Devices for creating collateral channels in the lungs

• US 20020049370A1
• Filed: 07/18/2001
• Published: 04/25/2002
• Est. Priority Date: 08/05/1999
• Status: Active Grant

• Current Assignee: Broncus Medical Incorporated
• Original Assignee: Broncus Technologies, Inc
• Inventors: Tanaka, Don, Laufer, Michael D., Roschak, Ed
• Granted Patent: US 6,629,951 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 18/1445 at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 18/1815 using microwaves
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2018/00005 Cooling or heating of the probe or tissue immediately surrounding the probe
• CPC Class Codes: A61B 2018/00029 : open
• CPC Class Codes: A61B 2018/00214 : Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00273 : Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00285 : Balloons
• CPC Class Codes: A61B 2018/00541 : Lung or bronchi
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/1437 : whereby the windings of the spiral touch each other such as to create a continuous surface
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/1497 : Electrodes covering only part of the probe circumference
• CPC Class Codes: A61B 2090/08021 : of the patient or his organs
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/395 : with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 5/489 : Blood vessels
• CPC Class Codes: A61B 8/06 : Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 : Details of catheter construction
• CPC Class Codes: A61B 90/36 : Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61F 2/02 : Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/07 : Stent-grafts
• CPC Class Codes: A61F 2/20 : Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith tracheae, bronchi per se A61F2/04 ; tracheostomy tubes A61M16/0465
• CPC Class Codes: A61F 2/2412 : with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 : Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/856 : Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/90 : characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 : made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/92 : Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2002/043 : Bronchi
• CPC Class Codes: A61F 2002/8483 : Barbs
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0066 : stapled
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0058 : X-shaped
• CPC Class Codes: A61F 2230/0076 : ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61N 2007/0078 : with multiple treatment transducers

Abstract

The devices and methods disclosed herein are directed to altering gaseous flow within a lung to improve the expiration cycle of, for instance, an individual having Chronic Obstructive Pulmonary Disease. More particularly, these devices and methods produce and to maintain collateral openings or channels through the airway wall so that expired air is able to pass directly out of the lung tissue to facilitate both the exchange of oxygen ultimately into the blood and/or to decompress hyper-inflated lungs. The devices and methods also disclose locating and selecting a site for creation of a collateral opening.

FIELD OF THE INVENTION

The invention is directed to methods and devices to altering gaseous flow within a lung to improve the expiration cycle of an individual, particularly individuals having Chronic Obstructive Pulmonary Disease (COPD). More particularly, methods and devices are disclosed to produce and to maintain collateral openings or channels th rough the airway wall so that expired air is able to pass directly out of the lung tissue to facilitate both the exchange of oxygen ultimately into the blood and/or to decompress hyper-inflated lungs.

BACKGROUND OF THE INVENTION

The term “Chronic Obstructive Pulmonary Disease” (COPD) is generally used to describe the disorders of emphysema and chronic bronchitis. Previously, COPD was also known as Chronic Obstructive Lung Disease (COLD), Chronic Airflow Obstruction (CAO), or Chronic Airflow Limitation (CAL). Some also consider certain types of asthma to fall under the definition of COPD. Emphysema is characterized by an enlargement of air spaces inside the lung. Hence, Emphysema is an anatomic definition and it can only be presumed in a living patient. Chronic bronchitis is characterized by excessive mucus production in the bronchial tree. Chronic bronchitis is a clinical definition and denotes those individuals who meet criteria defining the disease. It is not uncommon for an individual to suffer from both disorders.

Claims

1. A method of improving gaseous flow within a diseased lung comprising the step of altering the gaseous flow paths within the lung.

2. The method of claim 1 wherein the step of altering the gaseous flow comprises the steps of:

selecting at least one site for collateral ventilation of the lung, and

creating at least one collateral channel in at least one of the sites.

3. The method of claim 2 further comprising the step of locating the at least one site within a portion of a natural airway of the respiratory system prior to said selecting step.

4. The method of claim 3 wherein said locating step includes visually examining the airway for dynamic airway collapse.

5. The method of claim 4 wherein visual examination of the airway is performed via a fiber optic line.

6. The method of claim 1 wherein said locating step comprises transmitting a first signal into an area of tissue, receiving a second signal, comparing said first and second signal for Doppler shifting.

