• 전자통신동향분석
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• 제32권6호
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• pp.27-39
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• 2017

A variety of medical devices are utilized to repair or help injured body functions after accidental injury(such as a traffic accident), population aging, or disease. Such medical devices are being actively researched and developed in portable form, skin patchable type, and further, implantable form. In the future, active implantable medical devices for neuro and brain sciences are expected to be developed. Active implantable medical devices that detect brain signals and control neurology for a wider understanding of human cognition and nerve functions, and for an understanding and treatment of various diseases, are being actively pursued for future use. In this paper, the core elements of implantable devices that can be applied to neuro and brain sciences are classified into electrode technologies for bio-signal acquisition and stimulation, analog/digital circuit technologies for signal processing, human body communication technologies, wireless power transmission technologies for continuous device use, and device integration technologies to integrate them. In each chapter, the latest technology development trends for each detailed technology field are reviewed.

• 대한의용생체공학회:의공학회지
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• 제26권5호
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• pp.309-317
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• 2005

It is expected that fully-implantable middle-ear hearing devices (FIMEHDs) will soon be available with the advantages of complete concealment, easy surgical implantation, and low power operation to resolve the problems of semi-implantable middle-ear hearing devices (SIMEHDs) such as discomfort of wearing an external device and replacement of battery. Over the last 3 years, a Korean research team at Kyungpook National University has developed an FIMEHD called ACRHS-1 based on a differential floating mass transducer (DFMT). The main research focus was functional improvement, the establishment of easy surgical procedures for implantation, miniaturization, and a low-power operation. Accordingly, this paper reviews the overall system architecture, functions, and experimental results for ACRHS-1 and its related accessories, including a wireless battery charger and remote controller.

• 전기학회논문지P
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• 제64권3호
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• pp.175-181
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• 2015

In this paper, the neuromuscular electrical stimulation medical devices for non-implantable incontinence treatment other than vaginal insertion type was developed and commercialized. The structure of medical devices for electrical stimulation based on the anatomy of the pelvic floor muscle designed. Then, the optimum parameters that may be effective in pelvic floor muscle electrical stimulation was set. The circuit system based on the optimum parameters were designed and manufactured. The frequency of the pulse voltage for electrical stimulation is 75[Hz], the pulse width is 300[${\mu}s$], the development of medical devices was to have seven program functions to the various treatments. The circuit system of medical devices was composed of microcontroller, comparator and converter. The performance of the developed circuit system in KTC(Korea Testing Certification) were carried out medical equipment inspection test. Test results, test specifications were satisfied with the medical device, the performance was verified to be commercialized as a medical device. The development of medical devices were validated risk assessment and product performance through a software validation. Commercialization of medical equipment was acquired to enable the certification standards of the international standard IEC 60601-1.

• International Journal of Precision Engineering and Manufacturing
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• 제7권4호
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• pp.40-46
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• 2006

The market of programmable implantable pumps has bound to a monopolistic situation, inducing high device costs, thus making them inaccessible to most patients. Micro-mechanical and medical innovations allow improved performances by reducing the dimensions. This affects the consumption and weight, and, by reducing the number of parts, the cost is also affected. This paper presents the procedure followed to design an innovative implantable drug delivery system. This drug delivery system consists of a low flow pump which shall be implanted in the human body to relieve pain. In comparison to classical known solutions, this pump presents many advantages of high interest in both medical and mechanical terms. The first section of the article describes the specifications which would characterize a perfect delivery system from every points of view. This concerns shape, medication, flow, autonomy, biocompatibility, security and sterilization ability. Afterwards, an overview of existing systems is proposed in a decisional tree. Positive displacement motorized pumps are classified into three main groups: the continuous movement group, the fractioned translation group and the alternative movement group. These systems are described and the different problems which are specific to these mechanisms are presented. Since none of them fully satisfy the specifications, an innovation is justified.. The decisional tree is therefore extended by adding new principles: fractioned refilling and fractioned injection within the fractioned translation movement group, spider guiding system within the alternative translation movement group, rotational bearing guided device and notch hinge guided device in the alternative rotation movement group.

• 대한의용생체공학회:의공학회지
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• 제36권1호
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• pp.31-36
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• 2015

In this study, we evaluated the effects of static magnetic fields of earphones and headphones on pacemakers and implantable cardioverter defibrillators(ICDs). Five pacemakers and three ICDs were subjected to in-vitro test with three headphones which were an in-ear earphone, clip-on headphone, and closed-back headphone. Each implantable device was placed in close proximity(within 3 mm) to the ear-pad of each of the earphone and headphones for 3 min. As a result, no effects were observed on the pacemakers for the earphone and headphones during the test, but an effect was observed on one ICD for the clip-on and closed-back headphone during the test. When the ICD was placed in close proximity to the headphones, the ICD temporarily suspended functions of tachyarrhythmia detection and therapy. The effect was not observed in this study when the headphones were at least 2 cm from the ICD. Based on these findings, patients with ICDs should be advised to keep earphones and headphones at least 2 cm apart from their ICDs.

