Capillary blood sampling device and method of use

Abstract

The disposable fluid sampling device comprises a body fluid sampling device, and optionally comprises a body fluid sampling device for automatic sampling; and optionally an analysis device for analyzing the fluid using one or more droplets of the sampled fluid; the invention relates to a device for analyzing a fluid sample, comprising at least one vacuum tube or vacuum source, and an interface for at least one sample tube or medical analysis tube adapted to be filled with a fluid sample for analysis at a point of care or in a medical laboratory, the device comprising an interface for at least one vacuum tube or vacuum source, the vacuum tube or vacuum source is adapted to provide a suction force required to fill the at least one sample tube with a fluid.

Description

[0001] Copyright and Legal Notice

[0002] Part of the disclosure of this patent document contains material which is subject to copyright protection. The applicant does not object to anyone making a facsimile reproduction of any patent document or patent disclosure as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights. In addition, the citation of any third party patents or articles in this document does not indicate an admission that the present invention is not entitled to antedate such material by virtue of a prior invented invention. Field of the Invention

[0003] The present invention relates to a device for capillary blood sampling. In many cases, it is desirable to avoid sampling blood by venipuncture, which may be because the patient's veins are too fragile, or for comfort reasons, or because of a lack of a sufficient number of trained phlebotomists. Background Art

[0004] Due to the patient's veins being possibly fragile or for comfort reasons, or due to a lack of a sufficient number of trained phlebotomists, capillary blood sampling is generally more desirable than venipuncture.

[0005] There is a need for a capillary fluid sampling device suitable for safe use that can provide the necessary blood samples for analytical equipment or analytical systems at the point of care or in a medical laboratory. There is a need for a capillary blood collection device that can use a single incision or puncture system at a single location to collect one or, ideally, multiple consecutive blood samples, each sample being at least 500 μl per tube, into one or, ideally, multiple standard test tubes for blood testing, using the vacuum of one or more evacuated tubes or the vacuum generated by an external vacuum source. Summary of the Invention

[0006] A disposable body fluid sampling device enables a user to collect capillary blood and fill one or more sample tubes for analysis. The disposable body fluid sampling device may include: a body fluid reservoir for containing the sampled body fluid, and a liquid extraction mechanism including at least one catheter or hollow needle connected to a vacuum reservoir or an external vacuum source. When the vacuum reservoir or the external vacuum source is connected to the body fluid reservoir, a seal of the vacuum reservoir or the external vacuum source is adapted to be ruptured, pierced or opened so as to suck blood into the body fluid reservoir. The sampling device of the present invention allows for collection of capillary blood samples without the intervention of medically trained personnel (especially in cases where there is a lack of personnel trained in venipuncture). The sampling device enables the user to: (a) collect a body fluid sample, or optionally perform an automatic sampling; (b) optionally use one or more drops of the sampled body fluid for immediate analysis of the body fluid; and (c) provide one or more medical analysis tubes filled with the sampled body fluid for analysis at the point of care or in a medical laboratory. The sampling device may include a vacuum tube or an external vacuum source and its interface. The vacuum tube or the external vacuum source provides the necessary suction to draw body fluid from the user / patient and fill the body fluid reservoir.

[0007] This task is solved by a fluid sampling device adapted to collect a body fluid sample, which body fluid sample preferably consists of one or more drops of body fluid for optional immediate analysis, and a large amount of body fluid (0.5 to 1.5 ml per sampling tube) similar to that collected by venipuncture blood collection for further analysis at the point of care or in a medical laboratory. The disposable fluid sampling device is optionally adapted for automatic sampling, wherein the disposable fluid sampling device includes a vacuum interface for connecting a first vacuum source and a second vacuum source, the vacuum sources being interconnected with at least one container for providing the suction required to fill the at least one container with body fluid. Preferably, the body fluid is blood. The fluid sampling device is optionally disposable. In the present disclosure, the description of the body fluid sampling device is specifically directed to the case of sampling capillary blood, but the same invention can also be used for sampling other body fluids, such as pus or venom.

[0008] In another embodiment of the fluid sampling device, at least one, preferably two, vacuum sources are configured as containers for containing body fluid. Thus, by activating the first vacuum source, the first vacuum source can be filled with body fluid, thereby constituting a first body fluid reservoir, and by activating the second vacuum source, the second vacuum source can be filled with body fluid, thereby constituting a second body fluid reservoir. Thus, at least one vacuum source is adapted to be filled with body fluid.

[0009] Alternatively, the fluid sampling device includes a tube interface adapted to dock with at least one container, which is preferably a sample container or a medical analysis container. Thus, such a container constitutes a body fluid reservoir. Accordingly, the vacuum source can be different from the at least one container. This is advantageous because the vacuum source does not have to be configured as a body fluid reservoir. Such a medical analysis container can be adapted to fill a body fluid sample for further analysis, optionally at the point of care or in a medical laboratory. A single vacuum source can consist of a vacuum tube.

[0010] A first vacuum source can be interconnected with a first container, while a second vacuum source can be interconnected with a second container. Thus, activation of the first vacuum source will initiate filling of the first container. Then, by activating the second vacuum source, the second container can be filled with body fluid. According to the above, at least one vacuum source and / or at least one additional container can constitute a body fluid reservoir.

[0011] In another embodiment, the fluid sampling device includes an analysis device, where the analysis device is adapted to analyze body fluid. Optionally, the tube interface can be connected to the analysis device.

[0012] Another embodiment of the fluid sampling device includes a valve, preferably a three-way valve, for switching the inlet from at least a first body fluid reservoir to at least a second body fluid reservoir, each body fluid reservoir being constituted by the vacuum source or the container. Thus, the manner of filling the body fluid reservoir can be controlled. To control which body fluid reservoir is supplied with fluid, the valve can be turned to an appropriate position to allow fluid to flow from the patient's wound to the selected reservoir or container, respectively.

