Embodiments of the present disclosure generally relate to swabs for biological sample collection. Swabs may be generally described as a wad of absorbent material (e.g., cotton) wound around one end of a small stick (e.g., paper, plastic, or wood) and may be used for sample collection in many types of biological tests. For example, swabs may be used for DNA, RNA, bacterial, viral, blood, and/or fecal testing. However, commercially-available swab kits do not fully transfer the collected sample during extraction, which may affect accuracy and precision of the resulting test. Accordingly, a new swab is needed that recovers more of the collected sample for biological processing and analysis.
The purpose and advantages of the disclosed subject matter will be set forth in and apparent from the description that follows, as well as will be learned by practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and attained by the methods and systems particularly pointed out in the written description and claims hereof, as well as from the appended drawings.
To achieve these and other advantages and in accordance with the purpose of the disclosed subject matter, as embodied and broadly described, the disclosed subject matter includes an apparatus including an elongated body having a proximal end, a distal end, and a length therebetween. The apparatus further includes a swab head having a proximal end and a distal end, and the proximal end of the swab head is attached to the distal end of the elongated body. The swab head includes a plurality of openings. The apparatus further includes a lumen extending from the proximal end of the elongated body into at least a portion of the swab head. The lumen is in fluidic communication with the plurality of openings.
In various embodiments, an apparatus includes an elongated body having a proximal end, a distal end, and a length therebetween along a longitudinal axis. The apparatus further includes a swab head having a proximal end and a distal end, and the proximal end of the swab head is attached to the distal end of the elongated body. The swab head includes a plurality of openings. The apparatus further includes a bore extending along the longitudinal axis from the distal end of the swab head at least partially into the swab head. The bore is in fluidic communication with the plurality of openings, and the bore is configured to engage a pin of a container when the swab is inserted into the container thereby forcing fluid through the plurality of openings.
In various embodiments, an apparatus includes an elongated body having a proximal end, a distal end, and a length therebetween. The apparatus further includes a swab head having a proximal end and a distal end, and the proximal end of the swab head is attached to the distal end of the elongated body. The swab head comprises a plurality of surface features (e.g., grooves, bumps, scoring, etc.) on an outer surface of the swab head.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the disclosed subject matter claimed.
The accompanying drawings, which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the method and system of the disclosed subject matter. Together with the description, the drawings serve to explain the principles of the disclosed subject matter.
A detailed description of various aspects, features, and embodiments of the subject matter described herein is provided with reference to the accompanying drawings, which are briefly described below. The drawings are illustrative and are not necessarily drawn to scale, with some components and features being exaggerated for clarity. The drawings illustrate various aspects and features of the present subject matter and may illustrate one or more embodiment(s) or example(s) of the present subject matter in whole or in part.
In various embodiments, a purge swab includes an elongated body having a proximal end and a distal end, and a swab head at the distal end of the body. In various embodiments, the purge swab may be used to collect a biological sample from a target (e.g., human, animal, etc.). For example, the purge swab may be inserted into a nasal passageway of a human such that the swab head contacts nasal secretions that are collected thereon. In various embodiments, the swab head is removed from the nasal passageway, inserted into a container (e.g., a tubular specimen container), and purged to more efficiently dislodge the collected sample from the swab head and/or transfer (e.g., disperse) the collected sample into a collection fluid. In various embodiments, purging of the swab head may be achieved in any suitable way to thereby improve the transfer of collected sample material into the container (e.g., into the collection fluid). In various embodiments, the elongated body has an axial lumen along its length. In various embodiments, because the purge swab more efficiently transfers collected sample from the swab head and into the container, the purge swabs described herein may reduce the amount of reagents required for downstream processing of the sample. In various embodiments, the purge swabs described herein may reduce the number of steps required for downstream processing.
In various embodiments, a purge swab and container may handle sample collection to sample recovery. In various embodiments, sample recovery may be based on a purging mechanism. In various embodiments, sample recovery may be based on an abrasive pumping mechanism. In various embodiments, purging is the forcing of liquid through one or more (e.g., a plurality of) apertures at the collection area (e.g., the swab head) to recover the specimen sample. In various embodiments, the purge swab includes an aperture array at the swab head. In various embodiments, although the aperture array may be designed differently with respect to the purge technique, the objective of the array is to provide jets of liquid adjacent to and striking zones of high sample collection in the swab head. In various embodiments, this is achieved by utilizing the variation in aperture shape to negate the pressure drop associated to the system and to maintain force of the purge across the swab head. In various embodiments, the aperture(s) may be square, rectangular, circular, ovular, or any other suitable shape.
