Body fluid collection device and method of using the same

Abstract

A bodily fluid collection device and method are provided that comprise collecting a bodily fluid sample from a blood cylinder without the intervention of trained medical personnel. The bodily fluid collection device advantageously comprises 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 heat shrinkage of an element, after the device has reached a sufficiently low temperature in a refrigerator. The bodily fluid collection device optionally carries an electronically readable identification tag with a unique identification code. In some cases, the collection device optionally comprises geolocalization and long-range communication capabilities to allow collection without further user action after the collection step is performed. Advantageously, bodily fluid collection devices according to the present invention are optionally configured to use standard analytical tubes well known in the art. Related methods are provided for using such collection devices to collect bodily fluid samples and ensuring sealed transport of the collected bodily fluid sample to an analytical laboratory.

Description

Cross - reference to related applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 002,581, filed on March 31, 2020, "Fluid Sampling Device, and Method of Using the Same"; U.S. Provisional Application No. 63 / 006,337, filed on April 7, 2020, "Fluid Sampling Device, and Method of Using the Same"; U.S. Provisional Application No. 63 / 025,692, filed on May 15, 2020, "Fluid Sampling Device, and Method of Using the Same"; U.S. Provisional Application No. 63 / 011,010, filed on April 16, 2020, "Fluid Sampling Method with Automatic User Identification"; U.S. Provisional Application No. 63 / 069,112, filed on August 23, 2020, "Capillary Blood Sampling Device, and Method of Using the Same"; U.S. Provisional Application No. 63 / 114,162, filed on November 16, 2020, "Self - medical Process Verification System"; U.S. Provisional Application No. 63 / 142,756, filed on January 28, 2021, "Capillary Blood Sampling System Including User / Patient Authentication"; U.S. Provisional Application No. 63 / 150,113, filed on February 17, 2021, "Capillary Blood Sampling Device"; and U.S. Provisional Application No. 63 / 153,088, filed on February 24, 2021, "Vaccine and / or Drug Injection and Dosing Device". Copyright and legal notice

[0002] Some of the material disclosed in this patent document may contain copyrighted material. The applicant has no objection to third - party facsimile reproduction of the patent documents disclosed as patents in the records of each patent and trademark office, but in all other cases reserves all copyrights. Also, third - party patents or articles described in this application should not be considered as an admission that the invention has no right to precede such material on the ground of prior art.

Technical Field

[0003] This invention relates to a device that enables the collection of bodily fluids and their transport to an analytical laboratory without the intervention of medical personnel. In the event of war or an epidemic, it may be necessary to analyze the bodily fluids, such as blood, of a large portion of any population, potentially a neighborhood, a block or group of blocks, a suburb, a city, an entire country, or the entire population of a continent. In such cases, due to a combination of factors including confinement obligations, contamination risks, hazardous areas, travel distances, lack of transportation infrastructure, and / or personnel shortages, it may be impossible for medical personnel to personally oversee the collection of bodily fluids from each patient. Therefore, there is a need for a bodily fluid collection device that can be adapted for use by any individual without rigorous medical training, and for methods to ensure user / patient authentication, the association between the authenticated user / patient and the bodily fluid sample, and the intact, safe, and hygienic transport of the bodily fluid sample to the analytical laboratory. [Background technology]

[0004] A body fluid collection device and method are provided, comprising the collection of a body fluid sample, such as blood, without the intervention of a trained medical professional. The body fluid collection device optionally, and advantageously, includes an insulating cover or sleeve adapted to slide over the sample container to extend possible transport time. In one embodiment, the insulating cover or sleeve is manually positioned by the user via a tab activated by the user in accordance with documentation provided with the device, or automatically slid into position by a second mechanism optionally driven by thermal contraction of the elements after the device has reached a sufficiently low temperature in a refrigerator. The body fluid collection device optionally includes 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 includes geo-localization and long-range communication capabilities so that collection can be performed without further action by the user after the collection process is completed. Advantageously, the body fluid collection device according to the present invention is optionally configured to use standard analytical tubes well known in the industry so that the contents of the tubes can be analyzed in standard automated analytical equipment. Relevant methods are provided to authenticate the user / patient, optionally associate or guarantee the match between the authenticated user / patient and the sample container using the sampling device, collect the bodily fluid sample using the sampling device, and ensure that the collected bodily fluid sample is transported to the analytical laboratory in a sealed, hygienic, complete, and safe manner. [Brief explanation of the drawing]

[0005] [Figure 1A] This is a flowchart of the first embodiment of the method of the present invention. [Figure 1B] This is a flowchart of a second embodiment of the method of the present invention. [Figure 1C] This is a flowchart of a third embodiment of the method of the present invention. [Figure 1D] This is a flowchart of a fourth embodiment of the method of the present invention. [Figure 2A] This is a perspective view of the internal mechanism of the sampling device, showing the first embodiment of the cutting blade of the present invention before use. [Figure 2B]This is a perspective view of the internal mechanism of the sampling device according to the present invention during use. [Figure 2C] This is a perspective view of the internal mechanism of the sampling device according to the present invention after use. [Figure 3A] This is a side view of the internal mechanism of the sampling device according to the present invention, before use. [Figure 3B] This is a perspective view showing the internal mechanism of the sampling device according to the present invention in use. [Figure 3C] This is a side view of the internal mechanism of the sampling device according to the present invention during use. [Figure 3D] This is a side view of the internal mechanism of the sampling device according to the present invention after use. [Figure 4] This is a lower perspective view of the contact surface with the user's skin of the sampling device according to the present invention. [Figure 5] This is a perspective view of the internal fluid channel of the sampling device according to the present invention. [Figure 6] This is a plan view of the thermal display panel according to the present invention. [Figure 7A] This is a partial cross-sectional view of the internal elements of the sampling device according to the present invention, showing the extraction of a bodily fluid sample. [Figure 7B] This is a partial cross-sectional view of the internal elements of the sampling device according to the present invention, showing the extraction of a bodily fluid sample. [Figure 8A] This is a cross-sectional view showing two stages of operation of the bodily fluid collection device of the present invention, namely the pre-use step (Figure 8A) and the post-collection step (Figure 8B). [Figure 8B] This is a cross-sectional view showing two stages of operation of the bodily fluid collection device of the present invention, namely the pre-use step (Figure 8A) and the post-collection step (Figure 8B). [Figure 9] This is a perspective view of another embodiment of the bodily fluid collection device of the present invention for collecting capillary blood from the earlobe. [Figure 10A] This is a schematic diagram of a fluid collection device for collecting capillary blood from the earlobe. [Figure 10B] This is a schematic diagram of a fluid collection device for collecting capillary blood from the earlobe. [Figure 11]Flowchart of a fifth embodiment of a method for collecting a body fluid of the present invention and ensuring user-patient identification. [Figure 12] Side view of an embodiment of a capillary blood collection device according to the present invention, having a main structure that houses a suction interface adapted to adhere to the skin of a user / patient. [Figure 13] Localized partial cross-sectional view of an embodiment of the capillary blood collection device of FIG. 12 showing a second embodiment of the cutting blade of the present invention, the device being in contact with the user / patient via its suction interface. [Figure 14A] Partial cross-sectional view showing the function of the device of the present invention for use with a standard sample container. [Figure 14B] Partial cross-sectional view showing the function of the device of the present invention for use with a standard sample container. [Figure 14C] Partial cross-sectional view showing the function of the device of the present invention for use with a standard sample container. [Figure 14D] Partial cross-sectional view showing the function of the device of the present invention for use with a standard sample container. [Figure 14E] Partial cross-sectional view showing the function of the device of the present invention for use with a standard sample container. [Figure 14F] Partial cross-sectional view showing the function of the device of the present invention for use with a standard sample container. [Figure 14G] Partial cross-sectional view showing the function of the device of the present invention for use with a standard sample container. [Figure 14H] Partial cross-sectional view showing the function of the device of the present invention for use with a standard sample container. [Figure 14I] Partial cross-sectional view showing the function of the device of the present invention for use with a standard sample container. [Figure 15A] Side view of a second embodiment of a cutting blade or lancet in a releasable position for use in the present invention. [Figure 15B] Side view of a second embodiment of a cutting blade in a semi-extended position for use in the present invention. [Figure 15C]It is a plan view of a second embodiment of a fully extended cutting blade. [Figure 16A] It is a perspective view of a third embodiment of the cutting blade of the present invention, which consists of a single piece of metal. [Figure 16B] It is a side view of a third embodiment of the cutting blade of the present invention. [Figure 16C] It is a front view of a third embodiment of the cutting blade of the present invention. [Figure 16D] It is a plan view of a third embodiment of the cutting blade of the present invention. [Figure 16E] It is a side view of a third embodiment of the cutting blade of the present invention when it is semi-extended. [Figure 16F] It is a side view of a third embodiment of the cutting blade of the present invention when it is fully extended. [Figure 17] It is a multi-turn torsion spring that may be used in the elastic zone in a specific embodiment of the present invention. [Figure 18A] It is an upper perspective view of another embodiment of the blood collection device of the present invention. [Figure 18B] It is a lower perspective view of another embodiment of the blood collection device of the present invention. [Figure 19] It is a perspective view of the injection device of the present invention. [Figure 20A] It is a schematic diagram showing the steps of a sixth embodiment of the method of using the system of the present invention. [Figure 20B] It is a schematic diagram showing the steps of a sixth embodiment of the method of using the system of the present invention. [Figure 20C] It is a schematic diagram showing the steps of a sixth embodiment of the method of using the system of the present invention. [Figure 20D] It is a schematic diagram showing the steps of a sixth embodiment of the method of using the system of the present invention. [Figure 20E] It is a schematic diagram showing the steps of a sixth embodiment of the method of using the system of the present invention. [Figure 20F] It is a schematic diagram showing the steps of a sixth embodiment of the method of using the system of the present invention. [Figure 20G] It is a schematic diagram showing the steps of a sixth embodiment of the method of using the system of the present invention. [Figure 20H] This is a schematic diagram showing the steps of a sixth embodiment of a method using the system of the present invention. [Figure 20I] This is a schematic diagram showing the steps of a sixth embodiment of a method using the system of the present invention. [Figure 20J] This is a schematic diagram showing the steps of a sixth embodiment of a method using the system of the present invention. [Figure 20K] This is a schematic diagram showing the steps of a sixth embodiment of a method using the system of the present invention. [Figure 20L] This is a schematic diagram showing the steps of a sixth embodiment of a method using the system of the present invention. [Figure 20M] This is a schematic diagram showing the steps of a sixth embodiment of a method using the system of the present invention. [Figure 20N] This is a schematic diagram showing the steps of a sixth embodiment of a method using the system of the present invention. [Figure 20O] This is a schematic diagram showing the steps of a sixth embodiment of a method using the system of the present invention. [Figure 20P] This is a schematic diagram showing the steps of a sixth embodiment of a method using the system of the present invention. [Figure 21A] This is a schematic diagram illustrating in more detail the specific features of the adhesive integrated dressing included in the capillary blood collection device. [Figure 21B] This is a schematic diagram illustrating in more detail the specific features of the adhesive integrated dressing included in the capillary blood collection device. [Figure 21C] This is a schematic diagram illustrating in more detail the specific features of the adhesive integrated dressing included in the capillary blood collection device. [Figure 21D] This is a schematic diagram illustrating in more detail the specific features of the adhesive integrated dressing included in the capillary blood collection device. [Figure 22A]This is a perspective view of a fourth embodiment of the cutting blade of the device of the present invention, which consists of a single piece. [Figure 22B] This is a side view of the four-position shutter of the fourth embodiment of the cutting blade of the apparatus of the present invention. [Figure 22C] This is a side view of the shutter at position 4 of the fourth embodiment of the cutting blade of the device of the present invention, and shows its retraction. [Figure 23A] This is a perspective view of a fifth embodiment of the cutting blade of the present invention. [Figure 23B] This is a front view of a fifth embodiment of the cutting blade of the present invention. [Figure 24A] This is a side view of a sixth embodiment of the cutting blade of the device of the present invention, before it penetrates the epidermal layer of the patient's body. [Figure 24B] A sixth embodiment of the cutting blade of the apparatus of the present invention is shown as a side view of the blade in the middle of its motion cycle. [Figure 24C] A sixth embodiment of the cutting blade of the apparatus of the present invention is shown as a side view where its movement cycle is at the end position and returning to the start position. [Figure 25A] This is a perspective view of a seventh embodiment of the cutting blade of the apparatus of the present invention, and shows a standard scalpel blade. [Figure 25B] This is a side view of the seventh embodiment of the cutting blade of the device of the present invention, before it penetrates the epidermal layer. [Figure 25C] This is a side view of the seventh embodiment of the cutting blade of the device of the present invention, after it has penetrated the epidermal layer and just before it is removed from that layer. [Figure 25D] This is a side view of the epidermal layer, showing an incision made according to the seventh embodiment of the cutting blade. [Figure 26A] Examples of features that can be incorporated into the apparatus of the present invention and are visible, and are easily recognizable by a human observer or easily identified by real-time image analysis software. [Figure 26B] Examples of features that can be incorporated into the apparatus of the present invention and are visible, and are easily recognizable by a human observer or easily identified by real-time image analysis software. [Figure 26C]Examples of features that can be incorporated into the apparatus of the present invention and are visible, and are easily recognizable by a human observer or easily identified by real-time image analysis software.

