Method and apparatus for treatment of adipose tissue

• US 20070239075A1
• Filed: 02/16/2006
• Published: 10/11/2007
• Est. Priority Date: 02/16/2006
• Status: Active Grant

• Current Assignee: Syneron Medical Limited (Syneron Incorporated)
• Original Assignee: Syneron Medical Limited (Syneron Incorporated)
• Inventors: Rosenberg, Avner, Kreindel, Michael, Eckhouse, Shimon
• Granted Patent: US 8,133,191 B2
• Time in Patent Office: Days
• US Class Current: 601/2
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00061 spectrum
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2018/0047 Upper parts of the skin, e.g. skin peeling or treatment of wrinkles
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61N 1/0408 Use-related aspects
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• CPC Class Codes: A61N 1/328 for improving the appearance of the skin, e.g. facial toning or wrinkle treatment
• CPC Class Codes: A61N 2007/0008 Destruction of fat cells
• CPC Class Codes: A61N 2007/0039 using microbubbles
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

The invention provides methods and apparatuses for the treatment of adipose tissue. The methods comprise application of ultrasound energy to a region of adipose tissue, and the apparatuses comprise at least one source of ultrasound energy configured to direct ultrasound energy through a skin surface into the subcutaneous adipose tissue. In one embodiment, a pressure gradient is created in the region generating relative movement between fat cell constituents having different densities. In another embodiment, a protrusion of skin and underlying adipose tissue containing is formed and ultrasound energy is radiated into the adipose tissue in the protrusion. In another embodiment, an RF electric field is generated inside a region of adipose tissue together with the ultrasound energy.

Claims

1. A method for treatment of adipose tissue in a region of subcutaneous adipose tissue comprising directing applying at least one source of ultrasound energy to a skin surface to generate a pressure gradient in the region, said pressure gradient generating relative movement between fat cells constituents having different densities the relative movement having sufficient intensity to cause a treatment of the fat cells.

2. The method according to claim 1, where the pressure gradient in the fat tissue is from 0.5 GPa/m to 50 GPa/m.

3. The method according to claim 2, where the pressure gradient in the fat tissue is from 2 GPa/m to 15 GPa/m.

4. The method according to claim 1 wherein the ultrasound frequency is less than 1 MHz.

5. The method according to claim 4, wherein the ultrasound frequency is less than 300 kHz.

6. The method according to claim 1 wherein the ultrasound is pulsed.

7. The method according to claim 6 wherein pulse length is 10 μ

sec to 10 msec.

8. The method according to claim 7 wherein the pulse length is from 100 μ

sec to 1 msec.

9. The method according to claim 1 wherein the ultrasound energy is delivered by an ultrasound source having view angle from the focal point of less than 120°

.

10. The method according to claim 9 wherein the ultrasound energy is delivered by an ultrasound source having view angle from the focal point of less than 90°

.

11. The method according to claim 6 where the ultrasound radiation has a pulse length and pulse repetition rate selected to minimize generation of cavitations at the body tissues.

12. The method according to claim 1 wherein a body tissue temperature is controlled to rise to a temperature from 37°

to 44°

by a power duty of the ultrasound energy source.

13. The method according to claim 1, wherein the ultrasound source is a flat transducer having a uniform radiating phase, and the depth of the region of maximum pressure gradient is controlled by the ultrasound frequency.

14. The method according to claim 1 wherein the ultrasound energy is generated by a phased array ultrasound transducer.

15. The method according to claim 1 further comprising forming a protrusion of skin and underlying adipose tissue containing the region and directing the ultrasound energy into the region.

16. The method according to claim 15 wherein the protrusion is formed by applying a negative pressure to a region of the skin surface.

17. The method according to claim 15 wherein the protrusion is formed by applying mechanical forces to a region of the skin surface.

18. The method according to claim 15 where two or more ultrasound sources are applied, the ultrasound sources having overlapping regions of maximum ultrasound intensity inside the protruding adipose tissue.

19. The method according to claim 18, wherein the relative phase of the ultrasound sources is controlled.

20. The method according to claim 15, wherein the ultrasound energy is applied by a flat transducer having a uniform radiating phase, and the depth of the region of maximum intensity is controlled by the ultrasound frequency.

21. The method according to claim 15 wherein the ultrasound is applied by a phased transducer array.

22. The method according to claim 15 wherein the ultrasound energy is applied by a source having at least one mechanical degree of freedom to adapt to the protrusion.

