Capillary blood sampling device and method of use

Abstract

The disposable bodily fluid collection device (100) provides a user with the ability to collect and / or analyze bodily fluids, such as blood, pus, or venom. The device (100) includes at least a bodily fluid reservoir containing the collected bodily fluid, a conduit inlet / outlet mechanism connected to at least one conduit or needle, and a bodily fluid extraction mechanism including a vacuum reservoir. After connecting the bodily fluid reservoir to the collection device, the bodily fluid is aspirated into the bodily fluid reservoir by breaking the vacuum seal of the bodily fluid reservoir. The collection device (100) assists in the implementation of the inventive method (200) of collecting bodily fluids, such as capillary blood samples, without the intervention of medically trained personnel. The collection device (100) allows a user to: (a) collect bodily fluids, possibly automatically; (b) immediately analyze the bodily fluid using one or more drops of the collected bodily fluid; and (c) fill the collected bodily fluid into a medical analysis tube (4000) conforming to size and interface standards for analysis at the point of care or in a medical laboratory. The collection device includes a vacuum tube and its interface. The vacuum tube provides the suction necessary to draw bodily fluid from the user / patient and fill the vacuum tube with bodily fluid.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of U.S. Provisional Application Nos. 63 / 069,112, filed August 23, 2020, entitled "Capillary Blood Collection Device and Method of Use Thereof," 63 / 142,756, filed January 28, 2021, entitled "Capillary Blood Collection System Including User / Patient Authentication," 63 / 153,088, filed February 24, 2021, entitled "Vaccine and / or Medication Injection and Administration Device," and 63 / 150,113, filed February 17, 2021, entitled "Vaccine and / or Medication Injection and Administration Device." No. PCT / IB2021 / 000187, filed March 31, 2021, entitled "Capillary Blood Collection Device," and International Patent Application No. PCT / IB2021 / 000187, filed March 31, 2021, entitled "Body Fluid Collection Device and Method for Use Thereof," all of whose contents are understood to contribute to the solution of the technical problem underlying the invention, and certain features referred to herein are deemed to be of particular importance. Copyright and Legal Notices

[0002] Portions of the disclosure of this patent document contain material that is subject to copyright protection. Applicant has no objection to the facsimile reproduction by third parties of the patent document as it appears on the patent documents of record with the respective Patent and Trademark Offices, but otherwise reserves all copyrights. Furthermore, the disclosure of any third-party patent or article herein should not be construed as an admission that the present invention is not entitled to antedate such material by virtue of prior art. [Technical Field]

[0003] The present invention relates to a device that allows for self-collection of bodily fluids without the intervention of medical personnel. In the event of war, large-scale epidemic, or pandemic, analysis of bodily fluids, such as blood, of a substantial portion of any population, potentially the entire population of a neighborhood, suburb, city, country, entire continent, or the entire planet, may be required. In such cases, collection of bodily fluids by medical personnel from each patient may be impossible due to restrictions, contamination risks, dangerous areas, travel distances, lack of transportation infrastructure, or personnel shortages.

[0004] There is a need for a body fluid collection device that is suitable for safe self-use by any individual without medical training and that can provide the necessary body fluid sample needed for a home analyzer or a point-of-care or medical laboratory analyzer. [Background technology]

[0005] A disposable bodily fluid collection device provides a user with the ability to collect and / or analyze bodily fluids (body fluids), such as blood, pus, or toxins. The device includes at least a bodily fluid reservoir for containing the collected bodily fluid and a fluid extraction mechanism including at least one conduit or needle connected to a vacuum reservoir. The vacuum seal of the vacuum reservoir is adapted to break upon connecting the vacuum reservoir to the bodily fluid reservoir, allowing the bodily fluid to be aspirated into the bodily fluid reservoir. The collection device aids in carrying out the method of the present invention, which comprises collecting a bodily fluid, such as a capillary blood sample, without the intervention of a medical trainee. The collection device allows a user to (a) collect, optionally automatically collect, the bodily fluid; (b) optionally perform emergency analysis of the bodily fluid using one or more droplets of the collected bodily fluid; and (c) provide a standard analysis tube, corresponding in size and interface standard, filled with the collected bodily fluid for analysis at a point-of-care or medical laboratory. The collection device includes a vacuum tube and an interface therefor. The evacuated tube provides the suction necessary to draw bodily fluid from the user / patient and fill the evacuated tube with bodily fluid. [Brief explanation of the drawings]