[0006] The elements shown in the drawings are depicted for simplification and clarity and are not necessarily drawn to scale. For example, dimensions may be emphasized relative to other elements to enhance understanding of the invention and its embodiments. Furthermore, terms such as “first,” “second,” and similar terms used herein are used to distinguish similar elements and do not necessarily indicate a sequential or chronological order. Also, terms such as “front,” “back,” “top,” “bottom,” and similar terms in the specification and / or claims are used for convenience and do not necessarily comprehensively represent a limited relative position. Therefore, those skilled in the art should understand that such terms may be replaced with other terms, and that the embodiments disclosed herein may be operable in orientations different from those clearly illustrated or described. Detailed Description of Preferred Embodiments

[0007] The following description is illustrative in nature and illustrates the best mode of the invention as known to the inventors at the time of filing of this application, and does not limit the scope of the invention in any way. As a result, the arrangement and / or function of all elements in the exemplary embodiments disclosed herein can be modified without departing from the spirit and scope of the invention.

[0008] The bodily fluid sampling device according to the present invention has different sizes and shapes depending on one (or more) types and sizes of fluid to be collected and the body part from which the sample is collected. The sample is collected on the skin or mucous membrane, but the sample must be collected through the skin or mucous membrane, in which case the sampling device may be equipped with a cutting blade to open the skin / mucous membrane and release the bodily fluid to be collected. The user may add a reactant to the surface of the skin / mucous membrane to facilitate sample storage or enable specific analysis. Optionally, the thermal inertia of the bodily fluid sampling device may be adapted to the above parameters and transport constraints, with sufficient margin to ensure that the storage temperature of the bodily fluid sample is optimally maintained from the user's refrigerator to the laboratory's refrigerator. The collected sample may be transported from the user's location to the laboratory by the user themselves, by the postal service, by human carriers, or by a specialized logistics organization using automated or remotely controlled unmanned vehicles. In some cases, the sampling device may be equipped with geolocalization and long-range communication capabilities so that collection can be performed without further action by the user after the sampling process has been completed.

[0009] For example, the results may pose a very high risk to the patient, potentially serving as confirmation of treatment effectiveness and / or the release of payment for a treatment, such as determining whether the patient should be isolated or released from isolation, whether travel should be permitted, whether work should be permitted, or whether treatment effectiveness and / or the release of payment for a treatment should be confirmed. Therefore, by optionally changing the level of tamper-proof measures, the patient may be authenticated using the collection device, and the match between the authenticated user / patient and the sample may be optionally guaranteed. Such tamper-proof measures may include filming the entire process of fluid collection, from opening the box containing the collection device to sealing the box, mailing the sample to the tissue for analysis, and optionally encrypting it, and saving the video for later use, such as use as evidence in court in the event of legal proceedings.

[0010] Next, the first embodiment of the method according to the present invention, shown in Figure 1A, a) A step of disinfecting and moisturizing the body part from which the blood sample will be taken, b) A step of collecting a blood sample, c) A step of taking a picture of a filled micro-sampler and, optionally, the patient's ID, d) Place the filled microcollection device in the patient's refrigerator, optionally before step a) or b) above, cool the microcollection device until it has acquired the necessary shelf life for transport, and also optionally slide the insulating sleeve over the sample reservoir by activating the tab according to the instructions provided to the user. e) The step of transporting the microcollection device from the patient's home to a doctor, pharmacist, hospital, or designated collection point, f) Optionally, the step of intermediate storage in a refrigerator at a doctor's office, pharmacist's office, hospital, or other collection point, g) A step of examining the blood itself in relation to the photograph taken by the patient, Includes.

[0011] Next, a second embodiment of the method according to the present invention, shown in Figure 1B, i. Disinfect the body part from which the sample will be taken, and optionally moisturize it. ii. Steps to collect a fluid sample, iii. The step of optionally photographing the filled microcollection device along with the patient's ID, thereby associating the microcollection device with the test subject as needed, and sending the same image to a designated recipient via SMS, MMS, or other email, etc. iv. Store the filled microcollection device in the patient's refrigerator, optionally before step i) or ii) above, cool the microcollection device until it has acquired at least the shelf life required for transport, and also optionally slide the insulating sleeve over the sample reservoir by activating the tab according to the instructions provided to the user. v. Steps to remove the sample from the refrigerator, vi. Optionally, the step of transporting the microcollection device from the patient's home refrigerator to a doctor, pharmacist, hospital, or designated collection site. vii. Optionally, take the step of storing the item in a refrigerator at a doctor's office, pharmacist's office, hospital, or other collection point. viii. A step of diagnosing the pathogen using a sample in a micro-collection device, ix. The step of notifying the appropriate person of the analysis results, Includes.

[0012] Next, the third embodiment of the method of the present invention shown in Figure 1C consists of the following steps. Step 1: By collecting the identification tag attached to the device upon delivery, or by any other appropriate means, the user scans the unique identification code of their sampling device using a dedicated software application (app) on their smartphone (connected to the Internet or Cloud®), and scans the QR code on their sampling device with their smartphone. Optionally, the user associates the sampling device with the patient by taking a photograph of the device with the identification visualized, together with the patient's ID document or the patient's face. Step 2: Optionally, the user disinfects the skin surface, providing surface disinfection and, optionally, moisturizing to enable better aspiration. Optionally, the user applies the reactant to their own skin / mucous membrane, and such reactant is mixed with the biological sample to enable / improve the preservation of the biological sample and / or enable / improve its analysis. Step 3: The user places the collection device on an appropriate area of ​​skin / mucous membrane. Step 4: Optionally, after cooling the device according to the method described above, the user begins the sampling process. Step 5: In the following substeps, the sampling process is automatically executed by the sampling device. Step 5.1: The starter spring is released. Step 5.2: The piston begins suction, creating a vacuum between the user's skin / mucous membrane and the contact surface of the harvesting device, and any cutting blade begins cutting. Step 5.3: Any cutting blade cuts into the user's skin / mucous membrane. Step 5.4: Bodily fluids begin to be released due to the small wounds. Step 5.5: Body fluids are drawn into the reservoir. Step 5.6: Any cutting blade is retracted. Step 5.7: The piston reaches its end. Step 5.8: A visible indicator notifies the user that the collection process is complete. Such a visible indicator may be provided by a transparent reservoir that allows the user to visually confirm that the reservoir is filled with bodily fluids. Step 5.9: If the sampling device is equipped with a long-range wireless communication device, information that the sampling process has been performed is transmitted directly to the sample collection tissue. Step 6: The user removes the collection device from their skin / mucous membrane and closes it to protect the integrity of the bodily fluid sample. Optionally, the user applies a bandage to any minor wounds, which may heal naturally. Optionally, the user associates the collection device with the patient by taking a photograph of the device with its identification visible, such as with the patient's ID document or the patient's face. Step 7: Optionally, before sample collection, the user stores the sampling device in their refrigerator. Step 8: Optionally, before sample collection, the user shall adjust the temperature of the sampling device to an appropriate temperature according to the instructions, and optionally observe the temperature display to monitor the temperature development of the sampling device. If the sampling device is equipped with a temperature sensor and a long-range wireless communication device, information regarding the temperature of the sampling device will be transmitted directly to the tissue being sampled. Step 9: If instructions are followed, for example, once the transport temperature is achieved, the user may optionally notify the sample collection organization that the sample is ready for pickup or have the device delivered to a suitable collection location. If the sampling device is equipped with a long-range wireless communication device, information regarding whether the sampling device is ready for pickup is transmitted directly to the sample collection organization. Step 10: Collect the sample tissue, retrieve the sampling equipment, and take it to the analytical laboratory. Step 11: The analytical laboratory performs the sample analysis and notifies the user and / or the appropriate institution of the results via any means of communication, such as a dedicated software application (app) on the user's smartphone (connected to the internet or cloud®), or any other appropriate means of communication. The identification of the sampling device (step 1) may be performed between steps 5 and 6 (after the start of the sampling process).