23. The method according to claim 21 wherein the radiation pattern of the phased array is dynamically matched to a source and protrusion position.

24. The method according to claim 1 further comprising generating an RF electric field inside the adipose tissue.

25. The method according to claim 24 wherein the application of the RF energy is at least partially simultaneous with the application of the ultrasound energy.

26. The method according to claim 24 wherein the RF electric field has a frequency between 100 KHz and 100 MHz.

27. The method according to claim 26 wherein the RF frequency is between 500 KHz and 5 MHz.

28. The method according to claim 24 wherein the RF voltage is between 10V peak and 1000V peak.

29. The method according to claim 28 wherein the RF voltage is between 30V peak and 300V peak.

30. The method according to claim 24 further comprising monitoring an RF impedance on the RF electrodes.

31. The method according to claim 15 further comprising generating an RF electric field inside the region.

32. The method according to claim 1 further comprising measuring an electrical impedance of an ultrasound transducer to monitor coupling of the ultrasound energy to the body.

33. The method according to claim 1 further comprising illuminating at least a portion of the body surface with infrared light.

34. A method for treatment of adipose tissue in a region of subcutaneous adipose tissue comprising:

a. forming a protrusion of skin and underlying adipose tissue containing the region; and

b. radiating ultrasound energy into the region.

35. The method according to claim 34 wherein the protrusion is formed by applying a negative pressure to the skin surface.

36. The method according to claim 34 wherein the protrusion is formed by applying mechanical forces to a region of the skin surface.

37. The method according to claim 34 wherein the ultrasound energy is directed at an angle to the normal to the non-protruding skin surface.

38. The method according to claim 37 wherein the angle is greater than 30°

.

39. The method according to claim 38 wherein the angle is greater than 45°

.

40. The methods according to claim 34 where two or more ultrasound sources are applied, the ultrasound sources having overlapping regions of maximum ultrasound intensity inside the protruding adipose tissue.

41. The method according to claim 40 where the relative phase of the ultrasound sources is controlled.

42. The method according to claim 34 wherein the ultrasound energy is applied from a flat transducer having a uniform radiating phase, and the depth of the region of maximum intensity is controlled by the ultrasound frequency.

43. The method according to claim 34 wherein the ultrasound energy is applied from a phased array.

44. The method according to claim 34 wherein the ultrasound energy is applied from a source having at least one mechanical degree of freedom to adapt to the protrusion.

45. The method according to claim 43 wherein the phased array has a radiation pattern that is dynamically matched to the array and protrusion position.

46. The method according to claim 34 wherein the ultrasound frequency is less than 1 MHz.

47. The method according to claim 46 wherein the ultrasound frequency is less than 300 kHz

48. The method according to claim 34 wherein the ultrasound is pulsed.

49. The method according to claim 48 wherein pulse length is from 10 μ

sec to 10 msec.

50. The method according to claim 49 wherein the pulse length is from 100 μ

sec to 1 msec.

51. The method according to claim 35 wherein negative pressure is applied for duration between 50 msec and 1 sec.

52. The method according to claim 51, wherein the negative pressure is applied for a duration between 100 msec and 500 msec.

53. The method according to claim 35 wherein the ultrasound radiation starts when a predetermined negative pressure is applied to the skin surface.

54. The method according to claim 34 further comprising measuring an electrical impedance of an ultrasound transducer to monitor coupling of the ultrasound energy to the body.

55. The method according to claim 34 further comprising generating an RF electric field inside the adipose tissue.

56. The method according to claim 55 wherein the application of the RF energy is at least partially simultaneous with the application of the ultrasound energy.

57. The method according to claim 55 wherein the RF electric field has a frequency between 100 KHz and 100 MHz.

58. The method according to claim 57 wherein the RF frequency is between 500 KHz and 5 MHz.

59. The method according to claim 55 wherein the RF voltage is between 10V peak and 1000V peak.

60. The method according to claim 59 wherein the RF voltage is between 30V peak and 300V peak.

61. The method according to claim 55 further comprising monitoring an RF impedance on the RF electrodes.

62. The method according to claim 34 further comprising illuminating at least part of the treated body surface with infrared light.

