Embolic compositions and methods
Inventors
Groom, Jeffrey • WILTSEY, Craig • Pham, Quynh • MANSUKHANI, Nikhita • Guertin, Courtney • Core, Lee • Sharma, Upma
Assignees
Publication Number
US-12285538-B2
Publication Date
2025-04-29
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 crosslinkable, biocompatible compositions, kits, and methods for in situ formation of crosslinked compositions within a patient. These compositions are specifically designed for use as embolic materials to occlude vasculature, including neurovasculature. The core formulation involves mixing two or more fluid compositions, each containing distinct components such as a polysiloxane with unsaturated groups, a hydride material with hydride groups, silica fillers, imaging agents, and a catalyst that promotes crosslinking between the unsaturated and hydride groups.
A key problem addressed is the need for injectable, in-situ-forming embolic agents that can be delivered to closed cavities, hard-to-access body sites, and spaces within the body where they can fill and support tissues efficiently. The crosslinkable compositions of the disclosure specifically address challenges in delivering embolic agents to the vasculature for occlusion, providing versatility in formulation and delivery, and ensuring controllable gelation after placement in the body.
The disclosed methods and kits allow the separate storage and mixing of fluid and dry components, enabling precise formulation at the time of use. The crosslinkable compositions can contain hydrophilic or hydrophobic silica, plasticizers, and imaging agents such as bismuth trioxide for radiopacity. The mixing process results in a shear-thinning, flow-responsive material that is readily injectable and then forms a solid cast upon crosslinking at the target site, enabling effective embolization tailored to clinical need.
Claims Coverage
The patent includes three independent method claims, each introducing a distinct inventive feature relating to the formation and use of crosslinkable compositions for vascular embolization.
Method for forming and injecting a crosslinkable composition for vascular embolization by mixing suspensions with silica filler
A method comprising: 1. Forming a crosslinkable composition for vascular embolization by: - Providing a first suspension containing a crosslinkable polymer and a first imaging agent with an average primary particle size from 80 nm to 200 nm. - Providing a second suspension containing a crosslinker and, optionally, a second imaging agent with an average primary particle size from 80 nm to 200 nm. - Mixing the first and second suspensions with a dry composition comprising a first silica filler and optionally a second silica filler, thereby dispersing all agents and fillers in the composition. 2. Preparing the crosslinkable composition for injection. 3. Injecting the composition into an injection site within the vasculature of a patient so that it flows into and occludes a target vessel and then crosslinks to form a solid.
Method for vascular embolization using polysiloxane and hydride-based suspensions and filler
A method comprising: 1. Forming a crosslinkable composition for vascular embolization by: - Providing a first suspension containing a polysiloxane with at least two unsaturated groups and a first imaging agent (average particle size 80 nm to 200 nm). - Providing a second suspension comprising a hydride material with at least two hydride groups and, optionally, a second imaging agent (average particle size 80 nm–200 nm). - Mixing these with a dry composition including a first filler and optionally a second filler so that the imaging agents and fillers are evenly dispersed. 2. Preparing the composition for injection. 3. Injecting it into a vasculature site so it flows, occludes, and then crosslinks to form a solid within the vessel.
Method of embolization using crosslinkable polymers combined with bismuth trioxide and fillers
A method comprising: 1. Forming a crosslinkable composition by: - Providing a first suspension of a crosslinkable polymer and bismuth trioxide (average particle size 80 nm–200 nm). - Providing a second suspension of a crosslinker and, optionally, bismuth trioxide (average particle size 80 nm–200 nm). - Mixing both suspensions with a dry composition containing a first filler and, optionally, a second filler, dispersing bismuth trioxide and fillers evenly throughout. 2. Preparing the composition for injection. 3. Injecting it into an injection site in the patient's vasculature where the composition flows, occludes the target vessel, and crosslinks to a solid.
The claims broadly cover methods for preparing and delivering crosslinkable embolic compositions using multiple suspensions and dry fillers—particularly emphasizing the use of polysiloxane, hydride materials, silica fillers, and imaging agents such as bismuth trioxide—to achieve in situ crosslinking and permanent vascular occlusion after injection.
Stated Advantages
The crosslinkable compositions provide in-situ-forming embolic agents that can be delivered to closed cavities and difficult-to-access body sites, allowing for the occlusion of vasculature, including distal and small vessel branches.
Shear-thinning properties enable ease of injection through microcatheters and allow the material to penetrate deeply into distal branches while providing proximal control as flow is reduced.
The compositions can form a complete cast of the vasculature, ensuring thorough and permanent vessel occlusion without non-target embolization.
Inclusion of radiopaque agents, such as bismuth trioxide, permits real-time visualization during procedures and minimal imaging artifact on follow-up imaging.
Formulations are biocompatible and exhibit minimal to mild inflammation with an absence of vessel injury or necrosis, indicating suitability for use in vivo.
Compositions can be tailored in viscosity and injection force, enabling hand injection via syringe and compatibility with a variety of delivery devices including balloon catheters.
The approach allows for preparation flexibility—mixing components at the time of use for optimized shear-thinning, stability, and injectability.
The cured compositions can be terminally sterilized, including by electron-beam irradiation, enhancing safety for clinical use.
Documented Applications
Occlusion of the vasculature for treatment of tumors.
Pre-surgical embolization of tumors to minimize blood loss.
Treatment of chronic subdural hematoma.
Treatment of brain aneurysms.
Treatment of arteriovenous malformations.
Treatment of arteriovenous fistulas.
Treatment of gastrointestinal bleeds.
Treatment of bleeding due to trauma.
Treatment of abdominal aortic aneurysm.
Treatment of intracranial aneurysm.
Treatment of pulmonary aneurysm.
Treatment of hemorrhage.
Prostate artery embolization.
Uterine artery embolization.
Treatment of visceral aneurysms.
Treatment of varicoceles.
Treatment of varices.
Treatment for pelvic congestion.
Treatment of epistaxis.
Treatment of endoleaks.
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