Embolic compositions and methods
Inventors
Groom, Jeffrey • WILTSEY, Craig • Pham, Quynh • MANSUKHANI, Nikhita • Guertin, Courtney • Core, Lee • Sharma, Upma
Assignees
Publication Number
US-12364787-B2
Publication Date
2025-07-22
Expiration Date
2041-06-09
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Abstract
The present disclosure pertains to crosslinkable compositions and systems as well as methods for forming crosslinked compositions in situ, including the use of the same for embolizing vasculature including the neurovasculature within a patient, among many other uses.
Core Innovation
The invention relates to biocompatible crosslinkable compositions, systems, and methods for forming crosslinked compositions in situ. Specifically, it involves polysiloxane-based fluid compositions with two or more unsaturated groups and hydride materials with two or more hydride groups, combined with silica fillers and imaging agents. These compositions, when mixed, form a crosslinkable material that can be injected into body sites such as the vasculature, where they cure to provide embolization.
The problem addressed is the need for compositions capable of forming crosslinked materials in situ with biomedical advantages such as delivery to closed cavities and difficult-to-access sites, filling potential or blood-filled spaces, and supporting surrounding tissues. Current embolic materials lack optimal flow-responsive properties, biocompatibility, and imaging visibility, and may not provide controlled distal penetration or proximal control during vascular embolization.
The invention provides kits and methods comprising two fluid compositions and optionally dry compositions, each containing combinations of polysiloxanes with unsaturated groups, hydride materials, silica fillers, imaging agents, and catalysts. These compositions exhibit shear-thinning properties allowing injection through catheters and flow responsiveness that enables distal vessel penetration, proximal control, and complete vasculature casting. The compositions can be prepared by mixing components at the time of use or as preformulated stable mixtures, optionally annealed for enhanced ductility. The compositions also allow terminal sterilization and possess adjustable gel times and viscosities suitable for in vivo embolization.
Claims Coverage
The patent contains one independent method claim describing a method of forming and using a crosslinkable embolic composition. The main inventive features include composition formation steps with specific component annealing and mixing, and the method of vascular injection resulting in vessel occlusion.
Method of forming a crosslinkable embolic composition via annealed suspensions and dry mixing
Forming a crosslinkable composition for vascular embolization by (i) annealing a first suspension containing a polysiloxane with two or more unsaturated groups and a first imaging agent, (ii) annealing a second suspension containing a hydride material with two or more hydride groups and a second imaging agent, and (iii) mixing these annealed suspensions with a dry composition comprising a first silica filler and optionally a second silica filler to form the final crosslinkable composition with dispersed imaging agents.
Method of injecting the crosslinkable composition for occlusion of target vasculature
Injecting the formed crosslinkable composition into the vasculature of a patient where it crosslinks in situ and forms a solid that occludes the target vessel into which it is injected.
These inventive features combine the specific preparation of embolic compositions via annealing and mixing of distinct suspensions and dry fillers with the administration of these compositions to occlude vessels, providing improved embolization methods and materials.
Stated Advantages
Crosslinkable compositions enable delivery to difficult-to-access body sites and closed cavities such as vasculature for embolization.
Shear-thinning properties allow for controlled injection, proximal control, and distal penetration into vessels as small as less than 100 microns in diameter.
The compositions provide complete casting and occlusion of targeted vasculature without non-target embolization.
High radiopacity and imaging agent incorporation allow for real-time visualization and improved surgical outcomes.
Biocompatibility is demonstrated with minimal inflammation, no vessel injury or necrosis, and suitability for chronic in vivo use.
Terminal sterilization of kits and compositions is possible using methods such as electron beam irradiation.
Documented Applications
Use in vascular embolization, including treatment and occlusion of tumors and pre-surgical tumor embolization.
Treatment of chronic subdural hematoma, brain aneurysms, arteriovenous malformations and fistulas, gastrointestinal bleeds, bleeding due to trauma, abdominal and intracranial aneurysms, and pulmonary aneurysms.
Procedures including prostate artery embolization, uterine artery embolization, treatment of visceral aneurysms, varicocele, varices, and pelvic congestion syndrome.
Treatment of epistaxis and endoleaks.
Injection into proximal vessels to occlude distal branching branches, including vessels with diameters less than 100 microns.
Delivery via catheters including use with balloon catheters for flow control during embolization.
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