In the past few decades,additive manufacturing(AM)has been developed and applied as a cost-effective and versatile technique for the fabrication of geometrically complex objects in the medical industry.In this review,...In the past few decades,additive manufacturing(AM)has been developed and applied as a cost-effective and versatile technique for the fabrication of geometrically complex objects in the medical industry.In this review,we discuss current advances of AM in medical applications for the generation of pharmaceuticals,medical implants,and medical devices.Oral and transdermal drugs can be fabricated by a variety of AM technologies.Different types of hard and soft clinical implants have also been realized by AM,with the goal of producing tissue-engineered constructs.In addition,medical devices used for diagnostics and treatment of various pathological conditions have been developed.The growing body of research on AM reveals its great potential in medical applications.The goal of this review is to highlight the usefulness and elucidate the current limitations of AM applications in the medical field.展开更多
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 co...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.展开更多
This paper presents a high-efficiency charge pump circuit composed of cascaded cross-coupled voltage doublers implemented in an isolated bipolar-CMOS-DMOS（BCD） technology for implantable medical devices.Taking advan...This paper presents a high-efficiency charge pump circuit composed of cascaded cross-coupled voltage doublers implemented in an isolated bipolar-CMOS-DMOS（BCD） technology for implantable medical devices.Taking advantage of the transistor structures in the isolated BCD process, the leakage currents caused by the parasitic PNP transistors in the cross-coupled PMOS serial switches are eliminated by simply connecting the inside substrate terminal to the isolation terminal of each PMOS transistor. The simple circuit structure leads to small parasitic capacitance in the voltage doubler, which in turn ensures high efficiency of the overall charge pump. The proposed charge pump with 5 cascaded voltage doublers is fabricated in a 0.35-μm isolated BCD process. Measurement results with 2-V power supply, 1-MHz driving clock frequency and 40-μA current load show that an efficiency of 72.6% is achieved, and the output voltage can be pumped to about 11.5 V at zero load current. The chip area of the charge pump is 1.6 × 0.35 mm^2.展开更多
This article analyses and summarizes issues of intellectual property involved in animal-derived regenerative,implantable medical devices(ADRIMD)in order to better understand global trends in patent applications and di...This article analyses and summarizes issues of intellectual property involved in animal-derived regenerative,implantable medical devices(ADRIMD)in order to better understand global trends in patent applications and disclosures,the legal status of patent families(i.e.sets of patents filed in various countries to protect a single invention),and International Patent Classification topics such as main assignee and core expertise.Analysis of research trends will enhance and inform the decision-making capacity of researchers,investors,government regulators and other stake-holders as they undertake to develop,deploy,invest in or regulate ADRIMD.展开更多
An adaptive closed-loop system for spinal cord injury(SCI) repair is designed. It integrates stimulation and recording on 16 pairs of electrodes. Two switches(SAS3 T16/SAS1 T16 X2) fabricated in high-voltage 0.8 μm p...An adaptive closed-loop system for spinal cord injury(SCI) repair is designed. It integrates stimulation and recording on 16 pairs of electrodes. Two switches(SAS3 T16/SAS1 T16 X2) fabricated in high-voltage 0.8 μm process with online re-configurable function are proposed. These two switches are combined with commercial off-the-shelf(COTS) electronics to implement the closed-loop implantable system in compact module. The system includes amplifier for recording neural signals, high-voltage stimulator, power transmission device, central processing module and flexible implantable electrodes. Two customized switches route any electrode to amplifier or stimulator, and nerve stimulation and signal recording are performed through lead wire-driven channels. The entire system is able to operate at up to 28 V, and is a biocompatible package with a volume of 42 mm×35 mm×8 mm. This system solves several problems encountered in implantable devices: low flexibility, negative influence of stimulus artifacts on neural detection and low integration of electrodes.展开更多
目的探讨无源植入性医疗器械(Non-Active Implantable Medical Devices,NAIMDs)临床使用安全的影响因素及相关风险防范措施。方法以“implantable medical devices”“use safety”为英文检索关键词,以“植入性医疗器械”“临床使用”...目的探讨无源植入性医疗器械(Non-Active Implantable Medical Devices,NAIMDs)临床使用安全的影响因素及相关风险防范措施。方法以“implantable medical devices”“use safety”为英文检索关键词,以“植入性医疗器械”“临床使用”“安全”为中文检索关键词,在PubMed、CNKI、万方等数据库进行文献检索、筛选及分析,整理归纳NAIMDs临床使用安全的影响因素。结果通过筛选得到51篇NAIMDs临床使用安全相关文献,确定了医护人员、患者、植入物、环境及管理是NAIMDs临床使用安全中的5个风险因素。结论NAIMDs临床使用安全的保障工作需要生产厂家、医疗机构、医护人员、患者及其家属等多方齐心协力,共同为患者健康保驾护航。展开更多
基金This work is sponsored by the National Key R&D Program of China(2018YFB1105504)the National Natural Science Foundation of China(81572093)This work is also supported by the funding support from Beijing Laboratory of Biomedical Materials and start-up fund from Beijing University of Chemical Technology。
文摘In the past few decades,additive manufacturing(AM)has been developed and applied as a cost-effective and versatile technique for the fabrication of geometrically complex objects in the medical industry.In this review,we discuss current advances of AM in medical applications for the generation of pharmaceuticals,medical implants,and medical devices.Oral and transdermal drugs can be fabricated by a variety of AM technologies.Different types of hard and soft clinical implants have also been realized by AM,with the goal of producing tissue-engineered constructs.In addition,medical devices used for diagnostics and treatment of various pathological conditions have been developed.The growing body of research on AM reveals its great potential in medical applications.The goal of this review is to highlight the usefulness and elucidate the current limitations of AM applications in the medical field.
