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-11766511-B2
Publication Date
2023-09-26
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 provides an antithrombogenic extracorporeal blood circuit in which a blood tubing, an array of hollow fiber membranes, and/or other extracorporeal components are formed from a base polymer admixed with a surface modifying macromolecule (SMM). The SMM is described by formula (VII) having a polyfluoroorgano group (FT), a hard segment (B) formed from hexamethylene diisocyanate, and an Oligo segment defined as polypropylene oxide having a theoretical molecular weight of from 500 to 3,000 Daltons.
In described embodiments, the SMM-modified base polymers are used for hollow fiber membranes and blood tubing, and the components are arranged as extracorporeal blood circuits that include dialysis filters and/or potted bundles within an encasement. The potted bundle includes lumens of the hollow fiber membranes providing a path for the flow of blood from a first internal wall to a second internal wall, with first and second fiber-end sets potted in potting resin defining respective internal walls near opposite ends of the encasement.
The document relates the antithrombogenic approach to hemodialysis, hemofiltration, hemodiafiltration, hemoconcentration, and extracorporeal oxygenation. The SMM-modified base materials are described as migrating toward the surface/top region, supporting formation of an antithrombogenic surface for the extracorporeal blood-contacting components.
Claims Coverage
The claims coverage is based on three independent claims. These independent claims define an extracorporeal blood circuit, a dialysis kit with multiple possible components, and a potted bundle structure with a specified potting resin composition comprising SMM as defined by formula (VII) and its enumerated alternatives.
Extracorporeal blood circuit with SMM-defined polymer modification
An extracorporeal blood circuit comprising a blood tubing and an array of hollow fiber membranes, wherein the blood tubing, the hollow fiber membranes, or both comprise a base polymer admixed with from 0.005% to 10% (w/w) of a surface modifying macromolecule described by formula (VII), where Oligo is polypropylene oxide of theoretical molecular weight 500 to 3,000 Daltons, B is a hard segment formed from hexamethylene diisocyanate, FT is a polyfluoroorgano group, and n is an integer from 1 to 10.
Dialysis kit with component-level SMM-defined polymer modification
A dialysis kit comprising a hollow fiber membrane, a potted bundle, a dialysis filter, and/or blood tubing, wherein one or more of the hollow fiber membrane, potted bundle, dialysis filter, and/or blood tubing comprises a base polymer admixed with from 0.005% to 10% (w/w) of a surface modifying macromolecule described by formula (VII), where Oligo is polypropylene oxide of theoretical molecular weight 500 to 3,000 Daltons, B is a hard segment formed from hexamethylene diisocyanate, FT is a polyfluoroorgano group, and n is an integer from 1 to 10.
Potted bundle with lumen blood flow path and SMM-containing potting resin
A potted bundle of hollow fiber membranes within an encasement comprising lumens that provide a path for the flow of blood from a first internal wall to a second internal wall, with first and second fiber-end sets potted in potting resin defining respective internal walls near opposite ends of the encasement, wherein the potting resin comprises from 0.005% to 10% (w/w) surface modifying macromolecule described by the structural formulae including FT-[B-(Oligo)]n-B-FT (VII).
Across the independent claims, the inventive coverage centers on extracorporeal blood-contacting polymer components formed from base polymers admixed with a surface modifying macromolecule defined by formula (VII), including the potted bundle geometry and potting resin composition.
Stated Advantages
Reduced thrombi deposition as measured by γ-count reduction.
Reduced operating/header pressure.
Prolonged working life.
Reduced adverse events.
Reduced anticoagulant requirements, including less/no heparin.
Documented Applications
Hemodialysis using extracorporeal blood circuits including dialysis filters and hollow fiber membranes.
Hemofiltration using extracorporeal blood circuits and hemofilter/thrombosis evaluations in vitro.
Hemodiafiltration using extracorporeal blood circuits.
Hemoconcentration using extracorporeal blood circuits.
Extracorporeal oxygenation.
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