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ASTM F2027 조직공학적 의료용제품(TEMPs)을 위한 기질의 특성결정 및 테스트를 위한 표준 지침서
백미옥 ( Mi Ock Baek ),소정원 ( Jung Won So ),김순희 ( Soon Hee Kim ),노혜원 ( Hye Won Roh ),이나리 ( Na Ri Lee ),김문석 ( Moon Suk Kim ),유규하 ( Gyu Ha Ryu2 ),조양하 ( Yang Ha Cho ),이승진 ( Seung Jin Lee ),강길선 ( Gilson Khang 한국조직공학·재생의학회 2007 조직공학과 재생의학 Vol.4 No.4
Tissue engineering medical products are those protocols and products developed for use in the human body as biological substitutes to restore, maintain, or improve tissue function. The purpose of this standard is to locate relevant existing guideline and test methods and to provide guidance for interim use of materials for which a standard does not exist. The standard may be use as guideline in tissue engineered research.
ASTM F813-07 의료용디바이스를 위한 생체재료의 직접촉 세포배양측정에 대한 표준지침서
김순희 ( Soon Hee Kim ),백미옥 ( Mi Ock Baek ),소정원 ( Jung Won So ),노혜원 ( Hye Won Roh ),이나리 ( Na Ri Lee ),김문석 ( Moon Suk Kim ),유규하 ( Gyu Ha Ryu2,),조양하 ( Yang Ha Cho ),이승진 ( Seung Jin Lee ),강길선 ( Gilson Khang 한국조직공학·재생의학회 2007 조직공학과 재생의학 Vol.4 No.4
We provided standard practice for direct contact cell culture evaluation of materials for medical devices in this report. This practice introduced a reference method of direct contact cell culture testing. This method of direct contact cell culture may be used in the construction of medical materials and devices for test the cytotoxic potential of materials. Researcher for medical devices could use this practice to compare other cytotoxicity tests or directly to evaluate materials. Cell or materials could be sometimes modified depending on use in offered extend of this practice.
최진욱,유규하,민병구,Choi, Jin-Wook,Ryu, Gyu-Ha,Min, Byoung-Goo 대한의용생체공학회 1990 의공학회지 Vol.11 No.1
To improve antithrombogenicity of polymer that used in vascular graft and artificial organs, seeding of human endothelial cells on the polyurethane was studied. Human endothelial cells were ismlated from human umbilical veins, using type I collagenase, and identified with goat anti vWF antibodies. Human endothilial cell seeding was tried upon the polyurethane which has good mechanical property and resists stresses. The hydrophobic polyurethane surface was changed hydrophilic by corona discharf:e treatment. Surface hydrophilicity was measured with Wilhemly plate method and the goniometer. To evaluate matrix protein adsorption, fibronectin adsorption test was done. To eveluate cell adhesion, human endothelial cell attachment forces were measured rising a perfusion chamber of , ism diamter. Less cells were detached from the hydrophilically treated polyurethane. This showed that corona discharge on the polyurethane could improve matrix adsorption and endothelial cell attachment.
박기정,유규하,이성희,이창형,정진백,이재근,허찬회,김형범,최민용,김용우,황상연,정재훈,구자중,홍혜경,임경택,강세구,곽지영,Park, Ki-Jung,Ryu, Gyu-Ha,Lee, Sung-Hee,Lee, Chang-Hyung,Jung, Jin-Baek,Lee, Jae-Keun,Hur, Chan-Hoi,Kim, Hyung-Bum,Choi, Min-Yong,Ki 대한의용생체공학회 2010 의공학회지 Vol.31 No.6
For approval of medical devices manufactured or imported, submission of technical documents as well as the application form is required. The manufacturer (or importer) should properly identify the raw materials the applied product is made of and the manufacturing processes the product undergoes before it is shipped in the application form. In the technical documents, scientific data to evaluate the efficacy, safety, and quality of the applied product that has been described in the application form should be provided. Therefore, identifying the raw materials that were used for the parts of the applied product and describing the physical and chemical characteristics of the raw materials are quite important and essential in ensuring the efficacy, safety, and quality of the applied product. To describe the physical and chemical characteristics of the raw materials correctively, the applicant is required to have broad knowledge in the scientific fields such as chemical, polymer, metal, and ceramic science and engineering. But most of the applicant are not experts in these fields, so that the description in the application form often includes wrong and improper descriptions. Thus, we developed a guideline which explains the raw materials for medical devices, show the their examples. The purpose of this description guideline is to help the applicant properly completing the "Raw materials or constituents and their volumes" part in the application form.