7. The method of claim 6 wherein said comparing step comprises determining whether a blood vessel is present near said area of tissue.

8. The method of claim 3 wherein said locating step includes

(a) examining the lung using an imaging method selected from radiography, computer tomography, ultrasound, Doppler, MRI, PET and acoustic imaging to determine a location to alter the gaseous flow, and

(b) examining the lung using the non-invasive imaging method selected from radiography, computer tomography, ultrasound, doppler, MRI, PET and acoustic imaging to determine a number of collateral channels to be created.

9. The method of claim 8 further including the step of inserting a fluid into the airway to assist in ultrasound or doppler imaging.

10. The method of claim 3 further comprising the step of inserting an additive to enhance the visibility of the airway during the examining step.

11. The method of claim 3 wherein said locating step includes determining the degree of collateral ventilation between a plurality of air sacs of the lung in a region adjacent to the airway.

12. The method of claim 11 wherein said step of determining the degree of collateral ventilation includes:

(a) forcing a volume of a gas through the airway and into the air sacs;

(b) reducing pressure in the airway after the forcing step;

(c) determining the reduction in a diameter of the airway as a result of the reduced pressure.

13. The method of claim 12 further including the step of occluding a segment of the airway and wherein said steps of reducing pressure and determining the reduction in diameter are performed distally of the occluded segment.

14. The method of claim 11 wherein said step of determining the degree of collateral ventilation includes:

(a) occluding a segment of the airway;

(b) adding or removing gas distally of the occluded segment; and

(c) monitoring flow or pressure distally of the occluded segment.

15. The method of claim 11 wherein said step of determining the degree of collateral ventilation includes:

(a) forcing a volume of a gas within the lung near to the airway; and

(b) measuring pressure, flow, or return volume of the gas within the airway, wherein said measuring step is performed after said forcing step.

16. The method of claim 15 further including the step of occluding a segment of the airway and wherein said measuring step is performed distally of the occluded segment.

17. The method of claim 15 wherein said forcing step comprises forcing the gas through a wall of the airway directly into the air sacs.

18. The method of claim 17 further comprising the step of measuring the difference between the forced volume and the return volume to determine the degree of collateral ventilation.

19. The method of claim 3 wherein the step of selecting each of the sites comprises locating blood vessels in the region of said at least one site and selecting a site non-adjacent to any blood vessels.

20. The method of claim 19 wherein said step of locating blood vessels includes providing a remote signal to indicate the presence of any blood vessel.

21. The method of claim 19 wherein the step of locating blood vessels is performed using ultrasound.

22. The method of claim 19 further including the step of marking a location of said at least one site.

23. The method of claim 19 where said locating is conducted using an imaging method selected from radiography, computer tomography, ultrasound, doppler, acoustic, pulse oxymetry and thermal.

24. The method of claim 3 wherein the step of selecting each of the sites comprises detecting the absence of blood vessels at a particular site and selecting the site where the blood vessel is not detected.

25. The method of claim 24 wherein said step of detecting the absence of any blood vessel includes providing a remote signal to indicate the absence of any blood vessel.

26. The method of claim 24 wherein the step of detecting the absence of any blood vessels is performed using ultrasound.

27. The method of claim 3 wherein the portion of the natural airway is selected from a group consisting of bronchi, upper lobe, middle lobe, lower lobe, segmental bronchi, and bronchioles.

28. The method of claim 27 wherein the step of selecting each of the sites comprises introducing a probe into a wall of the natural airway, and detecting the presence of a blood vessel.

29. The method of claim 28 wherein said step of detecting the blood vessel includes providing a remote signal to indicate the presence or absence of any blood vessel.

30. The method of claim 27 further comprising de-laminating a blood vessel from a wall of the natural airway.

31. The method of claim 30 wherein the step of de-laminating comprises inflating a balloon within the natural airway until delamination occurs.

32. The method of claim 30 wherein the step of de-laminating comprises generating a vacuum within the natural airway to separate the wall of the natural airway from the vessel.

33. The method of claim 27 further comprising the step of pushing a blood vessel away from a wall of the natural airway prior to creating the collateral channel.

34. The method of claim 27 wherein the step of creating at least one collateral airway comprises mechanically forming the collateral channel.

35. The method of claim 34 wherein the at least one collateral channel is mechanically formed using a process selected from dilation, cutting, piercing, and bursting.

