University of Rochester

Sts Biopolymers, Inc.

Angiotech Biocoatings, Inc.

Kuvio, Inc.

Michael R Violante

Richard J Whitbourne

Margaret Lydon

John F Lanzafame

Youti Kuo

Kevin J Parker

Xianping Zhang

Daniel G Hullihen

Charles E Sparks

Harry W Fischer

Frank Guo-Bin Wang

Janet D Sparks

Roy T Steigbigel

The invention relates generally to implantable drug delivery devices. Devices having a single drug chamber configuration, a divided drug chamber configuration and a compact dual-drug configuration are described. The devices have features to prevent clogging of the dispensing catheter and the creation of a local vacuum caused by the dispensing of the drug fluid. Also provided are features of a failsafe refilling process, automatic refill notification, and performance verification process. The divided drug chamber configuration enables frequent or continuous minute doses. A dual-drug chamber configuration uses self-locking refill containers to prevent mismatching between refill containers and drug chambers.

Implantable drug delivery devices

Generally, the present invention provides devices and methods for delivering high, efficacious concentrations of therapeutic agents, i.e., medicaments such as drugs, antibiotics, etc., to specific sites in a patient's body, such as tumors and infected lesions. In one aspect of the present invention there are provided devices to accomplish the aforesaid delivery of therapeutic agents and methods to accomplish the delivery by positioning a device in the body using minimally invasive techniques such as, for example, catheterization or via trochar. The devices may contain a carrier substrate and a coating on the substrate. The carrier substrate provides structural integrity to the device and the coating thereon contains at least one layer of polymeric material containing one or more medicaments. Optionally, there may be a non-medicated binder coat between the carrier substrate and the medicated polymer layer. The medicated polymer layer may contain a hydrophilic/hydrophobic polymer composition.

Targeted therapeutic agent release devices and methods of making and using the same

An ultrasonically visible solid device for inserting into a non-gas target medium comprises an echogenic surface having structures entrapping gas when the device is in the target medium, the entrapped gas causing the device to be ultrasonically visible, wherein the gas-entrapping structures are covered with a flexible overcoat that does not significantly reduce the compressibility of the gas trapped in the structures.

Echogenic coatings with overcoat

Coatings to enhance the echogenicity of materials are especially useful for medical devices wherein the practitioner desires to locate or visualize a device by ultrasonic imaging when the device is inserted into a body cavity. These coatings can be applied to any device of virtually any composition. To accomplish this, a polymer matrix is formed containing an entrapped gas in enclosed bubbles or open surface channels or cavities. Coated needles are visible in ultrasound when inserted in animals. A pre-coat or base coat may be applied to condition the surface to enhance adhesion. A finish coat or top coat may be applied to improve durability, smoothness, and biocompatibility, lubricity, antibiotic, antimicrobial, antithrombogenic activity, and other desirable properties for the finished product. Coating liquids and methods for preparing and applying such coatings are disclosed, including forming bubbles by chemical reaction during the coating process.

Echogenic coatings

This invention relates to the preparation, composition and applications of suspensions of ultra-small, substantially non-aggregated, non-crystalline particles of predetermined uniform size which, when suspended in a liquid, contain entrapped gaseous bubbles. These gaseous bubble particles are prepared by simultaneous co-precipitation of two compounds. In accordance with the present invention, the two compounds chosen for co-precipitation are such that one is substantially more soluble than the other in a given vehicle. When this vehicle is used for washing the co-precipitated particles, part of the soluble material is dissolved leaving a porous matrix. The porous particles then are dried and stored. The porous particles, which can be resuspended immediately prior to use, contain entrapped gas in the evacuated crevices or pores which is not displaced for a period of time because of surface tension of the suspending vehicle. These ultrasmall, substantially non-aggregated porous particles therefore can be used to advantage as ultrasound contrast agents as well as other applications.

Ultrasmall porous particles for enhancing ultrasound back scatter

Ultrasmall, non-aggregated porous particles of uniform size for

The invention relates to a process for preparing standards and controls for immunoassays employing monoclonal antibodies. Monoclonal antibodies are used to isolate a restricted portion of an antigen containing an epitope that determines the specificity of the monoclonal antibody-antigen reaction so as to distinguish it from the antigen as a whole, following fragmentation of the complex antigen by procedures including proteolysis. Isolated epitopes are attached covalently or by physical adsorption to particles to immobilize and stabilize the epitope. The particles can be composed of iodipamide ethyl ester, polyvinyl chloride, polystyrene and other inert substances and can be chemically activated to improve epitope binding and stability. Experimental details demonstrate the binding of lipoprotein epitopes to IDE, polyvinyl chloride and polystyrene and the subsequent reaction of monoclonal antibodies to these particle-stabilized epitopes. This invention is useful particularly for measuring the lipoprotein components associated with cholesterol, and includes a monoclonal based immunoassay kit for measuring the lipoprotein components in biological fluids to assess risk related to coronary artery disease complications.

Particle-stabilized epitopes for standardization and control of

The invention involves a method for making uniformly sized particles from solid compounds. First, a suitable solid compound is dissolved in a suitable solvent. Then, a precipitating liquid is infused, precipitating non-aggregated particles with substantially uniform mean diameter. The particles are then separated from the solvent. Depending on the solid compound and the desired particle size, the parameters of temperature, ratio of non-solvent to solvent, infusion rate, stir rate, and volume can be varied according to the invention. The precipitating liquid may be aqueous or non-aqueous, depending upon the relative solubility of the compound and the desired suspending vehicle.

Method for making uniformly-sized particles from insoluble compounds

A pharmaceutical composition combines a physiologically acceptable carrier with substantially uniformly sized particles of an organoiodide or organobromide which is solid at physiological tempertures, has a solubility in blood serum of less that one part per ten thousand, and has a mean particle diameter of from about 0.01 microns to about 4 microns. The method of the invention involves administering to a patient an effective amount of such particles.

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Pittsford, NY, United States of America

Michael R Violante