Medical device and method for diagnostic sensing

• US 7,445,766 B2
• Filed: 04/10/2006
• Issued: 11/04/2008
• Est. Priority Date: 03/02/2000
• Status: Expired due to Fees

• Current Assignee: Microchips Biotech, Inc. (Keratin Biosciences, Inc.)
• Original Assignee: MicroCHIPS Inc.
• Inventors: Sheppard, Norman F. Jr., Santini, John T. Jr.
• Primary Examiner(s): Le; Long V.
• Assistant Examiner(s): Counts; Gary W
• Application Number:
  US11/279,227
• Publication Number:
  US 20060171888A1
• Time in Patent Office: 939 Days
• Field of Search: 435/6, 435/7.1, 435 792- 794, 435/287.1, 435/287.2, 435/288.4, 436/501, 436/518, 436/524, 436/164, 422/58, 422/101, 600/300, 600/309, 600/310, 604/891.1, 424/9.1
• US Class Current: 424/9.1
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61K 47/6957 the form being a device or a kit, e.g. stents or microdevices
• CPC Class Codes: A61K 49/0002 General or multifunctional contrast agents, e.g. chelated agents
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: B01J 19/0093 Microreactors, e.g. miniaturised or microfabricated reactors laboratory containers with capillary fluid transport in microfabricated channels or chambers B01L3/5027
• CPC Class Codes: B01J 2219/00317 Microwell devices, i.e. having large numbers of wells
• CPC Class Codes: B01J 2219/00351 Means for dispensing and evacuation of reagents
• CPC Class Codes: B01J 2219/00783 Laminate assemblies, i.e. the reactor comprising a stack of plates
• CPC Class Codes: B01J 2219/00819 Materials of construction
• CPC Class Codes: B01J 2219/00822 Metal
• CPC Class Codes: B01J 2219/00824 Ceramic
• CPC Class Codes: B01J 2219/00828 Silicon wafers or plates
• CPC Class Codes: B01J 2219/00831 Glass
• CPC Class Codes: B01J 2219/00833 : Plastic
• CPC Class Codes: B01J 2219/00835 : Comprising catalytically active material
• CPC Class Codes: B01J 2219/00844 : Comprising porous material
• CPC Class Codes: B01J 2219/00853 : Employing electrode arrangements
• CPC Class Codes: B01J 2219/00873 : Heat exchange
• CPC Class Codes: B01J 2219/00889 : Mixing
• CPC Class Codes: B01J 2219/00907 : using membranes
• CPC Class Codes: B01J 2219/00925 : Irradiation
• CPC Class Codes: B01J 2219/00952 : Sensing operations
• CPC Class Codes: B01J 2219/00957 : Compositions or concentrations
• CPC Class Codes: B01J 2219/00966 : pH
• CPC Class Codes: B01J 2219/0097 : Optical sensors
• CPC Class Codes: B01J 2219/00984 : Residence time
• CPC Class Codes: B01J 2219/00986 : Microprocessor
• CPC Class Codes: B01L 2200/12 : Specific details about manufacturing devices
• CPC Class Codes: B01L 2300/023 : Sending and receiving of information, e.g. using bluetooth
• CPC Class Codes: B01L 2300/049 : Valves integrated in closure
• CPC Class Codes: B01L 2300/0627 : Sensor or part of a sensor is integrated
• CPC Class Codes: B01L 2300/0654 : Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0819 : Microarrays; Biochips
• CPC Class Codes: B01L 2400/0677 : phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
• CPC Class Codes: B01L 3/50853 : with covers or lids
• CPC Class Codes: C40B 60/14 : for creating libraries
• CPC Class Codes: G01N 2035/00158 : Elements containing microarrays, i.e. "biochip"
• CPC Class Codes: G01N 2035/00247 : Microvalves
• CPC Class Codes: Y10T 29/49007 : Indicating transducer
• CPC Class Codes: Y10T 29/49117 : Conductor or circuit manufacturing
• CPC Class Codes: Y10T 436/25 : including sample preparation

Abstract

Devices are provided for use in medical diagnostics which include a substrate, a plurality of discrete reservoirs located in the substrate, each reservoir having at least one opening, at least one diagnostic substance contained in each reservoir, and at least one non-degradable barrier layer covering each reservoir opening, the barrier layer being permeable to an agent to be detected, wherein the diagnostic substance remains inside the reservoirs and can react with the agent to be detected.

