Body fluid sampling device and method of using same

Abstract

A liquid sampling device and method is provided, comprising the collection of a sample of bodily fluid, such as blood, without intervention of a medically trained individual. The bodily fluid sampling device advantageously comprises an isolating cap or envelope adapted to slide over the sample container to prolong the transport time as much as possible. In one embodiment, the isolating cap or envelope is manually set in place by the user according to written operating instructions provided with the device via a user actuated tab, or is automatically slid into place by a second mechanism optionally triggered by thermal contraction of an element after the device has reached a sufficiently low temperature in a refrigerator. The bodily fluid sampling device is optionally equipped with a unique identification code and carries an electronically readable identification tag. Depending on the environment, the sampling device is optionally equipped with geolocation and remote communication capabilities to enable collection after the sampling process has been performed without further action by the user. Advantageously, the bodily fluid sampling device according to the invention is optionally configured to use a standard analysis tube well known in the industry, enabling analysis of the contents of the tube on standard automated analysis equipment. Associated methods are provided for collecting a sample of bodily fluid using such a sampling device and ensuring the sealed transport of the collected sample of bodily fluid to an analysis laboratory.

Description

[0001] Cross-referencing of related patent applications

[0002] This application claims that the following documents were filed on March 31, 2020: No. 63 / 002,581 entitled "BODY FLUIDS SAMPLING DEVICE AND METHOD OF USING THE SAME"; No. 63 / 006,337 filed on April 7, 2020: "BODY FLUIDS SAMPLING DEVICE AND METHOD OF USING THE SAME"; No. 63 / 025,692 filed on May 15, 2020: "BODY FLUIDS SAMPLING METHOD WITH AUTOMATICUSER IDENTIFICATION"; No. 63 / 011,010 filed on April 16, 2020: "BODY FLUIDS SAMPLING METHOD WITH AUTOMATICUSER IDENTIFICATION"; and No. 23, 2020: "CAPILLARY BLOODS SAMPLING DEVICE AND METHOD OF USING THE SAME". The rights to SAME's U.S. Provisional Application No. 63 / 069,112, filed November 16, 2020, entitled "Self-made Medical Process Verification System", No. 63 / 114,162, filed January 28, 2021, entitled "Capillary Blood Sampling System Including USER / Patient Authentication", No. 63 / 142,756, filed January 28, 2021, entitled "Capillary Blood Sampling Device", No. 63 / 150,113, filed February 17, 2021, entitled "Capillary Blood Sampling Device", and No. 63 / 153,088, filed February 24, 2021, entitled "Vacine and / ordrug Injection and Administration Device".

[0003] Copyright and Legal Notice

[0004] This patent specification contains a portion of copyrighted material. The applicant does not object to any fax copy of any patent document or patent disclosure appearing in the Patent and Trademark Office's patent files or records, but otherwise reserves all copyright rights. Furthermore, any references to third-party patents or articles herein do not imply an admission that the invention is not entitled to a priority invention preceding such material. Technical Field

[0005] This invention relates to a device capable of sampling bodily fluids and transporting them to an analytical laboratory without medical intervention. Background Technology

[0006] In the event of war or a large-scale epidemic, analyzing the bodily fluids (e.g., blood) of a large portion of a given population (potentially a residential area, a block or group of blocks, a suburb, a city, or the entire population of a country or continent) may become necessary. In such situations, medical personnel may be unable to personally participate in the sampling of bodily fluids from each patient due to a number of reasons, such as caregiving responsibilities, risk of contamination, unsafe areas, distance traveled, lack of transportation infrastructure, and / or staff shortages. Therefore, there is a need for a fluid sampling device suitable for use by any individual without rigorous medical training, as well as a method to ensure the identification of the user / patient and the association between the identified user / patient and the bodily fluid sample, and the intact, safe, and hygienic transport of the bodily fluid sample to the analytical laboratory. Summary of the Invention

[0007] A liquid sampling device and method are provided, comprising collecting bodily fluid samples, such as blood, without intervention by a medically trained person. Optionally, the bodily fluid sampling device advantageously includes an isolation cap or sash adapted to slide over a sample container to maximize transport time. In one embodiment, the isolation cap or sash is manually positioned by a user via a user-actuated tab according to written operating instructions provided for the device, or automatically slid into position by a second mechanism optionally triggered by thermal shrinkage of the elements after the device has reached a sufficiently low temperature in a refrigerator. The bodily fluid sampling device is optionally equipped with a unique identification code and optionally carries an electronically readable identification tag, such as an RFID tag. Depending on the environment, the sampling device is optionally equipped with geolocation and remote communication capabilities to enable collection without further user intervention after the sampling process has been performed. Advantageously, the bodily fluid sampling device according to the invention is optionally configured to use standard analytical tubes well-known in the industry, enabling analysis of the tube contents on standard automated analytical equipment. Provide association methods for identifying users / patients, associating or ensuring the correspondence between identified users / patients and sample containers, and using such sampling devices to collect body fluid samples and ensure that the collected body fluid samples are sealed, hygienic, intact, and safely transported to the analytical laboratory. Attached Figure Description

[0008] Figure 1A This is a flowchart of the first embodiment of the method of the present invention.

[0009] Figure 1B This is a flowchart of a second embodiment of the method of the present invention.

[0010] Figure 1C This is a flowchart of the third embodiment of the method of the present invention.

[0011] Figure 1D This is a flowchart of the fourth embodiment of the method of the present invention.

[0012] Figure 2A This is a perspective view of the internal mechanism of the sampling device, showing a first embodiment of the cutting blade of the present invention before use.

[0013] Figure 2B This is a perspective view of the internal mechanism of the sampling device according to the present invention in use.

[0014] Figure 2C This is a perspective view of the internal mechanism of the sampling device according to the present invention after use.

[0015] Figure 3A This is a side view of the internal mechanism of the sampling device according to the present invention before use.

[0016] Figure 3B This is a perspective view of the internal mechanism of the sampling device according to the present invention in use.

[0017] Figure 3C This is a side view of the internal mechanism of the sampling device according to the present invention in use.

[0018] Figure 3D This is a side view of the internal mechanism of the sampling device according to the present invention after use.

[0019] Figure 4 This is a lower perspective view of the contact surface between the sampling device according to the invention and the user's skin.

[0020] Figure 5 This is a perspective view of the internal fluid passage of the sampling device according to the present invention.

[0021] Figure 6 This is a plan view of the thermal indicator panel according to the present invention.

[0022] Figures 7A-7B This is a partial cross-sectional view of the internal components of the sampling device according to the present invention, showing the extraction of body fluid samples.

[0023] Figure 8A - 8B is a cross-sectional view of two moving stages of the body fluid sampling device according to the present invention, namely, the step before use ( Figure 8A ) and the steps after sampling ( Figure 8B ).

[0024] Figure 9 This is a perspective view of another embodiment of the body fluid sampling device of the present invention for collecting capillary blood from the earlobe.

[0025] Figures 10A-10B This is a schematic diagram of a body fluid sampling device used to collect capillary blood from the earlobe.

[0026] Figure 11 This is a flowchart of a fifth embodiment of the method for sampling bodily fluids according to the present invention, which ensures the identification of the user-patient.

[0027] Figure 12 This is a side view of an embodiment of the capillary blood sampling device according to the present invention, which has a main structure including an adsorption interface suitable for application to the skin of a user / patient.

[0028] Figure 13 yes Figure 12 A partial cross-sectional view of an embodiment of a capillary blood sampling device, showing a second embodiment of the cutting blade of the invention, the device contacting the user / patient via its adsorption interface.

[0029] Figures 14A to 14I This is a partial cross-sectional view showing the operation of the device of the present invention used with a standard sample container.

[0030] Figure 15A This is a side view of a second embodiment of the cutting blade or lancet used in this invention, located in the ready-to-release position.

[0031] Figure 15B This is a side view of a second embodiment of the cutting blade used in this invention, located in a half-extended position.

[0032] Figure 15C This is a top view of a second embodiment of a fully extended cutting blade.

[0033] Figure 16A This is a perspective view of a third embodiment of the cutting blade of the present invention, which is made from a single piece of metal.

[0034] Figure 16B This is a side view of the third embodiment of the cutting blade of the present invention.

[0035] Figure 16C This is a front view of the third embodiment of the cutting blade of the present invention.

[0036] Figure 16D This is a top view of the third embodiment of the cutting blade of the present invention.

[0037] Figure 16E This is a side view of a third embodiment of the semi-extended cutting blade of the present invention.

[0038] Figure 16F This is a side view of a third embodiment of the fully extended cutting blade of the present invention.

[0039] Figure 17 This is a multi-turn torsion spring that can be used in the elastic zone in a specific embodiment of the present invention.

[0040] Figure 18A This is a top perspective view of another embodiment of the blood sampling device of the present invention.

[0041] Figure 18B This is a lower perspective view of another embodiment of the blood sampling device of the present invention.

[0042] Figure 19 This is a perspective view of the injection device of the present invention.

[0043] Figures 20A to 20P This is a schematic diagram illustrating the steps of a sixth embodiment of a method for using the system of the present invention.

[0044] Figures 21A to 21D This is a more detailed schematic diagram of the specific features of the adhesive integral dressing contained in a capillary blood sampling device.

[0045] Figure 22A This is a perspective view of a fourth embodiment of the cutting blade of the device of the present invention, which is made of a single component.

[0046] Figure 22B This is a four-position shutter side view of the fourth embodiment of the cutting blade of the device of the present invention.

[0047] Figure 22C This is a four-position shutter side view of a fourth embodiment of the cutting blade of the device of the present invention, showing its retraction.

[0048] Figure 23A This is a perspective view of the fifth embodiment of the cutting blade of the present invention.

[0049] Figure 23B This is a front view of the fifth embodiment of the cutting blade of the present invention.

[0050] Figure 24A This is a side view of the sixth embodiment of the cutting blade of the device of the present invention before it enters the epidermis of the patient's body.

[0051] Figure 24B This is a side view of the sixth embodiment of the cutting blade of the device of the present invention when it is in the middle of its motion cycle.

[0052] Figure 24C This is a side view of the sixth embodiment of the cutting blade of the device of the present invention, after it has returned to its initial position and its motion cycle has ended.

[0053] Figure 25A This is a perspective view of the seventh embodiment of the cutting blade of the device of the present invention, which shows a standard surgical bloodletting needle.

[0054] Figure 25B This is a side view of the seventh embodiment of the cutting blade of the device of the present invention before it enters the epidermis.

[0055] Figure 25C This is a side view of the seventh embodiment of the cutting blade of the device of the present invention when it enters the epidermis and is removed from the epidermis.

[0056] Figure 25D This is a side view of the epidermis, showing the cut made by the seventh embodiment of the cutting blade.

[0057] Figures 26A to 26C Examples of visible features that can be integrated into the device of the present invention and are easily identifiable by an observer or easily recognized by real-time image analysis software are shown.

