Devices and Methods for Anchoring an Endoluminal Sleeve in the GI Tract

Abstract

An endoluminal sleeve device for internally lining a section of the GI tract, comprises a sleeve configured for deployment inside a duodenum, the sleeve having walls of a flexible material defining a sleeve lumen, a proximal end defining a proximal lumen opening, and a distal end defining a distal lumen opening, an anchoring component having a slender transport configuration and a bulky deployed configuration, wherein the anchoring component is locatable at a distance from the proximal sleeve end and connected thereto by an elongated tether.

1 . Endoluminal sleeve device for internally lining a section of the GI tract, comprising:
 a sleeve configured for deployment inside a duodenum, the sleeve having walls of a flexible material defining a sleeve lumen, a proximal end defining a proximal lumen opening, and a distal end defining a distal lumen opening,   an anchoring component having a slender transport configuration and a bulky deployed configuration, the anchoring component being attached to the proximal end of the sleeve.   
     
     
         2 . Endoluminal sleeve device according to  claim 1 , in which the anchoring component comprises a gastric coil which can change shape from an extended free-ended string shape adapted for endoluminal transportation into the stomach, to a deployed arched shape adapted to shape connect with the stomach. 
     
     
         3 . Endoluminal sleeve device according to  claim 2 , in which the gastric coil comprises means for locking thereof in the deployed arched shape. 
     
     
         4 . Endoluminal sleeve device according to  claim 1 , in which the anchoring component comprises a gastric balloon which can be expanded from a collapsed shape to an expanded shape. 
     
     
         5 . Endoluminal sleeve device according to  claim 4 , in which, the expanded configuration, the gastric balloon may defines a through hole and a proximal end of tether is fastened at a distal aperture of the through hole. 
     
     
         6 . Endoluminal sleeve device according to  claim 1 , in which the anchoring component comprises a set of individual, initially separate segments adapted to be individually transportable into the stomach and which can be assembled to form a rigid body of greater dimensions than the individual segments. 
     
     
         7 . Endoluminal sleeve device of  claim 1 , wherein the anchoring component has a ring shaped deployed configuration and a proximal end of the sleeve is connected to the anchoring component with a tether. 
     
     
         8 . Endoluminal sleeve device of  claim 7 , further comprising at least one elastic spread ring supported by the proximal sleeve end in a deformed wavy shape with undulations in a sleeve longitudinal direction, wherein the spread ring elastically biases the proximal sleeve end in a radially spread configuration while preserving a continuously convex outer contour. 
     
     
         9 . Endoluminal sleeve device according to  claim 8 , wherein a total circumferentially developed length of the spread ring is between 1.5 and 2.5 times the diameter of the proximal sleeve end. 
     
     
         10 . Endoluminal sleeve device of  claim 1 , wherein a proximal edge of the proximal sleeve end forms a funneled shaped sealing lip. 
     
     
         11 . Endoluminal sleeve device of  claim 1 , further comprising an elastic spring interposed between the anchoring component and the proximal sleeve end. 
     
     
         12 . Endoluminal sleeve device according to  claim 11 , wherein said spring is formed by an elastic section. 
     
     
         13 . Endoluminal sleeve device according to  claim 11 , in which the spring comprises an elastic coil connected to the proximal sleeve end and tapered in a proximal direction towards the anchoring component. 
     
     
         14 . Endoluminal sleeve device of  claim 1 , wherein the proximal end of the sleeve is connected to the anchoring component with a tether, and further comprising a distance adjusting mechanism adapted to adjust a non-stretched length of the tether between the anchoring component and the proximal sleeve end. 
     
     
         15 . Endoluminal sleeve device anchoring system, comprising an endoluminal sleeve device according to  claim 1  and an applier with a flexible shaft and an applier head arranged at a distal end of the flexible shaft, the applier head comprising:
 a proximal coupler mount adapted to carry the anchoring component, 
 a distal coupler mount operable to translate with respect to the proximal coupler mount and adapted to carry a ring-shaped proximal mounting structure of sleeve, 
 at least one pushing tube adapted to receive the tether and operable to translate with respect to both the proximal and distal coupling mounts through tether holes formed in the anchoring component and towards a coupling seat formed in the sleeve mounting structure, 
 the tether being provided with a distal coupling tip adapted to connect with the coupling seats in the sleeve mounting structure 
 
     
     
         16 . Endoluminal sleeve device for internally lining a section of the GI tract, comprising:
 a sleeve configured for deployment inside a duodenum, the sleeve comprising a proximal end and a distal end,   an anchoring ring attached to the proximal end of the sleeve, the sleeve extending radially outward from the ring.   
     
     
         17 . The device of  claim 16 , wherein the ring is substantially planar, and the sleeve extends radially outward from the ring and substantially in the same plane as the ring. 
     
     
         18 . The device of  claim 17 , wherein the anchoring ring comprises a slender transport configuration and a bulky deployed configuration. 
     
     
         19 . The device of  claim 18 , further comprising at least one elastic spread ring biasing the proximal end of the sleeve in a radially spread configuration. 
     
     
         20 . The device of  claim 19 , wherein the elastic spread ring comprises a spring with longitudinal undulations supported by the proximal end of the sleeve.