In various embodiments, one category of purge swab may be a shaft stored purge (SSP). In various embodiments, another category of purge swab may be a collection tube stored purge (CTSP). In various embodiments, yet another category of purge swab may be an external fluid purge.
In various embodiments, a fluid (e.g., buffer solution, qPCR solution, etc.) may be contained within at least a portion (e.g., a proximal portion) of the lumen. In various embodiments, the fluid may be forced out of the lumen and out of a plurality of openings in the swab head. In various embodiments, the resulting flow through the openings in the swab head may improve the transfer of collected sample material from the swab head into the container.
In various embodiments, after the purge swab is inserted into the container (and the swab head is seated within the seating portion), at least a portion of the elongated body may be removed (e.g., broken off) to thereby allow the cap to be affixed (e.g., screwed on) to the container. In various embodiments, the elongated body of the purge swab may be marked (e.g., scored) at a predetermined location so that a user knows where to break off the elongate body after sample collection.
In various embodiments, a SSP swab may be implemented using a pumping mechanism (e.g., a plunger). In various embodiments, the purge swab may be capped (e.g., sealed) after use within the associated collection tube. In various embodiments, a purge liquid may be stored within a lumen of the body of the purge swab. In various embodiments, the purge liquid may be stored between a frangible layer (e.g., film, foil, sheath, etc.) and the pumping mechanism (e.g., a plunger). In various embodiments, the purge swab may be manually pumped by the user (after the purge swab is capped inside the collection tube) to thereby force the purge liquid out of the swab head. In various embodiments, the cap may include a purge mechanism (e.g., a piston) configured to engage and force the pumping mechanism (e.g., plunger) in the purge swab distally into the body of the purge swab thereby forcing the liquid optionally past the frangible layer and through one or more apertures in the swab head, thus transferring material captured by the swab head into the collection tube. In various embodiments, the piston may be forced down a lumen of the shaft, thereby ejecting a purge liquid through one or more apertures in the swab tip. In various embodiments, the piston may reach the full length of the swab tip, thus providing pressure to push purge liquid through the last apertures which would have less pressure in other designs. In various embodiments, the piston mechanism may be integrated into the cap of the collection tube. In various embodiments, the piston may be a separate component from the collection tube, and may be inserted into the cap after the cap has been attached (e.g., screwed onto) the collection tube.
In various embodiments, rather than using a piston to force the purge liquid through the lumen of the purge swab, a compressed gas (e.g., air or other inert and non-reactive gas such as CO2 or nitrogen) may be used to force the purge liquid through the lumen and out the one or more apertures in the swab head. In various embodiments, the cap may contain a compressed gas configured to force the purge liquid through the swab head. In various embodiments, forcing the purge liquid through the lumen may be triggered by screwing the collection tube cap onto the collection tube (e.g., after the cap has been fully screwed on the collection tube). In various embodiments, the cap may include a gas port configured to receive a compressed gas (e.g., CO2) cartridge configured to provide compressed gas and force the purge liquid through the swab head.
In various embodiments, a cap dropper may be used to provide purge liquid to the lumen of the purge swab. In various embodiments, the cap dropper includes a cap having a rubber bulb and a tube extending from the bulb and through the cap (e.g., a Pasteur pipette). In various embodiments, a syringe may be used to provide purge liquid to the system via the cap. In various embodiments, where the purge liquid is contained within the cap or the swab itself, a locking system may be used to ensure the purge liquid cannot be activated prematurely. In various embodiments, the locking system may include a frangible piece of material (e.g., plastic) that requires a predetermined amount of force to break. In various embodiments, the locking system may include a pin (e.g., split pin, cotter pin, etc.). Premature purging could result in redundancy of the swab, loss of the sample, or jetting of the liquid into the patient during sample collection. In various embodiments, when a locking system is included, purging may only occur after capping the purge swab into its associated collection tube.
In various embodiments, any suitable locking system may be used to ensure purging cannot be activated prematurely. In various embodiments, for a syringe type purge system, a clip may be positioned between a thumb pad of the plunger and the syringe body. In various embodiments, the clip may be made of any suitable material (e.g., plastic, metal). In various embodiments, the clip may be any suitable color, for example, a bright color (e.g., red) to direct attention to the clip. In various embodiments, for a dropper-type purge system, an additional screw-on cap may protect the rubber bulb of the dropper. In various embodiments, the cap may be a screw-on cap. In various embodiments, the cap may be any suitable color, e.g., red. In various embodiments, for a piston-type purge system, a circlip (C-clip) may be placed close to a distal end of the piston (e.g., over a circumferential groove), necessitating removal of the circlip before the purge step. In various embodiments, for a compressed gas purge system, the compressed gas canister may include a frangible seal that is pierced when the canister is screwed into a receptacle. In various embodiments, the receptacle may be formed partly by the tube and partly by the tube cap, thereby forming an interlock to only allow canister insertion to a completed tube/cap assembly. In various embodiments, the cap and/or tube may include a metering orifice. In various embodiments the cap and/or tube may include a filtered vent arrangement to mitigate over-pressurization of the tube assembly.