[0013] Next, the fourth embodiment of the method of the present invention shown in Figure 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: In the following substep, the sampling process is automatically performed by the sampling device. Step 5b.1: The starter spring is released. Step 5b.2: The piston begins suction, creating a vacuum between the user's skin / mucous membrane and the contact surface of the harvesting device, and the cutting blade begins cutting. Step 5b.3: The cutting blade cuts the user's skin / mucous membrane. Step 5b.4: The cutting blade is retracted. Step 5b.5: Bodily fluids begin to be released due to the small wounds. Step 5b.6: Depending on the bodily fluid to be collected, the mechanism may optionally include a device (for example, a device including a spring that is loosened via a loaded flywheel connected to a reduction gear drive system) that allows for a waiting time of 0.1 to 10 seconds, 0.2 to 5 seconds, or 0.5 to 3 seconds before the bodily fluid is fully released. Step 5b.7: The mechanism activates the absorbent pad, collects the first droplet or first body fluid volume through absorption, and removes it from the collection area. Step 5b.8: The micro-injuries continue to release bodily fluids, which are then drawn into the reservoir. Step 5b.9: The piston reaches its end. Step 5b.10: A visible indicator notifies the user that the sampling process is complete. Such a visible indicator may be provided by a transparent reservoir that allows the user to visually confirm that the reservoir is filled with bodily fluids. If the sampling device is equipped with a long-range wireless communication device, information that the sampling process has been performed is transmitted directly to the tissue being sampled.

[0014] Next, the internal mechanism 10 of the bodily fluid collection device shown in Figures 2A to 2C includes an energy source 200, such as a spring, sufficient to ensure the execution of the entire collection process. The device includes a rigid reservoir 502 which is closed by a plunger 504. Mechanism 10 connects the energy source 200 to the plunger 504 via a piston 242, so that the plunger 504 retracts to create a vacuum and allow the bodily fluid sample to be aspirated. Depending on the bodily fluid to be collected and the skin / mucosa protecting it, mechanism 10 may optionally connect the energy source 200 to a first embodiment 302 of a cutting blade capable of cutting the user's skin / mucosa to release the collected bodily fluid sample. Mechanism 10 is equipped with a trigger 210, which is activated by the user to start the collection process. The mechanism 10 comprises gears, levers, cams, snaps, racks, pinions, springs, and other optional mechanical components 220, 222, 224, the selection of their appropriate assembly is within the skill of those skilled in the art of microengineering to ensure that the entire process of taking is performed without any further action by the user after the release of the trigger 210.

[0015] Next, the sampling device 10 (also known as devices 1100, 2010, 2210, 4100, and 3100) shown in Figure 2B has a unique identification in one of many forms, such as a QR code readable by the user's smartphone or a number written down by the user for reference. To provide geolocalization and status information directly to the sample collection tissue, the sampling device 10 (and optionally 1100, 2010, 2210, 4100, and 3100) optionally includes a long-range wireless communication device. The status of the sampling device, geolocalization, and the user's name are notified by the user directly, by their smartphone using a dedicated software application (the “App” connected to the Internet or Cloud®), or by any other appropriate means. The sampling process may be initiated by the user themselves or by direction of any local health authority.

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

[0017] Next, the contact surface 100 of the body fluid collection device 10 shown in Figure 4 has an appropriate shape 110 to correspond to the shape of the body part of the user from which the sample is to be collected. The contact surface 100 may be made of a soft material to ensure a tight seal, or it may include a flexible seal 120, so as to ensure that a sufficient vacuum level is achieved when the plunger 504 is retracted via the piston 242 to collect the body fluid sample. Optionally, the contact surface 100 may be protected by a film, which is removed by the user before use of the collection device, and the protective film can be reused to seal the surface 100 after collection.

[0018] Next, the bodily fluid collection device 10 shown in Figure 5 is equipped with a channel 404, which at the contact surface 100 of the device is connected to the opening 112 at one end 402 and to the inlet 506 of the reservoir 502 at the other end 406.

[0019] Next, the body fluid collection device shown in Figure 6 is equipped with a temperature monitoring display / indicator 600. Such a display / indicator may consist of a printed adhesive piece 600 having several zones 602, 604, 606, 608 of different colors, the color of which changes to indicate when the collection device reaches a corresponding temperature range, and the labels on the zones may include instructions for the user. The temperature range is, for example, -602: The temperature is too high (for example, if the temperature of the sampling device exceeds 8°C). ―604: It will soon be ready for transport (for example, if the temperature of the sampling device is 5°C to 7°C). -606: Transportable (for example, when the temperature of the sampling device is between 1°C and 5°C) 608: The temperature is too low (for example, if the temperature of the sampling device is below a certain temperature, e.g., below 1°C, a different temperature range would be more appropriate for the particular fluid sample, and the corresponding process and / or instructions will be given to the user). That is the case.

[0020] Next, referring to Figures 7A and 7B, the bodily fluid sample is collected from the sampling device by the needle 944. An access hole 244 is provided via the piston 242 so that the needle 944 can penetrate the plunger 504 and aspirate the bodily fluid sample contained in the reservoir 502.

[0021] The bodily fluid collection device optionally includes an insulating cover or sleeve adapted to slide over the sample container to extend possible transport time. In one embodiment, the insulating cover or sleeve is manually positioned by the user via a tab activated by the user in accordance with the documentation provided with the device, or automatically slid into position by a second mechanism optionally driven by thermal contraction of the elements after the device has reached a sufficiently low temperature in a refrigerator.

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

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

[0024] Therefore, the bodily fluid collection device according to the present invention can be used by, for example, the patient themselves, or by any other user who is not medically trained. 1. Collection of bodily fluids (blood, etc.), optional automated collection (self-managed collection), 2. Arbitrary distribution of one or more droplets of the collected fluid for immediate analysis. 3. Provision of standard medical analysis tubes filled with bodily fluid (blood, etc.) samples to medical laboratories. It provides the following main functions.

[0025] Next, referring to Figures 8A and 8B, one embodiment of the body fluid collection device 1100 is shown before use (Figure 8A) and after collection (Figure 8B). The body fluid collection device 1100 consists of a standard medical analysis tube 1007 with a standard color cover (c) and label (e), which is preferably always visible. 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 pressing of a safety button 1001 to start the collection process. By combining levers, stoppers, cams, or other mechanical elements well known in the art, when buttons 1001 and 1002 are pressed by the user, the movement of one or more lancets or cutting blades 1004 in a second embodiment and the movement of a piston p1 are triggered via a sealing sleeve I. It should be noted that the device has one or more cutting blades 1004 (cutting blades 302, 5450, 5456, 3260, 3360, 3460, etc., but not limited to these), and in practice, one cutting blade for up to 500 μl and two or more cutting blades for 1 ml or more in order to collect for a duration that is acceptable to the patient. As background information, the duration of blood flow is approximately 30 mins for one incision and 500 μl, and for two incisions and 1 ml. The movement of the cutting blades 1004 to make an incision in the patient's skin to release capillary blood and retract into the structure / housing 1008 of the device is usually ensured by a dedicated spring such as a torsion spring as shown in Figure 17, or by an element 3362 as shown in Figure 22A. The suction portion 1010 is kept airtight by a skirt 1005 and a sealing sleeve I, the skirt 1005 being made of a flexible material such as silicone or any other suitable material, and connecting the device to the patient's skin. The suction portion 1010 is connected to the tube chamber 1011 by a cannula 1006. The tip ii of the cannula 1006 resembles the tip of an injection needle and can penetrate the plunger partition p2 when moving the piston p1 to create a vacuum in the tube chamber 1011 and aspirate blood from the suction portion 1010 into the tube chamber 1011.The plunger partition p2 provides a cylindrical recessed void i that minimizes friction with the cannula during operation, and a sealing lip v and sealing zone iii that are penetrated by the tip of the needle 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, discharging a small amount of the collected blood sample back through the cannula 1006 to distribute 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 partition p2, and when released from the device structure 1008, the plunger partition p2 remains engaged with the tube 1007 and maintains a sealed state. For the collection process and any droplet distribution process, the standard medical analysis tube 1007 is held within the device structure 1008. The apparatus structure 1008 consists of multiple parts and may include elements that can be destroyed or disassembled to release the standard medical analysis tube 1007, so that it can be transported to a laboratory and processed in standard medical laboratory analytical equipment. Before releasing the standard medical analysis tube 1007, the piston p1 must be separated from the plunger partition p2 by pressing the button 1003 to rotate the piston p1, for example, by pulling it out with a thread x. The starter spring 1012 is held within the apparatus structure by a washer 1013. One end of the piston shaft engages with the button and rotates on it as the suction cycle nears its end, allowing the shaft to be removed 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 finger, with their index finger resting on the two buttons 2 and the safety button 1001. 2. By combining levers, stoppers, cams, or any other mechanical elements well known in the field of micro-machinery technology, when buttons 1001 and 1002 are pressed by the user, the movement of piston p1 is triggered. At the same time, the movement of cutting blade 1004 is also triggered. 3. The spring 1012 activates the piston p1 to which the plunger partition p2 is attached, allowing the plunger to penetrate with the tip ii of the needle, opening the connection between the suction section 1010 and the tube chamber 1011. The cutting blade moves and incises the patient's skin. 4. The spring continues to pull the piston p1, creating a vacuum in the chamber 1011 of the medical analysis tube 1007. The patient begins to bleed, and the 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 relative to button 1003, suction stops, and the sample is contained within the tube chamber 1011. Typically, the sample volume is 500 μL with one cutting blade and 1 ml with two cutting blades. 6. The user removes the device from the patient's skin, cleans the wound, and applies a bandage if necessary. 7. Optionally, the user may use button 1003 to dispense a small portion of the sample, typically 1025 μL, for use in a commercially available rapid test. 8. The user uses button 1003 to pull the piston p1 away from the plunger partition p2, so that the plunger partition p2 remains inside the tube 1007 and maintains its seal. 9. The user releases tube 1007 from the device structure, and when the tube is removed, the plunger partition p2 is pulled away from cannula 1006 and closes. 10. The user delivers or brings the tube to a medical analysis laboratory for analysis. 11. The analytical laboratory analyzes the blood sample and notifies the patient and / or the relevant authorities of the test results. 12. Optionally, treatment and / or isolation protocols may be initiated to ensure that positive test subjects are handled in a manner that minimizes the spread of the pathogen.

