WO2013141834A1 - Systèmes de prélèvement d'échantillon de salive - Google Patents

Systèmes de prélèvement d'échantillon de salive Download PDF

Info

Publication number
WO2013141834A1
WO2013141834A1 PCT/US2012/029584 US2012029584W WO2013141834A1 WO 2013141834 A1 WO2013141834 A1 WO 2013141834A1 US 2012029584 W US2012029584 W US 2012029584W WO 2013141834 A1 WO2013141834 A1 WO 2013141834A1
Authority
WO
WIPO (PCT)
Prior art keywords
receiving vessel
collection
conveyance apparatus
reservoir
sealing cap
Prior art date
Application number
PCT/US2012/029584
Other languages
English (en)
Inventor
James Plante
David Becker
Kathryn ELLIOTT
Edgar Macbean
Original Assignee
Pathway Genomics
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 Pathway Genomics filed Critical Pathway Genomics
Priority to PCT/US2012/029584 priority Critical patent/WO2013141834A1/fr
Priority to RU2012124156/15A priority patent/RU2012124156A/ru
Publication of WO2013141834A1 publication Critical patent/WO2013141834A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0096—Casings for storing test samples

Definitions

  • the following invention disclosure is generally concerned with kits and systems for collection of biological matter and more specifically concerned with saliva collection, storage and transmission systems configured for non-expert use.
  • Container arts and engineering presentl enjoys an advanced state whereby container design and function is configured for particular purpose.
  • orange juice container made from cardboard may have incorporated features therein specifically designed for the acidic nature of orange juice which is quite different from attributes of similar cardboard containers designed for milk for example.
  • particulars relating to shelf life, exposure to UV damage, pulp content, in example affects design of a high-performance container system having a specific application.
  • Containers designed for nonfood applications also are highly advanced with many incorporated features designed to cooperate with the nature of the service for whic it is designed. This is particularly true for containers designed to collect biological material and even more particularly when those containers are to be used without assistance from experts— i .e. for use by untrained consumers in a setting where professionals may not be present. Further such containers must sometimes support special features for long-term storage, durability., sate handling, transmission via postal and delivery sendees, among others. In some special cases, it is desirable to provide a container suitable for safe transmission of biological matter via the mails and private delivery services.
  • packages may be arranged with a view towards use with private delivery systems and services such as those provided by Federal Express company, in this regard, a package system must be provided to protect against shock, temperature changes, duration, et cetera - those attributes associated with the normal procedures used by deli very service companies. It Is further desirable that containers are designed for ease of use by non experts without need for special training— and without comple instructions and procedures.
  • containers for collection of biological samples are to be used by a donor without assistance of experts or medical professi onal .
  • the container In home collection systems, the container must be highl functional without complex instructions and further it must be devoid of failure mechanisms which fend to render collection of a sample defective.
  • containers which effectively capture a sample with a minimal amount of steps and a minimal number of parts is a great benefit with respect to system success,
  • D'Angelo teaches in U.S. Patent 7,387,999 dated June 17, 2008 a saliva sample collection system.
  • A. sponge portion is used to swap saliva and saliva is thereafter extracted from the sponge by squeezing or centrifuge.
  • a container with specific design directed to a 'transportable container' for a medical specimen ⁇ takes the design of a 'Coplin' j r.
  • "A lid hmgedly coupled to the top of the jar” accommodates both 'open' and 'closed' positions. Included in these systems is a tray which receives the container in a "sideways fashion". However, this tray does not. support a dual-mode accommodation for the jar.
  • Minnesota inventors Lenmark Sr. and Koentopp teach a specialized kit particularly suited for shipping transport.
  • the container provides for a foam member with prescribed cut-outs to receive sample containing vials therein. While these cut-outs are not designed in support of any dual-mode shipping objectives, they do indeed accompany a plurality of elements in an application specific shipping box.
  • a first important shortcoming of the Genotech system is that it is comprised of four discrete parts which must repeatedly be coupled and decoupled in a series of complex steps which must be executed in a particular order. While the kit includes a detailed instruction booklet in six languages with a series of grayscale photo-like diagrams, the steps illustrated are difficult to execute without error for some users.
  • a recei ving vessel is coupled by way of a thread set to a funnel element.
  • the funnel h provided so that a user can easily spit into the device and the received saliva will be conveyed into the small aperture of the receiving vessel.
  • the funnel After a sufficient quantity of saliva is received into the vessel, the funnel must be decoupled from the receiving vessel by twisting the funnel about: an axis in a rotational direction opposite to that of which the vessel is twisted.
  • this must be done only after a special DNA preserving and stabilizing fluid is introduced to the receiving vessel.
  • another thread set system is coupled to the funnel at an opposing end. That is, at the large end of the funnel, a specifically prepared container of fluid is screwed onto the funnel at its top.
  • a membrane is pierced and fluid released into the funnel through which it passes and finally received into the receiving vessel to mix with the saliva. Then, the funnel may be finally decoupled from the receiving vessel Thereafter, a stopper cap with a thread set identical to that of the funnel's narrow end is screwed onto the vessel aperture end to form a seal thereby trapping and containing both collected saliva and stabilization fluid therein.
  • the funnel and large cap / container are left as waste material.
  • the reservoir contains residue chemicals which tend to cause anxiety in some persons. While it is not necessary to discard these pieces as medical waste, these leftover parts tend to at least hav the appearance of medical waste and thus give rise to worry and a need for special and sometimes expensive treatment. It is surely preferable to devise a system with no leftover par is to be discarder as medical waste. Because the funnel needs to be coupl ed to and decoupled from the receiving vessel, it is formed with integrated finger grips which are easily engaged and economically cooperative with human finger tips.
  • An apparatus for saliva sample collection, temporary storage and conveyance via delivery services is formed of two primary elements - each of these two elements having a plurality of features integrated therewith. Preferably formed of plastic in molding processes, these two elements cooperate together to provide 'coupled 1 and 'decoupled' states.
  • a receiving vessel and sealing cap which couple together in best versions via mechanical interlock, in example a thread set type coupling, form a liquid tight
  • containment cavity suitable for long-term and durable storage of a D A in a saliva sample.
  • a receiving vessel may be provided include an integrated fimml portion which allows ergonomic cooperation with the human mouth with regard to spitting and efficiently receives saliva from a donor as the donor spits into a large aperture of the funnel at its top end.
  • the funnel terminates at a narrow, generally cylindrical tubular portion suitable for containing liquids received therein.
