WO2020180535A1 - Joint de réceptacle à double fonction - Google Patents

Joint de réceptacle à double fonction Download PDF

Info

Publication number
WO2020180535A1
WO2020180535A1 PCT/US2020/019643 US2020019643W WO2020180535A1 WO 2020180535 A1 WO2020180535 A1 WO 2020180535A1 US 2020019643 W US2020019643 W US 2020019643W WO 2020180535 A1 WO2020180535 A1 WO 2020180535A1
Authority
WO
WIPO (PCT)
Prior art keywords
tamper
seal
receptacle
evident seal
dipstick
Prior art date
Application number
PCT/US2020/019643
Other languages
English (en)
Inventor
Ashley PETIX
John Patrick MURPHY
Original Assignee
Thomas Jefferson University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Thomas Jefferson University filed Critical Thomas Jefferson University
Publication of WO2020180535A1 publication Critical patent/WO2020180535A1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5029—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures using swabs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/141—Preventing contamination, tampering
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B01L2300/042—Caps; Plugs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/046—Function or devices integrated in the closure

Definitions

  • Test kits are sold for the detection of various substances.
  • One aspect of the invention provides a system including: a detachable cap; a dipstick coupled to the detachable cap; a tamper-evident seal tearably coupled to the detachable cap; and a receptacle comprising: a sidewall terminating in a proximal end releasably engaged with the tamper-evident seal; a distal chamber; and a seal isolating the distal chamber.
  • the detachable cap, the dipstick, the tamper-evident seal, and the receptacle are dimensioned such that: the dipstick is restrained by the tamper-evident seal from advancing distally and breaching the seal until the tamper-evident seal is removed from the detachable lid; and upon removal of the tamper-evident seal, the dipstick can be advanced distally to breach the seal.
  • the system can further include a reactant agent contained in the distal chamber.
  • the tamper-evident seal’s attachment to the detachable lid is indicative of an uncompromised status of the reactant agent.
  • the tamper- evident seal’s removal from the detachable lid is indicative of a potentially compromised status of the reactant agent.
  • the dipstick can further include an end.
  • the end can be dimensioned such that the dipstick is attachable to a test sample. Advancing the test sample into the reactant agent can result in a chemical reaction.
  • the system can further include a transparent window within the receptacle. An observer can view the chemical reaction via the transparent window. The transparent window can be adjacent to the distal chamber.
  • the detachable lid can be further dimensioned so that the detachable lid can be attached to the receptacle upon the tamper-evident seal being removed from the detachable lid.
  • the receptacle, the tamper-evident seal, and the detachable lid can include complementary mating features.
  • the complementary mating features can include ridges.
  • the ridges can be annular in shape.
  • Another aspect of the invention provides a method of performing a chemical analysis on a test sample using a system.
  • the method includes: obtaining the system described herein;
  • the method can further include: coupling a test sample to an end of the dipstick; and advancing the test sample through the seal and into the reactant agent upon removal of the tamper-evident seal.
  • the method can further include attaching the detachable lid directly to the receptacle subsequent to the tamper-evident seal being removed from the detachable lid.
  • kits including: the system as described herein; and a set of instructions for implementing a chemical analysis test within the system.
  • FIG. 1 depicts a dual-function receptacle seal and corresponding receptacle according to an embodiment of the invention.
  • FIG. 2 depicts a cross-sectional view of a dual-function receptacle seal and corresponding receptacle according to an embodiment of the invention.
  • FIG. 3 depicts several views of a dual-function receptacle seal according to an embodiment of the invention.
  • FIG. 4 depicts a process for a dual-function receptacle seal and corresponding receptacle according to an embodiment of the invention.
  • FIG. 5 depicts an exemplary workflow process for performing a chemical analysis on a test sample using a container, according to an embodiment of the invention.
  • FIGS. 6 through 12 depict various receptacle assemblies according to embodiments of the invention.
  • FIG. 13 depicts an immunoassay -based test according to an embodiment of the invention.
  • the term“about” is understood as within a range of normal tolerance in the art, for example within 2 standard deviations of the mean. “About” can be understood as within 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, 0.05%, or 0.01% of the stated value. Unless otherwise clear from context, all numerical values provided herein are modified by the term about.