[0006] [Figure 1] 1 is a side view of a first embodiment of a capillary blood collection device of the present invention. [Figure 2] FIG. 2 is a partial cross-sectional side view of the embodiment of FIG. 1. [Figure 3A] 2 is a cross-sectional side view of the embodiment of FIG. 1 at step 1 of the method. [Figure 3B] 2 is a cross-sectional side view of the embodiment of FIG. 1 at step 2 of the method. [Figure 3C] 2 is a cross-sectional side view of the embodiment of FIG. 1 at step 3 of the method. [Figure 3D]2 is a partial cross-sectional side view of the embodiment of FIG. 1 at step 4 of the method. [Figure 3E] 2 is a partial cross-sectional side view of the embodiment of FIG. 1 at step 5 of the method. [Figure 3F] 2 is a partial cross-sectional side view of the embodiment of FIG. 1 at step 6 of the method. [Figure 3G] 2 is a partial cross-sectional side view of the embodiment of FIG. 1 at step 7 of the method. [Figure 3H] 2 is a partial cross-sectional side view of the embodiment of FIG. 1 at step 8 of the method. [Figure 3I] 2 is a partial cross-sectional side view of the embodiment of FIG. 1 at step 9 of the method. [Figure 4A] 1 is a side view of a first embodiment of a dissection blade used in a device of the present invention before use. FIG. [Figure 4B] 1 is a side view of a first embodiment of a dissection blade used in a device of the present invention in use; FIG. [Figure 4C] 1 is a side view of a first embodiment of a dissection blade used in a device of the present invention after use. FIG. [Figure 5A] FIG. 10 is an overall view of a second embodiment of a dissection blade used in the device of the present invention before use. [Figure 5B] FIG. 5B is a side view of the dissection blade of FIG. 5A before use. [Figure 5C] FIG. 5B is a front view of the dissection blade of FIG. 5A before use. [Figure 5D] FIG. 5B is a plan view of the dissection blade of FIG. 5A before use. [Figure 5E] FIG. 5B is a side view of the dissection blade of FIG. 5A in use. [Figure 5F] FIG. 5B is a side view of the dissection blade of FIG. 5A after use. [Figure 6A] FIG. 10 is a side view of a third embodiment of a dissection blade used in the device of the present invention prior to use. [Figure 6B] FIG. 6B is a side view of the dissection blade of FIG. 6A after use. [Figure 7A] FIG. 2 is a cross-sectional side view of the embodiment of FIG. 1, showing the inclusion of an anticoagulant substance. [Figure 7B]FIG. 7B is a cross-sectional side view of the embodiment of FIG. 7A, showing contact with a user / patient via its suction interface. [Figure 8] FIG. 14 is a cross-sectional side view of a variation of the embodiment of FIG. 1 showing contact with a user / patient via its suction interface, illustrating a reduction in the volume of the suction chamber 1400. [Figure 9A] FIG. 3 is a cross-sectional side view of a variation of the embodiment of FIG. 2, the embodiment comprising a membrane that is elastic and movable within a cavity, the embodiment contacting the user / patient via its suction interface. [Figure 9B] FIG. 3 is a cross-sectional side view of a variation of the embodiment of FIG. 2, the embodiment comprising a membrane that is elastic and movable within a cavity, the embodiment contacting the user / patient via its suction interface. [Figure 10A] FIG. 10 is a cross-sectional side view of another variation of the embodiment of FIG. 2, the embodiment comprising a membrane that is elastic and movable within a cavity, the embodiment contacting the user / patient via its suction interface. [Figure 10B] FIG. 10 is a cross-sectional side view of another variation of the embodiment of FIG. 2, the embodiment comprising a membrane that is elastic and movable within a cavity, the embodiment contacting the user / patient via its suction interface. [Figure 11] 10A-10C show alternative methods of collecting body fluids using the second and third embodiments of the device of the present invention. [Figure 12] 10A and 10B are diagrams showing examples of mechanisms of an incision device that can be used in the second and third embodiments of the device of the present invention. [Figure 13A] 1A and 1B are top perspective views of first and second embodiments of the blood collection device of the present invention. [Figure 13B] 1A and 1B are bottom perspective views of first and second embodiments of the blood collection device of the present invention. [Figure 14A] FIG. 10 is a top perspective view of a third embodiment of the body fluid collection device of the present invention prior to use. [Figure 14B] FIG. 10 is a bottom perspective view of a third embodiment of the body fluid collection device of the present invention before use. [Figure 14C] FIG. 10 is a plan view of a third embodiment of the body fluid collection device of the present invention before use. [Figure 14D] FIG. 10 is a bottom view of a third embodiment of the body fluid collection device of the present invention before use. [Figure 14E] FIG. 10 is a left side view of a third embodiment of the body fluid collection device of the present invention before use. [Figure 14F] FIG. 10 is a right side view of a third embodiment of the body fluid collection device of the present invention before use. [Figure 14G] FIG. 10 is a front view of a third embodiment of the body fluid collection device of the present invention before use. [Figure 14H] FIG. 10 is a rear view of a third embodiment of the body fluid collection device of the present invention before use. [Figure 14I] FIG. 10 is a top perspective view of a third embodiment of the body fluid collection device of the present invention in use. [Figure 14J] FIG. 10 is a bottom perspective view of a third embodiment of the body fluid collection device of the present invention in use. [Figure 14K] FIG. 10 is a plan view of a third embodiment of the body fluid collection device of the present invention in use. [Figure 14L] FIG. 10 is a bottom view of the third embodiment of the body fluid collection device of the present invention in use. [Figure 14M] FIG. 10 is a left side view of a third embodiment of the body fluid collection device of the present invention in use. [Figure 14N] FIG. 10 is a right side view of the third embodiment of the body fluid collection device of the present invention in use. [Figure 14O] FIG. 10 is a front view of a third embodiment of the body fluid collection device of the present invention in use. [Figure 14P] FIG. 10 is a rear view of a third embodiment of the body fluid collection device of the present invention in use. [Figure 15A] FIG. 1 is a view of an adhesive pad of the present invention before use. [Figure 15B] 1A-1C are diagrams illustrating adhesive pads of the present invention in use. [Figure 16A] 1A-1D illustrate steps for applying an adhesive pad of the present invention. [Figure 16B]1A-1D illustrate steps for installing a fluid collection device of the present invention. [Figure 16C] FIG. 1 illustrates the steps for initiating collection using the device of the present invention. [Figure 16D] FIG. 10 illustrates the steps of waiting and monitoring collection using the device of the present invention. [Figure 16E] FIG. 10 illustrates the step of removing the device of the present invention after collection. [Figure 16F] 1A-1D illustrate steps for dressing a wound with an adhesive pad of the present invention. [Figure 17] 1 is a cross-sectional side view of a suction chamber of a fluid collection device of the present invention. [Figure 18A] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 18B] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 18C] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 18D] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 18E] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 18F] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 18G] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 18H] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 18I] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 18J] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 18K] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 18L] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 18M] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 18N] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 18O] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 18P] FIG. 10 is a schematic diagram showing the steps of a fourth embodiment of a method for using the system of the present invention. [Figure 19A] 1 is a schematic diagram illustrating in greater detail certain features of an adhesive-integrated dressing included in a capillary blood collection device. [Figure 19B] 1 is a schematic diagram illustrating in greater detail certain features of an adhesive-integrated dressing included in a capillary blood collection device. [Figure 19C] 1 is a schematic diagram illustrating in greater detail certain features of an adhesive-integrated dressing included in a capillary blood collection device. [Figure 19D] 1 is a schematic diagram illustrating in greater detail certain features of an adhesive-integrated dressing included in a capillary blood collection device. [Figure 20A] FIG. 10 is a perspective view of a fourth embodiment of a dissecting blade of a device of the present invention, which is made of a single piece. [Figure 20B] FIG. 10 is a side four-position shutter view of a fourth embodiment of the dissecting blade of the device of the present invention. [Figure 20C] FIG. 10 is a side view of a four-position shutter of a fourth embodiment of the incision blade of the device of the present invention, showing its retraction. [Figure 21A] FIG. 10 is a perspective view of a fifth embodiment of the incision blade of the present invention. [Figure 21B] FIG. 10 is a front view of a fifth embodiment of the incision blade of the present invention. [Figure 22A] FIG. 10 is a side view of a sixth embodiment of a dissecting blade of a device of the present invention prior to penetration into the epidermal layer of a patient's body. [Figure 22B]FIG. 10 is a side view of a sixth embodiment of a dissecting blade of a device of the present invention midway through its movement cycle. [Figure 22C] FIG. 10 is a side view of a sixth embodiment of a cutting blade of a device of the present invention at the end of its movement cycle and returning to its starting position. [Figure 23A] FIG. 10 is a perspective view showing a seventh embodiment of the dissection blade of the device of the present invention as a standard scalpel blade. [Figure 23B] FIG. 10 is a side view of a seventh embodiment of a dissecting blade of a device of the present invention prior to penetration into the epidermal layer. [Figure 23C] FIG. 10 is a side view of a seventh embodiment of a dissecting blade of a device of the present invention after penetration into the epidermis layer and immediately prior to removal from said layer. [Figure 23D] FIG. 10 is a side view of the epidermis layer, showing the incision by the seventh embodiment of the incision blade. [Figure 24] 10A-10C are examples of visible features that can be incorporated into the devices of the present invention that are easily recognized by a human observer or easily identified by real-time image analysis software.

[0007] Elements illustrated in the figures are depicted for simplicity and clarity and are not necessarily drawn to scale. For example, dimensions may be exaggerated relative to other elements to facilitate a better understanding of the present invention and its embodiments. Furthermore, terms such as "first," "second," and the like are used herein to distinguish between similar elements and do not necessarily denote a sequential or chronological order. Furthermore, terms such as "front," "back," "planar," "bottom," and the like in the specification and / or claims are used for convenience only and do not necessarily collectively denote a definitive relative position. Therefore, those skilled in the art will appreciate that such terms may be substituted with other terms and that the embodiments disclosed herein may be operated in orientations different from those explicitly illustrated or described.

[0008] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The following description is exemplary in nature and describes the best mode of the invention known to the inventors at the time of filing, and is not intended to limit the scope of the invention in any way. Consequently, the arrangement and / or function of any element in the exemplary embodiments disclosed herein may be changed without departing from the spirit and scope of the invention.

[0009] Capillary blood collection devices according to the present invention come in different sizes and shapes depending on the size of the sample to be collected and the body part from which the sample is to be collected. A user may add a reactive substance to the surface of the skin to facilitate sample storage or enable specific analysis. The capillary blood collection device may be equipped with a unique identification code or may carry an electronically readable identification tag. In some cases, the collection device may be equipped with geolocalization (GPS) and long-range communication capabilities to allow collection without further action by the user after the collection process is performed.

[0010] The capillary blood collection device of the present invention is adapted to use medical analysis vacuum tubes known in the art that are compatible with the size and interface standards commonly used for venous blood collection, allowing the tube contents to be analyzed by standard automated analysis equipment. Such tubes are available in standard formats that accommodate a variety of vacuum levels. Nevertheless, larger tubes and / or higher vacuums may be advantageous in some embodiments of the present invention.

[0011] The collection device 100 assists in carrying out the method 200 of the present invention, which comprises collecting bodily fluids, such as capillary blood, without the intervention of a medical trainee. The collection device 100 allows a user to (a) collect, optionally automatically collect, bodily fluids; (b) optionally perform emergency analysis of the bodily fluid using one or more droplets of the collected bodily fluid; and (c) provide a medical analysis tube (4000) filled with the collected bodily fluid and corresponding size and interface standards for analysis at a point of care or medical laboratory. The collection device includes a vacuum tube and an interface therefor. The vacuum tube provides the suction necessary to aspirate the bodily fluid from the user / patient and fill the vacuum tube with the bodily fluid. The vacuum tube may be a standard medical analysis tube (4000) or a customized tube corresponding to a specific size or interface standard.

