Sample collection and transfer device

• US 10,350,592 B2
• Filed: 07/20/2015
• Issued: 07/16/2019
• Est. Priority Date: 07/25/2014
• Status: Active Grant

• Current Assignee: Global Life Sciences Solutions Operations UK Ltd. (Danaher Corporation)
• Original Assignee: General Electric Company
• Inventors: Lenigk, Ralf, Finehout, Erin Jean, Wang, Xuefeng
• Primary Examiner(s): White, Dennis
• Application Number:
  US15/326,412
• Publication Number:
  US 20170203292A1
• Time in Patent Office: 1,457 Days
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• 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 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0838 Capillaries
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2300/161 Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/0258 using stamps
• CPC Class Codes: B01L 3/0262 using touch-off at substrate or container
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/561 Tubes; Conduits in general F16L
• CPC Class Codes: C12Q 1/6806 Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay C12Q1/6804 takes precedence
• CPC Class Codes: G01N 1/14 Suction devices, e.g. pumps; Ejector devices
• CPC Class Codes: G01N 2001/149 Capillaries; Sponges

Abstract

An integrated device for a sample collection and transfer is provided. The integrated device comprises a capillary channel disposed between a first layer and a second layer, wherein the first layer comprises a hydrophilic layer comprising a fluid inlet for receiving a sample fluid to the capillary channel, wherein the capillary channel comprises an inner surface and an outer surface and an outlet for driving out the sample fluid. The device further comprises an interface assembly comprising: a third layer, a fourth layer, a fifth layer, and a flow path. The interface assembly is disposed on the outer surface of the capillary, at a determining position relative to the outlet, such that the capillary is in contact with the third layer of the interface assembly and the outlet is in contact with the flow path of the interface assembly for driving out the sample fluid from the integrated device.

Claims

1. An integrated device for a sample collection and transfer, comprising:

a capillary comprising a first layer, a middle layer, and a second layer;

a capillary channel disposed between the first layer and the second layer, wherein the first layer comprises a hydrophilic layer comprising a fluid inlet for receiving a sample fluid to the capillary channel, wherein the capillary channel comprises a cavity defined in the middle layer disposed between the first layer and the second layer of the capillary; and

an outlet for allowing the sample fluid to flow out of the capillary channel; and

an interface assembly comprising;

a third layer comprising an adhesive material, a fourth layer comprising a hydrophilic material, a fifth layer comprising a patterned adhesive material, and a flow path, wherein the third layer is disposed on the fourth layer and the fourth layer is disposed on the fifth layer;

wherein the interface assembly is disposed on an outer surface of the capillary, such that the capillary is in contact with the third layer of the interface assembly and the outlet is aligned the flow path of the interface assembly for transferring the sample fluid out of the integrated device, and

wherein the capillary channel has a channel width, the inlet has a first diameter and the outlet has a second diameter, and channel width is greater than the second diameter.

2. The integrated device of claim 1, wherein the first layer comprises the outlet.

3. The integrated device of claim 1, wherein the second layer comprises the outlet.

4. The integrated device of claim 1, wherein the channel width is in a range between 3 to 50 mm and the second diameter is in a range between 0.5 to 10 mm.

5. The integrated device of claim 1, wherein the capillary channel has a length in a range from 5 mm to 200 mm.

6. The integrated device of claim 1, wherein the capillary channel is made of a material selected from polymer, metal, glass or combinations thereof.

7. The integrated device of claim 1, wherein the first layer comprises a hydrophilic film with a water contact angle of less than 60 degree.

8. The integrated device of claim 1, wherein the first layer comprises a polymer.

9. The integrated device of claim 1, wherein the capillary channel, inlet and outlet are formed by laser drilling, rotation cutting, ballistic pressing or combination thereof.

10. The integrated device of claim 1, wherein the third layer comprises a pressure sensitive adhesive.

11. The integrated device of claim 1, wherein the fourth layer comprises a hydrophilic material, polymeric material, a material with hydrophilic coatings, a material with hydrophilic surface treatment or combinations thereof.

12. The integrated device of claim 1, wherein the fifth layer comprises a gasket made of pressure sensitive adhesive material.

13. The integrated device of claim 12, wherein the pressure sensitive adhesive material of the gasket comprises acrylics, butyl rubber, ethylene-vinyl acetate (EVA), natural rubber;

nitriles;

silicone rubbers, styrene block copolymers (SBC), styrene-butadiene-styrene (SBS), styrene-ethylene/butylene-styrene (SEBS), styrene-ethylene/propylene (SEP), styrene-isoprene-styrene (SIS), vinyl ethers or combinations thereof.

14. The integrated device of claim 1, wherein the integrated device is coupled to a substrate.

15. The integrated device of claim 14, wherein the integrated device is configured to transfer the sample fluid to the substrate.

16. The integrated device of claim 15, further comprising a hydrophilic pad adjacent to the inlet to facilitate receiving the sample fluid to the capillary.

