Transdermal analyte extraction and detection system and the method thereof

• US 9,700,245 B2
• Filed: 03/23/2012
• Issued: 07/11/2017
• Est. Priority Date: 09/23/2011
• Status: Expired due to Fees

• Current Assignee: iTrace Biomedical Inc.
• Original Assignee: iTrace Biomedical Inc.
• Inventors: Bandura, Bhaskara Rao, Ramdas, Radhakrishnan, Sharma, Krishnamohan, Karri, Kartik
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan (JJ)
• Application Number:
  US13/428,670
• Publication Number:
  US 20130079605A1
• Time in Patent Office: 1,936 Days
• Field of Search: 600309, 600310, 600316, 600322, 600323, 600326, 600340, 600344, 600473, 600476, 600345, 422 8201, 422 8202, 422 8205, 435 14, 435 25, 435176, 4352871, 435817, 436 15, 436149, 436151, 436518, 436525, 436806, 604 22, 424402
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/6833 Adhesive patches

Abstract

The present invention relates to an active transdermal analyte detection system performing extraction and detection of body analytes comprising of a patch accepting at least one electrical input; a plurality of transducers configured for converting input electrical energy to different forms of energies for activating extraction procedure; a controller configured for providing the control signals, intensity, sequence, nature, and timing information for the different energies supplied to the said patch vide said transducers; and at least one layer/compartment configured for either collection of extracted fluids and/or delivering at least one reagent formulation that detects the body analyte on activation and a method for performing transdermal extraction and detection of body fluids using said electronic patch.

Claims

1. An active transdermal analyte extraction system for extraction of body analytes through a biological membrane of a subject, the system comprising:

a non-invasive transdermal patch without microneedle arrays, the patch configured to be attached to a skin of the subject, wherein the patch includes three energy treatment transducers consisting of;

a thermal transducer;

an ultrasonic transducer;

an electromotive force transducer; and

a reservoir configured to collect an extracted body analyte;

a controller operatively connected to each of the transducers, wherein the controller comprises a programmable microprocessor configured to pulse the three energy treatments sequentially or simultaneously together, comprising pulsing heat in a range of 30-60°

C., pulsing ultrasonic vibrations in a frequency range of 20 KHz-25 KHz, and pulsing an electromotive force in a range of 0.01 mA-10 mA to the skin of the subject to extract a body analyte through the skin of the subject into the reservoir, wherein the pulses vary in intensity, sequence, and timing and are applied in tandem sequentially or simultaneously; and

one or more sensors for delivering feedback to the controller.

2. The active transdermal analyte extraction system as claimed in claim 1, wherein the patch is configured to detect the extracted body analyte using one or more of chemical, electrical and optical methods.

3. The active transdermal analyte extraction system as claimed in claim 1, wherein the programmable microprocessor is preprogrammed for detecting a targeted body analyte.

4. The active transdermal analyte extraction system as claimed in claim 1, wherein the reservoir comprises a formulation configured to react with the extracted body analyte and to provide a measurable result.

5. The active transdermal analyte extraction system as claimed in claim 4, wherein the formulation comprises enzymes and chemicals capable of reacting with the extracted body analyte to provide a measurable result.

6. The active transdermal analyte extraction system as claimed in claim 1, wherein the reservoir is in direct contact with the electromotive force transducer.

7. The active transdermal analyte extraction system as claimed in claim 4, wherein the formulation comprises polymers, co-polymers, cross linking agents, humectants, chemical permeation enhancers, anti-microbial agents, chelating agents, ions, counter ions, or a combination of any of the foregoing.

8. The active transdermal analyte extraction system as claimed in claim 1, wherein the patch comprises a plurality of electrodes configured to extract the body analyte and to detect the extracted body analyte.

9. The active transdermal analyte extraction system as claimed in claim 1, wherein the patch comprises a membrane layer configured to allow selective transport of the extracted body analyte.

10. The active transdermal analyte extraction system as claimed in claim 1, wherein the patch comprises a protective liner, a coating or a seal configured to be removed before application of the patch to the skin of the subject.

11. The active transdermal analyte extraction system as claimed in claim 1, comprising an input power source operably connected to each of the transducers, wherein the input power source is selected from a battery, an AC power adaptor, a capacitor, and a combination of any of the foregoing.

12. The active transdermal analyte extraction system as claimed in claim 11, wherein the input power source is configured to deliver current in a range of 0.01 mA-1000 mA.

13. The active transdermal analyte extraction system as claimed in claim 11, wherein the input power source is configured to deliver potential in a range of 0 to 12 V DC.

14. The active transdermal analyte extraction system as claimed in claim 1, wherein the ultrasonic transducer comprises a piezoelectric device.

15. The active transdermal analyte extraction system as claimed in claim 1, wherein the ultrasonic transducer comprises a plurality of piezoelectric devices configured to deliver ultrasonic vibrations in a frequency range of 20 KHz-25 KHz.

