Systems and methods for monitoring health and delivering drugs transdermally

• US 8,568,315 B2
• Filed: 04/13/2011
• Issued: 10/29/2013
• Est. Priority Date: 06/01/2000
• Status: Active Grant

• Current Assignee: Georgetown University, Science Applications International Corporation
• Original Assignee: Georgetown University, Science Applications International Corporation
• Inventors: Currie, John F., Paranjape, Makarand, Peck, Carl C., White, Robert, Schneider, Thomas W.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US13/085,775
• Publication Number:
  US 20120010487A1
• Time in Patent Office: 930 Days
• Field of Search: 600/309, 600/310, 600/316, 600/317, 600/322, 600/323, 600/324, 600/473, 600/476
• US Class Current: 600/309
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150007 Details
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

The present invention pertains to a system and method for transdermal sampling, comprising: at least one sampler for retrieving and transferring at least one analyte obtained transdermally from the skin of a subject; at least one detector system for identifying and quantifying said at least one analyte; and at least one logic module for (i) receiving and storing input data from said at least one detector, (ii) relating the input data to other data obtained from the subject, (iii) displaying output information, (iv) transmitting the output information to another system, and (v) controlling the operation of said at least one sampler and at least one detector.

Claims

1. A transdermal sampling system, comprising:

a substrate including;

at least one capillary formed therein, the capillary having a first end with a microablation heater associated therewith, the microablation heater including a conductive serpentine pathway connected to electrodes for generating current therein, wherein the microablation heater is configured to ablate an individual confined volume of the stratum corneum of a subject'"'"'s skin in order to access interstitial fluid from the epidermis; and

a detection system formed on the substrate and located at a second end of the at least one capillary for receiving the accessed interstitial fluid from the at least one capillary and analyzing the interstitial fluid to detect one or more analytes of interest;

wherein a length of the at least one capillary is perpendicular to a skin contact surface of the substrate.

2. The system of claim 1 wherein the substrate is approximately 300 μ

m thick.

3. The system of claim 1 wherein the analytes of interest are selected from the group consisting of glucose, bilirubin, D-amino acids, an insecticide, atropine, pralidoxime, cytokine, dextromethorphan, caffeine, antihistamines, an organophosphate, microbial toxin, inflammatory sequeli to microbial toxin, spore metabolite, prealbumin, C-reactive protein, troponin I, estrogen, and testosterone.

4. The system of claim 1, wherein the confined volume of the stratum corneum is 50 μ

m×

50 μ

m×

30 μ

m.

5. The system of claim 1, wherein the microablation heater protrudes from a surface of the substrate.

6. The system of claim 5, wherein the microablation heater is formed on a mesa that protrudes from the substrate.

7. The system of claim 1, wherein the microablation heater includes a heat-sink material.

8. A transdermal sampling system, comprising:

a substrate including;

multiple capillaries formed therein, each of the multiple capillaries having a first end associated with a microablation heater, each microablation heater including electrodes for generating current therein, wherein each microablation heater is configured to ablate an individual confined volume of the stratum corneum of a subject'"'"'s skin at separate times in order to access interstitial fluid from the epidermis; and

a detection system formed on the substrate at a second end of each of the multiple capillaries for receiving the accessed interstitial fluid from each of the multiple capillaries at separate times and analyzing the interstitial fluid from each of the independent confined volumes of the stratum corneum to detect one or more analytes of interest,

wherein a length of each of the multiple capillaries is perpendicular to a skin contact surface of the substrate.

9. The system of claim 8 wherein the substrate is approximately 300 μ

m thick.

10. The system of claim 8 wherein the analytes of interest are selected from the group consisting of glucose, bilirubin, D-amino acids, an insecticide, atropine, pralidoxime, cytokine, dextromethorphan, caffeine, antihistamines, an organophosphate, microbial toxin, inflammatory sequeli to microbial toxin, spore metabolite, prealbumin, C-reactive protein, troponin I, estrogen, and testosterone.

11. The system of claim 8, wherein the each individual confined volume of the stratum corneum is 50 μ

m×

50 μ

m×

30 μ

m.

12. The system of claim 8, wherein each microablation heater protrudes from a surface of the substrate.

13. The system of claim 12, wherein the microablation heater is formed on a mesa that protrudes from the substrate.

14. The system of claim 8, wherein each microablation heater includes a heat-sink material.

15. The system of claim 8, wherein each microablation heater includes a conductive serpentine pathway connected to the electrodes.

16. A transdermal sampling system, comprising:

a first substrate including;

an array of capillaries formed therein, each capillary includes a first end and second end thereof;

an individual microablation heater associated with a first end of each capillary, each microablation heater including electrodes for generating current therein, wherein each microablation heater is configured to ablate an individual confined volume of the stratum corneum of a subject'"'"'s skin in order to access interstitial fluid from the epidermis; and

a detection system formed on the substrate at a second end of each capillary for receiving the accessed interstitial fluid from each capillary at separate times and analyzing separately the interstitial fluid from each of the independent confined volumes of the stratum corneum received from a corresponding capillary in the array to detect one or more analytes of interest;

wherein a length of each of the capillaries is perpendicular to a skin contact surface of the substrate;

a second substrate including at least a logic module and associated circuitry, wherein the logic module and associated circuitry is configured to control each of the microablation heaters and the detection system; and

further wherein the first substrate is removably connected to the second substrate and is replaceable with a third identical substrate.

17. The system of claim 16 wherein the first substrate is approximately 300 μ

m thick.

18. The system of claim 16 wherein the analytes of interest are selected from the group consisting of glucose, bilirubin, D-amino acids, an insecticide, atropine, pralidoxime, cytokine, dextromethorphan, caffeine, antihistamines, an organophosphate, microbial toxin, inflammatory sequeli to microbial toxin, spore metabolite, prealbumin, C-reactive protein, troponin I, estrogen, and testosterone.

19. The system of claim 16, wherein the each individual confined volume of the stratum corneum is 50 μ

m×

50 μ

m×

30 μ

m.

20. The system of claim 16, wherein each microablation heater protrudes from a surface of the substrate.

21. The system of claim 20, wherein the microablation heater is formed on a mesa that protrudes from the substrate.

22. The system of claim 16, wherein microablation heater includes a heat-sink material.

23. The system of claim 16, wherein microablation heater further includes a conductive serpentine pathway connected to the electrodes.

24. The system of claim 16, wherein analyzing separately the interstitial fluid from each of the independent confined volumes occurs at separate times.

25. The system of claim 16, wherein analyzing separately the interstitial fluid from each of the independent confined volumes occurs simultaneously.