White Paper: Implantable Device Communication and Application of MICS Communications

Background

1. Purpose

This white paper aims to explore and elucidate the role of Medical Implant Communication Service (MICS) in enabling reliable, low-power, and interference-resistant wireless communication for implantable medical devices. It will examine the technical specifications, as well as regulatory considerations of MICS.

2. Background

Implantable device communication overview

• Inductive – Uses large diameter coils for the implant and the programmer that are inductively coupled. Inductive transmissions work over a very short range typically requiring the programmer to be placed very close to the patient’s body and located directly above the implant’s coil.
• Bluetooth – This is a well-known RF transmission technology with high data rates and moderately long range. Bluetooth exists in the FCC’s ISM (Instrumentation, Scientific or Medical) band which operates at microwave frequencies around 2.4GHz. The ISM band allows relatively high-powered transceivers and can be applied to virtually any type of device.
• MICS – This RF transmission technology targeted specifically for implant applications. It operates on a restricted RF band that has been set aside just for this purpose, around 403MHz, and is recognized internationally. It provides moderate data rates over limited distances and transmits at lower power compared to Bluetooth.

Challenges For Implantable Devices

1. Body Environment

The body presents some unique issues for implantable devices. These include biocompatibility and hermeticity. Devices need to be constructed of materials that are not dangerous to the body and can withstand constant exposure to the fluids, temperatures and other stresses in the body environment. Since the body is largely comprised of water, ensuring that the device is hermetically sealed to eliminate the ingress of fluids is necessary. 

2. Size

Implantable devices present unique design challenges with size and power consumption being among the top considerations. Physically smaller devices are desirable because of the reduced incision length which provides for better patient outcomes.

3. Power

Due to the invasive nature of the process of implantation process, it is not desirable to do it repeatedly. Therefore, with a non-rechargeable primary battery as the power source, minimal power consumption is crucial. For systems that use inductive communications, it is possible to also implement a power delivery capability that works along with the communications.

4. Communications

There are several aspects to selecting a suitable communications technology. The two most prevalent concerns are typically range and data rate. Additionally, there are usually requirements data integrity and perhaps cybersecurity. The communications technology chosen will impact on the power draw and life expectancy of the implant. 

5. Interference

Wireless technology is widely used which leads to crowed traffic on certain frequency bands, ISM in particular. Techniques to ensure data integrity are built into modern communication approaches but this can lead to unexpended impact on both range and data rates. 

Comparison of communications technologies 

1. Body Environment

    1.1Penetration Depth

    To reach implanted devices, RF signals must penetrate body tissue. Due to its high-water content and high conductivity, body tissue readily absorbs RF signals. 

    Table 1 shows how different communication signals attenuate as their signals penetrate tissue. The skin depth cited in this table is defined as the depth where the signal is attenuated by a factor of 0.368 and allows for a useful comparison between the technologies. It is clear from the table that the inductive approach has far superior penetration of Muscle Tissue, it also shows that MICS, at 403.5MHz, can penetrate almost 2.5 times as far as Bluetooth at 2.45GHz. Generally, tissue penetration decreases with increasing frequency. 

    1.2 Specific Absorption Rate

    The idea of depth penetration is usually thought of as the external device reaching the implant. Generally, implant communications are bidirectional, so the tissue attenuation also affects the implant’s transmissions. One way to overcome the attenuation is by increasing the implant’s transmit power, but this has practical as well as regulatory implications. The FCC limits the maximum power levels allowed for certain bands and increased transmitting power directly impacts the life expectancy of the implant. However, because tissue is so absorptive of RF energy, there is also a risk of heat damaging the tissue by exposing it to too much energy, and this risk increases with increasing frequency. The Specific Absorption Rate (SAR) is a measure of the rate at which energy is absorbed per unit mass by a human body when exposed to radio frequency energy. The FCC limits the SAR that a device can subject tissue to. Generally, a better way to deal with high signal attenuation though tissue is not to increase transmit power, but rather to design more sensitive receivers for both the implant and external device. 

