CA2370223A1 - Modification of airways by application of energy - Google Patents

Modification of airways by application of energy Download PDF

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Publication number
CA2370223A1
CA2370223A1 CA002370223A CA2370223A CA2370223A1 CA 2370223 A1 CA2370223 A1 CA 2370223A1 CA 002370223 A CA002370223 A CA 002370223A CA 2370223 A CA2370223 A CA 2370223A CA 2370223 A1 CA2370223 A1 CA 2370223A1
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Canada
Prior art keywords
energy transfer
airway
transfer apparatus
lung
energy
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002370223A
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French (fr)
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CA2370223C (en
Inventor
Christopher James Danek
Thomas Keast
Bryan Loomas
Michael Biggs
Keith M. Burger
Dave Haugaard
John Arthur Ross
Michael D. Laufer
Gary Kaplan
Kelly Shriner
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Boston Scientific Scimed Inc
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Individual
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Publication date
Priority claimed from US09/296,040 external-priority patent/US6411852B1/en
Priority claimed from US09/436,455 external-priority patent/US7425212B1/en
Application filed by Individual filed Critical Individual
Publication of CA2370223A1 publication Critical patent/CA2370223A1/en
Application granted granted Critical
Publication of CA2370223C publication Critical patent/CA2370223C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Abstract

This relates to methods and devices for treating reversible chronic obstructive pulmonary disease, and more partic-ularly, relates to a device for exchanging energy with airway tissue such as that found in the airways of human lungs. The exchange of energy with this airway tissue in the airways reduces the ability of the airways to constrict and/or reduces the resistance within the airway to the flow of air through the airway. This also relates to a method for decreasing responsiveness or decreasing resistance to airflow of airways involves the transfer of energy to or from the airway walls to prevent or reduce airway constriction and other symptoms of lung diseases. The treatment reduces the ability of the airways to contract during an acute narrowing of the airways, reduces mucus plugging of the airways, and/or increases the airway diameter.
The methods according to the present invention pro-vide a longer duration and/or more effective treatment for lung diseases than currently used drug treatments, and obviate patient compliance issues. This also includes additional steps that reduce the ability of the lung to produce at least one of the symptoms of reversible obstructive pulmonary disease and to reduce the resistance to the flow of air through a lung.

Claims (239)

1. An energy transfer apparatus for transferring energy to or from the wall of an airway in a lung, said apparatus sized to enter a bronchus or bronchiole of a human lung and comprising:
a flexible elongated body having a proximal portion and a distal portion and at least one lumen extending therebetween;
a distally located expandable portion of said elongated body, said expandable portion comprising a plurality of legs terminating at a distal tip, said expandable portion having a first state and a radially-expanded second state, wherein said legs are shaped and dimensioned so as to contact the airway wall when said expandable portion is received in said airway and is in said second state;
at least one energy transfer element at an exterior of said expandable portion, wherein each of said energy transfer elements is configured to contact a wall of the bronchus or bronchiole when said expandable portion is in said second state;
and a deployment member configured to move said expandable portion between said first and second state, said deployment member extending at least between said expandable portion and said proximal portion of said elongated body.
2. The energy transfer apparatus of claim 1 further comprising a temperature detecting element in proximity to said expandable portion.
3. The energy transfer apparatus of claim 1 wherein said energy transferring element each comprises a radio frequency electrode configured to heat the airway tissue by delivering radio frequency energy.
4. The energy transfer apparatus of claim 3 wherein said radio frequency generating electrode is monopolar.
5. The energy transfer apparatus of claim 3 wherein said radio frequency generating electrode is bipolar.
6. The energy transfer apparatus of claim 1 wherein said energy transferring element each comprises a resistively heated element configured to conductively heat the airway tissue.
7. The energy transfer apparatus of claim 6 wherein each of said resistively heated elements are conductively attached to said expandable portion.
8. The energy transfer apparatus of claim 6 wherein said resistively heated element uses AC current.
9. The energy transfer apparatus of claim 6 wherein said resistively heated element uses DC current.
10. The energy transfer apparatus of claim 6 wherein said resistively heated element uses RF energy.
11. The energy transfer apparatus of claim 1 wherein said energy transferring elements comprise at least one resistively heated element configured to heat the airway tissue and at least one radio frequency generating electrode configured to heat the airway tissue.
12. The energy transfer apparatus of claim 1 wherein a diameter of said expandable portion in said second state is less than 15 mm, and wherein said elongated body has a diameter less than said diameter of said expandable portion in said second state.
13. The energy transfer apparatus of claim 1 wherein said expandable portion comprises pre-shaped tines configured to expand upon advancement out a sheath and contract when withdrawn into said sheath, said pre-shaped tines also having a portion which is biased against the wall of the bronchus or bronchiole when said tines are expanded.
