Sample collection device, system and method for extracting and collecting user's body fluid sample

Abstract

The present application discloses a sample collection device (3200) for collecting a patient's blood sample (3500), wherein the sample collection device (3200) comprises at least: a partially deformable first shell (3110), and a second shell (3201) that is at least partially pierceable, wherein in an installed state of the collection device (3200), a pre-installed vacuum is sealed between the first shell (3110) and the second shell (3201), and further wherein the second shell (3201) accommodates a sample container (3212) and an automatic mechanical cutting mechanism in the installed state, The mechanism includes a rotatable cutting blade (3206) and an actuator spring (3204), wherein the actuator spring (3204) can be actuated by pressing the first shell (3110) to release and rotate the cutting blade (3206), and further wherein by pressing the first shell (3110), the pre-installed vacuum is released to the collecting opening (3231) of the second shell (3201), so that the vacuum produces a suction effect, so that the blood flowing out of the incision established by the rotatable cutting blade (3206) will leak into the sample container (3212).

Description

Technical Field

[0001] The present application relates to a sample collection device for collecting a body fluid sample of a user, such as blood, especially capillary blood. The present application also relates to a system and method for extracting and collecting the sample. Background Art

[0002] Venipuncture is a method of collecting blood in which a vein is punctured with a hollow needle and blood is collected into a tube. This method allows large, high-quality blood samples to be collected into tubes, filling several tubes with a single blood draw. In addition, these tubes are compatible with highly automated blood analyzers, which can analyze thousands of samples per day. These high-throughput capabilities meet the need for rapid, clinical-grade diagnostics at minimal cost.

[0003] However, this method requires healthcare professionals (e.g., nurses) with specific qualifications and dedicated infrastructure. In addition, puncturing a vein carries risks: if the vein is fragile or the gesture is performed incorrectly, it can cause a hematoma. There is also the risk of needlestick injuries, which can expose healthcare workers to blood-borne diseases.

[0004] On the other hand, finger prick method involves cutting the skin at the fingertip using a lancet and collecting one or several drops of capillary blood into a capillary tube or a dedicated analytical device (e.g., microfluidic device, lab-on-a-chip, paper-based diagnostic tool, etc.). Although the technique does not require a trained professional and can be performed by the patient himself, it is very difficult to collect more than 100 μl of blood and perform many analyses on each sample.

[0005] Furthermore, blood collected into glass capillary tubes or by other means cannot be analyzed by automated analyzers used in central laboratories, which require a minimum void volume of 100 μl to 200 μl of blood in a single tube.

[0006] In some cases, finger pricks can collect up to 0.5 ml of blood. However, this requires pressing and squeezing the finger to collect more blood, and excessive squeezing may cause hemolysis (damage to red blood cells) and interstitial fluid in the spaces between tissue cells, which can dilute the blood sample. For these reasons, and to maintain good blood quality, the use of finger pricks is usually limited to the collection of small amounts of blood.

[0007] Document US6283926 describes a method and a device for obtaining a blood sample for diagnostic purposes. The device comprises a vacuum pump requiring a power source, and a microcontroller arranged to drive the pump and the lancet according to a signal from a pressure sensor. The lancet of this device moves in a direction perpendicular to the user's skin. This device is complex because it contains multiple electronic components. In addition, it is arranged to extract a relatively small amount of blood (1 μl).

[0008] The present application aims to propose a sample collection device which simplifies the collection of a user's body fluids, such as blood, while maintaining high analytical standards.

[0009] Another object of the present application is to propose a sample collection device that is safer for the user or operator (eg, a nurse) to minimize the risk of injury through handling.

[0010] Another object of the present application is to provide a sample collection device that reduces the risk of contamination of the collected sample.

[0011] Another object of the present application is to provide a sample collection device that is compatible with standard blood analyzers in central laboratories.

[0012] Another object of the present application is to provide a system for extracting and collecting a user's body fluid sample, wherein the system can be used without requiring high-skill training, for example, by the user himself (ie, the patient).

[0013] Another object of the present application is to provide a system for extracting and collecting a fluid sample from a user that requires minimal action from the user.

[0014] Another object of the present application is to provide a system for extracting and collecting a user's fluid sample, wherein the system can collect approximately 0.5 ml to 2 ml of fluid, such as 1 ml of fluid.

[0015] Another object of the present application is to propose a system for extracting and collecting a fluid sample from a user that is as painless as possible.

[0016] Another object of the present application is to provide a system for extracting and collecting a user's fluid sample, wherein the system avoids and / or prevents cross contamination of the fluid sample. Summary of the invention

[0017] According to the present application, these objects are achieved by a sample collecting device, a system and a method for extracting and collecting a user fluid sample according to the appended independent claims.

[0018] In particular, according to the present application, a sample collection device for collecting a patient's blood sample is provided, the sample collection device comprising at least:

[0019] - a partially deformable first shell,

[0020] - an at least partially pierceable second shell,

[0021] wherein in the installed state of the collecting device, a pre-installed vacuum is sealed between the first shell and the second shell,

[0022] Further wherein the second housing contains a sample container and an automatic mechanical cutting mechanism in the installed state, the mechanism comprising a rotatable cutting blade and an actuator spring, the actuator spring being directly and / or indirectly actuated by pressing the first housing to release and rotate the cutting blade,

[0023] Further, the pre-installed vacuum is released to a collection port of the second shell by pressing the first shell, so that the vacuum produces a suction effect, so that blood flowing out of the incision created by the rotatable cutting blade leaks into the sample container.

[0024] The present application is based on the basic idea that blood collection can be performed more or less painlessly on the patient by using an automatically actuated cutting blade to perform minimal cutting of the patient's skin. The pain can be further reduced by a chordal cut. By having the pre-installed vacuum between the first housing and the second housing, wherein the two housings form a vacuum housing in the mounted state, sufficient suction or mechanism is provided, by which the blood flows out of the incision created by the rotatable cutting blade and / or flows into the sample container. In particular, the vacuum can and / or deform the skin, which produces a concentrated vasodilation. The vasodilation then allows a large amount of blood to be extracted from the wound created by the blade.

[0025] By using a cutting blade (which should be understood to also cover sub-blade-like elements), an incision can be made on the patient's skin. Unlike a needle or lancet or any sharp tip, according to the inventor's experience, the use of a cutting blade allows a more accurate and less painful opening for blood collection to be formed in the patient's skin. In particular, the blade allows for soft penetration and cutting into the skin with less pressure without causing much pain. In some cases, the patient is not even aware of the pain. This concept is inspired by the experience of being cut by a sharp blade or even a piece of paper, which is not felt at the first time, but nevertheless creates a sufficient opening to produce the amount of blood required for analysis.

[0026] Also, another effect that makes the cutting painless is that the skin is stretched when the device performs the cutting. If the skin is pinched before puncturing, the pain is also reduced. Here, the pain of the cutting is reduced by stretching the skin first and then cutting it. The skin is stretched, which triggers the spring and the blade, and then the skin is cut. This mechanism ensures that the skin is stretched before it is cut.

[0027] The actuator spring can be released directly, for example by pressing, for example, a button. However, the actuator spring can also be activated indirectly. This happens by pressing the housing, piercing the pierceable housing, thereby transferring a vacuum into the second housing, which has the effect of sucking and stretching the skin. The stretched skin then presses on the movable part of the cover, which then releases the spring.

[0028] The second housing may be at least partially pierceable, which may be achieved, for example, by having a portion of the second housing formed from a pierceable film. The film may be, for example, made of aluminum or any other suitable material, such as a polymer or plastic material.

[0029] Alternatively, the entirety may be pierceable, for example made of a pierceable material.

[0030] Furthermore, the cutting blade may be mounted on and / or be part of the rotatable plunger.

[0031] The plunger can be a rotatable more or less cylindrical element, which is preferably arranged to hold and / or carry the cutting blade. The plunger and the cutting blade can only be connected by a form fit or a snap fit. Furthermore, the form fit can only be used for correct placement during the manufacturing process. The connection can then be established by gluing or welding.

[0032] In particular, the blade may have one or two recesses (or other specially formed portions) which fit into corresponding counterparts of the plunger.

[0033] The plunger may further comprise a sealing portion, which is arranged and configured such that after blood is collected, the sample container is and / or can be sealed by the sealing portion, so that the sample container is closed by the plunger and its sealing member. In this way, the plunger can be used as a closure member for the sample container. After blood is collected, it can be pressed into the sample container as a closure device. In particular, it can be pressed into the opening of the sample container, for example by a finger, such as a thumb of a user, so as to close and seal the sample container and its opening.

[0034] Furthermore, the plunger further comprises a septum. When the blood collected in the sample container is to be analyzed, the septum can be used to create an opening. The septum is pierceable, and a common syringe needle can be used to pierce the septum and remove blood from the sample container. Likewise, the septum can be used in an automatic analyzer and its analyte collector, probe or sample collector.

[0035] In association with the septum, the plunger, cap and trigger may also allow access to the septum. Such access may be formed as a tapered hole for guiding a probe for blood analysis. The diameter of the tapered hole at the maximum opening should be about 4.5 mm to conform to and allow compatibility with standard probes (e.g., analyzers).

[0036] In addition, in a further possible embodiment, the cutting blade may include a cutting edge, wherein the cutting edge has a sharp end and a rounded end. The sharp end may penetrate into the patient's skin during the rotation and incision action. The rounded end is provided to create more blade handling safety while facilitating the rotational movement of the blade, thereby further reducing the space required for the blade.

[0037] Furthermore, the cutting edge of the cutting blade may have an angle selected in the range of 15°-25°, in particular about 19°-21°, and preferably about 20°. Said angle has been shown to produce a very sharp incision, which is however less painful than other incisions, skin openings or skin piercing methods due to its smooth but still sharp penetration and penetration of the skin.

[0038] In addition, the sharp end of the cutting blade has an angle selected in the range of 45°-55°, in particular about 47°-53°, preferably about 50°. The angle forms a sharp tip at the sharp end, which will make first contact with the skin and start the incision.

