Device for collecting biological samples

Abstract

The present disclosure relates to a device for collecting biological samples, which allows the collection and transport of a liquid sample, especially saliva with infectious potential, in a manner that is safe and simple for patients and health professionals. To carry out these functions, the collecting device includes various means to prevent the release of the contained liquid. In addition, the device is "self-contained" and does not require pieces to added or be discarded to collect the samples.

Description

[0001] BIOLOGICAL SAMPLE COLLECTION DEVICE

[0002] related technical field

[0003] This disclosure relates to devices for collecting biological samples from a user. In particular, this disclosure describes a saliva sample collector that can be used in the field of medicine and scientific research.

[0004] Description of the state of the art

[0005] Currently, saliva is used to perform convenient, easy, safe, and effective screening tests for various diseases. These screening tests include, for example, COVID-19, hepatitis, HIV, nicotine, and cocaine. Furthermore, oncology, neurology, infertility, allergy, orthopedics, and pain clinics, which previously used urine, blood, and serum samples to determine their patients' medical conditions, now use saliva samples for the same purpose.

[0006] Currently, there are also various devices for collecting biological samples, particularly various devices for collecting saliva from patients, although the way in which these obtain the fluid sample varies depending on each device.

[0007] Therefore, in the state of the art, documents related to obtaining saliva are identified, for example, documents US5260031A, US5910122A and CN108703775A.

[0008] Patent US5260031A discloses a saliva sample collection device comprising a holder, a saliva collector, and an indicator. The saliva collector is a piece of filter paper attached to the holder that selectively receives a saliva sample. The indicator is activated by a preselected amount of the collected saliva sample. The indicator is coupled to both the holder and the collector.

[0009] Page 1 of 26 of saliva so that a technician can collect the saliva sample and determine the appropriate amount.

[0010] Additionally, document US5260031A discloses that the device also includes a wettable element and that the indicator reacts with saliva from the wettable element to change its appearance.

[0011] On the other hand, patent US5910122A discloses a saliva collector with an aspiration pipette. Saliva samples are collected for body fluid constituent analysis by placing a sponge in a patient's oral cavity, which absorbs the saliva. The patent further discloses that a filter can be placed between the sponge and the pipette, through which the saliva is cleaned and selectively prepared according to molecular weight, allowing only substances with a molecular weight below a cutoff or reference weight to pass through. Additionally, patent US5910122A also discloses that the saliva collector has an integral unit that detaches after the saliva has been transferred to the collection pipette, and the pipette is hermetically sealed for subsequent handling.

[0012] Additionally, patent CN108703775A discloses a saliva collection device and a saliva acquisition method. The saliva collection device includes a saliva collector used to collect saliva from a user, a saliva preservative that communicates sequentially with the saliva collector to preserve the saliva collected by the collector, and a filter coated with a salivary secretion-stimulating material mounted on the saliva collector. Furthermore, patent CN108703775A discloses that the saliva collector has a funnel shape, with the funnel tube entering the preservation device. Its primary function is to channel the saliva sample into the preservation device for contact with a preservation solution.

[0013] However, very few state-of-the-art devices use nozzles or straws to collect the saliva sample, and safe handling of the saliva is not guaranteed to protect both users and technicians handling the devices and collecting the samples from accidents. Therefore, devices that allow for more efficient saliva sample collection are needed.

[0014] Page 2 of 26 efficient, more comfortable for the user, and that allows guaranteeing both the integrity of said sample, as well as providing protection to the user in charge of extracting the sample.

[0015] Brief description of the disclosure

[0016] This disclosure relates to devices for collecting fluid samples for subsequent analysis, including body fluids such as saliva.

[0017] Specifically, this disclosure describes embodiments of a biological sample collection device comprising a container with an inlet for receiving a biological sample and a base at the bottom of the container. The saliva sample collection device also comprises a receiving element with a through-hole where the receiving element is coupled to the container. Furthermore, the device includes a protective element that is coupled to the receiving element and configured to cover a portion of the receiving element, such that when the protective element is removed, the receiving element is configured to allow the passage of the biological sample into the container.

[0018] Brief description of the figures

[0019] FIG. 1 shows an exploded view of the components that make up the saliva sample collection device of this disclosure.

[0020] FIG. 2 shows an exploded view illustrating the relationship or assembly order of the components that make up the saliva sample collection device.