36. The method of claim 27 wherein the step of creating at least one collateral channel comprises electrically forming the collateral channel.

37. The method of claim 36 wherein the at least one collateral channel is electrically formed using RF energy.

38. The method of claim 27 wherein the step of creating at least one collateral channel comprises ultrasonically forming the collateral channel.

39. The method of claim 27 wherein the step of creating at least one collateral channel comprises forming the collateral channel using a laser.

40. The method of claim 27 wherein the step of creating at least one collateral channel comprises forming the collateral channel using microwave energy.

41. The method of claim 27 wherein the step of creating at least one collateral channel comprises chemically forming the collateral channel.

42. The method of claim 27 wherein the channel comprises an opening in the wall of the airway.

43. The method of claim 27 wherein the channel has an approximate area between 0.196 mm² to 254 mm².

44. The method of claim 27 wherein the channel extends immediately beyond an epithelial layer.

45. The method of claim 27 wherein the channel extends up to 12 cm beyond an epithelial layer.

46. The method of claim 27 wherein the channel has a shape selected from a hole, slit, skive, tear, and partially removed flap.

47. The method of claim 27 wherein the channel comprises a periphery of the wall of the airway wall that is removed.

48. The method of claim 27 further comprising the step of applying a glue in proximity to the at least one site for collateral ventilation.

49. The method of claim 27 further comprising the step of delivering steroids to the lung.

50. The method of claim 27 wherein the step of creating the at least one collateral channel comprises making an incision in a wall of the natural airway, placing the wall of the natural airway in tension, advancing a blunt instrument into the incision.

51. The method of claim 27 wherein the step of altering includes the step of inserting conduits having various cross-sectional areas in discrete areas of the lung to improve gaseous flow.

52. The method of claim 27 wherein the step of creating at least one collateral channel comprises inserting a conduit within a wall of the natural airway.

53. The method of claim 27 further comprising the step of inserting at least one conduit within each of the collateral channels.

54. The method of claim 53 wherein each of said conduit has a length to a diameter ratio of 1:

1.

55. The method of claim 53 wherein the conduit is comprised of a material selected from the group consisting of elastomers, polymers, metals, metal alloys, shape memory alloys, and shape memory polymers.

56. The method of claim 53 wherein the conduit has a wall extending between a proximal end and a distal end, the wall forming a lumen, and where the conduit is inserted so the lumen extends longitudinally with the collateral channel.

57. The method of claim 56 wherein the conduit has at least one opening within a wall of the conduit.

58. The method of claim 53 wherein the conduit is removable from the body.

59. The method of claim 1 where the altering step comprises collaterally ventilating the lung by forming at least one opening in a natural airway wall within said lung that is in fluid communication with lung tissue.

60. The method of claim 59 further comprising the step of folding tissue through the opening in the airway wall.

61. The method of claim 59 further comprising the step of placing a bioabsorbable material in the opening to maintain patency of the opening.

62. The method of claim 61 wherein the bioabsorbable material comprises small intestine submucosa.

63. The method of claim 65 wherein said preserving step comprises cooling the tissue adjacent to the opening.

64. The method of claim 59 wherein said step of forming at least one opening comprises creating at least one section of airway wall tissue and folding the flap through the opening.

65. The method of claim 1 where the altering step comprises promoting flow through parenchymal inter-conduits.

66. The method of claim 1 where the altering step comprises bypassing restricted airways.

67. The method of claim 1 where the altering step comprises making an inspiratory path different from an expiratory path within the lung.

68. The method of claim 1 where the altering step comprises promoting patency and gaseous flow within at least one natural airway by relieving pressure external to a wall of at least that area.

69. The method of claim 1 where the altering step comprises creating at least one secondary artificial airflow path parallel to at least one natural airflow path.

70. The method of claim 1 where the altering step comprises increasing a cross-sectional area of an airflow at a treatment site.

71. A device for altering gaseous flow in a diseased lung comprising a locator for locating at least one site for creating a collateral channel in the lung.

72. The device of claim 71 further comprising a means for creating at least one collateral channel in the at least one site.

73. The device of claim 72 further comprising a means for coagulating blood upon entry into a blood vessel.

74. The device of claim 72 wherein said means for locating comprises a probe configured to puncture a wall of an airway within the lung and detect the presence of blood.