63. A method for treatment of fat tissue in a region of subcutaneous adipose tissue comprising:

a. radiating ultrasound energy into the region; and

b. generating an RF electric field inside the region.

64. The method according to claim 63 wherein the application of the RF energy is at least partially simultaneous with the application of the ultrasound energy.

65. The method according to claim 63 wherein the ultrasound frequency is less than 1 MHz.

66. The method according to claim 65 wherein the ultrasound frequency is less than 300 kHz.

67. The method according to claim 63 wherein the ultrasound is pulsed.

68. The method according to claim 67 wherein pulse length is 10 μ

sec to 10 msec.

69. The method according to claim 68 wherein the pulse length is from 100 μ

sec to 1 msec.

70. The method according to claim 63 wherein the RF electric field has a frequency between 100 KHz and 100 MHz.

72. The method according to claim 63, wherein the RF voltage is between 10V peak and 1000V peak.

73. The method according to claim 72 wherein the RF voltage is between 30V peak and 300V peak.

74. The method according to claim 63 wherein an RF impedance on the RF electrodes is monitored.

75. The method according to claim 63 further comprising measuring an electrical impedance of an ultrasound transducer to monitor coupling of the ultrasound energy to the body.

76. The method according to claim 63 further comprising illuminating at least part of the treated body surface with infrared light.

77. An apparatus for treatment of adipose tissue in a region of subcutaneous adipose tissue comprising at least one source of ultrasound energy configured to direct ultrasound energy through a skin surface to generate a pressure gradient in the region, said pressure gradient generating relative movement between fat cell constituents having different densities with sufficient intensity to cause treatment of the fat cells.

71. The method according to claim 79 wherein the RF frequency is between 500 KHz and 5 MHz.

78. The apparatus according to claim 77 where the pressure gradient at the fat tissue is from 0.5 GPa/m to 50 GPa/m.

79. The apparatus according to claim 78 where the pressure gradient at the fat tissue is from 2 GPa/m to 15 GPa/m.

80. The apparatus according to claim 77 wherein the ultrasound energy has a frequency less than 1 MHz.

81. The apparatus according to claim 80 wherein the ultrasound energy has a frequency less than 300 kHz

82. The apparatus according to claim 77 wherein the ultrasound energy is pulsed.

83. The apparatus according to claim 82 wherein pulse length is 10 μ

sec to 10 msec.

84. The apparatus according to claim 83 wherein the pulse length is from 100 μ

sec to 1 msec.

85. The apparatus according to claim 77 wherein the ultrasound source has a view angle from the focal point less than 120°

.

86. The apparatus according to claim 85 wherein the view angle of the ultrasound source from the focal point is less than 90°

.

87. The apparatus according to claim 77 wherein the ultrasound radiation has a pulse length and pulse repetition rate selected to minimize generation of cavitations at the body tissues.

88. The apparatus according to claim 87 further comprising a cavitations sensor and a control unit, the control unit changing the pulse length and repetition rate of the ultrasound source to minimize the output of the cavitations sensor.

89. The apparatus according to claim 77 further comprising a control unit configured to control the pulse length or pulse repetition rate to achieve a predetermined tissue temperature.

90. The apparatus according to claim 89 wherein the predetermined tissue temperature is from 37°

to 44°

.

91. The apparatus according to claim 77 wherein the ultrasound source is a flat transducer having a uniform radiating phase, the depth of the region of maximum pressure gradient being controlled by the ultrasound frequency.

92. The apparatus according to claim 77 wherein the ultrasound source is a phased array transducer.

93. The apparatus according to claim 77 further comprising a device configured to form a protrusion of skin and underlying adipose tissue containing the region and ultrasound energy is directed into the region.

94. The apparatus according to claim 93 wherein the device is configured to form a protrusion by applying a negative pressure to the skin.

95. The apparatus according to claim 93 wherein the device is configured to form a protrusion by applying mechanical forces to a region of the skin surface.

96. The apparatus according to claim 93 comprising two or more ultrasound sources, the ultrasound sources have overlapping regions of maximum ultrasound intensity inside the protruding adipose tissue.

97. The apparatus according to claim 96 wherein the relative phase of the ultrasound sources is controlled.

98. The apparatus according to claim 93 wherein the ultrasound source has at least one mechanical degree of freedom to adapt to the protrusion.

99. The apparatus according to claim 98 wherein the ultrasound source is a phased array having a radiation pattern that is dynamically matched to the source and protrusion position.