    Because SAR is proportional to the square of the RF frequency, as the frequency increases, the SAR increases at an increasing rate. At the microwave frequencies of the ISM band (2.4GHz), and with the transmitting antenna in intimate contact with tissue, SAR can be a significant concern. The ISM band also allows transmitters to operate at raw power levels of up to one watt. For MICS SAR is less of an issue, not only because the frequency is 6 times lower, but also because the FCC limits the level that can be transmitted out of the body to 25uW. Even considering the additional power needed at the antenna to overcome the tissue attenuation to reach the FCC maximum limit outside the body, the power will be below the SAR requirements for the MICS band frequencies. SAR is even less of a concern for inductive system. The operating frequency for these systems is very low, table 1 shows an inductive system that is operating at 170KHz (several thousand times less than the MICS frequency). Additionally, the antenna is housed in the interior volume of the device case separating it from the tissue by a significant distance versus the other RF approaches.

    1.3 Hermiticity

    Although not immediately apparent, there is another consideration that has practical implications – the need for penetrations through the metal case of the implant. Why is this important? Implantable devices need to be hermetically sealed to a high degree to protect what lies within from bodily fluid and visa-versa. Penetrations for electrical connections through the device’s case need to be accomplished using special feedthrough components that guarantees the hermiticity of the device. Custom versions of these devices can be expensive and time consuming to develop, usually done usually through a supplier, they can have long development timelines.

Figure 1 Electrical Feedthrough

    Referring to Table 1, inductive signals have superior tissue penetration characteristics and can also pass though certain non-ferrous metals. A widely used non-ferrous biocompatible metal is Titanium. A receiving coil housed in a titanium enclosure can readily receive inductive signals. Locating the inductive communication coil within the metal housing avoids the need for electrical case penetrations. MICS and Bluetooth antennas need to be located outside of the metal housing, usually in some type of polymeric header since, at those frequencies the housing would act like a shield and prevent any reception of the RF signal. This necessitates the use of a feedthrough to get the antenna signals back into the main housing of the device where the RF circuitry usually resides. If the implant does not use a metal enclosure, then of course, the feedthrough is unnecessary.

    1.4 Antenna Characteristics

    Antennas must be tuned to operate efficiently at their frequency of operation. The characteristics of the antenna when used in air will be significantly different when implanted. It typically takes specialized equipment and knowledge to both design the antenna and match it to the RF transceiver. The process is easier to do if the transceiver provides built-in resources that allow trimming the various system tuning components. Not all transceivers provide this convenience. If this type of capability is not provided, then the trimming will need to be done through a manual process of changing hardware components which can be more difficult.

Figure 2: Body Phantom

    In order to test and make tuning adjustment, there needs to be a way to simulate the body environment from an RF standpoint, a body phantom is used for this purpose. The phantom is generally a large glass or acrylic cylinder that is filled with a medium that has the same electrical properties as the tissue that the implant will be surrounded by. A test device is suspended in the media and the necessary measurements are taken. The phantom is not only used to optimize the antenna performance, but also when testing the transmit level of the implant. The FCC sets limits on the transmit level detected outside the body and the phantom provides the necessary attenuation expected when the device is implanted. 

2. Size

Implant size is dictated by its function, for instance a drug pump will need to at least have the volume of its reservoir. Although miniaturization of electronics has allowed for smaller more sophisticated control assemblies, other system components can drive the overall size. Size is important for patient comfort, but the device size also determines how large an incision is needed for the implant. Smaller incisions correlate with better patient outcomes. Generally speaking, the lower the RF frequency the larger the antenna will be. So, the Bluetooth antenna at 2.4GHz will be significantly smaller than the MICS at 403.5MHz for the same level of sensitivity. Antennas can be made virtually of any size, but there are tradeoffs. As antennas shrink to a size much smaller than the RF frequency’s wavelength, they lose sensitivity and become inefficient both as a receiver and a transmitter. The loss of efficiency means that more power is needed to achieve the same range.  So, device size if driven by the antenna can be improved but typically at the cost of shorter electrical life due to increased power demands. 

