Method and apparatus for controlled contraction of collagen tissue

• US 6,453,202 B1
• Filed: 09/17/1999
• Issued: 09/17/2002
• Est. Priority Date: 05/05/1995
• Status: Expired due to Term

• Current Assignee: Thermage Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Thermage Incorporated (Bausch Health Cos., Inc.)
• Inventors: Knowlton, Edward W.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/399,455
• Time in Patent Office: 1,096 Days
• Field of Search: 607/96, 607/98-104, 607/108, 606/33, 606/41, 606/50
• US Class Current: 607/102
• 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 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2018/0066 without feedback, i.e. open loop control
• CPC Class Codes: A61M 15/0028 using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• CPC Class Codes: A61M 15/0036 hollow piercing means
• CPC Class Codes: A61M 15/0041 with movable piercing or cutting means
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/073 Syringe, piston type
• CPC Class Codes: A61N 5/04 Radiators for near-field treatment

Abstract

A method and apparatus applies radiant energy through the skin to underlying collagen tissue without substantially modifying melanocytes and other epithelial cells in the epidermis. A porous membrane is adapted to receive an electrolytic solution and become inflated to substantially conform a contacting exterior surface of the membrane to a skin layer. The membrane includes a cooling lumen for receiving cooling fluid. One or more thermal electrodes positioned in the membrane and transfers thermal energy to the electrolytic solution. The electrolytic solution and cooling fluid creates a reverse thermal gradient from the skin surface to the underlying collagen tissue. A thermal power source is coupled to the thermal electrodes, and a source of electrolytic solution is coupled to the membrane.

Claims

1. An apparatus for treating the skin comprising:

a housing configured to receive a membrane structure;

a membrane positioned within the housing, the membrane at least partially insulative to the flow of electric current, at least partially conductive to the flow of heat and configured to be coupled to at least one of a fluid source or a power source, the membrane having at least a tissue contacting layer;

an energy delivery device coupled to the membrane, the energy delivery device configured to deliver energy to a collagen containing tissue site, the energy delivery device configured to be coupled to a power source;

a cooling fluid fluidically coupled to the membrane, the cooling fluid configured to provide a cooling effect to at least one of the membrane or the energy delivery device,

a sensor coupled to the membrane; and

a feedback control device electronically coupled to at least one of the sensor and the energy delivery device,

wherein the energy delivery device comprises an electrode configured to be capacitively coupled to an epidermal layer overlying a collagen containing tissue layer, and the feedback control device includes at least one of an electronic controller and a multiplexer, multiplexed to at least one of the sensor or the energy delivery device.

2. The apparatus of claim 1, wherein the energy delivery device is substantially positioned within the membrane.

3. The apparatus of claim 1, wherein the cooling fluid includes a cooled gas or a cooled liquid.

4. The apparatus of claim 1, wherein the energy delivery device comprises an electrode configured to be cooled by the cooling fluid.

5. The apparatus of claim 1, wherein the membrane is configured to produce a reverse thermal gradient of about 30 to 80 degrees C. between the skin and underlying collagen containing tissue.

6. The apparatus of claim 1, wherein the cooling effect is an evaporative effect.

7. The apparatus of claim 1, wherein the membrane comprises at least one polyamide layer.

8. The apparatus of claim 6, further comprising:

a sensor coupled to the membrane;

a feedback control device electronically coupled to at least one of the sensor and the energy delivery device;

a power source electronically coupled to at least one of the energy delivery device and the feedback control device;

a fluid source fluidically coupled to the membrane; and

a fluid control means coupled to at least one of the fluid source and the control device,

wherein the fluid control means comprises a control valve.

9. The apparatus of claim 1, further comprising:

a sensor coupled to the membrane;

a feedback control device electronically coupled to at least one of the sensor and the energy delivery device;

a power source electronically coupled to at least one of the energy delivery device and the feedback control device;

a fluid source fluidically coupled to the membrane; and

a fluid control means coupled to at least one of the fluid source and the control device,

wherein the energy delivery device comprises a flexible circuit.

