Body fluid sampling device and method of using the same

Abstract

To provide a system and method for authenticating a user / patient, collecting a body fluid sample using a collection device, and ensuring that the body fluid sample is sealed and transported to an analytical laboratory in a hygienic, complete and safe manner.SOLUTION: A system comprising a combination of a device for injection of a medicament or vaccine and an app connected to the internet, wherein the app is associated with self-injection performed by a non-medically trained user and comprises means for enabling verification of the identity of the user and / or of the used device, A data entry means for entering information of the medicament or vaccine input by the user manually or by scanning a QR code into the data storage device, and a safety means adapted to be activated upon reaction of the user immediately after injection and / or a certain time after injection, wherein the device is adapted to be shipped under thermal protection.SELECTED DRAWING: FIG. 1C

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is related to U.S. Provisional Application Nos. 63 / 002,581, filed March 31, 2020, entitled "Body Fluid Collection Devices and Methods of Use Thereof," 63 / 006,337, filed April 7, 2020, entitled "Body Fluid Collection Devices and Methods of Use Thereof," 63 / 025,692, filed May 15, 2020, entitled "Body Fluid Collection Devices and Methods of Use Thereof," 63 / 011,010, filed April 16, 2020, entitled "Body Fluid Collection Methods with Automatic User Identification," and 63 / 069,112, filed August 23, 2020. No. 63 / 114,162, filed November 16, 2020, entitled "Voluntary Medical Process Verification System," No. 63 / 142,756, filed January 28, 2021, entitled "Capillary Blood Collection System Including User / Patient Authentication," No. 63 / 150,113, filed February 17, 2021, entitled "Capillary Blood Collection Device," and No. 63 / 153,088, filed February 24, 2021, entitled "Vaccine and / or Medication Injection and Administration Device." 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 the collection of bodily fluids and their transport to an analytical laboratory without the intervention of medical personnel. During wars or epidemics, analysis of bodily fluids, such as blood, from a large portion of a population—potentially the entire population of a neighborhood, a block or group of blocks, a suburb, a city, an entire country, or even a continent—may be required. In such cases, medical personnel may be unable to personally attend to the collection of each patient's bodily fluid for a number of reasons, including confinement obligations, contamination risks, dangerous areas, travel distances, lack of transportation infrastructure, and / or personnel shortages. Therefore, what is needed is a bodily fluid collection device adapted for personal use by any individual without rigorous medical training, and a method that ensures user / patient authentication, association of the bodily fluid sample with the authenticated user / patient, and intact, safe, and sanitary transport of the bodily fluid sample to an analytical laboratory. [Background technology]

[0004] A bodily fluid collection device and method are provided that comprise collecting a bodily fluid sample, such as blood, without the intervention of trained medical personnel. The bodily fluid collection device optionally and advantageously comprises an insulating cover or sleeve adapted to slide over the sample container to extend the potential transport time. In one embodiment, the insulating cover or sleeve is manually deployed by a user via a user-activated tab according to instructions provided with the device, or automatically slid into place by a second mechanism, optionally actuated by heat contraction of an element, after the device has reached a sufficiently low temperature in a refrigerator. The bodily fluid collection device optionally comprises a unique identification code and optionally carries an electronically readable identification tag, such as an RFID-readable tag. In some cases, the collection device optionally comprises geo-localization and long-range communication capabilities to allow collection without further user action after the collection step is performed. Advantageously, the bodily fluid collection device of the present invention is optionally configured to use standard analytical tubes well known in the art, so that the contents of the tubes can be analyzed by standard automated analytical equipment. Associated methods are provided for authenticating a user / patient, optionally associating or ensuring a match between the authenticated user / patient and a sample container at the collection device, collecting a bodily fluid sample using the collection device, and ensuring a sealed, sanitary, complete, and safe transport of the collected bodily fluid sample to an analytical laboratory. [Brief explanation of the drawings]

[0005] [Figure 1A] 1 is a flowchart of a first embodiment of the method of the present invention. [Figure 1B] 4 is a flow chart of a second embodiment of the method of the present invention. [Figure 1C] 4 is a flowchart of a third embodiment of the method of the present invention. [Figure 1D] 4 is a flowchart of a fourth embodiment of the method of the present invention. [Figure 2A] 1 is a perspective view of the internal mechanism of a collection device, showing a first embodiment of a cutting blade of the present invention before use. FIG. [Figure 2B]1 is a perspective view of the internal mechanism of a collection device according to the present invention in use; FIG. [Figure 2C] 1 is a perspective view of the internal mechanism of the collection device of the present invention after use. FIG. [Figure 3A] 1 is a side view of the internal mechanism of a collection device according to the present invention prior to use. FIG. [Figure 3B] 1 is a perspective view of the internal mechanism of the collection device of the present invention in use; FIG. [Figure 3C] 1 is a side view of the internal mechanism of the collection device of the present invention in use; FIG. [Figure 3D] 1 is a side view of the internal mechanism of the collection device according to the present invention after use. [Figure 4] 1 is a bottom perspective view of the surface of a collection device in accordance with the present invention that comes into contact with the user's skin. FIG. [Figure 5] 1 is a perspective view of the internal fluid channels of a collection device according to the present invention. [Figure 6] FIG. 2 is a plan view of a thermal indicator panel according to the present invention. [Figure 7A] 1 is a partial cross-sectional view of the internal elements of a collection device according to the present invention, illustrating the extraction of a bodily fluid sample. [Figure 7B] 1 is a partial cross-sectional view of the internal elements of a collection device according to the present invention, illustrating the extraction of a bodily fluid sample. [Figure 8A] 8A-8B are cross-sectional views illustrating two stages of operation of a bodily fluid collection device of the present invention: a step before use (FIG. 8A) and a step after collection (FIG. 8B). [Figure 8B] 8A-8B are cross-sectional views illustrating two stages of operation of a bodily fluid collection device of the present invention: a step before use (FIG. 8A) and a step after collection (FIG. 8B). [Figure 9] FIG. 10 is a perspective view of another embodiment of the body fluid collection device of the present invention for collecting capillary blood from an earlobe. [Figure 10A] 1 is a schematic diagram of a body fluid collection device for collecting capillary blood from an earlobe. [Figure 10B] 1 is a schematic diagram of a body fluid collection device for collecting capillary blood from an earlobe. [Figure 11]10 is a flow chart of a fifth embodiment of a method for collecting body fluids and ensuring user-patient identification of the present invention. [Figure 12] 1 is a side view of one embodiment of a capillary blood collection device according to the present invention, having a main structure housing a suction interface adapted to adhere to the skin of a user / patient. [Figure 13] FIG. 13 is a localized, partial cross-sectional view of the capillary blood collection device embodiment of FIG. 12 showing a second cutting blade embodiment of the present invention, with the device in contact with a user / patient via its suction interface. [Figure 14A] FIG. 1 is a partial cross-sectional view showing the ability of the device of the present invention to be used with standard sample containers. [Figure 14B] FIG. 1 is a partial cross-sectional view showing the ability of the device of the present invention to be used with standard sample containers. [Figure 14C] FIG. 1 is a partial cross-sectional view showing the ability of the device of the present invention to be used with standard sample containers. [Figure 14D] FIG. 1 is a partial cross-sectional view showing the ability of the device of the present invention to be used with standard sample containers. [Figure 14E] FIG. 1 is a partial cross-sectional view showing the ability of the device of the present invention to be used with standard sample containers. [Figure 14F] FIG. 1 is a partial cross-sectional view showing the ability of the device of the present invention to be used with standard sample containers. [Figure 14G] FIG. 1 is a partial cross-sectional view showing the ability of the device of the present invention to be used with standard sample containers. [Figure 14H] FIG. 1 is a partial cross-sectional view showing the ability of the device of the present invention to be used with standard sample containers. [Figure 14I] FIG. 1 is a partial cross-sectional view showing the ability of the device of the present invention to be used with standard sample containers. [Figure 15A] FIG. 10 is a side view of a second embodiment of a cutting blade or lancet in a releasable position for use with the present invention. [Figure 15B] FIG. 10 is a side view of a second embodiment of a cutting blade in a semi-extendable position for use with the present invention. [Figure 15C]FIG. 10 is a plan view of a second embodiment of a cutting blade fully extended. [Figure 16A] FIG. 10 is a perspective view of a third embodiment of a cutting blade of the present invention, which is made from a single piece of metal. [Figure 16B] FIG. 10 is a side view of a third embodiment of a cutting blade of the present invention. [Figure 16C] FIG. 10 is a front view of a third embodiment of a cutting blade of the present invention. [Figure 16D] FIG. 10 is a plan view of a third embodiment of a cutting blade of the present invention. [Figure 16E] FIG. 10 is a side view of a third embodiment of a cutting blade of the present invention, semi-extended. [Figure 16F] FIG. 10 is a side view of a third embodiment of a cutting blade of the present invention, fully extended. [Figure 17] A multi-turn torsion spring may be used in the elastic zone in certain embodiments of the present invention. [Figure 18A] FIG. 10 is a top perspective view of another embodiment of the blood collection device of the present invention. [Figure 18B] FIG. 10 is a bottom perspective view of another embodiment of the blood collection device of the present invention. [Figure 19] 1 is a perspective view of an injection device of the present invention. FIG. [Figure 20A] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 20B] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 20C] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 20D] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 20E] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 20F] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 20G] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 20H] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 20I] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 20J] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 20K] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 20L] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 20M] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 20N] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 20O] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 20P] FIG. 10 is a schematic diagram showing the steps of a sixth embodiment of a method for using the system of the present invention. [Figure 21A] 1 is a schematic diagram illustrating in greater detail certain features of an adhesive integrated dressing included in a capillary blood collection device. [Figure 21B] 1 is a schematic diagram illustrating in greater detail certain features of an adhesive integrated dressing included in a capillary blood collection device. [Figure 21C] 1 is a schematic diagram illustrating in greater detail certain features of an adhesive integrated dressing included in a capillary blood collection device. [Figure 21D] 1 is a schematic diagram illustrating in greater detail certain features of an adhesive integrated dressing included in a capillary blood collection device. [Figure 22A]FIG. 10 is a perspective view of a fourth embodiment of a cutting blade of a device of the present invention, which is made of a single piece. [Figure 22B] FIG. 10 is a side, four-position, shutter view of a fourth embodiment of a cutting blade of a device of the present invention. [Figure 22C] FIG. 10 is a side view of a four-position shutter of a fourth embodiment of the cutting blade of the device of the present invention, showing its retraction. [Figure 23A] FIG. 10 is a perspective view of a fifth embodiment of a cutting blade of the present invention. [Figure 23B] FIG. 10 is a front view of a fifth embodiment of a cutting blade of the present invention. [Figure 24A] FIG. 10 is a side view of a sixth embodiment of a cutting blade of a device of the present invention prior to penetration into the epidermal layer of a patient's body. [Figure 24B] FIG. 10 is a side view of a sixth embodiment of a cutting blade of a device of the present invention midway through its movement cycle. [Figure 24C] 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 25A] FIG. 10 is a perspective view of a seventh embodiment of a cutting blade of the device of the present invention, showing a standard scalpel blade. [Figure 25B] FIG. 10 is a side view of a seventh embodiment of a cutting blade of a device of the present invention prior to penetration into the epidermal layer. [Figure 25C] FIG. 10 is a side view of a seventh embodiment of a cutting blade of a device of the present invention after penetration into the epidermal layer and immediately prior to removal from said layer. [Figure 25D] FIG. 10 is a side view of the epidermis layer showing the incision made by the seventh embodiment of the cutting blade. [Figure 26A] 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. [Figure 26B] 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. [Figure 26C]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.

