Intragastric implant devices

Abstract

An intragastric anchor implant device is provided with a substantially rigid member having proximal and distal ends and atraumatic tips or features disposed near the proximal and distal ends. The atraumatic features prevent damage to the tissues of the stomach and the gastrointestinal track and may help to anchor the device in the stomach, while the substantially rigid member resists bending so as to engage a tissue of the stomach or the gastrointestinal tract to prevent passage through the stomach. The anchor implant device is coupled with a therapeutic device, typically a sleeve, such as an intestinal bypass sleeve. Ideally, the device includes a sliding seal to direct a flow of food particles from the stomach through the sleeve, so as to be useful in treating a disorder, including obesity and diabetes. Methods of deploying the anchor implant devices are also disclosed.

What is claimed is: 
     
         1 . A method for treating a patient having a metabolic related disorder, said method comprising:
 deploying an implant within a gastrointestinal tract of the patient so that a proximal end of an anchor of the implant is disposed within a stomach of the patient, the anchor having a proximal atraumatic feature at the proximal end and a distal atraumatic feature at a distal end with an elongate element extending therebetween;   supporting a sleeve of the implant with the anchor so that the sleeve extends along an intestine of the patient, and so that a flow including ingested matter enters a lumen of the sleeve from the stomach, the flow being in contact with a wall of the stomach;   inhibiting advancement of the anchor around a bend of the intestine near the stomach by engaging a proximal portion of the anchor against a surface area of a mucosa of the stomach, by engaging a distal feature of the anchor against a surface area of the gastrointestinal tract distal of the mucosal surface area and by resisting bending of the elongate element between the proximal and distal ends;   advancing the flow along the intestine within the lumen of the sleeve, the ingested matter comprising ingested nutrients and particles of food.   
     
     
         2 . The method of  claim 1 , wherein the flow further comprises stomach secretions. 
     
     
         3 . The method of  claim 1 , wherein the proximal portion of the anchor comprises the proximal atraumatic feature. 
     
     
         4 . The method of  claim 1 , wherein engagement of the surface areas with the proximal and distal portions of the anchor substantially limits the displacement of a longitudinal axis of the anchor so as to maintain a position of the anchor within the stomach and to prevent passage of the anchor through the gastrointestinal tract. 
     
     
         5 . The method of  claim 1 , wherein the sleeve comprises an intestinal bypass sleeve having a lumen extending between a proximal opening and a distal opening, wherein the sleeve comprises a material substantially impenetrable to the flow of the ingested matter advancing therethrough when the ingested matter enters the sleeve from within the stomach and advances along the lumen of the sleeve so as to inhibit contact of the flow with an intestinal wall along the sleeve such that the disorder is mitigated. 
     
     
         6 . The method of  claim 5 , wherein the disorder comprises diabetes, and wherein the sleeve is substantially impenetrable to chyme advanced through the lumen of the sleeve so as to inhibit production of a hormone affecting the diabetes. 
     
     
         7 . The method of  claim 5 , wherein deploying the implant is performed such that the anchor extends across the pyloric valve such that the distal end of the anchor is positioned distal of the pyloric valve in a proximal portion of the duodenum and the proximal end of the anchor is positioned in the stomach, the gastrointestinal surface area comprising a lumenal area of the duodenum. 
     
     
         8 . The method of  claim 7 , wherein the elongate element between the ends has a profile smaller than the sleeve, and further comprising radially supporting the proximal opening of the sleeve with the distal feature of the anchor, wherein the distal feature extends laterally from the elongate element of the anchor to the sleeve so that a majority of the flow advances around the elongate element and through the pyloric valve, and enters the proximal opening and advances within the sleeve. 
     
     
         9 . The method of  claim 8 , wherein the distal feature comprises an array of projections extending radially between the elongate element and the proximal opening, and wherein the projections compliantly deflect within the gastrointestinal tract so to spread anchoring loads across the area of the duodenum. 
     
