Method of manufacturing integrated biosensors

• US 20060000549A1
• Filed: 06/29/2004
• Published: 01/05/2006
• Est. Priority Date: 06/29/2004
• Status: Abandoned Application

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Allen, John J., Lang, David K., Johnson, John
• Application Number:
  US10/881,306
• Publication Number:
  US 20060000549A1
• Time in Patent Office: Days
• US Class Current: 156/320
• 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 5/150358 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin

Abstract

The determination of analyte concentration in physiological samples is of ever increasing importance to today'"'"'s society. Such assays find use in a variety of applications, including clinical laboratory testing, home testing, etc., where the results of such testing play a prominent role in the diagnosis and management of a variety of disease conditions. In the present application, a method is described which may be used for the manufacture of medical devices which include an integrated lancet and sensor.

Claims

1. A method of assembling integrated medical devices, the method comprising:

providing a medical device assembly apparatus including;

a body including;

a proximal end; and

a distal end;

a detachable clamping bar; and

a pusher plate,

wherein said proximal end includes a plurality of recesses for receiving and removably retaining a plurality of test strips at least partially therein;

loading a test strip containing a top layer of heat-seal adhesive into each recess

placing a plurality of tissue penetration members on top of said test strips;

securing said plurality of tissue penetration members with said clamping bar to minimize movement;

urging said test strips into alignment with said tissue penetration members using said pusher plate;

heating said tissue penetration members to a predetermined temperature to bond said strips to said tissue penetration members; and

removing said medical devices from said assembly apparatus for further processing.

2. The method of claim 1, wherein heat is applied evenly across said tissue penetration members to ensure complete adhesion between said strips and said dermal tissue penetration members.

3. The method of claim 1, wherein said tissue penetration members are connected by a bandolier.

4. The method of claim 1, where said predetermined temperature is between 95°

C. and 150°

C.