Abstract: A method of modifying surfaces of a device, for example, a medical device, is disclosed. The method includes modifying a surface of a device by providing a device, exposing the device to a reactive gas and plasma energy to create a plasma deposited surface on the device, and quenching the device with the reactive gas. The device exhibits changes in its surface properties thereby making it more desirable for an intended use.

Abstract: A method of modifying surfaces of a device, for example, a medical device, is disclosed. The method includes modifying a surface of a device by providing a device, exposing the device to a reactive gas and plasma energy to create a plasma deposited surface on the device, and quenching the device with the reactive gas. The device exhibits changes in its surface properties thereby making it more desirable for an intended use.

Abstract: A medical device having a surface graft matrix comprising carboxyl-functional groups located on the device, the surface graft matrix comprising an outer portion; and one or more biomolecules covalently coupled to the surface graft matrix, wherein a majority of the biomolecules are located in the outer portion of the surface graft matrix. The surface graft matrix can also be loaded with a pharmaceutical agent.

Abstract: To minimize the incidence and consequences of device related infection that occur after prosthetics implants of neuro-muscular stimulating devices, an infection resistant intra-muscular lead has been developed and is disclosed herein. Infection incidence has been decreased by using biomaterials able to release antibacterial drugs (gentamicin) at a controlled rate for the first 3-6 weeks after implant.

Abstract: A medical device having a surface graft matrix comprising carboxyl-functional groups located on the device, the surface graft matrix comprising an outer portion; and one or more biomolecules covalently coupled to the surface graft matrix, wherein a majority of the biomolecules are located in the outer portion of the surface graft matrix. The surface graft matrix can also be loaded with a pharmaceutical agent.

Abstract: A medical article having a metal or glass surface with the surface having an adherent coating of improved biocompatibility. The coating is made by first applying to the surface an silane compound having a pendant vinyl functionality such that the silane adheres to the surface and then, in a separate step, forming a graft polymer on the surface with applied vinylsilane such that the pendant vinyl functionality of the vinylsilane is incorporated into the graft polymer by covalent bonding with the polymer. Biomolecules may then be covalently attached to the base layer.

Abstract: To minimize the incidence and consequences of device related infection that occur after prosthetics implants of neuro-muscular stimulating devices, an infection resistant intramuscular lead has been developed. Infection incidence has been decreased by using biomaterials able to release antibacterial drugs (gentamicin) at a controlled rate for the first 3-6 weeks after implant.

Abstract: A medical lead having a lead body and a biocompatible cuff and especially suitable for use as a nerve electrode. In the preferred bipolar embodiment the lead body has two conductors running therethrough. The distal end is coupled to a pulse generator, the proximal end is coupled to the biocompatible cuff. The biocompatible cuff is cylindrical and is constructed from collagen. Preferably the collagen is multi-layer, i.e. the first portion is cross-linked to an amount greater than the second portion. Through such a construction the collagen promotes tissue ingrowth in the region proximate a nerve and does not permit tissue ingrowth in the region away from the nerve, e.g. the exterior of the cuff.

Abstract: An improved spacer material for improving the biocompatibility of a biomaterial and a method for making it in which a polyalkylimine is covalently attached to an aminated substrate and combined with a crosslinking agent which is at least difunctional in aldehyde groups. The polyalkylimine can be for example, polyethyleneimine and the crosslinking agent can be, for example, glutaraldehyde. Preferably, the crosslinking agent is applied in dilute solution and at a pH suitable to accomplish light crosslinking of the polyalkylimine and also provide aldehyde linkages at the interface between the biomolecule and the spacer.

Abstract: An improved method of making a medical device having immobilized heparin on a blood-contacting surface in which heparin is admixed with sufficient periodate to react with not more than two sugar units per heparin molecule in a buffer solution having a pH in the range of about 4.5-8. This mixture is reacted for at least 3 hours while protected from light and is then applied to the immobilized amine groups. This is an improvement over the prior art methods which included using an excess of periodate and then stopping the reaction at a desired point by the addition of glycerol since the conversion of only a few of the natural functional groups to aldehydes better preserves the antithrombotic bioeffectiveness of the heparin molecules bound to the surface. The invention also avoids the prior art steps of drying and reconstituting the heparin by providing a reacted mixture of heparin and periodate that can be stored as a stable liquid and applied directly to the aminated surface several days later.

