SYSTEMS AND METHODS FOR CREATING AN EFFECT USING MICROWAVE ENERGY TO SPECIFIED TISSUE

• US 20080269851A1
• Filed: 04/21/2008
• Published: 10/30/2008
• Est. Priority Date: 04/19/2007
• Status: Active Grant

• Current Assignee: miraDry, Inc. (Sientra Incorporated)
• Original Assignee: Miramar Technologies, Inc (Mist Holdings, Inc.)
• Inventors: Kim, Steven, Su, Ted, Salamini, Alexey, Deem, Mark E., Francis, Dan, Smith, Peter, Johnson, Jessi Ernest, Hallock, Dan
• Granted Patent: US 9,427,285 B2
• Time in Patent Office: Days
• US Class Current: 607/101
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2018/00005 Cooling or heating of the probe or tissue immediately surrounding the probe
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00041 Heating, e.g. defrosting
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/0047 Upper parts of the skin, e.g. skin peeling or treatment of wrinkles
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/0091 Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/1823 Generators therefor
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61F 2007/0075 using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61N 2005/007 for cooling the patient
• CPC Class Codes: A61N 5/02 using microwaves
• CPC Class Codes: A61N 5/04 Radiators for near-field treatment

Abstract

Systems, methods and devices for creating an effect using microwave energy to specified tissue are disclosed. A system for the application of microwave energy to a tissue includes a signal generator adapted to generate a microwave signal having predetermined characteristics, an applicator connected to the generator and adapted to apply microwave energy to tissue. The applicator includes one or more microwave antennas and a tissue interface, a vacuum source connected to the tissue interface, a cooling source connected to the tissue interface, and a controller adapted to control the signal generator, the vacuum source, and the coolant source. The tissue includes a first layer and a second layer, the second layer below the first layer. The controller is configured so that the system delivers energy such that a peak power loss density profile is created in the second layer.

Claims

1. A system for the application of microwave energy to a tissue, comprising:

a signal generator adapted to generate a microwave signal having predetermined characteristics;

an applicator connected to the generator and adapted to apply microwave energy to tissue, the applicator comprising one or more microwave antennas and a tissue interface;

a vacuum source connected to the tissue interface;

a cooling source connected to said tissue interface; and

a controller adapted to control the signal generator, the vacuum source, and the coolant source.

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34. An apparatus for delivering microwave energy to target tissue, the apparatus comprising:

a tissue interface;

a microwave energy delivery device;

a cooling element positioned between the tissue interface and the microwave energy device, the cooling element comprising a cooling plate positioned at the tissue interface; and

a cooling fluid positioned between the cooling element and the microwave delivery device, the cooling fluid having a dielectric constant greater than a dielectric constant of the cooling element.

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41. An apparatus for delivering microwave energy to a target region in tissue, the apparatus comprising:

a tissue interface having a tissue acquisition chamber;

a cooling element having a cooling plate; and

a microwave energy delivery device having a microwave antenna.

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48. An apparatus for delivering microwave energy to a target region in tissue, the apparatus comprising:

a vacuum chamber adapted to elevate tissue including the target region and bring the tissue into contact with a cooling plate, wherein the cooling plate is adapted to contact a skin surface above the target region, cool the skin surface, and physically separate the skin tissue from the microwave energy delivery device; and

a microwave antenna configured to deliver sufficient energy to the target region to create a thermal effect.

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54. A system for coupling microwave energy into tissue, the system comprising:

a microwave antenna;

a fluid chamber positioned between the microwave antenna and the tissue; and

a cooling plate positioned between the cooling chamber and the tissue.

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65. A method of creating a tissue effect in a target tissue layer, comprising the steps of:

irradiating the target tissue layer and a first tissue layer through a skin surface with electromagnetic energy having predetermined frequency and electric field characteristics, wherein the first tissue layer is above the target tissue layer, the first tissue layer being adjacent to a surface of the skin; and

generating a power loss density profile, wherein the power loss density profile has a peak power loss density in a region of the target tissue layer.