10. The apparatus of claim 1, further comprising:

a sensor coupled to the membrane;

a feedback control device electronically coupled to at least one of the sensor and the energy delivery device;

a power source electronically coupled to at least one of the energy delivery device and the feedback control device;

a fluid source fluidically coupled to the membrane; and

a fluid control means coupled to at least one of the fluid source and the control device,

wherein the feedback control device includes a multiplexor and the energy delivery device is multiplexed to at least one of the power source and the feedback control device.

11. The apparatus of claim 1, further comprising:

a sensor coupled to the membrane;

a feedback control device electronically coupled to at least one of the sensor and the energy delivery device;

a power source electronically coupled to at least one of the energy delivery device and the feedback control device;

a fluid source fluidically coupled to the membrane; and

a fluid control means coupled to at least one of the fluid source and the control device,

wherein the feedback control device includes logic resources configured to produce a duty cycle.

12. The apparatus of claim 11, wherein the duty cycle includes at least one of a period of cooling initiated prior to a period of energy delivery, a period of cooling at least partly concurrent to a period of energy delivery, and a period of cooling occurring after a period of energy delivery.

13. The apparatus of claim 11, wherein the duty cycle is configured to produce a reverse thermal gradient between about 30°

C. to about 80°

C., and wherein the temperature of an epidermal layer is less than an underlying collagen containing tissue layer.

14. The apparatus of claim 1, wherein the membrane includes a first zone and a second zone, the first zone having a lower temperature than the second zone, the first zone providing a cooling effect to the second zone.

15. The apparatus of claim 14, wherein the first zone is cooled by the cooling fluid.

16. The apparatus of claim 1, further comprising:

a cooling lumen disposed within the membrane, the lumen adapted to receive the cooling fluid and provide a cooling effect to an epidermal layer substantially overlying a collagen containing tissue layer,

wherein the membrane includes a first zone and a second zone, the first zone having a lower temperature than the second zone, the first zone providing a cooling effect to the second zone.

17. The apparatus of claim 16, wherein the first zone is cooled by the cooling fluid.

18. The apparatus of claim 17, wherein the first zone is substantially proximate to the cooling lumen.

19. The apparatus of claim 1, wherein the electrode is a monopolar electrode.

20. An apparatus for treating the skin comprising:

a housing configured to receive a membrane structure;

a membrane positioned within the housing, the membrane at least partially insulative to the flow of electric current, at least partially conductive to the flow of heat and configured to be coupled to at least one of a fluid source or a power source, the membrane having at least a tissue contacting layer;

an energy delivery device coupled to the membrane, the energy delivery device configured to deliver energy to a collagen containing tissue site, the energy delivery device configured to be coupled to a power source; and

a cooling fluid fluidically coupled to the membrane, the cooling fluid configured to provide a cooling effect to at least one of the membrane or the energy delivery device,

wherein the energy delivery device comprises a bipolar electrode.

21. An apparatus for treating the skin comprising:

a housing configured to receive a membrane structure;

a porous membrane positioned within the housing, the porous membrane at least partially insulative to the flow of electric current, at least partially conductive to the flow of heat and configured to be coupled to at least one of a fluid source or a power source, the porous membrane having at least a tissue contacting layer;

an energy delivery device coupled to the porous membrane, the energy delivery device configured to deliver energy to a collagen containing tissue site, the energy delivery device configured to be coupled to a power source; and

a cooling fluid fluidically coupled to the porous membrane, the cooling fluid configured to provide a cooling effect to at least one of the porous membrane or the energy delivery device.

22. The apparatus of claim 21, wherein the energy delivery device is positioned on the nontissue contacting layer.

23. The apparatus of claims 21, wherein the energy delivery device is substantially positioned within the porous membrane.

24. The apparatus of claim 21, wherein the energy delivery device is substantially positioned at a vertical offset from a skin surface.

25. The apparatus of claim 21, wherein the porous membrane is a dielectric.

26. The apparatus of claim 25, wherein the energy delivery device comprises an electrode configured to be capacitively coupled to an epidermal layer overlying a collagen containing tissue layer.