[0021] FIG. 3 shows a preferred embodiment of the receiving element of the saliva sample collection device.

[0022] FIG. 4 illustrates one modality of the container of this disclosure.

[0023] Page 3 of 26 FIG. 5 illustrates a view of the components of the fully assembled saliva sample collection device.

[0024] Detailed description

[0025] This disclosure concerns a biological sample collection device (1) that allows for the safe and effective collection and preservation of a saliva sample. Additionally, the device (1) is specifically designed to facilitate the collection and storage of biological samples for diagnostic, research, or health monitoring purposes.

[0026] Referring to Figures 1, 2, and 5, in a first embodiment of this disclosure, a device (1) for collecting biological samples is described, comprising a container (2) with an inlet (3) for receiving a biological sample (4), and a base (7) at the bottom of the container (2). The device (1) also comprises a receiving element (6) with a through-hole, where the receiving element (6) is coupled to the container (2). Furthermore, the device (1) also comprises a protective element (12) that is coupled to the receiving element (6) and configured to cover a portion of the receiving element (6), wherein, when the protective element (12) is removed, the receiving element (6) is configured to allow the passage of the biological sample (4) into the container (2).

[0027] For the purposes of this disclosure, the container (2) may be an object designed to collect, contain, store, or transport liquids, gases, or solids. Specifically, the container (2) may also be an object designed to obtain samples of various types of biological fluids, such as blood, urine, saliva, or other bodily fluids, and may have various shapes and sizes. Furthermore, the container (2) may have, but is not limited to, a straight cylindrical shape, an oblique cylindrical shape, an equilateral cylindrical shape, a triangular prism, a cube, and other shapes known to a person reasonably skilled in the subject.

[0028] In one embodiment of this disclosure, the container (2) may be transparent to allow viewing of the contents inside.

[0029] Page 4 of 26 Also, in one form of this disclosure, the container (2) may include an adhesive or printed label that is placed on the container (2) to identify and provide information about the collected biological sample (4), e.g., patient name, date and time of collection, sample type, and other relevant data.

[0030] Likewise, in one embodiment of the invention, the container (2) may include graduation marks on the body of the container (2) and said graduation marks may be used to measure specific volumes of the collected biological sample (4).

[0031] Furthermore, the container material (2) can be selected from polypropylene, polyethylene, glass, polystyrene, acrylic, polylactic acid (PLA), other thermoplastics known to a person with a reasonable grasp of the subject, and combinations thereof. Also, in one embodiment of the present invention, the container material (2) can be mixed with microorganism-eliminating agents, for example, antimicrobial agents, to improve safety for the healthcare professional who receives or handles the device (1).

[0032] Specifically, in one embodiment of this disclosure, the container (2) may have a base reinforcement (7). This base reinforcement (7) may be an additional structure or material placed on the base (7) to make the container (2) more robust or stable. Furthermore, the base reinforcement (7) may prevent the tube from deforming or collapsing due to the weight of the collected biological sample (4) or the pressure exerted on the container (2) during the centrifugation process.

[0033] Also, the reinforcement structure at the base (7) allows the vessel (2) to withstand the forces applied to it by any type of rotor, since this reinforcement helps distribute the normal forces in their vertical and / or horizontal compressive components, and uniformly across the entire convex surface of the base (7) and the walls of the vessel (2), minimizing or preventing any type of deformation that the vessel (2) might undergo. For example, the base (7) could be a

[0034] Page 5 of 26 part that helps distribute the forces applied to the container (2) during a centrifugation process, and that allows said container (2) to remain upright.

[0035] In addition, the reinforcement at the base (7) can be selected from the group that includes rib or rib type reinforcements, longitudinal reinforcements, circumferential reinforcements, spiral reinforcements, combinations of the above or other types of reinforcements known to a person moderately versed in the subject.

[0036] In the preferred embodiment of this disclosure, the reinforcement at the base (7) has the same circumference as the container (2). Furthermore, in this preferred embodiment, the reinforcement at the base (7) is of the rib or ribbing type, and these ribs or ribbing surround the convex portion of the container (2); therefore, these ribs or ribbing have the same height as the container (2).

[0037] Also, the container (2) can be located in a receptacle of a rotor, for example, said rotor can be a centrifuge rotor, a rotor with flat bottom receptacles, a rotor with conical receptacles in centrifuges, a tilting rotor, an oscillating rotor or other types of rotors known to a person moderately versed in the subject.