基金Supported in part by the National Key Technology Research andDevelopment Program (No 2009BAI79B03)in part by the National Natural Science Foundation of China (No 60906050/F040604)the Opening Foundation of the State Key Laboratory of Space Medicine Fundamentals and Application (Chinese Astronaut Research and Training Center) (No SMFA09K08)
文摘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.
基金Project supported by the National Natural Science Foundation of China(No.61474092)
文摘This paper presents a high-efficiency charge pump circuit composed of cascaded cross-coupled voltage doublers implemented in an isolated bipolar-CMOS-DMOS（BCD） technology for implantable medical devices.Taking advantage of the transistor structures in the isolated BCD process, the leakage currents caused by the parasitic PNP transistors in the cross-coupled PMOS serial switches are eliminated by simply connecting the inside substrate terminal to the isolation terminal of each PMOS transistor. The simple circuit structure leads to small parasitic capacitance in the voltage doubler, which in turn ensures high efficiency of the overall charge pump. The proposed charge pump with 5 cascaded voltage doublers is fabricated in a 0.35-μm isolated BCD process. Measurement results with 2-V power supply, 1-MHz driving clock frequency and 40-μA current load show that an efficiency of 72.6% is achieved, and the output voltage can be pumped to about 11.5 V at zero load current. The chip area of the charge pump is 1.6 × 0.35 mm^2.
基金supported by the National Engineering Laboratory for Regenerative Medical Implantable Devices(Grant No.2012NEL2MD005).
文摘This article analyses and summarizes issues of intellectual property involved in animal-derived regenerative,implantable medical devices(ADRIMD)in order to better understand global trends in patent applications and disclosures,the legal status of patent families(i.e.sets of patents filed in various countries to protect a single invention),and International Patent Classification topics such as main assignee and core expertise.Analysis of research trends will enhance and inform the decision-making capacity of researchers,investors,government regulators and other stake-holders as they undertake to develop,deploy,invest in or regulate ADRIMD.
基金Supported by the National Natural Science Foundation of China(No.61474107)the National Key Technologies R&D Program(No.2016YFC0105604)。
文摘An adaptive closed-loop system for spinal cord injury(SCI) repair is designed. It integrates stimulation and recording on 16 pairs of electrodes. Two switches(SAS3 T16/SAS1 T16 X2) fabricated in high-voltage 0.8 μm process with online re-configurable function are proposed. These two switches are combined with commercial off-the-shelf(COTS) electronics to implement the closed-loop implantable system in compact module. The system includes amplifier for recording neural signals, high-voltage stimulator, power transmission device, central processing module and flexible implantable electrodes. Two customized switches route any electrode to amplifier or stimulator, and nerve stimulation and signal recording are performed through lead wire-driven channels. The entire system is able to operate at up to 28 V, and is a biocompatible package with a volume of 42 mm×35 mm×8 mm. This system solves several problems encountered in implantable devices: low flexibility, negative influence of stimulus artifacts on neural detection and low integration of electrodes.
文摘目的探讨无源植入性医疗器械(Non-Active Implantable Medical Devices,NAIMDs)临床使用安全的影响因素及相关风险防范措施。方法以“implantable medical devices”“use safety”为英文检索关键词,以“植入性医疗器械”“临床使用”“安全”为中文检索关键词,在PubMed、CNKI、万方等数据库进行文献检索、筛选及分析,整理归纳NAIMDs临床使用安全的影响因素。结果通过筛选得到51篇NAIMDs临床使用安全相关文献,确定了医护人员、患者、植入物、环境及管理是NAIMDs临床使用安全中的5个风险因素。结论NAIMDs临床使用安全的保障工作需要生产厂家、医疗机构、医护人员、患者及其家属等多方齐心协力,共同为患者健康保驾护航。
