Intragastric device
View Patent ↗Devices and methods for treating obesity are provided. More particularly, intragastric devices and methods of fabricating, deploying, inflating, monitoring, and retrieving the same are provided.
1. An intragastric balloon configured to have a useful life in an in vivo gastric environment of at least 30 days, comprising:
an initial fill gas consisting essentially of an inert gas and CO 2 , wherein the inert gas is excess in concentration to CO 2 in the initial fill gas and wherein the CO 2 is at a similar concentration to gastric pCO 2 ;
a polymeric wall configured to have, under conditions of an in vivo gastric environment, a permeability to CO 2 of more than 10 cc/m 2 /day, such that a rate and an amount of diffusion of CO 2 from the in vivo gastric environment into a lumen of the balloon through the polymeric wall is controlled, at least in part, by a concentration of the inert gas and the concentration of CO 2 in the initial fill gas; and
a valve system configured for introducing the initial fill gas into the lumen of the balloon in the in vivo gastric environment.
2. The intragastric balloon of claim 1 , wherein the polymeric wall comprises a three layer CO 2 barrier material consisting of nylon/polyvinylidene chloride/polyethylene.
3. The intragastric balloon of claim 1 , wherein the polymeric wall comprises a two layer CO 2 barrier material consisting of nylon/polyethylene material and no additional CO 2 barrier material.
4. The intragastric balloon of claim 1 , wherein the polymeric wall is configured to have, under conditions of an in vivo gastric environment, a permeability to CO 2 of more than 50 cc/m 2 /day.
5. The intragastric balloon of claim 1 , wherein the inert gas consists of a first inert gas in conjunction with a second inert gas, wherein the first inert gas has lower diffusivity through the polymeric wall than the second inert gas and wherein the second inert gas is more soluble in the in vivo intragastric environment than the first inert gas.
6. The intragastric balloon of claim 1 , wherein the initial fill gas consists of the inert gas and CO 2 .
7. A method for inflating an intragastric balloon, comprising:
introducing, in an in vivo intragastric environment, an initial fill gas consisting essentially of an inert gas and CO 2 into a lumen of an intragastric balloon through a valve system, wherein the inert gas is excess in concentration to CO 2 in the initial fill gas and wherein the CO 2 is at a similar concentration to gastric pCO 2 , and wherein the intragastric balloon comprising a polymeric wall configured to have, under conditions of an in vivo gastric environment, a permeability to CO 2 of more than 10 cc/m 2 /day; and
exposing the balloon to the in vivo intragastric environment for a useful life of at least 30 days, wherein a rate and an amount of diffusion of CO 2 from the in vivo gastric environment into the lumen of the balloon through the polymeric wall is controlled, at least in part, by a concentration of the inert gas and the concentration of CO 2 in the initial fill gas.
8. The method of claim 7 , wherein the polymeric wall comprises a three layer CO 2 barrier material consisting of nylon/polyvinylidene chloride/polyethylene.
9. The method of claim 7 , wherein the polymeric wall comprises a two layer CO 2 barrier material consisting of nylon/polyethylene and no additional CO 2 barrier material.
10. The method of claim 7 , wherein the polymeric wall is configured to have, under conditions of an in vivo gastric environment, a permeability to CO 2 of more than 50 cc/m 2 /day.
11. The method of claim 7 , wherein the inert gas consists of a first inert gas in conjunction with a second inert gas, wherein the first inert gas has lower diffusivity through the polymeric wall than the second inert gas and wherein the second inert gas is more soluble in the in vivo intragastric environment than the first inert gas.
12. The method of claim 7 , wherein the initial fill gas consists of the inert gas and CO 2 .