[0038] In particular, when the container (2) is placed in the rotor receptacle, the reinforcement at the base (7) can help the container (2) rest in said receptacle, thereby increasing the versatility of the device (1), i.e., improving the capacity and adaptability of the device (1) to collect the biological sample (4) efficiently and safely, and allowing the device (1) to be used in a wide range of situations, such as, for example, medical testing, scientific research, drug testing, genetic testing, and infectious disease research.

[0039] Furthermore, when the container (2) is placed in the rotor housing, said container (2) can withstand speeds between 0.01 rpm and 6000 rpm. The container (2) can also withstand speeds between 1 rpm and 5000 rpm. In a specific example, and referring to FIG. 2, the container (2) can withstand speeds between 0.1 rpm and 4000 rpm.

[0040] Page 6 of 26 Additionally, the length of the container (2) can vary between 2 cm and 25 cm. The length of the container (2) can be between 4 cm and 20 cm. In a particular example and referring to FIG. 2, the length of the container (2) can be between 6 cm and 15 cm.

[0041] On the other hand, the inlet (3) of the vessel (2) is the section at one end of the vessel (2) configured to allow the entry or exit of fluids, gases, or solids through the vessel (2). Likewise, the inlet (3) may be an opening or perforation that passes through the surface of the vessel (2), creating a passage or connection through it. Furthermore, the inlet (3) may be used to connect the vessel (2) to other components.

[0042] Furthermore, a biological sample (4) can be any material of biological origin used for analysis, research, or diagnosis in the fields of medicine, biology, or health sciences. Additionally, a biological sample (4) can be obtained from humans, animals, or even plant organisms. Furthermore, a biological sample (4) may include, but is not limited to, blood, urine, saliva, tissues, and other bodily fluids.

[0043] In the preferred form of this disclosure, the biological sample (4) is a saliva sample. Furthermore, the saliva sample may be understood to be a material of biological origin, a liquid secreted by the salivary glands, of variable viscosity, with a composition similar to that of plasma, containing water, ions, mucin, plasma proteins, leukocytes, and cellular debris, and which is used for analysis, research, or diagnosis in the field of medicine, biology, or health sciences.

[0044] On the other hand, the base (7) at the bottom of the container (2) can be an end of the container (2) that provides stability and support to it. Alternatively, the base (7) can be a part of the container (2) that rests on a surface, for example, a flat surface, allowing the container (2) to stand upright and securely.

[0045] Page 7 of 26 Furthermore, the base (7) can have different shapes and designs depending on the type of container (2) and its specific function. In particular, the base (7) can be flat, conical, rounded, or U-shaped and can be used, for example, to provide greater stability to the container (2), especially when it is necessary to prevent the biological sample (4) from tipping over or spilling.

[0046] Additionally, the base (7) can be an integral part of the container (2) itself, either molded as an extension of the container body (2) or formed by a cap or plug that fits onto the bottom end of the container (2).

[0047] Referring to FIG. 1, in one embodiment of the present disclosure, the container (2) may have a cross-section reduction (5) between the inlet (3) and the base (7) of said container (2).

[0048] For the purposes of this disclosure, the reduction in cross-section (5) refers to the decrease in the area or size of a cross-section of the vessel (2) along its length. Furthermore, the reduction in cross-section (5) allows and facilitates the secure connection or joining of the vessel (2) to other components of the device (1).

[0049] In one embodiment of this disclosure, the shape and design of the cross-section reducer (5) may vary depending on its specific function and application. Furthermore, it may allow attachment to other elements of the device (1), for example, by means of threads, press fittings, hose connectors, and special connections.

[0050] Referring to FIG. 1, FIG. 2 and FIG. 5, the device (1) also comprises a receiving element (6) with a through hole, where the receiving element (6) is coupled to the container (2).

[0051] On the other hand, the receiving element (6) can be a component used to seal and hermetically close the inlet (3) of the container (2).

[0052] One advantage of the receiving element (6) of this disclosure is that it allows for increased safety both at the time of taking the biological sample (4), as

[0053] Page 8 of 26, as well as during handling or storage. Another advantage of the receiving element (6) is that it prevents the biological sample (4) from escaping and coming into contact with, for example, the operator responsible for extracting the sample.

