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WO2025207813A1 - Dosage de collecte de biofluide et kits et procédés associés - Google Patents

Dosage de collecte de biofluide et kits et procédés associés

Info

Publication number
WO2025207813A1
WO2025207813A1 PCT/US2025/021615 US2025021615W WO2025207813A1 WO 2025207813 A1 WO2025207813 A1 WO 2025207813A1 US 2025021615 W US2025021615 W US 2025021615W WO 2025207813 A1 WO2025207813 A1 WO 2025207813A1
Authority
WO
WIPO (PCT)
Prior art keywords
insert
aperture
collection tube
kit
fluidic channel
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/US2025/021615
Other languages
English (en)
Inventor
Amanda Haack
Ashleigh Brooks Theberge
Erwin Stefan Peter Berthier
Filip Stefanovic
Madeleine EAKMAN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
University of Washington
Original Assignee
University of Washington
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 University of Washington filed Critical University of Washington
Publication of WO2025207813A1 publication Critical patent/WO2025207813A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0096—Casings for storing test samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • 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

Definitions

  • RNA expression analyses using RNA are established methods of monitoring health and disease over time, allowing for immunological studies of diseases including Covid- 19 and cancers. Blood is commonly used for such studies, because it circulates through the entire body and contains immune cells including lymphocytes that are part of the lymphatic system.
  • blood collection has also historically presented challenges for participation in transcriptomics studies because venous blood draws have to be performed by a trained phlebotomist in a clinic, leading to barriers caused by scheduling, aversion to needles, or proximity to a clinic. Shifting sample collection from a clinic to a participant’s home therefore addresses previous barriers to participation in transcriptomics studies.
  • the present disclosure provides inserts for a specimen collection tube and kits for collecting and metering biofluids.
  • the side of the fluidic channel separator is a first side
  • the insert further comprises a flange extending from the fluidic channel separator on a second side opposite to the first side.
  • the kit further comprises a reagent disposed in the second compartment.
  • the reagent comprises an RNA stabilization reagent.
  • the aperture is sized and shaped to allow a Pasteur pipette to pass through the aperture to the second compartment.
  • FIGURE 1 A is a perspective view of an insert according to embodiments of the present disclosure.
  • FIGURE IB is another perspective view of the insert of FIGURE 1 A, according to embodiments of the present disclosure.
  • FIGURE 1C is side view of the insert of FIGURE 1A, according to embodiments of the present disclosure.
  • FIGURE 2E is a top-down plan view of the insert of FIGURE 2A, according to embodiments of the present disclosure.
  • FIGURE 2F is a bottom-up plan view of the insert of FIGURE 2A, according to embodiments of the present disclosure.
  • FIGURE 3 is a side view of a kit according to an embodiment of the present disclosure.
  • FIGURE 4A schematically illustrates a method of using a kit according to an embodiment of the present disclosure.
  • FIGURE 4B is an image of a kit according to an embodiment of the present disclosure containing a biofluid and a reagent.
  • FIGURE 4C is an illustration of the kit of FIGURE 4B according to an embodiment of the present disclosure.
  • FIGURE 4D is an image of the kit of FIGURE 4B after mixing the biofluid and the reagent, according to embodiments of the present disclosure.
  • FIGURE 4E is an illustration of the kit of FIGURE 4D according to embodiments of the present disclosure.
  • the present disclosure provides an insert for a specimen collection tube.
  • the insert comprises a fluidic channel separator defining an aperture, wherein the aperture is configured to limit flow of a fluid therethrough by hydrostatic forces between the fluid and the aperture; and a plurality of legs extending outwardly from a side of the fluidic channel separator.
  • the insert 100 is for use with a specimen collection tube, such as to meter a volume of a biofluid for collection or other use in the specimen collection tube.
  • the insert 100 is shaped and sized to fit within a specimen collection tube, such as is discussed further herein with respect to FIGURE 3.
  • the insert 100 is configured to meter a volume of a biofluid and separate the biofluid from a reagent disposed in another chamber of the specimen collection tube, such as until agitation by a user.
  • the insert 100 is shown to comprise a fluidic channel separator 106 defining an aperture 108; and a plurality of legs 110 extending outwardly from a side 118 of the fluidic channel separator 106.
  • the aperture 108 is configured to limit flow of a fluid therethrough by hydrostatic forces between the biofluid and the aperture 108.