[0027] In another embodiment, the bodily fluid collection device according to the present invention may include an integrated analytical function. The sample may be collected from the skin or mucous membrane, but the sample may have to be collected from the skin / mucous membrane, in which case the collection device optionally includes a cutting blade which opens the skin / mucous membrane and releases the bodily fluid to be collected. A reactant is optionally added to the surface of the user's skin / mucous membrane to facilitate sample preservation or enable specific analysis.

[0028] Next, referring to Figure 9, the fluid collection device 2010 for collecting capillary blood from the earlobe has a main body 2100 and a movable part 2200 that pinch the user-patient's earlobe, so that the device 2010 is effective in the collection process without the need for the user-patient to hold it. The fluid collection device 2010 is disclosed in U.S. Patent No. 63 / 002,581 or U.S. Patent No. 63 / 006,337 by the same applicant (the contents of which are incorporated by reference and rely upon), and houses an internal mechanism or any other suitable mechanism that ensures the complete execution of the fluid collection process without any intervention other than activation. Automated analysis features and / or systems are incorporated into the device.

[0029] Next, referring to Figures 10A and 10B, a fluid collection device 2210 for collecting capillary blood from the earlobe 2230 of the user-patient 2200 is made to have an appropriate shape, size, and weight, is held at the collection position 2230, and is visible along with the patient's face to the camera of the user-patient's smart 250. Optical properties 2212 such as a QR code, i.e., a visual symbol of the device 2210, are provided to help identify and localize the device and may include indicators showing that the collection process is ready, progressing, and completed, or other optional visual communication elements, which are captured by the camera of the user-patient's smartphone 2250 and analyzed and used by an application run by the user-patient's smartphone 2250 to enhance device identification. The device 2210 includes a wireless communication system for notifying the user-patient's smartphone of information, initiating the fluid collection process, and optionally initiating a collection analysis process after the collection is complete. Information communicated between the device 2210 and the user-patient smart 2250 includes device unique identifier, sampling activation, sampling process progress, sampling process completion, and / or error messages. Communication between the device 2210 and the user-patient smart 2250, and communication between the user-patient's smartphone and the cloud, may be encrypted and blockchain technology may be used to make tampering, misuse, or hacking difficult or impossible. The sampling information, along with the user-patient identification, is provided to the relevant authorities for further processing.

[0030] Next, a fifth method for collecting bodily fluids and ensuring user-patient identification, as shown in Figure 11, 1. The steps taken by the user to install a specific application on their smartphone (first use), 2. Optionally, the user disinfects the skin surface, and optionally, the user applies the reactive substance to the skin / mucous membrane. 3. The user applies the sampling device to their own skin / mucous membrane, 4. The user starts a specific application on their smartphone, 5. The application communicates with and identifies the sampling device, 6. The application switches on the smartphone's camera and instructs 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 runs facial recognition software and authenticates the user, b. The application runs image analysis software and recognizes the identification of the sampling device, 8. The application communicates with the sampling device and starts the sampling process, 9. In parallel, a. The application saves a time-lapse video as evidence of the sampling process, b. Steps in which the sampling device performs the sampling process, 10. When the sampling process is completed, the sampling device communicates with the application. 11. The application stores information regarding the sampling device identification, sampling time, and user identification in the cloud and / or its initial memory. Includes.

[0031] Next, referring to Figure 12, one embodiment of the capillary blood collection device 4100 according to the present invention has a main structure 5000, which includes a suction interface 5100 adapted to adhere to the skin of a user / patient, one or more push buttons 5200 for the user / patient to activate the device 4100, and a tube holder 6000 configured to receive a vacuum collection tube, such as a vacuum collection tube well known in the industry for venous blood collection. Inside the main structure 5000 are a suction chamber 5400 connected to the inside 6100 of the tube holder 6000 via a channel 7000, an activation mechanism 5300 which translates the motion of the user / patient pressing one or more buttons 5200 into activating the device 4100, and any electrical and / or connected features such as a GPS or geolocalization system, identification tags, a wireless communication system, or a countdown with audible feedback.

[0032] The device structure 5000 preferably comprises two or more push buttons 5200, and the mechanism 5300 is configured to ensure that the sampling process is initiated only when all push buttons 5200 are activated, in order to minimize the risk of accidental activation. The mechanism 5300 may include a combination of levers, stoppers, cams, or any other mechanical elements well known in the field of micro-mechanical technology, or preferably consist of a flexible element that can release the sampling only by deforming when a user / patient presses a push button 5200. The device structure 5000 optionally includes a method for discharging a small amount of blood from the device 4100 for rapid analysis in the field. A second embodiment of the cutting blade 5450 is shown in these drawings, but it goes without saying that any modification is available.

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

[0034] The suction chamber 5400 includes one or more cutting blades 5450 of the second embodiment, and in principle, depending on the size of the sample to be collected, one blade is needed for up to 500 μl and two blades for 1 ml. For reader information, the duration of blood flow is approximately 30' for one incision and 500 μl, and for two incisions and 1 ml. The cutting blade 5450 has an elastic or spring portion 5458 that is loaded when the device 4100 is assembled and is held under tension by a mechanical finger 5350. The mechanical finger 5350 is connected to the mechanism 5300 so that the mechanism 5300 can release the cutting blade 5450 when activated. When released, the cutting blade is positioned to cut the user / patient's skin through the passage 5150. The suction chamber is closed by an airtight membrane 5420 made of an airtight material that is cut by the cutting blade 5450 while simultaneously cutting the user / patient's skin without tearing it. Optionally, the suction chamber 5400 includes an airtight elastic lining 5410 on which the mechanism 5300 can activate the mechanical finger 5350 in an airtight manner, and optionally includes a method for discharging a small amount of blood for rapid analysis in situ. Suitable materials for the membrane 5420 and the optional elastic lining 5410 are well known in the art and include silicone, rubber, and other elastomers and / or plastics in one or more layers. The suction chamber 5400 is constructed to have a minimum volume so that the majority of the collected blood does not remain in the suction chamber 5400 and is drawn into the vacuum tube, and only a small portion of the vacuum provided by the tube is used to establish a vacuum in the suction chamber 5400. The channel 7000 connecting the suction chamber 5400 to the interior 6100 of the tube holder 6000 may be a needle 7200 comprising a suction end 7100 of a needle connected to the suction chamber 5400 and a distribution end 7300 of a needle adapted to enter the vacuum tube and discharge the collected blood into the tube. Typically, the needle 7200 is made of stainless steel, but it may also be made of other metals, composites, and / or plastics, or other materials currently available in the industry.

[0035] Next, the functions of the devices shown in Figures 14A to 14I can be explained as follows. 1. See Figure 14A: The sampling device 4100 and vacuum tube 8000 are delivered individually to the user / patient in sterile packaging. The needle dispensing end 7300 is sharp enough to penetrate the partition 8100 (sometimes called the “rubber stopper”) of the vacuum tube 8000 and is protected by an elastic (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 inside the tube holder 6000 6100. Optionally, the rubber sleeve 7400 is made of a “self-healing” material well known in the industry, which automatically closes the needle dispensing end 7300 after use. 2. Refer to Figure 14B: The user / patient removes the optional protective film 6110 and inserts the vacuum tube 8000 into the tube holder 6000, with the partition wall 8100 of the vacuum tube 8000 facing the needle distribution end 7300 until it reaches the bottom 6160 of the inside 6100 of the tube holder 6000. 3. See Figure 14C: Upon reaching the bottom 6120 of the interior 6100 of the tube holder 6000, the vacuum tube 8000 compresses the rubber sleeve 7400, disengaging the distribution end of the needle 7300, allowing the distribution end of the needle 7300 to penetrate the partition wall 8100 of the vacuum tube 8000, and establishing an airtight connection from the vacuum tube 8000 to the suction chamber 5400 via the needle 7200. As a result, the suction chamber 5400 is placed under vacuum. 4. See Figure 14D: The user / patient disinfects the area of ​​skin 9000 from which blood should be drawn, removes the protective film 5140, and places the device 4100 on the area from which blood should be drawn. As a result, the adhesive bandage 5120 and glues 5110, 5130 allow the device to hold and seal the user / patient's skin 9000. 5. See Figure 14E: The user / patient activates the mechanism 5300 by pressing one or more push buttons 5200. The mechanism then activates the mechanical finger 5350, releasing one or more cutting blades 5450. One or more cutting blades 5450 incise the membrane 5420 and the user / patient's skin 9000, cutting multiple capillaries in the patient's skin 9000, allowing the vacuum to access the user / patient's skin 9000. 6. See Figure 14F: After the membrane 5420 and the user / patient's skin 9000 have been incised, one or more cutting blades 5450 move away from the wound 9100 and terminate their movement at the incision in the suction chamber 5400, moving their sharp edges out of the user / patient's reach. As the wound 9100 begins to bleed, the suction chamber 5400 is gradually filled with the user / patient's blood 10000. 7. See Figure 14G: Blood 10000 fills the vacuum tube 8000 through the suction end 7100 of needle 7200, the dispensing end 7300 of needle 7200. 8. Refer to Figure 14H: When the vacuum tube 8000 is sufficiently filled with blood 10000, the user / patient removes the vacuum tube 8000 from the device. Indication that the vacuum tube is sufficiently filled is provided by an electrical or mechanical timer incorporated in the mechanism 5300, a scale on the vacuum tube through which the user / patient can see the transparent tube holder 6000, a magnetic or capacitance-sensitive strip in contact with the blood, or the transparent window 6200, or by observing the cessation of blood flow when the vacuum is evacuated, or by any other suitable means. Once the vacuum tube is removed from the tube holder 6000, the elastic sleeve 7400 expands freely to cover the needle dispensing end 7300 and close the passage for blood 10000. Optionally, the user / patient inserts additional vacuum tubes to collect further blood samples and repeats steps 7 and 8. 9. See Figure 14I: The user / patient removes the device 4100 and applies a small wound dressing 9200, usually purchased separately, to the wound 9100. Any blood remaining in the suction chamber 5400 is retained in the suction chamber 5400 by the membrane 5420. If rapid analysis is required in the field, a few drops of blood contained in the suction chamber 5400 can be obtained by pressing the membrane 5420. Optionally, a second mechanism (not shown) incorporated into the structure 5000 provides a method for discharging a small amount of blood by compressing the elastic lining 5410 when a push button is pressed. 10. The user sends or brings Tube 8000 to a medical analysis laboratory or point of care for analysis. To facilitate the delivery of appropriate samples to the laboratory, the user / patient's own refrigerator and optionally a container with high thermal inertia, or a container with high thermal inertia and / or thermal insulation and equipped with temperature monitoring and / or signal notification, as disclosed in, for example, U.S. Patent No. 63 / 002,581 or U.S. Patent No. 63 / 006,337, the contents of which are incorporated and relied upon. 11. The analytical laboratory analyzes the blood sample and notifies the patient and / or the relevant authorities of the test results. 12. Optionally, treatment and / or isolation protocols may be initiated to ensure that positive test subjects are handled in a manner that minimizes the spread of the pathogen.

