Biological sample collection system with push activated valve for sample release

Abstract

A biological sample collection system is provided, the system comprising: a sealed container; a sample collection reservoir disposed toward the first end of the sealed container and including a valve disposed in the sample receiving region, the valve including a closed configuration wherein the biological sample remains in the sample collection reservoir when the valve is in the closed configuration and an open configuration wherein the biological sample remains in the sample collection reservoir when the valve is in the open configuration. Wherein the biological sample is released from the sample collection reservoir into a sample storage chamber of the sealed container when the valve is in the open configuration; and a cap, the cap comprising a pusher; wherein when the biological sample collection system is closed by engagement of the sealed container with the cap, the pusher engages with the valve, thereby moving the valve from the closed configuration to the open configuration to allow release of the biological sample from the sample collection reservoir into the sealed container.

Description

Technical Field

[0001] The present invention relates to a biological sample collection system. More particularly, the present invention relates to a biological sample collection system having a push-activated valve for sample release. Background Art

[0002] On-site collection of biological samples (such as saliva or sputum) can provide invaluable information about patients or donors. It may be inconvenient to require patients / donors to go to biological sample collection sites or laboratories. Similarly, it may be difficult and expensive for laboratory personnel to directly contact patients / donors for sample collection, especially if the sample size is large and / or geographically different. In addition, patients / donors are usually inexperienced first-time donors, so it is crucial that biological sample collection systems are easy for novice users to operate or manipulate. The desired collection system does not require professional / clinicians, facilities and equipment when collecting, transporting and storing biological samples.

[0003] At ambient temperatures, nucleic acids and other biomolecules (e.g., metabolites) in biological samples degrade rapidly and must often be stored at refrigerated temperatures to remain stable. This problem is magnified when biological samples are collected at remote field locations or at a significant distance from a laboratory or doctor's office, and especially when electricity and refrigeration are nonexistent or inconsistent. In addition, transporting biological samples with dry ice or ice packs is expensive, complicated, and impractical, and may result in worker exposure to infectious agents or pathogens. Therefore, there is a need for a safe collection, transportation, and storage system that can maintain the integrity of the collected biomolecules in biological samples under ambient conditions for further molecular analysis or diagnostic testing.

[0004] An improved reservoir system for releasably and reliably storing a substance is needed. It is often desirable to store a substance (e.g., a liquid, solid, slurry, gas, mixtures thereof, etc.) in a reservoir or compartment prior to mixing the contents of the reservoir with another material. For example, prior to combining one or more compounds with another material, it may be desirable to package and store the compounds in a reservoir for transport and / or safe storage and handling.

[0005] Before toxic compounds are combined with detoxification materials or reagents, it may be desirable to package and store such toxic compounds in a reservoir. Similarly, it is generally desirable to separate concentrated active ingredients from diluents until just before use. The reservoir system with a separate sealed compartment / chamber for sample preservatives protects patients / sample donors from contact, ingestion and / or spilling preservatives. Toxic compounds or preservatives are safely confined in a separate compartment of a sample collection device or system to allow the use of more effective chemicals or preservatives (e.g., denaturants), to stabilize biomarkers / biomolecules, e.g., nucleic acids and metabolites, contained in the collected sample. Only after closing the device or system containing the biological sample with a lid or cap, the compartment for the preservative will be opened, and the biological sample is allowed to mix with the preservative.

[0006] There are various reservoirs / systems for containing substances in a manner that allows a user to seal the closure to combine the substances. Typically, these reservoirs are dual compartment systems in which the substances are stored separately and the substances are combined by the user applying the reservoir / system closure. There are many ways to design the two compartment / chamber system. In particular, there is a need for a patient-friendly sample collection device or system that allows Safety Collection at home followed by leak-proof transport and storage at ambient or room temperature. A two compartment / chamber system is ideal for protecting the donor / patient from preservatives required to preserve the sample or analyte of interest until analysis. Ideally, the method or instructions involve a minimum number of steps for use.

[0007] Biological sample collection systems are needed to facilitate sample collection.

[0008] The purpose of providing this background information is to make known information that the applicant believes may be relevant to the present invention. It is not necessary to admit, nor should it be construed, that any of the foregoing information constitutes prior art to the present invention. Summary of the invention

[0009] On the one hand, a biological sample collection system is provided, the system comprising: (a) a sealed container, the sealed container comprising: a first end, the first end is used to receive the biological sample; a second end, the second end comprises a sample storage chamber; and a connecting member, the connecting member is disposed at the first end; (b) a sample collection reservoir, the sample collection reservoir is disposed toward the first end of the sealed container, wherein the sample collection reservoir comprises: an opening, the opening is used to receive the biological sample; one or more walls, the one or more walls define a sample receiving area; and a valve, the valve is disposed in the sample receiving area, the valve comprises a closed configuration and an open configuration, wherein when the valve is in the closed configuration, the biological sample is retained in the sample collection reservoir, wherein when the valve is in the open configuration, the biological sample is released from the sample collection reservoir into the sample storage chamber of the sealed container; and (c) a cap comprising: a top end; an open end; a pusher comprising a first end extending from an interior portion of the cap and an opposite second end, the second end of the pusher extending a certain distance from the interior portion of the cap toward the open end of the cap and being configured to engage with the valve of the sample collection reservoir; and a connecting member, the connecting member being complementary to the connecting member of the sealed container and being configured to engage the open end of the cap with the first end of the sealed container; wherein when the biological sample collection system is closed by engagement of the connecting member of the sealed container with the connecting member of the cap, the second end of the pusher engages with the valve of the sample collection reservoir, thereby moving the valve from the closed configuration to the open configuration to allow the biological sample to be released from the sample collection reservoir into the sample storage chamber of the sealed container.

[0010] On the other hand, a method for preserving biological molecules in a biological sample is provided, the method comprising: a) obtaining a biological sample; b) obtaining a biological sample collection system as described herein; c) placing the biological sample in the sample collection reservoir; d) placing the cap over the first end of the sealed container; e) engaging the connecting member of the sealed container with the connecting member of the cap, which engages the second end of the pusher with the valve of the sample collection reservoir, thereby moving the valve from the closed configuration to the open configuration to allow the biological sample to be released from the sample collection reservoir into the sample storage chamber of the sealed container; and f) mixing the released biological sample with a stabilizing composition in the sealed container for preserving the biological molecules within the biological sample. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] For a better understanding of the present invention, including the development process to obtain the final product, reference is made to the following description used in conjunction with the accompanying drawings, in which:

[0012] Figure 1 A perspective exploded view of a biological sample collection system 100 according to one embodiment of the present application is shown.

[0013] Figure 2a Shown Figure 1 1 is a side exploded view of the biological sample collection system 100 in FIG. Figure 2b It is along Figure 2a A simplified cross-sectional view taken along line BB. Figure 2c Shows the insertion into Figure 1 1. A perspective view of a sample collection reservoir 112 in a tube 102 of a biological sample collection system 100.