[0013] In yet another embodiment of the fluid sampling device, a plurality of body fluid reservoirs can be used to store the withdrawn body fluid. In one aspect of the embodiment, the body fluid can flow into a first body fluid reservoir, then into a second body fluid reservoir, and even into other reservoirs. The switching from one reservoir to the next can be achieved by a valve (preferably a three-way valve). Another embodiment of the fluid sampling device includes a watertight fluid extraction channel or catheter for connecting the patient's wound and the container, and the watertight fluid extraction channel or catheter includes a flexible tube, respectively. This is advantageous because the disposable body fluid collection device can be placed on the human body and can be operated by a third person independently of the patient, whether lying or standing.

[0014] Another embodiment of the fluid sampling device includes a heating element that can be attached to the skin near the area where body fluid is withdrawn from the body. This simplifies the operability of the disposable fluid sampling device. Thus, the skin around the location where body fluid (especially blood) is withdrawn from the patient's body can be heated. Such heating will dilate the capillaries near the above-mentioned location, thereby resulting in an increased rate of blood extraction from the human body.

[0015] The heating element should be thin enough to be located between the blood collection device and the patient's skin during blood collection, with a thickness preferably of 0.5 mm to 4 mm, more preferably 1 mm to 3 mm. Such a heating element may contain capsaicin extract, which is derived from chili peppers and helps increase blood flow by reducing blood pressure and stimulating the release of nitric oxide and other substances that relax and dilate blood vessels, thereby increasing the rate of blood extraction from the human body. It is already known that heat patches containing capsaicin can be used for applications unrelated to blood collection (see the web page, for example: ninelife.ch / products / hansaplast-lion-heat-plaster-capsicumplaster-intensive-long-lasting-4-sheets-x-12-total-48-sheets?gclid=EAIaIQobChMIpazOsODPgAMVE-F3Ch3OEglmEAQYASABEglfzPDBwE, the content of which is incorporated herein by reference and relied upon and is shown in Appendix A).

[0016] Alternatively, the heating element may not contain any skin-irritating active agent, but instead directly provide external heat through, for example, an exothermic chemical reaction. For example, such a reaction can be initiated by exposing the active agent to air. The active agent can, for example, contain iron powder or any other easily oxidizable substance that is oxidized and generates heat when exposed to air. Other exothermic chemical reactions can also be used, such as the dissolution of calcium chloride or magnesium sulfate in water, or the crystallization of sodium acetate. In another embodiment of the fluid sampling device, the container for holding the body fluid is made of a translucent material, which preferably has a color and / or contains an additive suitable for contacting the body fluid and changing color after contact without affecting the measurable blood characteristics.

[0017] The body fluid reservoir can be made of a translucent material and preferably has a color. Therefore, the color of the body fluid seen by the user may be different from, or even very different from, the original color of the body fluid. Thus, the user can see that the body fluid reservoir is filling, but since the color is no longer dark red, the non-dark red color reduces the visual discomfort of patients with hematophobia (also known as blood phobia or blood panic). Alternatively or additionally, the body fluid sampling device can contain an additive that is suitable for contacting the body fluid stored in the body fluid reservoir and thereby changing the color of the body fluid without affecting the parameters or characteristics to be measured subsequently. In addition, the body fluid sampling device may not contain an additive that changes the color of the body fluid, but instead has a device outside the body fluid reservoir that only appears to change the color of the body fluid but actually does not change the color of the body fluid. For example, such a device can include a layer of cholesteric liquid crystal located outside the body fluid reservoir that changes color when the body fluid reservoir is filled with warm body fluid.

[0018] This task can also be solved by a method for sampling body fluids (optionally self - sampling), which method comprises the following steps:

[0019] a) In the first step, install the fluid sampling device according to claim 1 on the patient's arm, the disposable fluid sampling device comprising a first vacuum source that can be inserted into a vacuum interface;

[0020] b) In the second step, respectively initiate a skin nick or incision to pierce the skin,

[0021] c) In the third step, insert the first vacuum source into the vacuum interface;

[0022] d) In the fourth step, fill the container of the fluid sampling device with body fluid;

[0023] e) In the fifth step, remove the first vacuum source.

[0024] Another embodiment of the method includes repeating steps (c), (d), (e) to activate the second vacuum source of the fluid sampling device and optionally fill a second container with a body fluid sample.

[0025] In another embodiment of the method, the heating element of the body fluid sampling device is activated for a period of time to keep the patient's skin at an elevated temperature in order to increase the amount of body fluid drawn during sampling. Preferably, the heating element remains activated throughout the sampling process.

[0026] This task can also be solved by a container used in conjunction with a disposable device, wherein a tamper - proof label can be attached to the container lid so that it can only be opened in a non - tamper - proof manner in a laboratory where the body fluid sample is analyzed, thereby allowing the origin of the body fluid sample to be confirmed.

[0027] In another embodiment of the fluid sampling device, an additional vacuum source is used to collect body fluid by providing a vacuum to a first ventless tube.

[0028] In another embodiment of the fluid sampling device, the amount of additive present in the container for capillary sampling is adapted to the amount of body fluid to be collected. Generally, the amount of body fluid to be collected is 0.5 to 1.5 milliliters.

[0029] In another embodiment of the fluid sampling device, the vacuum level in the vacuum source is adapted to the needs of capillary sampling and may thus differ from Annex B of ISO - 6710 standard.

[0030] Advantageously, the incision in the skin for body fluid sampling is formed in a direction parallel to the container, or in a direction parallel to the main length of the catheter or main fluid passage that guides the body fluid to the container. This is beneficial for the blood collection process.

