Anchored non-piercing duodenal sleeve and delivery systems

• US 10,070,980 B2
• Filed: 06/18/2013
• Issued: 09/11/2018
• Est. Priority Date: 10/19/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Apollo Endosurgery US, Inc. (Boston Scientific Corporation)
• Inventors: Babkes, Mitchell H., Dominguez, Zachary P., Mudd, Christopher S.
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): SASS, SARA A
• Application Number:
  US13/921,082
• Publication Number:
  US 20130281911A1
• Time in Patent Office: 1,911 Days
• 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

Abstract

An intragastric implant for obesity treatment is disclosed. The device delays digestion by providing a duodenal sleeve, and may also slows gastric emptying by limiting flow through the pyloric sphincter. The implant includes an elongated axially-compressible duodenal sleeve having a non-tissue-piercing anchor on a proximal end sized to lodge within the duodenal bulb. The anchor may have oppositely-directed anchoring flanges to resists migration in both directions. The sleeve may also have barbed ribs to resist proximal movement back up into the stomach. A method of implant includes collapsing/compressing the device and transorally advancing it through the esophagus to be deployed within the duodenum. A dissolvable jacket may constrain the implant for delivery and naturally dissolve upon implant. Removal of the implant may occur in the reverse.

Claims

1. A transorally inserted, intragastric device for a treatment of obesity, comprising:

a sleeve for placement in a duodenum having a tubular body with proximal and distal ends and an inner lumen; and

a radially collapsible anchor surrounding the proximal end of the tubular body, the anchor having an expanded state that can act to prevent passage of the device through a pyloric sphincter, the anchor including tubular a proximal conical flange and a distal conical flange concentrically-disposed around the tubular body and angled away from one another so as to impede movement of the anchor within the duodenum in both a proximal direction and in a distal direction, wherein the proximal conical flange forms an intake funnel having a proximal opening, the intake funnel leading into the inner lumen of the sleeve, the inner lumen being smaller than the proximal opening of the intake funnel,

wherein the device is formed of a material that will resist structural degradation over a period of at least six monthly within a gastrointestinal tract.

2. The device of claim 1, wherein the sleeve includes exterior ribs to resist movement within the duodenum in one direction.

3. The device of claim 2, wherein the exterior ribs on the sleeve are conical and extend the length of the sleeve and angle in the proximal direction to resist movement within the duodenum in the proximal direction.

4. The device of claim 3, wherein the sleeve is axially collapsible/expandable and the conical ribs are shaped to nest within one another for axial collapse of the sleeve.

5. The device of claim 1, wherein the anchor surrounding the proximal end of the tubular body has no metal component.

6. The device of claim 1, wherein the proximal flange tapers from a wide base at a proximal end and to a narrow circular edge at a distal end and wherein the distal flange tapers from a wide base at a distal end to a narrow circular edge at a proximal end.

7. The device of claim 1, wherein a smallest diameter of the intake funnel coincides with a diameter of the lumen.

8. The device of claim 7, wherein the smallest diameter of the intake funnel and the diameter of the lumen are sized to reduce a flow rate exiting the stomach through the pyloric sphincter.