3. Power

Many implanted devices sleep a lot and only need to communicate with external devices to download collected data or to upload changes to therapy. In many devices the sleep time is far greater than its active time, so the power drawn during sleep becomes critical since it may be the dominant source of battery power consumption. As mentioned earlier it is a simple matter to put a device to sleep but a tricky thing to wake it up externally. Generally, the approach now used is to periodically sniff the environment for radio signals specific to the implant. To preserve battery life the current draw and time used to sniff should be as low as possible. One commercially available MICS module specs an average sniff current as 810nA. Since the current drawn when the device is actively receiving can be several milliamps, average sleep power consumed by sniffing can be reduced by increasing the time interval between sniffs. However, this must be traded off against the responsiveness of establishing communication because several sniffs may be needed before the device positively responds to the wake-up transmission.

4. Communications

Table 2 shows typical performance levels for the three communications technologies under consideration here. 

Table 2: Typical Performance

*open-air, un-implanted, range and data rated reduce when implanted

Generally, the higher the frequency of operation, the higher the data rate that can be achieved. This can be seen in comparing the Bluetooth approach, which has a data rate up to 2Mbps at 2400MHz to MICS with data rate of 400Kbps at 400MHz. The Bluetooth range and rate are obtained when the system is tested in open-air. Once implanted, the attenuation though the tissue will reduce the range but, it will likely be greater than the MICS range. This is because the power levels for MICS are restricted to quite a low level whereas the Bluetooth power levels are high. However, the restrictions due to SAR at Bluetooth frequencies will limit the implant’s output level and there for the actual range. 

In addition to range there is also a need to ensure the integrity of the data exchange. Ensuring this typically entails implementing forward error correction and end-to-end error correction scheme that includes a means of identifying bad portions of a transmission and then a way to retransmit the corrupted portions. Additionally, there could be a requirement to encode data for cybersecurity purposes. This capability could be part of the communications process or a part of the data storage and delivery approach.

Implantable devices typically communicate with external devices infrequently. Communications between a programmer at a physician’s office or even an external patient device happen only a few times over a period of days to weeks, so it’s wasteful to keep the radios powered up continuously ready to receive transmissions. While it is simple to determine when to power down a radio receiver, knowing when to power it back up is tricky. In the past there have been nonelectrical attempts made to wake up an implant. For instance, the use of a magnetic reed switch that would close when it was exposed to a strong magnetic field and wake up the communications system (problematic for MRIs), or an optical approach that generates a signal in response to a specific light. Generally, with the decrease of power consumption in modern microelectronics, the communication circuits in implants periodically wake up and scan the environment for indications of an incoming transmission. The receiver circuits in these designs are optimized to provide this sniff with an exceptionally small power penalty. The average sniff current of modern communications modules can be in the sub one microamp range.

5. Interference

Interference from devices in the same RF band and, also from out-of-band sources will have a large effect on the integrity and data rates. In crowded bands, like ISM/Bluetooth, in environments where it is likely to have many devices, interference can greatly reduce the effective data rate. With end-to-end data correction, a single piece of data that is received with corruptions may need to be retransmitted numerous times. This delays the delivery of the data and ultimately reduces the actual data rate.  Restricted bands like MICS at 402 – 405MHz, are established to reduce interference which improves the general performance of the communications system. The MICS band does share its spectrum with other devices, but they are limited in number and low power, and present little interference issues.

MICS

1. Background of MICS

The MICS acronym stands for Medical Implant Communication Service, which was established in 1999 and has more recently been included into the FCC’s wider MedRadio1 classification which contains additional bands of frequencies and applications like Medical Body Area Networks which operate on frequencies near Bluetooth. 

In its original form, the aim was to create a band in the RF spectrum (402MHz to 405MHz) that would be limited to just communications with implant devices. The frequency range was selected to be a good compromise between operating frequency, which impacts data rate, and body penetration.  A MICS communications system consists of an implant side and an external programmer or base station side. The band is use-restricted to reduce interference, and the power limited to provide a reasonable range while reducing the possibility of interference between nearby systems. MICS does share its band with meteorological satellites and meteorological aids. However, the signal level from these devices is so small that when they reach the earth, buildings effectively shield MICS devices within, so interference is not an issue. The MICS band is recognized internationally in US, Canada, Europe, Australia, and throughout the Asia-Pacific region. 

2. Requirements for using MICS

The FCC requirements for implementing MICS system are specific and stringent. Beyond the typical FCC requirements for transmitter power, bandwidth and out-of- band emissions, there are several processes that must be implemented. These are there to ensure the lowest possibility of interference from other MICS systems that are located nearby.

