IP Library Granted Patent US 7,153,651
Granted Patent B1
US 7,153,651 · App. 08/950,963 · Granted Dec 26, 2006

Flow-through optical assay devices providing laminar flow of fluid samples, and methods of construction thereof

View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 7,153,651
App. No.
08/950,963
Granted
Dec 26, 2006
Kind
B1
Abstract

An optical assay device for the detection of an analyte of interest in a sample comprising a support containing channels, an optically functional layer positioned on the support such that the optically functional layer and the support allow for laminar flow of the sample through layers of the device, an attachment layer positioned on the optically functional layer, and an analyte specific receptive layer positioned on the attachment layer.

Claims (100)

1. An optical assay device for the detection of an analyte of interest in a fluid sample comprising:

a support containing channels;

an optically functional layer containing channels, said optically functional layer having an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, positioned on said support;

an attachment layer containing channels positioned on said optically functional layer; and

an analyte specific receptive layer containing channels positioned on said attachment layer,

wherein said channels in said support, said optically functional layer, said attachment layer and said analyte specific receptive layer are positioned to allow fluid flow from the analyte specific receptive layer to the support.

2. An optical assay device for the detection of an analyte of interest in a fluid sample comprising:

a support containing channels;

an optically functional layer containing channels, said optically functional layer having an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, positioned on said support; and

an attachment layer containing channels positioned on said optically functional layer to provide nonspecific capture of said analyte,

wherein said channels in said support, said optically functional layer and said attachment layer are positioned to allow fluid flow from the attachment layer to the support.

3. An optical assay device for the detection of an analyte of interest in a fluid sample comprising:

a porous support;

an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, comprising discrete, optically functional particles embedded in said support configured and arranged to provide channels through said optically functional layer;

an attachment layer containing channels positioned on said particles; and

an analyte specific receptive layer containing channels positioned on said attachment layer,

wherein said channels in said optically functional layer, said attachment layer and said analyte specific receptive layer are positioned to allow fluid flow from said analyte specific receptive layer to said attachment layer and to said optically functional layer wherein fluid enters pores of said porous support.

4. An optical assay device for the detection of an analyte of interest in a sample comprising:

a porous support;

an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, comprising discrete, optically functional particles embedded in said support configured and arranged to provide channels through said optically functional layer; and

an attachment layer containing channels positioned on said particles to provide nonspecific capture of said analyte,

wherein said channels in said optically functional layer and said attachment layer are positioned to allow fluid flow from the attachment layer to said optically functional layer wherein fluid enters pores of said porous support.

5. An optical assay device for the detection of an analyte of interest in a sample comprising:

a porous support;

an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, containing channels positioned on said support;

an attachment layer containing channels positioned on said optically functional layer; and

an analyte specific receptive layer containing channels positioned on said attachment layer,

wherein said channels in said optically functional layer, said attachment layer and said analyte specific receptive layer are positioned to allow fluid flow from said analyte specific receptive layer to said attachment layer and to said optically functional layer wherein fluid enters pores of said porous support.

6. An optical assay device for the detection of an analyte of interest in a sample comprising:

a porous support;

an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, containing channels positioned on said support; and

an attachment layer containing channels positioned on said optically functional layer to provide nonspecific capture of said analyte,

wherein said channels in said optically functional layer and said attachment layer are positioned to allow fluid flow from said attachment layer to said optically functional layer wherein fluid enters pores of said porous support.

7. The device of any of claims 1 , 2 , 3 , 4 , 5 or 6 wherein said optically functional layer further comprises an antireflective layer.

8. The device of any of claim 1 , 2 , 3 , 4 , 5 or 6 , wherein said attachment layer is nickel.

9. The device of any of claim 1 , 2 , 3 , 4 , 5 or 6 , wherein said device further comprises a liquid absorbent material surrounding said optically functional layer or beneath said support.

10. The device of any of claims 1 , 2 , 3 , 4 , 5 or 6 , wherein

said support comprises polyester or polycarbonate,

said optically functional layer comprises a layer of silicon nitride positioned on a layer of amorphous silicon, and

said attachment layer comprises nickel.

11. The device of any of claims 1 , 2 , 3 , 4 , 5 or 6 wherein said support comprises polycarbonate or polyester, and

said optically functional layer comprises a layer of germanium on which is positioned a layer of diamond-like carbon.

12. The device of any of claims 1 , 2 , 3 , 4 , 5 or 6 wherein said optically functional layer comprises a layer of germanium on which is positioned a layer of diamond-like carbon, and said attachment layer comprises nickel.

