Locking gastric obstruction device and method of use

Abstract

The present invention relates to a device for intermittently obstructing a bodily opening, such as a gastric opening, and includes a proximal member connected to a distal member by a tether. The proximal member is formable from an elongated and narrower configuration to a contracted or expanded but wider configuration. When employed in the stomach, the device may be arranged transluminally with the distal member disposed in the duodenum and the proximal 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 device for intermittently obstructing a gastric opening, the device comprising:
 a proximal occluding member, wherein the proximal occluding member is reconfigurable between an elongated narrowed configuration and a compacted widened configuration having a plurality of turns nesting one adjacent to the other;   a distal member;   a flexible tether connecting the proximal occluding member and the distal member;   a distal hub coupled to a distal end of the proximal occluding member; and   a proximal plug coupled to a proximal end of the proximal occluding member, wherein the proximal plug and the distal hub are detached and maintained at a distance from one another when the proximal occluding member is in the compacted widened configuration.   
     
     
         2 . The device of  claim 1 , further comprising a plurality of lock lines extending transversely through the plurality of turns of the proximal occluding member and coupling a distal end of the proximal occluding member with a proximal end of the proximal occluding member. 
     
     
         3 . The device of  claim 2 , wherein the plurality of lock lines are arranged around a circumference of the proximal occluding member. 
     
     
         4 . The device of  claim 3 , wherein the plurality of lock lines extend transversely through the proximal occluding member in a curvilinear manner through lumens defined through the plurality of turns of the proximal occluding member. 
     
     
         5 . The device of  claim 2 , further comprising an attachment collar, wherein at least part of the attachment collar extends into a cavity formed by the proximal occluding member in the compacted widened configuration, and wherein the attachment collar is configured to receive pins at terminal ends of the plurality of lock lines to lock the proximal occluding member in the compacted widened configuration. 
     
     
         6 . The device of  claim 1 , wherein the distal hub and the proximal plug are configured to engagingly mate with one another. 
     
     
         7 . The device of  claim 1 , further comprising a covering attached to the flexible tether and surrounding the proximal occluding member. 
     
     
         8 . The device of  claim 7 , further comprising a delivery tube which is removably coupled to an opening defined along a proximal end of the covering, wherein the delivery tube is configured to provide access passage for the introduction of the proximal occluding member having the plurality of turns into the covering. 
     
     
         9 . The device of  claim 7 , wherein the proximal occluding member further comprises a strain relief hub section between the covering and the flexible tether. 
     
     
         10 . The device of  claim 1 , wherein the distal member further comprises a weight disposed within the distal member. 
     
     
         11 . A method of deploying an occluding device within a patient, comprising:
 advancing an obstructing device into a stomach of the patient, the obstructing device having a proximal occluding member configured in an elongated narrowed configuration and having a distal member and a flexible tether connecting the proximal occluding member and the distal member;   urging the proximal occluding member into a compacted widened configuration having a plurality of turns nesting one adjacent to the other;   positioning a distal hub connected to a distal end of the proximal occluding member toward a proximal plug connected to a proximal end of the proximal occluding member; and   locking a position of the distal hub and the proximal plug relative to one another when the proximal plug and the distal hub are detached and maintained at a distance from another.   
     
     
         12 . The method of  claim 11 , wherein urging the proximal occluding member comprises compacting the proximal occluding member into a helical structure where the plurality of turns nest in an interfitted profile. 
     
     
         13 . The method of  claim 11 , wherein urging the proximal occluding member into the compacted widened configuration further comprises tensioning a plurality of lock lines extending transversely through the plurality of turns of the proximal occluding member. 
     
     
         14 . The method of  claim 13 , wherein urging the proximal occluding member further comprises tensioning the plurality of lock lines by pulling the plurality of lock lines through collets. 
     
     
         15 . The method of  claim 13 , wherein urging the proximal occluding member further comprises tensioning the plurality of lock lines as the plurality of lock lines extend transversely through the proximal occluding member in a curvilinear manner through lumens defined through the plurality of turns of the proximal occluding member. 
     
     
         16 . The method of  claim 13 , wherein the obstructing device further comprises an attachment collar, wherein at least part of the attachment collar extends into a cavity formed by the proximal occluding member in the compacted widened configuration, and wherein the attachment collar is configured to receive pins at terminal ends of the plurality of lock lines to lock the proximal occluding member in the compacted widened configuration. 
     
     
         17 . The method of  claim 11 , wherein urging the proximal occluding member into the compacted widened configuration comprises introducing the proximal occluding member through an opening defined along a covering. 
     
     
         18 . The method of  claim 17 , wherein the proximal occluding member further comprises a strain relief hub section between the covering and the flexible tether. 
     
     
         19 . The method of  claim 11 , further comprising withdrawing the proximal occluding member from the stomach of the patient when the proximal occluding member is reconfigured into an elongated narrowed configuration. 
     
     
         20 . The method of  claim 11 , wherein the distal member further comprises a weight disposed within the distal member.