Method and Apparatus for Ablation of Benign, Pre-Cancerous and Early Cancerous Lesions That Originate Within the Epithelium and are Limited to the Mucosal Layer of the Gastrointestinal Tract

• US 20090012518A1
• Filed: 07/03/2008
• Published: 01/08/2009
• Est. Priority Date: 07/06/2007
• Status: Abandoned Application

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Utley, David S., Wallace, Michael P.
• Application Number:
  US12/168,042
• Publication Number:
  US 20090012518A1
• Time in Patent Office: Days
• US Class Current: 606/41
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/044 the surgical action being effected by a circulating hot fluid
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1497 Electrodes covering only part of the probe circumference
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2218/007 Aspiration

Abstract

Devices and methods are provided for ablating areas of the gastrointestinal tract affected with certain benign, pre-cancerous, or early cancerous lesions that originate within the epithelium and are limited to the mucosal layer of the gastrointestinal tract wall. Examples of such lesions include benign conditions such as cervical inlet patch (ectopic gastric mucosa in the upper esophagus), as well as pre-cancerous and cancerous conditions such as intestinal metaplasia/intra-epithelial neoplasia/early cancer of the stomach, squamous intra-epithelial neoplasia and early cancer of the esophagus, oral and pharyngeal leukoplakia, flat colonic polyps, anal intra-epithelial neoplasia (AIN), and early cancers of the anal canal. Ablation, as provided the invention, commences at the epithelial layer of the gastrointestinal wall and penetrates deeper into the gastrointestinal wall in a controlled manner to achieve a successful patient outcome, the latter of which is defined generally as eradication of the targeted lesion, and/or a change in the targeted lesion to prevent or forestall patient morbidity. Embodiments of the device include an ablational electrode array that spans 360 degrees and an array that spans an arc of less than 360 degrees.

Claims

1. A method of providing ablation based therapy in a target area having a cervical inlet patch within a portion of the proximal esophagus, comprising:

manipulating a portion of the proximal esophagus to expose the target area;

deploying an ablation device into contact with the target area;

delivering ablative energy to a tissue surface in the target area; and

controlling the delivery of ablative energy to the tissue surface and layers of the target area.

2. The method of claim 1, the manipulating step further comprising:

identifying a cervical inlet patch within the target area.

3. The method of claim 1, further comprising:

continuing the manipulating step to expose the target area during the delivering and controlling steps.

4. The method of claim 1, further comprising:

removing debris from the target area after the controlling step.

5. The method of claim 1, further comprising:

removing debris from the target area after performing the controlling step more than once.

6. The method of claim 1 wherein the controlling step delivers an energy density within the range of 10-15 J/cm².

7. The method of claim 1 wherein the delivering ablative energy step comprises delivering ablative energy without an electrode structure penetrating tissue in the target area.

8. The method of claim 1, the controlling step further comprising:

delivering sufficient ablative energy to achieve ablation in one fraction of the tissue target surface and delivering insufficient ablative energy to achieve ablation to another fraction of the target tissue surface.

9. The method of claim 1, the controlling step further comprising:

controlling the delivery of ablative energy within the target tissue surface to provide sufficient treatment to achieve ablation within the cercal inlet patch and yet provide insufficient energy to other tissue layers beneath the cervical inlet patch.

10. The method of claim 1 wherein controlling the delivery of ablative energy across the surface and into tissue layers in the target area is such that some fraction of the tissue volume is ablated and another fraction of the tissue volume is not ablated.

11. The method of claim 2 wherein controlling the delivery of energy into target tissue layers consists of ablating a fraction of tissue in the epithelial layer of the cervical inlet patch.

12. The method of claim 2 wherein controlling the delivery of energy into target tissue layers consists of ablating a fraction of tissue in the epithelial layer and the lamina propria of the cervical inlet patch.

13. The method of claim 2 wherein controlling the delivery of energy into the tissue layers consists of ablating a fraction of cervical inlet patch tissue in the epithelial layer, the lamina propria, and the muscularis mucosae.

14. The method of claim 2 wherein controlling the delivery of energy into tissue layers consists of ablating a fraction of cervical inlet patch tissue in the epithelial layer, the lamina propria, the muscularis mucosae, and the submucosa.

15. The method of claim 1, the delivering energy step further comprising:

delivering energy in an ablation pattern configured to conform to a cervical inlet patch.

16. The method of claim 1, further comprising:

evaluating the target area after the delivering energy step.

17. The method of claim 1, the controlling step further comprising:

adjusting the controlling step based on a feedback control of the energy delivery to provide any of a specific power, a power density, an energy level, an energy density, a circuit impedance, target tissue temperature, a number of applications of energy, or a pressure of application against the tissue.

