EA039960B1 - SAMPLE COLLECTION SYSTEM CONTAINING A SEALING CAP AND A VALVE - Google Patents

Description

The technical field to which the invention belongs

The present disclosure generally relates to tubes and reservoirs for collecting and storing biological samples. More specifically, the present disclosure relates to systems and kits for collecting and preserving biological samples for subsequent analysis in a laboratory or other biological sample analysis facility.

State of the art

The collection of biological samples in the field can provide scientists, physicians, geneticists, epidemiologists or similar personnel with invaluable information. For example, access to a fresh sample of a patient's blood, pus, or sputum can help a clinician or epidemiologist isolate or identify an infectious agent. Similarly, a saliva sample may allow a scientist or geneticist to access the necessary nucleic acid for genetic sequencing, phylotyping, or other genetic research. In the examples above, and in many other situations, it is desirable to work with a fresh biological sample to ensure accurate results. However, isolation of an evidence composition (eg, nucleic acid, proteins, chemical compounds, etc.) often requires the use of special equipment and other advantages of controlled laboratory conditions.

It may be inconvenient, and sometimes impossible, to require patients/individuals to travel to a biological sample collection center that has the appropriate equipment and the desired controlled environment for sample preparation. Similarly, it may be difficult for staff to gain direct access to a patient/individual, especially if the sample size is large and/or geographically diverse (for example, this may be the case in large genetic studies of thousands of people across a country, ethnic population, or geographic region). Further complicating this issue, it is often beneficial to immediately process any biological sample obtained, and field personnel may be limited by lack of access to appropriate specialized equipment or a controlled environment to process samples with high precision.

Some devices and kits for the collection of biological samples solve some of the above problems. For example, some commercial kits provide the user with a biological sample collection tube and a preservative reagent that can be added to the collected biological sample to preserve the elements in the biological sample (to a certain extent and for a certain period of time). However, implementations of self-collection systems often rely on inexperienced or untrained individuals to place a biological sample in a receiving tank. This poses a number of challenges, including, for example, technical preparation and precise measurements, which are often required for the proper preservation of a biological sample for further processing. In the absence of these, it is important to provide a biological sample collection system that can be easily implemented by a novice user and that can store the resulting biological sample for later processing.

Accordingly, systems for the collection and storage of biological samples have a number of disadvantages that can be eliminated.

The essence of the invention

Embodiments of the present disclosure address one or more of the above or other problems in the art with kits, devices, and methods for collecting and preserving a biological sample.

For example, one or more embodiments may include a biological sample collection system having a sample collection reservoir with a biological sample receiving port, a selectively movable valve configured to be at least partially in communication with the reservoir port for collection of samples, and a sealing cap configured to communicate with a selectively movable valve and a reservoir for collecting samples.

In one aspect, the selectively movable valve includes a pin having a hollow body and a fluid outlet defined by a portion of its side wall, and a valve head associated with the distal portion of the pin and having a slot selectively aligned with the fluid outlet.

In one aspect, the seal cap includes a reagent chamber for storing a quantity of sample preservation reagent and is in fluid communication with the hollow body of the pin.

In one aspect, the connection of the seal cap to the sample collection reservoir causes the pin and valve head to be physically repositioned so that the fluid outlet aligns with the slot defined by the valve head, providing fluid communication between the reagent chamber and the sample collection reservoir. .

In one aspect, the physical permutation is or includes

- 1 039960 rotational adjustment of the pin relative to the valve head.

In one aspect, the sample collection container includes a connector, and the sealing lid includes a complementary connector configured to couple with the connector of the sample collection container so as to connect the sample collection container and the sealing lid.

In one aspect, the connector includes a ridge protruding from the sample collection container or a recess within the sample collection container, and the complementary connector includes a hook or ridge that is sized and shaped to engage the connector.

In one aspect, the connecting element and the complementary connecting element contain a thread. The thread of the complementary connecting element may be located on the inner surface of the sealing cap.

In one aspect, the fluid outlet is occluded by the valve head when the selectively movable valve is in a closed configuration, and the fluid outlet is at least partially aligned with the valve head when the selectively movable valve is in an open configuration.

In one aspect, the pin includes a retaining ring configured to engage with a protrusion or retainer within the interior of the seal cap.

In one aspect, one or more of the valve stem or head members comprise an annular retainer configured to maintain tight association between the stem and valve head.

In one aspect, the valve head comprises an upper lip located proximal to a sidewall portion defining a fluid outlet, wherein the upper lip has a larger diameter than the sidewall portion defining the fluid outlet and configured to interact with an internal side wall of the sample collection chamber.

In one aspect, the sealing force between the valve head and the pin is less than the compression force between the top collar of the valve head and the inner side wall of the sample collection container.

Embodiments of the present disclosure include methods for collecting and preserving a biological sample. An exemplary method may include the steps of receiving a biological sample into a sample collection reservoir of a sample collection system disclosed herein and associating a seal cap of the sample collection system with the sample collection reservoir to cause a selectively movable valve associated with the seal cap to open. whereby the sample preservation agent held in the seal cap is released into the sample collection chamber.

In one aspect, associating a sealing lid to a sample collection container includes threading a connector located on the outer surface of the sample collection container with a complementary connector located on the inner surface of the sealing lid.

In one aspect, associating a seal cap with a sample collection reservoir to cause a selective movable valve associated with the seal cap to open includes rotating a pin in an associated valve head to at least partially align the fluid outlet of the pin with a slot, defined valve head.

In one aspect, the method further includes the step of accessing the preserved sample in the sample collection reservoir by detaching the seal cap from the sample collection reservoir such that the release of the seal cap from the sample collection reservoir causes the selectively movable valve to move from an open configuration to a closed configuration. configuration.

Embodiments of the present disclosure further include kits for collecting and preserving a biological sample. For example, the kit may include a sample collection reservoir, a sealing cap, and an additional funnel configured to communicate with the sample reservoir and to direct the receipt of a biological sample from the user into the sample collection chamber of the sample reservoir.

In one aspect, the sample collection tank includes a sample collection chamber having an opening configured to receive a biological sample into the sample collection chamber, and a connector located on the outer portion of the sample collection tank.

In one aspect, the seal cap includes a reagent chamber that stores a predetermined amount of sample preservation reagent, a complementary connector configured to engage with a sample collection reservoir connector, and a selectively movable valve coupled to the seal cap.

In one aspect, the selectively movable valve is configured to communicate with a sample collection chamber and includes a pin defining a fluid outlet in

- 2 039960 in its distal portion, and a valve head associated with the distal portion of the pin and defining a slot.

