TRANSDERMAL ANALYTE EXTRACTION & DETECTION SYSTEM AND THE METHOD THEREOF

• US 20130079605A1
• Filed: 03/23/2012
• Published: 03/28/2013
• Est. Priority Date: 09/23/2011
• Status: Active Grant

• Current Assignee: iTrace Biomedical Inc.
• Original Assignee: Kartik Karri, Krishnamohan Sharma, Radhakrishnan Ramdas
• Inventors: BANDARU, Bhaskara Rao, SHARMA, Krishnamohan, RAMDAS, Radhakrishnan, KARRI, Kartik
• Granted Patent: US 9,700,245 B2
• Time in Patent Office: Days
• US Class Current: 600/310
• 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 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.

2. An active transdermal analyte detection system as claimed in claim 1, wherein the patch is configured for detecting the elements/analytes of body fluids using at least one or more of chemical, electrical and optical methods.

3. An active transdermal analyte detection system as claimed in claim 1, wherein the analyte is of particular clinical and therapeutic interest and is at least one from glucose, electrolytes such as lithium, sodium, potassium and calcium;

toxins;

lipids such as cholesterol;

hormones such as insulin;

therapeutic and pharmacologic agents;

drugs of abuse;

amino acids;

blood gases;

enzymes, antibiotics, cytokines and other biologically relevant molecules.

4. An active transdermal analyte detection system as claimed in claim 1, wherein the controller comprises of a microprocessor which is preprogrammed for detecting the targeted analytes.

5. An active transdermal analyte detection system as claimed in claim 1, wherein the layer/compartment includes formulation capable of reacting with the analyte of interest and give out a signal that are qualitatively and/or quantitatively measured.

6. An active transdermal analyte detection system as claimed in claim 5, wherein the said formulation comprises of enzymes, chemicals etc which also acts as reagent including glucose oxidase and reacts with the body analytes to give respective bi-products along with or without output electrical signal, which can be measured.

7. An active transdermal analyte detection system as claimed in claim 1, wherein the formulation includes a coating (solid, semi-solid or gel or adhesive) or contained as a liquid/semi-solid or gel in the compartment is deposited in direct contact with transducers/electrode.

8. An active transdermal analyte detection system as claimed in claim 1, wherein the said formulation comprise of polymer and co-polymers, cross linking agents, humectants, chemical permeation enhancers, anti microbial agents, chelating agents and may also contain some ions and counter ions, but not limited to.

9. An active transdermal analyte detection system as claimed in claim 1, where extraction is assisted by porations, cavitations, reverse iontophoresis and heat and combination thereof.

10. An active transdermal analyte detection system as claimed in claim 1, wherein the patch further includes, a plurality of electrodes configured to activate extraction and detection of the analyte.

11. An active transdermal analyte detection system as claimed in claim 1, wherein the said body fluids migrate rapidly to the top layer of the skin using a plurality of energies applied in combination.

12. A detection system as claimed in claim 1, wherein the skin patch comprises a membrane layer that allows selective transportation of target analytes.

13. A detection system as claimed in claim 1, wherein the skin patch further comprises a protective liner or a coating or a seal that is removed at the time of or before sticking or attaching it to the skin.

14. A detection system as claimed in claim 1, wherein the input power source is a battery, an AC power adaptor and/or a capacitor.

15. A detection system as claimed in claim 14, wherein the input power source is configured for delivering current of range 0.01 mA-1000 mA.

16. A detection system as claimed in claim 14, wherein the input power source is configured for delivering potential of range 0 to 12 V DC.

17. A detection system as claimed in claim 1, wherein the patch comprises of a plurality of circuit blocks which are configured and connected to various transducers for converting the input electrical energy to heat, ultrasonic vibration, electromotive force.

18. A detection system as claimed in claim 17, wherein one of the said transducers use resistive conductive patterns/coating/material for converting electrical energy into heat energy.

19. A detection system as claimed in claim 17, wherein the said resistive conductive patterns/coating/material are either integral part of the controller and reusable or integrated into the skin patch and disposable.

20. A detection system as claimed in claim 17, wherein the resistive pattern is configured for heating the skin and/or patch to a temperature range of 25-200°

C. and preferably 30-60°

C.

21. A detection system as claimed in claim 17, wherein the said patch further includes an ultrasonic transducer/piezoelectric device configured for delivering ultrasonic energy.

22. A detection system as claimed in claim 21, wherein the ultrasonic transducer is preferably part of the controller and is reusable.

