Method and system for photoselective vaporization for gynecological treatments

• US 7,063,694 B2
• Filed: 02/21/2003
• Issued: 06/20/2006
• Est. Priority Date: 02/22/2002
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Laserscope (Endo International PLC)
• Inventors: Davenport, Scott A., Arnold, Ken, Coleman, Tony D., Nahen, Kester, Garlich, Henry, Murray, Steven C.
• Primary Examiner(s): Gibson, Roy D
• Assistant Examiner(s): Johnson, III, Henry M
• Application Number:
  US10/371,080
• Publication Number:
  US 20030216717A1
• Time in Patent Office: 1,215 Days
• Field of Search: 606 1- 19, 600104-108, 128/898
• US Class Current: 606/15
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00625 Vaporization
• CPC Class Codes: A61B 2018/2272 with reflective or refractive surfaces for deflecting the beam A61B2018/2261, A61B2018/2266 take precedence

Abstract

A method for photoselective vaporization of uterine tissue includes delivering laser radiation to the treatment area on the tissue, via an optical fiber for example, wherein the laser radiation has a wavelength and irradiance in the treatment area on the surface of the tissue sufficient because vaporization of a substantially greater volume of tissue than a volume of residual coagulated tissue caused by the laser radiation. The laser radiation is generated using a neodymium doped solid-state laser, including optics producing a second or higher harmonic output with greater than 60 watts average output power. The delivered laser radiation has a wavelength for example in a range of about 200 nm to about 650 nm, and has an average irradiance in the treatment area greater than about 10 kilowatts/cm², in a spot size of at least 0.05 mm².

Claims

1. A method for photoselective vaporization of tissue for treatment of gynecological conditions, comprising:

delivering laser radiation to a treatment area on a surface of tissue of a female reproductive organ, the laser radiation being absorbed substantially completely by the tissue within about 1 mm of the surface, and having average irradiance in the treatment area greater than 10 kiloWatts/cm² in a spot size at least about 0.05 mm²;

wherein said delivering comprises using a hysteroscope, with one of an optical fiber having a side firing optical element and an end firing optical fiber adapted for directing laser radiation from the fiber to the treatment area, and placing said side firing optical element or end firing optical fiber within about 1 mm, or less, of the treatment area.

2. The method of claim 1, wherein the spot size is between about 0.1 and 0.8 mm² in the treatment area.

3. The method of claim 1, wherein the irradiance is at least 30 kiloWatts/cm² in the treatment area.

4. The method of claim 1, wherein the laser radiation has a wavelength in a range from about 200 to about 700 nm.

5. The method of claim 1, wherein the delivered laser radiation has a wavelength in a range of about 200 nm to about 700 nm, and has an average irradiance in the treatment area greater than 20 kiloWatts/cm².

6. The method of claim 1, wherein the delivered laser radiation has a wavelength in a range of about 200 nm to about 700 nm, and has an average irradiance in the treatment area greater than 30 kiloWatts/cm².

7. The method of claim 1, wherein said tissue comprises uterine tissue.

8. The method of claim 1, wherein said tissue comprises uterine tissue located in a cornua of the uterus.

9. The method of claim 1, wherein said delivering comprises using a hysteroscope, with an optical fiber adapted to direct laser radiation from the fiber to the treatment area.

10. The method of claim 1, wherein said delivering comprises using a hysteroscope, with an end firing optical fiber.

11. The method of claim 1, including generating said laser radiation using a solid state laser with greater than 40 Watts average output power.

12. The method of claim 1, including generating said laser radiation using a solid state laser with greater than 60 Watts average output power.

13. The method of claim 1, including generating laser radiation using a macro-pulsed solid state laser having output power greater than about 200 Watts during a macro-pulse.

14. The method of claim 1, wherein said delivering comprises delivering a macro-pulse consisting of a sequence of micro-pulses of laser radiation, and said irradiance is greater than 50 kiloWatts/cm² during the macro-pulse.

15. The method of claim 1, including generating said laser radiation using Neodymium doped solid state laser medium, and optics to produce an output at a second or higher harmonic frequency with greater than 40 Watts average output power.

16. The method of claim 1, wherein said tissue comprises uterine tissue, and said treatment is for a gynecological condition selected from leiomyoma uteri, rhabdomyoma, endometriosis, endometrial hyperplasia, endometrial cysts, endometrial polyps, menorrhagia, uterine septa, intrauterine adhesions, or cervical intraepithelial neoplasia.