[0054] With current devices, when taking a biological sample (4), for example, a saliva sample from a patient infected with COVID-19, if that sample spills onto a person or a commonly used surface, the saliva could infect other people. Another advantage of the receiving element (6) of the device (1) described in this disclosure is that the biological sample (4) does not need to be removed from the device (1), as it is extracted directly from a patient, thus increasing the safety of collecting biological samples (4) from patients with infectious diseases.

[0055] Another advantage of the receiving element (6) of the present disclosure is that although a hermetic seal is produced by means of the container (2), said receiving element (6) still allows the passage of liquids or the biological sample (4) into said container (2).

[0056] Furthermore, the material in which the receiving element (6) is manufactured can be selected from the group consisting of: polypropylene, polyethylene, low-density polyethylene, polylactic acid (PLA), silicone, combinations of the above, and, in addition, the aforementioned materials can be mixed with antimicrobial materials to improve safety for the user or health professional handling the device (1).

[0057] Referring to FIG. 3, the receiving element (6) has a first section (8) and a second section (9), and where the first section (8) protrudes from the container (2) and has a larger cross-sectional area than the cross-sectional area of ​​the second cross-section (9).

[0058] The first section (8) may be a first conduit or internal passage through which the biological sample (4) flows. Furthermore, the first section (8) may be a section

[0059] Page 9 of 26 cylindrical that can be inserted into a patient's mouth so that, through this, the patient deposits the biological sample (4) directly into the container (2).

[0060] Also, the first section (8) can be adapted to facilitate the taking of the biological sample (4), for example, with a design that avoids direct contact with a patient's mouth or with an ergonomic shape that facilitates the accurate collection of said biological sample (4).

[0061] An advantage of the first section (8) is that it facilitates the collection of the biological sample (4) without the need to remove the receiving element (6) from the device (1), and in this way, spillage of the biological sample (4) is avoided, and, in addition, the flow of the biological sample (4) from the patient's mouth to the container (2) is controlled.

[0062] Also, in the modality in which the biological sample (4) is a saliva sample, the first section (8) facilitates the salivation reflex, since, usually, this reflex occurs when a patient holds an object in the mouth and this object is held by the patient's lips.

[0063] Furthermore, in one form of the present disclosure, the first section (8) has a cross-section reduction (8A).

[0064] In one form of the present disclosure, the first section (8) is nozzle-shaped.

[0065] Furthermore, the cross-section reduction (8A) of the first section (8) can have a diameter ranging from 2 mm to 15 mm. Also, the cross-section reduction (8A) can have a diameter between 6 mm and 10 mm. Specifically, and referring to FIG. 1, the cross-section reduction (8A) can have a diameter between 4 mm and 8 mm.

[0066] Furthermore, in one embodiment of this disclosure, the length of the first section (8) can vary between 2 mm and 25 mm. The length of the first section (8) can be between 4 mm and 22 mm. Specifically, and referring to FIG. 1, the length of the first section (8) can be between 6 mm and 20 mm.

[0067] Page 10 of 26. On the other hand, the second section (9) can be a second conduit or internal passage through which the biological sample (4) flows into the container (2). Specifically, the second section (9) can extend as a straw system that is inserted into the container (2), allowing the biological sample (4) to be directed into the container (2). Furthermore, the second section (9) makes it difficult to retrieve the biological sample (4) already contained in the container (2) due to the negative pressure, surface tension, and diameter of the second section (9).

[0068] Furthermore, during the extraction of the biological sample (4), a hermetic seal is created between the container (2) and the receiving element (6), and the biological sample (4) passes through the reduced cross-section (8A) of the first section (8). This allows the biological sample (4) to wet the walls of the first section (8), thus enabling a liquid / gas exchange or two-phase flow. Additionally, the slight pressure exerted by the patient's mouth or tongue as the biological sample (4) is forced into and through the receiving element (6) results in a higher Weber number in this direction than in the opposite direction when the container (2) is nearly full of the biological sample (4).

[0069] Furthermore, the negative pressure produced due to any attempt by the biological sample (4) to exit through the second section (9), even up to the connection with the interior of the second section (8), keeps the biological sample (4) in place, since surface tension forces end up predominating and hindering a two-phase flow, which is facilitated by the narrowness of the second section (9), in case the device (1) is in an inverted vertical or horizontal position, i.e., to a lesser degree.