[0058] Those skilled in the art will understand that the elements in these figures are illustrated for simplicity and clarity and are not necessarily drawn to scale. For example, dimensions may be enlarged relative to other elements to aid in understanding the invention and its embodiments. Furthermore, when the terms “first,” “second,” and similar terms are used herein, their use is intended to distinguish similar elements and does not necessarily describe a sequential or chronological order. Additionally, relative terms such as “front,” “back,” “top,” and “bottom,” and similar terms in the specification and / or claims are not necessarily used to describe unique relative positions. Therefore, those skilled in the art will understand that such terms are interchangeable with other terms, and that the embodiments described herein can operate in orientations other than those explicitly illustrated or otherwise described. Detailed Implementation

[0059] The following description is not intended to limit the scope of the invention in any way, as it is exemplary in nature and is used to describe the best mode of the invention known to the inventors up to the date of this application. Therefore, changes may be made to the arrangement and / or function of any elements described in the exemplary embodiments disclosed herein without departing from the spirit and scope of the invention. Depending on the fluid and size of the sample to be collected and the area of ​​the body to which the sample is to be collected, the body fluid sampling device according to the invention may take different sizes and shapes. Samples may be collected on the skin or mucous membranes, but samples may have to be collected through the skin / mucous membrane; in this case, the sampler may be equipped with a cutting blade to cut the skin / mucous membrane and release the body fluid to be collected. The user may attach reactants to the surface of the skin / mucous membrane to facilitate sample preservation or enable specific analysis. Optionally, the thermal inertia of the body fluid sampling device is adapted to the parameters described above and the parameters specified for the transport system, such that the storage temperature of the body fluid sample remains optimal from the user's refrigerator to the refrigerator of the analytical laboratory, with sufficient margin. The transportation of collected samples from the user's location to the analytical laboratory can be accomplished by the user themselves, by postal services, or by professional logistics companies using manpower, or by self-controlled or remotely controlled unmanned vehicles. Depending on the environment, the sampling device can be equipped with geolocation and remote communication capabilities to allow collection to proceed without further user intervention after the sampling process has been completed.

[0060] Patient authentication and ensuring the correspondence between the authenticated user / patient and the sample (optionally using the sampling device) can be optionally achieved through different levels of tamper-proofing measures because they are of great importance to the patient. For example, the result can determine whether the patient is under quarantine or released from quarantine, whether they are permitted to travel, or whether they are permitted to work; it can also be used to confirm the effectiveness of treatment and / or exemption from payment for treatment. Such tamper-proofing measures can include photographing the entire fluid sampling process, from opening the box containing the sampling device to sealing the box to be mailed to the sample analysis facility. The photographs can optionally be encrypted and stored for later use, such as as evidence in court in the event of legal proceedings.

[0061] Now for reference Figure 1A A first embodiment of the method according to the present invention includes the following steps:

[0062] a) Disinfect and moisten the area of ​​the body from which the blood sample will be taken;

[0063] b) Take a blood sample;

[0064] c) A fully loaded miniature sampler and, optionally, a photograph of the patient's ID;

[0065] d) Optionally, prior to the first step a) or b) above, the filled microsampler is placed in the patient's refrigerator, where the microsampler is cooled until it reaches its shelf life necessary for transport. In addition, according to the operating instructions provided to the user, the isolation sleeve is slid on the sample storage section by actuating the tab.

[0066] e) Transporting miniature samplers from patients’ homes to physicians, pharmacists, hospitals, or specialized collection points;

[0067] f) Optionally, intermediate storage before entering the refrigerator of a physician, pharmacist, hospital, or other collection point; and

[0068] g) The blood test itself related to the photos sent by the patient.

[0069] Now for reference Figure 1B A second embodiment of the method according to the present invention includes the following steps:

[0070] i. Disinfect and optionally moisten the area of ​​the body from which the sample will be taken;

[0071] ii. Take a liquid sample;

[0072] iii. The microsampler can be associated with the subject of the test at any time, such as by optionally taking a picture of the filled microsampler along with the patient's ID, and by sending it to a specific recipient, for example, via SMS, MMS, or other email;

[0073] iv. Optionally, prior to step i) or ii) above, the filled microsampler is stored in the patient’s refrigerator, where the microsampler is cooled to at least the shelf life necessary for its transport. Alternatively, according to the operating instructions provided to the user, the isolation sleeve is slid across the sample storage section by actuating the tab.

[0074] v. To take a sample out of the refrigerator;

[0075] vi. Optionally transport the miniature sampler from a refrigerator that may be located in the patient's home to a physician, pharmacist, hospital, or specialized collection point;

[0076] vii. Optionally, store in a refrigerator at a physician, pharmacist, hospital, or other collection point;

[0077] viii. Diagnosing pathogens using samples from microsamplers; and

[0078] ix. Notify the appropriate people of the analysis results.

[0079] Now for reference Figure 1C A third embodiment of the method according to the present invention includes the following steps:

[0080] Step 1: By capturing the identification tag affixed to the device upon delivery, or other suitable means, the user captures the QR code on their sampling device via a dedicated software application (app) on their smartphone (connected to the Internet or CLOUD™) to uniquely identify the sampling device. Alternatively, for example, the user can associate the sampling device with the patient by taking a photo of the device, making its identification visible along with the patient's ID file or the patient's face.

[0081] Step 2: Optionally, the user disinfects the skin surface, providing disinfection but optionally also wetting the surface to allow for better adsorption. Optionally, the user applies a reactant to their skin / mucous membranes, which is mixed with the body sample to allow / improve the protection of the body sample and / or enable / improve analysis.

[0082] Step 3: The user attaches the sampling device to their skin / mucous membrane in a suitable area.

[0083] Step 4: Optionally, after cooling the device according to the method described above, the user initiates the sampling process.

[0084] Step 5: Automatically perform the sampling process using the sampling device according to the following sub-steps:

[0085] Step 5.1: Release the drive spring.

[0086] Step 5.2: The piston begins to retract to create a vacuum between the user's skin / mucous membrane and the contact surface of the sampling device, and an optional cutting blade begins to cut.

[0087] Step 5.3: Optional cutting blade cuts the user's skin / mucous membrane.

[0088] Step 5.4: The micro-wound begins to release bodily fluids.

[0089] Step 5.5: Body fluids are drawn into the storage compartment.

[0090] Step 5.6: Optional cutting blade retraction.

[0091] Step 5.7: The piston reaches its end point.

[0092] Step 5.8: A visible indicator shows the user that the sampling process is complete. This visible indicator can also be provided by a transparent storage compartment, allowing the user to see the storage compartment containing the bodily fluids.

[0093] Step 5.9: If the sampling device is equipped with a remote wireless communication device, the information that the sampling process has been performed can be directly sent to the sample collection agency.

[0094] Step 6: The user removes the sampling device from their skin / mucous membrane and seals it to protect the integrity of the bodily fluid sample. Optionally, the user may apply adhesive tape to the micro-wound, which will close naturally. Alternatively, the user may associate the sampling device with the patient, for example, by photographing the device and making its identification visible alongside the patient's ID file or face.

[0095] Step 7: Optionally, the user stores the sampling device in their refrigerator before taking the sample.

[0096] Step 8: Optionally, before taking a sample, the user follows the operating instructions to bring the sampling device to a suitable temperature, and optionally monitors the temperature evolution of the sampling device by observing the temperature display. If the sampling device is equipped with a temperature sensor and a remote wireless communication device, the information about the sampling device temperature is directly sent to the sample collection agency.

[0097] Step 9: When following operating guidelines, such as when the transport temperature is reached, the user may optionally notify the sample collection agency that the sample is ready to be picked up or deliver the device to a suitable collection point. If the sampling device is equipped with a remote wireless communication device, information about the sampling device being ready to be picked up can be sent directly to the sample collection agency.

[0098] Step 10: The sample collection unit collects the sampling device and brings it to the analysis laboratory.

[0099] Step 11: The analytical laboratory performs sample analysis and uses 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 suitable means of communication, to notify the user and / or appropriate authorities of the results.

[0100] The identification of the sampling device (step 1) can also be performed between steps 5 and 6 (after the sampling process).

[0101] Now for reference Figure 1D The fourth embodiment of the method of the present invention has all the steps of the third embodiment of the method of the present invention, but steps 5b are modified in place of steps 5 as follows:

[0102] Step 5b: The sampling device automatically performs the sampling process according to the following sub-steps:

[0103] Step 5b.1: Release the drive spring.

[0104] Step 5b.2: The piston begins to retract to create a vacuum between the user's skin / mucous membrane and the contact surface of the sampling device, and the cutting blade begins to cut.

[0105] Step 5b.3: The cutting blade cuts the user's skin / mucous membrane.

[0106] Step 5b.4: Retract the cutting blade.

[0107] Step 5b.5: The micro-wound begins to release bodily fluids.

[0108] Step 5b.6: The mechanism may optionally include means (such as means including a load flywheel loosened via a spring connected to a reduction gear drive system) that take into account the waiting time before the body fluid is fully released (e.g., suitable for collecting body fluid in 0.1 to 10 seconds, or 0.2 to 5 seconds, or 0.5 to 3 seconds).

[0109] Step 5b.7: The mechanism actuates the absorbent pad to collect the first drop or first volume of body fluid by suction and remove it from the collection area.

[0110] Step 5b.8: As the micro-wound continues to release fluid, the fluid is drawn into the storage compartment.

[0111] Step 5b.9: The piston reaches its end point.

[0112] Step 5b.10: A visible indicator shows the user that the sampling process is complete. This visible indication can also be provided by a transparent storage compartment, allowing the user to see the storage compartment containing the bodily fluids. If the sampling device is equipped with a remote wireless communication device, information that the sampling process has been performed is sent directly to the sample collection unit.

[0113] Now for reference Figure 2A-2C The internal mechanism 10 of the body fluid sampling device contains an energy source 200, such as a spring, sufficient to ensure the execution of the entire sampling process. The device includes a rigid storage section 502 enclosed by a plunger 504. The mechanism 10 connects the energy source 200 to the plunger 504 via a piston 242, allowing the plunger 504 to retract, creating a vacuum and aspirating the body fluid sample. Optionally, depending on the type of body fluid to be collected and the skin / mucous membrane protecting it, the mechanism 10 may also connect the energy source 200 to a cutting blade 302 capable of cutting the user's skin / mucous membrane to release the body fluid sample to be collected (in a first embodiment). The mechanism 10 includes a trigger 210 that can be actuated by the user to initiate the sampling process. The mechanism 10 may include gears, levers, cams, snaps, racks, pinions, springs, and any other mechanical components 220, 222, 224, the appropriate combination of which is within the technical skill of a person skilled in the art of micromechanics, to ensure that the entire sampling process is executed without further user action after the trigger 210 is released.