38. The method of claim 1, 17, 19, 35, 37, wherein the laser radiation has a wavelength of about 532 nm.

17. A method for photoselective vaporization of tissue for treatment of gynecological conditions, comprising:

delivering laser radiation to a treatment area on a surface of tissue of a female reproductive organ, the laser radiation being absorbed substantially completely by the tissue within about 1 mm of the surface, and having average irradiance in the treatment area greater than 10 kiloWatts/cm² in a spot size at least about 0.05 mm², wherein the laser radiation has a beam quality (M²) that is less than or equal to 100.

18. The method of claim 17, wherein said delivering comprises using a hysteroscope, with an optical fiber adapted to direct laser radiation from the fiber to the treatment area.

19. A method for photoselective vaporization of tissue of a female reproductive organ, comprising:

delivering laser radiation and a flow of a transparent liquid irrigant to a treatment area on a surface of target tissue of a female reproductive organ, the laser radiation causing vaporization of a volume of tissue greater than a volume of residual coagulation of tissue, and having irradiance in the treatment area greater than 10 kiloWatts/cm² in a spot size at least 0.05 mm²;

wherein said delivering comprises using a hysteroscope, with one of an optical fiber having a side firing optical element and an end firing optical fiber adapted for directing laser radiation from the fiber to the treatment area, ad placing said side firing optical element or end firing optical fiber within about 1 mm, or less, or the treatment area.

20. The method of claim 19, wherein the spot size is less than about 0.8 mm² in the treatment area.

21. The method of claim 19, wherein the irradiance is at least 30 kiloWatts/cm² in the treatment area.

22. The method of claim 19, wherein the laser radiation has a wavelength in a range from about 200 to about 700 nm.

23. The method of claim 19, wherein the delivered laser radiation has a wavelength in a range of about 200 nm to about 700 nm, and has an average irradiance in the treatment area greater than 20 kiloWatts/cm².

24. The method of claim 19, wherein the delivered laser radiation has a wavelength in a range of about 200 nm to about 700 nm, and has an average irradiance in the treatment area greater than 30 kiloWatts/cm².

25. The method of claim 19, wherein the irrigant comprises physiologic saline.

26. The method of claim 19, wherein said delivering comprises using a hysteroscope with a flexible tip.

27. The method of claim 19, wherein said delivering comprises using a hysteroscope, with an optical fiber having a side firing optical element.

28. The method of claim 19 wherein said delivering comprises using a hysteroscope, with an end firing optical fiber.

29. The method of claim 19, including generating said laser radiation using a solid state laser with greater than 40 Watts average output power.

30. The method of claim 19, including generating said laser radiation using a solid state laser with greater than 60 Watts average output power.

31. The method of claim 19, including generating laser radiation using a macro-pulsed solid state laser having output power greater than about 200 Watts during a macro-pulse.

32. The method of claim 19, wherein said delivering comprises delivering a macro-pulse consisting of a sequence of micro-pulses of laser radiation, and said irradiance is greater than 50 kiloWatts/cm² during a macro-pulse.

33. The method of claim 19, including generating said laser radiation using Neodymium doped solid state laser medium, and optics to produce an output at a second or higher harmonic frequency with greater than 40 Watts average output power.

34. The method of claim 19, wherein said target tissue comprises uterine tissue, and said treatment is for a gynecological condition selected from leiomyoma uteri, rhabdomyoma, endometriosis, endometrial hyperplasia, endometrial cysts, endometrial polyps, menorrhagia, uterine septa, intrauterine adhesions, or cervical intraepithelial neoplasia.

35. A method for photoselective vaporization of tissue of a female reproductive organ, comprising:

delivering laser radiation and a flow of a transparent liquid irrigant to a treatment area on a surface of a target tissue of a female reproductive organ, the laser radiation causing vaporization of a volume of tissue greater than a volume of residual coagulation of tissue, and having irradiance in the treatment area greater than 10 kioWatts/cm² in a spot size at least 0.05 mm², wherein the irrigant comprises Ringer'"'"'s Lactate.

36. The method of claim 35, wherein said delivering comprises using a hysteroscope, with an optical fiber adapted to direct laser radiation from the fiber to the treatment area.

37. A method for photoselective vaporization of tissue of a female reproductive organ, comprising:

delivering laser radiation and a flow of a transparent liquid irrigant to a treatment area on a surface of target tissue of a female reproductive organ, the laser radiation causing vaporization of a volume of tissue greater than a volume of residual coagulation of tissue, and having irradiance in the treatment area greater than 10 kiloWatts/cm² in a spot size at least 0.05 mm², wherein the laser radiation has a beam quality (M²) that is less than or equal to 100.