In various embodiments, purge liquid may be stored within a frangible vessel (e.g., a disc). In various embodiments, purge liquid may be stored as a semi-solid matrix. In various embodiments, purge liquid may be stored within a channel or reservoir structure within the purge swap and/or cap. In various embodiments, if liquid is stored in the swab, the purge swap may include an upper seal and/or lower seal to maintain isolation from the ambient environment. In various embodiments, the lower seal may separate the liquid from the swab material. In various embodiments, the lower seal may be a pressure frangible material (e.g., plastic, foil, sheet, etc.). In various embodiments, the upper seal may be a frangible material (e.g., plastic, foil, sheet, etc.). In various embodiments, the upper seal may be a deformable membrane configured to maintain a barrier with the ambient environment even after activation.
In various embodiments, a fluid (e.g., buffer solution, qPCR solution, etc.) may be forced into a fluidic connection in the proximal end of the body such that the fluid flows through the lumen and out of a plurality of openings in the swab head. In various embodiments, the resulting fluid flow through the openings in the swab head improves the transfer of collected sample material from the swab head into the fluid.
In various embodiments, a CTSP swab may use a conventional swab shaft (e.g., a solid shaft). In various embodiments, the purge liquid may be stored within the collection tube. In various embodiments, the collection tube may include a molded-in pin feature at the bottom of the tube. In various embodiments, the collection tube may include one or more (e.g., two, three, four, etc.) guidance fins on the inner diameter of the tube configured to guide pumping of the swab up and down during the purging step. In various embodiments, a user may pump the swab head up and down one or more times to draw the purge liquid in and force the purge liquid out of or around the swab head. In various embodiments, larger ports towards the distal end may increase distal flushing in the initial part of the downward stroke. In various embodiments, smaller ports at the proximal end may be flushed when the pin acts like a piston closing ports during the down stroke.
In various embodiments, the purge swab may include a one-way valve that allows fluid flow in a single direction. For example, a one-way valve may only allow purge liquid (e.g., VTM) to flow out of the swab head. In various embodiments, a two-way valve may be incorporated into the swab to provide recirculation of VTM from the distal end of the swab tip and through the apertures along the tip.
In various embodiments, the purge system may use the walls of the collection tube to engage with the swab tip at any point during insertion of the swab head into the collection tube. In various embodiments, repeated pumping of the swab head into the collection tube may provide abrasive contact between an engagement structure within the tube (e.g., a a coarse inner surface of the tube and/or structure(s) configured to modify, e.g., deform, the surface of an object passing therethrough). For example, an inner surface of the collection tube may include one or more circumferential ribs and/or vertical fins configured to engage the swab head as the swab head is inserted into the collection tube.
In various embodiments, the swab head may be molded from a polymer template. In various embodiments, two or more polymer templates may be used for different portions of the purge swab, and the portions of the purge swab may be assembled together. In various embodiments, the polymer template of the purge swab may be designed to incorporate rough textures, which act as accumulation zones for the sample. In various embodiments, sample collection with swabs often requires a level of disruption to the zone of collection (e.g., the nasopharyngeal passage). In various embodiments, disruption may be performed by scratching, scraping, or rolling the swab along a surface of the collection zone. In various embodiments, the purge swab may be designed to collect (e.g., accumulate) sample using any suitable disruption technique.
In various embodiments, the outer surface of the swab head may include a double helix collection structure. In various embodiments, the collection structure may include sharp edges. In various embodiments, the collection structure may include rough textures to thereby provide a course surface to improve sample collection. In various embodiments, rolling the swab head in one or both the clockwise and anti-clockwise directions is possible because of the bidirectionality of the collection structure.
In various embodiments, the collection zones may be symmetrical 90-degree cut outs from the swab tip which provide the accumulation zones for the sample. In various embodiments, the swab tip may be cylindrical in shape. In various embodiments, zones and/or textures may be added to increase surface roughness on the tip, thus increasing the collection ability of the swab head. In various embodiments, the surface of the swab head may
In various embodiments, the purge swab may be designed to be injection molded. In various embodiments, the purge swab may be designed to be over-molded. In various embodiments, the particular manufacturing method may depend on the complexity of the design and the capabilities of the molding process. In various embodiments, the narrow-hollowed shaft may be manufactured using over-molding. In various embodiments, the narrow-hollowed shaft may be manufactured using injection molding.