[0012] 1 , one embodiment of a capillary blood collection device 100 of the present invention includes a main structure 1000 including a suction interface 1100 suitable for attachment to a user / patient's skin, one or more push buttons 1200 for a user / patient to activate the device 100, and a tube holder 2000 for receiving an evacuated collection tube similar to those well known in the art for venous blood collection. Inside the main structure 1000 is a suction chamber 1400 connected to the interior 2100 of the tube holder 2000 via a channel 3000, a mechanism 1300 for translating the user / patient's act of pressing the one or more buttons 1200 into activation of the device 100, and optional electrical and / or connectivity features such as a GPS or geolocalization system, an identification tag, a wireless communication system, or a countdown with audible feedback.

[0013] Device structure 1000 preferably includes two or more push buttons 1200 and mechanisms 1300 to ensure that activation of all push buttons 1200 alone initiates the collection process, minimizing the risk of inadvertent initiation. Mechanism 1300 may include a combination of levers, stops, cams, or other mechanical elements well known in the art, or preferably, may consist of a flexible element that can release the collection simply by deforming when the user / patient presses push button 1200. Device structure 1000 may also include a method for ejecting a small amount of blood from device 100 for rapid on-site analysis.

[0014] Next, one embodiment of the capillary blood collection device 100 of the present invention, shown in FIG. 2, contacts the user / patient via its suction interface 1100, which is attached to a bandage 1120 comprising a permanent adhesive 1110. The bandage 1120 has a temporary adhesive 1130 on its surface facing the user / patient's skin, suitable for holding the device 100 to the user / patient's skin at least during the collection process. Prior to use of the device, the temporary adhesive 1130 is protected by a removable protective film 1140. The adhesives 1110, 1130, and bandage 1120 are airtight around their periphery to expose a passage 1150 to allow blood collection and to ensure the establishment of a vacuum between the user / patient's skin and the suction chamber 1400 for the collection process. To ensure a sufficient airtight seal with the user / patient's skin, the bandage 1120 may have a relatively large surface compared to the surface of the suction interface.

[0015] The suction chamber 1400 contains one or more lancets 1450, depending on the size of the sample to be collected; ideally, one lancet 1450 is needed for up to 500 mul samples, and two lancets 1450 are needed for 1 ml samples. For the reader's information, the duration of blood flow is approximately 30 minutes for one 500 mul incision and two 1 ml incisions. The lancing blade 1450 has a resilient or springy portion 1458 that is loaded during assembly of the device 100 and is held under tension by the mechanical fingers 1350. The mechanical fingers 1350 are connected to the mechanism 1300 so that, when activated, the mechanism 1300 can release the lancet 1450. Upon release, the lancet is positioned to lancing the user / patient's skin through the passageway 1150. The suction chamber is closed by an airtight membrane 1420, made of an airtight material that is simultaneously incised by the lancet 1450 and lancing the user / patient's skin without tearing it. Optionally, suction chamber 1400 includes an airtight elastomeric liner 1410 that enables mechanism 1300 to actuate mechanical finger 1350 in an airtight manner and optionally includes a means for expelling a small amount of blood for rapid on-site analysis. Suitable materials for membrane 1420 and optional elastomeric liner 1410 are well known in the art and may include silicone, rubber, and other elastomers and / or plastics in one or more layers. To ensure that the majority of the collected blood does not remain within suction chamber 1400 but is instead drawn into the vacuum tube, suction chamber 1400 is sized to have a minimal volume, and only a small portion of the vacuum provided by the tube is used to establish the vacuum within suction chamber 1400. The channel 3000 connecting the suction chamber 1400 to the interior 2100 of the tube holder 2000 may be a conduit or needle 3200 comprising a suction end 3100 of the conduit that connects to the suction chamber 1400 and a dispensing end 3300 of the conduit suitable for entry into a vacuum tube and dispensing the collected blood into the tube. Typically, the conduit or needle 3200 is made of stainless steel, although other materials currently available in the industry may be used, such as other metals, composites, and / or plastics.

[0016] The function of the apparatus 100 shown in Figures 3A-3I and the corresponding method 200 can now be explained as follows. 1. Figure 3A: The collection device 100 and vacuum tube 4000 are delivered separately to the user / patient in sterile packaging. The dispensing end 3300 of the conduit is sharp enough to pierce the septum 4100 (sometimes called a "rubber stopper") of the vacuum tube 4000 and is protected by a resilient (preferably silicone or rubber) sleeve 3400. Optionally, the tube holder 2000 is closed by a removable protective membrane 2110. Optionally, the tube holder 2000 is made of a transparent material. Alternatively, optionally, the tube holder 2000 includes a transparent window 2200 that allows the user / patient to see the interior 2100 of the tube holder 2000. Optionally, the rubber sleeve 3400 is made of a "self-healing" material well known in the art so as to automatically close the dispensing end 3300 of the conduit or needle after use. 2. FIG. 3B: The user / patient peels off the optional protective film 2110 and inserts the vacuum tube 4000 into the tube holder 2000 until it reaches the bottom 2120 of the interior 2100 of the tube holder 2000, with the septum 4100 of the vacuum tube 4000 facing the dispensing end 3300 of the conduit or needle. 3C: Upon reaching the bottom 2120 of the interior 2100 of the tube holder 2000, the vacuum tube 4000 compresses the rubber sleeve 3400, withdrawing the conduit or needle dispensing end 3300 and allowing the conduit dispensing end 3300 to penetrate the septum 4100 of the vacuum tube 4000, establishing an airtight connection from the vacuum tube 4000 to the suction chamber 1400 via the conduit or needle 3200. Consequently, the suction chamber 1400 is placed under vacuum. 4. Figure 3D: The user / patient disinfects the area of ​​skin 5000 from which blood is to be drawn, removes the protective film 1140, and applies the device 100 to the area from which blood is to be drawn. Consequently, the bandage 1120 and glue 1110, 1130 allow the device to hold and seal to the user / patient's skin 5000. 5. Figure 3E: The user / patient presses one or more push buttons 1200, activating mechanism 1300. The mechanism then activates mechanical fingers 1350, releasing one or more lancets 1450. The one or more lancets 1450 pierce membrane 1420 and the user / patient's skin 5000, piercing multiple capillaries in the patient's skin 5000 and allowing vacuum access to the user / patient's skin 5000. 6. Figure 3F: After incision of membrane 1420 and user / patient's skin 5000, one or more lancets 1450 terminate their movement away from the wound 5100 in a recess in the suction chamber 1400, removing their sharp ends from the user / patient's reach. As the wound 5100 begins to bleed, the suction chamber 1400 gradually fills with the user / patient's blood 6000. 7. FIG. 3G: Blood 6000 fills the vacuum tube 4000 through the suction end 3100 of the conduit or needle 3200, the conduit 3200, and the dispensing end 3300 of the conduit. 8. Figure 3H: Once the vacuum tube 4000 is sufficiently filled with blood 6000, the user / patient removes the vacuum tube 4000 from the device. Indication that the vacuum tube is sufficiently filled can be provided by an electronic timer built into the mechanism 1300, a scale on the vacuum tube that the user / patient can see through the transparent tube holder 2000, a magnetically or capacitively sensitive strip in contact with the blood, or the transparent window 2200, or by observing cessation of blood flow when the vacuum is vented, or any other suitable means. Once the vacuum tube is removed from the tube holder 2000, the elastic sleeve 3400 is free to expand to cover the dispensing end 3300 of the conduit or needle, closing off the passage of blood 6000. Optionally, the user / patient can insert an additional vacuum tube to obtain an additional blood sample and repeat steps 7 and 8. 9. Figure 3I: The user / patient removes device 100 and applies a small wound bandage 5200, typically purchased separately, to wound 5100. Any blood remaining in suction chamber 1400 is retained therein by membrane 1420. If rapid on-site analysis is required, a few drops of blood contained in suction chamber 1400 can be obtained by pressing membrane 1420. Optionally, a second mechanism (not shown) incorporated into structure 1000 provides a method for expelling a small amount of blood by squeezing elastic liner 1410 upon depression of a push button. 10. The user sends or takes tube 4000 to a medical analysis laboratory or point of care for analysis, and may use the user's / patient's own refrigerator and, optionally, a high thermal inertia container or a container with high thermal inertia and / or insulation and temperature monitoring and / or signaling, such as those disclosed in U.S. Application No. 63 / 002,581 or U.S. Application No. 63 / 006,337, the contents of which are incorporated by reference, to facilitate delivery of the appropriate sample to the laboratory. 11. The analytical laboratory will analyze the blood sample and notify the patient and / or the relevant authorities of the test results. 12. Optionally, treatment and / or isolation protocols ensure that test subjects with positive tests are handled in a manner that minimizes the spread of pathogens.

