• Title/Summary/Keyword: Autoinjector

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A Multi-chambered Single Autoinjector: Design and Performance Assesment (다중챔버 단일주사기: 설계, 성능 평가)

  • An, Seoyeon;Lee, Keunwoo;Kwon, Taekeun;Kim, Dongyeon
    • Journal of the Korea Institute of Military Science and Technology
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    • v.20 no.2
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    • pp.170-180
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    • 2017
  • An autoinjector allows a single use medical device serving for automatic intramuscular injection to deliver a dose of a particular emergency drug through an intuitive activation mechanism. By design and structure, autoinjectors are easy to use and are intended for self-administration by patients or untrained personnel. Depending on the number of drugs filled in the cartridge, autoinjectors are divided by one-chamber type and multi-chamber type. Most autoinjectors may have a special structure including spring-loading syringes and needle which is specially designed to ensure strength due to the necessity of penetration through layers of clothing. The purpose of this study was to introduce the design technology of autoinjector of multi-chamber type that could be released into the two drugs sequentially. Additionally, we verified performance of the prototype developed by applying the design.

A Case Study on the FDA Approval of Medical Treatments against Nerve Agent Poisoning (신경작용제 해독제 의약품 품목허가 사례 연구)

  • Lee, Keunwoo;An, Seoyeon;Hur, Byungil
    • Journal of the Korea Institute of Military Science and Technology
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    • v.19 no.1
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    • pp.119-126
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    • 2016
  • The US Army used MARK-1 composed of atropine autoinjector and 2-PAM autoinjector as a medical countermeasure against nerve agent poisoning. Recently, it has been being replaced by the ATNAA(Antidote Treatment Nerve Agent AutoInjector) for improvement the convenience in use and rapid detoxification effect. ATNAA(FDA approval, NDA 21-175, 2002. 1. 17) is a multi-chambered autoinjector that sequentially delivers atropine and 2-PAM through a single needle to allow Warfighters to survive against lethal exposure to nerve agents. In this paper, our group investigated the case of FDA approval of ATNAA in a point of the various data required by FDA guideline, thereby making it easy to meet the KFDA guideline for the approval of the prototype our group has been developed. The purpose of this study is to provide a reference for efficient research activities to minimize time and cost. Additionally, the purpose of this study is to provide a reference for the planning for the development of similar drug.

A Multi-chambered Single Autoinjector and KMARK-1 Containing Atropine and 2-PAM: Comparative Bioavailability Studies Using Single Intramuscular Injection with Beagle Dogs (아트로핀 및 팜 함유 다중챔버 단일주사기 및 KMARK-1: 비글개를 이용한 단회 근육투여 비교 생체이용률 연구)

  • Lee, Keunwoo;An, Seoyeon;Kwon, Taekeun;Jung, Inhong;Kim, Dongyeon
    • Journal of the Korea Institute of Military Science and Technology
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    • v.20 no.4
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    • pp.587-596
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    • 2017
  • In this study, multi-chambered single autoinjector(2in1) and KMARK-1 containing atropine and 2-PAM(pyridine-2-aldoxime methylchloride) were administered to the beagle's muscle, and blood samples were taken for a certain period of time to compare and evaluate the pharmacokinetic profiles of the two drugs. Male beagles were used and classified into two test groups(G1, G2), and crossover pharmacokinetic studies were performed in two test groups. Blood samples were collected from the jugular vein for analysis after administration. The 90 % confidence interval(CI) for log transformed data indicated that the Cmax for both atropine(log 0.9683 ~ log 1.113) and 2-PAM(log 0.9453 ~ log 1.214) was within the limits of bioequivalence criteria, but the AUC for atropine(log 1.1786 ~ log 1.3238) failed to meet this criteria. This is expected as the amount of atropine dose is 25 % higher for the test as compared to the reference formulation. In summary, in view of the ATNAA(antidote for nerve agent of US) authorization, the Cmax equivalence was more important than AUC equivalence, so in this study, we also focused on verifying the equality of Cmax between the two autoinjectors.

Evaluation of Roadmap Image Quality by Parameter Change in Angiography (혈관조영검사에서 매개변수 변화에 따른 Roadmap 영상의 화질평가)

