Methods, Devices, Kits and Systems for Defunctionalizing the Cystic Duct

Abstract

The application discloses devices, systems, kits and methods for treating biliary disease. Devices comprise, for example, a component configurable for deployment between within a cystic duct of a patient which has a proximal end and a distal end. In some embodiments, a lumen may also extend therethrough.

1 . A device for treating biliary disease comprising: a component configurable for placement within a cystic duct of a biliary system of a patient which has a proximal end and a distal end. 
   
   
       2 . The device of  claim 1  further comprising a delivery mechanism for delivering a substance. 
   
   
       3 . The device of  claim 1  wherein the device is formed from at least one of a bioresorbable material or an activatable material. 
   
   
       4 . The device of  claim 1  wherein the device is removable. 
   
   
       5 . The device of  claim 1  wherein the device is expandable. 
   
   
       6 . The device of  claim 1  further comprising one or more configurations selected from a deployment configuration, a delivery configuration and a final configuration. 
   
   
       7 . The device of  claim 6  further comprising a variable profile. 
   
   
       8 . The device of  claim 1  wherein a cross-sectional area of the device is variable along a length. 
   
   
       9 . The device of  claim 1  wherein the device is configurable for deployment by an endoscope. 
   
   
       10 . The device of  claim 1  wherein the device is configurable for deployment by a guidance element. 
   
   
       11 . The device of  claim 1  wherein a lumen is provided that is configurable to provide restrictable fluid flow. 
   
   
       12 . The device of  claim 10  further comprising one or more fluid control components. 
   
   
       13 . (canceled) 
   
   
       14 . (canceled) 
   
   
       15 . The device of  claim 1  wherein the device is flexible. 
   
   
       16 . A biliary disease treatment device comprising:
 an implant adapted to be delivered by an endoscope, guidance element to a gastrointestinal site in proximity to a gallbladder, and further adapted to form a conduit between the gastrointestinal site and the gallbladder.   
   
   
       17 . (canceled) 
   
   
       18 . (canceled) 
   
   
       19 . (canceled) 
   
   
       20 . (canceled) 
   
   
       21 . (canceled) 
   
   
       22 . (canceled) 
   
   
       23 . (canceled) 
   
   
       24 . (canceled) 
   
   
       25 . (canceled) 
   
   
       26 . (canceled) 
   
   
       27 . (canceled) 
   
   
       28 . A method of delivering a device to treat biliary disease comprising:
 a. using an endoscope to place a guidance element between an access lumen and a gallbladder;   b. inserting a delivery catheter over the guidance element and into the gallbladder;   c. delivering a cystic duct defunctionalizing device on the guidance element; and   d. positioning the cystic duct defunctionalizing device within a cystic duct.   
   
   
       29 . (canceled) 
   
   
       30 . (canceled) 
   
   
       31 . (canceled) 
   
   
       32 . (canceled) 
   
   
       33 . (canceled) 
   
   
       34 . The method of  claim 28  further comprising the step of localizing the gallbladder via endoscopic ultrasound. 
   
   
       35 . The method of  claim 28  further comprising the step of removing gallstones. 
   
   
       36 . The method of  claim 28  further comprising the step of altering gallstones. 
   
   
       37 . The method of  claim 36  further comprising the step of removing the altered gallstones. 
   
   
       38 . (canceled) 
   
   
       39 . The method of  claim 28  wherein the biliary disease is treated without removal of the gallbladder. 
   
   
       40 . The method of  claim 28  wherein the biliary disease is treated without removal of the cystic duct. 
   
   
       41 . (canceled) 
   
   
       42 . The method of  claim 28  further comprising the step of forming a biological duct in situ from a patient's tissue. 
   
   
       43 . The method of  claim 28  further comprising the step of changing the cystic duct defunctionalizing device from a delivery configuration to a deployment configuration. 
   
   
       44 . The method of  claim 28  further comprising the step of changing the cystic duct defunctionalizing device from a delivery configuration to a final configuration. 
   
   
       45 . The method of  claim 28  further comprising the step of changing the cystic duct defunctionalizing device from a deployment configuration to a final configuration. 
   
