Patent Application
20250235188
This disclosure generally relates to saliva collection devices and kits.
Saliva is rapidly becoming a very common sample type for diagnostic and genealogy studies. Over the last two years more samples are collected at home rather than at a medically supervised facility. This means that the saliva collection device must be extremely easy to use and understood by a wide range of ages, intellectual abilities and physical abilities. This device—which in some cases is an empty device or it might contain transport media—should be also safe for at home use and transportation. The device should be easy to pack and ship to an analytical lab for analysis. And finally, the saliva collection device must be compatible with standard lab equipment for the most efficient analysis workflows-which involve analysis of DNA, RNA, protein or small molecules derived from saliva.
Saliva collection is much easier and painless for individuals versus common nasopharyngeal (NP) swabs for respiratory virus detection, such as SARS-COV-2. For this reason, many people prefer to collect saliva than have an NP swab. NP swabs are especially difficult for the young and elderly, who may have more difficulty to sit still or in a position for an NP swab. The other benefit of saliva is that it can be collected at home and a medical professional is not required to collect the sample. Accordingly, a saliva collection device and process needs to be easy to use for all ages and abilities. Furthermore, once the saliva sample arrives at a lab for analysis, the sample collection device needs to be easy to open and process, and compatible with standard laboratory equipment.
There are several saliva collection devices currently on the market for purchase, however none of these are very user friendly for at home collection. Typically, there are multiple parts in these devices that a user has to assemble in a correct orientation for the saliva to collect properly. Furthermore, once the collection tubes arrive at a lab for analysis, some of these devices are incompatible with standard lab equipment, such as liquid handlers and tube racks. One current saliva collection device (Spectrum™) has a false bottom on the collection tube, making the tube top heavy and prone to falling over. This device also has a cap design that contains the inactivation/stabilization reagent. However, the cap design is not compatible with automated decappers. The cap also requires a lot of force from a user to screw the cap on to fully release the reagent from the cap. Further, because the cap is perforated, liquid can be both in the bottom of the tube and in the cap, which makes it very challenging to ensure homogenous mixing of the inactivation reagent with the saliva. Another saliva collection device (Isohelix™) has a funnel design to prevent spillage if the tube should fall over while collecting saliva. However, this design slows the saliva going into the tube, thus taking longer to collect the saliva sample. Yet another collection device (DNA Genotek™), has the inactivation/stabilization reagent in an attached funnel lid and a false bottom on the collection tube. This makes the design extremely top heavy and very prone to tipping over. Once a user has collected saliva, the user must close the funnel lid to break open the seal for the reagent to flow into the tube. This can lead to splashing of the liquid out of the funnel as the lid is snapped close. Once the reagent is in the tube with the saliva, a standard size cap is screwed onto the tube and is ready to go to the lab for analysis.
Existing devices are plagued by one or more problems, such as, require assembly by a user, and/or difficult to release a stabilization reagent, and/or top heavy and prone to tipping over and spilling saliva everywhere, and/or have complex instructions unsuitable for general public use, and/or incompatible with lab processing. Hence, there is still no saliva collection device on the market that is user friendly and compatible with downstream lab analysis.
One embodiment of the present disclosure comprises a sample collection kit for a standard specimen tube and standard cap. A kit of the disclosure comprises a funnel detachably coupled to the specimen tube and configured to direct test material in the test tube; and a reagent cartridge configured to comprise a reagent wherein the reagent cartridge can be coupled to the funnel. In some embodiments, the funnel can comprise one or more protrusions on the funnel that are configured to puncture the reagent cartridge when the reagent cartridge is manipulated by a user such that the reagent will pass into the test tube.
Another embodiment is a sample collection kit for a specimen tube. The sample collection kit can comprise a funnel configured to receive a sample from a user; wherein the funnel is configured to be attachable to a specimen tube.
Another embodiment is another sample collection kit for a specimen tube. It can comprise a casing configured to contain a specimen tube, a top edge of the casing comprising an opening configured to receive the specimen tube therein and a coupler configured to hold a tube cap.
Another embodiment is a sample collection kit for a specimen tube. The kit can comprise a funnel detachably coupled to the specimen tube and configured to direct test material into the specimen tube; a reagent cartridge configured to contain a reagent and to be coupled to the funnel; and one or more protrusions on the funnel configured to puncture the reagent cartridge when the reagent cartridge is manipulated by a user such that the reagent will pass into the specimen tube; wherein the funnel and one or more protrusions comprise a funnel apparatus configured to attach to a top edge of a casing, and further configured to cover an opening for a specimen tube and a coupler for a tube cap on the top edge.
