Patent Description:
Field collection of biological samples can provide scientists, physicians, geneticists, epidemiologists, or similar personnel with invaluable information. For example, access to a fresh sample of a patient's blood, purulent discharge, or sputum can help a physician or epidemiologist to isolate or identify a causative agent of infection. Similarly, a saliva sample can permit a scientist or geneticist access to the requisite nucleic acid for genetic sequencing, phenotyping, or other genetic-based studies. In the foregoing examples, in addition to many other situations, it is desirable to work with a fresh biological sample to ensure procurement of accurate results. However, isolation of the probative composition (e.g., nucleic acid, proteins, chemicals, etc.) often requires the use of specialized equipment and often benefits from controlled laboratory conditions.

It can be inconvenient and sometimes improbable to require patients/individuals to travel to a biological sample collection center having the appropriate equipment and desirable controlled environment for sample preparation. Similarly, it may be difficult for personnel to directly access the patient/individual, particularly if the sample size is large and/or geographically diverse (e.g., as can be found in large genetic studies of thousands of individuals across an entire country, ethnic population, or geographic region). Further complicating this issue, it is often beneficial to immediately process any procured biological sample, and field personnel may be limited by lack of access to appropriate specialized equipment or a controlled environment for high-fidelity sample processing.

Some biological sample collection devices and kits have addressed some of the foregoing issues. For example, some commercial kits provide a user with a vial for receiving a biological sample and a preservation reagent that can be added to the collected biological sample, acting to preserve elements within the biological sample (to a certain extent and for a period of time). However, implementations of self-collection systems often rely on inexperienced or untrained individuals to deposit the biological sample into the receiving vessel. This presents a number of problems, including, for example, technical training and precise measurements often required to properly preserve the biological sample for later processing. In the absence of such, it is important to provide a biological sample collection system that can be easily implemented by a novice user and which can preserve the received biological sample for later processing.

Accordingly, there are a number of disadvantages with biological sample collection and preservations systems that can be addressed. <CIT> describes containers, and in particular containers suitable for storing biological samples. <CIT> describes a bodily fluid sample collection device for the collection of naturally expressed bodily fluids and a cap engageable with a tube to close a mouth of the tube.

The sample collection systems according to the present invention are defined in appended claims <NUM> and <NUM>. Implementations of the present disclosure solve one or more of the foregoing or other problems in the art with kits, apparatus, and methods for collecting and preserving a sample, for example a biological sample. In particular, in one or more implementations the kit is a biological sample collection system for collecting and preserving a biological sample. The biological sample collection system can include a sample collection vessel for receiving a biological sample and a sealing cap configured to removably engage with the sample collection vessel. The biological sample collection system can also include an inner vessel securely engaged with the sealing cap and Figured to store a measure of reagent(s). The inner vessel may be further configured with a body and fluid vent located on the body. An outer sleeve frictionally engages with the inner vessel while sliding translationally relative to the inner vessel between a first position and a second position. In the first position, the outer sleeve covers the fluid vent and in the second position opens the fluid vent. When the sample collection vessel is fully engaged with the sealing cap, the sample collection vessel is configured to push the outer sleeve to the second position, thereby opening the fluid vent.

In another implementation, a sealing cap removably engages with a sample collection vessel to receive a biological sample. The sealing cap comprises an outer cap, an inner vessel for storing a measure of reagent(s), and an outer sleeve to frictionally engage with the inner vessel. The inner vessel further comprises a body and a fluid vent located on the body. The outer sleeve is configured to slide translationally relative to the inner vessel between a first position covering the fluid vent and a second position opening the fluid vent.

In another implementation, a biological sample collection system includes a sample collection vessel for receiving a biological sample, a sealing cap configured to removably engage with the sample collection vessel, an inner vessel securely engaged with the sealing cap to store a measure of reagent. The inner vessel is further comprised of a cylindrical body including a fluid vent and raised surface areas on the cylindrical body to surround the fluid vent. The biological sample collection system further includes an outer sleeve movably engaged with the inner vessel and in contact with the outer sleeve. The outer sleeve is configured to cover the fluid vent when the sealing cap is disengaged from the sample collection vessel and to be moved relative to the inner vessel to open the fluid vent when the sealing cap is engaged with the sample collection vessel. When moved to open the fluid vent, the reagent is dispensed into the sample collection chamber through the fluid vent.

Accordingly, systems, methods, and kits for collecting a biological sample are disclosed herein. This summary is provided to introduce a selection of concepts in a simplified form that is further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it 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 obvious from the description, or may be learned by the practice of the disclosure. The features and advantages of the disclosure may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features of the present disclosure will become more fully apparent from the following description and appended claims, or may be learned by the practice of the disclosure as set forth hereinafter.

In order to describe the manner in which the above recited and other advantages and features of the disclosure can be obtained, a more particular description of the disclosure briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the disclosure and are not therefore to be considered to be limiting of its scope. The disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:.

Embodiments of the present disclosure address one or more problems in the art of systems, kits, and/or methods for collecting and preserving a biological sample. A biological sample can be collected and its contents evaluated for various reasons, including, for example, identifying or characterizing a causative agent of disease (e.g., for treatment of the affected individual, for epidemiological reasons, etc.) or for genetic analysis of a subject's nucleic acid (e.g., genetic phenotyping, gene expression studies, genome sequencing, etc.). In most instances, including within the foregoing examples, it is desirous that the fidelity of the biological sample is maintained so that it retains its probative value. However, collecting and preparing biological samples for analysis has traditionally been an endeavor for the skilled technician or specialized professional. This is problematic for obvious reasons, including the time and cost associated with individually collecting and transporting biological samples, particularly when the subjects reside in disparate rural locations and require service from personnel with the proper skill set to properly collect and preserve the biological sample.

Embodiments of the present disclosure provide sample collection and preservation systems and kits, and methods for using the same, which address one or more of the foregoing problems. For example, utilizing systems, kits, and methods for collecting and preserving biological samples, as disclosed herein, remove the need for specialized personnel when collecting and initially preserving a biological sample. Furthermore, sample collection and preservation are simplified, which decreases the likelihood that even an unskilled user will err 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-piece sample collection and preservation system. A first portion includes a sample collection vessel or vial, which can be detachably associated with a funnel. When used, the funnel acts to guide the receipt of a sample from a user into the sample collection chamber of the collection vessel or vial. The funnel can also make it easier for a user to engage the sample collection vessel and deposit a biological sample into the sample collection chamber. After depositing the requisite amount of biological sample, a user can remove the funnel (if used) and associate the second portion of the two-piece sample preservation system-e.g., a sealing cap associated with a reagent chamber-with sample collection vessel. The reagent chamber has been pre-filled with a predetermined amount of sample preservation reagent(s), and as the sealing cap is drawn down to seal the received biological sample within the sample collection chamber, the reagent(s) are released from the reagent chamber and into the sample collection chamber, mixing with and preserving the received biological sample.

As described in more detail below, the reagent chamber can be opened to release reagents into the sample collection chamber in a plurality of ways. In some embodiments, the reagent chamber is associated with a selectively movable sleeve valve, and when the sealing cap and reagent chamber are associated with the sample collection vessel, the selectively movable sleeve valve opens (e.g., by undergoing a physical rearrangement), permitting previously obstructed fluid vent(s) to communicate fluid between the reagent compartment and the sample collection chamber. Reagent(s) in the reagent compartment can be released into the sample collection chamber through the fluid vent(s). In some embodiments, the opening of the selectively movable sleeve valve is reversible. For example, disassociating the sealing cap from the sample collection vessel can cause the selectively movable sleeve valve to close.

As can be appreciated from the foregoing, in addition to alternative and/or additional embodiments provided herein, the systems, kits, and methods of the present disclosure can be used by skilled or unskilled individuals with reduced likelihood of error associated with collecting and at least initially preserving a biological sample. Accordingly, implementations of the present disclosure can reduce the cost associated with procuring biological samples for diagnostic, scientific, or other purposes and can increase the geographic reach of potential sample collection areas without the need of establishing the necessary infrastructure (e.g., controlled environments conducive to sample collection and preservation, skilled personnel to physically collect, transport, and/or preserve the biological samples, etc.).

As used herein, the term "biological sample" can include any cell, tissue, or secretory fluid (whether host or pathogen related) that can be used for diagnostic, prognostic, genetic, or other scientific analysis. This can include, for example, a human cell sample such as skin. It can also include a non-human cell sample that includes any of a bacterium, virus, protozoa, fungus, parasite, and/or other prokaryotic or eukaryotic symbiont, pathogen, or environmental organism. The term "biological sample" is also understood to include fluid samples such as blood, urine, saliva, and cerebrospinal fluid and extends to other biological samples including, for example, mucus from the nasopharyngeal region and the lower respiratory tract (i.e., sputum). Examples of biological samples include, but are not limited to, saliva, sputum, spit, blood, perspiratory fluid, sweat, pus, tear, mucosal excretion, vomit, urine, stool, semen, vaginal fluids, other type of bodily fluid, cell-free samples, cheek swabs, swabs of a different bodily part, homogenous samples, heterogeneous samples, tumor samples, plasma, or serum samples.

As used herein, the "probative component" of the biological sample refers generally to any protein, nucleic acid, surface moiety, or other compound that can be isolated from the biological sample. Preferably, the probative component is or includes nucleic acid, more preferably DNA. In a preferred embodiment, the biological sample is or includes saliva, which presumptively contains a preferable probative component in the form of the user's genetic material (e.g., DNA and RNA).

In one embodiment, a biological sample is collected, preserved, and stored in a collection vessel as part of a multi-piece, self-contained sample collection system or kit. A first piece of the system or kit includes a sample collection vessel, a second piece includes a sample collection funnel, which may be packaged separately from or removably connected to the sample collection vessel, and a third piece includes a sealing cap having a selectively movable sleeve valve comprised of an inner vessel and an outer sleeve and a reagent chamber disposed within or integrated with the sealing cap. The sealing cap is configured to associate with the sample collection vessel, to dispense sample preservation reagents into the sample collection vessel through the selectively movable sleeve valve, and to seal the contents therein.