[0031] Those skilled in the art will understand that the elements in these figures are illustrated for simplicity and clarity and are not necessarily drawn to scale. For example, to facilitate understanding of the present invention and its embodiments, the dimensions may be enlarged relative to other elements. In addition, when terms such as "first", "second", etc. are used herein, their use is intended to distinguish similar elements and not necessarily to describe a sequential or chronological order. Further, relative terms such as "front", "rear", "top", and "bottom" in the specification and / or claims do not necessarily describe a unique relative position. Thus, those skilled in the art will understand that such terms may be interchanged with other terms, and the embodiments described herein are capable of operating in other orientations than those explicitly illustrated or otherwise described. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 is a view of a patient's upper arm with a capillary blood sampling device attached.

[0033] Figure 2 is a view of the capillary blood sampling device during insertion into a vacuum tube.

[0034] Figure 3 is a view of the capillary blood sampling device with a vacuum tube inserted.

[0035] Figure 4A is a top view of the capillary blood sampling device including a thin heating element.

[0036] Figure 4B is a first side view of the capillary blood sampling device including a thin heating element.

[0037] Figure 4C is a second side view (rear view of the first side view) of the capillary blood sampling device including a thin heating element.

[0038] Figure 5 is a view of three sample tubes connected to the sampling device, showing the sequential filling of each sample tube.

[0039] Figure 6 is a view of the capillary blood sampling device where a larger vacuum tube is connected to a smaller sample tube.

[0040] Figure 7 is a flow chart of the method of the present invention, showing the various stages of removal and replacement of the sample tube.

[0041] Figure 8A is a view of a sample tube including a lid with tamper-evident features (TEF).

[0042] Figure 8BThese are diagrams of sample tubes in various forms.

[0043] Figure 9 These are diagrams of the venting mechanism that provides release of the remaining vacuum after blood sampling.

[0044] Figure 10 These are diagrams of a patient's upper arm with an incision for blood sampling.

[0045] Figure 11A These are diagrams of a capillary blood sampling device connected to an external vacuum source.

[0046] Figure 11B These are diagrams of a capillary blood sampling device connected to a vacuum tube different from the blood sample tube.

[0047] Figure 11C These are schematic cross-sectional views of the interior of the sample tube connection when the vacuum source is different from the blood sample tube. Detailed Description

[0048] The following description is not intended to limit the scope of the present invention in any way, as it is exemplary in nature and is used to describe the best mode of the present invention known to the inventors as of the filing date of this application. Accordingly, changes can be made to the arrangement and / or function of any of the elements described in the exemplary embodiments disclosed herein without departing from the spirit and scope of the present invention.

[0049] Note that in this application, wherever blood or capillary blood sampling is mentioned, it should be understood that pus or venom can be substituted for blood.

[0050] Also note that the terms body fluid reservoir, fluid reservoir, vacuum tube, sample tube, and analysis tube may refer to the same object, depending on the details of the body fluid sampling device of the present invention.

[0051] Since the sampling device may be used by untrained users and even in some cases for automated sampling, the main components to be operated by the user can be color-coded to facilitate the assignment and identification of instructions, as described below.

[0052] Now refer to Figures 1 to 3, a first embodiment of a capillary body fluid sampling device includes (a) a capillary blood sampling device 10, e.g., according to PCT / IB2021 / 000187 and / or PCT / IB2021 / 000580, the contents of which are incorporated herein by reference and relied upon. The capillary blood sampling device 10 is shown mounted on the skin 12 of a patient 14. A flexible tube 16 is provided between the blood sampling device 10 and a vacuum tube 20, which is inserted into a vacuum tube connector 20' or an external vacuum source during operation, thereby providing a watertight extraction channel or conduit between the patient's wound 100 and the sample tube (vacuum tube 20). This arrangement allows for easy insertion / removal of one or more vacuum tubes in a row without the risk of the blood sampler becoming unstable or detaching from the patient's skin 12.

[0053] The vacuum degree of the vacuum tube or the external vacuum source can be adjusted according to the needs of capillary sampling and may be different from Appendix B of ISO-6710 standard.

[0054] Now refer to Figure 4A , a second embodiment (optionally for single use) of the fluid sampling device 10 optionally includes a heating element 22. Preferably, the thickness range of the heating element 22 is about 0.5 to 4 millimeters, more preferably about 1 to 3 millimeters. Here, the fluid sampling device 10 with the heating element 22 is shown in a top view. The heating element 22 is provided to heat the area around the patient's wound from which body fluid (preferably blood) is drawn. The fluid sampling device can be attached to the skin 12, so when the skin 12 is heated with the help of the heating element 22, the capillaries dilate, allowing more body fluid to be drawn from the body. Note that here the vacuum source 20 or the external vacuum source is optionally directly connected to the fluid sampling device 10 instead of through the flexible tube 16.

[0055] Now refer to Figure 4B and 4C , the fluid sampling device 10 of the second embodiment is shown in two side views in the figure. The device is optionally a single-use device and includes an optional heating element 22. The heating element 22 can be in direct contact with the patient's skin, i.e., on one side of the patient's skin. In other words, the heating element 22 is thin enough to be located between the blood collection device and the patient's skin during blood collection. Such a heating element 22 can contain capsaicin extract, which is derived from chili peppers and helps increase blood flow by reducing blood pressure and stimulating the release of nitric oxide and other substances that relax and dilate blood vessels, thereby increasing the rate of blood extraction from the human body. When it is attached to the skin 12 and heated, the capillaries dilate, allowing more blood to be drawn from the body.

