Methods and devices for detection and control of selective disruption of fatty tissue during controlled cooling

• US 20050251120A1
• Filed: 12/17/2004
• Published: 11/10/2005
• 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: Manstein, Dieter, Anderson, Richard R.
• Granted Patent: US 8,840,608 B2
• Time in Patent Office: Days
• 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 cooling method for selective disruption of lipid rich cells in a non-infant human treatment subject comprising:

applying at least one cooling element proximate to an application site of the treatment subject;

utilizing the cooling element to decrease the temperature beneath the application site, wherein the temperature decrease is sufficient to disrupt and thereby reduce lipid rich cells therein; and

while the temperature is decreased, utilizing at least one feedback device to provide feedback information sufficient to confirm that non lipid rich cells proximate to the cooling element are not disrupted, thereby selectively disrupting lipid rich cells in the subject.

2. The method of claim 1, wherein the feedback information comprises information about at least one physiological parameter of the dermis, epidermis or subcutaneous adipose tissue, wherein the information indicates that non lipid rich cells proximate to the cooling element are not disrupted.

3. The method of claim 1, wherein the temperature decrease creates a local temperature gradient through the dermis, epidermis and subcutaneous adipose tissue of the subject.

4. The method of claim 1, wherein the lipid rich cells are adipocytes within subcutaneous adipose tissue.

5. The method of claim 1, wherein the cooling element contacts the application site.

6. The method of claim 2, wherein the physiological parameter is the temperature of the epidermis of the subject.

7. The method of claim 6, wherein the temperature is from about −

10°

C. to about 20°

C. in the epidermis of the subject.

8. The method of claim 2, wherein the physiological parameter is the temperature of the dermis of the subject.

9. The method of claim 8, wherein the temperature is from about −

10°

C. to about 35°

C. in the dermis of the subject.

10. The method of claim 2, wherein the physiological parameter is the temperature of the subcutaneous adipose tissue of the subject.

11. The method of claim 10, wherein the temperature is from about −

10°

C. to about 37°

C. in the subcutaneous adipose tissue of the subject.

12. The method of claim 2, wherein the physiological parameter is the absence of substantial crystal formation in one of the dermis or epidermis of the subject.

13. The method of claim 12, wherein the absence of substantial crystal formation is indicated by an electrical impedance of between about 10 kΩ

/mm to about 50 kΩ

/mm in one of the dermis or epidermis of the subject.

14. The method of claim 12, wherein the absence of substantial crystal formation is indicated by an ultrasound velocity of between about 1450 to less than about 2700 M/S in one of the dermis or epidermis of the subject.

15. The method of claim 2, wherein the physiological parameter is stiffness in one of the dermis or epidermis of the subject.

16. The method of claim 15, wherein the stiffness is increased.

17. The method of claim 2, wherein the physiological parameter is pressure in one of the dermis or epidermis of the subject.

18. The method of claim 17, wherein the pressure is at least about 240 MM HG.

19. The method of claim 2, wherein the physiological parameter is a phase transition in one of the subject'"'"'s dermis or epidermis.

20. The method of claim 2, wherein the physiological parameter is acoustic velocity in one of the dermis or epidermis of the subject.

21. The method of claim 20, wherein the acoustic velocity is between about 1450 to less than about 2700 M/S in one of the dermis or epidermis of the subject.

22. The method of claim 6, wherein the feedback device is a non-invasive temperature probe.

23. The method of claim 8, wherein the feedback device is an invasive temperature probe.

24. The method of claim 10, wherein the feedback device is an invasive temperature probe.

25. The method of claim 22, wherein the wherein the temperature probe is a thermoprobe selected from the group consisting of a radiation thermometer, fiber optical temperature sensor and thermal imaging thermoprobe.

26. The method of claim 22, 23, or 24, wherein the temperature probe is a thermoprobe.

27. The method of claim 26, wherein the thermoprobe is selected from the group consisting of a themocouple, thermistor, bimetallic thermometer, color changing thermal indicator paper, semiconductor thermometer, fiber optical thermometer, and liquid in glass thermometer.

