Endoscopic Device Delivery System

Abstract

A system and method are disclosed for an implantable gastric stimulation system within the stomach. The stimulation system includes an electronics anchor, electrode lead anchor, implantable pulse generator and external programmer. The electronics anchor is configured to attach to the stomach wall at a first location and the electrode lead anchor configured to attach to the stomach wall at a second location. The electrode lead anchor includes one or more electrodes configured to contact the stomach wall and a flexible lead portion coupled to the one or more electrodes at one end with an the electrical connector portion at the other end. The implantable pulse generator has electronic circuitry and is attached to the electronics anchor; the electronic circuitry is connected to the electrical connector of the electrode lead anchor and can communicate with the one or more electrodes. The external programmer is used to communicate with the electronic circuitry of the pulse generator via a telemetry device to provide stimulation instructions to the pulse generator.

1 . A method for implanting an electrical stimulator comprising:
 providing stimulator electronic circuitry and a first anchor configured to anchor stimulator electronic circuitry to a stomach wall wherein the first anchor comprises: an anchor portion, a coupling portion and a guide coupling portion;   anchoring the first anchor to the stomach wall of a subject with the anchor portion;   coupling a guide to the guide coupling portion of the first anchor wherein the guide extends out of an esophagus of the subject;   guiding the stimulator electronic circuitry with the guide portion from out of the esophagus, into a coupled position with the coupling portion of the first anchor.   
     
     
         2 . The method of  claim 1  further comprising the steps of:
 providing a second anchor configured to anchor an electrode to a stomach wall wherein the second anchor comprises: an anchor portion: a lead portion; and an electrical connector portion, and wherein the stimulator further comprises a lead connector; 
 anchoring the second anchor to the stomach wall of the subject with the anchor portion wherein the electrical connector portion extends out of the esophagus of the patient; and 
 coupling the electrical connector portion of the anchor to the lead connector of the stimulator electronic circuitry. 
 
     
     
         3 . The method of  claim 2  further comprising the step of advancing the stimulator electronic circuitry through the esophagus into the stomach after coupling the electrical connector portion of the anchor to the lead connector of the stimulator electronic circuitry. 
     
     
         4 . A method for implanting an electrical stimulator comprising:
 providing stimulator electronic circuitry and an electrode anchor configured to anchor an electrode to a stomach wall, wherein the electrode anchor comprises: an anchor portion: a lead portion; and an electrical connector portion, and wherein the stimulator further comprises a lead connector;   anchoring the electrode anchor to the stomach wall of the subject with the anchor portion wherein the electrical connector portion extends out of the esophagus of the patient; and   coupling the electrical connector portion of the anchor to the lead connector of the stimulator electronic circuitry.   
     
     
         5 . A system for implanting an anchor on a stomach wall from within the stomach, the system comprising:
 an anchor comprising an expandable portion and an elongate portion wherein when implanted in a stomach wall, the expandable portion is expanded to engage an outside of a stomach wall and the elongate portion extends through a stomach wall;   a dilator configured to dilate an opening through the stomach wall; and   a delivery cannula positionable through the opening in the stomach wall and configured to receive the anchor advanced through the cannula into an implanted position.   
     
     
         6 . The system of  claim 5  wherein the elongate portion of the anchor further comprises a guide coupling portion, and wherein the system further comprises a guide configured to couple to the guide coupling portion. 
     
     
         7 . The system of  claim 6  wherein the guide further comprises a tension mechanism configured to provide tension with respect to the elongate portion of the anchor when coupled thereto. 
     
     
         8 . The system of  claim 7  wherein the guide is configured to manipulate the anchor when coupled to the guide coupling portion and the tension mechanism. 
     
     
         9 . A system for accessing space adjacent a serosa of a stomach through an esophagus, the system comprising:
 a first balloon catheter having an expandable first balloon configured to slide over a guidewire extending out of the esophagus, the first balloon being sized to span the stomach wall thickness and to inflate to a first diameter and dilate an opening through the stomach wall; and   a sheath configured to slide over the first balloon catheter and contact the balloon inflated to the first diameter, the first diameter being sufficient to slide the sheath in unison with the first balloon catheter through the dilated opening until the sheath extends through the stomach wall into the space, the balloon being withdrawable proximally through the sheath when deflated.   
     
     
         10 . The system of  claim 9 , wherein the first balloon has a length of greater than approximately 4 mm. 
     
     
         11 . The system of  claim 9 , further comprising:
 a hollow needle having a proximal end and a distal end, the proximal end configured to extend out of the esophagus of the patient and the distal end configured to pierce the stomach wall to create the opening into the space; and   a first guidewire configured to slide within the hollow needle.   
     
