Delivery systems for control of gastrointestinal bleeding
Inventors
Perry, Kenneth E. • Perry, Kenneth P. • Xie, Hua • ENESTVEDT, Brintha • McCarthy, Simon J.
Assignees
Oregon Health and Science University • Echobio LLC • Tricol Biomedical Inc
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Publication Number
US-11564673-B2
Publication Date
2023-01-31
Expiration Date
Abstract
The present disclosure relates to a gastrointestinal delivery device of a dressing, where the delivery device is capable of fitting through a narrow channel before expanding and applying the dressing. The gastrointestinal delivery device may be used in all gastrointestinal bleeding applications and can be used with a biocompatible, foldable, thin profile, chitosan dressing. Various aspects of the device and its uses are provided herein.
Core Innovation
The invention provides a gastrointestinal delivery device that includes an expandable support and a releasable dressing. The device is capable of fitting through a channel of 4 mm diameter or less when the expandable support is in an unexpanded format, and the expandable support enables narrow-channel delivery followed by expansion and release of the releasable dressing onto target gastrointestinal mucosa.
The releasable dressing comprises a catechol modified chitosan and is tissue adhesive and hemostatic. The dressing has a thickness of 500 microns or less and has at least one of resistance to substantial swelling in presence of biological fluid or a porous configuration.
The document describes expandable supports that transition between unexpanded and expanded formats, optional protective sheath and rupturable distal diaphragm structures, and dressing tabs and attachment structures for connecting the releasable dressing to the expandable support. It further describes functional principles including mucoadhesion, clot promotion, prevention of premature wetting, controlled dissolution and removal while leaving the dressing in place, and performance targets including fast wet adhesion and resistance to swelling and dissolution in acidic/enzymatic gastrointestinal fluid.
In the described embodiments, the dressing is catechol-modified chitosan configured as a thin hemostatic dressing with controlled dissolution behavior, including protection for specified times in gastrointestinal fluid. The document includes in vivo swine gastric arterial bleeding model studies and comparative prototype results demonstrating adhesion and hemostatic performance after short application using narrow-channel delivery.
Claims Coverage
The independent claim defines one main inventive concept with four core inventive features focused on narrow-channel fitting, expandable support deployment, and a catechol-modified chitosan releasable tissue-adhesive hemostatic dressing with defined thickness and swelling or porosity behavior.
Expandable support for narrow-channel fitting
The device is capable of fitting through a channel of 4 mm diameter or less when the expandable support is in an unexpanded format.
Catechol-modified chitosan releasable tissue-adhesive hemostatic dressing
The releasable dressing comprises a catechol modified chitosan, wherein the dressing is tissue adhesive and hemostatic.
Thin dressing thickness
The dressing has a thickness that is 500 microns or less.
Resistance to swelling and/or porous structure
The dressing is at least one of resistant to substantial swelling in presence of biological fluid or porous.
Overall, the claim coverage centers on combining an expandable support capable of passing through a channel of 4 mm diameter or less in an unexpanded format with a thin catechol modified chitosan releasable dressing that is tissue adhesive and hemostatic and that provides at least one of swelling resistance in biological fluid or a porous structure.
Stated Advantages
Fast wet adhesion.
Resistance to swelling and dissolution in acidic/enzymatic gastrointestinal fluid.
Controlled slow dissolution/removal while leaving the dressing in place.
Ability to address specified gastrointestinal bleeding rates.
Narrow-channel delivery through channels of 4 mm diameter or less.
Documented Applications
Endoscopic or minimally invasive control of upper gastrointestinal bleeding and lower gastrointestinal bleeding using a gastrointestinal expandable-delivery hemostatic dressing system.
In vivo swine gastric arterial bleeding model studies demonstrating hemostasis and adhesion performance.
Targeted delivery via narrow channels associated with an endoscope or gastroscope channel.
Addressing bleeding rates associated with upper gastrointestinal bleeding, including Forrest 1a.
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