[0056] In one aspect of this embodiment, the heating element 22 does not contain any skin-irritating reactants, but can provide direct external heat, for example, through an exothermic chemical reaction. For example, such a reaction can be initiated by exposing the reactants to air. The reactants can, for example, contain iron powder or any other oxidizable substance that will be oxidized and generate heat when exposed to air. The oxidation of the oxidizable substance and the resulting heating are optionally initiated by lifting the baffle 24 on the heating element 22, thereby allowing air to penetrate into the oxidizable substance.

[0057] In another aspect of this embodiment, the heating element 22 can consist of at least two compartments. By successively pulling the baffle 24, the oxidizable substances located in the two compartments can be separately exposed to air so as to keep the patient's skin at an optimal temperature for a long time during the sampling process for blood collection. Other exothermic chemical reactions can also be used, such as calcium chloride or magnesium sulfate dissolved in water, or sodium acetate crystallization.

[0058] As described above, the main components operated by the user can be color-coded for easy assignment and identification of instructions. For example, the lever 11 can be yellow, the button 9 can be green, and the sampling device itself can be basically white. However, it should be understood that other color-codings can also be used to provide sufficient contrast to achieve the same purpose. Now referring to Figure 5 , in a third embodiment of the fluid sampling device 10, for example, three body fluid reservoirs 30, 32, 34 are connected to a valve 40 that communicates with a wound 100 on the patient's skin 12, and body fluid will be drawn from this wound. The valve 40 can include a three-way valve. The body fluid 50 drawn from the wound 100 on the patient's skin 12 can flow into one of the body fluid reservoirs 30, 32, 34 at a time. To control which body fluid reservoir 30, 32, 34 is supplied, the valve 40 can be rotated. At Figure 5 's left side, the valve is in position 42, so that only the first fluid reservoir 30 is filled. At Figure 5 's middle, the valve 40 has been rotated to position 44, so that the second fluid reservoir 32 is filled. Finally, at Figure 5 's right side, after rotating the valve 40 to position 46, all three reservoirs 30, 32, 34 are filled. The body fluid reservoirs 30, 32, 34 described in all embodiments herein do not have to be exactly the same, so they can have different sizes and / or colors. The recognizable first container can contain a specific reactant different from the reactants in the other containers, thereby allowing certain tests to be performed on the contents of the first container.

[0059] Referring to Figure 6, A fourth embodiment of the fluid sampling device 10 includes two optionally different containers. The first container 20 can be a smaller container that has been FDA validated for capillary blood sampling and is thus expected to be more easily approved by the FDA. The larger second container 60 is connected by a flexible tube 62 that is adapted to pass through the septum 23 of the first container 20. The larger second container 60 creates a vacuum in the device and in the smaller first container, thereby facilitating the filling of the smaller first container 20.

[0060] In all four embodiments of the fluid sampling device 10, the skin incision or nick for blood sampling is preferably formed along a direction parallel to the sample container 20, or along a direction parallel to the main length of the catheter 16 or the main fluid channel that guides the body fluid to the container. This facilitates making multiple incisions for faster capillary blood sampling.

[0061] Now referring to Figure 7 , steps of a method 700 for removal and / or replacement of the sample container 20 are shown. In a first step 70, the user presses a color-coded marker actuator (such as the green marker 9 of the fluid sampling device 10) to lift the lever 11 that secures the container 20. Pressing the green button 9 disengages the tube 20 from the hollow needle (such that the septum closes) and lifts the lever 11 so that the tube 20 can be removed and replaced with the next tube. The "color-coded marker" aspect of the actuator helps make it easier for the user / patient to find in the case of self-sampling, for example, through the authentication software mentioned in PCT application PCT / US2021 / 25087 filed on March 31, 2023, the content of which is incorporated herein in its entirety and is hereby incorporated by reference. In a second step 72, the user removes the container 20. In a third step 74, the user locates the second container 20. In a fourth step 76, the user installs the next container 20. In a fifth step 78, the user optionally closes the lever 11, thereby securing the container 20 and ejecting the color-coded marker actuator 9, and then continues the sampling process.

[0062] Now referring to Figure 8A , An embodiment of the sample container 80 optionally has a size that is approximately twice the volume of the body fluid (preferably blood) to be collected (e.g., a 4 ml tube volume for collecting 2 ml of blood). Optionally, the sample container 80 of this embodiment provides an excess vacuum that exceeds the vacuum level required to fill the sample container 80 (e.g., from -0.85 bar to -0.30 bar) in order to speed up the blood collection process. The size of the sample container 80 and the amount of excess vacuum are particularly suitable for withdrawing blood from capillaries in a patient's skin because the blood flow rate from skin capillaries is not as fast as the blood flow rate from a punctured vein. Given its larger volume, the vacuum level in the sample container 80 may be different from the standards of standard venipuncture, depending on the amount of blood to be collected and / or the patient's sensitivity to the suction pressure.

[0063] Optionally, the interior of the sample container 80 has a coating 82 to prevent blood coagulation (e.g., a heparin coating or a similar coating). The sample container 80 may also contain an additive 84 and / or a separation gel 86 for preserving / transporting blood cells separated from plasma.

[0064] Now referring back to Figure 8A , the sample container 80 is typically closed by a lid or a stopper 88. Optionally, the lid 88 can advantageously provide a tamper-evident feature (TEF) 89 (an additional feature for ensuring that the blood is the user's own blood). With such a feature 89, only the laboratory can open the sample container. The laboratory can check whether the test tube has been tampered with before testing its contents. The TEF 89 also marks the test tube 80 with a label 87 during the blood collection process, indicating that the test tube has been in use.

[0065] Now referring to Figure 8B , various tamper-evident functions are very useful for home blood or body fluid collection. These tamper-evident functions include, for example, a plastic covering on the lid or a tape at the connection between the tube and the lid.

