IP Verse

Intragastric Device

Patent No. US11779482 (titled "Intragastric Device") was filed by Ascent Partners Fund Llc on Jan 21, 2022.

What is this patent about?

’482 is related to the field of medical devices, specifically devices and methods for treating obesity. The patent addresses the problem of existing intragastric devices having shortcomings such as requiring complex gastric procedures for insertion, or lacking control over inflation and deflation timing. The background highlights the significant health and economic burden of obesity and the need for less invasive and more effective weight loss solutions.

The underlying idea behind ’482 is to create a swallowable intragastric balloon system that can be deployed, inflated, and eventually deflated automatically within the stomach to induce satiety and reduce caloric intake. The key inventive insight is to combine a swallowable capsule containing a compacted balloon with a self-sealing fill valve for inflation via a catheter, and a separate release valve with a degradable portion that triggers deflation after a predetermined time.

The claims of ’482 focus on an intragastric balloon system comprising a swallowable capsule, a compacted balloon within the capsule, a self-sealing fill valve, and a separate release valve. The claims cover a catheter for inflating the balloon with saline liquid, where the catheter detaches after inflation. Crucially, the claims specify that a degradable portion of the release valve degrades in response to contact with the saline liquid inside the balloon, causing the release valve to open and the balloon to deflate.

In practice, the patient swallows the capsule containing the deflated balloon and attached catheter. Once in the stomach, saline is pumped through the catheter to inflate the balloon. The catheter is then detached, and the fill valve self-seals. The saline liquid inside the balloon then begins to degrade the degradable portion of the release valve. After a pre-determined period, the release valve opens, allowing the saline to escape and the balloon to deflate, enabling it to pass through the digestive system.

This design differentiates itself from prior approaches by offering a completely swallowable system with controlled inflation and deflation. Unlike surgically implanted devices, this system is minimally invasive. The use of a separate, degradable release valve allows for precise timing of deflation, addressing the limitations of earlier self-inflating balloons with less predictable deflation mechanisms. The saline-activated degradation of the release valve provides a reliable and controllable trigger for deflation, ensuring the balloon deflates within the desired timeframe.

How does this patent fit in bigger picture?

Technical landscape at the time

In the early 2010s when ’482 was filed, intragastric balloons were at a time when deployment typically relied on endoscopic procedures or complex insertion tools. At that time, systems commonly relied on external tubes for inflation and deflation rather than self-contained mechanisms. Hardware or software constraints made precise, controlled deflation non-trivial.

Novelty and Inventive Step

The examiner allowed the claims because, while the prior art taught the individual components of the claimed invention (an intragastric balloon system with a swallowable capsule, fill valve, and release valve), no prior art reference specifically taught a degradable portion of the release valve that is degraded by saline liquid to an extent that the degradation itself opens the release valve, allowing saline liquid to travel from the interior cavity of the balloon into the gastric environment. Prior art taught that pressure inside the device would rupture the seal, not the degradation of the seal itself.

Claims

This patent contains 15 claims, with claim 1 being independent. Independent claim 1 is directed to an intragastric balloon system that includes a swallowable capsule, a compacted balloon with separate fill and release valves, and a catheter for inflating the balloon. The dependent claims generally specify details, features, or variations of the intragastric balloon system described in the independent claim.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Degradable portion
(Claim 1)		“The term “degradable” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a process by which structural integrity of the balloon is compromised (e.g., by chemical, mechanical, or other means (e.g., light, radiation, heat, etc.) such that deflation occurs.”A part of the release valve that is configured to degrade in the internal environment of the balloon when saline liquid is in contact with it.
Fill valve
(Claim 1)		“In preferred embodiments, a self-sealing valve system is attached to the balloon (e.g., on its inside surface) that is “universal” or compatible with the swallowable catheter and a physician-assisted catheter. The valve system serves to allow for balloon inflation using a miniature catheter that includes a needle assembly and also provides a mechanism for detachment of the catheter after inflation has been completed.”A valve on the balloon that connects to a catheter for inflation and self-seals after the catheter is detached.
Release valve
(Claim 1)		“According to another embodiment of the preferred embodiments, the functionality of the volume-occupying subcomponent and the deflation component is combined either in part or in whole. For example, the volume-occupying subcomponent may be formed of a substance that is degraded within the stomach over a desired period of time. Once the degradation process has formed a breach in the wall of the volume-occupying subcomponent, the volume-occupying subcomponent deflates, continues to degrade and passes through the remainder of the digestive tract.”A separate valve on the balloon that degrades in response to contact with saline liquid inside the balloon, allowing the balloon to deflate.
Saline liquid
(Claim 1)		“Once the device is residing within the stomach, the physician uses the tube to transmit a fluid, such as air, other gas(es), saline solution, pure water, or the like, into the volume-occupying subcomponent and thereby inflate it.”A saline solution used to inflate the balloon.
Self-sealing valve
(Claim 1)		“In preferred embodiments, a self-sealing valve system is attached to the balloon (e.g., on its inside surface) that is “universal” or compatible with the swallowable catheter and a physician-assisted catheter. The valve system serves to allow for balloon inflation using a miniature catheter that includes a needle assembly and also provides a mechanism for detachment of the catheter after inflation has been completed.”A valve that automatically closes and seals after a catheter is detached from it.

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US11779482

ASCENT PARTNERS FUND LLC
Application Number
US17581792
Filing Date
Jan 21, 2022
Status
Granted
Expiry Date
Jan 21, 2031
External Links
Slate, USPTO, Google Patents