METHOD OF ANALYZING AN ANALYTE

• US 20100210932A1
• Filed: 12/21/2007
• Published: 08/19/2010
• Est. Priority Date: 03/20/2007
• Status: Abandoned Application

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Rebec, Mihailo V.
• Application Number:
  US12/531,634
• Publication Number:
  US 20100210932A1
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• 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 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150977 Arrays of piercing elements for simultaneous piercing
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/15134 Bladeless capillary blood sampling devices, i.e. devices for perforating the skin in order to obtain a blood sample but not using a blade, needle, canula, or lancet, e.g. by laser perforation, suction or pressurized fluids
• CPC Class Codes: A61B 5/15136 by use of radiation, e.g. laser
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/681 Wristwatch-type devices

Abstract

A method of using a diffusion-based, continuous-monitoring system to analyze an analyte includes creating at least one diffusion channel in an area of skin. The diffusion channel is maintained for a desired duration. The levels of the analyte are continuously monitored for the desired duration via a diffusion-based, continuous-monitoring device. The levels of the analyte at the area of skin are analyzed to determine if a condition associated with the analyte is present.

Claims

1. A method of using a diffusion-based, continuous-monitoring system to analyze an analyte, the method comprising the acts of:

creating at least one diffusion channel in an area of skin;

maintaining the at least one diffusion channel for a desired duration;

continuously monitoring the levels of the analyte for the desired duration via a diffusion-based, continuous-monitoring device; and

analyzing the levels of the analyte at the area of skin to determine if a condition associated with the analyte is present.

2. The method of claim 1, wherein the at least one diffusion channel is a plurality of diffusion channels.

3. The method of claim 1, wherein the at least one diffusion channel is created by skin abrasion, microporation, microneedle-diffusion enhancement, pressure members, a lancet, ultrasound energy or laser ablation.

4. The method of claim 1, wherein the continuous time period is at least 8 hours.

5. The method of claim 1, wherein the continuous time period is at least 24 hours.

6. The method of claim 1, wherein the diffusion-based, continuous-monitoring system is an electrochemical-monitoring system.

7. The method of claim 1, wherein the diffusion-based, continuous-monitoring system is an optical-monitoring system.

8. The method of claim 1, further including storing the levels of the analyte.

9. The method of claim 1, further including topographically applying a hydrogel or liquid on the skin to assist in enhancing the diffusion of the analyte and positioning the diffusion-based, continuous monitoring device in communication with the hydrogel or liquid.

10. The method of claim 9, wherein the hydrogel or liquid includes a diagnostic element to assist in analyzing the levels of the analyte at the area of skin.

11. The method of claim 9, wherein positioning the monitoring device includes attaching the monitoring device to the skin.

12. The method of claim 1, further including displaying the levels of the analyte on the continuous-monitoring device.

13. The method of claim 1, wherein the analyte is glucose.

14. A method of using a diffusion-based, continuous-monitoring system to analyze an analyte, the method comprising the acts of:

providing a diffusion-based, continuous-monitoring device, the device including a communications interface that is adapted to connect with a receiving module via a communications link;

creating at least one diffusion channel in an area of skin;

maintaining the at least one diffusion channel for a desired duration;

continuously monitoring the levels of the analyte for the desired duration via the diffusion-based, continuous-monitoring device; and

analyzing the levels of the analyte at the area of skin to determine if a condition associated with the analyte is present.

15. The method of claim 14, further including transmitting information directed to the levels of the analyte to the receiving module via the communications link.

16. The method of claim 15, further including receiving instructions from the receiving module via the communications link.

17. The method of claim 15, wherein the transmitting of information is performed on a wireless system.

18. The method of claim 15, wherein the transmitting of information is performed on a wired system.

19. The method of claim 15, wherein the transmitting of information occurs at intervals between 5 minutes and 4 hours.

20. The method of claim 14, wherein the at least one diffusion channel is a plurality of diffusion channels.

21-28. -28. (canceled)