Systems and methods for locating and/or characterizing intragastric devices

Abstract

Devices and methods for treating obesity are provided. More particularly, intragastric devices and methods of tracking and locating the same are provided.

What is claimed is: 
     
         1 . A system for electromagnetically locating an intragastric device in three dimensional space, in real time, the system comprising:
 a) an electromagnetic field generator configured to generate an electromagnetic field;   b) a removably attachable inductive reference sensor adapted to be removably attached to a body positioned within the electromagnetic field, whereby a reference sensor signal is generated and the reference sensor signal carries reference sensor position information associated with a position of the reference sensor within the electromagnetic field at an instance in time;   c) a swallowable target sensor adapted to be positioned within the electromagnetic field, whereby a target sensor signal is generated and the target sensor signal carries target sensor position information associated with a position of the target sensor within the electromagnetic field at the instance in time;   d) a processor adapted to be in electronic communication with the reference sensor and the target sensor, so as to receive the reference sensor signal and the target sensor signal; wherein
 i) the processor processes the reference sensor signal so as to create one or more reference indicia associated with the position of the reference sensor at the instance in time; and 
 ii) the processor processes the target sensor signal so as to create one or more target indicia associated with the position of the target sensor at the instance in time; and 
   e) a display adapted to be in electronic communication with the processor and configured to display the one or more reference indicia and the one or more target indicia.   
     
     
         2 . The system of  claim 1 , wherein the instance in time comprises a plurality of instances in time. 
     
     
         3 . The system of  claim 2 , wherein
 a) the processor iteratively processes the received reference sensor signal information associated with the plurality of instances in time, so as to generate a first series of indicia associated with each of the plurality of instances in time,   b) the processor iteratively processes the received target sensor position information associated with the plurality of instances in time, so as to generate a second series of indicia associated with each of the plurality of instances in time; and   c) the display displays the first series of indicia and the second series of indicia.   
     
     
         4 . The system of  claim 1 , wherein the one or more reference indicia and/or the one or more target indicia comprise at least one of:
 a) a graphical representation associated with the body, and   b) a reference sensor icon.   
     
     
         5 . The system of  claim 1 , wherein the position of the target sensor inside the body is the stomach. 
     
     
         6 . The system of  claim 1 , further comprising a swallowable intragastric device comprising the target sensor. 
     
     
         7 . The system of  claim 6 , wherein, when the target sensor is swallowed, the target sensor position information is associated with the locations of the target sensor at each of the plurality of instances in time. 
     
     
         8 . The system of  claim 6 , wherein the swallowable intragastric device comprises a swallowable inflatable intragastric balloon and an inflation catheter. 
     
     
         9 . The system of  claim 6 , wherein the swallowable intragastric device comprises an inflation catheter, wherein a distal end of the inflation catheter comprises the target sensor. 
     
     
         10 . The system of  claim 6 , wherein the swallowable intragastric device comprises an intragastric balloon. 
     
     
         11 . The system of  claim 10 , wherein the intragastric balloon comprises
 a) a polymeric wall comprising one or more layers, wherein the polymeric wall is configured to have, under in vivo conditions, a permeability to CO 2  of more than 10 cc/m 2 /day, and wherein the polymeric wall is configured such that, in vivo, the balloon is configured to gain in volume and in pressure during a useful life of the intragastric balloon when filled with the initial fill gas;   b) a valve system configured for introducing the initial fill gas into the balloon in vivo; and   c) an initial fill gas consisting of one or more inert gasses selected from the group consisting of nitrogen, SF 6 , C 2 F 6 , C 3 F 8 , C 4 F 10 , C 4 F 8 , C 4 F 8 , C 3 F 6 , CF 4 , and C(ClF 2 )—CF 3 .   
     