[0006] Elements shown 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, used herein, are used 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, used 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 for other terms and that the embodiments disclosed herein may be operated in orientations different from those explicitly illustrated or described. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] 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.

[0008] The body fluid collection device of the present invention has different sizes and shapes depending on the type(s) of fluid and size of the sample to be collected and the body part from which the sample is to be collected. While samples can be collected on the skin or mucosa, if the sample must be collected through the skin or mucosa, the collection tool may be equipped with a cutting blade to open the skin / mucosa and release the collected body fluid. The user may add a reactive substance to the surface of the skin / mucosa to facilitate sample storage or enable specific analysis. Optionally, the thermal inertia of the body fluid collection device may be adapted to the above parameters and transportation constraints, allowing sufficient margin from the user's refrigerator to the analytical laboratory refrigerator to ensure optimal storage temperature of the body fluid sample. The collected sample may be transported from the user's location to the analytical laboratory by the user, by the postal service, or by specialized logistics organizations using human transporters or automated or remote-controlled unmanned vehicles. In some cases, the collection device may be equipped with geolocalization and long-distance communication capabilities to allow collection without further user action after the collection process is performed.

[0009] Since the risks to the patient may be so high that the results may determine whether the patient is quarantined or released, may be allowed to travel, may be allowed to work, may serve as confirmation of treatment effectiveness and / or the releasing of payment for a treatment, the patient may be authenticated and the match of the sample to the authorized user / patient may be optionally ensured, optionally by changing the level of tamper-resistant measures. Such tamper-resistant measures may include filming the entire process of bodily fluid collection, from opening the box containing the collection device, to sealing the box, mailing to the sample analysis organization, and optionally encoding, and storing the video for later use, such as for use as evidence in court in the event of legal proceedings.

[0010] Next, a first embodiment of the method according to the present invention, shown in FIG. 1A, a) disinfecting and moisturizing the body part from which the blood sample is to be taken; b) taking a blood sample; c) photographing the filled micro-sampler and, optionally, the patient's ID; d) placing the filled micro-collection device in the patient's refrigerator and, optionally prior to step a) or b) above, cooling the micro-collection device until it has the necessary shelf life for transport, and also, optionally, sliding the insulating sleeve over the sample reservoir by activating the tab according to instructions provided to the user; e) transporting the microcollection device from the patient's home to a doctor, pharmacist, hospital, or dedicated collection point; f) optionally intermediate storage in a refrigerator at the doctor's, pharmacist's, hospital or other collection point; g) examining the blood itself on the photograph taken by the patient; Includes:

[0011] Next, a second embodiment of the method according to the present invention, shown in FIG. 1B, i. disinfecting and optionally moisturizing the body part from which the sample is to be taken; ii. taking a fluid sample; iii. Associating the filled micro-collection device with the test subject at any time, such as by photographing the micro-collection device, optionally with the patient's ID, and sending the same via SMS, MMS, or other email to a designated recipient; iv. storing the filled micro-collection device in the patient's refrigerator, optionally prior to the first step i) or ii) above, to cooling the micro-collection device until it has at least the required shelf life for transport, and also optionally sliding the insulating sleeve over the sample reservoir by activating the tab according to instructions provided to the user; v. Removing the sample from the refrigerator; vi. Optionally, transporting the microcollection device from the patient's home refrigerator to a doctor, pharmacist, hospital, or dedicated collection point; vii. Optionally, intermediate storage in a refrigerator at a doctor's, pharmacist's, hospital, or other collection point; viii. diagnosing the pathogen using the sample in the microcollection device; ix. notifying an appropriate person of the results of the analysis; Includes:

[0012] Next, the third embodiment of the method of the present invention shown in FIG. 1C comprises the following steps: Step 1: By collecting the identification tag attached to the device upon delivery, or by any other suitable means, the user captures their collection device's unique identification code in a dedicated software application (app) on their smartphone (connected to the internet or cloud) and captures the QR code on their collection device with their smartphone. Optionally, the user associates the collection device with a patient, such as by photographing the device with visible identification along with the patient's ID document or the patient's face. Step 2: Optionally, the user disinfects the skin surface to provide surface disinfection and optionally moisturization to allow for better suction. Optionally, the user applies a reactive substance to their skin / mucosa, which reacts with the biological sample to enable / enhance preservation of the biological sample and / or enable / enhance analysis. Step 3: The user applies the sampling device to the appropriate area of ​​skin / mucosa. Step 4: After optionally cooling the device according to the methods described above, the user begins the collection process. Step 5: The collection process is automatically carried out by the collection device in the following substeps. Step 5.1: The activation spring is released. Step 5.2: The piston initiates suction to create a vacuum between the user's skin / mucosa and the contact surface of the collection device, and any cutting blades begin to cut. Step 5.3: An optional cutting blade incises the user's skin / mucosa. Step 5.4: The micro-injuries cause fluids to begin to release. Step 5.5: Body fluid is aspirated into the reservoir. Step 5.6: Any cutting blades are retracted. Step 5.7: The piston reaches its end. Step 5.8: A visual indicator notifies the user that the collection process is complete. Such a visual indication may be provided by a reservoir that is transparent so that the user can see that the reservoir is filling with bodily fluid. Step 5.9: If the collection device is equipped with a long-range wireless communication device, information that the collection process has been performed is transmitted directly to the sample collection organization. Step 6: The user removes the collection device from their skin / mucosa and closes it to protect the integrity of the bodily fluid sample. Optionally, the user applies a bandage to the micro-incision, which then closes naturally. Optionally, the user associates the collection device with the patient, such as by photographing the device with visible identification along with the patient's ID document or face. Step 7: Optionally, before collecting the sample, the user stores the collection device in their refrigerator. Step 8: Optionally, before sample collection, the user follows instructions to bring the temperature of the collection device to the appropriate temperature and optionally monitors the temperature evolution of the collection device by observing the temperature display. If the collection device is equipped with a temperature sensor and a long-range wireless communication device, information about the collection device temperature is transmitted directly to the sample collection organization. Step 9: Upon following the instructions, e.g., achieving transport temperature, the user optionally notifies the sample collection organization that the sample is available for pickup or has the device delivered to an appropriate collection location. If the collection device is equipped with long-range wireless communication equipment, information regarding whether the collection device is available for pickup is transmitted directly to the sample collection organization. Step 10: The sample collection organization collects the collection device and takes it to the analytical laboratory. Step 11: The analytical laboratory performs the sample analysis and notifies the user and / or the appropriate authority of the results by any means of communication, such as a dedicated software application (app) on the user's smartphone (connected to the internet or cloud®), or by any other suitable means of communication. The capture of the collection device identification (step 1) may occur between steps 5 and 6 (after the start of the collection process).

