Biliary Shunts, Delivery Systems, Methods of Using the Same and Kits Therefor

• US 20090143713A1
• Filed: 11/25/2008
• Published: 06/04/2009
• Est. Priority Date: 11/30/2007
• Status: Abandoned Application

• Current Assignee: Treus Medical, Inc.
• Original Assignee: Treus Medical, Inc.
• Inventors: Milroy, J. Craig, Van Dam, Jacques, Ohline, R. Matthew
• Application Number:
  US12/277,491
• Publication Number:
  US 20090143713A1
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2002/041 Bile ducts
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

The application discloses devices, systems, kits and methods for treating biliary disease. Device comprise, for example, a component configured for deployment between a gallbladder and location within a gastrointestinal tract of a patient which has a proximal end and a distal end with a lumen extending therethrough. A method of deploying the device can be achieved by, for example, creating a duct or fistula between a gallbladder lumen and a portion of a gastrointestinal tract; and providing for drainage from the gallbladder to the gastrointestinal tract.

Claims

1. A device for treating biliary disease comprising:

a component configured for deployment between a gallbladder and a location within a gastrointestinal tract of a patient, the component having a proximal end and a distal end with a lumen extending therethrough.

2. The device of claim 1 wherein a conduit is formed between a gallbladder lumen and a target location within the gastrointestinal tract.

3. The device of claim 2 wherein the target location within the gastrointestinal tract is proximal to a duodenum.

4. The device of claim 1 wherein the device is formed from a bioresorbable material.

5. The device of claim 1 wherein the device is removable.

6. The device of claim 1 wherein the device is expandable.

7. The device of claim 1 further comprising one or more configurations selected from a deployment configuration, a delivery configuration and a final configuration.

8. The device of claim 7 further comprising a variable profile.

9. The device of claim 1 wherein a cross-sectional area of the device is variable along a length.

10. The device of claim 1 wherein the device is configured for deployment by at least one of an endoscope, a needle, a guidewire, a guidance catheter and a dilatation catheter.

11. The device of claim 1 further comprising a flareable end.

13. The device of claim 1 further comprising a configurable retainable feature.

14. The device of claim 1 wherein the component has one or more clips configured to secure the component at one or more positions.

16. The device of claim 1 wherein the lumen is configurable to provide restrictable fluid flow.

17. The device of claim 16 further comprising one or more fluid control components.

18. The device of claim 1 further comprising an enlargeable portion comprising two or more legs.

19. The device of claim 1 further comprising a valve.

20. The device of claim 19 wherein the valve is at least one of a flow-restrictor and a one-way valve.

21. The device of claim 1 wherein the device is flexible.

22. The device of claim 1 wherein the device is an elongate tube adapted and configured to extend into the gastrointestinal tract.

23. The device of claim 22 wherein the tube is patent at a first end.

24. The device of claim 23 wherein the patent first end is adjacent the gallbladder.

25. The device of claim 22 wherein the tube is not patent at a second end.

26. The device of claim 22 wherein the tube has an adjustable length.

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27. A biliary disease treatment device comprising:

an implant adapted to be delivered by an endoscope to a gastrointestinal site in proximity to a gallbladder, and further adapted to form a conduit between the gastrointestinal site and the gallbladder.

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52. A method for treating biliary disease comprising:

a. creating a duct or fistula between a gallbladder lumen and a portion of a gastrointestinal tract; and

b. providing for drainage from the gallbladder to the gastrointestinal tract.

53. The method of claim 52 further comprising the step of delivering a substance to the gallbladder via the duct.

55. The method of claim 53 wherein the substances are one or more of antibiotics, inflammatory and anti-inflammatory agents.

57. The method of claim 52 further comprising the step of localizing the gallbladder via endoscopic ultrasound.

58. The method of claim 52 further comprising the step of accessing the gallbladder via the gastrointestinal tract.

59. The method of claim 58 wherein the step of accessing is performed in the gastrointestinal tract at a duodenum.

60. The method of claim 52 further comprising the step of removing gallstones.

61. The method of claim 52 further comprising the step of altering gallstones.

62. The method of claim 61 further comprising the step of removing the altered gallstones.

64. The method of claim 52 further comprising the step of delivering a device to the gallbladder through the created duct.

65. The method of claim 64 wherein the delivered device is one or more of a stent, a drug-coated stent, and a catheter.

66. The method of claim 52 wherein the biliary disease is treated without removal of the gallbladder.

67. The method of claim 52 further comprising the step of visualizing a treatment area.

68. The method of claim 52 wherein the step of creating the duct further comprises the step of inserting a device in communication between the gastrointestinal tract and the gallbladder lumen.

69. The method of claim 52 wherein the step of creating the duct between a gallbladder lumen and a portion of a gastrointestinal tract comprises the step of inserting a conduit between the gallbladder lumen and the portion of the intestinal tract.

70. The method of claim 69 further comprising the step of forming a biological duct in situ from a patient'"'"'s tissue.

71. The method of claim 70 wherein the step of inserting a conduit between the gallbladder lumen and the portion of the gallbladder tract occurs at a first time and the step of forming the biological duct in situ from the patient'"'"'s tissue occurs at a second time remote from the first time.

72. The method of claim 52 further comprising the step of anchoring the device in place.

73. The method of claim 52 further comprising the step of changing the device from a delivery configuration to a deployment configuration.

74. The method of claim 52 further comprising the step of changing the device from a delivery configuration to a final configuration.