[0039] The circular end of the cutting blade may also have the same radius as the outer edge of the cutting blade on the side of the circular end. This facilitates the rotational movement of the cutting blade. Further, the processing safety is improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The present application will be better understood with the aid of the description of specific embodiments shown by way of examples and by way of illustration in the drawings, in which:

[0041] Figure 1 A perspective view showing a portion of the sample collection device according to a specific embodiment of the present application;

[0042] Figure 2 A perspective view showing a system for extracting and collecting a user's fluid sample according to a specific embodiment of the present application;

[0043] Figure 3 show Figure 2 A perspective view of the system described in, in particular with its cover removed;

[0044] Figure 4 show Figure 2 and Figure 3 A perspective view of the system (without the cover);

[0045] Figure 5 show Figure 4 A perspective view of the system of claim 1, wherein the vacuum generating mechanism thereof is in a first position;

[0046] Figure 6 show Figure 4 A perspective view of the system of claim 1, wherein the vacuum generating mechanism is in a second position;

[0047] Figure 7 A perspective view showing one embodiment of the system according to the present application placed on a user's arm;

[0048] Figure 8 A perspective view showing a portion of an embodiment of the system according to the present application, wherein the notch mechanism is in a first notch mechanism position;

[0049] Fig. 9 show Figure 8 A perspective view of a portion of a specific embodiment of the system described in , wherein the notching mechanism is in a second notching mechanism position;

[0050] Fig. 10A A perspective view showing a portion of the sample collection device according to a specific embodiment of the present application, wherein the cover is in the first cover position;

[0051] Fig. 10B Display according to Fig. 10A A perspective view of a specific embodiment of a portion of the sample collection device, wherein the cover is in the second cover position;

[0052] Fig.11A A cross-sectional view showing a specific embodiment of the sample collection device in the system for extracting and collecting a user's fluid sample according to the present application;

[0053] Fig. 11B A cross-sectional view showing a specific embodiment of the sample collection device according to the present application;

[0054] Fig. 11C Display according to Fig. 11B A front view of the specific embodiment of the sample collection device;

[0055] Fig.12A cross-sectional view showing a specific embodiment of the system for extracting and collecting a user's fluid sample according to the present application, wherein the sample collection device has been inserted into the sample extraction device;

[0056] Fig.13 show Fig.12 A cross-sectional view of a specific embodiment of the system described in , wherein the cover of the sample extraction device is removed;

[0057] Fig.14 show Fig.13 A cross-sectional view of a specific embodiment of the system described in the embodiment of the present invention is close to a user, such as the user's arm;

[0058] Fig.15 show Fig.14 A cross-sectional view of a specific embodiment of the system, wherein the system is placed on the user;

[0059] Fig.16 show Fig.15 A cross-sectional view of a specific embodiment of the system, wherein the valve control mechanism has been activated;

[0060] Fig.17 show Fig.16 A cross-sectional view of a specific embodiment of the system, wherein the suction created by the vacuum stretches and deforms the user's skin;

[0061] Fig.18 show Fig.17 A cross-sectional view of a specific embodiment of the system, wherein the incision mechanism is in the second incision mechanism position and the user's skin has been incised by the incision mechanism;

[0062] Fig.19 show Fig.18 A cross-sectional view of a specific embodiment of the system, wherein blood flows out of the incision created by the incision mechanism;

[0063] Fig. 20 show Fig.19 A cross-sectional view of a specific embodiment of the system, wherein according to one specific embodiment, once the amount of sample in the sample container has reached a predetermined value, at least one sensor of the system notifies the user;

[0064] Fig.21 show Fig. 20 A cross-sectional view of a specific embodiment of the system described in , wherein according to a specific embodiment, the valve control mechanism is pressed to re-equilibrate the system with atmospheric pressure;

[0065] Fig. 22 show Fig.21a cross-sectional view of a specific embodiment of the system described in , wherein the system has been removed from the user;

[0066] Fig.23 show Fig. 22 A cross-sectional view of a specific embodiment of the system, wherein the cover is moved to the second cover position;

[0067] Fig.24 show Fig.23 a cross-sectional view of a specific embodiment of the system, wherein the cover is in the second cover position and seals the sample container;

[0068] Fig.25 show Fig.24 A cross-sectional view of a specific embodiment of the system, wherein the sealed sample container has been removed from the suction bag;

[0069] Fig.26 show Fig.25 A cross-sectional view of a specific embodiment of the system in which the suction bag has been removed from the sample extraction device;

[0070] Fig.27A A front view showing a portion of the sample collection device according to a specific embodiment of the present application;

[0071] Fig.27B Display according to Fig.27A A specific embodiment of a cross-sectional view of a portion of the sample collection device described in;

[0072] Fig.27C Display according to Fig.27A Another specific embodiment of a cross-sectional view of a portion of the sample collection device described in;

[0073] Fig.28 Another specific embodiment showing a cross-sectional view of the sample extraction device;

[0074] Fig.29 Another embodiment showing a front view of the sample collection device;

[0075] Fig.30 A perspective view showing another specific embodiment of the sample collection device according to the present application;

[0076] Fig.31 show Fig.30 A cross-sectional view of the specific embodiment of the sample collection device described in;

[0077] Fig.32 A perspective view showing another specific embodiment of the sample collection device according to the present application;

[0078] Fig.33 show Fig.32 A cross-sectional view of the specific embodiment of the sample collection device described in;

[0079] Fig.34 show Fig.32 Another cross-sectional view of the specific embodiment of the sample collection device;

[0080] Fig.35A A cross-sectional view showing a portion of another specific embodiment of the sample collection device according to the present application;

[0081] Fig.35B show Fig.35A Another cross-sectional view of the specific embodiment of the sample collection device;

[0082] Fig.36 A perspective view showing another specific embodiment of the system for extracting and collecting a user fluid sample according to the present application;

[0083] Fig.37 show Fig.36 An exploded view of a specific embodiment of the system described in;

[0084] Fig.38 show Fig.36 A cross section of a specific embodiment of the system described in Figure 1 part;

[0085] Fig.39 show Fig.36 Another cross-sectional view of another portion of a specific embodiment of the system described in;

[0086] Fig.40 show Fig.36 A perspective view of one embodiment of the trigger and incision mechanism of the system described in;

[0087] Fig.41A show Fig.36 A perspective view (front view) of a specific embodiment of the sample collection device of the system described in;

[0088] Fig.41B show Fig.41A A perspective view (back side) of the specific embodiment of the sample collection device described in ;

[0089] Fig.42 A top view of the system according to the present application is shown, the system being placed near a user's part acting as an arm;

[0090] Fig.43 An exploded view showing a further specific embodiment of a sample collection device for collecting a patient's blood sample in the present application;

[0091] Fig.44a -c display Fig.43 Details of the specific embodiment shown in the figure, which details are related to the function of the device;

[0092] Fig.45a -e is Fig.43 Different views of the device described in;

[0093] Fig.46a -e is Fig.43 Different views of the sample container of the specific embodiment shown in FIG.

[0094] Fig.47a -f is Fig.43 Different views of the plunger and the cutting blade of the specific embodiment shown in ;

[0095] Fig.48a -b is Fig.43 Different views of the cutting blade of the specific embodiment shown in FIG. ; and

[0096] Figure 49 is Fig.43 Different views of the tension spring of the specific embodiment are shown in FIG.

[0097] Reference numerals:

[0098] 100: Sample extraction device

[0099] 101: Vacuum Chamber

[0100] 102: Valve control mechanism

[0101] 103: Washer

[0102] 104: Valve

[0103] 105: Electronic board

[0104] 106: Sensor

[0105] 107: Sample collection device interface

[0106] 108: Vacuum generating mechanism

[0107] 109: Connecting rod

[0108] 110: Second suction bag

[0109] 120: first connecting device

[0110] 130: Label of the second suction bag

[0111] 140: Cover inside the second suction bag

[0112] 200: Sample collection device

[0113] 201: Suction bag or first suction bag

[0114] 202: Lid

[0115] 203: Support element

[0116] 204: Elastic element

[0117] 205: Collection Window

[0118] 206: Blade

[0119] 207: Cover

[0120] 208:Thin film

[0121] 209: Trigger element

[0122] 210: protrusion (finger)

[0123] 211: Recess (jointed with finger)

[0124] 212: Sample container

[0125] 213: Sealed edge

[0126] 214: Biomarker Pad

[0127] 215: Opening of lid

[0128] 216: Recess in the second cover portion for receiving the cutting element

[0129] 217: ID element

[0130] 218: Opening in the suction bag

[0131] 219: Edge

[0132] 219': Sealed edge

[0133] 220: Second connecting device

[0134] 230: protrusion

[0135] 232: Finger

[0136] 300: System

[0137] 400: User's location

[0138] 401: The deformed part to be cut by the user

[0139] 402: Deformed part of the user

[0140] 410:Incision

[0141] 500: Sample

[0142] 1100: Recess of the second suction bag

[0143] 2010: Hole of the second suction bag

[0144] 2011: The first suction bag edge

[0145] 2012: Bistable components

[0146] 2013: The first suction bag curvature

[0147] 2014: Piercing the protrusion

[0148] 2010: The first suction bag cavity

[0149] 2020: Deformable Elements

[0150] 2021: Lid cutout

[0151] 2025: Trigger surface of the lid

[0152] 2121: Open end of sample container

[0153] 2122: Closed end of sample container

[0154] 2123: First sample container part

[0155] 2124: Second sample container part

[0156] 2021: First Cover Section

[0157] 2022: Second cover part

[0158] 3110: Shell

[0159] 3200: Sample collection device

[0160] 3201: Shell

[0161] 3202: Lid

[0162] 3203: Plunger

[0163] 3203a: Sealing part

[0164] 3203b: Diaphragm

[0165] 3204:Actuator spring, tension spring

[0166] 3206: Cutting blade

[0167] 3209: Trigger

[0168] 3206a: Cutting edge

[0169] 3206b: sharp end

[0170] 3206c: Round end

[0171] 3206d: Fixer opening

[0172] 3206e: Fixed dent

[0173] 3206f:Fracture Line

[0174] 3207: Cover

[0175] 3208: Pierceable film

[0176] 3212: Sample container

[0177] 3220: Electronic Module

[0178] 3222: Label with frangible seal in button area

[0179] 3224: Deformable Button

[0180] 3226: Electronic module interface

[0181] 3228: Stabilizing ribs

[0182] 3229: Fixer recessed

[0183] 3230:Substrate

[0184] 3230a::Protrusions on the substrate

[0185] 3231: Collection opening

[0186] 3232:Handle part

[0187] 3234: Vacuum release element

[0188] 3236: Vacuum release element

[0189] 3238: Film position

[0190] 3240: Gap

[0191] 3250: Extension tube

[0192] 3500: Blood sample

[0193] g: gravity

[0194] Fi: arrow (i=1, 2, ...)

[0195] a: Main direction of system 300

[0196] θ: Angle between the vertical direction (gravity direction) of the system 300 and the main direction

[0197] α: The first angle of the cutting element

[0198] β: Second angle of the cutting element

[0199] γ: cutting edge angle

[0200] δ: Angle of the sharp end of the cutting edge

[0201] C1: Mount location

[0202] C2: Mount status

[0203] C3: Initial position (not mounted)

[0204] P: Contact point or area

[0205] R: Radius of the circular end of the cutting edge

[0206] S1: Step 1

[0207] S2: Step 2

[0208] S3: Step 3

[0209] S4: Step 4

[0210] S5: Step 5

[0211] S6: Step 6

[0212] S8: Step 8

[0213] d1: diameter of the first sample container part

[0214] d2: diameter of the second sample container portion DETAILED DESCRIPTION

[0215] In the following description provided by way of example, for the sake of simplicity, reference will be made to a system for collecting and extracting a user's blood, said system comprising a blood collection device and a blood extraction device. However, it must be understood that the present application is not limited to such fluids, but also includes a collection device and an extraction device, both of which are arranged to collect and extract other kinds of fluids, in particular body fluids, respectively.

[0216] In the description provided below by way of example, for simplicity reference will be made to a "sample collection device" and a "sample extraction device". However, it must be understood that the "sample" represented in these expressions is a fluid sample, in particular a body fluid, such as blood, especially capillary blood.