     
         10 . The method of  claim 9 , wherein the anchoring loads are forces exerted on the anchor by a tissue of the stomach or gastrointestinal tract substantially imparted by gastric motility. 
     
     
         11 . The method of  claim 8 , wherein the distal feature comprises a plurality of flexible struts, and wherein the struts compliantly deflect within the gastrointestinal tract while urging the proximal opening of the sleeve radially outwardly toward the surrounding duodenum. 
     
     
         12 . The method of  claim 5 , wherein deploying the implant is performed such that a distal end of the anchor is positioned within the stomach proximal of the pyloric valve and the proximal end of the anchor is positioned in the stomach. 
     
     
         13 . The method of  claim 12 , further comprising:
 expanding the distal atraumatic feature so as to increase a profile of the distal feature so as to prevent passage of the distal feature across the pyloric valve.   
     
     
         14 . The method of  claim 5 , wherein supporting the sleeve comprises axially restraining the sleeve with a flexible connector extending distally from the anchor toward the sleeve, and radially supporting the proximal opening of the sleeve with a compliant coupling support extending laterally from the flexible connector, and wherein deploying the implant comprises positioning the sleeve so that the proximal opening is located in the duodenum, 
     
     
         15 . The method of  claim 5 , wherein the implant includes a sliding seal circumscribing the proximal opening of the sleeve, and wherein positioning the sleeve comprises positioning the sliding seal in a proximal portion of a duodenum of the patient to sealingly engage an inner wall of the duodenum so as to direct the flow from the stomach through the proximal opening into the lumen of the sleeve. 
     
     
         16 . The method of  claim 5 , wherein the implant includes a sliding seal circumscribing the proximal opening of the sleeve, and wherein positioning the proximal opening comprises positioning the sliding seal in the antrum of the stomach to sealingly engage an inner wall of the antrum so as to direct a fluid or solid flowing from the stomach through the proximal opening into the lumen of the implant. 
     
     
         17 . The method of  claim 1 , further comprising radially constraining at least one of the proximal feature or the distal feature in a small profile configuration and releasing the at least one feature to expand elastically radially outwardly into a large profile configuration for use of the implant within the gastrointestinal tract. 
     
     
         18 . An implant for treating a patient having a metabolic related disorder, said implant comprising:
 an anchor having an elongate element extending between a proximal end and a distal end, a proximal atraumatic feature disposed near the proximal end, and a distal atraumatic feature disposed near the distal end;   the proximal atraumatic feature configured to inhibit tissue trauma when urged against a surface area along a mucosa of a stomach of the patient, the distal atraumatic feature configured to inhibit tissue trauma when urged against a surface of a gastrointestinal tract of the patient, and the elongate element being substantially rigid so as to resist bending between the proximal and distal ends and sufficiently long so that the anchor is configured to inhibit advancement of the anchor around a bend of the intestine near the stomach when under the anchoring loads; and   an intestinal bypass sleeve having a lumen extending between a proximal opening and a distal opening, wherein the sleeve comprises a material substantially impenetrable to a flow including ingested matter when passed through the lumen, the flow of matter being in contact with a wall of the stomach, the proximal opening supported distally of the proximal end of the anchor so that the flow flows from within the stomach into the lumen.   
     
     
         19 . The method of  claim 18 , wherein the flow comprises chyme including stomach secretions, ingested nutrients and food particles, wherein the disorder comprises diabetes, and wherein the sleeve is further substantially impenetrable to the flow and is configured so as to inhibit production of a hormone affecting diabetes within the intestine. 
     
     
         20 . The implant of  claim 18 , wherein the distal feature is sized and configured to be advanced through a pyloric valve of the patient such that, when implanted, the distal end of the anchor is distal of the pyloric valve in a proximal portion of a duodenum and the proximal end of the anchor is in the stomach, the distal surface area comprising a lumenal area of the duodenum.