In vitro assessment of tissue heating near metallic medical implants by exposure to pulsed radio frequency diathermy.

A patient with bilateral implanted neurostimulators suffered significant brain tissue damage, and subsequently died, following diathermy treatment to hasten recovery from teeth extraction. Subsequent MRI examinations showed acute deterioration of the tissue near the deep brain stimulator (DBS) lead's electrodes which was attributed to excessive tissue heating induced by the diathermy treatment. Though not published in the open literature, a second incident was reported for a patient with implanted neurostimulators for the treatment of Parkinson's disease. During a diathermy treatment for severe kyphosis, the patient had a sudden change in mental status and neurological deficits. The diathermy was implicated in causing damage to the patient's brain tissue. To investigate if diathermy induced excessive heating was possible with other types of implantable lead systems, or metallic implants in general, we conducted a series of in vitro laboratory tests. We obtained a diathermy unit and also assembled a controllable laboratory exposure system. Specific absorption rate (SAR) measurements were performed using fibre optic thermometry in proximity to the implants to determine the rate of temperature rise using typical diathermy treatment power levels. Comparisons were made of the SAR measurements for a spinal cord stimulator (SCS) lead, a pacemaker lead and three types of bone prosthesis (screws, rods and a plate). Findings indicate that temperature changes of 2.54 and 4.88 degrees C s(-1) with corresponding SAR values of 9129 and 17,563 W kg(-1) near the SCS and pacemaker electrodes are significantly higher than those found in the proximity of the other metallic implants which ranged from 0.04 to 0.69 degrees C s(-1) (129 to 2471 W kg(-1)). Since the DBS leads that were implanted in the reported human incidents have one-half the electrode surface area of the tested SCS lead, these results imply that tissue heating at rates at least equal to or up to twice as much as those reported here for the SCS lead could occur for the DBS leads.

On the mechanisms of interference between mobile phones and pacemakers: parasitic demodulation of GSM signal by the sensing amplifier.

The aim of this study was to investigate the mechanisms by which the radiated radiofrequency (RF) GSM (global system for mobile communication) signal may affect pacemaker (PM) function. We measured the signal at the output of the sensing amplifier of PMs with various configurations of low-pass filters. We used three versions of the same PM model: one with a block capacitor which short circuits high-frequency signals; one with a ceramic feedthrough capacitor, a hermetically sealed mechanism connecting the internal electronics to the external connection block, and one with both. The PMs had been modified to have an electrical shielded connection to the output of the sensing amplifier. For each PM, the output of the sensing amplifier was monitored under exposure to modulated and non-modulated RF signals, and to GSM signals (900 and 1800 MHz). Non-modulated RF signals did not alter the response of the PM sensing amplifier. Modulated RF signals showed that the block capacitor did not succeed in short circuiting the RF signal, which is somehow demodulated by the PM internal non-linear circuit elements. Such a demodulation phenomenon poses a critical problem because digital cellular phones use extremely low-frequency modulation (as low as 2 Hz). which can be mistaken for normal heartbeat.

Cellular phone interference testing of implantable cardiac defibrillators in vitro.

An in vitro study was undertaken to investigate the potential for cellular telephones to interfere with representative models of presently used ICDs. Digital cellular phones (DCPs) generate strong, amplitude modulated fields with pulse repetition rates near the physiological range sensed by the ICD as an arrhythmia. DCPs with Time Division Multiple Access (TDMA) pulsed amplitude modulation caused the most pronounced effect--high voltage firing or inhibition of pacing output of the ICDs. This electromagnetic interference (EMI) occurred only when the phones were within 2.3-5.8 cm of the ICD pulse generator that was submerged 0.5 cm in 0.18% saline. ICD performance always reverted to baseline when the cellular phones were removed from the immediate proximity of the ICD. Three models of ICDs were subjected to EMI susceptibility testing using two types of digital phones and one analog cellular phone, each operating at their respective maximum output power. EMI was observed in varying degrees from all DCPs. Inhibition of pacer output occurred in one ICD, and high voltage firing occurred in the two other ICDs, when a TDMA-11 Hz DCP was placed within 2.3 cm of the ICD. For the ICD that was most sensitive to delivering unintended therapy, inhibition followed by firing occurred at distances up to 5.8 cm. When a TDMA-50 Hz phone was placed at the minimum test distance of 2.3 cm, inhibition followed by firing was observed in one of the ICDs. EMI occurred most frequently when the lower portion of the monopole antenna of the cellular phone was placed over the ICD header.