In one aspect, when the selectively movable valve is in a closed configuration, the fluid outlet forms a fluid-tight connection with the valve head, and when the selectively movable valve is in an open configuration, the fluid outlet is at least partially aligned with the slot.

Accordingly, systems, methods, and kits for collecting a biological sample are disclosed herein. This summary is provided to introduce a set of concepts in a simplified form, which are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter and is not intended to be used as an indication of the scope of the claimed subject matter.

Additional features and advantages of the disclosure will be set forth in the description which follows, and in part will be apparent from the description, or may be learned by practice of the present disclosure. The features and advantages of the disclosure may be practiced and obtained using the tools and combinations specifically set forth in the appended claims. These and other features of the present disclosure will become more apparent from the following description and the appended claims, or may be learned by practice of the disclosure as set forth herein below.

Brief description of the drawings

In order to describe the mechanism by which the above and other advantages and features of the disclosure can be obtained, a more specific description of the disclosure briefly described above will be presented with reference to specific embodiments thereof, which are illustrated in the accompanying drawings. It should be understood that these drawings only depict exemplary embodiments of the disclosure and should therefore not be construed as limiting its scope. The disclosure will be described and explained with further specificity and detail using the accompanying drawings, in which:

fig. 1 illustrates a sectional view of an assembled 3D model of a sample collection system showing a sealing cap attached to a sample collection reservoir and associated with a valve in an open configuration;

fig. 2 illustrates a front view of a selectively movable valve shown in a closed configuration;

fig. 3 illustrates a front view of the selectively movable valve shown in FIG. 2 shown in an open configuration;

fig. 4 illustrates an enlarged exploded view of a sample collection system similar to that shown in FIG. 1 which includes a lid configured to receive a selectively movable valve;

fig. 5A illustrates a perspective view of the pin shown in FIG. 4;

fig. 5B illustrates a front sectional view of the pin shown in FIG. 5A;

fig. 5C illustrates an enlarged view of the fluid outlet defined by the distal portion of the pin shown in FIG. 5B;

fig. 6A illustrates a perspective view of the valve head shown in FIG. 4; and fig. 6B illustrates a sectional view of the valve head shown in FIG. 6A.

Detailed description

Embodiments of the present disclosure are directed to solving one or more problems in systems, kits, and/or methods for collecting and storing a biological sample. A biological sample may be collected and its contents evaluated for a variety of reasons, including, for example, identification or characterization of a disease agent (e.g., to treat an affected individual, for epidemiological reasons, etc.) or for genetic analysis of a subject's nucleic acid (e.g., genetic phylotyping , gene expression studies, genome sequencing, etc.). In most cases, including the examples above, it is desirable that the validity of a biological sample be maintained in such a way that it retains its probative value. However, the collection and preparation of biological samples for analysis has traditionally been a difficult task for a skilled technician or a person skilled in the art. This is problematic for obvious reasons, including the time and cost associated with individual collection and transport of biological samples, especially when subjects live in remote rural areas and require the services of personnel with the appropriate skill set to properly collect and store a biological sample.

Embodiments of the present disclosure provide systems and kits for collecting and preserving samples, as well as methods of using them, that solve one or more of the above problems. For example, the use of systems, kits, and methods for the collection and preservation of biological samples as disclosed herein eliminates the need for

- 3 039960 specialized personnel during the collection and initial conservation of a biological sample. In addition, the disclosed embodiments simplify the collection and preservation of samples, which reduces the likelihood that even an unskilled user will make a mistake when collecting and preserving a biological sample.

As an illustrative example of the foregoing, biological sample collection kits disclosed herein include at least a two component sample collection and storage system. The first part includes a sample collection tank or a tank that can be detachably connected to the funnel. In use, the funnel serves to direct the intake of a biological sample from the user into the sample collection chamber of the collection tank or reservoir. The funnel may also make it easier for the user to contact the collection reservoir and introduce the biological sample into the sample collection chamber. After depositing the required amount of biological sample (which may be indicated by a label on the sample collection container), the user can remove the funnel (if used) and tie the second part of the two-piece sample storage system, such as a sealing cap associated with a selectively movable valve, with collection tank. The seal cap reagent chamber has been pre-filled with a predetermined amount of sample preservation reagent, and as the seal cap is lowered to seal the accepted biological sample in the sample collection chamber of the collection tank, the valve enters the open configuration and the preservation reagent is released from reagent chamber through the open valve into the sample collection chamber, where it is mixed with the obtained biological sample and ensures its conservation.

As described in more detail below, the valve may be opened to release reagents from the reagent chamber into the sample collection chamber. In some embodiments, the proximal portion of the selectively movable valve is mechanically locked (eg, via a friction fit) by the seal cap so that the pin moves in synchronism with the seal cap. The valve head is attached to the distal portion of the pin, forming a fluid-tight connection therebetween. The valve head is sized and shaped to fit the opening of the sample collection reservoir and includes a cuff sized and shaped to engage the inner wall of the sample collection chamber (or associated structure). After bonding the sealing cap to the sample collection container, the valve cover enters the sample collection chamber and engages its inner wall. As the seal cap continues to attach to the sample reservoir (for example, via a threaded connection), the pin moves with the seal cap and the valve cap remains stationary. Thus, the pin moves (eg, rotates) relative to the valve head, causing the selectively movable valve to open (eg, undergoing physical displacement). The independent movement of the pin relative to the valve cover can be ensured, for example, by the fact that the force (for example, the frictional force or the force required to overcome a mechanical blockage) between the pin and the valve head (which form a fluid-tight connection) is less than the force between valve head and sample chamber. When moved to an open configuration, the previously closed fluid outlet formed by the pin at least partially aligns with a slot formed in the head valve body, thereby creating a passage to transfer the sample preservation solution from the seal cap reagent chamber to the collection chamber. samples.

It should be appreciated that in some embodiments, the opening of the selectively movable valve is reversible. That is, the selectively movable valve can be moved from an open to a closed configuration. For example, embodiments of the disclosed apparatus may be configured such that detachment of the seal cap from the sample collection reservoir may cause the selective displacement valve to close. Typically, unscrewing the seal cap from the sample reservoir causes the pin to move relative to the valve cap. As a result, the valve cover slot and the pin fluid outlet are displaced so that the fluid outlet forms a fluid-tight seal with the inside surface of the valve cover, which brings the selectively movable valve into a closed configuration.