14. The energy transfer apparatus of claim 1 wherein said expandable portion comprises a balloon member.
15. The energy transfer apparatus of claim 14 further comprising a fluid which expands said balloon member into said second state.
16. The energy transfer apparatus of claim 15 further comprising a heat generating element within said balloon member, wherein said energy transfer element comprises a surface of said balloon member, and said fluid being configured to conduct heat from said heat generating element to said surface of said balloon member.
17. The energy transfer apparatus of claim 16 further comprising at least one RF
electrode at an exterior of said balloon, said RF electrode configured to heat the airway tissue.
18. The energy transfer apparatus of claim 1 further comprising a proximal joint at an intersection of said distal portion and said expandable portion, and wherein each of said legs having a first end extending from said proximal joint and a second end terminating at a distal joint, said distal joint being adjacent to said distal tip, each of said legs further having a center section substantially parallel to said elongated body and each of said legs being spaced around a circumference of said elongated body to form. a basket.
19. The energy transfer apparatus of claim 18 wherein each said basket leg has a circular cross section.
20. The energy transfer apparatus of claim 18 wherein each said basket leg has a rectangular cross section.
21. The energy transfer apparatus of claim 18 wherein at least of one of said legs comprises an electrically conductive material, and said leg functions as said energy transfer element.
22. The energy transfer apparatus of claim 21 wherein said basket legs comprise a stainless steel alloy.
23. The energy transfer apparatus of claim 18 wherein said basket has a length from said proximal joint to said distal joint of less than 35 mm when said basket is in said first state.
24. The energy transfer apparatus of claim 18 wherein said plurality of legs consists of four legs each spaced at approximately 90 degree intervals around said elongated body.
25. The energy transfer apparatus of claim 18 wherein said plurality of legs consists of five legs each spaced at approximately 72 degree intervals around said elongated body.
26. The energy transfer apparatus of claim 18 wherein said temperature detecting element is attached to a first leg of said plurality of single legs.
27. The energy transfer apparatus of claim 26 further comprising at least one additional temperature detecting element attached said plurality of legs.
28. The energy transfer apparatus of claim 26 wherein said temperature detecting element is attached in thermal communication to said first leg by soldering, welding, adhesive bonding, or other adherents.
29. The energy transfer apparatus of claim 28 wherein said temperature detecting element is a thermocouple having a first and second leads joined separately to said first leg, each lead in electrical communication with said first leg.
30. The energy transfer apparatus of claim 18 wherein a radio frequency electrode is attached to each leg of said basket.
31. The energy transfer apparatus of claim 30 wherein said radio frequency electrode is attached to each leg of said basket by a heat shrink fastener.
32. The energy transfer apparatus of claim 31 wherein said temperature detecting element is placed between at least one of said legs and said heat shrink fastener.
33. The energy transfer apparatus of claim 18 wherein a resistively heated element is coiled around at least a portion of each legs.
34. The energy transfer apparatus of claim 33 wherein said temperature detecting element is placed between at least one of said legs and said resistively heated element.
35. The energy transfer apparatus of claim 18 wherein a polymeric heating element is on at least a portion of each basket leg.
36. The energy transfer apparatus of claim 18 wherein an electrically conductive paint covers at least a portion of each basket leg.
37 The energy transfer apparatus of claim 18 wherein a printed flex circuit is on at least a portion of each basket leg.
38. The energy transfer apparatus of claim 18 wherein said legs are joined in electrical communication at either proximal, distal, or both joints by soldering, welding, or other means.
39. The energy transfer apparatus of claim 38 wherein said distal joint further comprise an adhesive which fixedly attaches said ends of legs to said joint.
40. The energy transfer apparatus of claim 38 wherein either said proximal or distal joint not in electrical communication is adhesively bonded or thermoformed.
41. The energy transfer apparatus of claim 18 wherein said elongated body comprises a plurality of basket leg lumens, wherein each of said ends of said basket legs is placed in each lumen.
42. The energy transfer apparatus of claim 18 wherein said plurality of legs is formed from a single sheet.
43. The energy transfer apparatus of claim 42 wherein said sheet is a stainless steel material.
44. The energy transfer apparatus of claim 1 wherein said deployment member further comprises a sheath being slidably coupled and exterior to said elongated body and said expandable portion, and wherein said expandable portion is resilient and upon advancement out of said sheath said expandable member self expand into said second state.
45. The energy transfer apparatus of claim 1 wherein said deployment member is force compensated to limit a force which said expandable member can apply to the airway while in said second expanded state.
