Hermetic implantable sensor

• US 10,041,897 B2
• Filed: 02/09/2011
• Issued: 08/07/2018
• Est. Priority Date: 02/13/2004
• Status: Active Grant

• Current Assignee: Mcnair Interests Limited
• Original Assignee: GlySens, Incorporated
• Inventors: Lucisano, Joseph Y., Catlin, Mark B.
• Primary Examiner(s): BERHANU, ETSUB D
• Application Number:
  US13/024,209
• Publication Number:
  US 20110137142A1
• Time in Patent Office: 2,736 Days
• Field of Search: 600345, 600347
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: G01N 27/12 of a solid body in dependence upon absorption of a fluid; of a solid body in dependence upon reaction with a fluid , for detecting components in the fluid

Abstract

At least one conductor is formed at a preselected location on a substrate made of a first insulating material having a high temperature resistance. The conductor is made from a solidified electrically conductive thick film material. A coating made of a second insulating material is formed over the substrate to hermetically seal at least a portion of the conductor. An exposed distal region of the conductor provides a detection electrode. The conductor has a reduced porosity that inhibits migration of fluid or constituents thereof through the conductor.

Claims

1. A sensor, comprising:

a substrate made of a first insulating material having a high temperature resistance;

at least one conductor disposed over a preselected external surface location on the substrate, wherein the external surface location is planar and disposed on an upper or lower external surface of the substrate, and the at least one conductor is elongated along the external surface location and made from a solidified electrically conductive thick film material which contains particles of a metal selected from the group consisting of platinum, palladium, rhodium, ruthenium, iridium and osmium;

a coating made of a second insulating material formed over at least a portion of the at least one conductor to hermetically seal at least a portion of the at least one conductor;

an exposed distal region of the at least one conductor providing a detection electrode; and

the at least one conductor being sintered by heating to a temperature within a range that extends from below a melting point of the particles of metal to approximately 300°

C. below the melting point of the particles of metal and having a reduced porosity that inhibits migration of fluid or constituents thereof through the at least one conductor, wherein the at least one conductor is hermetic along its elongated length.

2. The sensor of claim 1 wherein the first insulating material is selected from the group consisting of ceramic and glass/ceramic combinations.

3. The sensor of claim 2 wherein the ceramic is selected from the group consisting of oxides, carbides, borides, nitrides, and silicides of aluminum, zirconium, beryllium, silicon, titanium, yttrium, and zinc and mixtures thereof.

4. The sensor of claim 1, wherein the second insulating material is selected from the group consisting of glass, ceramic, glass/ceramic combinations, and polymers.

5. The sensor of claim 1 wherein the substrate has a generally planar configuration.

6. The sensor of claim 1 wherein there are at least two conductors that are elongated and parallel.

7. The sensor of claim 1 wherein at least one insulation-testing conductor is formed on the substrate in addition to the at least one conductor, and the coating of the second insulating material hermetically seals at least a portion of the insulation-testing conductor that may come into contact with a fluid.

8. The sensor of claim 1 further comprising a source of glucose oxidase (GO) positioned in operative contact with the detection electrode for catalyzing the reaction of glucose and oxygen.

9. The sensor of claim 1 wherein an exposed proximal region of the at least one conductor provides a contact pad.

10. The sensor of claim 1 wherein an electrical contact connects to the at least one conductor, the contact being selected from the group consisting of a metal wire, sintered metal particles, a sintered mixture of metal and inorganic oxide particles, and a metal plug.