  • Ranges provided herein are understood to be shorthand for all of the values within the range.
  • a range of 1 to 50 is understood to include any number, combination of numbers, or sub-range from the group consisting 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15,
  • the invention provides a dual-function seal and receptacle assembly. In other aspects, the invention provides for a method of performing a chemical analysis with a receptacle assembly. In other aspects, the invention provides for a kit including a receptacle assembly and a set of instructions. Receptacle Assembly
  • Test kits are used in order to determine whether a test sample includes a certain material or composition.
  • Test kits may become compromised in various ways outside of third-party interference. For example, a user may improperly use the test kit.
  • Conventional test kits may include several parts, some of which may need to be exposed to environs and different compositions at specific steps. If a user switches the order of the steps, or misses a step entirely, the test kit may return an inaccurate result.
  • Some test kits may also allow for different tests to be conducted, where each test may include its own specific steps and exposure to different compositions. This may further complicate the test procedure.
  • test kit Another example of improper use of a test kit involves the failure to properly perform a step of the test.
  • some conventional test kits include means for immersing a test sample into a chemical agent in order to identify whether the test sample is a specific composition.
  • a user may fail to completely immerse the test sample, or may not immerse the test sample for the required amount of time.
  • a compromised test kit or an improperly used test kit may return an inaccurate result. Some of these cases may be more serious than others. For example, if the test kit is utilized for identifying whether a test sample is fentanyl, receiving an inaccurate test result may prove fatal.
  • the receptacle assembly 100 can include a lid 105, a dipstick 110, a tamper-evident seal 115, a receptacle 120, a transparent window 125, a seal 130, and a reagent ampule 135.
  • the receptacle assembly 100 enables a testing kit that is easy to use, includes a tamper-evident seal indicative of whether the testing kit is compromised, and minimizes the risk of contamination from external environs. Further, the receptacle assembly 100 may be used for a variety of different purposes.
  • the receptacle assembly may be used for a variety of chemical testing, such as for pool testing kits, soil testing, glue mixtures (e.g., epoxy), or drug testing (e.g., fentanyl). While the below examples discussed may illustrate specific drug examples, it should be noted that the receptacle assembly 100 is not limited to those specific examples discussed below.
  • the assembly 100 can include a tamper-evident seal 115.
  • the tamper- evident seal 115 can form a ring or annulus.
  • the tamper-evident seal shape may be in such a shape so as to couple with the receptacle 120 and the lid 105.
  • the shape of the tamper-evident seal 115 may be dependent upon the shape of the lid 105 and/or the shape of the receptacle 120, or vice versa.
  • the tamper-evident seal 115 may attach the lid 105 to the receptacle 120.
  • the tamper- evident seal 115 may include dimensions to allow the tamper-evident seal 115 to attach directly to the receptacle 120.
  • the tamper-evident seal 115 may be threaded, allowing the tamper-evident seal 115 to be screwed onto the receptacle 120.
  • the tamper-evident seal 115 may include one or more hooks. Shown in FIG. 2, the open end of the receptacle 120 includes a hook 205.
  • the hook 205 may span the entire surface of the opening (e.g., the circumference) and thus be annular, or may alternatively may span only a portion of the surface, or there may be several hooks 205 that span the surface.
  • the tamper-evident seal 115 in FIG. 2 includes a lip 210. The lip 210 in some cases spans the entire surface of the tamper- evident seal 115 (e.g., the circumference of the tamper-evident seal 115) and is thus annular.
  • the lip 210 is pressed past the hook 205 of the receptacle 120, thereby allowing the tamper-evident seal 115 to be“snapped” to the receptacle opening and securely fastening the tamper-evident seal 115 to the receptacle 120.
  • the tamper-evident seal 115 can be attached to the receptacle 120 such that the tamper-evident seal 115 may not be removed from the receptacle without first detaching the tamper-evident seal 115 from the lid 105 (e.g., a divide between the tamper-evident seal 115 and the receptacle 120 is tearable, perforated, and the like).
  • the tamper-evident seal 115, the receptacle 120, or both may be engineered such that once removed, the tamper-evident seal 115 may be unable to be easily reattached to the receptacle 120.
  • the tamper-evident seal 120 may be tearably attached to the lid 105.