46. The energy transfer apparatus of claim 1 wherein said deployment member further comprises a deflection limiting stop to limit a size of said second state of said expandable member.
47. The energy transfer apparatus of claim 1 wherein said deployment member comprises:
a handle adjacent to a proximal end of said elongated body;
a wire extending from said handle through said lumen of said elongated body and fixedly attached to said distal tip; and and at least a first control member moveably attached to said handle.
48. The energy transfer apparatus of claim 47 wherein said elongated body is slidably attached to said handle;
said elongated body, said wire, and said distal tip are slidably moveable in distal and proximal directions; and further comprising a stop configured to prevent distal movement of said wire beyond a deployment point, wherein beyond said deployment point distal movement of said elongated body against said non-moving distal tip causes said expansion member to expand to said second state.
49. The energy transfer apparatus of claim 48 further comprising a sheath, said sheath being slidably coupled and exterior to said elongated body and said expandable portion, wherein said expandable portion advances out of a distal end of said sheath to expand to said second state.
50. The energy transfer apparatus of claim 48 wherein said first control member is configured to advance said elongated body and said wire in distal and proximal directions.
51. The energy transfer apparatus of claim 50 further comprising a detent means for maintaining said elongated body distally of said deployment point.
52. The energy transfer apparatus of claim 50 wherein said controlmember is configured to frictionally maintain said elongated body distally of said deployment point.
53. The energy transfer apparatus of claim 47 further comprising a sheath external to and covering said elongated body and said expandable portion, said sheath extending from said distal tip to said proximal portion; and wherein said handle is adjacent to a proximal end of said sheath, said sheath being slidably attached to said handle, said elongate body being rigidly attached to said handle;

said wire, and said distal tip are slidably moveable in distal and proximal directions;
said first control member being attached to said sheath, said first control member moveably secured to said handle, where distal movement of said first control member retracts said sheath distally on said elongate member uncovering said elongate member and said expandable portion; and a second control member attached to said wire, said second control member moveably secured to said handle, where distal movement of said second control member retracts said distal tip and said expandable portion against said non-moving elongated member causing said expandable portion to radially expand into said second state.
54. The energy transfer apparatus of claim 1 wherein said elongated body has a wall reinforced with a polymeric or metallic member.
55. The energy transfer apparatus of claim 1 wherein said apparatus is sized to fit within a working channel of a bronchoscope.
56. The energy transfer apparatus of claim 55 wherein a diameter of said working channel of said bronchoscope is less than or equal to 2 mm.
57. The energy transfer apparatus of claim 1 wherein said flexible elongated member has a stiffness sufficient to pass through a working channel seal of a bronchoscope.
58. The energy transfer apparatus of claim 1 wherein said distal tip is configured to minimize gouging of the airway.
59. The energy transfer apparatus of claim 58 further comprising a redundant joint attaching said distal tip to said elongated body.
60. The energy transfer apparatus of claim 58 wherein said distal tip is sized to fit within a bronchoscope.
61. The energy transfer apparatus of claim 1 wherein said deployment member comprises a wire extending from said distal tip to said proximal portion, said wire being configured to provide a current to said energy transfer elements.
62. The energy transfer apparatus of claim 1 wherein said deployment member comprises a wire extending from said distal tip to said proximal portion, said wire being configured to move said expansion portion between said first and second states.
63. The energy transfer apparatus of claim 62 wherein said wire is also configured to provide a current to said energy transfer elements.
64. The energy transfer apparatus of claim 62 wherein said temperature detecting element is attached to a portion of said wire located within said expandable portion.
65. The energy transfer apparatus of claim 1 wherein a portion of said elongated body is radiopaque.
66. The energy transfer apparatus of claim 1 further comprising a steering member configured to deflect said distal tip in a desired direction.
67. The energy transfer apparatus of claim 1 further comprising a vision member.
68. The energy transfer apparatus of claim 67 wherein said vision system comprises a fiber optic cable extending through said elongated body.
69. The energy transfer apparatus of claim 67 wherein said vision system comprises a CCD chip.
70. The energy transfer apparatus of claim 1 further comprising a power supply configured to deliver energy through said energy transfer elements to the airway walls.
71. The energy transfer apparatus of claim 70 wherein said power supply is configured to stop delivery of energy if said temperature detecting element detects a predetermined maximum temperature.
72. The energy transfer apparatus of claim 70 wherein said power supply is configured to stop delivery of energy if a predetermined temperature change is not detected within a predetermined time.
73. The energy transfer apparatus of claim 1 wherein said apparatus is sterile.
74. The energy transfer apparatus of claim 1 wherein said elongated body comprises a single tube having slits wherein an area between said slits comprises said expandable portion.