75. The device of claim 72 wherein the means for creating the at least one collateral channel uses a forming device selected from a group consisting of mechanical, electrical, laser, ultrasonic, microwave energy, and chemical.

76. The device of claim 75 wherein the forming device is electrical and uses RF energy.

77. The device of claim 75 further including a means for stopping the forming device upon contact with a blood vessel.

78. The device of claim 72 wherein the means for creating the at least one collateral channel uses a forming device comprises means capable of performing steps selected from dilation, cutting, piercing, and bursting.

79. The device of claim 72 wherein the device comprises a means for simultaneously creating a plurality of collateral channels.

80. The device of claim 72 wherein said locator includes a gas delivery member terminating at a distal end of the device, said delivery member being configured to transfer a volume of a gas to an air sac of the diseased lung.

81. The device of claim 80 further comprising a probe located at the distal end of the device configured to collect or transfer data within the lung.

82. The device of claim 80 where said probe collects data on pressure, volume, or flow rate of the gas within the airway.

83. The device of claim 80 wherein said device further comprises an expandable member at said distal end, said expandable member being proximal to said probe, said expandable member configured to sealingly occlude the airway while permitting said probe to extend proximally through said expandable member.

84. The device of claim 80 wherein said delivery member is configured to pass through a wall of the airway to force the gas directly into air sacs.

85. The device of claim 72 wherein said locator includes an expandable member located at a distal end of the device, said expandable member configured to sealingly occlude the airway, and a passageway extending from a proximal end of the device through said expandable member to a distal end of the device, said passageway being in fluid communication with said airway.

86. The device of claim 72 wherein locator includes a visualizing means for viewing an airway in the lung.

87. The device of claim 86 wherein said visualizing means comprises a fiber optic cable.

88. The device of claim 72 further comprising a means for marking the at least one site.

90. The medical device of claim 89 wherein said transducer assembly is adapted to generate said source signal and receive said reflected signal over a substantial portion of said tip.

91. The medical device of claim 90 wherein said transducer assembly comprises an ultrasound transducer and wherein said tip of said transducer assembly comprises a signal interfering medium, said transducer and said signal interfering medium being in acoustical communication, and wherein said source and said reflected signals are ultrasound signals.

92. The medical device of claim 91 wherein said signal interfering medium comprises an acoustic lens having an inner surface and an outer surface, said lens inner surface being in at least acoustical communication with said ultrasound transducer, wherein when said transducer generates said source signal said lens refracts and disperses said source signal substantially about said outer surface of said lens, and when said outer surface receives said reflected signal, said lens refracts said reflected signal towards said transducer.

93. The medical device of claim 91 wherein said signal interfering medium comprises a hemispherical outer surface.

94. The medical device of claim 91 wherein said signal interfering medium comprises a oblate spheroid shaped outer surface.

95. The medical device of claim 91 wherein said signal interfering medium comprises a prolate spheroid shaped outer surface.

96. The medical device of claim 91 wherein said signal interfering medium comprises a cone shaped outer surface.

97. The medical device of claim 89 wherein said tip comprises a hemispherical shaped ultrasound transducer.

98. The medical device of claim 89 wherein said elongate member has a joint between said proximal and distal ends, said joint adapted to permit a first portion of said device defined from said joint to said tip to form an angle with a second portion of said elongate member defined from said joint to said proximal end of said elongate member.

99. The medical device of claim 89 wherein at least a portion of said elongate member further comprises a reinforcing member.

100. The medical device of claim 89 wherein said reinforcing member comprises a braid.

101. The medical device of claim 89 wherein said hole-making assembly is adapted to mechanically create an opening in tissue.

102. The medical device of claim 89 further comprising a source of RF energy in electrical communication with said hole-making assembly, and wherein said hole-making assembly is configured to make holes using RF energy.

103. The medical device of claim 102 further comprising a heat sink adjacent to said hole-making assembly.

104. The medical device of claim 102 wherein said elongate member further comprises a fluid dispensing assembly adjacent to said hole-making assembly.

105. The medical device of claim 102 wherein said hole-making assembly comprises a first conductive portion on said tip, wherein said first conductive portion functioning as a first RF electrode.

106. The medical device of claim 105 further comprising a second conductive portion on said tip, said second conductive portion functioning as a second RF electrode, said second conductive portion being insulated from said first conductive portion.