[0066] In one aspect of this embodiment, the body fluid reservoirs 20, 80 may include a body 87 made of a color-changing and / or translucent and / or opaque and / or thermochromic material (e.g., glass, stained glass, PET, colored PET, PET filled with a thermochromic dye). Thus, the color of the body fluid seen by the user may be different from, or even very different from, the original color of the body fluid. Therefore, the user can see that the body fluid reservoir is being filled, but since the color is no longer dark red, the non-dark red color can relieve the visual discomfort of patients with hematophobia (also known as blood phobia or blood panic). Alternatively or additionally, the body fluid sampling device may contain an additive that is adapted to contact the body fluid stored in the body fluid reservoir, thereby changing the color of the body fluid without affecting the parameters or properties to be measured subsequently. Further, instead of containing an additive that changes the color of the body fluid, the body fluid sampling device may include a device located outside the body fluid container that seemingly changes the color of the body fluid but actually does not change its color. For example, such a device may consist of a layer of cholesteric liquid crystal located outside the body fluid reservoir, which changes color when the body fluid reservoir is filled with warm body fluid.

[0067] The amount of any final additive present in the body fluid reservoir for capillary sampling is adapted to the amount of body fluid 50 to be collected (0.5 - 1.5 ml).

[0068] Now referring to Figure 9, in one aspect of the embodiment of the sample container 80, a vent 90 may optionally be provided to release any remaining vacuum after blood sampling, thereby reducing the risk of hemolysis during storage or transportation. The vent 90 may be axially pulled away from the cap 88', for example, separating the vent surface 92 from the corresponding cap surface 94, thereby releasing any remaining vacuum through the passage 96 in the vent 90. The user may grasp the knob 91 with his / her finger to pull the vent 90, separating the surfaces 92, 94 and thereby releasing the remaining vacuum.

[0069] Now referring to Figure 10 , for example, the wound 100 for blood collection in the patient's upper arm 12 may consist of at least one incision or slit 102, 104 formed parallel to the direction of blood collection / sample container, or parallel to the main length of the catheter 16 or the main fluid passage that guides body fluid to the container. When multiple incisions 102, 104 need to be formed to accelerate capillary blood flow, the slit along the blood collection direction is particularly advantageous because in the case where the slit is perpendicular to the blood flow direction, the blood flowing out from the upper incision will flow through the lower incision.

[0070] Method of Use

[0071] 1. Figure 1 : The user (medical staff or untrained person) installs the fluid sampling device 10 on the patient's skin 12 using an adhesive pad (such as the thin heating element 22, but without heating). Any other suitable method known in the industry may be used to install the fluid sampling device 10. For example, it may be held or pressed against the skin by the patient himself / herself or a third person.

[0072] 2. The user triggers a skin incision or slit.

[0073] 3. Figure 2 : The user inserts the vacuum source 20 into the connector 20' (whether connected to the device through the flexible tube 16 or not) (Note: Steps 2 and 3 may also be performed in the reverse order).

[0074] 4. Figure 3 : The vacuum tube 20 is filled with body fluid 50, usually blood.

[0075] 5. The user removes the vacuum source 20.

[0076] 6. Optionally, the user inserts a second vacuum source 20 and repeats steps 4 to 6 as many times as needed.

[0077] 7. The user removes the device 10 from the patient's skin 12 and cleans and dresses the wound.

[0078] 8. The user sends the sampling tube 20 to the laboratory for analysis.

[0079] In any of the embodiments described herein, if the sampling tube 20 is different from the vacuum tube 60 ( Figure 6 ), then the user will also need to replace the sampling tube when replacing the vacuum tube.

[0080] In any of the embodiments described herein, if there is more than one sampling tube 30, 32, 34 connected to the sampling device 10 and more than one vacuum tube for the vacuum source ( Figure 5 and Figure 6 combination), then the user can replace the vacuum tube 60 and use a new vacuum tube to fill each sampling tube 30, 32, 34, even without using a valve when replacing the sampling tubes in a specific order. If a valve is to be used, it is preferably placed at the T-joint between tubes 112 and 116.

[0081] Now referring to Figure 11A , the fluid sampling device 10 includes: a connector 114 that is connected to the device 10 via a flexible tube 112 to receive a blood collection / sample container, and a catheter 116 that connects the container to a vacuum source (usually available at a medical center). In this configuration, the user can sequentially connect multiple containers to the connector 114, thereby providing multiple containers filled with blood samples.

[0082] Now referring to Figure 11B , the fluid sampling device 10 includes a connector 114 that is connected to the device 10 via a flexible tube 112 to receive a blood collection / sample container, and a second connector 118 that is connected to the container via a catheter 116 to connect to the vacuum tube 20. In such a configuration, after the fluid sampling device 10 is mounted on the skin 12 of the patient, the user performs the following steps:

[0083] 1. In the first step, connect the first container to the connector 114

[0084] 2. In the second step, connect the first vacuum tube to the second connector 118

[0085] 3. In the third step, create a skin incision or tear

[0086] (Step 3 can also be performed before the first step or before the second step)

[0087] 4. In the fourth step, wait for the first container to fill with blood

[0088] 5. In the fifth step, disconnect the first vacuum tube from the second connector 118

[0089] 6. In the sixth step, disconnect the first container from the connector 114

[0090] 7. In the seventh step, connect the second container to the connector 114

[0091] 8. Step eight, connect the second vacuum tube to the second connector 118

[0092] 9. Step nine, repeat steps 4 to 8 and steps 4 to 6 respectively until a sufficient number of containers filled with blood samples are obtained.