75. The energy transfer apparatus of claim 1 further comprising a proximal joint joining said distal portion of said elongated body to a proximal portion of said expandable portion.
said proximal joint being redundant.
76. The energy transfer apparatus of claim 1 wherein said energy transfer element is configured to deliver a treatment pattern selected from the group consisting of a longitudinal stripe, an axial stripe, a circumferential band, a helical stripe, a rectangular spot, an elliptical spot, and a circular spot.
77. The energy transfer apparatus of claim 1 wherein said energy transfer element is configured to produce fibrosis of the airway tissue.
78. The energy transfer apparatus of claim 1 having a plurality of energy transfer elements wherein said plurality of energy transfer elements are configured to deliver a pattern of treatment radially about a lumen of the airway.
79. The energy transfer apparatus of claim 1 further configured to produce at least one treatment pattern longer than a length of said energy transfer element.
80. The energy transfer apparatus of claim 79 wherein said apparatus is configured to be moved through a lumen of the airway while delivering treatment to the airway tissue.
81. A kit comprising an energy transfer apparatus for facilitating energy transfer into a mass of airway tissue, and a generator configured to deliver energy to said energy transfer apparatus.
82. The kit of claim 81 further comprising a bronchoscope.
83. The kit of claim 81 wherein said energy transfer apparatus is the apparatus of claim 1.
84. An energy transfer apparatus for facilitating energy transfer into a mass of airway tissue within a lung, said energy transfer apparatus having been rendered sterile for the purposes of prevention of infection of the lung.
85. A method for treating conditions of the lungs by decreasing air-way responsiveness comprising:
transferring energy to or from an airway wall to alter the airway wall in such a manner that the responsiveness of the airway is reduced.
86. The method of Claim 85, wherein the energy transfer alters the structure of the airway wall.
87. The method of Claim 85, wherein the energy transfer alters the function of the airway wall.
88. The method of Claim 85, wherein the method is used to treat asthma by preventing contraction of the airway.
89. The method of Claim 85, wherein the energy transfer alters the airway in such a manner that the ability of the airway to narrow is impaired.
90. The method of Claim 85, wherein the energy is transferred to the airway by moving an energy transfer device along the airway.
91. The method of Claim 85, wherein the energy is transferred to a portion of the airway by an energy transfer device which creates one or more energy transfer patterns.
92. The method of Claim 91, wherein the energy transfer pattern is a pattern of one or more spots having a rectangular, elliptical, circular, or other shape.
93. The method of Claim 91, wherein the energy is transferred to the airway in a band pattern covering a full diameter of the airway.
94. The method of Claim 91, wherein the energy is transferred to the airway in a pattern of at least one stripe extending along the airway in a longitudinal or helical pattern.
95. The method of Claim 85, wherein the energy is transferred to the airway at the location of an opening of an airway, a bifurcation, or an opening of a side branch.
96. The method of Claim 85, wherein the energy is transferred to the airway at a segment of the airway between bifurcations, openings, or side branches.
97. The method of Claim 85, wherein the energy is transferred to the airway by activating an energy transfer device, deactivating the energy transfer device, moving the energy transfer device, and reactivating the energy transfer device.
98. The method of Claim 85, wherein the energy transfer alters smooth muscle of the airway wall in such a manner that the responsiveness of the airway is reduced.
99. The method of Claim 98, wherein the ability of the smooth muscle to contract is altered.
100. The method of Claim 99, wherein shortening of all or some of the smooth muscle is reduced or prevented.
101. The method of Claim 98, wherein the energy transfer alters a connection between the smooth muscle and the airway wall.
102. The method of Claim 98, wherein the energy transfer eliminates at least a portion of the smooth muscle.
103. The method of Claim 98, wherein the energy transfer prevents the smooth muscle from replicating.
104. The method of Claim 85, wherein the energy transfer alters mucus producing cells or glands in the airway wall in such a manner that the responsiveness of the airway is reduced.
105. The method of Claim 104, wherein the energy transfer eliminates at least a portion of the mucus producing cells or glands.
106. The method of Claim 104, wherein the energy transfer prevents the mucus producing cells or glands from replicating.
107. The method of Claim 104, wherein the energy transfer alters the ability of the mucus producing cells or glands to produce or secrete mucus.
108. The method of Claim 85, wherein the energy transfer alters production or release of inflammatory mediators in at least a part of the airway.
109. The method of Claim 108, wherein the energy transfer prevents replication of structures producing or releasing inflammatory mediators.
110. The method of Claim 108, wherein the energy transfer eliminates at least a portion of the structures which produce or release inflammatory mediators.
