Variable Size Intragastric Implant Devices

Abstract

Transoral obesity treatment devices and related methods for operation thereof are described which occupy space within a stomach and/or stimulate the stomach wall. The transoral obesity treatment devices and related methods are intended to assist a patient in maintaining a healthy body weight. Features of the devices include insertion transorally and without invasive surgery, without associated patient risks of invasive surgery, and without substantial patient discomfort. The life span of these devices may be material-dependent upon long-term survivability within an acidic stomach, but is intended to last one year or longer. The devices have the capacity to vary in size and are desirably self-actuating in that they change shape and/or volume using internal motors or actuators. The changing character of the devices helps prevent the person's stomach from compensating for the implant, such as sometimes happens with static intragastric devices.

1 .- 11 . (canceled) 
     
     
         12 . A system for an implantable device of a size too large to pass through an opening of a patient's pylorus configured to be placed in a patient's stomach transorally without surgery to treat and prevent obesity by occupying space inside the patient's stomach, comprising:
 an elastic balloon configured to be variably filled with stomach liquid; and   a body of the implantable device attached to the elastic balloon, the body configured to inflate and deflate the elastic balloon by transferring stomach liquid into and out of the elastic balloon; and   a peristaltic pumping device housed within the body of the implantable device configured to transfer the stomach liquid from outside the elastic balloon to inside the elastic balloon in a first mode of operation, and further configured to transfer the stomach liquid from inside the elastic balloon to outside the elastic balloon in a second mode of operation.   
     
     
         13 . The system of  claim 12 , wherein the body of the implantable device further houses a motor configured to operate the peristaltic pumping device. 
     
     
         14 . The system of  claim 13 , wherein the motor rotates rollers that are in contact with a pair of flexible tubes that form a conduit between an external opening located outside the elastic balloon and an internal opening located within the inner cavity of the elastic balloon. 
     
     
         15 . The system of  claim 12 , further comprising:
 an aseptic ring configured to fit around a portion of the exterior of the body and contact the stomach liquid when the stomach liquid is inside the elastic balloon.   
     
     
         16 . The system of  claim 12 , wherein the device further comprises a control circuit board having a battery and a memory. 
     
     
         17 . The system of  claim 12 , wherein the device further comprises a control circuit board having a transceiver, and the system further includes a remote control for instructing the motor from outside the patient's body. 
     
     
         18 . The system of  claim 12 , wherein the elastic balloon includes uneven external surface stimulation features. 
     
     
         19 . The system of  claim 12 , wherein the elastic balloon includes an aggregation of spheres to encourage rotation within the stomach. 
     
     
         20 . The system of  claim 12 , wherein the elastic balloon includes a plurality of outwardly projecting legs terminating in rounded or bulbous feet that encourage rotation within the stomach. 
     
     
         21 . The system of  claim 12 , wherein the body has an outer surface that defines at least one opening in fluid communication with the peristaltic pump, the at least one hole constructed for transferring the stomach fluid in either of the first or second configurations. 
     
     
         22 . The system of  claim 12 , wherein the body has a length extending from a top and a bottom and the balloon spans almost the entire length of the body. 
     
     
         23 . The system of  claim 22 , wherein the top and the bottom are maintained outside of the balloon. 
     
     
         24 . The system of  claim 23 , wherein at least one of the top and the bottom defines at least one hole that is in fluid communication with the peristaltic pump, the hole constructed for transferring the stomach fluid in either of the first or second configurations. 
     
     
         25 . The system of  claim 12 , wherein the body defines at least one hole surrounded by the elastic balloon, the at least one hole being in fluid communication with the peristaltic pump. 
     
     
         26 . The system of  claim 22 , wherein the body is tubular having opposed ends and wherein the balloon is sealed to the body near the opposed ends. 
     
     
         27 . The system of  claim 16 , wherein:
 the control board includes a sensor configured to detect a current volume of the elastic balloon.   
     
     
         28 . The system of  claim 16 , wherein:
 the control board is configured to control the peristaltic pump in at least one of the first and second configurations.   
     
     
         29 . A method of controlling the volume of an inflatable device of a size too large to pass through an opening of a patient's pylorus configured to be placed in a patient's stomach transorally without surgery to treat and prevent obesity by occupying space inside the patient's stomach, the method comprising:
 i. accessing an inflation schedule including inflation volumes and corresponding times of adjustment;   ii. determining a target inflation volume according to the accessed inflation schedule;   iii. adjusting the volume based on the determined target inflation volume and the current inflation volume;   iv. determining whether or not a trigger to change the inflation volume is detected, wherein
 if the trigger is detected, repeating steps ii, iii, and iv based upon the trigger, and 
 if the trigger is not detected, maintaining the volume adjusted in step iii. 
   
     
     
         30 . The method according to  claim 29 , wherein:
 the trigger includes an inflation command that overrides the inflation schedule.   
     
     
         31 . The method according to  claim 29 , wherein:
 the trigger is based on the an inflation volume change dictated by the inflation schedule.   
     
     
         32 . The method according to  claim 30 , wherein:
 the inflation command includes a command to change the length of the elastic balloon.