For example, <FIG> illustrates an exploded view of a three-dimensional model depicting a biological sample collection system or kit <NUM>. The system <NUM> includes a sample collection vessel <NUM> and optionally, a funnel (not shown), which can be associated with a top portion of the sample collection vessel <NUM> and in fluid communication with a sample collection chamber <NUM> of the sample collection vessel <NUM>. The biological sample collection system <NUM> can also include a selectively movable sleeve valve <NUM> comprised of an inner vessel <NUM> and an outer sleeve <NUM> associated with a sealing cap <NUM> that has a reagent chamber <NUM> disposed within or integrated with the sealing cap <NUM>. The sealing cap <NUM>-together with the selectively movable sleeve valve <NUM>-can be sized and shaped to associate with a top portion of the sample collection vessel <NUM>, fitting over and sealing an opening of the sample collection chamber <NUM>. The sealing cap <NUM> may also be referred to as an outer cap. For example, the sealing cap <NUM> can be removably engaged with the sample collection vessel <NUM> by any suitable manners, such as by screw threads, snap fit, frictional fit, etc. Examples of mechanisms for removably engaging the sealing cap <NUM> with the sample collection vessel <NUM> include, but are not limited to, complementary threading, form-fitting pairs, interference fitting, hooks and loops, latches, screws, staples, clips, clamps, prongs, rings, brads, rubber bands, rivets, grommets, pins, ties, snaps, velcro, adhesives, tapes, vacuum, seals, or any combination thereof.

In various embodiments, the inner vessel <NUM> and the outer sleeve <NUM> may be coupled to each other using any suitable methods, such as interference fit, press fit, friction fit, compression fit, snap fit, mechanical features, chemical bond, material interaction (e.g. swelling), solvent bond, interference fit and snap fit, interference fit and mechanical features, interference fit and chemical bond, interference fit and solvent bond, interference fit and material interaction, compression fit and snap fit, compression fit and mechanical features, compression fit and chemical bond, compression fit and solvent bond, compression fit and material interaction, interference fit and snap fit and chemical bond, interference fit and snap fit and solvent bond, interference fit and snap fit and material interaction, interference fit and mechanical features and chemical bond, interference fit and mechanical features and solvent bond, interference fit and mechanical features and material interaction, or any suitable combination thereof.

In some embodiments, the reagent(s) within the reagent chamber <NUM> includes a preservation or buffering solution that protects the integrity of the probative 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<NUM>HPO<NUM>, KH<NUM>PO<NUM>, or similar, and which may, in some implementations, be combined as a phosphate buffered saline solution, as known in the art), lysing agents (e.g., detergents such as Triton X-<NUM> or similar), chelating agents (e.g., ethylenediaminetetraacetic acid (EDTA), ethylene glycol-bis(β-aminoethyl ether)-N,N,N',N'-tetraacetic acid (EGTA), or similar), distilled water, or other reagents known in the art. In one or more embodiments, the reagent or buffering solution stabilizes at least one probative component within the sample (e.g., nucleic acids, such as DNA and RNA, protein, etc., and combinations thereof) during transfer, transportation, and/or storage at a laboratory, clinic, or other destination. In some embodiments, the sample can be stored, at or below room temperature after the preservation solution is added, for weeks or months without significant loss of the probative component. That is, the sample can still be utilized for diagnostic, genetic, epidemiologic, or other purposes for which it was collected after storage for weeks or months in the preservation solution.

With continued reference to <FIG>, the sealing cap <NUM> and a saliva funnel (not shown) can each independently attach to the sample collection vessel <NUM> using a connection mechanism. The connection mechanism can include, for example, threads, snap or press fit connections, tongue and groove members, bayonet connection, or other interlocking or mechanically coupling mechanisms. For example, a funnel can be first attached to the sample collection vessel <NUM> via complementary connection mechanisms (e.g., complementary threads; not shown). After facilitating receipt of a biological sample from a user, the funnel can be removed by reversing the complementary connection mechanism (e.g., unscrewing the funnel; not shown), and a sealing cap <NUM> can be secured to the sample collection vessel <NUM> using a same or similar complementary connection mechanism, as shown in <FIG>. That is, the sealing cap <NUM> can include connection members <NUM> (e.g., threads) located on an inner circumferential wall of the sealing cap <NUM> that are complementary to and work in conjunction with the connection members <NUM> (e.g., complementary threads) disposed on an exterior surface of the sample collection vessel <NUM>.

In some embodiments, the connection mechanism between the funnel and sample collection vessel <NUM> is different than the connection mechanism between the sealing cap and the sample collection vessel <NUM>. For example, the funnel may be press fit or snap fit onto the sample collection vessel <NUM>, whereas the sealing cap is rotationally secured through engagement of complementary threads <NUM> and <NUM> located on an exterior portion of the sample collection vessel <NUM> and an interior portion of the sealing cap <NUM> or vice versa. Regardless of the attachment mechanism used, a sample preservation reagent can be introduced into the sample collection chamber <NUM> of the sample collection vessel <NUM> and mixed with the deposited biological sample as a result of the sealing cap <NUM> being attached to the sample collection vessel <NUM>. As provided earlier, this can be due to the selectively movable sleeve valve <NUM> opening and allowing reagent(s) to be released through fluid vents <NUM> defined by the selectively movable sleeve valve <NUM> and into the sample collection chamber <NUM>.

In an embodiment, the sealing cap <NUM> receives a measure of reagents into the reagent chamber <NUM>, and as shown by the cross-sectional views of the assembled biological sample collection system 100A in <FIG>, a selectively movable sleeve valve <NUM> (in a closed configuration) is associated with the sealing cap <NUM>, sealing the reagents within the sealing cap <NUM>. The inner vessel <NUM> is snap-fittingly received into the sealing cap <NUM> creating a fluid-tight connection. As illustrated, the inner vessel includes a retaining ring <NUM> into which a protrusion <NUM> of the interior sidewall of the sealing cap <NUM> inserts to stabilize the inner vessel <NUM>. In some embodiments, the interaction between the protrusion <NUM> and the retaining ring <NUM> creates the fluid-tight connection between the sealing cap <NUM> and the inner vessel <NUM>. Additionally, or alternatively, an upper collar <NUM> of the inner vessel extends into the reagent chamber <NUM> and associates there via an interference fit, creating a fluid-tight connection between the interior sidewall of the reagent chamber <NUM> and the exterior sidewall of the upper collar <NUM> of the inner vessel <NUM>.

As further illustrated by <FIG>, the inner vessel <NUM> includes a reagent retention chamber <NUM> in fluid communication with the reagent chamber <NUM>. The inner vessel <NUM> may be securely engaged with the sealing cap <NUM> such as by adhesion, snap fit, compression fit or another more permanent engagement manner. The inner vessel <NUM> includes fluid vents <NUM>, through which reagent may be transferred from the reagent chamber <NUM> to the sample collection chamber <NUM>. However, in <FIG>, any reagent within the reagent chamber <NUM> would be retained, owing to the closed configuration of the selectively movable sleeve valve <NUM>. That is, as illustrated in <FIG>, the fluid vents <NUM> are obstructed by an outer sleeve <NUM> of the selectively movable sleeve valve <NUM>. An interior sidewall <NUM> of the outer sleeve <NUM> defines an aperture into which the inner vessel <NUM> extends, and the interaction between the interior sidewall <NUM> of the outer sleeve <NUM> and the exterior sidewall <NUM> of the inner vessel <NUM> creates a fluid-tight connection-at least at and/or around fluid vents <NUM>. The fluid-tight connection between the outer sleeve <NUM> and the inner vessel <NUM> prevents the reagents within the reagent chamber <NUM> from passing into the reagent retention chamber <NUM> and out through fluid vents <NUM>. Fluid vents <NUM> may also be used to provide a path for air to enter into a reservoir associated with the reagent retention chamber <NUM> and the reagent chamber <NUM>. The entering air balances the air pressure inside the reservoir with the external air pressure, allowing the reagent to flow, by gravitational force, from the reservoir into the sample collection chamber <NUM> when the fluid vents <NUM> are opened.

As also shown in <FIG>, the outer sleeve <NUM> associates with sealing cap <NUM> and the opening of the sample collection chamber <NUM>. A guide member <NUM> of the outer sleeve <NUM> protrudes away from the body of the outer sleeve <NUM> and extends into a guide channel <NUM> formed by the interior surface of the sealing cap <NUM>. The guide member <NUM> acts, in some embodiments, to retain the outer sleeve <NUM> in association with the sealing cap <NUM>. The outer sleeve <NUM> additionally includes a lower collar <NUM> that associates with the interior sidewall of the sample collection chamber <NUM>. In some embodiments, the lower collar <NUM> associates with the sample collection chamber <NUM> via an interference fit, which can serve to stabilize the selectively movable sleeve valve <NUM>, the sealing cap <NUM>, and the sample collection vessel <NUM>. In some embodiments, the interference fit between the outer sleeve <NUM> and the sample collection chamber <NUM> is a liquid-tight fit. Some embodiments of the outer sleeve <NUM> may not include a guide member <NUM>, instead relaying on the raised ridges <NUM> of the inner vessel <NUM> to form a liquid-tight seal with the interior sidewall <NUM>.

As the complementary threads <NUM>, <NUM> between the sealing cap <NUM> and the sample collection vessel <NUM> are inter-engaged and the sealing cap <NUM> is advanced towards the sample collection vessel <NUM>, the inner vessel <NUM>-which is coupled to the sealing cap <NUM>-is similarly advanced. As shown in <FIG>, the inner vessel <NUM> is pushed through the aperture defined by the outer sleeve <NUM>, positioning the selectively movable sleeve valve <NUM> in an open configuration. In the open configuration depicted in <FIG>, the fluid vents <NUM> are positioned below-and now unobstructed by-the lower terminal edge of the outer sleeve <NUM>. Reagent(s) within the reagent chamber <NUM> can now freely pass through the reagent retention chamber <NUM> of the inner vessel <NUM>, through the fluid vents <NUM>, and into the sample collection chamber <NUM>.

In the embodiment shown in <FIG>, the outer sleeve <NUM> does not move relative to the sample collection vessel <NUM>. The sealing cap <NUM> and the associated inner vessel <NUM> advance relative to the outer sleeve <NUM> and the sample collection vessel <NUM>. In some embodiments, and as shown in <FIG>, the body of the outer sleeve <NUM> above the lower collar <NUM> has a larger diameter than the lower collar <NUM>, and this larger diameter body does not fit within the opening of the sample collection chamber <NUM>. Instead, it abuts and is impeded by the upper rim of the sample collection chamber <NUM> that defines the opening thereof. This prevents the outer sleeve <NUM> from advancing along with the inner vessel <NUM> and the sealing cap <NUM> toward sample collection vessel <NUM>. The resistive force impeding progress of the outer sleeve <NUM> is greater than the frictional force between the inner vessel <NUM> and the outer sleeve <NUM>, and the torque (or other force) applied to the sealing cap <NUM> to associate the sealing cap <NUM> with the sample collection vessel <NUM> is greater than the frictional force between the inner vessel <NUM> and the outer sleeve <NUM>. Accordingly, the selectively movable sleeve valve <NUM> undergoes a conformational change where the inner vessel <NUM> advances through the outer sleeve <NUM>, revealing the fluid vents <NUM> (as shown in <FIG>).

