Self-expanding devices and methods therefor

Inventors

Eaton, Donald J.Huang, BinAbbate, Anthony J.Zaler, Gail M.Gale, David C.

Assignees

Intersect ENT Inc

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Publication Number

US-11110210-B2

Patent

Publication Date

2021-09-07

Expiration Date


Abstract

Described here are delivery devices for delivering one or more implants to the body, and methods of using. The delivery devices may deliver implants to a variety of locations within the body, for a number of different uses. In some variations, the delivery devices have a cannula with one or more curved sections. In some variations, a pusher may be used to release one or more implants from the cannula. In some variations, one or more of the released implants may be a self-expanding device. Methods of delivering implants to one or more sinus cavities are also described here.

Core Innovation

The invention provides a method of treating one or more sinus conditions in a patient by dilating a paranasal sinus region with an expandable balloon. An expandable device is detachably coupled around the expandable balloon, delivered to the dilated paranasal sinus region, and disengages from the expandable balloon.

The expandable device is configured to expand from a first compressed configuration to a second expanded configuration for conformation against sinus tissue. The device is at least partially coated with a drug eluting layer comprising a drug, and the drug eluting layer is configured to release the drug at a daily dosage of about 500 μg or less per day.

In selected embodiments, the drug eluting layer releases the drug over a time period of about 5 to about 120 days and includes a release rate modifier. The expandable device includes biodegradable polymer filaments arranged in a repeating diamond-shaped pattern, with distal and proximal ends defined by respective diamond shapes.

Claims Coverage

The independent claim covers a sinus-treatment method combining balloon dilation of a paranasal sinus region with a detachably coupled, self-expanding drug-eluting device, followed by withdrawal of the expandable balloon. The claim includes three core inventive features.

Expandable device detachably coupled around the expandable balloon for disengagement

Dilating a paranasal sinus region with an expandable balloon, wherein an expandable device is detachably coupled around the expandable balloon; delivering the expandable device to the dilated paranasal sinus region, wherein the expandable device disengages from the expandable balloon.

Self-expansion from first compressed configuration to second expanded configuration for conformation against sinus tissue

The expandable device is configured to expand from a first compressed configuration to a second expanded configuration for conformation against sinus tissue.

Drug eluting layer releasing at about 500 μg or less per day

The expandable device is at least partially coated with a drug eluting layer comprising a drug, the drug eluting layer configured to release the drug at a daily dosage of about 500 μg or less per day.

Overall, the claim coverage centers on a balloon dilation step paired with a detachably coupled expandable device that self-expands to conform against sinus tissue and includes a drug eluting layer for controlled daily drug dosing at about 500 μg or less per day, with withdrawal of the expandable balloon after dilation.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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