11. A sensor suitable for implanting in living tissue for monitoring the level of a biological agent in a tissue fluid, comprising:

a substrate made of a first biocompatible insulating material having a high temperature resistance selected from the group consisting of ceramic and glass/ceramic combinations;

at least one conductor disposed over a preselected external surface location on the substrate, wherein the external surface location is planar and disposed on an upper or lower external surface of the substrate, and the at least one conductor is elongated along the external surface location and made from an electrically conductive thick film material containing particles of a metal selected from the group consisting of platinum, palladium, rhodium, ruthenium, iridium and osmium;

a coating made of a second biocompatible insulating material selected from the group consisting of glass, ceramic, glass/ceramic combinations, and polymers, and formed over at least a portion of the at least one conductor to hermetically seal at least a portion of the at least one conductor leaving at least one exposed region thereof to provide a detection electrode; and

the at least one conductor being made of metal particles sintered by heating to a temperature within a range that extends from below a melting point of the particles of metal to approximately 300°

C. below the melting point of the particles of metal and the at least one conductor having a reduced porosity that inhibits migration of the tissue fluid or any constituents thereof through the at least one conductor, wherein the at least one conductor is hermetic along its elongated length;

whereby instances of sensor failure and/or inaccuracy during implanted operation are minimized.

12. An electrochemical sensor, comprising:

a substrate made of a first insulating material having a high temperature resistance;

at least one conductor disposed over a preselected external surface location on the substrate, wherein the external surface location is planar and disposed on an upper or lower external surface of the substrate, and the at least one conductor is elongated along the external surface location and made from an electrically conductive thick film material containing particles of a metal selected from the group consisting of platinum, palladium, rhodium, ruthenium, iridium and osmium;

a coating made of a second insulating material formed over at least a portion of the at least one conductor to hermetically seal at least a portion of the at least one conductor leaving at least one exposed region to provide a detection electrode; and

the at least one conductor being sintered by heating to a temperature within a range that extends from below a melting point of the particles of metal to approximately 300°

C. below the melting point of the particles of metal and having a reduced porosity that inhibits migration of fluid or gaseous diffusion through the at least one conductor, where the at least one conductor is hermetic along its elongated length.

13. A device, a portion of which relies on the conduction of electricity for its function, suitable for implanting in living tissue, which may come into contact with tissue fluid, comprising:

a substrate made of a first biocompatible insulating material having a high temperature resistance;

at least one conductor disposed over a preselected external surface location on the substrate, wherein the external surface location is planar and disposed on an upper or lower external surface of the substrate, and the at least one conductor is elongated along the external surface location and made from a solidified electrically conductive thick film material containing particles of a metal selected from the group consisting of platinum, palladium, rhodium, ruthenium, iridium and osmium;

a coating made from a second biocompatible insulating material formed over at least a portion of the at least one conductor to hermetically seal at least a portion of the at least one conductor;

the at least one conductor being sintered by heating to a temperature within a range that extends from below a melting point of the particles of metal to approximately 300°

C. below the melting point of the particles of metal and having a reduced porosity that inhibits migration of the tissue fluid or constituents thereof through the at least one conductor, wherein the at least one conductor is hermetic along its elongated length;

a sealed internal portion of the device containing electrical circuitry; and

means for making an electrical connection to the at least one conductor from the exterior of the device.

14. A device as in claim 13 wherein the means for making an external electrical connection comprises a hole in said second biocompatible insulating material adjacent to the at least one conductor.

15. A device as in claim 13 wherein the means for making an external electrical connection comprises a wire.

16. A device as in claim 13 wherein the means for making an external electrical connection comprises an inductive coupling.

17. A device as in claim 13 wherein the means for making an external electrical connection comprises a radiative coupling.

18. A sensor, comprising:

a substrate made of a first insulating material having a high temperature resistance;

at least one conductor disposed over a preselected external surface location on the substrate, wherein the external surface location is planar and disposed on an upper or lower external surface of the substrate, and the at least one conductor is elongated along the external surface location and made from a solidified electrically conductive thick film material containing particles of a metal selected from the group consisting of platinum, palladium, rhodium, ruthenium, iridium and osmium;

a coating made of a second insulating material formed over at least a portion of the at least one conductor to hermetically seal at least a portion of the at least one conductor;

a conductive filled via formed in an aperture in the substrate and in electrical contact with the at least one conductor; and

the at least one conductor being sintered by heating to a temperature within a range that extends from below a melting point of the particles of metal to approximately 300°

C. below the melting point of the particles of metal and having a reduced porosity that inhibits migration of fluid or constituents thereof through the at least one conductor, wherein the at least one conductor is hermetic along its elongated length.