Device and methods for the application of mechanical force to a gel/sensor assembly

• US 6,398,562 B1
• Filed: 09/17/1999
• Issued: 06/04/2002
• Est. Priority Date: 09/17/1998
• Status: Expired due to Term

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cygnus, Inc. (Johnson & Johnson)
• Inventors: Butler, Michael J., Liu, David M., Parris, Norman A., Soni, Pravin L., Reidy, Michael, Conn, Thomas E.
• Primary Examiner(s): TA, THO DAC
• Application Number:
  US09/398,984
• Time in Patent Office: 991 Days
• Field of Search: 439/86, 439/91, 439/725, 439/909, 439/596
• US Class Current: 439/91
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 2562/0217 Electrolyte containing
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: Y10S 439/909 Medical use or attached to human body

Abstract

Devices and methods are described for improving the contact of a conductive material, for example, a hydrogel, with a sensor, for example an electrode, by means of using mechanical force to apply the conductive material to the sensor before use of the conductive material and sensor in a sampling device. The device and methods of the present invention improve the sensor response characteristics in transdermal sampling devices placed in operative contact with a skin or mucosal surface of a biological system to obtain a chemical signal associated with an analyte of interest.

Claims

1. A press device to apply mechanical force to improve contact between an ionically conductive gel and a sensor, comprising

a press device having first and second surfaces, wherein

the first surface is conformed to hold a gel and sensor assembly, and

the second surface is conformed to contact the assembly such that the application of mechanical force to the first and second surfaces of the device brings the gel into contact with the sensor, wherein the amount of mechanical force that can be applied is lower than the amount of force that would cause unacceptable deformation of the gel, sensor, or assembly.

2. The press device of claim 1, which further comprises a sliding means to hold the first and second surfaces together.

3. The press device of claim 1, wherein applying said mechanical force is accomplished using roller means.

4. The press device of claim 1, wherein an end of the first surface is connected to an end of the second surfaces.

5. The press device of claim 4, wherein the end of the first surface is connected to the end of the second surfaces by hinge means.

6. The press device of claim 1, wherein the second surface is conformed by the addition of contacting means.

7. The press device of claim 6, wherein said contacting means are formed from an elastomeric material.

8. The press device of claim 7, wherein said elastomeric material is silicone or polyurethane.

9. The press device of claim 4, which further comprises a latching means to hold the first and second surfaces together.

10. The press device of claim 9, wherein said latching means are timed to release after a specified period.

11. A method of improving signal detection in a transdermal sampling device, said device employing an ionically conductive material in contact with a sensor, comprising

applying force to bring the ionically conductive material into contact with the sensor, wherein the amount of force applied is lower than the amount of force that would cause unacceptable damage to the conductive material or sensor,

wherein said force is mechanical pressure, and the mechanical pressure is applied by a press device, said press device comprising,

a first surface on which the tonically conductive material and sensor are placed, said ionically conductive material and sensor being functionally aligned:

and,

a second surface which is conformed to contact the ionically conductive material and sensor in such a way as to apply a mechanical force that brings the ionically conductive material into contact with the sensor, where the amount of mechanical force applied is lower than the amount of force that would cause unacceptable deformation of the ionically conductive material or sensor.

12. The method of claim 11, wherein said ionically conductive material is a hydrogel.

13. The method of claim 11, wherein said press device further comprises a sliding means to hold the first and second surfaces together.

14. The method of claim 11, wherein applying said mechanical force is accomplished using roller means.

15. The method of claim 11, wherein the first and second surfaces are connected by a hinge means.

16. The method of claim 11, wherein the second surface is conformed by the addition of contacting means.

17. The method of claim 16, wherein said contacting means are formed from an elastomeric material.

18. The method of claim 17, wherein said elastomeric material is silicone or polyurethane.

19. The method of claim 15, which further comprises a latching means to hold the first and second surfaces together.

20. The method of claim 19, wherein said latching means are timed to release after a specified period.