• 대한의용생체공학회:의공학회지
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• 제44권6호
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• pp.414-427
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• 2023

Implantable bioabsorbable combination products undergo inherent degradation and systemic absorption within the physiological environment, thereby streamlining the therapeutic regimen and obviating the imperative for invasive extraction procedures. This inherent property not only enhances patient convenience and therapeutic efficacy but also underpins a paradigm of support characterized by heightened safety parameters. Within the regulatory landscapes of Korea, the United States, and Europe, implantable bioabsorbable combination products are meticulously classified into distinct categories, either as pharmaceutical implants or as implantable medical devices, depending on their primary mode of action. This scholarly investigation systematically examines the regulatory frameworks governing implantable bioabsorbable combination products in South Korea, the United States, and Europe. Notable discrepancies across national jurisdictions emerge concerning regulatory specifics, including terminology, product classification, and product name associated with these products. The conspicuous absence of standardized approval regulations presents a formidable barrier to the commercialization of these advanced medical devices. This academic discourse passionately emphasizes the critical need for formulating and implementing a sophisticated regulatory framework capable of streamlining the product approval process, thereby paving the way for a seamless path to commercializing implantable bioabsorbable combination products.

• 대한의용생체공학회:의공학회지
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• 제17권4호
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• pp.535-544
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• 1996

In this paper, we analyzed the coil-magnet type vibrating transducer for the implantable middle ear hearing aid which is appropriate for patient's hearing level, and an experimental transducer system is designed For the objective and quantitative analysis of the transducer, a theoretical equivalent model containing coil, magneto and inner ear is developed To perform effective evaluation of the transducer, a transforming ratio Tr is introduced and its range that is suitable for practical implantable middle ear hearing device is foun4 The result of applying physical parameters of ear system to the proposed analytical model shows that frequency response of the coil magrlet type vibrator is predominantly governed by resistive impedance of the coil rather than inertia effect of the magnet and the inner parameters. In addition, we realized an experimental middle ear hearing aid system to show the theoretical validity of designed system and this will provide the basis of the development for actually implantable system.

• 디지털융복합연구
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• 제12권5호
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• pp.249-254
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• 2014

최근 USN 기술의 발전으로 의료기술 분야에서 서비스를 받을 수 있는 체내 삽입장치 통신기술이 많은 발전을 하고 있다. 체내 삽입장치(Implantable Medical Device)는 환자와 장비사이에 무선으로 전송되는 구간이 있어서 외부 공격자의 해킹으로 인한 환자의 개인 의료정보 유출사고로 프라이버시 침해 발생이 우려되고 있다. 또한 환자의 의료 정보를 조작할 경우 심각한 의료 문제가 발생할 수 있다. 본 논문에서는 체내 삽입장치에 RFID/USN 기술을 이용할 때 공격자의 공격에 안전한 인증프로토콜을 제안한다. 해시함수 기반으로 연산하며 세션키와 난수를 도입하여 재 암호화를 방지하고 스푸핑공격, 정보노출 및 도청공격에 안전하며 이를 증명하기 위해 정형검증 도구인 Casper/FDR 도구를 이용하여 보안성을 검증 실험하였으며 안전함이 확인되었다.

• 대한의용생체공학회:의공학회지
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• 제19권5호
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• pp.487-495
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• 1998

본 논문에서는 회로가 간단하고 체내에 삽입되는 부분이 영구자석만.:-로 이루어져있는 새로운 방식의 이식형 인공중이를 제안하였다. 트랜스듀서의 갭 조정이 필요없어 수술이 간편해지며, 코일을 외부로 보이지 않게 옷 내부에 둘 수 있어서 미용적인 측면에서도 우수하다. 제안된 이식형 인공중이의 성능을 측정하고 난청자의 청각 역치에 맞는 시스템을 설계하기 위하여 트랜스듀서를 통해 내이로 전달되는 힘을 정량적으로 해 석하였으며, 진동특성 실험을 통해서 이 해석의 타당성을 증명하였다. 또한 사람의 측두골을 이용하여 직접 침골(incus)의 진동변위를 측정하였다. 이 실험으로 제안된 시스템이 실제로 사람의 몸에 설치되었을 때 이소골(ossicles)을 충분히 진동시킬 수 있음을 증명하였다.

• 한국정보통신학회논문지
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• 제17권1호
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• pp.49-56
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• 2013

최근 IT 기술과 의료기술이 접목된 유헬스케어 서비스 중 불치병을 갖고 있는 환자에게 의료서비스를 제공하는 체내삽입장치 기술이 각광을 받고 있다. 그러나 체내삽입장치 기술은 환자의 생체정보를 무선구간에서 제3자에게 쉽게 유출되어 악용될 수 있는 보안문제가 나타나고 있다. 본 논문에서는 환자와 병원관계자간 동기화를 통해 환자와 병원관계자가 서로 생성한 랜덤값과 인증서버가 생성한 랜덤값을 이용하여 환자와 병원관계자를 인증하는 인증프로토콜을 제안한다. 특히, 제안 프로토콜은 환자와 병원관계자가 사전에 인증서버에 등록된 정보를 이용하여 생성한 보안 정보를 세션키 생성과정에 이용함으로써 인증서버에게 허락 받지 못한 제3자의 접근을 차단함으로써 안정성을 높이고 있다.