[0070] On the other hand, the potential for unexpected leakage of a portion of the biological sample (4) depends on the liquid column formed by the biological sample (4) on the walls of the first section (8), the viscosity of the biological sample (4), liquid-air interface instabilities known as Rayleigh instabilities, and the efficiency of the sealing elements (13, 14) in creating an airtight seal. Furthermore, any leakage of a portion of the biological sample (4), however small, causes the negative pressure in the container (2) to increase, preventing further leakage of the biological sample (4) by reaching a more stable equilibrium.

[0071] Page 11 of 26 the forces present. For example, in the case of filling the tube with 3 milliliters of a biological sample, it simply surrounds the second section (9), and without the possibility of escape of the biological sample in case of placing the tube in an inverted horizontal or vertical position.

[0072] Furthermore, in another modality of the present disclosure, hydrophobic coatings can be added to one end of the second section (9), which allows for improved retention capabilities of the device (1).

[0073] In one embodiment of the present disclosure, the second section (9) allows for the safe preservation of between 0.1 and 8 milliliters (mi) of the biological sample (4), and advantageously, the device (1) allows for small losses of the biological sample (4) if the volume of said biological sample (4) contained in the container (2) exceeds the storage capacity of the container (2) and of the second section (9).

[0074] Also, in one form of the present disclosure, the cross-section of the first section (8) and the second section (9) is circular.

[0075] Furthermore, in the preferred embodiment of this disclosure, the cross-section of the second section (9) may have a diameter ranging from 1 mm to 20 mm. The second section (9) may have a diameter ranging from 2 mm to 15 mm. Specifically, and with reference to FIG. 1, the cross-section of the second section (9) may have a diameter ranging from 3 mm to 10 mm.

[0076] Also, the length of the second section (9) can vary between 2 mm and 80 mm. The length of the second section (9) can be between 5 mm and 70 mm. Specifically, and referring to FIG. 1, the length of the second section (9) can vary between 10 mm and 60 mm.

[0077] Referring again to FIG. 3, in one embodiment of the present disclosure, the receiving element (6) has an internal thread (10A) and the cross-section reduction (5) of the container (2) has an external thread (10B), wherein the receiving element (6) is coupled to the container (2) by means of the internal thread (10A) and the external thread (10B).

[0078] Page 12 of 26 Furthermore, the inner thread (10A) fits with the outer thread (10B), allowing a secure and rotatable fit between the receiving element (6) and the container (2), so that the receiving element (6) can be coupled to or uncoupled from the container (2).

[0079] Likewise, the internal thread (10A) and the external thread (10B) can be selected from the group which includes: cylindrical threads, tapered threads, round threads, triangular threads, trapezoidal threads, sawtooth threads, internal threads, external threads, extra-fine threads, coarse threads, left-hand threads, right-hand threads, multi-start threads, single-start threads and any type of thread known to a person moderately versed in the subject.

[0080] Referring to FIG. 3, in the preferred embodiment of the present disclosure, the receiving element (6) includes at least a first sealing element (13) disposed between the receiving element (6) and the container (2).

[0081] The first sealing element (13) is a component used to ensure the impermeability, airtightness, tamper-proofness, integrity, and impermeability of the device (1). The main function of the first sealing element (13) is to prevent leakage of the biological sample (4) or any other type of substance, ensure a certain pressurization, and guarantee that there is no escape or unwanted entry into the container (2).

[0082] Likewise, the material in which the first sealing element (13) is manufactured can be selected from the group consisting of: rubber, plastics, metals, fibers and fabrics known to a person moderately versed in the subject, and combinations of the above.

[0083] Furthermore, with reference to FIG. 1 and FIG. 3, the device (1) also comprises a protective element (12) that attaches to the receiving element (6) and is configured to cover a portion of the receiving element (6).

[0084] The protective element (12) is an element designed to fit securely into the first section (8) of the receiving element (6), providing a closure

[0085] Page 13 of 26 airtight, preventing contamination of the biological sample (4). In a particular example, the protective element (12) may include a threaded or pressure system to ensure a proper seal and prevent leakage of the biological sample (4).

[0086] In the preferred embodiment of this disclosure, when the protective element (12) is removed, the receiving element (6) is configured to allow the passage of the biological sample (4) into the container (2).