[0014] Figure 3a Shown Figure 1 1 is a side view of the assembled biological sample collection system 100. Figure 3b Shown along Figure 3a Simplified cross-sectional view taken along line DD. Figure 3c Yes Figure 3b An enlarged view of area F is shown in FIG.

[0015] Figure 4a Shown Figure 1 1 is a perspective view of the cap 126 of the biological sample collection system 100. Figure 4b Shown Figure 1 1 is a bottom view of the cap 126 of the biological sample collection system 100.

[0016] Figure 5a Shown Figure 1 A perspective view of a sample collection reservoir 112 of a biological sample collection system 100; Figure 5b A top view is shown; Figure 5c The bottom view is shown; Figure 5d shows a side view; and Figure 5e It is along Figure 5d A cross-sectional view of the sample collection reservoir 112 taken along line GG. Figure 5f Shown Figure 1 1 is a perspective view of an alternative embodiment of a sample collection reservoir 112 of a biological sample collection system 100, wherein the sample collection reservoir includes indicia corresponding to fluid volumes in a sample receiving area.

[0017] Figure 6a -c shows a simplified cross-sectional view of an alternative biological sample collection system 100 ′. Figure 6aA simplified cross-sectional view of an alternative biological sample collection system 100 ′ is shown with the cap 126 ′ detached from the tube 102 ′ and the sample collection reservoir 112 ′ positioned toward the first end 104 ′ of the tube 102 ′ with the valve 120 ′ in a closed configuration. Figure 6b A simplified cross-sectional view of the biological sample collection system 100 ′ is shown with the biological sample collection system 100 ′ closed and the valve 120 ′ in an open configuration. Figure 6c is an enlarged view of the ring / snap features that secure the sample collection reservoir 112' to the tube 102'.

[0018] Figure 7a -c shows a simplified cross-sectional view of an alternative biological sample collection system 100". Figure 7a A simplified cross-sectional view of an alternative biological sample collection system 100" is shown with the cap 126" detached from the tube 102" and the sample collection reservoir 112" positioned toward the first end 104" of the tube 102" with the valve 120" in a closed configuration. Figure 7b A simplified cross-sectional view of the biological sample collection system 100 ″ is shown with the biological sample collection system 100 ″ closed and the valve 120 ″ in an open configuration. Figure 7c is an enlarged view of the lip / shoulder joint that secures the sample collection reservoir 112" to the tube 102".

[0019] Figure 8a An exploded side view of an alternative biological sample collection system 100a is shown. Figure 8b Shown along Figure 8a Simplified cross-sectional view taken along line DD.

[0020] Figure 9a Shown Figure 8a 1 is an exploded side view of the biological sample collection system 100a showing the cap 126a and showing the sample collection reservoir 112a inserted into the tube 102a. Figure 9b Shown along Figure 9a A simplified cross-sectional view taken along line AA.

[0021] Fig.10a Shown in its initial shipping configuration Figure 8a 1 is a side view of the assembled biological sample collection system 100a with the cap 126a partially engaged with the tube 102a. Fig.10b Shown along Fig.10a A simplified cross-sectional view taken along line BB.

[0022] Fig.11a Shown in closed configuration after sample collection Figure 8a100a, with the cap 126a fully engaged with the tube 102a. Fig.11b Shown along Fig.11a Simplified cross-sectional view taken along line CC.

[0023] Fig.12a Shown Figure 8a A perspective view of a cap 126a of a biological sample collection system 100a; Figure 12b A side view is shown; Fig.12c A top view is shown; Fig.12d A bottom view is shown.

[0024] Fig.13a Shown Figure 8a A perspective view of a sample collection reservoir 112a of a biological sample collection system 100a; Fig.13b A side view is shown; Fig.13c Shown along Fig.13b A cross-sectional view taken along line EE of ; Fig.13d Shown as Fig.13c An enlarged view of the area F shown in; Fig.13e A top view is shown; and Fig.13f A bottom view of the sample collection reservoir 112a is shown.

[0025] Fig.14 An exploded side view of an alternative biological sample collection system 100b is shown.

[0026] Fig.15a Shown Fig.14 1 is an exploded side view of the biological sample collection system 100b showing the cap 126b and showing the sample collection reservoir 112b inserted into the tube 102b. Fig.15b Shown along Fig.15a A simplified cross-sectional view taken along line BB.

[0027] Fig.16a Shown in its initial shipping configuration Fig.14 100b is a side view of the assembled biological sample collection system 100b with the cap 126b partially engaged with the tube 102b. Fig.16b Shown along Fig.16a Simplified cross-sectional view taken along line CC. Fig.16c yes Fig.16b 102b, illustrating the interaction between the pusher 132b of the cap 126b and the valve 120b when the cap 126b is partially engaged with the tube 102b.

[0028] Fig.17a Shown in closed configuration after sample collection Fig.14100b, with the cap 126b fully engaged with the tube 102b. Fig.17b Shown along Fig.17a Simplified cross-sectional view taken along line DD. Fig.17c yes Fig.17b 102b, illustrating the interaction between the pusher 132b of the cap 126b and the valve 120b when the cap 126b is fully engaged with the tube 102b.

[0029] Fig.18a Shown Fig.14 A side view of a cap 126b of a biological sample collection system 100b; Fig.18b Shown along Fig.18a A simplified cross-sectional view taken along line TT; Fig.18c A top view is shown; and Fig.18d A bottom view is shown.

[0030] Fig.19a Shown Fig.14 A perspective view of a sample collection reservoir 112b of a biological sample collection system 100b; Fig.19b A side view is shown; Fig.19c Shown along Fig.19b a cross-sectional view taken along line RR of ; and Fig.19d A top view is shown. DETAILED DESCRIPTION

[0031] definition

[0032] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0033] As used in the specification and claims, the singular form "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0034] The term "comprising" as used herein will be understood to mean that the following list is non-exhaustive and may or may not include any other additional suitable items, such as one or more additional features, components, ingredients and / or elements, as the case may be.

[0035] As used herein, terms of degree such as "substantially", "about" and "approximately" refer to a reasonable amount of deviation of the modified term so that the end result is not significantly changed. These terms of degree should be interpreted as including a deviation of at least ±10% of the modified term if the deviation does not negate the meaning of the word modified by the term.

[0036] The term "body fluid" as used herein will be understood to mean naturally occurring fluids from humans or animals and includes, but is not limited to, urine; saliva; sputum; serum; plasma; blood; pharyngeal, nasal / nasopharyngeal and sinus secretions; mucus; gastric juice; pancreatic juice; bone marrow aspirate; cerebrospinal fluid; feces; semen; products of lactation or menstruation; cervical secretions; vaginal fluid; tears or lymph fluid. In one embodiment, the body fluid is selected from sputum or saliva.

[0037] As used herein, the term "ambient temperature" refers to a range of temperatures that may be encountered by a biological sample collection system as described herein, starting from the point of collection, during transportation (which may involve relatively extreme temperatures, although typically for a short period of time (e.g., <5 days)), and during long-term storage prior to analysis, the biological sample collection system may contain a mixture of body fluids (e.g., saliva samples) and a stabilizing composition. In one embodiment, the ambient temperature is in the range of from about -20°C to about 50°C. In another embodiment, the ambient temperature is room temperature (RT) and ranges from about 15°C to about 25°C.

