• 제목/요약/키워드: clinical device

검색결과 905건 처리시간 0.032초

TRL을 이용한 R&D 프로젝트 성과 평가지표 개발: 의료기기 사업을 중심으로 (Development of Performance Measure Indices using TRL: Focused on the National Medical Device R&D Projects)

  • 이만표;정미진;최경현
    • 대한의용생체공학회:의공학회지
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    • 제38권3호
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    • pp.89-94
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    • 2017
  • In order to improve national competitiveness through technological research and development, the government puts in R&D budget every year and manages to improve the R&D results. Accordingly, various R&D project management methods have applied for successful advancement of technology and product. TRL is a measurement system developed by NASA to assess the maturity of technology since the 1970s. To apply medical device, the characteristics such as regulation, clinical trials are considered as a significant influence. In this study, we would like to derive PMI(performance measures index) for medical device R&D projects by using TRL and stage-gate model. As a result of this study, it is possible to use the PMI for decision making and evaluation in the R&D projects and believed that the objectivity can be ensured by the approval or certification of regulatory authority.

하지 (下脂) 조직내의 말초 혈관계 질환 진단을 위한 산소 측정장치의 개발에 관한 연구 (A study on the development of oxygen measurement device for diagnosis of peripheral vascular disease in lower extremity)

  • 임현수;이준규;박동철
    • 한국의학물리학회지:의학물리
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    • 제10권1호
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    • pp.9-15
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    • 1999
  • 혈액에서의 산소 포화도는 Hb와 HbO$_2$의 광학 스펙트라에서 흡수계수의 차이에 의해서 측정할 수 있다. 본 연구는 하지 조직에서 발생하는 말초혈관계 질환진단을 위하여 파장이 660nm 와 940nm의 LED를 이용하여 산소포화도를 측정하는 장치를 개발하였다. 산소측정장치는 광 탐촉자와 광 신호처리부, LED 구동회로, 컴퓨터와 인터페이스로 구성하고, 데이터의 수집과 분석을 위한 프로그램 을 개발하였다. 구현된 산소측정장치에 대한 임상적인 평가를 위하여 하지조직에서 운동 부하에 따른 실험을 하여 생체조직내 생리적변화에 따른 산소량의 변화를 측정하고, 기기의 성능을 평가하였다. 실험결과 생체조직내의 산소포화도는 광원과 검출기의 간격에 따라 측정이 가능함을 보여 주었다.

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이동형 X-ray 발생장치를 이용한 복부 촬영 시 공간 선량률에 관한 연구 (Analysis of Space Radiation Dose Rate using portable X-ray Generating Device for Abdomen)

  • 박창희
    • 대한디지털의료영상학회논문지
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    • 제12권2호
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    • pp.97-101
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    • 2010
  • This experimental study is carried out one of the General Hospital in Kyungbok providence. Abdomen Phantom being located Anterior-posterior(AP) position on portable bed, and the portable X-ray generating device was placed the phantom at $-90^{\circ}$ direction. The experiment were set 65 kVp, 10 mAs, $10{\times}10\;cm^2$, 100 cm(FOD) for the measurement. Digital proportional counting tube survey meter was used for measuring the space scatter dose. Measurement points of horizontal distribution was set up at $30^{\circ}$ interval by increasing 50 cm radius of upside, downside, left and right. Vertical distribution of measurement points were set up for the vertical plane with a radius of at $30^{\circ}$ intervals with 50cm increments. It is concluded that longer distance from the soure of X-ray significantly decrease radiation dose to the patient and use of the radiation protection device should be applied in clinical practice to reduce dose to the patient.

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치주탐침과 초음파기구를 이용한 구개 점막 두께 측정치의 비교연구 (A Comparative study on the palatal mucosa thickness measurements using periodontal probe and pltrasonic device)

  • 김태우;이재관;엄흥식;장범석
    • Journal of Periodontal and Implant Science
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    • 제36권4호
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    • pp.901-911
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    • 2006
  • Maxillary palatal mucosa is the most frequently used donor site of the soft tissue for periodontal plastic surgery. In our study, thickness of the palatal mucosa between the mesial side of the maxillary first premolars and the distal side of the maxillary first molars was measured with a periodontal probe and an ultrasonic device in 30 young Korean adults. Using the data, the possibility of the clinical application of ultrasonic devices was evaluated. The results of this study were as follow; 1. The thickness of the palatal mucosa of the maxillary premolars is the thickest and that of the mid-palatal portion of the maxillary first molar is the thinnest. 2. The thickness of the palatal mucosal tissue increases from the gingival margin to the mid-palatal suture. 3. The measurements of the periodontal probe and the ultrasonic device revealed the strong positive correlations.

