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: A system and method for calibrating a sensor. The method may include, without limitation, compiling an array of data relating to the sensor; adjusting a sensor parameter a first time based on data in the array; adjusting a curve representing the sensor output based on data in the array; and adjusting the sensor parameter a second time based on data in the array. The sensor may be an in vivo glucose sensor and the sensor parameter adjusted may be a current. The array may include historical as well as recent data, such as, for example, blood glucose readings and sensor electrode readings.

Abstract: A sterile device immersed in a sterile buffer and a method for providing same. The sterile device may be a medical device such as a biosensor having a biomolecule as a sensing element such as, for example, a glucose oxidase enzyme. The buffer may be a bicarbonate solution. Both the device and the buffer may be packaged and stored over long term while maintaining sterilization. The sterilization method may comprise a combination of gaseous, liquid and light sterilization.

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 comprises a thin layer or layers of alumina, zerconia, 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 area while soaking in a saline solution at temperatures up to 80° C. over a three month period.

Abstract: A method and system for non-vascular sensor implantation. An implant unit is implanted in an area of a body and a foreign body capsule is allowed to form around the area of the implant unit. The sensor may be directed into a body cavity such as, for example, the peritoneal space, subcutaneous tissues, the foreign body capsule, or other area of the body. A subcutaneous area of the body may be tunneled to place the sensor. The system may include an implant unit such as, for example, for delivering drug to a human body and a sensor for detecting a physiological parameter. The sensor may be separate from and connectable to the implant unit and may be placed in a non-vascular area of the human body.

Abstract: A system and method of sensing multiple parameters. The method may include implanting an implantable sensor in a patient and reading an output from at least one of the implantable sensing elements. The implantable sensor may have a housing within which are disposed a plurality of implantable sensing elements. At least one of the implantable sensing elements may respond to lactate. In addition, a medical professional may administer to the patient for myocardial ischemia, myocardial infarction angina, sepsis based on the output read. A medical professional may also administer to the patient having an implantable cardiovascular defibrillator or who is receiving extracorporeal membrane oxygenation. The method may be used in a surgical or intensive care environment.

Abstract: An electronic circuit for sensing an output of a sensor having at least one electrode pair and circuitry for obtaining and processing the sensor output. The electrode pair may be laid out such that one electrode is wrapped around the other electrode in a U-shaped fashion. The electronic circuitry may include, among other things, a line interface for interfacing with input/output lines, a rectifier in parallel with the line interface, a counter connected to the line interface and a data converter connected to the counter and the electrode pair. The data converter may be a current-to-frequency converter. In addition, the rectifier may derive power for the electronic circuit from communication pulses received on the input/output lines.

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 system and method for restenosis mitigation at a trauma site within the vasculature. The system may include a catheter capable of delivering a restenosis mitigating drug and a sensor extending through a lumen in the catheter. The catheter may be positioned adjacent the trauma site and the restenosis mitigating drug may be delivered to the trauma site through the catheter. The restenosis mitigating drug or some other parameter may be sensed by the sensor.

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 comprises 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 area while soaking in a saline solution at temperatures up to 80° C. over a three month period.

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: A substrate with hermetically sealed vias extending from one side of the substrate to another and a method for fabricating same. The vias may be filled with a conductive material such as, for example, a fritless ink. The conductive path formed by the conductive material aids in sealing one side of the substrate from another. One side of the substrate may include a sensing element and another side of the substrate may include sensing electronics.

Abstract: A system and method for providing closed loop infusion formulation delivery which accurately calculates a delivery amount based on a sensed biological state by adjusting an algorithm's programmable control parameters. The algorithm calculates a delivery amount having proportional, derivative, and basal rate components. The control parameters may be adjusted in real time to compensate for changes in a sensed biological state that may result from daily events. Safety limits on the delivery amount may be included in the algorithm. The algorithm may be executed by a computing element within a process controller for controlling closed loop infusion formulation delivery. The biological state is sensed by a sensing device which provides a signal to the controller. The controller calculates an infusion formulation delivery amount based on the signal and sends commands to an infusion formulation delivery device which delivers an amount of infusion formulation determined by the commands.

Abstract: A multilayer substrate device formed from a base substrate and alternating metalization layers and dielectric layers. Each layer is formed without firing. Vias may extend through one of the dielectric layers such that two metalization layers surrounding the dielectric layers make. contact with each other. The vias may be formed by placing pillars on top of a metalization layer, forming a dielectric layer on top of the metalization layer and surrounding the pillars, and removing the pillars. Dielectric layers may be followed by other dielectric layers and metalization layers may be followed by other metalization layers. Vias in the substrate may be filled by forming an assembly around the substrate, the assembly including printing sheets containing a conductive ink and pressure plates for applying pressure. A vacuum may be applied to remove air in the ink. Pressure may then be applied to the printing sheets through the pressure plates.

Abstract: An electronic circuit for sensing an output of a sensor having at least one electrode pair and circuitry for obtaining and processing the sensor output. The electrode pair may be laid out such that one electrode is wrapped around the other electrode in a U-shaped fashion. The electronic circuitry may include, among other things, a line interface for interfacing with input/output lines, a rectifier in parallel with the line interface, a counter connected to the line interface and a data converter connected to the counter and the electrode pair. The data converter may be a current-to-frequency converter. In addition, the rectifier may derive power for the electronic circuit from communication pulses received on the input/output lines.

Abstract: A reusable analyte sensor site for use with a replaceable analyte sensor for determining a level of an analyte includes a site housing and a resealable insertion site coupled to one end of the site housing. Preferably, the site housing is formed to have an interior cavity, and includes an outer membrane made of a material selected to promote vascularization and having a first pore size, and an inner membrane made of a material selected to be free of tissue ingress. Also, the site housing permits the analyte to pass through the site housing to the interior cavity to permit measurement by the replaceable analyte sensor. The resealable insertion site is provided for inserting the replaceable analyte sensor into the interior cavity of the site housing.

Abstract: A method for formulating a glucose oxidase enzyme with peroxide resistant properties and a glucose oxidase enzyme formulated by the method. The enzyme formulation method results in a glucose oxidase enzyme with improve resistance to peroxide, and therefore, with improved resistance to oxidative inactivation. The method employs directed evolution techniques to evolve glucose oxidase to achieve the desirable properties. A peroxide resistant glucose oxidase may improve the longevity of, for example, glucose biosensors in which a peroxide resistant glucose oxidase may be placed.

Abstract: A system and method for providing closed loop infusion formulation delivery which accurately calculates a delivery amount based on a sensed biological state by adjusting an algorithm's programmable control parameters. The algorithm calculates a delivery amount having proportional, derivative, and basal rate components. The control parameters may be adjusted in real time to compensate for changes in a sensed biological state that may result from daily events. Safety limits on the delivery amount may be included in the algorithm. The algorithm may be executed by a computing element within a process controller for controlling closed loop infusion formulation delivery. The biological state is sensed by a sensing device which provides a signal to the controller. The controller calculates an infusion formulation delivery amount based on the signal and sends commands to an infusion formulation delivery device which delivers an amount of infusion formulation determined by the commands.

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.