Methods and Devices for Thermal Treatment

• US 20080045879A1
• Filed: 05/31/2005
• Published: 02/21/2008
• Est. Priority Date: 05/28/2004
• Status: Active Grant

• Current Assignee: Georgia Tech Research Corporation (University System of Georgia)
• Original Assignee: Georgia Tech Research Corporation (University System of Georgia)
• Inventors: Park, Jung-Hwan, Park, Jin-Woo, Yoon, Yong-Kyu, Allen, Mark, Prausnitz, Mark
• Granted Patent: US 8,690,865 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/10 Power sources therefor
• CPC Class Codes: A61B 2018/00005 Cooling or heating of the probe or tissue immediately surrounding the probe
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61K 41/0047 Sonopheresis, i.e. ultrasonically-enhanced transdermal delivery, electroporation of a pharmacologically active agent
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation

Abstract

The present invention comprises methods and devices for thermal treatment of a barrier to increase the permeability of the barrier. One form of increasing the permeability of the barrier comprises forming micropores which may be used for administration of active agents across the barrier, or may be used for sampling or collecting fluids, or may be used for detecting, measuring or determining analytes, or may be used for monitoring of physiological or other conditions. Devices of the present invention may comprise microheaters that are activated by inductive or ohmic heating power supply components.

Claims

1. A method for increasing the permeability of a barrier, comprising the steps of:

a) applying an effective amount of a substance to a selected site on the surface of a barrier;

b) providing a thermal treatment device including a microheater component having at least one microheater and positioning the thermal treatment device relative to the surface of the barrier;

c) energizing at least one microheater of the microheater component with a power supply component;

d) heating the substance to a temperature sufficient to increase the volume of the substance which ablates the surface of the barrier thereby increasing the permeability of the barrier.

2. The method of claim 1, wherein the barrier includes at least one of human skin, animal skin and mucous membrane.

3. The method of claim 1, wherein the thermal treatment device is a unitary device where the microheater component is electrically coupled to the power supply component.

4. The method of claim 1, wherein the power supply component energizes the microheater component by at least one of ohmic heating and inductive heating.

5. The method of claim 1, wherein the power supply component is separate from the thermal treatment device and a wireless device interfaces between the microheater component and the power supply component.

7. The method of claim 1, wherein the substance includes an ablation material selected from the group consisting of liquids, gels, solutions, multiphase materials, or solids, comprising hydrophobic liquids, hydrophilic liquids, water, ethanol, methanol, organic compounds, alcohols, ketones, aldehydes, amines, ethers, esters, oils, paraffins, fatty acids, salt hydrates, including but not limited to calcium hydrates, sodium sulphate decahydrate, sodium phosphate dodecahydrate, calcium chloride hexahydrate and sodium thiosulfate pentahydrate, mixtures and combinations thereof.

8. The method of claim 1 wherein the geometric configuration of the microheater is selected from the group consisting of a disk, a cone, a donut, a hollow post, and a loop, all of which range from less than 1 micron to hundreds of microns in length.

9. The method of claim 1, wherein the microheater includes at least one of a single type of metal and layers of metal selected from the group consisting of conductive oxides, conductive polymers or alloys, nickel, nickel-iron, ferromagnetic materials, copper, NiCu, PdCo, gadolinium-silicon-germanium alloy, aluminum, ceramic materials, electrodeposited or vapor-deposited gold, platinum, or palladium outer layer coating of nickel, nickel iron, a magnetic stainless steel-type alloy, 4OO-series alloy, indium tin oxide, lanthanum strontium cobalt oxide, and aluminum doped zinc oxide.

6. (canceled)

10. A method for increasing the permeability of a barrier, comprising the steps of:

a) providing a microheater component including at least one microheater having an ablation material disposed therein;

b) energizing the microheater component with a power supply component;

c) heating the ablation material to a temperature sufficient to rapidly increase the volume of the ablation material which, in turn, ablates the surface of the barrier thereby increasing the permeability of the barrier.