As shown in <FIG>, the guide member <NUM> moves along the guide channel <NUM> as the sealing cap <NUM> threadedly secures to the sample collection vessel <NUM>.

In some embodiments, the distance required to open the selectively movable sleeve valve <NUM> is proportional to the distance required to at least partially unobstruct the fluid vents <NUM>. This distance may be the same or less than the distance between the terminal edge of the sealing cap <NUM> and the stop member <NUM> disposed on the external surface of the sample collection vessel <NUM> when the connection members <NUM>, <NUM> thereof initially engage.

Although there are only two fluid vents <NUM> illustrated in <FIG>, it should be appreciated that in some embodiments there can be more or fewer fluid vents <NUM>. For example, a second pair of fluid vents <NUM> (not shown) can be defined on the opposite side of the inner vessel <NUM>. In some embodiments, the fluid vents <NUM> can be a different shape and/or the selectively movable sleeve valve <NUM> may operate differently than illustrated in <FIG>. For example, the outer sleeve <NUM> may define an open-ended chamber into which the inner vessel <NUM> is inserted. However, instead of being pushed through an open bottom of the outer sleeve <NUM>, depression of the inner vessel <NUM> (e.g., by association of the sealing cap <NUM> with the sample collection vessel <NUM>) can align fluid vents <NUM> defined by the inner vessel <NUM> with analogous fluid vents <NUM> defined by the outer sleeve <NUM>, thereby providing a through hole between the sample collection chamber <NUM>, the reagent retention chamber <NUM> of the inner vessel, and the reagent chamber <NUM> of the sealing cap <NUM>.

Referring now to <FIG>, the sealing cap <NUM> may additionally include a plurality of external ridges <NUM>. The external ridges <NUM> can facilitate a user to better grip the sealing cap <NUM> while positioning the sealing cap <NUM> over the sample collection vessel <NUM>. Additionally, or alternatively, the external ridges <NUM> can be used to rotate and close the sealing cap <NUM> onto the sample collection vessel <NUM>. In some embodiments, ridges <NUM> may beneficially enable the user to more forcefully turn the sealing cap <NUM>, and the external ridges <NUM> can provide the user with a better grip during that process. Ridges <NUM> can also facilitate retraction and/or closure of the selectively movable sleeve valve <NUM> and/or removal of the sealing cap <NUM> at the laboratory when accessing the biological sample, such as manually or by an automated removal mechanism.

Referring now to <FIG>, the inner vessel <NUM> includes one or more tapered regions, which can, among other things, help fit the inner vessel <NUM> into the sealing cap <NUM> and into the aperture <NUM> of the outer sleeve <NUM>. For example, the inner vessel <NUM> can include an upper collar <NUM> that is sized and shaped to fit within the sealing cap <NUM> and to create a fluid-tight seal therewith (as described above). As shown, the upper collar <NUM> can be tapered with a larger diameter adjacent to the retaining ring <NUM> and a smaller diameter moving away from the retaining ring <NUM> toward the terminal end thereof. The smaller diameter end of the upper collar <NUM> can be a smaller diameter than the diameter of the reagent chamber <NUM>, which can beneficially allow the inner vessel <NUM> to be more easily associated with the sealing cap <NUM>. As the diameter of the upper collar <NUM> increases when moving toward the retaining ring <NUM>, it forms an interference fit with the associated reagent chamber <NUM>, which can additionally be a fluid-tight fit.

The inner vessel <NUM> additionally includes a tapered exterior sidewall <NUM> that is sized and shaped to fit within the aperture <NUM> of the outer sleeve <NUM>. As illustrated, the exterior sidewall <NUM> can taper from a first diameter d1 to a second diameter d2, where d1>d2.

As shown in <FIG>, the interior sidewall <NUM> defining the aperture <NUM> of the outer sleeve <NUM> can additionally be tapered. For example, as shown in <FIG>, the interior sidewall <NUM> can be tapered from a proximate end having a diameter d3 to a distal end having a diameter d4, where d3>d4. The distal end diameter d4 can be, in some embodiments, about the same size as the second diameter d2 (shown in <FIG>) of the inner vessel <NUM> such that when the inner vessel <NUM> is associated with the outer sleeve <NUM>, an interference fit is created, which can additionally be a fluid-tight fit. <FIG> illustrates a front perspective view and a rear perspective view of the outer sleeve <NUM>, according to one embodiment.

In some embodiments, the exterior sidewall <NUM> of the inner vessel <NUM> is tapered to the same degree as the interior sidewall <NUM> of the outer sleeve <NUM>. In such an embodiment, the interior sidewall <NUM> may associate directly with the exterior sidewall <NUM> along its entire length and forming an interference fit therebetween.

In some embodiments, the exterior sidewall <NUM> of the inner vessel <NUM> is tapered to a different degree than the interior sidewall <NUM> of the outer sleeve <NUM>. For example, the interior sidewall <NUM> can be tapered more aggressively than the exterior sidewall <NUM> such that d1<d3. In such an embodiment, a gap would form between the outer sleeve <NUM> and the inner vessel <NUM> at the proximate end of the outer sleeve <NUM>. In some embodiments, the length of the aperture <NUM> is shorter than the length of the exterior sidewall <NUM>, and only a portion of the exterior sidewall <NUM> associates with the aperture <NUM>. Accordingly, d1 may be roughly equivalent to d3, and the degree of taper of the exterior sidewall <NUM> would still be less than the degree of taper of the interior sidewall <NUM> defining aperture <NUM>. In such an embodiment, a gap would form between the outer sleeve <NUM> and the inner vessel <NUM> at the proximate end of the outer sleeve <NUM>, similar to that described above.

In some embodiments, the exterior sidewall <NUM> of the inner vessel <NUM> is lined with one or more raised surface areas. <FIG> illustrates a perspective view of an inner vessel <NUM> with a raised surface area <NUM>, according to an embodiment. For example, the raised surface area <NUM> is formed on the outer surface of the cylindrical body of the inner vessel <NUM>. The raised surface area <NUM> includes or provides one or more raised ridges <NUM> lined around the exterior sidewall <NUM> to partially or completely cover the circumference of the inner vessel <NUM> and also forms a surface ring <NUM> on the cylindrical surface of the inner vessel <NUM>. The surface ring <NUM> surrounds a fluid vent <NUM>, which may be located at the circumferential surface of the cylindrical body of the inner vessel <NUM>. The raised ridges <NUM> may be individually configured at a range of depths and widths. In the embodiment illustrated in <FIG>, the raised surface area <NUM> includes three raised ridges (best shown in <FIG>), 121a, 121b, and 121c (which may be collectively referred to as <NUM>). <FIG> shows an embodiment where the raised surface area <NUM> takes the form of a sleeve band <NUM> coupled to the inner vessel <NUM>. This sleeve band <NUM> may be manufactured using a plurality of materials including, but not limited to, polymeric materials such as thermoplastics and its variants (e.g., thermoplastic elastomers, thermoplastic vulacnizates), rubber, including nitrile, silicone, polyurethane, PTFE, and neoprene, other plastics, ceramics, fiber materials, or any other material with suitable elasticity, rigidity or other suitable properties and characteristics. In embodiments in which the raised surface area <NUM> comprises multiple raised ridges <NUM>, the raised ridges <NUM> may be equally spaced along the exterior sidewall <NUM> or may be spaced varying distances apart over the exterior sidewall <NUM>, for example, the embodiment illustrated in <FIG>. There may be raised ridges <NUM> above and below the fluid vents <NUM> to create raised surface areas.

In some embodiments, the raised surface area <NUM> includes a raised surface surrounding the fluid vents <NUM> of the inner vessel to prevent preservation fluid from filling up the space between the upper ridge 121a and the lower ridge 121b of the inner vessel, thus reducing the surface area needing to be sealed. In such an embodiment, the raised surface reduces the surface area needed to form a fluid-tight seal. As described above, the inner vessel <NUM> may be designed as a hollow or a semi-hollow vessel to allow the transfer of fluid from the reagent chamber <NUM> into the sample collection chamber <NUM>.

In the illustrated embodiment, the raised surface area <NUM> lines the inner vessel <NUM> near the face of the inner vessel <NUM> which inserts into the outer sleeve <NUM>. However, in alternate embodiments, the raised surface area <NUM> may be adjusted to line the inner vessel closer to the retaining ring <NUM>. When the inner vessel <NUM> is inserted into the outer sleeve <NUM>, for example in a closed configuration, each of the raised ridges <NUM> are placed in contact with the interior sidewall of the outer sleeve <NUM> to provide a friction fit for better engagement between the inner vessel <NUM> and the outer sleeve <NUM>. The surface ring <NUM> of the raised surface area <NUM>, which surrounds the fluid vent <NUM>, frictionally engages with inner sidewall <NUM> of the outer sleeve <NUM> to provide a fluid-tight seal at the interface of the inner vessel <NUM> and outer sleeve <NUM> and to prevent preservation reagent from seeping through the space between the exterior sidewall <NUM> of the inner vessel <NUM> and the inner sidewall <NUM> of the outer sleeve <NUM> into any open space. <FIG> illustrates a side view of an inner vessel <NUM> comprising the raised surface area <NUM>, according to an embodiment. In the illustrated embodiment, the raised surface area <NUM> includes a surface ring <NUM> coupled to the two raised ridges 121a and 121b closest to the face of the inner vessel <NUM> which is oriented towards the outer sleeve <NUM>.

<FIG> illustrates additional front perspective and rear perspective views of an inner vessel <NUM> lined with a raised surface area <NUM>, according to an embodiment. <FIG> are two cross-sectional views of the inner vessel <NUM> with raised surface area <NUM>, according to an embodiment. <FIG> is rotated <NUM> degrees compared to <FIG> so that the fluid vents <NUM> are shown as facing up and down instead of sideways. <FIG> illustrates enlarged views of detail E <NUM> of <FIG>, which shows the raised surface area <NUM> of the inner vessel <NUM> with recesses <NUM> that form the raised ridges <NUM> in the raised surface area <NUM>. The recesses <NUM> enhance the frictional fit of the inner vessel <NUM> with the outer sleeve <NUM>. The raised ridge 121a is positioned on the end of the inner vessel <NUM> that engages with the outer sleeve <NUM> (not shown in <FIG>) and the raised ridge 121b is positioned at the end of the inner vessel <NUM> that engages with the sealing cap <NUM>. <FIG> illustrates enlarged views of detail E <NUM> of <FIG>, showing two alternative embodiments. For the embodiment on the right, the raised surface area <NUM> may include an additional recess <NUM> to further enhance frictional fit.

