IP Library Granted Patent US 8,567,602
Granted Patent B2
US 8,567,602 · App. 12/396,932 · Granted Oct 29, 2013

Package for hydrophilic medical instruments

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Quick Facts
Patent No.
US 8,567,602
App. No.
12/396,932
Granted
Oct 29, 2013
Kind
B2
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 (21)

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 μg/cm 2 , 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 μm.

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 μg/cm 2 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 μg/cm 2 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.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 23, 2015
From: ROCHE DIAGNOSTICS OPERATIONS, INC.
To: ROCHE DIABETES CARE, INC.
Reel/Frame 036008/0670 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 24, 2009
From: ZIMMER (ON BEHALF OF VOLKER ZIMMER), KLAUS
To: ROCHE DIAGNOSTICS GMBH
Reel/Frame 022593/0173 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 24, 2009
From: ROCHE DIAGNOSTICS GMBH
To: ROCHE DIAGNOSTICS OPERATIONS, INC.
Reel/Frame 022593/0215 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 24, 2009
From: NIEDERBERGER, BRIGITTE
To: ROCHE DIAGNOSTICS AG
Reel/Frame 022593/0226 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 24, 2009
From: ROCHE DIAGNOSTICS AG
To: ROCHE DIAGNOSTICS OPERATIONS, INC.
Reel/Frame 022593/0241 →