[0217] The system 300 for extracting and collecting a user fluid sample according to the present application comprises two parts:

[0218] - a sample collection device 200; and

[0219] - A sample extraction device 100.

[0220] In one advantageous embodiment, the sample collection device 200 is consumable, while the sample extraction device 100 is, on the contrary, reusable. In another embodiment, the sample extraction device 100 is also consumable. In this case, the sample collection device 200 and the sample extraction device 100 may form a single consumable system 300. Fig.36 An example of such a consumable system 300 is discussed.

[0221] We will first describe the features of the sample collection device 200, then describe the features of the sample extraction device 100, and finally describe the methods and systems for collecting and extracting such samples.

[0222] Figure 1 A perspective view showing a portion of the sample collection device 200 according to a specific embodiment of the present application.

[0223] According to a specific embodiment of the present application, the sample collection device 200 includes:

[0224] - a sample container 212 arranged to receive said sample and comprising an open end 2121;

[0225] - a cover 202 arranged to cooperate with the sample container 212 so as to close the open end 2121 .

[0226] exist Figure 1 In the specific embodiment of the present invention, the sample container 212 is a test tube having a substantially cylindrical shape and including an open end 2121 having a substantially spherical shape and a closed end 2122 .

[0227] In a particular embodiment, the tubes are "standard" tubes, ie, tubes that are compatible with a standard blood analyzer at a central laboratory.

[0228] For example, the diameter of a standard test tube is in the range of 12 mm to 16 mm, for example equal to 13 mm.

[0229] In one embodiment, the length of the test tube is compatible with a standard blood analyzer in a central laboratory. In another embodiment, the length of the test tube is shorter than the standard length, i.e., a length compatible with a standard blood analyzer in a central laboratory. In this case, the test tube may include a connection device to connect it to an extension tube so that the total length of the assembly including the test tube and the extension tube is a standard length, for example, a length ranging from 50 mm to 120 mm, for example equal to 75 mm. In another embodiment, this extension tube may also correct the final diameter of the test tube. The diameter of the test tube may be smaller than the standard diameter, but can be adjusted using a larger extension tube to be compatible with a standard blood analyzer in a central laboratory.

[0230] In a specific embodiment, the connection means for connecting the test tube to the extension tube are arranged so that they allow easy connection of the test tube to the extension tube, but prevent or make it difficult to disconnect the extension tube from the test tube. This feature is particularly useful if a label identifying the fluid sample is placed on the outer surface of the extension tube to prevent the user from removing the extension tube from the test tube: this ensures traceability of the fluid sample. In a specific embodiment, the connection means include a clamping device and / or a screwing device.

[0231] In certain embodiments, the tube is arranged to receive at least 0.5 ml, and preferably 1 ml, of a fluid sample, as will be discussed.

[0232] exist Figure 1 In a specific embodiment, the sample container 212 is (at least partially) transparent so that its contents can be directly seen.

[0233] exist Figure 1 In the specific embodiment of the present invention, the cover 202 is also a "standard" cover, that is, a cover compatible with a standard blood analyzer in a central laboratory. For example, the diameter of the outer portion of the standard cover is 15 mm.

[0234] exist Figure 1 In a specific embodiment, the sample container 212 and its cover 202 are placed in the suction bag 201. Therefore, the size and shape of the suction bag 201 are arranged to receive the sample container 212 and the cover 202. In a specific embodiment, the suction bag 201 is at least partially made of a flexible material.

[0235] The suction bag 201 has two main functions: 1) to serve as packaging for the sample container 212 and its lid 202; and 2) as discussed below, to serve as a suction cup in which a vacuum is applied to the user's skin and collect fluid.

[0236] exist Figure 1In a specific embodiment, the suction bag 201 comprises a cover 207 to ensure sterilization of its contents and / or to comprise a moisture barrier. This cover 207 is removable. In a specific embodiment, it is a semipermeable membrane that allows the interior of the suction bag 201 to be kept sterile, for example In another embodiment, the cover 207 is impermeable: this allows to maintain an airtight environment during storage and / or transport, thereby preventing moisture from entering the suction bag 201 and / or the sample container 212. In fact, humidity can affect the stability of the additives present in the sample container 212.

[0237] exist Figure 1 In the specific embodiment, the suction bag 201 is also (at least partially) transparent to provide a good visual indication of the integrity of its contents. Before use, the user (or operator, such as a nurse) does check that the cover 207 of the suction bag 201 has not been opened, indicating that its contents are still sterile and safe to use.

[0238] In one example, the suction bag 201 is made of polycarbonate, PET-G, etc., so that a user or operator can track the progress of fluid collection by optically monitoring the amount of fluid sample in the sample container 212.

[0239] As will be discussed below, in one particular embodiment, the suction bag 201 includes a semi-permeable membrane that allows vacuum to enter the suction bag.

[0240] In a specific embodiment, the suction bag 201 includes or is at least partially made of a material that enhances the seal between the suction bag 201 and the user's skin to ensure a good seal between the skin and the suction bag 201 .

[0241] In one embodiment, the suction bag 201 is a bubble pack.

[0242] Consumables or so-called disposables in bubble packaging are a common practice in healthcare.

[0243] The advantages of bubble packaging are that it is cost effective, can be closed by a removable cover 207, and can be shipped and handled while preserving the sterility of its contents.

[0244] According to the present application, the cover 202 comprises:

[0245] - A collection window 205, which can be seen, such as Figure 8 , Fig. 11B and Fig. 11C As shown therein, and arranged to contact the area or portion of the user to be cut;

[0246] - a trigger mechanism; and

[0247] - a cutout mechanism, which can be moved from a first cutout mechanism position (e.g., at a position of Figure 8 ) to a second incision mechanism position (e.g., Fig. 9 exemplified in ).

[0248] Advantageously, during this movement, the cutting mechanism is arranged to cut at the user's collection window 205 so that the sample leaves the user. During the movement from the first cutting mechanism position to the second cutting mechanism position, the cover 202 is always in a first cover position, for example Figure 1 , Figure 8 , Fig. 9 and Fig. 10A as shown in .

[0249] In fact, according to the present application, the cover 202 itself is arranged to be on the sample container 212 from a first cover position (such as Figure 1 , Figure 8 , Fig. 9 or Fig. 10A ) to a second cover position (as illustrated in Fig. 10B ), wherein in the first and second cover positions, the open end 2121 of the sample container 212 is at least partially in contact with the cover 202 and the edge of the collection window 205, thus guiding the cover 202 to move from the first cover position to the second cover position. In the non-limiting illustrated embodiment, in the first and second cover positions, the open end 2121 of the sample container 212 is closed by the cover 202.

[0250] According to the present application, the cover 202 further comprises a sealing mechanism (not shown) so that when the cover is in the second cover position (such as Fig. 10B The sample container is sealed when illustrated in FIG. 1 to ensure safe transportation of the sample.

[0251] Since a sufficient amount of fluid is collected (approximately 1 ml), adjusted into a sample container 212 containing a cap 202, matched to two standards for standard blood analyzers (container size, cap form and / or additives required for different types of analyses), and safely transported, multiple analyses can be performed from a fluid sample collected by the device according to the present application.

[0252] Therefore, the collection device according to the present application has the following advantages:

[0253] - the cover 202 integrates the cutout mechanism;

[0254] - the same lid allows sealing the sample container 212 after collecting the fluid sample, in order to safely transport said fluid sample;

[0255] - When the fluid, such as blood, falls directly into the sample container 212, the fluid is collected directly into the sample container 212 for transportation and analysis.

[0256] It must be noted that the movement of the incision mechanism does not require active movement by the user: in fact, it is triggered in an automatic manner by a trigger mechanism, which will be explained below.

[0257] In a particular embodiment, the movement of the cover 202 is performed manually by a user or operator. However, in another embodiment, it is also performed automatically.

[0258] In a preferred embodiment, Figure 8 and Fig. 9 As can be seen in FIG. 2 , the cover 202 includes a first cover portion 2021 and a second cover portion 2022. The two portions 2021, 2022 may be two different portions connected together by a connecting device (not shown). In another specific embodiment, the cover 202 is integral, i.e., made of a single piece including the two portions 2021, 2022.

[0259] In a specific embodiment, the first cover portion 2021 includes a collection window 205 .

[0260] like Figure 8 and Fig. 9 As can be seen, the first cover part 2021 comprises an opening 215, which is along the main direction of the first cover part 2021. In other words, due to the presence of this opening 215, the first cover part 2021 has a substantially C-shaped cross section.

[0261] In the illustrated embodiment, at least a portion 2021 ′ of this first cover portion 2021 is inserted into the sample container 212 during all operations of the system 300 so as to close the open end 2121 of the sample container 212 during movement of the cutting mechanism.

[0262] like Figure 8 As shown, when the cover 202 is in its first position, another portion 2021″ of the first cover portion 2021 is outside the sample container 212.

[0263] In one specific embodiment, the second cover portion 2022 has a larger size than the first cover portion 2021. It does not fit into the sample container 212, but seals the sample container.

[0264] In a specific embodiment, the second cover portion 2022 includes the above-mentioned sealing mechanism.

[0265] In one embodiment, the second cover portion 2022 includes Figure 8 and Fig. 9 Once the incision mechanism is in the second incision mechanism position (eg, Fig. 9 216) for accommodating the cutting mechanism, in particular the blade 206, so that the cutting mechanism can be irreversibly and safely retracted into this recess 216 so that it can no longer cut the user.

[0266] In one embodiment, a user or operator may access at least a portion of the cover 202 to manually extract a fluid sample from the sample container 212 without removing the cover 202 from the sample container 212 .

[0267] In a specific embodiment, the incision mechanism comprises:

[0268] - a supporting element 203; and

[0269] - an elastic element 204.

[0270] In a preferred embodiment, the support element 203 is a piston, for example Figure 8 and Fig. 11B this support element is connected to, preferably directly connected to, the blade 206, so that once the support element 203 moves, the blade 206 also moves together.

[0271] The blade 206 may be a razor blade, or any other blade-like element capable of forming an opening in the skin of a user.

[0272] In a preferred embodiment, the elastic element 204 is a spring, such as Figure 8 and Fig. 11B Before using the system according to the present application, for example in a compressed position, the elastic element 204 is blocked.

[0273] Once the incision mechanism is triggered, the elastic element 204 is free to decompress, and the decompression causes the support element 203 and then the blade 206 to move from the first incision mechanism position (eg, Figure 8 ) moves to the second incision mechanism position (as shown in Fig. 9 (see ).

[0274] It must be understood that the present application is not limited to compression elastic elements only, i.e. elastic elements that can be compressed and decompressed (e.g. springs), but also involves other elastic elements, such as torsion and / or traction elastic elements, i.e. elastic elements that can perform torsion and / or traction actions (e.g. springs).

[0275] like Figure 8 It can be seen that when the cutting mechanism is in the first cutting mechanism position, the blade 206 is located in the sample container 212 to ensure the safety of the user and / or operator.

