Method for treating subcutaneous tissues

• US 20070055179A1
• Filed: 12/02/2005
• Published: 03/08/2007
• Est. Priority Date: 09/07/2005
• Status: Active Grant

• Current Assignee: Ulthera Inc. (Merz Pharma GmbH & Company Kgaa)
• Original Assignee: Cabochon Aesthetics, Inc. (Merz Pharma GmbH & Company Kgaa)
• Inventors: Gifford, Hanson, Sutton, Douglas, Deem, Mark
• Granted Patent: US 7,967,763 B2
• Time in Patent Office: Days
• US Class Current: 601/2
• CPC Class Codes: A61B 2017/00747 Dermatology
• CPC Class Codes: A61B 2017/22008 used or promoted
• CPC Class Codes: A61K 41/0028 Disruption, e.g. by heat or ultrasounds, sonophysical or sonochemical activation, e.g. thermosensitive or heat-sensitive liposomes, disruption of calculi with a medicinal preparation and ultrasounds
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 2007/0008 Destruction of fat cells
• CPC Class Codes: A61N 2007/0039 using microbubbles
• 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

An apparatus and method for treating subcutaneous tissues using acoustic waves in the range of low acoustic pressure ultrasound waves is disclosed. The method includes injections of enhancing agents, wherein disruption of subcutaneous tissues and subcutaneous cavitational bioeffects are produced by ultrasound waves having a power that will not produce tissue cavitation in the absence of the enhancing agents. The apparatus and method of use is useful for treatment of subcutaneous abnormalities including cellulite, lipomas, and tumors.

Claims

1. A method of treating subcutaneous tissue, comprising:

providing a source of low acoustic pressure ultrasound waves;

providing an enhancing agent;

disposing the enhancing agent to the subcutaneous tissue to be treated; and

applying the low acoustic pressure ultrasound waves to the enhancing agent in the subcutaneous tissue, wherein energy released from the enhancing agent produces subcutaneous cavitational bioeffects, wherein at least some of the subcutaneous tissue is disrupted.

2. The method of claim 1, wherein the enhancing agent is a gas.

3. The method of claim 1, wherein the enhancing agent is microbubbles.

4. The method of claim 1, wherein the enhancing agent is a perfluorocarbon.

5. The method of claim 1, wherein the enhancing agent is a solution.

6. The method of claim 1, wherein the enhancing agent is a hypotonic solution.

7. The method of claim 1, wherein the enhancing agent is a solution including gaseous bodies.

8. The method of claim 1, wherein the enhancing agent is a pharmaceutical compound.

9. The method of claim 1, wherein disposing the enhancing agent to the subcutaneous tissue to be treated and applying the low acoustic pressure ultrasound waves to the enhancing agent is performed simultaneously.

10. The method of claim 1, wherein applying low acoustic pressure ultrasound waves to the subcutaneous tissue to be treated is performed within one minute of disposing the enhancing agent to the subcutaneous tissue to be treated.

11. The method of claim 1, wherein applying low acoustic pressure ultrasound waves to the subcutaneous tissue to be treated is performed within ten minutes of disposing the enhancing agent to the subcutaneous tissue to be treated.

87. The method of claim 1, wherein the peak negative pressure of the ultrasonic waves range from 0.1 MPa to 10.0 MPa.

12. A method for the disruption of subcutaneous tissue, comprising:

infiltrating the subcutaneous tissue with a solution including microbubbles;

providing a source of unfocused acoustic waves in the power range of low acoustic pressure ultrasound waves; and

applying the unfocused acoustic waves to at least some of the microbubbles, wherein energy transmitted from rupture of the at least some of the microbubbles injures at least some of the subcutaneous tissue.

13. The method of claim 12, wherein the injury to the at least some of the subcutaneous tissue causes cellular death of the at least some of the subcutaneous tissue.

14. The method of claim 12, further including providing a solution including microbubbles.

15. The method of claim 12, further including providing an apparatus for generating a solution including microbubbles.

16. The method of claim 12, wherein the injury to the at least some of the subcutaneous tissue includes injury to at least some fat cells.

17. The method of claim 12, wherein the injury to the at least some of the subcutaneous tissue includes injury to at least some septae.

18. The method of claim 12, wherein the solution is hypotonic relative to normal tissue.

19. The method of claim 12, wherein the solution includes a perfluorocarbon.

20. The method of claim 12, wherein the solution includes a tumescent solution.

21. The method of claim 20, wherein the solution further includes lidocaine.

22. The method of claim 12, wherein the solution further includes lidocaine.

23. The method of claim 12, wherein infiltrating the subcutaneous tissue and applying the acoustic waves is performed about simultaneously.

