Pub Date : 2020-04-15DOI: 10.2530/jslsm.jslsm-40_0060
T. Sugai
{"title":"Did the Issuance of the Notification Accelerate the Development of Medical Device?","authors":"T. Sugai","doi":"10.2530/jslsm.jslsm-40_0060","DOIUrl":"https://doi.org/10.2530/jslsm.jslsm-40_0060","url":null,"abstract":"","PeriodicalId":19350,"journal":{"name":"Nippon Laser Igakkaishi","volume":"17 1","pages":"47-51"},"PeriodicalIF":0.0,"publicationDate":"2020-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89645961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-04-15DOI: 10.2530/jslsm.jslsm-41_0002
Yutaku Kaneta
In the result of discussions between industry, academia and government, yakuseikishinhatsu 0629 No. 4 ‘Management of medical laser application for approval’ was notified. The new notification shows not the range of specification without clinical trial but the guideline for development of medical laser including laser scalpel, which is mainly composed of non-clinical evaluation items and basic concepts of indication for use and necessity of clinical trial. The consultation with pharmaceuticals and medical devices agency is recommended for the decision that it is possible to evaluate the differences between devices with only non-clinical testing. Additionally, it is important for medical devices to take safety measures for the post marketing, which is not subjected to the notification but one of the review points for approval. Especially, it should be noted that safety manager selection and safety management area setting are essential for medical laser use. It is significant for resolving the clinical problems relative to medical laser to keep discussing continuously and cooperating closely with industry, academia and government.
{"title":"Explanation for Notification and Precautions of Medical Laser","authors":"Yutaku Kaneta","doi":"10.2530/jslsm.jslsm-41_0002","DOIUrl":"https://doi.org/10.2530/jslsm.jslsm-41_0002","url":null,"abstract":"In the result of discussions between industry, academia and government, yakuseikishinhatsu 0629 No. 4 ‘Management of medical laser application for approval’ was notified. The new notification shows not the range of specification without clinical trial but the guideline for development of medical laser including laser scalpel, which is mainly composed of non-clinical evaluation items and basic concepts of indication for use and necessity of clinical trial. The consultation with pharmaceuticals and medical devices agency is recommended for the decision that it is possible to evaluate the differences between devices with only non-clinical testing. Additionally, it is important for medical devices to take safety measures for the post marketing, which is not subjected to the notification but one of the review points for approval. Especially, it should be noted that safety manager selection and safety management area setting are essential for medical laser use. It is significant for resolving the clinical problems relative to medical laser to keep discussing continuously and cooperating closely with industry, academia and government.","PeriodicalId":19350,"journal":{"name":"Nippon Laser Igakkaishi","volume":"76 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87014114","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-04-15DOI: 10.2530/jslsm.jslsm-41_0001
T. Nishimura, Yu Shimojo, K. Awazu
This paper discusses perspective directions of evaluation of medical laser devices from an engineering side in response to the notification “Handling of application for approval of laser medical devices.” To accelerate the application approval of novel laser devices by safety and efficient use of this notification, we propose computer-aided regulatory science and introduce photothermal damage evaluation in laser medicine by simulation.
{"title":"Computer-aided Regulatory Science for Laser Medicine","authors":"T. Nishimura, Yu Shimojo, K. Awazu","doi":"10.2530/jslsm.jslsm-41_0001","DOIUrl":"https://doi.org/10.2530/jslsm.jslsm-41_0001","url":null,"abstract":"This paper discusses perspective directions of evaluation of medical laser devices from an engineering side in response to the notification “Handling of application for approval of laser medical devices.” To accelerate the application approval of novel laser devices by safety and efficient use of this notification, we propose computer-aided regulatory science and introduce photothermal damage evaluation in laser medicine by simulation.","PeriodicalId":19350,"journal":{"name":"Nippon Laser Igakkaishi","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89985913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-15DOI: 10.2530/JSLSM.JSLSM-40_0032
K. Ishii
Efficient algorithm of Monte-Carlo simulation of scattered light which re-emerges from the incident point of light and has a specific pathlength is reviewed. Calculation procedures of this algorithm for uniform and nonuniform scattering media are explained and examples of simulation results are shown. This algorithm can efficiently analyze scattered light detected by optical coherence tomography.
