Delivery devices and methods for gastrointestinal implants

Abstract

Several gastrointestinal surgery procedures are effective as treatments for metabolic disorders such as obesity and diabetes. Minimally invasive procedures including intra-luminal gastrointestinal implants have been proposed to mimic the anatomical, physiological and metabolic changes achieved by these procedures. Many of these designs include long sleeve like elements that prevent contact of food with the walls of the small intestine. It is desirable to have simple delivery systems that can place these implants under endoscopic guidance. However, in order to anchor these sleeve elements safely and reliably, the inventors have previously disclosed anchoring means that anchor the sleeves at the junctions of the stomach and the intestine or the stomach and esophagus.

We claim: 
     
         1 . A system for delivery and implantation of a gastrointestinal device within one or more of a pyloric antrum, a pylorus, a duodenal bulb, a duodenum, and a jejunum of a patient's gastrointestinal tract, the system comprising:
 an anchor having a collapsed configuration for delivery and an expanded configuration for anchoring within one or more of the pyloric antrum, the pylorus, and the duodenum;   an intestinal bypass sleeve coupled to and extending from an end of the anchor;   an anchor delivery catheter having an anchor capsule coupled to a proximal outer sheath, both the capsule and the proximal outer sheath having a central longitudinal lumen, wherein a diameter of the capsule portion of the central lumen is sized and configured to retain the expandable anchor in the collapsed configuration; and   a pusher catheter slideably disposed within the central longitudinal lumen of the anchor delivery catheter, the pusher catheter having a coupling feature disposed within the anchor capsule and the pusher catheter defining an internal lumen;   wherein the coupling feature is adapted to engage the anchor such that the coupling feature is operable to deploy the anchor from the anchor capsule;   an outer sheath delivery catheter slideably disposed partially within the internal lumen of the pusher catheter and having a distal portion extending distal to the distal end of the anchor delivery catheter, the sleeve delivery catheter having an internal lumen; and   an inner sheath delivery catheter slideably disposed within the internal lumen of the outer sheath delivery catheter, wherein the inner sleeve delivery catheter has a sleeve retention feature disposed at or near a distal end.   
     
     
         2 . The system of  claim 10  further comprising a handle, the handle including an actuation handle coupled to a proximal end of each of the anchor delivery catheter, the pusher catheter, the outer sheath delivery catheter, and the inner sheath delivery catheter. 
     
     
         3 . The system of  claim 10  wherein the inner sheath delivery catheter includes a flexible tip adapted to track over a guide wire. 
     
     
         4 . The system of  claim 10  wherein the distal outer capsule has a distal tip having a plurality of movable leaflets configured to allow loading and deploying of the expandable anchor. 
     
     
         5 . The system of  claim 10  wherein the coupling feature of the pusher catheter includes a retention mechanism for releasably attaching to the expandable anchor. 
     
     
         6 . The system of  claim 14  wherein the coupling feature includes a plurality of spring retainer arms adapted to retain the expandable anchor such that it resists the anchor from slipping out of the distal capsule. 
     
     
         7 . A gastrointestinal device for implanting within one or more of a pyloric antrum, a pylorus, a duodenal bulb, a duodenum, and a jejunum of a patient's gastrointestinal tract, the implant comprising:
 an expandable structure including a proximal portion and a distal portion coupled by a central cylinder having a diameter capable of fitting within the pylorus and having a length greater than a width of the pylorus;   wherein each of the proximal portion and the distal portion includes a toroidal element coupled to the central cylinder by a plurality of control arms;   a membrane coupled to and covering at least a portion of one of the proximal portion and the distal portion of the expandable structure; and   an intestinal bypass sleeve coupled to at least one of the proximal and distal portions of the expandable structure and having a length sufficient to extend at least partially into the duodenum;   wherein, in the expanded configuration, the toroidal element of the proximal portion has a diameter larger than a maximum opening diameter of the pylorus and further wherein, in the expanded configuration, the toroidal element of the distal portion has a diameter larger than a maximum opening diameter of the pylorus.   
     
     
         8 . The gastrointestinal device of  claim 16  wherein the central cylinder portion includes an anti-reflux valve adapted for preventing reflux of the duodenal contents back into the stomach. 
     