  • the lid 105 and the tamper-evident seal 115 may be composed of the same material (e.g.,
  • a divide between the lid 105 and the tamper- evident seal 115 may be a perforated or thinned portion. If enough force (e.g., torque) is applied to the tamper-evident seal 115, the perforated portion may break completely, allowing the lid 105 to be detached from the tamper-evident seal 115. Further, the tamper-evident seal 115 may include a portion to allow for ease of removal. For example, the tamper-evident seal 300 illustrated in FIG.
  • the tamper-evident seal 300 which may be an example of the tamper-evident seal 115, provides for a pull tab 305 attached to the ring portion 310 of the tamper-evident seal 300.
  • the pull tab 305 may allow for a user to grip the pull tab 305 and pull the tamper-evident seal 300, rather than grip the ring portion 310 itself.
  • the tamper-evident seal 300 may include ridges across the exterior of the tamper-evident seal 300, so as to allow for a better grip by a user.
  • the tamper-evident seal 115 may alter the locations of the lid 105 and the dipstick 110 with respect to the other components of the assembly 100, based on whether the tamper-evident seal 115 is attached or detached from the lid 105. For example, when the tamper-evident seal 115 is attached to the lid 105, the tamper-evident seal 115 may connect the lid 105 to the
  • the dipstick 110 may be dimensioned such that when the tamper-evident seal 115 is attached to the lid 105, the distal end of the dipstick 110 rests above the seal 125 and the reagent ampule 130 of the assembly 100 (e.g., the dipstick 110 does not penetrate the seal 125). Further, when the tamper-evident seal is detached from the lid 105, the lid 105 may be attached directly to the receptacle without sitting above the tamper-evident seal 115. Thus, the dipstick 110 may rest lower within the cavity of the receptacle 120 as compared to with the tamper-evident seal 115 attached. The dipstick 110 may be dimensioned such that, with the tamper-evident seal 115 detached, the distal end of the dipstick may penetrate the seal 125 and enter the reagent ampule 130.
  • the assembly 100 may include the receptacle 120, which may house various other components of the assembly 100.
  • the receptacle 120 may house a reagent ampule 135.
  • the dipstick 110 resides within the cavity of the receptacle 120.
  • the receptacle 120 may include additional features to shape the cavity.
  • the receptacle 120 may include a tapered inner wall. The tapered inner wall may narrow from the receptacle opening to bottom of the receptacle (e.g., where the reagent ampule 135 resides). This tapering of the receptacle 120 may act as a guide for the dipstick 110, such that if the
  • the tapered inner wall may direct the dipstick 110 further downward into the cavity. This may mitigate any issues with the dipstick failing to enter the reagent ampule 135, and thereby further mitigating the possibility of user error in using the assembly 100.
  • the reagent ampule 135 may house or store a reagent for use in identifying a test sample.
  • Reagents that the reagent ampule 135 may house include, but are not limited to, cobalt(II) thiocyanate, colbalt(II) acetate, glacial acetic acid, methanol, p-Dimethylaminocinnamaldehyde (DMACA), acetaldehyde, vanillin, ethanol, hydrochloric acid, chloroform, p- dimethylaminobenzaldehyde (DMAB), molybdic acid, sulfuric acid, ammonium molybdate, gallic acid, gold(III) bromide, potassium nitrite, ammonium metavanadate, formaldehyde, mercuric chloride, potassium iodide, selenous acid, potassium tetraiodomercurate(II), nitric acid, acetaldehyde, acetone,
  • a seal 130 may enclose the reagent ampule 135 from external environs, including other items located in the receptacle 120.
  • the seal 130 may be a duckbill valve (e.g., a Kalrez duckbill valve, a joker valve).
  • the seal 130 may include a thinned portion (e.g., a metal or plastic foil, which can be perforated), which may include a weaker integrity from the rest of the seal 130, allowing an object to puncture the seal 130 with minimal force.
  • the seal may be composed of rubber, synthetic elastomer, or a similar composition. Detachable Lid
  • a lid 105 may enclose the receptacle 120 and prevent contaminants from coming in contact with other portions of the assembly 100 enclosed in the receptacle, as well as preventing the other components of the assembly 100 from accidentally being removed/falling out. When detached, the lid 105 may act as a handle for the dipstick 110, allowing for easier use by a user in attaching a test sample and conducting a chemical analysis of the test sample.
  • the lid 105 may include dimensions to allow the lid to attach directly to the receptacle 120.
  • the lid 105 may be threaded, allowing the lid 105 to be screwed onto the receptacle 120.
  • the lid 105 and/or an end of the receptacle 120 may include one or more hooks for a snap fit.
  • the open end of the receptacle 120 and the lid 105 include a hook 205.