[0093] Of course, a configuration similar to that described in Figure 5 can also be used, in which a valve is used to connect multiple containers in sequence, or multiple vacuum tubes are arranged in a row.

[0094] Now refer to Figure 11C , for the two configurations shown in Figure 11A and Figure 11B , the connection between tubes 112 and 116 may superficially resemble a T-shaped connection, but the internal configuration details are provided here. Functionally, the connection between tubes 112 and 116 is advantageously formed through the blood sample tube in connector 114. Connector 114 provides a first connection to device 10 through flexible tube 112, which enters sample tube 120 via hollow needle 112.1 capable of piercing diaphragm 124, which is held in cap 122 that closes sample tube 120. Connector 114 also provides a second connection to a vacuum source through conduit 116 via hollow needle 116.1 capable of piercing diaphragm 124, which is held in cap 122 that closes sample tube 120. Thus, when a new vacuum tube is inserted into connector 118, or when the vacuum source is directly activated or activated by opening a valve, a vacuum is first established inside sample tube 120 and then continues through flexible tube 112 until sampling device 10 provides the suction required to collect blood into sample tube 120.

[0095] Specific embodiments of the present invention can be summarized as belonging to at least one of the following feature sets:

[0096] 1. A disposable fluid sampling device, comprising:

[0097] (a) A body fluid sampling device, optionally a body fluid sampling device for automatic sampling;

[0098] (b) Optionally, an analysis device that uses one or more droplets of the sampled fluid to analyze the fluid; and

[0099] (c) A device for at least one medical body fluid reservoir, body fluid sample tube or analysis tube, the at least one tube being adapted to be filled with a fluid sample for analysis at the point of care or in a medical laboratory, wherein the device includes an interface for at least one vacuum tube or an external vacuum source, the vacuum tube or external vacuum source being adapted to provide the suction required to fill the at least one body fluid sample tube with the fluid.

[0100] 2. The disposable fluid sampling device according to Feature Set 1, wherein the liquid-tight fluid extraction channel or catheter from the patient's wound to the body fluid sample tube includes a flexible tube.

[0101] 3. The disposable fluid sampling device according to Feature Set 1, wherein a thin heating element is provided to provide heating in the area around the patient's wound from which blood is to be drawn. The thickness of the thin heating element is in the range of about 0.5 to 4 mm, or preferably about 1 to 3 mm. When the sampling device is attached to the skin and heated, the capillaries thus dilate, allowing more blood to be drawn from the body. The evacuated tube or an external vacuum source can be directly connected to the sampling device or connected to the sampling device through a flexible tube, both providing a liquid-tight fluid extraction channel or catheter from the patient's wound to the body fluid sample tube.

[0102] 4. The thin heating element according to Feature Set 3, wherein the heating element comprises at least one of the following elements: (a) capsaicin extract, which is derived from chili peppers and helps to increase blood flow by reducing blood pressure and stimulating the release of nitric oxide and other substances that can relax and dilate blood vessels, thereby increasing the rate of blood extraction from the human body.

[0103] (b) a reactant that provides an exothermic chemical reaction. The reactant can, for example, comprise iron powder or any other easily oxidizable substance that is oxidized when exposed to air and thereby generates heat. Other exothermic chemical reactions can be used, such as calcium chloride or magnesium sulfate dissolved in water, or sodium acetate crystallization. The exothermic reaction can be initiated, for example, by pulling a baffle, whereby the reactant is no longer isolated from the surrounding air.

[0104] 5. The disposable fluid sampling device according to Feature Set 1, wherein more than one (e.g., three) tubes are connected to a valve that communicates with the patient's skin from which blood is drawn. The valve can consist of a three-way valve. The body fluid drawn from the patient's skin can flow into at least one body fluid container at a time. To control which body fluid container is supplied, the valve can be rotated. The body fluid containers do not have to be exactly the same; they can have different sizes and / or colors. The identifiable first tube can contain a specific reactant different from the reactants in the other tubes, thereby allowing certain tests to be performed on the contents of the first tube.

[0105] 6. The disposable fluid sampling device according to Feature Set 1, wherein, for example, two optionally different tubes are used. The first tube can be a smaller tube that has been verified by the FDA for capillary blood sampling and is therefore expected to be more easily approved by the FDA. The larger tube connected through a flexible tube that fits through the septum of the first tube creates a vacuum in the device and the small tube, thus helping to fill the small tube.

[0106] 7. The disposable fluid sampling device according to Feature Set 1, wherein the sampling tube is optionally sized to be approximately twice the volume of the blood to be collected (e.g., a 4 ml tube volume for collecting 2 ml of blood). Optionally, the sampling tube provides an excess vacuum over the vacuum required to fill it (e.g., from -0.85 bar to -0.30 bar) to speed up the blood collection process. The size and excess vacuum of the sampling tube are particularly suitable for drawing blood from a patient's skin capillaries, as the blood flow rate from skin capillaries is not as fast as that from a punctured vein.

[0107] Due to the relatively large volume of the sampling tube, its vacuum level may differ from standard venipuncture standards, depending on the volume of blood to be collected and / or the patient's sensitivity to the suction pressure.

[0108] Optionally, the inside of the sampling tube has a coating to prevent blood clotting (e.g., a heparin coating or a similar coating). The sample tube may also contain additives and / or a separating gel for preserving / transporting blood cells separated from the plasma.

[0109] The sample tube is typically closed with a cap or a stopper. Optionally, the cap can be equipped with a tamper-evident feature (TEF) (an additional feature for ensuring that the blood is the user's own). With this feature, only a laboratory can open the sample tube. The laboratory can check if the tube has been tampered with before testing its contents. The TEF also marks the tube during the blood collection process to indicate that the tube is in use. Various tamper-evident features are very useful for home blood or body fluid collection. These tamper-evident features include, for example, a plastic covering on the tube cap or a tape at the connection between the cap and the tube.