As can be understood from the foregoing, in addition to the alternative and/or additional embodiments presented herein, the systems, kits, and methods of the present disclosure can be used by skilled or unskilled persons with a reduced likelihood of errors associated with collection, and at least initial conservation of the biological sample. Accordingly, implementations of the present disclosure may reduce the costs associated with the procurement of biological samples for diagnostic, scientific, or other purposes and may increase the geographic coverage of potential sample collection areas without the need for the necessary infrastructure (e.g., controlled environment to facilitate sample collection and storage, qualified personnel for physical collection,

- 4 039960 transportation and/or conservation of biological samples, etc.).

As used herein, the term biological sample can include any cell, tissue, or secretory fluid (regardless of whether it refers to a host or pathogen) that can be used for diagnostic, prognostic, genetic, or other scientific analysis. It may include, for example, a sample of human cells, such as skin. It may also include a non-human cell sample that includes any of bacteria, viruses, protozoa, fungi, parasites, and/or other prokaryotic or eukaryotic symbionts, pathogens, or environmental organisms. The term biological sample also includes fluid samples such as blood, urine, saliva and cerebrospinal fluid and extends to other biological samples including, for example, mucus from the nasopharynx and lower respiratory tract (i.e., sputum).

As used herein, the term evidence component of a biological sample generally refers to any protein, nucleic acid, surface fragment, or other compound that can be isolated from a biological sample. Preferably, the evidence component is or contains a nucleic acid, more preferably DNA. In a preferred embodiment, the biological sample is or contains saliva that is believed to contain the preferred evidence component in the form of the user's genetic material (eg, DNA and RNA).

Sample collection systems and kits

In one embodiment, the biological sample is collected, preserved, and stored in a collection tank that is part of a multi-assembly collection system or kit. The first unit of the system or kit includes a collection reservoir, the second unit includes a sample collection funnel that can be packaged separately from the collection reservoir or removably connected to it, and the third unit includes a sealing lid having a selectively movable a valve consisting of a valve pin and head, and a reagent chamber housed within or integrated with the sealing cap. The sealing lid is configured to communicate with the collection reservoir, to dispense sample preservation reagents into the collection reservoir via a selectively movable valve, and to seal the contents of the sample collection chamber therein.

For example, FIG. 1 illustrates a sectional view of an assembled 3D model of a sample collection system 100. The system 100 includes a sample collection tank 102 and optionally a funnel (not shown) that may be connected to the top portion of the sample collection tank 102 and can be in fluid communication with the sample collection chamber 103 of the collection tank 102 samples. The biological sample collection system 100 may also include a selectively movable valve 104 consisting of a pin 106 and a valve head 108 associated with a seal cap 110 that has a reagent chamber 111 located within or integral with the seal cap 110. The seal cap 110, together with the selectively movable valve 104, may be sized and shaped to mate with the upper portion of the collection reservoir 102 such that the cap 110 fits into and closes the opening of the sample collection chamber 103 and at least a portion of the valve 104 (eg, valve head 108 and associated portion of pin 106) protruding into the opening of the sample collection chamber 103.

In some embodiments, the reagent in the reagent chamber 111 contains a preservative or buffer solution that protects the integrity of the evidence component of the biological sample prior to purification or testing. Preservation reagents are typically chemical solutions and may contain one or more salts (e.g., NaCl, KCl, Na ₂ HPO ₄ , KH2PO4 or the like, and which in some embodiments may be combined as phosphate buffered saline, as is known in the art), lysing agents (for example, detergents such as Triton X-100 or the like), chelating agents (for example, ethylenediaminetetraacetic acid (EDTA), ethylene glycol-bis(b-aminoethyl ether)-N, N,N',N'-tetraacetic acid (EGTA) or the like), distilled water, or other reagents known in the art. In one or more embodiments, the reagent or buffer solution stabilizes at least one evidence component in the sample (e.g., nucleic acids such as DNA and RNA, protein, etc., and combinations thereof) during transfer, transport, and/or storage. in a laboratory, clinic, or other location. After the addition of the preservative solution, the specimen can be stored at or below room temperature for weeks or months without significant loss of the evidentiary component. That is, the sample can still be used for the diagnostic, genetic, epidemiological, or other purposes for which it was collected after being stored for weeks or months in a preservative solution.

Referring again to FIG. 1; and the sealing cap 110 and the saliva funnel (not shown) can be independently attached to the sample collection container 102 using a coupling mechanism. The connection mechanism may include, for example, threads, snap or press fit connections, tongue and groove elements, bayonet

- 5 039960 connection or other interlocking or mechanical connection mechanisms. For example, the funnel may first be attached to the sample collection reservoir 102 via complementary coupling mechanisms (eg, complementary threads; not shown). After facilitating the acceptance of a biological sample from the user, the funnel can be removed by reversing the complementary coupling mechanism (e.g., unscrewing the funnel; not shown) and the sealing cap 110 may be attached to the collection reservoir 102 using the same or a similar complementary coupling mechanism. For example, as shown in FIG. 1, the seal cap 110 may include connectors 112 (eg, threads) located on the inner annular wall of the seal cap 110 that are complementary to and work in conjunction with the connectors 114 (eg, complementary threads) located on the outer surface of the tank 102. to collect samples.

In some embodiments, the connection mechanism between the funnel and the collection reservoir is different from the connection mechanism between the solution cap and the collection reservoir. For example, the funnel may be press-fit or snap-fitted to the collection reservoir while the solution cap is rotatably secured by engagement with complementary threads located on the outer portion of the collection reservoir and the inner portion of the solution cap, or vice versa. . Regardless of the attachment mechanism used, the sample preservation fluid may be introduced into the sample collection chamber 103 and mixed with the precipitated biological sample by attaching the sealing cap 110 to the sample collection reservoir 102. As previously stated, this may be due to the valve 104 opening and allowing the reagent to be released through the fluid outlet 116 formed by the open valve into the sample collection chamber 103.

The seal cap 110 is configured to receive a quantity of reagents into the reagent chamber 111, and as shown in the cross-sectional views of the assembled sample collection system 100 in FIG. 1, the selectively movable valve 104 is associated with the seal cap 110. The pin 106 can be snapped into the seal cap 110 to create a fluid-tight connection therebetween. As illustrated, the pin includes a retaining ring 118 into which a protrusion 120 of the inner side wall of the seal cap 110 is inserted to stabilize the pin 106. In some embodiments, the interaction between the protrusion 120 and the retainer ring 118 creates a fluid-tight connection between the seal cap 110 and the pin 106. Additionally or alternatively, the top collar 122 of the pin extends into the body of the seal cap 110 or the reagent chamber 111 and is secured with an interference fit, thereby creating a fluid-tight connection between the reagent chamber 111 and the pin 106. ring 118, in some embodiments, may secure pin 106 with cap 110 and prevent creep associated with thermoplastic components secured with threaded engagement members.