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91. A method of creating a lesion in a target tissue layer in the absence of cooling, wherein the target tissue layer is below a first tissue layer, the first tissue layer being adjacent to a skin surface, the method comprising the steps of:

irradiating the target tissue layer and a first tissue layer through a skin surface with electromagnetic energy having predetermined frequency and electric field characteristics, wherein the first tissue layer is above the target tissue layer, the first tissue layer being adjacent to a surface of the skin; and

generating a power loss density profile, wherein the power loss density profile has a peak power loss density in a region of the target tissue layer.

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108. A method of generating heat in a target tissue layer wherein the heat is sufficient to create a lesion in or proximate to the target tissue layer, wherein the target tissue layer is below a first tissue layer, the first tissue layer being adjacent to a skin surface, the method comprising the steps of:

irradiating the target tissue layer and the first tissue layer through the skin surface with electromagnetic energy having predetermined frequency and electric field characteristics; and

generating a power loss density profile wherein the power loss density profile has a peak power loss density in a region of the target tissue layer.

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130. A method of generating heat in a target tissue layer in the absence of cooling wherein the heat is sufficient to create a tissue effect in or proximate to the target tissue layer, wherein the target tissue layer is below a first tissue layer, the first tissue layer being adjacent to a skin surface, the method comprising the steps of:

irradiating the target tissue layer and the first tissue layer through the skin surface with electromagnetic energy having predetermined frequency and electric field characteristics; and

generating a power loss density profile wherein the power loss density profile has a peak power loss density in a region of the target tissue layer.

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147. A method of generating a temperature profile in tissue wherein the temperature profile has a peak in a target tissue layer, wherein the target tissue layer is below a first tissue layer, the first tissue layer being adjacent to a skin surface, the method comprising the steps of:

irradiating the target tissue layer and the first tissue layer through the skin surface with electromagnetic energy having predetermined frequency and electric field characteristics; and

generating a power loss density profile wherein the power loss density profile has a peak power loss density in a region of the target tissue layer.

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164. A method of generating a temperature profile in tissue in the absence of cooling wherein the temperature profile has a peak in a target tissue layer, wherein the target tissue layer is below a first tissue layer, the first tissue layer being adjacent to a skin surface, the method comprising the steps of:

irradiating the target tissue layer and the first tissue layer through the skin surface with electromagnetic energy having predetermined frequency and electric field characteristics; and

generating a power loss density profile wherein the power loss density profile has a peak power loss density in a region of the target tissue layer.

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180. A method of creating a lesion in a first layer of tissue, the first layer having an upper portion adjacent an external surface of the skin and a lower portion adjacent a second layer of the skin, the method comprising the steps of:

exposing the external surface of the skin to microwave energy having a predetermined power, frequency, and electric field orientation;

generating an energy density profile having a peak in the lower portion of the first layer; and

continuing to expose the external surface of the skin to the microwave energy for a time sufficient to create a lesion, wherein the lesion begins in the peak energy density region.

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186. A method of creating a lesion in the skin wherein the skin has at least an external surface, a first layer below the external surface and a second layer, the method comprising the steps of:

positioning a device adapted to radiate electromagnetic energy adjacent the external surface;

radiating electromagnetic energy from the device, the microwave energy having an electric field component which is substantially parallel to a region of the external surface; and

generating a standing wave pattern in the first layer, the standing wave pattern having a constructive interference peak in the first layer, wherein a distance from the constructive interference peak to the skin surface is greater than a distance from the constructive interference peak to an interface between the first layer and the second layer.

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194. A method of creating a temperature gradient in the skin wherein the skin has at least an external surface, a first layer below the external surface and a second layer, the method comprising the steps of:

positioning a device adapted to radiate electromagnetic energy adjacent the external surface;

radiating electromagnetic energy from the device, the microwave energy having an electric field component which is substantially parallel to a region of the external surface; and

generating a standing wave pattern in the first layer, the standing wave pattern having a constructive interference peak in the first layer, wherein a distance from the constructive interference peak to the skin surface is greater than a distance from the constructive interference peak to an interface between the first layer and the second layer.

195. A method of creating a lesion in a dermal layer of the skin, the dermal layer having an upper portion adjacent an external surface of the skin and a lower portion adjacent a subdermal layer of the skin, the method comprising the steps of:

exposing the external surface to microwave energy having a predetermined power, frequency, and electric field orientation;

generating a peak energy density region in the lower portion of the dermal layer; and

continuing to radiate the skin with the microwave energy for a time sufficient to create a lesion, wherein the lesion begins in the peak energy density region.