     
         12 . The system of  claim 9 , further comprising:
 a crossing catheter;   a second balloon catheter having a second balloon expandable from a deflated configuration to a second diameter; the second balloon in the deflated configuration being smaller than the dilated opening to facilitate positioning the second balloon within the opening when the opening has been dilated by the first balloon, the second diameter being greater than an outer diameter of the crossing catheter, the second balloon of the second balloon catheter slidably advanceable through the crossing catheter when in the deflated configuration for bringing a distal end of the crossing catheter into contact with the inflated second balloon, the crossing catheter and second balloon catheter advanceable in unison from outside the esophagus through the opening until the crossing catheter extends through the stomach wall.   
     
     
         13 . An anchor for implantation of a stimulation system within the stomach, the system comprising:
 an elongated portion having distal end, a proximal end and one or more detents along the elongated portion, wherein the elongate portion is configured to extend through a hole in the stomach wall;   an expandable portion coupled to the distal end of the elongated portion, the expandable portion being configured to collapse when inserted through the hole in the stomach wall and expand to engage an outside of a stomach wall; and   a retaining element configured to engage one of the detents on the elongate portion to hold the anchor in place in the stomach wall.   
     
     
         14 . The anchor of  claim 13 , wherein the anchor is an electronics anchor, further comprising:
 a tapered end on the proximal end of the elongate portion; and   a loop on the tapered end, wherein the tapered end and loop are configured to engage the distal end of a guide element for attachment of the retaining element to the elongate portion.   
     
     
         15 . The anchor of  claim 13 , wherein the anchor is an electrode lead anchor, further comprising:
 one or more electrodes with exposed surfaces on the elongate portion and/or the expandable portion; and   a flexible lead portion with electrical connectors therethrough having a distal end coupled to the one or more electrodes and a proximal end coupled to a lead connector, wherein the lead connector is configured to couple with electronic circuitry of a stimulator.   
     
     
         16 . A method for implanting a stimulation system within the stomach comprising:
 attaching an electrode lead anchor to the stomach wall at a first location, the electrode lead anchor having one or more electrodes in contact with the stomach wall and an electrical connector coupled to the electrode(s);   temporarily capping the electrical connector;   allowing a healing period for the first location in the stomach wall;   after the healing period, coupling the connector to a pulse generator having electronic circuitry;   implanting the electronic circuitry and transmitting stomach stimulation signals from the electronic circuitry to the stomach via the electrode(s).   
     
     
         17 . The method of  claim 16 , wherein the healing period is longer than two weeks. 
     
     
         18 . The method of  claim 16 , the electrode lead anchor further comprising a flexible lead portion with electrical connectors therethrough coupled to the electrodes at a distal end and the electrical connector portion at a proximal end, and a retaining element having one or more arms; the method further comprising:
 attaching an electronics anchor to the stomach wall at a first location;   attaching a temporary cap to the electrical connector portion;   attaching the temporary cap with the one or more arms of the retaining element;   after the healing period, separating the temporary cap from the one or more arms and removing the temporary cap;   coupling the electrical connector portion of the electrode lead anchor to the electronic circuitry in the electrical pulse generator; and   attaching the pulse generator with the electronics anchor.   
     
     
         19 . A stimulation system for implantation within the stomach comprising:
 an electronics anchor configured to attach to the stomach wall at a first location;   an electrode lead anchor configured to attach to the stomach wall at a second location, the electrode lead anchor having one or more electrodes configured to contact the stomach wall and a flexible lead portion with electrical connectors therethrough coupled to the one or more electrodes at a distal end and an the electrical connector portion at a proximal end;   a pulse generator coupled to the electronics anchor, the pulse generator having electronic circuitry coupled to the electrical connector portion of the electrode lead anchor, wherein the electronic circuitry is configured to communicate with the one or more electrodes;   an external programmer configured to communicate with the electronic circuitry of the pulse generator via a telemetry device to provide stimulation instructions.   
     
     
         20 . The system of  claim 19 , wherein the electronics anchor comprises:
 an elongated portion having distal end, a proximal end and one or more detents along the elongated portion, wherein the elongate portion is configured to extend through a hole in the stomach wall   an expandable portion coupled to the distal end of the elongated portion, the expandable portion being configured to collapse when inserted through the hole in the stomach wall and expand to engage an outside of a stomach wall;   a retaining element configured to engage one of the detents on the elongate portion to hold the anchor in place in the stomach wall;   a tapered end on the proximal end of the elongate portion; and   a loop on the tapered end, wherein the tapered end and loop are configured to engage the distal end of a guide element for attachment of the retaining element to the elongate portion.   
     
     
         21 . The system of  claim 19 , wherein the electrode lead anchor further comprises:
 an elongated portion having distal end, a proximal end and one or more detents along the elongated portion, wherein the elongate portion is configured to extend through a hole in the stomach wall   an expandable portion coupled to the distal end of the elongated portion, the expandable portion being configured to collapse when inserted through the hole in the stomach wall and expand to engage an outside of a stomach wall   wherein the one or more electrodes have exposed surfaces on the elongate portion and/or the expandable portion; and   a retaining element configured to engage one of the detents on the elongate portion to hold the anchor in place in the stomach wall.