18. The method of claim 1, the deploying step further comprising:

moving the ablation structure into therapeutic contact with the target area prior to the delivering energy step.

19. The method of claim 18, the moving step further comprising:

expanding an expandable member to enhance the therapeutic contact with the target tissue.

20. The method of claim 18, the moving step further comprising:

operating a deflection mechanism to enhance the therapeutic contact with the target tissue.

21. A method of providing ablation based therapy to a target area in a stomach having a region containing abnormal gastric tissue, within the target area, comprising:

manipulating a portion of the stomach to expose the target area;

deploying an ablation device into contact with the target area;

delivering ablative energy to a tissue surface in the target area; and

controlling the delivery of ablative energy to the tissue surface and layers of the target area.

22. The method of claim 21, the manipulating step further comprising:

identifying the region of abnormal gastric tissue within the target area after the manipulating step.

23. The method of claim 21, further comprising:

continuing the manipulating step to expose the target area during the delivering and controlling steps.

24. The method of claim 21, further comprising:

removing debris from the target area after the controlling step.

25. The method of claim 21, further comprising:

removing debris from the target area after performing the controlling step more than once.

26. The method of claim 21 wherein the controlling step delivers an energy density of more than 10 J/cm² or higher.

27. The method of claim 21 wherein the delivering ablative energy step comprises delivering ablative energy without an electrode structure penetrating tissue in the target area.

28. The method of claim 21, the controlling step further comprising:

delivering sufficient ablative energy to achieve ablation in one fraction of the tissue target surface and delivering insufficient ablative energy to achieve ablation to another fraction of the target tissue surface.

29. The method of claim 21, the controlling step further comprising:

controlling the delivery of ablative energy from the target tissue surface with sufficient energy to achieve ablation within the region of abnormal gastric tissue within the target area and insufficient energy is delivered to other target tissue layers beneath the region of abnormal gastric tissue within the target area.

30. The method of claim 21 wherein controlling the delivery of ablative energy across the surface and into tissue layers in the target area is such that some fraction of the tissue volume is ablated and another fraction of the tissue volume is not ablated.

31. The method of claim 22 wherein controlling the delivery of energy into target tissue layers consists of ablating a fraction of tissue in the epithelial layer of the region of abnormal gastric tissue within the target area.

32. The method of claim 22 wherein controlling the delivery of energy into target tissue layers consists of ablating a fraction of tissue in the epithelial layer and the lamina propria of the region of abnormal gastric tissue within the target area.

33. The method of claim 22 wherein controlling the delivery of energy into the tissue layers consists of ablating a fraction of the region of abnormal gastric tissue within the target area tissue in the epithelial layer, the lamina propria, and the muscularis mucosae.

34. The method of claim 22 wherein controlling the delivery of energy into tissue layers consists of ablating a fraction of abnormal gastric tissue within the target area in the epithelial layer, the lamina propria, the muscularis mucosae, and the submucosa.

35. The method of claim 21, the delivering energy step further comprising:

delivering energy in an ablation pattern configured to conform to the region of abnormal gastric tissue within the target area.

36. The method of claim 21, further comprising:

evaluating the target area after the delivering energy step.

37. The method of claim 21, the controlling step further comprising:

adjusting the controlling step based on a feedback control of the energy delivery to provide any of a specific power, a power density, an energy level, an energy density, a circuit impedance, target tissue temperature, a number of applications of energy, or a pressure of application against the tissue.

38. The method of claim 21, the advancing step further comprising:

moving the ablation structure into therapeutic contact with the target area prior to the delivering energy step.

39. The method of claim 38, the moving step further comprising:

expanding an expandable member to enhance the therapeutic contact with the target tissue.

40. The method of claim 38, the moving step further comprising:

operating a deflection mechanism to enhance the therapeutic contact with the target tissue.

41. A method of providing ablation based therapy to a target area in an esophagus having a region of a squamous intra-epithelial neoplasia and early cancer of the esophagus, hereafter referred to as abnormal esophageal tissue, within the target area, comprising:

identifying the region of a abnormal esophageal tissue within the target area;

advancing an ablation device into contact with the target area;

delivering ablativeenergy to a tissue surface in the target area; and

controlling the delivery of ablative energy to the tissue surface and layers of the target area.

42. The method of claim 41 the delivering step further comprising:

delivering energy nearly circumferentially about the esophagus to a region of abnormal esophageal tissue within a nearly circumferential target area in the esophagus.

43. The method of claim 41 wherein delivering energy from the ablation structure includes delivering energy less than circumferentially about the esophagus to a region of a squamous intra-epithelial neoplasia within a less than circumferential target area in the esophagus.