13. Method for constructing an optical assay device with laminar flow properties, comprising the steps of:

providing a support comprising channels;

providing an optically functional layer containing channels, said optically functional layer having an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, on said support;

providing an attachment layer containing channels on said optically functional layer, and

providing an analyte specific receptive layer containing channels on said attachment layer,

wherein said channels in said support, said optically functional layer, said attachment layer and said an analyte specific receptive layer are positioned to allow fluid flow from the analyte specific receptive layer to the support.

14. Method for constructing an optical assay device with laminar flow properties, comprising the steps of:

providing a support comprising channels;

providing an optically functional layer containing channels, said optically functional layer having an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, on said support; and

providing an attachment layer containing channels on said optically functional layer to provide nonspecific capture of said analyte,

wherein said channels in said support, said optically functional layer and said attachment layer are positioned to allow fluid flow from the attachment layer to the support.

15. A composition comprising:

a support comprising channels or a porous support, and an optically functional layer containing channels positioned on said support, said optically functional layer having an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding;

wherein said channels in said optically functional layer are positioned to allow fluid flow to the support either through channels in the support or via pores in the porous support.

16. The composition of claim 15 , wherein said support is porous and said channels in said optically functional layer are formed from optically functional particles.

17. The composition of claim 15 , wherein said support is porous.

18. The composition of claim 15 , wherein said support comprises polycarbonate and said optically functional layer comprises amorphous silicon.

19. The composition of claim 18 , wherein said optically functional layer further comprises a layer of silicon nitride positioned on said amorphous silicon.

20. The composition of claim 15 , wherein said support comprises polycarbonate and said optically functional layer comprises germanium.

21. The composition of claim 20 , wherein said optically functional layer further comprises a layer of diamond-like carbon positioned on said germanium.

22. The composition of claim 15 , wherein said support comprises polyester and said optically functional layer comprises amorphous silicon.

23. The composition of claim 22 , wherein said optically functional layer further comprises a layer of silicon nitride positioned on said amorphous silicon.

24. The composition of claim 15 , wherein said support comprises polyester and said optically functional layer comprises germanium.

25. The composition of claim 24 , wherein said optically functional layer further comprises a layer of diamond-like carbon positioned on said layer of germanium.

26. Method for constructing an optical assay device with laminar flow properties, comprising the steps of:

providing a porous support;

providing an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, comprising discrete, optically functional particles embedded in said support configured and arranged to provide channels through said optically functional layer;

providing an attachment layer containing channels positioned on said particles; and

providing an analyte specific receptive layer containing channels positioned on said attachment layer,

wherein said channels in said optically functional layer, said attachment layer and said analyte specific receptive layer are positioned to allow fluid flow from said analyte specific receptive layer to said attachment layer and to said optically functional layer wherein fluid enters pores of said porous support.

27. Method for constructing an optical assay device with laminar flow properties, comprising the steps of:

providing a porous support;

providing an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, comprising discrete, optically functional particles embedded in said support configured and arranged to provide channels through said optically functional layer; and

providing an attachment layer containing channels positioned on said particles to provide nonspecific capture of said analyte,

wherein said channels in said optically functional layer and said attachment layer are positioned to allow fluid flow from the attachment layer to said optically functional layer wherein fluid enters pores of said porous support.

28. Method for constructing an optical assay device with laminar flow properties, comprising the steps of:

providing a porous support,

providing an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, containing channels positioned on said support;

providing an attachment layer containing channels positioned on said optically functional layer; and

providing an analyte specific receptive layer containing channels positioned on said attachment layer,

wherein said channels in said optically functional layer, said attachment layer and said analyte specific receptive layer are positioned to allow fluid flow from said analyte specific receptive layer to said attachment layer and to said optically functional layer wherein fluid enters pores of said porous support.

29. Method for constructing an optical assay device with laminar flow properties, comprising the steps of:

providing a porous support;

providing an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, containing channels positioned on said support; and

providing an attachment layer containing channels positioned on said optically functional layer to provide nonspecific capture of said analyte,

wherein said channels in said optically functional layer and said attachment layer are positioned to allow fluid flow from said attachment layer to said optically functional layer wherein fluid enters pores of said porous support.

30. The device of any of claims 1 , 2 , 3 , 4 , 5 6 , 13 , 14 , 15 or 21 – 29 wherein said analyte is selected from the group consisting of antigens, antibodies, receptors, ligands, chelates, proteins, enzymes, nucleic acids, DNA, RNA, pesticides, and herbicides.