[0276] exist Figure 8 and Fig. 9 In a specific embodiment of the present invention, the movement of the incision mechanism from the first incision mechanism position to the second incision mechanism position is a linear movement (i.e., translation) performed in a direction parallel to the user surface to be cut, such as Fig.27B exemplified.

[0277] However, in another alternative embodiment, the movement of the notching mechanism from the first notching mechanism position to the second notching mechanism position is a circular motion (ie, rotation), such as Fig.27C As illustrated, the axis of rotation of this circular motion is preferably the main axis of the sample container 212.

[0278] For example, if the elastic element 204 is a torsion elastic element 204, such a circular motion is possible. Another example of such a circular motion is to refer to Fig.36 The specific embodiments of the present invention are discussed in detail.

[0279] The trigger mechanism of the sample collection device includes a trigger element, which is Fig. 11B and Fig. 11C Visible inside.

[0280] The trigger mechanism comprises a trigger element 209 which in the illustrated embodiment is a half ring surrounding at least a portion of the support element 203 .

[0281] In particular, the trigger element 209 comprises a protrusion 210, such as a finger, which is arranged to be received by a corresponding recess 211 in the support element 203 to hold the trigger element 209 in place, for example. Fig. 11B The first trigger element position is visible in .

[0282] In the illustrated embodiment, the cover 202 comprises a trigger mechanism, in particular a trigger element 209. In another alternative embodiment (not illustrated), the support element 203 comprises a trigger mechanism, in particular a trigger element 209.

[0283] As will be discussed below, once the system 300 according to the present application is on the user's skin, it is arranged to deform and / or stretch a portion of the user's skin so that the deformed and / or stretched portion moves the trigger element 209 from a first trigger element position (e.g., Fig.17 ) moves to a second trigger element position (as shown in Fig.18), wherein in a first trigger element position, the trigger element maintains the elastic element 204 in a compressed position and maintains the support element 203 in a fixed position within the sample container 212, wherein in a second trigger element position, the trigger element 209 no longer maintains the elastic element 204 or the support element 203.

[0284] The sample extraction device will now be described. Fig.11A It can be seen that it includes

[0285] an interface 107 (e.g. a recess or a depression) arranged to receive at least a portion of said collecting device 200;

[0286] - a vacuum chamber 101;

[0287] - a vacuum generating mechanism 108, which is arranged to generate a vacuum in the vacuum chamber 101; a non-limiting example of such a vacuum generating mechanism is shown in Figure 5 and Figure 6 ; The vacuum generating mechanism is preferably completely mechanized and has no electronic components;

[0288] - a valve (or valve assembly) 104, which is arranged to close and / or open the vacuum chamber 101 and / or release the sample collection device (200) to atmospheric pressure;

[0289] - a valve control mechanism 102 arranged to command the valve 104 (or valve assembly) so as to transfer the vacuum from the vacuum chamber 101 to the collecting device 200, but also to release the collecting device 200 to atmospheric pressure, in particular after collection.

[0290] As used herein, the term "vacuum" refers to a region where the gas pressure is much less than atmospheric pressure, for example, a gas pressure between -70 kPa and -20 kPa, for example about -40 kPa, compared to atmospheric pressure.

[0291] In a preferred embodiment, the valve control mechanism 102 is a button, such as a push button, or a combination of buttons. In a preferred embodiment, it is arranged to control three modes of the valve 104, namely, open, close, and release.

[0292] In a preferred embodiment, the sample extraction device comprises an electronic module 105, such as Fig.11A As can be seen from the figure, it includes a communication module (not shown) and a power supply (not shown).

[0293] In another preferred embodiment, Fig.11A As can be seen from the above, the sample extraction device at least includes a sensor 106, such as a light sensor, for detecting a predetermined sample volume in the sample container.

[0294] In another preferred embodiment, the sample extraction device comprises an alarm mechanism (not shown) which informs the user of the end of sample extraction, for example by an audible and / or visible signal.

[0295] In another preferred embodiment, the sample extraction device includes a gasket 103, such as Fig.11A As can be seen in FIG. 2 , it cooperates with the area of ​​the sample collection device 200 that includes the membrane 208 .

[0296] In one variation, the membrane 208 is semi-permeable. In another variation, the membrane 208 is impermeable: this allows to maintain an airtight environment during storage and / or transportation, thereby preventing moisture from entering the suction bag 201 and / or the sample container 212. In fact, humidity can affect the stability of the additives present in the sample container 212.

[0297] Now, a method for collecting and extracting a user fluid sample according to the system of the present application is described.

[0298] In one embodiment, the cover 202 is placed in and / or on the sample container 212 to close the open end 2121 thereof. Figure 1 shown.

[0299] Then, the sample container 212 and the cover 202 are packed in the suction bag 201 , the suction bag 201 is closed by the cover plate 207 , and the closed suction bag 201 including the sample container 212 and the cover 202 is sterilized.

[0300] In one embodiment, the sample collection device 200 is consumable, while the sample extraction device 100 is not consumable. Then, a new sample collection device 200 is placed on or in the sample extraction device 100, in particular in an interface 107 of the sample extraction device 100. Fig.11A Visible in.

[0301] The sample collection device 200 is then mechanically connected to the sample extraction device 100, for example by using first and second connection means 120, 220, respectively, such as Fig.11A and Fig. 11B exemplified in .

[0302] These devices ensure connection by means of clips or snap-fit ​​devices, but of course any other type of device may be used to ensure mechanical connection between the sample collection device 200 and the sample extraction device 100, such as, in a non-limiting manner, a magnet on one device to a ferromagnetic area on the other device, a screw or rivet in one device to a hole within the other device, a docking device, etc.

[0303] Fig.12A cross-sectional view of a specific embodiment of a system 300 for extracting and collecting a user's fluid sample according to the present application is shown, wherein the sample collection device 200 has been inserted into the interface 107 of the sample extraction device 100. Arrow F1 indicates that the sample collection device 200 moves toward the sample extraction device 100.

[0304] The sample collection device 200 and the sample extraction device 100 form a system 300 according to the present application.

[0305] although Fig.12 A specific embodiment is illustrated in which the sample collection device 200 moves to the extraction device 100 in the direction of arrow F1, but this specific embodiment is not limiting, and a skilled person may think of other possibilities. For example and without limitation, the sample collection device 200 may slide in some (not shown) tracks of the extraction device 100 in a direction perpendicular to the arrow F1. In this case, the illustrated first connection device 120 and the second connection device 220 will be modified accordingly.

[0306] Figure 2 A perspective view of the system 300 according to one embodiment of the present application is shown. In this case, arrow F1 indicates that the sample collection device 200 moves toward the sample extraction device 100 .

[0307] 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 possible gasket 103 of the sample extraction device 100 are placed to correspond to the membrane 208 of the sample collection device 200; in addition, where present, one or more sensors 106 of the sample extraction device 100 are placed to correspond to the sample container 212 of the sample collection device 200.

[0308] The system 300 according to the present application is portable and has a size that allows it to be easily operated by the user's hands. Figure 2 In a specific embodiment, it is substantially a parallelepiped. But other shapes are also possible, such as cylindrical. In another specific embodiment, its length is in the range of 5 cm to 20 cm, such as 10 cm.

[0309] Then, if Figure 3 (arrow F2) or Fig.13 As shown in (arrow F6), the user (or operator) removes the cover 207 of the suction bag 201. The cover 207 ensures that the contents thereof are sterile. As will be discussed, the film 208 of the collection device 200 also helps prevent cross contamination of the fluid sample.

[0310] Figure 4An embodiment of the system 300 is illustrated without the cover plate 207. In this embodiment, the suction bag 201 is at least partially transparent so that its contents are visible.

[0311] like Figure 5 and Figure 6 As illustrated therein, the user (or operator) then activates a vacuum generating mechanism 108 in the sample extraction device 100 (in this case, a piston including a connecting rod 109 that moves in a direction F3 and then in an opposite direction F4) to load vacuum into the vacuum chamber 101.

[0312] It should be noted that the vacuum can also be established in the vacuum chamber 101 before removing the cover plate 207. In another embodiment, the vacuum does not need to be established by the user, for example by activating the vacuum generating mechanism 108, but the mechanism is already pre-packaged in the system 300 according to the present application. In other words, the system 300 includes a chamber that is under vacuum in a production assembly line or a medical facility. Fig.36 An example of this specific embodiment is described below.

[0313] Then, the system 300 approaches the user 400 (eg Fig.14 ), and place it on the user 400, as shown Figure 7 and Fig.15 As shown inside.

[0314] It must be noted that in a preferred embodiment, the system 300 according to the present application is placed on the arm of the user, in particular the arm is kept vertical, in particular with an orientation such that the cover 202 is at the top and the bottom of the sample container 212 is at the bottom. However, it can also be placed on other parts of the user (e.g. legs, body, etc.), as long as the part is kept substantially vertical (i.e. substantially parallel to the direction z of gravity g) or at a predetermined angle θ to this direction z. In particular, in a preferred embodiment, the angle θ formed by the main axis direction a of the system 300 according to the present application and the direction z of gravity g is in the range of 0° to 45°. In practice, the system 300 also advantageously utilizes gravity (in combination with vacuum) to extract a desired volume of a fluid sample.

[0315] Then, the user (or operator) activates a valve control mechanism 102, which Fig.16 In the example of , it is a button that pushes in the direction of arrow F8. Of course, other types of valve control mechanisms 102 can be used to replace buttons, such as rotary buttons, etc.

[0316] The valve control mechanism 102 allows the valve 104 to be opened in order to transfer the vacuum from the vacuum chamber 101 of the sample extraction device 100 to the suction bag 201 .

[0317] In a particular embodiment, this transfer is performed through an opening 218 in the suction bag 201, which is covered by a film 208 located in the suction bag 201. In a preferred embodiment, the film 208 is made of the same material as the cover plate 207 (e.g., ) is made.

[0318] This membrane 208 also allows to protect the system 300 from blood contamination, which may lead to bacterial growth and cross contamination between patients. In a specific embodiment, the membrane 208 prevents the penetration of body fluids such as blood while allowing air to pass through.

[0319] The vacuum created in the suction bag 201 also allows the entire system 300 to be held against the user's skin.

[0320] It also stretches and / or deforms the user parts 401 and 402 (in Fig.17 201 ), wherein there is a user part 401 to be cut. The user part 401 to be cut is the user part in contact with the collection window 205 of the sample collection device. When the user part 401 to be cut is stretched and / or deformed due to the vacuum transferred in the suction bag 201, the trigger mechanism is activated, and then the incision mechanism is triggered.

[0321] In fact, if Fig.17 It can be seen that the skin stretched and / or deformed in the collection window 205 (i.e. the user's part 401 to be cut) causes the trigger element 209 to move. Fig.17 In the specific embodiment, the trigger element is around the support element 23 ( Fig.17 A half ring of at least a portion of the piston in the piston) to release the support element 23.

[0322] In fact, the trigger element 209 is Fig.17 The finger 210 is disengaged from the recess of the cutout 211 in the trigger element 209 by moving in the direction of the arrow F9 .

