# US 12,370,286 B2 · Embolic compositions and methods

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- Number: US 12,370,286 B2
- Document ID: US12370286B2
- Status: Granted
- Kind: B2
- Application number: 18/910,388
- Filed: 2024-10-09
- Published: 2025-01-23
- Granted: 2025-07-29
- Earliest claimed: 2020-06-09
- Assignees: Arsenal Medical, Inc.
- Applicants: Arsenal Medical, Inc.
- Inventors: Jeffrey Groom; Craig Wiltsey; Quynh Pham; Nikhita Mansukhani; Courtney Guertin; Lee Core; Upma Sharma
- Web page: https://patentgrep.com/patent/US12370286B2

## CPC

- A61L 24/06: obtained by reactions only involving carbon-to-carbon unsaturated bonds {(A61L24/043, A61L24/046 take precedence)}
- A61K 47/02: Inorganic compounds
- A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence)
- A61K 49/04: X-ray contrast preparations
- A61K 49/0409: {Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is not a halogenated organic compound}
- A61L 24/0021: {Plasticisers}
- A61L 24/02: containing inorganic materials
- A61L 24/043: {Mixtures of macromolecular materials}
- A61L 24/046: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds (A61L24/043 takes precedence)}
- C08L 83/04: Polysiloxanes
- A61L 2400/06: Flowable or injectable implant compositions
- A61L 2430/36: for embolization or occlusion, e.g. vaso-occlusive compositions or devices
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)

## 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.

## Claims

### Claim 1

A method of embolizing a hypervascular tumor in a patient in need thereof, the method comprising:
(a) forming a crosslinkable composition for vascular embolization comprising:
(i) providing a first fluid composition comprising (A) a crosslinkable polymer and
(B) a first imaging agent having an average primary particle size from 80 nm to 200 nm;
(ii) providing a second fluid composition comprising (A) a crosslinker and, optionally, (B) a second imaging agent having an average primary particle size from 80 nm to 200 nm; and
(iii) mixing the first fluid composition and the second fluid composition with a dry composition, the dry composition comprising a first silica filler and, optionally, a second silica filler that is the same or different from the first silica filler;
thereby forming the crosslinkable composition, wherein the first imaging agent, the second imaging agent, the first silica filler, and the optional second silica filler are dispersed in the crosslinkable composition;
(b) preparing the crosslinkable composition for injection; and
(c) injecting the crosslinkable composition into an injection site within a vasculature of the hypervascular tumor whereupon the crosslinkable composition substantially flows into and occludes a target vessel in the vasculature, and whereafter the crosslinkable composition crosslinks and forms into a solid.

### Claim 2 (depends on 1)

The method of claim 1, wherein the hypervascular tumor is a hypervascular brain tumor.

### Claim 3 (depends on 1)

The method of claim 1, wherein the hypervascular tumor is to be embolized prior to surgical resection of the hypervascular tumor.

### Claim 4 (depends on 2)

The method of claim 2, wherein the hypervascular brain tumor is to be embolized prior to surgical resection of the hypervascular brain tumor.

### Claim 5 (depends on 1)

The method of claim 1, wherein the crosslinkable polymer is a polysiloxane having two or more unsaturated groups.

### Claim 6 (depends on 1)

The method of claim 1, wherein the crosslinker is a hydride material having two or more hydride groups.

### Claim 7 (depends on 1)

The method of claim 1, wherein the first imaging agent is bismuth trioxide.

### Claim 8 (depends on 1)

The method of claim 1, wherein the optional second imaging agent is bismuth trioxide.

### Claim 9 (depends on 1)

The method of claim 1, wherein the crosslinkable composition is injected into the vasculature via an inflatable balloon catheter.

### Claim 10 (depends on 9)

The method of claim 9, wherein a balloon of the balloon catheter is inflated at a site proximal to the injection site and maintained in place for a period of time following injection of the crosslinkable composition.

### Claim 11 (depends on 1)

The method of claim 1, wherein the first silica filler and the second silica filler, if present, are fumed silica.

### Claim 12 (depends on 1)

The method of claim 1, wherein the second fluid composition comprises a hydride material having two or more hydride groups.

### Claim 13 (depends on 1)

The method of claim 1, wherein the crosslinkable composition comprises a total amount of at least 10 wt % of bismuth trioxide in each of the first fluid composition and second fluid composition.

### Claim 14 (depends on 1)

The method of claim 1, wherein the ratio of the volume of the first fluid composition to the volume of the second fluid composition is in the range of from 4:1 to 1:4.

### Claim 15 (depends on 1)

The method of claim 1, wherein the crosslinkable composition contains a catalyst modifier.
