Delivery devices and methods for gastrointestinal implants
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.
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 and sleeve delivery device comprising:
a distal outer capsule having a 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; and
an anchor pusher slidably disposed in the proximal outer sheath and configured to extend into the first lumen of the distal outer capsule to push the anchor out of the distal outer capsule and deploy the anchor to the expanded configuration.
2. The system of claim 1 wherein the anchor is self-expanding such that upon deployment from the outer capsule the anchor assumes the expanded configuration.
3. The system of claim 1 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.
4. The system of claim 1 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.
5. The system of claim 4 wherein the anchor pusher has 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.
6. The system of claim 4 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.
7. The system of claim 1 wherein the distal outer capsule has an inner lining made from PTFE and a length of from about 1 to about 3 inches.
8. The system of claim 5 wherein the anchor contact feature includes a retention feature for releasably coupling with the anchor.
9. The system of claim 1 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.