DEVICE, SYSTEM AND METHOD OF REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS

• US 20100280582A1
• Filed: 04/30/2010
• Published: 11/04/2010
• Est. Priority Date: 04/30/2009
• Status: Active Grant

• Current Assignee: ZELTIQ Aesthetics, Inc. (Abbvie Incorporated)
• Original Assignee: ZELTIQ Aesthetics, Inc. (Abbvie Incorporated)
• Inventors: Yee, Peter, Baker, Mark, Martens, Paul William, Pennybacker, William P., Ollerdessen, Albert L., Coakley, Joseph, Rosen, Jesse N., Weber, Bryan, Allison, John W.
• Granted Patent: US 8,702,774 B2
• Time in Patent Office: Days
• US Class Current: 607/113
• CPC Class Codes: A61F 2007/0022 Abdomen
• CPC Class Codes: A61F 2007/0075 using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61F 2007/0093 programmed
• CPC Class Codes: A61F 2007/0096 with a thermometer
• CPC Class Codes: A61F 2007/029 Fat cell removal or destruction by non-ablative heat treatment
• CPC Class Codes: A61F 7/007 characterised by electric heating

Abstract

Devices, systems and methods for removing heat from subcutaneously disposed lipid-rich cells are disclosed. In selected embodiments, suction and/or heat removal sources are coupled to an applicator. The applicator includes a flexible portion and a rigid portion. The rigid portion includes a thermally conductive plate and a frame coupling the thermally conductive plate and the flexible portion. An interior cavity of the applicator is in fluid communication with the suction source, and the frame maintains contiguous engagement between the heat removal source and the thermally conductive plate.

Claims

1. A device for treating subcutaneous lipid-rich cells, comprising:

a rigid portion including a thermal conductor having an inside surface and an outside surface positioned opposite the inside surface; and

a flexible portion having an inner surface, an outer surface positioned opposite the inner surface, and a cutout extending between the inner and outer surfaces;

wherein the thermal conductor is positioned in the cutout and the flexible and rigid portions define a body having

an interior surface including the inside face of the rigid portion and the inner surface of the flexible portion; and

an exterior surface including the outside face of the rigid portion and the outer surface of the flexible portion.

2. The device of claim 1 wherein the rigid portion comprises:

at least one thermoelectric cooling unit having a cold side in thermal contact with the thermal conductor and a hot side positioned opposite the cold side; and

a heat exchanger in thermal contact with the hot side of the thermoelectric cooling unit.

3. The device of claim 2, further comprising a frame coupling the rigid and flexible portions.

4. The device of claim 1 wherein the rigid portion comprises a heat exchanger in thermal contact with the thermal conductor, the heat exchanger includes a passage configured to circulate a heat exchange fluid.

5. The device of claim 1 wherein the inside surface of the thermal conductor comprises a printed circuit.

6. The device of claim 5 wherein the printed circuit includes a first measurement sensor and the thermal conductor includes a first recess receiving the first measurement sensor.

7. The device of claim 5 wherein the printed circuit comprises a first measurement sensor and a second measurement sensor is positioned in a second recess on the outside surface of the thermal conductor.

8. The device of claim 6 or claim 7 wherein the measurement sensors comprise at least one of a temperature sensor and a heat flux sensor.

9. The device of claim 6 or claim 7 wherein the measurement sensors are configured to provide differential measurement signals.

10. The device of claim 1, further comprising:

a housing coupled to the flexible portion, the housing includes a receptacle having a first electric contact; and

a token configured to interface with the receptacle, the token including

a second contact configured to electrically couple with the first electric contact;

a microelectronic device electrically coupled with the second contact; and

an enclosure configured to support the second electric contact and the microelectronic device and to cooperatively engage the receptacle.

11. The device of claim 10, further comprising a measurement sensor positioned on the inside surface of the thermal conductor.

12. The device of claim 11 wherein the measurement sensor electrically communicates via the first electric contact.

13. The device of claim 11 wherein the inside surface of the thermal conductor comprises a printed circuit electrically coupled to the measurement sensor.

14. The device of claim 11 or claim 13 wherein the measurement sensor comprises at least one of a temperature sensor and a heat flux sensor.