<FIG> illustrate embodiments that show additional or alternative features of different possible variations of a sample collection system. The sample collection system may include a sealing cap <NUM>, an inner vessel <NUM> that is securely engaged with a sealing cap <NUM>, an outer sleeve <NUM> that is frictionally engaged with the raised surface area <NUM> of the inner vessel <NUM>, and a sample collection vessel, for example, the sample collection vessel <NUM>. <FIG> show various components of a sealing cap <NUM>. An example of an outer sleeve <NUM> includes dual layers and is configured to slide over the fluid vents <NUM> of an inner vessel <NUM>. <FIG> illustrates a perspective view of a cross-section of the sealing cap <NUM> having an inner vessel <NUM> securely coupled to the sealing cap <NUM> and with an outer sleeve <NUM> movably coupled to the inner vessel <NUM>, which surrounds a portion of the inner vessel <NUM>. The outer sleeve <NUM> includes two layers: an inner band <NUM> and an outer band <NUM>. The inner band <NUM> may be referred to as a sealant band of an outer sleeve <NUM> and the outer band <NUM> may be referred to as a backing band of the outer sleeve <NUM>. In one embodiment, the raised surface area <NUM> may be functionally consistent with the above description of the raised surface area <NUM> and may also take the shape shown in <FIG>. As described above, the inner vessel <NUM> includes fluid vents <NUM> through which preservation reagent flows into the sample collection chamber <NUM>. In a resting state, in which the inner vessel <NUM> is unengaged with the sample collection vessel <NUM>, the inner band <NUM> of the outer sleeve <NUM> frictionally engages with the raised surface area <NUM> of the inner vessel <NUM> and covers the fluid vents <NUM> to provide a fluid-tight seal around the fluid vents <NUM>. The fluid-tight seal prevents preservation reagent from seeping through the space between the raised surface area <NUM> of the exterior sidewall <NUM> of the inner vessel <NUM> and the interior sidewall <NUM> defining the aperture of the outer sleeve <NUM>. Each of the inner band <NUM> and the outer band <NUM> may be manufactured using a plurality of materials including, but not limited to, polymeric materials such as thermoplastics and their variants (e.g., thermoplastic elastomers, thermoplastic vulcanizates), rubber, including nitrile, silicone, polypropylene, polyurethane, PTFE, and neoprene, other plastics, ceramics, fiber materials, or any other material with suitable elasticity and rigidity or other suitable properties and characteristics. The inner band <NUM> and the outer band <NUM> may be made from different materials with different physical properties. For example, in one embodiment, the inner band <NUM> may be made from a first material that is softer than the material of the outer band <NUM>. The softer inner band <NUM> may provide a better sealing effect to the inner vessel <NUM> while the stiffer outer band <NUM> may provide sufficient mechanical strength for interacting with other components to open the fluid vent <NUM> in a manner that will be discussed below. In one embodiment, the interior diameter of the inner band <NUM> is smaller than the outer diameter of the raised surface area <NUM> of the inner vessel <NUM> so that the inner band <NUM> is compressed between the outer band <NUM> and the raised surface area <NUM>. When the inner band <NUM> frictionally engages with the raised surface area <NUM>, the compression between the outer band <NUM> and the raised surface area <NUM> forms a fluid-tight seal between the inner vessel <NUM> and the outer sleeve <NUM>.

<FIG> is a cross-sectional view of an embodiment of outer sleeve <NUM> that includes a inner band <NUM> (not shaded) and a outer band <NUM> (shaded), in accordance with an embodiment. The exterior face of the inner band <NUM> may take the form of a ridged surface configured to couple with a complimentary ridged interior face of the outer band <NUM> at the backing band-sealant band interface <NUM>. The exterior face of the inner band <NUM> includes multiple locking ridges <NUM> and the interior face of the outer band <NUM> includes a complementary set of locking ridges <NUM> that enable the inner band <NUM> and the outer band <NUM> to interlock and form an outer sleeve <NUM>. At the backing band-sealant band interface <NUM>, the outer band <NUM> and the inner band <NUM> may be coupled by various methods such as frictionally fit, chemically bonded, overmolded, induction welded, thermally welded or any other suitable technique or combination of techniques, to form an outer sleeve <NUM>. The raised ridges of the inner band <NUM> interlock with the complementary ridges of the outer band <NUM> to provide a mechanical means of holding the sealant band and the backing band together. The ridged surface of the inner band <NUM> and the corresponding complementary ridges of the outer band <NUM> provide additional surface area to improve the coupling properties between the outer band <NUM> and the inner band <NUM>. In some embodiments, additional mechanical features, such as the ridges of the inner band <NUM> and the outer band <NUM> described above, may contribute to the coupling properties of the materials of the inner band <NUM> and the outer band <NUM>. For example, additional features contributing to the coupling properties include, but are not limited to, fasteners, snap fits, tabs, increased contact surface area, interference fits or other means. The inner band <NUM> and the outer band <NUM> may also be coupled by frictional fit, chemical bonding, solvent bonding, overmolding, induction welding, thermal welding, tapes, adhesives, etc. to generate an integrated outer sleeve <NUM>. The raised ridges <NUM> of the inner band <NUM> and the complementary ridges <NUM> of the outer band <NUM> may be equally spaced or may be spaced at varying distances apart. The outer sleeve <NUM> may also include an exterior ridge <NUM> that allows a component (e.g., the upper rim of the sample collection vessel <NUM>) to push the outer sleeve <NUM>.

In various embodiments, the outer sleeve <NUM> may take different forms and include one or more components. In one embodiment, the outer sleeve <NUM> shown in <FIG> is an example of outer sleeve <NUM>. In another embodiment, the outer sleeve may also be formed of a single material. In one embodiment, the outer sleeve is symmetrical to allow the sleeve to be coupled with the inner vessel <NUM> in any orientation. In one embodiment, the outer sleeve is asymmetrical. In one embodiment, the outer sleeve may also have raised surface areas or ridges in the interior surface to enhance the friction between the inner vessel <NUM> and the outer sleeve. Other combinations of features mentioned are also possible. For the embodiment shown in <FIG>, the inner band <NUM> and outer band <NUM> may be coupled using overmolding, interference fit, frictional fit, fasteners, mechanical features, snap fits, press fit, tabs, adhesives, tapes, solvent bonding, chemical bonding, UV bonding, induction welding (ultrasonic, vibration, friction), thermal welding, overmolding and mechanical features, frictional fit and mechanical features, adhesive and mechanical features, chemical bonding and mechanical features, friction welding and mechanical features, or another suitable combination of interface joining methods.

<FIG> illustrates a side view of a cross-section of an inner vessel <NUM> with an outer sleeve <NUM> in a closed position. The outer sleeve <NUM> can be frictionally engaged with the inner vessel <NUM>. The friction permits the outer sleeve <NUM> to be slidable translationally relative to the longitudinal body of the inner vessel <NUM> between a closed position (shown in <FIG>) and an open position (shown in <FIG>). The outer sleeve <NUM> at the closed position covers the fluid vents <NUM>. The outer sleeve <NUM> at the open position is displaced from the fluid vents <NUM>, thereby opening the fluid vents <NUM>. In the closed position illustrated in <FIG>, the inner band <NUM> of the outer sleeve <NUM> has a first surface area that is in contact with the raised surface area <NUM> of the inner vessel <NUM> on either side of the fluid vents <NUM>. The surface area contact forms a fluid-tight seal that prevents preservation fluid from flowing out of the fluid vents <NUM>. In some embodiments, the inner band <NUM> interacts with preservation fluid stored in the inner vessel <NUM> to improve the performance of the fluid-tight seal formed around the fluid vents. For example, the inner band <NUM> may be designed using material that swells upon contact with a preservation fluid. The swollen inner band <NUM> increases compression of the sealant band against the fluid vents <NUM> and raised surface area <NUM> adjacent to the fluid vents <NUM>, thereby improving the effectiveness of the fluid-tight seal. As another example, the inner band <NUM> may, upon contact with a preservation fluid, undergo a chemical reaction to create a fluid-tight seal or to improve upon the performance of an existing fluid-tight seal.

<FIG> also shows an additional or alternative feature in coupling the inner vessel <NUM> and the sealing cap <NUM>. In this example, the inner vessel <NUM> includes a cap band <NUM> (represented as having crosshatched pattern) and an inner layer <NUM> (shown as shaded). The cap band <NUM> and the inner layer <NUM> can be made of different materials. The cap band <NUM> may be formed of a softer and more elastic material such as thermoplastics and their variants (e.g., thermoplastic elastomers, thermoplastic vulcanizates), silicone, etc. The cap band <NUM> acts as a sealant layer, being compressed between the inner layer <NUM> of the inner vessel <NUM> and the inside wall of the sealing cap <NUM> to form a fluid-tight seal. A press fit between the inner layer <NUM> of the inner vessel <NUM> and the sealing cap <NUM> forms a liquid-tight seal. The inner layer <NUM> may be formed of a stiffer material such as any suitable polymer, including a thermoplastic polymer such as polypropylene.

Both the inner layer <NUM> and cap band <NUM> of the inner vessel <NUM> can take many forms and engage with the sealing cap <NUM> by any suitable methods such as interference fit (press fit, friction fit), compression fit, snap fit, mechanical features, chemical bonding, material interaction (e.g. swelling), solvent bonding, interference fit with snap fit, interference fit with mechanical features, interference fit with chemical bonding, interference fit with solvent bonding, interference fit with material interaction, compression fit with snap fit, compression fit with mechanical features, compression fit with chemical bonding, compression fit with solvent bonding, compression fit with material interaction, interference fit with snap fit with chemical bonding, interference fit with snap fit with solvent bonding, interference fit with snap fit with material interaction, interference fit with mechanical features with chemical bonding, interference fit with mechanical features with solvent bonding, interference fit with mechanical features with material interaction, any combination thereof, or any other suitable methods not explicitly described.

