Abstract: A protective, biocompatible coating or encapsulation material protects and insulates a component or device intended to be implanted in living tissue. The coating or encapsulation material includes a thin layer or layers of alumina, zirconia, or other ceramic, less than 25 microns thick, e.g., 5-10 microns thick. The alumina layer(s) may be applied at relatively low temperature. Once applied, the layer provides excellent hermeticity, and prevents electrical leakage. Even though very thin, the alumina layer retains excellent insulating characteristics. In one embodiment, an alumina layer less than about 6 microns thick provides an insulative coating that exhibits less than 10 pA of leakage current over an area 75 mils by 25 mils while soaking in a saline solution at temperatures up to 80.degree. C. over a three month period.

Abstract: An improved apparatus is disclosed for maintaining a medical assembly, e.g., a blood chemistry electrode assembly, filled with a bubble-free storage liquid for an extended storage time period. The apparatus achieves this result by connecting to the assembly a pressurized reservoir that supplies additional storage liquid, to replenish any storage liquid lost due to diffusion from the medical assembly.

Abstract: Methods are described for extending the service life of implantable sensors having a silver-containing anodic reference electrode maintained at a high impedance, at least one noble metal cathodic working electrode, and at least one noble metal anodic counter electrode maintained at a low impedance, particularly sensors for the in vivo detection of oxygen and/or glucose in bodily fluids. The methods described involve increasing the input impedance of the reference electrode up to a maximum for implanted circuitry and shielding said electrode, and/or alternating the operating roles of the reference and working electrodes, switching the working electrodes with counter electrodes in the circuit, reversing the polarities of the reference and working electrodes, and sequentially activating each electrode in a plurality of working and/or reference electrodes in the circuit.

Abstract: An improved sensor apparatus of a kind that positions a semi-permeable membrane adjacent to an electrode assembly, for measuring a predetermined parameter, e.g., glucose concentration, of an adjacent fluid sample. A special compressible ring serves a first function of tensioning the membrane so that it is maintained in intimate contact with the electrode assembly, and it further serves a second function of sealing the fluid sample from the external environment.

Abstract: An improved electrode assembly is disclosed for use in assaying glucose in solution, e.g., in undiluted whole blood. The assembly includes a sensor electrode and a special overlaying multi-layer membrane that can be sterilized by gamma radiation without reducing the activity of a glucose oxidase enzyme located in an intermediate layer of the membrane. An outer layer of the membrane is formed with microscopic pores having a predetermined density and predetermined size, for reliably controlling the flux of glucose and oxygen from the solution to the intermediate layer, where they react in the presence of the glucose oxidase enzyme to form reactions products that include hydrogen peroxide. The outer layer thus functions as a diffusion barrier, to eliminate the adverse effects of any oxygen deficit that might be present. In addition, an inner layer of the membrane functions as an interference barrier, for controlling the permeation of the hydrogen peroxide reaction product to the underlying electrode.

Abstract: A patient monitoring system measures the concentration of a particular substance in a patient's tissue, blood, or other bodily fluids, provides an indication of the rate of change of such concentration, and determines whether the measured concentration and rate of change are within certain preset limits. If not, an audible and/or visual alarm signal is generated. The patient monitoring system includes at least one enzymatic sensor adapted to be inserted into the patient, where it produces sensor signals related to the concentration of the substance being measured. The sensor signals are delivered through a suitable interconnect cable to a monitor. In one embodiment, the interconnect cable includes a contactless connector that electrically isolates the enzymatic sensor from the monitor, and reduces the number of conductors required to interface with a plurality of sensors.

Abstract: A glucose monitoring system continuously measures the glucose concentration in a patient's blood, provides an indication of the rate of change of such concentration, and determines whether the measured concentration and rate of change are within certain preset limits. If not, an audible and/or visual alarm signal is generated. The glucose monitoring system includes a glucose sensor adapted to be inserted into the venous system of the patient, where it responds to blood glucose and produces sensor signals related to the glucose concentration. The sensor signals are delivered through a suitable interconnect cable to a glucose monitor. In one embodiment, the interconnect cable includes a contactless connector that electrically isolates the glucose sensor from the monitor, and reduces the number of conductors required to interface with a plurality of sensors. The glucose monitor interprets the sensor signals by applying a previously determined calibration to quantitatively determine the blood glucose value.

Abstract: A glucose monitoring system continuously measures the glucose concentration in a patient's blood, provides an indication of the rate of change of such concentration, and determines whether the measured concentration and rate of change are within certain preset limits. If not, an audible and/or visual alarm signal is generated. The glucose monitoring system includes a glucose sensor adapted to be inserted into the venous system of the patient, where it responds to blood glucose and produces sensor signals related to the glucose concentration. The sensor signals are delivered through a suitable interconnect cable to a glucose monitor. In one embodiment, the interconnect cable includes a contactless connector that electrically isolates the glucose sensor from the monitor, and reduces the number of conductors required to interface with a plurality of sensors. The glucose monitor interprets the sensor signals by applying a previously determined calibration to quantitatively determine the blood glucose value.

Abstract: An electrochemical system includes a sensor module suitable for implantation in the body to monitor glucose and oxygen levels therein. The module has two oxygen sensors situated in an oxygen-permeable housing, arranged in a tandem relationship, and recessed in the housing, one sensor being unaltered and the other contacting glucose oxidase allowing for differential measurement of oxygen content in bodily fluids or tissues indicative of glucose levels. The module includes a communication capability for transmitting measurement information to an external recording device outside the body.