Method of therapeutic drug monitoring

• US 20080152592A1
• Filed: 12/06/2007
• Published: 06/26/2008
• Est. Priority Date: 12/21/2006
• Status: Abandoned Application

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Rebec, Mihailo V.
• Application Number:
  US11/999,530
• Publication Number:
  US 20080152592A1
• Time in Patent Office: Days
• US Class Current: 424/9.2
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• 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 5/14532 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 5/4839 combined with drug delivery
• 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 monitor the effectiveness of delivering a drug includes creating and maintaining a diffusion channel in an area of skin. The levels of the drug, metabolite, or affected substance of the drug are continuously monitored in the area of the skin for a desired duration via a diffusion-based, continuous-monitoring device. The levels of the drug, the metabolite, or affected substance is analyzed to determine the effectiveness of delivering the therapeutic drug.

Claims

1. A method of using a diffusion-based, continuous-monitoring system to monitor the effectiveness of delivering a therapeutic drug, 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 therapeutic drug, the levels of a metabolite of the therapeutic drug or the levels of a substance that is affected by the therapeutic drug in the area of the skin for the desired duration via a diffusion-based, continuous-monitoring device; and

analyzing the levels of the therapeutic drug, the metabolite of the therapeutic drug or the substance that is affected by the therapeutic drug so as to determine the effectiveness of delivering the therapeutic drug.

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 process is continuously monitored for at least 8 hours.

5. The method of claim 4 wherein the process is continuously monitored for 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 wherein the levels of the therapeutic drug are continuously monitored.

9. The method of claim 1 wherein the levels of a metabolite of the therapeutic drug are continuously monitored.

10. The method of claim 1 wherein the levels of a substance that is affected by the therapeutic drug are continuously monitored.

11. The method of claim 10 wherein the substance is glucose and the therapeutic drug is insulin.

12. The method of claim 1 wherein the therapeutic drug is a water-soluble drug.

13. The method of claim 1 wherein the therapeutic drug is a water-insoluble drug.

14. A method of using a diffusion-based, continuous-monitoring system to monitor the effectiveness of delivering a therapeutic drug, the method comprising the acts of:

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

topographically applying a hydrogel or liquid on the skin to assist in enhancing the diffusion of the therapeutic drug, a metabolite of the therapeutic drug or a substance that is effected by the therapeutic drug;

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

positioning a diffusion-based, continuous monitoring device in communication with the hydrogel or liquid;

continuously monitoring the levels of the therapeutic drug, the levels of a metabolite of the therapeutic drug or the levels of a substance that is affected by the therapeutic drug in the area of the skin via the diffusion-based, continuous monitoring device; and

analyzing the levels of the therapeutic drug, the metabolite of the therapeutic drug or the substance that is affected by the therapeutic drug so as to determine the effectiveness of delivering the therapeutic drug.

15. The method of claim 14 wherein the hydrogel or liquid includes a diagnostic element to assist in analyzing the levels of the therapeutic drug, the metabolite of the therapeutic drug or the substance that is affected by the therapeutic drug.

16. The method of claim 14 wherein positioning the monitoring device includes attaching the monitoring device to the skin.

17. The method of claim 14 wherein the levels of a substance that is affected by the therapeutic drug are continuously monitored, the substance being glucose and the therapeutic drug being insulin.

18. A method of using a diffusion-based, continuous-monitoring system to monitor the effectiveness of delivering a therapeutic drug, 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 therapeutic drug, the levels of a metabolite of the therapeutic drug or the levels of a substance that is affected by the therapeutic drug in the area of the skin for the desired duration via the diffusion-based, continuous-monitoring device; and

analyzing the levels of the therapeutic drug, the metabolite of the therapeutic drug or the substance that is affected by the therapeutic drug so as to determine the effectiveness of delivering the therapeutic drug.

19. The method of claim 18 further including transmitting information directed to the levels of the therapeutic drug, the levels of a metabolite of the therapeutic drug or the levels of a substance that is affected by the therapeutic drug to the receiving module via the communications link.

20. The method of claim 19 further including receiving instructions from the receiving module via the communications link directed to the deliver of the therapeutic drug.

21. The method of claim 19 wherein the transmitting of information is performed on a wireless system.

22. The method of claim 19 wherein the transmitting of information is performed on a wired system.

23. The method of claim 19 wherein the transmitted information occurs at intervals between 5 minutes and 2 hours.