Lancet Magazine and Method for the Production Thereof

• US 20130066171A1
• Filed: 11/06/2012
• Published: 03/14/2013
• Est. Priority Date: 05/06/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Harttig, Herbert
• Granted Patent: US 10,524,709 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• 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 5/150328 by aseptic fluid
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15115 Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B65B 55/02 Sterilising, e.g. of complete packages

Abstract

A lancet magazine is disclosed which includes a housing and a plurality of lancets each of which is enclosed in a sterile chamber of the housing, wherein the chambers each have a puncturing opening which is closed with a foil, wherein the lancets include a sample receiving device for receiving body fluid and the chambers each include a further opening which is closed with a membrane that is permeable to gas and fluid and includes a lower side that faces the lancet and serves to receive body fluid from the sample receiving device and an upper side that serves to transfer body fluid to a test field arranged on the membrane.

Claims

1. A lancet magazine, comprising a housing and a plurality of lancets each of which is enclosed in a sterile chamber of the housing, wherein the chambers each have a puncturing opening which is closed with a foil, wherein the lancets comprise a sample receiving device for receiving body fluid and the chambers each comprise a further opening which is closed with a membrane that is permeable to gas and fluid and comprises a lower side that faces the lancet and serves to receive body fluid from the sample receiving device and an upper side that serves to transfer body fluid to a test field arranged on the membrane.

2. The lancet magazine of claim 1, wherein the membrane is produced from a polymeric material.

3. The lancet magazine of claim 2, wherein the membrane is produced according to a phase inversion method.

4. The lancet magazine of claim 1, wherein the membrane is hydrophilic.

5. The lancet magazine of claim 1, wherein the membrane comprises pores on the lower side the size of which is in excess of that of the pores on the upper side.

6. The lancet magazine of claim 1, wherein the membrane is a sheet that covers a plurality of chamber openings.

7. The lancet magazine of claim 1, wherein the lancet tips are in contact with a gas contained in the chambers.

8. The lancet magazine of claim 1, wherein the sample receiving device comprises a channel.

9. The lancet magazine of claim 1, wherein analytical reagents of the test field are in contact with the membrane.

10. The lancet magazine of claim 1, wherein the test field is formed on a backing film, and wherein the analytical reagents are arranged between the backing film and the gas-permeable membrane.

11. The lancet magazine of claim 10, wherein the backing film covers a plurality of openings.

12. The lancet magazine of claim 1, wherein the foil is impermeable to gas.

13. A method for the production of a lancet magazine, wherein a lancet is arranged in each of the chambers of a magazine housing and the chambers are closed thereafter, wherein at least one opening of each chamber containing a lancet is closed with a gas-permeable membrane and a sterilizing gas is subsequently introduced through the membrane and into the chamber by exposing the closed magazine housing to the sterilizing gas.

14. The method of claim 13, wherein the sterilizing gas is water vapor and/or ethylene oxide.

15. The method of claim 13, wherein, after sterilization, a test field with analytical reagents for the examination of a body fluid sample is applied onto the membrane.

16. A method of using a membrane that is permeable to gas and fluid and that closes an opening of a chamber of a lancet magazine, to transport a body fluid sample from a lancet on one side of the membrane to a test field on the other side of the membrane.