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AssigneeSemprus Biosciences Corp.
InventorsLaurence A. Roth, Zheng Zhang, Chad C. Huval, Michael A. Bouchard, Christopher R. Loose
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Processes are described herein for preparing medical devices and other articles having a low-fouling surface on a substrate comprising a polymeric surface. The polymeric surface material may possess a range of polymeric backbones and substituents while providing the articles with a highly efficient, biocompatible, and non-fouling surface. The processes involve treating the substrate to reduce the concentration of chemical species on the surface of or in the substrate without altering the bulk physical properties of the device or article, and thereafter forming a grafted polymer layer on the treated substrate surface.
A process for preparing an article having a low-fouling surface on a substrate, the substrate having a surface, a bulk beneath the surface, and a near-surface zone lying between the surface and the bulk, the surface, near-surface zone and bulk containing a composite, the composite comprising a continuous phase of a first material and particles of a second material dispersed in the continuous phase, the first material being polymeric and the first and second material being different, the process comprising (a) treating the substrate surface to reduce the second material from the substrate surface and (b) forming a grafted polymer layer on the treated substrate surface, the treated surface and the grafted polymer layer, in combination, constituting a low-fouling surface having a fibrinogen adsorption of less than about 125 ng/cm2 in a fibrinogen binding assay in which the low-fouling surface is incubated for 60 minutes at 37° C. in a composition containing 70 μg/ml fibrinogen derived from human plasma and 1.4 μg/ml I-125 radiolabeled fibrinogen, wherein treating the substrate surface comprises contacting the substrate surface with a solution containing an acid, a base or a chelating agent to remove the second material from the substrate surface.
A process for preparing an article having a low-fouling surface on a substrate, the substrate having a surface, a bulk beneath the surface, and a near-surface zone lying between the surface and the bulk, the surface, near-surface zone and bulk containing a composite, the composite comprising a continuous phase of a first material and particles of a second material dispersed in the continuous phase, the first material being polymeric and the first and second material being different, the process comprising (a) treating the substrate surface to reduce the second material from the substrate surface and (b) forming a grafted polymer layer on the treated substrate surface, the treated surface and the grafted polymer layer, in combination, constituting a low-fouling surface having a fibrinogen adsorption of less than about 125 ng/cm2 in a fibrinogen binding assay in which the low-fouling surface is incubated for 60 minutes at 37° C. in a composition containing 70 μg/ml fibrinogen derived from human plasma and 1.4 μg/ml I-125 radiolabeled fibrinogen, wherein treating the substrate surface comprises polishing the substrate surface.
A process for preparing an article having a low-fouling surface on a substrate, the substrate having a surface, a bulk beneath the surface, and a near-surface zone lying between the surface and the bulk, the surface, near-surface zone and bulk containing a composite, the composite comprising a continuous phase of a first material and particles of a second material dispersed in the continuous phase, the first material being polymeric and the first and second material being different, the process comprising (a) treating the substrate surface to reduce the second material from the substrate surface and (b) forming a grafted polymer layer on the treated substrate surface, the treated surface and the grafted polymer layer, in combination, constituting a low-fouling surface having a fibrinogen adsorption of less than about 125 ng/cm2 in a fibrinogen binding assay in which the low-fouling surface is incubated for 60 minutes at 37° C. in a composition containing 70 μg/ml fibrinogen derived from human plasma and 1.4 μg/ml I-125 radiolabeled fibrinogen, wherein treating the substrate surface comprises mechanically, chemically, or chemomechanically polishing the substrate surface.
A process for preparing an article having a low-fouling surface on a substrate, the substrate having a surface, a bulk beneath the surface, and a near-surface zone lying between the surface and the bulk, the surface, near-surface zone and bulk containing a composite, the composite comprising a continuous phase of a first material and particles of a second material dispersed in the continuous phase, the first material being polymeric and the first and second material being different, the process comprising (a) treating the substrate surface to reduce the second material from the substrate surface and (b) forming a grafted polymer layer on the treated substrate surface, the treated surface and the grafted polymer layer, in combination, constituting a low-fouling surface having a fibrinogen adsorption of less than about 125 ng/cm2 in a fibrinogen binding assay in which the low-fouling surface is incubated for 60 minutes at 37° C. in a composition containing 70 μg/ml fibrinogen derived from human plasma and 1.4 μg/ml I-125 radiolabeled fibrinogen, wherein, after the surface is treated, the particles have an average particle size and a distribution such that the number density of the particles in the near-surface zone is less than the overall number density of the particles in the composite, the near-surface zone extends a distance, D, from the substrate surface and into the substrate, and D has a value that does not exceed twice the average particle size.
A process for preparing an article having a low-fouling surface on a substrate, the substrate having a surface, a bulk beneath the surface, and a near-surface zone lying between the surface and the bulk, the surface, near-surface zone and bulk containing a composite, the composite comprising a continuous phase of a first material and particles of a second material dispersed in the continuous phase, the first material being polymeric and the first and second material being different, the process comprising (a) treating the substrate surface to reduce the second material from the substrate surface and (b) forming a grafted polymer layer on the treated substrate surface, the treated surface and the grafted polymer layer, in combination, constituting a low-fouling surface having a fibrinogen adsorption of less than about 125 ng/cm2 in a fibrinogen binding assay in which the low-fouling surface is incubated for 60 minutes at 37° C. in a composition containing 70 μg/ml fibrinogen derived from human plasma and 1.4 μg/ml I-125 radiolabeled fibrinogen, wherein the treated surface has a Rrms surface roughness of no more than 100 nm and a surface defect density of less than 0.1 defects/μm2 of defects having a size greater than 0.5 micrometers.
A process for preparing an article having a low-fouling surface on a substrate, the substrate having a surface, a bulk beneath the surface, and a near-surface zone lying between the surface and the bulk, the surface, near-surface zone and bulk containing a composite, the composite comprising a continuous phase of a first material and particles of a second material dispersed in the continuous phase, the first material being polymeric and the first and second material being different, the process comprising (a) treating the substrate surface to reduce the second material from the substrate surface and (b) forming a grafted polymer layer on the treated substrate surface, the treated surface and the grafted polymer layer, in combination, constituting a low-fouling surface having a fibrinogen adsorption of less than about 125 ng/cm2 in a fibrinogen binding assay in which the low-fouling surface is incubated for 60 minutes at 37° C. in a composition containing 70 μg/ml fibrinogen derived from human plasma and 1.4 μg/ml I-125 radiolabeled fibrinogen, wherein the substrate surface is treated with a surfactant.
Dependencies are inferred from the claim text.