Systems and Methods For Monitoring Health and Delivering Drugs Transdermally

• US 20140025000A1
• Filed: 09/25/2013
• Published: 01/23/2014
• Est. Priority Date: 06/01/2000
• Status: Active Grant

• Current Assignee: Georgetown University, Leidos, Inc. (Leidos Holdings, Inc.)
• Original Assignee: Georgetown University, Science Applications International Corporation
• Inventors: Currie, John F., Paranjape, Makarand, Peck, Carl C., White, Robert, Schneider, Thomas W.
• Granted Patent: US 9,332,937 B2
• Time in Patent Office: Days
• US Class Current: 604/66
• 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 monitoring and fluid delivery microsystem, comprising:

a substrate including a power source, logic module and at least one connection receptacle;

at least one removable transdermal monitoring subsystem mounted to the at least one connection receptacle, the at least one transdermal monitoring subsystem including at least one analyte detector and multiple single-use sampling units, each of the multiple single-use units including;

a microablation heater for ablating a portion of the stratum corneum of a subject'"'"'s skin in order to access interstitial fluid from the underlying epidermis; and

a microchannel for transmitting the accessed interstitial fluid to the at least one analyte detector, wherein the at least one analyte detector communicates detection results to the logic module; and

at least one removable microelectromechanical (MEMS) fluid delivery subsystem mounted to the at least one connection receptacle for delivering a fluid to the subject in response to the detection of the analyte by the at least one analyte detector, the MEMS fluid delivery subsystem including means for transdermal fluid delivery to the subject;

wherein the logic module provides fluid delivery instructions to the at least one MEMS fluid delivery subsystem in accordance with the detection results from the at least one analyte detector.

2. The microsystem of claim 1, wherein the at least one analyte detector is configured to detect an analyte of interest selected from the following 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.

3. The microsystem of claim 1, wherein the fluid is selected from the group consisting of a drug, chemical and target probe.

4. The microsystem of claim 3, wherein the fluid further comprises a physiologically compatible solution.

5. The microsystem of claim 2, wherein the at least one analyte detector is configured to detect an amount of analyte of interest in the interstitial fluid of the subject and, further wherein, the logic module determines if the detected amount is at a predetermined level and, when the detected amount is below the predetermined level, the logic module instructs the MEMS fluid delivery subsystem to administer an analyte amount to the subject.

6. The microsystem of claim 1, wherein the logic module controls operation of each of the multiple single-use sampling units and the MEMS fluid delivery subsystem on-demand.

7. The microsystem of claim 1, further comprising at least one environmental detector in communication with the logic module for sampling one or more target analytes in one of the air and water to which the subject is being exposed and communicating outward analyte detection results to the logic module, wherein the logic module provides fluid delivery instructions to the at least one MEMS drug delivery subsystem in accordance with the detection results from the at least one analyte detector and the outward analyte detection results from the at least one environmental detector.

8. The microsystem of claim 1, further comprising a communication means interconnected with the logic module for telemetrically communicating detection results.

9. A transdermal monitoring and fluid delivery microsystem, comprising:

a substrate including a power source, logic module, and at least one connection receptacle;

at least one removable transdermal monitoring subsystem mounted to the at least one connection receptacle, the at least one transdermal monitoring subsystem including at least one analyte detector and multiple single-use sampling units, each of the multiple single-use units including;

a microablation heater for ablating a portion of the stratum corneum of a subject'"'"'s skin in order to access interstitial fluid from the underlying epidermis; and

a microchannel for transmitting the accessed interstitial fluid to the at least one analyte detector, wherein the at least one analyte detector communicates detection results to the logic module; and

at least one removable microelectromechanical (MEMS) fluid delivery subsystem mounted to the at least one connection receptacle for delivering a fluid to the subject in response to the detection of the analyte by the at least one analyte detector, the MEMS fluid delivery subsystem including multiple individual reservoir capillaries, each of the multiple individual reservoir capillaries containing a predetermined amount of the fluid therein and including a breakable seal closure;

wherein the logic module provides fluid delivery instructions to the at least one MEMS fluid delivery subsystem in accordance with the detection results from the at least one analyte detector.

10. The microsystem of claim 9, wherein the breakable seal closure is formed of a heat responsive material connected to a metallic microheating element and further wherein the heat generated by the metallic microheating element simultaneously ablates a portion of the stratum corneum of a subject'"'"'s skin to provide access for delivering the fluid to the subject and breaks the breakable seal closure to release the fluid from the reservoir capillary.

11. The microsystem of claim 9, wherein the fluid delivery instructions include instructions for addressing the metallic microheating element.

12. The microsystem of claim 9, wherein the at least one analyte detector is configured to detect an analyte of interest selected from the following 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.

13. The microsystem of claim 9, wherein the fluid is selected from the group consisting of a drug, chemical and target probe.

14. The microsystem of claim 13, wherein the fluid further comprises a physiologically compatible solution.

15. The microsystem of claim 12, wherein the at least one analyte detector is configured to detect an amount of analyte of interest in the interstitial fluid of the subject and, further wherein, the logic module determines if the detected amount is at a predetermined level and, when the detected amount is below the predetermined level, the logic module instructs the MEMS fluid delivery subsystem to administer an analyte amount to the subject.

16. The microsystem of claim 9, wherein the logic module controls operation of each of the multiple single-use sampling units and the MEMS fluid delivery subsystem on-demand.

17. The microsystem of claim 9, further comprising at least one environmental detector in communication with the logic module for sampling one or more target analytes in one of the air and water to which the subject is being exposed and communicating outward analyte detection results to the logic module, wherein the logic module provides fluid delivery instructions to the at least one MEMS drug delivery subsystem in accordance with the detection results from the at least one analyte detector and the outward analyte detection results from the at least one environmental detector.

18. The microsystem of claim 9, further comprising a communication means interconnected with the logic module for telemetrically communicating detection results.

19. A transdermal monitoring and fluid delivery microsystem, comprising:

a substrate including a power source, logic module, and at least one connection receptacle;

at least one removable transdermal monitoring subsystem mounted to the at least one connection receptacle, the at least one transdermal monitoring subsystem including at least one analyte detector and multiple single-use sampling units, each of the multiple single-use units being individually controllable to access and retrieve a sample of interstitial fluid of a subject and provide detection results; and

at least one removable microelectromechanical (MEMS) fluid delivery subsystem mounted to the at least one connection receptacle for delivering a fluid to the subject in response to the detection of the analyte by the at least one analyte detector, the MEMS fluid delivery subsystem including multiple individual reservoir capillaries, each of the multiple individual reservoir capillaries containing a predetermined amount of the fluid therein and including a breakable seal closure;

wherein the logic module provides fluid delivery instructions to the at least one MEMS fluid delivery subsystem in accordance with the detection results from the at least one analyte detector.

20. The microsystem of claim 19, wherein the breakable seal closure is formed of a heat responsive material connected to a metallic microheating element and further wherein the heat generated by the metallic microheating element simultaneously ablates a portion of the stratum corneum of a subject'"'"'s skin to provide access for delivering the fluid to the subject and breaks the breakable seal closure to release the fluid from the reservoir capillary.