27. The apparatus of claim 25, wherein the electrode is configured to be capacitively coupled to an epidermal layer overlying a collagen containing tissue layer.

28. The apparatus of claim 21, wherein the cooling fluid includes a cooled gas or a cooled liquid.

29. The apparatus of claim 21, further comprising:

a cooling lumen disposed within the porous membrane, the lumen adapted to receive the cooling fluid and provide a cooling effect to an epidermal layer substantially overlying a collagen containing tissue layer.

30. The apparatus of claim 29, wherein the porous membrane includes a first zone and a second zone, the first zone having a lower temperature than the second zone, the first zone providing a cooling effect to the second zone.

31. The apparatus of claim 30, wherein the first zone is cooled by the cooling fluid.

32. The apparatus of claim 31, wherein the first zone is substantially proximate to the cooling lumen.

33. The apparatus of claim 29, wherein the cooling fluid is one of a gas or a liquid.

34. The apparatus of claim 29, wherein the energy delivery device comprises an electrode configured to be cooled by the cooling fluid.

35. The apparatus of claim 34, wherein the electrode is positioned substantially proximate to the cooling lumen.

36. The apparatus of claim 21, wherein the cooling effect is a conductive effect.

37. The apparatus of claim 36, wherein the porous membrane is configured to convectively cool an epidermal layer.

38. The apparatus of claim 36, wherein the porous membrane is configured to be in close contact with the skin.

39. The apparatus of claim 21, wherein the porous membrane is configured to produce a reverse thermal gradient of about 30 to 80 degrees C between the skin and underlying collagen containing tissue.

40. The apparatus of claim 39, wherein a temperature of the epidermal layer is less than a temperature of an underlying collagen containing tissue.

41. The apparatus of claim 21, wherein the cooling effect is an evaporative effect.

42. The apparatus of claim 21, wherein the porous membrane is at least partially conformable to a skin surface.

43. The apparatus of claim 21, wherein the porous membrane comprises one of a polyamide or a polyamide layer.

44. The apparatus of claim 21, wherein the energy delivery device comprises an RF electrode.

45. The apparatus of claim 44, wherein the RF electrode is a monopolar electrode.

46. The apparatus of claim 44, further comprising:

an RF power supply electronically coupled to the RF electrode; and

a ground pad electrode positioned on the skin and electronically coupled to the RF power source and the RF electrode.

47. The apparatus of claim 46, wherein the ground pad electrode is positioned substantially adjacent to the RF electrode.

48. The apparatus of claim 44, wherein the RF electrode is a bipolar electrode and comprises a plurality of electrodes.

49. The apparatus of claim 21, wherein at least one of the porous membrane or the housing is coupled to a fluid source.

50. The apparatus of claim 49, wherein the fluid source is at least one of a gas source, and an electrolytic solution source.

51. The apparatus of claim 21, further comprising:

the power source coupled to the energy delivery device.

52. The apparatus of claim 21, further comprising:

a sensor coupled to the porous membrane.

53. The apparatus of claim 52, wherein the sensor is positioned at at least one of the energy delivery device, the porous membrane tissue contacting surface, a porous membrane interior or the porous membrane non tissue contacting surface.

54. The apparatus of claim 52, wherein the sensor is at least one of a thermal sensor or an impedance sensor.

55. The apparatus of claim 52, wherein the sensor is configured to measure a thermal property of an epidermal layer.

56. The apparatus of claim 52, further comprising:

a feedback control device electronically coupled to at least one of the sensor and the energy delivery device.

57. The apparatus of claims 56, wherein the feedback control device includes one of an electronic controller or a multiplexor, multiplexed to at least one of the sensor or the energy delivery device.

58. The apparatus of claim 56, further comprising:

a power source electronically coupled to at least one of the energy delivery device or the feedback control device;

a fluid source fluidically coupled to porous membrane; and

a fluid control means coupled to at least one of the fluid source and the control device.