15. The device of claim 11, further comprising a plurality of the measurement sensors configured to provide differential measurement signals.

16. The device of claim 10 wherein the receptacle and the enclosure include corresponding asymmetrical features that are cooperatively engaged when the token interfaces with the receptacle.

17. The device of claim 10 wherein the first and second electrical contacts include corresponding asymmetrical features that are cooperatively engaged when the token interfaces with the receptacle.

18. The device of claim 1, further comprising a barrier overlying at least the interior surface of the body.

19. The device of claim 18 wherein the barrier comprises a barrier configured to be disposed between patients.

20. The device of claim 18 wherein the barrier overlies the exterior surface of the body.

21. The device of claim 18 wherein the body includes a magnet and the barrier includes a ferrous material configured to cooperatively engage the magnet.

22. The device of claim 18 wherein the barrier comprises:

a liner including a thin gauge film; and

a frame including a frame material that is relatively stiff compared to the thin gauge film, the frame being coupled to the liner and configured to hold the liner taut over the inside surface of the thermal conductor.

23. The device of claim 18 wherein the barrier comprises a selectively permeable membrane coupled to the liner, the member is configured to allow air to pass when drawing a vacuum in the body and to restrict passage of a gel.

24. A system for treating subcutaneous lipid-rich cells in a target area, comprising:

a treatment device including an applicator configured to operably engage the target area, the applicator including a heat removal source configured to remove heat from the lipid-rich cells; and

a token permitting a treatment with the treatment device, the token including a microelectronic device electrically coupled with the heat removal source.

25. The system of claim 24, wherein the token interfaces with the treatment device.

26. The system of claim 25, further comprising an asymmetric interface coupling the treatment device and the token.

27. The system of claim 24 wherein the token comprises an asymmetric interface.

28. The system of claim 27 wherein the asymmetric interface comprises asymmetrical male and female members and the asymmetrical female member receives the asymmetrical male member while the token permits a treatment with the treatment device.

29. The system of claim 24, further comprising a liner configured to be positioned between the treatment device and the target area.

30. The system of claim 29 wherein the liner is configured to be disposed between patients and the treatment device is configured to be used for more than one treatment.

31. The system of claim 29 wherein the liner includes a thin gauge film and a ferrous material operably coupled to the film, and wherein the treatment device includes a magnet configured to magnetically couple with the ferrous material.

32. The system of claim 29 wherein a microelectronic device determines when the liner is positioned with respect to the treatment device.

33. A method for treating subcutaneous lipid-rich cells in a target area, comprising:

configuring a treatment system for the target area, the treatment system including a heat removal source configured to remove heat from the lipid rich cells;

permitting use of the treatment system within a predetermined limit;

verifying that continued use of the treatment system is within the predetermined limit; and

prohibiting use of the treatment system when the predetermined limit is exceeded.

34. The method of claim 33, further comprising:

storing the predetermined limit on a token including a microelectronic device; and

coupling the token to the treatment system.

35. The method of claim 34 wherein the microelectronic device verifies that the use of the treatment system is within the predetermined limit stored on the token, and the microelectronic device prohibits use of the treatment system when the predetermined limit is exceeded.

36. The method of claim 34, further comprising:

replacing the token with a replacement token when the predetermined limit is exceeded;

storing on the replacement token another predetermined limit; and

coupling the replacement token to the treatment system to again permit use of the treatment system.

37. The method of claim 33, further comprising

metering the use of the treatment system with a token, the token being configured to be releasably attached to the treatment system;

and

charging fees for the use of the treatment system based on the metering by the token.

38. A vacuum applicator for treating lipid-rich cells disposed under a cutaneous layer with a cooling/heating unit, comprising:

a rigid portion having an inside surface, an outside surface, and a rigid edge extending between the inside and outside surfaces, wherein the rigid portion includes a thermal conductor coupling the inside and outside surfaces; and

a flexible portion having an inner surface, an outer surface positioned opposite the inner surface, and a flexible edge extending between the inner and outer surfaces;

wherein the flexible and rigid portions define a body having

an interior surface including the inside surface of the rigid portion and the inner surface of the flexible portion;

an exterior surface including the outside surface of the rigid portion and the outer surface of the flexible portion; and

an aperture including the rigid edge of the rigid portion and the flexible edge of the flexible portion.