100. The apparatus according to claim 77 further comprising at least two electrodes and an RF power source driving these electrodes to generate an RF electric field inside the adipose tissue.

101. The apparatus according to claim 100 further comprising a controller configured to apply the RF energy at least partially simultaneous with the application of the ultrasound energy.

102. The apparatus according to claim 100 wherein the RF electric field has a frequency between 100 KHz and 100 MHz.

103. The apparatus according to claim 102 wherein the RF frequency is between 500 KHz and 5 MHz.

104. The apparatus according to claim 100 wherein the RF voltage is between 10V peak and 1000V peak.

105. The apparatus according to claim 104 wherein the RF voltage is between 30V peak and 300V peak.

106. The apparatus according to claim 100 further comprising a device for monitoring an RF impedance on the RF electrodes.

107. The apparatus according to claim 77 further comprising measuring an electrical impedance of an ultrasound transducer to monitor coupling of the ultrasound energy to the body.

108. The apparatus according to claim 77 further comprising a source of infrared light for illuminating at least part of the treated body surface with infrared light.

109. An apparatus for treatment of adipose tissue in a region of subcutaneous adipose tissue comprising:

a. a device configured to form a protrusion of skin and underlying adipose tissue containing the region; and

b. at least one ultrasound energy source configured to radiate ultrasound energy into the region.

110. The apparatus according to claim 109 wherein the device is configured to form a protrusion by applying a negative pressure to the skin surface.

111. The apparatus according to claim 109 wherein the device is configured to form the protrusion by applying a mechanical forces on the skin surface.

112. The apparatus according to claim 109 wherein the ultrasound energy is directed at an angle to the normal to the non-protruding skin surface.

113. The apparatus according to claim 112 wherein the angle to the normal is greater than 30°

.

114. The apparatus according to claim 113 wherein the angle is greater than 45°

.

115. The apparatus according to claim 109 including two or more ultrasound sources, the ultrasound sources having overlapping regions of maximum ultrasound intensity inside the protruding adipose tissue.

116. The apparatus according to claim 115 wherein the relative phase of the ultrasound sources is controlled.

117. The apparatus according to claim 109 wherein the ultrasound source is a flat transducer having a uniform radiating phase, and the depth of the region of maximum intensity is controlled by the ultrasound frequency.

118. The apparatus according to claim 109 wherein the ultrasound source is a phased array transducer.

119. The apparatus according to claim 109, wherein the ultrasound source has at least one mechanical degree of freedom to adapt to the protrusion.

120. The apparatus according to claim 119 wherein where the ultrasound source is a phased array having a selectable radiation pattern to dynamically match the source and protrusion position.

121. The apparatus according to claim 109 configured to generate ultrasound energy having a frequency less than 1 MHz.

122. The apparatus according to claim 121 configured to generate ultrasound having a frequency less than 300 kHz.

123. The apparatus according to claim 109 configured to apply pulsed ultrasound energy.

124. The apparatus according to claim 123 configured to apply pulsed ultrasound energy having a pulse length from 10 μ

sec to 10 msec.

125. The apparatus according to claim 124 configured to apply pulsed ultrasound energy having a pulse length from from 100 μ

sec to 1 msec.

126. The apparatus according to claim 123 configured to apply ultrasound radiation having a pulse length and pulse repetition rate selected to minimize generation of cavitations in the body tissues.

127. The apparatus according to claim 109 further comprising a cavitations sensor and a control unit, the control unit being configured to determine the pulse length and repetition rate of the ultrasound source to minimize the output of the cavitations sensor.

128. The apparatus according to claim 110 configured to apply negative pressure to a skin surface for a duration between 50 msec and 1 sec.

129. The apparatus according to claim 128 configured to apply negative pressure for a duration between 100 msec and 500 msec.

130. The apparatus according to claim 110 configured to apply the ultrasound radiation when a predetermined negative pressure is achieved on the skin surface.

131. The apparatus according to claim 109 further configured to measure an electrical impedance of an ultrasound transducer array to monitor coupling of the ultrasound energy to the skin.

132. The apparatus according to claim 109 further comprising at least two RF electrodes and an RF driver configured to produce an RF electric field inside the protrusion.

133. The apparatus according to claim 132 further comprising a controller configured to apply the RF energy at least partially simultaneous with the application of the ultrasound energy.