  • the aperture 108 is sized, shaped, and otherwise configured to limit and, in embodiments, prevent flow of the biofluid through the aperture 108 in the absence of agitation of the insert 100, such as by shaking.
  • the insert 100 when disposed in a specimen collection tube, is configured to meter a volume of biofluid collected in the specimen collection tube as no additional biofluid will fit in the specimen collection tube, such as without overflowing from the specimen collection tube.
  • hydrostatic forces are generated, at least in part, due to differences in hydrophobicity between an insert 100 material and the biofluid.
  • the insert 100 comprises a material that is at least partially hydrophilic.
  • the insert 100 comprises a material that is at least partially hydrophobic.
  • the insert 100 comprises a material selected from the group consisting of a polycarbonate, a polystyrene, a polypropylene, or any combination thereof. In an embodiment, the insert 100 comprises a polypropylene.
  • a material of the insert 100 can contribute other beneficial characteristics of the insert 100.
  • the material of the insert 100 is flexible or otherwise deformable such that a portion of the insert 100 can conform to an inner surface of a specimen collection tube, such as to form a seal between the insert 100 and the specimen collection tube.
  • a flexible material such as a polypropylene, is beneficial for biofluid collection and metering when used in conjunction with a specimen collection tube into which the insert 100 is disposed and in contact therewith.
  • such a circular outer circumference 126 is shaped and sized to form a seal between an interior portion, such as an interior wall, of a specimen collection tube into which the insert 100 is disposed.
  • the diameter 120 of the insert 100 is sized and shaped to match a diameter of at least a portion of an interior wall or other portion of the specimen collection tube, thereby forming a seal between the insert 100 and the specimen collection tube and the insert 100.
  • a reagent also disposed in the interior portion of the specimen collection tube does not leak from the specimen collection tube as flow is limited by the seal and the aperture 108.
  • the diameter 120 and outer circumference 126 are sized and shaped to fit into an interior portion of a standard biofluid collection tube, such as a BD microtainer®.
  • the diameter 120 is about 8 mm.
  • a diameter 121 of legs 110 of the plurality of legs 110 defines a draft, such as a draft of at least about 1 degree, about 2 degrees, or more, narrowing in a direction away from the fluidic channel separator 106.
  • the diameter of legs 110 of the plurality defines a draft, such as a draft in a range of about 1 degree to about 10 degrees. Such a draft can allow for injection molding of the insert 100 where the insert 100 can be removed from a mold used to injection mold the insert 100.
  • FIGURE 2A is a perspective view of the insert 200.
  • FIGURE 2B is another perspective view of the insert 200.
  • FIGURE 2C is a side view of the insert 200.
  • FIGURE 2D is a cross-sectional view of the insert 200.
  • FIGURE 2E is a top-down plan view of the insert 200.
  • FIGURE 2F is a bottom-up plan view of the insert 200.
  • the insert 200 is for use with a specimen collection tube, as discussed further herein with respect to FIGURES 1A-1F.
  • the insert 200 shares components, materials, shapes, dimensions, and other characteristics with the insert 100 discussed further herein with respect to FIGURES 1 A-1F.
  • the insert 200 includes a fluidic channel separator 206 defining an aperture 208; and a plurality of legs 210 extending outwardly from a side 218 of the fluidic channel separator 206.
  • the aperture 208 is configured to limit flow of a fluid therethrough by hydrostatic forces between the fluid and the aperture 208.
  • the fluidic channel separator 206 comprises a disc 214 defining the aperture 208.
  • the side 218 of the fluidic channel separator 206 is a first side 218, and the insert 200 further comprises a flange 216 extending from the disc 214 from a second side 212 opposite to the first side 218.
  • a thickness of the flange 216 is less than a thickness of the disc 214 of the fluidic channel separator 206 such that the flange 216 is more flexible than the disc 214.
  • the relatively flexible flange 216 is configured to conform to an interior wall of a specimen collection tube in which the insert 200 is disposed and which the flange 216 contacts.
  • the conformation of the flange 216 to the interior wall forms, at least in part, a seal between the insert 200 and the interior wall of the specimen collection tube.
  • the discshaped fluidic channel separator 206 defines a circular outer circumference 226 and a diameter 220.
  • a circular outer circumference 226 is shaped and sized to form a seal between an interior portion, such as an interior wall, of a specimen collection tube into which the insert 200 is disposed.
  • the diameter 220 of the insert 200 is sized and shaped to match a diameter of at least a portion of an interior wall or other portion of the specimen collection tube, thereby forming a seal between the insert 200 and the specimen collection tube and the insert 200.