107. The medical device of claim 106 wherein said first conductive portion and said second conductive portion extend spirally along said tip.

108. The medical device of claim 105 wherein said transducer assembly comprises an ultrasound transducer and said tip comprises an acoustic lens, wherein said transducer assembly and said lens are in acoustic communication, said transducer assembly adapted to generate said source signal and receive said reflected signal, wherein said lens is separated from said transducer by a separation medium, said separation medium being adapted to transmit ultrasound energy.

109. The medical device of claim 105 wherein said transducer assembly further comprises a transducer adapted to generate said source signal and receive said reflected signal wherein said conductive distal surface of said transducer assembly and said transducer are moveable relative to each other.

110. The medical device of claim 102 wherein said hole-making assembly further comprises a conductive wire-like member extending away from said elongate member.

111. The medical device of claim 110 wherein said wire-like member is retractable into said elongate member.

112. The medical device of claim 102 wherein said hole-making assembly further comprises a conductive member located on a surface of said elongate member.

113. The medical device of claim 102 wherein said hole-making assembly further comprises a conductive member located coaxially about said transducer assembly, and wherein said transducer assembly is axially moveable within said conductive member.

114. The medical device of claim 102 wherein said hole-making assembly further comprises an electrode extending from a side of said elongate member adjacent to said distal end.

115. The medical device of claim 114 wherein said elongate member is conductive and said electrode is a protrusion integral with said elongate member, wherein said elongate member is covered with an insulative covering.

116. The medical device of claim 114 wherein said electrode is a spherical member which is retractable into said elongate member.

117. The medical device of claim 102 further comprising an RF energy source.

118. The medical device of claim 89 further comprising an ultrasound device capable of triggering said source signal and detecting said reflected signal.

119. The medical device of claim 118 wherein said ultrasound device is further capable of detecting a Doppler shift between said source and said reflected signal.

120. The medical device of claim 89 wherein said device is configured to fit within a working channel of an endoscope.

122. The medical device of claim 121 wherein at least said outer surface of acoustic lens is hemispherical.

123. The medical device of claim 121 wherein at least said outer surface of acoustic lens is oblate spheroid shaped.

124. The medical device of claim 121 wherein at least said outer surface of acoustic lens is prolate spheroid shaped.

125. The medical device of claim 121 wherein at least said outer surface of acoustic lens is cone shaped.

126. The medical device of claim 121 wherein said transducer assembly is further adapted to produce therapeutic ultrasound to create openings in or mark tissue.

127. The medical device of claim 126 wherein said transducer assembly is adapted to produce a high energy ultrasound to create openings in tissue.

128. The medical device of claim 121 wherein said elongate member has a joint between said proximal and distal ends, said joint adapted to permit a first portion of said device defined from said joint to said tip to form an angle with a second portion of said elongate member defined from said joint to said proximal end of said elongate member.

129. The medical device of claim 121 wherein at least a portion of said elongate member comprises a support member.

130. The medical device of claim 129 wherein said support member is a braid.

132. The medical device of claim 131 wherein said body of said dilating member has at least two regions of varying diameter.

133. The medical device of claim 131 wherein said heating element comprises a plurality of conductive windings about a surface of said dilating member.

134. The medical device of claim 131 wherein said heating element comprises a resistive wire wrapped about a surface of said dilating member.

135. The medical device of claim 131 further comprising a heat sink adjacent to said body of said dilating member, said heat sink having a first profile extending radially farther from said elongate member than said dilating member.

136. The medical device of claim 135 wherein said heat sink comprises an expandable balloon.

137. The medical device of claim 136 wherein said expandable balloon contains saline.

138. The medical device of claim 131 wherein said elongate member further comprises a fluid dispensing assembly adjacent to said body of said dilating member.

139. The medical device of claim 138 wherein said fluid dispensing assembly is adapted to spray a fluid about and away from said dilating member.

141. The conduit of claim 140 wherein said center section is radially expandable away from said central axis to allow said center section to assume an expanded profile from a reduced profile.

142. The conduit of claim 141 wherein a length of said center section is less than twice the square root of a cross sectional area of said center section when said center section is in said expanded profile.

143. The conduit of claim 141 wherein a length of said center section measured along said central axis decreases as said center section expands from said reduced profile to said expanded profile.