24. The method of claim 12, wherein infiltrating the subcutaneous tissue and applying the acoustic waves is repeated for at least one more superficial depth of subcutaneous tissue.

25. A method for the disruption of subcutaneous tissue, comprising:

infiltrating the subcutaneous tissue with a solution including a plurality of gas bodies;

providing a source of acoustic waves having a frequency in the range of about 0.25 MHz to about 10 MHz and having a peak negative pressure less than 10.0 MPa; and

applying the acoustic waves to at least some of the gas bodies, wherein energy transmitted from the source of acoustic waves ruptures the at least some of the gas bodies causing subcutaneous cavitational bioeffects and disruption to at least some of the subcutaneous tissue.

26. The method of claim 25, wherein the at least some of the subcutaneous tissue disrupted is fat cells.

27. The method of claim 25, wherein the at least some of the subcutaneous tissue disrupted is septae.

28. The method of claim 25, wherein the gas bodies include gas bubble precursors.

29. The method of claim 25, wherein the gas bodies include microbubbles.

30. The method of claim 29, wherein the microbubbles are encapsulated.

31. The method of claim 25, wherein the gas bodies include nanobubbles.

32. The method of claim 31, wherein the nanobubbles are encapsulated.

33. The method of claim 25, wherein the solution is hypotonic relative to normal tissue.

34. The method of claim 25, wherein the solution includes a perfluorocarbon.

35. The method of claim 25, wherein the solution includes a tumescent solution.

36. The method of claim 25, wherein the acoustic waves have an amplitude that is less than the amplitude of an acoustic wave required to produce cavitation of tissue in the absence of gas bodies.

37. The method of claim 25, wherein the time between infiltrating the subcutaneous tissue with the solution including gas bodies and applying the acoustic waves is between about 10 minutes to about 30 minutes.

38. The method of claim 25, wherein the time between infiltrating the subcutaneous tissue with the solution including gas bodies and applying the acoustic waves is between about 1 minutes to about 10 minutes.

39. The method of claim 25, wherein the time between infiltrating the subcutaneous tissue with the solution including gas bodies and applying the acoustic waves is between about 1 second to about 1 minute.

40. The method of claim 25, wherein the time between infiltrating the subcutaneous tissue with the solution including gas bodies and applying the acoustic waves is between about 0.05 seconds and about 10 seconds.

41. The method of claim 25, wherein the time between infiltrating the subcutaneous tissue with the solution including gas bodies and applying the acoustic waves is between about 50 milliseconds to about 1000 milliseconds.

42. The method of claim 25, wherein the acoustic waves are applied to the subcutaneous tissue to be treated at a time substantially simultaneous with infiltrating the subcutaneous tissue with the solution including gas bodies to a time about 15 seconds after infiltrating the subcutaneous tissue with the solution including gas bodies.

43. The method of claim 25, wherein the subcutaneous tissue is infiltrated within about 2 mm and about 30 mm of the cutaneous surface.

44. The method of claim 25, wherein the acoustic waves are unfocused.

45. The method of claim 25, further including applying a first pattern of non-cavitational acoustic waves to condition the gas bodies into a prescribed size range before applying a second pattern of acoustic waves to rupture the at least some of the gas bodies.

46. The method of claim 25, further including applying a first pattern of non-cavitational acoustic waves to disperse the solution before applying a second pattern of acoustic waves to rupture the at least some of the gas bodies.

47. The method of claim 25, wherein the subcutaneous tissue disrupted contributes to the pathology of cellulite.

48. The method of claim 25, wherein the subcutaneous tissue disrupted is left in the body to be reabsorbed through the body'"'"'s lymphatic system.

49. The method of claim 25, wherein the subcutaneous tissue disrupted is removed from the body by a clinician.

50. The method of claim 25, wherein the acoustic waves are delivered in a pulsed manner.

51. The method of claim 25, wherein the step of infiltrating the subcutaneous tissue with a solution including a plurality of gas bodies, and applying the acoustic waves to at least some of the gas bodies is repeated in at least one additional region of subcutaneous tissue.

52. The method of claim 25, wherein the solution enhances subcutaneous cavitational bioeffects of low acoustic pressure ultrasound.

53. The method of claim 25, wherein infiltrating the subcutaneous tissue includes infiltrating between dermis layer and deep fat layer.

54. The method of claim 25, wherein infiltrating the subcutaneous tissue includes infiltrating between muscle layer and superficial fat layer.

55. The method of claim 25, wherein infiltrating the subcutaneous tissue is performed in stages at different depths with applications of acoustic waves after each stage of infiltration.

