Gastrointestinal prostheses

Abstract

A system for therapy within a gastrointestinal system includes anchoring or attachment functionality embodied in a low-profile implant technology and removable therapy components, which can be reversibly attached to these low-profile implants to accomplish various therapies. This design allows the physician to tailor the therapy to the patient's needs. The system has the potential to create conduits for diversion and/or restriction of food and organ secretions and to facilitate the treatment of metabolic disorders such as obesity and T2DM.

1 . An implant for treating metabolic disorders such as diabetes and obesity, the implant comprising:
 an anchoring element including an expandable structure having a first portion configured for engaging a first wall of the pylorus at a first location adjacent the pyloric antrum and a second portion configured for engaging a second wall of the pylorus at a second location adjacent the duodenal bulb;   the anchoring element including a neck portion adapted to extend through and engage an inner surface of the pylorus; and   a therapy implant adapted for placement within the duodenum, the therapy implant coupled to the anchoring element, such that the therapy implant does not penetrate into or exert a radial force upon the duodenal bulb.   
     
     
         2 . The implant of  claim 1  wherein the second portion of the anchoring element has an unconstrained diameter smaller than a duodenal bulb diameter, such that the second portion would not contact the duodenal bulb upon implantation. 
     
     
         3 . The implant of  claim 1  wherein the second portion of the anchoring element has an unconstrained diameter larger than a duodenal bulb diameter, such that at least a portion of the second portion would contact at least a portion of the duodenal bulb upon implantation. 
     
     
         4 . The implant of  claim 1  wherein the second portion is at least partially covered with a sleeve element that extends into the duodenum or the proximal jejunum. 
     
     
         5 . The implant of  claim 1  wherein the neck portion is made from a flexible material configured to at least partially collapse in response to a radial force typically applied by a pylorus to allow unconstrained closing of the pylorus. 
     
     
         6 . The implant of  claim 1  wherein the neck portion is made from a material configured to have an unconstrained diameter smaller than a maximum diameter of the pylorus, such that the neck portion acts to restrict flow through the pylorus. 
     
     
         7 . The implant of  claim 1  wherein the second portion includes a plurality of circumferential openings configured to function as a docking feature and further wherein the therapy implant includes a plurality of circumferentially disposed protrusions configured to mate with the plurality of openings, such that the therapy implant is releasably coupled to the anchoring element to facilitate removal of the therapy implant. 
     
     
         8 . The implant of  claim 1  wherein the neck portion is made from a material configured to have an unconstrained diameter greater than a minimum diameter of the pylorus, such that the neck portion acts to enhance flow through the pylorus. 
     
     
         9 . An implant for treating metabolic disorders such as diabetes and obesity, the implant comprising:
 an anchoring element including an expandable structure having a first portion configured for positioning within the pyloric antrum and for engaging a proximal wall of the pylorus and a second portion configured for positioning within the duodenum and for engaging a distal wall of the pylorus;   the anchoring element including a neck portion adapted to extend through and engage an inner surface of the pylorus; and   a therapy implant adapted for placement within the duodenum, the therapy implant having a length such that it extends into the duodenum or proximal jejunum;   wherein neither of the anchoring element or the therapy implant penetrate into or exert a radial force upon the duodenal bulb.   
     
     
         10 . The implant of  claim 9  wherein the second portion is at least partially covered with a sleeve element that extends into the duodenum or the proximal jejunum. 
     
     
         11 . The implant of  claim 9  wherein the neck portion is made from a flexible material configured to at least partially collapse in response to a radial force typically applied by a pylorus to allow unconstrained closing of the pylorus. 
     
     
         12 . The implant of  claim 9  wherein the neck portion is made from a material configured to have an unconstrained diameter smaller than a maximum diameter of the pylorus, such that the neck portion acts to restrict flow through the pylorus. 
     
     
         13 . The implant of  claim 9  wherein the neck portion is made from a material configured to have an unconstrained diameter greater than a minimum diameter of the pylorus, such that the neck portion acts to enhance flow through the pylorus. 
     
     
         14 . The implant of  claim 9  wherein the second portion includes a plurality of circumferential and further wherein the therapy implant includes a plurality of circumferentially disposed protrusions configured to mate with the plurality of openings, such that the therapy implant is releasably coupled to the anchoring element to facilitate removal of the therapy implant. 
     
     
         15 . The implant of  claim 9  wherein the second portion of the anchoring element has an unconstrained diameter smaller than a duodenal bulb diameter, such that the second portion would not contact the duodenal bulb upon implantation. 
     
     
         16 . The implant of  claim 9  wherein the second portion of the anchoring element has an unconstrained diameter smaller than a duodenal bulb diameter, such that the second portion would not contact the duodenal bulb upon implantation. 
     
     
         17 . The implant of  claim 9  wherein the second portion of the anchoring element has an unconstrained diameter larger than a duodenal bulb diameter, such that at least a portion of the second portion would contact at least a portion of the duodenal bulb upon implantation. 
     
     
         18 . An implant for treating metabolic disorders such as diabetes and obesity, the implant comprising:
 an anchoring element including an expandable structure having a first portion configured for positioning within the pyloric antrum and for engaging a proximal wall of the pylorus and a second portion configured for positioning within the duodenum and for engaging a distal wall of the pylorus;   the anchoring element including a neck portion adapted to extend through and engage an inner surface of the pylorus; and   a therapy implant adapted for placement within the duodenum, the therapy implant having a length such that it extends into the duodenum or proximal jejunum;   wherein neither of the anchoring element or the therapy implant penetrate into or exert a radial force upon the duodenal bulb; and   further wherein the first portion is disk-shaped and has an first unconstrained outer diameter larger than a second unconstrained outer diameter of the second portion.   
     
     
         19 . The implant of  claim 18  wherein the first unconstrained outer diameter of the first portion is larger than the pyloric antrum diameter, such that at least a portion of the first unconstrained outer diameter would contact at least a portion of the pyloric antrum upon implantation. 
     
     
         20 . The implant of  claim 18  wherein the first unconstrained outer diameter of the first portion is smaller than the pyloric antrum diameter, such that the first unconstrained outer diameter would not contact the pyloric antrum upon implantation.