Development of Respiratory Motion Reduction Device System (RMRDs) for Radiotherapy in Moving Tumor: Construction of RMRDs and Patient Setup Verification Program

  • Lee, Suk;Chu, Sung-Sil;Lee, Sei-Byung;Jino Bak;Cho, Kwang-Hwan;Kwon, Soo-Il;Jinsil Seong;Lee, Chang-Geol;Suh, Chang-Ok
    • 한국의학물리학회:학술대회논문집
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    • 한국의학물리학회 2002년도 Proceedings
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    • pp.86-89
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    • 2002
  • The purpose is to develop a system to reduce the organ movement from the respiration during the 3DCRT or IMRT. This research reports the experience of utilizing personally developed system for mobile tumors. The patients clinical database was structured for 10 mobile tumors and patient setup error measurement and immobilization device effects were investigated. The RMRD system is composed of the respiratory motion reduction device utilized in prone position and abdominal strip device(ASD) utilized in the supine position, and the analysis program, which enables the analysis on patients setup reproducibility. Dose to normal tissue between patients with RMRDs and without RMRDs was analyzed by comparing the normal tissue volume, field margins and dose volume histogram(DVH) using fluoroscopy and CT images. And, reproducibility of patients setup verify by utilization of digital images. When patients breathed freely, average movement of diaphragm was 1.2 cm in prone position in contrast to 1.6 cm in supine position. In prone position, difference in diaphragm movement with and without RMRDs was 0.5 cm and 1.2 cm, respectively, showing that PTV margins could be reduced to as much as 0.7 cm. With RMRDs, volume of the irradiated normal tissue (lung, liver) reduced up to 20 % in DVH analysis. Also by obtaining the digital image, reproducibility of patients setup verify by visualization using the real-time image acquisition, leading to practical utilization of our software. Internal organ motion due to breathing can be reduced using RMRDs, which is simple and easy to use in clinical setting. It can reduce the organ motion-related PTV margin, thereby decrease volume of the irradiated normal tissue.

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피부 열전도 온도에 근거를 둔 거짓 뜸 개발 및 평가 연구 (Credibility of a Newly Developed Sham Moxibustion)

  • 장민기;윤은혜;정찬영;변혁;김은정;김경호;김갑성;이승덕
    • Journal of Acupuncture Research
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    • 제27권1호
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    • pp.117-127
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    • 2010
  • Background : To demonstrate the efficacy of moxibustion therapy, randomized controled trials are required. But, clinical trials of moxibustion had limitations due to the absence of a sham moxibustion model for an appropriate placebo. Objectives : To develop a new sham moxibustion model based on the thermal characteristics of commercial indirect moxibustion, especially temperature, and to evaluate whether it could be applied in clinical trials. Methods : By applying heat insulation, we created a sham moxibustion device that was indistinguishable from a real one with the naked eye. It also stimulated heat but had inert remedial value. A clinical trial was performed on subjects to test double blinding. The subjects were randomly assigned into two groups, a treatment group and a sham group. Acupoint Zusanli($ST_{36}$) was used in each group for 3 times. A sham acupuncture credibility questionnaire was modified into a moxibustion credibility questionnaire and was filled out after treatment. Results : No major difference was detected in the subjects' baseline data. Most subjects and practitioners could not distinguish the sham moxibustion device from the real one. But, subjects who had experience of moxibustion therapy more likely to distinguish the sham moxibustion device from the real one than subjects who didn't have experience of moxibustion therapy. The treatment group showed a significant difference in the VAS(Visual Analog Scale) for intensity of sensation during treatment than that of the sham group. Conclusions : The sham moxibustion device in this study is proved sufficient and credible to be applied in investigations of the effect of moxibustion. But it is more appropriate for the people who don't have experience of moxibustion therapy.