In the open position illustrated in <FIG>, the outer sleeve <NUM> is moved to another location that is only partially in contact with the raised surface area <NUM> of the inner vessel <NUM>. In some variations, the outer sleeve <NUM> may also be distanced from the raised surface area <NUM>. The outer sleeve <NUM> is moved to a thinner body portion <NUM> of the inner vessel <NUM>. The thinner body portion <NUM> has a smaller outer diameter than that of the portion at the raised surface area <NUM>. Hence, the outer sleeve <NUM> is less compressed at the thinner body portion <NUM>. As the inner vessel <NUM> slides translationally relative to the outer sleeve <NUM>, or alternatively as the outer sleeve <NUM> slides translationally relative to the inner vessel <NUM>, the amount of surface area of the outer sleeve <NUM> being in contact with the raised surface area <NUM> of the inner vessel <NUM> decreases, thereby reducing the amount of force required to slide the inner vessel <NUM> translationally as the fluid vent <NUM> is exposed. For example, in one embodiment, the outer diameter D5 of the inner vessel <NUM> is larger at a first position where the outer sleeve <NUM> resides in the closed position (shown in <FIG>) than the outer diameter D6 of the inner vessel <NUM> at a second position where the outer sleeve <NUM> resides in the open position (shown in <FIG>). The smaller diameter D6 reduces the area of compression of the inner band <NUM> between the outer band <NUM> and the inner vessel <NUM>, thereby reducing the frictional force between the inner band <NUM> and the inner vessel <NUM>. Hence, after a user applies initial forces to surpass the friction between the inner band <NUM> and the inner vessel <NUM> in the closed position, the friction is further reduced as the inner vessel <NUM> tapers thinner (diameter D5 to diameter D6), thereby reducing the amount of force needed to slide the outer sleeve <NUM> translationally as the fluid vents <NUM> are being opened.

<FIG> illustrate interactions between the sealing cap <NUM> and the sample collection vessel <NUM> when the sample collection vessel <NUM> engages with the sealing cap <NUM>, in accordance with an embodiment. The outer sleeve <NUM> includes an exterior ridge <NUM>, which is a protrusion from the exterior face of the outer band <NUM>. The exterior ridge <NUM> enables the translational movement of the outer sleeve <NUM> over and away from the fluid vents <NUM>. <FIG> illustrates a side view of a cross-section of a sample collection system <NUM> with an outer sleeve <NUM> engaged with a sample collection vessel <NUM>. To release preservation reagent stored in the reagent chamber <NUM> of the sealing cap <NUM>, a user screws the sealing cap <NUM> onto the sample collection vessel <NUM> that may carry the user's biological sample. The engaging of the sealing cap <NUM> to the sample collection vessel <NUM> and the continuing screwing of the sealing cap <NUM> onto the sample collection vessel <NUM> cause an upper rim <NUM> (also labeled in <FIG>) of the sample collection vessel to make contact with the opposing edge of the exterior ridge <NUM> of the outer sleeve <NUM>, as illustrated in <FIG>.

As a user continues to screw the sealing cap <NUM> onto the sample collection vessel <NUM>, the resulting contact between the sample collection vessel <NUM> and the exterior ridge <NUM> overcomes the compression force that forms the fluid-tight seal over the fluid vents <NUM> and raised surface area <NUM> adjacent to the fluid vents <NUM>, causing the outer sleeve <NUM> to slide translationally along the exterior sidewall <NUM> of the inner vessel, exposing the fluid vents <NUM>. The sealing cap <NUM> may include a first set of screw threads <NUM> and the sample collection vessel <NUM> may include a second set of screw threads <NUM> that are complementary to the first set of screw threads <NUM>. Before the sample collection vessel <NUM> makes contact with the outer sleeve <NUM>, the user may feel a relatively easy movement of the sealing cap <NUM>. In one example embodiment shown in <FIG>, the outer sleeve <NUM>, in the closed position, may translationally overlap with at least a portion of the first set of screw threads <NUM>. After the sealing cap <NUM> is partially engaged with the sample collection vessel <NUM> and the sample collection vessel <NUM> begins to make contact with the outer sleeve <NUM>, the user may feel additional resistance for the further screwing of the sealing cap <NUM> onto the sample collection vessel. In some embodiments, a signal may be provided to the user that the preservation reagent will be released into the sample collection vessel <NUM>. When the sealing cap <NUM> is fully engaged with the sample collection vessel <NUM> (e.g., fully screwed on), the sample collection vessel <NUM> will have pushed the outer sleeve <NUM> to the open position, thereby opening the fluid vents <NUM>. When the sealing cap <NUM> is fully engaged with the sample collection vessel <NUM>, the outer sleeve <NUM> is displaced away from the first set of screw threads <NUM>, as shown in <FIG> in the open position.

<FIG> illustrates a side view of a cross-section of a sample collection system <NUM> with an outer sleeve <NUM> engaged with a sample collection vessel <NUM> to expose fluid vents <NUM> of the inner vessel <NUM>. Once exposed, preservation reagent flows through the fluid vents <NUM> into the sample collection chamber <NUM> of the sample collection vessel <NUM>. Additionally, while shifting the outer sleeve <NUM> along the exterior sidewall <NUM> to expose the fluid vents <NUM>, the sample collection vessel <NUM> locks in place by connection members <NUM> (e.g., complementary threads) on the exterior sidewall of the sample collection vessel <NUM> with connection members <NUM> (e.g., complementary threads) on an interior sidewall the sealing cap <NUM>. In one embodiment, in a fully engaged configuration, outer sleeve <NUM> is pushed in until it meets a cap band <NUM> so that the outer sleeve <NUM> is held in place between the cap band <NUM> and the sample collection vessel <NUM>. The cap band <NUM> may serve as a hard stop for the outer sleeve <NUM>. When the sample collection vessel <NUM> is locked in place, the outer sleeve <NUM> forms a fluid-tight seal against the exterior sidewall <NUM> of the inner vessel <NUM>. The outer sleeve <NUM> is also in contact with the top surface of the sample collection vessel <NUM>. In some embodiments, the contact between the outer sleeve <NUM> and the sample collection vessel <NUM> can form a fluid-tight seal. In some embodiments, the inner vessel <NUM>, the outer sleeve <NUM>, and the sample collection vessel <NUM> cooperate to form an enclosed environment for the biological sample. The formed fluid-tight seal prevents preservation reagent from flowing into open spaces in the sealing cap <NUM> and directs fluid flowing out of the fluid vents <NUM> into the sample collection chamber <NUM> of the sample collection vessel <NUM>. In some embodiments, the inner vessel <NUM> may be retained in an engaged position with the sealing cap <NUM> by use of a number of joining methods, such as, but not limited to, a snap fit, a press fit, a compression fit, a chemical bond, a UV bond, induction welding, thermal welding, adhesives, fasteners, and/or other applicable means, or a combination thereof, for retaining the engagement of the inner vessel <NUM> to the sealing cap <NUM>. The cap band <NUM> may also help to securely retain the inner vessel <NUM> in the sealing cap <NUM>.

As shown in <FIG>, the selectively movable sleeve valve <NUM> can be configured in a closed configuration (<FIG>) and an open configuration (<FIG>). In the open configuration illustrated in <FIG>, the inner vessel <NUM> protrudes through the outer sleeve <NUM>. As discussed above with respect to various <FIG> and <FIG>, this causes a region of the inner vessel <NUM> having a diameter d2 to be associated with the distal end of the outer sleeve <NUM> (e.g., the region associated with d3). In some embodiments, the outer sleeve <NUM> can be made of a material configured to flex under such strain, allowing the larger diameter portion d2 to extend through the distal end of the outer sleeve <NUM>, as shown in <FIG>. For example, the outer sleeve may be made of polypropylene or a thermoplastic elastomer. The properties of the material should allow for a fluid-tight seal between the inner vessel <NUM> and the outer sleeve <NUM> and also allow the selectively movable sleeve valve <NUM> to move between open and closed positions.

In some embodiments, when the inner vessel <NUM> protrudes through the outer sleeve <NUM>, causing the outer sleeve <NUM> to elastically flex (e.g., when the selectively movable sleeve valve <NUM> is in an open configuration), the tapered nature of the exterior sidewall <NUM> and the interior sidewall <NUM> defining the aperture <NUM> can cause the selectively movable sleeve valve <NUM> to return to a closed configuration (as shown in <FIG>) when whatever force that is being applied to cause the open configuration is relieved (e.g., the sealing cap <NUM> is loosened). Upon relief of the force causing the open configuration, the elastically flexed outer sleeve <NUM> can provide sufficient force to move the inner vessel <NUM> back through the aperture <NUM>.

Accordingly, in some embodiments, tightening the association of the sealing cap <NUM> with the sample collection vessel <NUM> forces the selectively movable sleeve valve <NUM> into an open configuration where the outer sleeve <NUM> is elastically flexed, and loosening the association of the sealing cap <NUM> with the sample collection vessel <NUM> allows the outer sleeve <NUM> to return to a less flexed state, pushing the inner vessel <NUM> back into the aperture <NUM>, obstructing fluid vents <NUM>, and returning the selectively movable sleeve valve <NUM> to a closed position.

In <FIG>, the inner vessel <NUM> and the outer sleeve <NUM> contact one another through frictional fit. In some embodiments, the open and closed configurations may be defined by any suitable spatial relationship between the inner vessel <NUM> and the outer sleeve <NUM>. For example, the fluid vents130 of the inner vessel <NUM> may be in a rotational relationship with a portion of the wall of the outer sleeve <NUM> covering the fluid vents <NUM>. Put differently, in the closed configuration, the fluid vents <NUM> may be in a first rotational position relative to the outer sleeve <NUM> so that the fluid vents <NUM> are covered by the interior wall of the outer sleeve <NUM>. The outer sleeve <NUM> may include an opening or have a shape, such as a recess or such as by plastic deformation, that may serve as an opening. From the closed position, the fluid vents <NUM> may be rotated and be in a second rotational position, relative to the outer sleeve <NUM>, so that the fluid vents <NUM> lines up with the opening of the outer sleeve <NUM> to allow the preservation reagent to release. In another embodiment, the open and closed positions may be defined by a longitudinal spatial relationship between the inner vessel <NUM> and outer sleeve <NUM>. For example, in a transition from a closed position to an open position, the inner vessel <NUM> may be moved longitudinally relative to the outer sleeve <NUM>, thereby exposing the fluid vents <NUM> and allowing the preservation reagent to be released. In yet another embodiment, the open and closed positions may be defined by a combination of rotational and longitudinal relationships. As shown in <FIG>, some embodiments of the present disclosure include a sample collection system <NUM> having a sample collection vessel <NUM>, a sleeve valve <NUM> that can be selectively and reversibly opened and closed and which comprises an outer sleeve <NUM> and an inner vessel <NUM>, and a sealing cap <NUM> operable to cover and seal the opening of the sample collection vessel <NUM>. The outer sleeve <NUM> can include a detent <NUM> that mates with or otherwise selectively associates with a ring structure <NUM> disposed on an interior sidewall <NUM> of the sample collection vessel <NUM>. When assembled, the detent-ring association can enable or assist the sleeve valve device <NUM> in being selectively and, if desired, reiteratively opened and closed.

