DEVICES AND METHODS FOR PERCUTANEOUS ENERGY DELIVERY

• US 20100010484A1
• Filed: 10/10/2008
• Published: 01/14/2010
• Est. Priority Date: 07/14/2008
• Status: Abandoned Application

• Current Assignee: Syneron Medical Limited (Syneron Incorporated)
• Original Assignee: Primaeva Medical, Inc. (Syneron Incorporated)
• Inventors: MEHTA, Bankim H., McGILL, Scott A.
• Application Number:
  US12/249,807
• Publication Number:
  US 20100010484A1
• Time in Patent Office: Days
• US Class Current: 606/33
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 18/203 applying laser energy to the outside of the body
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00994 combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/1807 using light other than laser radiation
• CPC Class Codes: A61B 2018/208 with multiple treatment beams not sharing a common path, e.g. non-axial or parallel
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

The invention provides a system and method for percutaneous energy delivery in an effective, manner using one or more probes. Additional variations of the system include array of probes configured to minimize the energy required to produce the desired effect.

Claims

1-68. -68. (canceled)

69. A system for applying energy to a target layer of tissue with in a plurality of tissue layers, the system comprising:

a plurality of probes, each having an active area coupled to a device body, at least one of the probes being configured to measure a tissue parameter adjacent to the active area;

a power supply coupled to the probes, the power supply having a controller to adjust energy delivery to the probes in response to the tissue parameter to produce a plurality of fractional lesions in the tissue layer where each fractional lesion is separated from an adjacent fractional lesion by a region of viable tissue.

70. The system of claim 69, where each probe includes an active area and each probe is configured measure the tissue parameter adjacent to the respective active area.

71. The system of claim 69, where at least one of the probes comprises a first sensor located on the active area.

72. The system of claim 69, where at least one of the probes comprises a second sensor located on a non-active area of the probe.

73. The system of claim 69, where the parameter comprises an impedance value of the tissue.

74. The system of claim 73, where the controller prevents energy delivery to at least one of the probes when the tissue parameter is less than 250 ohms or greater than 3000 ohms.

75. The system of claim 73, where the controller provides energy delivery to at least one of the probes using a first set of parameters when the tissue parameter is between 700 and 1500 ohms.

76. The system of claim 73, where the controller provides energy delivery to at least one of the probes using a second set of parameters when the tissue parameter is between 1500 and 3000 ohms.

77. The system of claim 73, where the plurality of probes comprises a plurality of pairs of probes where each fractional lesion is created between adjacent pairs of probes.

78. A method of improving a cosmetic appearance of skin by applying energy from an energy source, the method comprising:

positioning at least one electrode pair beneath a surface of the skin in tissue, where the electrode pair comprises a first and second electrodes of opposite polarity;

confirm placement of the electrode pair in a dermal layer;

selecting a set of controller parameters;

supplying an initial energy level from the energy source between the electrodes in the electrode pair to injure tissue and create a fractional lesion between electrodes of the electrode pair;

measuring a temperature of the injured tissue; and

modifying the initial energy level using thee controller parameters to obtain a target temperature in the injured tissue.

79. The method of claim 78, while confirming placement of the electrode pair comprises measuring an impedance of the tissue located between the electrodes of the electrode.

80. The method of claim 79, further comprising selecting the set of control parameters based on the measured impedance of the tissue.

81. The method of claim 79, further comprising selectively energizing one or more electrode pairs based on the respective impedance value of tissue located between the electrodes of the pair to pass current between the electrodes to damage the tissue and create at least one focal lesion, where the focal lesion is surrounded by uninjured tissue.

82. The method of claim 78, where the supply of the electrical current is adjusted during the application to maintain the temperature of the damaged tissue at a pre-determined temperature.

83. The method of claim 79, where the electrical current is limited to a maximum level pre-determined by a maximum power from the energy source.

84. The method of claim 79, where supplying the electrical current comprises supplying energy while maintaining the pre-determined temperature over an increased period of time to increase the volume of the fractional lesion to create a focal lesion in the reticular dermis layer, the focal lesion comprises multiple fractional lesions.

85. The method of claim 79, supplying the electrical current further comprises comparing the measured temperature of the damaged tissue to the pre-predetermined temperature to control application of energy to prevent the measured temperature from exceeding the pre-determined temperature.

86. The method of claim 79, where supplying the electrical current comprises supplying the electrical current while maintaining a viability of an adnexal structure in the dermal layer.

87. The method of claim 79, where the pre-determined temperature is between 60 to 80 degrees Celsius.

88. The method of claim 84, where the application time is between 0 and 10 seconds.

89. The method of claim 83, where the adnexal structure comprises a structure selected from the group consisting of blood vessels, sweat glands, sebaceous glands, and hair follicles.

91. The method of claim 87, where inserting the array of electrode pairs comprises inserting the array of electrode pairs in an oblique angle.

92. The method of claim 88, further comprising cooling the surface of the tissue directly normal to the focal lesion.

93. The method of claim 78, where the method comprises creating a plurality of focal lesions separated by undamaged tissue, where the at least one electrode pair comprises a plurality of electrode pairs, and where selectively energizing the electrode pairs based on the respective impedance value of tissue located between the electrodes of the electrode pairs to create the plurality of focal lesions.

