System and self-metering cartridges for point of care bioassays
US-2024360497-A1 · Oct 31, 2024 · US
US9694360B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-9694360-B2 |
| Application number | US-201414500710-A |
| Country | US |
| Kind code | B2 |
| Filing date | Sep 29, 2014 |
| Priority date | Sep 29, 2014 |
| Publication date | Jul 4, 2017 |
| Grant date | Jul 4, 2017 |
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A system for fluid manipulation includes a composite wafer and a movable compression device. The composite wafer includes a flexible layer and a substantially rigid layer adhered to the flexible layer. The flexible layer defines one or more recesses that are covered by the substantially rigid layer to form one or more reservoirs and one or more fluid channels among the one or more reservoirs. The movable compression device contacts the flexible layer and is configured to progressively compress the flexible layer such that when the movable compression device traverses the flexible layer, fluid is forced through the one or more fluid channels and the one or more reservoirs in a sequence determined by the layout of the one or more fluid channels and the one or more reservoirs. Certain reservoirs may be pre-loaded with fluids and reagents for performing a specified medical test.
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What is claimed is: 1. A system for fluid manipulation, the system comprising: a composite wafer having a flexible layer and a substantially rigid layer adhered to the flexible layer, the flexible layer defining one or more recesses that are covered by the substantially rigid layer to form one or more reservoirs and one or more fluid channels among the one or more reservoirs, wherein the substantially rigid layer also defines at least one fluid flow channel within the substantially rigid layer; and a movable compression device in contact with the flexible layer and configured to progressively compress the flexible layer such that when the movable compression device traverses the flexible layer, fluid is forced through the one or more fluid channels and the one or more reservoirs in a sequence determined by the layout of the one or more fluid channels and the one or more reservoirs; wherein the movable compression device is a roller, and wherein the fluid flow channel defined within the substantially rigid layer is positioned such that the roller forces fluid through the fluid flow channel within the substantially rigid layer past the roller in a direction counter to the direction of motion of the roller. 2. The system of claim 1 , wherein the movable compression device is a cylindrical roller. 3. The system of claim 1 , wherein the movable compression device is a conical roller. 4. The system of claim 1 , wherein at least one of the one or more reservoirs is pre-loaded with a fluid. 5. The system of claim 4 , further comprising at least one valve formed in the flexible layer, each valve preventing flow of fluid from a pre-loaded reservoir until the fluid is forced from the reservoir by action of the movable compression device. 6. The system of claim 4 , wherein at least one of the one or more reservoirs is pre-loaded with a diluent. 7. The system of claim 4 , wherein at least one of the one or more reservoirs is pre-loaded with a reagent. 8. The system of claim 4 , wherein at least one of the one or more reservoirs is pre-loaded with an antibody. 9. The system of claim 1 , wherein the substantially rigid layer defines a sample loading port for loading a sample of an analyte into the composite wafer. 10. The system of claim 1 , wherein the composite wafer further comprises a sampling medium to which fluid is delivered from one of the fluid flow channels. 11. The system of claim 1 , wherein: a first one of the reservoirs is pre-loaded with a diluent; the substantially rigid layer defines a sample loading port connected by one of the fluid flow channels downstream of the first reservoir for loading a sample of an analyte into the composite wafer; and a second one of the reservoirs is connected by one of the fluid flow channels downstream of the sample loading port, such that upon actuation of the movable compression device, diluent is forced from the first reservoir, and carries the analyte to the second reservoir in a test fluid. 12. The system of claim 11 , further comprising a sampling medium, wherein the test fluid is delivered from the second reservoir to the sampling medium via one of the fluid flow channels. 13. The system of claim 12 , wherein one or two additional reservoirs are disposed between the second reservoir and the sampling medium. 14. The system of claim 12 , wherein: a third reservoir is pre-loaded with a washing fluid; and the substantially rigid layer defines a fluid flow layer that delivers the washing fluid to the sampling medium. 15. The system of claim 14 , wherein the third reservoir is positioned such that the advancement of the movable compression device forces the washing fluid from the third reservoir after the test fluid has reached the sampling medium. 16. The system of claim 12 , wherein the analyte is blood, and the system is configured to perform process steps in the measurement of HbA1c in the blood. 17. The system of claim 1 , wherein the movable compression device is configured to be manually actuated. 18. The system of claim 1 , wherein the movable compression device and the composite wafer undergo rotary relative motion. 19. The system of claim 1 , wherein the movable compression device and the composite wafer undergo linear relative motion. 20. The system of claim 1 , further comprising a protective holder that substantially encloses the flexible layer, the protective holder defining an opening providing access to the flexible layer by the movable compression device. 21. A fluid manipulation device, comprising: a flexible layer having one or more recesses in one face, the one or more recesses defining one or more reservoirs and one or more fluid channels among the one or more reservoirs; a substantially rigid layer adhered to a face of the flexible layer such that the substantially rigid layer forms a closing side of the one or more recesses; and an analysis area; wherein the reservoirs, fluid channels, and analysis area are arranged such that a test fluid is moved through reservoirs, fluid channels, and analysis area in a prescribed order by progressive application of a movable compression device to the flexible layer; and wherein the substantially rigid layer also defines at least one fluid flow channel within the substantially rigid layer; and wherein the fluid flow channel defined within the substantially rigid layer is positioned such that the movable compression device forces fluid through the fluid flow channel within the substantially rigid layer past the movable compression device in a direction counter to the direction of motion of the movable compression device with respect to the fluid manipulation device. 22. The fluid manipulation device of claim 21 , wherein at least one reservoir is pre-loaded with a fluid. 23. The fluid manipulation device of claim 21 , wherein the substantially rigid layer defines at least one fluid flow channel. 24. The fluid manipulation device of claim 23 , wherein the fluid flow channel defined in the substantially rigid layer permits flow of fluid counter to the direction of progression of the movable compression device. 25. A method, comprising: providing a composite wafer having a flexible layer and a substantially rigid layer adhered to the flexible layer, the flexible layer defining one or more recesses that are covered by the substantially rigid layer to form one or more reservoirs and one or more fluid channels among the one or more reservoirs, wherein the substantially rigid layer also defines at least one fluid flow channel within the substantially rigid layer; and contacting a movable compression device with the flexible layer; and progressively compressing the flexible layer such that when the movable compression device traverses the flexible layer, fluid is forced through the one or more fluid channels and the one or more reservoirs in a sequence determined by the layout of the one or more fluid channels and the one or more reservoirs; wherein the movable compression device is a roller, and wherein the fluid flow channel defined within the substantially rigid layer is positioned such that the roller forces fluid through the fluid flow channel within the substantially rigid layer past the roller in a direction counter to the direction of motion of the roller. 26. The method of claim 25 , further comprising stopping and restarting the progressive compression. 27. The method o
Multiple sequential chambers · CPC title
Disc shape · CPC title
Flexible; Elastomeric · CPC title
membrane valves, flap valves · CPC title
characterised by the means or forces applied to move the fluids · CPC title
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