Intragastric device
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. A free-floating intragastric balloon comprising:
an initial fill gas, wherein the initial fill gas consists essentially of one or more gases selected from the group consisting of SF 6 , C 2 F 6 , C 3 F 8 , C 4 F 10 , C 4 F 8 , C 4 F 8 , C 3 F 6 , CF 4 , and C(ClF 2 )—CF 3 ;
a valve system configured for introducing the initial fill gas into the balloon in vivo; and
a polymeric wall comprising one or more layers, wherein the polymeric wall is configured to have, under in vivo conditions, a permeability to CO 2 of more than 10 cc/m 2 /day, and wherein the polymeric wall is configured such that, in vivo, the balloon is configured to gain in volume and in pressure during a useful life of the intragastric balloon when filled with the initial fill gas.
2. The free-floating 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 free-floating intragastric balloon of claim 1 , wherein the polymeric wall comprises a three layer CO 2 barrier material consisting of nylon/ethylene vinyl alcohol/polyethylene.
4. The free-floating intragastric balloon of claim 1 , wherein the polymeric wall comprises a two layer CO 2 barrier material consisting of nylon/polyethylene and no additional CO 2 barrier material.
5. The free-floating intragastric balloon of claim 1 , wherein the polymeric wall comprises a four layer CO 2 barrier material consisting of nylon/ethylene vinyl alcohol/polyvinylchloride/polyethylene.
6. The free-floating intragastric balloon of claim 1 , wherein the polymeric wall comprises a nylon layer, a polyvinylidene chloride layer, and a polyethylene layer.
7. The free-floating intragastric balloon of claim 1 , wherein the polymeric wall comprises a nylon layer, a polyvinylidene chloride layer, a polyethylene layer, and an ethylene vinyl alcohol layer.
8. The free-floating intragastric balloon of claim 1 , wherein the polymeric wall comprises a nylon layer, a polyethylene layer, and an ethylene vinyl alcohol layer.
9. The free-floating intragastric balloon of claim 1 , wherein the intragastric balloon is configured to have a useful life in an in vivo gastric environment of at least 6 months.
10. The free-floating intragastric balloon of claim 1 , wherein the initial fill gas is SF 6 .
11. The free-floating intragastric balloon of claim 1 , which when inflated with the initial fill gas is ellipsoid with a nominal radius of from 2.5 cm to 7.6 cm, a nominal height of from 0.6 cm to 7.6 cm, and a volume of from 90 cm 3 to 350 cm 3 at 37° C.
12. The free-floating intragastric balloon of claim 1 , which when inflated with the initial fill gas has an internal nominal pressure at 37° C. of 0 Pa to 103421 Pa.
13. The free-floating intragastric balloon of claim 1 , which when inflated with the initial fill gas has a weight of less than 15 g.
14. A method for inflating a free-floating intragastric balloon, comprising:
providing an intragastric balloon comprising a valve system and a polymeric wall, wherein the polymeric wall comprises one or more layers, and wherein the polymeric wall is configured to have, under in vivo conditions, a permeability to CO 2 of more than 10 cc/m 2 /day;
introducing, in an in vivo intragastric environment, an initial fill gas into the intragastric balloon through the valve system so as to inflate the intragastric balloon, wherein the initial fill gas consists essentially of inert gas' one or more gases selected from the group consisting of SF 6 , C 2 F 6 , C 3 F 8 , C 4 F 10 , C 4 F 8 , C 4 F 8 , C 3 F 6 , CF 4 , and C(ClF 2 )—CF 3 ; and
exposing the filled balloon, which floats free in a patient's stomach, to the in vivo intragastric environment for a useful life of the intragastric balloon, whereby the initial fill gas diffuses through the polymeric wall and into the in vivo intragastric environment, and whereby gases in the in vivo intragastric environment diffuse into the balloon through the wall, whereby the intragastric balloon gains in volume and in pressure over the useful life.
15. The method of claim 14 , wherein the initial fill gas is SF 6 .
16. The method of claim 14 , wherein the free-floating intragastric balloon when inflated has a nominal radius of from 2.5 cm to 7.6 cm, a nominal height of from 0.6 cm to 7.6 cm, and a volume of from 90 cm 3 to 350 cm 3 at 37° C.
17. The method of claim 14 , wherein the free-floating intragastric balloon when inflated has an internal nominal pressure at 37° C. of 0 Pa to 103421 Pa.
18. The method of claim 14 , wherein the free-floating intragastric balloon when inflated has a weight of less than 15 g.