[0036] Next, the second embodiment 5450 of the cutting blade shown in Figures 15A to 15C consists of a single piece, usually pressed sheet metal or spring steel, but may also consist of other materials, including composites exhibiting suitable mechanical properties. The cutting blade has one end 5460 facing the harvesting device structure 5000 so as to be able to attach thereto, followed by an elastic zone 5458 that elastically bends 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 a suitable, preferably smooth cross-section to provide a suitable release trajectory perpendicular to its attachment end 5460.

[0037] Next, Figures 16A to 16F show a third embodiment 5456 of the cutting blade, which is formed to be created in a different and advantageous manner. In the above two embodiments 302 and 5456 of the cutting blade, the release trajectory is indicated by a curved arrow in Figures 15B and 16E. In one embodiment, the cutting blade is twisted 90° in region 5456 to provide a blade 5452 that lies in the same plane as the release trajectory after the elastic zone 5458.

[0038] Next, referring to Figure 17, in another embodiment, it may take the form of a multi-turn torsion spring, as in the peg. In that case, the cross-section of the blade is circular, and the variable stiffness required for the function is obtained by varying the heat treatment of different zones of the blade. The blade 5452 has high stiffness in the open trajectory direction. A cutting edge 5454 is provided at the end of the blade 5452 to cut the membrane 5420 and the user / patient's skin 9000. After the movement of the cutting blade 5450 is complete, the cutting edge 5454 turns toward the same side as the attachment end 5460 and moves out of the user / patient's reach.

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

[0040] In another embodiment, the capillary blood collection device according to the present invention includes a patient biometric authentication system, a device authentication system, and a disposable capillary blood collection device that provides an untrained user with the ability to (a) collect capillary blood and optionally automatically collect it, (b) optionally immediately analyze the blood using one or more droplets of the collected capillary blood, and (c) provide a standard medical analysis tube filled with a sample of capillary blood for analysis at a nursing station or medical laboratory, wherein the device is equipped with a vacuum tube interface, and the vacuum tube provides the suction necessary to fill the vacuum tube with blood.

[0041] Next, referring to Figures 18A and 18B, the main features of the blood collection device are shown. The blood collection device has a dressing on its top surface, which includes a grip 3122, a draw blood button 3120, a collect blood button 3126, a flush window 3130 for indicating that blood can be collected, a blood collection tube 3132, wing tabs 3134 for removing the device, and a backer. The blood collection device 3100 further includes a blood draw reservoir 3140 with wound sealing, a removable wing tab 3142 with adhesive backing, and a machine-readable code 3144.

[0042] Next, the main body 3110 of the injection device 3100 shown in Figure 19 includes a mechanism (not shown) that activates the needle of the present invention within the area of ​​the injection site 3125 when the user / patient presses the "inject" button 3120. Such mechanisms are well known in the field of micromachinese 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 Applications No. 63 / 114,162, No. 62 / 864,572, No. 62 / 511,361, No. 15 / 524,748, No. 31 / 040,459, No. 14 / 235,107, or No. 16 / 930,383, the contents of which are incorporated by reference and rely upon.

[0044] Next, referring to Figures 20A to 20P, a sixth embodiment of a method 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 and 4100, and the adhesive-embedded dressings 3174 included in the capillary blood collection devices 3100 and 4100 can be omitted.

[0045] Figure 20A shows step 1 of a sixth embodiment of a method using the system of the present invention. Step 1 consists of a) scanning a website or prescription to download a dedicated app using the present invention, b) completing a consent form, c) filling out demographic information, d) taking a photograph of a government-issued ID or other means of identification, and e) taking a selfie to associate the patient, the device, and the collected sample.

[0046] Figure 20B shows step 2 of a sixth embodiment of a method 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 start the app and guide, e) checking the contents, and f) cleaning the phone with the sanitary wipe included in the kit.

[0047] Figure 20C shows step 3 of a sixth embodiment of a method using the system of the present invention. Step 3 consists of a) placing the built-in telephone stand inside the box, b) wiping the telephone clean with the included sanitary towel, and c) washing hands.

[0048] Figure 20D shows step 4 of a sixth embodiment of a method using the system of the present invention. Step 4 consists of a) taking a selfie with a phone on a stand, and b) starting to record a video of oneself with one's face and arms in the frame.

[0049] Figure 20E shows step 5 of a sixth embodiment of a method using the system of the present invention. Step 5 consists of a) following the app guide (reading the text / reviewing the figures), b) preparing the arm with a warm towel, c) opening the alcohol towel from the kit, and d) wiping the upper arm area with alcohol and drying it.

[0050] Figure 20F shows step 6 of a sixth embodiment of a method 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 a stand.

[0051] Figure 20G shows step 7 of a sixth embodiment of a method using the system of the present invention. Step 7 consists of a) removing the adhesive support and b) applying the device to the upper arm.

[0052] Figure 20H shows step 8 of a sixth embodiment of a method using the system of the present invention. Step 8 consists of confirming that the facial device's own video fits within the frame.

[0053] Figure 20I shows step 9 of a sixth embodiment of a method using the system of the present invention. Step 9 consists of a) pressing a first button, b) waiting until a display appears in the flash window, c) checking the display, and d) returning the kit according to the guide if no display appears within a predetermined time.

[0054] Figure 20J shows step 10 of a sixth embodiment of a method using the system of the present invention. Step 10 consists of a) pressing a second button and b) waiting for the timer on the app to indicate that the tube is full using the communication means.

[0055] Figure 20K shows step 11 of a sixth embodiment of a method using the system of the present invention. Step 11 consists of a) pulling the wing tab to remove the device from the arm, b) leaving the dressing on the arm, and c) returning the device to the kit box.

[0056] Figure 20L shows step 12 of a sixth embodiment of a method using the system of the present invention. Step 12 consists of a) removing the dressing support to expose the gauze pad and adhesive portion, and b) folding the gauze dressing to cover the wound.

[0057] Figure 20M shows step 13 of a sixth embodiment of a method using the system of the present invention. Step 13 consists of a) removing the end of the bottle from the device and b) pulling the bottle out of the device.

[0058] Figure 20N shows step 14 of a sixth embodiment of a method using the system of the present invention. Step 14 consists of a) securing the sample vial in a biohazard pouch in the kit, and b) securing the device in a separate biohazard pouch in the kit.

[0059] Figure 20O shows step 15 of a sixth embodiment of a method using the system of the present invention. Step 15 consists of a) stopping the video, b) removing the phone from the kit stand, c) disassembling the phone stand, and d) securing both biohazard pouches inside the kit box.

[0060] Figure 20P shows step 16 of a sixth embodiment of a method 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] Next, referring to Figures 21A to 21D, specific 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, which is provided separately from the adhesive portion 3152 at the bottom of the device. The blood collection device further includes an adhesive support portion 3154 that is detachably located on the adhesive portions 3150 and 3152, the adhesive support portion 3154 being removed before the device is applied to the patient's body. Once the device is placed on the patient's arm, the device is pulled up to 3157 of the wing tabs 3156 and, once the tube 3132 is filled, the device is pulled away from the patient's skin. The adhesive portion 3150 surrounding the wound site 3162 remains in place with the skin, providing a surrounding feature that temporarily prevents blood from flowing out of the exposed area. Subsequently, the dressing support portion 3164 is peeled away from 3165, exposing the gauze pad 3166 surrounded by the adhesive portion 3170. The dressing 3174 includes a dressing tab 3172 without an adhesive portion. The dressing tab 3172 can be pulled 3173, which may fold the gauze pad over the wound and secure it to cover the wound.

[0062] Consequently, the adhesive-integrated dressing 3174 is suitable for ensuring the adhesion of the blood collection device 3100 to the patient's skin, airtightness between the patient's skin and the blood collection device 3100 during the collection process, and wound dressing after the collection process.

[0063] In another embodiment, the vaccine and / or drug injection device according to the present invention provides to an untrained user (a) the ability to inject, optionally automatically inject, vaccines and / or drugs; (b) a data processing and activation system configured to receive data relating to vaccines and / or drugs, which is entered by the user / patient through 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 data to and optionally receive data from a network (such as the Internet).

[0064] Self-administration may be achieved by devices incorporated for reference and relying upon as disclosed in PCT / US2012 / 048044, PCT / IB2018 / 000559, PCT / IB2013 / 000659, and PCT / IB2020 / 055874.

[0065] As already emphasized, the present invention provides a method for injecting and administering vaccines and / or drugs by an untrained user, the method being implemented in a vaccine and / or drug injection device. The vaccine and / or drug injection device of the present invention may use one or more needles as a method for injecting vaccines and / or drugs into the body of a user / patient. For the purposes of this disclosure, the function of the vaccine and / or drug injection device of the present invention is 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 drug injected and / or to shorten the injection time. The vaccine and / or drug injection device according to the present invention provides to an untrained user (a) the ability to inject, optionally self-inject, a vaccine and / or drug; (b) a data processing and activation system configured to receive data, the data relating to the vaccine and / or drug, which is entered by the user / patient through 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 data to and optionally receive data from a network (such as the Internet).

