Herpetic Keratitis Recurred after the Use of a Thermal Medical Device

Nicht lieferbare Medizinprodukte sind für Kliniken ein Albtraum – mitunter müssen sogar geplante OPs abgesagt werden. Die Folge: Die mit den Kostenträgern vereinbarten Leistungszahlen sind schwieriger zu erfüllen und es könnte zu schwer kompensierbaren Erlöseinbußen für die Leistungserbringer kommen. Die Medical Device Regulation (MDR) wird die Liefersituation von Medizinprodukten ab 2020 wahrscheinlich noch weiter verschärfen.

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The study for constant force characteristic of C-shaped superelastic SMA

International Journal of Applied Electromagnetics and Mechanics ◽

10.3233/jae-209443 ◽

2020 ◽

Vol 64 (1-4) ◽

pp. 1253-1259

Author(s):

Minghui Wang ◽

Hongliu Yu

Keyword(s):

Shape Memory Alloys ◽

Shape Memory ◽

Medical Device ◽

Soft Tissues ◽

Computational Simulation ◽

Force Characteristic ◽

Constant Force ◽

Curve Shape ◽

Artificial Sphincter ◽

Round Bar

Clamping devices with constant force or pressure are desired in medical device, such as hemostatic forceps and the artificial sphincter, to prevent soft tissues from injures due to overloading. It is easily obtained by stretching an SMA wire. However, studies with SMA bending round bar have seldom been reported before. This paper studied constant force characteristic of C-shaped round bar with shape memory alloys. Optimization designs of the components were carried out with computational simulation. Numerical results show that the phenomenon of constant force strongly depends on contour curve shape and geometric dimensions of the C-shaped round bar of SMA component.

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Attrarre la produzione e la ricerca di imprese farmaceutiche e di medical device

MECOSAN ◽

10.3280/mesa2016-099006 ◽

2017 ◽

pp. 103-108

Author(s):

Patrizio Armeni ◽

Giuditta Callea ◽

Rosanna Tarricone ◽

Aleksandra Torbica

Keyword(s):

Medical Device

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Development of Wafer Level Chip Size Packaging Process and its Application to the CMOS Image Sensor Module for Medical Device

IEEJ Transactions on Sensors and Micromachines ◽

10.1541/ieejsmas.137.48 ◽

2017 ◽

Vol 137 (2) ◽

pp. 48-58

Author(s):

Noriyuki Fujimori ◽

Takatoshi Igarashi ◽

Takahiro Shimohata ◽

Takuro Suyama ◽

Kazuhiro Yoshida ◽

...

Keyword(s):

Medical Device ◽

Cmos Image Sensor ◽

Image Sensor ◽

Wafer Level ◽

Packaging Process ◽

Sensor Module ◽

Chip Size

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A Fluidic Vibrational Energy Harvester for Implantable Medical Device Applications

IEEJ Transactions on Sensors and Micromachines ◽

10.1541/ieejsmas.137.152 ◽

2017 ◽

Vol 137 (6) ◽

pp. 152-158

Author(s):

Satoshi Inoue ◽

Takuya Takahashi ◽

Momoko Kumemura ◽

Kazunori Ishibashi ◽

Hiroyuki Fujita ◽

...

Keyword(s):

Medical Device ◽

Energy Harvester ◽

Vibrational Energy ◽

Implantable Medical Device ◽

Device Applications

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Long-term efficacy of a new medical device containing Fernblock® and DNA repair enzyme complex in the treatment and prevention of cancerization field in patients with actinic keratosis.

Journal of Current Medical Research and Opinion ◽

10.15520/jcmro.v2i02.129 ◽

2019 ◽

Vol 2 (02) ◽

pp. 80-89

Author(s):

Blanca De Unamuno Bustos ◽

Natalia Chaparr´´o Aguilera ◽

Inmaculada Azorín García ◽

Anaid Calle Andrino ◽

Margarita Llavador Ros ◽

...

Keyword(s):

Dna Damage ◽

Dna Repair ◽

Medical Device ◽

Actinic Keratosis ◽

Statistical Significance ◽

Dna Lesions ◽

Enzyme Complex ◽

Repair Enzyme ◽

P53 Expression ◽

Cancerization Field

Actinic keratosis (AKs) are part of the cancerization field, a region adjacent to AKs containing subclinical and histologically abnormal epidermal tissue due to Ultraviolet (UV)-induced DNA damage. The photoproducts as consequence of DNA damage induced by UV are mainly cyclobutane pyrimidine dimers (CPDs). Fernblock® demonstrated in previous studies significant reduction of the number of CPDs induced by UV radiation. Photolyases are a specific group of enzymes that remove the major UV-induced DNA lesions by a mechanism called photo-reactivation. A monocentric, prospective, controlled, and double blind interventional study was performed to evaluate the effect of a new medical device (NMD) containing a DNA-repair enzyme complex (photolyases, endonucleases and glycosilases), a combination of UV-filters, and Fernblock® in the treatment of the cancerization field in 30 AK patients after photodynamic therapy. Patients were randomized into two groups: patients receiving a standard sunscreen (SS) andpatients receiving the NMD. Clinical, dermoscopic, reflectance confocal microscopy (RCM) and histological evaluations were performed. An increase of AKs was noted in all groups after three months of PDT without significant differences between them (p=0.476). A significant increase in the number of AKs was observed in SS group after six (p=0.026) and twelve months of PDT (p=0.038); however, this increase did not reach statistical significance in the NMD group. Regarding RCM evaluation, honeycomb pattern assessment after twelve months of PDT showed significant differences in the extension and grade of the atypia in the NMD group compared to SS group (p=0.030 and p=0.026, respectively). Concerning histopathological evaluation, keratinocyte atypia grade improved from baseline to six months after PDT in all the groups, with no statistically significant differences between the groups. Twelve months after PDT, p53 expression was significantly lower in the NMD group compared to SS group (p=0.028). The product was well-tolerated, with no serious adverse events reported. Our results provide evidence of the utility of this NMD in the improvement of the cancerization field and in the prevention of the development of new AKs.

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