[0114] Now for reference Figure 2B Sampling device 10 (and devices 1100, 2010, 2210, 4100, 3100) has a unique identifier, which can take many forms: a QR code that can be read by the user's smartphone; or a number that the user can write down for viewing, etc. Sampling device 10 (and 1100, 2010, 2210, 4100, 3100, as applicable) optionally includes a remote wireless communication device for geolocation and direct provision of status information to the sample collection agency. Users can also use their smartphones with a dedicated software application (an "app" connected to the Internet or CLOUD™) or any other suitable means to directly transmit the status of the sampling device, its geolocation, and the user's name. The sampling process can be initiated autonomously by the user or by an instruction from the health authority of a given area.

[0115] Now for reference Figures 3A-3D The internal mechanism 10 of the body fluid sampling device is illustrated with fewer visible elements, and the storage section 502, piston 242, plunger 504, mechanism elements 220, 222, 224, and cutting blade 302 are shown in a clearer manner.

[0116] Now for reference Figure 4The contact surface 100 of the body fluid sampling device 10 has a suitable shape 110 to correspond to the shape of the area on the user's body where a sample must be taken. The contact surface 100 may be made of a soft material or include a flexible sealing gasket 120 for a tight fit, such that a sufficiently high level of vacuum is established when the plunger 504 is retracted via the piston 242 to collect a body fluid sample. Optionally, the contact surface 100 is protected by a thin film that can be removed by the user before using the sampler; the protective film can be reused to seal the surface 100 after sampling.

[0117] Now for reference Figure 5 The body fluid sampling device 10 includes a channel 404, which is connected at one end 402 to an opening 112 in the contact surface 100 of the device, and at the other end 406 to an inlet 506 of the storage unit 502.

[0118] Now for reference Figure 6 The body fluid sampling device includes a temperature monitoring display / indicator 600. This display / indicator may consist of printed tape 600 with several zones 602, 604, 606, and 608 of different colors. The color changes of these zones indicate when the sampling device has reached a corresponding temperature range. The markings on these zones may include operating instructions for the user. Examples of temperature ranges may be:

[0119] - 602: Too hot (e.g., if the temperature of the sampling device is above 8°C).

[0120] - 604: Ready to transport immediately (e.g., when the temperature of the sampling device is between 5°C and 7°C).

[0121] 606: Ready for transport (e.g., when the temperature of the sampling device is between 1°C and 5°C).

[0122] 608: Too cold (e.g., when the temperature of the sampling device is below a certain temperature, such as below 1°C, another temperature range may be more suitable for the specific fluid sample and the corresponding process and / or instructions to be given to the user).

[0123] Now for reference Figures 7A-7B The removal of bodily fluid samples from the sampling device is achieved using a needle 944. An inlet 244 is provided through the piston 242, allowing the needle 944 to penetrate the plunger 504 and aspirate the bodily fluid samples contained in the storage section 502.

[0124] Optionally, the body fluid sampling device advantageously includes an isolation cap or cover adapted to slide over the sample storage section to maximize transport time. In one embodiment, the isolation cap or cover is manually positioned by the user via a user-actuated tab according to written operating instructions provided for the device, or automatically slid into position by a second mechanism optionally triggered by thermal shrinkage of the components after the device has reached a sufficiently low temperature in a refrigerator.

[0125] Any embodiment of the bodily fluid sampling devices described herein may optionally be equipped with a unique identification code and may carry an electronically readable identification tag. Depending on the environment, the sampling device may optionally be equipped with geolocation and remote communication capabilities to collect data without further action by the user after the sampling process has been performed.

[0126] The body fluid sampling device according to the invention is manufactured to use standard analytical tubes well-known in the industry, enabling the contents of the tubes to be analyzed on standard automated analytical equipment.

[0127] Therefore, the body fluid sampling device according to the present invention provides the following main functions for users without medical training (e.g., the patient himself / herself):

[0128] 1. Sample bodily fluids (e.g., blood), optionally automatically sampled (self-performed sampling);

[0129] 2. Optionally, one or more drops of sampled liquid can be dispensed for immediate analysis; and

[0130] 3. Provide standard medical analysis tubes containing samples of bodily fluids (e.g., blood) for analysis in medical laboratories.

[0131] Now for reference Figure 8A - 8B, The embodiment of the body fluid sampling device 1100 is shown before use ( Figure 8A ) and after sampling ( Figure 8BThe body fluid sampling device 1100 includes a standard medical analysis tube 1007 with a cap (c) and a marking (e) made of a standard color, the marking (e) preferably always remaining visible. The device is preferably constructed to include two buttons 1002 on each side of the device 1100, which, in one embodiment, must be actuated in conjunction with pressing a safety button 1001 to initiate the sampling process. When the user presses buttons 1001 and 1002, a combination of levers, stoppers, cams, or any other mechanical elements known in the art triggers the movement of one or more lancets or cutting blades 1004 and the movement of a piston pl via a sealing sleeve I. It should be noted that the device may have one or more cutting blades 1004 (e.g., but not limited to, cutting blades 302, 5450, 5456, 3260, 3360, 3460), theoretically for a single cutting blade at most 500 μl, while two or more cutting blades can collect 1 ml or more over a patient-acceptable duration. Regarding the background information, for one incision, the blood flow duration of 500 μl is approximately 30 seconds; therefore, for 1 ml, two incisions are needed for the same time. The movement of the cutting blade 1004 is controlled by a dedicated spring (typically as...). Figure 17 (as shown) torsion spring or Figure 22AElement 3362 ensures that an incision is made in the patient's skin to release capillary blood and retract the device into the structure / housing 1008. The adsorption zone 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, which connects the device to the patient's skin. The adsorption zone 1010 is connected to the chamber 1011 via a cannula 1006, the tip ii of which is similar to the tip of an injection needle and, when the piston pl moves to create a vacuum in the chamber 1011, can penetrate the plunger septum p2 and draw blood from the adsorption zone 1010 into the chamber 1011. The plunger septum p2 provides: a columnar groove i to minimize friction with the cannula during operation; a sealing lip v and a closure zone iii, through which the needle tip ii penetrates the sealing lip v and closure zone iii to allow aspiration of bodily fluids; and closure when the cannula tip ii is disengaged when the tube 1007 is removed from the device structure 1008. After sampling, button 1003 provides the possibility of pushing the piston p1 back a short distance to expel a small amount of collected blood sample backward through the cannula 6, thereby dispensing one or more drops from the protruding end 1009 of the cannula 1006 for immediate analysis using, for example, a home testing kit. Button 1003 enables the piston p1 to disengage from the plunger septum p2, allowing the plunger septum p2 to remain engaged in the tube 1007 and remain tightly sealed when released from the device structure 8. For both the sampling process and the optional droplet dispensing process, the standard medical analysis tube 1007 remains within the device structure 1008. The device structure 1008 can be made of several components and may contain elements that can be broken or disassembled for releasing the standard medical analysis tube 1007, thus enabling its delivery to a laboratory for processing with standard medical laboratory analytical equipment. Before releasing the standard medical analysis tube 1007, piston p1 must be rotated, for example by rotating button 1003, to separate piston p1 from plunger septum p2, such that it disengages from plunger p2 by leaving it unthreaded at thread x. Drive spring 1012 is held within the structure of the device by washer 1013. Note that the end of piston shaft engages with button to rotate with it when it reaches the end of the suction cycle, thereby removing the shaft from the plunger.

[0132] The following describes the use or operation of the device:

[0133] 1. Typically, the user holds the device between their thumb and middle finger, with their thumb and middle finger on the two buttons 2, and their index finger on the safety button 1001.

[0134] 2. When buttons 1001 and 1002 are pressed by the user, a combination of levers, stoppers, cams, or any other mechanical components well known in micromechanical technology triggers the movement of piston p1. At the same time, this triggers the movement of cutting blade 1004.

[0135] 3. Spring 1012 actuates piston p1, and plunger septum p2 is attached to piston p1, causing needle tip ii to pierce the plunger and separate the connection between adsorption zone 1010 and chamber 1011. The cutting blade moves and cuts the patient's skin.

[0136] 4. The spring continuously pulls the piston p1, creating a vacuum in chamber 1011 of the medical analysis tube 1007. The patient begins to bleed, and the blood is drawn into chamber 1011 through cannula 1006. The cutting blade 1004 continues its movement and retracts into the structure of the device.

[0137] 5. When piston p1 reaches the end of its stroke opposite button 1003, aspiration stops, and the sample is contained in chamber 1011. Typically, the sample volume is 500 μl with one cutting blade and 1 ml with two cutting blades.

[0138] 6. The user removes the device from the patient's skin, cleans the wound, and applies a bandage if necessary.

[0139] 7. Optionally, the user uses button 1003 to dispense a small sample, typically 1025 μl, and uses it for commercially available point-of-care tests.

[0140] 8. The user uses button 1003 to disconnect the piston pl from the plunger septum p2, so that the plunger septum p2 remains in the tube 1007 to maintain a tight seal.

[0141] 9. The user releases the device from the structural release tube 1007. After the tube is removed, the plunger septum p2 disengages from and closes the insertion tube 1006.

[0142] 10. The user delivers or takes the tube to a medical analysis laboratory for analysis.

[0143] 11. The analytical laboratory analyzes blood samples and transmits the test results to the patient and / or relevant authorities.

[0144] 12. Optionally, treatment and / or isolation protocols may be initiated to ensure that individuals testing positive are treated in a manner that minimizes the spread of the pathogen.

[0145] In another embodiment, the bodily fluid sampling device according to the invention may include integrated analytical functions. Samples may be collected on the skin or mucous membranes, but samples may have to be collected by penetrating the skin / mucous membrane; in this case, the sampler may optionally be equipped with a cutting blade to open the skin / mucous membrane and release the bodily fluid to be sampled. Reactants may optionally be attached by the user to the surface of the skin / mucous membrane to facilitate sample preservation or enable specific analysis.

[0146] Now for reference Figure 9 The body fluid sampling device 2010 for collecting capillary blood from the earlobe has a main body 2100 and a moving part 2200 for clamping the user-patient's earlobe, allowing the device 2010 to remain in place for the sampling process without the user-patient needing to hold it. The body fluid sampling device 2010 contains an internal mechanism, such as those disclosed in US63 / 002,581 or US63 / 006,337 (the contents of which are incorporated herein by reference and are relied upon herein), or any other suitable mechanism that ensures the complete execution of the body fluid sampling process without triggering external intervention. Automated analysis features and / or systems can be integrated into the device.