  • a receiving vessel additionally has integrated therewit an outer body portion which forms a rigid standing means upon which the system may rest upright on flat surfaces. This outer body portion may support additional structure such as a viewing window and indicia.
  • a receiving vessel may also include an integrated knife element.
  • a sealing cap has integrated therewith a seal mechanism, piercable liquid reservoir, grip surface, label receiving surface, among others.
  • the action of forming a seal therewith additionally causes breach to the integrity of the liquid reservoir such that the reservoir contents are released into and mix with matter already in the receiving vessel while at the same time forming a seal between the receiving vessel and the sealing cap such that no liquid can escape containment
  • An auxiliary element of these systems is also included in some versions.
  • An application-specific shipping container provides two operational modes for shipping and delivery of these devices. That is, the shipping container supports containment of a receiving vessel and sealing cap held separate from each other in a 'decoupled' state, and additionally provides for containment, of a receiving vessel and sealing cap in a 'coupled' state. In a shipping mode characterized as a 'decoupled * state, the device is shipped to a user/customer. In a shipping mode characterized as a 'coupled' state the system is returned shipped to a laboratory for analysts.
  • this invention additionally
  • Figure I is a cross-section view of a first version of one sali va sample collection system
  • Figures 2 and 3 illustrate a cap being coupled to a receiving vessel via a thread set to cause a reservoir membrane to be punctured releasing fluid into the receiving vessel;
  • Figure 4 presents one version of a dual-mode shipping containe system.
  • FIG. 1 illustrates in cross-sectional view of two primary elements in a spatially proximate relationship on a symmetry axis.
  • a receiving vessel 1 is a
  • the receiving vessel element includes an integrated funnel portion 3 with an entrance aperture 4 and elongated cylindrical tubular portion 5 which lies coaxially with respect to a second cylindrical structure a rigid body 6 including terminus surface 7.. for example an annul us, lying in a plane forming a 'foot' or 'base'.
  • a thread set system 8 is formed as a part of a coupling .means between the receiving vessel element and the cap element.
  • This coupling may further include a well-designed seating surface 9 to cooperate with an annular flange 10
  • a liquid tight reservoir 12 contains therein a special formula which operable to stabilize and preserve a biological sample such as saliva.
  • the reservoir is comprised in part of one surface which may be pierced or otherwise
  • the cap element may additionally include a knurled outer surface 14 and label recei ving surface 15.
  • the knurled outer surface promotes ease-of-use by permitting good ergonomtc cooperation with the human fingers whereby the cap may be tightly coupled to the receiving vessel despite some resisting pressure due in-part to friction between the thin film membrane and knife and further the annular flange and its seat.
  • the label receiving surface is adopted to accept by way of adhesives a label so that these containers might more easily be marked with identifying information. It is generally convenient, o associate the contents of a used contai ner with a particular donor and sometimes this is done by way of a label affixed to the cap which does not easily separate therefrom and remains quite accessible for every person in the processing chain.
  • the receiving vessel element may additionally have integrated therewith indicia 16 in support to promote ease-of-use.
  • a "fill-line” mark can be included on the tubular cylindrical portion of the receiving vessel or other outside surface of the body. Other indicia may be also provided to similarly promote proper use.
  • a slot may be provided in the body to effect a viewing window 1 7 by which a user may vie more easily the tubular portion which contains sample matter (saliva) being collected. More precisely, to view a ridge 18 formed into the tubular portion which operates as a fill-line or fill-limit.
  • Figures 2 and 3 further illustrate important aspects of these systems including the coupling between a sealing cap 21 and receiving vessel 22.
  • a cap By way of counter-rotation (indicators 23) about a common axis, a cap is screwed on to a receiving vessel to couple therewith. As the cap is turned, the thread set causes the cap to advance towards (indicated by 24) the receiving vessel along the axi As the reservoir 25 containing preserving fluid therein advances to the knife 26 and comes into contact therewith, the thin-film 27 is pierced 3 1 to release the fluid 32 whereb it passes into the receiving vessel to mix with collected saliva 33.
  • the cap is further advanced such that a liquid-tight seal is formed between the annular flange of the sealing cap 34 and an inside surface 35 of the receiving vessel which forms a. cooperating seat. A pressure between these two elements assures liquid is securely contained within the receiving vessel for a durable and long-term storage.
  • a outer tube fashioned as a rigid body is shaped with a base for 'foot * portion to assure the vessel is held upright when resting on a table. While the base ma include an opening at its bottom, at least an annular ring which lies substanti ally in a plane provides a resting surface for these devices.
  • Some versions may include a flared Sip on the body to increase the surface area of the annulus for improved stability.
  • the rigid body is sometimes transparent or translucent for an attractive 'clean' feel and may be formed of molded plastic.
  • its outside surface may be scored or scuffed to provide for an improved grip and handling.
  • it is sometimes desirable for these apparatus to prepare the outside surface of the body has a. 'gripping' surface economically suitable for being handl ed easi S y by human fl ngertips.
  • a reservoir is preferably integrated within an interior cavity portion, of the cap element.
  • the reservoir may be formed integrally with the cap in a plastic molding step. It is preferably cylindrical in shape and approximately 1 cm deep.
  • the reservoir may be filled with a preserving fluid by automated machinery, and thereafter the reservoir may be sealed to contain and protect the fluid until it is required for use, in anticipated systems, a reservoir may contain a specially prepared bonding surface to which a thin- fi!m or foil ma be affixed for example by adhesive* or plastic weld.
  • a thin-film or toil is used to complete the reservoi cell .
  • a cap element when a cap element is coupled to the receiving vessel element, it is desirable to automatically have the fluid mixed with the saliva. Accordingly, without taking any extra steps, measuring, pouring, calculation, et cetera, an unskilled user preserves the saliva sample merely by screwing the cap io the receiving vessel together.
  • the in a preserving fluid contained in the reservoir is colored with a dye agent. This yields a mechanism by which a user can easily determine that the foil seal was appropriately compromised and that the fluid previously contained in the reservoir has been released therefrom and has further mixed with the saliva sample. In systems where a. dye is not used, it has been observed that failure due to malfunction of the foil piercing system went undetected in the sample subsequently was spoiled.
  • a bo 41 may have insetted therein a. foam core element 42.
  • the shipping container including this foam core element by way of cut-out cavities therein supports /wo discrete shipping modes.
  • a first cutout cavity 43 is provided to accommodate the cap 44 containing the reservoir therein.
  • a second cut-out cavity 45 is provided to accommodate the receiving vessel 46.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Pathology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Hematology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