28. The method of claim 12, wherein the feedback device is an electrical feedback probe.

29. The method of claim 12, wherein the feedback device is an ultrasound probe

30. The method of claim 29, wherein the ultrasound probe is an echographic cryoprobe.

31. The method of claim 15, wherein the feedback device is an oscillating feedback probe.

32. The method of claim 31, wherein the oscillating feedback probe is a piezoelectric vibrator.

33. The method of claim 17, wherein the feedback device is a contact probe.

34. The method of claim 33, wherein the contact probe is a pressure probe.

35. The method of claim 34, wherein the pressure probe is a spring loaded cooling element.

36. The method of claim 19, wherein the feedback device is an optical coherence tomographic device.

37. The method of claim 19, wherein the feedback device is a magnetic resonance imaging device.

102. The method of claim 2, wherein the physiological parameter is reflectance or transmittance from within one of the dermis or epidermis of the subject.

103. The method of claim 102, wherein the spectrum of reflectance from within the dermis or epidermis of the subject is continuously monitored.

104. The method of claim 103, wherein the feedback device is an optical spectropic device.

109. The method of claim 1, further comprising applying pressure proximate to the application site of the treatment subject, wherein the pressure applied is effective to decrease blood flow beneath the application site.

38. A system for providing feedback in connection with selective disruption of lipid rich cells in a non-infant human treatment subject, comprising:

at least one non-invasive cooling element proximate to an application site of the treatment subject, wherein the non-invasive cooling element is effective to decrease the temperature beneath the treatment site, and wherein the temperature decrease is sufficient to disrupt and thereby reduce lipid rich cells beneath the application site; and

an ultrasound-based feedback device having a transducer that is less than about 2 cm in diameter in contact with the at least one non-invasive cooling element, wherein the feedback device is effective to provide feedback information sufficient to confirm that non lipid rich cells proximate to the cooling element are not disrupted.

39. A system for providing feedback information in connection with selective disruption of lipid rich cells in a non-infant human treatment subject, comprising:

at least one cooling element proximate to an application site of the treatment subject, wherein the cooling element is effective to decrease the temperature beneath the application site, and wherein the temperature decrease is sufficient to disrupt and thereby reduce lipid rich cells beneath the application site; and

at least one feedback device in communication with at least one cooling element, wherein the feedback device provides feedback information sufficient to confirm that non lipid rich cells proximate to the cooling element are not disrupted.

40. The system of claim 39, wherein at least one feedback device is connected to at least one cooling element.

41. The system of claim 39, wherein at least one feedback device is in direct contact with at least one cooling element.

42. The system of claim 41, wherein at least one feedback device is integrated within small channels of the cooling element.

43. The system of claim 42, wherein the channels are less than about 1 cm in diameter.

44. The system of claim 39, wherein at least one feedback device is in communication with the application site.

45. The system of claim 39, wherein at least one feedback device is in direct contact with the application site.

46. The system of claim 39, wherein the feedback device is a non-invasive temperature probe.

47. The system of claim 39, wherein the feedback device is an invasive temperature probe.

48. The system of claim 46 or 47, wherein the temperature probe is a thermoprobe.

49. The system of claim 46, wherein the wherein the temperature probe is a thermoprobe selected from the group consisting of a radiation thermometer, fiber optical temperature sensor and thermal imaging thermoprobe.

50. The system of claim 47, wherein the wherein the temperature probe is a thermoprobe selected from the group consisting of a themocouple, thermistor, bimetallic thermometer, color changing thermal indicator paper, semiconductor thermometer, fiber optical thermometer, and liquid in glass thermometer.

51. The system of claim 39, wherein the feedback device is an electrical feedback probe.

52. The system of claim 39, wherein the feedback device is an ultrasound probe.

53. The system of claim 52, wherein the ultrasound probe is an echographic cryoprobe.

54. The system of claim 39, wherein the feedback device is an oscillating feedback probe.

55. The system of claim 54, wherein the oscillating feedback probe is a piezoelectric vibrator.

56. The system of claim 39, wherein the feedback device is a contact probe.

57. The system of claim 56, wherein the contact probe is a pressure probe.

58. The system of claim 57, wherein the pressure probe is a spring loaded cooling element.

59. The system of claim 39, wherein the feedback device is an optical coherence tomographic device.

60. The system of claim 39, wherein the feedback device is a magnetic resonance imaging device.

61. The system of claim 39, wherein the cooling element is comprised of a metal.

62. The system of claim 61, wherein the metal is selected from the group consisting of copper, silver and aluminum.

63. The system of claim 39, wherein the cooling element contains a solid cooling agent.

64. The system of claim 63, wherein the cooling agent is comprised of any member of the group consisting of a metal, glass, gel, ceramic, peltier element, ice and ice slurry.

