Stomach-Spanning Gastric Implants
A variety of passive intragastric implant devices for obesity treatment are disclosed. Such passive implants do not autonomously change shape, but instead react within the stomach to induce satiety. The implants may take up volume within the stomach, thus reducing the digestive capacity. Additionally, the implants may contact areas within the stomach, such as the cardia surrounding the esophageal sphincter, to stimulate satiety-inducing nerves. Also, a number of implants slow gastric emptying by blocking or otherwise impeding flow through the pyloric sphincter. Other implants delay digestion by providing a duodenal sleeve. A number of implants combine two or more of these satiety-inducing features. Methods of implant are disclosed including compressing the implants within a delivery tube and transorally advancing the implants through the esophagus to be deployed within the stomach. Removal of the implants occurs in the reverse.
1 . A passive intragastric obesity treatment implant, comprising:
a cardia flange sized and shaped to conform to a cardia region of the stomach and resist passage through the esophageal sphincter and having a central through hole centered at the esophageal sphincter through which food passes;
an antrum stent sized and shaped to seat within the antrum; and
a plurality of struts connecting the cardia flange and antrum stent that are flexible enough to straighten out and be passed transorally down an access tube, while also being somewhat stiff to provide light pressure to both the cardia flange and antrum stent on each end, the struts of sufficient length to cause the cardia flange and the antrum stent to provide slight pressure against the cardia and the antrum,
the implant being formed of materials that permit it to be compressed into a substantially linear transoral delivery configuration and that will resist degradation over a period of at least six months within the stomach.
2 . The implant of claim 1 , wherein the cardia flange is a flexible, flat partial conical ring that includes a central through hole.
3 . The implant of claim 1 , wherein the cardia flange comprises a braided wire mesh covered with a soft polymer.
4 . The implant of claim 3 , wherein the braided wire mesh includes nitinol wires, and the polymer is a silicone.
5 . The implant of claim 1 , wherein the antrum stent comprises a braided wire mesh covered with a soft polymer.
6 . The implant of claim 5 , wherein the braided wire mesh includes nitinol wires, and the polymer is a silicone.
7 . The implant of claim 1 , wherein the cardia flange comprises a solid silicone member with wire reinforcements.
8 . The implant of claim 1 , wherein the antrum stent comprises a solid silicone member with wire reinforcements.
9 . The implant of claim 1 , further comprising a narrow neck region attached to a distal end of the antrum stent that fits within the pylorus.
10 . The implant of claim 1 , further comprising a duodenal stent connected in series with the antrum stent at a narrow neck region such that the antrum stent, neck region, and duodenal stent conforms closely to the antrum, pylorus and upper end of the duodenum.
11 . The implant of claim 1 , wherein the plurality of struts consists of three struts.
12 . The implant of claim 1 , wherein the entire implant is made of silicone and nitinol.
13 . A passive intragastric obesity treatment implant, consisting of:
a cardia flange sized and shaped to conform to a cardia region of the stomach and resist passage through the esophageal sphincter and having a central through hole centered at the esophageal sphincter through which food passes;
an antrum stent sized and shaped to seat within the antrum; and
a plurality of struts connecting the cardia flange and antrum stent that are flexible enough to straighten out and be passed transorally down an access tube, while also being somewhat stiff to provide light pressure to both the cardia flange and antrum stent on each end, the struts of sufficient length to cause the cardia flange and the antrum stent to provide slight pressure against the cardia and the antrum,
the implant being formed of materials that permit it to be compressed into a substantially linear transoral delivery configuration and that will resist degradation over a period of at least six months within the stomach.
14 . A passive intragastric obesity treatment implant, consisting of:
a cardia flange sized and shaped to conform to a cardia region of the stomach and resist passage through the esophageal sphincter and having a central through hole centered at the esophageal sphincter through which food passes;
an antrum stent sized and shaped to seat within the antrum;
a duodenal stent connected in series with the antrum stent at a narrow neck region such that the antrum stent, neck region, and duodenal stent conforms closely to the antrum, pylorus and upper end of the duodenum; and
a plurality of struts connecting the cardia flange and antrum stent that are flexible enough to straighten out and be passed transorally down an access tube, while also being somewhat stiff to provide light pressure to both the cardia flange and antrum stent on each end, the struts of sufficient length to cause the cardia flange and the antrum stent to provide slight pressure against the cardia and the antrum,
the implant being formed of materials that permit it to be compressed into a substantially linear transoral delivery configuration and that will resist degradation over a period of at least six months within the stomach.