[0323] Therefore, if Fig.18 As shown, the loaded elastic element 204 will displace the support element 203 of the notching mechanism in the cover 202. In other words, the notching mechanism will be displaced from the first notching mechanism position (such as Figure 8 or Fig.17 ) moves to a second cutout mechanism position in the cover 202 (as shown in Fig. 9 and Fig.18 Since the support element 203 of the incision mechanism is connected to the blade 206, this blade 206 will cut the local part 401 of the stretched and / or deformed skin in the collection window 205 during this displacement.

[0324] In other words, the incision is triggered by the stretching and / or deformation of the skin when a vacuum is applied in the suction bag 201: no user action is required to trigger the incision. The system 300 ensures that the skin is sufficiently stretched and / or deformed before the incision mechanism is triggered. The skin, when stretched and / or deformed, presses on the trigger element 209, which, when pushed, displaced or deformed, releases the support element 203 to which the blade 206 is attached.

[0325] When released, the blade 206 moves along the (linear or circular) trajectory of the elastic element 204 to which it is attached and cuts the skin in its trajectory.

[0326] exist Figure 8 and Fig. 9 In a specific embodiment, the movement of the incision mechanism from the first incision mechanism position to the second incision mechanism position is a linear movement (ie a translation) performed in a direction parallel to the user surface to be cut.

[0327] The incision into the skin is relatively shallow (the length of the incision into the skin is less than 5 mm, in particular less than 3 mm; the depth varies between 1 mm and 2 mm). The blade 206 makes a sharp cut into the skin. Furthermore, the incision is advantageously made while and / or after the vacuum is applied: the skin is deformed and / or stretched and / or squeezed into the sample collection device 200 before the incision is made, which reduces the pain felt by the patient.

[0328] In a preferred embodiment, Figures 17 to 19 As illustrated in FIG. 2 , at least a portion of the edge 219 of the sample container 212 contacts the user 400 at a contact point or area P, which is above or below the incision made by the incision mechanism of the system 300 on the user 400. This contact point or area P ensures that there is no gap between the user 400 and the sample container 212, so that the fluid sample can fall into the sample container 212. In other words, at least a portion of the edge 219 is the edge of the collection window.

[0329] Advantageously, after the skin incision, the blade 206 is retracted into the cover 202, in particular into the Figure 8 and Fig. 9 The recess 216 is visible in the sample collection device 200, which poses no risk of injury or contamination to anyone handling the sample collection device 200.

[0330] In a preferred embodiment, the blade 206 is at an angle α (eg Fig.34The blade 206 may be placed at a 90° angle to the skin, or may be placed at a 45° angle relative to the normal axis of the skin, thereby maximizing the surface of the incision without increasing the depth of the incision. In general, the plane containing the blade 206 may be positioned at any position between 45° and 90° relative to the plane of the user's skin.

[0331] In one embodiment, the path length of the blade 206 allows for more capillaries to be cut, thereby maximizing blood flow.

[0332] Thus, the vacuum in system 300 according to the present application has three main functions: 1) it holds the system 300 on the user during fluid sample collection; 2) it stretches and / or deforms the user's skin, thereby causing local vasodilation of the user's capillaries; and 3) extracts body fluids, such as blood from capillaries after incision.

[0333] To ensure a good seal between the user's skin and the suction bag 201 and maintain the vacuum in the suction bag 201, two factors need to be considered: first, the better the skin stretches and / or deforms in the suction bag 201, and the higher the surface between the skin and the edge of the suction bag 201, the better the seal.

[0334] In order to facilitate good stretching and / or deformation of the skin in the blister, the friction between the skin and the suction bag 201 must be minimized. This can be achieved, for example, by using the correct surface properties of the suction bag 201 and the material inside the suction bag 201, and / or the coating of the suction bag 201 and the material inside the suction bag 201, and / or applying silicone, silicone spray or any other lubricant to the skin.

[0335] Second, the seal between the skin and the suction bag 201 can be enhanced and better secured if no air can penetrate between the skin and the suction bag 201. In a preferred embodiment, silicone, silicone spray or any other lubricant placed between the suction bag 201 and the skin can play the role of a sealant.

[0336] In other words, the vacuum will be enhanced using the selected materials and the use of a lubricant on the suction bag 201 or on the skin.

[0337] like Fig.19 As shown, fluid (e.g., blood) flows out of the cutout created in the deformed window 205. The sealed edge (e.g., Fig.31 and Fig.33 As illustrated in FIG. 4 , reference numeral 219′) ensures that the fluid does not flow out of the sample container 212, the edge of which is located near the cutout 401. A droplet of the fluid 500 formed at the cutout point falls into the sample container 212 by gravity g.

[0338] Since gravity g and vacuum are always used to collect fluid sample 500, the system 300 according to the present application is designed to collect about 1 ml of fluid sample 500. In addition, the size of sample container 212 is similar to the tube used in venipuncture (e.g., 13 mm in diameter), making it compatible with known blood analyzers.

[0339] exist Fig.21 In the embodiment of the present invention, the sample extraction device 100 includes at least one sensor 106, such as a light sensor corresponding to the closed end 2121 of the sample container 212, to detect the amount of the fluid sample.

[0340] In another embodiment (not shown), the sensor 106 is additionally or also placed on the sample collection device 200 .

[0341] In one embodiment, once the fluid sample volume has reached a predetermined value, the system 300 according to the present application notifies the user (or operator) that the fluid sampling is finished, for example, through light, sound or any other appropriate signal.

[0342] After a sufficient amount of sample fluid has been collected, Fig.21 In the specific embodiment of FIG. 1 , a user (or operator) depresses the valve control mechanism 102 (or another valve control mechanism) to return the system 300, and in particular the suction bag 201, to atmospheric pressure.

[0343] like Fig. 22 As shown by arrow F11 in FIG. , the user (or operator) removes the system 300 from the skin of the user 400 .

[0344] It is thus apparent that the system 300 according to the present application is arranged to collect body fluids without requiring highly skilled training and can be used by a doctor, nurse, untrained personnel or the user (i.e. the patient) himself. The system 300 is designed to require minimal action from the user. The system 300 is placed on the user, preferably on his arm held vertically, and against the skin.

[0345] The user simply activates the valve control mechanism 102 to trigger the vacuum. The vacuum stretches and / or deforms the skin into the suction bag 201, thereby holding it in place against the user. The user does not need to hold the system 300, just wait for blood to be drawn.

[0346] Once the desired amount has been collected, the system 300 notifies the user and then activates the valve control mechanism 102 again to return the system 300 to atmospheric pressure.

[0347] In a preferred embodiment, the time for collecting about 1 mL of body fluid is in the range of 1 minute to 8 minutes, in particular 5 minutes.

[0348] In a preferred embodiment, once cut by the blade 206 of the system 300, the rate at which fluid, particularly blood, flows from the user is in the range of 4 milligrams per second to 11 milligrams per second.

[0349] Then, if Fig.23 As shown, the user (or operator) moves the cover 202 onto the sample container 212 to seal it. In the illustrated embodiment, the cover 202 is moved while it is still in the suction bag 201 to avoid any spillage. In another embodiment, not illustrated, the cover 202 and the sample container 212 are removed from the suction bag 201 and then the sample container 212 is sealed with the cover 202.

[0350] exist Figure 23-24 (or Figures 10A-10B ), the movement of the cover 202 from the first cover position to the second cover position is a linear movement, during which the cover 202 slides on (the outer surface of) the sample container 212, such as Fig.23 As shown by arrow F12.

[0351] However, in another embodiment (not shown), the movement of the cover from the first cover position to the second cover position is complementary, or may be a circular movement. For example, the cover 202 may be screwed onto (the outer surface of) the sample container 212.

[0352] like Fig.25 As shown, the sealed sample container 212 can be removed from the suction bag 201 and is ready for transport and sample analysis.

[0353] like Fig.26 As shown, the suction bag 201 can then be removed from the sample extraction device 100.

[0354] In another specific embodiment that is not illustrated, the suction bag 201 is first taken out from the sample extraction device 100 , and the sample container 212 including the cover 202 is taken out from the suction bag 201 .

[0355] exist Fig.28 In a specific embodiment, the sample collection device 200 can be used to combine sample collection and testing. In this case, the sample container 212 located in the sample collection device 200 can contain one or more biomarker pads 214 that react with the fluid sample, thereby allowing the system 300 to directly analyze the fluid sample. The chemical reaction will produce a signal, such as a visible signal (light, color, etc.), which is proportional to the concentration of the target to be detected in the fluid sample (non-complete list: such as fluorescence, reflectance photometry, etc.). The color change is captured by the sensor 106 of the sample extraction device and converted into a concentration.

[0356] exist Fig.29 In the embodiment, the sample collection device 200, in particular the sample container 212, includes an ID element 217, such as a QR code, a barcode, a number, an RF tag, etc.

[0357] In another embodiment, the sample collection device 200 and / or the sample extraction device 100 is arranged to store data, such as blood collection data (e.g., blood collection time, blood collection volume, etc.), patient information, sample container barcode, doctor's prescription data, etc.

[0358] In another embodiment, the sample collection device 200 and / or the sample extraction device 100 are arranged to communicate with an external device, in particular a portable device (eg, a smartphone, a tablet computer, etc.), or also with a cloud service that can transmit data.

[0359] It must be noted that in Figures 1 to 29 The different features illustrated in the specific embodiment (e.g., the trigger element 209 is a half ring around at least a portion of the support element 203, the sample container 212 enters the cover 202, the linear movement of the cutting mechanism, etc.) do not necessarily have to appear together. In other words, the skilled person can imagine different specific embodiments in which not all the illustrated features appear together.

[0360] Fig.30 and Fig.31 A perspective view and a cross-sectional view of another specific embodiment of the sample collection device 200 according to the present application are respectively shown. In the illustrated specific embodiment, the trigger element 209 is a half ring on the cover 202. In this specific embodiment, the blade 206 is also inclined at an angle β relative to the normal axis of the skin (corresponding to the normal axis of the piston 203 when the system 300 is placed on the user's skin), and this angle is not 90°. This allows the cutting element to enter the user's skin in a more tangential manner. In this specific embodiment, the cover 202 is on a portion of the sample container 212. In other words, the cover 202 does not enter the sample container 212, but the sample container 212 enters the cover 202, in particular at least its end 2121. Finally, in this specific embodiment, the sample container 212 includes at least two parts 2123, 2124, which have different diameters d1 and d2, respectively. In a specific specific embodiment, the diameter d1 is a standard diameter defined according to the above known.

[0361] It must be noted that in Fig.30 and Fig.31The different features illustrated in the specific embodiment (e.g., the trigger element 209 is a half ring on the cover 202, the sample container 212 enters the cover 202, the sample container 212 includes two parts 2123, 2124, the inclined blade 206, etc.) do not necessarily have to exist at the same time. In other words, the technician can imagine different specific embodiments in which not all the illustrated features exist at the same time.

[0362] For example, one can imagine a sample collection device 200 in which the trigger element 209 is a half ring on the lid 202, the sample container 212 enters the lid 202, the blade 206 is tilted, but the sample container 212 comprises a single part. Fig.30 , Fig.31 An embodiment may be combined with any other previously or later described embodiment.

