Multi-functional hemocompatible porous polymer bead sorbent for removing protein based toxins and potassium from biological fluids
Inventors
Golobish, Thomas • Gruda, Maryann • Guliashvili, Tamaz • O'SULLIVAN, Pamela • SCHEIRER, Andrew • DAN, Vi • Young, Wei-Tai • Capponi, Vincent • Chan, Phillip
Assignees
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Publication Number
US-11723916-B2
Publication Date
2023-08-15
Expiration Date
Abstract
The invention concerns biocompatible polymer systems comprising at least one polymer with a plurality of pores, said polymer comprising a sulfonic acid salt functionality designed to adsorb a broad range of protein based toxins from less than 0.5 kDa to 1,000 kDa and positively charged ions including but not limited to potassium.
Core Innovation
The invention relates to a biocompatible polymer system comprising at least one polymer that has a plurality of pores and a sulfonic acid salt functionality. The polymer is a crosslinked polymer or a porous polymer, and the pore structure has a total volume of pore sizes from 10 Å to 40,000 Å greater than 0.1 cc/g and less than 5.0 cc/g dry polymer.
The polymer has been sulfonated under mild conditions that retain residual functionality of unreacted double bonds and chloromethyl groups. The porous or crosslinked structure supports adsorption targets including protein-based toxins and inflammatory mediators within a molecular weight range, and positively charged ions including potassium (K+).
The system is described as usable in hemocompatible porous polymer bead sorbents and as being formulated into device formats for extracorporeal blood contacting configurations, including perfusion/hemoperfusion and once-through filtration formats. Documented work includes testing and characterization of pore structure and surface chemistry, and filtration performance comparisons for different polymer variants with selective removal behavior for potassium versus albumin.
Claims Coverage
The partial content includes one independent claim. It is supported by multiple dependent claims that refine polymer form, post-modification using residual functional groups, specific pore morphology, biocompatibility/hemocompatibility coatings, adsorption targets, and device integration into an extracorporeal circuit.
Biocompatible sulfonic acid salt porous or crosslinked polymer with specified pore volume range
A biocompatible polymer system comprising at least one polymer having a plurality of pores and a sulfonic acid salt functionality, where the polymer's pore structure has a total volume of pore sizes in the range from 10 Å to 40,000 Å greater than 0.1 cc/g and less than 5.0 cc/g dry polymer.
Mild sulfonation retaining residual functionality of unreacted double bonds and chloromethyl groups
The crosslinked polymer or porous polymer has been sulfonated under mild conditions that retain residual functionality of any unreacted double bonds and chloromethyl groups.
Adsorption of protein-based toxins or inflammatory mediators and positively charged ions
The biocompatible polymer system is capable of adsorbing protein-based toxins or inflammatory mediators within a molecular weight range of from about 0.5 kDa to about 1,000 kDa and can also adsorb positively charged ions.
Post-modification using residual unreacted double bonds or chloromethyl groups
Reacting unreacted double bonds or chloromethyl groups using free-radical or SN2-type chemistry to attach biocompatible and hemocompatible monomers, cross-linkers, or low molecular weight oligomers.
Macroreticular porous polymer form
The porous polymer is a macroreticular porous polymer.
Biocompatibility via selected coating or heparin coating
The biocompatible polymer system is provided with either a selected coating from specified polymer materials or their mixtures, or a coating comprising heparin, to improve biocompatibility.
Device integration for extracorporeal circuit use
The biocompatible polymer system includes the polymer in a device configured to hold the polymer and enable its incorporation into an extracorporeal circuit.
Overall claim coverage centers on a biocompatible porous or crosslinked polymer bearing sulfonic acid salt functionality and having a defined pore volume range, produced by mild sulfonation that retains residual unreacted double bonds and chloromethyl groups. Dependent refinements add target adsorption scope, optional chemical post-modification using residual groups, a macroreticular morphology, biocompatibility coatings including heparin, and device configuration for extracorporeal circuit incorporation.
Stated Advantages
Selective adsorption/removal behavior is described for potassium (K+) relative to albumin, with minimal albumin removal.
Hemocompatibility is described as supported by biocompatible and hemocompatible coatings, including heparin or heparin-mimicking polymer materials.
Documented Applications
Extracorporeal blood contacting use is described, including perfusion/hemoperfusion formats and once-through filtration using polymer bead sorbents.
Filtration performance testing is documented for single-pass hemoglobin and potassium removal, and for dynamic recirculation removal/selectivity for potassium and myoglobin with minimal albumin removal.
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