[0017] Next, FIGS. 4A-4C, 5A-5F, and 6A-6B show three different embodiments of a lancet 1450, which is typically made of a single piece of stamped sheet metal, but may also be made of other materials, including composites, exhibiting suitable mechanical properties. The lancet has one end 1460 facing the collection device structure 1000 to allow attachment thereto, followed by an elastic zone 1458 that elastically bends when the lancet is ready for use. In this way, the lancet 1450 accommodates all of the energy required for its movement. The elastic zone 1458 has a suitable, preferably smooth, cross-section to provide a suitable release trajectory perpendicular to its attached end 5460. The release trajectory is indicated by a curved arrow in FIGS. 4B and 5E. After the elastic zone 1458, the lancet is twisted 90° in region 1456 to provide a blade 1452 that is in the same plane as the release trajectory. The blade 1452 has high stiffness in the direction of the release trajectory. A cutting edge 1454 is provided towards the end of the blade 1452 for cutting through the membrane 1420 and the user / patient's skin 5000. After movement of the lancet 1450 is completed, the cutting edge 1454 faces in the same direction as the attached end 1460 and is out of the reach of the user / patient.

[0018] 6A and 6B, in a third embodiment, the elastic zone 1458 is bent in multiple turns and takes the shape of a torsion spring, familiar from watch mechanisms.

[0019] 7A and 7B is then optionally filled with an anticoagulant substance, such as heparin, so that the drawn blood 6100 (see FIG. 7B) travels through and mixes with the anticoagulant substance, slowing the clotting rate of the drawn blood 6100 and preventing clogging of the conduit or needle 3200.

[0020] Next, the volume of the suction chamber 1400 shown in Figure 8 must be kept as small as possible, and a smooth surface transition must be maintained to avoid favoring local coagulation of the drawn blood 6100. Particular care must be taken to ensure a smooth surface transition at the connection between the suction chamber 1400 and the conduit or needle 3200. Optionally, the inner surface of the suction chamber may be coated with an anticoagulant substance 1430, such as heparin. The drawn blood 6100 mixes with the anticoagulant substance 1430 within the suction chamber 1400, slowing the clotting rate of the drawn blood 6100 and preventing clogging of the conduit or needle 3200.

[0021] 9A, 9B, 10A, and 10B, in an alternative embodiment, the blood collection process includes a waiting step between incising the patient's skin 5000 to open the wound 5100 and collecting the collected blood 6100. Such a waiting step may have a duration ranging from a few seconds to a few minutes and may be ensured by a timer built into the blood collection device 100, a timer provided by any electronic device or initiated by the user / patient, a timer included in an app running on the user / patient's smartphone that monitors the blood collection process, or by the user / patient themselves as they observe the wound 5100 bleeding through a transparent window provided for viewing within the device structure.

[0022] 9A and 9B, in a first embodiment, the suction chamber 1400 comprises a first airtight elastic membrane 1410 attached at its end to the device structure 1000 but free to move within a cavity 1010 provided within the device 1000, and a second airtight elastic membrane forming a second chamber 1402 adjacent to the suction chamber 1400. The second chamber 1402 includes attachment features 1414 on its outer surface. The blood collection device 100 includes one or more mechanical mechanisms 1416, well known in the micromachining industry, that hold the membrane's attachment features 1414. Prior to initiation of the process, the suction end 3100 of the needle penetrates the second chamber 1402 and is held airtight. In this manner, the user / patient can connect the vacuum tube 4000 to the needle 3200 without risk of compromising the vacuum before the blood collection process begins. The suction end 3100 of the needle 3200 is sharp enough to pierce the airtight elastic membrane 1410. At the end of the waiting step of the blood collection process, the mechanical mechanism 1416 is activated by the user / patient to pull the membrane 1410 via its attachment feature 1414, piercing it with the suction end 3100 of the needle 3200 and opening a passageway with the needle 3200 from the patient's wound 5100 to the collection tube 4000. In a second embodiment, the membrane 1410 may be fixed and the needle 3200 may move toward the membrane until its suction end 3100 pierces the membrane 1410. As a result, an airtight connection between the vacuum tube 4000 and the suction chamber 1400 is established via the needle 3200, and the suction chamber 1400 is placed under vacuum, assisting in the extraction of blood from the patient's wound 5100 and allowing the collected blood 6100 to flow into the collection tube 4000.

[0023] 10A and 10B, in a third embodiment, the suction chamber 1400 comprises an airtight elastic membrane 1410 that is attached at its end to the device structure 1000 but that is free to move within a cavity 1010 provided within the device 1000. The suction end 3100 of the needle 3200 is attached to the elastic membrane 1410 by a flat, semi-rigid or rigid elastic airtight fitting 3102 that intersects the inner surface of the elastic membrane 1410. At the end of the waiting step of the blood collection process, the needle 3200 is urged by the user / patient into the collection tube 4000. As a result, the dispensing end 3300 of the needle pierces the septum 4100 of the vacuum tube 4000, establishing an airtight connection between the vacuum tube 4000 and the suction chamber 1400 via the needle 3200. As a result, the suction chamber 1400 is placed under vacuum to assist in the extraction of blood from the patient's wound 5100 and allow the collected blood 6100 to flow into the collection tube 4000. The geometry and stiffness of the mating portion 3102 is selected to form a flat funnel with the inner surface of the elastic membrane 1410 when deformed as shown in FIG. 10B, allowing a smooth transition from the suction chamber 1400 to the needle 3200 and avoiding triggering clotting of the collected blood 6100 before it reaches the collection tube 4000.

[0024] In all embodiments described herein, an anticoagulant substance such as heparin is applied to the patient's wound (as illustrated in Figures 7A and 7B) or as a coating within the blood collection device (as illustrated in Figure 8) to slow the clotting rate of the collected blood and prevent clogging of the conduits.

[0025] Next, an alternative method 200 shown in FIG. 11 is shown in combination with the second and third embodiments of the blood collection device using a separate lancing device, such as one commercially available. Step 11a) Optional step of inserting a blood sample vacuum tube into a blood collection device. Step 11b) Disinfecting the body part from which the blood sample is to be taken. Step 11c) Placing an adhesive pad at the location where the blood sample will be taken. Step 11d) placing a lancing device at the location defined by the adhesive pad and lancing the skin with the lancing device. Step 11e) Applying the fluid collection device over the wound at a location defined by the adhesive pad, and optionally adhering the fluid collection device to the patient's arm. Step 11f) Connecting the vacuum tube to the wound and activating the push button if using the second embodiment of the fluid collection device, or the push button and lever if using the third embodiment of the fluid collection device, in which the push button is a safety lock that prevents inadvertent closure of the lever. Step 11g) Waiting for the vacuum tube to be sufficiently filled. Such a waiting step may have a duration ranging from a few seconds to a few minutes and may be ensured by a timer built into the fluid collection device, a timer provided by any electronic device or initiated by the user / patient, a timer included in an app running on the user / patient's smartphone that monitors the fluid collection process, or by the user / patient themselves as they observe the fluid flow through a transparent window provided for viewing into the device structure. Step 11h) Removing the fluid collection device from the user / patient. Step 11i) Covering the wound with the adhesive pad dressing. Step 11j) Optionally, remove and close the fluid sample tube from the device. Step 11k) Sending / delivering the blood sample tube to the laboratory for analysis.

[0026] Standard lancing devices, as shown in Figures 12A-12C, are commercially available. One example of a lancing device that can be used in the process of the present invention is the Cardinal Health gentleheel® Heel Incision Device, specifically the TGH10X50 gentleheel® Toddler, Blue®, although other similar lancing devices may be used. Lancing devices suitable for use in the process of the present invention are capable of making an incision in the patient's skin approximately 3 mm long and 2 mm deep. Depending on the amount of blood to be collected at a given time, the lancing device may have two or more blades to incise two or more wounds, making multiple parallel incisions in a single movement. To provide the appropriate wound geometry, mechanism 12000 activates blade 12100 using a combination of rotational and linear motion. The blade is attached to lever 12200, which is pivotable about pin 12210, which moves freely within groove 12400 in the lancing device's structure. Lever 12200 is activated by a user-activated second lever 12300, optionally by a trigger mechanism well known in the micromachining industry, optionally by a spring. As a result, prior to incision (FIG. 12A), blade 12100 is kept out of the reach of the user / patient, and safety features (not shown) prevent inadvertent activation of mechanism 12000 by the user / patient. During incision (FIG. 12B), blade 12100 passes through a path defined by mechanism 12000, cutting one or more lesions in the user / patient's skin. After incision (FIG. 12C), blade 12100 retracts out of the reach of the user / patient, avoiding inadvertent injury.