23. A detection system as claimed in claim 22, wherein the said patch further includes a plurality of piezoelectric devices configured for delivering ultrasonic vibrations in the frequency range of 20 KHz-25 KHz.

24. A detection system as claimed in claim 17, wherein one of the circuit block uses at least two conductive electrodes to deliver a current of range 0.01 mA-10 mA and act as conduit for transferring electromotive force to the skin.

25. A detection system as claimed in claim 24, wherein the conductive patterns are either integral part of the controller and reusable or preferably integrated into the skin patch and disposable.

26. A detection system as claimed in claim 1, wherein the patch is configured to accept and transfer at least one energy form in combination with other energy forms such as heat, electromotive force, and ultrasonic vibrations to the skin.

27. A detection system as claimed in claim 1, wherein the various forms of energy are supplied in sequential and/or simultaneous manner.

28. A detection system as claimed in claim 1, wherein the said patch contains a plurality of conductive and/or resistive patterns/coatings/materials for transferring energy to the analyte and/or skin.

29. A detection system as claimed in claim 1, wherein the various forms of energy is supplied in pulses with a minimum duration of 1 millisecond or more.

30. A detection system as claimed in claim 29, wherein the pulsing sequence and duration of pulses are optimized according to the required detection accuracy.

31. A detection system as claimed in claim 1, wherein the patch further includes support material which is a thin flexible sheet made of polymer, or rubber, or resin, or textile, or thin metal acceptable for medical applications and at least a part of the support material have adhesive to stick it to the skin and can be perforated.

32. A detection system as claimed in claim 1, wherein the patch includes a plurality of sensors, which provides feedback information to the controller.

33. A detection system as claimed in claim 1, wherein the controller includes a microprocessor with related electronics and software configured for controlling the different factors comprising of temperature, rate of heating, duration of heating, the ultrasonic energy, frequency, intensity, and its duration for the patch detection of analytes and displaying of collected data using a program for accurate and efficient detection.

34. A detection system as claimed in claim 1, wherein the detection is programmed based on analyte, time, computed electrical energy generated and skin permeability.

35. A detection system as claimed in claim 1, wherein the said controller further includes a display.

36. A detection system as claimed in claim 1, wherein the said controller further includes a memory for the storage, recording and retrieval of data for further use and also capable of connecting and data sharing to the external devices via wire and/or wirelessly.

37. A detection system as claimed in claim 1, wherein the said system includes patch insertion and release mechanisms vide a patch tab which is capable of being mechanically and electrically connected to and disconnected from the controller.

38. A method for performing transdermal extraction and detection of body fluids using an electronic patch comprising the steps of:

attaching the patch to the skin of the subject;

inputting electrical energy from a power source;

controlling the electrical energy power input using a controller;

converting the electrical energy to different forms of energy using a plurality of configured circuit blocks;

delivering different forms of energy using a plurality of suitable transducers;

controlling the intensity, sequence, nature, and timing signals for activating the different energies supplied to the said patch;

activating the extraction procedure for analyte using at least one energy; and

detecting and/or collecting the extracted analyte.

39. The method as claimed in claim 38, wherein the patch is configured for detecting the elements/analytes of body fluids using at least one or more of chemical, electrical and optical methods

40. The method as claimed in claim 38, wherein the analyte is of particular clinical and therapeutic interest including glucose, electrolytes such as lithium, sodium, potassium and calcium;

toxins;

lipids such as cholesterol;

hormones such as insulin;

therapeutic and pharmacologic agents;

drugs of abuse;

amino acids;

blood gases;

enzymes, antibiotics, cytokines and other biologically relevant molecules.

41. The method as claimed in claim 38, wherein the controller comprises of a microprocessor which is preprogrammed for the detection of targeted analyte.

42. The method as claimed in claim 38, where extraction of body analyte is assisted by poration cavitation, reverse iontophoresis, and heat and combination thereof.

43. The method as claimed in claim 38, wherein the said body fluids rapidly migrate to the top layer of the skin using a plurality of energies applied in combination.

44. The method as claimed in claim 38, wherein the said formulation comprise of polymer and co-polymers, cross linking agents, humectants, chemical permeation enhancers, anti microbial agents, chelating agents and may also contain some ions and counter ions, but not limited to.

45. The method as claimed in claim 38, wherein the chemical formulation is capable of reacting with the analyte of interest when the extracted body fluid comes in contact with the formulation and give out a signal that is qualitatively and/or quantitatively measured.

46. The method as claimed in claim 38, wherein the said formulation comprises of enzymes, chemicals etc which also acts as reagent and reacts with the body analytes to give respective bi-products which can be measured.