Rapid and uniform electromagnetic heating of aqueous cryoprotectant solutions from cryogenic temperatures.

Devitrification (ice formation during warming) is one of the primary obstacles to successful organ vitrification (solidification without ice formation). The only feasible approach to overcoming either devitrification or its damaging effects in a large organ appears at present to be the use of some form of electromagnetic heating (EH) to achieve the required high heating rates. One complication of EH in this application is the need for warming within a steel pressure vessel. We have previously reported that resonant radiofrequency (RF) helical coils provide very uniform heating at ambient temperatures and low heating rates and can be modified for coaxial power transmission, which is necessary if only one cable is to penetrate through the wall of the pressure vessel. We now report our initial studies using a modified helical coil, high RF input power, and cryogenic aqueous cryoprotectant solutions [60% (w/v) solution of 4.37 M dimethylsulfoxide and 4.37 M acetamide in water and 50% (w/w) 1,2-propanediol]. We also describe the electronic equipment required for this type of research. Temperatures were monitored during high-power conditions with Luxtron fiberoptic probes. Thermometry was complicated by the use of catheters needed for probe insertion and guidance. The highest heating rates we observed using catheters occurred at temperatures ranging from about -70 to -40 degrees C, the temperature zone where devitrification usually appears in unstable solutions during slow warming. We find that in this range we can achieve measured heating rates of approximately 300 degrees C/min in 30- to 130-ml samples using 200 to 700 W of RF power without overheating the sample at any point. However, energy conservation calculations imply that our measured peak heating rates may be considerably higher than the true heating rates occurring in the bulk of our solutions. We were able to estimate the overall true heating rates, obtaining an average value of about 20 degrees C/min/100 W/100 ml, which implies a heating efficiency close to 100%. It appears that it should be possible to warm vitrified rabbit kidneys rapidly enough under high-pressure conditions to protect them from devitrification.

CDRH RF phantom for hyperthermia systems evaluations.

The National Cancer Institute (NCI) sponsored clinical evaluations of investigational 'regional' hyperthermia systems at four clinical institutions. To support this project, the Center for Devices and Radiological Health (CDRH) developed a series of test instruments to evaluate the magnitude and repeatability of the induced heating by radiofrequency (RF) systems. Data from three institutions using the same model hyperthermia system have been analyzed. After heating, the average temperature from measurements taken at several points in the test phantom at each institution agree within +/- 0.002 degrees C. These differences are about equal to the measurement uncertainty. Thus, this technique can be used for preclinical evaluation and quality control of the total system operation. After one of the institutions relocated its hyperthermia system, a subsequent set of data showed inconsistencies compared to their earlier data. Investigation traced this to cable loss and power meter interference. From the analysis of the data from the three institutions, the utility of the CDRH RF phantom for hyperthermia systems evaluation is demonstrated.

Magnetic fields associated with a nuclear magnetic resonance medical imaging system.

Measurements were made of magnetic and electric field levels in and around a nuclear magnetic resonance imaging system undergoing a clinical trial. Magnetic field levels ranged from 0.04 tesla (T) in the imaging volume down to about 0.0006 T at the end of the patient table. The peak radio-frequency magnetic field level was 15 amperes per meter (A/m) in the imaging volume, while the rms value was 4.6 A/m. The specific absorption rate resulting from the radio-frequency magnetic field was calculated to be no more than 0.017 watts per kilogram (W/kg). The radio-frequency electric field was detectable only within a few centimeters of the coil assembly, and does not significantly contribute to the specific absorption rate. These exposure levels were much lower than existing guidelines for clinical NMR procedures.