[0027] 13A-13C, the key features of the blood collection device of the present invention are shown. In a first embodiment, the blood collection device includes, on its top surface, a grip 3122, a blood draw button 3120, a blood draw button 3126, a flash window 3130 indicating blood is available for collection, a blood collection tube 3132, a wing tab 3134 for device removal, and a dressing 3136 with a support. The blood collection device 3100 further includes a blood draw reservoir 3140 with a wound seal, a removal wing tab 3142 with an adhesive support, and a machine-readable code 3144. This first embodiment provides the functionality of both lancing the user / patient's skin and aspirating a blood sample. A second embodiment of the device relies on lancing the user / patient's skin with a separate lancing device, as shown in FIG. 12, and the method follows the path disclosed in FIG. 11. Accordingly, the second embodiment of the fluid collection device does not include a blood draw button 3120.

[0028] Next, a third embodiment of device 14000, shown in Figures 14A-14P, relies on lancing the user / patient's skin with a separate lancing device, using lever 14120 in step 11f, with the method following the outline of Figure 11. In third embodiment of fluid collection device 14000, device body 14100 includes mechanism 14200 that is activated by the user / patient via lever 14120. Mechanism 14200 holds vacuum tube 14400 by mechanical mechanism 14420, for example, the mechanical mechanism being a cap for vacuum tube 14400. Vacuum tube 14400 carries a unique identification tag 14430 that is readable by human and / or machine means. Since lever 14120 includes safety feature 14130 to prevent accidental activation and device 14000 includes vacuum tube 14400 already disposed within the device, step 11a) of the method of Figure 11 is not required. 14A-14H show the fluid collection device 14000 before use, with the lever 14120 in the open position. After the user / patient follows the steps to prepare the wound, the suction opening 14110 of the fluid collection device 14000 is positioned over the wound. For blood collection, the user / patient uses the mechanical mechanism provided by the adhesive pad for precise positioning; for other uses, such as collecting pus or toxins, the user / patient visually positions the fluid collection device 14000. The user / patient can visually observe the suction opening 14110 of the fluid collection device 14000 filling with fluid by looking through a transparent window (not shown) in the fluid collection device body 14100 or by waiting a predetermined duration, which may last from a few seconds to a few minutes and may be ensured by a timer built into the fluid collection device 14000, a timer provided by any electronic device or initiated by the user / patient, or a timer included in an app running on the user / patient's smartphone that monitors the fluid collection process. At this point, the user / patient releases the safety feature 14130 and activates the lever 14120, moving the mechanism 14200. The mechanism 14200 moves the vacuum tube 14400 towards the fluid collection device body 14100, piercing the septum 14110 (not shown) of the vacuum tube 14400 in the conduit and connecting the vacuum tube 14400 to the patient's wound, thereby allowing the collected fluid to flow from the wound into the vacuum tube 14400.Alternatively, the mechanism 14200 moves a conduit toward the vacuum tube 14400 and penetrates a septum 14110 (not shown) of the vacuum tube 14400, connecting the vacuum tube 14400 to the patient's wound, thereby allowing collected fluid to flow from the wound into the vacuum tube 14400. To avoid risking pulling the fluid collection device 14000 away from the patient's skin, the fluid collection device 14000 is configured so that the user / patient presses a lever 14120 over the wound location. Figures 14I-14P show the fluid collection device 14000 after the lever 14120 has been pressed.

[0029] Next, the adhesive pad 15000 shown in Figures 15A and 15B includes at least one mechanical feature that allows for precise positioning of the lancing device and fluid collection device. The adhesive pad 15000 includes an adhesive zone 15100 for attachment to the patient's skin, one or more targets and mechanical features 15200 that allow for precise positioning of the lancing device and fluid collection device, and a dressing portion 15300 for covering the wound after the fluid collection process. The target mechanical feature 15200 may have the shape of a bump against which the user / patient can press the lancing device and fluid collection device. Prior to initiating the fluid collection process, the adhesive zone 15100 is covered with a support portion 15110, the target mechanical positioning feature 15200 is covered with a support portion 15210, and the dressing portion 15300 is covered with a support portion 15310. The user / patient removes the appropriate support portion to follow the fluid collection process.

[0030] 16A-16F, there are shown several key steps of a method for using an adhesive pad 16100, a lancing device, and a fluid collection device 16200 of the present invention to collect blood from a patient's arm 16300.

[0031] FIG. 16A illustrates the step of attaching adhesive pad 16100 to a patient's arm 16300, exposing target mechanical feature 16110.

[0032] FIG. 16B illustrates the step of placing a fluid collection device 16200 using a target mechanical mechanism 16110 onto a wound 16310 after it has been cut with a lancing device.

[0033] FIG. 16C illustrates the step of initiating collection using the fluid collection device 16200 by depressing the safety button 16230 and then closing the lever 16240.

[0034] FIG. 16D illustrates the step of waiting and monitoring fluid 16400 entering the vacuum tube 16250 of the fluid collection device.

[0035] FIG. 16E illustrates the step of removing the fluid collection device 16200 after collection.

[0036] FIG. 16F illustrates the step of dressing the wound 16310 with the adhesive pad 16100.

[0037] Next, the geometry of the suction chamber 17100 of the fluid collection device 17000 of the present invention shown in Figure 17 is adapted to provide an airtight interface of the suction opening 17200 to the patient's skin, allowing collection and free flow of the collected fluid into the vacuum tube via the conduit 7300. The internal volume of the suction chamber 17100 is as small as possible to avoid unnecessary reduction in volume and stagnation of the collected fluid. The inner surface 17110 of the suction chamber 17100 and the inner surface 17310 of the conduit 17300 are as smooth and flat as possible, and are optionally coated with an anti-adhesive coating and optionally provided with an anticoagulant coating to minimize the risk of clotting of the collected fluid and to promote the freest possible flow of the collected fluid through the suction chamber 17100, the conduit 7300, and into the vacuum tube. The edge 12710 of the suction opening 17200 is concave to prevent any collected fluid from stagnating at the suction opening 17200 and / or slipping under the collection device 17000. The top surface 17120 and bottom surface 17130 of the suction chamber 17100 together form a funnel leading from the suction opening 17200 to the conduit 7300. The bottom surface 17130 of the suction chamber 17100 slopes downward relative to gravity when the device 17000 is placed on a patient's arm.

[0038] 18A-18P, a fourth embodiment of a method for using the system of the present invention is shown, in which certain features of the user authentication system 1900, the device authentication system 1902, the capillary blood collection devices 3100, 4100, and the adhesive-integrated dressing 3174 included in the capillary blood collection devices 3100, 4100 can be omitted.

[0039] 18A illustrates step 1 of a fourth embodiment of a method for using the system of the present invention, which includes a) scanning a website or prescription and loading a dedicated app using the present invention, b) completing a consent form, c) filling out demographic information, d) photographing a government-issued ID or other means of identification, and e) taking a selfie to associate the patient with the device and the collected sample.

[0040] 18B illustrates step 2 of a fourth embodiment of a method for using the system of the present invention. Step 2 consists of a) opening the package, b) reading the instructions, c) removing the contents from the package, d) scanning the QR code on the kit box to launch the app and guide, e) verifying the contents, and f) cleaning the phone with the sanitary wipes included in the kit.

[0041] 18C illustrates step 3 of a fourth embodiment of a method for using the system of the present invention, which consists of a) placing the built-in phone stand inside the box, b) wiping the phone clean with the included sanitary towelette, and c) washing your hands.

[0042] 18D illustrates step 4 of a fourth embodiment of a method for using the system of the present invention, which consists of a) taking a selfie with the phone on the stand and b) starting a video recording of yourself with your face and arms in the frame.