[0363] Fig.32 , Fig.33 and Fig.34 2 and 3 show a perspective view and a cross-sectional view of another specific embodiment of the sample collection device 200 according to the present application. In the illustrated specific embodiment, the trigger element 209 is not a half ring on the cover 202, such as Fig.30 and Fig.31 As shown inside.

[0364] In this particular embodiment, the trigger element 209 is a tab 209' in the cover 202, which is held in place by a finger 210'. Once deformed by the vacuum, the user's skin will move the tab 209' in the direction of the arrow F14 by releasing the tab 209' from the finger 210', thereby releasing the elastic element 204 and thus releasing the piston 203 and the blade 206.

[0365] exist Fig.32 , Fig.33 and Fig.34 In a specific embodiment, the blade 206 is inclined at an angle β relative to the normal axis of the skin, and the angle is different from 90°, such as Fig.30 and Fig.31 In this embodiment, the cover 202 is on a portion of the sample container 212, such as Fig.30 and Fig.31 Finally, in this specific embodiment, the sample container 212 includes two parts 2123 and 2124, which have different diameters d1 and d2 respectively. Again, Fig.32 , Fig.33 and Fig.34 The features illustrated in the specific embodiments do not necessarily exist at the same time. Fig.32 , Fig.33 An embodiment may be combined with any other previously or later described embodiment.

[0366] Fig.35A and Fig.35B A cross-sectional view of another embodiment of a sample collection device 200 according to the present application is shown. In this embodiment, the support element 203 comprises a protrusion 230 which, once the support element is moved in the direction of arrow F15 by the trigger mechanism, will come into contact with a finger 232 of the cover 202: this will result in a mechanical movement of all the support elements 203 and then the blade 206 towards the user's skin, so that the cutting element will move towards the user's skin when cutting. In this way, a deeper cut can be achieved on the user's skin. The shape and size of the protrusion 230 and / or the finger 232 are selected so that the movement of the blade 206 towards the user's skin is performed while the blade 206 cuts the user's skin. Other means can be envisaged to move the blade 206 towards the user's skin when it cuts the skin. This embodiment can be combined with any other previously or later described embodiment.

[0367] Fig.36 A perspective view of another specific embodiment of a system 300 for extracting and collecting a fluid sample from a user according to the present application is shown.

[0368] In this specific embodiment:

[0369] - System 300 is fully consumable / disposable;

[0370] - The vacuum is pre-installed in the system 300;

[0371] - the trigger mechanism is arranged to perform a circular motion;

[0372] - the incision mechanism is arranged to perform a circular motion;

[0373] - the suction bag comprises a narrow opening near or above the collection window;

[0374] - the cover is impermeable;

[0375] -The part in contact with the skin is adapted to the shape of the part in contact with the user; etc.

[0376] However, it must be noted that Fig.36 The features shown in a particular embodiment do not have to exist at the same time. In other words, the skilled person can imagine different embodiments in which not all the exemplified features exist at the same time. Fig.36 An embodiment of the invention may be combined with any other previously described embodiment.

[0377] Fig.37 show Fig.361 and 2. An exploded view of an embodiment of the system 300 is shown in FIG. 1. In this figure, the suction bag 201 present in the previously described embodiment is a first suction bag 201 (or inner suction bag 201), and the system 300 includes a second suction bag 110 (or outer suction bag 110).

[0378] The first suction bag 201 includes a recess 2010 arranged to receive the sample container 212 and the lid 202 and having a first thickness. The second suction bag 110 includes a recess 1100 having a second thickness, the second thickness being greater than the first thickness. The first suction bag 201 is arranged to be received by the second suction bag 110 so that the difference between the two thicknesses creates a chamber that is under vacuum in a manufacturing assembly line or medical facility. In other words, a pre-installed vacuum is created by adding the second suction bag 110 on top of the first suction bag 201 to form this chamber.

[0379] The first and second suction bags are arranged such that once the second suction bag 110 receives the first suction bag 201 , they can be permanently sealed together.

[0380] Fig.37 The system 300 of the specific embodiment also includes a device for transferring the vacuum from a chamber under vacuum in a manufacturing assembly line or a medical facility (hereinafter, the second vacuum chamber) to the first vacuum chamber 101 once a user wants to activate the system 300.

[0381] In a particular embodiment, the second suction bag 110 comprises a bistable element (as a button) on one of its outer surfaces. Fig.38 An example of such a bistable element can be seen in FIG. Fig.36 , Fig.37 A cross section of a specific embodiment of the system described in Figure 1 part.

[0382] In this specific embodiment, the first suction bag 201 further includes a piercing protrusion ( Fig.34 2014 in the reference). Once the user activates the bistable element 2012, for example by pressing the second suction bag 110, the piercing protrusion 2014 will pierce the film 208 placed on the first suction bag 201, thereby transferring the vacuum in the first vacuum chamber or collection chamber. This will start the collection of the liquid sample. In a preferred embodiment, this film is impermeable to avoid vacuum transfer before using the system 300.

[0383] In one embodiment, the second suction bag 110 further includes one or more holes 2010 that are completely covered by a removable cover 140 (e.g., a rubber removable cover 140). To stop collecting the liquid sample, the user can remove the removable cover 140, such as by pulling, to reduce the pressure in the collection chamber to atmospheric pressure, thereby stopping collecting the liquid sample.

[0384] exist Fig.36 In the example of , a (removable) label 130 may cover the back side of the second suction bag 110 .

[0385] Fig.39 show Fig.36 Another cross-sectional view of another portion of a specific embodiment of the system described in . In the illustrated specific embodiment, the blade 206 forms an incision on the user's skin by rotating about the main central axis of the test tube (and the cover 202). This rotational movement allows for a more compact trigger and incision mechanism. In fact, by selecting the rotational movement of the blade 206, the overall length of the trigger mechanism is reduced, thereby allowing the size of the cover 202 to be smaller and the entire system 300 to be smaller.

[0386] In one embodiment, the cover 202 includes one or more Fig.39 2020, which is arranged to deform in the direction of arrow F16. One or more deformable elements 2020 are part of the trigger mechanism. When a vacuum is applied, the skin is sucked into the chamber and pressed against the deformable element 2020 on the lid 202. By pushing the deformable element 2020, it releases the rotating piston 203 which is previously equipped with a (torsion) spring 204.

[0387] Fig.41A Display according to Fig.36 A perspective view (front) of a specific embodiment of the sample collection device of the system described in FIG. Fig.41B Display according to Fig.41A 2020 is a perspective view (back side) of the embodiment of the sample collection device. In the illustrated embodiment, the trigger element is a part of the cover 202. In another embodiment, the deformable element 2020 is a supplementary part, which is fixed (movably or immovably) to the cover 202. The deformable element 2020 is larger than the previous variants because the contact area between the skin and the trigger mechanism is larger, which makes the trigger mechanism more reliable.

[0388] In this embodiment, the cap 202 includes a release notch 2021. When the vacuum is released, the skin will press the trigger surface 2025 of the cap 202 by pushing the notch 2021 and releasing the piston 203.

[0389] Increasing the length of the collection window 205 allows for increased skin stretching. With the rotational motion of the blade 206, the length of the incision is not dependent on the length of the collection window 205 (which is proportional to the width of the window), as with the translational motion of the blade 206.

[0390] By restoring, the rotational motion of the blade 206 has the following advantages:

[0391] - Smaller system 300;

[0392] -More reliable trigger mechanism;

[0393] - Skin stretching for greater control and definition.

[0394] In a specific embodiment, for example Fig.36 As can be seen from the figure, the recess 2010 of the suction bag 201 arranged to receive the sample container 212 has a waisted shape, which is narrower at or near the collection window 205, especially at or near the incision area, so as to allow better stretching of the skin. The applicant has noticed that the skin has better deformation along the edge 2011 of the recess 2010 of the suction bag 201. In order to maximize the deformation of the skin at or near the incision area, the edge of the recess 2010 of the suction bag 201 is narrowed so that it is closer to the incision area.

[0395] Fig.42 A top view of a system 300 according to the present application is shown, the system being placed near a user's part, such as an arm. In this embodiment, the suction bag 201 in contact with the skin has a shape and / or curvature 2013 to fit the shape and / or curvature of the arm 400, ensuring a better seal between the skin and the suction bag 201. In another embodiment (not shown), this shape and / or this curvature can be adjusted or changed by the user to better fit the user, particularly a young user.

[0396] Figures 43 to 49b A further specific embodiment of a sample collection device 3200 for collecting a patient's blood sample 3500 in the present application is shown.

[0397] The sample collection device 3200 includes the same structural and functional features and capabilities as the above-mentioned specific embodiments.

[0398] It may be combined with one or more of the above-mentioned features of the sample collection device already described.

[0399] Similar or identical features are denoted by the same (or similar reference numerals), with the numerals being increased by 3000 or by Figures 36 to 42 In the case of the specific embodiment shown, 2000 is added.

[0400] Fig.43 An exploded view of a further specific embodiment of a sample collection device 3200 for collecting a patient's blood sample in the present application is shown.

[0401] The sample collection device 3200 includes a first shell 3110 and a second shell 3201 .

[0402] The first shell 3110 is a partially deformable shell 3110 .

[0403] The housing 3110 includes a deformable button 3224 .

[0404] The deformable button is formed integrally with the housing 3110. In this area, the housing can be deformed in a predetermined manner, that is, it is allowed to deform elastically or plastically by squeezing in this portion.

[0405] Button 3224 has the size based on the size of people's fingerprints. In the specific embodiment shown, the diameter of button 3224 is about 30mm.

[0406] Furthermore, the housing 3110 has an electronic module interface 3226 .

[0407] The electronic module interface 3226 is integrated into the housing 3110 .

[0408] In particular, the electronic module interface 3226 is formed by a recess.

[0409] The electronic module interface 3226 is configured to receive and secure the electronic module 3220 .

[0410] The electronics module 3220 is an optional component that is reusable, while the rest of the sample collection device 3200 is disposable.

[0411] The electronic module 3220 may include the sensors described in this application (particularly the portions described above).

[0412] The electronic module 3220 may include electronic components configured to measure blood volume, but may also be used for in situ diagnosis. It may include at least one of the following elements, such as one or more sensors (sensors of any type, such as temperature sensors, pH sensors, pressure sensors, etc.), one or more power storage units, such as batteries, electronic circuits, at least one communication module, at least one controller, at least one telemetry unit, etc.

[0413] The second housing 3201 is a partially pierceable housing 3201. However, the partially pierceable portion is provided by a film 3208, which is placed in a pierceable film position 3238. In this position, the film 3208 is tightly welded to the second housing 3201.

[0414] In the installed state of the collecting device 3200 , a pre-installed vacuum is sealed between the first shell 3110 and the second shell 3201 .

[0415] Also as described above, a pierceable membrane 3208 is also present.

[0416] The second housing 3201 is configured such that in the installed state, the sample container 3212 and the automatic mechanical cutting mechanism are fixed by the second housing 3201 .

[0417] The second housing 3201 includes a base plate 3230 having stabilizing ribs 3228 and a primary retainer recess 3229. The ribs 3228 prevent the first housing 3110 from collapsing under a vacuum.

