Methods and devices to curb appetite and/or reduce food intake
The present invention relates to methods and devices that help to curb appetite and/or reduce food intake. In one embodiment, the methods and devices of the present invention include a small intestinal/duodenal insert comprising an elongated member with at least one flow reduction element that can cause the stimulation of one or more biological signals of satiety.
1. A duodenal/small intestinal insert comprising:
an elongated member configured to be placed in the duodenum, wherein the elongated member has a proximal end, a distal end, and a longitudinal axis extending from the proximal end to the distal end;
a sleeve positioned around the elongated member, the sleeve slideable along the longitudinal axis to transition the sleeve from a stowed configuration wherein the sleeve is substantially axially aligned with the longitudinal axis to a deployed configuration wherein at least one portion of the sleeve expands away from the longitudinal axis at a predefined location to form a flow reduction element; and
an anchor connected to the proximal end of the elongated member and separated from the sleeve, wherein the anchor is configured to be placed in an antrum to anchor the sleeve in the duodenum.
2. The duodenal/small intestinal insert of claim 1 , wherein the longitudinal axis of the elongated member has a pre-shaped curve to mimic a bend configuration of the duodenum.
3. The duodenal/small intestinal insert of claim 1 , wherein, in the deployed configuration, the sleeve is shorter than the elongated member along the longitudinal axis.
4. The duodenal/small intestinal insert of claim 1 , wherein the flow reduction element is approximately the shape of a sphere.
5. The duodenal/small intestinal insert of claim 1 , wherein, when in use in the duodenum, the flow reduction element has a diameter approximately equal to an interior of a small intestine.
6. The duodenal/small intestinal insert of claim 1 , wherein when the sleeve transitions from the stowed configuration to the deployed configuration, another portion of the sleeve expands at a predefined location to form a second flow reduction element.
7. The duodenal/small intestinal insert of claim 6 , wherein the sleeve further comprises at least one segment that does not expand between each flow reduction element.
8. The duodenal/small intestinal insert of claim 1 , wherein the sleeve is configured to self expand from the stowed configuration to the deployed configuration.
9. The duodenal/small intestinal insert of claim 8 , further comprising a constraining mechanism configured to constrain the sleeve in the stowed configuration.
10. The duodenal/small intestinal insert of claim 9 , wherein the constraining mechanism comprises a sheath, a string wound around the sleeve, or a mechanism configured to apply sustained traction on a proximal end of the sleeve.
11. The duodenal/small intestinal insert of claim 1 , further comprising a locking mechanism configured to lock the sleeve in the deployed configuration.
12. The duodenal/small intestinal insert of claim 11 , wherein the locking mechanism includes a traction mechanism on the elongated member configured to interact with an extension on the sleeve.
13. The duodenal/small intestinal insert of claim 1 , wherein the flow reduction element encircles the elongated member.
14. The duodenal/small intestinal insert of claim 1 , wherein the sleeve comprises a polymer mesh, knit, weave, or braid.
15. The duodenal/small intestinal insert of claim 1 , wherein the sleeve comprises a metal mesh, knit, weave, or braid.
16. The duodenal/small intestinal insert of claim 1 , wherein the sleeve is attached to the elongated member only at a distal end of the sleeve.
17. The duodenal/small intestinal insert of claim 1 , wherein the flow reduction element is sized to restrict, but not occlude, a flow of chime through the duodenum.
18. A duodenal/small intestinal insert comprising:
an elongated solid shaft member having a longitudinal axis configured to conform to the duodenum;
a sleeve positioned around the elongated solid shaft member, the sleeve moveable along the longitudinal axis of the elongated solid shaft member to cause the sleeve to expand at a plurality of predefined locations to form a plurality of flow reduction elements spaced apart along the longitudinal axis; and
an anchor connected to a proximal end of the elongated solid shaft member and separated from the sleeve, wherein the anchor is configured to be placed in an antrum to anchor the sleeve in the duodenum.
19. A method of reducing flow of chime through a duodenum, comprising:
advancing a flow reducing device in a stowed condition into a duodenum of a patient, the flow reducing device including an elongated member and a sleeve positioned around the elongated member;
placing an anchor in an antrum, wherein the anchor is connected to a proximal end of the elongated member and separated from the sleeve, so as to anchor the sleeve in the duodenum; and
sliding a sleeve along a longitudinal axis of the elongated member, the longitudinal axis extending from the proximal end of the elongated member to a distal end of the elongated member, so as to transition the sleeve from a stowed configuration wherein the sleeve is substantially axially aligned with a longitudinal axis of the elongated member to a deployed configuration wherein at least one portion of the sleeve expands away from the longitudinal axis at a predefined location to form a flow reduction element.
20. The method of claim 19 , further comprising removing a constraining mechanism from the sleeve such that the sleeve can slide.