     
         12 . A method for electromagnetically locating an intragastric device inside the body of a patient, the method comprising:
 a) placing a reference sensor on a fixed location on a surface of a patient's body, wherein the reference sensor is configured to:
 i) sense an electromagnetic field directed at the body of a patient, and 
 ii) produce a reference sensor signal in response to the sensed electromagnetic field, wherein 
 ii) the reference sensor signal is associated with the reference sensor location; 
   c) positioning a target sensor on the patient's body, wherein the target sensor:
 i) senses the electromagnetic field, and 
 ii) produces a target sensor signal in response to the sensed electromagnetic field, wherein 
 iii) the target sensor signal is associated with a plurality of target sensor locations along the path; 
   d) creating one or more indicia by processing the signal associated with the locations of the reference and target sensors with a processor;   e) introducing an intragastric device into the body of the patient, via swallowing, wherein the target sensor is releasably coupled with the intragastric device;   f) producing a target sensor signal associated with a plurality of intragastric device locations within the patient's body;   g) confirming a location of the intragastric device inside the patient's body based on the signal associated with the plurality of intragastric device locations within the patient's body; and   h) displaying, on a display, the one or more indicia and an icon indicative of a current location of the intragastric device.   
     
     
         13 . The method of  claim 12 , wherein the one or more indicia comprises at least one of:
 a) a graphical representation associated with the patient's body, and   b) a reference sensor icon.   
     
     
         14 . The method of  claim 12 , wherein confirming a location of the intragastric device inside the patient's body based further comprises at least one of:
 a) on a display, observing one or more target sensor indicia offsetting left of lateral from an initial vertical track;   b) on the display, observing the track suddenly accelerate left of lateral;   c) on the display, observing rotation of the one or more target sensor indicia rotation from a vertical configuration to a horizontal configuration; and   d) on the display, observing vertical movement of the one or more target sensor indicia upon patient deep respiration.   
     
     
         15 . The method of  claim 12 , wherein the location of the intragastric device inside the patient's body is the patient's stomach. 
     
     
         16 . The method of  claim 12 , further comprising:
 a) when the icon is displayed in a position relative to the one or more indicia, wherein the displayed position is indicative of the intragastric device being in the patient's stomach, introducing an initial fill fluid into a lumen of the intragastric device through a releasable fluidly coupled catheter, whereby the intragastric device is inflated; and   b) exposing the inflated intragastric device to the in vivo intragastric environment for a useful life of at least 30 days.   
     
     
         17 . The method of  claim 16 , wherein the polymeric wall of the inflated intragastric device in the in vivo gastric environment has a permeability to CO 2  of more than 10 cc/m 2 /day, and comprises a three layer CO 2  barrier material comprising a nylon layer, a polyvinylidene chloride layer, and a polyethylene layer. 
     
     
         18 . The method of  claim 16 , wherein the polymeric wall of the inflated intragastric device in the in vivo gastric environment has a permeability to CO 2  of more than 10 cc/m 2 /day, and comprises a three layer CO 2  barrier material comprising a nylon layer, an ethylene vinyl alcohol layer, and a polyethylene layer. 
     
     
         19 . The method of  claim 16 , wherein the polymeric wall of the inflated intragastric device in the in vivo gastric environment has a permeability to CO 2  of more than 10 cc/m 2 /day, and comprises a two layer CO 2  barrier material comprising a nylon layer and a polyethylene layer. 
     
     
         20 . The method of  claim 16 , wherein the polymeric wall of the inflated intragastric device in the in vivo gastric environment has a permeability to CO 2  of more than 10 cc/m 2 /day, and comprises a CO 2  barrier material comprising an ethylene vinyl alcohol layer. 
     
     
         21 . The method of  claim 16 , wherein the initial fill fluid comprises SF 6  in one or more of liquid form, vapor form, or gaseous form. 
     
     
         22 . The method of  claim 16 , wherein the initial fill fluid comprises gaseous N 2  and gaseous SF 6 . 
     
     
         23 . The method of  claim 16 , wherein the polymeric wall of the inflated intragastric device has, under conditions of an in vivo gastric environment, a permeability to CO 2  of more than 50 cc/m 2 /day. 
     
     
         24 . The method of  claim 16 , wherein the target sensor is coupled with the catheter.