111. The method of Claim 108, wherein the energy transfer alters the ability of structures in the airway to produce or release inflammatory mediators.
112. The method of Claim 85, wherein the energy transfer increases resistance to airway caliber reduction in at least a part of the airway.
113. The method of Claim 112, wherein the increased resistance is produced by thickening or fibrosing the airway wall.
114. The method of Claim 112, wherein the increased resistance is produced by increasing parenchymal tethering.
115. The method of Claim 112, wherein the increased resistance is produced by increasing connection support between the airway and support structures.
116. The method of Claim 85, wherein the energy transfer alters at least a part of the epithelium in the airway wall.
117. The method of Claim 116, wherein the energy transfer eliminates epithelium.
118. The method of Claim 116, wherein the energy transfer stimulates healing of the epithelium.
119. The method of Claim 116, wherein the energy transfer stimulates replacement of the epithelium.
120. The method of Claim 85, wherein the energy transfer alters at least a part of a submucosal layer in the airway wall.
121. The method of Claim 120, wherein the energy transfer reduces a thickness of the submucosal layer.
122. The method of Claim 85, wherein the energy transfer alters mucosal folding.
123. The method of Claim 122, wherein the structure of the airway wall is altered by increasing a number of mucosal folds or decreasing a size of mucosal folds.
124. The method of Claim 85, wherein a photodynamic agent is delivered to the airway wall and the energy transfer stimulates the photodynamic agent.
125. The method of Claim 85, wherein the airways treated are at least 1 mm in diameter.
126. The method of Claim 125, wherein the airways treated are at least 3 mm in diameter.
127. The method of Claim 85, wherein the airways treated are generations 2 through 8.
128. The method of Claim 127, wherein the airways treated are generations 2 through 6.
129. The method of Claim 85, wherein the airway treated are visualizable with a bronchoscope.
130. A method for treating conditions of the lungs by decreasing airway resistance to airflow comprising:
transferring energy to or from an airway wall to alter the airway wall in such a manner that a resistance to airflow of the airway is decreased.
131. The method of Claim 130, wherein the energy transfer alters a structure of the airway wall to increase an effective caliber of the airway.
132. The method of Claim 131, wherein the structure of the airway wall is altered by decreasing a thickness of the airway wall.
133. The method of Claim 130, wherein the energy transfer alters a function of the airway wall to increase an effective caliber of the airway.
134. The method of Claim 133, wherein the function of the airway wall is altered by reducing mucus or mucus plugging.
135. The method of Claim 133, wherein the function of the airway is altered by reducing tissue inflammation.
136. The method of Claim 135, wherein inflammation is reduced by reducing edema or healing epithelium.
137. The method of Claim 133, wherein the function of the airway wall is altered by altering a resting tone of the airway wall.
138. The method of Claim 137, wherein the resting tone is altered by altering the smooth muscle or by denervation.
139. A method for treating a lung having at least one symptom of reversible obstructive pulmonary disease comprising the steps of:

a) advancing a treatment device into the lung; and b) treating the lung with the device to at least reduce the ability of the lung to produce at least one reversible obstructive pulmonary disease symptom.
140. The method of claim 139 further comprising the steps of:
a) locating one or more treatment sites within an airway of the lung;
b) selecting at least one of the treatment sites located in said locating step; and c) wherein said treating step comprises treating the at least one treatment site selected in said selecting step.
141. The method of claim 140 wherein said steps are performed while the lung is experiencing at least one symptom of reversible obstructive pulmonary disease
142. The method of claim 140 further comprising the step of stimulating the lung to produce at least one artificially induced symptom of reversible obstructive pulmonary disease.
143. The method of claim 142 wherein said stimulating step is performed prior to said locating step.
144. The method of claim 140 wherein said locating step is performed by a non-invasive imaging technique.
145. The method of claim 144 where the non-invasive imaging technique is selected from a group consisting of a bronchography, magnetic resonance imaging, computed tomography, chest x-ray, and ventilation perfusion scans.
146. The method of claim 140 further comprising the steps of:
a) testing the lung for at least one pre-treatment pulmonary function value prior to said treating step; and b) re-testing the lung for at least one post-treatment pulmonary function value subsequent to said treating step.
147. The method of claim 146 further comprising the step of treating additional sites in the lung after said re-testing step to at least reduce the effect of at least one symptom of reversible obstructive pulmonary disease in the lung until a desired post-treatment pulmonary function value is measured.
148. The method of claim 146 further comprising the step of stimulating the lung to produce at least one artificially induced symptom of reversible obstructive pulmonary disease.