44. The method of claim 41, further comprising:

removing debris from the target area after the controlling step.

45. The method of claim 41, further comprising:

removing debris from the target area after performing the controlling step more than once.

46. The method of claim 41 wherein the controlling step delivers a power density in the range of 10 to 15 J/cm².

47. The method of claim 41 wherein the delivering ablative energy step comprises delivering ablative energy without an electrode structure penetrating tissue in the target area.

48. The method of claim 41, the controlling step further comprising:

delivering sufficient ablative energy to achieve ablation in one fraction of the tissue target surface and delivering insufficient ablative energy to achieve ablation to another fraction of the target tissue surface.

49. The method of claim 41, the controlling step further comprising:

controlling the delivery of ablative energy from the target tissue surface with sufficient energy to achieve ablation within the region of a abnormal esophageal tissue in the target area and insufficient energy is delivered to other target tissue layers beneath the region of abnormal esophageal tissue within the target area.

50. The method of claim 41 wherein controlling the delivery of ablative energy across the surface and into tissue layers in the target area is such that some fraction of the tissue volume is ablated and another fraction of the tissue volume is not ablated.

51. The method of claim 42 wherein controlling the delivery of energy into target tissue layers consists of ablating a fraction of tissue in the epithelial layer of the region of abnormal esophageal tissue within the target area.

52. The method of claim 42 wherein controlling the delivery of energy into target tissue layers consists of ablating a fraction of tissue in the epithelial layer and the lamina propria of the region of abnormal esophageal tissue within the target area.

53. The method of claim 42 wherein controlling the delivery of energy into the tissue layers consists of ablating a fraction of the region of abnormal esophageal tissue within the target area tissue in the epithelial layer, the lamina propria, and the muscularis mucosae.

54. The method of claim 42 wherein controlling the delivery of energy into tissue layers consists of ablating a fraction of abnormal esophageal tissue within the target area in the epithelial layer, the lamina propria, the muscularis mucosae, and the submucosa.

55. The method of claim 41, the delivering energy step further comprising:

delivering energy in an ablation pattern configured to conform to the region of abnormal esophageal tissue within the target area.

56. The method of claim 41, further comprising:

evaluating the target area after the delivering energy step.

57. The method of claim 41, the controlling step further comprising:

adjusting the controlling step based on a feedback control of the energy delivery to provide any of a specific power, a power density, an energy level, an energy density, a circuit impedance, target tissue temperature, a number of applications of energy, or a pressure of application against the tissue.

58. The method of claim 41, the advancing step further comprising:

moving the ablation structure into therapeutic contact with the target area prior to the delivering energy step.

59. The method of claim 58, the moving step further comprising:

expanding an expandable member to enhance the therapeutic contact with the target tissue.

60. The method of claim 58, the moving step further comprising:

operating a deflection mechanism to enhance the therapeutic contact with the target tissue.

61. A method of providing ablation based therapy in a target area having a region of leukoplakia within the oral and/or pharyngeal cavity, comprising:

manipulating a portion of the oral and pharyngeal cavity to expose the target area;

deploying an ablation device into contact with the target area;

delivering ablative energy to a tissue surface in the target area; and

controlling the delivery of ablative energy to the tissue surface and layers of the target area.

62. The method of claim 61, the manipulating step further comprising:

identifying a region of leukoplakia within the target area.

63. The method of claim 61, further comprising:

continuing the manipulating step to expose the target area during the delivering and controlling steps.

64. The method of claim 61, further comprising:

removing debris from the target area after the controlling step 65.

65. The method of claim 61, further comprising:

removing debris from the target area after performing the controlling step more than once.

66. The method of claim 61 wherein the controlling step delivers a power density within the range of 10-15 J/cm².

67. The method of claim 61 wherein the delivering ablative energy step comprises delivering ablative energy without an electrode structure penetrating tissue in the target area.

68. The method of claim 61, the controlling step further comprising:

delivering sufficient ablative energy to achieve ablation in one fraction of the tissue target surface and delivering insufficient ablative energy to achieve ablation to another fraction of the target tissue surface.

69. The method of claim 61, the controlling step further comprising:

controlling the delivery of ablativeenergy from the target tissue surface with sufficient energy to achieve ablation within the region of leukoplakia and insufficient energy is delivered to other target tissue layers beneath the region of leukoplakia.

70. The method of claim 61 wherein controlling the delivery of ablative energy across the surface and into tissue layers in the target area is such that some fraction of the tissue volume is ablated and another fraction of the tissue volume is not ablated.

