Granted Patent B1

US 12,383,675 · App. 18/907,846 · Granted Aug 12, 2025

Inventors: William Kenneth Ward (Portland, OR); Robert S. Cargill (Portland, OR); Gabriel Heinrich (Portland, OR); Sheila Benware (Clackamas, OR); Mark Vreeke (Aliso Viejo, CA); Joseph D. Kowalski (Portland, OR); Thomas Seidl (Tigard, OR)

Assignee: Pacific Diabetes Technologies Inc

A61M5/1723A61M5/142

Abstract

Claims (20)

1. A method comprising:

(a) inserting an insulin delivery device subcutaneously into a body of a subject via a single puncture site in said body of said subject,

wherein said insulin delivery device comprises an amperometric glucose sensor comprising an electrode layer comprising at least one indicating electrode, wherein said electrode layer underlies a redox-catalytic layer comprising a redox mediator;

(b) using said insulin delivery device to deliver an insulin or insulin analog formulation subcutaneously to said subject via said single puncture site,

wherein said insulin delivery device comprises a hollow tube comprising a proximal end and a distal end, wherein said proximal end is in fluid communication with a source of said insulin or insulin analog formulation; and

(c) using said amperometric glucose sensor to measure a subcutaneous glucose concentration in said body of said subject via said single puncture site,

wherein said measuring comprises using said redox-catalytic layer to allow electron transfer from subcutaneous glucose to said at least one indicating electrode sufficient to cause a response of said amperometric glucose sensor to said subcutaneous glucose concentration at an applied bias potential of no more than +250 millivolts (mV) relative to a reference electrode,

wherein (b) and (c) are performed at the same time for a time period of at least one hour subsequent to said positioning in (a), while maintaining a sensitivity of said sensor of at least 50% of an initial sensitivity of said sensor up to one hour subsequent to said positioning in (a).

2. The method of claim 1 , wherein said redox-catalytic layer comprises an osmium-based redox mediator.

3. The method of claim 2 , wherein said osmium-based redox mediator comprises an osmium compound covalently bound to a pyridine-based or imidazole-based ligand, and an enzyme comprising glucose oxidase or glucose dehydrogenase.

4. The method of claim 3 , wherein said pyridine-based or imidazole-based ligand is pyridine-based.

5. The method of claim 4 , wherein said pyridine-based ligand is 4,4′-dimethyl-2,2′-bipyridine.

6. The method of claim 3 , wherein said pyridine-based or imidazole-based ligand is imidazole-based.

7. The method of claim 1 , wherein said at least one indicating electrode comprises gold, carbon, graphite, platinum, or iridium.

8. The method of claim 1 , wherein said applied bias potential of no more than +250 mV relative to said reference electrode allows said electrode layer to undergo substantially no electropolymerization of an excipient during continuous operation of at least one hour of said amperometric glucose sensor.

9. The method of claim 1 , wherein said reference electrode comprises a silver/silver chloride (Ag/AgCl) reference electrode.

10. The method of claim 1 , wherein said amperometric glucose sensor further comprises an insulating layer and a metal layer, wherein said insulating layer is coupled to said metal layer, and wherein said metal layer is coupled to said electrode layer.

11. The method of claim 10 , wherein said insulating layer comprises a polyimide.

12. The method of claim 10 , wherein said metal layer comprises titanium, gold, or platinum.

13. The method of claim 1 , wherein said insulin or insulin analog formulation comprises an excipient comprising a phenol or cresol.

Assignments (3)

Continuity (4)

References Cited (143)

Cited By (1)

US 12,611,504