1. Maximum allowed transmit power is 25uW or -16dBm ERP (effective Radiating Power)
2. Ten channels each with a 300KHz bandwidth.
3. Spurious emissions less than -36dBm (100KHz BW)
4. Clear Channel Assessment (CCA) before commencing communications (further details below). 
5. Relinquish channel if transmission ceases for more than 5 seconds. 
6. Data transmissions should happen at intervals of less than 10ms.

    2.1 Clear channel assessment 

    The original MICS band from 402 to 405MHz provides 10 channels, each 300KHz wide. One of the main objectives of MICS is to reduce interference with ongoing implant communications sessions. To achieve this, MICS has a requirement known as a Clear Channel Assessment (CCS). To do this, less than before starting a communication session, the external device (programmer), measures the signal strength of each of the 10 channels for a minimum of 10ms. It then selects the quietest of the channels for its transmissions. 

    2.2 Relinquish Channel Use

    Once the CCA is complete, communications can continue for as long as necessary. However, if there is a pause in transmission of useful data for longer than 5 seconds, the channel must be dropped. Another CCA will need to be done to once again commence transmissions. This provision is intended to ensure that the limited number of MICS channels are as available as possible. 

    2.3 Maximum Silent Intervals

    While actively using the channel there can be pauses in transmissions. These silent intervals should be shorter than 10ms to ensure that channel currently in use will show up during a CCA from another system. If no data is available to transfer, then housekeeping, retransmission requests or heartbeat info should be exchanged within the maximum interval. If no useful data is transferred within 5 seconds, the channel should be relinquished as mentioned above. 

3. Wake Up

As mentioned earlier in this document, most RF based communications systems sniff the environment for indications of a transmission. There are no FCC regulations that dictate the means for waking up an implant, or even a requirement to put an implant to sleep. So, it is left to the designer to implement the wake-up process. In the following text, the implementation of the Microchip ZL70103 MICS module family is described. 

4. MICS Modules 

Implementing a MICS compliant system from scratch can be a daunting task. The RF design of the transmitters and receivers themselves requires a high level of expertise. The implant side is particularly problematic since it requires the RF system to be efficient to draw as little power as possible during transmissions, be able to sniff for incoming transmissions at exceptionally low power draws while the system is sleeping, all while taking up as little physical room as possible. 

Currently there is only one commercial MICS chipset available, from Microchip. This set was originally developed by Zarlink, then transferred to Microsemi and eventually became part of Microchip. Known as the ZL70103 group of modules, it offers a very small (4.5 x 5.5mm) implant module and a base station module for use in external devices.

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Figure 3: Microchip ZL70323 Implant Module

Figure 4: Microchip ZL70123 Base Station Module

The core of both modules is a chip, ZL70103, that integrates the 400MHz transmitter, receiver and a state machine that automates most of the processes involved in executing a MICS communications session. 

The ZL70132 base station module also incorporates a 2.45GHz transmitter to wake up the implant. The transmitter is centered around the CC2500 Transceiver produced by Texas Instruments. Used only for its transmitter function, it provides the synthesis and amplitude control of the 2.45GHz RF signal. The CC2500 can provide up to -1dBm of output power, then an additional 26dB of signal power is added by another power amp stage. The power range of the combined stages is about +23 to -35dBm with a power step resolution of 0.4dB (+23dBm into 50 ohms is 200mW of power). The base station module will draw upwards of 56mA when attempting to wake up the implant module at full power. 

The implant side of the communications link is the ZL70323 module, also based around the ZL70103 chip but it adds the necessary passive components to match the transceiver to a single, simple, loop antenna. The antenna is matched to the implant’s transceiver for operation in the MICS band (402 – 405MHz) but is also designed to receive the 2.45GHz wake-up signal. For implants that use titanium cases, the antenna must fit into some type of nonmetallic header assembly which is outside of the main metallic case. To accommodate this, while not grossly affecting the implant’s size, requires that the antenna be relatively small. As mentioned previously, as antennas shrink in size, they become less efficient. The wavelength of a 400MHz signal in air is approximately 0.75m (2.5 ft) far too large to fit into an implant. Even using a ¼ wavelength antenna size, which is a common, the antenna is still quite large for the physical constrains.  So, a tradeoff is made to shrink the antenna to 1/10 of a wavelength and deal with the loss of efficiency by improving the receiver sensitivity. Because the final characteristics of the implanted antenna are so varied, the ZL70103 chip contains a significant amount of resources to measure and match the transceiver to the antenna.

