Expandable devices and methods for treating a nasal or sinus condition
Inventors
Assignees
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Publication Number
US-11484693-B2
Publication Date
2022-11-01
Expiration Date
Abstract
Described here are expandable devices and methods for using them. The devices generally comprise a hub and a plurality of legs extending therefrom. In some variations, the hub may comprise one or more domed portions, tapered portions, or the like. The legs may comprise one or more straight segments, one or more curved segments, or a combination thereof. The devices may comprise one or more polymers, and/or one or more portions of the device may be configured to biodegrade. In other variations, the device may be configured to release one or more drugs therefrom. Additionally, in some variations the devices may be configured to be self-expandable from a low-profile configuration to an expanded configuration.
Core Innovation
The invention relates to an expandable device for treating nasal polyposis. The device has a low profile configuration and an expanded configuration, and includes a plurality of legs connected to a hub. A coating layer on the expandable device includes one or more therapeutic agents, and the legs are configured to extend into the expanded configuration and contact nasal polyps and surrounding tissue.
In use, the expandable device is advanced in the low-profile configuration to a nasal passageway or paranasal sinus cavity having one or more nasal polyps. The device is deployed so the plurality of legs extend into the expanded configuration and contact at least one nasal polyp, and the therapeutic agents are released from the coating layer into the nasal polyps and surrounding tissue. The plurality of legs applies a force of from about 0.5 Newtons to about 15 Newtons on the nasal polyps and surrounding tissue.
The invention further includes mechanical continuation of contact as polyps recede due to release of the therapeutic agents. Deploying the device allows the legs to contact the nasal polyps, and the legs continue to expand to maintain contact with the nasal polyps and surrounding tissue. The expandable device and deployment can also incorporate features such as meshes between legs to catch and move nasal polyps and leg actions including puncturing and/or pushing between nasal polyps.
The expandable device may be delivered using a delivery device having a shaft and a sheath, where deploying is performed by retracting the sheath so the expandable device expands into the expanded configuration. The device may include a domed hub and different biodegradable copolymer compositions for the hub and the legs using different composition ratios. The coating layer can include a poly(lactide-co-caprolactone) copolymer, supporting therapeutic agent release into the polyps and surrounding tissue.
Claims Coverage
Two independent method claims are identified. Both claims cover treatment of nasal polyposis using the same core device concept with a low profile configuration, an expanded configuration, a plurality of legs connected to a hub, and a coating layer with therapeutic agent release.
Expandable device with low profile and expanded configuration for nasal polyp contact
Providing an expandable device having a low profile configuration and an expanded configuration, including a plurality of legs connected to a hub, with the expanded configuration allowing the plurality of legs to extend and contact at least one of the one or more nasal polyps.
Therapeutic agent coating layer released into nasal polyps and surrounding tissue
Providing a coating layer having one or more therapeutic agents, and releasing the one or more therapeutic agents from the coating layer of the expandable device into the one or more nasal polyps and surrounding tissue of the nasal passageway or paranasal sinus cavity.
Leg force applied to nasal polyps and surrounding tissue
The plurality of legs applies a force of from about 0.5 Newtons to about 15 Newtons on the nasal polyps and surrounding tissue.
Legs maintain contact as nasal polyps recede
As the nasal polyps recede due to release of the one or more therapeutic agents, the plurality of legs continue to expand to maintain contact with the nasal polyps and surrounding tissue of the nasal passageway or paranasal sinus cavity.
Across the independent claims, the core coverage is a method that deploys a low-profile expandable device with a hub and plurality of legs into a nasal passageway or paranasal sinus cavity to contact nasal polyps while releasing therapeutic agents from a coating layer into the polyps and surrounding tissue. One independent claim further requires a defined force range, and the other requires continued leg expansion to maintain contact as the polyps recede.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating nasal polyposis by advancing and deploying an expandable device in a nasal passageway or paranasal sinus cavity having one or more nasal polyps, with legs contacting the polyps and therapeutic agents being released into the polyps and surrounding tissue.
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