  • the lid 105 in FIG. 2 includes a lip 215. The lip 215 in some cases spans the entire surface of the lid 105 (e.g., the circumference of the lid 105) and is thus annular.
  • any other fastening means for securely attaching a lid to a container may be used (e.g, a press fit, a friction fit, an interference fit, and the like).
  • the lid 105 may be coupled to the dipstick 110.
  • the dipstick 110 may be distal in shape, for example, an elongated rectangle, an elongated orthotope, a pipe, a cylinder, a pipette, a strip, and the like.
  • the distal end of the dipstick 110 may allow for a test sample to be attached to the dipstick 110 (e.g, through surface tension, absorption, capillary action, adhesion, and the like).
  • the distal end may form a swab, a pipette, a straw, a pin, a hook, a claw, a strip, a porous portion, or a similar structure or shape.
  • the dipstick 110 may be dimensioned such that the location of the distal end of the dipstick 110 within the receptacle cavity is dependent upon whether the tamper-evident seal is attached to, or detached from, the assembly 100.
  • the dipstick 100 may have a length such that the distal end of the dipstick 110 is located above the reagent ampule 135, thereby leaving the seal 130 intact.
  • the length of the dipstick 110 may allow for the distal end of the dipstick 110 to enter the reagent ampule 135 by penetrating the seal 130.
  • the penetration of the seal 130 and exposure of the composition contained within the reagent ampule 135 is dependent upon whether the tamper- evident seal 115 has been removed from the assembly 100.
  • the assembly 100 may also include a viewing window 125.
  • the observer window 125 may be transparent and may be coupled to the receptacle 120.
  • the observer window 125 may be adjacent to the reagent ampule 135, which may allow a user of the assembly 100 to view the contents of the reagent ampule 135 without having to open the assembly 100.
  • the observer window 125 may allow a user to observe a chemical reaction (e.g ., by appearance of a color depending on the result) occurring if a test sample reacts positively to the reagent composition contained within the reagent 135. This may assist in minimizing exposing the assembly 100 to external contaminants and/or improper use of the assembly 100.
  • the invention provided herein can be fabricated from a variety of materials such as plastic, rubber, metal, and the like by use of various manufacturing techniques such as molding, casting, machining, and the like.
  • components can be formed from polymeric materials such as polypropylene (PP), polyethylene terephthalate (PET), polycarbonate (PC), copolyesters (e.g., PTCG and
  • copolyesters available under the TRITANTM mark from Eastman Chemical Company of Kingsport, Tenn.
  • PPC polyphthalate carbonate
  • FIG. 5 illustrates an exemplary process 500 for performing a chemical analysis on a test sample.
  • the exemplary process 500 may be implemented in conjunction with a container, such as assembly 100 as described with reference to FIG. 1. Additionally, FIG. 4 may provide an illustrated workflow process 400 for the assembly 100.
  • a container such as assembly 100
  • a tamper- evident seal of the container may be removed from a detachable cap of the container.
  • the detachable cap may be detached from a receptacle of the container.
  • the detachable lid may be attached directly to the receptacle subsequent to the tamper-evident seal being removed from the detachable lid.
  • a dipstick of the container may be advanced distally to breach a seal of the container and enter a distal chamber of the container.
  • a test sample may be coupled to the dipstick prior to advancing the dipstick distally.
  • fentanyl in opioids such as heroin
  • embodiments of the invention can be combined with other reagents to detect a variety of substances. Exemplary reagents and detectable substances are summarized below.
  • Embodiments of the invention can also be used in combination with other reagents that do not detect substances.
  • embodiments of the invention can be utilized to perform organic chemistry reactions (e.g ., in a laboratory).
  • FIG. 13 depicts a fentanyl testing kit.
  • the fentanyl testing kit there is a pre-wetted (e.g., at manufacture) swab on a rigid backer stick that is attached to the lid and can be wiped across a surface or through a sample.
  • a pre-wetted (e.g., at manufacture) swab on a rigid backer stick that is attached to the lid and can be wiped across a surface or through a sample.
  • immunoassay paper mounted on the rigid backer just above the pre-wetted swab (after a dry separation area so the immunoassay paper is not wetted ahead of testing).
  • the rigid backer stick Upon obtaining a sample on the swab, the rigid backer stick is pressed into the body of the kit and into the buffer solution (contained in the ampule) upon which the buffer solution is wicked up into the immunoassay paper (the level of the buffer liquid is such that it is higher than the dry separation area at this time).

