Submucosal gastric implant device and method

Abstract

A device, system and method for diagnosing and treating gastric disorders is provided. A submucosal gastric implant device is placed within the submucosal layer of a patient's stomach wall. The device in one embodiment provides electrical stimulation of the stomach wall and may use multiple electrode pairs for sequential stimulation. The device may also have other functional aspects such as a sensor for sensing various parameters of the stomach or stomach environment, or a therapeutic delivery device. The implant may be programmed to respond to sensed information or signals. The device may be modular with a portion of the device accessible outside the stomach wall for removal and replacement. An endoscopic delivery system prepares and delivers the functional device through the esophagus and into the stomach where it is placed through an opening in the mucosa into the submucosal layer of the stomach wall. The endoscopic instruments may be used to prepare a cavity in the submucosal layer of the stomach wall and deliver the device to the prepared cavity and if appropriate close the opening in the mucosa.

What is claimed is: 
     
         1 . A method for implanting a device in a stomach wall comprising the steps of:
 providing an implant device for treating or diagnosing a condition of the stomach;   forming an opening in the stomach wall to access the submucosal layer; and   inserting the implant device into the submucosal layer.   
     
     
         2 . The method for implanting a device in a stomach wall of  claim 1  wherein the step of providing an implant device comprises providing a gastric stimulator comprising a housing having at least one stimulating electrode thereon, sA/C stimulator being configured to provide electrical stimulation pulses to the stomach wall when in electrical contact with the stomach wall. 
     
     
         3 . The method for implanting a device in the stomach wall of  claim 2  wherein the step of providing a stimulator comprises providing an electronic circuit with the stimulator wherein the electronic circuit is configured to telemetrically communicate with an external controller arranged to control the electrical stimulation pulses to the stomach wall. 
     
     
         4 . The method for implanting a device in the stomach wall of  claim 2  wherein the step of providing a stimulator comprises providing a sensor on the housing and an electronic circuit with the stimulator, wherein the sensor is coupled to the electronic circuit and wherein the electronic circuit is configured to telemetrically communicate with an external controller to provide information sensed by the sensor to the external controller. 
     
     
         5 . The method for implanting a device in a stomach wall of  claim 2  wherein the step of inserting the implant device comprises orienting the implant device so that the at least one stimulating electrode is preferentially facing a layer of the stomach wall so that it is in electrical contact with the layer of the stomach wall. 
     
     
         6 . The method for implanting a device in a stomach wall of  claim 1  wherein the device comprises an anti-rotation element. 
     
     
         7 . The method for implanting a device in a stomach wall of  claim 1  wherein the step of providing an implant device comprises providing a therapeutic agent delivery device configured to release a therapeutic agent when implanted in the stomach wall. 
     
     
         8 . The method of  claim 1  further comprising the step of forming a pocket in the submucosal layer of the stomach wall before inserting the implant device in the pocket. 
     
     
         9 . The method for implanting a device in a stomach wall of  claim 8  wherein the step of forming a pocket in a submucosal layer of the stomach wall comprises:
 forming a bleb in the submucosal layer of the stomach wall; and 
 forming a pocket in the bleb. 
 
     
     
         10 . The method for implanting a device in a stomach wall of  claim 9  wherein the step of forming a bleb comprises:
 endoscopically accessing a mucosal layer of the stomach wall; 
 endoscopically inserting a needle through the mucosal layer into the submucosal layer of the stomach wall; and 
 injecting a substance through the needle into the submucosal layer. 
 
     
     
         11 . The method for implanting a device in a stomach wall of  claim 1  wherein the step of inserting the implant device comprises removably coupling the implant device to a distal end of an endoscopic instrument; inserting the implant device into the submucosal layer using the endoscopic instrument; and uncoupling the implant device from the endoscopic instrument. 
     
     
         12 . The method for implanting a device in a stomach wall of  claim 11   wherein the step of providing an implant device comprises providing a gastric stimulator comprising a housing having at least one stimulating electrode thereon, sA/C stimulator being configured to provide electrical stimulation pulses to the stomach wall when in electrical contact with the stomach wall; and   wherein the step of inserting the implant device into the submucosal layer using the endoscopic instrument comprises orienting the gastric stimulator so that the at least one stimulating electrode is facing a muscle layer of the stomach wall.   
     
     
         13 . The method for implanting a device in the stomach wall of  claim 1   wherein the step of providing an implant device comprises providing a lumen through at least a portion of the implant device, and   wherein the step of inserting the implant device comprises placing a guide through the lumen and guiding the implant device into the submucosal layer.   
     
     
         14 . A method for electrically stimulating a stomach wall comprising the steps of:
 providing a gastric stimulator comprising a housing, at least one electrode coupled to the housing and an electronic circuit coupled to the at least one electrode and configured to deliver electrically stimulating pulses to a stomach wall;   implanting the gastric stimulator in a submucosal layer of the stomach wall so that the at least one electrode is in electrical contact with a muscle layer of the stomach wall from within the submucosal layer; and   delivering stimulating pulses to the muscle layer through the at least one electrode.   
     
     
         15 . The method for electrically stimulating a stomach wall of  claim 14  wherein the step of implanting the gastric stimulator in the submucosal layer of the stomach wall comprises implanting the stimulator by endoscopically accessing the patient's stomach wall; and inserting the stimulator through a mucosal layer into the submucosal layer. 
     
     
         16 . The method for electrically stimulating a stomach wall of  claim 15  wherein the step of implanting the gastric stimulator comprises:
 forming a bleb in the submucosal layer of the stomach wall; 
 forming a pocket in the bleb; and 
 inserting the gastric stimulator in the pocket. 
 
     
     
         17 . The method for electrically stimulating a stomach wall of  claim 14  wherein the step of delivering stimulating pulses comprises telemetrically communicating with the electronic circuit from an external controller to control the electrical stimulation pulses delivered to the stomach wall. 
     
     
         18 . The method for electrically stimulating a stomach wall of  claim 14  wherein the step of providing a stimulator further comprises providing a sensor on the housing coupled to the electronic circuit and further comprising the step of sensing a parameter of the stomach with the sensor and controlling stimulation parameters based upon information sensed by the sensor. 
     
     
         19 . The method for electrically stimulating a stomach wall of  claim 18  wherein the step of controlling the stimulation parameters based upon information sensed by the sensor comprises controlling the stimulation parameters with the electronic circuit and wherein the electronic circuit is configured to telemetrically communicate with an external controller to provide information sensed by the sensor to the external controller and further comprising the step of telemetrically communicating sensed information from the electronic circuit to the external controller, and wherein the step of controlling the stimulation parameters based upon information sensed by the sensor comprises controlling the stimulation parameters with the external controller. 
     
     
         20 . The method for electrically stimulating a stomach wall of  claim 14  wherein the step of inserting the gastric stimulator comprises orienting the gastric stimulator so that at least one stimulating electrode is preferentially facing a layer of the stomach wall so that it is in electrical contact with the layer of the stomach wall.