Abstract: A small implantable stimulator(s) includes at least two electrodes for delivering electrical stimulation to surrounding tissue and/or a pump and at least one outlet for delivering a drug or drugs to surrounding tissue. One electrochemotherapy method disclosed includes delivery of electrical stimulation in the form of a direct electric current and/or a periodic waveform that locally potentiates the cytotoxic effects of a systemically and/or locally administered chemotherapy agent(s). Open- and closed-loop systems are disclosed.

Abstract: A method and system for treatment of incontinence and/or pelvic pain includes the injection or laparoscopic implantation of one or more battery- or radio frequency-powered microstimulators (10) beneath the skin of the perineum and/or adjacent the tibial nerve. The devices are programmed using radio-frequency control via an external controller (20, 30)) that can be used by a physician to produce patterns of output stimulation pulses judged to be efficacious by appropriate clinical testing to diminish symptoms. The stimulation program is retained in the microstimulator device (10) or external controller (20) and is transmitted when commanded to start and stop by a signal from the patient or caregiver.

Abstract: A neural stimulation system allows the magnitude of electrical stimuli generated by the system to be programmed to a desired level greater than or equal to a minimum perceived threshold and less than or equal to a maximum tolerable perceived threshold. The electrical stimuli are applied through selected groupings of individual electrode contacts of a multi-electrode-contact electrode array attached to pulse generation circuitry as either cathodes or anodes. The electrode array is implanted so that the individual electrode contacts are in contact with the body tissue to be stimulated. Stimulating electrical current pulses, defined by a prescribed set of stimulus parameters are generated and applied to the selected electrode contacts so as to flow from the anode electrodes to the cathode electrodes. The perceived magnitude of the applied stimuli is equalized in order to enable quick, automated, and/or interactive programming of the values of the stimulation parameters.

Abstract: An envelope based amplitude mapping achieves the signal compression required to provide a natural sound level without the high processor loading or waveform alteration. In a preferred embodiment, the output of a family of parallel bandpass filters is processed by an envelope detector, followed by decimation. The resulting reduced data rate envelope is log mapped to produce a scaling factor for the original high data rate bandpass filter output sequence. The resulting scaled signal determines the current level for stimulation of the cochlea for each frequency band, which stimulation achieves a log mapping of the sound amplitude effect similar to natural hearing, while reducing processor load, and preserving waveform shape.

Abstract: A tool-less connector with multiple contacts and a compact design is provided. Therefore, a connector that is normally tunneled through body tissue will now require only a minimally invasive subcutaneous tunnel, which should reduce tissue healing time, patient discomfort, and risk of infection. In addition, providing additional contacts allows enhanced stimulation protocols. One embodiment of the present invention provides a connector pin containing multiple in-line contacts. Each “line” consists of a row of independent contacts arranged in a linear array running along the long axis of the pin. In other embodiments of the invention, the mating receptacle of the connector allows for multiple contacts while minimizing the space required for the increased number of contacts. Additional embodiments provide features that, for instance, prevent the contacts on the connector pin to touch the contacts in the receptacle until all contacts are appropriately aligned.

Abstract: An activity monitoring system measures the effectiveness of pain management using using data from motion or activity sensors attached to the patient's body to compute measures of exertion level of a patient. Increased levels of exertion are an indication of successful pain management. The patient's walking gait smoothness and walking gait stability are also graded as indicators of pain management effectiveness. The motion or activity sensors may be part of a temporary stimulation system used during percutaneous trials, part of a permanent implanted system, or an independent sensor package carried on the patient's body. The particular location and axes of the motion or activity sensors may be chosen based on the location of the pain being treated. The effectiveness of a particular pain management stimulation parameter set is based on the statistics accumulated over a period of time, for example one hour.

Abstract: An insertion needle facilitates the implantation of an electrode array carried on a flexible, foldable or compressible, subcarrier or substrate. Such subcarrier or substrate folds or compresses during implantation, thereby facilitating its insertion using the insertion needle. Once implanted, such subcarrier or substrate expands, thereby placing the electrodes in a desired spaced-apart positional relationship, and thus achieving a desired electrode array configuration. The insertion needle has a lumen with a non-circular cross-sectional shape, e.g., having a width greater than its height, to facilitate sliding the folded or compressed paddle-type electrode array therein, and further includes a longitudinal slit.

