Embolic compositions and methods
Inventors
Groom, Jeffrey • WILTSEY, Craig • Pham, Quynh • MANSUKHANI, Nikhita • Guertin, Courtney • Core, Lee • Sharma, Upma
Assignees
Publication Number
US-12357724-B2
Publication Date
2025-07-15
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 present disclosure relates to biocompatible crosslinkable compositions, systems for forming such compositions, and methods of their use. These compositions include a first polysiloxane with two or more unsaturated groups, a first silica filler, imaging agents, a hydride material with two or more hydride groups, and catalysts that catalyze reactions between unsaturated and hydride groups to form crosslinked compositions in situ. Kits and formulations involve mixing different fluid and dry components to produce compositions capable of being injected and crosslinked within a patient.
The disclosed compositions exhibit shear-thinning behavior and flow responsiveness, enabling them to be delivered intravascularly or into otherwise difficult-to-access body sites. On injection, these compositions fill and cast vasculature or spaces, cure to form elastic solids, and can be used for embolization applications. The polymers, often based on polydimethylsiloxane (PDMS), and fillers such as silica and bismuth oxide provide desirable properties including biocompatibility, controlled viscosity, radiopacity, and cure times suitable for clinical use.
Claims Coverage
The patent includes one independent method claim focused on forming and using a crosslinkable composition for embolizing the middle meningeal artery (MMA). There is a single inventive feature extracted reflecting this method.
Method of embolizing the middle meningeal artery (MMA) using a crosslinkable composition
A method comprising: forming a crosslinkable composition by mixing a first fluid composition containing a crosslinkable polymer and a first imaging agent (80-200 nm particle size), a second fluid composition containing a crosslinker and optionally a second imaging agent (80-200 nm particle size), with a dry composition containing a first silica filler and optionally a second silica filler; preparing the mixture for injection; and injecting it into the MMA vasculature where it flows and occludes a target vessel, then crosslinks into a solid.
The claims focus on a specific method of forming and injecting a crosslinkable composition involving polysiloxane polymers, hydride crosslinkers, imaging agents, and silica fillers to embolize the middle meningeal artery. The method includes compositions with specified particle sizes of imaging agents and potential use of balloon catheters for delivery.
Stated Advantages
Provides in situ formation of crosslinked embolic compositions capable of filling and occluding vasculature including neurovasculature.
Exhibits shear-thinning properties permitting controlled injection and distal vessel penetration through microcatheters.
Achieves complete casting and occlusion of targeted vasculature without significant non-target embolization.
Allows real-time imaging due to incorporation of imaging agents comprising radiopaque materials such as bismuth trioxide.
Utilizes biocompatible and non-cytotoxic components, such as polydimethylsiloxane (PDMS), enabling safe embolization.
Capable of curing into elastic solids facilitating post-procedure surgical resection if needed.
Has adjustable viscosity and injection force optimized for clinical use and catheter delivery.
Documented Applications
Occlusion and embolization of vasculature including neurovasculature and specifically the middle meningeal artery (MMA).
Treatment of chronic subdural hematoma via MMA embolization.
Embolization of tumors including meningioma and peripheral tumors.
Pre-surgical embolization of tumors to minimize blood loss.
Treatment of brain aneurysms, arteriovenous malformations, arteriovenous fistulas, gastrointestinal bleeds, bleeding due to trauma, prostate artery embolization, uterine artery embolization, visceral aneurysms, varicocele, varices, pelvic congestion, epistaxis, and treatment of endoleaks.
Portal vein embolization (PVE) to induce hypertrophy of liver segments prior to hepatic resection.
Embolization therapy in conditions such as dural arteriovenous fistula (DAVF), pseudoaneurysm, traumatic arteriovenous fistula (AVF), moyamoya disease (MMD), recurrent chronic subdural hematoma (CSDH), migraine, and meningioma.
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