Method for the selective sterilization of diagnostic test elements

• US 7,794,654 B2
• Filed: 01/08/2007
• Issued: 09/14/2010
• 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
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US11/620,931
• Publication Number:
  US 20070176120A1
• Time in Patent Office: 1,345 Days
• Field of Search: 600/583, 250/492.1, 250/492.3, 206/305, 422/22, 422/1
• US Class Current: 422/50
• 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, wherein the method comprises the steps

screening the detection areas from electron radiation, wherein said screening includes packing the test elements in a package that has an integrated screen aligned with the detection areas of the test elements to screen the detection areas from the electron radiation;

and subsequently

irradiating the integrated screen and the package with the electron radiation to sterilize the lancing areas of the test elements.

2. Method according to claim 1, further comprising:

wherein the package includes a drum with a lower area coated with metal to act as the integrated screen; and

wherein said packing includes loading the test elements into the drum with the detection areas received in the lower area coated with the metal and the lancing areas extending past the lower area coated with the metal.

3. Method according to claim 2, wherein said packing further includes individually arranging in an axially symmetric manner the test elements in chambers inside the drum.

4. Method according to claim 1, further comprising:

wherein the package includes a box;

wherein the screen includes a metal plate integrated into the box; and

wherein said packing includes stacking the test elements in a matrix-like manner within the box with the detection areas screened by the metal plate.

5. Method according to claim 1, further comprising:

sealing the lancing area with a protection that prevents penetration of germs from the detection area and allows sterilization of the lancing area with electron radiation.

6. 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, wherein the method comprises the steps

sealing the detection area with a protective cover to create a barrier that prevents germs from the detection area from reaching the lancing area;

packing the test element into a package;

locating a radiation screen between the detection area of the test element and a source of electron radiation;

screening the detection area of the test element from electron radiation with the radiation screen;

irradiating the test element with the electron radiation after said screening; and

locating the radiation screen at a location other than between the detection area and the source of electron radiation after said irradiating.

7. Method according to claim 6, wherein said packing occurs before said screening.

8. Method according to claim 6, wherein said packing includes sealing the test element in a plastic foil.

9. Method according to claim 6, wherein said packing includes packing the test elements inside in the package without additional protection for the lancing area.

10. Method according to claim 6, wherein said packing includes packing includes individually packing the test element within a primary packaging.

11. Method according to claim 10, wherein said individually packing the test element within the primary package includes sealing the test element within an individual chamber within the primary packaging.

12. Method according to claim 6, wherein said screening permits electron radiation to sterilize the lancing area.

13. 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, wherein the method comprises the steps

sealing the detection area with a protective cover to prevent the escape of germs to the lancing area while the lancing area remains exposed;

packing the test element into a package;

screening the detection area of the test element from electron radiation;

irradiating the test element with the electron radiation after said screening;

sterilizing the outside of the protective cover with plasma treatment;

wherein the package includes a drum with a lower area coated with metal to act as the integrated screen; and

wherein said packing includes loading the test element into the drum with the detection area received in the lower area coated with the metal and the lancing area extending past the lower area coated with the metal.

14. 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, wherein the method comprises the steps

sealing the detection area in an air-tight manner with a protective cover to prevent the escape of germs to the lancing area while the lancing area remains exposed;

packing the test element into a package;

screening the detection area of the test element from electron radiation;

irradiating the test element with the electron radiation after said screening;

sterilizing the outside of the protective cover with plasma treatment;

wherein the package includes a box;

wherein the screen includes a metal plate integrated into the box; and

wherein said packing includes stacking a plurality of the test elements in a matrix-like manner within the box with the detection areas screened by the metal plate.