Device for monitoring at least one body function of a user and method for manufacturing the same

• US 10,080,497 B2
• Filed: 06/26/2013
• Issued: 09/25/2018
• Est. Priority Date: 06/28/2012
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Harttig, Herbert
• Primary Examiner(s): Gross, Carson
• Application Number:
  US13/927,487
• Publication Number:
  US 20140005492A1
• Time in Patent Office: 1,917 Days
• Field of Search: 156295
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• 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 5/6849 in combination with a needle set
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor

Abstract

A method for manufacturing a device for monitoring at least one body function of a user comprising providing an evaluation unit, providing a sensor unit, aligning a connector portion of the sensor unit next to an electric contact pad of the evaluation unit such that the connector portion faces the electric contact pad, providing at least one anisotropic conductive adhesive between the electric contact pad and the connector portion, and bonding the evaluation unit substrate and the connector substrate together, wherein the electric contact pad and the connector portion are pressed together, and wherein an electric connection of the electric contact pad and the connector portion is created via the anisotropic conductive adhesive.

Claims

1. A method for manufacturing a device for monitoring at least one body function of a user, wherein the device comprises at least one evaluation unit and at least one sensor unit, wherein the method comprises the following steps:

a) a step of providing the evaluation unit, wherein the evaluation unit has at least one electric contact pad applied to at least one evaluation unit substrate, wherein the electric contact pad is electrically connected to at least one electronic device of the evaluation unit;

b) a step of providing the sensor unit, wherein the sensor unit comprises at least one connector part, wherein the connector part comprises at least one connector substrate and at least one conductive path applied to the connector substrate, wherein the conductive path comprises at least one electrically conductive material, wherein the electrically conductive material comprises an electrically conductive polymer, and wherein the conductive path has at least one connector portion;

c) a preparation step, wherein the connector portion is aligned next to the electric contact pad such that the connector portion faces the electric contact pad, wherein at least one anisotropic conductive adhesive is provided in between the electric contact pad and the connector portion, wherein the anisotropic conductive adhesive is applied in an amorphous form; and

d) a bonding step, wherein the evaluation unit substrate and the connector substrate are pressed together, wherein the electric contact pad and the connector portion are pressed together, and wherein an electric connection of the electric contact pad and the connector portion is created via the anisotropic conductive adhesive, wherein in the preparation step, the anisotropic conductive adhesive is applied excessively such that, after performing the bonding step, a bead of excess anisotropic conductive adhesive is formed at at least one edge of at least one of the evaluation unit substrate and the connector substrate.

2. The method of claim 1 wherein the sensor unit comprises at least one implantable sensor unit and wherein the implantable sensor unit comprises at least one implantable portion adapted for implantation into a body tissue of the user.

3. The method of claim 1 wherein the sensor unit comprises at least two sensor electrodes and wherein the at least two sensor electrodes are adapted for electrochemically determining at least one concentration of an analyte in a body tissue or body fluid of the user.

4. The method of claim 3 wherein the sensor electrodes comprise at least one working electrode, the working electrode having at least one detector substance adapted for performing at least one electrochemical reaction in the presence of the analyte.

5. The method of claim 1 wherein the step of providing the sensor unit comprises at least one substep of structuring the conductive path.

6. The method of claim 1 wherein the connector substrate comprises at least one plastic substrate.

7. The method of claim 1 wherein step b) comprises providing a plurality of sensor units on a common substrate and at least one cutting step wherein the sensor units are cut from the common substrate.

8. The method of claim 1 wherein the connector substrate is flexible or deformable.

9. The method of claim 1 wherein the sensor unit comprises a plurality of conductive paths, each conductive path having at least one connector portion, wherein the evaluation unit comprises a plurality of electric contact pads, and wherein in the preparation step, each connector portion is aligned to a corresponding electric contact pad.

10. The method of claim 1 wherein in the bonding step, one or more of pressure, heat and radiation are applied.

11. The method of claim 1 wherein after performing the bonding step, the device is at least partially sterilized by radiation sterilization.