[0013] Next, a fourth embodiment of the method of the present invention shown in FIG. 1D has all the steps of the third embodiment of the method of the present invention, but has the following modified step 5b instead of step 5. Step 5b: The collection process is carried out automatically by the collection device in the following substeps: Step 5b.1: The activation spring is released. Step 5b.2: The piston initiates suction to create a vacuum between the user's skin / mucosa and the contact surface of the collection device, and the cutting blade begins to cut. Step 5b.3: The cutting blade incises the user's skin / mucosa. Step 5b.4: The cutting blade is retracted. Step 5b.5: The micro-injuries cause fluids to begin to release. Step 5b.6: Depending on the bodily fluid being collected, the mechanism optionally includes a device (e.g., a device including a spring that is released via a loaded flywheel connected to a reduction gear drivetrain) that allows the waiting time before fully expelling the bodily fluid to be 0.1-10 seconds, 0.2-5 seconds, or 0.5-3 seconds, etc. Step 5b.7: The mechanism activates the absorbent pad to collect the first droplet, or volume of bodily fluid, through absorption and move it away from the collection area. Step 5b.8: The micro-injuries continue to release fluid, which is then drawn into the reservoir. Step 5b.9: The piston reaches its end. Step 5b.10: A visual indicator notifies the user that the collection process is complete. Such a visual indication may be provided by a reservoir that is transparent so that the user can see that the reservoir is filling with bodily fluid. If the collection device is equipped with long-range wireless communication equipment, information that the collection process has been performed is transmitted directly to the sample collection organization.

[0014] 2A-2C, the internal mechanism 10 of the bodily fluid collection device includes an energy source 200, such as a spring, sufficient to ensure the entire collection process. The device includes a rigid reservoir 502 that is closed by a plunger 504. The mechanism 10 couples the energy source 200 to the plunger 504 via a piston 242, which retracts to create a vacuum and aspirate the bodily fluid sample. Depending on the bodily fluid to be collected and the skin / mucosa protecting it, the mechanism 10 optionally couples the energy source 200 to a first embodiment of a cutting blade 302 capable of incising the user's skin / mucosa to expel the collected bodily fluid sample. The mechanism 10 includes a trigger 210 that is activated by the user to initiate the collection process. The mechanism 10 may comprise gears, levers, cams, snaps, racks, pinions, springs or any other mechanical components 220, 222, 224, the selection of the appropriate assembly of which is within the level of one skilled in the art of micro-engineering to ensure that the entire collection process is carried out without any other action by the user after the trigger 210 is released.

[0015] Next, the collection device 10 (also devices 1100, 2010, 2210, 4100, and 3100) shown in FIG. 2B has a unique identification that can take many forms, such as a QR code readable by the user's smartphone or a number that the user dictates for reference. The collection device 10 (and possibly 1100, 2010, 2210, 4100, and 3100) optionally includes a long-range wireless communication device to geolocalize and provide status information directly to the sample collection organization. The collection device status, geolocalization, and user name are communicated by the user directly, by their smartphone using a dedicated software application (an "app" connected to the internet or cloud), or by any other suitable means. The collection process may be initiated by the user's own initiative or by direction from any local health authority.

[0016] Next, the internal mechanism 10 of the bodily fluid collection device shown in Figures 3A-3D has fewer visualized elements, and the reservoir 502, piston 242, plunger 504, mechanism elements 220, 222, 224, and cutting blade 302 are more clearly shown.

[0017] 4 has a suitable shape 110 to correspond to the shape of the user's body part from which a sample is to be collected. The contact surface 100 may be made of a soft material to provide a tight fit or may include a flexible seal 120 to ensure that a sufficient vacuum level is achieved when retracting the plunger 504 via the piston 242 to collect the bodily fluid sample. Optionally, the contact surface 100 may be protected with a membrane that is removed by the user before use of the collection device, and the protective membrane can be reused to seal the surface 100 after collection.

[0018] Next, the body fluid collection device 10 shown in FIG. 5 comprises a channel 404 which connects at one end 402 to the opening 112 and at the other end 406 to an inlet 506 of a reservoir 502 at the contact surface 100 of the device.

[0019] 6 is equipped with a temperature monitoring display / indicator 600. Such a display / indicator may consist of a printed adhesive strip 600 having multiple zones 602, 604, 606, 608 of different colors that change color to indicate when the collection device reaches a corresponding range of temperature, and the labels for the zones may include instructions for the user. The temperature ranges may be, for example: - 602: Temperature is too high (e.g., the temperature of the sampling device is above 8°C) -604: Will be ready for transport soon (for example, if the temperature of the collection device is 5°C to 7°C) -606: Transport is possible (for example, if the temperature of the collection device is 1°C to 5°C) 608: Temperature too low (e.g., if the temperature of the sampling device is below a certain temperature, e.g., below 1°C, a different temperature range may be more appropriate for the particular fluid sample, and corresponding steps and / or instructions will be provided to the user) is.

[0020] 7A-7B, a bodily fluid sample is collected from the collection device by needle 944. An access hole 244 is provided through piston 242 to allow needle 944 to pierce plunger 504 and aspirate the bodily fluid sample contained in reservoir 502.

[0021] The fluid collection device optionally and advantageously includes an insulating cover or sleeve adapted to slide over the sample container to extend the possible transport time. In one embodiment, the insulating cover or sleeve is manually deployed by a user via a user-activated tab according to instructions provided with the device, or automatically slid into place by a second mechanism, optionally actuated by thermal contraction of an element, after the device has reached a sufficiently low temperature in a refrigerator.

[0022] Any form of bodily fluid collection device, such as the embodiments disclosed herein, may optionally include a unique identification code and carry an electronically readable identification tag. In some cases, the collection device may optionally include geolocalization and long-range communication capabilities so that collection can occur without further action by the user after the collection step has been performed.

[0023] The body fluid collection device of the present invention is manufactured to use standard analytical tubes well known in the art so that the contents of the tubes can be analyzed by standard automated analytical equipment.

[0024] This allows the body fluid collection device of the present invention to be easily accessible to users without medical training, such as patients themselves. 1. Collection of body fluids (blood, etc.), voluntary automatic collection (self-administered collection), 2. Optionally dispensing one or more droplets of said collected fluid for immediate analysis; 3. Providing standard medical analysis tubes filled with body fluid (blood, etc.) samples to medical laboratories; It provides the main function.

[0025] 8A and 8B, one embodiment of a bodily fluid collection device 1100 is shown before use (FIG. 8A) and after collection (FIG. 8B). The bodily fluid collection device 1100 consists of a standard medical analysis tube 1007 with a standard color cover (c) and label (e), preferably visible at all times. Preferably, the device structure includes two push buttons 1002 on each side of the device 1100, the activation of which, in one embodiment, must be combined with the depression of a safety button 1001 to initiate the collection process. When buttons 1001 and 1002 are depressed by the user, a combination of levers, stops, cams, or other mechanical elements well known in the art triggers the movement of one or more lancets or cutting blades 1004 of a second embodiment, and the movement of piston p1, through a sealing sleeve I. It should be noted that the device may have one or more cutting blades 1004 (such as, but not limited to, cutting blades 302, 5450, 5456, 3260, 3360, 3460, etc.), in fact one cutting blade for up to 500 μl, and two or more cutting blades for 1 ml or more, to collect blood over a duration acceptable to the patient. For background information, the duration of blood flow is approximately 30 minutes for one incision and 500 μl, and two incisions and 1 ml. The movement of the cutting blades 1004 to incise an opening in the patient's skin, release capillary blood, and retract into the structure / housing 1008 of the device is typically ensured by a dedicated spring, such as a torsion spring as shown in FIG. 17, or element 3362 as shown in FIG. 22A. The suction portion 1010 is kept airtight by a skirt 1005 and a sealing sleeve I, which is made of a flexible material such as silicone or any other suitable material and connects the device to the patient's skin. The suction portion 1010 is connected to the chamber 1011 by a cannula 1006, whose tip ii resembles the tip of a syringe needle and can pierce the plunger septum p2 when it moves a piston p1 to create a vacuum in the chamber 1011 and draw blood from the suction portion 1010 into the chamber 1011.The plunger septum p2 provides a cylindrical recessed cavity i that minimizes friction with the cannula during operation, and a sealing lip v and sealing zone iii that is penetrated by the needle tip ii to allow aspiration of bodily fluids and closes when the cannula tip ii is disengaged when the tube 1007 is removed from the device structure 1008. After collection, the button 1003 may push back the piston p1 at a short distance, expelling a small amount of the collected blood sample back through the cannula 1006 and dispensing one or more droplets from the protruding end 1009 of the cannula 1006 for immediate analysis, such as using a home test kit. The button 1003 provides access to separate the piston p1 from the plunger septum p2, ensuring that the plunger septum p2 remains engaged and sealing with the tube 1007 upon release from the device structure 1008. A standard medical analysis tube 1007 is retained within the device structure 1008 for the collection step, and any droplet dispensing step. The device structure 1008 may be comprised of multiple parts and may include elements that can be broken or disassembled to release the standard medical analysis tube 1007 so that it can be transported to a laboratory and processed using standard medical lab analysis equipment. Prior to release of the standard medical analysis tube 1007, the piston p1 must be separated from the plunger septum p2, such as by depressing button 1003 to rotate the piston p1, which is then separated from the plunger p2, for example by pulling it with string x. The actuation spring 1012 is held within the device structure by washer 1013. Note that one end of the piston shaft engages the button and rotates with it as it nears the end of the aspiration cycle, allowing removal of the shaft from the plunger.

