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

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.

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. 
   
   
       12 . (canceled) 
   
   
       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. 
   
   
       15 . (canceled) 
   
   
       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. 
   
   
       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.   
   
   
       28 . (canceled) 
   
   
       29 . (canceled) 
   
   
       30 . (canceled) 
   
   
       31 . (canceled) 
   
   
       32 . (canceled) 
   
   
       33 . (canceled) 
   
   
       34 . (canceled) 
   
   
       35 . (canceled) 
   
   
       36 . (canceled) 
   
   
       37 . (canceled) 
   
   
       38 . (canceled) 
   
   
       39 . (canceled) 
   
   
       40 . (canceled) 
   
   
       41 . (canceled) 
   
   
       42 . (canceled) 
   
   
       43 . (canceled) 
   
   
       44 . (canceled) 
   
   
       45 . (canceled) 
   
   
       46 . (canceled) 
   
   
       47 . (canceled) 
   
   
       48 . (canceled) 
   
   
       49 . (canceled) 
   
   
       50 . (canceled) 
   
   
       51 . (canceled) 
   
   
       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. 
   
   
       54 . (canceled) 
   
   
       55 . The method of  claim 53  wherein the substances are one or more of antibiotics, inflammatory and anti-inflammatory agents. 
   
   
       56 . (canceled) 
   
   
       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. 
   
   
       63 . (canceled) 
   
   
       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. 
   
   
       81 . (canceled) 
   
   
       82 . (canceled) 
   
   
       83 . (canceled) 
   
   
       84 . (canceled) 
   
   
       85 . (canceled) 
   
   
       86 . (canceled) 
   
   
       87 . (canceled) 
   
   
       88 . (canceled) 
   
   
       89 . (canceled) 
   
   
       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. 
   
   
       94 . (canceled) 
   
   
       95 . (canceled) 
   
   
       96 . (canceled) 
   
   
       97 . (canceled) 
   
   
       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. 
   
   
       104 . (canceled) 
   
   
       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. 
   
   
       115 . (canceled) 
   
   
       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. 
   
   
       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. 
   
   
       122 . (canceled) 
   
   
       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. 
   
   
       130 . (canceled) 
   
   
       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. 
   
   
       133 . (canceled) 
   
   
       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. 
   
   
       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.   
   
   
       148 . (canceled) 
   
   
       149 . (canceled) 
   
   
       150 . (canceled) 
   
   
       151 . (canceled) 
   
   
       152 . (canceled) 
   
   
       153 . (canceled) 
   
   
       154 . (canceled) 
   
   
       155 . (canceled) 
   
   
       156 . (canceled)