Packaging system for analyte sensors

• US 9,717,843 B2
• Filed: 02/09/2015
• Issued: 08/01/2017
• Est. Priority Date: 02/11/2014
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Grucela, Minda McDorman, Gao, Jinsong
• Primary Examiner(s): GEHMAN, BRYON P
• Application Number:
  US14/617,197
• Publication Number:
  US 20150224247A1
• Time in Patent Office: 904 Days
• Field of Search: 206305, 206363, 206438, 206569, 206588-590, 206592, 73431, 422401, 600309, 600345, 600347, 600365, 702 19
• CPC Class Codes: A61B 2050/0057 about a transverse axis in the lid plane
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2050/3008 having multiple compartments
• CPC Class Codes: A61B 2560/04 Constructional details of apparatus
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 50/20 Holders specially adapted for surgical or diagnostic appliances or instruments drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 50/33 Trays
• 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: A61L 2/20 Gaseous substances, e.g. vapours
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 5/003 : Kits for diabetics
• CPC Class Codes: A61M 5/3287 : Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: B65B 55/02 : Sterilising, e.g. of complete packages
• CPC Class Codes: B65B 55/10 : by liquids or gases
• CPC Class Codes: B65B 55/18 : by liquids or gases B65B55/14 takes precedence

Abstract

A system and method are provided for packaging and sterilizing analyte sensors. The packaging system provides a structure for securing the analyte sensors in a fixed position and fixed orientation within the package.

Claims

1. A package for receiving and securing a product, the package comprising:

at least one product, each product comprising;

an on-skin assembly comprising an adhesive patch configured to adhere to a host'"'"'s skin;

a transcutaneous glucose sensor operably connected to the on-skin assembly, wherein the glucose sensor comprises an electrode surrounded by a membrane configured to be exposed to interstitial fluid;

at least one first container configured to receive and secure the at least one product therein, wherein the at least one first container is configured to be impermeable to water vapor;

a second container configured to receive the at least one first container; and

a retainer configured to secure the at least one first container in a fixed position and fixed orientation within the second container such that movement of the second container does not result in substantial movement of the at least one first container within the second container.

2. The package of claim 1, wherein the at least one first container comprises a plurality of first containers, wherein the retainer comprises a plurality of regions each configured to secure one of the plurality of first containers.

3. The package of claim 2, wherein the plurality of regions of the retainer are spaced apart at an equal distance such that the plurality of first containers are spaced apart at an equal distance.

4. The package of claim 2, wherein the at least one product comprises a plurality of products, wherein the plurality of products are aligned in a uniform orientation.

5. The package of claim 1, wherein the retainer is an integral component of the second container.

6. The package of claim 1, wherein the retainer is an insert releasably attached to the second container.

7. The package of claim 6, wherein the retainer comprises an aperture or pocket shaped to receive and conform to a region of the at least one first container.

8. The package of claim 1, wherein the on-skin assembly further comprises a housing configured to receive an electronics unit.

9. The package of claim 8, wherein the at least one product further comprises an insertion device configured to insert the glucose sensor into a host.

10. The package of claim 1, wherein the at least one first container comprises a shaped layer and a backing layer adhered to the shaped layer.

11. The package of claim 10, wherein the backing layer comprises:

a material selected from the group consisting of polyvinyl chloride, polyvinylidenechloride, polyacrylonitrile, polyethylene, polyethylene terephthalate, polyethylene naphthalate, polypropylene, polyacrylate, cyclic olefins, polystyrene, polyesters, polyamides, ethylene vinyl alcohol, polyvinyl alcohol, and copolymers thereof; and

paper.

12. The package of claim 10, wherein the shaped layer is a molded part with a chamber for receiving the at least one product.

13. The package of claim 10, wherein the shaped layer is formed of a film.

14. The package of claim 13, wherein the film comprises a polymer selected from the group consisting of polyvinyl chloride, polyethylene, polyethylene terephthalate, polyethylene terephthalate glycol, polyvinylidene chloride, polypropylene, polyethylene, styrene, and copolymers thereof.

15. The package of claim 10, wherein the shaped layer comprises at least one region configured to secure the at least one product in a fixed position and fixed orientation within the at least one first container such that movement of the at least one first container or the second container does not result in substantial movement of the at least one product within the at least one first container.

16. The package of claim 15, wherein the at least one region of the shaped layer comprises a plurality of regions configured to secure the at least one product in a fixed position and fixed orientation within the at least one first container.

17. The package of claim 10, wherein the shaped layer is shaped and dimensioned to prevent bending of the adhesive patch.

18. The package of claim 1, further comprising a third container, wherein the third container is dimensioned and configured to receive a plurality of second containers and secure the plurality of second containers in a fixed position and fixed orientation.

19. The package of claim 1, further comprising a third container, wherein the third container is dimensioned and configured to hold only one level of a plurality of second containers.

20. The package of claim 1, wherein the glucose sensor is sterilized.