Gastric space filler delivery system and related methods

Abstract

According to features of the present disclosure, a gastric space filler device and methods effective for reducing stomach volume are disclosed. A gastric space filler comprising at least one inflatable space filler and a sleeve to prevent leakage out of the gastric space filler device is disclosed. The gastric space filler device may be inflated with an insufflation fluid and with mineral oil, which further has the effect of reducing leakage. Delivery systems and methods for inserting a gastric space filler device into a patient are also disclosed. Sheaths and methods for covering a gastric space filler device during delivery into a patient are also disclosed.

1 - 20 . (canceled) 
     
     
         21 . A gastric space filler device, comprising:
 a flexible, elongate infusing member having a proximal end, a distal end, and a guide wire channel extending completely through the infusing member from the proximal end to the distal end; and   a plurality of inflatable gastric space fillers secured to the infusing member, wherein the infusing member extends completely through the gastric space fillers, and wherein the inflatable gastric space fillers are configured to be implanted and inflated in a stomach of a human patient.   
     
     
         22 . The gastric space filler device of  claim 21 , further comprising a delivery system configured to be releasably attached to the gastric space filler device, wherein the delivery system comprises:
 a proximal barb positioned to engage a proximal delivery lumen of the infusing member and provide fluid communication between the delivery system and a proximal inflatable space filler coupled to the infusing member; and   a distal barb positioned to engage a distal lumen of the infusing member and provide fluid communication between the delivery system and a distal inflatable space filler coupled to the infusing member.   
     
     
         23 . The gastric space filler device of  claim 22  wherein the delivery system is configured to be attached to the gastric space filler device with the proximal barb and/or the distal barb of the delivery system inserted into a gate at the proximal end of the infusing member. 
     
     
         24 . The gastric space filler device of  claim 22  wherein the delivery system further comprises a delivery guide wire channel aligned with the guide wire channel when the delivery system is releasably attached to the gastric space filler device. 
     
     
         25 . The gastric space filler device of  claim 24 , further comprising a guidewire threaded through the filler guide wire channel and the delivery guide wire channel. 
     
     
         26 . The gastric space filler device of  claim 21  wherein at least one of the gastric space fillers has an outer diameter of at least about 40 mm when inflated with a fluid. 
     
     
         27 . The gastric space filler device of  claim 21  wherein the gastric space fillers are configured to at least partially fill a portion of the stomach of the human patient to create a feeling of satiety. 
     
     
         28 . The gastric space filler device of  claim 22  wherein the infusing member comprises a gate at the proximal end, and wherein the gate is configured to close when the proximal barb and/or the distal barb is removed from the proximal end of the infusing member. 
     
     
         29 . The gastric space filler device of  claim 21  wherein the gastric space filler device is configured to be at least partially covered with a sheath before guiding the gastric space filler device along a guide wire. 
     
     
         30 . The gastric space filler device of  claim 21  wherein:
 the infusing member includes a docking notch; and 
 wherein the gastric space filler device further comprises a delivery system having a docking clip configured to be releasably attached over the docking notch of the infusing member.