149. The method of claim 146 wherein the pulmonary function value is selected from a group consisting of FEV (forced expiratory volume), FVC (forced vital capacity), FEF
(forced expiratory flow), Vmax (maximum flow), PEFR (peak expiratory flow rate), FRC
(functional residual capacity), RV (residual volume), TLC (total lung capacity), or a combination thereof.
150. The method of claim 140 wherein said locating step comprises identifying treatment sites within the airway being susceptible to a symptom selected from the group consisting of airway inflammation, airway constriction, excessive mucous secretion, and any other symptom of reversible obstructive pulmonary disease.
151. The method of claim 150 wherein said identifying step comprises stimulating the airway to produce at least one of the symptoms to identify the treatment sites.
152. The method of claim 151 where said stimulating step comprises pharmacologically stimulating the airway.
153. The method of claim 151 where said stimulating step comprises electrically stimulating the airway.
154. The method of claim 139 further comprising the step of stimulating the lung to produce at least one artificially induced symptom of reversible obstructive pulmonary disease.
155. The method of claim 154 wherein said stimulating step comprises electrically stimulating the lung.
156. The method of claim 154 wherein said stimulating step comprises pharmacologically stimulating the lung.
157. The method of claim 154 further comprising the step of evaluating the result of said stimulating step.
158. The method of claim 157 wherein said evaluating step comprises visually evaluating the effect of said stimulating step on the airway.
159. The method of claim 157 wherein said evaluating step comprises measuring the pressure change in the lung before and after said stimulating step.
160. The method of claim 159 wherein said measuring step comprises measuring a global pressure change in the lung.
161. The method of claim 159 wherein said measuring step comprises measuring a local pressure change in an airway.
162. The method of claim 157 wherein said evaluating step comprises measuring the resistance to airflow within the lungs before and after the stimulating step.
163. The method of claim 157 wherein said evaluating step comprises measuring the electrical properties of the tissue before and after the stimulating step.
164. The method of claim 157 further comprising the step of selecting at least one treatment parameter based upon said evaluating step.
165. The method of claim 164 wherein said stimulating step, evaluating step, and selecting at least one treatment parameter step are performed subsequent to said treating step.
166. The method of claim 139 wherein said steps are performed while the lung is experiencing an attack of reversible obstructive pulmonary disease.
167. The method of claim 139 wherein said treating step comprises treating at least airway tissue within the lung, the method further comprising the step of determining the effect of the treatment by visually observing the airway for blanching of airway tissue.
168. The method of claim 167 further comprising the step of adjusting at least one treatment parameter based upon said monitoring step.
169. The method of claim 139 wherein said treating step comprises treating at least airway tissue at a treatment site within the lung, the method further comprising the step of monitoring impedance in the tissue.
170. the method of claim 169 wherein said monitoring step includes monitoring impedance at one or more points within the lung.
171. The method of claim 169 further comprising the step of adjusting at least one treatment parameter based upon said monitoring step.
172. The method of claim 139 wherein said treating step comprises treating at least airway tissue at a treatment site within the lung, the method further comprising the step of sub-mucosal sensing of the treatment to the lung tissue
173. The method of claim 172 wherein the sensing comprises non-invasive sensing.
174. The method of claim 172 wherein the sensing comprises invasive sensing.
175. The method of claim 174 wherein the invasive sensing comprises temperature, impedance, or blood flow monitoring.
176. The method of claim 139 wherein said step of treating the lung comprises depositing a radioactive substance in at least one treatment site within the lung.
177. The method of claim 139 further comprising the steps of scraping epithelial tissue from a wall of an airway within the lung prior to said treating step.
178. The method of claim 177 further comprising the step of depositing a substance on the scraped wall of the airway after said treatment step.
179. The method of claim 178 wherein said substance is epithelial tissue, collagen, growth factors, or any other tissue from the patient's body.
180. The method of claim 139 wherein said treating step comprises treating an airway wall within the lung using a modality selected from the group consisting of frequency, radioactive, and heat.
181. The method of claim 139 further comprising the step of pre-treating the lung to at least reduce the ability of the lung to produce at least one symptom of reversible obstructive pulmonary disease prior to said treating step, wherein at least one parameter of said pre-treating step is lesser than at least one parameter of said treating step.
182. The method of claim 181 wherein the pre-treating step parameter of time or temperature is less than the treating step parameter of time or temperature.
183. The method of claim 139 wherein said treating step comprises separating said treating step into stages to reduce a healing load on the lung.
184. The method of claim 183 wherein said separating step comprises treating different regions of the lung at different times.
185. The method of claim 183 wherein said separating step comprises dividing a total number of treatment sites into at a plurality of groups of treatment sites, and treating each group at a different time.