   
       46 . The method of  claim 28  further comprising the step of reducing a cross-sectional profile of the cystic duct defunctionalizing device. 
   
   
       47 . (canceled) 
   
   
       48 . The method of  claim 28  further comprising the step of defunctionalizing the cystic duct in situ. 
   
   
       49 . The method of  claim 48  wherein the step of defunctionalizing is achieved by delivering a substance into a space within the cystic duct. 
   
   
       50 . The method of  claim 49  wherein the delivered substance is selected from the group consisting of gel and foam. 
   
   
       51 . The method of  claim 49  further comprising the step of activating the delivered substance in situ. 
   
   
       52 . The method of  claim 49  further comprising delivering an amount of substance sufficient to fill, or substantially fill, the cystic duct lumen. 
   
   
       53 . The method of  claim 48  wherein the step of defunctionalizing is achieved by delivering a plug into a space within the cystic duct. 
   
   
       54 . The method of  claim 53  wherein the plug is configurable either internally or externally to seat within the lumen. 
   
   
       55 . The method of  claim 53  wherein the plug further comprises one or more thread profiles, ridges or steps about its exterior surface. 
   
   
       56 . (canceled) 
   
   
       57 . A kit for treating biliary disease comprising:
 a. a device configurable to be positioned within a cystic duct; and optionally   b. a compound for delivery to a tissue.   
   
   
       58 . (canceled) 
   
   
       59 . (canceled) 
   
   
       60 . (canceled) 
   
   
       61 . (canceled) 
   
   
       62 . (canceled) 
   
   
       63 . (canceled) 
   
   
       64 . (canceled) 
   
   
       65 . (canceled) 
   
   
       66 . A method of treating biliary disease comprising:
 a. accessing a lumen associated with a gallbladder;   b. defunctionalizing a cystic duct.   
   
   
       67 . (canceled) 
   
   
       68 . (canceled) 
   
   
       69 . (canceled) 
   
   
       70 . The method of  claim 69  wherein the substance is one or more of antibiotics, inflammatory agents, and anti-inflammatory agents. 
   
   
       71 . The method of  claim 66  further comprising the step of preventing bile from entering the gallbladder lumen. 
   
   
       72 . (canceled) 
   
   
       73 . The method of  claim 66  further comprising the step of accessing the gallbladder via the gastrointestinal tract. 
   
   
       74 . The method of  claim 73  wherein the step of accessing is performed in the gastrointestinal tract at a duodenum. 
   
   
       75 . The method of  claim 73  wherein the step of defunctionalizing the cystic duct further comprises one or more of sclerosing, necrotizing or ablating tissue. 
   
   
       76 . The method of  claim 75  wherein an ablation technique is selected from the group comprising cryoablation, thermal ablation, chemical ablation, radio frequency ablation, ultrasound ablation, and microwave ablation. 
   
   
       77 . The method of  claim 73  further comprising the step of delivering a fluid with an angular orientation. 
   
   
       78 . The method of  claim 73  further comprising the step of delivering a fluid with at least one of a 360 degree radial pattern, a sharp stream, and a cone shape. 
   
   
       79 . The method of  claim 73  further comprising the step of delivering a fluid with a device comprising an articulating member. 
   
   
       80 . The method of  claim 73  wherein the step of defunctionalizing the cystic duct further comprises applying a vacuum to a lumen of the cystic duct or the gallbladder. 
   
   
       81 . The method of  claim 80  further comprising the step of applying all adhesive to the lumen of the cystic duct. 
   
   
       82 . (canceled) 
   
   
       83 . A device for treating biliary disease comprising a plug adapted and configurable to be positioned within a lumen of a cystic duct of a patient having a proximal end and a distal end and is configurable either internally or externally to seat within the lumen after deployment. 
   
   
       84 . The device of  claim 83  wherein the external configuration is one or more of threads, ridges and steps. 
   
   
       85 . (canceled) 
   
   
       86 . (canceled) 
   
   
       87 . The device of  claim 83  wherein the plug is positioned within or proximal to a cystic duct.