[0147] refer to Figures 10A-10B A body fluid sampling device 2210 for collecting capillary blood from the earlobe 2230 of a user-patient 2200 is manufactured in a suitable shape, size, and weight to be held by itself at the collection site 2230 and visible to the patient's face via the camera of a user-patient's smartphone 2250. Optional features 2212, such as QR codes or visual symbols, are provided on the device 2210 to aid in device identification and location. It may also include a display showing preparation, progress, and completion of the sampling process, or any other visual communication elements that can be captured by the camera of the user-patient's smartphone 2250 and analyzed and used by an application of the user-patient's smartphone 2250 to enhance device identification. The device 2210 includes a wireless communication system for communicating with the user-patient's smartphone to trigger the body fluid sampling process and, optionally, to initiate a sample analysis process after sampling is completed. Information communicated between the device 2210 and the user-patient's smartphone 2250 includes: a unique device identifier, sampling trigger, sampling process progress, sampling process completion, and / or error messages. Communication between device 2210 and the user-patient's smartphone 2250, as well as communication between the user-patient's smartphone and the cloud, is encrypted, and blockchain technology can be used to make tampering, misuse, or unauthorized access difficult or impossible. The sampling information, along with the user-patient's identity, is transmitted to the relevant authorities for further processing.

[0148] Now for reference Figure 11 The fifth method for sampling liquids and ensuring user-patient identification includes the following steps:

[0149] 1. The user installs the specific application on his or her smartphone (for first-time use);

[0150] 2. Optionally, the user disinfects the skin surface - optionally the user applies a reactant to the skin / mucous membrane;

[0151] 3. The user attaches the sampling device to their skin / mucous membrane;

[0152] 4. The user launches a specific application on their smartphone;

[0153] 5. The application communicates with and identifies the sampling device;

[0154] 6. The app opens the smartphone's camera and invites the user to orient themselves so that both their face and device are visible on the smartphone screen.

[0155] 7. In parallel:

[0156] a: The application runs facial recognition software and identifies the user;

[0157] b. Use image analysis software to identify the sampling device;

[0158] 8. The application communicates with the sampling device and initiates the sampling process;

[0159] 9. In parallel:

[0160] a. Use stored time-lapse video footage as evidence of the sampling process;

[0161] b. The sampling device performs the sampling process;

[0162] 10. When the sampling process is complete, the sampling device communicates with the application; and

[0163] 11. The application stores information about the sampling device identifier, sampling time, and user identity in the cloud and / or its internal storage.

[0164] Now for reference Figure 12 An embodiment of the capillary blood sampling device 4100 according to the present invention has a main structure 5000, which includes: an adsorption interface 5100 adapted to attach to the skin of a user / patient; one or more push-buttons 5200 for user / patient actuation of the device 4100; and a tube holder 6000 configured to accommodate a vacuum sampling tube, such as a vacuum sampling tube for venous blood sampling well known in the industry. Inside the main structure 5000 are arranged: a suction chamber 5400 connected via a channel 7000 to the interior 6100 of the tube holder 6000; an actuation mechanism 5300 for converting the user / patient's action of pushing one or more buttons 5200 into actuation of the device 4100; and optional electronic components and / or connectivity features, such as GPS or geolocation systems, identification tags, wireless communication systems, or countdown devices with audio feedback.

[0165] The device structure 5000 preferably includes two or more push buttons 5200, and the mechanism 5300 is configured to ensure that the sampling process is initiated only by actuation of all push buttons 5200, thereby minimizing the risk of unintentional initiation. The mechanism 5300 may include a combination of levers, stoppers, cams, or any other elements well-known in micromechanical technology, or preferably may be made of flexible elements that can release sampling simply by deforming when the user / patient presses the push buttons(multiple)) 5200. The device structure 5000 may optionally include means for expelling a small amount of blood from the device 4100 for rapid on-site analysis. A second embodiment of the cutting blade 5450 is shown in these figures, but of course any other form may be used.

[0166] Now for reference Figure 13 According to the invention, the capillary blood sampling device 4100 contacts the user / patient via its adsorption interface 5100, which is attached to a bandage 5120 with a suitable permanent adhesive 5110. The surface of the bandage 5120 facing the user / patient's skin has a temporary adhesive 5130, suitable for holding the device 4100 on the user / patient's skin for at least the duration of the sampling process. The temporary adhesive 5130 is protected with a removable protective film 5140 before use. The adhesives 5110, 5130, and the bandage 5120 expose the passageway 5150 to allow blood sampling and are hermetically sealed around it to ensure a vacuum is established between the user / patient's skin and the suction chamber 5400 for the sampling process. The bandage 5120 may have a relatively large surface area compared to the adsorption interface to ensure sufficient hermetical sealing with the user / patient's skin.

[0167] Depending on the size requirements of the sample to be collected, the suction chamber 5400 contains one or more cutting blades 5450 according to the second embodiment. Theoretically, one cutting blade can collect up to 500 μl, while two cutting blades are required to collect 1 ml. For reference, the blood flow duration for 500 μl from one incision is approximately 30 seconds, and therefore two incisions are used for approximately the same time for 1 ml. The cutting blade 5450 has a resilient or spring portion 5458, which is loaded during the assembly of the device 4100 and is held under tension by a mechanical finger 5350. The mechanical finger 5350 is connected to a mechanism 5300 so that the mechanism 5300 can release the cutting blade 5450 when actuated. The cutting blade is positioned to puncture the user's / patient's skin through a passage 5150 upon release. The suction chamber is sealed by an airtight membrane 5420 made of an airtight material, which can be cut by the cutting blade 5450 while cutting the user's / patient's skin without being torn off. Optionally, the suction chamber 5400 includes an airtight elastic liner 5410, which allows the mechanism 5300 to actuate the mechanical finger 5350 in an airtight manner and optionally includes means for expelling a small amount of blood for rapid on-site analysis. Suitable materials for the membrane 5420 and the optional elastic liner 5410 are well known in the art and may include silicone, rubber, and other elastomers and / or plastics in one or more layers. The suction chamber 5400 is manufactured to minimize its volume so that most of the collected blood is not retained in the suction chamber 5400 and can be fed into a vacuum tube, and a very 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 can be a needle 7200, with the suction end 7100 of the needle connected to the suction chamber 5400, and the dispensing end 7300 of the needle adapted to enter the vacuum tube and carry the collected blood into the tube. Typically, the needle 7200 can be made of stainless steel, but other materials available in the industry today, such as other metals, composite materials, and / or plastics, can be used.

[0168] Now for reference Figures 14A to 14I The operation of the device is described below:

[0169] 1. See Figure 14AThe sampling device 4100 and vacuum tube 8000 are delivered to the user / patient separately in sterile packaging. The dispensing end 7300 of the needle is sharp enough to penetrate the septum 8100 (sometimes referred to as a "rubber stopper") of the vacuum tube 8000 and is protected by an elastic (preferably silicone or rubber) sheath 7400. Optionally, the tube retainer 6000 is sealed by a removable protective film 6110. Optionally, the tube retainer 6000 is made of a transparent material. Alternatively, the tube retainer 6000 may include a transparent window 6200 to allow the user / patient to see the interior 6100 of the tube retainer. Optionally, the rubber sheath 7400 is made of a "self-healing" material, such as that known in the art, which automatically seals the dispensing end of the needle 7300 after use.

[0170] 2. See also Figure 14B The user / patient removes the optional protective film 6110 and inserts the vacuum tube 8000 into the tube holder 6000 with the septum 8100 of the vacuum tube 8000 facing the dispensing end 7300 of the needle until the bottom of the inner 6100 of the tube holder 6000 is reached.

[0171] 3. See also Figure 14C When the vacuum tube 8000 reaches the bottom 6120 of the inner 6100 of the tube holder 6000, the vacuum tube 8000 compresses the rubber sleeve 7400 and the dispensing end of the stripping needle 7300, allowing the dispensing end of the needle 7300 to penetrate the septum 8100 of the vacuum tube 8000, and to establish 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.

[0172] 4. See also Figure 14D The user / patient disinfects the area of ​​skin 9000 where blood will be collected, removes the protective film 5140, and attaches the device 4100 to the area where blood will be collected. As a result, the device remains on and seals the user / patient's skin 9000 due to the bandage 5120 and the adhesives 5110 and 5130.

[0173] 5. See also Figure 14E The user / patient actuates mechanism 5300 by pushing one or more push buttons 5200. This mechanism then actuates mechanical finger 5350 and releases one or more cutting blades 5450. The one or more cutting blades 5450 cut through membrane 5420 and the user / patient's skin 9000, rupturing several capillaries in the patient's skin 9000, and allowing negative pressure to enter the user / patient's skin 9000.

[0174] 6. See also Figure 14FAfter the membrane 5420 and the user's / patient's skin 9000 are punctured, one or more cutting blades 5450 terminate their movement in the recessed area of ​​the suction chamber 5400 and leave the wound area 9100, out of the user's / patient's reach of their sharp edges. As the wound begins to bleed, the suction chamber 5400 gradually fills with the user's / patient's blood 10000.

[0175] 7. See also Figure 14G 10,000 ml of blood is injected into the vacuum tube 8000 through the suction end 7100 of needle 7200, through the dispensing end of needle 7200, and through needle 7300.

[0176] 8. See also Figure 14H When the vacuum tube 8000 is fully filled with blood 10000, the user / patient removes the vacuum tube 8000 from the device. An indication that the vacuum tube is fully filled can be provided by an electronic or mechanical timer integrated in the mechanism 5300, by a scale on the vacuum tube visible to the user / patient through the transparent tube holder 6000, by a magnetic or capacitive sensitive band in contact with the blood, or through the transparent window 6200, or by observing the cessation of blood flow when the vacuum is depleted, or by any other suitable means. When the vacuum tube is removed from the tube holder 6000, the resilient sheath 7400 extends freely and covers the dispensing end of the needle 7300, closing the path of the blood 10000. Optionally, the user / patient inserts another vacuum tube to collect a blood sample again, repeating steps 7 and 8.

[0177] 9. See also Figure 14I The user / patient removes the device 4100 and attaches a small wound bandage 9200, typically purchased separately, to the wound 9100. Residual blood in the suction chamber 5400 is retained in the suction chamber by a membrane 5420. In cases requiring rapid on-site analysis, 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) integrated into the structure 5000 provides a component for expelling a small amount of blood by squeezing the elastic liner 5410 when a push button is pressed.

[0178] 10. Users may send or take the tube 8000 to a medical analysis laboratory or point of care for analysis. The delivery of suitable samples to the laboratory may also be facilitated by the use of the user's / patient's own refrigerator and, optionally, by containers with high thermal inertia, such as those described in U.S. Application No. 63 / 002,581 or U.S. Application No. 63 / 006,337 (the contents of which are incorporated herein by reference and are relied upon herein), or containers with high thermal inertia and / or insulation, optionally equipped with temperature monitoring and / or signaling devices.

[0179] 11. The analytical laboratory analyzes blood samples and transmits the test results to the patient and / or relevant authorities.

[0180] 12. Optionally, treatment and / or isolation protocols may be initiated to ensure that individuals testing positive are treated in a manner that minimizes the spread of the pathogen.