31. The device of any of claims 1 , 2 , 3 , 4 , 5 6 , 13 , 14 , 15 or 21 – 29 wherein said optically functional layer comprises a layer of silicon nitride positioned on a layer of amorphous silicon.

32. The device of any of claims 1 , 2 , 3 , 4 , 5 or 6 , 13 , 14 , 15 or 21 – 29 wherein said attachment layer comprises diamond-like carbon.

33. The device of any of claims 2 , 4 , 6 , 14 , 27 or 29 wherein said channels in said attachment layer do not exceed 15% of the surface area of the layer.

34. The device of any of claims 2 , 4 , 6 , 14 , 27 or 29 wherein said channels in said device are not interconnected.

35. The device of any of claims 1 , 3 , 5 , 13 , 26 or 28 wherein said channels in said analyte specific receptive layer do not exceed 15% of the surface area of the layer.

36. The device of any of claims 1 , 3 , 5 , 13 , 26 or 28 wherein said channels in said device are not interconnected.

37. The composition of claim 15 wherein said channels in said optically functional layer do not exceed 15% of the surface area of the layer.

38. The composition of claim 15 wherein said channels in said device are not interconnected.

39. The device of any of claims 1 - 3 , 5 , and 6 , wherein said channels are configured to provide laminar flow of sample across the layer which binds analyte of said support, said flow achieved by the movement of sample into channels that connect the layer which binds analyte to the support.

40. The composition of any of claims 15 , 16 – 25 , 37 and 38 wherein said channels are configured to provide laminar flow of sample across the layer which binds analyte of said support, said flow achieved by the movement of sample into channels that connect the layer which binds analyte to the support.