{"title":"Efficient Algorithm of Monte-Carlo Simulation of Light Propagation for Optical Coherence Tomography","authors":"K. Ishii","doi":"10.2530/JSLSM.JSLSM-40_0032","DOIUrl":"https://doi.org/10.2530/JSLSM.JSLSM-40_0032","url":null,"abstract":"Efficient algorithm of Monte-Carlo simulation of scattered light which re-emerges from the incident point of light and has a specific pathlength is reviewed. Calculation procedures of this algorithm for uniform and nonuniform scattering media are explained and examples of simulation results are shown. This algorithm can efficiently analyze scattered light detected by optical coherence tomography.","PeriodicalId":19350,"journal":{"name":"Nippon Laser Igakkaishi","volume":"54 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85208361","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-15DOI: 10.2530/jslsm.jslsm-40_0051
Nobuyuki Takeuchi, M. Matsumoto
The immediate effects of pulse irradiation with a 10-W semiconductor laser on current perception threshold and current pain threshold were examined. As a result, the minimum perceptual current value reflecting the current perception threshold did not change, but the minimum pain current value reflecting the current pain threshold showed a significant increase after laser irradiation in the irradiation group. However, there was no significant change in the minimum perceived current value and minimum pain current value in the control group. Hence, it was suggested that laser irradiation increased the pain threshold.
{"title":"Immediate Effect of Pulse Irradiation with a 10-W Semiconductor Laser on Current Perception Threshold and Current Pain Threshold","authors":"Nobuyuki Takeuchi, M. Matsumoto","doi":"10.2530/jslsm.jslsm-40_0051","DOIUrl":"https://doi.org/10.2530/jslsm.jslsm-40_0051","url":null,"abstract":"The immediate effects of pulse irradiation with a 10-W semiconductor laser on current perception threshold and current pain threshold were examined. As a result, the minimum perceptual current value reflecting the current perception threshold did not change, but the minimum pain current value reflecting the current pain threshold showed a significant increase after laser irradiation in the irradiation group. However, there was no significant change in the minimum perceived current value and minimum pain current value in the control group. Hence, it was suggested that laser irradiation increased the pain threshold.","PeriodicalId":19350,"journal":{"name":"Nippon Laser Igakkaishi","volume":"671 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76858653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-15DOI: 10.2530/jslsm.jslsm-40_0063
Hirotake Murakami, M. Matsuya, M. Adachi, Toshiya Itoh, Toshiaki K. Shibata, Takeshi Nakayama, S. Okazaki, H. Itoh, N. Kanayama
[Purpose] Cervical intraepithelial neoplasia (CIN) and early cervical cancer are frequently detected in women of reproductive age. The appropriate treatments for these diseases should be selected considering sparing fertility. Of these treatments, photodynamic therapy (PDT) is a minimally invasive therapeutic technique that enables sparing of the cervix and is as effective as cervical conization in terms of treatment results. Talaporfin sodium (NPe6)-mediated PDT was administered intravenously to nine CIN cases. This study aimed to evaluate the effect of PDT and photosensitivity in these cases. [Methods] PDT was administered to nine patients who were diagnosed with CIN based on cervical cytology, histology, and colposcopy findings. NPe6 was administered intravenously at a dose of 40 mg/m 2 . Four hours after the administration of NPe6, the patients were exposed to photoradiation (100 J/cm 2 ). [Results] PDT was used to treat a total of nine patients (two patients with CIN2 and seven patients with CIN3). Cure was confirmed in eight cases who were available for follow up thorough examinations conducted at three and six months after photoradiation. Seven patients exhibited no photosensitivity at day 14 after NPe6 administration. Mild photosensitivity by direct sunlight test was observed in one patient up to day 28. [Conclusion] This study suggests that NPe6-mediated PDT might be a promising treatment for CIN.
