Radiopaque monomers, polymers, microspheres, and methods related thereto

Inventors

Reb, Philippe

Assignees

Biosphere Medical Inc

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Publication Number

US-11845823-B2

Patent

Publication Date

2023-12-19

Expiration Date


Abstract

Radiopaque monomers, polymers, and microspheres are disclosed herein. Methods of using the radiopaque monomers, polymers, and microspheres are disclosed herein. Methods of manufacturing radiopaque monomers, polymers, and microspheres are disclosed herein.

Core Innovation

The disclosed invention relates to radiopaque monomers, radiopaque polymers, and embolic microspheres based on a polymerized monomer having a structure according to Formula I, wherein n is 0-12 and R is either an oxygen-containing moiety or a nitrogen-containing moiety. The polymeric microspheres are formed from these polymerized monomer structures and can optionally include additional composition components described in the specification.

The invention further describes polymer compositions that can be polymerized from the Formula I monomer and can include optional materials such as acrylamide, acrylate, and methacrylate, together with cross-linkers. Additional formulation components can include gelatin, coloring agents, additional radiopaque agents, and magnetic agents such as superparamagnetic iron oxide particle and Ferucarbotran, thereby enabling radiopaque and/or magnetic contrast behavior as described in the document.

As an embolic composition, the invention also describes swellable microspheres and shrinkable microspheres, and resorbable versus non-resorbable behavior depending on cross-linking. The document describes methods of embolization that include injecting such an embolic composition into a blood vessel and tracking or detecting a location of the polymeric microsphere by imaging without a separate contrast agent, with detection after prolonged times such as more than about 24 hours, more than about 48 hours, more than about a week, and more than about a month.

Claims Coverage

The independent claims are clm-00001 and clm-00011. Across these, the claim coverage focuses on two main inventive features: an embolic method using polymeric microspheres defined by Formula I monomer parameters (n and R), and a non-resorbable, radiopaque microsphere with prolonged detection of location after introduction.

Injecting an embolic composition with a polymeric microsphere defined by Formula I

Injecting an embolic composition into a blood vessel of a patient, where the composition comprises a polymeric microsphere comprising a polymerized monomer having a structure according to Formula I, with n being 0-12, and where R is either an oxygen-containing moiety or a nitrogen-containing moiety.

Non-resorbable, radiopaque polymeric microspheres and prolonged detection

Injecting an embolic composition into a blood vessel of a patient, where the composition comprises a polymeric microsphere comprising a polymerized monomer having a structure according to Formula I, with n being 0-12 and where R is either an oxygen-containing moiety or a nitrogen-containing moiety, wherein the polymeric microsphere is non-resorbable within a body of the patient, wherein the polymeric microsphere is radiopaque, and detecting a location of the polymeric microsphere more than about 24 hours, more than about 48 hours, more than about a week, or more than about a month after introduction of the polymeric microsphere.

Overall, the claim set covers embolization methods that use polymeric microspheres derived from a Formula I polymerized monomer (n=0-12; R is oxygen- or nitrogen-containing). The broader coverage is in claim clm-00001, while clm-00011 adds explicit non-resorbable and radiopaque limitations together with detecting the microsphere location after prolonged time periods.

Stated Advantages

Enables detecting/tracking the location of polymeric microspheres after prolonged time periods (e.g., more than about 24 hours, 48 hours, a week, or a month).

Radiopaque microspheres provide radiopaque behavior for imaging/detection of microsphere location.

Documented Applications

Embolization of a patient by injecting an embolic composition into a blood vessel for medical treatment, with detection/imaging of microsphere location after introduction.

Tumor treatment via embolization as described in the document, and embolization-related indications including varicocele, hemorrhage prevention, vascular anomaly, and disease/cosmetic indications.

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