Anchored non-piercing duodenal sleeve and delivery systems

Abstract

An intragastric implant for obesity treatment is disclosed. The device delays digestion by providing a duodenal sleeve, and may also slows gastric emptying by limiting flow through the pyloric sphincter. The implant includes an elongated axially-compressible duodenal sleeve having a non-tissue-piercing anchor on a proximal end sized to lodge within the duodenal bulb. The anchor may have oppositely-directed anchoring flanges to resists migration in both directions. The sleeve may also have barbed ribs to resist proximal movement back up into the stomach. A method of implant includes collapsing/compressing the device and transorally advancing it through the esophagus to be deployed within the duodenum. A dissolvable jacket may constrain the implant for delivery and naturally dissolve upon implant. Removal of the implant may occur in the reverse.

1 . A transorally inserted, intragastric device for the treatment of obesity, comprising:
 a sleeve for placement in the duodenum having a tubular body with proximal and distal ends; and   a radially collapsible anchor surrounding the proximal end of the tubular body, the anchor having an expanded state that can act to prevent passage of the device through the pyloric sphincter, the anchor including two conical flanges concentrically-disposed around the tubular body and angled away from one another so as to impede movement of the anchor within the duodenum in both a proximal direction and in a distal direction,   wherein the device is formed of a material that will resist structural degradation over a period of at least six months within the gastrointestinal tract.   
     
     
         2 . The device of  claim 1 , wherein the sleeve is axially collapsible/expandable and includes exterior ribs to resist movement within the duodenum in one direction. 
     
     
         3 . The device of  claim 2 , wherein the exterior ribs on the sleeve are conical and extend the length of the sleeve and angle in the proximal direction to resist movement within the duodenum in the proximal direction. 
     
     
         4 . The device of  claim 3 , wherein the conical ribs are shaped to nest within one another for axial collapse of the sleeve. 
     
     
         5 . The device of  claim 1 , wherein the anchor surrounding the proximal end of the tubular body has no metal component. 
     
     
         6 . A transorally inserted, intragastric device for the treatment of obesity, comprising:
 a stomach anchoring member having a collapsed, delivery size, and an expanded, deployed size larger than a pyloric sphincter, the stomach anchoring member having no tissue-piercing elements;   a duodenal anchoring member having a collapsed, delivery size, and an expanded, deployed size larger than a pyloric sphincter, the duodenal anchoring member having no tissue-piercing elements;   an elongated duodenal sleeve for placement in the duodenum having a tubular body with proximal and distal ends, the proximal end extending to the stomach anchoring member on the stomach side of the pyloric sphincter, and forming a compressible channel through the pyloric sphincter; and   a plurality of cords extending the length of the device from the stomach anchoring member to the distal end of the duodenal sleeve,   wherein the device is formed of a material that will resist structural degradation over a period of at least six months within the gastrointestinal tract.   
     
     
         7 . The device of  claim 6 , wherein the stomach anchoring member comprises a funnel-shaped structure that extends into the stomach, and wherein the duodenal sleeve continues and widens in a proximal direction along the funnel-shaped structure. 
     
     
         8 . The device of  claim 7 , wherein the stomach anchoring member comprises a plurality of resilient rings sufficiently compressible to be delivered transorally, and sufficiently large to spring outward to form the funnel-shaped structure in contact with the antrum area of the stomach. 
     
     
         9 . The device of  claim 6 , wherein the duodenal anchoring member comprises a plurality of resilient rings sufficiently compressible to be delivered transorally, and sufficiently large to spring outward into contact with a duodenal bulb area of the duodenum, the plurality of resilient rings being differently sized and having a central larger ring such that the duodenal sleeve has a bulge in the area of the duodenal anchoring member. 
     
     
         10 . The device of  claim 6 , further including a plurality of spaced resilient rings along the duodenal sleeve and connected to the cords. 
     
     
         11 . The device of  claim 6 , further including a flexible annular membrane spanning the stomach anchoring member and having a central through hole that defines the flow orifice from the stomach into the duodenal sleeve. 
     
     
         12 . The device of  claim 6 , further including a plurality of grasping tabs projecting proximally from the stomach anchoring member. 
     
     
         13 . The device of  claim 12 , wherein the grasping tabs comprise proximal ends of the cords. 
     
     
         14 . A transorally inserted, intragastric device for the treatment of obesity, comprising:
 a stomach anchoring member comprising at least one resilient ring sufficiently compressible to be delivered transorally, and sufficiently large to spring outward into contact with the lower stomach adjacent the pyloric sphincter;   a duodenal anchoring member comprising a plurality of resilient rings sufficiently compressible to be delivered transorally, and sufficiently large to spring outward into contact with a duodenal bulb area of the duodenum; and   an elongated duodenal sleeve for placement in the duodenum having a tubular body with proximal and distal ends, the proximal end extending to the stomach anchoring member on the stomach side of the pyloric sphincter, and forming a compressible channel through the pyloric sphincter;   wherein the device is formed of a material that will resist structural degradation over a period of at least six months within the gastrointestinal tract.   
     
     
         15 . The device of  claim 14 , wherein the stomach anchoring member comprises a funnel-shaped structure that extends into the stomach, and wherein the duodenal sleeve continues and widens in a proximal direction along the funnel-shaped structure. 
     
     
         16 . The device of  claim 14 , wherein the stomach anchoring member comprises a plurality of the resilient rings forming a funnel-shaped structure in contact with the antrum area of the stomach. 
     
     
         17 . The device of  claim 14 , further including a flexible annular membrane spanning the resilient ring of the stomach anchoring member and having a central through hole that defines the flow orifice from the stomach into the duodenal sleeve. 
     
     
         18 . The device of  claim 17 , wherein the stomach anchoring member comprises a plurality of the resilient rings sized progressively larger in the proximal direction to form a funnel-shaped structure that extends into the stomach, and wherein the flexible annular membrane spans the resilient ring closest to the duodenal anchoring member. 
     
     
         19 . The device of  claim 14 , further including a plurality of grasping tabs projecting proximally from the stomach anchoring member, wherein the grasping tabs comprise proximal ends of the cords. 
     
     
         20 . The device of  claim 14 , wherein the plurality of resilient rings of the duodenal anchoring member spring outward into contact with a duodenal bulb area of the duodenum, the plurality of resilient rings being differently sized and having a central larger ring such that the duodenal sleeve has a bulge in the area of the duodenal anchoring member. 
     
     
         21 . The device of  claim 14 , further including a plurality of spaced resilient rings along the duodenal sleeve and connected to the cords.