Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
1999-09-24
2001-10-23
Getzow, Scott M. (Department: 3737)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
Reexamination Certificate
active
06308101
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to implantable devices, and more particularly, to a fully implantable device or system for stimulating or sensing within living tissue wherein the implantable device has a rechargeable battery or other replenishable power source. One aspect of the invention relates to partitioning the circuit functions within the implantable system to allow upgrading the circuit functions and/or to permit existing partially implantable systems (having both implanted and external, or non-implanted, components) to be converted to fully implantable systems; and/or to allow fully implantable systems to also function as a partially implantable system.
Presently available implantable stimulation devices, such as a cochlear implant device or a neural stimulator, typically have an implanted unit, an external ac coil, and an external belt-mounted control unit and power source. The external control unit and power source includes a suitable control processor and other circuitry that generates and sends the appropriate command and power signals to the implanted unit to enable it to carry out its intended function. The external control unit and power source is powered by a battery that supplies electrical power through the ac coil to the implanted unit via inductive coupling for providing power for any necessary signal processing and control circuitry and for electrically stimulating select nerves or muscles. Efficient power transmission through a patient's skin from the external unit to the implanted unit via inductive coupling requires constant close alignment between the two units.
Rechargeable implantable sensing and/or stimulation devices (e.g., heart pacemakers) are relatively bulky devices (e.g., 3 inches×2 inches×0.5 inches) and are quite heavy. Further, these rechargeable implantable devices require a substantial amount of charging time each week.
Accordingly, there exists a need for a small lightweight implantable device that does not require constant external power and that includes a long-lasting internal battery that may be recharged within a relatively short time period.
Further, there exists a need, should the battery within such a small, lightweight implantable device malfunction, or should the user desire to not use the internal battery for certain time periods, to still be able to provide power to the device, e.g., from an external power source, so that the device can continue to operate and provide its intended function, e.g., sensing and/or stimulating, to the patient, without having to implant a new device in the patient. Further, there exists a need for a fast, simple method for the battery module to be replaced during surgery, should replacement be necessary or desired.
Moreover, there are many patients who have received an implant system, e.g., a cochlear implant system of the type described in U.S. Pat. No. 5,603,726, incorporated herein by reference, which system includes both an implantable cochlear stimulator (ICS) attached to an electrode array that is inserted inside of the cochlea, and an external (non-implanted) battery, speech processor and headpiece. The speech processor (SP) and battery are housed within a wearable unit that is worn or carried by the patient, e.g., on a belt pack. The headpiece includes the external ac coil, a magnet, and a microphone. It is connected to the wearable unit via a cable. In use, the headpiece is positioned next to the external skin of the patient in close proximity to the ICS so as to provide efficient inductive coupling thereto. The magnet properly positions and holds the headpiece against the ICS implant location. Many of the patients who have and use the existing ICS system could greatly benefit from a fully implantable system, i.e., a system that eliminates the need for constantly wearing and/or carrying the external components of the system.
SUMMARY OF THE INVENTION
The present invention addresses the above and other needs by providing a fully implantable cochlear implant system having a rechargeable power source. In some embodiments, the rechargeable device of the invention may be used to upgrade the ICS portion of existing implant systems to fully implantable systems. The device may be recharged at a relatively fast rate thus minimizing disruptions to a patient's lifestyle. Once charged or recharged, the device may be used to power various implant configurations, including a fully implantable single unit, a wired system, or a proximity system.
Additionally, as a backup option, or for diagnostic purposes, the rechargeable device may be continuously powered from a small, lightweight external unit, if necessary or desirable. Thus, in the event the internal (implanted) battery within the device malfunctions, or for whatever reason cannot be used, or the user or clinician (or other medical personnel) does not want to use it, it is still possible, through use of the lightweight external device, to provide operating power to the implantable device so that it may continue to provide its intended function (e.g., stimulating and/or sensing). Advantageously, by having such a backup option available, the patient may delay indefinitely battery-replacement and/or corrective surgery.
One embodiment of the invention, hereafter referred to as the “single unit” embodiment, resides in an implantable device having a case, a coil, electronic circuitry, and a rechargeable battery. The case forms a substantially hermetic housing and the coil surrounds the case to enclose a relatively large area and generates electrical power in the presence of externally induced ac magnetic fields passing through the coil's enclosed area. The rechargeable battery and electronic circuitry are housed within the case.
Another embodiment of the invention, hereafter referred to as the “wired system” embodiment, resides in a fully implantable system that includes two implantable devices, each having its own case, jointed together by a detachable cable. A first of the implantable devices houses electronic circuitry for performing a desired function, e.g., stimulation of tissue. A second of the implantable devices houses a rechargeable battery or other replenishable power source, and may also include additional circuitry, e.g., to perform signal processing. The second device provides operating power for the first implantable device. Appropriate switching circuitry is included with the battery in the second device to convert the dc power of the battery to ac power for transmission to the first device. This ac power may be modulated, as desired, to also transmit information, e.g., control signals, from the second device to the first device. Thus, only ac power passes through the connecting cable.
In a preferred implementation of the “wired System” embodiment, there is provided a fully implantable cochlear implant system that includes an implantable cochlear stimulator (ICS) joined to an implantable speech processor (ISP) by way of a detachable cable. The ICS includes a cochlear electrode array permanently attached thereto. Such cochlear electrode array has a plurality, e.g., sixteen, spaced-apart electrode contacts thereon. The electrode array is adapted to be fully inserted into the patient's cochlea, where electrical stimulation may be selectively applied for the purpose of directly stimulating the auditory nerve, thereby providing the patient with the sensation of hearing. Also permanently attached to the ICS is a coil, which coil may be coupled, e.g., inductively coupled, with an external coil in a headpiece during a recharging and/or a programming mode of operation. Finally, a cable, having only five conductors therein, is also permanently attached to the ICS. This cable has a connector plug on its other end adapted to mate with a matching connector socket on the ISP. The ISP includes an implantable microphone as an integral part thereof, a rechargeable battery, and speech processing and other circuitry for processing and powering the various circuits used within the implant system.
In use
Faltys Michael A.
Gord John C.
Kuzma Janusz A.
Advanced Bionics Corporation
Getzow Scott M.
Gold Bryant R.
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