[0418] The ribs may also be arranged and designed differently. In particular, there may also be a rib design with, for example, at least one surrounding rib surrounding the primary fixture recess 3229. The ribs may then surround the primary fixture recess 3229 in an elliptical form.

[0419] The ribs 3228 may be positioned perpendicular to the base plate 3230 .

[0420] In the base plate 3230, there is a collecting opening 3231. As already described, the collecting opening comprises a narrow portion in the region of the cutting mechanism. The narrow portion is formed by a circular protrusion 3230a of the base plate 3230. The function of the narrow portion, which facilitates the blood collection and cutting process, has been described in more detail above.

[0421] For example, Fig.45c and Fig.45e As can be seen, the base plate 3230 is curved to better fit and adjust to the skin surface, such as a person's arm.

[0422] The base plate 3230 may be made of a rigid plastic material (medical grade).

[0423] All components of the device 3200 are made of plastic (except the electronic module 3220, the spring 3204 and the cutting blade 3206).

[0424] On the outside of the main retainer recess 3229 there is a vacuum unlocking element 3234 in the form of a bendable arm which carries a piercing portion of a vacuum unlocking element 3236 .

[0425] Furthermore, as part of the wall of the primary retainer recess 3229, a pierceable membrane 3208 is placed at location 3208, which is tightly welded to the second housing 3201. In this particular embodiment it is made of aluminum, but any other suitable material may be used.

[0426] The film 3208 is arranged such that it can be pierced via the vacuum unlocking element 3236 .

[0427] The base plate 3230 also includes 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 completed. The handle portion 3232 or tab 3232 can also be formed on the first housing 3110 or on the first housing 3110 and the second housing 3201.

[0428] In order to enclose the automatic mechanical cutting mechanism and the sample container within the main holder recess 3229 of the second housing 3201 and ensure their sterility, a cover plate 3207 is provided (as described above in conjunction with the cover plate 207).

[0429] The automatic mechanical cutting mechanism includes a trigger 3209, an actuator spring 3204 (here a tension spring 3204), a plunger 3203 that fixes the cutting blade 3206, a cover 3202 and a sample container 3212.

[0430] The sample container 3212 is formed as a cylindrical tube having a closed end and an open end, the open end facing the cap and plunger 3203.

[0431] The plunger 3203 also includes a sealing portion 3203a and a diaphragm 3203b.

[0432] The sealing portion 3203 a is formed as an O-ring on the radially outer side of the plunger 3203 .

[0433] Fig.44a -c display Fig.43 Details of the device 3200 shown in FIG. 3 , which details are related to the functionality of the device 3200 .

[0434] In step S1 , after placing the device 3200 on a collection site, such as an arm of a patient, the user deforms the button 3224 of the blister 3110 (ie, the first shell 3110 ).

[0435] In step S2, the deformable arm 3234 (also the deformable beam 3234) is thus deflected and pierces the aluminum film 3208 (placed at position 3238).

[0436] In step S3, the vacuum is released.

[0437] In step S4 , the skin is stretched and pressed against the trigger 3209 .

[0438] In step S5, the trigger 3209 releases the spring loaded plunger 3203, and the spring loading is generated by the tension spring 3204 (see also Fig.49a and Fig.49b ).

[0439] In step S6, the cutting blade 3206 tightly fixed to the released plunger 3203 rotates and forms an incision on the stretched skin.

[0440] In step S7, blood flows into the sample container 3212 and is collected.

[0441] In step S8, the user pulls the handle 3232 to stop blood collection, thereby releasing the device 3200 from the skin. The closure of the sample container 3212 is described below.

[0442] like Fig.46e As shown, the trigger 3209, the plunger 3203, the sealing portion 3203a engages with the radial outer wall (radial outer side) of the plunger 3203 and the inner wall of the sample container 3212, so that the sample container 3212 for conveying blood 3500 can be closed and sealed.

[0443] This can be accomplished by simply placing a finger in gap 3240 (see Fig.44c ) and then closing the sample container 3212 by pressing all parts together to close and seal the sample container.

[0444] Fig.45a -e is Fig.43 Different views of device 3200 in FIG.

[0445] Fig.46a -e display Fig.43 Different views of the sample container of the illustrated embodiment are connected to the extension tube 3250 (as described above).

[0446] Fig.47a -f display Fig.43 Different views of the plunger 3203 and cutting blade 3206 of the specific embodiment are shown in FIG.

[0447] Fig.48a -b display Fig.43 Different views of the metal cutting blade of the specific embodiment are shown in FIG.

[0448] As shown, the cutting blade 3206 includes a cutting edge 3206a, wherein the cutting edge 3206a has a sharp end 3206b and a rounded end 3206c.

[0449] The cutting edge 3206a of the cutting blade 3206 may have an angle δ selected in the range of 15°-25°, in particular about 19°-21°, here 20°. Deviations of ±1° are not problematic and are tolerated in this specific embodiment.

[0450] The sharp end 3206b of the cutting blade 3206 may have an angle γ selected in the range of 45°-55°, in particular about 47°-53°, here about 50°.

[0451] The rounded end 3206c of the cutting blade 3206 may also have the same radius R as the outer edge of the cutting blade 3206 on the side of the rounded end 3206c.

[0452] For form-fitting attachment to the plunger 3203, there is a retainer opening 3206d having a retaining recess 3206e.

[0453] For easier manufacturing, a break line 3206f is present.

[0454] On this fracture line, two blades can be manufactured jointly and then separated into individual blades. In addition, a manufacturing part or carrier can also be present therein during manufacturing, which allows easier handling.

[0455] Figure 49 is Fig.43 Different views of the metal tension spring 3204 of the specific embodiment are shown in FIG.

[0456] The tension spring 3204 is shown in a loaded position C1 and an unloaded position C3.

[0457] The following explicit disclosure matters are combined with the above-mentioned contents of this application to disclose the following aspects:

[0458] Aspect 1: A sample collection device (200) for collecting a fluid from a user, such as a blood sample (500), the sample collection device (200) comprising:

[0459] - a sample container (212) arranged to receive said sample (500) and comprising an open end (2121);

[0460] - a trigger mechanism (209, 210, 209', 210', 211); - a cover (202) arranged to cooperate with the sample container (212) to close the open end (2121), the cover (202) being arranged to move from a first cover position to a second cover position in and / or on the sample container (212), wherein in the first cover position and the second cover position, the cover (202) at least partially contacts the sample container (212) to guide the cover (202) to move from the first cover position to the second cover position, the cover (202) comprising:

[0461] - a collecting window (205) arranged to be in contact with the area to be cut by the user;

[0462] - a notching mechanism (203, 204, 206) which can be moved from a first notching mechanism position to a second notching mechanism position in the cover (202) by the trigger mechanism (209, 210, 209', 210', 211), wherein moving the notching mechanism (203, 204, 206) is arranged to cut an area of ​​the user in the collection window (205) so as to separate the sample (500) from the user, the sample being received by the sample container (212), and wherein during the movement from the first notching mechanism position to the second notching mechanism position, the cover (202) is in the first cover position;

[0463] - a sealing mechanism, such that when the lid (202) is in the second lid position, the sample container (212) is sealed, thereby safely transporting the sample (500).

[0464] Aspect 2: A sample collection device (200) as in aspect 1, wherein the cover (202) comprises a first cover portion (2021) and a second cover portion (2022), wherein the first cover portion (2021) comprises the collection window (205) arranged to come into contact with the user.

[0465] Aspect 3: The sample collection device (200) of aspect 2, wherein the cover (202) includes an opening (215), and the collection window (205) includes a portion of the opening (215).

[0466] Aspect 4: The sample collection device (200) of one of Aspects 2 or 3, wherein at least a portion (2021') of the first cover portion (2021) has been inserted into the sample container (212).

[0467] Aspect 5: A sample collection device (200) as in one of aspects 2 to 4, wherein the second cover portion (2022) includes a recess (216) for receiving the cutting mechanism (203, 204, 206) when it is in the second cutting mechanism position, so that the cutting mechanism (203, 204, 206) is irreversibly and safely retracted into this recess (216) so that it can no longer cut the user.

[0468] Aspect 6: A sample collection device (200) as one of aspects 1 to 5, wherein the incision mechanism (203, 204, 206) comprises: - a support element (203), such as a piston, which comprises a cutting element (206), such as a blade or a blade-like element; - an elastic element (204), such as a spring, which is locked in a compressed position, and once the incision mechanism is triggered, the elastic element (204) can be freely decompressed, and the decompression causes the support element (203) and the cutting element (206) to move from the first incision mechanism position to the second incision mechanism position.

[0469] Aspect 7: A sample collection device (200) as in aspect 6, wherein when in the first incision mechanism position, the cutting element (206) is located in the sample container (212) to ensure the safety of the user and / or an operator.

[0470] Aspect 8: A sample collection device (200) as one of aspects 1 to 7, wherein the movement of the cutting mechanism (203, 204, 206) from the first cutting mechanism position to the second cutting mechanism position is a linear movement performed in a direction parallel to the user area to be cut.

[0471] Aspect 9: A sample collection device (200) as 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 motion, wherein the rotation axis of this circular motion is preferably a main axis of the sample container (212).

[0472] Aspect 10: A sample collection device (200) as one of aspects 1 to 9, wherein the support element includes a protrusion (230) that cooperates with a finger-like member (232) of the cover (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 skin of the user when the incision mechanism (203, 204, 206) cuts the skin.

[0473] Aspect 11: A sample collection device (200) as one of aspects 1 to 10, wherein the movement of the lid (202) from the first lid position to the second lid position is a linear movement, during which the lid slides onto the sample container (212).

[0474] Aspect 12: The sample collection device (200) of any one of aspects 1 to 10, wherein the movement of the cover (202) from the first cover position to the second cover position is a circular movement.

[0475] Aspect 13: A sample collection device (200) as in any one of aspects 1 to 12, comprising a suction bag (201) arranged to receive the sample container (212) and the lid (202) and perform sterilization, the suction bag (201) comprising a film (208) that allows vacuum to enter the suction bag (201).

[0476] Aspect 14: In the sample collection device (200) of aspect 13, the suction bag (201) comprises a removable cover (207), in particular an impermeable removable cover (207), to ensure moisture-proofing and sterilization of its contents.

[0477] Aspect 15: The sample collection device (200) of one of Aspects 13 or 14, wherein the suction bag (201) is at least partially transparent.

[0478] Aspect 16: The sample collection device (200) of any one of aspects 13 to 15, comprising a lubricant material inside the suction bag (201) and / or on the suction bag (201) to enhance the seal between the suction bag (201) and the user.

[0479] Aspect 17: A sample collection device (200) as one of aspects 6 to 16, wherein the trigger mechanism (209, 210, 209', 210', 211) includes a mechanism arranged to move from a first trigger element position to a second trigger element position, wherein in the first trigger element position, the elastic element (204) is fixed in a locked position, such as a compressed position, and the support element (203) is fixed in a fixed position, wherein in the second trigger element position, the trigger element (209) no longer fixes the elastic element (204) or the support element (203).

