Method of analyzing for at least disease or condition marker

• US 20080154106A1
• Filed: 12/06/2007
• Published: 06/26/2008
• Est. Priority Date: 12/21/2006
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Rebec, Mihailo V.
• Granted Patent: US 8,032,197 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14528 invasively
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence

Abstract

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

Claims

1. A method of using a diffusion-based, continuous-monitoring system to analyze for a state of a disease or condition, 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 level of at least one disease/condition marker for the desired duration via a diffusion-based, continuous-monitoring device; and

analyzing the levels of the at least one disease/condition marker at the area of skin to determine if the disease or condition associated with the at least one disease/condition marker 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 continuous time period is at least 8 hours.

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

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

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

7. The method of claim 1 further including storing the level of the at least one disease marker.

8. The method of claim 1 further including topographically applying a hydrogel or liquid on the skin to assist in enhancing the diffusion of the at least one disease or condition marker and positioning the diffusion-based, continuous monitoring device in communication with the hydrogel or liquid.

9. A method of using a diffusion-based, continuous-monitoring system to analyze for a state of at least one disease or condition, 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 level of at least one disease or condition marker for the desired duration via the diffusion-based, continuous-monitoring device; and

analyzing the levels of the at least one disease or condition marker at the area of skin to determine if the disease or condition associated with the at least one disease or condition marker is present.

10. The method of claim 9 further including transmitting information directed to the levels of the at least one disease or condition marker to the receiving module via the communications link.

11. The method of claim 10 further including receiving instructions from the receiving module via the communications link.

12. The method of claim 10 wherein the transmitting of information occurs at intervals between 5 minutes and 4 hours.

13. The method of claim 9 further including storing the levels the at least one disease or condition marker.

14. A method of using a diffusion-based, continuous-monitoring system to analyze for a heart attack, 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 level of at least one of troponin, creatine phosphokinase, lactate dehydrogenase, and aspartate transaminase via a diffusion-based, continuous monitoring device; and

analyzing the levels of the at least one of troponin, creatine phosphokinase, lactate dehydrogenase, and aspartate transaminase at the area of skin to determine the presence of a heart attack.

15. The method of claim 14 wherein the troponin is continuously monitored.

16. The method of claim 14 wherein the creatine phosphokinase is continuously monitored.

17. The method of claim 14 wherein the lactate dehydrogenase is continuously monitored.

18. The method of claim 14 wherein the aspartate transaminase is continuously monitored.

19. The method of claim 14 wherein at least two of troponin, creatine phosphokinase, lactate dehydrogenase, and aspartate transaminase are continuously monitored.

20. A method of using a diffusion-based, continuous-monitoring system to analyze for kidney disease, 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 level of blood urea nitrogen and/or creatinine via a diffusion-based, continuous monitoring device; and

analyzing the levels of the blood urea nitrogen and/or creatinine at the area of skin to determine if kidney disease is present.

21. The method of claim 20 wherein the level of blood urea nitrogen is continuously monitored.

22. The method of claim 20 wherein the level of creatinine is continuously monitored.

23. The method of claim 20 wherein at the levels of blood urea nitrogen and creatinine are continuously monitored.