196. A method of creating a lesion in a dermal layer of the skin wherein the skin has at least a dermal layer and a subdermal layer, the method comprising the steps of:

positioning a device adapted to radiate microwave energy adjacent an external surface of the skin; and

radiating microwave energy having an electric field component which is substantially parallel to a region of the external surface of the skin above the dermal layer, wherein the microwave energy has a frequency which generates a standing wave pattern in the dermal layer, the standing wave pattern having a constructive interference peak in the dermal layer proximal to an interface between the dermal layer and the subdermal layer.

197. A method of creating a lesion in a dermal layer of the skin wherein the skin has at least a dermal layer and a subdermal layer, the method comprising the steps of:

positioning a device adapted to radiate microwave energy adjacent an external surface of the skin;

radiating microwave energy having an electric field component which is substantially parallel to a region of the external surface of the skin above the dermal layer, wherein the microwave energy has a frequency which generates a standing wave pattern in the dermal layer, the standing wave pattern having a constructive interference peak in the dermal layer proximal to an interface between the dermal layer and the subdermal layer; and

heating the lower portion of the dermal region using the radiated microwave energy to create the lesion.

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199. A method of heating a tissue structure located in or near a target tissue layer, wherein the target tissue layer is below a first tissue layer, the first tissue layer being adjacent a skin surface, the method comprising the steps of:

irradiating the target tissue layer and the first tissue layer through the skin surface with electromagnetic energy having predetermined frequency and electric field characteristics; and

generating a power loss density profile wherein the power loss density profile has a peak power loss density in a region of the target tissue layer.

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227. A method of raising the temperature of at least a portion of a tissue structure located below an interface between a dermal layer and subdermal layer in skin, the dermal layer having an upper portion adjacent an external surface of the skin and a lower portion adjacent a subdermal region of the skin, the method comprising the steps of:

radiating the skin with microwave energy having a predetermined power, frequency and e-field orientation;

generating a peak energy density region in the lower portion of the dermal layer;

initiating a lesion in the peak energy density region by dielectric heating of tissue in the peak energy density region;

enlarging the lesion, wherein the lesion is enlarged, at least in part, by conduction of heat from the peak energy density region to surrounding tissue;

removing heat from the skin surface and at least a portion of the upper portion of the dermal layer; and

continuing to radiate the skin with the microwave energy for a time sufficient to extend the lesion past the interface and into the subdermal layer.

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229. A method of raising the temperature of at least a portion of a tissue structure located below an interface between a dermal layer and a subdermal layer of skin, wherein the dermal layer has an upper portion adjacent an external surface of the skin and a lower portion adjacent a subdermal region of the skin, the method comprising the steps of:

positioning a device adapted to radiate microwave energy adjacent the external surface of the skin;

radiating microwave energy having an electric field component which is substantially parallel to a region of the external surface above the dermal layer, wherein the microwave energy has a frequency which generates a standing wave pattern in the dermal layer, the standing wave pattern having a constructive interference peak in the lower portion of the dermal layer;

creating a lesion in the lower portion of the dermal region by heating tissue in the lower portion of the dermal region using the radiated microwave energy;

removing heat from the skin surface and at least a portion of the upper portion of the dermal layer to prevent the lesion from spreading into the upper portion of the dermal layer; and

ceasing the radiating after a first predetermined time, the predetermined time being sufficient to raise the temperature of the tissue structure.

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235. A method of controlling the application of microwave energy to tissue, the method comprising the steps of:

generating a microwave signal having predetermined characteristics;

applying the microwave energy to tissue, through a microwave antenna and a tissue interface operably connected to the microwave antenna;

supplying a vacuum pressure to the tissue interface; and

supplying cooling fluid to the tissue interface;

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265. A method of positioning tissue prior to treating the tissue using radiated electromagnetic energy, the method comprising:

positioning a tissue interface adjacent a skin surface;

engaging the skin surface in a tissue chamber of the tissue interface;

substantially separating a layer comprising at least one layer of the skin from a muscle layer below the skin; and

holding the skin surface in the tissue chamber.

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