Biomechanical Comparison of Spinal Fusion Methods Using Interspinous Process Compressor and Pedicle Screw Fixation System Based on Finite Element Method

  • Choi, Jisoo;Kim, Sohee;Shin, Dong-Ah
    • Journal of Korean Neurosurgical Society
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    • 제59권2호
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    • pp.91-97
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    • 2016
  • Objective : To investigate the biomechanical effects of a newly proposed Interspinous Process Compressor (IPC) and compare with pedicle screw fixation at surgical and adjacent levels of lumbar spine. Methods : A three dimensional finite element model of intact lumbar spine was constructed and two spinal fusion models using pedicle screw fixation system and a new type of interspinous devices, IPC, were developed. The biomechanical effects such as range of motion (ROM) and facet contact force were analyzed at surgical level (L3/4) and adjacent levels (L2/3, L4/5). In addition, the stress in adjacent intervertebral discs (D2, D4) was investigated. Results : The entire results show biomechanical parameters such as ROM, facet contact force, and stress in adjacent intervertebral discs were similar between PLIF and IPC models in all motions based on the assumption that the implants were perfectly fused with the spine. Conclusion : The newly proposed fusion device, IPC, had similar fusion effect at surgical level, and biomechanical effects at adjacent levels were also similar with those of pedicle screw fixation system. However, for clinical applications, real fusion effect between spinous process and hooks, duration of fusion, and influence on spinous process need to be investigated through clinical study.

환자감시장치를 위한 HL7 V2.5 미들웨어의 개발 (Development of HL7 V 2.5 Middleware for Patient Monitoring Device)

  • 김형회;조훈;트란퉁;홍해숙;김화선
    • 전기학회논문지
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    • 제56권9호
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    • pp.1680-1687
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    • 2007
  • A hospital room has multiple patient monitoring devices at the bedside to monitor his or her status. However, vital sign monitors, ventilator and other bedside devices are made by a variety of different manufacturers and often cannot easily interface to the hospital information system. Medical environments incorporate complex and integrated data networks to transfer vast amounts of patient information, such as images, waveforms, and other forms of digital data. Hence, to assure interoperability of images, waveforms and patient data, Health Level Seven (HL7) was developed as an international standard to facilitate the communicating and storing of medical data. In this study, we developed middleware capable of receiving data from mCare 300 vital signs monitoring devices and converting the data to HL7 data format. The HL 7 middleware streamline clinical workflow and support patients. Therefore, clinical expertise are empowered to respond to dynamic healthcare situation as soon as they emerged, and consequently quality of care while helping to reduce the length of a patient's stay in a hospital.

Anti-effects of Photodynamic Therapy in Peroxiredoxin IV-induced AMC-HN3 Cell Lines

  • 안진철
    • 대한의생명과학회지
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    • 제14권4호
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    • pp.263-267
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    • 2008
  • Photodynamic therapy (PDT) is a treatment utilizing the generation of singlet oxygen and other reactive oxygen species (ROS), which selectively accumulate in target cells. Peroxiredoxin (prx) plays an important role in eliminating peroxides generated during metabolism. Prx exert protective antioxidant role in cells though peroxidase activity. The aim of present work is to investigate the cytotoxicity of photofrin-mediated PDT in prx IV-transfectant AMC-HN3 cell lines. We confirmed that PDT has an effect on ROS generation in prx IV-induced cell lines. Treatment of PDT in prx IV-HN3 cell lines inhibits cytotoxic effects. Prx IV-induced HN3 cell lines resists in cell death during PDT. Also, prx IV-HN3 cell lines treated PDT inhibited ROS generation in contrast with vector control. We indicated that prx IV-induced AMC-HN3 cell lines have a function as inhibitors during PDT.

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한국형 인공심장(AnyHeart)의 임상경험 (A Clinical Experience of Korean Artificial Heart(AnyHeart))

  • 선경;손호성;정재승;정봉규;이성호;신재승;김광택;이혜원;민병구;김형묵
    • Journal of Chest Surgery
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    • 제35권7호
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    • pp.548-552
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    • 2002
  • 한국형 인공심장(AnyHeart)은 single moving actuator mechanism을 이용한 일체형 및 이식형 양심실 박동펌프이다. 저자 등은 양심 부전증에 의한 말기 심장병 환자에서 구난의료 차원으로 시도된 한국형 인공심장 (AnyHeart) 이식 1례를 경험하였기에 그 결과를 보고한다.