[0026] The use or operation of the device can be described as follows. 1. Typically, the user holds the device with their thumb and long fingers positioned on the two buttons 2 and their index finger on the safety button 1001. 2. By combining levers, stops, cams, or any other mechanical elements well known in the field of micromechanical engineering, when the buttons 1001 and 1002 are pressed by a user, they trigger the movement of the piston p1, which in turn triggers the movement of the cutting blade 1004. 3. The spring 1012 activates the piston p1 to which the plunger septum p2 attaches, causing the plunger to be penetrated by the needle tip ii, which penetrates the plunger, opening the connection between the suction portion 1010 and the chamber 1011. The cutting blade moves, cutting the patient's skin. 4. The spring continues to pull on the piston p1, causing a vacuum to be created within the chamber 1011 of the medical analysis tube 1007. The patient begins to bleed and blood is drawn into the tube chamber 1011 via the cannula 1006. The cutting blade 1004 continues to move and retracts into the device structure. 5. The piston p1 reaches the end of its stroke against the button 1003, the suction stops and the sample is contained in the chamber 1011. Typically the sample volume is 500 μL for one cutting blade and 1 ml for two cutting blades. 6. The user removes the device from the patient's skin, cleans the wound, and applies a band-aid if necessary. 7. Optionally, the user uses button 1003 to dispense a small portion of the sample, typically 1025 μL, to be used in a commercial instant test. 8. The user uses button 1003 to pull piston p1 away from plunger septum p2 so that plunger septum p2 remains within tube 1007, maintaining its sealing condition. 9. The user releases the tube 1007 from the device structure and upon removal of the tube the plunger septum p2 pulls away from the cannula 1006, closing it. 10. The user delivers or takes the tube to a medical analysis laboratory for analysis. 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 will be initiated to ensure that subjects who test positive are handled in a manner that minimizes the spread of the pathogen.

[0027] In another embodiment, the body fluid collection device of the present invention may include integrated analytical functionality. Samples may be collected at the skin or mucosa, but may need to be collected through the skin / mucosa, in which case the collection tool optionally includes a cutting blade that opens the skin / mucosa and releases the collected body fluid. A reactive substance may optionally be added to the surface of the user's skin / mucosa to facilitate sample preservation or enable specific analysis.

[0028] 9, a bodily fluid collection device 2010 for collecting capillary blood from an earlobe has a main body portion 2100 that grips the user-patient's earlobe and a movable portion 2200, allowing the device 2010 to be effective for the collection process without the need for the user-patient to hold it. The bodily fluid collection device 2010 contains an internal mechanism, or any other suitable mechanism, as disclosed in commonly assigned U.S. Patent No. 63 / 002,581 or U.S. Patent No. 63 / 006,337 (the contents of which are incorporated by reference and relied upon), that ensures complete execution of the bodily fluid collection process without any intervention other than activation. Automatic analysis features and / or systems may be incorporated into the device.

[0029] 10A and 10B, a bodily fluid collection device 2210 for collecting capillary blood from a user-patient's 2200 earlobe 2230 is made to have an appropriate shape, size, and weight and is held at collection position 2230 so that it is visible along with the patient's face through the camera of the user-patient's smart phone 250. An optical characteristic 2212, i.e., a visual symbol on the device 2210, such as a QR code, is provided to aid in device identification and localization and may include indications of readiness, progress, and completion of the collection process, or any other visual communication element that is captured by the camera of the user-patient's smart phone 2250 and analyzed and used by an application running on the user-patient's smart phone 2250 to enhance device identification. The device 2210 includes a wireless communication system for communicating information to the user-patient's smart phone, initiating the bodily fluid collection process, and optionally initiating the collection and analysis process after collection is complete. Information communicated between the device 2210 and the user-patient smart 2250 includes device unique identification, collection activation, collection process progress, collection process completion, and / or error messages. Communications between the device 2210 and the user-patient smart 2250, and between the user-patient smartphone and the cloud, may be encrypted and may use blockchain technology to make tampering, misuse, or hacking difficult or impossible. Collection information, along with the user-patient identification, is communicated to the relevant authorities for further processing.

[0030] Next, a fifth method for collecting body fluids and ensuring user-patient identification, shown in FIG. 11, is 1. The user installs a specific application on their smartphone (first time use), 2. Optionally, the user disinfects the skin surface, and optionally the user applies a reactive substance to the skin / mucosa; 3. The user applies the collection device to their skin / mucosa; 4. The user starts a specific application on his / her smartphone; 5. The application communicates with and identifies the collection device; 6. The application turns on the smartphone camera and asks the user to tilt it so that both their face and the device are visible on the smartphone screen; 7. In parallel, a. the application executes facial recognition software to authenticate the user; b. the application executes image analysis software to recognize the identity of the collection device; 8. The application communicates with the collection device and initiates the collection process; 9. In parallel, a. the application stores the time-lapse video as evidence of the harvesting process; b. a collection device performing a collection process; 10. When the collection process is completed, the collection device communicates with the application; 11. The application stores information about the collection device identification, collection time, and user identification in the cloud and / or its initial memory; Includes:

[0031] 12, one embodiment of a capillary blood collection device 4100 in accordance with the present invention includes a main structure 5000 including a suction interface 5100 adapted to attach to a user / patient's skin, one or more push buttons 5200 for a user / patient to activate the device 4100, and a tube holder 6000 configured to receive an evacuated collection tube, such as an evacuated collection tube well known in the art for venous blood collection. Disposed within the main structure 5000 are a suction chamber 5400 coupled to the interior 6100 of the tube holder 6000 via a channel 7000, an activation mechanism 5300 that converts the user / patient's depression of the one or more buttons 5200 into activation of the device 4100, and any 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.

[0032] The device structure 5000 preferably includes two or more push buttons 5200, and the mechanism 5300 is configured to ensure that the collection process begins only when all push buttons 5200 are activated, to minimize the risk of inadvertent initiation. The mechanism 5300 may include a combination of levers, stops, cams, or any other mechanical elements well known in the micromechanical arts, or preferably, may consist of a flexible element that can release collection only by deforming when the user / patient presses the push buttons 5200. The device structure 5000 optionally includes a method for ejecting a small amount of blood from the device 4100 for rapid analysis on-site. While a second embodiment of the cutting blade 5450 is shown in these figures, it will be appreciated that any variation may be used.

[0033] 13, one embodiment of a capillary blood collection device 4100 according to the present invention is in contact with a user / patient via its suction interface 5100, which is attached to a bandage 5120 with a suitable permanent adhesive 5110, and which has a temporary adhesive 5130 on its surface facing the user / patient's skin, suitable for holding the device 4100 to the user / patient's skin at least during the collection process. Prior to use of the device, the temporary adhesive 5130 is protected by a removable protective film 5140. The adhesive 5110, 5130, and bandage 5120 are airtight around their periphery to expose a passage 5150 to allow blood collection and to ensure the establishment of a vacuum between the user / patient's skin and the suction chamber 5400 for the collection process. To ensure a sufficient airtight seal with the skin of the user / patient, the bandage 5120 may have a relatively large surface compared to the surface of the suction interface.

[0034] The aspiration chamber 5400 includes one or more cutting blades 5450 of the second embodiment, and in principle, one cutting blade 5450 is required for up to 500 μl or two cutting blades for 1 ml, depending on the size of the sample to be collected. For the reader's information, the duration of blood flow is approximately 30 minutes for one incision and 500 μl, and two incisions and 1 ml. The cutting blade 5450 has a resilient or spring portion 5458 that is loaded upon assembly of the device 4100 and is held under tension by mechanical fingers 5350. The mechanical fingers 5350 are connected to the mechanism 5300 so that, when activated, the mechanism 5300 can release the cutting blade 5450. When released, the cutting blade is positioned to incise the user / patient's skin through the passageway 5150. The aspiration chamber is closed by an airtight membrane 5420 made of an airtight material that is cut by the cutting blade 5450 while simultaneously incising without tearing the user / patient's skin. Optionally, the aspiration chamber 5400 includes an airtight elastomeric liner 5410 that allows the mechanism 5300 to actuate the mechanical finger 5350 in an airtight manner and optionally includes a means for expelling a small amount of blood for rapid on-site analysis. Suitable materials for the membrane 5420 and optional elastomeric liner 5410 are well known in the art and 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 the aspiration chamber 5400 but is instead drawn into the vacuum tube, the aspiration chamber 5400 is constructed to minimize its volume, and only a small portion of the vacuum provided by the tube is used to establish the vacuum within the aspiration chamber 5400. The channel 7000 connecting the aspiration chamber 5400 to the interior 6100 of the tube holder 6000 may be a needle 7200 comprising a needle aspiration end 7100 connected to the aspiration chamber 5400 and a needle dispensing end 7300 adapted to enter the vacuum tube and expel the collected blood into the tube. Needle 7200 is typically made from stainless steel, but may be made from other materials currently available in the industry, such as other metals, composites, and / or plastics.