As further illustrated in FIG. 1, pin 106 includes a reagent retention chamber 107 in fluid communication with reagent chamber 111 of seal cap 110. Pin 106 defines a fluid outlet 116, and when valve 104 is in an open configuration, reagent can be transferred out of the chamber. 111 for reagents into the sample collection chamber 103 through the fluid outlet 116 . Valve 104 is shown in FIG. 1 as aligned in an open configuration. However, as shown in FIG. 2, the selectively movable valve 104 may be located in a closed configuration, and when associated with the seal cap 110 in this state, any reagent located in the reagent chamber 111 will be retained and sealed within the reagent chamber 111 and the containment chamber 107 reagents.

That is, the fluid outlet 116 is closed off by the head 108 of the selectively movable valve 104 when the valve 104 is in a closed configuration, as shown in FIG. 2. In this state, the slot 124 defined by the side wall of the valve head 108 is offset from the fluid outlet 116 of the pin 106, and the interaction between the inner side wall of the valve head 108 and the outer side wall of the pin 106 creates a fluid-tight connection of at least least at and/or around the fluid outlet 116 . A fluid-tight connection between the valve head 108 and the pin 106 prevents premature or inadvertent expulsion of the reagent from the solution cap 110.

In some embodiments, the fluid outlet includes a raised or raised surface around the mouth of the fluid outlet. The protruding surface cooperates with the inner surface of the valve head, concentrating the sealing force between the fluid outlet throat and the valve head, creating a fluid-tight seal. This element configuration can further reduce the overall rotational force required to rotate the pin relative to the valve head. In addition, the protruding surface around the neck of the exhaust port for

- 6 039960 fluid may be sized and shaped to engage with the opening of the valve head (for example, as shown in Fig. 3), which can help prevent excessive rotation of the valve.

Since the complementary threads 114, 112 between the seal cap 110 and the sample collection reservoir 102 are mutually engaged, and the seal cap 110 is advanced towards the sample reservoir 102, the valve head 108 and the associated distal portion of the pin 106 are inserted or further retracted into the opening of the chamber 103 to collect samples. The cuff 126 of the valve head 108 has a larger diameter than the distal portion of the valve head containing the slot 124, and this larger diameter cuff 126 is sized and shaped to fit within the opening of the sample collection chamber 103 where it engages with its side wall. The drag force resulting from the engagement of the valve head 108 with the side wall of the chamber is greater than the force between the pin 106 and the valve head 108. When a torque (or other force) is applied to the solution cap 110 to further bind the solution cap 110 to the sample collection container 102, the force between the pin 106 and the valve head 108 is overcome, resulting in the pin 106, which is directly connected to the sealing cap , rotates with the sealing cap while the valve head 108 remains correspondingly stationary. Accordingly, the selectively movable valve 104 undergoes a conformational change from a closed configuration (as shown in FIG. 2) to an open configuration in which the pin 106 rotates within the valve head 108 to at least partially align the fluid outlet 116 with the slot. 124 (as shown in Fig. 1 and Fig. 3).

In some embodiments, the drag force resulting from the engagement of the valve head 108 with the chamber side wall is the result of an interference fit formed between the valve head 108 and the chamber side wall. An interference fit, in some embodiments, may be a liquid-tight fit.

As further illustrated in FIG. 1, the valve head 108 may include a flange 128 that abuts and is obstructed by an edge of the sample collection chamber 103 that defines an opening therein. This prevents the valve head 108 from fully advancing within the sample collection chamber 103 and may, in some embodiments, provide additional force to hold the valve head 108 in a stationary position while the pin 106 rotates relative to it. In some embodiments, cuff 126 is angled so that the frictional force increases as the distal portion of the valve 104 is drawn further into the opening of the chamber 103. Thus, the frictional force between the valve head 108 and the side wall of the chamber increases until it will not exceed a threshold value equivalent to the initial friction between the pin 106 and the valve head 108, after which the pin 106 begins to rotate relative to the valve head 108. Pin 106 may continue to rotate relative to valve head 108 until slot 124 and fluid outlet 116 are at least partially aligned, causing valve 104 to structurally transition into an open configuration. The reagent within the reagent chamber 103 can then flow from the reagent retention chamber 107 of the pin 106 through the fluid outlet 116 and slot 124 and into the sample collection chamber 103.

In some embodiments, the pivot distance required to open the selectively movable valve 104 is proportional to the distance required to at least partially unlock the fluid outlet 116. This distance may be the same or less than the distance traveled by the solution cap 110 from the initial engagement of the connectors 114, 112 with the sealed position of the cap 110 and reservoir 102. The fluid outlet 116 and slot 124 may be aligned substantially in the same plane in both open and closed configurations, and fluid outlet 116 and slot 124 may remain substantially (or at least partially) aligned in the open configuration when seal cap 110 is sealed to reservoir 102.

However, it should be understood that although one fluid outlet 116 and one slot 124 are illustrated in FIG. 1-3, in some embodiments, additional fluid outlets and/or additional slots may be provided. For example, a second fluid outlet (not shown) may be defined on the opposite side of the pin. Additionally or alternatively, one or more additional fluid outlets and/or slots may be defined at 15°, 30°, 45°, 60°, 75°, 90°, 105°, 120°, 135°, 150 °, 165°, or 180° from the first fluid outlet/slot, or an arbitrary angular distance between any two of the above endpoints from the first fluid outlet/slot clockwise and/or counterclockwise. In addition, fluid outlets and/or slots may be placed at different heights along the valve stem and/or head, respectively.

Additionally or alternatively, the fluid outlets and/or slots may be shaped differently and/or aligned to a different extent than shown in the figures. IN

- 7 039960 some embodiments, the fluid outlet and the slot are at least partially aligned for a period of time sufficient to allow the preservative volume of reagent to flow from the reagent chamber to the sample collection chamber. For example, the fluid outlet may be positioned adjacent to an elongated slot defined by the valve head (e.g., extending a quarter to half way around the circumference of the valve head) so that as the pin rotates within the valve head, the fluid outlet is not partially obstructed by the side wall of the valve head and is aligned with part of the slot. The reagent may enter through the partially unoccluded fluid outlet, and as the pin continues to rotate, the fluid outlet becomes less and less obstructed until it is substantially completely unoccluded. Continued rotation of the pin relative to the valve head can cause the fluid outlet to cross the slot to maintain the open configuration. Such an embodiment reduces the need for consistent accuracy in the distance between the fluid outlet and the slot relative to the rotational distance to seal the reservoir with the seal cap.

