DEVICES AND METHODS FOR GASTROINTESTINAL BYPASS
Gastrointestinal bypass devices are described. A gastrointestinal bypass device may comprise a cuff configured to be placed at least partially in an esophagus of the patient, and a sleeve configured to be placed at least partially in a stomach of the patient. In one embodiment, the gastrointestinal bypass device may also comprise a tether coupled to the cuff and/or the sleeve. The tether may be configured to be placed through a fistula between an esophagus and a skin of the patient. The tether may have a length sufficient to extend from the cuff and/or the sleeve to the skin.
1 . A gastrointestinal bypass device, comprising:
a cuff configured to be placed at least partially in an esophagus of the patient;
a sleeve coupled to the cuff, the sleeve configured to be placed at least partially in a stomach of the patient; and
a tether having a distal portion coupled to the cuff and/or the sleeve, the tether configured to be placed through a fistula between an esophagus and a skin of the patient, the tether having a length sufficient to extend from the cuff and/or the sleeve to the skin.
2 . The device of claim 1 , wherein the tether has a length of 10 cm to 30 cm.
3 . The device of claim 1 , wherein the tether has a thickness of at least 8 Fr (2.67 mm) where the tether passes through a wall of the esophagus.
4 . The device of claim 1 , wherein the tether has a bending stiffness configured to hold the tether away from an inside of the esophageal wall where the tether passes through a wall of the esophagus.
5 . The device of claim 1 , wherein the tether has a bending stiffness configured to not allow the tether to rest against an inside of the esophageal wall immediately below where the tether passes through a wall of the esophagus.
6 . The device of claim 1 , wherein the tether has an outer surface that is soft.
7 . The device of claim 1 , wherein the tether has an outer surface with a hardness of Shore 70A to Shore 100A.
8 . The device of claim 1 , wherein the tether elongates less than 10% under tension.
9 . The device of claim 1 , wherein the tether includes a tube.
10 . The device of claim 9 , wherein the tube is reinforced with a mesh and/or a braid.
11 . The device of claim 1 , wherein the tether includes one or more lumens.
12 . The device of claim 1 , wherein a proximal portion of the tether is tapered.
13 . The device of claim 1 , further comprising:
a pull tab coupled to a proximal portion of the tether.
14 . The device of claim 1 , further comprising:
a tether anchor configured to be coupled to a proximal portion of the tether, the tether anchor configured to secure the proximal portion of the tether to an anchor site.
15 . The device of claim 14 , wherein the tether anchor is configured to be placed on the skin.
16 . The device of claim 15 , wherein the tether anchor includes a skin button.
17 . The device of claim 14 , wherein the tether anchor is configured to be placed under the skin.
18 . The device of claim 17 , wherein the tether anchor includes one or more barbed sutures.
19 . The device of claim 14 , wherein the tether anchor is configured to be placed in the fistula.
20 . A gastrointestinal bypass device, comprising:
a cuff configured to be placed at least partially in an esophagus of the patient;
a sleeve coupled to the cuff, the sleeve configured to be placed at least partially in a stomach of the patient; and
a tether means coupled to the cuff and/or the sleeve, the tether means configured to maintain the cuff and the sleeve in a particular portion of the gastrointestinal tract.
21 - 40 . (canceled)