[0066] The apparatus according to the present invention enables authentication of vaccine and / or drug administration. Accordingly, the apparatus according to the present invention comprises means that enable verification of one or more of the following items. 1. Data from the surgeon or medical officer (MED) regarding the administration of the vaccine / medical agent, and the MED's specific approval for the use of the vaccine and / or medical agent to the user / patient. The device according to the present invention is adapted to receive data, which is related to the vaccine and / or medical agent and is entered by the user / patient via an app or by the HMO that has received it in advance (data entry may be performed manually or by scanning a QR code, etc.). 2. The temperature of the vaccine and / or drug administration from transport to injection (if necessary). The device according to the present invention is suitable for handling information from a temperature tracer or reagent documents (usually placed inside the transport box during transport), and optionally a GPS tracer (also usually placed inside the transport box during transport). Optionally, the tracer can be returned to the vaccine and / or drug manufacturer. In relation to the device, if the user / patient removes the device from thermal protection, the timer must be switched on in the app. In relation to this event, the system (app and / or device) must alert the user / patient. 3. Patient safety relating to the patient's response, in a) immediately after injection (e.g., fainting) and b) after vaccination (e.g., 15 minutes after injection). In the case of situation a) described above, the device according to the present invention is adapted to accept input from the user / patient (e.g., by pressing a physical button or a button in the app) and to activate that the injection has been administered. If no activation occurs after a certain period of time has elapsed since the patient started the injection, an alarm is triggered to warn the MED, who can optionally initiate emergency treatment. In the case of situation b) described above, the system according to 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 drug injection device of the above embodiment of the present invention is that the body of the injection device includes a mechanism for activating the needle of the present invention when the user / patient presses the “inject” button. Such mechanisms are well known in the field of micromachinese and include levers, clips, springs, flexible elements, sliders, gears, cams, etc.

[0068] Injection devices may be any suitable injection devices disclosed in U.S. Patent Applications No. 63 / 114,162, No. 62 / 864,572, No. 62 / 511,361, No. 15 / 524,748, No. 31 / 040,459, No. 14 / 235,107, and No. 16 / 930,383, the contents of which are incorporated by reference and rely upon.

[0069] Current capillary blood collection devices for non-medical training users typically create a wound in the patient's skin by puncturing with one or more needles, or without puncture, but they can only collect relatively small amounts of bodily fluid, usually less than 150 μl in 5-10 minutes.

[0070] In another embodiment, the present invention provides capillary blood collection devices 10, 1100, 2010, 2210, 3100, and 4100 that provide a method of incision that is significantly larger than the incisions typically known in existing capillary blood collection devices, enabling the collection of a significantly larger volume of blood, typically 500 μl or more, preferably 1 ml, within a reasonable period of typically less than 15 minutes, preferably less than 10 minutes. The capillary blood collection devices of the present invention use one or more cutting blades 1004 (e.g., cutting blades 302, 5450, 5456, 3260, 3360, and 3460) instead of one or more needles, and make an incision instead of puncturing the user / patient's skin. For the purposes of this disclosure, the function of the collection devices of the present invention is disclosed as including one cutting blade, but it should be understood that the collection devices of the present invention may have one or more cutting blades to increase the volume of blood collected and / or to shorten the blood collection time. Furthermore, the present invention provides cutting solutions that facilitate the rapid healing of wounds after blood collection. Therefore, the objective of the present invention is to create wounds in the user / patient's skin with an optimal depth for cutting as many capillaries as possible, while avoiding unnecessary wound width and length, so that the wounds heal naturally and as quickly as possible after blood collection. The ideal cutting depth may vary depending on the patient's age, gender, ethnic group, and / or health condition, but consequently, multiple adaptive variations of the collection device are provided. Typically, the ideal cutting depth is 1mm to 2mm.

[0071] Next, a fourth embodiment of the cutting blade 3260 of the apparatus of the present invention shown in Figures 22A to 22C consists of a single piece, usually pressed sheet metal or spring steel, but may also consist of other materials including composites exhibiting suitable mechanical properties. The cutting blade 3260 has one end 3261 facing the collection device structure so as to be able to attach thereto, followed by an elastic zone 3262 that elastically bends when the cutting blade is ready for use. In this way, the cutting blade 3260 contains all the energy required for its movement, and the user / patient only needs to release it by pressing the blood aspiration button 3120. The elastic zone 3262 has a suitable, preferably smooth cross-section and is designed to provide a suitable release trajectory perpendicular to its attachment end 3261. In one embodiment, the cutting blade is twisted 90° in region 3263 so as to provide a blade portion 3264 that lies in the same plane as the release trajectory after the elastic zone 3262. The blade portion 3264 has high rigidity in the direction of the release trajectory.

[0072] Next, referring to Figure 22A, the device may take the form of a multi-turn torsion spring, such as those found in clothes pins, in which case the cross-section of the blade is circular, and the required variable stiffness for the function is obtained by varying the heat treatment of different zones of the blade. A cutting edge 3265 is provided at the end of the blade portion 3264 to incise the user / patient's skin 3290. After the incision motion is complete, the tip 3265 is removed from the user / patient's reach. Optionally, the cutting blade 3260 includes fingers 3270 that interact with device structural elements 3242, 3244, and 3246 to deflect the natural release trajectory 3250 of the cutting blade 3260 when released, thereby obtaining a modified trajectory 3240.

[0073] Typically, the natural release trajectory 3250 of the cutting blade 3260 is approximately circular, elliptical, or spiral. Consequently, the incision in the patient's skin 3290 is approximately circular with a relatively large radius, and the wound length 3296 is relatively long for a small portion of the desired depth 3292. When the device structural elements 3242, 3244, and 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 descent and retreat, resulting in a shorter wound length 3294 for a longer portion of the desired depth 3292. The modified trajectory 3240 allows for the collection of a larger volume of capillary blood with a smaller wound overall, which contributes to faster wound healing after blood collection.

[0074] Next, referring to Figure 22B, as an example, device structural element 3242 is designed to locally expand the radius of the natural free track 3250, and device structural element 3244 is designed to locally shorten the radius of the natural free track 3250.

[0075] Next, referring to Figure 22C, as a further example, the device structural element 3246 is designed to locally shorten the radius of the natural open orbit 3250.

[0076] Next, a fifth embodiment 3360 of the cutting blade of the apparatus of the present invention shown in Figures 23A and 23B consists of a single piece, usually a pressed sheet metal, but may consist of other materials including composite materials exhibiting appropriate mechanical properties. The cutting blade 3360 has one end 3361 facing the collection device structure so as to be able to adhere thereto, followed by an elastic zone 3362 that elastically bends when the cutting blade 3360 is ready for use. In this way, the cutting blade 3360 contains all the energy required for its movement, and 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, so as to provide a suitable, planar, and natural release trajectory 3350. In one embodiment, after the elastic zone 3362, the cutting blade is twisted 90° in region 3363 so as to provide a blade portion 3364 that lies in the same plane as the release trajectory. The blade portion 3364 has high rigidity in the direction of the release trajectory. A cutting edge 3365 is provided at the end of the blade portion 3364 to cut the user / patient's skin (not shown). After the movement is complete, the cutting edge 3365 is removed from the user / patient's reach. Optionally, the cutting blade 3360 includes fingers 3370 that interact with the device structural element 3342, causing the cutting blade 3360's natural release trajectory 3350 to be deflected upon release, resulting in a modified trajectory 3340.

[0077] Typically, the natural release trajectory 3350 of the cutting blade 3360 is approximately circular or spiral. Consequently, the incision in the patient's skin is approximately circular with a relatively large radius, and the wound length is relatively long 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 descent and retreat, resulting in a longer wound portion and a shorter wound length at the desired depth. The modified trajectory 3340 allows for the collection of a larger volume of blood with a smaller wound overall, which contributes to faster wound healing after blood collection. As an example, the device structural element 3342 is designed to locally shorten the radius 3352 of the natural release trajectory 3350 by a displacement 3341 in part of the release trajectory 3340. Furthermore, the device structural element 3342 may be made to have a more complex shape in order to provide a more precisely modified track 3340.

[0078] Next, a sixth embodiment 3460 of the cutting blade of the apparatus of the present invention shown in Figures 24A to 24C is made of a single piece, usually a pressed sheet metal, but may be made of other materials including composite materials exhibiting appropriate mechanical properties. Next, the cutting blade 3460 shown in Figure 24A has a rotating attachment 3466 to the apparatus structure and a cutting edge 3465 that remains in a retracted position before the cutting process.

[0079] Next, referring to Figure 24B, when activated, the cutting blade 3460 rotates and engages with the patient's skin 3490, but this rotation is limited by the structure so as not to completely incise the patient's skin.

[0080] Next, referring to Figure 24C, after the incision, the cutting blade 3460 retracts by moving in the reverse direction, leaving a wound under the patient's skin, but this wound is much smaller than if a complete incision were made. Consequently, a deeper incision allows for the collection of a larger volume of blood, but the opening on the surface of the patient's skin 3490 is smaller, which facilitates faster wound healing after blood collection.

[0081] Next, the fifth embodiment 3660 of the cutting blade of the apparatus of the present invention, shown in Figures 25A to 25D, may be a standard scalpel blade or any other rigid blade, which is usually made of pressed sheet metal, but may be made of other materials including composite materials exhibiting appropriate mechanical properties. The cutting blade 3660 has a cutting edge 3665, which is positioned substantially parallel to the user / patient's skin 3690. The cutting blade is guided by linear movement by the apparatus mechanism (not shown) to penetrate the user / patient's skin at a substantially non-orthogonal angle (Figure 25B). In this way, the cutting edge 3665 completely penetrates the user / patient's skin, reaching a substantially uniform depth along its entire length, creating a substantially rectangular wound, which is oriented non-orthogonal to the user / patient's skin (Figure 25C). When the cutting blade is retracted (Figure 25D), the flap created by the non-orthogonal wound naturally closes the wound, contributing to faster wound healing after blood collection.

[0082] Another embodiment provides verification of a self-administered medical process. The objective of this embodiment is to confirm that the blood in the collection tube is the patient's blood, i.e., for the purpose of blood collection, and that the user / patient has been identified, i.e., for the purpose of injection, that the injection was made for the patient.

[0083] Potential risks here include, for blood collection purposes, reliable blood collection, work permits, travel permits, and permission to contact family during epidemics, approval for the use of specific treatments, automated detection of epidemics through large-scale collection programs, and verification of the effectiveness of prescribed treatments (payment for treatment success). For injection purposes, potential risks include work permits, travel permits, and permission to contact family after vaccine treatment. Furthermore, keeping individual immunization records up-to-date and automated monitoring of large-scale vaccination programs are also risks. In addition, payment for treatments associated with vaccination, and only if complete administration is achieved, can also be a risk. Therefore, thorough verification of patients and processes is extremely important.

