Methods and devices for selective disruption of fatty tissue by controlled cooling

• US 8,840,608 B2
• Filed: 12/17/2004
• Issued: 09/23/2014
• Est. Priority Date: 03/15/2002
• Status: Active Grant

• Current Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Original Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Inventors: Anderson, Richard R., Manstein, Dieter
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US11/016,196
• Publication Number:
  US 20050251120A1
• Time in Patent Office: 3,567 Days
• Field of Search: 606 20- 26
• US Class Current: 606/20
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 5/6804 Garments; Clothes
• CPC Class Codes: A61B 8/485 involving measuring strain or elastic properties
• CPC Class Codes: A61F 2007/0001 Body part
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 2007/0094 using a remote control
• CPC Class Codes: A61F 2007/029 Fat cell removal or destruction by non-ablative heat treatment
• CPC Class Codes: A61F 7/00 Heating or cooling appliances for medical or therapeutic treatment of the human body heating or cooling means in connection with bedsteads or mattresses A47C21/00 ; massage, therapeutic baths A61H; hyperthermia using electric or magnetic fields or ultrasound A61N; electric heating elements H05B
• CPC Class Codes: A61F 7/10 Cooling bags, e.g. ice-bags

Abstract

The present invention relates to methods for use in the selective disruption of lipid-rich cells by controlled cooling. The present invention further relates to a device for use in carrying out the methods for selective disruption of lipid-rich cells by controlled cooling.

Claims

1. A system for the selective disruption of lipid rich cells in a non-infant human subject, comprising:

at least one thermoelectric cooling element configured for application proximal to an application site of the subject, wherein the thermoelectric cooling element is effective to decrease the temperature beneath the application site, and wherein the temperature decrease is sufficient to selectively damage lipid rich cells beneath the application site, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged;

at least one feedback device configured to provide feedback information pertaining to at least one physiological parameter of tissue of the subject; and

a control unit in communication with the at least one feedback device, the control unit configured to control the operation of the thermoelectric cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to selectively damage lipid rich cells beneath the application site, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged.

2. The system of claim 1, wherein the feedback device is non-invasive.

3. The system of claim 1, wherein the feedback device is a temperature probe.

4. The system of claim 3, wherein the temperature probe is a thermoprobe.

5. The system of claim 3, wherein the temperature probe is a thermoprobe selected from the group consisting of a radiation thermometer, fiber optical temperature sensor, thermal imaging thermoprobe, thermocouple, thermistor, bimetallic thermometer, color-changing thermal indicator paper, semiconductor thermometer, fiber optical thermometer, and liquid in glass thermometer.

6. The system of claim 1, wherein the feedback device is a contact probe.

7. The system of claim 6, wherein the contact probe is a pressure probe.

8. The system of claim 7, wherein the pressure probe is a spring loaded cooling element.

9. The system of claim 1, wherein the feedback device is a magnetic resonance imaging device.

10. The system of claim 1, wherein the thermoelectric cooling element comprises a metal.

11. The system of claim 10, wherein the metal is selected from the group consisting of copper, silver and aluminum.

12. The system of claim 1, wherein the thermoelectric cooling element contains a solid cooling agent.

13. The system of claim 12, wherein the thermoelectric cooling agent is comprised of any member of the group consisting of a metal, glass, gel, ceramic, peltier element, ice and ice slurry.

14. The system of claim 1, wherein the tissue is selected from the group consisting of dermis, epidermis, and subcutaneous adipose tissue.

15. The system of claim 1, wherein the feedback device is configured to determine whether non lipid rich cells proximate to the cooling element are disrupted.

16. The system of claim 1, wherein the feedback device is configured to provide feedback regarding the selective reduction of the lipid rich cells.

17. The system of claim 1, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

10 and 20°

C.

18. The system of claim 1, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

15 and 15°

C.

19. The system of claim 1, further comprising a vibrating device configured to physically manipulate the application site.

20. The system of claim 1, wherein the temperature decrease is sufficient to cause localized crystallization of highly saturated fatty acids.

21. The system of claim 1, wherein the control unit is programmed to control the operation of the thermoelectric cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to selectively damage lipid rich cells beneath the application site, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged.

22. The system of claim 1, wherein the control unit includes:

storage means for storing instructions for controlling the operation of the thermoelectric cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to selectively damage lipid rich cells beneath the application site, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged; and

a processor device programmed to read and execute the instructions stored on the storage means.

23. The system of claim 1, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

10 and 15°

C.

24. The system of claim 1, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

10 and 10°

C.

25. The system of claim 1, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

10 and 4°

C.