186. The method of claim 139 wherein said treating step includes sensing movement of the lung and repositioning the treatment device in response to said sensing step.
187. The method of claim 139 further comprising the step of reducing or stabilizing the temperature of lung tissue adjacent to a treatment site.
188. The method of claim 187 wherein said reducing step comprises injecting a cold fluid into lung parenchyma, the method further comprising the step of removing the fluid from the lung.
189. The method of claim 139 wherein said treating step occurs below an epithelial layer of lung tissue.
190. The method of claim 139 further comprising the step of providing drug therapy to further reduce the effects of reversible obstructive pulmonary disease or aid in the healing process from said treatment.
191. The method of claim 139 further comprising the step of providing exercise therapy to further reduce the effects of reversible obstructive pulmonary disease.
192. The method of claim 139 further comprising the step of providing respiratory therapy to further reduce the effects of reversible obstructive pulmonary disease or aid in the healing process from said treatment.
193. The method of claim 139 further comprising the step of educating a patient on reversible obstructive pulmonary disease management techniques to reduce effects of reversible obstructive pulmonary disease.
194. A method for reversing a treatment to reduce the ability of the lung to produce at least one symptom of reversible obstructive pulmonary disease comprising the step of stimulating re-growth of smooth muscle tissue in the lung.
195. The method of claim 57 wherein said stimulating step comprises electrostimulation.
196. A method of evaluating an individual having reversible obstructive pulmonary disease as a candidate for a procedure to reduce the ability of the individual's lung to produce at least one reversible obstructive pulmonary disease symptom by treating an airway within the lung of the individual, said method comprising the steps of:
(a) assessing the pulmonary condition of the individual;
(b) comparing said pulmonary condition to a corresponding predetermined state; and (c) evaluating the individual based upon said comparing step.
197. The method of claim 196 further comprising the steps of:
(a) performing pulmonary function tests on the individual to obtain at least one pulmonary function value;
(b) comparing the at least one pulmonary function value to a corresponding predetermined pulmonary function value; and (c) evaluating the individual based upon said comparing step.
198. The method of claim 197 wherein the pulmonary function value is selected from a group consisting of FEV (forced expiratory volume), FVC (forced vital capacity), FEF

(forced expiratory flow), Vmax (maximum flow), PEFR (peak expiratory flow rate), FRC
(functional residual capacity), RV (residual volume), TLC (total lung capacity), or a combination thereof.
199. The method of claim 196 further comprising the step of stimulating the lung to produce at least one artificially induced symptom of reversible obstructive pulmonary disease.
200. The method of claim 196 further comprising the step of obtaining clinical information from the individual, and wherein said evaluating step further includes accounting for the clinical information.
201. The method of claim 196 wherein said step of assessing the pulmonary condition of the individual includes determining the subtype of asthma.
202. The method of claim 201 wherein said determining said subtype of asthma includes assessing the severity of the asthma in the individual.
203. The method of claim 201 wherein said determining said subtype of asthma includes assessing a trigger that induces the asthma in the individual.
204. The method of claim 201 wherein said determining said subtype of asthma includes assessing a characteristic feature of an immune system response in the individual having asthma.
205. The method of claim 201 wherein said determining said subtype of asthma includes assessing an expression of genes controlling at least one interleukin in the individual.
206. The method of claim 196 further comprising the step of determining how the individual's tissue will react to treatment.
207. The method of claim 196 further comprising the step of feeding at least one gas into the lung where said at least one gas has properties which aid in the assessment of pulmonary function.
208. The method of claim 207 wherein the properties of each gas which aid in the assessment of pulmonary function are different.
209. The method of claim 208 wherein at least on gas comprises an inert gas.
210. The method of claim 208 where the at least one gas is selected from helium, oxygen, nitrogen, carbon monoxide, and carbon dioxide.
211. A method of evaluating the effectiveness of a procedure to reduce the ability of lung to produce at least one symptom of reversible obstructive pulmonary disease previously performed on an individual having reversible obstructive pulmonary disease, said method comprising the steps of:
(a) assessing the pulmonary condition of the individual;
(b) comparing said pulmonary condition to a corresponding predetermined state; and (c) evaluating the effectiveness of the procedure based upon said comparing step.
212. The method of claim 211 further comprising the steps of:
(a) performing pulmonary function tests on the individual to obtain at least one pulmonary function value;
(b) treating the lung to at least reduce the ability of the lung to produce at least one symptom of reversible obstructive pulmonary disease;
(c) performing post-procedure pulmonary function tests on the individual to obtain at least one post-procedure pulmonary function value; and (e) comparing the pulmonary function value with the post-procedure pulmonary function value to determine the effect of said treating step.
