Implantable medical device incorporating self-timed logic

Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems

Reexamination Certificate

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Reexamination Certificate

active

06389315

ABSTRACT:

FIELD OF THE INVENTION
This invention relates generally to implantable medical devices, and more particularly to an improved operating system architecture incorporating self-timed logic for reducing power consumption and increasing and improving processing capabilities.
BACKGROUND OF THE INVENTION
A wide variety of implantable medical devices (IMDs) that employ electronic circuitry for providing electrical stimulation of body tissue and/or monitoring a physiologic condition are known in the art. A number of IMDs of various types are known in the art for delivering electrical stimulating pulses to selected body tissue and typically comprise an implantable pulse generator (IPG) for generating the stimulating pulses under prescribed conditions and at least one lead bearing a stimulation electrode for delivering the stimulating pulses to the selected tissue. For example, cardiac pacemakers and implantable cardioverter/defibrillators (ICDs) have been developed for maintaining a desired heart rate during episodes of bradycardia or for applying cardioversion or defibrillation therapies to the heart upon detection of malignant tachyarrhythmias. Other IMDs have been developed for applying electrical stimulation or other therapies, e.g., drugs, to nerves, the brain, muscle groups and other organs and body tissues for treating a variety of conditions.
Over the past 40 years, such IMDs have evolved from relatively bulky, crude, and short-lived devices providing simple stimulation therapies and monitoring functions to complex, long-lived, and miniaturized IMDs, e.g., cardiac IMDs providing a wide variety of pacing and/or cardioversion and defibrillation therapies and/or monitoring functions. Numerous other programmable functions have been incorporated including enhanced capacity to detect and discriminate cardiac arrhythmias, to store data and to uplink telemetry data related to arrhythmia episodes and applied therapies (if any). Moreover, the capability of interrogating stored device data and initiating real time uplink telemetry of physiologic data, e.g. the real time cardiac EGM and blood pressure and the like, have been incorporated into such IMDs.
The earliest implantable pacemaker IPGs employed very simple analog circuit oscillators formed by discrete transistors and other circuit components and were very short-lived and electrically inefficient. Integrated circuit (IC) technology and battery improvements were made that enabled hermetic sealing of IMD housings, improved reliability and lengthened the operating life of the IMD. The MEDTRONIC® SPECTRAX® pacemaker IPGs incorporated an analog IC with digital IC into a digital clocked logic operating system architecture providing an array of sophisticated operating functions, programmability of operating modes and parameters, data storage, and uplink telemetry functions. Successive generations of IMDs of this type have incorporated increased operating modes and functions through further improvements in circuitry and long-lived, low current output, low voltage batteries. Most recently, a wide number of IMD system architectures have been developed that incorporate custom microcomputers comprising a microprocessor, RAM and ROM, bus, and related elements of a typical microcomputer and other control logic, memory, input signal processing circuitry and therapy delivery output circuitry. The complexity of the circuitry, the functions provided, the longevity, and the reliability of the IMDs have all increased dramatically while the IMD size has decreased.
Current IMD operating system architectures typically are embodied in two or more ICs and discrete components mounted to one (or more) substrate employing hybrid fabrication circuitry techniques. Certain of the ICs or circuitry on a particular IC perform analog functions, input signal processing, and output therapy delivery. Digital logic ICs or circuitry are formed employing complementary metal oxide semiconductor (CMOS) fabrication technology. The digital logic ICs perform signal processing, timing, and state change functions embodying Boolean logic timed synchronously by a system-wide, clock, and are referred to herein as “clocked logic” ICs or circuits.
The power consumption of CMOS circuits consists generally of two power consumption factors, namely “dynamic” power consumption and “static” power consumption. The static power consumption is only due to current leakage, as the quiescent current of such circuits is zero. Dynamic power consumption is due to the current required to charge internal and load capacitances during switching, i.e., the charging and discharging of such capacitances, and is the dominant form of power consumption for CMOS technology. The dynamic power (P) for the CMOS circuit is a function of nodal capacitance (C), the clock or switching frequency (F), and the supply voltage (V
DD
) in accordance with the formula P=C V
DD
2
F.
In accordance with this formula for dynamic power (P) consumption, efforts have been made conventionally in CMOS IC designs to scale down the supply voltage for an entire device (e.g., a hybrid or IC) to provide the minimally required power to reliably operate all of the clocked logic of the device. For example, in the Medtronic SYMBIOS® pacemaker IPGs, the logic circuitry was powered by a voltage regulator controlling the IC supply voltage to a “sum of thresholds” supply. This regulator provided a supply to the IC (i.e., V
DD
) of several hundred millivolts above the sum of the n-channel and p-channel thresholds of the CMOS transistors making up the IC. This regulator was self calibrating regarding manufacturing variations of the transistor thresholds. This same approach of specifying a high enough voltage to account for fabrication variances is followed even when only a single such CMOS IC is employed in the IMD system. Therefore, in practice, excessive power may be consumed by the CMOS IC or ICs of the IMD operating system.
Other IMDs have reduced power consumption in other varied manners, e.g., by shutting down analog blocks and/or shutting off clocks to logic blocks not being used at particular times. In commonly assigned U.S. Pat. No. 5,916,237, it is proposed that the power delivered to selected sections of the digital logic circuitry in IMDs be cycled between power ON and power OFF states to reduce static power consumption. In many applications, most of the digital logic circuitry may be turned off at various times during each system clock cycle, which reduces static power consumption and average power consumption of the digital clocked logic circuitry.
In addition, microprocessor based IMDs provided by virtually all pacemaker and ICD manufacturers have historically used a “burst clock” design to perform processing operations at a relatively high clock rate (e.g., generally 500-1000 KHz) for relatively short periods of time to gain the benefit of a “duty cycle” to reduce average current drain. A much lower frequency clock (e.g., generally 32 KHz) is used for other timing and control circuitry and/or the processor when not in the high clock rate, burst clock mode. A few illustrative examples which describe the use of a burst clock are provided in U.S. Pat. Nos. 4,561,442, 5,022,395, 5,154,170, and 5,388,578.
Even with these improvements, clocked logic CMOS circuits assembled from logic gates, flip-flops, and other Boolean logic blocks used in IMD system architectures suffer from several limitations and disadvantages. It is necessary to route clock distribution over the complete IC chip area as a clock tree of discrete electrical conductors or lines to reach all clocked logic. The clock tree takes up IC chip real estate that could be used to increase device functions or memory capacity, dissipates power as heat, and increases overall power drain of the IC, decreasing useful life of the IMD battery. Complex timing analysis and worst case design analysis and simulation are required in clocked logic circuits to ensure design integrity because of possible clock skew and the resultant timing errors induced by race conditions. Consequently,

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