144. The conduit of claim 141 wherein said center section is spring biased to assume said expanded profile.

145. The conduit of claim 140 where said extension members extending from said first end of said conduit are longer than said extension members extending from a second end of said conduit.

146. The conduit of claim 140 wherein said at least one extension member comprises a plurality of extension members extending from each end of said center section, said extension members arranged around a circumference of said center section.

147. The conduit of claim 140 wherein said center section comprises a mesh formed from a plurality of ribs.

148. The conduit of claim 147 further comprising a coating about said center section adapted to preventing tissue from extending through said mesh.

149. The conduit of claim 140 wherein said conduit is fully coated.

150. The conduit of claim 140 further comprising a fluid-tight cover about said center section of said conduit.

151. The conduit of claim 140 further comprising a fluid-tight cover about a portion of said conduit containing said extension members.

152. The conduit of claim 140 further comprising a fluid-tight cover about an entirety of said conduit.

153. The conduit of claim 140 wherein said center section comprises a rolled sheet of material, wherein said extension members are extend from a first and a second end of said sheet.

154. The conduit of claim 140 wherein said passageway has a cross sectional area between 0.196 mm² to 254 mm².

155. The conduit of claim 140 wherein said passageway has a cross sectional area between 3 mm² to 20 mm²

156. The conduit of claim 140 wherein said conduit has an asymmetrical profile.

157. The conduit of claim 140 wherein said conduit has a ratio of a length to a diameter of approximately 1:

1.

158. The conduit of claim 140 wherein said conduit comprises a material selected from a group consisting of elastomers, metals, metal alloys, polymers, shape memory alloys, and shape memory plastics.

159. The conduit of claim 140 further comprising a self-cleaning mechanism within said passageway.

160. The conduit of claim 159 wherein said self-cleaning mechanism is a ball bearing shaker valve.

161. The conduit of claim 140 further comprising a one-way valve located within said passageway.

162. The conduit of claim 140 further comprising a gas-permeable bacterial-resistant barrier located within said passageway.

164. The implant of claim 163 wherein said conduit is sized to fit an airway selected from the group consisting of a trachea, a bronchus, and a bronchiole.

165. The implant of claim 163 wherein said conduit has a lumen having a substantial cross-sectional area between 0.196 mm² to 254 mm².

166. The implant of claim 163 wherein said conduit has an asymmetrical profile.

167. The implant of claim 163 wherein said conduit has a ratio of a length to a diameter of approximately 1:

1.

168. The implant of claim 163 wherein said conduit is removable.

169. The implant of claim 163 comprising a material selected from a group consisting of elastomers, metals, metal alloys, polymers, shape memory alloys, and shape memory plastics.

170. The implant of claim 163 wherein said conduit further comprises a wall extending from a distal end and a proximal end, where the wall is gas permeable.

171. The implant of claim 163 further comprising a barrier layer extending from a distal end to a proximal end to define a lumen, said barrier layer being sufficiently non-porous to prevent the tissue from entering the lumen.

172. The implant of claim 163 further comprising an anchor located at an end of said conduit, said anchor having a diameter decreasing in a direction away from said conduit to prevent dislodging of said conduit from the airway wall, and said anchor having at least one ventilation opening.

173. The implant of claim 172 wherein said anchor has an internal thread to receive an external thread of said conduit.

174. The implant of claim 163 wherein said conduit has an opening in a wall of said conduit.

177. The kit of claim 176 wherein said delivery catheter further comprises an an ultrasound transducer assembly for transmitting and receiving an ultrasound signal, and a hole-making assembly for creating a collateral channel.

178. The kit of claim 177 wherein said hole-making assembly uses RF energy and further comprising a RF energy supply.

179. The kit of claim 177 further comprising an ultrasound device capable of detecting an ultrasound signal and determining a Doppler shift between a transmitted signal and a reflected signal.

181. The method of claim 180 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), PFER (peak expiratory flow rate), FRC (functional residual capacity), RV (residual volume), TLC (total lung capacity), or a combination thereof.

182. The method of claim 180 further comprising the step of obtaining clinical information from the individual, and wherein said assigning step further includes accounting for the clinical information to assign the rating.

183. The method of claim 182 further comprising the step of using imaging to identify an amount of the lung that is hyper-inflated, and wherein said assigning step further includes accounting for the amount of the lung that is hyper-inflated to assign the rating.