A further embodiment under the present disclosure is a method for collecting and testing a sample. Steps of the method include receiving a sample in a funnel and directing the sample from the funnel through a debris filter to a specimen tube, the debris filter coupled to the funnel and extending into the specimen tube. Further steps include manipulating a reagent cartridge coupled to the funnel to be punctured by one or more protrusions comprising the funnel such that reagent will pass through the debris filter and into the specimen tube.
A further embodiment under the present disclosure is a method for collecting and testing a sample. Steps of the method include receiving a sample in a funnel and directing the sample from the funnel through a debris filter to a specimen tube, the debris filter coupled to the funnel and extending into the specimen tube, wherein the specimen tube is contained by a casing, the casing comprising a top edge comprising an opening configured to receive the specimen tube and a coupler configured to hold a tube cap. Further steps include manipulating a reagent cartridge coupled to the funnel to be punctured by one or more protrusions comprising the funnel such that reagent will pass through the debris filter and into the specimen tube; wherein the funnel and the reagent cartridge comprise a funnel apparatus configured to cover the opening and the coupler of the top edge.
Another embodiment comprises a method of manufacturing a sample collection kit for a specimen tube. Steps include providing a debris filter configured to extend into the specimen tube and to filter test material passing therethrough; providing a funnel coupled to the debris filter and configured to direct test material through the debris filter; providing a reagent cartridge configured to contain a reagent and to be coupled to the funnel; and providing one or more protrusions on the funnel configured to puncture the reagent cartridge when the reagent cartridge is manipulated by a user such that the reagent will pass into the specimen tube.
Another method under the present disclosure is a method of manufacturing a sample collection kit. Steps include providing a casing configured to contain a specimen tube, a top edge of the casing comprising an opening configured to receive the specimen tube therein and a coupler configured to hold a tube cap.
This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an indication of the scope of the claimed subject matter.
The foregoing has outlined rather broadly the features and technical advantages of the present disclosure in order that the detailed description of the embodiments that follows may be better understood. 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. It should be appreciated by those skilled in the art that the conception and specific embodiment disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present invention. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the spirit and scope of the invention as set forth in the appended claims. The novel features which are believed to be characteristic of the invention, both as to its organization and method of operation, together with further objects and advantages will be better understood from the following description when considered in connection with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the present invention.
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:
Before describing various embodiments of the present disclosure in detail, it is to be understood that this disclosure is not limited to the parameters of the particularly exemplified systems, methods, apparatus, products, processes, and/or kits, which may, of course, vary. Thus, while certain embodiments of the present disclosure will be described in detail, with reference to specific configurations, parameters, components, elements, etc., the descriptions are illustrative and are not to be construed as limiting the scope of the claimed invention. In addition, the terminology used herein is for the purpose of describing the embodiments and is not necessarily intended to limit the scope of the claimed invention.
Embodiments under the present disclosure include sample collection kits that are easy to use for the public, compatible with standard laboratory equipment, and do not tip over.
Advantages of the embodiments described herein include:
One benefit of certain embodiments under the present disclosure is that all the parts required can be integrated into a single consumable. All other sample collection devices on the market come in multiple pieces—putting the burden on the user to figure out what part goes where/when. With the present disclosure, it can pre-assembled and ready to use. The user can have the directions on the device making it easy to know what to do to have a successful sample collection. Also, the parts of the device can be numbered to match the step in the directions, making it very easy to understand what to do at each step.
Advantages of the embodiment shown in
Two different perspective views of funnel 710 of
Debris filter 935 is designed to filter out larger debris or viscous fluids from the sample. Embodiments of the debris filter can take many forms as illustrated in various embodiment described herein. Debris filter 935 as show includes 2 mm slits that extend down the entire portion of the filter below the housing. However, many different configurations are possible. The slits may be sizes other than 2 mm such as 0.5 mm, 1 mm, 1.5 mm, 2.5 mm, or any other appropriate size desired by a user. In addition, the slits may only extend through half of the projection or may extend for more or less. Instead of slits, holes may be incorporated into the funnel projection to perform the same function, as shown in
The embodiments described herein can be used with any type of tube or receptacle. Test tubes, specimen tubes, storage tubes, of any shape and size, with or without caps, can be used as part of the embodiments described. Sample collection can be of saliva, sputum, mucus, blood, or other bodily fluids or substances.
Embodiments may be with or without reagent. Reagent may be added upon manufacturing, before shipping to users. Alternatively, sample collection kits and embodiments may be manufactured empty and reagent may be added later by labs or other users. Substances added to test or specimen tubes can include reagent or other substances. Such substances can be used for preservation of pathogens, inactivation of pathogens, for preservation of nucleic acids, or for preservation or inactivation of various functionalities or traits. Downstream analysis can be for DNA or RNA (human, viral, bacterial, fungal), protein analysis, analysis of miscellaneous small molecules, general medical examinations, doping tests, and other uses.
