Specific Absorption Rate and Current Densities in the Human Eye and Head Induced by the Telemetry Link of an Epiretinal Prosthesis

The fields induced in the human head by the wireless telemetry used for Second Sight Medical Product, Inc.'s epiretinal prosthesis system are characterized for compliance testing with international safety standards using a three-dimensional (3-D) finite-difference time-domain (FDTD) code in D-H formulation. The specific system under consideration utilizes an inductive link with a primary coil mounted on the subject's eyeglasses and a secondary coil that is strapped on the eye, over the sclera. The specific absorption rate (SAR) and the current density have been obtained computationally for different relative positions of the primary and secondary coils to account for the relative misalignment of the two due to the movement of the eye with the implant. For a peak normalized current of 0.62 A in the primary coil at 10 MHz, the highest peak 1-g SAR was found to be 0.45 W/Kg, and the maximum root mean square (rms) current density averaged over a 1-cm2 area was found to be 16.05 A/m2, both of which are within the limits imposed by IEEE and ICNIRP safety standards. Simulations between 2 and 20 MHz indicated that the induced electric field values scale well with frequency, thus providing guidelines for the determination of the final frequency and input power requirements of operation for the telemetry system to meet safety standards.

[1]  K R Foster,et al.  Health and safety implications of exposure to electromagnetic fields in the frequency range 300 Hz to 10 MHz , 2002, Bioelectromagnetics.

[2]  Ieee Standards Board IEEE standard for safety levels with respect to human exposure to radio frequency electromagnetic fields, 3kHz to 300 GHz , 1992 .

[3]  Wentai Liu,et al.  Retinal Prosthesis , 2018, Essentials in Ophthalmology.

[4]  S. C. DeMarco,et al.  Computed SAR and thermal elevation in a 0.25-mm 2-D model of the human eye and head in response to an implanted retinal stimulator - part I: models and methods , 2003 .

[5]  M. Stuchly,et al.  Interaction of low-frequency electric and magnetic fields with the human body , 2000, Proceedings of the IEEE.

[6]  Arup Roy,et al.  On the Thermal Elevation of a 60-Electrode Epiretinal Prosthesis for the Blind , 2008, IEEE Transactions on Biomedical Circuits and Systems.

[7]  James D. Weiland,et al.  Thermal elevation in the human eye and head due to the operation of a retinal prosthesis , 2004, IEEE Transactions on Biomedical Engineering.

[8]  R. Pethig,et al.  Dielectric properties of body tissues. , 1987, Clinical physics and physiological measurement : an official journal of the Hospital Physicists' Association, Deutsche Gesellschaft fur Medizinische Physik and the European Federation of Organisations for Medical Physics.

[9]  J. Weiland,et al.  Retinal prosthesis for the blind. , 2002, Survey of ophthalmology.

[10]  M J Ackerman,et al.  The Visible Human Project , 1998, Proc. IEEE.

[11]  国際非電離放射線防護委員会 ICNIRP statement on the "Guidelines for limiting exposure to time-varying electric, magnetic, and electromagnetic fields (up to 300 GHz)". , 2009, Health physics.

[12]  G. Lazzi,et al.  Thermal effects of bioimplants , 2005, IEEE Engineering in Medicine and Biology Magazine.

[13]  Joseph F. Rizzo,et al.  Ocular implants for the blind , 1996 .

[14]  M.A. Stuchly,et al.  Neural stimulation with magnetic fields: analysis of induced electric fields , 1992, IEEE Transactions on Biomedical Engineering.

[15]  A. Ahlbom Guidelines for limiting exposure to time-varying electric, magnetic, and electromagnetic fields (up to 300 GHz) , 1998 .

[16]  S. C. DeMarco,et al.  Computed SAR and Thermal Elevation in a 0 . 25-mm 2-D Model of the Human Eye and Head in Response to an Implanted Retinal Stimulator — Part I : Models and Methods , 2001 .