[0181] Now for reference Figures 15A-15C The second embodiment of the (multiple) cutting blades 5450 is made from a single piece, typically from stamped sheet metal or spring steel, but may also be made from other materials, including composite materials exhibiting suitable mechanical properties. The cutting blade has an end 5460 facing the sampling device structure 5000, to which it can be attached, followed by a resilient region 5458 that is elastically bent when the cutting blade is ready for use. In this way, the cutting blade 5450 contains all the energy necessary for its movement. The resilient region 5458 has a suitable, preferably flat cross-section to provide a preferred release trajectory orthogonal to the attachment end 5460.

[0182] Now for reference Figures 16A to 16F This illustrates a third embodiment of the cutting blade 5456, which is formed in a different and advantageous manner. In the two embodiments of the cutting blades 302 and 5456 above, Figure 15B and Figure 16E The curved arrow in the diagram illustrates the release trajectory. In one embodiment, after the elastic zone 5458, the cutting blade is twisted 90° in region 5456 to provide a blade 5452 in the same plane as the release trajectory.

[0183] Now for reference Figure 17 In another embodiment, the elastic zone may take the form of a multi-turn torsion spring, as found in clothespins. In this case, the blade has a circular cross-section, and the required stiffness is achieved by varying the heat treatment of different areas of the blade. Blade 5452 has high stiffness in the release trajectory direction. A cutting edge 5454 is provided near the end of 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 faces the same side as the mounting end 5460, away from the user / patient's reach.

[0184] In another embodiment, the device 4100 can be remotely triggered via a smartphone, optionally followed by facial recognition or recognition of a QR code visible on the device. Assuming the device is attached to the arm, the patient has one hand free to control this remote triggering.

[0185] In yet another embodiment, the capillary blood sampling system according to the invention includes a patient-based biometric identification system, a device identification system, and a disposable capillary blood sampling device, providing untrained users with the ability to: (a) sample capillary blood, optionally automatically; (b) optionally analyze the blood immediately using one or more droplets of the sampled capillary blood; and (c) provide a standard medical analysis tube containing the capillary blood sample for analysis in a healthcare center or medical laboratory, the device including an interface to a vacuum tube that provides the suction necessary for the blood to fill the vacuum tube.

[0186] Now for reference Figure 18A and Figure 18B The main features of the blood sampling device of the present invention are shown below. The blood sampling device includes, on its top side: a grip 3122, a blood draw button 3120, a blood collection button 3126, a flashing window 3130 indicating that blood collection is ready, a blood collection tube 3132, and a wing 3134 for device removal, and a dressing 3136 with padding on it. The blood sampling device 3100 further includes a blood collection reservoir 3140 with a wound seal, a removal wing 3142 with an adhesive substrate, and a machine-readable code 3144.

[0187] Now for reference Figure 19 The body 3110 of the injection device 3100 includes a mechanism (not shown) that actuates the needle of the present invention located in the injection position 3125 when the user / patient presses the "inject" button 3120. Such a mechanism is well known in micromechanical technology and can include levers, clips, springs, flexible elements, sliders, gears, cams, etc. The injection device 3100 may further include a safety button 3123.

[0188] The injection device may be any suitable injection device, such as those described in U.S. Patent Applications Nos. 63 / 114,162, 62 / 864,572, 62 / 511,361, 15 / 524,748, 31 / 040,459, 14 / 235,107, and 16 / 930,383, the contents of which are incorporated herein by reference and relied upon as material disclosure of this application.

[0189] Now for reference Figures 20A to 20P This illustrates a sixth embodiment of the method of using the system of the present invention, and specific features of the user identification system 1900, the device identification system 1902, the capillary blood sampling devices 3100 and 4100, and the adhesive integrated dressing 3174 included in the capillary blood sampling devices 3100 and 4100 may be removed.

[0190] Figure 20A Step 1 of a sixth embodiment of a method using the system of the present invention is shown. Step 1 includes: a) loading a dedicated app for use with the present invention by scanning a website or prescription; b) signing an informed consent form; c) entering demographic information; d) taking a photograph of a government-issued ID or other means of identification; and e) taking a selfie to associate with the patient, the device, and the sample taken.

[0191] Figure 20B Step 2 of a sixth embodiment of the method using the system of the present invention is shown. Step 2 includes: a) opening the packaging; b) reading the operating instructions; c) removing the contents from the packaging; d) scanning the QR code on the kit box to launch the App and instructions; e) inspecting the contents; and f) cleaning the phone with the disinfecting wipes included in the kit.

[0192] Figure 20C Step 3 of a sixth embodiment of the method using the system of the present invention is shown. Step 3 includes: a) deploying the integrated telephone holder in the box; b) wiping the phone with the included disinfectant wipes; and c) washing hands.

[0193] Figure 20D Step 4 of a sixth embodiment of the method using the system of the present invention is shown. Step 4 includes: a) placing the phone on a stand to take a selfie; b) starting a video selfie, including the face and arms in the frame.

[0194] Figure 20E Step 5 of a sixth embodiment of the method using the system of the present invention is shown. Step 5 includes: a) following the instructions of the App (reading text / viewing images); b) preparing the arm with a hot towel; c) opening the alcohol wipes in the kit; and d) wiping the spots on the upper arm with alcohol and then letting it air dry.

[0195] Figure 20F Step 6 of a sixth embodiment of the method using the system of the present invention is shown. Step 6 includes: a) removing the device from the kit packaging; and b) displaying the camera device on the bracket and the QR code on the tube.

[0196] Figure 20G Step 7 of a sixth embodiment of the method using the system of the present invention is shown. Step 7 includes: a) removing the adhesive substrate; and b) adhering the device to the upper arm.

[0197] Figure 20H Step 8 of a sixth embodiment of the method using the system of the present invention is shown. Step 8 includes: confirming that the face and the selfie video of the device are in the frame.

[0198] Figure 20IStep 9 of a sixth embodiment of the method using the system of the present invention is shown. Step 9 includes: a) pushing a first button; b) waiting until an indication appears in a flashing window; c) confirming the indication; and d) if no indication appears within a specified time, following the guidance to put the kit back.

[0199] Figure 20J Step 10 of a sixth embodiment of the method using the system of the present invention is shown. Step 10 includes: a) pushing a second button; and b) waiting for a timer on the App to indicate that the tube is full via a communication process.

[0200] Figure 20K Step 11 of a sixth embodiment of the method using the system of the present invention is shown. Step 11 includes: a) pulling the flap to peel the device off the arm; b) leaving the dressing on the arm; and c) placing the device back into the kit box.

[0201] Figure 20L Step 12 of a sixth embodiment of the method using the system of the present invention is shown. Step 12 includes: a) removing the dressing padding to expose the gauze pad and adhesive; and b) folding the gauze dressing over the wound.

[0202] Figure 20M Step 13 of a sixth embodiment of the method using the system of the present invention is shown. Step 13 includes: a) the end of the vial suddenly protruding from the device; and b) pulling the vial out of the device.

[0203] Figure 20N Step 14 of a sixth embodiment of the method using the system of the present invention is shown. Step 14 includes: a) securing a sample vial in a biohazard bag from the kit; b) securing the device in a separate biohazard bag from the kit.

[0204] Figure 200 Step 15 of a sixth embodiment of the method using the system of the present invention is shown. Step 15 includes: a) stopping the video; b) removing the phone from the kit holder; c) folding the phone holder; and d) securing the two biohazard bags in the kit box.

[0205] Figure 20P Step 16 of a sixth embodiment of the method using the system of the present invention is shown. Step 16 includes: a) sealing the kit box in a return shipping bag; b) scanning the QR code on the shipping package; c) mailing the package; d) confirming the shipment; e) the App notifying the patient of the measurement results.

[0206] Now for reference Figures 21A to 21DFurther details are shown regarding the specific features of the adhesive-integrated dressing 3174 included in the capillary blood sampling device 3100 of the present invention. The blood sampling device 3100 includes an adhesive 3150 separated from the adhesive 3152 on the bottom of the device surrounding the wound site. The blood sampling device further includes an adhesive substrate 3154 removably disposed on the adhesives 3150, 3152, which is removed before the device is attached to the patient's body. After the device is applied to the patient's arm, it can be removed from the patient's skin by pulling up 3157 via the wing 3156 after the tube 3132 is filled. The adhesive 3150 surrounding the wound site 3162 remains on the skin, having an enclosing feature to temporarily inhibit blood flow from the exposed site area. The dressing liner 3164 is then peeled off 3165 to expose a gauze pad 3166 surrounded by adhesive 3170. The dressing 3174 includes a dressing tab 3172 without adhesive. The dressing tab 3172 can be pulled to place the gauze pad on the wound site and can be secured to cover the wound.

[0207] As a result, the adhesive-integrated dressing 3174 is suitable for ensuring that the blood sampling device 3100 adheres to the patient's skin, and that the patient's skin is airtight with the blood sampling device 3100 during the sampling process and airtight with the wound dressing after the sampling process.

[0208] In another embodiment, the vaccine and / or drug injection device according to the invention provides untrained users with the following capabilities: (a) injecting vaccines and / or drugs, optionally automatically; (b) a data processing and verification system configured to receive data relating to vaccines and / or drugs input by the user / patient via an app or by an HMO that previously received it (wherein the input of data may be performed, for example, manually or by scanning a QR code); and (c) a system configured to transmit data to a network (such as the Internet) and optionally receive data from a network (such as the Internet).

[0209] Devices that enable self-drug administration, such as those described in PCT / US2012 / 048044, PCT / IB2018 / 000559, PCT / IB2013 / 000659, and PCT / IB2020 / 055874, the contents of which are incorporated herein by reference and are relied upon herein.

[0210] As emphasized above, the present invention provides a means for injecting and administering vaccines and / or drugs by untrained users, 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 means of injecting vaccines and / or drugs into the body of a user / patient. For the purposes of this disclosure, the operation of the vaccine and / or drug injection device of the present invention is described as containing one needle; however, it must be understood that the injection device of the present invention may contain more than one needle 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 untrained users with the following capabilities: (a) injecting vaccines and / or drugs, optionally self-injecting; (b) a data processing and verification system configured to receive data related to vaccines and / or drugs input by the user / patient via an app or by an HMO previously receiving it (wherein the input of data may be performed, for example, manually or by scanning a QR code); and (c) a system configured to send data to a network (such as the Internet) and optionally receive data from a network (such as the Internet).

[0211] The device according to the invention allows for the certification of vaccine and / or drug administration. Therefore, the device according to the invention includes means that allow for the verification of one or more of the following:

[0212] 1. Data from the physician or healthcare professional (MED) responsible for vaccine / drug administration and his / her explicit consent to the user / patient's use of the vaccine and / or drug. The device according to the invention is adapted to receive vaccine and / or drug-related data entered by the user / patient via an app or by an HMO that previously received it (wherein the data entry may be performed, for example, manually or by scanning a QR code).