[0084] In another aspect, verification of the self-administered medical process is crucial. For example, a smartphone application could be used to create a video (or time-lapse), allowing the patient's face and the process itself to be viewed in video throughout the entire process. The patient's ID could be compared to the patient's face, and facial recognition of the patient and the entire process could be observed. The system could be configured so that the process only begins after all IDs have been verified. Automated management of logistics (collection and transport of collection tubes, resupply of treatment, etc.) may be implemented. If the smartphone app is configured to analyze the video in real time, step-by-step instructions may be provided to the patient in real time while the process is being executed. Automated monitoring of processing performance may also include other features. Despite the potential, there are always difficulties to address, especially in degraded situations such as insufficient network coverage during process execution. Optionally, temporary network coverage may be provided via drones / balloons during the treatment campaign. However, it would be best if the app could operate independently of network coverage. It is also desirable to store all data on the smartphone and then verify it. It goes without saying that complying with regulations regarding private data is also important. The app performs an initial analysis followed by an encryption routine to make the private data unreadable, and optionally saves the entire video for later use if needed (such as official evidence in court).

[0085] The main components of the system are a smartphone, laptop / computer, or similar device, and a camera (which may be present on the smartphone / laptop / computer), an application run on the smartphone or laptop / computer, and a reusable device for performing the injection / collection process. In addition, there are 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] A key feature of the system of the present invention is that 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 important process steps. The device may be equipped with automated wireless signal emission (information: ID / process start / process in progress / process complete / error). Such signals may be visualized (flashing / colored LED, etc.) to facilitate the interpretation of the video. The device of the present invention may optionally include visible features / reference points to further facilitate the orientation verification of the video. The app must be able to initiate the treatment process. The device optionally has a remote activation feature and, advantageously, includes a unique ID.

[0087] Next, referring to Figures 26A to 26C, the visible feature 2600 can take any form of a combination of different high-contrast patterns 2620 and 2630. The visible feature 2600 is incorporated into the device 2610 of the present invention and is easily recognizable. The high-contrast patterns 2620 and 2630 are applied to the movable part (in this example, the button 2650) and can only be viewed one at a time through the window 2612. As a result, the predetermined positions of the movable part (the button 2650 at a high position in Figure 26B, and the button 2650 at a low position in Figure 26D) can be easily recognized by a human observer or easily identified by image analysis software.

[0088] This invention has other applications. For example, it can be adapted for treatments other than injections (the device may be used for distributing tablets). It can also be adapted for home voting, signing documents, providing ID during conference calls, or taking remote exams.

[0089] The present invention can be summarized to include the following set of features. 1. A disposable body fluid collection device that provides, to an untrained user, (a) a function to collect body fluids (blood, etc.), a function to collect them either manually or automatically, (b) a function to manually dispense one or more droplets of the collected body fluid for immediate analysis, and (c) a function to provide a sample container chamber filled with body fluid (blood, etc.) samples for analysis in a medical laboratory. 2. A disposable body fluid collection device as described in Set 1, characterized in that the sample container chamber is a standard medical analysis tube. 3. A method using a fluid collection device described in Feature Set 1, in which, if the subject tested is positive for a pathogen, a treatment and / or isolation protocol is initiated to ensure that the positive subject is handled in a manner that minimizes the spread of the pathogen. 4. A method for using the apparatus described in feature set 1 to collect and potentially analyze samples of bodily fluids such as blood, while simultaneously ensuring the identification of the individual from whom the bodily fluids are collected. 5. A disposable body fluid collection device according to either feature set 1 or 2, having a sample container chamber made of a material having thermal inertia that allows the sample temperature to be maintained beyond a known time. 6. A disposable bodily fluid collection device as described in feature set 5, wherein the thermal inertia is selected to provide a known storage time in an ambient environment sufficient to enable non-refrigerated transport to the collection site. 7. An apparatus according to the above set of features, wherein the known time is in the range of 1 to 2 hours, preferably in the range of 1 to 6 hours, more preferably in the range of 1 to 8 hours, under normal ambient conditions. 8. A disposable bodily fluid collection device as described in Feature Set 5, comprising an insulating sleeve configured to be manually or automatically activated and to slide over the sample container chamber. 9. A disposable bodily fluid collection device as described in the above feature set, wherein the thermal inertia is selected to provide a known time sufficient to enable non-refrigerated transport to the collection site. 10. An apparatus according to the above set of features, wherein the known time is in the range of 1 to 2 hours, preferably in the range of 1 to 6 hours, more preferably in the range of 1 to 8 hours, under normal ambient conditions. 11. A disposable bodily fluid collection device according to feature set 1, comprising an interface and a vacuum tube, wherein the vacuum tube provides the suction necessary to fill the vacuum tube with the blood. 12. A disposable capillary blood collection device cutting blade for cutting user / patient skin, as described in feature set 11, wherein the cutting blade structure consists of a single material and provides energy and guiding for its movement. 13. A combination of a device and an app for administering a drug or vaccine, which provides an untrained user with the ability to perform a self-injection adapted to interact with the app, preferably wirelessly connected to the Internet via the cloud, wherein the app includes means for enabling verification of the patient's ID and / or the particular device being used, and the combination comprises at least: a) Access to data storage adapted to store data of the surgeon or medical officer (MED) relating to the administration of the vaccine / medical agent and their specific authorization for the use of the vaccine and / or medical agent to the user / patient, wherein the combination is adapted to the reception of data, and such data is entered by the user / patient or by a previously received HMO relating to the vaccine and / or medical agent (the entry of such data may be performed manually or by scanning a QR code, etc.), b) Recording means adapted to record the temperature of the vaccine / drug administration from transport to the substantially required injection time, c)i) Immediately after injection (e.g., fainting), and / or ii) After the vaccine (for example, 15 minutes after the injection), The combination according to the present invention includes, in the case of the above-mentioned situation i), a patient safety measure adapted to be activated in the event of a patient response, wherein the combination is adapted to receive input from the user / patient, and further, the device is adapted to be transported with thermal protection, and the combination optionally includes a temperature tracer or reagent documentation (usually placed inside the transport box during transport), and a GPS tracer (also usually placed inside the transport box during transport) for tracking the storage temperature during transport. 14. A system described in feature set 13, which is adapted to accept input by a user pressing a physical button or a button within the application, and which enables the injection to be performed. 15. A system described in the above feature set, wherein if no activation occurs after a certain period of time has elapsed since the patient started the injection, an alarm is triggered to warn the MED, and emergency treatment is optionally initiated. 16. The system of the present invention, as described in feature set 13, wherein, in the case of situation ii) above, the user / patient can confirm to the MED (by pressing a physical button or a button in the app, etc.) that there is no problem with them. 17. A system described in any one of feature sets 13 to 16, which is adapted to return the tracer to the manufacturer of the vaccine and / or drug. 18. A system as described in feature set 13, wherein a timer is provided in the app that is configured to be switched on in the app when the user / patient removes the device from thermal protection, and in connection with this event, the user / patient is to be alerted by the combination. 19. A capillary blood collection device that provides the ability for an untrained user to collect capillary blood, to arbitrarily analyze the blood using an analytical device, and to fill a sample tube with the blood, (a) A collection mechanism for collecting capillary blood, and for collecting it automatically as needed, (b) Optionally, an analyzer configured to immediately analyze the blood using one or more droplets of the collected capillary blood, (c) Apparatus comprising a filling mechanism configured to fill standard medical analysis tubes with capillary blood samples for analysis at a nursing base or medical laboratory, The apparatus comprises a vacuum tube and an interface therefor, the vacuum tube providing the suction necessary to fill the vacuum tube with the blood. 20. The apparatus according to one of feature sets 1 to 11 or 19, comprising one or more cutting blades for incising the skin of the user / patient. 21. A device according to feature set 20, wherein one or more cutting blades are configured such that their trajectory is substantially non-circular when cutting into the patient's skin, providing a wound shape that optimizes the number of capillary incisions and facilitates rapid healing of the wound after blood collection. 22. A device according to one of feature sets 19 to 21, comprising one or more cutting blades configured such that the trajectories of the one or more cutting blades are substantially non-orthogonal to the patient's skin, providing a wound shape that optimizes the number of capillary incisions and facilitates rapid healing of the wound after blood collection. 23. An apparatus according to feature set 22, wherein the trajectory of one or more cutting blades is configured such that rotation is restricted, and the apparatus cuts the skin essentially below its surface. 24. An apparatus as described in feature set 22, wherein the trajectories of the one or more cutting blades are configured to have substantially linear motion and are substantially non-orthogonal to the user / patient's skin. 25. A method for collecting capillary blood, which provides an untrained user with the ability to collect capillary blood, the ability to analyze the blood, and the ability to fill a sample tube with the blood, (a) A step of collecting capillary blood using the device described in any one of feature sets 1, 4-11, or 13-14, and optionally automatically collecting the blood, (b) Optionally, the step of immediately analyzing the blood using one or more droplets of the collected blood to determine its characteristics such as blood type, (c) The step of filling the sample container chamber with the capillary blood sample for analysis at a nursing station or medical laboratory, A method that includes this. 26. The method according to feature set 25, wherein the sample container chamber is a standard medical analysis tube. 27. A method using a capillary blood collection device described in any one of feature sets 1 to 7, wherein if a subject for testing is positive for a pathogen, a treatment and / or isolation protocol is initiated to ensure that the positive subject is handled in a manner that minimizes the spread of the pathogen. 28. A method according to feature set 25, further comprising the step of providing the results of the blood sample analysis, wherein the authority uses the evidence provided to the authority to grant the user / patient permission to perform a specific activity. 29. A method according to feature set 25, comprising the step of using the results of the blood sample analysis and the evidence provided to release the payment for the treatment. 30. A method for large-scale collection and analysis of biological samples, which includes collecting biological samples such as bodily fluid samples without the intervention of medical trainees, and which includes at least: a) Providing the object to be inspected with a sampling device described in any one of feature sets 1, 5-11, or 13-24 having a unique identifier and an instruction; b) Providing instructions, the instructions including instructions to place the device in a refrigerator to cool the device before and after collecting blood or other samples; c) The steps of collecting the sample and associating the unique identifier of the sampling device with the object to be tested, d) A step of transporting the sample to the collection site, e) The step of analyzing the sample to identify the pathogen and notifying the subject of the test of the results, A method that includes this. 31. A method for large-scale collection and analysis of biological samples described in feature set 30, The steps include providing instructions, the instructions including instructions for collecting blood or other samples, The steps include collecting the sample and associating the unique identifier of the sampling device with the object to be tested, The steps include providing additional instructions, the instructions including optional instructions for placing the device in a refrigerator to cool the device, A method that includes this. 32. A method by which, if the test subject is positive for a pathogen, the method includes an additional step of 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 bodily fluid samples without the intervention of medical trainees, and at least, a) Providing the object to be inspected with a sampling device described in any one of feature sets 1, 5-11, or 13-24 having a unique identifier and an instruction; b) Providing the instructions, including instructions for collecting blood or other samples; c) The steps of collecting the sample and associating the unique identifier of the sampling device with the object to be tested, d) Providing further instructions, optionally including instructions to cool the apparatus by placing it in a refrigerator before step c) in which the sample is taken, and further optionally including instructions to slide the insulating sleeve over the sample container chamber of the apparatus after the apparatus has reached a temperature within an acceptable temperature range, thereby extending the time that the sample is safely stored during transport and before the sample analysis in step f), e) The step of transporting the sample to the collection site, f) The step of analyzing the sample to identify the pathogen and notifying the subject of the test of the results, A method that includes this. 34. A method for large-scale collection and analysis of biological samples, comprising collecting biological samples such as bodily fluid samples without the intervention of medical trainees, and at least, a) Providing the object to be inspected with a sampling device described in any one of feature sets 1, 5-11, or 13-24 having a unique identifier and an instruction; b) Providing the instructions, which optionally include instructions to place the device in a refrigerator to optionally cool the device before and after the collection of blood or other samples; c) optionally place the sampling device in a refrigerator for the instructed time, optionally including instructions to slide the insulating sleeve over the sample container chamber of the device after step d) in which the sample is collected, in accordance with the instructions, after the device has reached a temperature within the permissible temperature range, thereby extending the time that the sample is safely stored during transport and before the sample analysis in step f), d) The steps of collecting the sample and associating the unique identifier of the sampling device with the object to be tested, e) The step of transporting the sample to the collection site, f) The step of analyzing the sample to identify the pathogen and notifying the subject of the test of the results, A method that includes this. 35. A method by which, if the subject tested is positive for a pathogen, a treatment and / or isolation protocol is initiated to ensure that the positive subject is handled in a manner that minimizes the spread of the pathogen, such as in accordance with the implementation of isolation procedures. 36. A system capable of verifying that a self-administered medical process, such as blood collection or injection, is being properly carried out, and using one of the devices described in any one of feature sets 1, 5-11, or 23-24, which includes a bioscanner configured to recognize the unique biological characteristics of the user / patient, such as the face, scalp, eyes, or fingerprints. 37. A system described in feature set 36, which is combined with an application that runs on a smartphone. 38. The system according to feature set 36, comprising an apparatus identification module adapted to recognize the apparatus performing the blood collection or injection step in real time. 39. The system according to feature set 38, comprising a device identification module adapted to analyze in real time the user / patient or the execution of the process by the sampling / injection device. 40. The system according to feature set 39, including an apparatus identification module adapted to distribute audible and / or visual instructions in real time to enable the user / patient to correctly perform the process. 41. The system according to feature set 39, comprising a start module configured to wirelessly activate part or all of the sampling or injection process. 42. A system described in any one of the feature sets 36 to 41 above, comprising a connection mechanism adapted to provide appropriate connectivity for real-time communication with health authorities while the process is being performed. 43. A system described in any one of the feature sets 36 to 42 above, which includes a self-contained application that runs on a smartphone, and which includes saving process execution videos or time lapses on the smartphone in a guaranteed manner for later use as evidence. 44. The system described in feature set 33, adapted to allow the authorities to use the evidence provided to grant the user / patient permission to perform a specific activity. 45. A system described in feature set 33, adapted to release the payment for treatment using the evidence provided. 46. ​​A system for capillary blood collection as described in any one of feature sets 36 to 45, comprising a patient biometric authentication system, an apparatus authentication system, and a disposable capillary blood collection device that provides an untrained user with the ability to (a) collect capillary blood and optionally automatically collect it, (b) optionally immediately analyze the blood using one or more droplets of the collected capillary blood, and (c) provide a standard medical analysis tube filled with a sample of capillary blood for analysis at a nursing station or medical laboratory, wherein the device comprises an interface and a vacuum tube, the vacuum tube being suitable for providing sufficient suction to fill the vacuum tube with the blood. 47. A capillary blood collection system relating to feature set 46, wherein the authentication system is suitable for providing real-time recognition of the user / patient and the operation of the device to the blood collection process. 48. A capillary blood collection system relating to the feature set 46 described above, wherein the authentication system includes storage means for storing a video or time lapse of the collection process in a guaranteed manner for later use as evidence. 49. A method using a capillary blood collection system described in any one of feature sets 36-48, wherein the authorities use the results of the blood sample analysis and the evidence provided to grant the user / patient permission to perform a specific activity. 50. A method using a capillary blood collection system described in any one of feature sets 36-48, wherein the results of the blood sample analysis and the evidence provided are used to release the payment for treatment. 51. A disposable bodily fluid collection device according to Feature Set 1, comprising an adhesive built-in dressing adapted to (i) ensuring the blood collection device adheres to the patient's skin, (ii) ensuring airtightness between the patient's skin and the blood collection device between the collection steps, and (iii) dressing the wound after the collection steps.