[0110] 8. The disposable fluid sampling device according to Feature Set 1, wherein the body fluid reservoir includes a body made of a color-changing and / or translucent and / or opaque and / or thermochromic material (e.g., glass, stained glass, PET, colored PET, PET filled with a thermochromic dye). Thus, the color of the body fluid seen by the user may be different from, or even very different from, the original color of the body fluid. Therefore, the user can see that the body fluid reservoir is filling up, but since the color is no longer dark red, this non-dark red color can reduce the visual discomfort of patients with hematophobia (also known as blood phobia or blood panic). Alternatively or additionally, the body fluid sampling device can contain an additive that is adapted to contact the body fluid stored in the body fluid reservoir, thereby changing the color of the body fluid without affecting the parameters or properties to be measured subsequently. In addition, instead of containing an additive that changes the color of the body fluid, the body fluid sampling device can have a device outside the body fluid reservoir that seemingly changes the color of the body fluid but actually does not. For example, such a device can consist of a layer of cholesteric liquid crystal located outside the reservoir that changes color when the reservoir is filled with warm body fluid.

[0111] The amount of any final additive in the body fluid reservoir for capillary sampling is adjusted according to the amount of body fluid to be collected (0.5 - 1.5 ml).

[0112] 9. The disposable body fluid sampling device according to Feature Set 1, wherein the vent can release any remaining vacuum after blood sampling, thereby reducing the risk of hemolysis during storage or transportation. The vent can be axially pulled away from the sample tube lid, thereby separating the vent surface from the corresponding lid surface, and releasing any remaining vacuum through the channel in the vent. The user can grasp the knob with his / her finger to pull the vent and separate the vent and the lid surface, thereby releasing the remaining vacuum.

[0113] 10. A method for capillary blood sampling, optionally self - blood sampling, which at least includes the following steps:

[0114] a) In the first step, prepare the site on the patient's arm where blood sample will be collected according to professional standards (pre - heating, shaving, disinfection, etc.); b) In the second step, install the device on the patient's arm;

[0115] c) In the third step, trigger a skin incision;

[0116] d) In the fourth step, insert the vacuum tube into the connector;

[0117] e) In the fifth step, inject blood into the body fluid sample tube;

[0118] f) In the sixth step, remove the body fluid sample tube;

[0119] g) In the seventh step, remove the device from the patient's arm;

[0120] h) In the eighth step, clean and dress the wound.

[0121] 11. The method according to Feature Set 10, further including repeating steps (d), (e), (f) to obtain multiple body fluid sample tubes filled with blood samples.

[0122] In addition, the present invention should be regarded as including all possible combinations of each feature that can be considered novel, creative, and industrially applicable described in this specification, the appended claims, and / or the drawings.

[0123] It should be understood that the specific embodiments shown and described herein are representative examples of the present invention and its best mode, and are not intended to limit the scope of the present invention in any way.

[0124] Those skilled in the art will understand that the present invention can be specifically implemented as a system, a device, or a method.

[0125] In addition, the system covers the use, sale, and / or distribution of any goods, services, or information having similar functions described herein.

[0126] The specification and drawings should be regarded in an illustrative rather than a restrictive sense, and all modifications described herein are intended to be included within the scope of the invention as claimed. Accordingly, the scope of the invention is determined by the appended claims (as currently existing or as later amended or added claims and their legal equivalents), and not solely by the examples described above. Unless otherwise expressly stated, the steps recited in any method or process claim can be performed in any order, and are not limited to the specific order presented in any claim. In addition, the elements and / or components recited in a device claim can be combined in various ways or otherwise functionally configured to produce substantially the same result as the present invention. Accordingly, the present invention should not be construed as limited to the specific configurations recited in the claims.

[0127] The benefits, other advantages, and solutions mentioned herein should not be regarded as critical, essential, or fundamental features or components of any claim or all claims.

[0128] As used herein, the term "comprises," "comprising," or any variation thereof is intended to refer to a non-exclusive listing of elements such that any device, process, method, article, composition of the present invention that includes a list of elements does not consist solely of those recited elements, but may also include other elements described in this specification. Unless otherwise indicated, the use of the terms "consisting of" or "consisting essentially of" is not intended to limit the scope of the present invention to the subsequently named elements recited. Those skilled in the art may vary or adapt other combinations and / or modifications of the above-described elements, materials, or structures used in the practice of the present invention to other designs without departing from the general principles of the present invention.

[0129] Unless otherwise indicated, the patents and articles mentioned above are hereby incorporated by reference herein, provided that they do not conflict with the present disclosure.

[0130] Other features and embodiments of the present invention are described in the appended claims.

[0131] In addition, the present invention should be considered to include all possible combinations of each feature described in this specification, the appended claims, and / or the drawings that may be considered novel, inventive, and industrially applicable.

[0132] Additional features and functions of the present invention are described in the appended claims. These claims are hereby incorporated by reference in their entirety into this specification and should be considered as part of the application as filed.

[0133] In the embodiments of the invention described herein, various variations and modifications are possible. Although certain illustrative embodiments of the invention are shown and described herein, the foregoing disclosure contemplates numerous changes, modifications, and alternatives. Although the foregoing description contains many specific details, these details should not be construed as limiting the scope of the invention, but rather as illustrative of one or another preferred embodiment thereof. In some instances, some features of the invention may be employed without correspondingly using other features. Accordingly, it should be understood that the foregoing description is to be broadly construed and understood as merely illustrative, and the spirit and scope of the invention are limited only by the claims ultimately issued in this application.