[0035] Next, the function of the device shown in FIGS. 14A to 14I can be explained as follows. 1. See FIG. 14A: The collection device 4100 and vacuum tube 8000 are delivered separately to the user / patient in sterile packaging. The dispensing end 7300 of the needle is sharp enough to pierce the septum 8100 (sometimes called a "rubber stopper") of the vacuum tube 8000 and is protected by a resilient (preferably silicone or rubber) sleeve 7400. Optionally, the tube holder 6000 is closed by a removable protective membrane 6110. Optionally, the tube holder 6000 is made of a transparent material. Alternatively, optionally, the tube holder 6000 includes a transparent window 6200 that allows the user / patient to see the interior 6100 of the tube holder 6000. Optionally, the rubber sleeve 7400 is made of a "self-healing" material well known in the art, allowing the dispensing end of the needle 7300 to automatically close after use. 2. See FIG. 14B: The user / patient peels off the optional protective film 6110 and inserts the vacuum tube 8000 into the tube holder 6000 until it reaches the bottom 6160 of the interior 6100 of the tube holder 6000, with the septum 8100 of the vacuum tube 8000 facing the dispensing end 7300 of the needle. 14C: Upon reaching the bottom 6120 of the interior 6100 of the tube holder 6000, the vacuum tube 8000 compresses the rubber sleeve 7400, withdrawing the dispensing end of the needle 7300 and allowing the dispensing end of the needle 7300 to penetrate the septum 8100 of the vacuum tube 8000, establishing an airtight connection from the vacuum tube 8000 to the aspiration chamber 5400 via the needle 7200. Consequently, the aspiration chamber 5400 is placed under vacuum. 4. See Figure 14D: The user / patient disinfects the area of ​​skin 9000 from which blood is to be drawn, removes the protective film 5140, and applies the device 4100 to the area from which blood is to be drawn. Consequently, the bandage 5120 and glues 5110, 5130 allow the device to hold and seal to the user / patient's skin 9000. 5. See FIG. 14E: The user / patient activates the mechanism 5300 by depressing one or more push buttons 5200. The mechanism then activates the mechanical fingers 5350, releasing one or more cutting blades 5450. The one or more cutting blades 5450 cut through the membrane 5420 and the user / patient's skin 9000, cutting multiple capillaries in the patient's skin 9000 and allowing the vacuum to access the user / patient's skin 9000. 6. See Figure 14F: After incising the membrane 5420 and the user / patient's skin 9000, one or more cutting blades 5450 terminate their movement at the incision of the suction chamber 5400, away from the wound 9100, and remove the acute angle from the user / patient's reach. As the wound 9100 begins to bleed, the suction chamber 5400 gradually fills with the user / patient's blood 10000. 7. See FIG. 14G: Blood 10000 fills the vacuum tube 8000 through the suction end 7100 of the needle 7200, the needle 7200, and the dispensing end 7300 of the needle. 8. See FIG. 14H: Once the vacuum tube 8000 is sufficiently filled with blood 10,000, the user / patient removes the vacuum tube 8000 from the device. Indication that the vacuum tube is sufficiently filled can be provided by an electrical or mechanical timer built into mechanism 5300, a scale on the vacuum tube that the user / patient can see through the transparent tube holder 6000, a magnetically or capacitively sensitive strip in contact with the blood, or transparent window 6200, 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 6000, the elastic sleeve 7400 is free to expand to cover the needle dispensing end 7300 and close the passage of blood 10,000. Optionally, the user / patient can insert an additional vacuum tube to obtain an additional blood sample and repeat steps 7 and 8. 9. See FIG. 14I: The user / patient removes device 4100 and applies a small wound bandage 9200, typically purchased separately, to wound 9100. Any blood remaining in suction chamber 5400 is retained therein by membrane 5420. If rapid on-site analysis is required, a few drops of blood contained in suction chamber 5400 can be obtained by pressing membrane 5420. Optionally, a second mechanism (not shown) incorporated into structure 5000 provides a method for expelling a small amount of blood by squeezing elastic lining 5410 upon depression of a push button. 10. The user sends or drops off tube 8000 to a medical analysis laboratory or point of care for analysis. To facilitate delivery of the appropriate sample to the laboratory, the user / patient may use their own refrigerator and, optionally, a container with high thermal inertia 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 and relied upon. 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 will be initiated to ensure that subjects who test positive are handled in a manner that minimizes the spread of the pathogen.

[0036] 15A-15C, a second embodiment of a cutting blade 5450 is shown. The cutting blade 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 cutting blade has one end 5460 facing the harvester structure 5000 to allow attachment thereto, followed by an elastic zone 5458 that resiliently flexes when the cutting blade is ready for use. In this way, the cutting blade 5450 accommodates all the energy required for its movement. The elastic zone 5458 has an appropriate, preferably smooth, cross-section to provide a suitable release trajectory perpendicular to its attached end 5460.

[0037] 16A-16F, a third embodiment 5456 of a cutting blade is shown, configured to be constructed in a different and advantageous manner. In the above two embodiments 302, 5456 of the cutting blade, the release trajectory is indicated by a bent arrow in FIGS. 15B and 16E. In one embodiment, after the elastic zone 5458, the cutting blade is twisted 90° in region 5456 to provide a blade 5452 that is in the same plane as the release trajectory.

[0038] 17, in another embodiment, the blade may take the form of a multi-turn torsion spring, similar to that of a peg. In this case, 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. The blade 5452 has high stiffness in the direction of the release trajectory. A cutting edge 5454 is provided towards the end of the blade 5452 to incise the membrane 5420 and the user / patient's skin 9000. After the cutting blade 5450 has completed its movement, the cutting edge 5454 faces the same side as the attachment end 5460 and is out of the reach of the user / patient.

[0039] In another embodiment, the device 4100 may be activated remotely via a smartphone, optionally following facial recognition or QR code recognition visible on the device. If the device is attached to an arm, the patient has a hand at their disposal to control such remote activation.

[0040] In yet another embodiment, a capillary blood collection device of the present invention includes a patient biometric authentication system, a device authentication system, and a disposable capillary blood collection device that provides a non-medically trained user with the following capabilities: (a) the ability to collect, and optionally automate, capillary blood; (b) optionally the ability to immediately analyze the blood using one or more droplets of the collected capillary blood; and (c) the ability to provide a standard medical analysis tube filled with a sample of capillary blood for analysis at a point-of-care or medical laboratory, wherein the device includes an interface for a vacuum tube, which provides the suction necessary to fill the vacuum tube with blood.

[0041] 18A and 18B, the main features of the blood draw device are shown. The blood draw device includes, on its top surface, a grip 3122, a draw blood button 3120, a collect blood button 3126, a flash window 3130 indicating blood is available for collection, a blood draw tube 3132, wing tabs 3134 for removing the device, and a dressing with a backer. The blood draw device 3100 further includes a blood draw reservoir 3140 with a wound seal, a removal wing tab 3142 with an adhesive backing, and a machine-readable code 3144.

[0042] 19 includes a mechanism (not shown) that activates the needle of the present invention in the area of ​​the injection site 3125 when the user / patient presses the "inject" button 3120. Such mechanisms are well known in the micromechanical field and include levers, clips, springs, flexible elements, sliders, gears, cams, etc. The injection device 3100 further includes a safety button 3123.

[0043] The injection device may be any suitable injection device disclosed in U.S. Patent Application Nos. 63 / 114,162, 62 / 864,572, 62 / 511,361, 15 / 524,748, 31 / 040,459, 14 / 235,107, or 16 / 930,383, the contents of which are incorporated by reference and relied upon.

[0044] 20A-20P, a sixth embodiment of a method for using the system of the present invention is shown, in which certain functions 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.

[0045] 20A illustrates step 1 of a sixth embodiment of a method for using the system of the present invention, which includes a) scanning a website or prescription to download a dedicated app using the present invention, b) executing a consent form, c) providing 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.

[0046] 20B illustrates step 2 of a sixth 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 a sanitary wipe included in the kit.

[0047] 20C illustrates step 3 of a sixth 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.

[0048] 20D illustrates step 4 of a sixth 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.

[0049] FIG. 20E illustrates step 5 of a sixth embodiment of a method for using the system of the present invention. Step 5 consists of a) following the app guide (reading the text / reviewing figures), 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 drying.

[0050] 20F illustrates step 6 of a sixth embodiment of a method for using the system of the present invention. Step 6 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.

[0051] 20G illustrates step 7 of a sixth 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.

[0052] Figure 20H illustrates step 8 of a sixth embodiment of a method for using the system of the present invention, which consists of making sure that the facial device keeps its own video in frame.

[0053] 20I illustrates step 9 of a sixth 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.

[0054] 20J illustrates step 10 of a sixth 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.

[0055] 20K illustrates step 11 of a sixth 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.

[0056] 20L illustrates step 12 of a sixth 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.

[0057] Figure 20M illustrates step 13 of a sixth 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.

[0058] 20N illustrates step 14 of a sixth 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.

[0059] Figure 20O illustrates step 15 of a sixth 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.

[0060] 20P illustrates step 16 of a sixth 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.

