Package for hydrophilic medical instruments

• US 8,567,602 B2
• Filed: 03/03/2009
• Issued: 10/29/2013
• Est. Priority Date: 09/04/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Niederberger, Brigitte, Zimmer, Volker
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): CHEUNG, CHUN HOI
• Application Number:
  US12/396,932
• Publication Number:
  US 20100044260A1
• Time in Patent Office: 1,701 Days
• Field of Search: 206/438, 206/439, 206/63.3, 206/484, 206/484.1, 206/484.2, 206/571, 206/569, 206/570, 206/363, 206/364, 206/365, 206/366
• US Class Current: 206/365
• 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 comprises 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 plastic package comprising at least one receiving compartment with at least one partially hydrophilic medical instrument for insertion into body tissue, wherein the medical instrument includes a capillary coated with a hydrophilic coating, characterized in that, after sterilization by radiation, it has a proportion of volatile constituents of ≦

0.1 μ

g/cm², wherein the plastic package has a several layer structure, wherein the innermost layer is a layer of polyester.

2. The plastic package as claimed in claim 1, characterized in that the medical instrument is chosen from the group comprising puncturing aids, lancets, medical aids and microneedles.

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

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

m.

5. The plastic package as claimed in claim 1, characterized in that the package further encloses a test unit to which body fluid is to be applied.

6. The plastic package as claimed in claim 1, characterized in that the package is sterilized by β

radiation.

7. The plastic package as claimed in claim 1, wherein the medical instrument is a microneedle with the capillary coated with the hydrophilic coating.

8. The plastic package as claimed in claim 7, further comprising:

a test unit configured to test a body fluid; and

separate receiving compartments in which the microneedle and the test unit are received.

9. A method, comprising:

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

0.1 μ

g/cm² after sterilization by radiation;

producing the plastic package with the material, wherein the plastic package has a several layer structure, wherein the innermost layer is a layer of polyester;

selecting a medical instrument including a capillary;

applying a hydrophilic coating to the capillary;

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

placing the at least one partially hydrophilic medical instrument into a compartment of the 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.

10. The method of claim 9, wherein the medical instrument is a microneedle with the capillary coated with the hydrophilic coating.

11. The method of claim 9, wherein the medical instrument includes the hydrophilic coating at least in some sections.

12. The method of claim 9, wherein said sterilizing includes sterilizing by β

radiation.