To assist in understanding the scope and content of this written description and the appended claims, a select few terms are defined directly below. 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.
The terms “approximately,” “about,” and “substantially,” as used herein, represent an amount or condition close to the specific stated amount or condition that still performs a desired function or achieves a desired result. For example, the terms “approximately,” “about,” and “substantially” may refer to an amount or condition that deviates by less than 10%, or by less than 5%, or by less than 1%, or by less than 0.1%, or by less than 0.01% from a specifically stated amount or condition.
Various aspects of the present disclosure, including devices, systems, and methods may be illustrated with reference to one or more embodiments or implementations, which are exemplary in nature. As used herein, the term “exemplary” means “serving as an example, instance, or illustration,” and should not necessarily be construed as preferred or advantageous over other embodiments disclosed herein. In addition, reference to an “implementation” of the present disclosure or invention includes a specific reference to one or more embodiments thereof, and vice versa, and is intended to provide illustrative examples without limiting the scope of the invention, which is indicated by the appended claims rather than by the following description.
As used in the specification, a word appearing in the singular encompasses its plural counterpart, and a word appearing in the plural encompasses its singular counterpart, unless implicitly or explicitly understood or stated otherwise. Thus, it will be noted that, as used in this specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. For example, reference to a singular referent (e.g., “a widget”) includes one, two, or more referents unless implicitly or explicitly understood or stated otherwise. Similarly, reference to a plurality of referents should be interpreted as comprising a single referent and/or a plurality of referents unless the content and/or context clearly dictate otherwise. For example, reference to referents in the plural form (e.g., “widgets”) does not necessarily require a plurality of such referents. Instead, it will be appreciated that independent of the inferred number of referents, one or more referents are contemplated herein unless stated otherwise.
As used herein, directional terms, such as “top,” “bottom,” “left,” “right,” “up,” “down,” “upper,” “lower,” “proximal,” “distal,” “adjacent,” and the like are used herein solely to indicate relative directions and are not otherwise intended to limit the scope of the disclosure and/or claimed invention.
It is understood that for any given component or embodiment described herein, any of the possible candidates or alternatives listed for that component may generally be used individually or in combination with one another, unless implicitly or explicitly understood or stated otherwise. Additionally, it will be understood that any list of such candidates or alternatives is merely illustrative, not limiting, unless implicitly or explicitly understood or stated otherwise.
In addition, unless otherwise indicated, numbers expressing quantities, constituents, distances, or other measurements used in the specification and claims are to be understood as being modified by the term “about,” as that term is defined herein. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the subject matter presented herein. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the subject matter presented herein are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical values, however, inherently contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
Any headings and subheadings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims.
The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention itemed. Thus, it should be understood that although the present invention has been specifically disclosed in part by preferred embodiments, exemplary embodiments, and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and such modifications and variations are considered to be within the scope of this invention as defined by the appended items. The specific embodiments provided herein are examples of useful embodiments of the present invention and various alterations and/or modifications of the inventive features illustrated herein, and additional applications of the principles illustrated herein that would occur to one skilled in the relevant art and having possession of this disclosure, can be made to the illustrated embodiments without departing from the spirit and scope of the invention as defined by the items and are to be considered within the scope of this disclosure.
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 or 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.
All references cited in this application are hereby incorporated in their entireties by reference to the extent that they are not inconsistent with the disclosure in this application. It will be apparent to one of ordinary skill in the art that methods, devices, device elements, materials, procedures, and techniques other than those specifically described herein can be applied to the practice of the invention as broadly disclosed herein without resort to undue experimentation. All art-known functional equivalents of methods, devices, device elements, materials, procedures, and techniques specifically described herein are intended to be encompassed by this invention.
When a group of materials, compositions, components, or compounds is disclosed herein, it is understood that all individual members of those groups and all subgroups thereof are disclosed separately. When a Markush group or other grouping is used herein, all individual members of the group and all combinations and sub-combinations possible of the group are intended to be individually included in the disclosure. Every formulation or combination of components described or exemplified herein can be used to practice the invention, unless otherwise stated. Whenever a range is given in the specification, for example, a temperature range, a time range, or a composition range, all intermediate ranges and subranges, as well as all individual values included in the ranges given are intended to be included in the disclosure. All changes which come within the meaning and range of equivalency of the items are to be embraced within their scope.
Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2023/017232 | 4/2/2023 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63327104 | Apr 2022 | US |
