Thromboresistant coatings for aneurysm treatment devices
Inventors
Yang, Yi • Suekama, Tiffany C. • Hossainy, Syed • Ton, Viet • Khosravi, Farhad • Rowson, Alex Jared • Palone, Benjamin Robert • Lao, Henry
Assignees
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Publication Number
US-11903588-B2
Publication Date
2024-02-20
Expiration Date
Abstract
Disclosed are coating compositions, processes, and designs for endowing vascular devices with thromboresistant and endothelializing properties. Also disclosed are designs of vascular devices used as aneurysm treating devices for assisting in the delivery, packing, and maintenance of embolization coils within an aneurysm, particularly a neurovascular aneurysm.
Core Innovation
The document discloses an aneurysm treatment device for insertion into a blood vessel lumen. The device includes a generally cylindrical section with a plurality of struts that form interstitial gaps, as well as proximal and distal faces defining a device lumen extending in an axial direction. The device lumen is configured to allow blood flow through the device while providing a strut-based structure for aneurysm treatment.
A proximal tapered section is provided with struts extending from a perimeter of the proximal face to a proximal apex. The proximal apex is either radially aligned with the perimeter of the proximal face or positioned radially outside of the perimeter of the proximal face. Each strut extends along the perimeter toward the proximal apex such that none of the plurality of struts cross through a cross-sectional area defined by the proximal face of the device lumen.
The document further provides that one or more struts of the proximal tapered section are inverted within the proximal tapered section. The inverted struts bend radially outward of the perimeter of the proximal face so that the proximal apex is positioned radially outside the perimeter of the proximal face.
The document describes thromboresistant and endothelializing coating compositions and conformal coating strategies for neurovascular aneurysm treatment vascular devices, including gradient approaches that distinguish thrombus reduction regions from endothelialization promotion regions. Coating materials described include phosphorylcholine, zwitterionic biomaterials, PVP, plasma-deposited fluorine/glyme, diamond-like carbon and fluorinated DLC, and heparin-like molecules, along with deposition approaches and priming layers.
Claims Coverage
The partial content includes one independent claim defining the core structural and geometric features of an aneurysm treatment blood-vessel insertion device, including the proximal tapered section geometry with an inverted-strut configuration. Dependent claims refine gap size and take-off angle, add a distal tapered section, add a polymeric sleeve, and specify distinct coating purposes for thrombus reduction versus endothelialization promotion.
Blood-vessel insertion aneurysm device with flow-permitting cylindrical strut structure
A device for insertion into a blood vessel lumen for treatment of an aneurysm includes a generally cylindrical section with a plurality of struts forming interstitial gaps, a proximal face, and a distal face, wherein the generally cylindrical section at least partially defines a device lumen extending axially from the proximal face toward the distal face and is configured to allow blood flow through the device.
Proximal tapered strut section with non-crossing proximal-face geometry
A proximal tapered section includes a plurality of struts extending from a perimeter of the proximal face to a proximal apex, where the proximal apex is radially aligned with the perimeter of the proximal face or positioned radially outside of the perimeter of the proximal face, and each strut extends along the perimeter toward the proximal apex such that none of the plurality of struts cross through a cross-sectional area defined by a proximal face of the device lumen.
Inverted proximal tapered struts bending radially outward to position the proximal apex outside the proximal face perimeter
One or more struts of the proximal tapered section are inverted within the proximal tapered section such that the inverted struts bend radially outward of the perimeter of the proximal face, thereby positioning the proximal apex radially outside the perimeter of the proximal face.
Constrained interstitial gaps in the generally cylindrical section
The device includes interstitial gaps in the generally cylindrical section having a width no greater than about 0.01 inches.
Distal tapered section with apex aligned with or outside the distal face perimeter and strut avoidance
The device further includes a distal tapered section comprising a plurality of struts extending from a perimeter of the distal face to a distal apex, where the distal apex is aligned with or positioned radially outside the perimeter of the distal face, and the struts extend along the perimeter so that none of the struts pass through a cross-sectional area defined by the distal face of the device lumen.
Proximal tapered strut take-off angle limit
The device includes a take-off angle relative to a longitudinal axis that is no greater than about 80 degrees.
Polymeric sleeve arranged around at least part of the device lumen
The device further includes a polymeric sleeve arranged around at least part of the device lumen.
Distinct coatings for thrombus reduction and endothelialization promotion
The device includes a first coating intended to reduce thrombus formation and a second coating intended to promote endothelialization.
Overall, the claim coverage centers on a flow-permitting aneurysm treatment device with a generally cylindrical strut structure and a proximal tapered strut section whose struts do not cross the proximal-face cross-sectional area. The proximal tapered section uses inverted struts that bend radially outward so the proximal apex is positioned radially outside the proximal face perimeter, with dependent claims refining geometric constraints, adding a distal tapered section, optionally adding a polymeric sleeve, and specifying distinct coating purposes for thrombus reduction versus endothelialization promotion.
Stated Advantages
Reduce thrombus formation.
Promote endothelialization.
Documented Applications
Treatment of an aneurysm with a device inserted into a blood vessel lumen.
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