Claims

1. A method of detecting an analyte in vivo comprising:

implanting at a site in a patient a device which comprises;

one or more discrete reservoirs each containing at least one reacting component,

at least one non-degradable barrier layer covering an opening in each of the one or more discrete reservoirs, the non-degradable barrier layer being selectively permeable to an analyte to be detected, wherein the reacting component remains inside the reservoirs, and

a degradable barrier layer, which is impermeable to the analyte to be detected and which covers the at least one non-degradable barrier layer over the reservoir opening;

disintegrating or permeabilizing the degradable barrier layer over at least one of the reservoirs to permit the analyte at the site to enter the reservoir and react with the at least one reacting component; and

using a sensor positioned externally from the reservoir to detect the reaction between the reacting component and the analyte.

2. The method of claim 1, wherein the detecting comprises imaging or optical detection.

3. The method of claim 1, wherein the at least one non-degradable barrier layer comprises a semi-permeable polymeric membrane.

4. The method of claim 1, wherein the at least one non-degradable barrier layer comprises a nanoporous or microporous silicon membrane.

5. The method of claim 1, wherein the non-degradable barrier layer is in the form of a plurality of discrete reservoir caps.

6. The method of claim 1, wherein the degradable barrier layer comprises a biodegradable polymeric material.

7. The method of claim 1, wherein the degradable barrier layer comprises a metal film and the device further includes a power source and control circuitry for disintegrating the degradable barrier layer.

8. The method of claim 1, wherein the reaction between the reacting component and the analyte to be detected is a binding reaction.

20. The method of claim 1, wherein the reacting component is selected from the group consisting of metals, proteins, nucleic acids, cells, and combinations thereof.

9. A method of detecting an analyte in vivo comprising:

implanting at a site in a patient a device which comprises;

a plurality of discrete reservoirs located in a substrate, each reservoir having at least one opening,

at least one reacting component contained in each reservoir,

at least one non-degradable barrier layer, which is permeable to an analyte to be detected and covers each reservoir opening, wherein the reacting component remains inside the reservoirs, and

a degradable barrier layer, which is impermeable to the analyte to be detected and which covers the at least one non-degradable barrier layer over the reservoir opening; and

disintegrating or permeabilizing the at least one degradable barrier layer to permit the analyte at the site to enter the reservoirs and undergo a binding reaction with the at least one reacting component; and

using a sensor positioned externally from the reservoir to detect the binding reaction between the reacting component and the analyte.

10. The method of claim 9, wherein the substrate comprises a polymer.

11. The method of claim 9, wherein the at least one degradable barrier layer comprises a biodegradable polymeric material.

12. The method of claim 9, wherein the at least one degradable barrier layer comprises a metal film and the device further includes a power source and control circuitry for disintegrating the degradable barrier layer.

13. The method of claim 9, wherein the at least one non-degradable barrier layer comprises a semi-permeable polymeric membrane.

14. The method of claim 9, wherein the at least one non-degradable barrier layer comprises a nanoporous or microporous silicon membrane.

21. The method of claim 9, wherein the reacting component is selected from the group consisting of metals, proteins, nucleic acids, cells, and combinations thereof.

15. A method of detecting an analyte in vivo comprising:

implanting in a patient a device which comprises;

a plurality of discrete reservoirs located in a substrate, each reservoir having at least one opening,

at least one non-degradable barrier layer which comprises a semi-permeable polymeric membrane, which is permeable to an analyte to be detected and which covers each reservoir opening,

a degradable barrier layer, which is impermeable to the analyte to be detected and which covers the at least one non-degradable barrier layer over the reservoir opening, and

at least one reacting component which remains contained inside each of the reservoirs and can undergo a binding reaction with the analyte,

passively or actively degrading the at least one degradable barrier layer to permit the analyte to enter the reservoirs and react with the at least one reacting component; and

using a sensor positioned externally from the reservoir to detect the reaction between the reacting component and the analyte.

16. The method of claim 15, wherein the degradable barrier layer comprises a biodegradable polymeric material.

17. The method of claim 15, wherein the degradable barrier layer comprises a metal film and the device further includes a power source and control circuitry for disintegrating the degradable barrier layer.

18. The method of claim 15, wherein the substrate comprises a polymer.

19. The method of claim 15, wherein the step of detecting comprises imaging or optical detection.

22. The method of claim 15, wherein the reacting component is selected from the group consisting of metals, proteins, nucleic acids, cells, and combinations thereof.