Abstract: A rechargeable hearing aid eliminates the requirement for frequent replacement of a disposable hearing aid battery. The rechargeable hearing aid features inductive recharging using a charging reservoir. In a preferred embodiment, a lithium-ion battery is used with a Completely-In-the-Canal (CIC) hearing aid. The CIC hearing aid is inserted into a reservoir throat of the charging reservoir. In a preferred embodiment a primary coil of the inductive recharger is wound around the reservoir throat, and a secondary coil of the hearing aid is wound around the diameter of the body of the CIC hearing aid, thus providing coupling of the primary and secondary coils that is independent of the rotation of the hearing aid in the charger throat.

Abstract: An implantable stimulator(s) with at least two electrodes, which is small enough to have the electrodes located adjacent to a cavernous nerve(s) or other nerve(s) innervating the reproductive organs, uses a power source/storage device, such as a rechargeable battery. Periodic recharging of such a battery is accomplished, for example, by inductive coupling with an external appliance. The small stimulator provides means of stimulating a nerve(s) when desired, without the need for external appliances during the stimulation session. When necessary, external appliances are used for the transmission of data to and/or from the stimulator(s) and for the transmission of power. In a preferred embodiment, the system is capable of open-and closed-loop operation. In closed-loop operation, at least one implant includes a sensor, and the sensed condition is used to adjust stimulation parameters.

Abstract: An implantable microphone system senses “sound” by sensing motion of middle ear components using a linear-variable-differential transformer. The transformer has a movable floating core that is affixed to one or more of the movable middle ear components, such as the tympanic membrane, incus, malleus, stapes, or oval window membrane. Motion of the middle ear component is sensed by applying out-of-phase signals to primary windings of the transformer while monitoring the signal magnetically induced through the movable core on a secondary winding of the transformer. In another embodiment, a capacitor has a movable plate affixed to the movable middle ear component, and motion of the middle ear component is sensed by applying out-of-phase signals to fixed plates of the capacitor.

Abstract: A voltage converter for use within small implantable electrical devices, such as a microstimulator, uses a coil, instead of capacitors, to provide a voltage step up and step down function. The output voltage is controlled, or adjusted, through duty-cycle modulation. Good efficiencies are achieved for virtually any voltage within the compliance range of the converter. In accordance with one aspect of the invention, applicable to implantable devices having an existing RF coil through which primary or charging power is provided, the existing RF coil is used in a time-multiplexing scheme to provide both the receipt of the RF signal and the voltage conversion function. This minimizes the number of components needed within the device, and thus allows the device to be packaged in a smaller housing, or frees up additional space within an existing housing for other circuit components.

Abstract: A threaded grommet, having an axial passageway therethrough, and made from a biocompatible material, such as titanium, is screwed into a cochleostomy made in the bony tissue adjacent the round window in order to provide a minimally-invasive access port into the cochlea. The threads included on the outside of the grommet engage the bony tissue and form a tight seal that holds the grommet securely in position. Such tight seal prevents cochlear fluids from escaping from inside of the cochlea. The axial passageway through the center of the grommet provides an opening, i.e., mechanical access, into the base end (the end of the cochlea nearest the round window) of the cochlea. Drugs, steroids, tissue-growth-inhibiting fluids, and the like, may be controllably delivered through the access hole into the cochlea, which access hole may be plugged when not needed. Additionally, an electrode array, e.g., a relatively short electrode array may, be inserted into the cochlea through the access hole.

Abstract: A patient and/or a clinician may program an implant device, e.g., an implanted spinal cord stimulator (SCS), through the use of a programming computer, or clinician programmer, linked with the implant device so that the paresthesia resulting from an applied electrical stimulus pattern is adjusted or programmed so as to match the area of perceived pain or other need. Data is initially stored in the computer that relates to known information regarding the anatomical relationships between the spine and the body. The body is divided into dermatomes and/or subdivisions of dermatomes, and a representation of the body, including its dermatomes and/or subdivisions of dermatomes are displayed on the screen (or other display device) associated with the computer. The patient moves a cursor over the regions of the body displayed on the computer screen to select the region of pain, or a region of paresthesia, by a click of a mouse or the press of a button.

Abstract: Non-polar tantalum capacitors and non-polar tantalum capacitor arrays with compact designs are provided. The reduced volume and footprint of the capacitors and arrays in turn reduces the amount of space required in any device in which they are used. In addition, the cost of materials is reduced, and the manufacturing is simplified. Some embodiments of the present invention provide an electromechanical connector between the anode rods of each pair of polar tantalum capacitors, and insulation between the remainder of the capacitor bodies, thus providing a non-polar tantalum capacitor. These non-polar capacitors are mechanically connected to make a non-polar tantalum capacitor array. Other embodiments of the present invention provide for physically connecting the anode rods of the polar capacitors. An insulating encapsulant around the connected rods and between the polar capacitor bodies also holds the capacitors and capacitor arrays together.