[0213] 2. Temperature of the vaccine and / or drug from shipment to injection (if necessary). The device according to the invention is adapted to process information from a temperature tracker or test strip (typically placed in the shipping container during shipment), optionally a GPS tracker (also typically placed in the shipping container during shipment). Optionally, the tracker can be returned to the vaccine and / or drug manufacturer. When the user / patient removes the device from its thermal protection, a timer associated with the device in the app must be activated. The system (app and / or device) must alert the user / patient associated with this event.

[0214] 3. Patient safety in cases where the patient reacts immediately upon injection (e.g., fainting) and after vaccination (e.g., 15 minutes after injection). For case a), the device according to the invention is adapted to receive input from the user / patient (e.g., by pressing a physical button or a button in an app) to verify that an injection has been administered. If no verification is made after a certain time following the start of the injection, an alarm is triggered to alert the MED and optionally, an emergency procedure is initiated. For case b), the system of the invention is configured to allow the user / patient to confirm to the MED (e.g., by pressing a physical button or a button in an app) that he or she does not require emergency assistance.

[0215] The main feature of the vaccine and / or drug injection device according to the above embodiments of the present invention is that the main body of the injection device includes a mechanism that actuates the needle of the present invention when the user / patient presses the "inject" button. Such a mechanism is well known in micromechanical technology and can include levers, clamps, springs, flexible elements, sliders, gears, cams, etc.

[0216] The injection device may be any suitable injection device, such as those set forth in U.S. Patent Applications Nos. 63 / 114,162, 62 / 864,572, 62 / 511,361, 15 / 524,748, 31 / 040,459, 14 / 235,107, and 16 / 930,383, the contents of which are incorporated herein by reference and relied upon as key disclosures of this application.

[0217] Current capillary blood sampling devices used by untrained users typically create an incision on the patient's skin through one or more needle punctures or even no punctures, allowing only the collection of relatively small volumes of fluid, usually less than 150 μL over 5-10 minutes.

[0218] In another embodiment, the present invention provides means for capillary blood sampling devices 10, 1100, 2010, 2210, 3100, and 4100 to make incisions significantly larger than those typically known in existing capillary blood sampling devices, enabling the collection of a significantly larger volume of blood, typically greater than 500 μL and preferably 1 ml, over a reasonable time period typically less than 15 minutes, preferably less than 10 minutes. The capillary blood sampling device of the present invention uses one or more cutting blades 1004 (e.g., but not limited to cutting blades 302, 5450, 5456, 3260, 3360, 3460) instead of one or more needles, so that the user / patient's skin is abraded rather than punctured. For the purposes of this disclosure, the operation of the sampling device of the present invention is described assuming it contains one cutting blade; however, it must be understood that the sampling device of the present invention may contain more than one cutting blade to increase the amount of blood collected and / or shorten the blood collection time. Furthermore, the present invention provides a cutting solution that facilitates rapid wound healing after blood sampling. Therefore, the object of this invention is to create a wound of optimal depth in the user's / patient's skin to cut as many capillaries as possible while avoiding unnecessary wound width and length, so that natural wound healing occurs as quickly as possible after blood collection. The ideal cutting depth can vary depending on the patient's age, sex, race, and / or health condition; therefore, several versions of the sampling device with adjustments are available. Typically, the ideal cutting depth is between 1 mm and 2 mm.

[0219] Now for reference Figures 22A to 22C In a fourth embodiment, the cutting blade 3260 of the device of the present invention is made of a single piece, typically of sheet metal or spring steel, but may also be made of other materials, including composite materials exhibiting suitable mechanical properties. The cutting blade 3260 has an end 3261 facing the sampling device structure to which it can be attached, followed by an elastic region 3262 that elastically bends when the cutting blade is ready to be used. In this way, the cutting blade 3260 contains all the energy necessary for its movement, and the user / patient simply releases it by pressing the blood draw button 3120. The elastic region 3262 has a preferably flat cross-section to provide a preferred release trajectory orthogonal to its attachment end 3261. In one embodiment, after the elastic region 3262, the cutting blade is twisted 90° in region 3263 to provide a blade portion 3264 in the same plane as the release trajectory. The blade portion 3264 has high rigidity in the direction of the release trajectory.

[0220] Now for reference Figure 17The elastic zone can take the form of a multi-turn torsion spring, as found in clothespins, in which case the blade cross-section is circular, and different stiffnesses required for the function are obtained by varying the heat treatment of different areas of the blade. A cutting edge 3265 is provided towards the end of the blade portion 3264 to cut the user's / patient's skin 3290. After the cutting motion is complete, the cutting edge 3265 is removed from the user's / patient's reach. Optionally, the cutting blade 3260 includes fingers 3270 that interact with the device's structural elements 3242, 3244, 3246 to bias the natural release trajectory 3250 of the cutting blade 3260 upon release to obtain a modified trajectory 3240.

[0221] Typically, the natural release trajectory 3250 of the cutting blade 3260 is substantially circular, elliptical, or spiral. As a result, the scratches in the patient's skin 3290 are substantially 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 elements 3242, 3244, 3246 of the device structure interact with the fingers 3270 of the cutting blade 3260, the resulting trajectory of the cutting blade 3260 is modified, resulting in a steeper downward and retraction path for the scratches in the patient's skin 3290, resulting in a shorter wound length 3294 for a larger proportion of the wound at the desired depth 3292. The modified trajectory 3240 allows for the collection of a larger volume of capillary blood from a relatively small wound, contributing to faster wound healing after blood collection.

[0222] Now for reference Figure 22B For example, element 3242 of the device structure is made to locally expand the radius of the natural release trajectory 3250, and element 3244 of the device structure is made to locally shrink the radius of the natural release trajectory 3250.

[0223] Now for reference Figure 22C As a further example, element 3246 of the device structure is made such that the radius of the natural release trajectory 3250 is locally reduced.

[0224] Now for reference Figures 23A to 23BIn a fifth embodiment, the cutting blade 3360 of the device of the present invention is made of a single piece, typically of sheet metal, but may also be made of other materials, including composite materials exhibiting suitable mechanical properties. The cutting blade 3360 has an end 3361 facing the sampling device structure to which it can be attached, followed by an elastic zone 3362 that elastically twists when the cutting blade 3360 is ready for use. In this way, the cutting blade 3360 contains all the energy necessary for its movement, and the user / patient simply releases it by pressing the blood draw button 3120. The elastic zone 3362 has a suitable, preferably flat cross-section to provide a preferred planar natural release trajectory 3350. In one embodiment, after the elastic zone 3362, the cutting blade is twisted 90° in region 3363 to provide a blade portion 3364 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 toward the end of the blade portion 3364 to cut the user / patient's skin (not shown). After the movement is completed, the cutting edge 3365 moves away from the user / patient's reach. Optionally, the cutting blade 3360 includes fingers 3370 that interact with structural elements 3342 of the device to bias the natural release trajectory 3350 of the cutting blade 3360 upon release to obtain a modified release trajectory 3340.

[0225] Typically, the natural release trajectory 3350 of the cutting blade 3360 is substantially circular or spiral. As a result, the scratch in the patient's skin 3290 is substantially circular with a relatively large radius, and the wound length is relatively long for a relatively small portion of the desired depth. When the element 3242 of the device structure interacts with the fingers 3370 of the cutting blade 3260, the trajectory 3340 of the resulting cutting blade 3360 can be modified, resulting in a scratch on the patient's skin with a steeper downward and retraction path, resulting in a shorter wound length and a longer proportionate wound at the desired depth. The modified trajectory 3340 allows for the collection of a larger volume of blood from a relatively small wound, contributing to faster wound healing after blood collection. For example, the element 3342 of the device structure is made to locally constrict the radius 3352 of the natural release trajectory 3350 by offset 3341 on a portion of the release trajectory 3340. Alternatively, the element 3342 of the device structure can be made with a more complex shape to provide a finer modified trajectory 3340.

[0226] Now for reference Figures 24A to 24C In a sixth embodiment, the cutting blade 3460 of the device of the present invention is made of a single piece, typically of a sheet of metal, but may also be made of other materials comprising composite materials exhibiting suitable mechanical properties. Referring now to... Figure 24AThe cutting blade 3460 has a rotating connector 3466 to the device structure; and a cutting edge 3465 in a retracted position before the cutting process.

[0227] Now for reference Figure 24B When actuated, the cutting blade 3460 enters the patient's skin 3490 in a rotating motion, but the rotating motion is restricted by the structure so that the patient's skin is not completely cut.

[0228] Now for reference Figure 24C After the incision, the cutting blade 3460 retracts in a counter-rotating motion, leaving a much smaller wound under the patient's skin than a complete incision would have. As a result, due to the deep incision, a larger volume of blood can be collected, but the smaller opening on the surface of the patient's skin 3490 helps the wound heal faster after blood collection.

[0229] Now for reference Figures 25A to 25D In a fifth embodiment, the cutting blade 3660 of the device of the present invention can be a standard scalpel or any other rigid blade, typically made of a sheet of metal, but may also be made of other materials, including composite materials exhibiting suitable mechanical properties. The cutting blade 3660 has a cutting edge 3665, which is positioned substantially parallel to the user's / patient's skin 3690. The mechanism of the device (not shown) guides the cutting blade in a linear motion to enter the user's / patient's skin at a substantially non-orthogonal angle. Figure 25B In this way, the cutting blade 3665 penetrates completely into the user's / patient's skin, reaching a substantially uniform depth along its entire length, creating a substantially rectangular wound that is non-orthogonally oriented within the user's / patient's skin. Figure 25C When the cutting blade retracts ( Figure 25D The skin flap generated by the non-orthogonal wound naturally closes the wound entrance, which helps the wound heal faster after blood collection.

[0230] In another embodiment, the invention provides verification of self-administered medical procedures. The objective of this embodiment is to ensure that the user / patient is identified:

[0231] - Regarding blood sampling: Ensure that the blood in (multiple) sampling tubes is from this patient.

[0232] - Regarding the injection: Make sure this patient receives the injection.

[0233] What is of vital importance here is:

[0234] Regarding blood sampling

[0235] • Reliable blood sampling;

[0236] • During the pandemic, authorization is granted for contact with work, travel, and family.

[0237] • Authorize the use of a certain treatment;

[0238] • Large-scale sampling procedures for the automated detection of epidemics;

[0239] • A test of the effectiveness of a given treatment (payment for successful treatment).

[0240] Regarding vaccination: Authorization of contact with the body at work, during travel, and at home after vaccination / treatment is adopted can be of interest. Furthermore, maintaining up-to-date individual immunization records and automating mass vaccination programs are of interest. Additionally, payment for treatment can be of interest, depending on vaccination status and only if full administration is achieved. Therefore, conducting reliable patient and process verification is crucial.