185. The method of claim 184 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), PFER (peak expiratory flow rate), FRC (functional residual capacity), RV (residual volume), TLC (total lung capacity), or a combination thereof.

89. A medical device for detecting motion within tissue by observing a Doppler shift and for creating channels in tissue, the medical device comprising:

a flexible elongate member having a proximal end and a distal end;

a transducer assembly adapted to generate a source signal and receive a reflected signal, a portion of said assembly located adjacent to said distal end of said elongate member, said transducer assembly comprising a tip located at said distal end of said medical device, said tip being distal to said elongate member; and

a hole-making assembly located adjacent to said transducer assembly.

121. A medical device for detecting blood vessels within tissue by observing a Doppler shift, the medical device comprising:

a flexible elongate member having a proximal end and a distal end;

a transducer assembly adapted to generate a source signal and receive a reflected signal, a portion of said transducer assembly located adjacent to said distal end of said elongate member, said transducer assembly comprising at least one an ultrasound transducer and an acoustic lens, said transducer located adjacent to said elongate member and adapted to generate said source signal and to receive said reflected signal, said acoustic lens located distally of said elongate member and comprising a tip of said device, said lens having an inner surface and an outer surface, said lens inner surface being in at least acoustic communication with said transducer, wherein when said transducer generates said source signal said lens refracts and disperses said source signal substantially about said outer surface of said lens, and when said outer surface receives said reflected signal, said lens refracts said reflected signal towards said transducer.

131. A medical device for creating an opening in tissue within the lungs and applying heat to the opening, said medical device comprising:

an elongate member having a proximal end and a distal end and at least one lumen extending therebetween, said elongate member including a reinforcing member extending through at least a portion of said elongate member, said reinforcing member adapted to increase an axial compressive strength of said elongate member;

a dilating member having a body extending from a distal end of said elongate member and a tapered end opposite to said elongate member;

a heating element affixed to said dilating member, said heating element adapted to heat said dilating member.

140. A conduit for maintaining the patency of an opening in tissue comprising:

a center section having a first end and a second end and a central axis extending between said ends, a passageway within said center section extending between said ends; and

at least one extension member extending from each end of said center section, each said extension member having a free end extending away from said center section, each of said extension members being parallel to said central axis of said center section, each of said free ends of said extension members being moveable such that said extension member may bend about said respective end of said center section.

163. An implantable device comprising a conduit for placement in a collateral channel within a diseased lung comprising a means for maintaining a gas passageway between parenchymal tissue and a natural airway within the lung.

175. A catheter for deploying a conduit within an airway in a lung comprising:

a flexible elongate portion having a distal end and a proximal end;

at least one lumen extending between said distal and proximal ends; and

an hour-glass shaped balloon located adjacent to said distal end, said balloon having a first portion, a second portion, and a third portion, wherein said first and second portions are capable of expanding to a greater diameter than said second portion.

176. A kit for maintaining the patency of an opening in tissue comprising:

a conduit comprising a tubular center section having a first end and a second end and a central axis extending between said ends, said center section comprising a mesh formed from a plurality of ribs, a plurality of extension members having a free end extending from each end of said center section, said extension members arranged around a circumference of said center section, each of said free ends of said extension members being independently moveable in a direction orthogonal to said central axis to form an angle with said central axis; and

a delivery catheter.

180. A method of evaluating an individual having a diseased lung as a candidate for a procedure to create collateral channels within an airway of the individual, said method 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 to a corresponding predetermined pulmonary function value;

(c) assigning a rating to the individual based upon said comparing step; and

(d) evaluating the individual based upon the rating.

184. A method of determining the effectiveness of a procedure to improve gaseous flow within a diseased lung, said method comprising the steps of:

(a) performing pulmonary function tests on the individual to obtain at least one pulmonary function value;

(b) creating collateral channels within the lung;

(c) performing post procedure pulmonary function tests on the individual to obtain at least one post-procedure pulmonary function value; and

(d) obtaining clinical information from the individual;

(e) comparing the pulmonary function value with the post-procedure pulmonary function value to determine the effect of creating collateral ventilation; and

(f) evaluating the comparing step with the clinical information to assess the effectiveness of the procedure to improve gaseous flow within the diseased lung.

186. A modified respiratory airway having an artificially created channel allowing gaseous communication between an exterior of the airway and an interior of the airway.