Various features and configurations shown in different embodiments of the sample collection system in <FIG> can be combined. For example, the inner vessel <NUM> with features shown in <FIG> or <FIG> can be used as the inner vessel <NUM> in <FIG>. The features used in the coupling between the sealing cap <NUM> and the inner vessel <NUM>, such as using a cap band <NUM> and/or using interference fit, may also be used in any of the embodiments of the sample collection system.

In various embodiments, the inner vessel <NUM> may take different forms and be coupled with different materials. For example, as shown in <FIG>, the inner vessel <NUM> may be formed of a single material with a flat profile to the right of the retaining ring <NUM>. In another example shown in <FIG>, the inner vessel <NUM> with the raised surface area <NUM> may also be formed as a single integrated article (e.g., injection molded as a single piece) including raised ridges <NUM> and recesses <NUM>. In yet another example, shown in <FIG>, the raised surface area <NUM> is a separate component that may be formed of a different material than the inner layer <NUM> of the inner vessel <NUM>. The two components being securely coupled to each other make an inner vessel <NUM>. The raised surface area <NUM> is referred to as a sleeve band <NUM>, which is shaded in the Figures. The sleeve band <NUM> may be coupled to the inner layer <NUM> of the inner vessel <NUM> at the interface of the inner vessel <NUM> by various methods, including but not limited to, overmolding, frictional fit, adhesives, chemical bonding, thermal welding, mechanical features, or any combination thereof.

Other forms and combinations of inner vessel <NUM> are also possible. In one embodiment, the inner vessel <NUM> includes raised surface area <NUM> that may take the form of ribs, raised features, snap fit features, press fit features, etc. In one embodiment, the inner vessel <NUM> includes a sleeve band <NUM> with or without raised surface area <NUM>. In one embodiment shown in <FIG>, the inner vessel <NUM> which includes a cap band <NUM> on the exterior surface of the inner vessel <NUM> where it engages with the sealing cap <NUM> to form a fluid-tight seal. In one embodiment, the cap band <NUM> on the exterior surface of the inner vessel <NUM> may or may not include a raised surface area <NUM>. In one embodiment, the inner vessel <NUM> may include both a sleeve band <NUM> and a cap band <NUM>. In one embodiment, the inner vessel <NUM> includes a cap band <NUM> and a sleeve band with a raised surface area <NUM>. In one embodiment, both the cap band <NUM> and sleeve band <NUM> both include raised surface areas. Other embodiments may include any combinations of various features described above.

Various components in the sample collection system, such as the inner vessel <NUM>, outer sleeve <NUM>, and sealing cap <NUM>, may take the form of a single integrated material or may include multiple layers that are made of different materials. For example, at an interface of two components (e.g., between inner vessel <NUM> and sealing cap <NUM>, between inner vessel <NUM> and outer sleeve <NUM>, etc.), at least one of the components may, or the two components may each, include a layer that is made of a softer and more elastic material to improve sealing at the interface. Sleeve band <NUM> of the inner vessel <NUM> shown in <FIG>, inner layer <NUM> of the outer sleeve <NUM> shown in <FIG>, and cap band <NUM> of the inner vessel <NUM> shown in <FIG> are examples of those sealant layers. The sealant layers may be made of suitable materials such as thermoplastics and its variants (e.g., thermoplastic elastomers, thermoplastic vulacnizates), soft rubber, silicone, etc. In addition to the softer sealant layer, one or more of the various components of the sample collection system may include a stiffer layer to provide mechanical support to the component. The inner layer <NUM> of the inner vessel <NUM> shown in <FIG> and outer band <NUM> of the outer sleeve <NUM> are examples of those structural layers. The structural layers may be made of suitable materials that provide sufficient strength to the sample collection system. Example materials may include suitable polymeric materials such as polypropylene, polycarbonate, fiber glass, etc..

In various embodiments of the sample collection system, various components or their layers may be securely coupled to other components or other layers. For example, the sealing cap <NUM> and the inner vessel <NUM> may be securely coupled to each other. Likewise, the inner band <NUM> and the outer band <NUM> are securely coupled to each other to form the outer sleeve <NUM>. The secured coupling between two components (including coupling of two layers) may be achieved by one or more methods, including but not limited to, interference fit (press fit, friction fit), compression fit, snap fit, mechanical features, chemical bonding, material interaction (e.g. swelling), solvent bonding, interference fit with snap fit, interference fit with mechanical features, interference fit with chemical bonding, interference fit with solvent bonding, interference fit with material interaction, compression fit with snap fit, compression fit with mechanical features, compression fit with chemical bonding, compression fit with solvent bonding, compression fit with material interaction, interference fit with snap fit with chemical bonding, interference fit with snap fit with solvent bonding, interference fit with snap fit with material interaction, interference fit with mechanical features with chemical bonding, interference fit with mechanical features with solvent bonding, interference fit with mechanical features with material interaction, any combination thereof, or any other suitable methods not explicitly described.

With continued reference to <FIG>, an exemplary method for implementing a multi-part sample collection kit, as described above, includes receiving a biological sample through a funnel connected to the sample collection vessel <NUM>. The received biological sample can enter directly into the sample collection vessel <NUM> or by gravitational flow along an interior funnel sidewall. The method can additionally include removing the funnel from the sample collection vessel <NUM> after facilitating receipt of the biological sample, and associating a sealing cap <NUM> with the sample collection vessel <NUM>. The method can additionally include securing the sealing cap <NUM> (e.g., by rotating the sealing cap <NUM> along complementary threads between the cap <NUM> and the collection vessel <NUM>) to close the cap <NUM> over the top of the sample collection vessel <NUM>. The sealing cap <NUM> can contain preservation reagent(s) that are released as the sealing cap <NUM> is rotated and closed over the sample collection vessel <NUM>. In some embodiments, a selectively movable sleeve valve <NUM> associated with the sealing cap <NUM> undergoes a conformational change when the sealing cap <NUM> is rotated and closed over the collection vessel <NUM>.

As shown in <FIG>, the sealing cap <NUM> secures to and seals the collection vessel <NUM> and can do so by any means described herein or as known in the art. In this closed and sealed state, the selectively movable sleeve valve <NUM> is in an open configuration, and the reagent(s) mix with the collected sample. The collection vessel <NUM> can be shaken to allow all or at least most of the preservation reagent to cover the collected sample. Additionally, the biological sample therewithin is beneficially protected from the outside atmosphere by being air- and water-tight. This reduces the chances of the sample contamination and helps maintain the integrity of the probative component during transportation to the laboratory.

In some embodiments, the sealing cap is under pressure and moving the selectively movable sleeve valve into an open position causes the preservation reagent(s) stored within the sealing cap to be forcefully expelled into the sample collection chamber. This can beneficially encourage stored reagent(s) to mix with the collected sample and may additionally act to preserve the reagent(s) and/or the probative component thereof.

Methods can additionally include removing the preserved sample from the sample collection system <NUM>. This can involve, for example, the steps of unscrewing or otherwise removing the sealing cap <NUM> from the sample collection vessel <NUM>. In doing so, the outer sleeve <NUM> can be retained by the sample collection vessel <NUM> while the sealing <NUM> cap and associated inner vessel <NUM> are drawn away from the sample collection vessel <NUM>. This can cause the sleeve valve <NUM> to reseal (e.g., return to a closed configuration). Further disassociation of the sealing cap <NUM> from the sample collection vessel <NUM> can cause the sleeve valve <NUM> to be removed in a resealed state, exposing the opening of the sample collection vessel <NUM> and allowing access to the preserved biological sample.

Referring now to <FIG>, an exemplary use of a sample collection system <NUM> can include a sealable and/or resealable sleeve valve <NUM>. For example, during assembly of the sealing cap <NUM> with the associated sleeve valve <NUM>, the reagent chamber <NUM> of the sealing cap <NUM> can be filled with a measure of sample preservation reagent(s). The inner vessel <NUM> of the sleeve valve <NUM> can then be press-fit into and retained by the sealing cap <NUM>. As shown in <FIG>, the inner vessel <NUM> defines a reagent retention chamber <NUM> that is in fluid communication with the reagent chamber <NUM> of the sealing cap <NUM> and further defines a plurality of fluid vents <NUM> through which reagent within the reagent chamber <NUM> can be delivered to a collected sample. An upper collar <NUM> of the inner vessel <NUM> extends into-and provides an interference fit with-the reagent chamber <NUM> of the sealing cap <NUM>, and a retaining ring <NUM> defined by the inner vessel receives a complementary protrusion <NUM> from the sealing cap <NUM> sidewall, further anchoring the inner vessel <NUM> within the sealing cap <NUM> to prevent separation. Together (or individually) these components of the inner vessel <NUM> can act to provide a fluid-tight seal between the inner vessel <NUM> and the solution cap <NUM>.

In the exemplified embodiment, the combination of inner vessel <NUM> and outer sleeve <NUM> comprises the sleeve valve <NUM>, which can be selectively and reversibly moved between a sealed configuration 200A and an unsealed configuration 200B. When the outer sleeve <NUM> is associated with the inner vessel <NUM> in the sealed configuration 200A, it can prevent the premature or unintentional expulsion of reagent from the sealing cap <NUM>.

Assembly of the sleeve valve <NUM> can occur before, during, or after the inner vessel <NUM> is attached to the sealing cap <NUM>. It can involve advancing the outer sleeve <NUM> over the inner vessel <NUM> and within the sealing cap <NUM> until an exterior-facing guide member <NUM> on the outer sleeve is received (e.g., snap-fittedly received) into a guide channel <NUM> of the sealing cap <NUM>. Once the outer sleeve <NUM> has been advanced over the inner vessel <NUM> and the guide member <NUM> received within the guide channel <NUM> of the sealing cap <NUM>, the outer sleeve <NUM> is in an initially sealed configuration 200A, thereby covering the fluid vents <NUM> of the inner vessel <NUM> and sealing and retaining the sample preservation reagent(s) inside the sealing cap <NUM> and inner vessel <NUM> (e.g., as illustrated in <FIG> but before the sealing cap has been placed onto the sample collection vessel).

The guide channel <NUM> of the sealing cap <NUM> can be sized to allow limited translational movement of the guide member <NUM> within the guide channel <NUM>. This, in turn, restricts the movement of the inner vessel <NUM> relative to the outer sleeve <NUM> when the sealing cap <NUM> is secured and unsecured from the sample collection vessel <NUM> (e.g., as illustrated in <FIG> when the sealing cap <NUM> is secured to the sample collection vessel <NUM>, causing the selective unsealing of the sleeve valve <NUM>). An inner facing edge or protrusion of the sealing cap <NUM> can define a lower end of the guide channel <NUM> and can act to retain the guide member <NUM> within the guide channel <NUM>, preventing separation of the outer sleeve <NUM> from the sealing cap <NUM> when the sealing cap <NUM> is decoupled from the sample collection vessel <NUM>.