[0043] 18E illustrates step 5 of a fourth embodiment of a method for using the system of the present invention. Step 5 consists of a) following the app guide (reading text / reviewing images), b) preparing the arm with a warm towel, c) opening an alcohol towelette from the kit, and d) wiping the upper arm location with alcohol and allowing to dry.

[0044] 18F illustrates step 6 of a fourth embodiment of a method for using the system of the present invention, which consists of a) removing the device from the kit packaging and b) showing the QR code on the device and tube to a camera on the stand.

[0045] 18G illustrates step 7 of a fourth embodiment of a method for using the system of the present invention, which consists of a) removing the adhesive support and b) applying the device to the upper arm.

[0046] 18H illustrates step 8 of a fourth embodiment of a method for using the system of the present invention. Step 8 consists of making sure that the facial device keeps its own video in frame.

[0047] 18I illustrates step 9 of a fourth embodiment of a method for using the system of the present invention, which includes a) pressing a first button, b) waiting for an indication to appear in a flash window, c) confirming the indication, and d) following a guide to return the kit if no indication appears within a predetermined time.

[0048] 18J illustrates step 10 of a fourth embodiment of a method for using the system of the present invention. Step 10 consists of a) pressing the second button and b) waiting for the timer on the app to indicate that the tube is full using a communication lapse means.

[0049] 18K illustrates step 11 of a fourth embodiment of a method for using the system of the present invention. Step 11 consists of a) pulling the wing tabs to remove the device from the arm, b) leaving the dressing on the arm, and c) returning the device to the kit box.

[0050] 18L illustrates step 12 of a fourth embodiment of a method for using the system of the present invention, which comprises a) removing the dressing support to expose the gauze pad and adhesive, and b) folding the gauze dressing over the wound.

[0051] 18M illustrates step 13 of a fourth embodiment of a method for using the system of the present invention. Step 13 consists of a) removing the end of the bottle from the device and b) withdrawing the bottle from the device.

[0052] 18N illustrates step 14 of a fourth embodiment of a method for using the system of the present invention, which consists of a) securing a sample bottle in a biohazard pouch within the kit, and b) securing a device in a separate biohazard pouch within the kit.

[0053] 18O illustrates step 15 of a fourth embodiment of a method for using the system of the present invention. Step 15 consists of a) pausing the video, b) removing the phone from the kit stand, c) disassembling the phone stand, and d) securing both biohazard pouches in the kit box.

[0054] 18P illustrates step 16 of a fourth embodiment of a method for using the system of the present invention. Step 16 consists of a) sealing the kit box in a return bag, b) scanning the QR code on the return bag packaging, c) mailing the package, d) confirming the mailing, and e) the app notifying the patient of the test results.

[0055] 19A-19D, certain features of the adhesive-integrated dressing 3174 included in the capillary blood collection device 3100 of the present invention are shown in more detail. The blood collection device 3100 includes a bandage 3150 around the wound site, separate from the bandage 3152 at the base of the device. The blood collection device further includes an adhesive support 3154 releasably disposed on the bandage 3150, 3152, which is peeled off before the device is applied to the patient's body. As the device is applied to the patient's arm, the device is pushed up 3157 by the wing tabs 3156, allowing the device to be pulled away from the patient's skin after filling the tube 3132. The bandage 3150, surrounding the wound site 3162, remains on the skin, and the enclosing feature temporarily prevents blood from leaking from the exposed area. The dressing support 3164 is then peeled away 3165 to expose a gauze pad 3166 surrounded by a bandage 3170. The dressing 3174 includes a dressing tab 3172 without the bandage. The dressing tab 3172 is peelable 3173 and may be secured to cover the wound site with a gauze pad.

[0056] As a result, the adhesive-integrated dressing 3174 is adapted to ensure adhesion of the blood collection device 3100 to the patient's skin, an airtight seal between the patient's skin and the blood collection device 3100 during the collection process, and dressing of the wound after the collection process.

[0057] Current state-of-the-art capillary blood collection devices for non-medical trainees typically involve wounding the patient's skin with one or more needles, with or without puncturing, but only allow for relatively small amounts of fluid collection, typically less than 150 μl in 5-10 minutes.

[0058] In another embodiment, the present invention provides a method for capillary blood collection devices 10, 1100, 2010, 2210, 3100, 4100 to make a significantly larger incision than typically known in existing capillary blood collection devices, allowing significantly larger volumes of blood, typically 500 μl or more, and preferably 1 ml, to be collected in a reasonable time, typically less than 15 minutes, and preferably less than 10 minutes. Capillary blood collection devices of the present invention use one or more cutting blades 1004 (e.g., including, but not limited to, cutting blades 302, 5450, 5456, 3260, 3360, 3460) instead of one or more needles to make an incision rather than a puncture in the user's / patient's skin. For purposes of this disclosure, the functionality of collection devices of the present invention will be disclosed as including one cutting blade, but it should be understood that collection devices of the present invention may have two or more cutting blades to increase the volume of blood collected and / or reduce collection time. The present invention also provides cutting solutions that benefit rapid wound healing after blood collection is complete. Accordingly, the objective of the present invention is to create an incision in the user's / patient's skin that has an optimal depth and length to cut as many capillaries as possible, while avoiding unnecessary wound width and length, allowing the wound to heal naturally as quickly as possible after blood collection. The ideal incision depth may vary as a function of the patient's age, gender, ethnic group, and / or health status, resulting in multiple adaptable variations of the collection device. Typically, the ideal incision depth is between 1 mm and 2 mm.

[0059] Next, a fourth embodiment of the dissecting blade 3260 of the device of the present invention, shown in Figures 20A-20C, is made of a single piece, typically stamped sheet metal or spring steel, but may be made of other materials, including composites, exhibiting suitable mechanical properties. The dissecting blade 3260 has one end 3261 facing the collection device structure, allowing it to be attached thereto, followed by an elastic zone 3262 that elastically flexes when the dissecting blade is ready for use. In this way, the dissecting blade 3260 accommodates all the energy required for its movement; the user / patient only needs to release it by depressing the blood aspiration button 3120. The elastic zone 3262 has a suitable, preferably smooth, cross-section to provide a suitable release trajectory perpendicular to its attached end 3261. In one embodiment, after the elastic zone 3262, the dissecting blade is twisted 90° in region 3263 to provide a blade portion 3264 that is in the same plane as the release trajectory. The blade portion 3264 has high stiffness in the direction of the release trajectory.

[0060] The elastic zones may take the form of multi-turn torsion springs, like those found in clothes pins, where the blade has a circular cross section and the varying stiffness required for function is achieved by varying the heat treatment of different zones of the blade. A cutting tip 3265 is provided towards the end of the blade portion 3264 for cutting the skin 3290 of the user / patient. After the cutting movement is completed, the tip 3265 is removed from the reach of the user / patient. Optionally, the cutting blade 3260 includes fingers 3270 that interact with the device structural elements 3242, 3244, 3246 to bias the natural release trajectory 3250 of the cutting blade 3260 upon release to achieve the modified trajectory 3240.

[0061] Typically, the natural release trajectory 3250 of the lancing blade 3260 is generally circular, elliptical, or spiral. The resulting incision in the patient's skin 3290 is generally circular and has a relatively large radius, resulting in a relatively long wound length 3296 for a small portion of the desired depth 3292. When the device structural elements 3242, 3244, 3246 interact with the fingers 3270 of the lancing blade 3260, the resulting trajectory 3240 of the lancing blade 3260 is modified so that the resulting incision in the patient's skin 3290 has a steeper drop-off and retreat, resulting in a shorter wound length 3294 for a longer wound portion of the desired depth 3292. The modified trajectory 3240 generally allows for a larger volume of capillary blood collection from a smaller wound, contributing to more rapid wound healing after blood collection.

[0062] Referring now to FIG. 20B, by way of example, device structural element 3242 is configured to locally expand the radius of natural release trajectory 3250, and device structural element 3244 is configured to locally shorten the radius of natural release trajectory 3250.

[0063] Referring now to FIG. 20C, as a further example, device structural elements 3246 are configured to locally shorten the radius of the natural release trajectory 3250.