Assignments (9)
NOTICE OF RELEASE OF SECURITY INTEREST IN PATENTS RECORDED AT REEL 026557 FRAME 0287 Recorded Jun 23, 2015
From: GENERAL ELECTRIC CAPITAL CORPORATION, AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
To: ADVANTAGE DIAGNOSTICS CORPORATION; ALERE MEDICAL, INC.; ALERE SAN DIEGO, INC.; ALERE SCARBOROUGH, INC.; AMEDITECH INC.; APPLIED BIOTECH, INC.; BINAX, INC.; BIOSITE INCORPORATED; CHOLESTECH CORPORATION; GENECARE MEDICAL GENETICS CENTER, INC.; HEMOSENSE, INC.; INSTANT TECHNOLOGIES, INC.; INVERNESS MEDICAL - BIOSTAR INC.; ISCHEMIA TECHNOLOGIES, INC.; MATRITECH, INC.; MATRIA HEALTHCARE, INC.; ZYCARE, INC.
Reel/Frame 036011/0581 →
SECURITY AGREEMENT Recorded Jul 7, 2011
From: ADVANTAGE DIAGNOSTICS CORPORATION; ALERE MEDICAL INCORPORATED; ALERE SAN DIEGO, INC.; ALERE SCARBOROUGH, INC.; AMEDITECH INC.; APPLIED BIOTECH, INC.; BINAX, INC.; BIOSITE INCORPORATED; CHOLESTECH CORPORATION; GENECARE MEDICAL GENETICS CENTER, INC.; HEMOSENSE, INC.; INSTANT TECHNOLOGIES, INC.; INVERNESS MEDICAL - BIOSTAR INC.; ISCHEMIA TECHNOLOGIES, INC.; MATRITECH, INC.; ZYCARE INC.; MARTIA HEALTHCARE, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION
Reel/Frame 026557/0287 →
SECOND LIEN INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jun 27, 2007
From: IM US HOLDINGS, LLC, A DELAWARE LIMITED LIABILITY COMPANY; INVERNESS MEDICAL INNOVATIONS, INC., A DELAWARE CORPORATION; ADVANTAGE DIAGNOSTICS CORPORATION, A DELAWARE CORPORATION; APPLIED BIOTECH, INC., A CALIFORNIA CORPORATION; BINAX, INC., A DELAWARE CORPORATION; FIRST CHECK DIAGNOSTICS CORP., A DELAWARE CORPORATION; FOREFRONT DIAGNOSTICS, INC., A CALIFORNIA CORPORATION; INCA ACQUISITION, INC., A DELAWARE CORPORATION; INNOVATIVE MOBILITY, LLC, A FLORIDA LIMITED LIABILITY COMPANY; INSTANT TECHNOLOGIES, INC., A VIRGINIA CORPORATION; INVERNESS MEDICAL - BIOSTAR, INC., A DELAWARE CORPORATION; INVERNESS MEDICAL INTERNATIONAL HOLDING CORP., A DELAWARE CORPORATION; INVERNESS MEDICAL INTERNATIONAL HOLDING CORP. II, A DELAWARE CORPORATION; INNOVATIONS RESEARCH, LLC, A DELAWARE LIMITED LIABILITY COMPANY; INVERNESS MEDICAL, LLC, A DELAWARE LIMITED LIABILITY COMPANY; ISCHEMIA TECHNOLOGIES, INC., A DELAWARE CORPORATION; IVC INDUSTRIES, INC., A DELAWARE CORPORATION; INNOVACON, INC., A DELAWARE CORPORATION; OSTEX INTERNATIONAL, INC., A WASHINGTON CORPORATION; QUALITY ASSURED SERVICES, INC., A FLORIDA CORPORATION; SELFCARE TECHNOLOGY, INC., A DELAWARE CORPORATION; SPDH, INC., A DELAWARE CORPORATION; UNIPATH ONLINE, INC., A MASSACHUSETTS CORPORATION; WAMPOLE LABORATORIES, LLC, A DELAWARE LIMITED LIABILITY COMPANY
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT
Reel/Frame 019477/0808 →
FIRST LIEN INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jun 26, 2007
From: IM US HOLDINGS, LLC, A DELAWARE LIMITED LIABILITY COMPANY; INVERNESS MEDICAL INNOVATIONS, INC., A DELAWARE CORPORATION; ADVANTAGE DIAGNOSTICS CORPORATION, A DELAWARE CORPORATION; APPLIED BIOTECH, INC., A CALIFORNIA CORPORATION; BINAX, INC., A DELAWARE CORPORATION; FIRST CHECK DIAGNOSTICS CORP., A DELAWARE CORPORATION; FOREFRONT DIAGNOSTICS, INC., A CALIFORNIA CORPORATION; INCA ACQUISITION, INC., A DELAWARE CORPORATION; INNOVATIVE MOBILITY, LLC, A FLORIDA LIMITED LIABILITY COMPANY; INSTANT TECHNOLOGIES, INC., A VIRGINIA CORPORATION; INVERNESS MEDICAL - BIOSTAR, INC., A DELAWARE CORPORATION; INVERNESS MEDICAL INTERNATIONAL HOLDING CORP., A DELAWARE CORPORATION; INVERNESS MEDICAL INTERNATIONAL HOLDING CORP. II, A DELAWARE CORPORATION; INNOVATIONS RESEARCH, LLC, A DELAWARE LIMITED LIABILITY COMPANY; INVERNESS MEDICAL, LLC, A DELAWARE LIMITED LIABILITY COMPANY; ISCHEMIA TECHNOLOGIES, INC., A DELAWARE CORPORATION; IVC INDUSTRIES, INC., A DELAWARE CORPORATION; INNOVACON, INC., A DELAWARE CORPORATION; OSTEX INTERNATIONAL, INC., A WASHINGTON CORPORATION; SELFCARE TECHNOLOGY, INC., A DELAWARE CORPORATION; SPDH, INC., A DELAWARE CORPORATION; UNIPATH ONLINE, INC., A MASSACHUSETTS CORPORATION; QUALITY ASSURED SERVICES, INC., A FLORIDA CORPORATION
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT
Reel/Frame 019477/0268 →
CHANGE OF NAME Recorded Oct 18, 2006
From: THERMO BIOSTAR, INC.
To: INVERNESS MEDICAL - BIOSTAR INC.
Reel/Frame 018398/0869 →
CHANGE OF NAME Recorded Sep 24, 2001
From: BIOSTAR, INC.
To: THERMO BIOSTAR INC.
Reel/Frame 012189/0506 →
RELEASE OF SECURITY INTEREST: 9445/0545 Recorded Jan 27, 1999
From: BIOSTAR, INC.
To: THERMO BIOANALYSIS CORPORAITON
Reel/Frame 009703/0920 →
SECURITY AGREEMENT Recorded Sep 4, 1998
From: BIOSTAR, INC.
To: THERMO BIOANALYSIS CORPORATION
Reel/Frame 009445/0545 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 23, 1998
From: DREWES, JOEL A.; BOGART, GREGORY R.; ETTER, JEFFREY B.; STEAFFENS, JEFFREY W.; OSTROFF, RACHEL M.; CROSBY, MARK
To: BIOSTAR, INC.
Reel/Frame 009077/0497 →