  • Kong, Chang gi;Song, Jong Nam;Han, Jae Bok
    • Journal of the Korean Society of Radiology
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    • v.14 no.1
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    • pp.53-60
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    • 2020
  • The purpose of this study is to identify factors affecting picture quality in Roadmap images, which were studied by varying the dilution rate, collimation field and flow rate of contrast medium. For a quantitative evaluation of the quality of the picture, a 3mm vessel model Water Phantom was self-produced using acrylic, a roadmap image was acquired with a self-produced vascular model Water Phantom, and the SNR(Signal to Noise Ratio) and CNR (Contrast to Noise Ratio) were analyzed. CM:N/S In the study on the change of dilution rate, CM:N/S dilution rate changed to (100%~10%:100%), and the measurement of the roadmap image taken using the vascular model Water Phantom showed that the measurement value of SNR gradually decreased as the N/S dilution rate was increased, and the measurement of CNR was gradually reduced. It was confirmed that the higher the dilution rate of CM:N/S, the lower the SNR and CNR, and also significant image can be obtained at the dilution rate of CM:N/S (100%~70:30%). The study showed the value of SNR and CNR in Roadmap image was increased as the Collimation Field was narrowed to the center of the vascular phantom; the Collimation Field was narrowed to the center of the vessel model by 2cm intervals to 0cm through 12cm. To verify the relationship with Roadmap image and Flow Rate, volume of the autoinjector was kept constant at 15 and the flow rate was gradually increased 1, 2, 3, 4, 5, 6, 7, 8, 9, 10. The value of SNR and CNR of images taken by using water Phantom gradually decreased as the Flow Rate increased, but at Flow Rate 9 and 10, the SNR and CNR value was increase. It was not possible to confirm the relationship with SNR and CNR by ROI mean value and Background mean value. It is considered that further study is needed to evaluate the correlation about Roadmap image and Flow Rate. In conclusion, as the dilution rate of N/S in contrast medium was increased, the value of SNR and CNR was decreased. The narrower the Collimation Field, the higher image quality by increasing value of SNR and CNR. However, it is not confirmed the relationship Roadmap image and Flow Rate. It is considered that appropriate contrast medium concentration to minimize the effects of kidney and proper Collimation Field to improve contrast of image and reduce exposure X-ray during procedure is needed.

Usefuless of Multi-functional Gastroduodenal Coil Catheter with Phantom (팬텀을 이용한 다기능 위.십이지장관 코일 카테타의 유용성 평가)

  • Lim, Jin-Oh;Kim, Tae-Hyung;Jung, Yang-Hwa;Choi, Won-Chan;Shin, Ji-Hoon;Song, Ho-Young
    • Journal of radiological science and technology
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    • v.26 no.4
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    • pp.21-26
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    • 2003
  • To evaluate the newly designed gastroduodenal coil catheter:in-vitro test. The coil catheter that we made in our laboratory was 150 cm. The coil that is made of stainless steel wire was composed 1.3 mm inner diameter and this coil spring was covered with heat-shrinkable polyethylene tube. To measure the length under fluorocopy, 8 radiopaque marks were attached at 5 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 20 cm apart from distal end of the catheter and 6, 2, 1 pores were made at 7 cm, 13 cm, 19 cm apart from the distal end. Radio-opacity and the amount of injected contrast was investigated in formerly used 5 Fr. vessel catheter, which is possible in measuring length, and newly designed coil catheter. Film density was tested for radio-opacity with autodensitometer. For measuring the volume of injected salin, the catheter was located in the acryl box(26 cm, 3 cm, 16 cm) that divided into 4 chambers. After injection 50 cc of contrast with autoinjector, the contrast's quantity in each chamber was measured with and without over the guide wire. Radio-opacity was 0.51 in 5 Fr. vessel catheter, 0.31 in newly made catheter. The amount of injected contrast was measured. In case of 5 Fr. vessel catheter, the amount was 99.5% from the distal part, there was no difference between with and without the guide wire. Otherwise, using a coil catheter, the pacentage the ejected saline was 1.17%, 18.8%, 41.8%, 38.2% from the distal part with the guide wire, 19.5%, 32.6%, 27.7%, 20.3% without the guide wire. Compare with formerly established catheter, this new coil catheter is easy to measure the length thanks to easy confirming under fluoroscopy and excellent in injecting contrast. Therefore, newly designed gastrointestinal catheter seems to be useful in gastrointestinal intervention procedure.

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주사용 요오드화 조영제 및 MRI용 가돌리늄 조영제 유해 반응에 대한 한국 임상진료지침: 개정된 임상적 합의 및 권고안(2022년 제3판)

  • Se Won Oh;So Young Park;Hwan Seok Yong;Young Hun Choi;Min Jae Cha;Tae Bum Kim;Ji Hyang Lee;Sae Hoon Kim;Jae Hyun Lee;Gyu Young Hur;Jae Yeon Hwang;Sejoong Kim;Hyo Sang Kim;Ji Young Ryu;Miyoung Choi;Chi-Hoon Choi
    • Journal of the Korean Society of Radiology
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    • v.83 no.2
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    • pp.254-264
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    • 2022
  • The Korean Society of Radiology and Medical Guidelines Committee amended the existing 2016 guidelines to publish the "Korean Clinical Practice Guidelines for Adverse Reactions to Iodide Contrast for Injection and Gadolinium Contrast for MRI: The Revised Clinical Consensus and Recommendations (2022 Third Edition)." Expert members recommended and approved by the Korean Society of Radiology, the Korean Academy of Asthma, Allergy and Clinical Immunology, and the Korean Nephrology Society participated together. According to the expert consensus or systematic literature review, the description of the autoinjector and connection line for the infection control while using contrast medium, the acute adverse reaction, and renal toxicity to iodized contrast medium were modified and added. We would like to introduce the revised contents.