[0090] Furthermore, it should be considered that the present invention comprises all possible combinations of all features described herein, the appended claims, and / or drawings, which are considered to possess novelty, inventiveness, and industrial applicability.

[0091] The specific implementations illustrated or disclosed herein are illustrative and best-functions of the present invention and do not limit the scope of the invention in any way.

[0092] As those skilled in the art will understand, the present invention can be embodied in a system, apparatus, or method.

[0093] Furthermore, the system of this application is intended for the use, sale, and / or distribution of all goods, services, or information having similar functions to those described herein.

[0094] The specification and drawings of this application should be understood as illustrative rather than restrictive, and all improvements described herein are intended to be included within the scope of the claimed invention. Accordingly, the scope of the invention should be determined not from the above-mentioned exemplary designs, but from the attached claims (the current claims, or any claims to be amended or added later, and their legal equivalents). The steps described in all method or process claims can be performed in any order unless otherwise specified, and are not limited to any particular order described in the claims. Furthermore, the elements and / or components described in the apparatus claims can be assembled or functionally configured with various substitutions that produce essentially similar results to the invention. In general, the invention should not be interpreted as being limited to any particular configuration described in the claims.

[0095] The benefits, other advantages, or solutions described herein should not be considered essential, important, or indispensable features or elements of any or all claims.

[0096] The phrases “consisting of,” “composed of,” and other similar expressions used herein are used to represent a non-exclusive list of elements, and all apparatuses, processes, methods, articles, or configurations of the present invention that constitute that list of elements do not necessarily include only the elements described, but may also include other elements described herein. Furthermore, the phrases “including,” “containing,” or “essentially including,” unless otherwise specified, are not intended to limit the scope of the invention to only the enumerated elements. The above-described combinations and / or modifications of elements, materials, or structures used in carrying out the present invention may be modified or adapted to other designs by those skilled in the art without departing from the general principles of the present invention.

[0097] The patents and documents mentioned above are incorporated herein by reference to the extent that they do not conflict with this disclosure, unless otherwise stated.

[0098] Other features and embodiments of the present invention are described in the appended claims.

[0099] Furthermore, it should be considered that the present invention comprises all possible combinations of all features described herein, the appended claims, and / or drawings, which are considered to possess novelty, inventiveness, and industrial applicability.

[0100] Additional features and functionalities of the present invention are described in the claims appended to this application. Those claims are incorporated herein by reference in their entirety and should be considered as part of the submitted application.

[0101] Various modifications and improvements are possible in 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 specific embodiments of the invention have been disclosed and described, a wide range of modifications, improvements, and substitutions are considered in the foregoing disclosure. The above description contains many specifics, but should be considered as examples of one or other preferred embodiments rather than as limiting the scope of the invention. In some cases, some features of the invention are used without using corresponding other features. Therefore, the above description should be interpreted broadly and understood as merely examples or illustrations, and the spirit and scope of the invention should be limited only by the claims finally issued in this application.

Claims

1. A disposable body fluid collection device (10, 1100, 2010, 3100, 4100) suitable for use by untrained users, The system is configured to place bodily fluid (13) collected from the epidermal layer into a suction chamber (5400), and includes a needle (7200) configured to penetrate a partition wall (8100), and a channel (7000) adapted to place the suction chamber under vacuum. The system includes an interface (6000) for a vacuum tube (8000) and the vacuum tube (8000), the vacuum tube providing the suction necessary to fill the body fluid (13) into collection tubes (1007, 3132) for analysis in a medical laboratory. It includes one or more cutting blades (302, 5450, 5456, 3260, 3360, 3460, 3660) adapted to incise the skin of the user / patient (2200), The cutting blade is rotatably supported in the housing, and the arc traced by the tip of the cutting blade as it rotates extends in part to the outside of the housing. A disposable bodily fluid collection device wherein, with the housing in contact with the skin, the cutting blade rotates in a manner restricted by the housing, causing the tip of the cutting blade to move outward from the housing, injuring the patient's skin without completely cutting it, and further, the cutting blade retracts by moving in the reverse direction.

2. A disposable body fluid collection device according to claim 1, having at least two cutting blades mounted parallel to each other on an axis to simultaneously incise the patient's skin.

3. The disposable bodily fluid collection device according to claim 1, wherein each of the one or more cutting blades includes an elastic zone adapted to store spring energy for providing guidance for movement.

4. The disposable bodily fluid collection device according to claim 1, wherein one or more cutting blades are biased by at least one torsion spring.

5. The disposable body fluid collection device according to claim 1, wherein the collection tubes (1007, 3132) are standard medical analysis tubes.

6. A disposable body fluid collection device according to any one of claims 1 to 5, comprising a container formed of a material having thermal inertia that enables the sample temperature to be maintained over a known period of time, wherein the thermal inertia is selected to provide a known storage time in an ambient environment sufficient to allow non-refrigerated transport to the collection site.

7. The disposable body fluid collection device according to claim 1, wherein the collection tubes (1007, 3132) are vacuum tubes (8000).

8. A disposable bodily fluid collection device according to claim 1, which is adapted to dispense one or more droplets of the collected bodily fluid for immediate analysis.

9. The disposable bodily fluid collection device according to claim 1, wherein the vacuum tube (8000) is closed by a partition (8100), and the interface (406, 6000) for the vacuum tube (8000) includes a needle (7200) configured to penetrate the partition (8100) and place the suction chamber under vacuum.

10. A disposable bodily fluid collection device according to claim 1, comprising a trigger and a spring, wherein the spring, when released by the trigger, provides energy to cut through the epidermal layer of the patient's skin.

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