Advances in Microelectronics for Implantable Medical Devices

Implantable medical devices provide therapy to treat numerous health conditions as well as monitoring and diagnosis. Over the years, the development of these devices has seen remarkable progress thanks to tremendous advances in microelectronics, electrode technology, packaging and signal processing techniques. Many of today’s implantable devices use wireless technology to supply power and provide communication. There are many challenges when creating an implantable device. Issues such as reliable and fast bidirectional data communication, efficient power delivery to the implantable circuits, low noise and low power for the recording part of the system, and delivery of safe stimulation to avoid tissue and electrode damage are some of the challenges faced by the microelectronics circuit designer. This paper provides a review of advances in microelectronics over the last decade or so for implantable medical devices and systems. The focus is on neural recording and stimulation circuits suitable for fabrication in modern silicon process technologies and biotelemetry methods for power and data transfer, with particular emphasis on methods employing radio frequency inductive coupling. The paper concludes by highlighting some of the issues that will drive future research in the field

A Low-Power DSP Architecture for a Fully Implantable Cochlear Implant System-on-a-Chip.

The National Science Foundation Wireless Integrated Microsystems (WIMS) Engineering Research Center at the University of Michigan developed Systems-on-a-Chip to achieve biomedical implant and environmental monitoring functionality in low-milliwatt power consumption and 1-2 cm3 volume. The focus of this work is implantable electronics for cochlear implants (CIs), surgically implanted devices that utilize existing nerve connections between the brain and inner-ear in cases where degradation of the sensory hair cells in the cochlea has occurred. In the absence of functioning hair cells, a CI processes sound information and stimulates the nderlying nerve cells with currents from implanted electrodes, enabling the patient to understand speech. As the brain of the WIMS CI, the WIMS microcontroller unit (MCU) delivers the communication, signal processing, and storage capabilities required to satisfy the aggressive goals set forth. The 16-bit MCU implements a custom instruction set architecture focusing on power-efficient execution by providing separate data and address register windows, multi-word arithmetic, eight addressing modes, and interrupt and subroutine support. Along with 32KB of on-chip SRAM, a low-power 512-byte scratchpad memory is utilized by the WIMS custom compiler to obtain an average of 18% energy savings across benchmarks. A synthesizable dynamic frequency scaling circuit allows the chip to select a precision on-chip LC or ring oscillator, and perform clock scaling to minimize power dissipation; it provides glitch-free, software-controlled frequency shifting in 100ns, and dissipates only 480μW. A highly flexible and expandable 16-channel Continuous Interleaved Sampling Digital Signal Processor (DSP) is included as an MCU peripheral component. Modes are included to process data, stimulate through electrodes, and allow experimental stimulation or processing. The entire WIMS MCU occupies 9.18mm2 and consumes only 1.79mW from 1.2V in DSP mode. This is the lowest reported consumption for a cochlear DSP. Design methodologies were analyzed and a new top-down design flow is presented that encourages hardware and software co-design as well as cross-domain verification early in the design process. An O(n) technique for energy-per-instruction estimations both pre- and post-silicon is presented that achieves less than 4% error across benchmarks. This dissertation advances low-power system design while providing an improvement in hearing recovery devices.Ph.D.Electrical EngineeringUniversity of Michigan, Horace H. Rackham School of Graduate Studieshttp://deepblue.lib.umich.edu/bitstream/2027.42/91488/1/emarsman_1.pd

Modulation Techniques for Biomedical Implanted Devices and Their Challenges

Implanted medical devices are very important electronic devices because of their usefulness in monitoring and diagnosis, safety and comfort for patients. Since 1950s, remarkable efforts have been undertaken for the development of bio-medical implanted and wireless telemetry bio-devices. Issues such as design of suitable modulation methods, use of power and monitoring devices, transfer energy from external to internal parts with high efficiency and high data rates and low power consumption all play an important role in the development of implantable devices. This paper provides a comprehensive survey on various modulation and demodulation techniques such as amplitude shift keying (ASK), frequency shift keying (FSK) and phase shift keying (PSK) of the existing wireless implanted devices. The details of specifications, including carrier frequency, CMOS size, data rate, power consumption and supply, chip area and application of the various modulation schemes of the implanted devices are investigated and summarized in the tables along with the corresponding key references. Current challenges and problems of the typical modulation applications of these technologies are illustrated with a brief suggestions and discussion for the progress of implanted device research in the future. It is observed that the prime requisites for the good quality of the implanted devices and their reliability are the energy transformation, data rate, CMOS size, power consumption and operation frequency. This review will hopefully lead to increasing efforts towards the development of low powered, high efficient, high data rate and reliable implanted devices

Improving the mechanistic study of neuromuscular diseases through the development of a fully wireless and implantable recording device