[0038] As mentioned above, the two compartment / chamber system is ideal for protecting the donor / patient from the influence of the preservative required for preserving the sample or analyte of interest until the analysis. A mechanism for separating the two compartments in the collection system is to use a valve. The sealing mechanism of the sample collection device can include a one-way valve or a check valve that allows fluid (liquid or gas) to flow through it only in one direction. There are various types of check valves used in various applications. An example of a common one-way valve is a duckbill valve. These valves are usually made of rubber or synthetic elastomers and have two or more valve flaps. The application of pressure causes the flat duckbill valve flap to open to allow pressurized fluid (or gas) to pass. When the pressure is removed, the duckbill valve returns to its flat shape, thereby preventing backflow. Other examples of one-way valves include ball one-way valves, diaphragm one-way valves, swing or tilt one-way valves, baffles or clapper valves, lift one-way valves, straight-through one-way valves and flow one-way valves.

[0039] As further outlined in detail below, the system described herein is a two compartment / chamber system that utilizes a valve to separate a sample collection reservoir from a sample storage chamber, wherein after collection of a biological sample, the valve is moved to an open position by a mechanical connection between the valve and a cap of the system.

[0040] In one embodiment, a biological sample collection system is provided, the system comprising: (a) a sealed container, the sealed container comprising: a first end, the first end being used to receive the biological sample; a second end, the second end comprising a sample storage chamber; and a connecting member, the connecting member being disposed at the first end; (b) a sample collection reservoir, the sample collection reservoir being disposed toward the first end of the sealed container, wherein the sample collection reservoir comprises: an opening, the opening being used to receive the biological sample; one or more walls, the one or more walls defining a sample receiving area; and a valve, the valve being disposed in the sample receiving area, the valve comprising a closed configuration and an open configuration, wherein when the valve is in the closed configuration, the biological sample is retained in the sample collection reservoir, wherein when the valve is in the open configuration, the biological sample is released from the sample collection reservoir to the sample storage chamber of the sealed container. and (c) a cap comprising: a top end; an open end; a pusher comprising a first end extending from an interior portion of the cap and an opposite second end, the second end of the pusher extending a certain distance from the interior portion of the cap toward the open end of the cap and being configured to engage with the valve of the sample collection reservoir; and a connecting member, the connecting member being complementary to the connecting member of the sealed container and being configured to engage the open end of the cap with the first end of the sealed container; wherein when the biological sample collection system is closed by engagement of the connecting member of the sealed container with the connecting member of the cap, the second end of the pusher engages with the valve of the sample collection reservoir, thereby moving the valve from the closed configuration to the open configuration to allow the biological sample to be released from the sample collection reservoir into the sample storage chamber of the sealed container.

[0041] In another embodiment, the connection member comprises a threaded connection.

[0042] In yet another embodiment, engagement of the connection member of the sealed container with the connection member of the cap creates a fluid-tight seal.

[0043] In still yet another embodiment, the sample collection reservoir comprises at least one marking located on the at least one or more walls, the at least one marking corresponding to a fluid volume in the sample receiving area.

[0044] In another embodiment, the sample collection reservoir is funnel-shaped.

[0045] In another embodiment, the valve is a duckbill valve, and when the biological sample collection system is closed by engagement of the connecting member of the sealed container with the connecting member of the cap, the second end of the pusher engages with the duckbill valve and extends through the duckbill valve to move the valve from the closed configuration to the open configuration.

[0046] In yet another embodiment, the valve is formed of a flexible material or a rigid plastic having at least one pre-scored cut, wherein the at least one pre-scored cut does not completely penetrate the flexible material or the rigid plastic, and when the biological sample collection system is closed by engagement of the connecting member of the sealed container with the connecting member of the cap, the second end of the pusher engages with the at least one pre-scored cut to penetrate and extend through the flexible material or the rigid plastic, thereby moving the valve from the closed configuration to the open configuration.

[0047] In another embodiment, the pusher includes a groove in an outer surface of the pusher, wherein the groove extends along at least a portion of the second end of the pusher and along the longitudinal axis of the pusher. In another embodiment, the groove extends from the first end of the pusher to the second end of the pusher.

[0048] In yet another embodiment, the valve has a valve seat and a valve face, wherein the valve face is movable relative to the valve seat between the closed configuration and the open configuration, in which the valve seat sealingly engages the valve face, and in the open configuration, the valve face is spaced apart from the valve seat to allow fluid to flow between the valve face and the valve seat, and when the biological sample collection system is closed by engagement of the connecting member of the sealed container with the connecting member of the cap, the second end of the pusher engages with the valve to move the valve face relative to the valve seat from the closed configuration to the open configuration.

[0049] In still yet another embodiment, the sample collection reservoir is connected toward the first end of the sealed container by a press-fit connection between a lip extending from the one or more walls of the sample collection reservoir and a complementary groove disposed at the first end of the sealed container.

[0050] In another embodiment, the sample collection reservoir is connected toward the first end of the sealed container by a snap-fit ​​connection between a lip extending from the one or more walls of the sample collection reservoir and a complementary groove disposed on the inner surface of the sealed container.

[0051] In yet another embodiment, the sample collection reservoir is connected toward the first end of the sealed container by a press-fit connection between a lip extending from the one or more walls of the sample collection reservoir and a shoulder on an inner surface of the sealed container.

[0052] In another embodiment, the sample storage chamber comprises a stabilizing composition.

[0053] In another embodiment, a method for preserving biological molecules in a biological sample is provided, the method comprising: a) obtaining a biological sample; b) obtaining a biological sample collection system as described herein; c) placing the biological sample in the sample collection reservoir; d) placing the cap over the first end of the sealed container; e) engaging the connecting member of the sealed container with the connecting member of the cap, which engages the second end of the pusher with the valve of the sample collection reservoir, thereby moving the valve from the closed configuration to the open configuration to allow the biological sample to be released from the sample collection reservoir into the sample storage chamber of the sealed container; and f) mixing the released biological sample with a stabilizing composition in the sealed container for preserving the biological molecules within the biological sample.

[0054] In another embodiment of the above-mentioned sample collection system, the top end of the cap includes a second open end (double-ended cap), and the second open end is separated from the open end of the cap by the inner part of the cap, and the inner part of the cap includes an inner cap wall, and the inner cap wall separates the second open end of the cap from the open end of the cap, and the first end of the pusher extends from the inner cap wall, wherein the second open end of the cap includes a second connecting member complementary to the connecting member of the sealed container.