134. The apparatus according to claim 132 wherein the RF electric field has a frequency between 100 KHz and 100 MHz.

135. The apparatus according to claim 134 wherein the RF frequency is between 500 KHz and 5 MHz.

136. The apparatus according to claim 132 wherein the RF voltage is between 10V peak and 1000V peak.

137. The apparatus according to claim 136 wherein the RF voltage is between 30V peak and 300V peak.

138. The apparatus according to claim 132 further comprising a device for monitoring an RF impedance on the RF electrodes.

139. The apparatus according to claim 110 further comprising:

a. a dome shaped applicator having an interior volume containing the one or more ultrasound transducers; and

b. a vacuum pump for generating a negative pressure in the interior chamber when the dome is applied to a skin surface.

140. The apparatus according to claim 111 comprising a device for mechanically manipulating the skin, the device comprising, at least two plates adapted for contacting a skin surface, the plates being movable from a first configuration in which the plates are spaced apart by a first distance and a second configuration in which the plates are spaced apart by a second distance, the second distance being less than the first distance, the protrusion being formed when the plates are applied to a skin surface and moved from the first configuration to the second configuration.

141. The apparatus according to claim 140 further comprising an actuator for moving the plates from the first configuration to the second configuration.

142. The apparatus according to claim 140 further comprising means for applying the ultrasound transducer arrays to the protrusion.

143. The apparatus according to claim 140 wherein at least one ultrasound transducer array is included in one of the plates.

144. The apparatus according to claim 140 wherein the ultrasound transducer has at least one degree of freedom to move with respect to said plates.

145. The apparatus according to claim 140 further comprising at least two RF electrodes and an RF driver configured to produce an RF electric field inside the protrusion.

146. The apparatus according to claim 145 further comprising a controller configured to apply the RF energy at least partially simultaneous with the application of the ultrasound energy.

147. The apparatus according to claim 109 further comprising a source of infrared light for illuminating at least part of the treated body surface with infrared light.

148. An apparatus for treatment of fat tissue in a region of subcutaneous adipose tissue comprising:

a. An ultrasound energy source configured to direct ultrasound energy through a skin surface into a region of subcutaneous adipose tissue; and

b. At least two electrodes driven by an RF power source configures to generate RF field inside said region of adipose tissue.

149. The apparatus according to claim 148 further comprising a controller configured to apply the RF energy at least partially simultaneous with the application of the ultrasound energy.

150. The apparatus according to claim 148 wherein the RF electric field has a frequency between 100 KHz and 100 MHz.

151. The apparatus according to claim 150 wherein the RF frequency is between 500 KHz and 5 MHz.

152. The apparatus according to claim 148 wherein the RF voltage is between 10V peak and 1000V peak.

153. The apparatus according to claim 152 wherein the RF voltage is between 30V peak and 300V peak.

154. The apparatus according to claim 148 further comprising a device for monitoring an RF impedance on the RF electrodes.

155. The apparatus according to claim 148 further comprising measuring an electrical impedance of an ultrasound transducer to monitor coupling of the ultrasound energy to the body.

156. The apparatus according to claim 148 configured to deliver pulsed ultrasound energy.

157. The apparatus according to claim 156 wherein ultrasound pulse length is 10 μ

sec to 10 msec.

158. The apparatus according to claim 157 wherein the ultrasound pulse length is from 100 μ

sec to 1 msec.

159. The apparatus according to claim 148 wherein the ultrasound energy has a frequency less than 1 MHz.

160. The apparatus according to claim 159 wherein the ultrasound energy has a frequency less than 300 kHz

161. The apparatus according to claim 148 further comprising a source of infra-red light configured to illuminate at least part of the treated body surface.

162. A method for treatment of adipose tissue in a region of subcutaneous adipose tissue comprising:

a. forming a protrusion of skin and underlying adipose tissue containing the region;

b. radiating ultrasound energy into the region; and

c. generating an RF electric field inside the adipose tissue.

163. An apparatus for treatment of adipose tissue in a region of subcutaneous adipose tissue comprising:

a. a device configured to form a protrusion of skin and underlying adipose tissue containing the region;

b. at least one ultrasound energy source configured to radiate ultrasound energy into the region; and

c. at least two RF electrodes and an RF driver configured to produce an RF electric field inside the protrusion.