Abstract: A straight-forward and tool-less mechanism is provided for securing lead wires to an implantable neurostimulator, or similar medical device. In one embodiment, a clip lock mechanism is pivotally connected to the enclosure of the medical device, which enclosure also includes at least one receptacle with contacts to the components within the device. The proximal end of the lead wires terminate in a connector, including at least one plug and at least one pin with contacts corresponding to the electrodes or other devices along the distal end of the lead. The pin is inserted into the receptacle, thus completing the connection between the pin and receptacle contacts, and the clip is pivoted over the plug. The plug preferably has depressions that provide a clear visual and tactual indication of the position of the properly placed clip.

Abstract: A programming system and method for use with an implantable tissue stimulator allows a clinician or patient to quickly determine a desired electrode stimulation pattern, including which electrodes of a multiplicity of electrodes in an electrode array should receive a stimulation current, including the amplitude, width and pulse repetition rate of such current. Movement of the selected group of electrodes is facilitated through the use of a directional pointing device, such as a joystick. As movement of the selected group of electrodes occurs, current redistribution amongst the various electrode contacts takes place. The redistribution of stimulus amplitudes utilizes re-normalization of amplitudes so that the perceptual level remains fairly constant. This prevents the resulting paresthesia from falling below the perceptual threshold or above the comfort threshold.

Abstract: A method of manufacturing an electrode array has an elongate flexible carrier that is much more flexible in a first direction than in a second direction orthogonal thereto. The elongate flexible carrier is formed with a bias force that causes the array to flex in the first direction so as to assume the general spiral or circular shape of the scala tympani duct within the cochlea. The less-flexible direction is the direction that makes it difficult for the array to twist as it is inserted within the scala tympani duct. The bias force is sufficiently strong to cause the array to assume its preformed spiral shape even after being straightened during initial insertion into the cochlea. Electrode contacts, embedded into the carrier so as to be exposed along an inner or concave surface of the spiral, thus wrap snugly around the modiolus, thereby positioning the electrode contacts against the modiolar wall in an optimum position for stimulation.

Abstract: A subcutaneous tunneling and carrying tool has a handle, a rod, and a carrier. The tool is used in connection with the implantation of electrical stimulators within the body, and more particularly facilitates the surgical procedure in the connection of an electrode lead extension to the implantable stimulator when the electrode and stimulator may not be co-located. In one embodiment, tunneling is accomplished by a tip that also serves to connect the tool to a disposable carrier in which the lead extension connector is packaged. In another embodiment the carrier comprises a carrier body and a removable cover, wherein the carrier cover covers a carrier cavity during tunneling and includes a tunneling end, and the carrier cover is removed after tunneling to expose the carrier cavity, into which carrier cavity the electrode lead extension is inserted to carry back through the tunnel.

Abstract: An external transmitter circuit drives an implantable neural stimulator having an implanted coil from a primary coil driven by a power amplifier. For efficient power consumption, the transmitter output circuit (which includes the primary coil driven by the power amplifier inductively coupled with the implanted coil) operates as a tuned resonant circuit. When operating as a tuned resonant circuit, it is difficult to modulate the carrier signal with data having sharp rise and fall times without using a high power modulation amplifier. Sharp rise and fall times are needed in order to ensure reliable data transmission. To overcome this difficulty, the present invention includes an output switch that selectively inserts a resistor in the transmitter output coil circuit in order to de-tune the resonant circuit only during those times when data modulation is needed. Such de-tuning allows sharp rise and fall times in the data modulation without the need for using a high power modulation amplifier.

Abstract: A neural stimulation system allows the magnitude of electrical stimuli generated by the system to be programmed to a desired level greater than or equal to a minimum perceived threshold and less than or equal to a maximum tolerable perceived threshold. The electrical stimuli are applied through selected groupings of individual electrode contacts of a multi-electrode-contact electrode array attached to pulse generation circuitry as either cathodes or anodes. The electrode array is implanted so that the individual electrode contacts are in contact with the body tissue to be stimulated. Stimulating electrical current pulses, defined by a prescribed set of stimulus parameters are generated and applied to the selected electrode contacts so as to flow from the anode electrodes to the cathode electrodes. The perceived magnitude of the applied stimuli is equalized in order to enable quick, automated, and/or interactive programming of the values of the stimulation parameters.