Systems, devices, and methods related to the individualized calibration and/or manufacturing of medical devices

Patent metadata

Field	Value
Publication number	US-12285252-B2
Application number	US-202217950538-A
Country	US
Kind code	B2
Filing date	Sep 22, 2022
Priority date	Aug 18, 2017
Publication date	Apr 29, 2025
Grant date	Apr 29, 2025

Abstract

Systems, devices, kits, and methods are provided herein in the form of example embodiments that relate to calibration of medical devices. The medical devices can be sensors adapted to sense a biochemical attribute. The embodiments can be used to determine calibration information specific to an individual medical device. The embodiments can determine the calibration information by reference to one or more parameters obtained during manufacturing of the medical device. The embodiments can also determine the calibration information by reference to in vitro testing of the medical devices. The embodiments also apply to systems incorporating those medical devices in their use in the field. Also described are embodiments of modifications to surfaces of sensor substrates, such as through applied radiation and/or the creation of a well, to aid in the placement and/or sizing of a sensor element on the substrate.

First claim

What is claimed is:

1. A method comprising:
physically associating with each of a first plurality of medical devices that comprise a lot, one or more identifiers that uniquely identifies the respective medical device of the first plurality, such that each respective medical device of the first plurality can be uniquely identifiable by the one or more identifiers associated with the respective medical device of the first plurality;
subjecting the first plurality of medical devices that were physically associated with the one or more respective identifiers to one or more manufacturing stages and, during at least one of the one or more manufacturing stages:
reading one or more of the identifiers physically associated with the respective medical device of the first plurality; and
obtaining one or more manufacturing parameters associated with the respective medical device of the first plurality;

storing the one or more obtained manufacturing parameters;
subjecting a second plurality of medical devices to one or more in vitro tests, wherein the second plurality is a first subset of the first plurality;
obtaining in vitro test data from one or more of the in vitro tests, and storing the in vitro test data;
determining, for a third plurality medical devices for which the one or more manufacturing parameters were stored, and based at least in part on the stored in vitro test data and one or more of the one or more stored manufacturing parameters associated with the respective medical device of the first plurality, individualized calibration information associated with the respective medical device of the first plurality, wherein the third plurality is a second subset of the first plurality;
for each of the third plurality of medical devices for which the individualized calibration information was determined:
reading one or more of the identifiers that were physically associated with the respective medical device of the third plurality;
retrieving, based at least in part on one or more of the identifiers that was read after determining the individualized calibration information associated with the respective medical device of the third plurality, the individualized calibration information associated with the respective medical device of the third plurality; and
wirelessly transmitting to an electronics unit associated with the respective medical device of the third plurality the retrieved individualized calibration information associated with the respective medical device of the third plurality, wherein after receipt by the electronics unit the individualized calibration information is stored in a non-transitory memory of the electronics unit, wherein:
the respective medical device of the third plurality is a transcutaneous electrochemical glucose sensor that comprises an ex vivo portion positionable above a skin surface of a user and an in vivo portion positionable below the skin surface to contact an interstitial fluid of the user to detect a plurality of glucose levels using a glucose-responsive enzyme; and
when the respective medical device of the third plurality is distributed to the user the respective medical device of the third plurality is integrated with the electronics unit and does not require user calibration.

2. The method of claim 1 , wherein the second plurality of medical devices are not distributed to users.

3. The method of claim 2 , wherein the one or more manufacturing parameters obtained at the one or more manufacturing stages comprises one or more quantitative manufacturing parameters and the individualized calibration information associated with the respective medical device of the third plurality is determined based at least in part on the one or more quantitative manufacturing parameters.

4. The method of claim 2 , wherein the one or more identifiers comprises a Near Field Communication (NFC) element.

5. The method of claim 2 , wherein the one or more identifiers comprises a printed two-dimensional code.

6. The method of claim 2 , wherein the one or more identifiers comprises a barcode.

7. The method of claim 2 , wherein the one or more identifiers comprises optical character recognizable (OCR) text.

8. The method of claim 2 , wherein the one or more identifiers comprises a resistive code.

9. The method of claim 3 , wherein obtaining the one or more quantitative manufacturing parameters comprises one or more of: measuring a value of the one or more quantitative manufacturing parameters, calculating a relative indication of the one or more quantitative manufacturing parameters, or calculating the one or more quantitative manufacturing parameters based at least in part on a measured value.

10. The method of claim 3 , wherein the one or more quantitative manufacturing parameters is specific to the respective medical device of the first plurality.

11. The method of claim 3 , wherein the one or more manufacturing parameters obtained at the one or more manufacturing stages comprises a qualitative manufacturing parameter that identifies:
a current date and time;
the respective manufacturing stage;
a particular piece of equipment used during the respective manufacturing stage; or
a length of time the respective medical device of the first plurality spent at the respective manufacturing stage.

12. The method of claim 3 , wherein the one or more quantitative manufacturing parameters comprises a size or dimensional measurement associated with the respective medical device of the first plurality.

13. The method of claim 3 , wherein the one or more quantitative manufacturing parameters comprises a chemical composition or chemical concentration associated with the respective medical device of the first plurality.

14. The method of claim 3 , wherein the one or more quantitative manufacturing parameters comprises an electrical characteristic associated with the respective medical device of the first plurality.

15. The method of claim 14 , wherein the electrical characteristic is impedance.

16. The method of claim 3 , wherein the individualized calibration information comprises a plurality of sensitivity slopes associated with the respective medical device of the first plurality.

17. The method of claim 3 , wherein the one or more manufacturing parameters is associated with an environmental condition.

18. The method of claim 17 , wherein the one or more manufacturing parameters associated with an environmental condition is associated with temperature, temperature variation, ambient pressure, pressure variation, an amount of time the respective medical device of the first plurality spent at the respective manufacturing stage, or an amount of time the respective medical device of the first plurality spent between the one or more of the manufacturing stages.

19. The method of claim 1 , wherein wirelessly transmitting the retrieved individualized calibration information comprises wirelessly transmitting using a Near Field Communication (NFC) element.

20. The method of claim 1 , wherein when the respective medical device of the third plurality is distributed to the user it does not require system calibration.

21. The method of claim 1 , wherein each of the one or more manufacturing parameters is an individualized manufacturing parameter.

22. The method of claim 21 , wherein each of the respective medical devices of the first plurality includes a membrane for a sensing region, and the one or more individualized manufacturing parameters is a size of the membrane.

Assignees

• Abbott Diabetes Care Inc

Inventors

• Scott Steven
• Bennell Christopher J
• Bhogal Claire
• Cranfield Katie A
• Taub Marc B
• Winter Bree M
• Reynolds Owen D
• Babka Jean-Pierre
• Patel Dharmendra S
• Thomas Christopher A
• Hoss Udo
• Yahnke Mark S
• Khan Tahir S

Classifications

• A61B2562/12

  Manufacturing methods specially adapted for producing sensors for in-vivo measurements · CPC title

• A61B2560/0223

  of calibration, e.g. protocols for calibrating sensors · CPC title

• A61B5/14546

  for measuring analytes not otherwise provided for, e.g. ions, cytochromes · CPC title

• A61B5/14532

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• A61B5/14503

  invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence) · CPC title