{"title":"Photodynamic Therapy Using Talaporfin Sodium for Cervical Intraepithelial Neoplasia","authors":"Hirotake Murakami, M. Matsuya, M. Adachi, Toshiya Itoh, Toshiaki K. Shibata, Takeshi Nakayama, S. Okazaki, H. Itoh, N. Kanayama","doi":"10.2530/jslsm.jslsm-40_0063","DOIUrl":"https://doi.org/10.2530/jslsm.jslsm-40_0063","url":null,"abstract":"[Purpose] Cervical intraepithelial neoplasia (CIN) and early cervical cancer are frequently detected in women of reproductive age. The appropriate treatments for these diseases should be selected considering sparing fertility. Of these treatments, photodynamic therapy (PDT) is a minimally invasive therapeutic technique that enables sparing of the cervix and is as effective as cervical conization in terms of treatment results. Talaporfin sodium (NPe6)-mediated PDT was administered intravenously to nine CIN cases. This study aimed to evaluate the effect of PDT and photosensitivity in these cases. [Methods] PDT was administered to nine patients who were diagnosed with CIN based on cervical cytology, histology, and colposcopy findings. NPe6 was administered intravenously at a dose of 40 mg/m 2 . Four hours after the administration of NPe6, the patients were exposed to photoradiation (100 J/cm 2 ). [Results] PDT was used to treat a total of nine patients (two patients with CIN2 and seven patients with CIN3). Cure was confirmed in eight cases who were available for follow up thorough examinations conducted at three and six months after photoradiation. Seven patients exhibited no photosensitivity at day 14 after NPe6 administration. Mild photosensitivity by direct sunlight test was observed in one patient up to day 28. [Conclusion] This study suggests that NPe6-mediated PDT might be a promising treatment for CIN.","PeriodicalId":19350,"journal":{"name":"Nippon Laser Igakkaishi","volume":"77 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83042812","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-15DOI: 10.2530/jslsm.jslsm-40_0045
Y. Okamoto, Masamichi Yamashita, T. Osaki, K. Azuma, Norihiko Ito, Y. Murahata, T. Tsuka, T. Imagawa, A. Suganami, Y. Tamura
We synthesized liposomally formulated phospholipid-conjugated indocyanine green (ICG-lipo) in 2010. Using the ICG-lipo and diode laser, we tried to treat in 38 cases of animal spontaneous tumors. Irradiation was performed for 10–20 min and its intervals were every day or 3 times per week after injection of the ICG-lipo. Due to Response Evaluation Criteria in Solid Tumors (RECIST), outcome of response rate of 38 cases was as follows; CR (Complete response): 3 cases, PR (Partial response): 13 cases, SD (Stable disease): 18 cases, PD (Progressive disease): 4 cases. Response and Efficacy rates were 42.1% and 89.5%, respectively. In particular, Response rate of lymphoma was 85.7%. In the tumors which have more than two cases, efficacy rate was 100.0% except for lymphoma and hemangiosarcoma. Out of veterinarians who performed this therapy, about half of them recognaized improvement of general condition of patients. This evidence suggests efficiency of this therapy as a cancer therapy.
{"title":"Outcome of Photodynamic Therapy With Diode Laser and Indocyanine Green Modified Liposome in Animal Spontaneous Occurring Tumors","authors":"Y. Okamoto, Masamichi Yamashita, T. Osaki, K. Azuma, Norihiko Ito, Y. Murahata, T. Tsuka, T. Imagawa, A. Suganami, Y. Tamura","doi":"10.2530/jslsm.jslsm-40_0045","DOIUrl":"https://doi.org/10.2530/jslsm.jslsm-40_0045","url":null,"abstract":"We synthesized liposomally formulated phospholipid-conjugated indocyanine green (ICG-lipo) in 2010. Using the ICG-lipo and diode laser, we tried to treat in 38 cases of animal spontaneous tumors. Irradiation was performed for 10–20 min and its intervals were every day or 3 times per week after injection of the ICG-lipo. Due to Response Evaluation Criteria in Solid Tumors (RECIST), outcome of response rate of 38 cases was as follows; CR (Complete response): 3 cases, PR (Partial response): 13 cases, SD (Stable disease): 18 cases, PD (Progressive disease): 4 cases. Response and Efficacy rates were 42.1% and 89.5%, respectively. In particular, Response rate of lymphoma was 85.7%. In the tumors which have more than two cases, efficacy rate was 100.0% except for lymphoma and hemangiosarcoma. Out of veterinarians who performed this therapy, about half of them recognaized improvement of general condition of patients. This evidence suggests efficiency of this therapy as a cancer therapy.","PeriodicalId":19350,"journal":{"name":"Nippon Laser Igakkaishi","volume":"20 2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87827855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：