Abstract: The invention provides amperometric analyte sensor systems comprising one or more electrodes designed to monitor in vivo levels of 3-hydroxybutyrate (and optionally glucose as well) in order to facilitate the management of diabetic ketoacidosis. The invention further includes compositions, elements and methods useful with such amperometric analyte sensor systems.

Abstract: Embodiments of the invention provide compositions useful in implantable devices such as analyte sensors as well as methods for making and using such compositions and devices. In typical embodiments of the invention, the device is a glucose sensor comprising a polymeric composition that includes amounts of one or more immunosuppressant agents so as to provide such membranes with improved material properties such as enhanced biocompatibility.

Abstract: Embodiments of the invention include polypeptide formulations and methods for making, using and characterizing them. Embodiment of the invention include stabilized polypeptide formulations, for example stable glucose oxidase formulations that can be used with glucose sensors used in the management of diabetes. Another embodiment of the invention includes methods to characterize the concentration of nonionic surfactants in stabilized polypeptide formulation for example stable insulin formulations that can be used in the treatment of diabetes.

Abstract: A multiple layer tubing for conveying a fluidic media in a medical or laboratory environment includes at least one outer layer of a copolyester ether (COPE) material. The tubing also includes an inner layer of a material compatible with sensitive fluidic media and at least one intermediate layer for bonding the outer layer to the inner layer. The material of the inner layer may be a high density polyethylene or a polyurethane material. The material of the intermediate layer may be ethylene-vinyl acetate (EVA). With the use of a COPE outer layer, a multiple layer medical tubing may be made without polyvinylchloride (PVC) or PVC plasticizers. The multiple layer tubing may be made by extrusion. The three layers may be co-extruded, simultaneously, as part of an efficient manufacturing processes.

Abstract: A method is provided for treating conditions that are susceptible of treatment with a cytokine wherein certain physiological processes normally associated with cytokine administration (e.g. the induction of SOCS 1 and/or SOCS 3) are diminished or eliminated. The method comprises continuously administering a controlled dose of a cytokine to an individual afflicted with a condition susceptible of treatment with the cytokine.

Abstract: Embodiments of the invention are directed to a method of estimating the physical stability of a protein formulation. A particular embodiment of the invention places the protein formulation under an agitational stress that causes the protein to aggregate at an accelerated rate. In one embodiment, the change in protein aggregation is monitored spectroscopically using Thioflavin-T. Embodiments of the invention then utilize a survival curve analysis to ascertain the relative physical stability of the different protein formulations under study. This method was used to develop novel surfactant-stabilized insulin formulations in a rapid, cost efficient manner, thus illustrating the utility of the inventive method to the discovery and development of pharmaceutical protein formulations.

Abstract: An improved pump, reservoir and reservoir piston are provided for controlled delivery of fluids. A motor is operably coupled to a drive member, such as a drive screw, which is adapted to advance a plunger slide in response to operation of the motor. The plunger slide is removably coupled to the piston. The piston comprises a first member and a second member. The first member has an external proximate side and an external distal side. The external proximate side is adapted to contact the fluid and is made of a material having a first stiffness. The second member has a first side and a second side and is at least partially disposed within the first member. The first side of the second member is adjacent to the external proximate side of the first member and is made of a material having a stiffness which is greater than the first stiffness.

Abstract: An improved pump, reservoir and reservoir piston are provided for controlled delivery of fluids. A motor is operably coupled to a drive member, such as a drive screw, which is adapted to advance a plunger slide in response to operation of the motor. The plunger slide is removably coupled to the piston. The piston comprises a first member and a second member. The first member has an external proximate side and an external distal side. The external proximate side is adapted to contact the fluid and is made of a material having a first stiffness. The second member has a first side and a second side and is at least partially disposed within the first member. The first side of the second member is adjacent to the external proximate side of the first member and is made of a material having a stiffness which is greater than the first stiffness.