In some embodiments, attaching the seal cap to the reservoir causes the pin to rotate relative to the valve head, which moves the valve from a closed to an open configuration. Continued tightening of the sealing cap causes the pin to continuously rotate so that the fluid outlet crosses the length of the slot and the fluid outlet is again occluded by the inner sidewall portion of the valve head, causing the valve to move from an open configuration to a closed configuration.

While in the preferred embodiment, direct mechanical interactions between the cuff 126 and the side wall of the sample collection chamber 103 allow the valve 104 to be structurally reconfigured from a closed configuration to an open configuration, other mechanisms for opening and/or closing the selectively movable valve are contemplated herein. . In some embodiments, the cuff includes a protrusion or other structure that engages with a feature attached or formed in the side wall of the sample collection chamber to prevent rotation of the valve head. For example, the collar may include a radially protruding rib that engages a protrusion or ridge on the sidewall that physically prevents movement of the valve head within the chamber. In some embodiments, the radially projecting rib (or plurality of ribs) is positioned such that the valve head engages with the rib, which causes the valve head to rotate a certain degree, causing the valve head to at least partially align with the slot after the reservoir has been sealed with a seal cap. . In some embodiments, a rib or other structural element engages a bore or keyway in the side wall of the chamber to allow the valve and bonnet to rotate through a measured angle of rotation, whereupon the bore/keyway ends or continues down to prevent rotation of the valve head. , while allowing the valve head to continue downward movement within the sample collection chamber.

Regardless of the shape, the selectively movable valve 104 is configured to restructuring from a closed configuration to an open configuration in response to the engagement of the seal cap 110 with the sample collection reservoir 102. Accordingly, tightening the engagement of the solution cap 110 with the sample collection reservoir 102 places the selectively movable valve 104 into an open configuration in which the valve head 108 rotates relative to the pin 106. In some embodiments, the process may be reversed. That is, loosening the bond of the solution cap 110 to the sample collection reservoir 102 allows the pin 106 to rotate in the opposite direction, occluding the fluid outlet 116 and/or causing the fluid outlet 116 and slot 124 to move, thereby returning the selectively movable valve 104 to the closed position. Accordingly, embodiments of the present disclosure enable the provision of sample collection systems having a sample collection reservoir and a selectively movable valve that can be selectively and reversibly sealed, depressurized, and resealed, both in connection with sealing and depressurization of the sample collection reservoir, and in other cases.

With reference to FIG. 4 illustrates an exploded side view of the sample collection system 100, similar to the sectional view of the 3D model shown in FIG. 1. Each element of seal cap 110, pin 106, valve head 108, and sample reservoir 102 is illustrated in an exploded state, showing the aligned arrangement of each component of system 100. As shown, seal cap 110 may further comprise a plurality of external ridges 130. External the ridges 130 may aid in better gripping of the seal lid 110 when placing the lid 110 over the sample collection container 102. Additionally or alternatively, the outer ridges 130 may be used to rotate and close the seal lid 110 on the sample collection container 102. In some variants

- 8 039960 external ridges 130 may be useful to allow the user to tighten the seal cap 110 more tightly and may provide the user with a better grip during this process. The outer ridges 130 may also facilitate the opening and closing of the selectively movable valve 104 and/or the removal of the seal cap 110 in a laboratory when accessing a biological sample, for example, manually or using an automated cap removal mechanism.

Let us now turn to FIG. 5A-5C; pin 106 is illustrated in perspective (FIG. 5A) and frontal cross-sectional views (FIGS. 5B and 5C) with an enlarged view of the fluid outlet 116 shown in FIG. 5C. As shown, the pin 106 includes one or more tapered regions, which, among other things, may facilitate the insertion of the pin 106 into the seal cap 110 and into the head 108 of the valve. For example, pin 106 includes an upper collar 122 that is sized and shaped to fit within seal cap 110 and form a fluid tight seal therewith (as described above). As shown, the upper cuff 122 may have a tapering with a larger diameter adjacent the retainer ring 118 and a smaller diameter extending from the retainer ring 118 toward its proximal end. The smaller diameter end of the upper collar 122 may have a smaller diameter than the reagent chamber 111 (or other portion of the sealing cap 110 to which the pin is attached), which may facilitate the association of the pin 106 with the solution cap 110. As the diameter of the upper cuff 122 increases away from the proximal end, it reaches a diameter sufficient to form an interference fit or mechanical engagement with the corresponding reagent chamber 111 (or other portion of the seal cap 110 to which the pin is attached). In some embodiments, the interference fit between the upper collar 122 and the corresponding reagent chamber 111 (or other portion of the seal cap 110 to which the pin is attached) is a fluid tight fit.

As further shown in FIG. 5A-5C, the pin 106 may include a retaining ring 118 into which a protrusion 120 of the inner side wall of the seal cap 110 is inserted to secure the pin 106 to the seal cap. Alternatively, retaining ring 118 may include a seal, such as an O-ring or elastomeric material, which may abut against seal cap 110 to form a fluid-tight seal between seal cap 110 and pin 106.

The pin 106 further includes a proximal end that is sized and shaped to match the valve head 108 . As shown, the distal end includes a tapered outer side wall, an annular retainer 132, and a fluid outlet 116. As shown, the fluid outlet 116 may extend some distance from the tapered outer side wall such that when the valve 104 is in the closed configuration, the fluid outlet 116 contacts and forms an airtight seal with the inner surface of the valve head 108. fluid connection, and when valve 104 is in an open configuration, fluid outlet 116 protrudes into slot 124 formed by valve head 108. In some embodiments, the fluid outlet 116 is flush with the inner side wall of the valve head 108 when the valve 104 is in the closed configuration and at least partially aligned with the slot 124 in the open configuration without protruding into it. In some embodiments, the curvature of the fluid outlet 116 is substantially the same or complementary to the curvature of the inner sidewall of the valve head 108, thereby providing a fluid-tight connection therebetween.

Locking member 132 may additionally or alternatively engage with a portion of valve head 108 such that a tight association between pin 106 and valve head 108 is maintained when valve 104 transitions to an open configuration. In some embodiments, an annular retainer 132 is located at the proximal end of the fluid outlet 116 and forms a fluid-tight connection with the valve head 108. Additionally or alternatively, an annular locking element 132 is placed at the distal end of the outlet channel 116 for the fluid.