Neuromuscular diseases manifest by a handful of known phenotypes affecting the peripheral nerves, skeletal muscle fibers, and neuromuscular junction. Common signs of these diseases include demyelination, myasthenia, atrophy, and aberrant muscle activity—all of which may be tracked over time using one or more electrophysiological markers. Mice, which are the predominant mammalian model for most human diseases, have been used to study congenital neuromuscular diseases for decades. However, our understanding of the mechanisms underlying these pathologies is still incomplete. This is in part due to the lack of instrumentation available to easily collect longitudinal, in vivo electrophysiological activity from mice. There remains a need for a fully wireless, batteryless, and implantable recording system that can be adapted for a variety of electrophysiological measurements and also enable long-term, continuous data collection in very small animals. To meet this need a miniature, chronically implantable device has been developed that is capable of wirelessly coupling energy from electromagnetic fields while implanted within a body. This device can both record and trigger bioelectric events and may be chronically implanted in rodents as small as mice. This grants investigators the ability to continuously observe electrophysiological changes corresponding to disease progression in a single, freely behaving, untethered animal. The fully wireless closed-loop system is an adaptable solution for a range of long-term mechanistic and diagnostic studies in rodent disease models. Its high level of functionality, adjustable parameters, accessible building blocks, reprogrammable firmware, and modular electrode interface offer flexibility that is distinctive among fully implantable recording or stimulating devices. The key significance of this work is that it has generated novel instrumentation in the form of a fully implantable bioelectric recording device having a much higher level of functionality than any other fully wireless system available for mouse work. This has incidentally led to contributions in the areas of wireless power transfer and neural interfaces for upper-limb prosthesis control. Herein the solution space for wireless power transfer is examined including a close inspection of far-field power transfer to implanted bioelectric sensors. Methods of design and characterization for the iterative development of the device are detailed. Furthermore, its performance and utility in remote bioelectric sensing applications is demonstrated with humans, rats, healthy mice, and mouse models for degenerative neuromuscular and motoneuron diseases

Low power circuits and systems for wireless neural stimulation

Thesis (Ph. D.)--Massachusetts Institute of Technology, Dept. of Electrical Engineering and Computer Science, 2011.Cataloged from PDF version of thesis.Includes bibliographical references (p. 155-161).Electrical stimulation of tissues is an increasingly valuable tool for treating a variety of disorders, with applications including cardiac pacemakers, cochlear implants, visual prostheses, deep brain stimulators, spinal cord stimulators, and muscle stimulators. Brain implants for paralysis treatments are increasingly providing sensory feedback via neural stimulation. Within the field of neuroscience, the perturbation of neuronal circuits wirelessly in untethered, freely-behaving animals is of particular importance. In implantable systems, power consumption is often the limiting factor in determining battery or power coil size, cost, and level of tissue heating, with stimulation circuitry typically dominating the power budget of the entire implant. Thus, there is strong motivation to improve the energy efficiency of implantable electrical stimulators. In this thesis, I present two examples of low-power tissue stimulators. The first type is a wireless, low-power neural stimulation system for use in freely behaving animals. The system consists of an external transmitter and a miniature, implantable wireless receiver-and-stimulator utilizing a custom integrated chip built in a standard 0.5 ptm CMOS process. Low power design permits 12 days of continuous experimentation from a 5 mAh battery, extended by an automatic sleep mode that reduces standby power consumption by 2.5x. To test this device, bipolar stimulating electrodes were implanted into the songbird motor nucleus HVC of zebra finches. Single-neuron recordings revealed that wireless stimulation of HVC led to a strong increase of spiking activity in its downstream target, the robust nucleus of the arcopallium (RA). When this device was used to deliver biphasic pulses of current randomly during singing, singing activity was prematurely terminated in all birds tested. The second stimulator I present is a novel, energy-efficient electrode stimulator with feedback current regulation. This stimulator uses inductive storage and recycling of energy based on a dynamic power supply to drive an electrode in an adiabatic fashion such that energy consumption is minimized. Since there are no explicit current sources or current limiters, wasteful energy dissipation across such elements is naturally avoided. The stimulator also utilizes a shunt current-sensor to monitor and regulate the current through the electrode via feedback, thus enabling flexible and safe stimulation. The dynamic power supply allows efficient transfer of energy both to and from the electrode, and is based on a DC-DC converter topology that is used in a bidirectional fashion. In an exemplary electrode implementation, I show how the stimulator combines the efficiency of voltage control and the safety and accuracy of current control in a single low-power integrated-circuit built in a standard 0.35 pm CMOS process. I also perform a theoretical analysis of the energy efficiency that is in accord with experimental measurements. In its current proof-of-concept implementation, this stimulator achieves a 2x-3x reduction in energy consumption as compared to a conventional current-source-based stimulator operating from a fixed power supply.by Scott Kenneth Arfin.Ph.D