Secure Method for Software Upgrades for Implantable Medical Devices

• Published in: Tsinghua science and technology Vol. 15; no. 5; pp. 517 - 525
• Main Author: 曹洋 胡春华 马伯志 郝红伟 李路明 王伟明
• Format: Journal Article
• Language: English
• Published: Elsevier Ltd 01.10.2010
• Subjects: implantable medical device; Macaca mulatta; non-invasive; secure upgrade; software upgrade; 医疗器械; 安全升级; 无线数据传输; 植入式; 神经刺激器; 脉冲发生器; 软件升级; 软件故障; implantable medical device; non-invasive; secure upgrade; software upgrade
• ISSN: 1007-0214; 1878-7606; 1007-0214
• DOI: 10.1016/S1007-0214(10)70095-X

A non-invasive software upgrade method for permanent implantable medical devices was developed to alleviate patients＇ suffering due to malfunctions because of software faults,which may cause serious adverse health consequences or require enhancements with new software.The programs distributed to the internal implantable pulse generator（IPG） from the external programmer have been developed so that the upgrade service program in the IPG is simplified with most complex functions executed by the external programmer.A bidirectional protocol including frame definition and transmission mode was designed to insure secure upgrades.A neuro-stimulator was used to verify the upgrade solution with no additional elements,to maintain the hardware reliability.This study emphasizes how to insure a secure and stable upgrade process and reduce power consumption for special wireless and life safety-critical applications.Tests on rhesus monkeys to evaluate the feasibility of the approach for an IPG used for brain stimulation evaluation show that the software upgrade can be implemented stably with good tolerance to the wireless data transmissions.