39. The vacuum applicator of claim 38, wherein the rigid portion comprises:

a panel including the thermal conductor; and

a frame surrounding the panel and connecting the rigid and flexible portions, wherein the frame includes a first frame portion positioned on the interior surface and a second frame portion positioned on the exterior surface.

40. The vacuum applicator of claim 39, wherein the rigid portion comprises a plurality of fasteners coupling the first and second frame portions, and wherein individual fasteners extend through the flexible portion.

41. The vacuum applicator of claim 38 wherein the outside face of the rigid portion is configured to contiguously engage the cooling/heating unit.

42. The vacuum applicator of claim 38 wherein the rigid portion comprises a cam configured to bias the cooling/heating unit into contiguous engagement with the thermal conductor.

43. The vacuum applicator of claim 38 wherein the rigid portion comprises a latch configured to releasably secure the cooling/heating unit to the body.

44. The vacuum applicator of claim 38 wherein the flexible portion comprises a central portion coupling first and second ends.

45. The vacuum applicator of claim 44 wherein an individual end comprises an individual flexible edge having a three dimensional geometry including at least one of straight segments, arcuate segments, and a combination of straight and arcuate segments.

46. The vacuum applicator of claim 44 wherein an individual end comprises at least a portion of an individual flexible edge slanting with respect to the central portion.

47. The vacuum applicator of claim 44 wherein an individual end comprises:

a top portion proximal to the central portion and an individual flexible edge distal from the central portion;

a shoulder flaring outwardly from the top portion to an arcuate waistline located between the top portion and the flexible edge;

an apron having a conical flare extending between the waistline and the flexible edge; and

individual flanks extending between the top portion and the flexible edge and also extending from the shoulder and waistline to an individual rigid portion.

48. The vacuum applicator of claim 44 wherein the flexible portion comprises:

first and second peripheries positioned adjacent to first and second rigid portions, wherein an individual periphery extends along the first, second, and central portions; and

at least one of a groove and a rib extend parallel to an individual periphery and engage an individual rigid portion.

49. The vacuum applicator of claim 44 wherein the flexible portion comprises:

first and second peripheries positioned adjacent to first and second rigid portions, wherein an individual periphery extends along the first, second, and central portions; and

at least one hole adjacent to an individual periphery, wherein an individual rigid portion extends through the hole.

50. The vacuum applicator of claim 38 wherein the flexible portion is elastically deformable between first and second arrangements and the rigid portion is approximately undeformed between the first and second arrangements of the flexible portion.

51. The vacuum applicator of claim 50 wherein the first arrangement of the flexible portion corresponds to a first geometry of the aperture and the second arrangement of the flexible portion corresponds to a second geometry of the aperture.

52. A vacuum applicator of claim 50 wherein the flexible portion comprises a vacuum port, and wherein the first arrangement of the flexible portion is in response to drawing a partial vacuum through the vacuum port and the second arrangement of the flexible portion is in response to relieving the partial vacuum.

53. The vacuum applicator of claim 38 wherein the thermal conductor is coupled to at least one of a thermoelectric cooling element and a circulating fluid cooling element.

54. The vacuum applicator of claim 38, further comprising a Peltier-type thermoelectric cooling element coupled to the thermal conductor.

55. The vacuum application of claim 38, further comprising a personal protection device configured to be positioned between the thermal conductor and the cutaneous layer, wherein the personal protection device includes a sensor detecting a temperature of at least one of the thermally conductive plate and the cutaneous layer.

56. The vacuum applicator of claim 38, further comprising a vacuum port and an obstruction partially occluding the vacuum port, wherein the obstruction is configured to inhibit passage of the cutaneous layer through the vacuum port while permitting a fluid to pass through the vacuum port.

57. The vacuum applicator of claim 38, further comprising a vacuum port and a fluid separator in fluid communication with the vacuum port, wherein the fluid separator is configured to pass a gas or vapor through the vacuum port while inhibiting passage of a liquid or gel through the vacuum port.