[0480] Aspect 18: In the sample collection device (200) of aspect 17, the cover (202) includes the trigger element (209), which is, for example, a semi-ring surrounding at least a portion of the support element (203), or a protrusion (209') in the cover (202).

[0481] Aspect 19: A sample collection device (200) as one of aspects 17 to 18, wherein the trigger element includes a protrusion (211), such as a finger-like member, and the support element includes a recess (210), which is arranged to receive the protrusion (211) to fix the trigger element (209) in the first trigger element position.

[0482] Aspect 20: The sample collection device (200) of any one of aspects 1 to 19, wherein the cover (202) is a standard cover arranged to be automatically opened by a blood analysis device.

[0483] Aspect 21: A sample collection device (200) as in the previous aspect, wherein the diameter of the second portion (2022) of the standard cover is 15 mm.

[0484] Aspect 22: The sample collection device (200) of any one of aspects 1 to 21, wherein the sample container (212) is a test tube, in particular a standard test tube arranged to be placed in a blood analysis device.

[0485] Aspect 23: As in the sample collection device (200) of the previous aspect, the diameter (d1) of the standard test tube is in the range of 12 mm to 16 mm, for example 13 mm.

[0486] Aspect 24: The sample collection device (200) of any one of aspects 1 to 23, wherein the sample container (212) is arranged to receive at least 0.5 ml, preferably 1 ml, of the fluid sample (500).

[0487] Aspect 25: The sample collection device (200) of any one of Aspects 1 to 24, wherein the sample container (212) is at least partially transparent.

[0488] Aspect 26: The sample collection device (200) of any one of aspects 1 to 25, wherein the sample collection device (200) is a consumable.

[0489] Aspect 27: In the sample collection device (200) of any one of aspects 1 to 26, the sample container (212) comprises one or more biomarker pads (214) that react with the fluid sample, so that the fluid sample can be directly analyzed.

[0490] Aspect 28: In the sample collection device (200) of one of aspects 1 to 27, the cover (202) comprises the trigger mechanism (209, 210, 209', 210', 211), in particular wherein the trigger mechanism comprises at least one deformable element (2020).

[0491] Aspect 29: A sample collection device (200) as one of aspects 1 to 28, wherein the cover (202), the suction bag (201) is a first suction bag (201), the sample collection device (200) includes a second suction bag (110), wherein the first suction bag (201) includes a recess (2010) arranged to receive the sample container (212) and the cover (202), and has a first thickness, wherein the second suction bag (110) includes a recess (1100) having a second thickness, the second thickness being greater than the first thickness, wherein the first suction bag (201) is configured to be received by the second suction bag (110), such that the difference between the two thicknesses creates a chamber, and the chamber is arranged to be placed under vacuum in a production assembly line or a medical facility.

[0492] Aspect 30: A sample collection device (200) as in aspect 29, wherein the second suction bag (110) comprises a bistable element, wherein the first suction bag (201) comprises a piercing protrusion (2014), wherein once the user activates the bistable element (2012), the piercing protrusion (2014) pierces a film (208) on the first suction bag (201), thereby transferring vacuum in the collection chamber.

[0493] Aspect 31: A sample collection device (200) as in one of aspects 28 or 29, wherein the second suction bag (110) also includes one or more holes (2010) completely covered by a removable cover (140).

[0494] Aspect 32: A sample collection device (200) as in any one of aspects 1 to 31, wherein the suction bag (201) is arranged such that the portion in contact with the user has a curvature (2013) to fit the shape and / or curvature of the user, thereby ensuring a better seal between the user and the suction bag (201).

[0495] Aspect 33: A system (300) for extracting and collecting a user fluid sample (500), comprising:

[0496] - The sample collection device (200) according to one of aspects 1 to 32;

[0497] - a sample extraction device (100), comprising

[0498] - an interface (107) arranged to receive at least a portion of said sample collection device (200);

[0499] - a vacuum chamber (101);

[0500] - a vacuum generating mechanism (108) arranged to generate a vacuum in said vacuum chamber (101);

[0501] - a valve (104) arranged to close and / or open the vacuum chamber (101) and / or release the sample collection device (200) to atmospheric pressure;

[0502] - a valve control mechanism (102) arranged to command the valve (104) in order 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 below atmospheric pressure.

[0503] Aspect 34: A system (300) as in aspect 33, wherein the sample extraction device 100 comprises a first connecting device (120), and the sample collection device 200 comprises a second connecting device (220) so as to establish a mechanical connection between the sample extraction device (100) and the sample collection device (200).

[0504] Aspect 35: The system (300) of one of aspects 33 or 34, wherein the sample extraction device (100) comprises an electronic module (105), the module comprising a communication module and a power supply.

[0505] Aspect 36: A system (300) as in any one of aspects 33 to 35, wherein the sample extraction device (100) comprises at least one sensor (106), such as a light sensor, for detecting a predetermined sample volume in the sample container (212).

[0506] Aspect 37: A system (300) as in either aspect 33 or aspect 36, wherein the sample extraction device (100) comprises an alert mechanism to inform the user that the sample extraction is complete, for example, via an audio and / or visible signal.

[0507] Aspect 38: The system (300) of one of aspects 33 or 37, wherein the extraction device comprises a gasket (103) that cooperates with a region of the sample collection device (200) comprising the membrane (208).

[0508] Aspect 39: A system (300) as in aspect 33 or aspect 38, wherein the sample collection device (200) and the sample extraction device (100) are arranged such that, when connected, the valve (104) of the sample extraction device (100) is positioned to correspond to the film (208) of the sample collection device (200), and / or the sensor (s) (106) of the sample extraction device (100) is positioned to correspond to the sample container (212) of the sample collection device (200).

[0509] Aspect 40: The system (300) of one of Aspects 33 or 39, wherein the sample extraction device (100) is a consumable.

[0510] 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).

[0511] Aspect 42: A method for extracting and collecting a user fluid sample (500) by using the system (300) according to aspects 33 to 40, comprising the following steps:

[0512] - placing the system (300) on an area where the user (400) remains substantially vertical, or making the angle (θ) formed by the main axis direction (a) of the system (300) and the direction (z) of the gravity (g) range from 0° to 45°;

[0513] - activating the valve control mechanism (102) to open the valve (104) to transfer the vacuum from the vacuum chamber (101) of the sample extraction device (100) to the suction bag (201) of the sample collection device (200) through an opening (218) in the suction bag (202), the opening (218) being covered by a film (208) located in the suction bag (202);

[0514] - the vacuum in the suction bag (201) causes a user part (401) to be cut to stretch and / or deform;

[0515] - The trigger mechanism (209, 210, 209', 210', 211) is activated by the stretched and / or deformed part of the user to be cut (401), and the trigger mechanism then triggers the incision mechanism (203, 204, 206);

[0516] - moving the cutting mechanism (203, 204, 206) from a first cutting mechanism position in the cover (202) to a second cutting mechanism position so that the supporting element (203) serving as the cutting mechanism is connected to the cutting element (206), and the cutting element (206) will cut the stretched and deformed user's part to be cut (401);

[0517] - collecting a certain volume of fluid sample in the sample container (212);

[0518] - moving the cover (202) from the first cover position to the second cover position to seal the sample container (212).

[0519] Aspect 43: The method of Aspect 42, further comprising:

[0520] - After the skin incision, the cutting element (206) is retracted into the cap (202) without risk of injury or contamination to anyone handling the sample collection device (200).

[0521] Aspect 44: The method of any of Aspects 42 or 43, further comprising:

[0522] - placing a cover (202) in and / or on the sample container (212), the cover (202) at least partially in contact with the sample container (212);

[0523] - packaging the sample container (212) and the lid (202) in the suction bag (202);

[0524] - closing the suction bag (202) with a cover plate (207);

[0525] - sterilizing the closed suction bag (202);

[0526] - Placing the sterilized suction bag (202) on or in the sample extraction device (100).

[0527] Aspect 45: The method of any one of Aspects 42 to 44, further comprising:

[0528] - Mechanically connecting the sterilized suction bag (202) to the sample extraction device (100);

[0529] - removing the cover plate (207) of the suction bag (201);

[0530] - Activating a vacuum generating mechanism (108) of the sample extraction device (100) to load vacuum into the vacuum chamber (101).

[0531] Aspect 46: The method of any one of Aspects 42 to 45, further comprising:

[0532] - once the fluid sample volume reaches a predetermined value, informing the user that the fluid sampling is finished;

[0533] - Pressing the valve control mechanism (102) to return the system (300), in particular the suction bag (201), to atmospheric pressure.

[0534] Aspect 47: The method of any one of Aspects 42 to 46, further comprising:

[0535] - removing the system (300) from the skin of the user (400);

[0536] - removing the sealed sample container (212) from the suction bag (201);

[0537] - Removing the suction bag (201) from the sample extraction device (100).

Claims

1. A sample collection device (3200) for collecting a blood sample (3500) from a patient, characterized in that: The sample collection device (3200) comprises at least: - a partially deformable first shell (3110), - an at least partially pierceable second shell (3201), Wherein, when the collecting device (3200) is in an installed state, a pre-installed vacuum is sealed between the first shell (3110) and the second shell (3201), Further wherein the second housing (3201) accommodates a sample container (3212) and an automatic mechanical cutting mechanism in the installed state, the mechanism comprising a rotatable cutting blade (3206) and an actuator spring (3204), the actuator spring (3204) being actuated by pressing the first housing (3110) to release and rotate the cutting blade (3206), Further, by pressing the first shell (3110), the pre-installed vacuum is released to the collection opening (3231) of the second shell (3201), so that the vacuum produces a suction effect, so that the blood flowing out of the incision established by the rotatable cutting blade (3206) will leak into the sample container (3212), The cutting blade (3206) comprises a cutting edge (3206a), a first circular end and a second circular end, and wherein the cutting edge (3206a) has a sharp end (3206b), and the sharp end (3206b) of the cutting edge (3206a) is between the first circular end and the second circular end of the cutting blade (3206).

2. The sample collection device (3200) according to claim 1, characterized in that: The cutting blade (3206) is fixed on and / or is a part of the rotatable plunger (3203).

3. The sample collection device (3200) according to claim 2, characterized in that: The plunger further includes a sealing portion (3203a), which is arranged and configured so that after blood is collected, the sample container is and / or can be sealed by the sealing portion, so that the sample container (3212) is closed by the plunger (3203) and its sealing portion (3203a).

4. The sample collection device (3200) according to claim 2 or 3, characterized in that: The plunger (3203) further includes a diaphragm (3203b).

5. The sample collection device (3200) according to any one of claims 1 to 3, characterized in that: The cutting edge (3206a) of the cutting blade (3206) has an angle δ selected from the range of 15°-25°.

6. The sample collection device (3200) according to any one of claims 1 to 3, characterized in that: The sharp end (3206b) of the cutting blade (3206) has an angle γ selected from the range of 45°-55°.

7. The sample collection device (3200) according to any one of claims 1 to 3, characterized in that: The first circular end and the second circular end of the cutting blade (3206) have the same radius R as the outer edge of the cutting blade (3206) on the side of the first circular end and the second circular end.

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