[0055] In another embodiment, a method for preserving biomolecules in a biological sample is provided, the method comprising: a) obtaining a biological sample; b) obtaining a biological sample collection system as described above, wherein the top end of the cap comprises a second open end (a double-ended cap), wherein the second open end of the cap is connected to the sealed container by engaging the second connecting member of the cap with the connecting member of the sealed container; c) disengaging the second connecting member of the cap from the connecting member of the sealed container and removing the cap from the sealed container; d) placing the biological sample in the sample collection reservoir; e) placing the The open end of the cap is placed above the first end of the sealed container so that the cap is inverted relative to the placement of the cap in step (b); f) engaging the connecting member of the sealed container with the connecting member of the cap, which engages the second end of the pusher with the valve of the sample collection reservoir, thereby moving the valve from the closed configuration to the open configuration to allow the biological sample to be released from the sample collection reservoir into the sample storage chamber of the sealed container; and g) mixing the released biological sample with a stabilizing composition in the sealed container for preserving the biological molecules within the biological sample.

[0056] Figure 1 , 2a -c, 3a-c, 4a-b and 5a-f illustrate a biological sample collection system 100 and its components according to an embodiment of the present application. System 100 includes a sealed container shown as a tube 102, which in the illustrated embodiment is generally cylindrical in shape. Any suitable sealed container can be used, such as a common sample collection tube known in the art or other vials / tubes / reservoirs / containers having the properties described herein. Tube 102 includes a first end 104, which is used to receive a biological sample, such as a body fluid (e.g., sputum or saliva); a second end 106, which includes a sample storage chamber 108 defined by a wall 107. As further outlined below, the sample storage chamber 108 of tube 102 can contain a stabilizing composition for stabilizing, preserving and / or promoting the recovery of biomolecules from a biological sample, the stabilizing composition being present in the sample storage chamber 108 before sample collection. The tube 102 further includes a connection member 110 disposed at the first end 104 , which, in the illustrated embodiment, is an external helical thread located on an outer surface of the wall 107 of the tube 102 .

[0057] The tube 102 can have any desired width, length, or thickness as desired, and is made of an inert, durable material such as polyethylene, polypropylene, polystyrene, or related plastics. The tube 102 is ideally free-standing. The sample storage chamber 108 is suitable for containing substances such as liquids, solids, semi-solids, slurries, suspensions, powders, colloids, gels, gases, mixtures thereof, and the like. The sample storage chamber 108 should have sufficient void volume to hold the biological sample, plus any desired composition for mixing with the sample.

[0058] The wall 107 of the tube 102 should ideally be transparent or translucent to allow the sample to be viewed once collected. The wall 107 may be free of any markings or other indicia, and should be adapted to be comfortably held by a user. However, if desired, the wall may be decorated, and / or have handles or raised textures on its outer surface for ease of holding, or graduated markings indicating volume.

[0059] The system 100 further includes a sample collection reservoir 112 configured to be positioned toward the first end 104 of the tube 102 . Figure 5a A perspective view of the sample collection reservoir 112 is shown. Figure 5b and 5c 1 and 2 respectively show a top view and a bottom view of the sample collection reservoir 112. Figure 5d A side view of the sample collection reservoir 112 is shown, and Figure 5e It is along Figure 5d A cross-sectional view of the sample collection reservoir 112 taken along line GG. Figure 5f Shown Figure 1 1 is a perspective view of an alternative embodiment of a sample collection reservoir 112 of a biological sample collection system 100, wherein the sample collection reservoir includes indicia on a wall 116 corresponding to a volume of fluid in a sample receiving area.

[0060] The sample collection reservoir 112 has an opening 114 for receiving a biological sample, one or more walls 116 defining the opening 114 and a sample receiving area 118, and a valve 120 disposed in the sample receiving area. Figure 1 , 2a In the embodiments shown in , 2b, 3b and 5a-f, the valve 120 is disposed at an end 122 of the sample collection reservoir 112 opposite the opening 114 for receiving the biological sample. Figure 1 , 2a, 2b, 3b and 5a-f are duckbill valves and can be formed of rubber, synthetic elastomers or another suitable elastic and / or flexible material. In one embodiment, the sample collection reservoir 112 is funnel-shaped, which facilitates the collection of biological samples through the opening 114 and facilitates the flow of biological samples to the opposite end 112 of the sample collection reservoir 112, where the valve 120 is located.

[0061] If you can Figure 2c , 3b As best seen in 3c, the sample collection reservoir 112 is disposed at the first end 104 of the tube 102. The sample collection reservoir 112 is not intended to be removed from the tube 102 by a user collecting a biological sample, and thus the sample collection reservoir 112 fits tightly to the tube 102, such as by a snap fit or press fit arrangement (e.g., lip and groove). Figure 3c As shown, a lip 124 extending from the one or more walls 116 (near the opening 114) of the sample collection reservoir 112 extends into a complementary groove 105 disposed at the first end 104 of the tube 102 to hold the sample collection reservoir 112 in place at the first end 104 of the tube 102. Other fastening arrangements known to those skilled in the art, such as gluing, welding, or threaded engagement, are also contemplated. The sample collection reservoir 112 may also be positioned at a lower portion of the tube 102, as further described below with respect to embodiments 100' and 100".

[0062] The biological sample collection system 100 also includes a cap 126 having one or more walls 127 defining a top end 128 and an open end 130 . Figure 4a A perspective view of the cap 126 is shown, and Figure 4b A bottom view of the cap 126 is shown. The cap 126 can be cylindrical and made of a durable material such as polyethylene, polypropylene or related plastics. Although the wall 127 between the open end 130 and the top end 128 of the cap 126 can be any desired thickness, it should be firm to ensure that the user can properly grip in order to attach the cap 126 to the tube 102. In another embodiment, the top end 128 of the cap can have features that facilitate the removal of the cap 126 from the tube 102 by an automated decapping device or a liquid handling robot. In another embodiment, the first end 104 of the tube 102 or the top end 128 of the cap 126 can have features (such as tabs and grooves) that facilitate automatic assembly of the cap 126 to the tube 102, such as when the system is ready to be shipped to the user.

[0063] The cap 126 has a pusher 132 including a first end 134 extending from an interior portion 131 of the cap 126 (see in particular Figure 2b and 3b) and an opposing second end 136, the second end 136 of the pusher extending a distance from the interior portion 131 of the cap 126 toward the open end 130 of the cap and configured to engage with the valve 120 of the sample collection reservoir 112. In one embodiment, the second end 136 of the pusher 132 extends a distance from the interior portion 131 of the cap 126 such that the second end 136 extends beyond the distal end 133 (see Figure 2b ), but other arrangements are possible, as will be appreciated by those skilled in the art and as will become apparent from the following description of alternative embodiments. The cap 126 further has a connection member 138 that is complementary to the connection member 110 of the tube 102. In the illustrated embodiment, the connection member 138 is an internal helical thread located on the inner surface of the portion of the wall 127 that defines the open end 130 of the cap 126.

[0064] like Figure 3c As shown in , the cap can further have a shoulder 139 that is configured to engage with a complementary front surface 141 of the lip 124 of the sample collection reservoir 112, which helps provide a fluid-tight seal when the connecting member 110 of the tube 102 engages with the connecting member 138 of the cap 126, as further described below.