59. The apparatus of claim 58, wherein the fluid control means comprises a control valve.

60. The apparatus of claim 58, wherein the feedback control device includes logic resources configured to control a temperature of one of an epidermal layer or the energy delivery device.

61. The apparatus of claim 60, wherein logic resources are configured to produce a duty cycle.

62. The apparatus of claim 61, wherein the duty cycle includes at least one of a period of cooling initiated prior to a period of energy delivery, a period of cooling at least partly concurrent to a period of energy delivery, and a period of cooling occurring after a period of energy delivery.

63. The apparatus of claim 61, wherein the duty cycle is configured to produce a reverse thermal gradient wherein the temperature of an epidermal layer is less than an underlying collagen containing tissue layer.

64. The apparatus of claim 63, wherein the logic resources are configured to produce the reverse thermal gradient at least one of a time prior to a period of energy delivery, a time during a period of energy delivery, and a time after a period of energy delivery.

65. The apparatus of claim 63, wherein the logic resources are configured to control the reverse thermal gradient to be between about 30°

C. to about 80°

C.

66. The apparatus of claim 58, wherein the energy delivery device comprises a plurality of RF electrodes.

67. The apparatus of claim 66, wherein the plurality of RF electrodes comprises a flexible circuit.

68. The apparatus of claim 66, wherein the feedback control device includes a multiplexor and at least one of the plurality of RF electrodes is multiplexed to at least one of the power supply and the feedback control device.

69. The apparatus of claim 21, wherein the porous membrane includes a first zone and a second zone, the first zone having a lower temperature than the second zone, the first zone providing a cooling effect to the second zone.

70. The apparatus of claim 69, wherein the first zone is cooled by the cooling fluid.

71. An apparatus for treating the skin comprising:

a porous membrane at least partially insulative to the flow of electric current, at least partially conductive to the flow of heat and configured to be coupled to at least one of a fluid source or a power source, the porous membrane having at least a tissue contacting layer;

an energy delivery device coupled to the porous membrane, the energy delivery device configured to deliver energy to the collagen containing tissue site, the energy delivery device configured to be coupled to a power source; and

a cooling fluid fluidically coupled to the porous membrane, the cooling fluid configured to provide a cooling effect to at least one of the porous membrane or the energy delivery device.

72. The apparatus of claim 71, wherein the energy delivery device is positioned on the non tissue contacting layer.

73. The apparatus of claim 71, wherein the energy delivery device is substantially positioned within the porous membrane.

74. The apparatus of claim 71, wherein the energy delivery device is substantially positioned at a vertical offset from the skin surface.

75. The apparatus of claim 71, wherein the porous membrane is a dielectric.

76. The apparatus of claim 71, wherein the cooling fluid is one of a cooled gas or a cooled liquid.

77. The apparatus of claim 71, further comprising:

a cooling lumen disposed within the porous membrane, the lumen adapted to receive the cooling fluid and provide a cooling effect to an epidermal layer substantially overlying a collagen containing tissue layer.

78. The apparatus of claim 77, wherein the cooling fluid is one of a gas or a liquid.

79. The apparatus of claim 77, wherein the electrode is configured to be cooled by the cooling fluid.

80. The apparatus of claim 79, wherein the electrode is positioned substantially proximate to the cooling lumen.

81. The apparatus of claim 71, wherein the cooling effect is a conductive effect.

82. The apparatus of claim 81, wherein the porous membrane is configured to convectively cool the epidermal layer.

83. The apparatus of claim 81, wherein the porous membrane is configured to be in close contact with the skin.

84. The apparatus of claim 71, wherein the porous membrane is configured to produce a reverse thermal gradient between the skin and underlying collagen containing tissue.

85. The apparatus of claim 84, wherein the temperature of the epidermal layer is less than a temperature of an underlying collagen containing tissue.

86. The apparatus of claim 71, wherein the cooling effect is a evaporative effect.

87. The apparatus of claim 71, wherein the porous membrane is at least partially conformable to the skin surface.