사용자 중심의 다차원적 융복합헬스케어산업 발전을 위한 새로운 정책(Autopoiesis)의 이론적 근거와 방향
이형배,이태곤,유규하,이규성,Lee, Hyung Bae,Lee, Tae Gon,Ryu, Gyu Ha,Lee, Kyu-Sung 대한의용생체공학회 2017 의공학회지 Vol.38 No.4
The convergence healthcare industry in Korea has been stalled due to conflicts between stakeholders as well as a supplier-centered industry structure. This situation is caused by the structural contradiction in which the Korean industry has a prolonged conflict structure among stakeholders due to a strong regulation and an institutional inertia from the viewpoint of the sociotechnical system. Therefore, it is necessary to identify new system management plan that enhances social acceptability such as laws, customs and ideas while reducing conflicts between stakeholders. In this study, mainly adapting the stakeholder-oriented autopoiesis and focusing on publicness of healthcare, we propose the rationale and direction for policy making to harmonize various systems within the convergence healthcare industry.
양해술,편웅범,이정림,유규하,Yang, Hae-Sool,Pyon, Ung-Bum,Lee, Jeong-Rim,Ryu, Gyu-Ha 한국정보처리학회 2003 정보처리학회논문지D Vol.10 No.5
오늘날 소프트웨어가 중심이 죄는 의료기기의 폭발적 증가로 인해 의료용 소프트웨어는 의료 서비스의 경쟁력 확보를 위한 중요한 수단이 되고 있으며 의료 서비스의 품질이 의료기기뿐만 아니라 의료용 소프트웨어의 품질에 지대한 영향을 받게 되었다. 그러나 의료용 소프트웨어의 품질에 관한 국내의 관련 연구ㆍ개발이 아직 미흡한 실정이며 의료용 소프트웨어의 품질저하로 인한 의료 서비스의 질적 저하를 유발할 수 있는 문제점이 발생할 수 있다. 따라서, 의료기기의 발전과 아울러 의료용 소프트웨어의 품질 향상을 통해 의료 서비스의 질적 수준을 제고할 필요가 있다. 따라서, 본 논문에서는 ISO/IEC 12119를 기반으로 의료용 소프트웨어를 시험하여 결과론 산출할 수 있는 시험모듈과 품질검사표를 개발하여 의료용 소프트웨어 시험에 적용할 수 있도록 하였다. We medical software is becoming important means to secure competitive power of medical service by explosive increase of medical device based on software, and the quality of medical service is affected to quality of medical software as well as medical devices. But domestic related study and development is not sufficient for quality of medical software, and a falling-off in medical software quality can induce a falling-off in quality of medical service. Therefore, it is necessary to raise qualitative level of medical service by progress and quality improvement of medical devices. Therefore, in this paper, we developed test module and qualify inspection table which can test medical software and produce result based on ISO/1EC 12119.
F2211-04 생체조직공학적 의료제품(TEMPs)에 대한 표준 분류
소정원 ( Jung Won So ),김순희 ( Soon Hee Kim ),백미옥 ( Mi Ock Baek ),노혜원 ( Hye Won Roh ),이나리 ( Na Ri Lee ),유규하 ( Gyu Ha Ryu ),조양하 ( Yang Ha Cho ),이승진 ( Seung Jin Lee ),강길선 ( Gil Son Khang ) 한국조직공학과 재생의학회 2008 조직공학과 재생의학 Vol.5 No.1
Tissue engineered medical products (TEMPs) are those protocols and products developed for use in the human body as biological substitutes to restore, maintain, or improve tissue function. So TEMPs may achieve a therapeutic potential from cells, biomolecules, scaffolds, and other materials, and processed tissue and derivatives used in various combinations or alone. Since interactions may occur among the components used in TEMPs, new standard descriptions, test methods, and practices are needed to aid the evaluation of these interactions. Therefore this technical report the aspects of tissue engineered medical that will be developed as standards.
