INTRAGASTRIC VOLUME-OCCUPYING DEVICE AND METHOD FOR FABRICATING SAME
First Claim
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1. An intragastric balloon system comprising a composite wall structure configured to maintain a CO2 leak rate of less than or equal to 40 cc/m2/day at 37°
- C., wherein the composite wall structure comprises;
a supporting film structure having a Young'"'"'s Modulus of 500 Mpa or greater;
a first CO2 barrier layer configured such that its CO2 barrier properties are not substantially affected by exposure to humidity levels within the gastric environment or within a central lumen of the balloon; and
a second CO2 barrier layer configured such that its CO2 barrier properties are not substantially affected by mechanical forces during processing, compacting, or application of external gastric pressures.
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Accused Products
Abstract
Intragastric volume-occupying devices and methods for treating obesity are provided. The devices, which are inflated by carbon dioxide, include an aluminum or silicon oxide barrier layer providing carbon dioxide retention and an alkylene vinyl alcohol polymer layer providing structural integrity in vivo.
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Citations
21 Claims
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1. An intragastric balloon system comprising a composite wall structure configured to maintain a CO2 leak rate of less than or equal to 40 cc/m2/day at 37°
- C., wherein the composite wall structure comprises;
a supporting film structure having a Young'"'"'s Modulus of 500 Mpa or greater; a first CO2 barrier layer configured such that its CO2 barrier properties are not substantially affected by exposure to humidity levels within the gastric environment or within a central lumen of the balloon; and a second CO2 barrier layer configured such that its CO2 barrier properties are not substantially affected by mechanical forces during processing, compacting, or application of external gastric pressures. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
- C., wherein the composite wall structure comprises;
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16. A method for fabricating a composite wall for use in an intragastric balloon system, comprising:
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providing a polyethylene terephthalate layer coated with a silicon dioxide layer having a thickness of from about 100 Å
to about 800 Å
;providing a trilayer system comprising ethylene vinyl alcohol layer sandwiched between polyethylene layers; and adhesively bonding the silicon dioxide layer to one of the polyethylene layers, whereby a composite wall structure configured to maintain a CO2 leak rate of less than or equal to 40 cc/m2/day at 37°
C. is obtained. - View Dependent Claims (17, 18, 19, 20, 21)
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Specification