Package for hydrophilic medical instruments

• US 9,504,782 B2
• Filed: 10/01/2013
• Issued: 11/29/2016
• Est. Priority Date: 09/04/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Niederberger, Brigitte, Zimmer, Volker
• Primary Examiner(s): CHEUNG, CHUN HOI
• Application Number:
  US14/043,364
• Publication Number:
  US 20140027328A1
• Time in Patent Office: 1,155 Days
• Field of Search: 206/438, 206/439, 206/63.3, 206/484, 206/484.1, 206/484.2, 206/384
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 50/3001 for sharps
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: B65B 55/12 Sterilising contents prior to, or during, packaging

Abstract

A plastic package for hydrophilic articles, in particular for hydrophilically coated medical instruments, is intended to ensure the hydrophilic nature of the enclosed instrument over a long period of time. The package includes at least one receiving compartment with a medical instrument for insertion into body tissue and is characterized in that, after sterilization by radiation, it has a proportion of volatile constituents of ≦0.1 μg/cm2.

Claims

1. A packaging system, comprising:

a plastic package comprising at least one receiving compartment with at least one partially hydrophilic medical instrument for insertion into body tissue, characterized in that, after sterilization by radiation, the plastic package has a proportion of volatile constituents of ≦

0.1 μ

g/cm².

2. The packaging system as claimed in claim 1, characterized in that the medical instrument is chosen from the group consisting of puncturing aids, lancets, medical aids and microneedles.

3. The packaging system as claimed in claim 1, characterized in that the medical instrument comprises a hydrophilic coating at least in some sections.

4. The packaging system as claimed in claim 1, characterized in that the plastic package is made of polyester.

5. The packaging system as claimed in claim 1, characterized in that the package has a wall thickness in the range of 1 to 500 μ

m.

6. The packaging system as claimed in claim 1, characterized in that the plastic package has a multi-layer structure.

7. The packaging system as claimed in claim 6, characterized in that the innermost layer is a layer of polyester.

8. The packaging system as claimed in claim 1, characterized in that the package encloses a test unit to which body fluid is to be applied.

9. The packaging system as claimed in claim 1, characterized in that the package is sterilized by β

radiation.

10. The packaging system as claimed in claim 1, wherein the volatile constituents are constituents of the package that are successively released by the latter and the volatile constituents being characterized and quantified by means of headspace chromatography.

11. The packaging system as claimed in claim 10, wherein:

the medical instrument is chosen from the group consisting of puncturing aids, lancets, medical aids and microneedles; and

the medical instrument comprises a hydrophilic coating at least in some sections.

12. The packaging system as claimed in claim 1, wherein the medical instrument is a microneedle with a capillary coated with a hydrophilic coating.

13. A method, comprising:

placing at least one partially hydrophilic medical instrument into a compartment of a plastic package;

sterilizing by radiation the medical instrument in the plastic package; and

wherein the plastic package has a proportion of volatile constituents of ≦

0.1 μ

g/cm² after said sterilizing by radiation.

14. The method of claim 13, wherein the medical instrument is a microneedle with a capillary coated with a hydrophilic coating.

15. The method of claim 13, wherein the medical instrument includes a hydrophilic coating at least in some sections.

16. The method of claim 13, wherein said sterilizing includes sterilizing by β

radiation.

17. The method of claim 13, further comprising:

selecting material to produce the plastic package by selecting a material that has a proportion of volatile constituents of ≦

0.1 μ

g/cm² after said sterilizing; and

producing the plastic package with the material.

18. The method of claim 17, wherein the material includes polyester.

20. The method of claim 13, further comprising:

quantifying the volatile constituents through headspace chromatography.

19. A method, comprising:

applying a hydrophilic coating to at least one partially hydrophilic medical instrument;

placing the medical instrument into a compartment of a plastic package;

sealing the plastic package after said placing;

sterilizing by radiation the medical instrument in the plastic package; and

wherein the plastic package has a proportion of volatile constituents of ≦

0.1 μ

g/cm² after said sterilizing by radiation.

21. A packaging system, comprising:

a plastic package comprising at least one receiving compartment with at least one partially hydrophilic medical instrument for insertion into body tissue;

wherein the plastic package has a proportion of volatile constituents of ≦

0.1 μ

g/cm² after sterilization by radiation; and

wherein the medical instrument is chosen from the group consisting of puncturing aids, lancets, medical aids and microneedles.

22. A packaging system, comprising:

a plastic package comprising at least one receiving compartment with at least one partially hydrophilic medical instrument for insertion into body tissue;

wherein the plastic package has a proportion of volatile constituents of ≦

0.1 μ

g/cm² after sterilization by radiation; and

wherein the volatile constituents are constituents of the package that are successively released by the latter and the volatile constituents being characterized and quantified by means of headspace chromatography.

23. A method, comprising:

placing at least one partially hydrophilic medical instrument into a compartment of a plastic package, wherein the medical instrument is chosen from the group consisting of puncturing aids, lancets, medical aids and microneedles;

sterilizing by radiation the medical instrument in the plastic package; and

wherein the plastic package has a proportion of volatile constituents of ≦

0.1 μ

g/cm² after said sterilizing by radiation.

24. A method, comprising:

placing at least one partially hydrophilic medical instrument into a compartment of a plastic package;

sterilizing by radiation the medical instrument in the plastic package;

wherein the plastic package has a proportion of volatile constituents of ≦

0.1 μ

g/cm² after said sterilizing by radiation; and

wherein the volatile constituents are constituents of the package that are successively released by the latter and the volatile constituents being characterized and quantified by means of headspace chromatography.