Medical device for sensing glucose

• US 8,095,197 B2
• Filed: 11/03/2004
• Issued: 01/10/2012
• Est. Priority Date: 11/03/2003
• Status: Active Grant

• Current Assignee: DARE MB Incorporated
• Original Assignee: MicroCHIPS Inc.
• Inventors: Santini, John T. Jr., Herman, Stephen J.
• Primary Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US10/980,551
• Publication Number:
  US 20050096587A1
• Time in Patent Office: 2,624 Days
• Field of Search: 600/347, 600/365
• US Class Current: 600/347
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/4839 combined with drug delivery
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

Medical devices, utilizing multiple reservoirs to protect and selectively expose sensors or other reservoir contents, are provided having (i) a reservoir contents destruction mechanism to interrupt the release or exposure of reservoir contents, for example, to deactivate an unneeded sensor and prevent it from negatively impacting other sensors, (ii) a protective covering material layer over the sensor underneath the reservoir cap, which protects the sensor membrane and sensor during reservoir cap disintegration and then is removed, (iii) a device design for containing sensors in shallow, wide reservoir structures to enhance sensor exposure by minimizing molecular diffusion distances, (iv) an implantable sensor unit and a separate drug delivery unit, or (v) combinations thereof.

Claims

1. A device for the controlled exposure of a secondary device, comprising:

a substrate having a reservoir;

an operational secondary device in the reservoir;

one or more reservoir caps covering the reservoir to isolate the secondary device from an environmental component outside the reservoir, wherein the one or more reservoir caps are impermeable to the environmental component;

means for disintegrating or permeabilizing the one or more reservoir caps to expose the secondary device to the environmental component; and

a resistive heater for selectively rendering the secondary device inoperable.

2. The device of claim 1, wherein the means for disintegrating or permeabilizing comprises a microprocessor programmed to initiate said disintegrating or permeabilizing at a specified time, upon receipt of a signal from another device, or upon detection of a specified sensed condition.

3. The device of claim 1, wherein the secondary device comprises a sensor or a sensing component.

4. The device of claim 3, wherein the sensor or sensing component comprises a glucose sensor.

5. The device of claim 4, wherein the sensor or sensing component comprises glucose oxidase.

6. The device of claim 3, wherein the sensor or sensor component comprises an enzyme and the resistive heater generates heat effective to deactivate the enzyme.

7. A method for detecting or measuring a property at a site, the method comprising the steps of:

providing at the site the device of claim 3; and

disintegrating or permeabilizing the one or more reservoir caps, using the means for disintegrating or permeabilizing, to expose the sensor or sensing component in the reservoir; and

detecting or measuring a property in or adjacent to the exposed sensor or sensing component.

8. The method of claim 7, further comprising the step of rendering the sensor or sensing component inoperable by passing an electric current through the resistive heater.

9. The method of claim 7, wherein the sensor or sensing component is a glucose sensor.

10. The device of claim 6, wherein the enzyme comprises a glucose oxidase.

11. The device of claim 3, wherein the sensor or sensing component comprises at least one working electrode, a counter electrode, an enzyme provided on the at least one working electrode, and a semipermeable membrane covering the enzyme and at least part of the at least one working electrode.

12. The device of claim 1, wherein the substrate is monolithic.

13. The device of claim 1, further comprising a biodegradable intermediary material disposed in the reservoir underneath the one or more reservoir caps and covering the secondary device.

14. The device of claim 1, further comprising a thin layer of a structural material underneath the one or more reservoir caps and an evacuated or gas-filled space in the reservoir between the secondary device and the structural material layer.

15. The device of claim 1, wherein the substrate comprises two or more portions bonded together.

16. A medical device comprising:

an implantable sensor unit which comprises the device of claim 1, wherein the secondary device comprises a sensor; and

a drug delivery unit comprising at least one therapeutic agent for release,

wherein the drug delivery unit is in communication with the implantable sensor unit and releases the therapeutic agent in response to the sensor'"'"'s sensing of the environmental component.

17. A device for the controlled exposure of a secondary device, comprising:

a substrate having a reservoir;

a secondary device in the reservoir;

one or more reservoir caps covering the reservoir to isolate the secondary device from an environmental component outside the reservoirs, wherein the one or more reservoir caps are impermeable to the environmental component;

a biodegradable intermediary material disposed in the reservoir underneath the one or more reservoir caps and covering the secondary device; and

means for disintegrating or permeabilizing the one or more reservoir caps to expose the biodegradable intermediary material to a fluid from outside the device to cause the biodegradable intermediary material to disintegrate to expose the secondary device to the environmental component.

18. The device of claim 17, further comprising a layer of a structural material underneath the one or more reservoir caps and disposed between the biodegradable intermediary material and the one or more reservoir caps.

19. The device of claim 18, wherein the structural material comprises a dielectric material.

20. The device of claim 17, wherein the biodegradable intermediary material comprises a water-soluble solid, liquid, or gel.

21. The device of claim 17, wherein the biodegradable intermediary material comprises a polyethylene glycol, a polyethylene oxide, or a copolymer of poly (lactic-co-glycolic) acid.

22. The device of claim 17, wherein the secondary device comprises a sensor or sensing component.

23. The device of claim 22, wherein the sensor or sensing component comprises a glucose sensor.

24. The device of claim 22, wherein the sensor or sensing component comprises glucose oxidase.

25. The device of claim 22, wherein the sensor or sensing component comprises at least one working electrode, a counter electrode, an enzyme provided on the at least one working electrode, and a semipermeable membrane covering the enzyme and at least part of the at least one working electrode.

26. The device of claim 17, further comprising a means for selectively rendering the secondary device inoperable.

27. A medical device comprising:

an implantable sensor unit which comprises the device of claim 17, wherein the secondary device comprises a sensor; and

a drug delivery unit comprising at least one therapeutic agent for release,

wherein the drug delivery unit is in communication with the implantable sensor unit and releases the therapeutic agent in response to the sensor'"'"'s sensing of the environmental component.

28. The device of claim 17, wherein the reservoir is a microreservoir.