58. The vacuum applicator of claim 57 wherein the fluid separator comprises a foam pad positioned in an interior cavity in fluid communication with the vacuum port.

59. The vacuum applicator of claim 57 wherein the fluid separator comprises a torturous passageway in fluid communication with the vacuum port.

60. The vacuum applicator of claim 57, further comprising a fluid configured to be positioned between the personal protection device and the cutaneous layer, wherein the vacuum port and the fluid separator are configured to inhibit passage of the fluid through the vacuum port while passing air through the vacuum port.

61. The treatment device of claim 60 wherein the fluid comprises a temperature depressant.

62. The treatment device of claim 60 wherein the fluid comprises at least one of a liquid, a gel, and a paste, and the fluid is hygroscopic, thermally conductive, and biocompatible.

63. A method for treating lipid-rich cells disposed under a cutaneous layer, comprising:

coupling a heat removal source to an exterior surface of a thermally conductive plate of a vacuum applicator;

coupling a suction source to an interior cavity of the vacuum applicator;

placing the vacuum applicator on the cutaneous layer;

activating the suction source to draw the cutaneous layer into the interior cavity of the vacuum applicator; and

activating the heat removal source to remove heat from the lipid-rich cells.

64. The method of claim 63, further comprising selecting a vacuum applicator sized and shaped to correspond to a contour of the cutaneous layer.

65. The method of claim 63, further comprising positioning a personal protection device between the cutaneous layer and the interior cavity of the vacuum applicator.

66. The method of claim 63, further comprising:

deactivating the suction and heat removal sources;

decoupling the suction and heat removal sources from the vacuum applicator; and

disposing of at least one of the personal protection device and the vacuum applicator.

67. The method of claim 66, further comprising reusing the suction and heat removal sources with another vacuum applicator.

68. The method of claim 63 wherein coupling the heat removal source comprises biasing the heat removal source into contiguous engagement with the thermally conductive plate and latching the heat removal source to the vacuum applicator.

69. The method of claim 63, further comprising placing a cryoprotectant including a temperature depressant in the vacuum applicator to avoid ice formation on the vacuum applicator and the cutaneous layer.

70. The method of claim 63, further comprising monitoring at least one of a temperature of the cutaneous layer and a temperature of the thermally conductive plate.

71. A device for treating lipid-rich cells disposed under a cutaneous layer, comprising:

a base including a first attachment;

a fitting including a first portion of a contour that defines a mouth of a cavity, the fitting includes a second attachment that is coupled to the first attachment in a first device arrangement and is decoupled from the first attachment in a second device arrangement; and

a thermal conductor disposed about at least a portion of the cavity, the thermal conductor is configured for heat transfer with respect to the lipid-rich cells when the contour engages the cutaneous layer in the first device arrangement.

72. The device of claim 71 wherein the contour is configured to conform to the cutaneous layer.

73. The device of claim 71 wherein the fitting is relatively flexible with respect to the base.

74. The device of claim 71 wherein the fitting defines the cavity.

75. The device of claim 71 wherein the base defines a first portion of the cavity and the fitting defines a second portion of the cavity.

76. The device of claim 71 wherein the base comprises a second portion of the contour.

77. The device of claim 76 wherein the first and second portions define the contour.

78. The device of claim 71 wherein the first portion defines the contour.

79. The device of claim 71 wherein the fitting comprises first and second lips defining the first portion of the contour.

80. The device of claim 79 wherein the first lip includes the first attachment and the second lip includes a third attachment that is coupled by a fourth attachment to the base.

81. The device of claim 71 wherein the mouth flares outwardly with respect to the cavity.

82. The device of claim 71, further comprising a vacuum pressure port in fluid communication with the cavity when the contour engages the cutaneous layer in the first device arrangement.

83. The device of claim 71 wherein one of the first and second attachments comprises a projection and another of the first and second attachments comprises a groove configured to receive the projection in the first arrangement.

84. The device of claim 71 wherein one of the first and second attachments comprises a magnet and another of the first and second attachments comprises a ferrous material magnetically coupled to the projection in the first arrangement.

