US 12,478,734 B2
Methods and systems for insulin delivery and glucose measurement
William Kenneth Ward, Portland, OR (US); Robert S. Cargill, Portland, OR (US); Gabriel Heinrich, Portland, OR (US); Sheila Benware, Clackamas, OR (US); Mark Vreeke, Aliso Viejo, CA (US); Joseph D. Kowalski, Portland, OR (US); and Thomas Seidl, Tigard, OR (US)
Assigned to PACIFIC DIABETES TECHNOLOGIES INC., Portland, OR (US)
Filed by Pacific Diabetes Technologies Inc, Portland, OR (US)
Filed on Jun. 24, 2025, as Appl. No. 19/247,755.
Application 19/247,755 is a continuation of application No. 18/907,846, filed on Oct. 7, 2024, granted, now 12,383,675.
Application 18/907,846 is a continuation of application No. 17/410,866, filed on Aug. 24, 2021, abandoned.
Application 17/410,866 is a continuation of application No. 16/992,772, filed on Aug. 13, 2020, granted, now 11,135,369, issued on Oct. 5, 2021.
Application 16/992,772 is a continuation of application No. 15/169,432, filed on May 31, 2016, granted, now 10,780,222, issued on Sep. 22, 2020.
Claims priority of provisional application 62/170,655, filed on Jun. 3, 2015.
Prior Publication US 2025/0319255 A1, Oct. 16, 2025
This patent is subject to a terminal disclaimer.
Int. Cl. A61M 5/172 (2006.01); A61M 5/142 (2006.01)
CPC A61M 5/1723 (2013.01) [A61M 5/142 (2013.01)] 14 Claims
OG exemplary drawing
 
1. A method comprising:
(a) inserting an insulin delivery device subcutaneously into a body of a 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,
wherein said insulin or insulin analog formulation comprises an excipient comprising a phenol or cresol,
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,
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).