Abstract: A method and apparatus for protecting an electronic implantable medical device prior to it being implanted in a patient's body. The apparatus affords protection against electronic component damage due to electrostatic discharge and/or physical damage due to improper handling. The apparatus is comprised of a circuit board having first and second spring clips mounted on the board. The spring clips are configured to receive and releasably grasp the electrodes of a medical device housing to support the housing just above the surface of the circuit board. First and second conductive paths are formed on the circuit board extending between the first and second clips for shunting electrostatic discharge currents to prevent such currents from passing through the device electronic circuitry. The respective shunt paths include oppositely oriented diodes, preferably comprising diodes which emit light (i.e., LEDs) when current passes therethrough.

Abstract: An implantable enzyme-based monitoring system suitable for long term in vivo use to measure the concentration of prescribed substances such as glucose is provided. In one embodiment, the implantable enzyme-based monitoring system includes at least one sensor assembly, an outer membrane surrounding the sensor assembly and having a window therein, and a polymeric window cover affixed to the outer membrane and covering the window. Preferably, the outer membrane of the monitoring system is silicone and the window cover is a polymer of 2-hydroxyethyl methacrylate (HEMA), N,N,-dimethylaminoethyl methacrylate (DMAEMA) and methacrylic acid (MA). Also provided herein is an implantable enzyme-based monitoring system having at least one sensor assembly, an outer membrane surrounding the sensor assembly and a coating affixed to the exterior surface of the outer membrane, wherein the coating resists blood coagulation and protein binding to the exterior surface of the outer membrane.

Abstract: This invention is a method and apparatus for implanting retinal tacks and retinal electrode element with spiked electrodes. In one aspect of the invention, a tack suitable for insertion into the retina is driven into the retina by the repeated minute blows from the rapid contractions and expansions of the piezoelectric crystal. In a different aspect of the invention, a retinal electrode element with spiked electrodes suitable for insertion into the retina is driven into the retina by the repeated minute blows from the rapid contractions and expansions of the piezoelectric crystal. In another aspect of the invention, a single, short impulse is used to drive the tack home. In a different aspect of the invention, a single, short impulse is used to drive the retinal electrode element with spiked electrodes home. With this mode of tack and electrode element implanting, a remotely placed driver couples its motion to the tack using a thin, elongated tube filled with a suitable hydraulic fluid.

Abstract: The present invention provides an implantable substrate sensor comprising electronic circuitry formed within, or on, a substrate. A protective coating then covers the substrate, forming a hermetically sealed package having the circuitry under the coating. The circuitry has electrically conductive pads for communicating and/or providing power to the circuitry. Electrical pathways provide hermetic electrical connection to the conductive pads for external connection to the sealed circuitry. In a first embodiment, the pathway is a via that is made from a biocompatible material that is made hermetic by either increasing its thickness or by ion beam deposition.

Abstract: Improved implantable monitoring systems suitable for long-term in vivo use to measure the concentration of one or more prescribed substances, such as glucose, are described herein. In particular, an implantable enzyme-based glucose monitoring system is described that includes at least one of the following: means for replenishing the enzyme solution as it is consumed by the enzymatic reaction; means for replenishing the electrolyte solution bathing the electrode assembly; and microprocessing means proximal the electrode assembly. In preferred embodiments, a microprocessor assembly is hermetically associated with the substrate to which the electrode assembly is affixed. Further, the monitoring systems employ one or more reservoir systems in fluid communication with enzyme and electrolyte chambers wherein the enzyme and electrolyte solutions are used.

Abstract: This invention is for directly modulating a beam of photons onto the retinas of patients who have extreme vision impairment or blindness. Its purpose is to supply enough imaging energy to retinal prosthetics implanted in the eye which operate essentially by having light (external to the eye) activating photoreceptors, or photo-electrical material. The invention provides sufficient light amplification and does it logarithmically. While it has sufficient output light power, the output light level still remains at a safe level. Most preferred embodiments of this invention provide balanced biphasic stimulation with no net charge injection into the eye. Both optical and electronic magnification for the image, as for example, using an optical zoom lens, is incorporated. Otherwise, it would not be feasible to zoom in on items of particular interest or necessity. Without proper adjustment, improper threshold amplitudes would obtain, as well as uncomfortable maximum thresholds.