71. The method of claim 62 wherein controlling the delivery of energy into target tissue layers consists of ablating a fraction of tissue in the epithelial layer of the region of leukoplakia.

72. The method of claim 62 wherein controlling the delivery of energy into target tissue layers consists of ablating a fraction of tissue in the epithelial layer and the lamina propria of the region of leukoplakia.

73. The method of claim 62 wherein controlling the delivery of energy into the tissue layers consists of ablating a fraction of the region of leukoplakia tissue in the epithelial layer, the lamina propria, and the muscularis mucosae.

74. The method of claim 62 wherein controlling the delivery of energy into tissue layers consists of ablating a fraction of the region of leukoplakia tissue in the epithelial layer, the lamina propria, the muscularis mucosae, and the submucosa.

75. The method of claim 61, the delivering energy step further comprising:

delivering energy in an ablation pattern configured to conform to a region of leukoplakia.

76. The method of claim 61, further comprising:

evaluating the target area after the delivering energy step.

77. The method of claim 61, the controlling step further comprising:

adjusting the controlling step based on a feedback control of the energy delivery to provide any of a specific power, a power density, an energy level, an energy density, a circuit impedance, target tissue temperature, a number of applications of energy, or a pressure of application against the tissue.

78. The method of claim 61, the deployment step further comprising:

moving the ablation structure into therapeutic contact with the target area prior to the delivering energy step.

79. The method of claim 78, the moving step further comprising:

expanding an expandable member to enhance the therapeutic contact with the target tissue.

80. The method of claim 78, the moving step further comprising:

operating a deflection mechanism to enhance the therapeutic contact with the target tissue.

81. The method of claim 78 the moving step further comprising:

deforming the ablation structure to at least partially conform to the region of leukoplakia.

82. The method of claim 61 further comprising:

placing the ablation structure on a finger of a user prior to the advancing step and keeping the ablation structure on the finger of the user during the delivering an controlling steps.

83. The method of claim 61 wherein the deploying step is performed using a hand held ablation device under direct visualization.

84. A method of providing ablation based therapy to a target area in a colon and/or rectum having a region of one or more flat-type polyps within the target area, comprising:

manipulating a portion of the colon to expose the target area;

deploying an ablation device into contact with the target area;

delivering ablative energy to a tissue surface in the target area; and

controlling the delivery of ablative energy to the tissue surface and layers of the target area.

85. The method of claim 84, the manipulating step further comprising:

identifying the region of one or more flat-type polyps within the target area after the manipulating step.

86. The method of claim 84, further comprising:

continuing the manipulating step to expose the target area during the delivering and controlling steps.

87. The method of claim 84, further comprising:

removing debris from the target area after the controlling step.

88. The method of claim 84, further comprising:

removing debris from the target area after performing the controlling step more than once.

89. The method of claim 84 wherein the controlling step delivers a power density of 10 J/cm2 or greater.

90. The method of claim 84 wherein the delivering ablative energy step comprises delivering ablative energy without an electrode structure penetrating tissue in the target area.

91. The method of claim 84, the controlling step further comprising:

delivering sufficient ablative energy to achieve ablation in one fraction of the tissue target surface and delivering insufficient ablative energy to achieve ablation to another fraction of the target tissue surface.

92. The method of claim 84, the controlling step further comprising:

controlling the delivery of ablative energy from the target tissue surface with sufficient energy to achieve ablation within the region of one or more flat-type polyps within the target area and insufficient energy is delivered to other target tissue layers beneath the region of one or more flat-type polyps within the target area.

93. The method of claim 84 wherein controlling the delivery of ablative energy across the surface and into tissue layers in the target area is such that some fraction of the tissue volume is ablated and another fraction of the tissue volume is not ablated.

94. The method of claim 85 wherein controlling the delivery of energy into target tissue layers consists of ablating a fraction of tissue in the epithelial layer of the region of one or more flat-type polyps within the target area.

95. The method of claim 85 wherein controlling the delivery of energy into target tissue layers consists of ablating a fraction of tissue in the epithelial layer and the lamina propria of the region of one or more flat-type polyps within the target area.

96. The method of claim 85 wherein controlling the delivery of energy into the tissue layers consists of ablating a fraction of the region of one or more flat-type polyps within the target area tissue in the epithelial layer, the lamina propria, and the muscularis mucosae.

97. The method of claim 85 wherein controlling the delivery of energy into tissue layers consists of ablating a fraction of the region of one or more flat-type polyps within the target area in the epithelial layer, the lamina propria, the muscularis mucosae, and the submucosa.

98. The method of claim 84, the delivering energy step further comprising:

delivering energy in an ablation pattern configured to conform to the region of one or more flat-type polyps within the target area.