39. A method for photoselective vaporization of tissue for treatment of a gynecological condition, comprising:

delivering laser radiation to a treatment area on tissue of a female reproductive organ, the laser radiation having a wavelength and having irradiance in the treatment area sufficient to cause vaporization of a substantially greater volume of said tissue than a volume of residual coagulated tissue caused by the laser radiation;

wherein said delivering comprises using a hysteroscope, with one of an optical fiber having a side firing optical element and an end firing optical fiber adapted for directing laser radiation from the fiber to the treatment area, and placing said side firing optical element or end firing optical fiber within about 1 mm, or less, of the treatment area.

40. The method of claim 39, wherein the delivered laser radiation has an average irradiance in the treatment area greater than 10 kiloWatts/cm² in a spot size at least 0.05 mm².

41. The method of claim 39, including delivering said laser radiation using an optical fiber, and wherein the delivered laser radiation has a wavelength in a range of about 200 nm to about 650 nm, and has an average irradiance in the treatment area greater than 10 kiloWatts/cm² and the optical fiber is adapted to cause a spot size of at least about 0.05 mm² in the treatment area.

42. The method of claim 39, wherein the delivered laser radiation has a wavelength in a range of about 200 nm to about 650 nm, and has an average irradiance in the treatment area greater than 20 kiloWatts/cm² and the optical fiber is adapted to cause a spot size of at least about 0.05 mm² in the treatment area.

43. The method of claim 39, wherein the delivered laser radiation has a wavelength in a range of about 200 nm to about 650 nm, and has an average irradiance in the treatment area greater than 30 kiloWatts/cm² and the optical fiber is adapted to cause a spot size of at least about 0.05 mm² in the treatment area.

44. The method of claim 39, wherein the spot size is less than about 0.8 mm² in the treatment area.

45. The method of claim 39, wherein the average irradiance is at least 30 kiloWatts/cm² in the treatment area.

46. The method of claim 39, wherein the laser radiation has a wavelength in a range from about 200 to about 700 nm.

47. The method of claim 39, including delivering a flow of irrigant to the treatment area.

48. The method of claim 39, wherein the tissue comprises uterine tissue.

49. The method of claim 39, wherein said delivering comprises using a hysteroscope, with an optical fiber having a side firing optical element.

50. The method of claim 39, wherein said delivering comprises using a hysteroscope, with an end firing optical fiber.

51. The method of claim 39, including generating said laser radiation using a solid state laser with greater than 40 Watts average output power.

52. The method of claim 39, including generating said laser radiation using a solid state laser with greater than 60 Watts average output power.

53. The method of claim 39, including generating laser radiation using a macro-pulsed solid state laser having output power greater than about 200 Watts during a macro-pulse.

54. The method of claim 39, wherein said delivering comprises delivering a macro-pulse consisting of a sequence of micro-pulses of laser radiation, and said irradiance is greater than 50 kiloWatts/cm² during the macro-pulse.

55. The method of claim 39, including generating said laser radiation using Neodymium doped solid state laser medium, and optics to produce an output at a second or higher harmonic frequency with greater than 40 Watts average output power.

56. The method of claim 39, including generating said laser radiation using a diode-pumped, Neodymium doped solid state laser medium, and optics to produce an output at a second or higher harmonic frequency with greater than 40 Watts average output power.

57. The method of claim 39, wherein said tissue comprises uterine tissue, and said treatment is for a gynecological condition selected from leiomyoma uteri, rhabdomyoma, endometriosis, endometrial hyperplasia, endometrial cysts, endometrial polyps, menorrhagia, uterine septa, intrauterine adhesions, or cervical intraepithelial neoplasia.

106. The method of claim 39, 58, 60, 98 or 87, wherein the wavelength is about 532 nm.

58. A method for photoselective vaporization of tissue for treatment of a gynecological condition, comprising:

delivering laser radiation to a treatment area on tissue of a female reproductive organ, the laser radiation having a wavelength and having irradiance in the treatment area sufficient to cause vaporization of a substantially greater volume of said tissue than a volume of residual coagulated tissue caused by laser radiation, wherein the laser radiation has a beam quality (M²) that is less than or equal to 100.