[0065] The valve 120 has a closed configuration, as indicated by Figure 2c When the valve 120 is in the closed configuration, a biological sample (e.g., a bodily fluid) can be deposited into the sample collection reservoir 112, such as by spitting from the user's mouth in an embodiment where the biological sample is sputum or saliva. In the closed configuration, the biological sample is retained in the sample collection reservoir 112.

[0066] The valve 120 further has an open configuration, as indicated by Figure 3b When the valve 120 is in the open configuration, the biological sample that has been collected in the sample collection reservoir 112 is released from the sample collection reservoir 112 into the sample storage chamber 108 of the tube 102. This is achieved by closing the biological sample collection system 100 by engaging the connecting member 110 of the tube 102 with the connecting member 138 of the cap 126. This closing of the biological sample collection system 100 causes the second end 136 of the pusher 132 to engage with the valve 120 of the sample collection reservoir 112, thereby moving the valve 120 from the closed configuration to the open configuration to allow the biological sample to be released from the sample collection reservoir 112 into the sample storage chamber 108 of the tube 102. Specifically, in the illustrated embodiment, the second end 136 of the pusher 132 engages with the duckbill valve 120 and extends through the duckbill valve to move the valve 120 from the closed configuration to the open configuration.

[0067] As in Figure 4a and4b As best seen in FIG. 1 , in one embodiment, the pusher 132 includes a channel or groove 135 in an outer surface of the pusher, wherein the groove 135 extends along at least a portion of the second end 136 of the pusher and along a longitudinal axis of the pusher 132. In another embodiment, the groove 135 extends from the first end 134 of the pusher 132 to the second end 136 of the pusher 132. The groove 135 allows the collected biological sample to flow smoothly from the sample collection reservoir 112 into the sample storage chamber 108 of the tube 102 because the groove prevents the valve 120 from self-sealing around the pusher 132, which may cause an obstruction to the flow of the sample from the sample collection reservoir 112 into the tube 102.

[0068] The sample storage chamber 108 of the tube 102 can contain a stabilizing composition for stabilizing, preserving and / or promoting the recovery of biomolecules (such as nucleic acids) from a biological sample. Suitable compositions include, for example, compositions described in U.S. Patent No. 7,482,116. Other suitable compositions will be well known to those skilled in the art. Before collecting the sample, the stabilizing composition is present in the sample storage chamber 108 of the tube 102.

[0069] like Figure 1 , 2a , 2b, 3a, 3b and 4a, in one embodiment, the wall 127 of the cap 126 can define a second open end 140 of the cap 126, which is separated from the open end 130 of the cap 126 by an inner portion 131 of the cap 126, which can form an inner cap wall that separates the second open end of the cap from the open end. The cap 126 further has a second connecting member 142 disposed at the second open end 140 that is complementary to the connecting member 110 of the tube 102. In the illustrated embodiment, the second connecting member 142 is an internal helical thread located on the inner surface of the portion of the wall 127 that defines the second open end 140 of the cap 126. Therefore, the open end 130 and the second open end 140 of the cap 126 can be interchangeably used to engage and seal the tube 102.

[0070] For example, the biological sample collection system 100 may be shipped in a configuration in which the second open end 140 of the cap 126 is connected to the tube 102 (the tube 102 having the structure described above and as described above) by engaging the connecting member 110 of the tube 102 with the connecting member 142 disposed at the second open end 140 of the cap 126. Figure 2c142 is disposed therein). This configuration closes the biological sample collection system 100 and prevents any contaminants from reaching its interior, while maintaining the valve 120 in a closed configuration so that any sample storage composition contained within the sample storage chamber 108 of the tube 102 is maintained in the biological sample collection system. When the biological sample collection system 100 is ready for use, the cap 126 can then be removed from the tube 102 by disengaging the connecting members 110 and 142, the biological sample can then be deposited into the sample collection reservoir 112, and the open end 130 of the cap 126 can then be connected to the tube 102 by engaging the connecting member 110 of the tube 102 with the connecting member 138 disposed at the open end 130 of the cap 126. As described above, this causes the second end 136 of the pusher 132 to engage the valve 120 of the sample collection reservoir 112, thereby moving the valve 120 from the closed configuration to the open configuration to allow the biological sample to be released from the sample collection reservoir 112 into the sample storage chamber 108 of the tube 102. The biological sample collection system 100 can be maintained in this closed configuration for storage and transportation of biological samples, for example, to a laboratory environment. As will be appreciated by those skilled in the art, positioning the sample collection reservoir 112 toward the first end 104 of the tube 102 can minimize or prevent spillage of the stabilizing composition and / or the sample mixed with the stabilizing composition when the tube 102 is accidentally tipped over.

[0071] The biological sample may then be recovered from the biological sample collection system 100 by disengaging the connection member 110 of the tube 102 from the connection member 138 of the cap 126 to remove the cap 126 from the tube 102. In one embodiment, a manual or automated pipetting device or other tool may then be inserted through the duckbill valve 120 to access the biological sample within the sample storage chamber 108 of the tube 102. In another embodiment, the second end 136 of the pusher 132 may include a flange (not shown) configured to engage the end 122 of the sample collection reservoir 112 to pull the sample collection reservoir 112 away from the tube 102, thereby disengaging the sample collection reservoir 112 from the tube 102 when the cap 126 is removed from the tube 102. In another embodiment, laboratory forceps or tweezers may be used to remove the sample collection reservoir 112 from the tube 102 after the cap 126 is removed. In embodiments that utilize a threaded engagement between the sample collection reservoir 112 and the tube 102 , the sample collection reservoir 112 may be removed from the tube 102 by disengaging the threads (ie, unthreading).

[0072] As will be appreciated by those skilled in the art, and as will become apparent from the following description of alternative embodiments, the cap 126 of the biological sample collection system 100 need not have opposing ends that can be interchangeably used to engage and seal the tube 102 as described above. In another embodiment, the biological sample collection system 100 can have a cap having a single open end with a pusher, and a separate conventional cap can be used to close the biological sample collection system 100 prior to sample collection.

[0073] Thus, in one embodiment, a method for preserving biological molecules in a biological sample is provided, the method comprising: a) obtaining a biological sample, such as sputum or saliva; b) obtaining a biological sample collection system 100 as described herein; c) placing the biological sample in a sample collection reservoir 112; d) placing the open end 130 of the cap 126 over the first end 104 of the tube 102; e) engaging the connecting member 110 of the tube 102 with the connecting member 138 of the cap 126, which engages the second end 136 of the pusher 132 with the valve 120 of the sample collection reservoir 112, thereby moving the valve 120 from a closed configuration to an open configuration to allow the biological sample to be released from the sample collection reservoir 112 into the sample storage chamber 108 of the tube 102; and f) mixing the released biological sample with a stabilizing composition in the tube 102 for preserving the biological molecules within the biological sample.