[0241] On another front, verification of the self-administered medication process is important. For example, a smartphone app can be used to record video (or time-lapse photography) in which the patient's face and the process itself are visible throughout the entire duration of the procedure. The patient's ID can be compared with their face. Patient facial recognition and the entire process can be observed. The system can be configured to initiate the process only when all IDs are confirmed. Logistics can be automated (sampling tube collection and transportation, processing and resupply, etc.). In cases where the smartphone app is configured to analyze video in real time, step-by-step instructions can be provided to the patient in real time while the process is being performed. Other features can be included, such as automated monitoring of process performance. While possible, processing is always challenging when it occurs in areas with insufficient network coverage, especially under degraded conditions. Optionally, temporary network coverage can be provided by drones or balloons during treatment activities. However, it is best if the app can operate independently of network coverage. Saving all data to the smartphone for verification at a later stage may also be desirable. Of course, respecting privacy data regulations is an issue. The app can be configured to run the first analysis and then run an encryption routine to make the private data unreadable, and optionally save the entire video for later use if needed (e.g., as formal evidence in court).

[0242] The main components of the system include a smartphone or laptop / computer or similar device and a camera (which may be included in the smartphone / laptop / computer); an application running on the smartphone or laptop / computer; and a reusable device for performing the injection / sampling process. Additionally, there is a therapeutic agent to be injected / one or more empty tubes / vials containing (multiple) blood samples (which can be collected under vacuum).

[0243] Regarding some key features of the system of the present invention, the app must be able to read the unique ID of the processing container / sampling tube using, for example, a standard barcode / QR code. The app must be able to identify key process steps. The device may need to include automatic wireless signal transmission (information: ID / process start / process in progress / process complete / error). This signal can be visible (e.g., flashing / colored LED) and easily decipherable in video. Optionally, the device of the present invention may include visible features / landmarks that are easily identifiable in video. The app should be able to initiate the treatment process. Optionally, the device is equipped with remote triggering features and, advantageously, includes a unique ID.

[0244] Now for reference Figures 26A to 26C Optionally, the easily identifiable visible feature 2600 integrated into the device 2610 of the present invention may preferably be applied to the moving part (in this example, the button 2650) and presented in the form of a combination of only one different high-contrast patterns 2620, 2630 visible at a time through the window 2612. As a result, the observer can easily identify or the image analysis software can easily recognize the moving part. Figure 26B Button 2650, located in a high position Figure 26C The predetermined position of the button 2650 in the low position.

[0245] This invention can have other uses. For example, it can be applied to medical treatments other than injections (the device can be a pill dispenser). It can be used for filling out ballot forms at home, signing documents, verifying a person's ID during a teleconference, or conducting remote examinations. This invention can be summarized as including the following set of features:

[0246] 1. A disposable body fluid sampling device that provides the following functions to a user without medical training: (a) sampling body fluids (e.g., blood), optionally automatically; (b) optionally dispensing one or more droplets of the collected fluid for immediate analysis; and (c) providing a sample chamber containing a sample of body fluid (e.g., blood) for analysis in a medical laboratory.

[0247] 2. The disposable body fluid sampling device according to feature set 1, wherein the sample receiving chamber is a standard medical analysis tube.

[0248] 3. A method of using a body fluid sampling device according to feature set 1, wherein if a pathogen test of a test subject is positive, a treatment and / or isolation protocol is initiated to ensure that the test subject with a positive test result is treated in a manner that minimizes the spread of the pathogen.

[0249] 4. A method for collecting and potentially analyzing bodily fluid samples, such as blood, using an apparatus according to feature set 1, while ensuring the identification of the individual whose bodily fluids are sampled.

[0250] 5. A disposable bodily fluid sampling device according to one of feature sets 1 or 2, having been made of a material having thermal inertia that allows the sample temperature to be maintained for a known period of time.

[0251] 6. A disposable bodily fluid sampling device according to feature set 5, wherein the thermal inertia is selected to provide storage for a known time period in the surrounding environment sufficient to allow non-refrigerated transport to the collection point.

[0252] 7. The apparatus according to the preceding feature set, wherein the known time period is in the range of 1 to 2 hours under normal ambient conditions, and preferably in the range of 1 to 6 hours, and more preferably in the range of 1 to 8 hours.

[0253] 8. The disposable body fluid sampling device according to feature set 5, comprising an insulated sleeve configured to be manually or automatically triggered to slide on the sample receiving chamber.

[0254] 9. A disposable bodily fluid sampling device according to the preceding feature set, wherein the thermal inertia is selected to provide a known time period sufficient to allow non-refrigerated transport to the collection point.

[0255] 10. The apparatus according to the preceding feature set, wherein the known time period is in the range of 1 to 2 hours under normal ambient conditions, and preferably in the range of 1 to 6 hours, and more preferably in the range of 1 to 8 hours.

[0256] 11. A disposable capillary blood sampling device according to feature set 1, the device comprising an interface and a vacuum tube, the vacuum tube providing the suction necessary for the blood to fill the vacuum tube.

[0257] 12. A cutting blade for making a cut in the skin of a user / patient using a disposable capillary blood sampling device according to feature set 11, wherein the cutting blade is constructed from a single piece of material and provides energy for its movement and guidance of its movement.

[0258] 13. A device and app combination for administering a drug or vaccine, providing an untrained user with the ability to perform self-injection, the self-injection being adapted to interact with the app, preferably wirelessly and optionally connected to the Internet via a cloud, the app including means for authenticating the patient's ID and / or the specific device used, the combination comprising at least the following:

[0259] a) Access to a data storage device adapted to store data of a physician or healthcare professional (MED) responsible for administering the vaccine / drug and his / her specific approvals for administering the vaccine and / or drug to a user / patient, wherein the combination is adapted to receive data related to the vaccine and / or drug input by the user / patient or input by an HMO that previously received it (wherein the input of the data may be performed, for example, manually or by scanning a QR code).

[0260] b) Recording means, suitable for recording the temperature of the time from shipment to the substantially required time for administration of the vaccine and / or drug;

[0261] c) Patient safety measures suitable for activation when the patient responds to:

[0262] i) Immediately upon injection (e.g., syncope); and / or

[0263] ii) After vaccination (e.g., 15 minutes after injection).

[0264] In the case i) mentioned above, the combination according to the invention is adapted to receive input from the user / patient.

[0265] Furthermore, the device is adapted for shipment under thermal protection, and the combination optionally includes a temperature tracker or test strip (typically placed in the shipping container during shipment) to track the storage temperature during shipment, and a GPS tracker (also typically placed in the shipping container during shipment).

[0266] 14. The system according to feature set 13, wherein the system is adapted to receive input from a user pressing a physical button or a key in an app to verify that an injection has been administered.

[0267] 15. The system according to the preceding feature set, wherein the system is adapted to trigger an alarm to alert the MED if no verification is performed some time after the patient has started the injection, and optionally trigger an emergency procedure.

[0268] 16. The system according to feature set 13, wherein the system of the present invention is configured to allow the user / patient to confirm (e.g., by pressing a physical button or a button in an app) that he or she is healthy in the aforementioned case ii).

[0269] 17. The system according to any one of feature sets 13 to 16, wherein the tracker is adapted to return to the vaccine and / or drug manufacturer.

[0270] 18. The system according to feature set 13, wherein a timer is provided in the app and configured to be activated in the app when the user / patient removes the device from its thermal protection, wherein the combination must alert the user / patient in connection with this event.

[0271] 19. A capillary blood sampling device provides an untrained user with the ability to sample capillary blood, optionally analyze the blood using an analytical device, and fill a sample tube with the blood, the device comprising:

[0272] (a) A sampling mechanism for sampling capillary blood, optionally automatically;

[0273] (b) Optionally, the analytical device using one or more droplets of the sampled capillary blood is configured to analyze the blood immediately; and

[0274] (c) A filling mechanism configured to fill standard medical analysis tubes with a sample of capillary blood for analysis at a healthcare point or medical laboratory.

[0275] The device includes a vacuum tube and an interface for the vacuum tube, the vacuum tube providing the necessary suction to fill the vacuum tube with blood.

[0276] 20. The device according to any one of feature set 1 to 11 or 19, comprising one or more cutting blades for cutting the skin of the user / patient.

[0277] 21. The device according to feature set 20, wherein the one or more cutting blades are cutting blades whose trajectory is configured to be substantially non-circular as the cutting blade passes through the patient's skin, providing a wound shape that optimizes the number of capillary cuts and facilitates rapid wound healing after blood collection.

[0278] 22. The device according to any one of feature sets 19 to 21 includes one or more cutting blades, wherein the trajectories of said one or more cutting blades are configured to be substantially non-orthogonal in the patient's skin, providing an optimized number of capillary cuts and a wound shape that facilitates rapid wound healing after blood collection.

[0279] 23. The apparatus according to feature set 22, wherein the trajectory of the one or more cutting blades is configured to have a limited rotation, cutting the skin substantially below the surface of the skin.

[0280] 24. The device according to feature set 22, wherein the trajectory of the one or more cutting blades is configured to have substantially linear motion that is substantially non-orthogonal to the skin of the user / patient.

[0281] 25. A capillary blood sampling method, said capillary blood sampling method providing untrained users with the ability to sample capillary blood, analyze blood, and fill a sample tube with said blood, said method comprising the steps of:

[0282] (a) Using the apparatus according to any one of feature sets 1, 4 to 11, 13 to 14, to sample capillary blood, optionally to automatically sample the blood;

[0283] (b) Optionally, one or more droplets of the sampled capillary blood are used to immediately analyze the blood and read characteristics such as blood type; and

[0284] (c) Fill the sample containment chamber with a sample of capillary blood for analysis at a health point or medical laboratory.

[0285] 26. The method according to feature set 25, wherein the sample receiving chamber is a standard medical analysis tube.

[0286] 27. A method of using a capillary blood sampling device according to any one of feature sets 1 to 7, wherein if the subject of the test is positive for a pathogen, a treatment and / or isolation protocol is initiated to ensure that the subject with a positive test is treated in a manner that minimizes the spread of the pathogen.

[0287] 28. The method according to feature set 25, wherein the method further comprises the step of providing blood sample analysis results, and the certificate provided to the authorities is used by the authorities to authorize the user / patient for certain activities.

[0288] 29. The method according to feature set 25, wherein the method includes the step of using the results of blood sample analysis and provided evidence to waive treatment costs.

[0289] 30. A method for bulk collection and analysis of organism samples, the method comprising collecting organism samples, such as bodily fluid samples, without intervention from a medically trained individual, the method comprising at least the steps of:

[0290] a) Provide the test subject with a uniquely identified sample device and operating instructions according to any one of feature sets 1, 5 to 11, 13 to 24;

[0291] b) Provide operating instructions, including instructions for placing the device in a refrigerator to cool the device before and / or after taking blood or other samples;

[0292] c) Take the sample and associate the unique identifier of the sample device with the object to be detected;

[0293] d) Transport the sample to the collection site;

[0294] e) Analyze the sample to identify the pathogen and notify the subject of the test of the results.