[0087] The material used to manufacture the protective element (12) can also be selected from the following group: polypropylene, polyethylene, low-density polyethylene, silicone, polylactic acid (PLA), antimicrobial materials mixed with resins, and combinations thereof. Furthermore, using antimicrobial material mixed with resin increases protection for the healthcare professional or user handling the device (1). Additionally, the antimicrobial material mixed with resin can be incorporated into the protective element (12) as a coating (10) or can be an integral part of the protective element (12).

[0088] In one embodiment of the present disclosure, the coating (10) may consist, for example, of copper oxide particles, which provide greater protection to the user collecting the biological sample (4) or other persons handling the device (1).

[0089] Referring to FIG. 2, in one embodiment of the present disclosure, the protective element (12) has an internal thread (HA) and the receiving element (6) has an external thread (1 IB), wherein the protective element (12) is coupled to the receiving element (6) by means of the internal thread (HA) and the external thread (1 IB).

[0090] In particular, the inner thread (11 A) fits with the outer thread (11B), allowing a secure and rotating fit between the protective element (12) and the receiving element (6), so that the protective element (12) can be coupled or uncoupled from the receiving element (6).

[0091] Page 14 of 26 Also, the material from which the internal thread (HA) and the external thread (11B) are manufactured may be selected and is not limited to the group that includes cylindrical threads, tapered threads, round threads, triangular threads, trapezoidal threads, sawtooth threads, internal threads, external threads, extra-fine threads, coarse threads, left-hand threads, right-hand threads, multi-start threads, single-start threads, and any type of thread known to a person moderately versed in the subject.

[0092] Referring to FIG. 1, in a preferred embodiment of the present disclosure, the protective element (12) includes at least a second sealing element (14) disposed between the protective element (12) and the receiving element (6).

[0093] The second sealing element (14) may be a component similar to the first sealing element (13) that can be used to ensure the impermeability, airtightness, tamper-proofness, integrity, and impermeability of the device (1). The main function of the second sealing element (14) is to prevent leakage of the biological sample (4) or any other type of substance, ensuring that there is no escape or unwanted entry into the receiving element (6).

[0094] Likewise, the material in which the second sealing element (14) is manufactured can be selected from the group consisting of: rubber, plastics, metals, fibers and fabrics and combinations of the above.

[0095] In one embodiment of the present disclosure and referring to FIG. 3 and FIG. 4, the container (2) and the receiving element (6) may have a coating (10).

[0096] In this disclosure, the lining (10) shall also be understood to refer to a thin material placed on the outside of the container (2) and / or the receiving element (6), in order to provide protection to the user collecting the biological sample (4) and other persons handling the device (1).

[0097] Page 15 of 26 In one embodiment of the present disclosure, the lining (10) may be a material that is incorporated or mixed with the material from which the container (2) and the receiving element (6) are made.

[0098] Furthermore, the coating (10) provides additional benefits to the container (2), the receiving element (6) and the protective element (12), such as, for example, extending their service life, facilitating their cleaning or improving their functionality.

[0099] Advantageously, the coating (10) may have non-stick or antimicrobial properties to prevent the adhesion of microorganisms or other particles to the walls of the container (2) or the receiving element (6), which helps to keep the biological sample (4) free of external contaminants and ensures the integrity of subsequent analyses.

[0100] Likewise, the coating (10) may be selected from, and not be limited to, the group that includes protective coatings, airtight coatings, non-stick coatings, decorative coatings, anticoagulants, separating gels, preservatives, antiseptics, combinations of the above, or other coatings known to a person moderately versed in the subject.

[0101] In one embodiment of the present disclosure, the coating (10) consists of copper oxide particles, which provide greater protection to the user collecting the biological sample (4) or other persons handling the device (1).

[0102] EXAMPLES

[0103] Example 1:

[0104] A device was designed to collect a saliva sample from a patient with COVID-19, which corresponded to a biological sample (4), the characteristics of the device were as follows:

[0105] Page 16 of 26. First, a 3D-printed prototype of the container (2) was created using MED610, a biocompatible photopolymer. This container (2) was 6.23 centimeters long. Graduation marks were also included along the length of the container (2) to measure the volume of saliva collected. Furthermore, the container (2) could withstand speeds of up to 14,000 rpm, allowing for a larger amount of saliva to be collected at the bottom of the container (2).