56. The method of claim 55, wherein infiltrating the subcutaneous tissue is performed in stages at depths of about 30 mm, about 25 mm, and about 20 mm.

57. The method of claim 55, wherein infiltrating the subcutaneous tissue is performed in stages at depths of about 15 mm, about 10 mm, about 5 mm and about 2 mm.

58. The method of claim 55, wherein infiltrating the subcutaneous tissue is performed in stages with each subsequent injection being performed between 2 mm and 2 centimeters more superficially than the previous stage of injection.

59. The method of claim 55, wherein infiltrating the subcutaneous layer is performed in stages at different depths, the depths being located between the dermal layer and the deep fat layer.

60. The method of claim 55, wherein infiltrating the subcutaneous layer is performed in stages at different depths, the depths being located between the superficial fat layer and the muscle layer.

61. A method for the disruption of a biologic tissue, comprising:

injecting a solution in proximity to the tissue to be disrupted;

allowing the solution to remain in proximity to the tissue to be disrupted;

exposing the solution to low acoustic pressure ultrasound, wherein a plurality of cells included in the tissue suffer cell lysis from subcutaneous cavitational bioeffects; and

allowing the patient'"'"'s body to reabsorb the dead cells.

62. The method of claim 61, wherein the solution is allowed to remain in proximity to the tissue to be treated for at least 10 seconds.

63. The method of claim 61, wherein the solution is allowed to remain in proximity to the tissue to be treated for at least 30 seconds.

64. The method of claim 61, wherein the solution is allowed to remain in proximity to the tissue to be treated for at least one minute.

65. The method of claim 61, wherein the solution is a hypotonic solution.

66. The method of claim 61, wherein the solution includes an enhancing agent.

67. The method of claim 61, further including dispersing the solution with an application of exogenous energy.

68. The method of claim 67, wherein the solution is a hypotonic solution.

69. The method of claim 67, wherein the solution includes an enhancing agent.

70. The method of claim 69, wherein the enhancing agent is a surfactant.

71. A method for the disruption of subcutaneous tissue, comprising:

infiltrating the subcutaneous tissue with a solution including an enhancing agent;

applying a first lower amplitude ultrasound wave in a pressure range of low acoustic pressure ultrasound waves to disperse the solution in the subcutaneous tissue; and

applying a second higher amplitude ultrasound wave in the pressure range of low acoustic pressure ultrasound waves to the tissue, wherein the second higher amplitude ultrasound wave has sufficient power to cause cavitation in the solution without having sufficient power to cause a direct cavitational effect on cells in the tissue.

72. The method of claim 71, wherein the enhancing agent includes a plurality of gaseous bodies, and wherein applying the second higher amplitude ultrasound wave causes subcutaneous cavitational bioeffects, thereby disrupting at least some of the subcutaneous tissue.

73. The method of claim 71, wherein the solution is a tumescent solution.

74. The method of claim 71, wherein the solution is a hypotonic solution.

75. The method of claim 71, wherein the first lower amplitude ultrasound wave has a mechanical index in the range of 0.01 to 0.7, and the second higher amplitude ultrasound wave has a mechanical index in the range of 0.7 to 5.0.

76. The method of claim 71, wherein the low acoustic pressure ultrasound wave is in the pressure range of that provided by diagnostic ultrasound.

77. The method of claim 71, wherein the low acoustic pressure ultrasound wave is in the pressure range of that provided by physical therapy ultrasound.

78. The method of claim 71, wherein infiltrating the subcutaneous layer includes infiltrating the superficial fat layer.

79. The method of claim 71, wherein infiltrating the subcutaneous layer includes infiltrating the deep fat layer.

80. The method of claim 71, further including repeating the steps at least once.

81. The method of claim 71, further including repeating the steps in the same tissue region at least once.

82. The method of claim 71, further including repeating the steps at a different depth in the same tissue region at least once.

83. The method of claim 71, further including repeating the steps at a different tissue region at least once.

84. The method of claim 71, wherein the solution is dispersed with the first lower amplitude ultrasound wave between 5 seconds and 5 minutes before applying the second higher amplitude ultrasound wave.

85. The method of claim 71, further including discontinuing the first lower amplitude ultrasound wave before applying the second higher amplitude ultrasound wave.

86. A method of treating subcutaneous tissue, comprising:

providing a source of ultrasonic waves;

disposing microbubbles to the subcutaneous tissue to be treated;

applying ultrasound waves to the microbubbles, thereby inducing cavitation of at least some of the microbubbles; and

the cavitation of the microbubbles causing disruption to at least some of the tissue.