LIVIVO - The Search Portal for Life Sciences

zur deutschen Oberfläche wechseln
Advanced search

Search results

Result 1 - 10 of total 37

Search options

  1. Book ; Online: Brain and Human Body Modeling

    Makarov, Sergey / Horner, Marc / Noetscher, Gregory

    Computational Human Modeling at EMBC 2018

    2019  

    Author's details edited by Sergey Makarov, Marc Horner, Gregory Noetscher
    Keywords Biomedical engineering ; Systems engineering ; Microwaves ; Computersimulation ; Körper ; Gehirn
    Subject Cerebrum ; Hirn ; Encephalon ; Enzephalon ; Hirngewebe ; Hirnmasse ; Gehirnmasse ; Mensch ; Menschlicher Körper ; Corpus ; Simulation ; Computer ; Simulationstechnik ; Systemsimulation ; Digitale Simulation ; Computermodell ; Rechnersimulation
    Subject code 610.28
    Language English
    Size 1 Online-Ressource (XI, 402 p. 175 illus., 148 illus. in color)
    Edition 1st ed. 2019
    Publisher Springer International Publishing ; Imprint: Springer
    Publishing place Cham
    Document type Book ; Online
    HBZ-ID HT020186987
    ISBN 978-3-030-21293-3 ; 9783030212926 ; 9783030212940 ; 9783030212957 ; 3-030-21293-9 ; 3030212920 ; 3030212947 ; 3030212955
    DOI 10.1007/978-3-030-21293-3
    Database ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

    More links

    Kategorien

  2. Book ; Online: Brain and Human Body Modeling : Computational Human Modeling at EMBC 2018

    Makarov, Sergey / Horner, Marc / Noetscher, Gregory

    2019  

    Keywords Biomedical engineering ; Circuits & components ; Microwave technology ; Engineering ; Electronic circuits ; Microwaves ; Optical engineering
    Size 1 electronic resource (402 pages)
    Publisher Springer Nature
    Publishing place Cham
    Document type Book ; Online
    Note English ; Open Access
    HBZ-ID HT021030647
    ISBN 978-3-030-21293-3 ; 3-030-21293-9
    Database ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

    More links

    Kategorien

  3. Article ; Online: Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard.

    Nagaraja, Srinidhi / Loughran, Galyna / Baumann, Andrew P / Kartikeya, Kumar / Horner, Marc

    Methods (San Diego, Calif.)

    2024  Volume 225, Page(s) 74–88

    Abstract: Computational modeling and simulation (CM&S) is a key tool in medical device design, development, and regulatory approval. For example, finite element analysis (FEA) is widely used to understand the mechanical integrity and durability of orthopaedic ... ...

    Abstract Computational modeling and simulation (CM&S) is a key tool in medical device design, development, and regulatory approval. For example, finite element analysis (FEA) is widely used to understand the mechanical integrity and durability of orthopaedic implants. The ASME V&V 40 standard and supporting FDA guidance provide a framework for establishing model credibility, enabling deeper reliance on CM&S throughout the total product lifecycle. Examples of how to apply the principles outlined in the ASME V&V 40 standard are important to facilitating greater adoption by the medical device community, but few published examples are available that demonstrate best practices. Therefore, this paper outlines an end-to-end (E2E) example of the ASME V&V 40 standard applied to an orthopaedic implant. The objective of this study was to illustrate how to establish the credibility of a computational model intended for use as part of regulatory evaluation. In particular, this study focused on whether a design change to a spinal pedicle screw construct (specifically, the addition of a cannulation to an existing non-cannulated pedicle screw) would compromise the rod-screw construct mechanical performance. This question of interest (?OI) was addressed by establishing model credibility requirements according to the ASME V&V 40 standard. Experimental testing to support model validation was performed using spinal rods and non-cannulated pedicle screw constructs made with medical grade titanium (Ti-6Al-4V ELI). FEA replicating the experimental tests was performed by three independent modelers and validated through comparisons of common mechanical properties such as stiffness and yield force. The validated model was then used to simulate F1717 compression-bending testing on the new cannulated pedicle screw design to answer the ?OI, without performing any additional experimental testing. This E2E example provides a realistic scenario for the application of the ASME V&V 40 standard to orthopedic medical device applications.
    MeSH term(s) Finite Element Analysis ; Pedicle Screws/standards ; Humans ; Computer Simulation ; Materials Testing/methods ; Materials Testing/standards ; Titanium/chemistry ; Compressive Strength
    Chemical Substances Titanium (D1JT611TNE)
    Language English
    Publishing date 2024-03-16
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1066584-5
    ISSN 1095-9130 ; 1046-2023
    ISSN (online) 1095-9130
    ISSN 1046-2023
    DOI 10.1016/j.ymeth.2024.03.003
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  4. Article ; Online: Modeling RF-Induced Power Deposition and Temperature Rise of Coaxial Leads with Helical Wires.