Abstract: An improved coating and spacer material for a medical device having a blood or tissue-contacting surface comprising a polyalkyleneimine layer which is crosslinked with a crosslinking agent which is at least difunctional in polymerizable vinyl groups which have adjacent strong electron-withdrawing groups and a biomolecule covalently bonded to the crosslinked polyalkyleneimine layer. For example, polyethyleneimine crosslinked with divinyl sulfone could be used. The resulting crosslinked spacer layer has improved uniformity and stability without materially limiting the covalent attachment of a biomolecule such as heparin.

Abstract: A medical article having a metal or glass surface with the surface having an adherent coating of improved biocompatibility. The coating is made by first applying to the surface an silane compound having a pendant vinyl functionality such that the silane adheres to the surface and then, in a separate step, forming a graft polymer on the surface with applied vinylsilane such that the pendant vinyl functionality of the vinylsilane is incorporated into the graft polymer by covalent bonding with the polymer. Biomolecules may then be covalently attached to the base layer.

Abstract: An improved spacer material for improving the biocompatibility of a biomaterial and a method for making it in which a polyalkylimine is covalently attached to an aminated substrate and combined with a crosslinking agent which is at least difunctional in aldehyde groups. The polyalkylimine can be, for example, polyethyleneimine and the crosslinking agent can be, for example, glutaraldehyde. Preferably, the crosslinking agent is applied in dilute solution and at a pH suitable to accomplish light crosslinking of the polyalkyaimine and also provide aldehyde linkages at the interface between the biomolecule and the spacer.

Abstract: An improved iontophoresis electrode employing a current distributing member and a drug reservoir containing an ionic drug. The drug reservoir is applied to the skin of a patient, and includes a charge selective ion permeable membrane adapted to contact the skin, through which the ionic drug is delivered.

Abstract: An improved spacer material for improving the biocompatibility of a biomaterial and a method for making it in which a polyalkylimine is covalently attached to an aminated substrate and combined with a crosslinking agent which is at least difunctional in aldehyde groups. The polyalkylizine can be, for example, polyethyleneimine and the crosslinking agent can be, for example, glutaraldehyde. Preferably, the crosslinking agent is applied in dilute solution and at a pH suitable to accomplish light crosslinking of the polyalkylimine and also provide aldehyde linkages at the interface between the biomolecule and the spacer.

Abstract: A method for modifying the surface characteristics of a polymeric material by irradiating a surface of the polymeric material in the presence of an oxygen and then grafting acrylamide to the irradiated surface by contacting the irradiated surface with an aqueous solution including acrylamide monomer and ceric ion. Grafted polymer surfaces with dense surface coverage are produced without using a deaerated monomer solution. Biofunctional molecules can be ionically or covalently bonded to the grafted surface.

Abstract: An improved biomedical appliance having disposed on a skin-contacting, operant portion thereof, a film or layer of a skin compatible, tacky, pressure sensitive polymeric adhesive, the reaction product consisting of at least one fatty acid dimer based or derived component and a suitable co-reactant. Electrodes, surgical tapes, TENS devices and iontophoresis devices employing the adhesive are disclosed.

Abstract: Improved electrical leads provided by the surface treatment of silicone rubber tubing covering on implantable pulse generator, or IPG leads and the like by exposure of the silicone rubber to radio frequency glow discharge in a polymer forming or non-polymer forming gas at reduced pressure whereby improved slip properties are provided and binding between two or more of the leads in contact with each other is minimized.

Abstract: An improved hydrogel adhesive, particularly adapted for adhesion and contact to tissue. It is especially useful in attaching electrical leads to tissue, for example in attaching pacemaker leads to the heart, interiorly or exteriorly.

Abstract: Reaction grade 2-acrylamido-2-methylpropane sulfonic acid is refined by mildly heating a slurry-like suspension formed of the acid and a liquid monohydric alcohol, recovering the acid from the alcohol and subsequently drying it.