[0295] 31. A method for batch collection and analysis of organism samples according to feature set 30, the method comprising the steps of:

[0296] - Provide operating instructions, including instructions for collecting blood or other samples;

[0297] - Take the sample and associate the unique identifier of the sample device with the object being detected;

[0298] - Additional operating instructions are provided, including optional operating instructions for placing the device in a refrigerator to cool the device.

[0299] 32. The method according to the preceding feature set, comprising the additional step of: if the pathogen test of the subject is positive, instructing a treatment and / or isolation protocol to ensure that the subject with a positive test result is treated in a manner that minimizes the spread of the pathogen.

[0300] 33. A method for bulk collection and analysis of organism samples, the method comprising collecting organism samples, such as bodily fluid samples, without intervention from a medically trained individual, the method comprising at least the steps of:

[0301] a) Provide the object to be detected with a uniquely identified sample device and operating instructions according to any one of feature sets 1, 5 to 11, 13 to 24;

[0302] b) Provide the aforementioned operating instructions, including instructions for obtaining blood or other samples;

[0303] c) Take the sample and associate the unique identifier of the sample device with the object to be detected;

[0304] d) Provide another operating guide, which optionally includes placing the device in a refrigerator to cool the device before step c) when taking the sample, and further optionally includes sliding an isolation sleeve on the sample holding chamber in the device after the device has reached a temperature within an acceptable temperature range, thus extending the time the sample can be safely stored during transport and before the sample analysis in step f).

[0305] e) Transport the sample to the collection site;

[0306] f) Analyze the sample to identify the pathogen and notify the test subjects of the results.

[0307] 34. A method for bulk collection and analysis of organism samples, the method comprising collecting organism samples, such as bodily fluid samples, without intervention from a medically trained individual, the method comprising at least the steps of:

[0308] a) Provide the object to be detected with a uniquely identified sample device and operating instructions according to any one of feature sets 1, 5 to 11, 13 to 24;

[0309] b) Provide the operating instructions, optionally including instructions for placing the device in a refrigerator to optionally cool the device before and / or after taking blood or other samples;

[0310] c) Optionally, when the sample is taken, after step d) and in accordance with the operating guidelines, the sample device is placed in a refrigerator for an indicated period of time, and further optionally includes sliding an isolation sleeve on the sample holding chamber in the device after the device has reached a temperature within an acceptable temperature range, thus extending the operating guidelines for the safe storage of the sample during transport and prior to the sample analysis in step f).

[0311] d) Transport the sample to the collection site;

[0312] f) Analyze the sample to identify the pathogen and notify the test subjects of the results.

[0313] 35. The method according to the preceding feature set, the method comprising the further step of: if the pathogen test of the test subject is positive, initiating a treatment and / or isolation protocol to ensure that the test subject with a positive test result is handled in a manner that minimizes the spread of the pathogen, such as by complying with the isolation protocol.

[0314] 36. A system capable of verifying the proper execution of a self-administered medical procedure such as blood sampling or injection, the system using an apparatus according to any one of the devices in the feature sets 1, 5 to 11, or 23 to 24, comprising: a biometric scanner configured to identify unique biometric features of the user / patient, such as face, scalp, eyes, fingerprints; and a video recorder for recording video or time-lapse photography of the procedure being performed.

[0315] 37. The system according to feature set 36, wherein the system is combined with an app running on a smartphone.

[0316] 38. According to the system of feature set 36, the device identification module is adapted to identify the device performing the blood sampling or injection process in real time.

[0317] 39. According to the system described in feature set 38, the device identification module is adapted to analyze the user / patient and / or sampling / injection device's execution of the process in real time.

[0318] 40. The system according to feature set 39 includes a device identification module adapted to assign auditory and / or visual instructions to the user / patient in real time to correctly operate the process.

[0319] 41. The system according to feature set 39 includes a triggering module configured to wirelessly trigger part or all of the sampling or injection process.

[0320] 42. The system according to any one of the aforementioned feature sets 36 to 41, including a connection mechanism adapted to provide a suitable connection for real-time communication with health authorities while the process is in operation.

[0321] 43. A system according to any one of the aforementioned feature sets 36 to 42, comprising a self-contained application running on a smartphone, including securely storing in the smartphone a video or time-lapse video of the process to be used as evidence later.

[0322] 44. The system according to feature set 33, wherein the provided proof is suitable for use by authorities to authorize a user / patient for certain activities.

[0323] 45. The system according to feature set 33, wherein the provided proof is suitable for waiving medical treatment costs.

[0324] 46. ​​A system for capillary blood sampling according to any one of feature sets 36 to 45 comprises a patient biometric identification system, a device identification system, and a disposable capillary blood sampling device, providing untrained users with the ability to: (a) sample capillary blood, optionally automatically; (b) optionally analyze the blood immediately using one or more droplets of the sampled capillary blood; and (c) provide a standard medical analysis tube containing a sample of capillary blood for analysis at a point of care or medical laboratory, the device comprising an interface and a vacuum tube adapted to provide the necessary suction to fill the vacuum tube with blood.

[0325] 47. The capillary blood sampling system according to feature set 46, wherein the identification system is adapted to provide real-time identification of the user / patient and the device performing the blood sampling process.

[0326] 48. A capillary blood sampling system according to feature set 46, wherein the identification system includes a storage means for securely storing video or time-lapse photography of the sampling process for later use as evidence.

[0327] 49. A method for using a capillary blood sampling system according to any one of feature sets 36 to 48, wherein the results of blood sample analysis and the evidence provided are used by authorities to authorize a user / patient for certain activities.

[0328] 50. A method for using a capillary blood sampling system according to any one of feature sets 36 to 48, wherein the results of blood sample analysis and the evidence provided are used to waive medical expenses.

[0329] 51. A disposable body fluid sampling device according to feature set 1, wherein the device comprises an adhesive integrated dressing adapted to (i) ensure that the blood sampling device adheres to the patient’s skin, (ii) ensure an airtight seal between the patient’s skin and the blood sampling device during the sampling process, and (iii) provide a dressing for a wound after the sampling process.

[0330] Furthermore, the invention should be considered as including all possible combinations of each feature that can be considered novel, inventive and industrially applicable as described in this specification, the appended claims, and / or the drawings.

[0331] It should be understood that the specific embodiments shown and described herein are typical representatives and best practices of the invention, and are not intended to limit the scope of the invention in any way.

[0332] Those skilled in the art will understand that the present invention can be embodied as a system, apparatus or method.

[0333] In addition, the system is intended to use, sell, and / or distribute any goods, services, or information with similar functionality as described herein.

[0334] The specification and drawings should be considered illustrative rather than restrictive, and all modifications described herein are intended to be included within the scope of the claimed invention. Therefore, the scope of the invention should be determined by the appended claims (current, amended, or supplementary claims and their legal equivalents), and not solely by the examples described above. Unless otherwise expressly stated, the steps recited in any method or process claim may be performed in any order, and are not limited to any particular order presented in any claim. Furthermore, the elements and / or components recited in the apparatus claims may be combined or otherwise configured in various permutations and combinations to produce substantially the same results as the invention. Therefore, the invention should not be construed as limited to the specific configurations recited in the claims.

[0335] The benefits, other advantages, and solutions mentioned herein are not to be regarded as key, required, or essential features or components described in any or all of the claims.

[0336] As used herein, the terms “comprises,” “comprising,” or any variation thereof are intended to refer to a non-exclusive enumeration of elements, such that any apparatus, process, method, article, or component of the invention that includes the list of elements may include not only those elements listed but also other elements described herein. Unless otherwise indicated, the use of the terms “composes,” “consisting of,” or “substantially composed of” is not intended to limit the scope of the invention to the elements subsequently named. Other combinations and / or modifications or adaptations of the above-described elements, materials, or structures used in the implementation of the invention may be made or adapted to other designs by those skilled in the art without departing from the general principles of the invention.

[0337] Unless otherwise stated, the patents and articles mentioned above are hereby incorporated herein by reference, provided that they do not conflict with the contents of this disclosure.

[0338] Other features and modes of the invention are described in the appended claims.

[0339] Furthermore, the invention should be considered as including all possible combinations of each feature that can be considered novel, inventive and industrially applicable as described in this specification, the appended claims, and / or the drawings.

[0340] The benefits, other advantages, and solutions mentioned herein are not to be regarded as key, required, or essential features or components described in any or all of the claims.

[0341] Additional features and functions of the invention are described in the appended claims. These claims are hereby incorporated in their entirety by reference and should be considered part of the filed application.

[0342] Various variations and modifications are possible in the embodiments of the invention described herein. For example, the cutting blade 1004 may take any form, and is not limited to the cutting blades 302, 5450, 5456, 3260, 3360, and 3460 disclosed herein. While certain illustrative embodiments of the invention have been shown and described herein, numerous changes, modifications, and substitutions are contemplated from the foregoing disclosure. Although the foregoing description contains many specific details, these details should not be construed as limiting the scope of the invention, but rather as illustrative of one or another preferred embodiment. In some instances, certain features of the invention may be employed without corresponding use of other features. Therefore, it should be understood that the foregoing description is broadly regarded and understood to be illustrative only, and the spirit and scope of the invention are limited only by the claims finally published in this application.

Claims

1. A process verification system for medical procedures performed without medical personnel intervention, characterized in that, include: – A disposable medical device for performing the procedure; – A computing device that includes a camera and is configured to execute applications; as well as – A storage medium configured to securely store and / or transmit the process evidence locally and / or remotely in an encrypted manner. The application is configured as follows: • Guide users through the medical procedure by providing text, audio, and / or visual instructions; • Acquire videos and / or photographs of the user and medical device during the process; • Perform biometric identification on the user, the biometric identification being selected from face recognition, fingerprint recognition, iris recognition, or scalp recognition, and perform identification on the device by scanning codes or analyzing visible markers; • Store and / or transmit the association between the user identity, device identity, timestamp, and process events; wherein the recorded media and related data constitute verifiable evidence that the medical procedure was performed by or on the identified patient.

2. The system of claim 1, wherein the application provides text, audio, and / or visual instructions in real time.

3. The system of claim 1, wherein the medical procedure is selected from capillary sampling, drug injection, or oral administration via a pill dispenser.

4. The system of claim 1, wherein the medical procedure is performed by the patient himself.

5. The system of claim 1, wherein the medical procedure is performed on the patient by a person without medical training.

6. The system according to claim 1, wherein the application provides real-time prompts and triggers an alarm if no user confirmation is received within a predetermined time.

7. The system of claim 1, wherein the computing device transmits the process evidence to the healthcare provider.

8. The system of claim 1, wherein the computing device transmits the process evidence to a medical authority.

9. The system of claim 2, wherein the computing device transmits the process evidence to the healthcare provider.

10. The system of claim 2, wherein the computing device transmits the process evidence to a medical authority.

11. The system of claim 1, wherein the computing device is a smartphone.

12. The system of claim 1, wherein the video is a time-lapse image.

13. The system of claim 3, wherein the drug is a vaccine.

Images