    Kozlov, Mikhail / Horner, Marc / Kainz, Wolfgang

    Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference

    2019  Volume 2019, Page(s) 1895–1898

    Abstract: The lead electromagnetic model (LEM) and the radiofrequency responses, i.e., the net dissipated electrode power and net temperature increase, above background, at the electrodes, were modelled for two coax-type insulated leads with inner and outer ... ...

    Abstract The lead electromagnetic model (LEM) and the radiofrequency responses, i.e., the net dissipated electrode power and net temperature increase, above background, at the electrodes, were modelled for two coax-type insulated leads with inner and outer helical wires with a pitch of 0.35 mm. The quotient of the variances of the fitted LEM values and observed values (R
    MeSH term(s) Electrodes ; Hot Temperature ; Humans ; Magnetic Resonance Imaging ; Models, Theoretical ; Radio Waves
    Language English
    Publishing date 2019-12-30
    Publishing country United States
    Document type Journal Article
    ISSN 2694-0604
    ISSN (online) 2694-0604
    DOI 10.1109/EMBC.2019.8856572
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  5. Article ; Online: Modeling radiofrequency responses of realistic multi-electrode leads containing helical and straight wires.

    Kozlov, Mikhail / Horner, Marc / Kainz, Wolfgang

    Magma (New York, N.Y.)

    2019  Volume 33, Issue 3, Page(s) 421–437

    Abstract: Purpose: To present a modeling workflow for the evaluation of a lead electromagnetic model (LEM) consisting of a transfer function (TF) and a calibration factor. The LEM represents an analytical relationship between the RF response of a lead and the ... ...

    Abstract Purpose: To present a modeling workflow for the evaluation of a lead electromagnetic model (LEM) consisting of a transfer function (TF) and a calibration factor. The LEM represents an analytical relationship between the RF response of a lead and the incident electromagnetic field. The study also highlights the importance of including key geometric details of the lead and the electrode when modeling multi-electrode leads.
    Methods: The electrical and thermal responses of multi-electrode leads with helical and straight wires were investigated using 3D electromagnetic (EM) and thermal co-simulations. The net dissipated power (P) around each lead electrode and the net temperature increase at the electrodes (ΔT) were obtained for a set of incident EM fields with different spatial distributions. A reciprocity approach was used to determine a TF for each electrode based on the results of the computational model. The evaluation of the calibration factors and the TF validation were performed using the linear regression of P versus the LEM predictions.
    Results: P and ΔT were investigated for four multi-electrode leads and four single-electrode leads containing either helical or straight wires. All electrodes of the multi-electrode lead were found to be points of high power deposition and temperature rise. The LEMs for the individual electrodes varied substantially. A significant dependence of the calibration factors on the surrounding tissue medium was also found. Finally, the model showed that the TF, the calibration factor, P and ΔT for multi-electrode leads differ significantly from those for single-electrode leads.
    Conclusion: These results highlight the need to evaluate a LEM for each electrode of a multi-electrode lead as well as for each possible surrounding medium. It is also shown that the results derived from simulations based on simplified single-electrode leads can significantly mislead multi-electrode lead analyses.
    MeSH term(s) Algorithms ; Animals ; Calibration ; Computer Simulation ; Electrodes ; Electrodes, Implanted ; Electromagnetic Fields ; Hot Temperature ; Humans ; Magnetic Resonance Imaging/methods ; Pattern Recognition, Automated ; Radio Waves ; Temperature
    Language English
    Publishing date 2019-11-19
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 1160826-2
    ISSN 1352-8661 ; 0968-5243
    ISSN (online) 1352-8661
    ISSN 0968-5243
    DOI 10.1007/s10334-019-00793-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  6. Article: In silico trials: Verification, validation and uncertainty quantification of predictive models used in the regulatory evaluation of biomedical products

    Viceconti, Marco / Bischoff, Jeff / Horner, Marc / Musuamba Tshinanu, Flora / Pappalardo, Francesco / Rodriguez, Blanca

    Methods. 2020 Jan. 14,

    2020  

    Abstract: Historically, the evidences of safety and efficacy that companies provide to regulatory agencies as support to the request for marketing authorization of a new medical product have been produced experimentally, either in vitro or in vivo. More recently, ... ...