[0061] 21A-21D, certain features of the adhesive-integrated dressing 3174 included in the blood collection device 3100 of the present invention are shown in more detail. The capillary blood collection device 3100 includes an adhesive portion 3150 around the wound site, separate from an adhesive portion 3152 at the bottom of the device. The blood collection device further includes an adhesive support portion 3154 removably positioned over the adhesive portions 3150, 3152, which is removed before the device is applied to the patient's body. When the device is placed on the patient's arm, the device is pulled up onto wing tabs 3156, 3157, which pull the device away from the patient's skin once the tube 3132 is filled. The adhesive portion 3150, which surrounds the wound site 3162, remains attached to the skin, providing a temporary containment feature that inhibits blood flow from the exposed area. The dressing support 3164 is then peeled away from 3165 to expose the gauze pad 3166 surrounded by adhesive 3170. The dressing 3174 includes an adhesive-free dressing tab 3172. The dressing tab 3172 can be pulled 3173 to fold the gauze pad over the wound site and secure it over the wound.

[0062] As a result, the adhesive-integrated dressing 3174 is suitable for ensuring 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 for dressing the wound after the collection process.

[0063] In another embodiment, the vaccine and / or medication injection device of the present invention provides a non-medically trained user with (a) the ability to inject, optionally automatically inject, vaccines and / or medications; (b) a data processing and validation system configured to receive data related to the vaccines and / or medications and entered by the user / patient via an app or by a previously received HMO (data entry may be performed manually or by scanning a QR code, etc.); and (c) a system configured to transmit, and optionally receive, data from a network (such as the Internet).

[0064] Self-administration may be achieved by devices disclosed in PCT / US2012 / 048044, PCT / IB2018 / 000559, PCT / IB2013 / 000659, and PCT / IB2020 / 055874, the contents of which are incorporated by reference and rely upon the same.

[0065] As already emphasized, the present invention provides a method for a non-medically trained user to inject and administer a vaccine and / or medication, the method being implemented in a vaccine and / or medication injection device. The vaccine and / or medication injection device of the present invention may use one or more needles as a method for injecting a vaccine and / or medication into the body of a user / patient. For purposes of this disclosure, the functionality of the vaccine and / or medication injection device of the present invention will be disclosed as having one needle, but it should be understood that the injection device of the present invention may have one or more needles to increase the amount of vaccine and / or medication injected and / or to reduce injection time. The vaccine and / or medication injection device of the present invention provides a non-medically trained user with (a) the ability to inject, and optionally self-inject, a vaccine and / or medication; (b) a data processing and validation system configured to receive data related to the vaccine and / or medication entered by the user / patient via an app or by a previously received HMO (data entry may be performed manually or by scanning a QR code, etc.); and (c) a system configured to transmit, and optionally receive, data from a network (such as the Internet).

[0066] The device according to the invention allows the authentication of the administration of vaccines and / or medicines. The device according to the invention therefore comprises means allowing the verification of one or more of the following items: 1. Data of the surgeon or medical director (MED) for the administration of the vaccine / medication and his (MED's) specific approval for the use of administering the vaccine and / or medication to the user / patient. The device according to the invention is adapted to receive data, said data relating to the vaccine and / or medication, entered by the user / patient through the app or by the HMO having received it beforehand (entry of data may be performed manually or by scanning a QR code, etc.). 2. Temperature of the vaccine and / or medication administration from transport until injection (if required). The device according to the invention is suitable for handling information from a temperature tracer or reagent documentation (usually placed in the transport box during transport), optionally a GPS tracer (also usually placed in the transport box during transport). Optionally, the tracer can be returned to the vaccine and / or medication manufacturer. In connection with the device, a timer must be switched on in the app when the user / patient removes the device from thermal protection. In connection with this event, a warning must be given to the user / patient by the system (app and / or device). 3. Patient safety with regard to patient reactions a) immediately after injection (e.g., passing out) and b) after vaccination (e.g., 15 minutes after injection). In case of situation a) above, the device of the present invention is adapted to receive input from the user / patient (e.g., by pressing a physical button or a button in the app) to validate that the injection has been administered. If no validation occurs within a certain period of time after the patient has started the injection, an alarm is activated to alert the MED and optionally initiate emergency treatment. In case of situation b) above, the system of the present invention is configured to allow the user / patient to confirm to the MED (e.g., by pressing a physical button or a button in the app) that they do not require emergency treatment.

[0067] A key feature of the vaccine and / or medication injection device of the above embodiments of the present invention is that the body of the injection device contains a mechanism that activates the needle of the present invention when the user / patient presses the "inject" button. Such mechanisms are well known in the field of micromechanics and include levers, clips, springs, flexible elements, sliders, gears, cams, etc.

[0068] The injection device may be any suitable injection device disclosed in U.S. Patent Application Nos. 63 / 114,162, 62 / 864,572, 62 / 511,361, 15 / 524,748, 31 / 040,459, 14 / 235,107, and 16 / 930,383, the contents of which are incorporated by reference and relied upon.

[0069] Current state-of-the-art capillary blood collection devices for non-medical trainees typically involve creating a wound in the patient's skin with or without puncturing one or more needles, but are only capable of collecting relatively small amounts of fluid, typically less than 150 μl in 5-10 minutes.

[0070] In another embodiment, the present invention provides a capillary blood collection device 10, 1100, 2010, 2210, 3100, 4100 that provides a method for making a larger incision than typically known in existing capillary blood collection devices, allowing for collection of significantly larger volumes of blood, typically 500 μl or more, preferably 1 ml, in a reasonable period of time, typically less than 15 minutes, preferably less than 10 minutes. The capillary blood collection device of the present invention utilizes 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 incise rather than puncture the skin of the user / patient. For purposes of this disclosure, the functionality of the collection device of the present invention is disclosed as including one cutting blade, but it should be understood that the collection device of the present invention may have more than one cutting blade to increase the volume of blood collected and / or reduce the blood 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 a wound in the user's / patient's skin with an optimal depth 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.

[0071] Next, a fourth embodiment of the cutting blade 3260 of the device of the present invention, shown in Figures 22A-22C, 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 cutting 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 cutting blade is ready for use. In this way, the cutting 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 cutting 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.

[0072] 22A, the blade may take the form of a multi-turn torsion spring, similar to that found in clothes pins, where the blade cross section is circular 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 to incise the skin 3290 of the user / patient. After the incision 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 a modified trajectory 3240.

[0073] Typically, the natural release trajectory 3250 of the cutting 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 cutting blade 3260, the resulting trajectory 3240 of the cutting 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.

[0074] Referring now to FIG. 22B, 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.

[0075] Referring now to FIG. 22C, as a further example, device structural elements 3246 are configured to locally shorten the radius of the natural release trajectory 3250.

[0076] Next, a fifth embodiment 3360 of the cutting blade of the device of the present invention, shown in Figures 23A and 23B, is made of a single piece, typically stamped sheet metal, but may be made of other materials, including composites, exhibiting suitable mechanical properties. The cutting blade 3360 has one end 3361 facing the collection device structure, allowing it to be attached thereto, followed by an elastic zone 3362 that elastically flexes when the cutting blade 3360 is ready for use. In this way, the cutting 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 cutting 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 reach of the user / patient. 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.

[0077] 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 blood 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 offset 3341. Additionally, the device structural elements 3342 may be made to have more complex shapes to provide a more finely tailored trajectory 3340 .

[0078] Next, a sixth embodiment 3460 of the cutting blade of the device of the present invention, shown in Figures 24A-24C, 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 cutting blade 3460 shown in Figure 24A has a rotating attachment 3466 to the device structure and a cutting edge 3465 that remains in a retracted position prior to the cutting process.

[0079] Referring now to FIG. 24B, when actuated, the cutting blade 3460 rotates to engage the patient's skin 3490, but the rotational movement is limited by structure so as not to completely incise the patient's skin.

[0080] 24C, after the incision, the cutting blade 3460 retracts in a counter-rotating motion, 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.

[0081] Next, a fifth embodiment 3660 of a cutting blade of a device of the present invention, shown in FIGS. 25A-25D, 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 cutting blade 3660 has a cutting edge 3665 that is positioned generally parallel to the user's / patient's skin 3690. The cutting 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. 25B ). 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. 25C ). When the cutting blade is retracted ( FIG. 25D ), the resulting flap from the non-orthogonal wound naturally closes the wound, contributing to more rapid wound healing after blood collection.

[0082] Another embodiment provides for verification of the self-administration medical process, the purpose of which is to verify that the blood in the collection tube is the blood of the patient, i.e., for blood collection purposes, and that the injection is given to the patient, i.e., for injection purposes, to verify that the user / patient has been identified.

[0083] For blood collection purposes, potential risks include reliable blood collection, work permits, travel permits, and permission to contact family members during epidemics, authorization to use specific treatments, automated detection of epidemics through large-scale collection programs, and verification of the efficiency of a given treatment (payment for successful treatment). For injection purposes, potential risks include work permits, travel permits, and permission to contact family members after vaccination. Further risks include keeping personal vaccination records up-to-date and automated monitoring of large-scale vaccination programs. Furthermore, potential risks include payment for treatments, only if they are accompanied by vaccination and fully administered. Therefore, reliable patient and process verification is crucial.

