TISSUE INGROWTH INTESTINAL BYPASS SLEEVE AND METHOD OF DEPLOYMENT
First Claim
Patent Images
1. A catheter assembly for deploying an endoluminal sleeve, the catheter assembly having an axis and comprising:
- a first catheter having a distal portion, a proximal portion, and a first outside diameter;
a balloon disposed at the distal portion of the first catheter, the balloon having an inflated configuration in which a balloon diameter is greater than the first outside diameter and a deflated configuration;
a sleeve having an lumen, the balloon being internal to the lumen, the sleeve being wrapped about the catheter assembly axis and having a porous outer ingrowth layer and an impermeable inner layer, the outer ingrowth layer having an outer surface with at least one temporary attachment mechanism for attachment to a body lumen; and
a second catheter disposed about the first catheter and being slidable from a first position in which the second catheter covers the balloon and a second position in which the second catheter does not cover the balloon.
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Abstract
A device and method for deploying an intestinal sleeve is disclosed. The intestinal sleeve has an impermeable layer and a tissue ingrowth layer. The intestinal sleeve is temporarily anchored to the wall of a patient'"'"'s duodenum and the wall tissue grows into the tissue ingrowth layer anchoring the intestinal sleeve within the patient'"'"'s duodenum.
8 Citations
17 Claims
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1. A catheter assembly for deploying an endoluminal sleeve, the catheter assembly having an axis and comprising:
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a first catheter having a distal portion, a proximal portion, and a first outside diameter; a balloon disposed at the distal portion of the first catheter, the balloon having an inflated configuration in which a balloon diameter is greater than the first outside diameter and a deflated configuration; a sleeve having an lumen, the balloon being internal to the lumen, the sleeve being wrapped about the catheter assembly axis and having a porous outer ingrowth layer and an impermeable inner layer, the outer ingrowth layer having an outer surface with at least one temporary attachment mechanism for attachment to a body lumen; and a second catheter disposed about the first catheter and being slidable from a first position in which the second catheter covers the balloon and a second position in which the second catheter does not cover the balloon. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, 16, 17)
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12. A method for deploying an intestinal bypass sleeve comprising:
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guiding a distal end of a catheter assembly to the duodenum of a patient, the distal end of the catheter assembly having a balloon, an intestinal bypass sleeve having an impermeable inner layer and an ingrowth outer layer disposed about the balloon, and an introducer sheath covering the intestinal bypass sleeve; retracting the introducer sheath of the catheter assembly to uncover at least a portion of the intestinal bypass sleeve; inflating the balloon to expand at least a portion the intestinal bypass sleeve within the duodenum of the patient; anchoring the ingrowth outer layer to the wall of the duodenum of the patient through a temporary anchor mechanism, wherein the ingrowth outer layer is anchored only to the duodenum along the entire length of the intestinal bypass sleeve; deflating the balloon leaving the intestinal bypass sleeve anchored to the wall of the duodenum; removing the distal end of the catheter assembly from the duodenum of the patient; and promoting tissue ingrowth into the ingrowth outer layer to durably anchor the intestinal bypass sleeve within the duodenum.
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Specification