    Abstract Historically, the evidences of safety and efficacy that companies provide to regulatory agencies as support to the request for marketing authorization of a new medical product have been produced experimentally, either in vitro or in vivo. More recently, regulatory agencies started receiving and accepting evidences obtained in silico, i.e. through modelling and simulation. However, before any method (experimental or computational) can be acceptable for regulatory submission, the method itself must be considered “qualified” by the regulatory agency. This involves the assessment of the overall “credibility” that such a method has in providing specific evidence for a given regulatory procedure. In this paper, we describe a methodological framework for the credibility assessment of computational models built using mechanistic knowledge of physical and chemical phenomena, in addition to available biological and physiological knowledge; these are sometimes referred to as “biophysical” models. Using guiding examples, we explore the definition of the context of use, the risk analysis for the definition of the acceptability thresholds, and the various steps of a comprehensive verification, validation and uncertainty quantification process, to conclude with considerations on the credibility of a prediction for a specific context of use. While this paper does not provide a guideline for the formal qualification process, which only the regulatory agencies can provide, we expect it to help researchers to better appreciate the extent of scrutiny required, which should be considered early on in the development/use of any (new) in silico evidence.
    Keywords bioinformatics ; business enterprises ; guidelines ; marketing ; models ; prediction ; risk analysis ; uncertainty
    Language English
    Dates of publication 2020-0114
    Publishing place Elsevier Inc.
    Document type Article
    Note Pre-press version
    ZDB-ID 1066584-5
    ISSN 1095-9130 ; 1046-2023
    ISSN (online) 1095-9130
    ISSN 1046-2023
    DOI 10.1016/j.ymeth.2020.01.011
    Database NAL-Catalogue (AGRICOLA)

    More links

    Kategorien

  7. Article ; Online: In Silico Fit Evaluation of Additively Manufactured Face Coverings.

    Carr, Ian A / D'Souza, Gavin / Xu, Ming / Ozarkar, Shailesh / Porter, Daniel / Horner, Marc / Hariharan, Prasanna

    Annals of biomedical engineering

    2022  

    Abstract: In response to the respiratory protection device shortage during the COVID-19 pandemic, the additive manufacturing (AM) community designed and disseminated numerous AM face masks. Questions regarding the effectiveness of AM masks arose because these ... ...

    Abstract In response to the respiratory protection device shortage during the COVID-19 pandemic, the additive manufacturing (AM) community designed and disseminated numerous AM face masks. Questions regarding the effectiveness of AM masks arose because these masks were often designed with limited (if any) functional performance evaluation. In this study, we present a fit evaluation methodology in which AM face masks are virtually donned on a standard digital headform using finite element-based numerical simulations. We then extract contour plots to visualize the contact patches and gaps and quantify the leakage surface area for each mask frame. We also use the methodology to evaluate the effects of adding a foam gasket and variable face mask sizing, and finally propose a series of best practices. Herein, the methodology is focused only on characterizing the fit of AM mask frames and does not considering filter material or overall performance. We found that AM face masks may provide a sufficiently good fit if the sizing is appropriate and if a sealing gasket material is present to fill the gaps between the mask and face. Without these precautions, the rigid nature of AM materials combined with the wide variation in facial morphology likely results in large gaps and insufficient adaptability to varying user conditions which may render the AM face masks ineffective.
    Language English
    Publishing date 2022-07-28
    Publishing country United States
    Document type Journal Article
    ZDB-ID 185984-5
    ISSN 1573-9686 ; 0191-5649 ; 0090-6964
    ISSN (online) 1573-9686
    ISSN 0191-5649 ; 0090-6964
    DOI 10.1007/s10439-022-03026-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  8. Article ; Online: An in silico testbed for fast and accurate MR labeling of orthopedic implants.

    Noetscher, Gregory M / Serano, Peter J / Horner, Marc / Prokop, Alexander / Hanson, Jonathan / Fujimoto, Kyoko / Brown, James / Nazarian, Ara / Ackerman, Jerome / Makaroff, Sergey N

    eLife

    2023  Volume 12

    Abstract: One limitation on the ability to monitor health in older adults using magnetic resonance (MR) imaging is the presence of implants, where the prevalence of implantable devices (orthopedic, cardiac, neuromodulation) increases in the population, as does the ...

