Flexible apparatus and method for monitoring and delivery

• US 8,333,874 B2
• Filed: 06/14/2006
• Issued: 12/18/2012
• Est. Priority Date: 12/09/2005
• Status: Active Grant

• Current Assignee: Cambridge Medical Technologies, LLC, Medina Isf Equity, LLC
• Original Assignee: Flexible Medical Systems, LLC
• Inventors: Currie, John Frederick
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US12/096,769
• Publication Number:
  US 20090308742A1
• Time in Patent Office: 2,379 Days
• Field of Search: 20440301-40315, 435 4- 4052
• US Class Current: 204/403.01
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/4547 Evaluating teeth
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention generally relates to a system and method that co-locates in a small flexible, configurable system and multi-level substrate sampling, rapid analysis, bio-sample storage and delivery functions to be performed on living tissues or matter obtained from living organisms. The types of the sampling may include chemical, biochemical, biological, thermal, mechanical, electrical, magnetic and optical sampling. In general, the analysis performed at the point of sampling measures the sample taken and records its value. The bio-sample storage function encapsulates a small sample of analyte and preserves it for subsequent examination or analysis, either on the organism by the system or at a remote location by an independent analysis system. Once stored, the sample can provide a record of a biological state at the precise time of sampling. The delivery at the point of sampling can include chemical, biochemical, biological, thermal, mechanical, electrical, magnetic and optical stimuli.

Claims

1. A sensor for sensing a property of a substance comprising a biomolecule, the sensor comprising:

a flexible substrate;

a micro-heater formed on the surface of the flexible substrate, wherein the micro-heater is configured to repeatedly generate a temperature sufficient to disrupt the stratum corneum without ablating the cells to obtain the biomolecule;

a first pair of electrically conductive paths coupled to the micro-heater;

a pair of electrodes supported by the flexible substrate and positioned proximate to the micro-heater, the pair of electrodes comprising;

a reference electrode; and

a working electrode being electrochemically activated and configured to react with the biomolecule; and

a second pair of electrically conductive paths coupled to the reference electrode and the working electrode.

2. The sensor of claim 1, further comprising a plurality of nanostructures supported on a surface of the working electrode.

3. The sensor of claim 2, wherein the nanostructures are selected from a group consisting of nanowires and nanotubes.

4. The sensor of claim 2, wherein the nanostructures comprise a polymer matrix, the polymer matrix comprising an electrically conductive polymer and one or more bioactive molecules.

5. The sensor of claim 4, wherein the bioactive molecules are selected from a group consisting of enzymes, antibodies, cells, and DNA.

6. The sensor of claim 5, further comprising:

a cavity formed within the flexible substrate;

a protective membrane sealing the cavity; and

a resistive element disposed between the reference and working electrodes, the resistive element being configured to disrupt the protective membrane to provide access to the cavity.

7. The sensor of claim 6, wherein the working and reference electrodes are at least partially disposed within the cavity.

8. The sensor of claim 6, further comprising one or more piezoelectric detection devices disposed within the cavity.

9. The sensor of claim 6, further comprising a delivery material contained within the cavity.

10. The sensor of claim 9, wherein the delivery material is selected from a group consisting of a chemical, a drug, a biomolecule a protein, a peptide, and a genetic material.

11. The sensor of claim 1, wherein the flexible substrate comprises one or more micro-capillary holes.

12. The sensor of claim 1, wherein the flexible substrate comprises a multilayer polymeric metal laminate structure.

13. The sensor of claim 1, wherein the flexible substrate includes a piezoelectric material configured for measuring a deformation of the sensor.

14. The sensor of claim 1, wherein at least the working electrode is encapsulated in a protective membrane, wherein the membrane is selected from a group consisting of selectively permeable membranes and non-permeable reactive membranes.

15. The sensor of claim 3, wherein the nanostructures comprise carbon-based nanotubes.

16. The sensor of claim 8, wherein the one or more piezoelectric detection devices are configured to measure a change in resonate frequency due to binding of the biomolecule.

17. A sensor for sensing a property of a substance comprising a biomolecule, the sensor comprising;

a flexible substrate;

a micro-heater formed on the surface of the flexible substrate, wherein the micro-heater is configured to repeatedly generate a temperature sufficient to disrupt the stratum corneum without ablating the cells to obtain the biomolecule;

a pair of electrodes supported by the flexible substrate, the pair of electrodes comprising;

a reference electrode, and

a working electrode being electrochemically activated and configured to react with the biomolecule; and

an external counter electrode.

18. A sensor for sensing a property of a substance comprising a biomolecule, the sensor comprising:

a flexible substrate, comprising;

a cantilevered beam formed using a piezoelectric material, wherein the cantilevered beam is configured to measure a deformation of the sensor; and

a pair of electrodes supported by the flexible substrate, the pair of electrodes comprising;

a reference electrode; and

a working electrode being electrochemically activated and configured to react with the biomolecule.

19. The sensor of claim 18, further comprising a plurality of nanostructures supported on a surface of the working electrode.

20. The sensor of claim 19, wherein the nanostructures are selected from a group consisting of a nanowires and nanotubes.

21. The sensor of claim 19, wherein the nanostructures comprise a polymer matrix, the polymer matrix comprising an electrically conductive polymer and one or more bioactive molecules.

22. The sensor of claim 21, wherein the bioactive molecules are selected from a group consisting of enzymes, antibodies, cells, and DNA.

23. The sensor of claim 22, further comprising:

a cavity formed within the flexible substrate;

a protective membrane sealing the cavity; and

a resistive element disposed between the reference and working electrodes, the resistive element being configured to disrupt the protective membrane to provide access to the cavity.

24. The sensor of claim 23, wherein the working and reference electrodes are at least partially disposed within the cavity.

25. The sensor of claim 23, further wherein the cantilevered beam is disposed within the cavity.

26. The sensor of claim 23, further comprising a delivery material contained within the cavity.

27. The sensor of claim 26, wherein the delivery material is selected from a group consisting of a chemical, a drug, a biomolecule a protein, a peptide, and a genetic material.

28. The sensor of claim 18, wherein the flexible substrate comprises one or more micro-capillary holes.

29. The sensor of claim 18, wherein the flexible substrate comprises a multilayer polymeric metal laminate structure.

30. The sensor of claim 18, wherein at least the working electrode is encapsulated in a protective membrane, wherein the membrane is selected from a group consisting of selectively permeable membranes and non-permeable reactive membranes.

31. The sensor of claim 20, wherein the nanostructures comprise carbon-based nanotubes.

33. The sensor of claim 18, wherein the cantilevered beam comprises an analyte receptor agent, wherein the cantilevered beam is further configured to measure a change in resonate frequency due to a change in the mass of the cantilevered beam that occurs when an analyte contained in the biomolecule binds to the analyte receptor agent.

34. The sensor of claim 18, wherein the cantilevered beam comprises an analyte receptor agent, wherein the cantilevered beam is configured to measure the deformation of the sensor by measuring surface stress resulting on the cantilevered beam when an analyte contained in the biomolecule binds to the analyte receptor agent.

32. A sensor for sensing a property of a substance comprising a biomolecule, the sensor comprising;

a flexible substrate, comprising;

a piezoelectric material configured to measure a deformation of the sensor; and

a pair of electrodes supported by the flexible substrate, the pair of electrodes comprising;

a reference electrode;

a working electrode being electrochemically activated and configured to react with a biomolecule; and

an external counter electrode.