Antithrombogenic hollow fiber membranes and filters
Inventors
Mullick, Sanjoy • Chang, Weilun • Chen, Hanje • STEEDMAN, Mark A. • Esfand, Roseita
Assignees
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Publication Number
US-9687597-B2
Publication Date
2017-06-27
Expiration Date
Abstract
The invention relates to extracorporeal blood circuits, and components thereof (e.g., hollow fiber membranes, potted bundles, and blood tubing), including 0.005% to 10% (w/w) surface modifying macromolecule. The extracorporeal blood circuits have an antithrombogenic surface and can be used in hemofiltration, hemodialysis, hemodiafiltration, hemoconcentration, blood oxygenation, and related uses.
Core Innovation
The invention relates to antithrombogenic extracorporeal blood circuits, including blood tubing and filtration components, formed from a base polymer admixed with a surface modifying macromolecule (SMM). The circuits are described as antithrombogenic when contacted with blood, with thrombi deposition reduced and functional performance maintained over extended use. The SMM is present at about 0.005% to 10% (w/w) in the base polymer to form the antithrombogenic materials.
The surface modifying macromolecule is described as migrating to the polymer surface and is characterized by a specified structural formula. The SMM includes a polyfluoroorgano group (FT) linked to a hard segment (B) and an oligomeric/soft segment (Oligo). Oligo is polypropylene oxide having a theoretical molecular weight of from 500 to 2,000 Daltons, B is a hard segment formed from hexamethylene diisocyanate, FT is a polyfluoroorgano group, and n is an integer from 1 to 10.
The antithrombogenic performance is supported through measurements including reduced thrombi deposition as measured by y-count (gamma-probe) and changes in operating pressure after use. The document also states prolonged working life and reduced adverse events associated with use of the antithrombogenic materials.
Claims Coverage
The provided claim set includes one independent claim, with dependent claims refining the surface-modifying macromolecule structure, base polymer selection, and fluorinated group definition. The inventive coverage is organized around antithrombogenic blood tubing formed by admixing a specified SMM at 0.005% to 10% (w/w), and an SMM defined by a structural formula using Oligo, a hard segment B formed from hexamethylene diisocyanate, a polyfluoroorgano group FT, and an integer parameter n.
Antithrombogenic blood tubing with specified SMM loading
A blood tubing comprising a base polymer admixed with from 0.005% to 10% (w/w) surface modifying macromolecule, wherein said blood tubing is antithrombogenic when contacted with blood, as measured by y-count.
SMM defined by polypropylene oxide soft segment, hexamethylene diisocyanate hard segment, polyfluoroorgano group, and repeat parameter
The surface modifying macromolecule is described by formula FT—[B-(Oligo)]_n—B—FT, where Oligo is polypropylene oxide having a theoretical molecular weight of from 500 to 2,000 Daltons, B is a hard segment formed from hexamethylene diisocyanate, FT is a polyfluoroorgano group, and n is an integer from 1 to 10.
Specified fluorinated segment structures for FT
FT is characterized by specified fluorinated segment structures selected from the listed repeating moieties.
Molecular-weight constraint on the polypropylene oxide Oligo segment
The [CH(CH3)CH2O]_n unit has a theoretical molecular weight from 500 to 2,000 Daltons.
Narrowed molecular-weight selection for the [CH(CH3)CH2O]_n unit
The [CH(CH3)CH2O]_n unit has a molecular weight (Mw) of 1000 g/mol.
Base polymer selected as polyvinyl chloride
The base polymer includes polyvinyl chloride.
FT formation precursor specified as a single perfluoro-1-octanol compound
FT is formed from 1H,1H,2H,2H-perfluoro-1-octanol.
Across the independent claim and dependent refinements, the coverage focuses on antithrombogenic blood tubing made by admixing 0.005% to 10% (w/w) of an SMM into a base polymer, where the SMM is defined by an FT-containing structure incorporating a polypropylene oxide Oligo segment (500–2,000 Daltons), a hard segment B formed from hexamethylene diisocyanate, and an integer n (1–10), with further specification of FT structures, Oligo molecular weight constraints, base polymer selection, and FT precursor.
Stated Advantages
Reduced thrombi deposition as measured by y-count (gamma-probe).
Reduced operating pressure after use.
Prolonged working life.
Reduced adverse events.
Documented Applications
Antithrombogenic extracorporeal blood circuits, including hollow fiber membranes, potted bundles, dialysis filters, and blood tubing, for contact with blood.
Membrane and circuit use in hemodialysis, hemofiltration, hemodiafiltration, hemoconcentration, and oxygenation.
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