[0084] Another aspect is the validation of the self-administered medical process. For example, a smartphone application can 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 can be compared with the patient's face, and the patient's facial recognition and the entire process can be observed. The system can be configured to initiate the process only if all identities are confirmed. Automated management of logistics (collection and transport of collection tubes, resupply of treatment, etc.) can be implemented. If the smartphone app is configured to analyze the video in real time, it can provide real-time step-by-step instructions to the patient as the process is carried out. Automated monitoring of process performance can also include other features. Despite the potential, there are always challenges to address, especially in degraded situations, such as when network coverage is insufficient during the process. Optionally, temporary network coverage can 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).

[0085] 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).

[0086] 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 / collection 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 wireless 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.

[0087] 26A-26C, a visible feature 2600 is incorporated into a device 2610 of the present invention, and is easily recognizable, and may 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. 26B and button 2650 in a low position in FIG. 26D) are easily recognizable by a human observer or easily distinguishable by image analysis software.

[0088] The invention has other uses as well, for example it could be adapted for other treatments besides injections (the device could be adapted for dispensing pills), for voting at home, signing documents, proving identity during a conference call, or taking a remote exam.

[0089] The invention can be summarized to include the following set of features: 1. A disposable body fluid collection device that provides a non-medically trained user with the ability to (a) collect, optionally automatically collect, a body fluid (such as blood), (b) optionally dispense one or more droplets of the collected body fluid for immediate analysis, and (c) provide a sample container chamber filled with a sample of the body fluid (such as blood) for analysis in a medical laboratory. 2. The disposable body fluid collection device of Feature Set 1, wherein said sample container chamber is a standard medical analysis tube. 3. A method utilizing the bodily fluid collection device of feature set 1, wherein if the test subject tests positive for a pathogen, a treatment and / or isolation protocol is initiated to ensure the positive test subject is handled in a manner that minimizes the spread of said pathogen. 4. A method for utilizing a device according to feature set 1 to collect and potentially analyze a sample of a bodily fluid, such as blood, while ensuring the identity of the individual from whom said bodily fluid is collected. 5. A disposable bodily fluid collection device according to any one of feature sets 1 or 2, having a sample container chamber made of a material having a thermal inertia that permits the sample temperature to be maintained for a known period of time. 6. A disposable bodily fluid collection device according to feature set 5, wherein the thermal inertia is selected to provide a known storage time in an ambient environment sufficient to allow unrefrigerated transport to a collection site. 7. An apparatus according to the above feature set, wherein the known time is in the range of 1 hour to 2 hours, preferably in the range of 1 hour to 6 hours, more preferably in the range of 1 hour to 8 hours under normal ambient conditions. 8. The disposable bodily fluid collection device of feature set 5, comprising an insulating sleeve configured to be manually or automatically activated and slid over the sample container chamber. 9. A disposable bodily fluid collection device according to the preceding feature set, wherein said thermal inertia is selected to provide a known time sufficient to allow unrefrigerated transport to the collection site. 10. An apparatus according to the above feature set, wherein the known time is in the range of 1 hour to 2 hours, preferably in the range of 1 hour to 6 hours, more preferably in the range of 1 hour to 8 hours under normal ambient conditions. 11. The disposable body fluid collection device of feature set 1, comprising an interface and a vacuum tube, said vacuum tube providing the suction necessary to fill said vacuum tube with said blood. 12. A cutting blade for a disposable capillary blood collection device for lancing the skin of a user / patient according to feature set 11, wherein the cutting blade structure is made of a single material and provides energy and guiding for its movement. 13. A combination of a device and an app for injection of a drug or vaccine, providing a non-medically trained user with the ability to perform self-injection, the device adapted to interact with the app, which is connected to the internet, preferably wirelessly, optionally via the cloud, and the app includes means to allow verification of the patient's identity and / or the particular device used, the combination comprising at least: a) access to a data storage adapted to store the data of the surgeon or medical director (MED) responsible for administering said vaccine / medication and his / her specific authorization for the use of administering said vaccine and / or drug to said user / patient, said combination adapted to receive data related to said vaccine and / or drug entered by said user / patient or by a previously received HMO (the entry of said data may be performed manually or by scanning a QR code, etc.); b) a recording means adapted to record the temperature of said vaccine / medication administration from transport until the time of substantially required injection; c) i) Immediately after injection (e.g., fainting), and / or ii) after the vaccination (e.g., 15 minutes after the injection), and patient safety means adapted to be activated upon a patient response, wherein in case of situation i) above the combination according to the invention is adapted to receive input from said user / patient and further wherein said device is adapted to be transported with thermal protection, said combination optionally comprising a temperature tracer or reagent documentation (typically placed inside the transport box during transport) and also a GPS tracer (also typically placed inside the transport box during transport) for tracking storage temperature during transport. 14. The system of feature set 13, adapted to accept input by a user pressing a physical button or a button within the app to validate that the injection has been administered. 15. The system of the preceding feature set, adapted to activate an alarm to alert the MED and optionally initiate emergency treatment if no activation occurs within a period of time after the patient has started the injection. 16. A system according to feature set 13, wherein in the case of the above-mentioned situation ii), the system of the present invention is configured to allow the user / patient to confirm to the MED (e.g., by pressing a physical button or a button within the app) that they are in good health. 17. A system according to any one of feature sets 13 to 16, adapted to return the tracer to the manufacturer of the vaccine and / or drug. 18. The system of Feature Set 13, wherein a timer is provided within the app that is configured to switch on within the app when the user / patient takes the device out of thermal protection, and wherein the combination requires that the user / patient be alerted in connection with this event. 19. A capillary blood collection device that provides a non-medically trained user with the ability to collect capillary blood, optionally analyze the blood using an analytical device, and fill a sample tube with said blood, comprising: (a) a collection mechanism for collecting, optionally automatically collecting, capillary blood; (b) optionally, the analyzer configured to perform real-time analysis of the blood using one or more droplets of the collected capillary blood; (c) a filling mechanism configured to fill a standard medical analysis tube with a sample of capillary blood for analysis at a point of care or medical laboratory; The device includes a vacuum tube and an interface therefor, the vacuum tube providing the suction necessary to fill the vacuum tube with the blood. 20. The device of one of feature sets 1-11, or 19, including one or more cutting blades for incising the skin of the user / patient. 21. The device of Feature Set 20, wherein the one or more cutting blades are configured to incise the patient's skin in a substantially non-circular trajectory, providing a wound geometry that optimizes the number of capillary incisions and contributes to rapid healing of the wound after blood collection. 22. The device of one of features sets 19-21, comprising one or more cutting blades configured such that the trajectory of the one or more cutting blades is substantially non-orthogonal to the patient's skin, providing a wound geometry that optimizes the number of capillary incisions and favors rapid healing of the wound after blood collection. 23. The device of feature set 22, wherein the orbit of the one or more cutting blades is configured to be limited in rotation, and the device incises the skin essentially below its surface. 24. The device of feature set 22, wherein the trajectory of the one or more cutting blades is configured to have a generally linear motion and is substantially non-orthogonal to the skin of the user / patient. 25. A method for collecting capillary blood, providing a non-medically trained user with the ability to collect capillary blood, analyze the blood, and fill a sample tube with said blood, comprising: (a) using a device according to any one of feature sets 1, 4-11, 13-14, to collect capillary blood, and optionally automatically collect the blood; (b) optionally, using one or more droplets of the collected blood, immediately analyzing the blood to determine characteristics such as blood type; (c) filling the sample container chamber with a sample of capillary blood for analysis at a point of care or medical laboratory; A method comprising: 26. The method of feature set 25, wherein the sample container chamber is a standard medical analysis tube. 27. A method of using a capillary blood collection device according to any one of feature sets 1-7, wherein if a test subject tests positive for a pathogen, a treatment and / or isolation protocol is initiated to ensure that the positive test subject is handled in a manner that minimizes the spread of said pathogen. 28. A method according to feature set 25, further comprising providing the results of the blood sample analysis to an authority, the authority using evidence provided to authorize the user / patient to perform a particular activity. 29. A method according to feature set 25, comprising using the results of said blood sample analysis and evidence provided to release payment for treatment. 30. A method for large-scale collection and analysis of biological samples, comprising collecting biological samples, such as body fluid samples, without the intervention of medical trainees, comprising at least: a) providing the test subject with a collection device according to any one of feature sets 1, 5-11, 13-24, having a unique identifier and instructions; b) providing instructions, said instructions including instructions for placing said device in a refrigerator to cool said device before and after collection of blood or other samples; c) collecting the sample and associating a unique identifier of the collection device with the test subject; d) transporting said sample to a collection site; e) analyzing the sample to identify the pathogen and notifying the test subject of the result; A method comprising: 31. A method for large-scale collection and analysis of biological samples according to feature set 30, comprising: providing instructions, said instructions including instructions for collecting a blood or other sample; collecting the sample and associating a unique identifier of the collection device with the test subject; providing additional instructions, said instructions including optional instructions to place said device in a refrigerator to cool said device; A method comprising: 32. A method according to the above feature set, comprising the additional step of, if the test subject tests positive for a pathogen, instructing that a treatment and / or isolation protocol be initiated to ensure that the positive test subject is handled in a manner that minimizes the spread of the pathogen. 33. A method for large-scale collection and analysis of biological samples, comprising collecting biological samples, such as body fluid samples, without the intervention of medical trainees, and comprising at least: a) providing the test subject with a collection device according to any one of feature sets 1, 5-11, 13-24, having a unique identifier and instructions; b) providing said instructions, including instructions for collecting a blood or other sample; c) collecting the sample and associating a unique identifier of the collection device with the test subject; d) providing further instructions, optionally including instructions for placing the device in a refrigerator to cool the device before step c) in which the sample is taken, and optionally further including instructions for sliding an insulating sleeve over the sample container chamber of the device after the device has reached a temperature within an acceptable temperature range, thereby extending the time that the sample is safely stored during transport and before sample analysis in step f); e) transporting said sample to a collection site; f) analyzing the sample to identify the pathogen and notifying the test subject of the result; A method comprising: 34. A method for large-scale collection and analysis of biological samples, comprising collecting biological samples, such as body fluid samples, without the intervention of medical trainees, and comprising at least: a) providing the test subject with a collection device according to any one of feature sets 1, 5-11, 13-24, having a unique identifier and instructions; b) providing said instructions, optionally including instructions to place said device in a refrigerator to optionally cool said device before and after collection of blood or other sample; c) optionally placing the collection device in a refrigerator for a prescribed time, optionally following step d) in which the sample is collected, and optionally further including instructions for sliding an insulating sleeve over the sample container chamber of the device after the device has reached a temperature within an acceptable temperature range, thereby extending the time that the sample is safely stored during transport and prior to sample analysis in step f); d) collecting the sample and associating a unique identifier of the collection device with the test subject; e) transporting said sample to a collection site; f) analyzing the sample to identify the pathogen and notifying the test subject of the result; A method comprising: 35. A method according to the above feature set, comprising the additional step of initiating a treatment and / or isolation protocol if the test subject tests positive for a pathogen to ensure that the positive test subject is handled in a manner that minimizes the spread of the pathogen, such as by following isolation protocols. 36. A system capable of verifying that a self-administered medical process, such as a blood draw or injection, is being performed properly, using one of the devices described in any one of feature sets 1, 5-11, or 23-24, including a biometric scanner configured to recognize a unique biometric feature of the user / patient, such as a face, scalp, eye, fingerprint, etc. 37. The system according to feature set 36 in combination with an app running on a smartphone. 38. The system of feature set 36, comprising a device identification module adapted to recognize in real time the device performing the blood drawing or injection procedure. 39. The system of feature set 38, comprising a device identification module adapted to analyze, in real time, performance of said step by said user / patient or said collection / injection device. 40. The system of Feature Set 39, including a device identification module adapted to dispense audible and / or visual instructions in real time for said user / patient to properly perform said procedure. 41. The system of feature set 39, comprising an activation module configured to wirelessly activate part or all of the collection or injection process. 42. The system of any one of feature sets 36 to 41, including a connection mechanism adapted to provide suitable connectivity for communicating in real time with health authorities while the process is being performed. 43. The system of any one of feature sets 36-42, including a self-contained application running on a smartphone, the system including storing process execution videos or time lapses within the smartphone in a secured manner for later use as evidence. 44. The system of feature set 33, adapted for the authority to use the evidence provided to grant the user / patient permission to perform a particular activity. 45. The system of feature set 33, adapted to release payment for treatment using the evidence provided. 46. ​​A system for capillary blood collection according to any one of feature sets 36-45, comprising: a patient biometric authentication system; a device authentication system; and a disposable capillary blood collection device providing a non-medically trained user with the following capabilities: (a) to collect, and optionally automatically collect, capillary blood; (b) optionally, to immediately analyze the blood using one or more droplets of the collected capillary blood; and (c) to provide a standard medical analysis tube filled with a sample of capillary blood for analysis at a point-of-care or medical laboratory; wherein the device comprises an interface and a vacuum tube adapted to provide suction sufficient to fill the vacuum tube with the blood. 47. A capillary blood collection system according to feature set 46, wherein the authentication system is adapted to provide real-time recognition of the user / patient and the performance of the device to the blood collection process. 48. A capillary blood sampling system according to feature set 46 above, wherein said authentication system includes storage means for storing a video or time lapse of the execution of said sampling process in a secured manner for later use as evidence. 49. A method of using a capillary blood collection system according to any one of feature sets 36-48, wherein the results of the blood sample analysis and the evidence provided are used by the authority to grant the user / patient permission to perform a particular activity. 50. A method of using a capillary blood collection system according to any one of feature sets 36-48, wherein the results of said blood sample analysis and said evidence provided are used to release payment for treatment. 51. A disposable bodily fluid collection device according to feature set 1, comprising an adhesive-integrated dressing adapted for (i) ensuring adherence of the blood collection device to the patient's skin, (ii) ensuring an airtight seal between the patient's skin and the blood collection device during the collection step, and (iii) dressing the wound after the collection step.