Selon l'invention, des systèmes de prélèvement d'échantillon de salive sont conçus dans le souci de porter une attention particulière à la facilité d'utilisation pour l'usager non qualifié et à la sécurité de transport et de livraison par un service de livraison classique comme Federal Express. Une cavité étanche est formée par couplage serré de deux éléments principaux: un élément récipient de réception et un élément capuchon hermétique. Le récipient de réception intègre, entre autres, un moyen fixe, une ouverture de tuyau de remplissage, un système d'entonnoir, un couteau, un filetage et un tube de confinement. Un élément capuchon complémentaire comprend un filetage coopérant, une surface de réception d'étiquette, une surface de préhension, des moyens d'étanchéité et un réservoir avec membrane à couche mince perforable. Ces deux éléments principaux peuvent être logés dans un récipient d'expédition spécialisé apprêté pour deux modes d'expédition pour assurer une expédition sécurisée du système depuis ou vers un donneur, chaque fois dans un mode d'expédition différent.
PCT/US2012/029584 2012-03-18 2012-03-18 Systèmes de prélèvement d'échantillon de salive WO2013141834A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/US2012/029584 WO2013141834A1 (fr) 2012-03-18 2012-03-18 Systèmes de prélèvement d'échantillon de salive
RU2012124156/15A RU2012124156A (ru) 2012-03-18 2012-03-18 Система для отбора образца слюны

