US 12,279,867 B2
Systems, devices, and methods related to the individualized calibration and/or manufacturing of medical devices
Steven Scott, Pleasanton, CA (US); Christopher J. Bennell, Carterton (GB); Claire Bhogal, Witney (GB); Katie A. Cranfield, Reading (GB); Marc B. Taub, Mountain View, CA (US); Bree M. Winter, Witney (GB); Owen D. Reynolds, Cricklade (GB); Jean-Pierre Babka, San Rafael, CA (US); Dharmendra S. Patel, Stanton Harcourt (GB); Christopher A. Thomas, Cheltenham (GB); Udo Hoss, San Ramon, CA (US); Mark S. Yahnke, Alameda, CA (US); and Tahir S. Khan, Fremont, CA (US)
Assigned to ABBOTT DIABETES CARE INC., Alameda, CA (US)
Filed by ABBOTT DIABETES CARE INC., Alameda, CA (US)
Filed on Aug. 15, 2023, as Appl. No. 18/233,935.
Application 18/233,935 is a continuation of application No. 17/950,538, filed on Sep. 22, 2022.
Application 17/950,538 is a continuation of application No. 17/891,588, filed on Aug. 19, 2022.
Application 17/891,588 is a continuation of application No. 17/543,633, filed on Dec. 6, 2021.
Application 17/543,633 is a continuation of application No. 17/306,833, filed on May 3, 2021, granted, now 11,191,463, issued on Dec. 7, 2021.
Application 17/306,833 is a continuation of application No. 15/999,212, filed on Aug. 17, 2018, granted, now 10,993,646, issued on May 4, 2021.
Claims priority of provisional application 62/547,635, filed on Aug. 18, 2017.
Prior Publication US 2023/0389838 A1, Dec. 7, 2023
Int. Cl. A61B 5/1495 (2006.01); A61B 5/00 (2006.01); A61B 5/145 (2006.01); A61M 1/16 (2006.01)
CPC A61B 5/1495 (2013.01) [A61B 5/14503 (2013.01); A61B 5/14532 (2013.01); A61B 5/14546 (2013.01); A61B 5/0002 (2013.01); A61B 2560/0223 (2013.01); A61B 2562/12 (2013.01); A61M 1/1603 (2014.02)] 29 Claims
OG exemplary drawing
 
1. A method for manufacturing an in vivo glucose sensor system, comprising:
providing a plurality of in vivo glucose sensors, each in vivo glucose sensor of the plurality of in vivo glucose sensors comprising a respective unique identifier for uniquely identifying each respective in vivo glucose sensor of the plurality of in vivo glucose sensors during each of a plurality of stages of manufacturing, wherein each unique identifier is one of a barcode, a printed QR code, an optical character recognizable text, a resistive code, and a radio frequency readable device, wherein each in vivo glucose sensor is configured to generate electrical signals indicative of levels of glucose in an interstitial fluid, and each glucose sensor includes:
a proximal portion configured to be positioned above a skin surface of a user, and
a distal portion configured to be inserted through the skin surface and in contact with the interstitial fluid;
subjecting a first in vivo glucose sensor of the plurality of in vivo glucose sensors to a first manufacturing stage, wherein the first manufacturing stage includes:
electronically reading the respective unique identifier to uniquely identify the first in vivo glucose sensor;
measuring a first individualized manufacturing parameter associated with the first in vivo glucose sensor; and
storing, in a log, the first individualized manufacturing parameter associated with the first in vivo glucose sensor, an indication of a first date corresponding to the first manufacturing stage, and an indication of a first time corresponding to the first manufacturing stage;
subjecting the first in vivo glucose sensor of the plurality of in vivo glucose sensors to a second manufacturing stage, wherein the second manufacturing stage includes:
electronically reading the respective unique identifier to uniquely identify the first in vivo glucose sensor;
measuring a second individualized manufacturing parameter associated with the first in vivo glucose sensor; and
storing, in the log, the second individualized manufacturing parameter associated with the first in vivo glucose sensor, an indication of a second date corresponding to the second manufacturing stage, and an indication of a second time corresponding to the second manufacturing stage;
obtaining, by at least one processor, individualized calibration information associated with the first in vivo glucose sensor, wherein the individualized calibration information is based at least in part on at least one of the first individualized manufacturing parameter associated with the respective in vivo glucose sensor and the second individualized manufacturing parameter associated with the respective in vivo glucose sensor;
assigning the first in vivo glucose sensor to a first electronics unit, the first electronics unit having a non-transitory memory;
fixedly connecting the first in vivo glucose sensor with the first electronics unit to form a first integrated in vivo glucose sensor system;
transmitting to the first electronics unit the individualized calibration information associated with the first in vivo glucose sensor for storage in the non-transitory memory of the first electronics unit; and
packaging the first integrated in vivo glucose sensor system;
wherein the first integrated in vivo glucose sensor system has a predetermined monitoring time period and is usable for the predetermined monitoring time period without an in vitro blood glucose measurement calibration using a finger stick and an in vitro glucose test strip.