17. The integrated device of claim 16, wherein the substrate comprises cellulose, nitrocellulose, modified porous nitrocellulose or cellulose based substrates, polyethyleneglycol-modified nitrocellulose, a cellulose acetate membrane, a nitrocellulose mixed ester membrane, a glass fiber, a polyethersulfone membrane, a nylon membrane, a polyolefin membrane, a polyester membrane, a polycarbonate membrane, a polypropylene membrane, a polyvinylidene difluoride membrane, a polyethylene membrane, a polystyrene membrane, a polyurethane membrane, a polyphenylene oxide membrane, a poly(tetrafluoroethylene-co-hexafluoropropylene) membrane, glass fiber membranes, quartz fiber membranes or a combination thereof.

18. The integrated device of claim 17, wherein the substrate comprises one or more dried reagents impregnated therein.

19. The integrated device of claim 18, wherein the dried reagents comprise protein stabilizing reganets, nucleic acid stabilizing reagents, cell-lysis reagents or combinations thereof.

20. The integrated device of claim 19, wherein the substrate is disposed on a substrate frame.

21. The integrated device of claim 1, wherein the device is disposable or re-usable.

22. A system, comprising:

a substrate; and

an integrated device comprising;

a capillary comprising a first layer, a middle layer, and a second layer;

a capillary channel disposed between the first layer and the second layer, wherein the first layer comprises a hydrophilic layer comprising a fluid inlet for receiving a sample fluid to the capillary channel and wherein the capillary channel comprises a cavity defined in the middle layer disposed between the first layer and the second layer of the capillary; and

an outlet connected to the capillary channel; and

an interface assembly comprising;

a third layer comprising an adhesive material, a fourth layer comprising a hydrophilic material, a fifth layer comprising a patterned adhesive material and a flow path, wherein the third layer is disposed on the fourth layer and the fourth layer is disposed on the fifth layer;

wherein the interface assembly is disposed on an outer surface of the capillary, such that the capillary channel is in connection with the flow path of the interface assembly;

wherein the integrated device is operatively coupled to the substrate such that the substrate is in contact with the interface assembly for transferring the sample fluid from the integrated device to the substrate, and

wherein the capillary channel has a channel width, the inlet has a first diameter and the outlet has a second diameter, and channel width is greater than the second diameter.

23. The system of claim 22, wherein the system further comprises a substrate frame having a substrate region configured to receive the substrate.

24. The system of claim 23, further coupled to an external device, wherein the external device comprises a fluidic device, an analytical instrument, or both.

25. A method for sample collection and transfer, comprising:

providing an integrated device, wherein the device comprises;

a capillary comprising a first layer, a middle layer, and a second layer;

a capillary channel disposed between the first layer and the second layer, wherein the first layer comprises a hydrophilic layer comprising a fluid inlet for receiving a fluid sample to the capillary channel, wherein the capillary channel comprises a cavity defined in the middle layer disposed between the first layer and the second layer of the capillary; and

an outlet for allowing the fluid sample to flow out from the capillary channel; and

an interface assembly comprising;

a third layer comprising an adhesive material, a fourth layer comprising a hydrophilic material, a fifth layer comprising a patterned adhesive material, and a flow path, wherein the third layer is disposed on the fourth layer and the fourth layer is disposed on the fifth layer;

wherein the interface assembly is disposed on an outer surface of the capillary, such that the capillary channel is in connection with the flow path of the interface assembly;

wherein the capillary channel has a channel width, the inlet has a first diameter and the outlet has a second diameter, and channel width is greater than the second diameter;

contacting the integrated device to a substrate comprising an absorbent material;

applying the fluid sample to the fluid inlet of the integrated device, wherein the fluid sample is transported from the inlet to the outlet of the capillary; and

transferring the fluid sample from the integrated device to the substrate through the flow path of the interface assembly.

26. The method of claim 25, wherein the sample collection and transfer is achieved in a time between 10 seconds and 120 seconds.

27. The method of claim 26, further comprising detaching the integrated device from the substrate after complete transfer of the sample to the substrate.

28. The method of claim 27, further comprising analysing the substrate comprising the sample fluid transferred from the device.

29. The method of claim 28, wherein the substrate is configured to store the fluid sample.

30. A method for sample collection and transfer, comprising:

providing an integrated device, wherein the device comprises;

a capillary comprising a first layer, a middle layer, and a second layer;

a capillary channel disposed between the first layer and the second layer, wherein the first layer comprises a hydrophilic layer comprising a fluid inlet for receiving a fluid sample to the capillary channel, wherein the capillary channel comprises a cavity defined in the middle layer disposed between the first layer and the second layer of the capillary; and

an outlet for driving out the fluid sample; and

an interface assembly comprising;

a third layer comprising an adhesive material, a fourth layer comprising a hydrophilic material, a fifth layer comprising a patterned adhesive material, and a flow path, wherein the third layer is disposed on the fourth layer and the fourth layer is disposed on the fifth layer;

wherein the interface assembly is disposed on an outer surface of the capillary, such that the capillary channel is in connection with the flow path of the interface assembly;

wherein the capillary channel has a channel width, the inlet has a first diameter and the outlet has a second diameter, and channel width is greater than the second diameter;

contacting the device to the substrate comprising an absorbent material;

applying the fluid sample to the fluid inlet of the integrated device, wherein the fluid sample is transported from the inlet to the outlet of the capillary; and

transferring the fluid sample from the integrated device to the substrate through the flow path of the interface assembly; and

analyzing a portion of the substrate comprising the fluid sample transferred from the device.