Let us now turn to FIG. 6A-6B; perspective views (FIG. 6A) and a front sectional view (FIG. 6B) of the valve head 108 are shown. As shown, the inner side wall defining the slot of the valve head 108 may be tapered in a complementary manner to the pin 106. For example, the inner side wall of the valve head 108 may be tapered proximal to distal at the same angle or degree as the pin 106. In such an embodiment, the inner side wall of the valve head 108 may be connected directly to the outer side wall of the pin 106 for substantially the entire length of the valve head and form an interference fit therebetween. As another example, the inner side wall of the valve head 108 may be tapered from the proximal end to the distal end at a greater angle or greater than that of the pin 106 so that a portion of the pin 106 remains spaced from the inner side wall when connected to it. In any of

- 9 039960 of the above examples and as shown in FIG. 1-3, an interference fit may be formed between the pin 106 and the valve head 108, which may further be fluid tight, to form a selectively movable valve 104.

The valve head 108 may further comprise one or more annular locking elements 134, 136 located on the inner side wall of the valve head 108. For example, as perhaps better shown in FIG. 6B, the valve head 108 includes a first annular stop element 134 located on the side wall of the valve head 108 on the distal side of the slot 124. The valve head 108 further includes a plurality of concentric annular stop elements 136 located on the lower, distal surface of the interior of the valve head 108. The annular locking elements 134, 136 may be connected to the pin 106 and, in some embodiments, form a fluid-tight connection with the pin 106.

For example, the annular locking member 134 may be a protrusion in the sidewall that forms a fluid-tight interference fit with the outer sidewall of the pin. The annular locking element may be a continuous annular space around the circumference of the valve head to provide a fluid-tight seal between the valve head and the pin. As shown in FIG. 6, an annular stop member 134 may be positioned distal to the slot 124 to prevent leakage or leakage of fluid from the reaction chamber between the valve head and the pin, and to facilitate fluid flow through the aperture into the sample collection chamber after the slot is aligned with the corresponding outlet channel for the fluid.

In some embodiments, the implementation of the pin may contain a complementary channel for receiving an annular locking element. In such embodiments, the passage is preferably sized and shaped to receive the annular retainer and allow the annular retainer to rotate therein while providing a fluid-tight connection therebetween. Alternatively, the pin includes its own annular retaining element that forms a fluid-tight connection (eg, by an interference fit) with the annular retaining element of the valve head. For example, when the valve head is initially associated with the pin (for example, during assembly), the annular retainer of the valve head may extend over the annular retainer of the pin, creating a fluid-tight connection between the distal surface of the annular retainer associated with the valve head and the proximal surface of the associated with a pin of an annular locking element.

In some embodiments, as shown in FIG. 5A-5C, 6A and 6B, valve pin 106 and/or valve head 108 may comprise an arcuate notch 138, 140. When both notches are present, the arcuate notch 140 of valve head 108 may be the same or substantially the same contour as the cutout 138 of pin 106. In some embodiments, arcuate cutout 138, particularly when present in pin 106, may facilitate more efficient flow of sample preservation reagent through fluid outlet 116 and may additionally or alternatively reduce reagent volume. to preserve the sample remaining (eg, collected) at the distal end of the post 106. In an alternative embodiment, the lower edge of the fluid outlet is formed by the lower surface of the distal end of the post.

In some embodiments, the pin 106, valve head 108, and/or any of the annular stop members 132, 134, 136 may be made of an elastic (e.g., elastomeric) material or comprise an elastic (e.g., elastomeric) material configured to bent under tension to allow an interference fit, in particular, fluid-tight seals formed between the interacting surfaces. Additionally or alternatively, any of the stem 106, valve head 108, and/or any of the annular stop members 132, 134, 136 may be made of or contain a rigid material (e.g., a thermoplastic, plastic, metal, or alloy). In a preferred embodiment, one of the stem 106 and valve head 108 is made from or contains a material that is more elastic and/or less rigid than the other. For example, the stem may be made of polypropylene or polyester (such as polyethylene terephthalate (PET) or glycol-modified polyethylene terephthalate (PETG)), while the valve head may be made of polyethylene (such as ultra high molecular weight polyethylene (UHMW) or high density polyethylene (HDPE). )). The properties of the material should provide a fluid-tight connection between the pin 106 and the valve head 108, and further allow the selectively movable valve 104 to transition between open and closed configurations.

In embodiments in which the valve head has an arcuate cutout (e.g., cutout 140 in FIG. 6), this cutout may press against the bottom surface of the pin and create sealing pressure between cooperating annular locking elements (e.g., elements 132,

- 10 039960

134). The arcuate notch can be designed to flex and therefore provide an advantageous mechanism for maintaining a fluid-tight connection between the valve stem and head despite changes in manufacturing tolerances affecting the contour and/or position of elements associated with the stem and head valve.

Methods for Realizing a Solution Cap Having a Selectively Moveable Sleeve Shoulder

Referring again to FIG. 1-6; the methods disclosed herein may include a method of assembling a multi-piece collection kit for use in the preservation of a biological sample. Assembling the collection kit may include preparing the solution cap 110. This may include, for example, filling the solution cap 110 with some sample preservation reagent followed by mechanically locking the valve 104 with the solution cap 110, or by successively press-fitting the pin 106 in association with the solution cap 110 followed by a fluid-tight connection. valve heads 108 with a pin 106, or in the form of a preformed valve 104 comprising a pin 106 and a valve head 108 connected in a closed configuration. Accordingly, assembly of the valve 104 may occur before, during, or after the pin 106 is attached to the solution cap 110. Assembling the kit may further include obtaining a sterile sample collection reservoir 102 and optionally a sterile funnel, and combining the components in a package for later use.

Once received by the user, the kit described above can be assembled and used to preserve a biological sample. In a typical implementation, the biological sample enters the reservoir 102 for collecting samples. The resulting biological sample may enter directly into the collection chamber 103 or may be introduced by gravity flow along the inner side wall of an optionally attached funnel. If a funnel is used, it is removed from the sample collection tank 102 after it has assisted in the intake of the biological sample. The seal cap 110 and its associated closed valve are brought into association with the sample collection reservoir 102 by inserting the distal portion of the valve 104 into the opening defined by the sample collection chamber 103 and securing the seal cap 110 over the top of the sample collection reservoir 102 (e.g., by rotating seal cap 110 along complementary threads 112, 114 between cap 110 and reservoir 102). The selectively movable valve 104 undergoes a reconfiguration when the seal cap 110 is secured over the collection container 102, moving the valve 104 from a closed to an open configuration. The reagent stored within the seal cap 110 is transferred to the sample collection chamber 103 and, in some embodiments, the collection reservoir 102 may be shaken or otherwise agitated to ensure that all or at least most of the preservative reagent covers the collected sample and mixes. with him. The sample is chemically and biologically preserved by interaction with the sample preservative and is advantageously protected from the outside atmosphere by a fluid-tight and/or air-tight seal formed between seal cap 110 and reservoir 102. This reduces the likelihood of sample contamination and helps maintain the integrity of the evidence component during time of transportation and/or storage at the point of processing.