[0134]

[0135]

Claims

1. A fluid sampling device (10) adapted to collect a sample of body fluid (50), preferably one or more drops of body fluid (50) for optional point-of-care analysis, and a volume of body fluid similar to that collected by venipuncture for further analysis at the point of care or in a medical laboratory, the disposable fluid sampling device being optionally adapted for automated sampling; (and optionally), wherein, The disposable fluid sampling device (10) includes a vacuum interface for connection to a vacuum source adapted to provide the suction required to fill the at least one container (20) with body fluid (50).

2. The fluid sampling device (10) according to claim 1, wherein the vacuum source is configured as a container (20) for containing body fluid (50).

3. The fluid sampling device (10) according to claim 1, wherein the vacuum source is different from the container (20) for containing body fluid (50).

4. The fluid sampling device (10) according to claim 3, comprising a connector (114) that allows a plurality of containers (20, 120) to be connected to the device (10) in sequence to fill the plurality of containers (20, 120) with body fluid samples.

5. The fluid sampling device (10) according to claim 3, wherein the vacuum source is a vacuum tube.

6. The fluid sampling device (10) according to claim 5, comprising a connector (118) that allows a plurality of vacuum tubes to be connected to the device (10) in sequence to fill the plurality of containers (20, 120) with body fluid samples.

7. The fluid sampling device (10) according to claim 1, comprising a tube interface adapted to dock with at least one container, preferably a sample container or a medical analysis container (20).

8. The fluid sampling device (10) according to claim 7, wherein, The first vacuum source (20, 60) is interconnected with the first container (114, 118), and the second vacuum source (60, 20) is interconnected with the second container (118, 114).

9. The fluid sampling device (10) according to claim 2, comprising an analysis device optionally connectable to the tube interface, wherein the analysis device is adapted to analyze body fluid (50).

10. The fluid sampling device (10) according to claim 8, comprising a valve (40), preferably a three-way valve, for switching the inlet from at least a first body fluid reservoir to at least one second body fluid reservoir, each body fluid reservoir (34, 36) being constituted by the vacuum source or the container.

11. The fluid sampling device (10) according to claim 1, comprising a watertight fluid extraction channel or catheter for connecting a patient wound (100) and the container (20), the watertight fluid extraction channel or catheter respectively comprising a flexible tube (16).

12. The fluid sampling device (10) according to claim 1, comprising a heating element (22) attachable to the skin in the vicinity of the area from which body fluid (50) is drawn from the body.

13. The fluid sampling device (10) according to claim 11, wherein the heating element (22) is thin enough to be located between the container and the patient's skin during blood collection, and its thickness is preferably from 0.5 mm to 4 mm, more preferably from 1 mm to 3 mm.

14. The fluid sampling device (10) according to claim 1, wherein the container for containing body fluid (50) is made of a translucent material, and the translucent material is preferably colored.

15. The fluid sampling device (10) according to claim 1, wherein the fluid sampling device (10) comprises: A connector (114) connected to the device (10) by a flexible tube (112) for receiving a blood collection / sample container (120); and a conduit (116) for providing a vacuum to the blood collection / sample container (120) and the device (10).

16. The fluid sampling device (10) according to claim 15, wherein the fluid sampling device (10) comprises a second connector (118) connected to the container through a conduit (116) for connection to a vacuum tube.

17. A method for sampling body fluid, optionally for self - sampling, the method comprising the steps of: a) In a first step, the fluid sampling device (10) according to claim 1 is mounted on a patient's arm, the fluid sampling device (10) including a first vacuum source insertable into the vacuum interface; b) In a second step, a skin incision is triggered to pierce the skin; c) In a third step, the first vacuum source is inserted into the vacuum interface; d) In a fourth step, the container (20) of the fluid sampling device (10) is filled with body fluid (50); and e) In a fifth step, the first vacuum source is removed.

18. The method according to claim 17, further comprising repeating steps (c), (d), (e) to activate a second vacuum source of the fluid sampling device (10) and optionally filling a second container with a sample of body fluid (50).

19. The method according to claim 17, wherein the fluid sampling device (10) comprises: A connector (114) connected to the device (10) by a flexible tube (112) for receiving a blood collection / sample container, and a conduit (116) for providing a vacuum to the blood collection / sample container (120) and the device (10).

20. The method according to claim 19, wherein the fluid sampling device (10) comprises a second connector (118) connected to the container through a conduit (116) for connection to a vacuum tube.

21. The method according to claim 12 or 13, wherein, The heating element (22) of the fluid sampling device (10) is activated and preferably remains activated for a period of time to keep the patient's skin at an elevated temperature to increase body fluid extraction during sampling.

22. A container (80) for use with the fluid sampling device (10) according to claim 1, wherein a tamper - proof label (89) can be attached to the lid (88) of the container (80) so as to be opened in a non - tamper - proof manner only in a laboratory where body fluid samples are analyzed, thereby allowing confirmation of the source of the body fluid sample.

23. The fluid sampling device (10) according to claim 1, wherein an additional vacuum source (60) is used to collect body fluid (50) by providing a vacuum to the non-vented first tube (20).

24. The fluid sampling device (10) according to claim 1, wherein the amount of additives (84, 86) present in the containers (20, 80) for capillary sampling is adapted to the amount of body fluid (50) to be collected (usually 1 to 1.5 ml).

25. The fluid sampling device (10) according to claim 1, wherein the degree of vacuum in the vacuum sources (20, 60) is adapted to the needs of capillary sampling and may thus differ from Annex B of ISO-6710 standard.

26. The capillary blood sampling method according to claim 25, wherein the incision in the skin for blood sampling is formed along a direction parallel to the container, or parallel to the direction of the catheter (16) guiding the body fluid to the container or the main length of the main fluid channel.

Images