METHOD FOR THE SELECTIVE STERILIZATION OF DIAGNOSTIC TEST ELEMENTS

• US 20070176120A1
• Filed: 01/08/2007
• Published: 08/02/2007
• Est. Priority Date: 07/09/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Fiedler, Wolfgang, Schwind, Karin
• Granted Patent: US 7,794,654 B2
• Time in Patent Office: Days
• US Class Current: 250/492.100
• CPC Class Codes: A61B 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: A61B 2090/0813 Accessories designed for easy sterilising, i.e. re-usable
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150335 by radiation
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/15045 comprising means for capillary action
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150541 Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2202/22 Blood or products thereof

Abstract

The invention concerns a method for producing integrated, diagnostic test elements (1) which have a lancing area (2) and a detection area (3). The lancing area is used to generate an opening in the skin and the detection area is used to detect an analyte in a body fluid. The selective sterilization sterilizes the lancing area but not the detection area by electron radiation. The method according to the invention comprises the steps of screening the detection area on the test element against electron radiation and subsequently irradiating the test element with electron radiation. The invention additionally concerns a method according to the invention in which the test elements and lancing areas are in a connected arrangement and are brought into the radiation area by moving the entire arrangement. Finally the invention concerns a diagnostic test element which has been produced according to the inventive method.

Claims

1. Method for producing integrated, diagnostic test elements which have a lancing area to generate an opening in the skin and a detection area to detect an analyte in a body fluid wherein the lancing area but not the detection area is sterilized by electron radiation.

2. Method according to claim 1, wherein the method comprises the steps

screening the detection area from electron radiation and subsequently

irradiating the test element with electron radiation.

3. Method according to claim 1, in which an arrangement of several test elements is screened by screening means and the entire arrangement is irradiated.

4. Method according to claim 2 in which test elements are arranged in a package and the package or a holder for the package is designed such that the detection area of the test elements is screened against electron radiation and the entire package is irradiated.

5. Method according to claim 2, in which the detection area is provided with a protection against the escape of germs and the lancing area is not provided with a protection against penetration by germs.

6. Method according to claim 2 in which the test elements are brought into the radiation area of a radiation source by a feeding device.

7. Method according to claim 6 in which the feeding device has a transport tape on which the test elements are arranged.

8. Method according to claim 4 in which the test elements or their packaging are designed to be connected and the test elements are brought into the radiation area by moving the connected arrangement.

9. Method according to claim 1 in which at least one region of the lancing area of the test elements which penetrates the skin is sealed with a protection which prevents penetration of germs.

10. Method according to claim 9, in which the protection is made of a pierceable material or the protection can be removed from the lancing area.

11. Method according to claim 1, in which the test element has a transport element between the lancing area and detection area by which means the analyte is transported from the lancing area to the detection area.

12. Diagnostic test element having a lancing area to generate an opening in the skin and a detection area to detect an analyte in a body fluid, characterized in that the lancing area but not the detection area is sterilized by electron radiation.

13. Test element according to claim 12 in which at least one region of the lancing area which penetrates the skin is sealed with a protection which prevents penetration of germs.

14. Test element according to claim 13 in which the protection is made of a pierceable material or the protection can be removed from the lancing area.

15. Test element according to claim 12 which has a transport path between the lancing area and detection area which transports the analyte from the lancing area to the detection area.

16. Test element according to claim 15 which has a capillary channel to transport body fluids from the lancing area into the detection area.