Typically, during assembly of the valve 104, the valve head 108 is coupled to the pin 106 such that the valve head 108 can rotate about the pin 106 but cannot move laterally with respect to it. Accordingly, slot 124 and fluid outlet 116 are aligned in the same horizontal plane when valve 104 is formed. 108 valve (for example, due to physical interaction between complementary opposite surfaces).

When the seal cap 110 is associated with the reservoir 102, the distal end of the valve 104 (including the distal ends of the pin 106 and the valve head 108, which constitute the closed fluid outlet 116 and slot 124, respectively) enters the sample collection chamber 103. As the sealing cap 110 is brought into closer engagement with the reservoir 102, the valve is retracted further into the sample collection chamber 103 until the distal end of the cuff 126 enters the inner side wall of the chamber 103. At this point, the cuff 126 enters engages with the chamber sidewall and resists the rotational force transitively applied thereto by the seal cap 110. The frictional force between the collar 126 and the chamber sidewall exceeds a threshold force (e.g., frictional force) preventing rotation of the pin 106 (and fluid outlet 116) relative to the valve head 108. As a result, valve head 108 stops rotating due to the torque applied to seal cap 110, but pin 106 continues to rotate with seal cap 110, causing fluid outlet 116 to move toward slot 124 and into an open configuration.

- 11 039960

It should be noted that as the pin 106 is rotated, it is also drawn further into the sample collection chamber 103, since the rotation of the seal cap 110 causes the seal cap 110 to advance towards the reservoir 102 and results in a tighter bond with it. Thus, as the pin 106 rotates and retracts further into the chamber 103, the pin 106, while not rotating, is nonetheless drawn even further into the chamber 103. Accordingly, the pin 106 can only rotate and retract into the chamber 103 as long as the flange 128 will not engage with the edge of chamber 103. In some embodiments, fluid outlet 116 and slot 124 are at least partially aligned after less than a half turn (180°; for example, a quarter turn (90° )), and at the same time that the flange 128 engages with the edge of the sample chamber 103.

Alternatively, fluid outlet 116 aligns with slot 124 before flange 128 prevents vertical movement of the valve in sample collection chamber 103. In some embodiments, aligning fluid outlet 116 with slot 124 causes fluid outlet 116 to protrude and mechanically lock into slot 124. In this case, the frictional force between cuff 126 and inner sidewall of chamber 103 may be less than the force required to disengage fluid outlet 116 from slot 124. Accordingly, valve head 108 can resume rotation with pin 106 and seal cap 110, although more rotational force will be required on seal cap 110 than before collar 126 was engaged. by friction with the side wall of the chamber.

It should be understood that the solution lid may secure and seal the collection reservoir by any of the means described herein or known in the art. Also, while one particular design and associated method of opening the selectively movable valve is depicted in FIG. 1-6, it should be understood that other methods and structural configurations are included within the scope of this disclosure. For example, although the depicted embodiments illustrate the pin as having a fluid outlet and the valve head as having a slot, in some embodiments, the fluid valve and slot may be interchanged between components or replaced with other complementary components that perform the same or similar function. For example, the pin may include a slot with which the fluid outlet of the valve head aligns when moving from a closed configuration to an open configuration.

As another example, the valve can be moved to an open configuration by pivoting the fluid outlet to a position where the valve head has no side wall. In other words, the slit may represent the absence of a side wall. For example, as described above, the fluid outlet may be tightly coupled to the inner side wall of the valve head, and as the fluid outlet rotates relative to the side wall of the valve head, the fluid outlet passes through the edge of the side wall and becomes open to any or a side wall that allows the sample preservative to pass freely through the fluid outlet. In some embodiments, the valve head lacks a sidewall configured to tightly bind and prevent fluid flow through the fluid outlet at an angle of less than 270°, less than 225°, less than 180°, less than 135°, less than 90°, or less than 45° of its circumference.

As another example, the slot may be a keyway within a valve head that has both a vertical and a horizontal component. Once the fluid outlet is aligned with the keyway, the valve head can remain stationary and the pin can move vertically within the valve head while also rotating. Likewise, the keyway curves down along the valve head body, following the path of the pin, to maintain the valve in an open configuration. In some embodiments, multiple keyways are arranged in a radially descending pattern. For example, the keyway may begin every 90° around the circumference of the valve head. Thus, assembly of the valve can be simplified since relatively any placement of a fluid outlet between adjacent keyways can provide valve functionality. This can further eliminate the potentially laborious and precise placement of the fluid outlet relative to the slot during assembly to ensure that the degree of available rotation of the pin relative to the valve head is sufficient to align the fluid outlet with the slot.

In some embodiments, the solution cap is pressurized and moving the selectively movable valve to the open configuration causes the sample preservation reagent stored in the solution cap to be forced out into the sample collection chamber. This may favorably encourage mixing of the stored reagent with the collected sample and may have the additional effect of preserving the reagent and/or

- 12 039960 evidentiary component.

The methods may further include removing the preserved sample from the sample collection system. This may include, for example, the steps of unscrewing or otherwise removing the solution cap from the sample collection reservoir. In some embodiments, the cap removal process causes the valve to return to a closed configuration, whereby the valve is resealed. The sample collection system is designed in some embodiments such that the solution cap and valve can - at this stage - be removed from the sample collection tank without catastrophic failure of any components. Thus, the sample collection system can be designed such that the valve head collar can be detached from the side wall of the sample collection chamber while maintaining the seal integrity of the valve cover assembly. This can be achieved, for example, by designing the components so that the mechanical force required to disengage the collar is less than the force required to remove the pin from the seal cap and less than the force required to disengage the valve head from the pin.

Unless otherwise indicated, all technical and scientific terms used in the present description have the same meaning as is generally understood by a person skilled in the art to which this disclosure pertains.

It should also be understood that systems, devices, products, kits, methods, and/or processes in accordance with some embodiments of the present disclosure may include, incorporate, or otherwise contain features, features (e.g., components, subparts, elements, parts, and/ or plots) described in other embodiments disclosed and/or described in the present description. Accordingly, various features of certain embodiments may be compatible, may be combined, included, and/or incorporated into other embodiments of the present disclosure. Thus, the disclosure of certain features relating to a particular embodiment of the present disclosure should not be construed as limiting the application or inclusion of said features in a particular embodiment. On the contrary, it should be understood that other embodiments may also include these features, components, elements, parts and/or areas, not necessarily beyond the scope of this disclosure.

