

     Aspect 44: The method of one of aspects 42 or 43, further comprising:
         placing a cap ( 202 ) in and/or on the sample container ( 212 ), said cap ( 202 ) being at least partially in contact with said sample container ( 212 );   packaging the sample container ( 212 ) and the cap ( 202 ) in the suction pack ( 202 ); closing the suction pack ( 202 ) by a lid ( 207 );   sterilizing the closed suction pack ( 202 ); placing the sterilized suction pack ( 202 ) on or in the sample extraction device ( 100 ).       

     Aspect 45: The method of one of aspects 42 to 44, further comprising:
         mechanically connecting the sterilized suction pack ( 202 ) to the sample extraction device ( 100 );   removing the lid ( 207 ) of the suction pack ( 201 ); activating a vacuum creation mechanism ( 108 ) of the sample extraction device ( 100 ) so as to load vacuum into the vacuum chamber ( 101 ).       

     Aspect 46: The method of one of aspects 42 to 45, further comprising:
         once the fluid sample volume has reached a pre-determined value, indicating to the user the end of fluid sampling;   pressing the valve control mechanism ( 102 ) to put back the system ( 300 ), and in particular the suction pack ( 201 ), at atmospheric pressure.       

     Aspect 47: The method of one of aspects 42 to 46, further comprising:
         removing the system ( 300 ) from the skin of the user ( 400 ); removing the sealed sample container ( 212 ) from the suction pack ( 201 ); removing the suction pack ( 201 ) from the sample extraction device ( 100 ).       

     As used herein, the term “approximately” is construed to mean plus or minus five percent of the range unless otherwise specified. 
     The following claims particularly point out certain combinations and sub-combinations regarded as novel and non-obvious. These claims may refer to “an” element or “a first” element or the equivalent thereof. Such claims should be understood to include incorporation of one or more such elements, neither requiring nor excluding two or more such elements. Other combinations and sub-combinations of the disclosed features, functions, elements, and/or properties may be claimed through amendment of the present claims or through presentation of new claims in this or a related application. Such claims, whether broader, narrower, equal, or different in scope to the original claims, also are regarded as included within the subject matter of the present disclosure.