[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] 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.

[0092] As will be appreciated by one skilled in the art, the present invention may be embodied as a system, device or method.

[0093] 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.

[0094] 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 any method or process claim 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 the 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.

[0095] 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.

[0096] 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 invention that comprises that list of elements may include not only the listed elements, but may also include 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 above-described elements, materials, or structures 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 invention.

[0097] The above-cited patents and publications are incorporated herein by reference to the extent they do not contradict this disclosure, unless otherwise stated.

[0098] Other features and embodiments of the invention are set forth in the appended claims.

[0099] 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.

[0100] 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.

[0101] Various modifications and improvements can be made to the embodiments of the invention disclosed herein. For example, the cutting blade 1004 can take any form and is not limited to the cutting blades 302, 5450, 5456, 3260, 3360, and 3460 disclosed herein. While certain specific embodiments of the invention have been disclosed and described, a wide range of modifications, improvements, 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 exemplifications of one or more preferred embodiments. In some cases, some features of the invention may be employed without the corresponding use of other features. Therefore, the foregoing description should be construed broadly and understood as merely illustrative or exemplary, with the spirit and scope of the invention being limited only by the claims ultimately issued on this application.

Claims

1. A system comprising a combination of a device for injecting medicines or vaccines and an app connected to the internet, the app is adapted to interface with a self-injection performed by a user without medical training; means for enabling verification of the identity of the user and / or the device used; a) data input means for a data storage device storing data of the doctor or medical officer in charge of administering the drug or vaccine and data of approval for administering the drug or vaccine to the user, the data input means inputting drug or vaccine information entered by the user manually or by scanning a QR code into the data storage device; b) a safety means adapted to be activated upon a user response immediately after injection and / or a certain time after injection, the safety means adapted to receive input from the user immediately after injection; At least The system, wherein the device is adapted to be shipped under thermal protection.

2. The system of claim 1 , wherein the app is connected to the internet wirelessly via the cloud.

3. 3. The system of claim 1 or 2, further comprising a recording means adapted to record the temperature of the administration of the drug or vaccine from transport until substantially the required injection time.

4. 3. The system of claim 1 or 2, including a temperature tracer or reagent paper and a GPS tracer for tracking storage temperatures during transport.

5. 3. The system of claim 1 or 2, wherein the device is adapted to receive input by a user pressing a physical button or a button within the app to validate that the injection has been administered.

6. 6. The system of claim 5, wherein the system is adapted to activate an alarm to alert a physician or medical officer if no validation occurs within a period of time after the user has initiated the injection.

7. The system of claim 6 , adapted to initiate first aid after activation of the alarm.

8. The system according to claim 1 or 2, which is configured so that when the safety means is activated a certain time after injection, the user can confirm to a doctor or medical officer that they are in good health.

9. 5. The system of claim 4, adapted to return the tracer to the drug or vaccine manufacturer.

10. 3. The system of claim 1 or 2, wherein a timer is provided within the app that is configured to switch on when a user removes the device from thermal protection, and a user is alerted in response to the timer operating.

11. 1. A method for patient identification during collection of a body fluid without the intervention of medically trained personnel, comprising: An application is provided that can be installed and run on a patient's smartphone, the smartphone having a camera, and a collection device is placed on the patient's skin or mucous membrane, the application comprising: identifying and communicating with the collection device; turning on the smartphone camera and prompting the patient to orient the smartphone so that both the patient's face and the collection device are visible on the smartphone screen; running face identification software to identify the patient and running image analysis software to identify the collection device; storing a time-lapse video while the collection device is performing the collection process to document the collection process; receiving a signal from the harvesting device when the harvesting process is completed; storing the identification of the collection device, the time taken for the collection process, and the patient's identification on the cloud and / or in an internal memory; The method causes the smartphone to execute the above.

12. The method of claim 11 , wherein the application further causes the smartphone to perform the step of communicating with the collection device after the collection process is initiated.

13. The method according to claim 11 or 12, wherein the collection device is a capillary blood collection device.

14. The method of claim 11 or 12, wherein each of the collection devices is assigned a unique identifier.

15. The method of claim 11 or 12, wherein the collection device is remotely activated.

16. 13. The method of claim 11 or 12, wherein the collection device comprises a visible feature (2600) that is recognizable by a human observer or identifiable by image analysis software.

17. 13. The method of claim 11 or 12, wherein the collection device comprises a temperature monitoring display / indicator (600).

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