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 comprising:
an initial fill gas, wherein the initial fill gas consists essentially of N 2 ;
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 intragastric balloon of claim 1 , wherein the polymeric wall comprises a CO 2 barrier material consisting of nylon/polyvinylidene chloride/polyethylene.
3. The intragastric balloon of claim 1 , wherein the polymeric wall comprises a nylon/polyethylene material and no additional CO 2 barrier material.
4. The intragastric balloon of claim 1 , wherein the balloon is configured to gain from 5% to 300% in volume during the useful life.
5. The intragastric balloon of claim 1 , wherein the balloon is configured to gain from 10% to 500% in pressure during the useful life.
6. The intragastric balloon of claim 1 , wherein the useful life is at least 30 days.
7. An intragastric balloon comprising:
an initial fill gas, wherein the initial fill gas consists essentially of N 2 and CO 2 ;
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.
8. The intragastric balloon of claim 7 , wherein the polymeric wall comprises a CO 2 barrier material consisting of nylon/polyvinylidene chloride/polyethylene.
9. The intragastric balloon of claim 7 , wherein the polymeric wall comprises a nylon/polyethylene material and no additional CO 2 barrier material.
10. The intragastric balloon of claim 7 , wherein the balloon is configured to gain from 5% to 300% in volume during the useful life.
11. The intragastric balloon of claim 7 , wherein the balloon is configured to gain from 10% to 500% in pressure during the useful life.
12. The intragastric balloon of claim 7 , wherein the useful life is at least 30 days.
13. A method for inflating an 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 to an initial volume and an initial pressure, wherein the initial fill gas consists essentially of N 2 ; and
exposing the filled balloon 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.
14. The method of claim 13 , wherein the polymeric wall comprises a CO 2 barrier material consisting of nylon/polyvinylidene chloride/polyethylene.
15. The method of claim 13 , wherein the polymeric wall comprises a nylon/polyethylene material and no additional CO 2 barrier material.
16. The method of claim 13 , wherein the balloon gains from 5% to 300% in volume over the useful life.
17. The method of claim 13 , wherein the balloon gains from 10% to 500% in pressure over the useful life.
18. The method of claim 13 , wherein the useful life is at least 30 days.
19. A method for inflating an 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 to an initial volume and an initial pressure, wherein the initial fill gas consists essentially of N 2 and CO 2 ; and
exposing the filled balloon 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.
20. The method of claim 19 , wherein N 2 is excess in concentration to CO 2 in the initial fill gas.
21. The method of claim 19 , wherein the polymeric wall comprises a CO 2 barrier material consisting of nylon/polyvinylidene chloride/polyethylene.
22. The method of claim 19 , wherein the polymeric wall comprises a nylon/polyethylene material and no additional CO 2 barrier material.
23. The method of claim 19 , wherein the balloon gains from 5% to 300% in volume over the useful life.
24. The method of claim 19 , wherein the balloon gains from 10% to 500% in pressure over the useful life.
25. The method of claim 19 , wherein the useful life is at least 30 days.
26. An intragastric balloon comprising:
an initial fill gas, wherein the initial fill gas consists essentially of N 2 ;
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 gains from 5 to 300% in volume and from 10% to 500% in pressure during a useful life of the intragastric balloon when filled with the initial fill gas, and wherein a concentration of N 2 in the initial fill gas relative to an in vivo concentration of N 2 limits a rate and an amount of diffusion of N 2 from the in vivo gastric environment into the intragastric balloon through the polymeric wall.
27. An intragastric balloon comprising:
an initial fill gas, wherein the initial fill gas consists essentially of N 2 and CO 2 ;
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 gains from 5 to 300% in volume and from 10% to 500% in pressure during a useful life of the intragastric balloon when filled with the initial fill gas, and wherein a concentration of one or more gases in the initial fill gas relative to an in vivo concentration of the one or more gases limits a rate and an amount of diffusion of the one or more gases from the in vivo gastric environment into the intragastric balloon through the polymeric wall.
28. The intragastric balloon of claim 27 , wherein a concentration of CO 2 in the initial fill gas relative to an in vivo CO 2 concentration limits a rate and an amount of diffusion of CO 2 from the in vivo gastric environment into the intragastric balloon through the polymeric wall.
29. The intragastric balloon of claim 27 , wherein the initial fill gas further comprises one or more gases that are also present in the in vivo gastric environment.
30. The intragastric balloon of claim 27 , wherein the polymeric wall comprises a CO 2 barrier material consisting of nylon/polyvinylidene chloride/polyethylene.
31. The intragastric balloon of claim 27 , wherein the polymeric wall comprises a nylon/polyethylene material and no additional CO 2 barrier material.
32. The intragastric balloon of claim 27 , wherein the useful life is at least 30 days.
33. A method for inflating an 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 to an initial volume and an initial pressure, wherein the initial fill gas consists essentially of N 2 and CO 2 and wherein a concentration of one or more gases in the initial fill gas relative to an in vivo concentration of the one or more gases limits a rate and an amount of diffusion of the one or more gases from the in vivo gastric environment into the intragastric balloon through the polymeric wall; and
exposing the filled balloon 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 from 5 to 300% in volume and from 10% to 500% in pressure over the useful life.
34. The method of claim 33 , wherein the polymeric wall comprises a CO 2 barrier material consisting of nylon/polyvinylidene chloride/polyethylene.
35. The method of claim 33 , wherein the polymeric wall comprises a CO 2 barrier material consisting of nylon/polyethylene and no additional CO 2 barrier material.
36. The method of claim 33 , wherein a concentration of CO 2 in the initial fill gas relative to an in vivo CO 2 concentration limits a rate and an amount of diffusion of CO 2 from the in vivo gastric environment into the intragastric balloon through the polymeric wall.
37. The method of claim 33 , wherein the initial fill gas further comprises one or more gases that are also present in the in vivo gastric environment.
38. The method of claim 33 , wherein N 2 is excess in concentration to CO 2 in the initial fill gas.
39. The method of claim 33 , wherein the useful life is at least 8 days.