Delivery devices and methods for gastrointestinal implants

• US 10,322,021 B2
• Filed: 10/01/2015
• Issued: 06/18/2019
• Est. Priority Date: 04/03/2009
• Status: Active Grant

• Current Assignee: MetaModix, Inc.
• Original Assignee: MetaModix, Inc.
• Inventors: Belhe, Kedar R., Thompson, Paul J., Grafov, Alexander D., Schwarz, Werner
• Primary Examiner(s): Klein, Benjamin J
• Assistant Examiner(s): Sass, Sara A
• Application Number:
  US14/872,990
• Publication Number:
  US 20160089256A1
• Time in Patent Office: 1,356 Days
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal

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.

Claims

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, the anchor being expandable from the collapsed configuration to the expanded configuration;

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 anchor capsule and the proximal outer sheath having a central longitudinal lumen, wherein a diameter of the central longitudinal lumen of the anchor capsule is sized and configured to retain the anchor in the collapsed configuration therein; and

a pusher catheter slideably disposed within the central longitudinal lumen of the anchor delivery catheter such that the pusher catheter is configured to slide relative to the anchor capsule and the proximal outer sheath, 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 a distal end of the anchor delivery catheter, the outer sheath 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 sheath delivery catheter has a sheath retention feature disposed at or near a distal end of the inner sheath delivery catheter.

2. The system of claim 1, 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 1, wherein the inner sheath delivery catheter includes a flexible tip adapted to track over a guide wire.

4. The system of claim 1, wherein the anchor capsule has a distal tip having a plurality of movable leaflets configured to allow loading and deploying of the anchor.

5. The system of claim 1, wherein the coupling feature of the pusher catheter includes a retention mechanism for releasably attaching to the anchor.

6. The system of claim 5, wherein the coupling feature includes a plurality of spring retainer arms adapted to retain the anchor such that it resists the anchor from slipping out of the anchor capsule.

7. The system of claim 1, wherein the anchor is self-expanding such that upon a deployment of the anchor from the anchor capsule, the anchor assumes the expanded configuration.

8. The system of claim 4, wherein the plurality of movable leaflets are configured to deflect from a closed positioned to an open position during a deployment of the anchor wherein the anchor is deployed from the distal end of the anchor delivery catheter.

9. The system of claim 7, wherein the plurality of movable leaflets are integral with the anchor capsule.

10. The system of claim 1, wherein the anchor capsule is made from a polymer selected from the group including, a polyether block amide, a polyester elastomer, a PTFE, an FEP, a nylon, a polyethylene or a polyurethane.

11. The system of claim 1, wherein the coupling feature of the pusher catheter includes a retention feature for releasably coupling the pusher catheter to the anchor.