Intragastric volume-occupying device and method for fabricating same
Inventors
Brister, Mark C. • Patel, Kaushik A. • Rasdal, Andrew P. • Quintana, Nelson • Drake, Neil R. • Llevares, Antonio C. • Markovic, Dubravka • VandenBerg, Amy D. L.
Assignees
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Publication Number
US-12102547-B2
Publication Date
2024-10-01
Expiration Date
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.
Core Innovation
An intragastric balloon system is provided having a composite wall structure configured to maintain a CO2 leak rate of less than or equal to 40 cc/m2/day at 37°C. The composite wall structure includes a supporting film structure having a Young's Modulus of 500 Mpa or greater, a first CO2 barrier layer, and a second CO2 barrier layer.
The first CO2 barrier layer is 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 system. The second CO2 barrier layer is configured such that its CO2 barrier properties are not substantially affected by mechanical forces during processing, compacting, or application of external gastric pressures.
The first CO2 barrier layer comprises a silicon dioxide layer having a thickness of from about 100 Å to about 800 Å. The second CO2 barrier layer comprises an ethylene vinyl alcohol layer having a thickness of at least about 2 microns.
Claims Coverage
The claims coverage centers on a single independent claim directed to an intragastric balloon system with a composite wall structure engineered to maintain a CO2 leak rate ≤ 40 cc/m2/day at 37°C, with humidity-resistant and mechanically resistant CO2 barrier layers. Dependent claims further specify supporting film material and multilayer barrier constructions, and add quantitative constraints for a self-sealing valve system and for an inflation agent formulation.
Intragastric balloon system with humidity- and mechanically-resistant composite CO2 barrier wall maintaining a leak rate ≤ 40 cc/m2/day at 37°C
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 so its CO2 barrier properties are not substantially affected by exposure to humidity levels within the gastric environment or within a central lumen, and a second CO2 barrier layer configured so its CO2 barrier properties are not substantially affected by mechanical forces during processing, compacting, or application of external gastric pressures; wherein the first CO2 barrier layer comprises a silicon dioxide layer having a thickness of from about 100 Å to about 800 Å and the second CO2 barrier layer comprises an ethylene vinyl alcohol layer having a thickness of at least about 2 microns.
Polyethylene terephthalate supporting film structure
The intragastric balloon system includes a supporting film structure that comprises a polyethylene terephthalate layer.
Multilayer arrangement with ethylene vinyl alcohol between polyethylene layers and silicon dioxide adhesively bonded
An ethylene vinyl alcohol layer is sandwiched between two polyethylene layers, with tie-layer bonding, and the silicon dioxide layer is adhesively bonded to one of the polyethylene layers.
Extruded ethylene vinyl alcohol barrier layer
The ethylene vinyl alcohol layer is extruded.
Self-sealing valve system with quantitative durometer and shear-force relationships plus low-mass, specified full-inflation shape and volume
The balloon system includes a self-sealing valve system attached via an adhesive with shear force greater than about 40 N, where the septum durometer is less than the retaining structure, and the balloon is less than about 15 g with full-inflation shape ellipsoid, spheroid, or oblate spheroid and volume about 90-350 cm3.
Quantified inflation agent in an inner container within the central lumen
An inner container in the central lumen holds about 0.28 g to about 4 g of an inflation agent comprising up to about 80 wt.% powdered citric acid and the remainder powdered sodium bicarbonate.
Across the independent claim and its refinements, the inventive coverage focuses on maintaining a CO2 leak rate at or below 40 cc/m2/day at 37°C using a composite wall with a high-modulus supporting film plus CO2 barrier layers whose barrier performance resists both humidity and mechanical forces. Dependent claims further specify supporting film material and multilayer barrier constructions, and add quantitative constraints for a self-sealing valve system and for an inflation agent formulation in an inner container.
Stated Advantages
Maintain a CO2 leak rate of less than or equal to 40 cc/m2/day at 37°C.
CO2 barrier properties are not substantially affected by exposure to humidity levels within the gastric environment or within a central lumen.
CO2 barrier properties are not substantially affected by mechanical forces during processing, compacting, or application of external gastric pressures.
Documented Applications
Intragastric use as a balloon system for an intragastric balloon system configured with a composite wall structure.
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