59. The method of claim 58, wherein said delivering comprises using a hysteroscope, with an optical fiber adapted to direct laser radiation from the fiber to the treatment area.

60. A method for photoselective vaporization of gynecological tissue, comprising:

generating laser radiation using a Neodymium doped solid state laser medium, and optics producing a second or higher harmonic output with greater than 40 Watts average output power;

coupling said output to an optical fiber in an endoscope having a flexible tip, the optical fiber adapted to direct laser radiation from the fiber to a treatment area on a surface of the tissue;

delivering a flow of irrigant to the treatment area; and

delivering laser radiation to a treatment area on the tissue via the optical fiber, the laser radiation having a wavelength and having irradiance in the treatment area sufficient to cause vaporization of a substantially greater volume of tissue than a volume of residual coagulated tissue caused by the laser radiation;

wherein the optical fiber includes one of a side firing tip and an end firing tip, and including placing said one of a side firing tip and an end firing tip within about 1 mm, or less, of the treatment area.

61. The method of claim 60, wherein said average output power is greater than 60 watts.

62. The method of claim 60, wherein the delivered laser radiation has an average irradiance in the treatment area greater than 10 kiloWatts/cm² and the optical fiber is adapted to cause a spot size of at least about 0.05 mm² in the treatment area.

63. The method of claim 60, wherein the delivered laser radiation has an average irradiance in the treatment area greater than 20 kiloWatts/cm² and the optical fiber is adapted to cause a spot size of at least about 0.05 mm² in the treatment area.

64. The method of claim 60, wherein the delivered laser radiation has an average irradiance in the treatment area greater than 30 kiloWatts/cm² and the optical fiber is adapted to cause a spot size of at least about 0.05 mm² in the treatment area.

65. The method of claim 60, wherein the delivered laser radiation has an average irradiance in the treatment area greater than 10 kiloWatts/cm², and the optical fiber is adapted to cause a spot size is less than about 0.8 mm² in the treatment area.

66. The method of claim 60, wherein the average irradiance is at least 30 kiloWatts/cm² in the treatment area.

67. The method of claim 60, wherein the optical fiber includes a side firing tip.

68. The method of claim 60, wherein the optical fiber includes an end firing tip.

69. The method of claim 60, including Q-switching said laser medium to produce micro-pulses during application of input power to the laser medium, and applying input power to the laser medium in a sequence of pulses to generate macro-pulses of output radiation, and wherein said output power is greater than about 200 Watts during said macro-pulses.

70. The method of claim 60, including Q-switching said laser medium to produce micro-pulses during application of input power to the laser medium, and applying input power to the laser medium in a sequence of pulses to generate macro-pulses of output radiation, and said irradiance is greater than 50 kiloWatts/cm² during the macro-pulse.

71. The method of claim 60, wherein said tissue comprises uterine tissue, and said treatment is for a gynecological condition selected from leiomyoma uteri, rhabdomyoma, endometriosis, endometrial hyperplasia, endometrial cysts, endometrial polyps, menorrhagia, uterine septa, intrauterine adhesions, or cervical intraepithelial neoplasia.

72. A method for photoselective vaporization of gynecological tissue, comprising:

generating laser radiation using a Neodymium doped solid state laser medium, and optics producing a second or higher harmonic output with greater than 40 Watts average output power;

coupling said output to an optical to an optical fiber in an endoscope having a flexible tip, the optical fiber adapted to direct laser radiation from the fiber to a treatment area on a surface of the tissue;

delivering a flow of irrigant to the treatment area; and

delivering laser radiation to a treatment area on the tissue via the optical fiber, the laser radiation having a wavelength and having irradiance in the treatment area sufficient to cause vaporization of a substantially greater volume of tissue than a volume of residual coagulated tissue caused by the laser radiation, wherein the laser radiation has a beam quality (M²) that is less than or equal to 100.

73. A method for treating gynecological conditions, comprising:

providing a solid-state laser emitting light with a wavelength of 200 to 1000 nm having a laser element positioned to receive pump radiation from a pump radiation source;

modulating the pump radiation source to cause the laser element to emit laser light having pulse duration between 0.1 and 500 milliseconds and pulse frequencies between 1 and 500 Hz; and

delivering the laser light to targeted tissue of a female reproductive organ;

wherein the laser radiation has a beam quality (M²) that is less than or equal to 100.

74. The method of claim 73, wherein the light is of a wavelength that is better absorbed by the targeted tissue than by a substance in an intermediate position between the tissue and a device used to deliver the laser light to the tissue.

