Flow control method and device

Abstract

Apparatus and methods are provided comprising an implantable non-hydraulic ring that encircles and provides a controllable degree of constriction to an organ or duct and an external control that powers and controls operation of the ring. The ring includes a rigid dorsal periphery that maintains a constant exterior diameter, and a compliant constriction system that reduces intolerance phenomena. A high precision, energy efficient mechanical actuator is employed that is telemetrically powered and controlled, and maintains the ring at a selected diameter when the device is unpowered, even for extended periods. The actuator provides a reversible degree of constriction of the organ or duct, which is readily ascertainable without the need for radiographic imaging. Methods of use and implantation also are provided.

1 . A laparoscopically implanted adjustable gastric banding device for encircling a stomach of a patient for the treatment of obesity, comprising:
 an elongated member having a first end and a second end, the elongated member configured to make atraumatic contact with the stomach of the patient when encircling the stomach;   a clip disposed on the first end of the elongated member, the clip having a slot and a tab; and   a flange disposed on the second end of the elongated member, the flange configured to engage the slot so that the elongated member encircles an upper part of the stomach of the patient to form a stoma;   wherein the elongated member for encircling the stomach is configured to have an adjustable interior diameter facing the stomach and an exterior diameter facing away from the stomach, the exterior diameter configured to resist changing when the interior diameter is adjusted.   
     
     
         2 . The gastric banding device of  claim 1  further comprising a tube coupled to the elongated member, wherein the tube is configured to facilitate adjustment of the interior diameter of the elongated member. 
     
     
         3 . The gastric banding device of  claim 2  further comprising a pod coupled to the tube and configured to interface outside the body of the patient for controlling the adjustment of the interior diameter of the elongated member. 
     
     
         4 . The gastric banding device of  claim 1  wherein the elongated member is configured to encircle the upper part of the stomach of the patient in a substantially circular loop. 
     
     
         5 . A method of laparoscopically implanting a gastric banding device within an abdominal cavity and around a stomach of a patient, the method comprising:
 providing a gastric banding device having an elongated member, the elongated member having a first end and a second end, the first end having a slot, the second end having a flange configured to engage the slot so that the elongated member encircles the stomach of the patient, wherein the elongated member encircling the stomach has an adjustable interior diameter facing the stomach and an exterior diameter facing away from the stomach, the exterior diameter configured to resist changing when the interior diameter is adjusted;   creating a plurality of incisions into the abdominal cavity of the patient;   establishing a pneumoperitoneum by insufflating the abdominal cavity of the patient;   inserting a tool into at least one of the plurality of incisions to create a path for the elongated member around the stomach;   inserting the elongated member into the abdominal cavity;   positioning the elongated member around the stomach of the patient; and   engaging the flange on the second end of the elongated member with the slot on the first end of the elongated member for wrapping the elongated member around an upper part of the stomach to form a stoma.   
     
     
         6 . The method of  claim 5  wherein the plurality of incisions are 10-18 mm in diameter and further comprising inserting at least one trocar into at least one of the plurality of incisions. 
     
     
         7 . The method of  claim 5  wherein positioning the elongated member around the stomach of the patient comprises using laparoscopic instruments to grasp the elongated member. 
     
     
         8 . The method of  claim 5  wherein insufflating the abdominal cavity of the patient comprises filling the abdominal cavity with carbon dioxide gas. 
     
     
         9 . The method of  claim 5  further comprising inserting a camera into at least one of the plurality of incisions. 
     
     
         10 . The method of  claim 5  further comprising:
 providing a pod and a tube coupled between the pod and the elongated member; 
 inserting the pod and the tube into the abdominal cavity; and 
 fastening the pod to a location within the body of the patient. 
 
     
     
         11 . A laparoscopically implanted adjustable gastric banding device for encircling a stomach of a patient for the treatment of obesity, comprising:
 an elongated member having a first end and a second end, the elongated member configured to make atraumatic contact with the stomach of the patient along an interior diameter of the elongated member when encircling the stomach;   a clip disposed on the first end of the elongated member, the clip having a slot;   a flange disposed on the second end of the elongated member, the flange configured to engage the slot so that the elongated member encircles an upper part of the stomach of the patient to form a stoma; and   an antenna coupled to the elongated member for enabling telemetric control of the interior diameter of the elongated member;   wherein the elongated member for encircling the stomach is configured to have an exterior diameter facing away from the stomach that resists changes in size during adjustment of the interior diameter.   
     
     
         12 . The gastric banding device of  claim 11  further comprising an external control positioned outside the body of the patient and configured to provide power and control signals to the antenna for adjusting the interior diameter of the elongated member. 
     
     
         13 . The gastric banding device of  claim 12  further comprising a patient microchip card for storing identification and adjustment data, the patient microchip card configured to interface with the external control. 
     
     
         14 . The gastric banding device of  claim 11  further comprising a spring coupled with the elongated member for allowing temporary expansion of the interior diameter of the elongated member during convulsive activity of the stomach. 
     
     
         15 . The gastric banding device of  claim 11  further comprising a reference position switch, the reference position switch activated when the interior diameter of elongated member is in the fully open configuration when encircling the stomach. 
     
     
         16 . The gastric banding device of  claim 11  further comprising:
 a tension element slidably positioned within the elongated member; and 
 an actuator coupled to the antenna, the actuator configured to engage the tension element within the elongated member for adjusting the interior diameter of the elongated member. 
 
     
     
         17 . The gastric banding device of  claim 16  wherein the tension element comprises screw threads defining a screw thread pitch. 
     
     
         18 . The gastric banding device of  claim 17  wherein the actuator comprises a motor coupled with a nut, the nut configured to rotatably engage the screw threads of the tension element. 
     
     
         19 . The gastric banding device of  claim 17  wherein the antenna telemetrically transmits the interior diameter of the elongated member to the external control, the interior diameter computed as a function of the screw thread pitch and the engagement with the actuator. 
     
     
         20 . The gastric banding device of  claim 17  wherein the tension element is configured to maintain a substantially constant screw thread pitch when the tension element is subjected to bending.