Medical Device and Method for Diagnostic Sensing

• US 20060171888A1
• Filed: 04/10/2006
• Published: 08/03/2006
• Est. Priority Date: 03/02/2000
• Status: Active Grant

• Current Assignee: Microchips Biotech, Inc. (Keratin Biosciences, Inc.)
• Original Assignee: MicroCHIPS Inc.
• Inventors: Sheppard, Norman F. Jr., Santini, John T. Jr.
• Granted Patent: US 7,445,766 B2
• Time in Patent Office: Days
• US Class Current: 424/9.100
• 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 micromixers B01F33/30
• 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 device for use in medical diagnostics comprising:

a substrate;

a plurality of discrete reservoirs located in the substrates 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.

2. The device of claim 1, wherein the non-degradable barrier layer comprises a semi-permeable polymeric membrane.

3. The device of claim 1, wherein the non-degradable barrier layer comprises a nanoporous or microporous silicon membrane.

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

5. The device of claim 1, further comprising at least one degradable barrier layer covering each reservoir opening, the barrier layer being impermeable to the agent to be detected.

6. The device of claim 5, wherein the degradable barrier layer comprises a biodegradable polymeric material.

7. The device of claim 1, wherein the reaction between the diagnostic substance and the agent to be detected is a binding reaction.

8. The device of claim 1, wherein the device is adapted for implantation into the body of a patient.

9. The device 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.

10. A method of diagnostic sensing comprising:

implanting the device of claim 1 in a patient; and

using a sensor to detect the reaction between the diagnostic substance and the agent to be detected.

11. The method of claim 10, wherein the detecting comprises imaging or optical detection.

12. An implantable medical device for use in medical diagnostics comprising:

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;

at least one non-degradable barrier layer covering each reservoir opening, the barrier layer being permeable to an agent to be detected, wherein the at least one non-degradable barrier layer comprises a semi-permeable polymeric membrane; and

at least one degradable barrier layer covering each reservoir opening,

wherein the diagnostic substance remains inside the reservoirs and, following degradation of the at least one degradable barrier layer in vivo, can undergo a binding reaction with the agent to be detected.

13. The device of claim 12, wherein the at least one degradable barrier layer comprises a degradable polymer.

14. The device of claim 12, wherein the substrate comprises a polymer.

15. The device of claim 12, wherein the degradable barrier layer is adapted to be actively removed and leave the non-degradable layer intact.

16. The device of claim 12, which is adapted to be implanted in a patient by injection.