    Abstract One limitation on the ability to monitor health in older adults using magnetic resonance (MR) imaging is the presence of implants, where the prevalence of implantable devices (orthopedic, cardiac, neuromodulation) increases in the population, as does the pervasiveness of conditions requiring MRI studies for diagnosis (musculoskeletal diseases, infections, or cancer). The present study describes a novel multiphysics implant modeling testbed using the following approaches with two examples: (1) an in silico human model based on the widely available Visible Human Project (VHP) cryo-section dataset; (2) a finite element method (FEM) modeling software workbench from Ansys (Electronics Desktop/Mechanical) to model MR radio frequency (RF) coils and the temperature rise modeling in heterogeneous media. The in silico VHP-Female model (250 parts with an additional 40 components specifically characterizing embedded implants and resultant surrounding tissues) corresponds to a 60-year-old female with a body mass index of 36. The testbed includes the FEM-compatible in silico human model, an implant embedding procedure, a generic parameterizable MRI RF birdcage two-port coil model, a workflow for computing heat sources on the implant surface and in adjacent tissues, and a thermal FEM solver directly linked to the MR coil simulator to determine implant heating based on an MR imaging study protocol. The primary target is MR labeling of large orthopedic implants. The testbed has very recently been approved by the US Food and Drug Administration (FDA) as a medical device development tool for 1.5 T orthopedic implant examinations.
    MeSH term(s) Female ; Humans ; Aged ; Middle Aged ; Prostheses and Implants ; Computer Simulation ; Temperature ; Hot Temperature ; Magnetic Resonance Imaging/methods
    Language English
    Publishing date 2023-12-14
    Publishing country England
    Document type Case Reports ; Journal Article
    ZDB-ID 2687154-3
    ISSN 2050-084X ; 2050-084X
    ISSN (online) 2050-084X
    ISSN 2050-084X
    DOI 10.7554/eLife.90440
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  9. Article: An In-Silico Testbed for Fast and Accurate MR Labeling of Orthopaedic Implants.

    Noetscher, Gregory M / Serano, Peter J / Horner, Marc / Prokop, Alexander / Hanson, Jonathan / Fujimoto, Kyoko / Brown, James E / Nazarian, Ara / Ackerman, Jerome / Makaroff, Sergey N

    bioRxiv : the preprint server for biology

    2023  

    Abstract: One limitation on the ability to monitor health in older adults using Magnetic Resonance (MR) imaging is the presence of implants, where the prevalence of implantable devices (orthopedic, cardiac, neuromodulation) increases in the population, as does the ...

    Abstract One limitation on the ability to monitor health in older adults using Magnetic Resonance (MR) imaging is the presence of implants, where the prevalence of implantable devices (orthopedic, cardiac, neuromodulation) increases in the population, as does the pervasiveness of conditions requiring MRI studies for diagnosis (musculoskeletal diseases, infections, or cancer). The present study describes a novel multiphysics implant modeling testbed using the following approaches with two examples: - an
    Language English
    Publishing date 2023-10-02
    Publishing country United States
    Document type Preprint
    DOI 10.1101/2023.07.16.549234
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  10. Article ; Online: In silico trials: Verification, validation and uncertainty quantification of predictive models used in the regulatory evaluation of biomedical products.

    Viceconti, Marco / Pappalardo, Francesco / Rodriguez, Blanca / Horner, Marc / Bischoff, Jeff / Musuamba Tshinanu, Flora

    Methods (San Diego, Calif.)

    2020  Volume 185, Page(s) 120–127

    Abstract: Historically, the evidences of safety and efficacy that companies provide to regulatory agencies as support to the request for marketing authorization of a new medical product have been produced experimentally, either in vitro or in vivo. More recently, ... ...

    Abstract Historically, the evidences of safety and efficacy that companies provide to regulatory agencies as support to the request for marketing authorization of a new medical product have been produced experimentally, either in vitro or in vivo. More recently, regulatory agencies started receiving and accepting evidences obtained in silico, i.e. through modelling and simulation. However, before any method (experimental or computational) can be acceptable for regulatory submission, the method itself must be considered "qualified" by the regulatory agency. This involves the assessment of the overall "credibility" that such a method has in providing specific evidence for a given regulatory procedure. In this paper, we describe a methodological framework for the credibility assessment of computational models built using mechanistic knowledge of physical and chemical phenomena, in addition to available biological and physiological knowledge; these are sometimes referred to as "biophysical" models. Using guiding examples, we explore the definition of the context of use, the risk analysis for the definition of the acceptability thresholds, and the various steps of a comprehensive verification, validation and uncertainty quantification process, to conclude with considerations on the credibility of a prediction for a specific context of use. While this paper does not provide a guideline for the formal qualification process, which only the regulatory agencies can provide, we expect it to help researchers to better appreciate the extent of scrutiny required, which should be considered early on in the development/use of any (new) in silico evidence.
    MeSH term(s) Computer Simulation ; Machine Learning ; Models, Theoretical ; Uncertainty
    Language English
    Publishing date 2020-01-25
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1066584-5
    ISSN 1095-9130 ; 1046-2023
    ISSN (online) 1095-9130
    ISSN 1046-2023
    DOI 10.1016/j.ymeth.2020.01.011
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

To top