Cuff and sleeve system for gastrointestinal bypass
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. A gastrointestinal implant system, for providing an endolumenal bypass from a patient's gastroesophageal junction to the patient's intestine, comprising:
a flexible, tubular attachment cuff, having a proximal end and a distal end;
a first plurality of apertures in the proximal end of the tubular attachment cuff, for receiving tissue anchor tension elements;
an elongate, flexible bypass sleeve, separate from the cuff;
a first attachment structure on the distal end of the attachment cuff, for attaching the cuff to the bypass sleeve;
a second attachment structure on the proximal end of the bypass sleeve, for cooperating with the first attachment structure to attach the cuff to the sleeve; wherein the first attachment structure on the attachment cuff is configured to removably attach the cuff to the bypass sleeve; and
an everting tool, configured to transform the bypass sleeve from a first, at least partially inverted configuration to a second everted configuration.
2. The gastrointestinal implant system of claim 1 , wherein the sleeve comprises a length of at least about 50 cm.
3. The gastrointestinal implant system of claim 1 , further comprising a reinforcement element configured to distribute the force of at least one of the anchor tension elements across a surface area.
4. The gastrointestinal implant system of claim 3 , wherein the reinforcement element comprises a T-tag.
5. The gastrointestinal implant system of claim 1 , wherein the first attachment structure comprises a first retention surface, and the second attachment structure comprises a second retention surface, the first retention surface configured to engage with the second retention surface to limit movement of a proximal end of the sleeve relative to the cuff when a distal end of the sleeve is advanced through a central lumen of the cuff.
6. The gastrointestinal implant system of claim 1 , wherein the first attachment structure comprises a flange configured to engage with the second attachment structure.
7. The gastrointestinal implant system of claim 1 , wherein at least one of the first attachment structure or the second attachment structure comprises a second plurality of apertures extending through a wall of said attachment cuff or tubular sleeve.
8. The gastrointestinal implant system of claim 1 , wherein at least one of the first attachment structure or the second attachment structure comprises a plurality of connectors for attaching the cuff to the bypass sleeve.
9. The gastrointestinal implant system of claim 8 , wherein at least one of the plurality of connectors is selected from the group consisting of: a suture, hook, and a clip.
10. The gastrointestinal implant system of claim 1 , wherein the first attachment structure comprises an annular ring.
11. The gastrointestinal implant system of claim 1 , wherein the first attachment structure and the second attachment structure are configured to allow the sleeve to be removed from the cuff while the attachment cuff is attached within a gastrointestinal tract of a patient.
12. The gastrointestinal implant system of claim 1 , wherein the everting tool comprises a source of everting media.
13. The gastrointestinal implant system of claim 12 , wherein the everting media comprises a source of liquid everting media.