[0106] The design also included a receiving element (6) and a protective element (12) for the receiving element (6), both made from VeroBlue, a rigid photopolymer. The receiving element (6) had a first cylindrical section (8) 1.895 cm long, which served as a nozzle for collecting the saliva sample. Additionally, the receiving element (6) also included a second cylindrical section (9) 2.574 cm long. These dimensions allowed for the rapid and efficient transfer of the saliva sample to the container (2), compared to collectors that use a funnel as the saliva collection element.Another advantage of the dimensions of the second section (9) is that it prevented part or all of the saliva sample from escaping from the container (2), this in combination with the effect of the negative pressure and surface tension exerted inside the container (2).

[0107] In addition, sealing elements (13, 14) were used, consisting of packaging printed with TangoBlack resin, a photopolymer resin. These packaging elements ensured a hermetic seal between the container (2), the receiving element (6), and the protective element (12). This hermetic seal was essential for the safety measures implemented by the second section (9) to be effective and satisfactory.

[0108] Finally, with the configuration of all the elements described above, it was possible to fill the container (2) quickly, following the filling instructions, which consisted of allowing the saliva sample to accumulate between the lips and tongue of a patient, and pushing said saliva sample with the help of the tongue, through a first section (8) of the receiving element (6), and passing the saliva sample through the receiving element (6) to the exit of the second section (9).

[0109] Page 17 of 26 Example 2

[0110] The device for collecting a saliva sample from Example 1 was modified, and a coating (10) consisting of copper oxide particles was added to the receiving element (6) and the protective element (12).

[0111] Furthermore, the same saliva sample collection procedure described in Example 1 was performed, and with the device configuration and by using the coating (10), the saliva sample was protected by keeping it free of external contaminants, which in turn allowed for better saliva sample quality for analysis and a more accurate diagnosis.

[0112] It should be understood that the present invention is not limited to the modalities described and illustrated, since, as will be evident to a person versed in the art, there are possible variations and modifications that do not depart from the spirit of the invention, which is defined only by the following claims.

[0113] Page 18 of 26

Claims

CLAIMS 1. A device (1) for collecting biological samples, comprising: a container (2) with an inlet (3) for receiving a biological sample (4) and a base (7) at the bottom of the container (2); a receiving element (6) with a through hole, wherein the receiving element (6) is coupled to the container (2); and a protective element (12) that is coupled to the receiving element (6) and is configured to cover a portion of the receiving element (6), wherein, when the protective element (12) is removed, the receiving element (6) is configured to allow the passage of the biological sample (4) into the container (2).

2. The device of Claim 1, wherein the receiving element (6) has a first section (8) and a second section (9), and wherein the first section (8) protrudes from the container (2) and has a larger cross-sectional area than the cross-sectional area of ​​the second section (9).

3. The device of Claim 1, wherein the first section (8) has a cross-section reduction (8A).

4. The device of Claim 1, wherein the container (2) has a cross-section reduction (5) between the inlet (3) and the base (7) of said container (2).

5. The device of Claim 1, wherein the receiving element (6) has an internal thread (10A) and the cross-section reduction (5) of the container (2) has an external thread (10B), wherein the receiving element (6) is coupled to the container (2) by means of the internal thread (10A) and the external thread (10B). Page 19 of 26 6. The device of Claim 1, wherein the protective element (12) has an internal thread (HA) and the receiving element (6) has an external thread (11B), wherein the protective element (12) is coupled to the receiving element (6) by means of the internal thread (HA) and the external thread (11B).

7. The device of Claim 1, wherein the receiving element (6) includes at least a first sealing element (13) disposed between the receiving element (6) and the container (2).

8. The device of Claim 1, wherein the protective element (12) includes at least a second sealing element (14) disposed between the protective element (12) and the receiving element (6).

9. The device of Claim 1, wherein the cross-section of the first section (8) and the second section (9) is circular.

10. The device of Claim 1, wherein the container (2) and the receiving element (6) have a coating (10).

11. The device of Claim 9, wherein the cross-section of the first section (8) has a diameter ranging from 8 mm to 15 mm.

12. The device of Claim 9, wherein the cross-section of the second section (9) has a diameter ranging from 4 mm to 7 mm.

13. The device of Claim 11, wherein the length of the first section (8) varies between 6 mm and 20 mm.

14. The device of Claim 12, wherein the length of the second section (9) varies between 10 mm and 60 mm. Page 20 of 26

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