Glucose sensor product

Patent metadata

Field	Value
Publication number	US-9616165-B2
Application number	US-201514788668-A
Country	US
Kind code	B2
Filing date	Jun 30, 2015
Priority date	Mar 9, 2011
Publication date	Apr 11, 2017
Grant date	Apr 11, 2017

Abstract

A glucose sensor product maintains the sterility of the glucose sensor while allowing gaseous manufacturing by-products to be vented from the inside of the glucose sensor package. An exemplary glucose sensor product includes a plastic package tray and a glucose sensor assembly in the plastic package tray. The glucose sensor assembly includes an electrochemical sensor with glucose oxidase enzyme, a sensor base formed at least in part from plastic, a sensor mounting pedestal formed at least in part from plastic, and a sensor introducer formed at least in part from plastic. The glucose sensor product also includes a microbial barrier material coupled to the plastic package tray to seal the glucose sensor assembly in the plastic package tray. The microbial barrier material maintains sterility of the glucose sensor assembly while venting substances outgassed from the plastic package tray, the sensor base, the sensor mounting pedestal, and the sensor introducer.

First claim

What is claimed is:

1. A glucose sensor product comprising:
a plastic package tray;
a glucose sensor assembly in the plastic package tray, the glucose sensor assembly comprising an electrochemical sensor with glucose oxidase enzyme, a sensor base formed at least in part from plastic, a sensor mounting pedestal formed at least in part from plastic, and a sensor introducer formed at least in part from plastic; and
a microbial barrier material coupled to the plastic package tray to seal the glucose sensor assembly in the plastic package tray, wherein the microbial barrier material maintains sterility of the glucose sensor assembly while venting substances outgassed from the plastic package tray, the sensor base, the sensor mounting pedestal, and the sensor introducer.

2. The glucose sensor product of claim 1 , wherein the substances outgassed from the plastic package tray, the sensor base, the sensor mounting pedestal, and the sensor introducer include substances selected from the group consisting of: alcohol; ethanol; solvents; volatile (non)condensable materials; low-molecular-weight additives; reactive diluents; and absorbed moisture.

3. The glucose sensor product of claim 1 , wherein the microbial barrier material vents substances that would otherwise degrade the glucose oxidase enzyme.

4. The glucose sensor product of claim 1 , wherein the microbial barrier material is composed of high-density polyethylene.

5. The glucose sensor product of claim 1 , wherein:
the glucose sensor assembly is subjected to a sterilization process; and
the microbial barrier material maintains sterility of the glucose sensor assembly while venting volatile substances produced as by-products of the sterilization process.

6. The glucose sensor product of claim 5 , wherein the sterilization process applies radiation to the glucose sensor assembly.

7. The glucose sensor product of claim 1 , wherein the plastic package tray comprises a retaining feature formed therein that conforms to and accommodates the sensor introducer.

8. The glucose sensor product of claim 1 , wherein the product is manufactured by a process comprising the steps of:
placing the glucose sensor assembly into the plastic package tray having a sealing surface surrounding an opening;
covering the opening with the microbial barrier material such that the microbial barrier material overlies the sealing surface;
forming a seal between the sealing surface and the microbial barrier material, resulting in a sealed package tray containing the glucose sensor assembly; and
sterilizing the glucose sensor assembly inside the sealed package tray, wherein the microbial barrier material maintains sterility of the glucose sensor assembly while allowing the substances outgassed from the glucose sensor assembly and the plastic package tray to pass therethrough.

9. The glucose sensor product of claim 8 , wherein the microbial barrier material vents volatile substances that would otherwise degrade the glucose oxidase enzyme.

10. The glucose sensor product of claim 9 , wherein:
the glucose sensor assembly comprises at least one liner for an adhesive element; and
the sensor mounting pedestal comprises a liner holder for the at least one liner, the liner holder retaining the at least one liner when the sensor mounting pedestal and the adhesive element are separated.

11. The glucose sensor product of claim 9 , wherein:
the glucose sensor assembly comprises a sensor introducer for the electrochemical sensor, the sensor introducer formed at least in part from a plastic material; and
the microbial barrier material vents volatile substances outgassed from the plastic material.

12. The glucose sensor product of claim 8 , wherein the microbial barrier material is composed of high-density polyethylene.

13. The glucose sensor product of claim 8 , wherein the glucose sensor assembly is sterilized by applying radiation to the sealed package tray.

14. A glucose sensor product comprising:
a plastic package tray;
a glucose sensor assembly in the plastic package tray, the glucose sensor assembly comprising an electrochemical sensor with glucose oxidase enzyme; and
a microbial barrier material coupled to the plastic package tray to seal the glucose sensor assembly in the plastic package tray, wherein the microbial barrier material maintains sterility of the glucose sensor assembly while venting substances outgassed from the glucose sensor assembly and/or the plastic package tray that would otherwise degrade the glucose oxidase enzyme.

15. The glucose sensor product of claim 14 , wherein the microbial barrier material maintains sterility of the glucose sensor assembly while volatile by-products outgassed from the glucose sensor assembly that would otherwise degrade the glucose oxidase enzyme.

16. The glucose sensor product of claim 14 , wherein the microbial barrier material maintains sterility of the glucose sensor assembly while volatile by-products outgassed from the plastic package tray that would otherwise degrade the glucose oxidase enzyme.

17. The glucose sensor product of claim 14 , wherein the microbial barrier material is composed of high-density polyethylene.

18. The glucose sensor product of claim 14 , wherein:
the glucose sensor assembly is subjected to a sterilization process; and
the microbial barrier material maintains sterility of the glucose sensor assembly while venting volatile substances produced as by-products of the sterilization process.

19. The glucose sensor product of claim 18 , wherein the sterilization process applies radiation to the glucose sensor assembly.

20. The glucose sensor product of claim 14 , wherein the glucose sensor assembly includes a sensor introducer, and wherein the plastic package tray comprises a retaining feature formed therein that conforms to and accommodates the sensor introducer.

Assignees

• Medtronic Minimed Inc

Inventors

• Larson Eric Allan
• Shah Rajiv

Classifications

• A61L2/08

  Radiation · CPC title

• A61B5/14532

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

• A61B5/1486 Primary

  using enzyme electrodes, e.g. with immobilised oxidase · CPC title

• B65B5/04

  Packaging single articles · CPC title

• A61B2562/242

  Packaging, i.e. for packaging the sensor or apparatus before use · CPC title