Abstract: A sensing apparatus with a connector, a sensor lead and a sensor module with a spacer placed over electrodes that have been deposited on a substrate. The spacer may have a space for receiving an enzyme. End portions of the sensor module may be encapsulated, such as with molded beads. A sensor lead may attach to the sensor module and may have an outer tubing that passes over the module and attaches to the beads at the end of the sensor module. The sensor lead may also attach to the connector such that the sensing apparatus may be electrically coupled to a pump, electronics or other devices. The sensing apparatus may be implanted into a vein or artery.

Abstract: Embodiments of the invention provide analyte sensors having stabilized coating compositions and methods for making such sensors. Illustrative embodiments include electrochemical glucose sensors having stabilized glucose oxidase coatings that are generated for example, via spin coating processes.

Abstract: A method and apparatus for enhancing the integrity of an implantable sensor. Voids formed between an outer tubing and a sensor substrate or spacing element may be back-filled with a curable, implantable material, minimizing the extent to which unwanted fluids diffuse within the sensor. An enzyme or protein matrix pellet below the sensor window may be pre-treated with a reducing agent to enhance its bond stability, and to reduce undesired swelling that may cause the sensor window to detach or leak. The bonding between the enzyme pellet and a hydrogel layer may be reinforced by application of an intervening bonding layer of a protein material, such as human serum albumin (HSA). The size of the window may be minimized by minimizing the size of an underlying electrode, providing reduced flux and lengthening sensor. A coating may be deposited on the surface of the sensor leads, providing stiffening and lubrication.

Abstract: A method for formulating and immobilizing a protein and a protein matrix formed by the method. The protein matrix preparation method results in a physically and chemically stable protein matrix that has low swelling, non-leaching, high activity, and high mechanical strength properties. The method includes cross-linking and hardening the protein mixture and using a mold to form a protein into a desired shape and size.

Abstract: A sensing apparatus with a connector, a sensor lead and a sensor module with a spacer placed over electrodes that have been deposited on a substrate. The spacer may have a space for receiving an enzyme. End portions of the sensor module may be encapsulated, such as with molded beads. A sensor lead may attach to the sensor module and may have an outer tubing that passes over the module and attaches to the beads at the end of the sensor module. The sensor lead may also attach to the connector such that the sensing apparatus may be electrically coupled to a pump, electronics or other devices. The sensing apparatus may be implanted into a vein or artery.

Abstract: Implantable enzymatic sensors (25, 43, 44) for biochemicals such as glucose are provided having an ideal size and geometry for optional long term implantation and linear responses over the concentration ranges of interest. The sensors (25, 43, 44) include an elongated body (10, 26, 46) supporting an indicating electrode section having an appropriate enzyme immobilized thereon to present an enzymatic indicating surface (21, 33, 54). A permeable synthetic polymer membrane (24, 42, 56) is applied over the sensor body (10, 26, 46) to protect the enzyme and regulate diffusion of analyte therethrough, to ensure linearity of sensor response. The sensors (25, 43) are of flexible design and can be implanted using a catheter. Alternately, the sensor (44) includes an internal indicating electrode body (46) housed within an apertured, hollow needle (48). A holder (66) affixed to the needle (48) allows for easy manipulation and implantation of the sensor (44).