[0064] 21A and 21B, in a fifth embodiment, the dissecting blade 3360 of the device of the present invention is made of a single piece, typically stamped sheet metal, but may be made of other materials, including composites, exhibiting suitable mechanical properties. The dissecting blade 3360 has one end 3361 facing the collection device structure to allow attachment thereto, followed by an elastic zone 3362 that allows the dissecting blade 3360 to bend elastically when ready for use. In this way, the dissecting blade 3360 accommodates all the energy required for its movement; the user / patient only needs to release it by pressing the blood aspiration button 3120. The elastic zone 3362 has a suitable, preferably smooth, cross-section to provide a suitable, flat, and natural release trajectory 3350. In one embodiment, after the elastic zone 3362, the dissecting blade is twisted 90° in region 3363 to provide a blade portion 3364 that is in the same plane as the release trajectory. The blade portion 3364 has high stiffness in the direction of the release trajectory. A cutting edge 3365 is provided towards the end of the blade portion 3364 for cutting the user / patient's skin (not shown). After the movement is completed, the cutting edge 3365 is out of the user / patient's reach. Optionally, the cutting blade 3360 includes fingers 3370 that interact with the device structural element 3342 to bias the natural release trajectory 3350 of the cutting blade 3360 upon release, resulting in a modified trajectory 3340.

[0065] Typically, the natural release trajectory 3350 of the cutting blade 3360 is generally circular or spiral-shaped. The resulting incision in the patient's skin is generally circular, has a relatively large radius, and a relatively long wound length for a small portion of the desired depth. When the device structural element 3342 interacts with the finger 3370, the resulting trajectory 3340 of the cutting blade 3360 is modified so that the resulting incision in the patient's skin has a steeper drop-off and retreat, resulting in a longer wound portion and a shorter wound length for the desired depth. The modified trajectory 3340 generally allows for a smaller wound to collect a larger volume of blood, contributing to more rapid wound healing after collection. By way of example, the device structural element 3342 is configured to locally shorten the radius 3352 of the natural release trajectory 3350 by offsetting a portion of the release trajectory 3340 with an offset 3341. Additionally, the device structural elements 3342 may be made to have more complex shapes to provide a more finely tailored trajectory 3340 .

[0066] 22A-22C, in a fourth embodiment, the dissecting blade 3460 of the device of the present invention is made of a single piece, typically stamped sheet metal, but may be made of other materials, including composites, that exhibit suitable mechanical properties. Next, the dissecting blade 3460 shown in FIG. 22A has a rotating attachment 3466 to the device structure and a cutting edge 3465, which remains in a retracted position prior to the dissecting process.

[0067] Referring now to FIG. 22B, when actuated, the cutting blade 3460 rotates to engage the patient's skin 3490, but the rotational movement is limited by structure so that the patient's skin is not completely cut.

[0068] 22C, after the incision, the cutting blade 3460 retracts in a counter-rotating movement, leaving a wound under the patient's skin that is much smaller than if the incision were made completely. As a result, a deeper incision allows for a larger volume of blood to be collected, but the opening on the surface of the patient's skin 3490 is smaller, which contributes to faster wound healing after the blood is collected.

[0069] Referring now to FIGS. 23A-23D, in a fifth embodiment, the incision blade 3660 of the device of the present invention may be a standard scalpel blade or any other rigid blade, typically made of stamped sheet metal, but may also be made of other materials, including composites, exhibiting suitable mechanical properties. The incision blade 3660 has a cutting edge 3665 and is positioned generally parallel to the user's / patient's skin 3690. The incision blade is guided in a linear motion by a device mechanism (not shown) to penetrate the user's / patient's skin at a substantially non-orthogonal angle ( FIG. 23B ). In this manner, the cutting edge 3665 completely penetrates the user's / patient's skin, reaching a generally uniform depth along its entire length, creating a generally rectangular wound and oriented non-orthogonally to the user's / patient's skin ( FIG. 23C ). When the incision blade is retracted ( FIG. 23D ), the resulting flap from the non-orthogonal incision naturally closes the wound, contributing to more rapid wound healing after blood collection.

[0070] In another embodiment, the present invention provides for verification of a self-administered medical process, the purpose of which is to verify that the user / patient has been identified and that the blood in the sample tube is that of the patient.

[0071] Potential risks here include reliable blood collection procedures, work permits, travel permits and permits for contact with family members during epidemics, approval to use specific treatments, automated detection of epidemics through large-scale collection programs and verification of the efficiency of prescribed treatments (payment for successful treatment).

[0072] Furthermore, payments for treatment may also be at risk if vaccination is administered and only if fully administered. Therefore, robust patient and process verification is crucial.

[0073] Another aspect is the validation of the self-administered medical process. For example, a smartphone application could be used to create a video (or time-lapse) that allows the patient's face and the process itself to be viewed throughout the entire process. The patient's ID could be compared with the patient's face, and the patient's facial recognition and the entire process could be observed. The system could be configured to initiate the process only if all identities are confirmed. Automated management of logistics (collection and transport of sample tubes, resupply of treatment, etc.) could be implemented. If the smartphone app is configured to analyze the video in real time, it could provide real-time step-by-step instructions to the patient as the process is carried out. Other features, such as automated monitoring of process performance, could also be included. Despite the potential, challenges always remain, especially in degraded situations, such as when network coverage is insufficient during the process. Optionally, temporary network coverage could be provided via drones / balloons during the treatment campaign. However, it would be best if the app could run independently of network coverage. It is also desirable for all data to be stored on the smartphone for subsequent validation. Of course, complying with regulations regarding private data is also important: the app performs a first analysis and then an encryption routine to make the private data unreadable, and optionally stores the entire video for later use if necessary (e.g., as official evidence in court).

[0074] The main components of the system are a smartphone, laptop / computer, or similar, a camera (which may reside on the smartphone / laptop / computer), an application run by the smartphone or laptop / computer, a reusable device for performing the injection / collection process, and one or more empty tubes / vials to contain the therapeutic agent to be injected and the collected blood sample (which may be under vacuum).

[0075] As an important feature of the system of the present invention, the app must be able to read the unique ID of the treatment container / sample tube using a standard barcode / QR code etc. and must be able to identify key process steps. The device may need to be equipped with automated radio signal emission (information: ID / process started / process in progress / process completed / error). Such signals may be made visible (blinking / colored LED etc.) to facilitate interpretation of the video. The device of the present invention may optionally include visible features / reference points to make orientation verification of the video easier. The app must be able to initiate the treatment process. The device may optionally include a remote activation feature and advantageously include a unique ID.

[0076] 24A-24D, readily recognizable visible features 2600 incorporated into device 2610 of the present invention can optionally take the form of a combination of different high-contrast patterns 2620, 2630, which are applied to a movable portion (in this example, button 2650) and are only visible one at a time through window 2612. As a result, the predetermined positions of the movable portion (button 2650 in a high position in FIG. 24B and button 2650 in a low position in FIG. 24D) are easily recognizable by a human observer or easily identifiable by image analysis software. Additionally, colored portions and / or features appear and / or disappear from / in the device at specific steps in the process, completing the steps and being easily recognizable by a human observer or easily identifiable by image analysis software.

[0077] For the purposes of this disclosure, the words blade, lancing blade, or lancet are used interchangeably and should be understood to be equivalent.

[0078] The invention has other uses as well, for example it can be adapted for other medical purposes besides drawing blood (the device can be an injection device, a pill dispensing device), it can be adapted for voting at home, signing documents, verifying identity during a conference call, or taking a remote exam.

[0079] Although reference is made to drawing blood in this application, it should be understood that pus or poison can be substituted for blood.

