Gastric obstruction device deployment assembly and methods of delivering and deploying a gastric obstruction device

Abstract

The present invention relates to gastric obstruction device deployment systems and a device for intermittently obstructing a bodily opening, such as a gastric opening, and includes a proximal occluding member connected to a distal occluding member by a tether. The proximal occluding member is formable from an elongated and narrower configuration to a contracted or expanded but wider configuration. When employed in the stomach, the gastric obstruction device may be arranged transluminally with the distal occluding member disposed in the duodenum and the proximal occluding member disposed against the pyloric valve, intermittently occluding the pyloric valve and preventing or delaying the flow of gastric contents through the pyloric valve.

What is claimed is: 
     
         1 . A method of delivering and deploying an intermittently obstructive gastric obstruction device, comprising:
 advancing a delivery tube distal end per-orally into proximity of a stomach of a patient;   advancing a control tube slidably positioned through the delivery tube, wherein a conforming portion of the gastric obstruction device positioned within the delivery tube is released from the delivery tube by the control tube;   advancing the gastric obstruction device while maintaining a position of the control tube relative to the delivery tube distal end such that the gastric obstruction device is advanced distally of the delivery tube distal end and nests into a compacted configuration;   tightening one or more lock lines passing through the gastric obstruction device in its compacted configuration until a corresponding tensioning wire pin is locked to maintain the compacted configuration; and   releasing the gastric obstruction device from the delivery tube.   
     
     
         2 . The method of  claim 1 , further comprising monitoring a pressure within the stomach and visualizing the gastric obstruction device while advancing a control tube. 
     
     
         3 . The method of  claim 2 , wherein advancing the control tube comprises actuating an advancement control on a control assembly attached to the delivery tube. 
     
     
         4 . The method of  claim 3 , wherein advancing the gastric obstruction device comprises advancing a plunger through the delivery tube to push the gastric obstruction device. 
     
     
         5 . The method of  claim 4 , wherein advancing the plunger further comprises releasing the plunger via a release mechanism from a first carriage slidably positioned within the control assembly. 
     
     
         6 . The method of  claim 3 , wherein tightening the one or more lock lines comprises actuating a tension control positioned along the control assembly to apply tension to one or more tension lines coupled to the lock lines. 
     
     
         7 . The method of  claim 6 , further comprising cutting or releasing the one or more tension lines. 
     
     
         8 . The method of  claim 3 , wherein releasing the gastric obstruction device comprises releasing an anchor line from the gastric obstruction device via the control assembly. 
     
     
         9 . The method of  claim 1 , further comprising inserting the delivery tube into an access sheath prior to advancing a delivery tube. 
     
     
         10 . The method of  claim 9 , further comprising inflating an expandable member near or at a distal end of the access sheath within the stomach of the patient. 
     
     
         11 . The method of  claim 10 , further comprising retracting the expandable member against a lower esophageal sphincter of the stomach of the patient. 
     
     
         12 . The method of  claim 1 , wherein advancing a delivery tube comprises advancing a delivery tube having a device cover attached to the distal end, and wherein the gastric obstruction device is advanced distally of the delivery tube and into an interior of the device cover. 
     
     
         13 . A method of delivering and deploying an intermittently obstructive gastric obstruction device, comprising:
 advancing a delivery tube distal end per-orally into proximity of a stomach of a patient;   advancing a control tube slidably positioned through the delivery tube such that a distal portion of the gastric obstruction device is released from the delivery tube;   maintaining a position of the control tube relative to the delivery tube distal end such that the gastric obstruction device is advanced distally of the delivery tube distal end and nests into a compacted configuration whereby the gastric obstruction device is formed from its distal end and towards its proximal end into its deployed configuration; and   tightening one or more lock lines passing through the gastric obstruction device in its compacted configuration until a corresponding tensioning wire pin is locked to maintain the compacted configuration.   
     
     
         14 . The method of  claim 13 , further comprising releasing the gastric obstruction device from the delivery tube. 
     
     
         15 . The method of  claim 13 , further comprising visualizing the gastric obstruction device while advancing the control tube, and wherein advancing the control tube comprises actuating an advancement control on a control assembly attached to the delivery tube. 
     
     
         16 . The method of  claim 15 , wherein tightening the one or more lock lines comprises actuating a tension control positioned along the control assembly to apply tension to one or more tension lines coupled to the lock lines. 
     
     
         17 . The method of  claim 16 , further comprising cutting or releasing the one or more tension lines. 
     
     
         18 . The method of  claim 13 , wherein advancing a delivery tube comprises advancing a delivery tube having a device cover attached to the distal end, wherein the gastric obstruction device is advanced distally of the delivery tube and into an interior of the device cover. 
     
     
         19 . A method of delivering and deploying an intermittently obstructive gastric obstruction device, comprising:
 advancing an access sheath per-orally into proximity of a patient stomach, wherein an obturator is coupled to the access sheath during introduction into the patient stomach;   removing the obturator from the access sheath when a distal end of the access sheath is in the patient stomach, wherein the access sheath is coupled to the obturator;   inflating an expandable member on the distal end of the access sheath in the patient stomach; and   advancing the gastric obstruction device through the proximal end of the access sheath into the patient stomach at the distal end of the access sheath.   
     
     
         20 . The method of  claim 19 , further comprising advancing an endoscope through the access sheath.