Hermetic implantable sensor

• US 7,894,870 B1
• Filed: 08/23/2004
• Issued: 02/22/2011
• Est. Priority Date: 02/13/2004
• Status: Active Grant

• Current Assignee: Mcnair Interests Limited
• Original Assignee: GlySens, Incorporated
• Inventors: Catlin, Mark B., Lucisano, Joseph Y.
• Primary Examiner(s): NASSER, ROBERT L
• Application Number:
  US10/925,074
• Time in Patent Office: 2,374 Days
• Field of Search: None
• US Class Current: 600/345
• 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 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 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 conductor leaving at least one exposed region thereof to provide a detection electrode; and

the at least one conductor consisting essentially of metal particles having been sintered by heating to a temperature within a range that extends from below a melting point of the metal particles to approximately three hundred degrees C. below the melting point of the metal particles, and having a reduced porosity that inhibits migration of the bodily fluid or any constituents thereof through the conductor;

whereby instances of sensor failure and/or inaccuracy during implanted operation are minimized, wherein the at least one conductor has a helium leak value below about 1E-8 (atm cc/s).

2. The sensor of claim 1 wherein the thick film material contains platinum particles and wherein the thick film material is heated to a peak temperature between about 1500 degrees C. and about 1700 degrees C.

3. The sensor of claim 1 wherein the thick film material is heated to the peak temperature for a dwell time up to about sixty minutes.

4. 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 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 consisting essentially of metal particles having been sintered by heating to a temperature within a range that extends from below a melting point of the metal particles to approximately three hundred degrees C. below the melting point of the metal particles, and having a reduced porosity that inhibits migration of fluid or gaseous diffusion through the at least one conductor, wherein the at least one conductor has a helium leak value below about 1E-8 (atm cc/s).

5. The sensor of claim 4 wherein the thick film material contains platinum particles and wherein the thick film material is heated to a peak temperature between about 1500 degrees C. and about 1700 degrees C.

6. The sensor of claim 4 wherein the thick film material is heated to the peak temperature for a dwell time up to about sixty minutes.

7. 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 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 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 conductor;

the at least one conductor consisting essentially of metal particles having been sintered by heating to a temperature within a range that extends from below a melting point of the metal particles to approximately three hundred degrees C. below the melting point of the metal particles, and having a reduced porosity that inhibits migration of the tissue fluid or constituents thereof through the conductor, wherein the at least one conductor has a helium leak value below about 1E-8 (atm cc/s);

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

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

8. A device as in claim 7 wherein the means for making an external electrical connection comprises a hole in said second biocompatible insulating material adjacent to the conductor.

9. A device as in claim 7 wherein the means for making an external electrical connection comprises a wire.

10. A device as in claim 7 wherein the means for making an external electrical connection comprises an inductive coupling.

11. A device as in claim 7 wherein the means for making an external electrical connection comprises a radiative coupling.

12. The device of claim 7 wherein the thick film material contains platinum particles and wherein the thick film material is heated to a peak temperature between about 1500 degrees C. and about 1700 degrees C.

13. The device of claim 7 wherein the thick film material is heated to the peak temperature for a dwell time up to about sixty minutes.

14. 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 and made from an electrically conductive thick film material having an inorganic portion consisting essentially of metal particles, the metal particles 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 conductor;

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

the metal particles of the at least one conductor having been sintered by heating the metal particles to a temperature within a range that extends from below a melting point of the metal particles to approximately three hundred degrees C. below the melting point of the metal particles, to yield a reduced porosity that inhibits migration of fluid or constituents thereof through the conductor, wherein the at least one conductor has a helium leak value below about 1E-8 (atm cc/s).

15. The sensor of claim 14 wherein the conductive filled via is formed of an element selected from the group consisting of a body of thick film material, a wire and a rivet.

16. The sensor of claim 14 wherein the first insulating material is selected from the group consisting of ceramic and glass/ceramic combinations.

17. The sensor of claim 14 wherein the second insulating material is selected from the group consisting of glass, ceramic, glass/ceramic combinations, and polymers.

18. The sensor of claim 14 and further comprising a first conductor formed on a first side of the substrate opposite from a second side of the substrate on which a second conductor is formed, the first conductor being in electrical contact with the conductive filled via.

19. The sensor of claim 14 and further comprising a case connected to the substrate and enclosing the conductor.

20. The sensor of claim 14 wherein the thick film material contains platinum particles and wherein the thick film material is heated to a peak temperature between about 1500 degrees C. and about 1700 degrees C.

21. The sensor of claim 14 wherein the thick film material is heated to the peak temperature for a dwell time up to about sixty minutes.

22. 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 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 consisting essentially of sintered metal particles having been sintered by heating at a time and temperature sufficient to sinter the particles to at least the extent resulting from heating for ten minutes at a temperature approximately three hundred degrees C. below a melting point of the metal particles, and having a reduced porosity that inhibits migration of fluid or gaseous diffusion through the at least one conductor, wherein the at least one conductor has a helium leak value below about 1E-8 (atm cc/s).

23. 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 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 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 conductor;

the at least one conductor consisting essentially of sintered metal particles having been sintered by heating at a time and temperature sufficient to sinter the particles to at least the extent resulting from heating for ten minutes at a temperature approximately three hundred degrees C. below a melting point of the metal particles, and having a reduced porosity that inhibits migration of fluid or gaseous diffusion through the at least one conductor, wherein the at least one conductor has a helium leak value below about 1E-8 (atm eels);

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

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