26. The system of claim 1, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

4 and 20°

C.

27. The system of claim 1, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

4 and 15°

C.

28. The system of claim 1, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

4 and 10°

C.

29. The system of claim 1, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

4 and 4°

C.

30. The system of claim 1, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

2 and 20°

C.

31. The system of claim 1, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

2 and 15°

C.

32. The system of claim 1, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

2 and 10°

C.

33. The system of claim 1, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

2 and 5°

C.

34. The system of claim 1, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

10 and 15°

C.

35. The system of claim 1, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

5 and 15°

C.

36. The system of claim 1, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

15 and 10°

C.

37. The system of claim 1, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

10 and 10°

C.

38. The system of claim 1, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

5 and 10°

C.

39. The system of claim 1, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

15 and 5°

C.

40. The system of claim 1, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

10 and 5°

C.

41. The system of claim 1, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

5 and 5°

C.

42. A cooling method for selectively disrupting lipid rich cells in a non-infant human subject comprising:

applying the system of claim 1 proximal to an application site of the subject;

utilizing the at least one cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to thereby selectively damage lipid rich cells therein, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged;

utilizing the at least one feedback device configured to provide feedback information pertaining to at least one physiological parameter of tissue of the subject; and

utilizing the control unit in communication with the at least one feedback device, the control unit configured to control the operation of the thermoelectric cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to selectively damage lipid rich cells beneath the application site, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged;

thereby selectively disrupting lipid rich cells in a non-infant human subject.

43. A system for the selective disruption of lipid rich cells in a non-infant human subject, comprising:

at least one non-invasive thermoelectric cooling element configured for application proximal to an application site of the subject, wherein the non-invasive thermoelectric cooling element is configured to decrease the temperature beneath the application site, and wherein the temperature decrease is sufficient to selectively damage lipid rich cells beneath the application site, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged;

at least one ultrasound-based feedback device configured to provide feedback information pertaining to at least one physiological parameter of tissue of the subject; and

a control unit in communication with the at least one feedback device, the control unit configured to control the operation of the thermoelectric cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to selectively damage lipid rich cells beneath the application site, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged.

44. The system of claim 43, wherein the tissue of the subject is selected from the group consisting of dermis, epidermis, and subcutaneous adipose tissue.

45. The system of claim 43, wherein the feedback device is configured to determine whether non lipid rich cells proximate to the cooling element are disrupted.

46. The system of claim 43, wherein the feedback device is configured to provide feedback regarding the selective reduction of the lipid rich cells.

47. The system of claim 43, wherein the temperature decrease is sufficient to cause localized crystallization of highly saturated fatty acids.

48. The system of claim 43, wherein the control unit is programmed to control the operation of the thermoelectric cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to selectively damage lipid rich cells beneath the application site, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged.

49. The system of claim 43, wherein the control unit includes:

storage means for storing instructions for controlling the operation of the thermoelectric cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to selectively damage lipid rich cells beneath the application site, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged; and

a processor device programmed to read and execute the instructions stored on the storage means.

50. The system of claim 43, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

10 and 20°

C.

51. The system of claim 43, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

10 and 15°

C.

52. The system of claim 43, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

10 and 10°

C.

53. The system of claim 43, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

10 and 4°

C.

54. The system of claim 43, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

4 and 20°

C.

55. The system of claim 43, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

4 and 15°

C.

56. The system of claim 43, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

4 and 10°

C.

57. The system of claim 43, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

4 and 4°

C.

58. The system of claim 43, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

2 and 20°

C.

59. The system of claim 43, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

2 and 15°

C.

60. The system of claim 43, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

2 and 10°

C.

61. The system of claim 43, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

2 and 5°

C.

62. The system of claim 43, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

10 and 15°

C.

63. The system of claim 43, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

5 and 15°

C.

64. The system of claim 43, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

15 and 10°

C.

65. The system of claim 43, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

10 and 10°

C.

66. The system of claim 43, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

5 and 10°

C.

67. The system of claim 43, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

15 and 5°

C.

68. The system of claim 43, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

10 and 5°

C.

69. The system of claim 43, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

5 and 5°

C.

106. A method for selectively disrupting lipid rich cells in a non-infant human subject comprising:

applying the system of claim 43 proximal to an application site of the subject;

utilizing the at least one cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to thereby selectively reduce lipid rich cells beneath the application site, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged;

utilizing the at least one ultrasound-based feedback device configured to provide feedback information pertaining to at least one physiological parameter of tissue of the subject; and

utilizing the control unit in communication with the at least one feedback device, the control unit configured to control the operation of the thermoelectric cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to selectively damage lipid rich cells beneath the application site, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged;

thereby selectively disrupting lipid rich cells in a non-infant human subject.