In various embodiments, the purge swab may be designed for naso-pharyngeal sample (e.g., mucus) collection. In various embodiments, the design of the purge swab may be similar to that of commercially-available oral swabs. In various embodiments, the purge swab head design may be altered to suit the desired application, as can the shaft.
In various embodiments, the swabs described herein may be used in applications such as: nasal, throat, vaginal, groin, armpit, rectal, wound, buccal, faeces, urethral, pediatric, neonatal, endo-esocervial, endocervical and mid turbinate. With the flexibility in the design of the invention regarding the tip structure, the purge system and the volume delivered for collection; all of these applications are feasibly catered for. In various embodiments, a purge swab (e.g., a syringe embodiment and with a syringe attached via a luer adapter) may be used for other surgical and non-surgical wash/purge/drain/irrigate operations, e.g., saline flush of vessels or structures during micro surgery or ear wax removal (e.g., a hot water purge).
In various embodiments, the purge swab may be used in combination with a receiving vessel to stabilize the sample. In various embodiments, the sample may be processed (e.g., with a lysis buffer) following sample collection. In various embodiments, the sample may be further processed, for example, via a Torus device (as disclosed in U.S. Pat. No. 11,000,780, which is hereby incorporated by reference in its entirety) or a microfluidic card using capillary motion to thereby generate a stable sample prior to isolation, diagnostic testing, and/or molecular testing.
In various embodiments, the purge liquid may include any suitable fluid for transferring a sample disposed on the swab head (after sample collection) into the collection container. In various embodiments, the purge liquid may include water. In various embodiments, the purge liquid may include Viral Transport Media (VTM). In various embodiments, the purge liquid may include a buffered saline solution. In various embodiments, the purge liquid may be sterile. In various embodiments, the purge liquid may include DNase and/or RNase-free water or buffer for embodiments testing for nucleic acid. In various embodiments, the purge liquid may include sterile culture media. In various embodiments, the purge liquid may include bacterial transfer fluid for recovery of contaminating bacteria from a location. In various embodiments, the purge liquid may include one or more chemical indicator for embodiments where presence of an analyte can be qualitatively detected by addition of a single chemistry (i.e., similar to Clean-Trace from 3M). In various embodiments, the purge liquid may include a first reagent of a dual reagent test such as the Kastle-Meyer blood detection test where the phenolphthalein is loaded in the swab and the H2O2 is added by a dropper. In various embodiments, the swab may dispense two liquids such that each liquid is released in series. In various embodiments, the purge liquid may be substituted with a gas, e.g., air. In various embodiments, the purge liquid may include one or more mineral oils having, e.g., silicon or fully/partially fluorinated compositions.
In various embodiments, after the purge swab is inserted into the container 230, at least a portion of the elongated body 210 may be removed (e.g., broken off) to thereby allow the cap 235 to be affixed (e.g., screwed on) to the container 230.
In various embodiments, the container 135 may include a predetermined amount of liquid in the container before the purge swab 100 is inserted. In various embodiments, the container 135 may be provided without liquid (i.e., dry).
In various embodiments, the source of pressurized gas 160 may include pressurized air. In various embodiments, the source of pressurized gas 160 may include pressurized carbon dioxide. In various embodiments, the source of pressurized gas 160 may include any suitable pressurized gas that is configured to force the purge liquid through the lumen 115, into the swab head 120, out of the one or more aperture 122, and into the container 130.
While the disclosed subject matter is described herein in terms of certain preferred embodiments, those skilled in the art will recognize that various modifications and improvements may be made to the disclosed subject matter without departing from the scope thereof. Moreover, although individual features of one embodiment of the disclosed subject matter may be discussed herein or shown in the drawings of the one embodiment and not in other embodiments, it should be apparent that individual features of one embodiment may be combined with one or more features of another embodiment or features from a plurality of embodiments.
In addition to the specific embodiments claimed below, the disclosed subject matter is also directed to other embodiments having any other possible combination of the dependent features claimed below and those disclosed above. As such, the particular features presented in the dependent claims and disclosed above can be combined with each other in other manners within the scope of the disclosed subject matter such that the disclosed subject matter should be recognized as also specifically directed to other embodiments having any other possible combinations. Thus, the foregoing description of specific embodiments of the disclosed subject matter has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosed subject matter to those embodiments disclosed.
It will be apparent to those skilled in the art that various modifications and variations can be made in the method and system of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Thus, it is intended that the disclosed subject matter include modifications and variations that are within the scope of the appended claims and their equivalents.
This application claims the benefit of U.S. Provisional Patent Application No. 63/030,741, filed on May 27, 2020, which is hereby incorporated by reference in its entirety.
Number | Date | Country | |
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63030741 | May 2020 | US |