Attachment cuff for gastrointestinal implant
View Patent ↗The present invention provides devices and methods for attachment of an endolumenal gastrointestinal device, such as an artificial stoma device, a gastrointestinal bypass sleeve or other therapeutic or diagnostic device, within a patient's digestive tract. In one application of the invention, an endolumenal bypass sleeve is removeably attached in the vicinity of the gastroesophageal junction to treat obesity and/or its comorbidities, such as diabetes. The bypass sleeve may be at least partially deployed by eversion.
1. An attachment cuff, for attaching an endolumenal bypass tube within a patient's gastrointestinal system, comprising:
a flexible, tubular body, having a proximal end and a distal end, and an axial length between the proximal end and the distal end of from about 0.5 inches to about 2.0 inches, wherein the flexible tubular body provides little or no radial support, the flexible body configured to expand and contract with the expansion and contraction of at least portions of the stomach and the esophagus, the flexible body reducing additional stress on attachment points between the cuff and adjacent tissue, the flexible body having a flow lumen therethrough having a substantially constant diameter from the proximal end of the cuff to the distal end of the cuff so as to not restrict ingested contents through the cuff;
a first plurality of apertures near the proximal end of the tubular body, the first plurality of apertures configured to receive tissue anchor tension elements; and
a coupler near the distal end of the tubular body, the coupler configured to removably receive an attachment element on the endoluminal bypass tube for connection to the endoluminal bypass tube.
2. The attachment cuff of claim 1 , wherein the cuff comprises an elastomeric material that provides approximately 150% or more stretch in the radial direction.
3. The attachment cuff of claim 1 , further comprising a reinforcing structure around each of the first plurality of apertures, the reinforcing ring reinforcing the first plurality of apertures to maintain proper positioning of the cuff and the endolumenal bypass tube attached to the cuff with respect to the tissue anchor tension elements.
4. The attachment cuff of claim 3 , wherein the reinforcing structure comprises a ring.
5. The attachment cuff of claim 4 , wherein the reinforcing ring comprises stitching around the perimeter of the apertures.
6. The attachment cuff of claim 1 , wherein each of the first plurality of apertures is spaced the same distance apart from the proximal end of the tubular body.
7. The attachment cuff of claim 1 , wherein the cuff is permeable to body fluids.
8. The attachment cuff of claim 1 , wherein the cuff is substantially impermeable to body fluids.
9. The attachment cuff of claim 1 , wherein the cuff has an inside diameter that is less than the inside diameter of the esophagus.
10. The attachment cuff of claim 1 , wherein the cuff has an inside diameter that is equal to or greater than the inside diameter of the esophagus.
11. The attachment cuff of claim 3 , wherein the reinforcing structure comprises a rib.
12. The attachment cuff of claim 1 , wherein the coupler comprises a hook.
13. The attachment cuff of claim 1 , wherein the coupler comprises a clip.
14. The attachment cuff of claim 1 , wherein the coupler comprises a plurality of coupling elements.