In an exemplary use, the sample collection vessel <NUM> is used to receive a biological sample through the opening of and into the sample collection vessel <NUM> (e.g., receiving saliva through an optional funnel temporarily attached to the sample collection vessel <NUM>). After the biological sample is received within the sample collection vessel <NUM>, the user can place the sealing cap <NUM> over the sample collection vessel <NUM>, with the sleeve valve <NUM> facing the opening of the sample collection vessel <NUM> and advance the sleeve valve <NUM> into the opening of the sample collection vessel <NUM>. When the sleeve valve <NUM> is advanced through the opening of the sample collection vessel <NUM>, a detent <NUM> formed within the lower collar of the outer sleeve <NUM> can mechanically engage a protruding retention ring <NUM> on the interior sidewall <NUM> of the sample collection vessel <NUM>. The ring-detent engagement can prevent the sleeve <NUM> from being pushed farther into the sample collection vessel <NUM>, but in some variations, the body <NUM> of the outer sleeve <NUM> above the lower collar abuts an upper rim <NUM> of the sample collection vessel <NUM>, thereby preventing the sleeve <NUM> from being pushed any farther into the sample collection vessel <NUM>.

Further advancement of the sealing cap <NUM> toward the sample collection vessel <NUM>, including engagement of complementary interlocking threads located on the sealing cap <NUM> and the sample collection vessel <NUM>, can force the inner vessel <NUM> through the outer sleeve <NUM> and affect a conformational change in the sleeve valve <NUM> from the sealed position 200A shown in <FIG> to the unsealed position 200B shown in <FIG>. Moving the sleeve valve <NUM> from the sealed position 200A to the unsealed position 200B un-occludes the fluid vents <NUM> and allows the reagent(s) to flow into the sample collection vessel <NUM>.

The foregoing unsealing of the sleeve valve can be temporary and reversible. For example, when the sealing cap <NUM> is removed from the sample collection vessel <NUM> to recover the biological sample, the sleeve valve <NUM> can be restored to the sealed configuration 200A, reestablishing the seal between the outer sleeve <NUM> and inner vessel <NUM>. As the sealing cap <NUM> is unscrewed from the sample collection vessel <NUM>, in some embodiments, the outer sleeve <NUM> can be temporarily retained in a fixed position within the sample collection chamber while the inner vessel <NUM> is withdrawn, causing the outer sleeve <NUM> to re-occlude the fluid vents <NUM> (e.g., moving the sleeve valve <NUM> from the unsealed configuration 200B of <FIG> to the resealed configuration 200A of <FIG>). The outer sleeve <NUM> can be temporarily retained in the fixed position due to the retention ring <NUM> within the sample collection vessel <NUM> mechanically engaging with the detent <NUM> on the lower collar of the outer sleeve <NUM>. The frictional forces between the outer sleeve <NUM> and inner vessel <NUM> can be less than the force required to disengage the ring-detent interaction, allowing such relative movement.

When the inner vessel <NUM> has been withdrawn relative to the outer sleeve <NUM> so as to reseal the fluid vents <NUM>, the guide member <NUM> can reach the end of the guide channel <NUM> where further movement is impeded by the inner facing edge or protrusion of the sealing cap <NUM>. The sample collection system <NUM> is designed in some embodiments so that the sealing cap <NUM> and sleeve valve <NUM> can-at this point-be removed from the sample collection vessel <NUM> without the catastrophic failure of any components. That is, the sample collection system <NUM> can be designed so that the detent <NUM> on the outer sleeve <NUM> can be disengaged from the protruding ring <NUM> of the sample collection vessel <NUM> while maintaining the integrity of the sealing cap-sleeve valve association. This can be enabled, for example, by engineering the components such that the mechanical force required to disengage the ring <NUM> and detent <NUM> is less than the force required to remove the guide member <NUM> from the guide channel <NUM>. Further withdrawal of the sealing cap <NUM> from the sample collection vessel can, therefore, overcome the ring-detent interaction, permitting the sealing cap <NUM>, inner vessel <NUM>, and outer sleeve <NUM> to be removed as a single unit from the sample collection vessel <NUM>-with the valve <NUM> in the resealed configuration 200A.

It should be appreciated that although the foregoing embodiment depicted the ring <NUM> being associated with the sample collection vessel <NUM> and the detent <NUM> being associated with the outer sleeve <NUM>, in some embodiments, the attachment mechanism between the two components may be switched or replaced by other complementary components that perform the same or similar function. For example, the sample collection vessel may include a detent within an interior sidewall that associates with a ring structure disposed on the outer sleeve.

<FIG> illustrate a cross-sectional, unassembled view 300A and a cross-sectional, assembled view 300B, respectively, of an additional embodiment of a sample collection system <NUM> with a selectively movable sleeve valve <NUM> depicted in an unsealed configuration and in a sealed/resealed configuration, respectively.

Similar to the embodiments of <FIG>, the system <NUM> includes a collection vessel <NUM> and optionally, a funnel (not shown), which can be associated with a top portion of the collection vessel <NUM> and in fluid communication with a sample collection chamber <NUM> of the collection vessel <NUM>. The biological sample collection system <NUM> can also include the selectively movable sleeve valve <NUM> comprised of an inner vessel <NUM> and an outer sleeve <NUM> associated with a sealing cap <NUM> that has a reagent chamber <NUM> disposed within or integrated with the sealing cap <NUM>. The sealing cap <NUM>-together with the selectively movable sleeve valve <NUM>-can be sized and shaped to associate with a top portion of the sample collection vessel <NUM>, fitting over and sealing an opening of the sample collection chamber <NUM>. For the sake of clarity, the description for corresponding components of the systems <NUM> and <NUM> applies to the system <NUM> and is incorporated herein.

In the exemplified embodiment, the combination of inner vessel <NUM> and outer sleeve <NUM> comprises the sleeve valve <NUM>, as shown in <FIG>. The sleeve valve <NUM> can be selectively and reversibly moved between the sealed configuration 300A and the unsealed configuration 300B. When the outer sleeve <NUM> is associated with the inner vessel <NUM> in the sealed configuration 300A, it can prevent the premature or unintentional expulsion of reagent from the sealing cap <NUM> through the fluid vent <NUM>. In the embodiments of <FIG>, the outer sleeve <NUM> encircles a bottom portion of the inner vessel <NUM> where the fluid vent <NUM> is positioned. The inner vessel <NUM> comprises a plurality of ribs <NUM> about an upper portion of the inner vessel <NUM>. The plurality of ribs <NUM> may be spaced evenly or at varying intervals about the outer surface of the inner vessel <NUM>.

After a biological sample is received within the sample collection vessel <NUM>, the user can place the sealing cap <NUM> over the sample collection vessel <NUM>, with the sleeve valve <NUM> facing the opening of the sample collection vessel <NUM> and advance the sleeve valve <NUM> into the opening of the sample collection vessel <NUM>. When the sleeve valve <NUM> is advanced through the opening of the sample collection vessel <NUM> toward the sample collection vessel <NUM>, including engagement of complementary interlocking threads located on the sealing cap <NUM> and the sample collection vessel <NUM>, it can force the inner vessel <NUM> through the outer sleeve <NUM> and affect a conformational change in the sleeve valve <NUM> from the sealed position 300A shown in <FIG> to the unsealed position 300B shown in <FIG>. The outer sleeve <NUM> is moved towards the plurality of ribs <NUM>. Moving the sleeve valve <NUM> from the sealed position 300A to the unsealed position 300B un-occludes the fluid vents <NUM> and allows the reagent(s) to flow into the sample collection vessel <NUM>.

<FIG> illustrate a perspective view, a cross-sectional view, and a top view of a sealing cap <NUM>. The design of a sealing cap may have various functional features, for example that enable a user to conveniently and reliably associate the sealing cap and the sample collection vessel, and various aesthetic features, such as a brand or logo. As described with regard to the embodiments of <FIG>, applying a rotational force threadedly associates the sealing cap <NUM> and the sample collection vessel <NUM>, and applying a directionally opposite rotation force disassociates the sealing cap and the sample collection vessel. In the embodiments of <FIG>, the sealing cap <NUM> comprises a plurality of gripping features <NUM> about an outer surface <NUM> and a logo <NUM>. The plurality of gripping features <NUM> enable a user to grip the sealing cap to apply a rotational force to associate and disassociate the sealing cap with the sample collection vessel. While the geometry of the outer surface <NUM> may vary, the sealing cap generally has a cylindrical core. The plurality of gripping features <NUM> may vary in shape, length, arrangement, and orientation.

<FIG> illustrates a front view and a rear view of a sealing cap with a design of the outer surface <NUM> of the sealing cap that is wide enough for a user to effectively grip the sealing cap <NUM> when coupling the cap to an inner vessel <NUM>. Alternatively, the sealing cap <NUM> may be designed to include a plurality of elongated and protruding gripping features 436a from the outer surface to improve a user's ability to apply a rotational force to the sealing cap. In one embodiment, the gripping feature 436a may extend substantially from the top to the bottom of the sealing cap <NUM>. In one embodiment, the elongated gripping features 436a are distributed radially at different rotational positions of the sealing cap <NUM>. For example, a sealing cap <NUM> may have a few pairs of the elongated gripping features 436a distributed radially. As a result, when associate the sealing cap <NUM> with the collection vessel <NUM> via the threaded features, the user is able to apply more torque to the sealing cap <NUM> resulting in a more effective liquid-tight seal. Additionally, the seal cap may be designed to prevent a user from associating the cap with the collection vessel by applying a normal longitudinal force to the exterior face of the seal cap <NUM> and instead prompt the user to apply a rotational force to couple the threaded interior of the seal cap <NUM> with the threaded exterior of the collection vessel <NUM>. The rotational force may force a rotation between the inner vessel <NUM> and the outer sleeve <NUM>, thereby opening the fluid vent <NUM> and releasing the preservation reagent. <FIG> illustrates a side view of a sealing cap <NUM> designed to be wide enough for a user to effectively grip the sealing cap <NUM>, according to one embodiment. In some embodiments, for example the embodiment illustrated in <FIG>, the interior of the sealing cap <NUM> is lined with threading mechanisms that correspond to threading mechanism on the exterior of outer vessel configured to couple to the sealing cap <NUM>. <FIG> illustrates a top view of a sealing cap designed to be wide enough for a user to effectively grip the sealing cap, according to one embodiment.

