ANALYTICAL DEVICE INCLUDING STERILE PROTECTION

• US 20080243032A1
• Filed: 04/18/2008
• Published: 10/02/2008
• Est. Priority Date: 10/20/2005
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Schwind, Karin, Hindelang, Fritz
• Application Number:
  US12/105,304
• Publication Number:
  US 20080243032A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• 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: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

An analytical device is provided comprising a lancet and a test element in an integrated arrangement. The lancet generally comprises a lancet needle and a protective cap wherein the lancet needle can be displaced relative to the protective cap and wherein the protective cap generally completely surrounds the tip of the lancet needle. The protective cap is typically comprised of an elastic or plastic material and is configured to generally seal an opening provided in a chamber of the test element. In certain embodiments, the lancet comprises a conductive material and can be configured for electrical connection to a detection and evaluation device in order to be used to measure the filling level of the sample liquid and/or to serve as a counter or reference electrode. The present invention also relates to a process for producing such an analytical device and the use thereof.

Claims

1. An analytical device comprising a lancet and a test element in an integrated arrangement, the lancet comprising a lancet needle with a tip and a protective cap which generally completely surrounds the lancet needle at least in the area of the tip, wherein the lancet needle can be displaced in at least one direction relative to the protective cap, and wherein the lancet needle is configured to engage the protective cap after displacement of the lancet needle in the at least one direction and thereafter to pull the protective cap during displacement of the lancet needle in a retracting direction, the test element comprising a chamber containing a reagent system, the chamber having a first opening configured to be generally sealed by the protective cap prior to and during displacement of the lancet needle in the at least one direction and configured thereafter to be generally opened upon displacement of the lancet needle in the retracting direction.

2. The analytical device according to claim 1 wherein the protective cap comprises an elastomer.

3. The analytical device according to claim 1 wherein the protective cap encloses the needle tip in a sterile manner.

4. The analytical device according to claim 1 wherein the analytical device comprises structural means for transporting sample liquid.

5. The analytical device according to claim 4 wherein the structural means for transporting sample liquid comprises a structure selected from the group consisting of a capillary gap, a capillary channel, a wick comprising an absorbent material, and a cross-piece made of an absorbent material.

6. The analytical device according to claim 1 wherein the chamber further comprises a second opening and wherein the lancet further comprises a seal configured to generally seal the second opening prior to displacement of the lancet needle in the at least one direction.

7. The analytical device according to claim 6 wherein the protective cap comprises the seal.

8. The analytical device according to claim 6 wherein the lancet further comprises a catching device provided on the lancet needle, the catching device being configured to engage and pull the protective cap when the lancet needle is displaced in the retracting direction, and wherein when the lancet needle is displaced in the retracting direction, the protective cap in turn pulls the seal along with it and opens the second opening, wherein the second opening comprises an air vent.

9. The analytical device according to claim 1 wherein the lancet further comprises a catching device provided on the lancet needle, the catching device being configured to engage and pull the protective cap when the lancet needle is displaced in the retracting direction.

10. The analytical device according to claim 1 wherein upon complete displacement of the lancet needle in the retracting direction, the lancet is configured for electrical connection to a measuring device wherein the tip then comprises an electrode to be used for at least one of measuring the level of sample liquid and serving as a counter electrode of the analytical device.

12. An analytical system comprising the analytical device of claim 1, the analytical device further comprising a reagent system disposed within the chamber, the analytical system further comprising a detection unit configured to engage the analytical device and to detect signals generated during a reaction of the reagent system with an analyte in a sample introduced into the chamber, and an evaluation device configured to determine a concentration of the analyte from the signals.

11. A method for producing an analytical device comprising the steps of:

providing a lancet comprising a lancet needle and a protective cap, the lancet needle having a tip located in the protective cap the lancet further comprising a catching device provided on the lancet needle configured to pull the protective cap back along with the needle when the lancet is displaced in a retracting direction;

providing a test element comprising a chamber containing a reagent system and an opening in the chamber;

sterilizing the lancet; and

introducing the lancet into the chamber such that the protective cap seals the opening of the chamber.