[0074] In another embodiment, a method for preserving biomolecules in a biological sample is provided, the method comprising: a) obtaining a biological sample; b) obtaining a biological sample collection system 100, wherein the second open end 140 of the cap 126 is connected to the tube 102 by engaging the second connecting member 142 of the cap 126 with the connecting member 110 of the tube 102; c) disengaging the second connecting member 142 of the cap 126 from the connecting member 110 of the tube 102 and removing the cap 126 from the tube 102; d) placing the biological sample in a sample collection reservoir 112; e) placing the open end 130 of the cap 126 in the tube 102; 02, so that the cap 126 is inverted relative to the placement of the cap 126 in step (b); f) engaging the connecting member 110 of the tube 102 with the connecting member 138 of the cap 126, which engages the second end 136 of the pusher 132 with the valve 120 of the sample collection reservoir 112, thereby moving the valve 120 from a closed configuration to an open configuration to allow the biological sample to be released from the sample collection reservoir 112 into the sample storage chamber 108 of the tube 102; and g) mixing the released biological sample with a stabilizing composition in the tube 102 for preserving the biological molecules within the biological sample.

[0075] Figure 6a -c shows a simplified cross-sectional view of an alternative biological sample collection system 100'. Figure 6a -c, elements having the same reference numerals as elements of biological sample collection system 100 operate in a similar manner, and for the sake of brevity, the functions of the elements will not be repeated here. Figure 6a The biological sample collection system 100' is shown with the cap 126' detached from a sealed container shown as tube 102'. The sample collection reservoir 112' is positioned toward the first end 104' of the tube 102', and the valve 120' is in a closed configuration. The sample collection reservoir 112' is held in place using a ring / snap feature, wherein a lip 124' of the sample collection reservoir 112' engages a groove 125' on the inner surface of the tube 102' via a snap-fit ​​connection to hold the sample collection reservoir 112' in place. Figure 6b A simplified cross-sectional view of the biological sample collection system 100 ′ is shown with the biological sample collection system 100 ′ closed and the valve 120 ′ in an open configuration. Figure 6c is an enlarged view of the ring / snap feature described above.

[0076] Figure 7a -c shows a simplified cross-sectional view of an alternative biological sample collection system 100". Figure 7a -c, elements having the same reference numerals as elements of biological sample collection system 100 operate in a similar manner, and for the sake of brevity, the functions of the elements will not be repeated here. Figure 7a A simplified cross-sectional view of an alternative biological sample collection system 100" is shown with a cap 126" separated from a sealed container shown as a tube 102". The sample collection reservoir 112" is positioned toward the first end 104" of the tube 102" and the valve 120" is in a closed configuration. The sample collection reservoir 112" is held in place by engaging a lip 124" of the sample collection reservoir 112" with a shoulder 129" on the inner surface of the tube 102" via a press-fit connection to hold the sample collection reservoir 112" in place. Figure 7b A simplified cross-sectional view of the biological sample collection system 100 ″ is shown with the biological sample collection system 100 ″ closed and the valve 120 ″ in an open configuration. Figure 7c is an enlarged view of the lip / shoulder joint described above.

[0077] Figure 8a -b, 9a-b, 10a-b, 11a-b, 12a-d and 13a-f illustrate a biological sample collection system 100a and components thereof according to alternative embodiments of the present application. Components of the biological sample collection system 100a that operate in a similar manner to the components described with respect to the above-described biological sample collection system 100 have been given the same reference numerals with an "a" designation and have similar features as described with respect to the biological sample collection system 100, unless otherwise indicated.

[0078] As with the biological sample collection system 100, the biological sample collection system 100a includes a sample collection reservoir 112a that is configured to be positioned toward a first end 104a of a sealed container, shown as a tube 102a. However, although the valve 120 of the biological sample collection system 100 is a duckbill valve, the valve 120a of the biological sample collection system 100a can be formed of a flexible material (e.g., rubber, synthetic elastomer) or a rigid plastic (e.g., low-density polyethylene (LDPE), high-density polyethylene (HDPE), polyethylene terephthalate (PET), etc.) having at least one pre-scored cut 144, wherein the at least one pre-scored cut 144 does not completely penetrate the flexible material / rigid plastic (see Figure 8b , 9b , 10b, 13c and 13d).

[0079] Unlike biological sample collection system 100, biological sample collection system 100a has a cap 126a with a single open end 130a (see, e.g., Figure 6b , 9b , 10b and 11b). In addition, the second end 136a of the pusher 132a extends from the inner portion 131a of the cap 126a by a distance such that the second end 136a does not extend beyond the farthest end 133a of the open end 130a of the cap 126a (see Figure 8b , 9b , 10b and 11b).

[0080] The biological sample collection system 100a has a transport configuration, such as Fig.10a and 10b , where cap 126a is partially engaged with tube 102a (and thus the connecting member of tube 110a is partially engaged with the complementary connecting member of cap 138a). This configuration closes biological sample collection system 100a and prevents any contaminants from reaching its interior, while maintaining valve 120a in a closed configuration such that any sample storage composition contained within sample storage chamber 108a of tube 102a is maintained in the biological sample collection system.

[0081] When the biological sample collection system 100a is ready for use, the cap 126a can then be removed from the tube 102a by disengaging the connecting members 110a and 138a, and the biological sample can then be deposited into the sample collection reservoir 112a. Figure 9b, a biological sample (e.g., a bodily fluid) can be deposited into the sample collection reservoir 112a, such as by spitting from the user's mouth in an embodiment where the biological sample is sputum or saliva. In the closed configuration, the biological sample is retained in the sample collection reservoir 112a. Once the biological sample has been collected, the open end 130a of the cap 126a is then fully engaged with the tube 102a by fully engaging the connecting member 110a of the tube 102a with the connecting member 138a disposed at the open end 130a of the cap 126a. When the biological sample collection system 100a is closed by fully engaging the connecting member 110a of the tube 102a with the connecting member 138a of the cap 126a, the second end 136a of the pusher 132a engages with the flexible material or rigid plastic near the at least one pre-scored cut 144 to penetrate and extend through the flexible material or rigid plastic, thereby moving the valve 120a from the closed configuration (see Fig.10b ) moves to the open configuration (see Fig.11b ). The valve 120a remains in a permanently open configuration and the flexible material / rigid plastic can remain partially attached to the remainder of the sample collection reservoir 112a or can be completely separated from the remainder. The biological sample collection system 100a can be maintained in this closed configuration for storage and transportation of biological samples, for example, to a laboratory environment.

[0082] The biological sample can then be recovered from the biological sample collection system 100a by disengaging the connecting member 110a of the tube 102a from the connecting member 138a of the cap 126a to remove the cap 126a from the tube 102a. In one embodiment, an automated or manual pipetting device or other tool can then be inserted through the permanent opening created by separating the flexible material / rigid plastic of the valve 120a from the remainder of the sample collection reservoir 112a to access the biological sample within the sample storage chamber 108a of the tube 102a. In another embodiment, the second end 136a of the pusher 132a can include a flange (not shown) configured to engage with the end 122a of the sample collection reservoir 112a to pull the sample collection reservoir 112a away from the tube 102a, thereby disengaging the sample collection reservoir 112a from the tube 102a when the cap 126a is removed from the tube 102a. In another embodiment, laboratory pliers or forceps can be used to remove the sample collection reservoir 112a from the tube 102a after removing the cap 126a. In embodiments using a threaded engagement between the sample collection reservoir 112a and the tube 102a, the sample collection reservoir 112a can be removed from the tube 102a by disengaging the threads (i.e., unthreading).