85. The device of claim 71 wherein one of the first and second attachments comprises a resilient snap lever and another of the first and second attachments comprises a snap pocket configured to receive the snap lever in the first arrangement.

86. The device of claim 71, further comprising an approximately air-tight seal between the base and fitting.

87. The device of claim 71, further comprising a release configured to separate the first and second attachments in the first arrangement.

88. The device of claim 71, further comprising:

a first aligner disposed on one of the base and fitting; and

a second aligner disposed on another of the base and fitting;

wherein the first and second aligners are configured to align the base and fitting in the second arrangement.

89. A device for treating lipid-rich cells disposed under a cutaneous layer, comprising:

a vacuum cup defining an interior cavity and including a contour that defines a mouth of a cavity;

a thermal conductor disposed about at least a portion of the cavity, the thermal conductor is configured for heat transfer with respect to the lipid-rich cells when the contour engages the cutaneous layer; and

an adjustor configured to adjust at least one of (a) dimensions of the interior cavity, and (b) position of the thermal conductor with respect to the interior cavity.

90. The device of claim 89, further comprising a plurality of thermal conductors disposed about at least a portion of the cavity.

91. The device of claim 90 wherein the adjuster is configured to vary at least one of applicator cavity dimension and spacing and orientation of a first thermal conductor relative to a second thermal conductor.

92. The device of claim 90, further comprising at least one sensor configured to sense at least one of applicator cavity dimension and spacing and orientation of a first thermal conductor relative to a second thermal conductor.

93. The device of claim 92 wherein data from at least one sensor is used to adjust a subcutaneous lipid-rich cell treatment parameter.

94. The device of claim 89 wherein the adjuster is configured to reshape the contour.

95. A system for treating subcutaneous lipid-rich cells in a target area, comprising:

a base including a first attachment;

a first fitting including a portion of a first contour that defines a first mouth of a first cavity, the fitting includes a second attachment that is coupled to the first attachment in a first device arrangement and is decoupled from the first attachment in a second device arrangement;

a second fitting including a portion of a second contour that defines a second mouth of a second cavity, the second fitting includes a third attachment that is coupled to the first attachment in a third device arrangement; and

a thermal conductor disposed about at least a portion of the cavity, the thermal conductor is configured for heat transfer with respect to the lipid-rich cells when the first contour engages the cutaneous layer in the first arrangement and when the second contour engages the cutaneous layer in the third arrangement.

96. The system of claim 95 wherein the first contour differs from the second contour.

97. The system of claim 95 wherein the first and second fittings are configured to be interchangeable with respect to the base.

98. The system of claim 95 wherein the first and third attachments are configured to similarly couple with respect to the second attachment.

99. The system of claim 95 wherein the first mouth flares outwardly with respect to the first cavity.

100. A method comprising:

coupling a first fitting to a base of a vacuum applicator;

placing the first fitting on a first cutaneous layer area;

transferring heat between a thermal conductor and lipid-rich cells disposed under the first cutaneous layer area;

displacing the first fitting from the first cutaneous layer area;

decoupling the first fitting from the base;

coupling a second fitting to the base;

placing the second fitting on a second cutaneous layer area; and

transferring heat between the thermal conductor and lipid-rich cells disposed under the second cutaneous layer area.

101. The method of claim 100, further comprising pulling the first cutaneous layer area into a cavity of the vacuum applicator in response to applying vacuum pressure to the cavity.

102. The method of claim 100, further comprising pulling the second cutaneous layer area into the cavity of the vacuum applicator in response to applying vacuum pressure to the cavity.

103. The method of claim 100 wherein the first and second cutaneous layer areas are disposed on a single patient.

104. The method of claim 100 wherein coupling the first fitting on the base defines a first contour that is placed on the first cutaneous layer area, and coupling the second fitting on the base defines a second contour that is placed on the second cutaneous layer area.

105. The method of claim 102 wherein the first contour differs from the second contour.

106. The method of claim 100, further comprising:

creating a first approximately air-tight seal between the first fitting and the first cutaneous layer area in response to placing the first fitting on the first cutaneous layer area; and

creating a second approximately air-tight seal between the second fitting and the second cutaneous layer area in response to placing the second fitting on the second cutaneous layer area.