16. The active transdermal analyte extraction system as claimed in claim 1, wherein the thermal transducer comprises a plurality of electrically conductive coatings configured to generate and transfer heat to the skin of the subject.

17. The active transdermal analyte extraction system as claimed in claim 1, wherein the controller is configured to simultaneously pulse the heat, the ultrasonic vibrations, and the electromotive force, wherein the pulse is characterized by a duration of 1 millisecond or more.

18. The active transdermal analyte extraction system as claimed in claim 1, wherein a sequence and a duration of the pulses are optimized according to a required detection accuracy.

19. The active transdermal analyte extraction system as claimed in claim 1, wherein the patch comprises a support material, wherein,

the support material is selected from a polymer, a rubber, a resin a textile, and a metal;

and

at least a part of the support material comprises an adhesive configured to attach the patch to the skin of the subject; and

at least a part of the support material is perforated.

20. The active transdermal analyte extraction system as claimed in claim 1, wherein the programmable microprocessor is configured to control temperature, rate of heating, duration of heating, ultrasonic energy, ultrasonic frequency, ultrasonic intensity, ultrasonic duration, and electromotive energy.

21. The active transdermal analyte extraction system as claimed in claim 1, wherein the controller comprises a display.

22. The active transdermal analyte extraction system as claimed in claim 1, wherein the controller comprises a memory and a wireless interface.

23. The active transdermal analyte extraction system as claimed in claim 1, comprising a patch insertion and release mechanism configured to mechanically and electrically connect and disconnect the patch from the controller.

24. A method for performing transdermal extraction, detection, and analysis of a body analyte using an electronic patch, the method comprising:

attaching an electronic patch to a skin of a subject, wherein the electronic patch includes a non-invasive transdermal patch without microneedle arrays and three energy treatment transducers, consisting of;

a thermal transducer;

an ultrasonic transducer;

an electromotive force transducer; and

a reservoir configured to collect an extracted body analyte;

inputting electrical energy from a power source to the thermal transducer, the ultrasonic transducer, and the electromotive force transducer to pulse heat in a range of 30-60°

C., pulse ultrasonic vibration in a frequency range of 20 KHz-25 KHz, and pulse electromotive force in a range of 0.01 mA-10 mA to the skin of the subject, wherein the pulses vary in intensity, sequence, and timing and are applied in tandem sequentially or simultaneously;

controlling the electrical energy power input using a controller; and

extracting a body analyte through the skin of the subject to the reservoir; and

analyzing the extracted body analyte.

25. The method as claimed in claim 24, wherein the patch is configured to analyze the extracted body analyte using one or more chemical, electrical and optical methods.

26. The method as claimed in claim 24, wherein the body analyte is selected from glucose, lithium, sodium, potassium, calcium, toxins, cholesterol, insulin, therapeutic and pharmacologic agents, drugs of abuse, amino acids, blood gases, enzymes, antibiotics, and cytokines.

27. The method as claimed in claim 24, wherein the controller comprises a microprocessor which is preprogrammed for analysis of a targeted body analyte.

28. The method as claimed in claim 24, wherein analyzing the extracted body analyte comprises reacting the extracted body analyte with a formulation comprising polymers, co-polymers, cross linking agents, humectants, chemical permeation enhancers, anti microbial agents, chelating agents, ions, or counter ions.

29. The method as claimed in claim 28, wherein,

the formulation is configured to react with the extracted body analyte to provide a reacted formulation;

and

the reacted formulation provides a measurable result.

30. The method as claimed in claim 28, wherein the formulation comprises enzymes or chemicals reactive with the extracted body analyte and that upon reaction produces a measurable result.

31. The method as claimed in claim 24, wherein the thermal transducer, the ultrasonic transducer, and the electromotive force transducer are simultaneously pulsed, wherein the pulses are characterized by a duration of 1 millisecond or more.

32. An active transdermal analyte extraction system for extraction of body analytes through a biological membrane, the system comprising:

a non-invasive transdermal patch without microneedle arrays, the patch configured to be attached to a skin of a subject, wherein the patch includes three energy treatment transducers consisting of;

a thermal transducer configured to deliver heat to the skin in a temperature range of 30-60°

C.;

an ultrasonic transducer configured to deliver ultrasonic vibrations in a frequency range of 20 KHz-25 KHz to the skin;

an electromotive force transducer configured to deliver current in a range of 0.01 mA-10 mA to the skin; and

a reservoir configured to collect an extracted body analyte;

a controller operatively connected to each of the transducers,

wherein the controller comprises a programmable microprocessor configured to simultaneously or sequentially apply pulses of heat, ultrasonic vibrations, and an electromotive force to the skin of the subject to extract a body analyte through the skin of the subject into the reservoir, wherein the pulses vary in intensity, sequence, and timing; and

one or more sensors for delivering feedback to the controller.