COMBINED DRUG DELIVERY AND ANALYTE SENSOR APPARATUS

• US 20060263839A1
• Filed: 05/10/2006
• Published: 11/23/2006
• Est. Priority Date: 05/17/2005
• Status: Abandoned Application

• Current Assignee: Konamite Limited
• Original Assignee: Isense Corporation
• Inventors: Ward, W. Kenneth, Neinast, Mark, Sass, Richard
• Application Number:
  US11/382,674
• Publication Number:
  US 20060263839A1
• Time in Patent Office: Days
• US Class Current: 435/14
• 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 5/14865 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: A61B 5/6848 Needles
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

Embodiments of the present invention provide methods and apparatuses for analyte sensing combined with drug delivery in an integrated system. In an embodiment, a device may be utilized to sense an analyte, and in response to a measurement obtained therefrom, introduce a controlled amount of a drug to a user as a corrective action.

Claims

1. A device, comprising:

a hollow structure configured for placement into the tissue of a mammal, said hollow structure having an outer surface, a proximal end and a distal end, and at least one lumen, said at least one lumen providing a passage through which a drug may be delivered to the mammal;

at least one indicating electrode disposed on at least a portion of the outer surface of said hollow structure; and

compounds disposed on at least a portion of said at least one indicating electrode, said compounds being responsive to a concentration of an analyte, said compounds including a sensing compound.

2. The device of claim 1, wherein said sensing compound comprises a redox enzyme.

3. The device of claim 1, wherein at least one of said at least one indicating electrode encircles said hollow structure in one or more rings.

4. The device of claim 1, wherein said at least one indicating electrode circumscribes and covers said hollow structure.

5. The device of claim 1, wherein at least one of said at least one indicating electrode comprises an electrical trace on said hollow structure.

6. The device of claim 1, wherein each of said at least one indicating electrode comprises at least one member selected from the group consisting of platinum, gold, silver, palladium, tantalum, and carbon.

7. The device of claim 1, wherein said hollow structure is coupled at said proximal end to a drug delivery apparatus.

8. The device of claim 7, wherein said drug delivery apparatus comprises a pump.

9. The device of claim 7, wherein said drug delivery apparatus comprises a drug reservoir.

10. The device of claim 1, where said at least one lumen comprises more than one lumen.

11. The device of claim 1, wherein said at least one lumen comprises a drug port at the distal end of said hollow structure.

12. The device of claim 1, wherein said at least one lumen comprises one or more drug ports along the device, proximal to the distal end of said hollow structure.

13. The device of claim 1, wherein the distal end of said hollow structure is closed.

14. The device of claim 1, wherein said hollow structure comprises a metal.

15. The device of claim 1, wherein said hollow structure comprises a polymer.

16. The device of claim 1, wherein said hollow structure comprises glass.

17. The device of claim 1, wherein said hollow structure is coupled at said proximal end to an on-skin electronics module comprising a transmitter.

18. The device of claim 17, wherein said on-skin electronics module further comprises a pump.

19. The device of claim 17, wherein said on-skin electronics module further comprises a drug reservoir.

20. The device of claim 17, wherein said hollow structure exits said on-skin electronics module at an angle of about 20-30°

with respect to the lower surface of the on-skin electronics module which is configured to contact a user'"'"'s skin.

21. The device of claim 17, wherein said on-skin electronics module further comprises a silver/silver-chloride layer on the lower surface of the on-skin electronics module, said layer configured to contact a user'"'"'s skin.

22. The device of claim 1, wherein said compounds define one or more sensing regions, each sensing region being associated with an indicating electrode.

23. The device of claim 22, wherein each sensing region is associated with a different indicating electrode.

24. The device of claim 23, wherein each sensing region comprises a different sensing compound.

25. The device of claim 1, wherein said compounds comprise a series of membrane layers.

26. The device of claim 25, wherein said series of membrane layers comprises an innermost specificity membrane layer, an intermediate enzyme layer, and an outermost permselective membrane layer.

27. A device, comprising:

an on-skin electronics module configured to be placed on the skin of a mammal;

a hollow structure coupled to said on-skin structure and configured for placement into the tissue of the mammal, said hollow structure having a lumen, said lumen providing a passage through which a drug may be delivered to the mammal;

an analyte sensor coupled to said on-skin structure and configured for placement into the tissue of the mammal, said analyte sensor having compounds disposed on a surface thereof, said compounds being responsive to a concentration of an analyte by generating an electrical current, said compounds including a sensing compound; and

wherein said hollow structure exits said on-skin structure at a first exit point and said analyte sensor exits said on-skin structure at a second exit point, said first exit point being separated from said second exit point.

28. The device of claim 27, wherein said first exit point is separated from said second exit point by about 6 mm or more.

29. The device of claim 27, wherein said first exit point is separated from said second exit point by more than about 15 mm.