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Closures For Containers (AREA)

Abstract

Un aspect de l'invention concerne un système comprenant : un capuchon détachable ; une jauge couplée au capuchon détachable ; un joint inviolable couplé de manière déchirable au capuchon détachable ; et un réceptacle comprenant : une paroi latérale se terminant par une extrémité proximale en prise amovible avec le joint inviolable ; une chambre distale ; et un joint isolant la chambre distale. Le capuchon détachable, la jauge, le joint inviolable et le réceptacle sont dimensionnés de telle sorte que : la jauge est empêchée, par le joint inviolable, d'avancer de manière distale et de rompre le joint jusqu'à ce que le joint inviolable soit retiré du capuchon détachable ; et, lors du retrait du joint inviolable, la jauge peut être avancée de manière distale pour rompre le joint.
PCT/US2020/019643 2019-03-05 2020-02-25 Joint de réceptacle à double fonction WO2020180535A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962814034P 2019-03-05 2019-03-05
US62/814,034 2019-03-05

Publications (1)

Publication Number Publication Date
WO2020180535A1 true WO2020180535A1 (fr) 2020-09-10

Family

ID=72337274

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2020/019643 WO2020180535A1 (fr) 2019-03-05 2020-02-25 Joint de réceptacle à double fonction

Country Status (1)

Country Link
WO (1) WO2020180535A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114200135A (zh) * 2021-12-01 2022-03-18 深圳市核子基因科技有限公司 一种病毒检测试剂盒

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3913564A (en) * 1974-04-24 1975-10-21 Richard C Freshley Anaerobic specimen collecting and transporting device
US4150950A (en) * 1977-09-28 1979-04-24 Corning Glass Works Transport system for clinical specimens
US4223093A (en) * 1978-08-25 1980-09-16 Precision Dynamics Corporation Culture collection and transport device
US4409988A (en) * 1973-05-08 1983-10-18 Donald J. Greenspan Apparatus for collecting cultures
WO1995025948A1 (fr) * 1994-03-22 1995-09-28 Celsis International Plc Dispositif d'examen et de prelevement d'un echantillon
US20140051178A1 (en) * 2012-08-20 2014-02-20 Berlin Packaging, Llc Specimen test unit
US20170320060A1 (en) * 2013-03-11 2017-11-09 Eurotrol B.V. Assembly for storing and mixing two substances
US20180185840A1 (en) * 2017-01-03 2018-07-05 Illumina, Inc. Sample tube with integrated mixing plunger head

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4409988A (en) * 1973-05-08 1983-10-18 Donald J. Greenspan Apparatus for collecting cultures
US3913564A (en) * 1974-04-24 1975-10-21 Richard C Freshley Anaerobic specimen collecting and transporting device
US4150950A (en) * 1977-09-28 1979-04-24 Corning Glass Works Transport system for clinical specimens
US4223093A (en) * 1978-08-25 1980-09-16 Precision Dynamics Corporation Culture collection and transport device
WO1995025948A1 (fr) * 1994-03-22 1995-09-28 Celsis International Plc Dispositif d'examen et de prelevement d'un echantillon
US20140051178A1 (en) * 2012-08-20 2014-02-20 Berlin Packaging, Llc Specimen test unit
US20170320060A1 (en) * 2013-03-11 2017-11-09 Eurotrol B.V. Assembly for storing and mixing two substances
US20180185840A1 (en) * 2017-01-03 2018-07-05 Illumina, Inc. Sample tube with integrated mixing plunger head

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114200135A (zh) * 2021-12-01 2022-03-18 深圳市核子基因科技有限公司 一种病毒检测试剂盒

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