65. The system of claim 39, wherein the cooling element contains a liquid cooling agent.

66. The system of claim 65, wherein the cooling agent is comprised of any member of the group consisting of a saline, glycerol, alcohol and mixtures thereof.

67. The system of claim 66, wherein the cooling element contains a gas cooling agent.

68. The system of claim 67, wherein the gas is cold air or liquid nitrogen.

105. The system of claim 39, wherein the feedback device is an optical spectropic device.

110. The system of claim 39 or 69, further comprising at least one element that provides pressure proximate to an application site of the treatment subject, wherein the pressure applied is effective to decrease blood flow beneath the application site.

69. A system for providing feedback information in connection with selective disruption of lipid rich cells in a non-infant human treatment subject, comprising:

at least one cooling element proximate to an application site of the treatment subject, wherein the cooling element is effective to decrease the temperature beneath the application site, and

at least one feedback device in communication with at least one cooling element, wherein the feedback device provides feedback information sufficient to confirm that the temperature decrease is sufficient to disrupt and thereby reduce lipid rich cells beneath the application site.

70. The system of claim 69, wherein the feedback information comprises information about at least one physiological parameter of the subcutaneous adipose tissue, wherein the information indicates that lipid rich cells therein are disrupted.

71. The system of claim 69, wherein the temperature decrease creates a local temperature gradient through the dermis, epidermis and subcutaneous adipose tissue of the subject.

72. The system of claim 69, wherein the lipid rich cells are adipocytes within subcutaneous adipose tissue of the subject.

73. The system of claim 69, wherein the cooling element contacts the application site.

74. The system of claim 70, wherein the physiological parameter is the temperature of the subcutaneous adipose tissue of the subject.

75. The system of claim 74, wherein the temperature is from about −

10°

C. to about 37°

C.

76. The system of claim 70, wherein the physiological parameter is crystal formation in the subcutaneous adipose tissue of the subject.

77. The system of claim 76, wherein the crystal formation is indicated by an electrical impedance of greater than about 0.5 kΩ

/mm in the subject'"'"'s subcutaneous adipose tissue.

78. The system of claim 77, wherein crystal formation is indicated by an ultrasound velocity of greater than about 2700 M/S in the subcutaneous adipose tissue of the subject.

79. The system of claim 70, wherein the physiological parameter is stiffness in the subcutaneous adipose tissue of the subject.

80. The system of claim 79, wherein the stiffness is increased.

81. The system of claim 70, wherein the physiological parameter is pressure in the subcutaneous adipose tissue of the subject.

82. The system of claim 81, wherein the pressure is between about 120 MM HG and about 240 MM HG in the subject'"'"'s in the subject'"'"'s subcutaneous adipose tissue.

83. The system of claim 70, wherein the physiological parameter is a phase transition in the subcutaneous adipose tissue of the subject.

84. The system of claim 70, wherein the physiological parameter is acoustic velocity in the subcutaneous adipose tissue of the subject.

85. The system of claim 84, wherein the acoustic velocity is greater than about 2700 M/S in the subcutaneous adipose tissue of the subject.

86. The system of claim 74, wherein the feedback device is an invasive temperature probe.

90. The system of claim 86, wherein the temperature probe is a thermoprobe.

91. The system of claim 90, wherein the thermoprobe is selected from the group consisting of a themocouple, thermistor, bimetallic thermometer, color changing thermal indicator paper, semiconductor thermometer, fiber optical thermometer, and liquid in glass thermometer.

92. The system of claim 69, wherein the feedback device is an electrical feedback probe.

93. The system of claim 69, wherein the feedback device is an ultrasound probe

94. The system of claim 93, wherein the ultrasound probe is an echographic cryoprobe.

95. The system of claim 94, wherein the feedback device is an oscillating feedback probe.

96. The system of claim 95, wherein the oscillating feedback probe is a piezoelectric vibrator.

97. The system of claim 69, wherein the feedback device is a contact probe.

98. The system of claim 97, wherein the contact probe is a pressure probe.

99. The system of claim 98, wherein the pressure probe is a spring loaded cooling element.

100. The system of claim 69, wherein the feedback device is an optical coherence tomographic device.

101. The system of claim 69, wherein the feedback device is a magnetic resonance imaging device.

106. The system of claim 70, wherein the physiological parameter is reflectance or transmittance from within the subcutaneous adipose tissue of the subject.

107. The method of claim 106, wherein the spectrum of reflectance from within the subcutaneous adipose tissue of the subject is continuously monitored.

108. The system of claim 107, wherein the feedback device is an optical spectropic device.