[0083] Therefore, in one embodiment, a method for preserving biological molecules in a biological sample is provided, the method comprising: a) obtaining a biological sample, such as sputum or saliva; b) obtaining a biological sample collection system 100a as described herein; c) placing the biological sample in a sample collection reservoir 112a; d) placing the open end 130a of the cap 126a over the first end 104a of the tube 102a; e) engaging the connecting member 110a of the tube 102a with the connecting member 138a of the cap 126a, which engages the second end 136a of the pusher 132a with the valve 120a of the sample collection reservoir 112a, thereby moving the valve 120a from a closed configuration to an open configuration to allow the biological sample to be released from the sample collection reservoir 112a into the sample storage chamber 108a of the tube 102a; and f) mixing the released biological sample with a stabilizing composition in the tube 102a for preserving the biological molecules within the biological sample.

[0084] Fig.14 , 15a 16a-c, 17a-c, 18a-d, and 19a-d illustrate a biological sample collection system 100b and components thereof according to an alternative embodiment of the present application. Components of the biological sample collection system 100b that operate in a similar manner to the components described with respect to the above-described biological sample collection system 100 have been given the same reference numerals with a "b" designation and have similar features as described with respect to the biological sample collection system 100, unless otherwise indicated.

[0085] As with biological sample collection system 100, biological sample collection system 100b includes a sample collection reservoir 112b configured to be disposed toward a first end 104b of a sealed container, shown as tube 102b. However, while valve 120 of biological sample collection system 100 is a duckbill valve, valve 120b of biological sample collection system 100b includes a valve seat 152 and a complementary valve face 154. Valve seat 152 is formed by an outer surface of sample collection reservoir 112b and defines an opening 153 disposed at end 122b of sample collection reservoir 112b. Valve face 154 is a front surface of a flange that engages valve seat 152, and opening 153 is blocked by engagement of valve seat 152 with valve face 154. Valve stem 156 extends from valve face 154 through opening 153 and is connected to locking tab 158. The valve 120b further has a spring 160 that surrounds a valve stem 156 disposed between the inner surface of the sample collection reservoir 112b and the locking tab 158. In the absence of an external force, the spring 160 maintains engagement between the valve seat 152 and the valve face 154, and the opening 153 is blocked. Those skilled in the art will appreciate that the spring 160 need not be a coil spring as shown in the drawings, but rather any spring-like / spring-loaded feature may be used, such as a molded spring-like feature or even a spring-like element made of plastic, rubber or other flexible or compressible material. The valve 120b may be made of any rigid or flexible material such as rubber, plastic or metal.

[0086] Therefore, in the biological sample collection system 100b, the valve 120b has a valve seat 152 and a valve face 154, wherein the valve face 154 can move relative to the valve seat 152 between a closed configuration and an open configuration, in which the valve seat 152 sealingly engages the valve face 154, and in the open configuration, the valve face 154 is spaced apart from the valve seat 152 to allow fluid to flow between the valve face 154 and the valve seat 152, and when the biological sample collection system 100b is closed by the engagement of the connecting member 110b of the tube 102b with the connecting member 138b of the cap 126b, the second end 136b of the pusher 132b engages with the valve 120b to move the valve face 154 relative to the valve seat 152 from the closed configuration to the open configuration.

[0087] Similar to biological sample collection system 100a, biological sample collection system 100b has a cap 126b with a single open end 130b (see, e.g., Fig.15b , 16b -c, 17b-c and 18b). The second end 136b of the pusher 132b extends from the interior portion 131b of the cap 126b a distance such that the second end 136b does not extend beyond the distal-most end 133b of the open end 130b of the cap 126b.

[0088] The biological sample collection system 100b has a transport configuration, such as Fig.16a -c, where cap 126b is partially engaged with tube 102b (and thus the connecting member of tube 110b is partially engaged with the complementary connecting member of cap 138b). This configuration closes biological sample collection system 100b and prevents any contaminants from reaching its interior, while maintaining valve 120b in a closed configuration so that any sample storage composition contained within sample storage chamber 108b of tube 102b is maintained in the biological sample collection system.

[0089] When the biological sample collection system 100b is ready for use, the cap 126b can then be removed from the tube 102b by disengaging the connecting members 110b and 138b, and the biological sample can then be deposited into the sample collection reservoir 112b. Fig.15b In the closed configuration shown in, biological sample (for example, body fluid) can be deposited in sample collection reservoir 112b, such as being deposited in sample collection reservoir by spitting from the mouth of the user in the embodiment where the biological sample is sputum or saliva. When valve 120b is in closed configuration, biological sample is retained in sample collection reservoir 112b. Once biological sample has been collected, the open end 130b of cap 126b is then fully engaged with the open end 130b of pipe 102b by the complete engagement of the connecting member 110b of pipe 102b and the connecting member 138b of cap 126b. When biological sample collection system 100b is closed by the complete engagement of the connecting member 110b of pipe 102b and the connecting member 138b of cap 126b, the second end 136b of pusher 132b engages with locking tab 158 and valve stem 156 and applies force to the locking tab and valve stem. The applied force causes axial movement of the valve stem 156 in the direction of the tube 102b and compression of the spring 160, which causes the valve seat 152 to disengage from the valve face 154, thereby exposing the opening 153 and allowing the biological sample to flow from the sample collection reservoir 112b into the sample storage chamber 108b of the tube 102b. The biological sample collection system 100b can be maintained in this closed configuration for storage and transportation of the biological sample, for example, to a laboratory environment.

[0090] The biological sample can then be recovered from the biological sample collection system 100b by disengaging the connecting member 110b of the tube 102b from the connecting member 138b of the cap 126b to remove the cap 126b from the tube 102b, at which point laboratory forceps or tweezers can be used to remove the sample collection reservoir 112b from the tube 102b after removing the cap 126b. In embodiments that use a threaded engagement between the sample collection reservoir 112b and the tube 102b, the sample collection reservoir 112b can be removed from the tube 102b by disengaging the threads (i.e., releasing the threaded connection).

[0091] Therefore, in one embodiment, a method for preserving biological molecules in a biological sample is provided, the method comprising: a) obtaining a biological sample, such as sputum or saliva; b) obtaining a biological sample collection system 100b as described herein; c) placing the biological sample in a sample collection reservoir 112b; d) placing the open end 130b of the cap 126b over the first end 104b of the tube 102b; e) engaging the connecting member 110b of the tube 102b with the connecting member 138b of the cap 126b, which engages the second end 136b of the pusher 132b with the valve 120b of the sample collection reservoir 112b, thereby moving the valve 120b from a closed configuration to an open configuration to allow the biological sample to be released from the sample collection reservoir 112b into the sample storage chamber 108b of the tube 102b; and f) mixing the released biological sample with a stabilizing composition in the tube 102b for preserving the biological molecules within the biological sample.