As illustrated in <FIG>, the outer surface <NUM> has a cylindrical core with three portions, each having different diameters. The gripping features <NUM> are elongated ribs that are equally and radially spaced about the outer surface <NUM>. A length of each gripping feature <NUM> may vary; <FIG> illustrates a plurality of long ribs 436a, medium ribs 436b, and short ribs 436c, corresponding to the differing diameters of the outer surface <NUM>. The gripping features <NUM> are arranged in a pattern, but in other embodiments they may be arranged differently (e.g., at varying intervals). As shown in the top view in <FIG>, a height of each gripping feature <NUM> (in a perpendicular direction relative to the outer surface <NUM>) may also vary. <FIG> illustrates the plurality of gripping features <NUM> forming approximately a triangular shape about the outer surface <NUM>, where a height of each gripping feature <NUM> corresponds to a length of each gripping feature <NUM>. In other words, the gripping features <NUM> with the longest length are the tallest in height, <NUM> the gripping features <NUM> with the shortest length are the shortest in height. <FIG> illustrates the logo <NUM> positioned on the outer surface <NUM> in the center of the radially spaced gripping features <NUM>.

<FIG> illustrate perspective views of various embodiments of a sealing cap. As previously described, the design of a sealing cap may have various functional features, for example that enable a user to conveniently and reliably associate the sealing cap and the sample collection vessel, and various aesthetic features, such as a brand or logo. While the geometry of the outer surface of the sealing cap may vary, the sealing cap generally has a cylindrical core. The gripping features on the outer surface may vary in shape, length, arrangement, and orientation, or similar.

<FIG> illustrates an embodiment of a sealing cap <NUM> that includes an outer surface and a plurality of gripping features. In the embodiment of <FIG>, the outer surface is substantially cone-shaped, and the plurality of gripping features are elongated ribs that are radially and equally spaced about the outer surface. The elongated ribs extend from a top edge of the sealing cap <NUM> to a bottom edge of the sealing cap <NUM>. Two gripping features that are positioned opposite each other protrude a greater distance from the outer surface than the remaining gripping features, creating two "wings" for gripping the sealing cap <NUM>.

<FIG> illustrates an embodiment of a sealing cap <NUM> that includes an outer surface and a plurality of gripping features. In the embodiment of <FIG>, the outer surface is substantially cone-shaped, and the plurality of gripping features are angled loops that protrude from a bottom portion of the sealing cap <NUM>. The plurality of gripping features are radially and equally spaced about the outer surface.

<FIG> illustrates an embodiment of a sealing cap <NUM> that includes an outer surface and a plurality of gripping features. In the embodiment of <FIG>, the outer surface is substantially cylindrical with a rounded top edge, and the plurality of gripping features are elongated ribs that are radially and equally spaced about the outer surface. The elongated ribs extend from the top edge of the sealing cap <NUM> to about the middle of the sealing cap <NUM>, covering an upper portion of the sealing cap <NUM>. On a bottom portion of the sealing cap <NUM>, the outer surface is smooth and includes a logo.

<FIG> illustrates an embodiment of a sealing cap <NUM> that includes an outer surface and a plurality of gripping features. In the embodiment of <FIG>, the outer surface is about cone-shaped with a rounded top edge, and the plurality of gripping features are elongated ribs that are radially and equally spaced about the outer surface. The elongated ribs extend from the top edge of the sealing cap <NUM> to a bottom edge of the sealing cap <NUM>. The elongated ribs protrude from the outer surface such that the elongated ribs create a substantially cylindrical boundary. On a top portion of the sealing cap <NUM>, the outer surface includes a logo.

<FIG> illustrates an embodiment of a sealing cap <NUM> that includes an outer surface and a plurality of gripping features. In the embodiment of <FIG>, the outer surface is substantially cylindrical, and the plurality of gripping features are loops that are arranged similar to a flower petal shape. In between the corner loops are elongated ribs. The loops and the elongated ribs extend from the top edge of the sealing cap <NUM> to the bottom edge of the sealing cap <NUM>. On one or more of the loops is a logo.

<FIG> illustrates an embodiment of a sealing cap <NUM> that includes an outer surface and a plurality of gripping features. In the embodiment of <FIG>, the outer surface is substantially cylindrical, and the plurality of gripping features are loops that are arranged similar to a flower petal shape. In between the corner loops are flat surfaces that bridge between the corner loops. The loops and the flat surfaces extend from the top edge of the sealing cap <NUM> to the bottom edge of the sealing cap <NUM>. On one or more of the flat surfaces is a logo.

<FIG> illustrates an embodiment of a sealing cap <NUM> that includes an outer surface and a plurality of gripping features. In the embodiment of <FIG>, the outer surface is substantially rectangular, and the plurality of gripping features are flat surfaces. The flat surfaces extend from near the top edge of the sealing cap <NUM> to near the bottom edge of the sealing cap <NUM>. On top and on bottom of the flat surfaces, a plurality of short ribs extend from the top edge or the bottom edge to the flat surfaces. The short ribs are radially and equally spaced about the outer surface. On one or more of the flat surfaces is a logo.

<FIG> illustrates an embodiment of a sealing cap <NUM> that includes an outer surface and a plurality of gripping features. In the embodiment of <FIG>, the outer surface is substantially rectangular, and the plurality of gripping features are elongated ribs that extend from a top edge of the sealing cap <NUM> to a bottom edge of the sealing cap <NUM>. The elongated ribs are radially and equally spaced about the outer surface.

<FIG> illustrates an embodiment of a sealing cap <NUM> that includes an outer surface and a plurality of gripping features. In the embodiment of <FIG>, the outer surface is substantially rectangular, and the plurality of gripping features are elongated ribs that extend from a top edge of the sealing cap <NUM> to a bottom edge of the sealing cap <NUM>. The elongated ribs are radially and equally spaced about the outer surface. A flat surface extends perpendicularly across the elongated ribs about the outer surface, and on the flat surface is a logo. In the embodiment of <FIG>, the flat surface is positioned near a bottom edge of the sealing cap <NUM>.

<FIG> illustrates an embodiment of a sealing cap <NUM> that includes an outer surface and a plurality of gripping features. In the embodiment of <FIG>, the outer surface is substantially cylindrical, and the plurality of gripping features are loops that protrude from the outer surface. The loops form concave surfaces with adjacent loops, creating a boundary resembling a square with concave surfaces, and the loops extend from near a top edge of the sealing cap <NUM> to near a bottom edge of the sealing cap <NUM>. Near the bottom edge, curved surfaces connect the loops to the bottom edge of the sealing cap <NUM>. At the top edge, the outer surface is exposed within the loops.

<FIG> illustrates an embodiment of a sealing cap <NUM> that includes an outer surface and a plurality of gripping features. In the embodiment of <FIG>, the outer surface is substantially cylindrical, and the plurality of gripping features are loops that protrude from the outer surface. The loops form concave surfaces with adjacent loops, creating a boundary resembling a triangle with rounded corners and concave surfaces between the corners, and the loops extend from near a top edge of the sealing cap <NUM> to a bottom edge of the sealing cap <NUM>. At the top edge, the outer surface is exposed within the loops. One of the concave surfaces includes a logo.

<FIG> illustrates an embodiment of a sealing cap <NUM> that includes an outer surface and a plurality of gripping features. In the embodiment of <FIG>, the outer surface is substantially cylindrical, and the plurality of gripping features are loops that protrude from the outer surface. The loops are flat surfaces, where the loops alternate in size between large and small, creating a boundary resembling a triangle flat corners, and the loops extend from a top edge of the sealing cap <NUM> to a bottom edge of the sealing cap <NUM>. At the top edge, the outer surface is exposed within the loops. One or more of the flat surfaces includes a logo.

<FIG> illustrates an embodiment of a sealing cap <NUM> that includes an outer surface and a plurality of gripping features. In the embodiment of <FIG>, the outer surface is substantially cylindrical, and the plurality of gripping features are elongated ribs that protrude from the outer surface. The elongated ribs create a boundary resembling a triangle flat corners, where the flat corners are formed by loops protruding from the outer surface. The gripping features extend from a top edge of the sealing cap <NUM> to a bottom edge of the sealing cap <NUM>. At the top edge, the outer surface is exposed within the loops. One or more of the loops includes a logo.

<FIG> illustrates an embodiment of a sealing cap <NUM> that includes an outer surface and a plurality of gripping features. In the embodiment of <FIG>, the outer surface is substantially cylindrical, and the plurality of gripping features are loops that protrude from the outer surface. The loops are flat surfaces, where the loops alternate in size between large and small, creating a boundary resembling a triangle flat corners, and the loops extend from a top edge of the sealing cap <NUM> to a bottom edge of the sealing cap <NUM>. On the larger flat surfaces, a plurality of elongated ribs extend along the flat surface. At the top edge, the outer surface is exposed within the loops. One or more of the corner loops includes a logo.

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 the present disclosure pertains.

It will also be appreciated that systems, devices, products, kits, methods, and/or processes, according to certain embodiments of the present disclosure may include, incorporate, or otherwise comprise properties, features (e.g., components, members, elements, parts, and/or portions) described in other embodiments disclosed and/or described herein. Accordingly, the various features of certain embodiments can be compatible with, combined with, included in, and/or incorporated into other embodiments of the present disclosure. Thus, disclosure of certain features relative to a specific embodiment of the present disclosure should not be construed as limiting application or inclusion of said features to the specific embodiment. Rather, it will be appreciated that other embodiments can also include said features, members, elements, parts, and/or portions without necessarily departing from the scope of the present disclosure.

Moreover, unless a feature is described as requiring another feature in combination therewith, any feature herein may be combined with any other feature of a same or different embodiment disclosed herein. Furthermore, various well-known aspects of illustrative systems, methods, apparatus, and the like are not described herein in particular detail in order to avoid obscuring aspects of the example embodiments. Such aspects are, however, also contemplated herein.

Claim 1:
A sample collection system (<NUM>, <NUM>, <NUM>), comprising:
a sample collection vessel (<NUM>, <NUM>, <NUM>) for receiving a sample;
a sealing cap (<NUM>, <NUM>) configured to be removably engaged with the sample collection vessel;
an inner vessel (<NUM>, <NUM>) securely engaged with the sealing cap, the inner vessel for storing a reagent, the inner vessel comprising a body and a fluid vent located on the body; and
an outer sleeve (<NUM>) frictionally engaged with the inner vessel, the outer sleeve slidable translationally relative to the inner vessel between a first position and a second position, the outer sleeve at the first position covering the fluid vent and at the second position opening the fluid vent, wherein, when the sample collection vessel is fully engaged with the sealing cap, the sample collection vessel is configured to push the outer sleeve to the second position, thereby opening the fluid vent, and wherein the outer sleeve comprises an inner layer and an outer layer, and the inner layer is made of a first material and an outer layer is made of a second material, different from the first material, wherein the second material is stiffer than the first material.