11-18. -18. (canceled)

19. A thermal treatment device, comprising:

a) a microheater component including at least one microheater having a thermal member including a base end and a tip end;

b) an ablation material in contact with the microheater; and

c) a power supply component which is configured to activate at least one microheater of the microheater component.

20. The device of claim 19, wherein the thermal treatment device is a unitary device where the microheater component is electrically coupled to the power supply component.

21. The device of claim 19, wherein the power supply component energizes the microheater component by at least one of ohmic heating and inductive heating.

22. The device of claim 19, wherein the power supply component is separate from the thermal treatment device and a wireless device interfaces between the microheater component and the power supply component.

24. The device of claim 19, wherein the ablation material is selected from the group consisting of liquids, gels, solutions, multiphase materials, or solids, comprising hydrophobic liquids, hydrophilic liquids, water, ethanol, methanol, organic compounds, alcohols, ketones, aldehydes, amines, ethers, esters, oils, paraffins, fatty acids, salt hydrates, including but not limited to calcium hydrates, sodium sulphate decahydrate, sodium phosphate dodecahydrate, calcium chloride hexahydrate and sodium thiosulfate pentahydrate, mixtures and combinations thereof.

25. The device of claim 19, wherein the ablation material contacts an open space area of the microheater.

26. The device of claim 19, wherein the ablation material contacts a tip end of the microheater.

27. The device of claim 19, wherein the geometric configuration of the microheater is selected from the group consisting of a disk, a cone, a donut, a hollow post, and a loop, all of which range from less than 1 micron to hundreds of microns in length.

28. The device of claim 19, wherein the microheater includes at least one of a single type of metal and layers of metal selected from the group consisting of conductive oxides, conductive polymers or alloys, nickel, nickel-iron, ferromagnetic materials, copper, NiCu, PdCo, gadolinium-silicon-germanium alloy, aluminum, ceramic materials, electrodeposited or vapor-deposited gold, platinum, or palladium outer layer coating of nickel, nickel iron, a magnetic stainless steel-type alloy, 400-series alloy, indium tin oxide, lanthanum strontium cobalt oxide, and aluminum doped zinc oxide.

23. (canceled)

29. A microheater, comprising:

a) a thermal member comprising a base end and a tip end; and

b) an ablation material in physical contact with the thermal member.

30-34. -34. (canceled)

35. A method of transdermal delivery of an active agent, comprising the steps of:

a) providing a transdermal patch having at least one active agent disposed therein;

b) contacting a selected site on a surface of a human or animal with a thermal treatment device including a microheater component having at least one microheater with a substance disposed therein;

c) energizing the at least one microheater, with a power supply component so as to heat the substance to a temperature sufficient to increase the volume of the substance thereby increasing the permeability of the surface; and

d) allowing the thermal treatment device to contact the surface for a sufficient amount of time for the transfer of an effective amount of the at least one active agent from the transdermal patch to the surface.

36. The method of claim 35, wherein the step of energizing the at least one microheater to increase the permeability of the surface includes forming one or more micropores in the surface.

37. The method of claim 35, wherein the surface is stratum corneum of a human.

38. The method of claim 35, wherein the thermal treatment device is a unitary device where the microheater component is electrically coupled to the power supply component.

39. The method of claim 38, wherein the power supply component energizes the microheater component by at least one of ohmic heating and inductive heating.

40. The method of claim 35, wherein the power supply component is separate from the thermal treatment device and a wireless device interfaces between the microheater component and the power supply component.

42. The method of claim 35, wherein the substance includes an ablation material selected from the group consisting of liquids, gels, solutions, multiphase materials, or solids, comprising hydrophobic liquids, hydrophilic liquids, water, ethanol, methanol, organic compounds, alcohols, ketones, aldehydes, amines, ethers, esters, oils, paraffins, fatty acids, salt hydrates, including but not limited to calcium hydrates, sodium sulphate decahydrate, sodium phosphate dodecahydrate, calcium chloride hexahydrate and sodium thiosulfate pentahydrate, mixtures and combinations thereof.

43. The method of claim 35, wherein the geometric configuration of the microheater is selected from the group consisting of a disk, a cone, a donut, a hollow post, and a loop, all of which range from less than 1 micron to hundreds of microns in length.