The Microchip modules provide several data rates and control over the packet size. The data rate is related to the modulation techniques, which also affect the receiver’s sensitivity. The necessary data rate is determined by the needs of the application. It is usually desirable to have as high a data rate as possible, but this is not always the best approach since that may sacrifice range or connection quality for unused data transfer capacity. Using a lower, more appropriate rate typically allows better range and data integrity. In the Microchip modules, dropping data rates from 400kbps to 40Kkbps can increase the receiver sensitivity by 16dB, that’s about 40X improvement in sensitivity.  This additional sensitivity can take a communication link that is very marginal with slow or intermittent connections and change it into a dependable high-performance connection. 

Another aspect of the data rate is the size of the data packets exchanged. In digital data communications the data is divided up into packets. These packets contain payload data, the desired info, and header data. Header data contains information about the transmission itself, like the amount of data, forward error correction data and CRC info that allows the receiving side to determine if any errors occurred during transmission and what to have retransmitted.

Figure 5: Packet Example

To ensure end-to-end data integrity, bad portions of packets are identified, and requests are made to the sender for retransmission of the corrupt portions. As packet size gets larger, the probability of corrupt receiving data increases and the effort to retransmit and correct the corruption reduces the effective data rate. Even with the corrective measures, erroneous data can make it through. There is a measure for this known as Bit Error Ratio (BER) which measures the number of bit errors divided by the total number of bits received. It is usually presented in scientific notation with a base 10 and a negative exponent. A BER of 1 X 10-6 would indicate that there is a one-bit error for every 1 million bits received.  As the quality of the link starts to degrade and the BER increases, it is often helpful to reduce the size of the payload data and send smaller packets more frequently. Although mathematically that is less efficient, when the delays associated with error correction and retransmission are considered, the smaller packets can cause less retransmission and overall better throughput. 

Packet size also has an impact on latency. Under good link conditions, larger packets provide high efficiency because header bits represent a smaller portion of the packet. However, it takes longer to load the larger quantity of data and to transmit it. At the destination it also takes longer to unload the data.  If low latency is an important aspect, then smaller packets will refresh data faster. For a particular application it was necessary to present a graph of ICP pressure to assist a surgeon in the placement of a ventricular catheter. Realtime feedback was critical, so the packet size of the MICS transmissions was reduced when that function was used to reduce latency in the data. 

The wake-up process for the ZL70323 implant module uses the 2.45GHz transmitter in the base station module. The implant has a specialized receiver optimized to use very little current to sniff. The tradeoff for this low current is that the receiver is not particularly sensitive. The base station, since it operates in the ISM band, can produce large output signal levels, high enough to be detected by the less sensitive wake-up receiver.  The 2.45GHz wake-up transmission carries information for the implant. It encodes the ID of the device it wants to connect with, the MICS band channel and modulation scheme to use for a response. With this information the implant can determine if it should respond to the transmission and how.  The ZL70323 can also wake up an implant using the MICS frequency bands. However, this is less desirable since the implant sniff power used for this approach is greater than using 2.54GHz. 

When the base station is attempting to wake up an implant, it will claim a MICS channel. The base station has previously completed a CCA to determine which channel to use. Now while it is transmitting a wake-up at 2.45GHz, it also begins to send transmissions on the MICS selected channel. By doing this, any other implants doing a CCA will avoid the selected channel since it can be seen to be in use. The claimed channel is encoded in the wake-up transmission, and when the implant determines it is the subject of the transmission, it will begin responding to the base station. Once the connection is made, the MICS link is in session.

5. Base Station Module and External Devices

One of the complications of using MICS, is that it is restricted to use for human implants and therefore not widely used. The use of mobile devices as user interfaces for medical devices is almost de rigueur currently, but they contain no radio link compatible with MICS. So, any use of a mobile device with a MICS implant necessitates some type of bridge between the communication standards. Figure 6 shows an example of a bridge developed at Vantage Medtech for an implantable pump communication system. Although MICS is superior in many fundamental ways to Bluetooth for implants, the lack of direct compatibility with mobile devices is particularly problematic. For a dedicated patient device that is not based on a mobile device, this is a non-issue. 

