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Publication Number

US-11974934-B2

Patent

Publication Date

2024-05-07

Expiration Date


Abstract

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.

Core Innovation

The invention describes an intragastric balloon system for obesity treatment that is configured to be swallowable by a patient by normal peristalsis and includes a capsule that degrades in a gastric environment. A balloon is compacted and contained within the capsule, and the balloon includes an outer surface, an inner surface, an interior cavity, a fill valve, and a release valve.

The fill valve is a self-sealing fill valve configured to self-seal after a catheter is detached from the fill valve. The release valve includes a degradable portion that degrades in response to liquid being in contact with the degradable portion while the liquid is in the interior cavity of the balloon, and the degradation process opens the release valve to allow the liquid to travel from the interior cavity of the balloon into the gastric environment thereby deflating the balloon.

The release valve comprises a seam where at least two portions of the balloon are joined together. The seam is associated with degradable behavior in an internal environment within the balloon, including degradation triggers related to liquid contact and, in refinements, conditions such as pH or humidity, and degradation of the seam can separate at least two balloon portions to break open the balloon into smaller passable pieces.

Claims Coverage

The independent claim covers a swallowable intragastric balloon system with a degradable capsule and a compacted balloon having separate fill and release valves. The inventive coverage centers on a self-sealing fill valve after catheter detachment and a liquid-triggered degradable release valve that opens to deflate the balloon, with a release valve seam joining balloon portions.

Swallowable degradable capsule for intragastric delivery

A capsule configured to be swallowable by a patient by normal peristalsis and to degrade in a gastric environment.

Separate fill and liquid-triggered release valves in a balloon interior cavity

A balloon compacted and contained within the capsule, the balloon including an outer surface, an inner surface, an interior cavity, a fill valve, and a release valve, wherein the fill valve and the release valve are separate valves.

Self-sealing fill valve after catheter detachment

The fill valve is a self-sealing valve that is configured to self-seal after a catheter is detached from the fill valve.

Degradable release valve portion that opens in response to liquid inside the balloon

At least a degradable portion of the release valve is configured to degrade in an internal environment of the interior cavity of the balloon when a liquid is in the interior cavity of the balloon and in response to the liquid being in contact with the degradable portion, such that the degradation process opens the release valve to allow the liquid to travel from the interior cavity of the balloon into the gastric environment thereby deflating the balloon.

Seam joining balloon portions as part of the release valve

The release valve comprises a seam where at least two portions of the balloon are joined together.

Release valve opening timing based on degradation after inflation

A degradable portion of the release valve degrades in an internal environment of the interior cavity of the balloon to open the release valve about 1 to 6 months after the balloon is inflated with liquid.

Approximately 3-month release timing refinement

A degradable portion of the release valve degrades in an internal environment of the interior cavity of the balloon to open the release valve at about 3 months after the balloon is inflated with liquid.

Seam degradation responsive to pH or humidity

Part of the seam degrades in response to pH or humidity conditions inside the balloon.

Seam degradation leading to separation of balloon portions to break open the balloon

A seam portion is configured to degrade such that, after the degradable seam portion degrades, at least two balloon portions separate to break open the balloon.

Seam includes erodible material

The seam includes an erodible material.

Overall, the claim set is centered on a swallowable, gastric-degrading capsule containing a compacted intragastric balloon with separate valves. The fill valve self-seals upon catheter detachment, while a degradable release valve portion degrades in response to liquid in the balloon interior cavity to open the release valve and deflate the balloon. The release valve includes a seam joining balloon portions, where degradation can be liquid-contact dependent and, in refinements, pH/humidity dependent, and can result in separation of balloon portions; dependent claims also refine degradation timing and define seam materials such as erodible material.

Stated Advantages

Documented Applications

No documented applications found

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