75. The method of claim 73, wherein the output power density of the light delivered to the targeted tissue is high enough to vaporize the tissue.

76. The method of claim 73, wherein the laser light has a repetition rate of between 1 Hertz and 500 Hertz.

77. The method of claim 73, wherein said delivering includes using an optical fiber which terminates in an end-firing probe emitting the laser light from an end of the optical fiber.

78. The method of claim 73, wherein said delivering includes using an optical fiber that terminates in a side-firing probe emitting the laser light in a direction transverse to the longitudinal axis of the optical fiber.

79. The method of claim 73, wherein the laser further comprises a frequency doubling element.

80. The method of claim 73, wherein the step of delivering the laser light further comprises transmitting the laser light through an optical fiber.

81. The method of claim 73, wherein the laser element is fabricated from neodymium doped YAG (Nd:

YAG).

82. The method of claim 73, further comprising the step of Q-switching the laser to produce a train of micropulses, each micropulse train collectively form a pulse.

83. The method of claim 73, wherein the pump radiation source is a laser diode.

84. The method of claim 73, wherein the pump radiation source is an arc lamp.

85. The method of claim 73, wherein the pump radiation source is a flash lamp.

86. The method of claim 73, wherein said tissue comprises uterine tissue, and said treatment is for a gynecological condition selected from leiomyoma uteri, rhabdomyoma, endometriosis, endometrial hyperplasia, endometrial cysts, endometrial polyps, menorrhagia, uterine septa, intrauterine adhesions, or cervical intraepithelial neoplasia.

87. A method for treating gynecological conditions comprising:

providing a solid-state laser emitting light of a wavelength of 200 to 700 nm having a laser element positioned to receive pump radiation from a pump radiation source, and

the laser has a beam quality (M²) that is less than or equal to 100, and

delivering the laser light to tissue of a female reproductive organ.

88. The method of claim 87, wherein the light is of a wavelength that is better absorbed by said tissue than by a substance in an intermediate position between the tissue and a device used to deliver the laser light to the tissue.

89. The method of claim 87, wherein the output power density of the light delivered to the targeted tissue is high enough to vaporize the tissue.

90. The method of claim 87, wherein said delivering the laser light comprises transmitting the laser light through an optical fiber.

91. The method of claim 87, wherein the laser light has a repetition rate of between 1 Hertz and 500 Hertz.

92. The method of claim 87, wherein the optical fiber terminates in an end-firing probe emitting the laser light from an end of the optical fiber.

93. The method of claim 87, wherein the optical fiber terminates in a side-firing probe emitting the laser light in a direction transverse to the longitudinal axis of the optical fiber.

94. The method of claim 87, wherein the laser further comprises a frequency doubling element.

95. The method of claim 87, further comprising Q-switching the laser to produce a train of micropulses, each micropulse train collectively comprising a pulse.

96. The method of claim 87, wherein the pump radiation source is a laser diode.

97. The method of claim 87, wherein the pump radiation source is an arc lamp.

98. The method of claim 87, wherein the pump radiation source is a flash lamp.

99. The method of claim 87, wherein said delivering the laser light comprises transmitting the laser light through an optical fiber.

100. The method of claim 87, further comprising Q-switching the laser to produce a train of micropulses.

101. The method of claim 87, wherein said light is absorbed substantially completely by the tissue within about 1 mm of the surface, and has average irradiance in the treatment area greater than 10 kiloWatts/cm² in a spot size at least about 0.05 mm².

102. The method of claim 87, wherein said light is absorbed substantially completely by the tissue within about 1 mm of the surface, and has average irradiance in the treatment area greater than 10 kiloWatts/cm² in a spot size between about 0.1 and 0.8 mm² in the treatment area.

103. The method of claim 87, wherein said light has an irradiance of at least 30 kiloWatts/cm² in the treatment area in a spot size at least about 0.05 mm².

104. The method of claim 87, wherein the light has a wavelength and has irradiance in the treatment area sufficient to cause vaporization of a substantially greater volume of said tissue than a volume of residual coagulated tissue caused by the laser radiation.

105. The method of claim 87, wherein said tissue comprises uterine tissue, and said treatment is for a gynecological condition selected from leiomyoma uteri, rhabdomyoma, endometriosis, endometrial hyperplasia, endometrial cysts, endometrial polyps, menorrhagia, uterine septa, intrauterine adhesions, or cervical intraepithelial neoplasia.