  • a diameter 221 of the plurality of legs 210 define, at least in part, a volume of a second compartment formed between the insert 200 and a specimen collection tube into which the insert is disposed.
  • a length 234 of the plurality of legs 210 defines, at least in part, a ratio of volumes of compartments defined by the insert 200 when disposed in an interior portion of a specimen collection tube.
  • kits for collecting and metering biofluids comprise a specimen collection tube; and an insert sized and shaped to fit within an interior portion of the specimen collection tube.
  • the insert comprises a fluidic channel separator defining an aperture, wherein the aperture is configured to limit flow of a fluid therethrough by hydrostatic forces between the fluid and the aperture; and a plurality of legs extending outwardly from a side of the fluidic channel separator.
  • the insert is an insert according to any embodiment of the present disclosure.
  • the insert is an example of inserts 100 or 200 described further herein with respect to FIGURES 1 A-1F or FIGURES 2A-2F.
  • FIGURE 3 is a side view of a kit 304 according to an embodiment of the present disclosure.
  • the kit 304 comprises a specimen collection tube 302; and an insert 300 sized and shaped to fit within an interior portion 324 of the specimen collection tube 302, the insert 300 comprising a fluidic channel separator 306 defining an aperture 308, wherein the aperture 308 is configured to limit flow of a fluid therethrough by hydrostatic forces between the fluid and the aperture 308; and a plurality of legs 310 extending outwardly from a side of the fluidic channel separator 306.
  • the fluidic channel separator 306 comprises a disc 314 defining the aperture 308.
  • the side 318 of the fluidic channel separator 306 is a first side 318
  • the insert 300 further comprises a flange 316 extending from the disc 314 from a second side 312 opposite to the first side 318, such as discussed further herein with respect to FIGURES 2A-2F.
  • the diameter 320 of the flange 316 matches diameter of the specimen collection tube 302 such that the flange 316 forms a seal with interior wall 328 of the specimen collection tube 302.
  • the insert 300 is shaped, sized, and otherwise configured to form a seal with an interior wall 328 of the sample collection tube when the insert 300 is disposed in the specimen collection tube 302.
  • a reagent 336 disposed in the specimen collection tube 302 generally does not travel between the outer circumference (see outer circumference 126) of the insert 300 and the interior wall, nor does it travel through the aperture 308 without agitation sufficient to break the hydrostatic forces between the insert 300. In other words, the reagent 336 does not leak out from the specimen collection tube 302 or contact a user collecting a biofluid.
  • FIGURES 4B and 4C human whole blood is collected at the top of the kit.
  • the insert (400) is placed into a BD microtainer® (402) tube as described in FIGURE 4A.
  • the blood is separated from the stabilizing agent, RNAlater (436) and sits in the first compartment (430).
  • the kit is shaken and the blood and RNAlater begin to mix in both compartments until homogenous, as seen in FIGURES 4D and 4E.
  • An insert for a specimen collection tube comprising:
  • a fluidic channel separator defining an aperture, wherein the aperture is configured to limit flow of a fluid therethrough by hydrostatic forces between the fluid and the aperture; and [0096] a plurality of legs extending outwardly from a side of the fluidic channel separator.
  • kits for collecting and metering biofluids comprising:
  • kit of any of Embodiments 10-14, wherein the kit defines a first compartment extending in a first direction from the disc and a second compartment extending in a second direction from the disc when the insert is disposed in the sample collection tube.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne des inserts destinés à un tube de collecte d'échantillon, et des kits de collecte et de dosage de biofluides. Dans un exemple, l'insert comprend un séparateur de canal fluidique définissant une ouverture, l'ouverture étant configurée pour limiter l'écoulement d'un fluide à travers celle-ci par des forces hydrostatiques intervenant entre le fluide et l'ouverture ; et une pluralité de pattes s'étendant vers l'extérieur depuis un côté du séparateur de canal fluidique. Dans un exemple, le kit comprend un tube de collecte d'échantillon et un insert dimensionné et formé de manière à s'ajuster dans le tube de collecte d'échantillon, afin de doser un biofluide placé dans le tube de collecte d'échantillon. Dans un exemple, l'insert comprend une bride s'étendant depuis un disque du séparateur de canal fluidique.
PCT/US2025/021615 2024-03-28 2025-03-26 Dosage de collecte de biofluide et kits et procédés associés Pending WO2025207813A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463571012P 2024-03-28 2024-03-28
US63/571,012 2024-03-28

