scholarly journals Considerations in biosimilar insulin device development

Biosimilars ◽  
2016 ◽  
pp. 9 ◽  
Author(s):  
Andrew Krentz ◽  
Marcus Hompesch ◽  
Andrew Fry
Keyword(s):  
Device Development

scholarly journals Design of a force-measuring setup for colorectal compression anastomosis and first ex-vivo results

2021 ◽  
Author(s):  
Jana Steger ◽  
Isabella Patzke ◽  
Maximilian Berlet ◽  
Stefanie Ficht ◽  
Markus Eblenkamp ◽  
...  
Keyword(s):  
Ex Vivo ◽  
Tissue Fixation ◽  
Force Transmission ◽  
Tissue Thickness ◽  
Colon Tissue ◽  
Device Development ◽  
Compression Anastomosis ◽  
Technical Requirements ◽  
Significant Difference

Abstract Purpose The introduction of novel endoscopic instruments is essential to reduce trauma in visceral surgery. However, endoscopic device development is hampered by challenges in respecting the dimensional restrictions, due to the narrow access route, and by achieving adequate force transmission. As the overall goal of our research is the development of a patient adaptable, endoscopic anastomosis manipulator, biomechanical and size-related characterization of gastrointestinal organs are needed to determine technical requirements and thresholds to define functional design and load-compatible dimensioning of devices. Methods We built an experimental setup to measure colon tissue compression piercing forces. We tested 54 parameter sets, including variations of three tissue fixation configurations, three piercing body configurations (four, eight, twelve spikes) and insertion trajectories of constant velocities (5 mms−1, 10 mms−1,15 mms−1) and constant accelerations (5 mms−2, 10 mms−2, 15 mms−2) each in 5 samples. Furthermore, anatomical parameters (lumen diameter, tissue thickness) were recorded. Results There was no statistically significant difference in insertion forces neither between the trajectory groups, nor for variation of tissue fixation configurations. However, we observed a statistically significant increase in insertion forces for increasing number of spikes. The maximum mean peak forces for four, eight and twelve spikes were 6.4 ± 1.5 N, 13.6 ± 1.4 N and 21.7 ± 5.8 N, respectively. The 5th percentile of specimen lumen diameters and pierced tissue thickness were 24.1 mm and 2.8 mm, and the 95th percentiles 40.1 mm and 4.8 mm, respectively. Conclusion The setup enabled reliable biomechanical characterization of colon material, on the base of which design specifications for an endoscopic anastomosis device were derived. The axial implant closure unit must enable axial force transmission of at least 28 N (22 ± 6 N). Implant and applicator diameters must cover a range between 24 and 40 mm, and the implant gap, compressing anastomosed tissue, between 2 and 5 mm.

Recent Statistical Contributions to Medical Device Development

2014 ◽  
Vol 48 (1) ◽  
pp. 90-97 ◽  
Author(s):  
Brian L. Wiens ◽  
Theodore C. Lystig ◽  
Scott M. Berry
Keyword(s):  
Medical Device ◽  
Medical Device Development ◽  
Device Development

scholarly journals Temperature Controlled and Monitored Ex Vivo Lung Perfusion System for Research and Training Purposes

2019 ◽  
Vol 5 (1) ◽  
pp. 293-295
Author(s):  
Christina Pongratz ◽  
Jens Ziegle ◽  
Axel Boese ◽  
Michael Friebe ◽  
Helena Linge ◽  
...  
Keyword(s):  
Storage Temperature ◽  
Ex Vivo ◽  
Culture Conditions ◽  
Lung Perfusion ◽  
Tissue Storage ◽  
Ex Vivo Lung Perfusion ◽  
Device Development ◽  
Preservation Method ◽  
Normothermic Perfusion ◽  
Short Period

AbstractEx vivo lung perfusion (EVLP) is a preservation method for donor lungs, which keep lungs viable in a physiological environment outside of a body for a short period of time. EVLP is established clinically for lung transplantation. Experimental applications for EVLP are e.g. lung cancer research or medical device development and testing. For preservation, a lung is ventilated artificially in an organ chamber and perfused antegrade through the pulmonary artery. Here we introduce a thermoregulation system for an experimental EVLP system to be used for translational research approaches as well as for training medical staff. To implement physiological culture conditions that are a prerequisite for lung preservation and tissue homeostasis, a thermoregulation is needed to rewarm the explanted lung tissue (storage temperature 4°C). Technically, the EVLP system must be thermally insulated, so loss of caloric is avoided. For monitoring, temperature sensors are integrated within the lung, in the organ chamber and in the afferent perfusate tube, whereby the measured values determine the thermoregulation. Initial tests using thermal packs (cooled to 4-6°C) placed on a heating mat, as a part of the perfusion circuit, showed that the perfusate temperature falls to 34°C, but restores after approximately 60 minutes (36.5°C), whereby the thermal pack is warmed. With this setup longer perfusion times should be obtained rather than without thermoregulation due to normothermic perfusion of the lung.

Scientific Reviews: Device Development for JSNS

Neutron News ◽  
2005 ◽  
Vol 16 (1) ◽  
pp. 29-33
Author(s):  
M. Furusaka
Keyword(s):  
Device Development

scholarly journals Assessment of Adhesion Response To 3D Printed Materials For Ophthalmic Device Development

2016 ◽  
Vol 19 (7) ◽  
pp. A564
Author(s):  
M Alband ◽  
RM Lee ◽  
M Penny ◽  
S Brocchini ◽  
ST Hilton
Keyword(s):  
Device Development ◽  
3D Printed ◽  
Printed Materials
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