[0092] List of elements and reference numerals

[0093]

[0094]

[0095] All publications, patents, and patent applications mentioned in this specification are indicative of the levels of skill of those skilled in the art to which this invention pertains and are incorporated herein by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

[0096] Having thus described the invention, it will be apparent that the invention may be varied in many ways. Such variations should not be regarded as departing from the spirit and scope of the invention, and all such modifications apparent to those skilled in the art are intended to be included within the scope of the following claims. The scope of the claims should not be limited to the preferred embodiments set forth for the specification, but should be given the broadest interpretation consistent with the specification as a whole.

Claims

1. A biological sample collection system, the system comprising: A sealed container, the sealed container comprising: a first end, the first end being used to receive a biological sample, a second end, the second end comprising a sample storage chamber, and a connecting member disposed at the first end; a sample collection reservoir disposed toward the first end of the sealed container, wherein the sample collection reservoir comprises: an opening for receiving the biological sample, one or more walls defining a sample receiving area, and a valve disposed in the sample receiving region, the valve comprising: a closed configuration, wherein when the valve is in the closed configuration, the biological sample is retained in the sample collection reservoir, and an open configuration, wherein when the valve is in the open configuration, the biological sample is released from the sample collection reservoir into the sample storage chamber of the sealed container; and A cap, comprising: top, Open end, a pusher comprising a first end extending from an interior portion of the cap and an opposing second end, the second end of the pusher extending a distance from the interior portion of the cap toward the open end of the cap and configured to engage the valve of the sample collection reservoir, and a connecting member complementary to the connecting member of the sealed container and configured to engage the open end of the cap with the first end of the sealed container; in, When the biological sample collection system is closed by engagement of the connecting member of the sealed container with the connecting member of the cap, the second end of the pusher engages with the valve of the sample collection reservoir, thereby moving the valve from the closed configuration to the open configuration to allow the biological sample to be released from the sample collection reservoir into the sample storage chamber of the sealed container.

2. The sample collection system of claim 1, wherein the connection member comprises a threaded connection.

3. A sample collection system according to claim 1 or 2, wherein the engagement of the connecting member of the sealed container with the connecting member of the cap creates a fluid-tight seal.

4. The sample collection system of any one of claims 1 to 3, wherein the sample collection reservoir comprises at least one marking located on the at least one or more walls, the at least one marking corresponding to a fluid volume in the sample receiving area.

5. The sample collection system according to any one of claims 1 to 4, wherein the sample collection reservoir is funnel-shaped.

6. A sample collection system according to any one of claims 1 to 5, wherein the valve is a duckbill valve, and when the biological sample collection system is closed by engagement of the connecting member of the sealed container with the connecting member of the cap, the second end of the pusher engages with the duckbill valve and extends through the duckbill valve to move the valve from the closed configuration to the open configuration.

7. A sample collection system according to any one of claims 1 to 5, wherein the valve is formed of a flexible material or a rigid plastic having at least one pre-scored cut, wherein the at least one pre-scored cut does not completely penetrate the flexible material or the rigid plastic, and when the biological sample collection system is closed by engagement of the connecting member of the sealed container with the connecting member of the cap, the second end of the pusher engages with the at least one pre-scored cut to penetrate and extend through the flexible material or the rigid plastic, thereby moving the valve from the closed configuration to the open configuration.

8. A sample collection system according to claim 6 or claim 7, wherein the pusher includes a groove located in an outer surface of the pusher, wherein the groove extends along at least a portion of the second end of the pusher and along the longitudinal axis of the pusher.

9. The sample collection system of claim 8, wherein the groove extends from the first end of the pusher to the second end of the pusher.

10. A sample collection system according to any one of claims 1 to 5, wherein the valve has a valve seat and a valve face, wherein the valve face is movable relative to the valve seat between the closed configuration and the open configuration, in which the valve seat sealingly engages the valve face, and in which the valve face is spaced apart from the valve seat to allow fluid to flow between the valve face and the valve seat, And when the biological sample collection system is closed by engaging the connecting member of the sealed container with the connecting member of the cap, the second end of the pusher engages with the valve to move the valve face from the closed configuration to the open configuration relative to the valve seat.

11. A sample collection system according to any one of claims 1 to 10, wherein the sample collection reservoir is connected toward the first end of the sealed container by a press-fit connection between a lip extending from one or more walls of the sample collection reservoir and a complementary groove disposed at the first end of the sealed container.

12. A sample collection system according to any one of claims 1 to 10, wherein the sample collection reservoir is connected toward the first end of the sealed container by a snap-fit ​​connection between a lip extending from one or more walls of the sample collection reservoir and a complementary groove disposed on the inner surface of the sealed container.

13. A sample collection system according to any one of claims 1 to 10, wherein the sample collection reservoir is connected toward the first end of the sealed container by a press-fit connection between a lip extending from one or more walls of the sample collection reservoir and a shoulder on the inner surface of the sealed container.

14. The sample collection system of any one of claims 1 to 13, wherein the sample storage chamber comprises a stabilizing composition.

15. The sample collection system of any one of claims 1 to 14, wherein the top end of the cap comprises a second open end separated from the open end of the cap by the interior portion of the cap, the interior portion of the cap comprising an inner cap wall separating the second open end of the cap from the open end of the cap, the first end of the pusher extending from the inner cap wall, The second open end of the cap includes a second connecting member complementary to the connecting member of the sealed container.

16. A method for preserving biomolecules in a biological sample, the method comprising: a) obtaining a biological sample; b) obtaining a biological sample collection system according to any one of claims 1 to 15; c) placing the biological sample in the sample collection reservoir; d) placing the cap over the first end of the sealed container; e) engaging the connecting member of the sealed container with the connecting member of the cap, which engages the second end of the pusher with the valve of the sample collection reservoir, thereby moving the valve from the closed configuration to the open configuration to allow the biological sample to be released from the sample collection reservoir into the sample storage chamber of the sealed container; as well as f) mixing the released biological sample with the stabilizing composition in the sealed container to preserve the biomolecules in the biological sample.

17. A method for preserving biomolecules in a biological sample, the method comprising: a) obtaining a biological sample; b) obtaining the biological sample collection system according to claim 15, wherein the second open end of the cap is connected to the sealed container by engagement of the second connecting member of the cap with the connecting member of the sealed container; c) disengaging the second connection member of the cap from the connection member of the sealed container and removing the cap from the sealed container; d) placing the biological sample in the sample collection reservoir; e) placing the open end of the cap over the first end of the sealed container such that the cap is inverted relative to the placement of the cap in step (b); f) engaging the connecting member of the sealed container with the connecting member of the cap, which engages the second end of the pusher with the valve of the sample collection reservoir, thereby moving the valve from the closed configuration to the open configuration to allow the biological sample to be released from the sample collection reservoir into the sample storage chamber of the sealed container; as well as g) mixing the released biological sample with the stabilizing composition in the sealed container to preserve the biomolecules in the biological sample.

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