천연재료가 함유된 조직공학용 지지체에 대한 세포독성 분석법의 비교
백미옥 ( Mi Ock Baek ),김순희 ( Soon Hee Kim ),소정원 ( Jung Won So ),노혜원 ( Hye Won Roh ),이나리 ( Na Ri Lee ),김문석 ( Moon Suk Kim ),유규하 ( Gyu Ha Ryu ),조양하 ( Yang Ha Cho ),이승진 ( Seung Jin Lee ),강길선 ( Gilson Khang 한국조직공학·재생의학회 2007 조직공학과 재생의학 Vol.4 No.4
Cytotoxicity measurements on materials are extremely important in tissue engineering field. The objective of this study is to measure and compare the cytotoxicity of scaffold for tissue engineered using 3-(4,5-dimethylthiazol- 2-yl)-2,5-diphenyl-tetrazolium bromide(MTT), 2-(methoxy-4-nitrophenyl)-3-(4-nitrophenyl)-5-(2-4- disulfophenyl)-H-tetrazolium(WST-8) and Alamar Blue cytotoxicity assay on cytotoxixity of scaffold for tissue engineering. In order to evaluate the sensitivity of rat bone marrow stromal cell(rBMSC) for cytotoxicity assays, a series of two-fold dilution of rBMSC were plated in 96-wells. rBMSC suspension was seeded on poly(lactide-coglycolide) (PLGA) scaffold and then cytotoxicity was measured in vitro by MTT, WST-8 and alamar blue assay. The MTT assay was more sensitive than WST-8, alamarblue assay for rBMSC. rBMSC suspension seeded on various content of demineralized bon particle(DBP) impregnated PLGA scaffold was measured to confirm on affect to natural material by MTT assay. In the MTT assay results, optical density was influenced by content of DBP. Finally, cytotoxicity of DBP/PLGA scaffold was assayed using modified method of ASTM F813-07. We confirmed that cell viability was significantly high in PLGA scaffold including DBP of 20 and 40% compared to other scaffolds. This report may be useful as guideline in tissue engineered scaffolds.
PLGA미립구의 크기에 따른 인간디스크세포의 증식 및 표현형 분석
소정원 ( Jeong Won So ),김순희 ( Soon Hee Kim ),백미옥 ( Mi Ock Baek ),임지예 ( Ji Ye Lim ),노혜원 ( Hye Won Roh ),이나리 ( Na Ri Lee ),김문석 ( Moon Suk Kim ),유규하 ( Gyu Ha Ryu ),조양하 ( Yang Ha Cho ),이승진 ( Seung Jin Lee ) 한국조직공학·재생의학회 2007 조직공학과 재생의학 Vol.4 No.4
The PLGA microspheres can create an environment conductive to promising candidate as an injectable system for tissue engineered intervertebral disc(IVD). The final goal of this study was to investigate the condition of PLGA microspheres as microcarriers for IVD cells. We prepared PLGA microspheres using oil-in-water(O/W) solvent evaporation method and investigated the size variation of the microspheres(180~425 μm). Human disc cells were used in a prospective study of attachment, proliferation, and gene expression within various size of PLGA microspheres. Mophology of cell attached on the microspheres was studied using scanning electron microscopy (SEM). Cellular behavior in response to various size of PLGA microspheres was analyzed using MTT assay and reverse transcriptase - polymerase chain reaction(RT-PCR). SEM showed that cells could be bridge between microspheres with elongated shapes. MTT assay revealed that the cells could be attach, proliferate and spread on PLGA microspheres, in particular on the ones having size below 250 μm. In RT-PCR results, we observed strongly specific gene expression of type collagen at more 250 μm microsphere. In conclusion, this result will be used to injectable system for disc regeneration.
PLGA 담체의 제조방법에 따른 골수간엽줄기세포의 골분화 유도
소정원 ( Jeong Won So ),김순희 ( Soon Hee Kim ),백미옥 ( Mi Ock Baek ),임지예 ( Ji Ye Lim ),노혜원 ( Hye Won Roh ),이나리 ( Na Ri Lee ),유규하 ( Gyu Ha Ryu ),조양하 ( Yang Ha Cho ),이승진 ( Seung Jin Lee ),강길선 ( Gilson Khang ) 한국조직공학·재생의학회 2008 조직공학과 재생의학 Vol.5 No.1
A key component in tissue engineering for bone regeneration is the scaffold that serves as a template for cell interaction and the formation of bone-extracellular matrix to provide structural support to the newly formed tissue. In this study, poly(L-Lactide-co-glicolide)(PLGA) scaffolds were prepared by solvent casting/salt-leaching, ice particle-leaching and gas-forming/salt-leaching. Cellular viability and proliferation were assayed by 3-(4,5-dimethylthiazole- 2-yl)-2,5-diphenyltetrazolium-bromide(MTT) test. Osteogenic differential cells were analyzed by ALP activity. Through RT-PCR analysis, we observed ALP and osteocalcin m RNA expression. Scaffold with BMSCs were implanted into the back of athymic nude mouse to observe in vivo behavior. Thin section were cut from paraffin embedded tissues and histological sections were stained by trichrome, immunohistochemical, von kossa staining. The cell proliferation and ALP activity of BMSCs in the scafoolds was the highest in the scaffolds using solvent casting/salt-leaching method. In RT-PCR results, in the all type of scaffolds observed specific gene expression of ALP, osteocalcin. By histological staining, we could observed collagen and calcification region in scaffolds by solvent casting/salt leaching method. Thus Solvent casting/salt-leaching method provided highly porous structure with good interconnections between each pores, which can support the surface of cell proliferation, differentiation. This result indicates that solvent casting/salt-leaching is useful for osteogenesis of BMSCs.