99. The method of claim 84, further comprising:

evaluating the target area after the delivering energy step.

100. The method of claim 84, the controlling step further comprising:

adjusting the controlling step based on a feedback control of the energy delivery to provide any of a specific power, a power density, an energy level, an energy density, a circuit impedance, target tissue temperature, a number of applications of energy, or a pressure of application against the tissue.

101. The method of claim 84, the advancing step further comprising:

moving the ablation structure into therapeutic contact with the target area prior to the delivering energy step.

102. The method of claim 101, the moving step further comprising:

expanding an expandable member to enhance the therapeutic contact with the target tissue.

103. The method of claim 101, the moving step further comprising:

operating a deflection mechanism to enhance the therapeutic contact with the target tissue.

104. The method of claim 84 wherein the delivering step comprises delivering ablative energy to a tissue surface containing residual flat-type polyp tissue in the target area where a partial or complete polypectomy has been performed.

105. A method of providing ablation based therapy in an anal target area having a region of abnormal anal tissue, comprising:

manipulating a portion of the anal canal to expose the target area;

deploying an ablation device into contact with the target area;

delivering ablative energy to a tissue surface in the target area; and

controlling the delivery of ablative energy to the tissue surface and layers of the target area.

106. The method of claim 105, the manipulating step further comprising:

identifying a region of abnormal anal tissue within the target area.

107. The method of claim 105, further comprising:

continuing the manipulating step to expose the target area during the delivering and controlling steps.

108. The method of claim 105, further comprising:

removing debris from the target area after the controlling step.

109. The method of claim 105, further comprising:

removing debris from the target area after performing the controlling step more than once.

110. The method of claim 105 wherein the controlling step delivers a power density within the range of 10-15 J/cm2.

111. The method of claim 105 wherein the delivering ablative energy step comprises delivering ablative energy without an electrode structure penetrating tissue in the target area.

112. The method of claim 105, the controlling step further comprising:

delivering sufficient ablativeenergy to achieve ablation in one fraction of the tissue target surface and delivering insufficient ablative energy to achieve ablation to another fraction of the target tissue surface.

113. The method of claim 105, the controlling step further comprising:

controlling the delivery of ablative energy from the target tissue surface with sufficient energy to achieve ablation within the region of abnormal anal tissue and insufficient energy is delivered to other target tissue layers beneath the region of abnormal anal tissue.

114. The method of claim 105 wherein controlling the delivery of ablative energy across the surface and into tissue layers in the target area is such that some fraction of the tissue volume is ablated and another fraction of the tissue volume is not ablated.

115. The method of claim 106 wherein controlling the delivery of energy into target tissue layers consists of ablating a fraction of tissue in the epithelial layer of the region of abnormal anal tissue.

116. The method of claim 106 wherein controlling the delivery of energy into target tissue layers consists of ablating a fraction of tissue in the epithelial layer and the lamina propria of the region of abnormal anal tissue.

117. The method of claim 106 wherein controlling the delivery of energy into the tissue layers consists of ablating a fraction of the region of abnormal anal tissue in the epithelial layer, the lamina propria, and the muscularis mucosae.

118. The method of claim 106 wherein controlling the delivery of energy into tissue layers consists of ablating a fraction of the region of abnormal anal tissue in the epithelial layer, the lamina propria, the muscularis mucosae, and the submucosa.

119. The method of claim 105, the delivering energy step further comprising:

delivering energy in an ablation pattern configured to conform to a region of intraepithelial neoplasia.

120. The method of claim 105, further comprising:

evaluating the target area after the delivering energy step.

121. The method of claim 105, the controlling step further comprising:

adjusting the controlling step based on a feedback control of the energy delivery to provide any of a of a specific power, a power density, an energy level, an energy density, a circuit impedance, target tissue temperature, a number of applications of energy, or a pressure of application against the tissue.

122. The method of claim 105, the deployment step further comprising:

moving the ablation structure into therapeutic contact with the target area prior to the delivering energy step.

123. The method of claim 122, the moving step further comprising:

expanding an expandable member to enhance the therapeutic contact with the target tissue.

124. The method of claim 122, the moving step further comprising:

operating a deflection mechanism to enhance the therapeutic contact with the target tissue.

125. The method of claim 122 the moving step further comprising:

deforming the ablation structure to at least partially conform to the region of abnormal anal tissue.

126. The method of claim 105 further comprising:

placing the ablation structure on a finger of a user prior to the advancing step and keeping the ablation structure on the finger of the user during the delivering an controlling steps.

127. The method of claim 105 wherein the deploying step is performed using a hand held ablation device under direct visualization.