Abstract: A system of implantable sensor/stimulation devices that is configured to communicate with a prosthetic device, e.g., an artificial limb, via a wireless communication link, preferably bidirectionally. By communicating between the implantable devices coupled to neural pathways within a man and motor/sensor interfaces in the prosthetic device, a machine, a man/machine interface is established to replace an absent limb. Systems of the present invention may extend to prosthetic devices, e.g., cranes or the like, that further extend the man/machine interface to allow a man to control a “large” remote piece of machinery directly via neural control.

Abstract: An implantable substrate sensor has electronic circuitry and electrodes formed on opposite sides of a substrate. A protective coating covers the substrate, effectively hermetically sealing the electronic circuitry under the coating. Exposed areas of the electrodes are selectively left uncovered by the protective coating, thereby allowing such electrodes to be exposed to body tissue and fluids when the sensor is implanted in living tissue. The substrate on which the electronic circuitry and electrodes are formed is the same substrate or “chip” on which an integrated circuit (IC) is formed, which integrated circuit contains the desired electronic circuitry. Such approach eliminates the need for an hermetically sealed lid or cover to cover hybrid electronic circuitry, and allows the sensor to be made much thinner than would otherwise be possible. In one embodiment, two such substrate sensors may be placed back-to-back, with the electrodes facing outward.

Abstract: The invention discloses methods of making electrical connections in living tissue between an electrically conductive wire and an implantable miniature device. The device may either stimulate muscles or nerves in the body or detect signals and transmit these signals outside the body or transmit the signals for use at another location within the body. The device is comprised of an electrically insulating or electrically conductive case with at least one electrode for transmitting electrical signals. The electrodes and the wire-electrode connections are protected from the aggressive environment within the body to avoid corrosion of the electrode and to avoid damage to the living tissue surrounding the device.

Abstract: The invention discloses methods of making electrical connections in living tissue between an electrically conductive wire and an implantable miniature device. The device may either stimulate muscles or nerves in the body or detect signals and transmit these signals outside the body or transmit the signals for use at another location within the body. The device is comprised of an electrically insulating or electrically conductive case with at least one electrode for transmitting electrical signals. The electrodes and the wire-electrode connections are protected from the aggressive environment within the body to avoid corrosion of the electrode and to avoid damage to the living tissue surrounding the device.

Abstract: The objective of the current invention is to restore color vision, in whole or in part, by electrically stimulating undamaged retinal cells, which remain in patients with, lost or degraded visual function. The invention is a retinal color prosthesis. Functionally, There are three main parts to this invention. One is external to the eye. The second part is internal to the eye. The third part is means for communication between those two parts. The external part has subsystems. These include an external imaging means, an eye-tracker, a head-motion tracker, a data processor, a patient's controller, a physician's local controller, a physician's remote controller, and a telemetry means. The imaging means may include a CCD or CMOS video camera. It gathers an image of what the eyes would be seeing if they were functional.

Abstract: An implantable enzyme-based monitoring system suitable for long term in vivo use to measure the concentration of prescribed substances such as glucose is provided. In one embodiment, the implantable enzyme-based monitoring system includes at least one sensor assembly, an outer membrane surrounding the sensor assembly and having a window therein, and a polymeric window cover affixed to the outer membrane and covering the window. Preferably, the outer membrane of the monitoring system is silicone and the window cover is a polymer of 2-hydroxyethyl methacrylate (HEMA), N,N,-dimethylaminoethyl methacrylate (DMAEMA) and methacrylic acid (MA). Also provided herein is an implantable enzyme-based monitoring system having at least one sensor assembly, an outer membrane surrounding the sensor assembly and a coating affixed to the exterior surface of the outer membrane, wherein the coating resists blood coagulation and protein binding to the exterior surface of the outer membrane.

