GLUCOSE SENSOR PRODUCT AND RELATED MANUFACTURING AND PACKAGING METHODS

• US 20120227358A1
• Filed: 03/09/2011
• Published: 09/13/2012
• Est. Priority Date: 03/09/2011
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: LARSON, Eric Allan, SHAH, Rajiv
• Granted Patent: US 9,101,305 B2
• Time in Patent Office: Days
• US Class Current: 53/425
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 50/3001 for sharps
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61M 5/003 Kits for diabetics
• CPC Class Codes: B65B 5/04 Packaging single articles
• CPC Class Codes: B65B 55/02 Sterilising, e.g. of complete packages
• CPC Class Codes: B65B 55/16 by irradiation
• CPC Class Codes: B65B 7/16 Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
• CPC Class Codes: B65B 7/2842 Securing closures on containers in general B65B51/00
• CPC Class Codes: B65D 65/38 Packaging materials of special type or form
• CPC Class Codes: B65D 75/326 and forming one compartment
• CPC Class Codes: B65D 77/26 Elements or devices for locating or protecting articles

Abstract

A glucose sensor product is manufactured by a process that maintains the sterility of the glucose sensor while allowing gaseous manufacturing by-products to be vented from the inside of the glucose sensor package. The method begins by placing a glucose sensor assembly into a plastic package tray having a sealing surface surrounding an opening. The method continues by covering the opening with a 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. The microbial barrier material maintains sterility of the glucose sensor assembly while allowing volatile by-products outgassed from the glucose sensor assembly and the plastic package tray to pass therethrough.

Claims

1. A method of manufacturing a medical device package, the method comprising:

fabricating a medical device assembly;

placing the medical device assembly into a package tray;

sealing the medical device assembly inside the package tray with a gas-permeable sealing material, resulting in a sealed package tray; and

sterilizing the medical device assembly inside the sealed package tray, wherein the sealing material maintains sterility of the medical device assembly while allowing volatile substances to vent from inside the sealed package tray to outside the sealed package tray.

2. The method of claim 1, wherein:

the medical device assembly comprises an electrochemical sensor with glucose oxidase enzyme; and

the sealing material vents volatile substances that would otherwise degrade the glucose oxidase enzyme.

3. The method of claim 2, wherein:

the medical device assembly comprises a sensor mounting pedestal for the electrochemical sensor, the sensor mounting pedestal formed at least in part from a plastic material; and

the sealing material vents volatile substances outgassed from the plastic material.

4. The method of claim 2, wherein:

the medical device assembly comprises a sensor introducer for the electrochemical sensor, the sensor introducer formed at least in part from a plastic material; and

the sealing material vents volatile substances outgassed from the plastic material.

5. The method of claim 1, wherein the package tray is formed at least in part from a plastic material;

and

the sealing material vents volatile substances outgassed from the plastic material.

6. The method of claim 1, wherein the sealing material is composed of high-density polyethylene that forms a microbial barrier for the medical device assembly.

7. The method of claim 1, wherein sterilizing the medical device assembly comprises radiating the sealed package tray with sterilizing energy.

8. A glucose sensor product manufactured by a process comprising the steps of:

placing a glucose sensor assembly into a plastic package tray having a sealing surface surrounding an opening;

covering the opening with a 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 volatile by-products outgassed from the glucose sensor assembly and the plastic package tray to pass therethrough.

9. The glucose sensor product of claim 8, wherein:

the glucose sensor assembly comprises an electrochemical sensor with glucose oxidase enzyme; and

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 a sensor mounting pedestal for the electrochemical sensor, the sensor mounting pedestal formed at least in part from a plastic material; and

the microbial barrier material vents volatile substances outgassed from the plastic material.

11. The glucose sensor product of claim 10, 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.

12. 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.

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

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

15. 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.

16. The glucose sensor product of claim 15, 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.

17. The glucose sensor product of claim 15, wherein the microbial barrier material vents substances that would otherwise degrade the glucose oxidase enzyme.

18. The glucose sensor product of claim 15, wherein the microbial barrier material is composed of high-density polyethylene.

19. The glucose sensor product of claim 15, 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.

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

21. The glucose sensor product of claim 15, wherein the plastic package tray comprises a retaining feature formed therein that conforms to and accommodates the sensor introducer.