Publications (1)

Publication Number Publication Date
WO2025207813A1 true WO2025207813A1 (fr) 2025-10-02

Family

ID=97218772

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/021615 Pending WO2025207813A1 (fr) 2024-03-28 2025-03-26 Dosage de collecte de biofluide et kits et procédés associés

Country Status (1)

Country Link
WO (1) WO2025207813A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3846077A (en) * 1972-09-18 1974-11-05 P Ohringer Liquid sample collection tube
US4152270A (en) * 1976-05-06 1979-05-01 Sherwood Medical Industries Inc. Phase separation device
US5275731A (en) * 1991-06-28 1994-01-04 Jahn Karl H Apparatus for rapidly separating blood into filtered fractions
US5454958A (en) * 1991-05-29 1995-10-03 Sherwood Medical Company Method for sampling in a container having a material therein which separates from a barrier material
US20100222196A1 (en) * 2007-10-24 2010-09-02 Jms Co., Ltd. Separation container, attachment and separation method
US20100288694A1 (en) * 2009-05-15 2010-11-18 Becton, Dickinson And Company Density Phase Separation Device
US20160123856A1 (en) * 2013-06-12 2016-05-05 Oasis Diagnostics Corporation Rna/prtein/dna preferential fluid sample collection system and methods

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3846077A (en) * 1972-09-18 1974-11-05 P Ohringer Liquid sample collection tube
US4152270A (en) * 1976-05-06 1979-05-01 Sherwood Medical Industries Inc. Phase separation device
US5454958A (en) * 1991-05-29 1995-10-03 Sherwood Medical Company Method for sampling in a container having a material therein which separates from a barrier material
US5275731A (en) * 1991-06-28 1994-01-04 Jahn Karl H Apparatus for rapidly separating blood into filtered fractions
US20100222196A1 (en) * 2007-10-24 2010-09-02 Jms Co., Ltd. Separation container, attachment and separation method
US20100288694A1 (en) * 2009-05-15 2010-11-18 Becton, Dickinson And Company Density Phase Separation Device
US20160123856A1 (en) * 2013-06-12 2016-05-05 Oasis Diagnostics Corporation Rna/prtein/dna preferential fluid sample collection system and methods

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