Abstract: A method and apparatus for protecting an electronic implantable medical device prior to its being implanted in a patient's body. The apparatus affords protection against electronic component damage due to electrostatic discharge and/or physical damage due to improper handling. The apparatus is comprised of a circuit board having first and second spring clips mounted on the board. The spring clips are configured to receive and releasably grasp the electrodes of a medical device housing to support the housing just above the surface of the circuit board. First and second conductive paths are formed on the circuit board extending between the first and second clips for shunting electrostatic discharge currents to prevent such currents from passing through the device electronic circuitry. The respective shunt paths include oppositely oriented diodes, preferably comprising diodes which emit light (i.e., LEDs) when current passes therethrough.

Abstract: A communication protocol that is configured to extend the battery life of devices that monitor and/or affect body parameters and is particularly useful in a system comprised of a system control unit (SCU) and one or more implanted devices. Each such implanted device is configured to be monitored and/or controlled by the SCU via a wireless communication channel. The time between battery rechargings is determined by the battery capacity and the device's power consumption. Accordingly, the present invention reduces their average power consumption by reducing the usage duty cycle of their power consuming transmit and receive modes used to communicate with the SCU. By dedicating addressable time slots to each of the implantable devices in the system and limiting their use of receive and transmit modes to time periods proximate to these time slots, the average power consumption is accordingly reduced.

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: The invention is a method for increasing the airflow to a zinc-air battery such that the energy density is 500 mwh/cc to 1000 mwh/cc. This allows 8 to 16 hours use as a primary (throw-away) battery, with, for example, high-duty cycle, high-drain cochlear implants, and neuromuscular stimulators for nerves, muscles, and both nerves and muscles together. The systems incorporating the high energy density source are also part of the invention, as well as the resulting apparatus of the method. The uses of this inexpensive, i.e., a $1.00 per day, throw-away primary battery are new uses of the modified zinc-air battery and are directed toward helping people hear again, walk again, and regain body functionality which they have otherwise lost permanently.

Abstract: The objective of the current invention is to restore color vision, in whole or in part, by electrically stimulating undamaged retinal cells, which remain in patients with, lost or degraded visual function. The invention is a retinal color prosthesis. Functionally, There are three main parts to this invention. One is external to the eye. The second part is internal to the eye. The third part is means for communication between those two parts. The external part has subsystems. These include an external imaging means, an eye-tracker, a head-motion tracker, a data processor, a patient's controller, a physician's local controller, a physician's remote controller, and a telemetry means. The imaging means may include a CCD or CMOS video camera. It gathers an image of what the eyes would be seeing if they were functional.

Abstract: The objective of the current invention is to restore color vision, in whole or in part, by electrically stimulating undamaged retinal cells, which remain in patients with, lost or degraded visual function. The invention is a retinal color prosthesis. Functionally, There are three main parts to this invention. One is external to the eye. The second part is internal to the eye. The third part is means for communication between those two parts. The external part has subsystems. These include an external imaging means, an eye-tracker, a head-motion tracker, a data processor, a patient's controller, a physician's local controller, a physician's remote controller, and a telemetry means. The imaging means may include a CCD or CMOS video camera. It gathers an image of what the eyes would be seeing if they were functional.

Abstract: Battery driven voltage control circuitry charges an output capacitor, which periodically supplies a current pulse. The circuitry converts battery voltage VBAT to a charging voltage VUPC based upon programmed parameters and the voltage VCOMPL at the capacitor. The circuitry includes a voltage converter for multiplying VBAT to produce VUPC. VCOMPL is sampled to determine its “droop” at the end of an output current pulse. If the droop is lower than a threshold, then the voltage converter increases the charging voltage. If the droop is above a threshold, then the voltage converter reduces the charging voltage. This feedback maintains the output voltage within an acceptable operating range to produce an efficacious output current pulse for stimulation without causing unproductive energy loss. In order to avoid premature depletion of battery energy, VUPC is compared with VCOMPL to determine the optimum clock rate to be used to convert VBAT to VUPC.

Abstract: An implantable sensor includes electronic circuitry for automatically performing on a periodic basis, e.g., every 1 to 24 hours, specified integrity tests which verify proper operation of the sensor.