Abstract: A sustained release drug delivery composition and a method of making same are provided which comprises microspheres containing a pharmaceutically active agent, a core of a ion-exchange resin and a polymeric coating completely surrounding the core wherein the coating is water-insoluble and hydrolytically stable in physiological environments. The coating is non-erodible in physiological environments and is characterized by a diffusion constant suitable for the pharmaceutical agent to diffuse from the core to an aqueous environment at a predetermined release rate.

Abstract: The present invention provides a sustained-release delivery composition for ophthalmic drugs comprising cross-linked hydrogel microspheres having a binding affinity for the drug.

Abstract: A method for forming a controlled release polymeric substrate is provided by contacting a polymeric substrate with a liquid mixture containing a cross-linking agent at least partially soluble therein comprising water and an organic liquid, for a period of time and at a temperature and concentration of the agent sufficient for the agent to penetrate the substrate to form cross-linking bridges in the substrate in a decreasing concentration gradient beneath the surface.

Abstract: A bioresorbable and hemostatic plug for embolization made from a collagen piece is compressed so as to be longitudinally insertable into a tubular biological vessel such as a blood vessel to be occluded. The collagen piece is capable of expanding radially inside the vessel by absorbing fluid such as the blood and thereby providing mechanical fixation in and occlusion of the vessel. Two such collagen pieces may be used with a spacer of a different material in between. Different kinds of therapeutic agents can be bonded to or physically absorbed by the collagen pieces so as to be delivered to the site of occlusion.

Abstract: A process is provided for manufacturing nonwoven, nonbiodegradable tissue ingrowth-inducing, tissue-interfacing substrates with predetermined oriented uniform pore diameter, pore density and pore depth. Pins are inserted to a predetermined depth into a softened thermoplastic substrate or, heated pins are inserted into the substrate, then removed to form the predetermined pore pattern.

Abstract: A method is provided for fabricating a shaped article from aqueous collagen-containing materials. A dispersion containing collagen and a surfactant is cast upon a mold of thermoplastic material and dried by a ramped drying profile under controlled conditions of relative humidity and temperature. The controlled drying allows for initial renaturation of the collagen dispersion then drying at high humidity to form a product with minimal residual stress.

Abstract: A process is provided for manufacturing nonwoven, nonbiodegradable tissue ingrowth-inducing, tissue-interfacing substrates with predetermined oriented uniform pore diameter, pore density and pore depth. The substrates have pores which have advantageous tissue ingrowth-inducing properties.

Abstract: A percutaneous access device for aseptically introducing catheters or other tubes into the body, is disclosed. In one aspect, the device comprises a valve housing having a tapered inner bore; a tapered tubular valve means which is inserted into the valve housing bore and comprises one or two valves; and a valve cap which is screwed into the valve housing behind the valve. The valve means, housing and cap have bores along a common axis to permit the insertion of a tube such as a catheter through the device and into the body. The cap and valve housing cooperatively compress the valve means to selectively seal the valve bore about the catheter, close the valve bore when the catheter is removed, and provide anti-microbial wiping action of the catheter during insertion. The valve means may comprise two valves, a hemostatic sealing valve and an anti-bacterial squeegee valve which provides accelerated release of the anti-bacterial agent under mechanical compression.

Abstract: A surgical cutter device for producing a skin incision of controlled length and depth at a guidewire skin puncture location is described. The cutter is particularly useful for making incisions for the insertion of catheters. In addition, there is described a device which takes full advantage of such precisely formed skin incisions, comprising a subcutaneous cuff for sealing the entrance incision for a catheter and providing antimicrobial action at the sealed entrance, and an introducer for inserting the cuff subcutaneously along the associated catheter. A preferred method for using the cutter, cuff and introducer is also described.

Abstract: An antimicrobial catheter shield is provided comprising an elastomeric catheter collar and a planar porous elastomeric peripheral flange, with an absorbent patch containing an antimicrobial agent attached to the surface of the flange opposite to the collar. A radial slit extends through the collar, flange and patch and the collar is adapted with a means for securing a catheter to prevent longitudinal motion of the catheter through the collar. The catheter shield provides an antimicrobial patch, as well as a longitudinal and lateral anchor for the catheter, which is easily applied and readily replaced.

Abstract: A method is provided for protecting renatured collagen against bacterial and fungal attack by contacting the collagen with a silver ion-containing solution at a pH from 4.0 to 9.0 and exposing the silver-chelated collagen to ultraviolet radiation.

Abstract: This invention is a sleeve-like tissue-interface device designed to reduce the incidence of nosocomial infection related to percutaneous conduits by promoting a tissue seal where the conduit and skin interface, and by the expression of antibacterial activity to reduce the possibility of bacteria advancing along the conduit into deeper tissues. In particular, the positionability of the invention allows it to be placed onto a catheter-like device, in the dermal and subcutaneous tissue below the catheter exit site, although this position relative to catheter length is variable at different anatomical sites, and from patient to patient. The positionability feature also allows the invention to be used in conjunction with existing percutaneous access devices such as catheters and wound drains, as an optional measure against bacterial infection.