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2012/029584 WO2013141834A1 (fr) 2012-03-18 2012-03-18 Systèmes de prélèvement d'échantillon de salive

Publications (1)

Publication Number Publication Date
WO2013141834A1 true WO2013141834A1 (fr) 2013-09-26

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2012/029584 WO2013141834A1 (fr) 2012-03-18 2012-03-18 Systèmes de prélèvement d'échantillon de salive

Country Status (2)

Country Link
RU (1) RU2012124156A (fr)
WO (1) WO2013141834A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016079611A1 (fr) * 2014-11-17 2016-05-26 Traces S.R.L. Récipient de collecte et de conservation d'échantillons de biopsie
CN106644602A (zh) * 2017-01-18 2017-05-10 广州新诚生物科技有限公司 集成式唾液采集器
RU177743U1 (ru) * 2017-06-16 2018-03-07 Федеральное государственное бюджетное образовательное учреждение высшего образования "Самарский государственный медицинский университет" Министерства здравоохранения Российской Федерации Контейнер для хранения биоматериала
FR3121828A1 (fr) 2021-04-14 2022-10-21 Heatlh Care Product Conception Réceptacle salivaire ergonomique

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020004019A1 (en) * 2000-07-06 2002-01-10 Bachand Steven S. Saliva testing and confirmation device
US20080020477A1 (en) * 2004-09-10 2008-01-24 Pronovost Allan D Salivary Glucose Monitoring
US20090209044A1 (en) * 2008-02-13 2009-08-20 Capitol Vial Inc. Fluid Sample Collection System and Method
US20100274155A1 (en) * 2007-07-31 2010-10-28 Micronics, Inc. Sanitary swab collection system, microfluidic assay device, and methods for diagnostic assays

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020004019A1 (en) * 2000-07-06 2002-01-10 Bachand Steven S. Saliva testing and confirmation device
US20080020477A1 (en) * 2004-09-10 2008-01-24 Pronovost Allan D Salivary Glucose Monitoring
US20100274155A1 (en) * 2007-07-31 2010-10-28 Micronics, Inc. Sanitary swab collection system, microfluidic assay device, and methods for diagnostic assays
US20090209044A1 (en) * 2008-02-13 2009-08-20 Capitol Vial Inc. Fluid Sample Collection System and Method

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016079611A1 (fr) * 2014-11-17 2016-05-26 Traces S.R.L. Récipient de collecte et de conservation d'échantillons de biopsie
CN107106146A (zh) * 2014-11-17 2017-08-29 踪迹责任有限公司 用于收集和保存活组织检查样本的容器
CN107106146B (zh) * 2014-11-17 2019-11-08 踪迹责任有限公司 用于收集和保存活组织检查样本的容器
CN106644602A (zh) * 2017-01-18 2017-05-10 广州新诚生物科技有限公司 集成式唾液采集器
RU177743U1 (ru) * 2017-06-16 2018-03-07 Федеральное государственное бюджетное образовательное учреждение высшего образования "Самарский государственный медицинский университет" Министерства здравоохранения Российской Федерации Контейнер для хранения биоматериала
FR3121828A1 (fr) 2021-04-14 2022-10-21 Heatlh Care Product Conception Réceptacle salivaire ergonomique

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