75. The method of claim 52 further comprising the step of changing the device from a deployment configuration to a final configuration.

76. The method of claim 52 further comprising the step of reducing a cross-sectional profile of the device.

77. The method of claim 52 further comprising the step of delivering the device via at least one of an endoscope, a needle, a guidewire, a guidance catheter and a dilatation catheter.

78. The method of claim 52 further comprising the step of providing a seal to prevent fluid from leaking into a peritoneum.

79. The method of claim 52 further comprising the step of restricting fluid flow from the gallbladder lumen to the gastrointestinal tract.

80. The method of claim 79 further comprising the step of operating a valve to restrict fluid flow.

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90. A method of delivering a device to treat biliary disease comprising:

a. using an endoscope to place at least one of a guidewire, a needle, a guidance catheter, and a dilatation catheter between an access lumen in a body and a gallbladder;

b. inserting a delivery catheter over the at least one of guidewire, needle, guidance catheter, and dilatation catheter and into the gallbladder;

c. delivering a conduit on the catheter; and

d. positioning the conduit between the access lumen in the body and the gallbladder to create a lumen therebetween.

91. The method of claim 90 further comprising the step of passively retaining a distal end of the guidewire in the gallbladder while the guidewire is used to deliver additional elements.

92. The method of claim 90 further comprising the step of retaining a distal end of the guidewire within the gallbladder.

93. The method of claim 90 further comprising the step of removing gallstones through the created lumen.

98. The method of claim 90 further comprising the step of localizing the gallbladder via endoscopic ultrasound.

99. The method of claim 90 further comprising the step of accessing the gallbladder via the gastrointestinal tract.

100. The method of claim 99 wherein the step of accessing is performed in the gastrointestinal tract at a duodenum.

101. The method of claim 90 further comprising the step of removing gallstones.

102. The method of claim 90 further comprising the step of altering gallstones.

103. The method of claim 102 further comprising the step of removing the altered gallstones.

105. The method of claim 90 wherein the delivered conduit is one or more of a stent, and a drug-coated stent.

106. The method of claim 90 wherein the biliary disease is treated without removal of the gallbladder.

107. The method of claim 90 further comprising the step of visualizing a treatment area.

108. The method of claim 90 further comprising the step of forming a biological duct in situ from a patient'"'"'s tissue.

109. The method of claim 108 wherein the step of positioning the conduit occurs at a first time and the step of forming the biological duct in situ from the patient'"'"'s tissue occurs at a second time remote from the first time.

110. The method of claim 90 further comprising the step of anchoring the conduit in place.

111. The method of claim 90 further comprising the step of changing the conduit from a delivery configuration to a deployment configuration.

112. The method of claim 90 further comprising the step of changing the conduit from a delivery configuration to a final configuration.

113. The method of claim 90 further comprising the step of changing the conduit from a deployment configuration to a final configuration.

114. The method of claim 90 further comprising the step of reducing a cross-sectional profile of the conduit.

116. The method of claim 90 further comprising the step of restricting fluid flow from the gallbladder lumen to the gastrointestinal tract.

117. The method of claim 116 further comprising the step of operating a valve to restrict fluid flow.

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118. A system for treating biliary disease comprising a device for configuring a duct between a gallbladder and a gastrointestinal tract of a patient having a proximal end and a distal end with a lumen extending therethrough between.

119. The system of claim 118 further comprising a delivery mechanism for delivering a substance.

120. The system of claim 118 wherein a conduit is formed between a gallbladder lumen and a target location within the gastrointestinal tract.

121. The system of claim 120 wherein the target location within the gastrointestinal tract is proximal to a duodenum.

123. The system of claim 118 wherein the device is removable.

124. The system of claim 118 wherein the device is expandable.

125. The system of claim 118 further comprising one or more configurations selected from a deployment configuration, a delivery configuration and a final configuration.

126. The system of claim 125 further comprising a variable profile.

127. The system of claim 118 wherein a cross-sectional area of the device is variable along a length.

128. The system of claim 118 wherein the device is configured for deployment by at least one of an endoscope, needle, guidewire, guidance catheter and a dilatation catheter.

129. The system of claim 118 further comprising a flareable end.

131. The system of claim 118 further comprising a configurable retainable feature.

132. The system of claim 118 wherein the component has one or more clips configured to secure the component at one or more positions.

134. The system of claim 118 wherein the lumen is configurable to provide restrictable fluid flow.

135. The system of claim 134 further comprising one or more fluid control components.

136. The system of claim 118 further comprising an enlargeable portion comprising two or more legs.

137. The system of claim 118 further comprising a valve.

138. The system of claim 137 wherein the valve is at least one of a flow-restrictor or one-way valve.

139. The system of claim 118 wherein the device is flexible.

140. The system of claim 118 wherein the device is an elongate tube adapted and configured to extend into the gastrointestinal tract.

141. The system of claim 140 wherein the tube is patent at a first end.

142. The system of claim 141 wherein the patent first end is adjacent the gallbladder.

143. The system of claim 140 wherein the tube is not patent at a second end.

144. The system of claim 140 wherein the tube has an adjustable length.

145. The system of claim 118 further comprising an endoscope.

146. The system of claim 145 wherein the endoscope further comprises an ultrasound device.

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147. A kit for treating biliary disease comprising:

(a) a duct forming component positioned between a gallbladder and a gastrointestinal tract; and

optionally

(b) a compound for delivery to a tissue.

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