94. The method of claim 78, where supplying all electrical current from the energy source comprises selectively energizing one or more electrode pairs based on the respective impedance value of tissue located between the electrodes of the pair to create the focal lesion.

95. The method of claim 78, further comprising providing an acceptable range of impedance values and preventing energy delivery to the electrodes if the measured impedance is outside of the acceptable range of impedance values.

96. The method of claim 78, further comprising providing an acceptable total amount of energy and preventing energy delivery to the electrodes if an amount of energy exceeds the acceptable total amount of energy.

97. The method of claim 78, further comprising providing an acceptable maximum temperature value and preventing energy delivery to the electrodes if the measured temperature exceed the maximum temperature value.

98. The method of claim 78, where positioning at least one electrode pair beneath the surface of the skin in tissue comprises subsequently retracting the electrode pair while keeping the electrode pair in tissue to ensure proper placement of the electrode pair.

100. The method of claim 97, where creating at least one lesion in the first lesion of tissue comprises monitoring at least one parameter and adjusting the application of RF current to create the at least one lesion in the first layer of tissue without substantially affecting the viability of the second and third layers of tissue.

107. The method of claim 97, where the pair of electrodes comprises a first and a second electrode of an opposite polarity.

108. The method of claim 97, where the pair of electrodes comprises a first and a second electrode of a same polarity.

90. The method of 78, where positioning at least one electrode pair beneath a surface of the tissue comprises inserting an array of electrode pairs beneath the surface of the epidermis.

99. A method of improving a cosmetic appearance of skin by:

inserting at least a pair of electrodes at least partially in a first layer of tissue where the first layer of tissue is embedded between at least a second and third layers of tissue and where an electrical conductivity of the first layer of tissue is higher than an electrical conductivity of the second and third layers of tissue;

applying RF current to the electrodes so that the RF current is preferentially applied in the first layer of tissue; and

creating at least one lesion in the first layer of tissue without substantially affecting the viability of the second and third layers of tissue.

101. The method of claim 99, where the lesion comprises a plurality of fractional lesions within the first layer of tissue where each fractional lesion is separated by an adjacent fractional lesion by a region of viable tissue.

102. The method of claim 99, where the supply of the RF current is adjusted during the application to maintain the temperature of the damaged tissue at a pre-determined temperature.

103. The method of claim 99, where the RF current is limited to a maximum level pre-determined by a maximum power.

104. The method of claim 99 where applying the RF current comprises supplying the RF current while maintaining the pre-determined temperature over an increased period of time to increase the volume of the lesion in the reticular dermis layer.

105. The method of claim 99, where supplying the RF current comprises supplying the RF current while maintaining a viability of adnexal structure in the first layer of tissue.

106. The method of claim 105, where the adnexal structure comprises a structure selected from the group consisting of blood vessels, sweat glands, sebaceous glands, and hair follicles.

109. A method of improving a cosmetic appearance of skin by:

inserting at least a pair of probes at least partially in a layer of tissue; and

applying energy to the pair of probes in a controlled manner such that the energy damages tissue to create at least a fractional lesion between each probe of the pair and where each fractional lesion is surrounded by a layer of viable tissue.

110. The method of claim 109 where applying energy to the pair of probes in a controlled manner comprises creating the fractional lesion within a single layer of tissue.

111. The method of claim 110, where the layer comprises a reticular dermal layer.

112. The method of claim 109, further comprising applying additional energy to create a focal lesion by joining more than one fractional lesion and where the focal lesion occurs within a single layer of tissue.

113. The method of claim 109, where applying energy comprises maintaining a viability of an adnexal structure in the first layer of tissue.

114. The method of claim 113, where the adnexal structure comprises a structure selected from the group consisting of blood vessels, sweat glands, sebaceous glands, and hair follicles.

115. The method of claim 109, where the energy is selected from an energy modality selected from the group consisting of thermal, electrical, electromagnetic, microwave, mechanical, ultrasound, light, radiation, chemical, and radioactive.

116. The method of claim 109, the application of energy is selected to maintaining the structural integrity of elastin.

117-122. -122. (canceled)

123. A method for treating tissue, the method comprising:

inserting an array of-electrode pairs within the tissue; and

applying energy to the array of electrodes using a controller configured to independently control energy delivery to each electrode pair in the array to create a plurality of fractional lesions within the tissue between adjacent electrode pairs.

124. The method of claim 123, further comprising placing at least one sensing element proximate to at least one electrode, where the sensing element is in communication with the controller to monitor at least one tissue condition adjacent to the electrode, and where the controller is configured to adjust the application energy in response to the local tissue condition.

125. The method of claim 124, where the tissue condition is selected from either a temperature of the tissue, or an impedance of the tissue.

126. The method of claim 123, applying energy results in creation of the fractional lesions such that the fractional lesions are totally embedded within the tissue.

127. The method of claim 123, where the electrode pairs comprise an active area spaced from an end of the electrodes, and where the active area creates the fractional lesion over a surface of the active area.