213. The method of claim 212 wherein the pulmonary function value is selected from a group consisting of FEV (forced expiratory volume), FVC (forced vital capacity), FEF
(forced expiratory flow), Vmax (maximum flow), PEFR (peak expiratory flow rate), FRC
(functional residual capacity), RV (residual volume), TLC (total lung capacity), or a combination thereof.
214. The method of claim 211 further comprising the step of obtaining clinical information from the individual and evaluating the comparing step with the clinical information to assess the effectiveness of the procedure.
215. The method of claim 211 further comprising the step of stimulating at least one symptom of reversible obstructive pulmonary disease before assessing said pulmonary condition and repeating stimulation before assessing said post-procedure pulmonary condition.
216. A method of increasing stiffness of an airway in a lung comprising:
inserting an energy-based apparatus into the airway; and causing trauma or damage to tissue of the airway through use of said apparatus to induce fibrosis to stiffen the airway.
217. The method of claim 216, wherein said trauma to cause fibrosis includes damaging smooth muscle tissue in the lung.
218. The method of claim 216, wherein said apparatus heats at least a portion of the lung to damage the tissue.
219. The method of claim 218, wherein said apparatus employs radio frequency energy.
220. The method of claim 218, wherein said apparatus employs microwave energy.
221. The method of claim 218, wherein said apparatus employs resistive heating.
222. The method of claim 221, wherein AC current heats the apparatus.
223. The method of claim 221, wherein DC current heats the apparatus.
224. The method of claim 216, wherein the apparatus cools at least a portion of the lung to damage the tissue.
225. The apparatus in any of the proceeding claims being slidably received within a bronchoscope.
226. The use of energy to produce a temperature variation for the therapeutic damaging of tissue of an airway in a lung to induce fibrosis to stiffen the airway.
227. The use of energy of claim 226, wherein said temperature variation is one of cooling.
228. The use of energy of claim 226, wherein said temperature variation is one of heating.
229. The use of energy of claim 228, wherein the energy used to produce the temperature variation is selected from a group of energies consisting of radio frequency, microwave and electrical current.
230. The use of energy to produce heat for the therapeutic damaging of tissue of an airway in a lung to induce fibrosis to stiffen the airway.
231. The use of energy of claim 230, wherein the energy used to produce the heat is selected from a group of energies consisting of radio frequency, microwave and electrical current.
232. The energy transfer apparatus as recited in claim 2 wherein said temperature detecting element is placed on the inside of one of said plurality of legs.
233. The energy transfer apparatus as recited in claim 29 wherein said temperature sensing detecting element is placed on the inside of one of said plurality of legs.
234. The energy transfer apparatus as recites in claim 1 wherein said elongate member is open such that fluid may flow into said lumen of said elongate member.
235. The energy transfer apparatus as recited in claim 1 wherein a diameter of said expandable portion in said second state is greater than 1 mm.
236. The energy transfer apparatus as recited in claim 1 wherein a diameter of said expandable portion in said second state is about 1.5 mm.
237. The energy transfer apparatus as recited in claim 1 wherein a diameter of said expandable portion in said second state is about 3.0 mm.
238. The energy transfer apparatus as recited in claim 12 wherein said diameter of said expandable portion in said second state is greater than 1 mm.
239. The energy transfer apparatus as recited in claim 1 wherein a ratio of a diameter of said expandable portion in said second state to a diameter of said expandable portion in said first state is between about 3/2 to about 15/2.
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US09/296,040 1999-04-21
US09/296,040 US6411852B1 (en) 1997-04-07 1999-04-21 Modification of airways by application of energy
US09/436,455 1999-11-08
US09/436,455 US7425212B1 (en) 1998-06-10 1999-11-08 Devices for modification of airways by transfer of energy
US09/535,856 US6634363B1 (en) 1997-04-07 2000-03-27 Methods of treating lungs having reversible obstructive pulmonary disease
US09/535,856 2000-03-27
PCT/US2000/010847 WO2000062699A2 (en) 1999-04-21 2000-04-21 Modification of airways by application of energy

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US8733367B2 (en) 2014-05-27
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US20060278244A1 (en) 2006-12-14
US20070062545A1 (en) 2007-03-22
AU777411B2 (en) 2004-10-14
US8534291B2 (en) 2013-09-17
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US20130211402A1 (en) 2013-08-15
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US7273055B2 (en) 2007-09-25
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US20130218158A1 (en) 2013-08-22
US7542802B2 (en) 2009-06-02
US20060278243A1 (en) 2006-12-14
US6634363B1 (en) 2003-10-21
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US20070118190A1 (en) 2007-05-24
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US8443810B2 (en) 2013-05-21

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