44. The method of claim 35, wherein the microheater includes at least one of a single type of metal and layers of metal selected from the group consisting of conductive oxides, conductive polymers or alloys, nickel, nickel-iron, ferromagnetic materials, copper, NiCu, PdCo, gadolinium-silicon-germanium alloy, aluminum, ceramic materials, electrodeposited or vapor-deposited gold, platinum, or palladium outer layer coating of nickel, nickel iron, a magnetic stainless steel-type alloy, 400-series alloy, indium tin oxide, lanthanum strontium cobalt oxide, and aluminum doped zinc oxide.

45. The method of claim 35, wherein the active agent includes agents selected from the group consisting of agents for gene therapy, nucleic acids, viruses, antigens, immunogens, chemical or biological materials or compounds that induce a desired biological or pharmacological effect, antiinfectives such as antibiotics and antiviral agents;

analgesics and analgesic combinations;

anorexics;

antihelminthics;

antiarthritics;

antiasthmatic agents;

anticonvulsants;

antidepressants;

antidiabetic agents;

antidiarrheals;

antihistamines;

antiinflammatory agents;

antimigraine preparations;

antinauseants;

antineoplastics;

antiparkinsonism drugs;

antipruritics;

antipsychotics;

antipyretics;

antispasmodics;

anticholinergics;

sympathomimetics;

xanthine derivatives;

cardiovascular preparations including potassium and calcium channel blockers, beta-blockers, alpha blockers, and antiarrhythmics;

antihypertensives;

diuretics and antidiuretics;

vasodilators including general coronary, peripheral and cerebral;

central nervous system stimulants;

vasoconstrictors;

cough and cold preparations, including decongestants;

hormones such as estradiol and other steroids, progesterone and derivatives, testosterone and derivatives, including corticosteroids;

angiogenic agents, antiangeogenic agents, hypnotics;

immunosuppressives;

muscle relaxants;

parasympatholytics;

nicotine, psychostimulants;

sedatives;

tranquilizers, ionized or nonionized active agents, or compounds of either high or low molecular weight.

41. (canceled)

46. A method of transdermal delivery of an active agent, comprising the steps of:

a) contacting a selected site on the surface of a human or animal with a thermal treatment device including a microheater component having at least one microheater with an ablation material in physical contact with the microheater;

b) energizing the microheater component with a power supply component so as to heat the ablation material to a temperature sufficient to increase the volume of the ablation material thereby increasing the permeability of the surface;

c) removing the microheater component; and

d) applying a transdermal patch having at least one active agent disposed therein to the selected site for a sufficient amount of time to transfer an effective amount of the at least one active agent from the transdermal patch to the surface.

65. The method of claim 46, wherein the active agent is at least one of a compound, molecule, chemical, and biological construct, that provides a physical or chemical change to an existing condition.

66. The method of claim 46, wherein increasing the permeability of the surface comprises forming micropores in the surface.

47-64. -64. (canceled)

67. A method of increasing the permeability of a barrier for sampling a fluid contained by the barrier, comprising the steps of:

a) contacting a selected site on the surface of a barrier with a thermal treatment device including a microheater component having at least one microheater with an ablation material in physical contact with the microheater;

b) providing a means for sampling a fluid;

c) energizing the microheater component with a power supply component so as to heat the ablation material to a temperature sufficient to increase the volume of the ablation material thereby increasing the permeability of the barrier; and

d) sampling a fluid released by the barrier.

76. The method of claim 67, further comprising the step of:

detecting, monitoring, or analyzing an analyte in the sample.

77. The method of claim 76, wherein the analyte is any substance which may be measured, determined, monitored, or analyzed in order to gain information or determine the status, related to the source of the analyte.

68-75. -75. (canceled)

78. A system for transdermal delivery comprising:

a) a thermal treatment device including a microheater component having at least one microheater with an ablation material in physical contact with the microheater;

b) a transdermal patch including at least one active agent; and

c) a power supply component which activates the microheater component to heat the ablation material to a temperature sufficient to increase the volume of the ablation material thereby increasing the permeability of an underlying barrier.