     
         9 . The gastrointestinal device of  claim 16  further including a supplemental securement mechanism for securing the device to the pylorus or the stomach, the supplemental securement mechanism including one or more of the following: a suture, a T-bar, a hook, a barb and a screw-type anchor. 
     
     
         10 . The gastrointestinal device of  claim 16  wherein the intestinal bypass sleeve has a length sufficient to extend at least partially into a jejunum of the patient's gastrointestinal tract. 
     
     
         11 . The gastrointestinal device of  claim 16  wherein the control arms have an expanded configuration extending generally parallel to a longitudinal axis of the device and the control arms including a first end coupled to the central cylinder at a first radial position and a second end coupled to the toroidal element at a second radial position. 
     
     
         12 . The gastrointestinal device of  claim 20  wherein each of the control arms include a corresponding eyelet near the second end and further wherein the toroidal element is coupled to each of the corresponding eyelets. 
     
     
         13 . The gastrointestinal device of  claim 16  wherein at least one of the toroidal elements is formed from a coiled wire into a toroidal-shaped spring have a central axis and further wherein the ends of the wire are fastened with a spring joiner. 
     
     
         14 . The gastrointestinal device of  claim 16  further comprising a drawstring extending along the central axis of at least one of the toroidal-shaped springs, the drawstring operable to reduce the diameter of the toroidal element. 
     
     
         15 . A system for delivery and implantation of a gastrointestinal device within one or more of a pyloric antrum, a pylorus, a duodenal bulb, a duodenum, and a jejunum of a patient's gastrointestinal tract, the system comprising:
 an anchor having a collapsed configuration for delivery and an expanded configuration for anchoring within one or more of the pyloric antrum, the pylorus, and the duodenum;   an intestinal bypass sleeve coupled to and extending from an end of the anchor;   an anchor and sleeve delivery device comprising:
 a distal outer capsule having first lumen that is sized and configured to retain the anchor in the collapsed configuration and a second lumen disposed adjacent to the first lumen; 
 a proximal outer sheath coupled to the distal outer capsule; 
 a sleeve delivery catheter slidably disposed within the second lumen of the distal outer capsule and the proximal outer sheath, the sleeve delivery catheter having a longitudinal guide wire lumen sized and shaped to accept a guide wire, the sleeve delivery catheter having a sleeve coupling feature for releasably coupling to the intestinal bypass sleeve, wherein the sleeve delivery catheter is adapted to be advanced into the patient's gastrointestinal tract over the guidewire. 
   
     
     
         16 . The system of claim  24  wherein the anchor is self-expanding such that upon deployment from the outer capsule the anchor assumes the expanded configuration. 
     
     
         17 . The system of claim  24  wherein the distal outer capsule of the anchor delivery device has a first diameter and the proximal sheath has a second diameter, smaller than the first diameter, further wherein the first lumen has a diameter of from about 3 mm to about 12 mm and the second lumen has a diameter of from about 1 mm to about 4 mm. 
     
     
         18 . The system of claim  24  wherein the proximal sheath has a first lumen in communication with the first lumen of the distal outer capsule and a second lumen in communication with the second lumen of the distal outer capsule. 
     
     
         19 . The system of claim  27  further comprising an anchor pusher having an anchor contact feature and an elongated pusher, wherein the anchor contact feature is sized and shaped to fit within the first lumen of the distal outer sheath and to contact the anchor and the elongated pusher is configured to fit within the first lumen of the proximal sheath. 
     
     
         20 . The system of claim  24  wherein the distal outer capsule is made from a polymer selecting from the group including: a polyether block amide, a polyester elastomer, a PTFE, an FEP, a nylon, a polyethylene or a polyurethane. 
     
     
         21 . The system of claim  24  wherein the distal outer capsule has an inner lining made from PTFE and a length of from about 1 to about 3 inches. 
     
     
         22 . The system of claim  28  wherein the anchor contact feature includes a retention feature for releasably coupling with the anchor. 
     
     
         23 . The system of claim  24  wherein the sleeve coupling feature of the sleeve delivery catheter is a loop, sized to extend around an outside diameter of the intestinal bypass sleeve.