The range limit of 2 meters for MICS can present an issue during implantation because the base station side might need to be located in an area that requires sterilization.  Due to its small size, and that it requires no manual interaction, the bridge can be contained in a sterile enclosure near the patient. The extended range of the Bluetooth link then allows the tablet to interact with the implant from well outside of the sterile field.

The ultimate physical size of the bridge is, to a large degree, limited by the antenna and it’s required ground plane. The antenna and ground plane of the PCB, make up a dipole antenna. The size of the ground plane, similar to the length of the antenna itself, is dictated by the frequency of operation. Because of this relationship, the area of the PCB cannot be reduced beyond a certain point without impacting the efficiency of the antenna. 

The base station differs from the implant mainly because of the 2.45GHz transmitter. The Microchip ZL70123 module contains the TI CC2500 RF transceiver which is used to synthesize and modulate the 2.45GHz wake-up transmission. The module is moderately large compared to most Bluetooth modules, but still small enough not to impact the physical size of the device using it. The base station module also requires an antenna that is capable of working at 403MHz while also transmitting, with reasonable efficiency, at 2.45GHz. Microchip recommends a simple, off-the-shelf, helical antenna. The antenna is designed to work on 433MHz, which is close enough to the MICS band to be a practical solution. Because the base station module is based on the same ZL70103 chip as the implant, it contains numerous resources for tuning and trimming RF performance for optimum matching to the antenna. To accommodate use of a single antenna though, an external RF circuit, called a diplexer, is needed. The purpose of this circuit is to greatly reduce the amount of 2.45GHz signal that reaches the 400MHz transceiver input during wake-up transmissions, and similarly, preventing 400MHz signals from reaching the 2.45GHz input, the purpose generally is to keep the 2.45GHz input from loading down the 400MHz and reducing its sensitivity. 

Figure 6: MICS to Bluetooth Bridge

6. FCC Regulatory

The Microchip implant and base station modules do not carry any pre-certifications for FCC compliance, so both devices will need to go through the full FCC certification process. The implant side requires the use of a body phantom for testing to simulate the RF performance when implanted (see 3.1.4 for an example of a body phantom). Including a Bluetooth module along with the base station module add a unique issue with certification. Typically, a Bluetooth module will have a precertification that can be used to avoid most of the FCC testing pertaining to the Bluetooth use in the final product. There is however generally a caveat in the pre-certification that the module cannot be co-located with other transmitters. Co-located is defined as transmitters operating simultaneous within 20cm of each other. This is because the interaction of the transmitted signals cannot be predicted and may not conform with the requirements for levels and spurious signals. The example bridge of figure 6 does co-locate transmitters. If it is possible to ensure that both transmitters will never transmit simultaneously, then the Bluetooth module can still use the precertification. However, this may not be possible for any particular application. 

7. Technical Support 

Much of the information for implementing the Microchip MICS solution comes from the evaluation kit. It is important to note that because of the specialized, and serious, nature of this module set, Microchip actively vets customers to ensure that their solution is not misused.  The eval kit contains an implant PCB assembly, a base station assembly and an extremely capable UI application for testing and operating the various aspects of the module set. Along with the eval kit is an extensive design manual, full set of schematics and board layout drawings. These proved to be extremely helpful for informing layout decisions. PCB layouts involving 2.45GHz can be challenging. Even though the Microchip modules are highly engineered to ease implementation of the MICS communication solution, there is still a good deal of firmware that needs to be developed to get the system up and running. Microchip makes the evaluation kit source code, both for the board firmware and the UI application, available to approved users, a no-cost software license is involved. This is immensely helpful as a reference for the customer’s code development.

References

• FCC 47 CFR Ch. I (10–1–20 Edition), Section 95.25
  

Author Biography

This White Paper written by:

Ernest Ketterer

Hardware Engineer III

This White Paper reviewed and edited by:

Kamesh Durvasula

Engineering Manager

About Vantage MedTech

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