[0080] The invention can be summarized to include the following set of features: 1. (a) a body fluid collection means, optionally for automated collection; (b) optionally, an analysis means configured to analyze the fluid using one or more droplets of the collected fluid; (c) an interface for a medical analysis tube corresponding to a size and interface standard, the tube being suitable for being filled with a fluid sample for analysis at a point of care or a medical laboratory; The device includes an interface for an empty tube, the vacuum tube being adapted to provide the suction necessary to fill the vacuum tube with the fluid. 2. A method of using the fluid collection device of feature set 1, wherein in a first step, a test subject is tested for a pathogen, and if the test subject tests positive, in a second step, treatment and / or isolation protocols are initiated to ensure that the test subject with a positive test is handled in a manner that helps minimize the spread of said pathogen. 3. A lancet for a disposable fluid collection device according to feature set 1, suitable for incising the skin of a user / patient and used for collection of bodily fluids, wherein the lancet is constructed from a single material and is placed within a holder to provide energy for movement and to guide movement. 4. The collection device of feature set 1, wherein a fluid extraction path or conduit from the patient's wound to the vacuum tube is formed by a needle. 5. The collection device of feature set 1, wherein the user is a non-medically trained user. 6. The collection device of feature set 1, wherein the fluid reservoir is the vacuum reservoir. 7. The collection device of feature set 1, wherein the fluid is at least partially blood. 8. The collection device of feature set 1, wherein the fluid is at least partially pus. 9. The collection device of feature set 1, wherein the fluid is at least partially poisonous. 10. The collection device of feature set 1, optionally wherein the device is adapted to analyze the bodily fluid using one or more droplets of the collected bodily fluid. 11. The collection device of feature set 1, said device including a vacuum tube and an interface therefor, said vacuum tube providing the suction necessary to fill said vacuum tube with said bodily fluid. 12. A collection device according to one of feature sets 1, 4-11, wherein the medical analysis tube is a standard medical analysis tube. 13. A method of capillary blood collection, optionally self-collection, comprising at least: a) placing an adhesive pad at an intended location for said capillary blood collection, said adhesive pad comprising at least one mechanical orientation feature and optionally a visual indicator; b) lancing the user / patient's skin with a lancing device, thereby opening at least one wound in the user / patient's skin, and positioning the lancing device using the at least one mechanical locating feature of the adhesive pad; c) collecting capillary blood from the patient with a fluid collection device, positioning the device over the at least one wound using the at least one mechanical locating feature of the adhesive pad, and using a vacuum to draw blood from the at least one wound and fill a sample analysis tube; d) dressing the at least one wound with the foldable portion of the adhesive pad; A method comprising: 14. The device of Feature Set 1, wherein the device further comprises an adhesive pad, the adhesive pad adapted to be placed at the intended location for the capillary blood collection, the adhesive pad comprising at least one mechanical positioning feature and optionally a visual indicator, the adhesive pad further comprising at least one mechanical positioning feature that allows for accurate positioning of the lancing device and the fluid collection device, and a foldable portion adapted to cover the at least one wound after the blood collection. 15. The device of feature set 1 or 14, wherein the device further comprises a lancing device including a lancet adapted to make one or more incisions in the skin of a user / patient, the lancet being comprised of a single material and providing energy and guidance for movement. 16. The device of feature set 1, 14, or 15, wherein the device further comprises a lancing device including a lancet adapted to make one or more incisions in the skin of a user / patient, the lancing device including one blade for each of the one or more incisions, and the device makes the one or more incisions simultaneously. 17. The lancing device of feature set 16, wherein, when lancing the patient's skin, the trajectory of the at least one blade follows a trajectory that combines at least one rotational movement element and at least one linear movement element.

[0081] Furthermore, the invention is considered to consist of all possible combinations of all features described in this specification, the appended claims, and / or the drawings that are considered to possess novelty, inventive step, and industrial applicability.

[0082] The particular implementations shown or disclosed herein are illustrative of the invention and the best mode thereof, and are not intended to limit the scope of the invention in any way.

[0083] As will be appreciated by one skilled in the art, the present invention may be embodied as a system, device or method.

[0084] The system of the present application is also intended for use, sale, and / or distribution of any goods, services, or information having similar functionality to the present application.

[0085] The present specification and drawings should be understood as illustrative rather than restrictive, and all improvements described herein are intended to be encompassed within the scope of the invention as claimed herein. Accordingly, the scope of the present invention should be determined by the appended claims (whether present or as subsequently amended or added, and their legal equivalents), and not by the mere illustrative examples described above. The steps recited in all method or process claims may be performed in any order unless otherwise specified, and are not limited to the specific order recited in the claims. Furthermore, the elements and / or components recited in apparatus claims may be assembled or functionally configured in various permutations to achieve essentially the same results as the present invention. In general, the present invention should not be construed as limited to the specific configurations recited in the claims.

[0086] The benefits, other advantages, or solutions described herein should not be construed as essential, critical, or essential features or elements of any or all claims.

[0087] As used herein, the terms "consisting of," "composed of," and similar phrases are used to express a non-limiting list of elements, and any device, process, method, article, or composition of the present invention that is made up of that list of elements may include not only the listed elements, but also other elements described herein. Furthermore, the terms "comprising," "comprising," or "essentially comprising" are not intended to limit the scope of the invention to only the listed elements, unless otherwise specified. The combinations and / or modifications of the elements, materials, or structures described above used in practicing the present invention may be modified or adapted to other designs by those skilled in the art without departing from the general principles of the present invention.

[0088] The above-cited patents and publications are incorporated herein by reference to the extent they do not contradict this disclosure, unless otherwise stated.

[0089] Other features and aspects of the practice of the invention are set forth in the appended claims.

[0090] Furthermore, the invention is considered to consist of all possible combinations of all features described in this specification, the appended claims, and / or the drawings that are considered to possess novelty, inventive step, and industrial applicability.

[0091] Additional features and functionality of the present invention are set forth in the claims appended hereto, which claims are incorporated herein by reference in their entirety and are to be considered part of the filed application.

[0092] Various modifications and improvements can be made in the embodiments of the invention disclosed herein. While certain specific embodiments of the invention have been illustrated and disclosed, a wide range of changes, modifications, and substitutions are contemplated in the foregoing disclosure. While the above description contains many specific details, these should not be considered as limitations on the scope of the invention, but rather as an exemplification of one or other preferred embodiments. In some cases, some features of the invention are employed without a corresponding use of other features. Therefore, the above description should be construed broadly and understood as merely illustrative, with the spirit and scope of the invention being limited only by the claims ultimately issued on this application.

Claims

1. (a) a bodily fluid collection means adapted to be applied to the skin of a user / patient and adapted for self-collection, the bodily fluid collection means including a lancet, which is a cutting device for creating a laceration for collecting capillary blood from the skin of the user / patient, and a main structure for supporting the lancet; (b) a medical analysis vacuum tube adapted to be filled with a fluid sample for analysis at a point-of-care or medical laboratory; and a needle for interfacing with the medical analysis vacuum tube corresponding to a size and interface standard, the needle configured to provide the suction necessary to fill the medical analysis vacuum tube with a fluid sample for analysis at the point-of-care or medical laboratory; A fluid collection device in which a suction chamber communicating with the needle channel is provided inside the main structure, the lancet is positioned within the suction chamber, and the lancet is stored within the suction chamber after incising a capillary in the user / patient's skin.

2. A lancet for a fluid collection device as described in claim 1, suitable for incising the skin of the user / patient and used for collecting capillary blood, wherein the lancet is made of a single material and is positioned within the main structure to provide energy for movement and to guide movement.

3. 10. The fluid collection device of claim 1, wherein the fluid extraction path or conduit from the user / patient's wound to the vacuum tube is formed by a needle.

4. 10. The fluid collection device of claim 1, comprising an analysis means configured to analyze the fluid using one or more droplets of the collected fluid.

5. 10. The fluid collection device of claim 1, comprising an adhesive pad adapted to be placed at an intended location for collection of capillary blood, the adhesive pad comprising at least one mechanical positioning feature and a visual indicator, the adhesive pad further comprising at least one mechanical positioning feature that enables accurate positioning of the cutting device of the fluid collection device, and a foldable portion adapted to cover the at least one wound after collection of capillary blood.

6. 10. The fluid collection device of claim 1, wherein the cutting device comprises an lancing device including the lancet adapted to make one or more incisions in the skin of a user / patient, the lancet being constructed from a single material and providing energy and guidance for movement.

7. 10. The fluid collection device of claim 1, wherein the cutting device comprises a lancing device including the lancet adapted to make one or more incisions in the skin of a user / patient, the lancing device including one blade for each of the one or more incisions, and wherein the fluid collection device makes the one or more incisions simultaneously.

8. 10. The fluid collection device of claim 7, wherein the cutting device comprises at least one blade that, when incising the patient's skin, follows a trajectory that combines at least one rotational movement element and at least one linear movement element.

9. A lancet adapted to create a laceration within and below the surface of a user / patient's skin for a fluid collection device as described in claim 1 used to collect capillary blood, wherein the cutting device follows a trajectory that creates a longer laceration below the surface of the user / patient's skin than a laceration created at the surface of the user / patient's skin, thereby promoting rapid healing of the wound after collection of capillary blood.

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