70. A system for the selective disruption of lipid rich cells in a non-infant human subject, comprising:

at least one thermoelectric cooling element configured for application proximal to an application site of the subject, wherein the thermoelectric cooling element is effective to decrease the temperature beneath the application site, wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged,

at least one feedback device configured to provide feedback information sufficient to confirm that the temperature decrease is sufficient to selectively disrupt and thereby reduce lipid rich cells beneath the application site; and

a control unit in communication with the at least one feedback device, the control unit configured to control the operation of the thermoelectric cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to selectively disrupt and thereby reduce lipid rich cells beneath the application site, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged.

71. The system of claim 70, wherein the feedback information comprises information about at least one physiological parameter of the lipid rich cells.

72. The system of claim 71, wherein the physiological parameter is the temperature of the subcutaneous adipose tissue of the subject.

73. The system of claim 71, wherein the physiological parameter is selected from the group consisting of:

crystal formation in the subcutaneous adipose tissue of the subject and stiffness in the subcutaneous adipose tissue of the subject.

74. The system of claim 72, wherein the feedback device is a temperature probe.

75. The system of claim 74, wherein the temperature probe is a thermoprobe.

76. The system of claim 75, wherein the thermoprobe is selected from the group consisting of a thermocouple, thermistor, bimetallic thermometer, color changing thermal indicator paper, semiconductor thermometer, fiber optical thermometer, and liquid in glass thermometer.

77. The system of claim 70, wherein the feedback device is a contact probe.

78. The system of claim 77, wherein the contact probe is a pressure probe.

79. The system of claim 78, wherein the pressure probe is a spring loaded cooling element.

80. The system of claim 70, wherein the feedback device is a magnetic resonance imaging device.

81. The system of claim 70, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

10 and 20°

C.

82. The system of claim 70, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

15 and 15°

C.

83. The system of claim 70, further comprising a vibrating device configured to physically manipulate the application site.

84. The system of claim 70, wherein the temperature decrease is sufficient to cause localized crystallization of highly saturated fatty acids.

85. The system of claim 70, wherein the control unit is programmed to control the operation of the thermoelectric cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to selectively disrupt and thereby reduce lipid rich cells beneath the application site, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged.

86. The system of claim 70, wherein the control unit includes:

storage means for storing instructions for controlling the operation of the thermoelectric cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to selectively disrupt and thereby reduce lipid rich cells beneath the application site, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged; and

a processor device programmed to read and execute the instructions stored on the storage means.

87. The system of claim 70, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

10 and 15°

C.

88. The system of claim 70, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

10 and 10°

C.

89. The system of claim 70, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

10 and 4°

C.

90. The system of claim 70, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

4 and 20°

C.

91. The system of claim 70, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

4 and 15°

C.

92. The system of claim 70, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

4 and 10°

C.

93. The system of claim 70, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

4 and 4°

C.

94. The system of claim 70, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

2 and 20°

C.

95. The system of claim 70, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

2 and 15°

C.

96. The system of claim 70, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

2 and 10°

C.

97. The system of claim 70, wherein the control unit is programmed to cool the lipid rich cells to a temperature between about −

2 and 5°

C.

98. The system of claim 70, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

10 and 15°

C.

99. The system of claim 70, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

5 and 15°

C.

100. The system of claim 70, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

15 and 10°

C.

101. The system of claim 70, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

10 and 10°

C.

102. The system of claim 70, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

5 and 10°

C.

103. The system of claim 70, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

15 and 5°

C.

104. The system of claim 70, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

10 and 5°

C.

105. The system of claim 70, wherein the control unit is programmed to maintain the thermoelectric cooling element at an average temperature between about −

5 and 5°

C.

107. A method for selectively disrupting lipid rich cells in a non-infant human subject comprising:

applying the system of claim 70 proximal to an application site of the subject;

utilizing the at least one cooling element to decrease the temperature beneath the application site, wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged;

utilizing at least one feedback device configured to provide feedback sufficient to confirm that the temperature decrease is sufficient to selectively disrupt and thereby reduce lipid rich cells beneath the application site; and

utilizing a control unit in communication with the at least one feedback device, the control unit configured to control the operation of the thermoelectric cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to selectively disrupt and thereby reduce lipid rich cells beneath the application site, and wherein non lipid rich cells proximal to the thermoelectric cooling element are not damaged;

thereby selectively disrupting lipid rich cells in a non-infant human subject.