Moreover, unless a feature is described as requiring another feature in combination with it, any feature herein may be combined with any other feature of the same or different embodiment disclosed herein. In addition, various well known aspects of exemplary systems, methods, devices, and the like. are not described herein in specific detail to avoid obscuring aspects of exemplary embodiments. However, such aspects are also provided in the present description.

The present disclosure may be embodied in other specific forms without departing from its form or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not as restrictive. Thus, the scope of the invention is defined by the appended claims and not by the preceding description. Although certain embodiments and details have been included in this specification and the accompanying disclosure for the purpose of illustrating embodiments of the present disclosure, those skilled in the art will appreciate that various changes to the methods, products, devices, and apparatus disclosed herein may be made without departing from the scope of the disclosure or invention as defined in the appended claims. All changes that are within the meaning and range of equivalence of the claims are to be included within the scope of the claims.

Claims (15)

CLAIM 1. System (100) for collecting biological samples, including: a reservoir (102) for collecting samples, having an opening for receiving a biological sample; a selectively movable valve (104) configured to at least partially connect to the opening of the sample collection tank (102), wherein the selectively movable valve (104) comprises: a pin (106) having a hollow body and a fluid outlet (116) defined by a portion of its side wall; and a valve head (108) associated with the distal portion of the pin (106) and having a slot (124) selectively aligned with the fluid outlet (116); and a sealing cap (110) configured to communicate with a selectively movable valve and a sample collection reservoir, wherein the sealing cap includes a reagent chamber for storing some reagent for sample preservation, the reagent chamber in fluid communication with the hollow body of the pin (106) - 13 039960 while linking the seal cap (110) to the sample collection reservoir (102) causes the pin (106) and valve head (108) to be physically repositioned so that the fluid outlet (116) is aligned with the slot (124) defined by the valve head (108), which allows fluid communication between the reagent chamber (111) and the sample collection reservoir (102). 2. The biological sampling system (100) of claim 1, wherein the physical repositioning includes rotational repositioning of the pin (106) relative to the valve head (108). 3. The system (100) for collecting biological samples according to claim 1 or 2, in which the reservoir (102) for collecting samples further comprises a connecting element (112) and the sealing cover (110) further comprises a complementary connecting element (114) configured for coupling with the connecting element (112) of the tank (102) for collecting samples to connect the tank (102) for collecting samples and the sealing cover (110). 4. The system (100) for collecting biological samples according to claim 3, in which the connecting element (112) contains a ridge protruding from the tank (102) for collecting samples, or a recess inside the tank (102) for collecting samples and a complementary connecting element (114 ) contains a hook or comb, the size and shape of which allow to engage the specified connecting element (112). 5. The system (100) for collecting biological samples according to claim 3, in which the connecting element (112) and the complementary connecting element (114) contain a thread (114, 112) and a thread (114, 112) of the complementary connecting element (114) is located on the inside surface of the seal cap (110). 6. A biological sample collection system (100) according to any one of claims 1 to 5, wherein the fluid outlet (116) is closed off by the valve head (108) when the selectively movable valve (104) is in a closed configuration, and the fluid outlet (116) is at least partially aligned with the valve head (108) when the selectively movable valve (104) is in an open configuration. 7. System (100) for collecting biological samples according to any one of claims 1-6, in which the pin (106) contains a retaining ring (118) configured to connect with a protrusion (120) or retainer inside the inside of the sealing cover (110). 8. System (100) collection of biological samples according to any one of claims 1-7, in which one or more elements of the pin (106) and head (108) of the valve contain an annular locking element (132, 134, 136), configured to maintain tight association between the pin (106) and the head (108) of the valve. 9. System (100) for collecting biological samples according to any one of claims 1 to 8, in which the head (108) of the valve contains the upper cuff (122), located proximally relative to the section of the side wall that defines the outlet channel (116) for the fluid, when In this case, the top collar (122) has a larger diameter than the side wall portion defining the fluid outlet (116) and is configured to cooperate with the inner side wall of the sample collection container (102). 10. The system (100) for collecting biological samples according to claim 9, in which the sealing force between the valve head (108) and the pin (106) is less than the compression force between the upper cuff (122) of the valve head (108) and the inner side wall of the reservoir (102) to collect samples. 11. A method for collecting and preserving a biological sample, including: receiving a biological sample into a sample collection tank (102) of the sample collection system (100) of claim 1; and associating the seal cap (110) of the sample collection system (100) of claim 1 with the sample collection reservoir (102) so as to cause the selectively movable valve (104) associated with the seal cap (110) to open, whereby the reagent for sample preservation held inside the sealing cap is released into the sample collection chamber. 12. The method of claim 11, wherein associating the seal cap to the sample collection container includes threading a connector located on the outer surface of the sample collection container with a complementary connector located on the inner surface of the seal cap. 13. The method of claim 11 or 12 wherein connecting the seal cap (110) to the sample collection reservoir (102) to open a selectively movable valve (104) associated with the seal cap (110) includes turning a pin (106 ) inside the respective valve head (108) to at least partially align the fluid outlet (116) of the pin (106) with the slot defined by the valve head (108). 14. The method according to any one of claims 11-13, further comprising accessing the preserved sample inside the sample collection tank (102) by detaching the sealing cover (110) from the sample collection tank (102), while detaching the sealing cover (110) away from the sample collection container (102) causes the selectively movable valve (104) associated with the seal cap (110) to move from an open configuration to a closed con - 14 039960 figure. 15. A set for the collection and preservation of a biological sample, containing: a reservoir (102) for collecting samples, containing: a sample collection chamber (103) having an opening configured to receive a biological sample into the sample collection chamber (103); and a connecting element (112) placed on the outside of the tank (102) for collecting samples; sealing cap (110) containing: a reagent chamber (111) in which a certain amount of a sample preservation reagent is stored; and a complementary connector (114) configured to engage with a connector (112) of the sample collection tank (102); and a selectively movable valve (104) associated with a sealing cap (110), while the selectively movable valve (104) is configured to communicate with the sample collection chamber (103) and contains: a pin (106) defining a fluid outlet (116) in its distal portion; and a valve head (108) associated with a distal portion of the pin (106), wherein the valve head (108) defines a slot (124); and a funnel configured to communicate with the sample collection reservoir (102) and to direct the receipt of a biological sample from the user into the sample collection chamber (103) of the sample collection reservoir (102), wherein when the selectively movable valve (104) is in closed configuration, the fluid outlet (116) forms a fluid-tight connection with the valve head (108), and when the selectively movable valve (104) is in the open configuration, the fluid outlet (116) at least partially aligned with slot (124).