Microfluidic devices and arrangements for introducing reagents and biological samples to such devices

• US 10,252,265 B2
• Filed: 02/20/2015
• Issued: 04/09/2019
• Est. Priority Date: 03/04/2014
• Status: Active Grant

• Current Assignee: Global Life Sciences Solutions Operations UK Ltd. (Danaher Corporation)
• Original Assignee: GE Healthcare UK Limited (Danaher Corporation)
• Inventors: Tatnell, Peter James, Horton, Jeffrey Kenneth, Seymour, Geraint
• Primary Examiner(s): Kwak, Dean
• Application Number:
  US15/121,147
• Publication Number:
  US 20160367986A1
• Time in Patent Office: 1,509 Days
• Field of Search: 422502-504, 422512, 422527, 422568, 422570, 422 681, 422400-402, 422408-410, 422413, 422417, 422420, 422424, 422425
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/041 Connecting closures to device or container
• CPC Class Codes: B01L 2300/06 Auxiliary integrated devices, integrated components
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/123 Flexible; Elastomeric
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 1/286 involving mechanical work, e.g. chopping, disintegrating, compacting, homogenising microtomes G01N1/06; pulverising in general B02C; mixing in general B01F
• CPC Class Codes: G01N 2001/288 Filter punches

Abstract

A microfluidic device 100 is disclosed comprising a body 112 including a biological sample S and/or reagent R receiving slot 122. The sample and reagent are carried on a solid support 10. The device 100 includes two punch assemblies 130 for removing portions of the solid support 10 and delivering them, together with the sample and/or reagent(s), to a receiving chamber 126 for subsequent processing. The device can be used for various assays including those which require just the addition of water in the reaction chamber with no pre-treatment of sample prior delivery into the chamber.

Claims

1. A microfluidic device for assaying a biological sample, the device comprising:

a single layer solid support impregnated with the one or more reagents including a weak base, a chelating agent, an anionic surfactant, and/or a chaotropic agent, and wherein the solid support carries both the one or more reagents and a biological sample, a body including a receiving area for receiving the biological sample and one or more reagents carried on the solid support, a receiving chamber at the receiving area, at least one microfluidic port, and a fluid processing area, wherein the receiving chamber is in microfluidic communication with the fluid processing area via said at least one microfluidic port such that the device is configured to assay the biological sample using microfluidics,

at least one punch assembly for punching a portion of the solid support and delivering said portion together with the sample and the one or more reagents to the receiving chamber at the receiving area.

2. A microfluidic device as claimed in claim 1, wherein said punch assembly is manually operable.

3. A microfluidic device as claimed in claim 2, wherein the punch assembly includes a punch member, a die co-operable with the punch member, said punch member and die being relatively moveable to cut the portion from the support and to provide the delivery of the portion.

4. A microfluidic device as claimed in claim 3, wherein the device further includes at least one elastomeric cover member covering, the punch assembly and allowing said manual operation of the assembly.

5. A microfluidic device as claimed in claim 4, wherein at least one said elastomeric cover member is clamped to said body at the receiving area thereby providing a seal around the punch assembly.

6. A microfluidic device as claimed in claim 3, wherein the body at the receiving area includes a slot for accepting a solid support, wherein the punch member is mounted to the body at one side of the slot and is slidable in a path which extends through the slot, and wherein the die is formed by an aperture in the body on an opposing side of the slot in the path of the punch member.

7. A microfluidic device as claimed in claim 6, wherein the punch assembly further includes a return spring reacting between the body and a flattened head of the punch member.

8. A microfluidic device as claimed in claim 1 wherein the solid support is formed from material selected from the group consisting of a fibrous material, a cellulose fibre material, a glass fibre/microfibre material, a porous polymer, a porous membrane material, a polyester, a polyether sulfone (PES), a polyamide (Nylon), a polypropylene, a polytetrafluoroethylene (PTFE), a polycarbonate, a cellulose nitrate, a cellulose acetate, an aluminium oxide, a polysaccharide, an alginate, a cellulose, a modified cellulose and any combination thereof.

9. A microfluidic device as claimed in claim 8, wherein the support includes a biological sample comprising dried blood;

blood plasma, or other blood components;

urine;

cerebral culture media;

cell samples;

cell culture;

or tissue exudate.

10. A microfluidic device as claimed in claim 9, wherein the support holds at least one dry reagent at a first location, and a dry biological sample material(s) at a second location separate from the first location.

11. A method of using a microfluidic device to provide an assay, the method comprising the following steps:

a) providing a microfluidic device comprising

a single layer solid support impregnated with the one or more reagents including a weak base, a chelating agent, an anionic surfactant, and/or a chaotropic agent, and wherein the solid support carries both the one or more reagents and a biological sample,

a body including a receiving area for receiving the biological sample and one or more reagents carried on the solid support, a receiving chamber at the receiving area, at least one microfluidic port, and a fluid processing area, wherein the receiving chamber is in microfluidic communication with the fluid processing area via said at least one microfluidic port such that the device is configured to assay the biological sample using microfluidics,

at least one punch assembly for punching a portion of the solid support and delivering said portion together with the sample and the one or more reagents to the receiving chamber at the receiving area;

b) removing the portion of the support which carries at least the portion of the sample;

c) delivering the support portion carrying the sample to the receiving chamber; and

d) operating the microfluidic device to process said portion according to requirements of the assay.

12. A method according to claim 11 further including the steps of:

a) providing on the support the reagents in a dried or lyophilised state, for performing the assay;

b) removing the portion of the support which carries at least the portion of the reagent(s); and

c) delivering the removed portion carrying the reagent(s) to the reaction chamber; and

wherein step d) includes hydrating the solid support in the chamber now containing the sample and the reagents, or introducing a solution into the chamber, in order to perform said assay.

13. A method according to claim 12, wherein the reagents include a sequestrant, such as cyclodextrin, for example α

-cyclodextrin.

14. A method according to claim 11, wherein the punch assembly is manually operable, for example one or more manually operable punches to remove said portions and to deliver the portions to the chamber using the force transmitted by the punch during operation.

15. A method according to claim 13, wherein said assay includes amplification of nucleic acids carried on said portion, in the reaction chamber with no intervening steps between delivery and said amplification.

16. A method according to claim 13, wherein said assay includes detection or measurement of drugs, proteins or enzymes from the biological sample carried on said portion in the reaction chamber with no intervening steps between delivery and said detection or measurement.