Delivery devices and methods for gastrointestinal implants

Inventors

Belhe, Kedar R. • Thompson, Paul J. • Grafov, Alexander D. • Schwarz, Werner

Assignees

MetaModix Inc

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.

Core Innovation

The invention is directed to 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. The system includes an anchor that is expandable from a collapsed configuration for delivery to an expanded configuration for anchoring in selected regions of the gastrointestinal tract, and an intestinal bypass sleeve coupled to and extending from an end of the anchor.

The system further includes coordinated delivery catheters that enable controlled deployment of the anchor from an anchor capsule. An anchor delivery catheter has an anchor capsule coupled to a proximal outer sheath, with both the anchor capsule and the proximal outer sheath having a central longitudinal lumen sized and configured to retain the anchor in the collapsed configuration, and a pusher catheter slideably disposed within the central longitudinal lumen with a coupling feature adapted to engage the anchor so the coupling feature is operable to deploy the anchor from the anchor capsule.

An outer sheath delivery catheter is slideably disposed partially within the internal lumen of the pusher catheter, with a distal portion extending distal to a distal end of the anchor delivery catheter. An inner sheath delivery catheter is slideably disposed within the internal lumen of the outer sheath delivery catheter and includes a sheath retention feature at or near a distal end of the inner sheath delivery catheter, and the described concepts also contemplate self-expanding anchor behavior and deployment-related structures such as a plurality of movable leaflets that move from a closed positioned to an open position when the anchor is deployed.

Claims Coverage

The independent claim is clm-00001. It defines an integrated delivery and implantation system combining a collapsible-to-expandable anchor, an intestinal bypass sleeve, and a multi-catheter delivery architecture. Associated inventive features include selectable polymer materials for an anchor capsule, a plurality of spring retainer arms for retaining the anchor, self-expanding deployment behavior, movable leaflets during deployment, and a flexible inner tip for guide-wire tracking.

Across the independent claim and associated dependent claims, the system centers on an expandable anchor deployable from an anchor capsule using a coordinated pusher/coupling feature within a multi-sheath catheter delivery architecture, with additional refinement features including selectable anchor capsule polymers, spring-retainer-based anti-slip coupling, self-expanding deployment behavior, leaflet movement, and guide-wire tracking via a flexible inner tip.

Stated Advantages

Documented Applications