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Publication Number
US-12240973-B2
Publication Date
2025-03-04
Expiration Date
Abstract
Various embodiments relate to compositions for use in endoluminal devices and to methods of using compositions in endoluminal devices. The compositions include two parts, a first part including a first solution and a second part including a second solution, wherein the first solution comprises one or more pre-polymers, a non-aqueous solvent, a polymerization co-initiator or initiator and optionally one or more chain extenders and additives, and the second solution comprises a polymerization initiator or co-initiator, a non-aqueous solvent and optionally one or more chain extenders and additives.
Core Innovation
The invention provides an endoluminal biostable organogel composition formed from two parts that are separately stored and mixed during use. A first part includes a first solution comprising one or more pre-polymers, a non-aqueous solvent, a polymerization co-initiator or initiator, and optionally one or more chain extenders and additives. A second part includes a second solution comprising a polymerization initiator or co-initiator, a non-aqueous solvent, and optionally one or more chain extenders and additives. The first and second parts remain separate prior to combination.
The pre-polymers include compounds having at least two functional groups selected from acrylate, methacrylate, and vinyl functional groups, including ethoxylated bisphenol A diacrylate, ethoxylated trimethylolpropane triacrylate, propoxylated trimethylolpropane triacrylate, pentaerythritol triacrylate, ethoxylated pentaerythritol tetraacrylate, methacrylic variants, divinyl adipate, divinyl ethers, allyl ether, diallyl maleate, and trimethyl propane diallyl ether and combinations thereof. The non-aqueous solvent of the first solution does not react with the one or more pre-polymers in the first solution, and may include alcohols, aldehydes, amides, carbonates, ethers, esters, glycols, glycol ethers, glycol esters, hydrocarbons, ketones, sulfoxides, vegetable oils, and aliphatic and/or aromatic solvents.
When the first and second parts are combined, the invention yields an organogel with defined viscosity, static compressive modulus, and gel time behavior measured by ASTM D575-91. The combined first part and second part exhibits viscosity from about 5 cP to about 100 cP at 25° C. for a 30% solution, and the organogel exhibits a static compressive modulus from about 0.1 MPa to about 50 MPa within a gel time of about 30 seconds to about 30 minutes. The disclosure also describes optional chain extenders and additives, including fillers, contrast agents, processing aids, plasticizers, and viscosity-reducing agents.
The disclosed endoluminal system uses the organogel composition in an aneurysm treatment context, including systems that include a filling structure filled with the organogel composition. The document describes aneurysm treatment systems using double-walled filling structures or endobags and reports that an endobag/injection example maintains shape and stability. The disclosure further reports gel set time and static compressive modulus performance, including low shrinkage-swelling and low solvent loss/vapor pressure targets, along with accelerated stability and component stability testing.
Claims Coverage
The independent claims are clm-00001, clm-00018, and clm-00020. Across these independent claims, the document centers on a two-part, separately stored organogel formulation with non-reactive non-aqueous solvents, specified multifunctional pre-polymers, and performance ranges for viscosity, static compressive modulus, and gel time, with an aneurysm-treatment system use also recited.
Two-part separately stored organogel composition with non-reactive first-part solvent
An organogel composition comprising two parts, a first part comprising a first solution and a second part comprising a second solution, where the first and second parts are separate from each other; wherein the non-aqueous solvent of the first solution does not react with the one or more pre-polymers in the first solution.
Multifunctional pre-polymers with acrylate, methacrylate, and vinyl functional groups
The one or more pre-polymers comprises compounds having at least two functional groups selected from acrylate, methacrylate, and vinyl functional groups; the one or more pre-polymers selected from the group consisting of ethoxylated bisphenol A diacrylate, ethoxylated trimethylolpropane triacrylate, propoxylated trimethylolpropane triacrylate, pentaerythritol triacrylate, ethoxylated pentaerythritol tetraacrylate, methacrylic variants, divinyl adipate, divinyl ethers, allyl ether, diallyl maleate, trimethyl propane diallyl ether, and combinations thereof.
Specified viscosity and gel performance measured by ASTM D575-91
Wherein a combination of the first part and second part exhibits a viscosity of from about 5 cP to about 100 cP, at 25° C., 30% solution, and forms an organogel exhibiting a static compressive modulus of from about 0.1 MPa to about 50 MPa, measured in accordance with ASTM D575-91, within a gel time of about 30 seconds to about 30 minutes.
Organogel based on two-part composition with defined non-aqueous solvent classes
The non-aqueous solvent includes aliphatic and/or aromatic solvents, the non-aqueous solvent selected from the group consisting of alcohols, aldehydes, amides, carbonates, ethers, esters, glycols, glycol ethers, glycol esters, hydrocarbons, ketones, sulfoxides, and vegetable oils; wherein a combination of the first part and second part forms an organogel exhibiting a static compressive modulus of from about 0.1 MPa to about 50 MPa, measured in accordance with ASTM D575-91, within a gel time of about 30 seconds to about 30 minutes.
Aneurysm treatment system using filling structure filled with the organogel composition
A system for treating an aneurysm includes a filling structure filled with the organogel composition.
Method of forming organogel by contacting separate first and second parts
A method of forming an organogel comprising contacting a first part of a composition and a second part of the composition, wherein the first part and second part are separate from each other prior to contacting; wherein initiating polymerization of the one or more pre-polymers to form the composition exhibits viscosity and forms an organogel exhibiting a static compressive modulus of from about 0.1 MPa to about 50 MPa, measured in accordance with ASTM D575-91, within a gel time of about 30 seconds to about 30 minutes.
The independent claims define a two-part, separately stored organogel composition in which a non-reactive first-part non-aqueous solvent contacts multifunctional pre-polymers, and an initiator/co-initiator second part triggers polymerization to form an organogel. The resulting organogel is characterized by specified viscosity, static compressive modulus measured per ASTM D575-91, and gel time, and the claims also recite an aneurysm-treatment system use.
Stated Advantages
Provides a biostable organogel composition for endoluminal use.
Achieves low shrinkage-swelling and low solvent loss/vapor pressure targets.
Provides organogel formation performance characterized by gel set/cure times and defined static compressive modulus ranges.
Maintains shape and stability in an endobag/injection example.
Documented Applications
Endoluminal devices for aneurysm treatment, including aneurysm treatment systems that include a filling structure filled with the organogel composition.
Endovascular aneurysm repair using a double-walled filling structure or endobags filled with the organogel composition.
Treatment contexts for aneurysms including AAA and TAA, as described in the document.
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