Participants

-Lisa Lim

-Jen Goode

-Marilou Baston

-Craig Bonsignore

-Ahmet Erdemir

-Lindsay Pack

-Tina Morrison

-Brian Berg

-Andy Bicek

-Achim Zipse

-Prasanna Hariharan

-Nandini Duraiswamy

-Vijaya Kolachalama

 

 

Introductory Comments

• Tina Morrison (FDA) – helping coordinate computational modeling efforts from an FDA perspective
• Peripheral Vascular Devices Branch, FDA Office of Device Evaluation
• Fellow:  Reviewer and Research
• FDA 16 months
• CV Biomechanics at Stanford

 

Status of R01 Grant

• AHMET:
• Helping Vik to write the R01 grant
• Will use info from web-site to set up a rough draft for grant
• Then will ask ASPECT for input – what do industry/FDA need?
• What data and how it is disseminated may change – focus will be to present that they can do this?
• CCF:  collect, disseminate, do some early modeling (4-5 yr project)
• While data are being collected, can start on dissemination planning:  e.g., database set-up, etc.
• VJ:  will fluids be included in grant? Yes/No
• LISA:  primary goal will be solids
• AHMET:  no
• BRIAN: started out as a collaborative project, but CCF is taking over
• JEN:  fluids – will discuss off-line
• Sharing data sets early to look at how different groups will do the modeling
• CRAIG:  get some data now to start figuring out methods for modeling
• Single example data set – make available
• Publically?
• LISA:  those who have chosen to be confidential participants
• Once we get the legal documents in place (CDAs and MTAs), we can share the data as it is collected
• Can’t share yet with the public, but can share with the group
• CRAIG:  can we grab any data – original data set that Paul gave VJ
• Not sure if this is a full DICOM dataset (bitmap images that were uploaded) – these were IVUS
• ACTION (Lisa):  ask Paul if there is a working image dataset for each of the imaging types that will be used in the study
• CRAIG: can set up web-site to differentiate confidential participants vs. non-confidential participants
• DICOM data sets might be too big to share on Openmedsystems
• AHMET:  wrote some similar grants; Vik already has some language for clinical write-up, will add some information to the computational section
• Provide to FDA prior to grant submission – let us know if anything is missing
• TINA:
• Gathering data & building models – what images will be used
• Taking anatomical measurements; with deformations?
• AHMET:  also Gate analysis on pts – quantify longitudinal deformation in artery
• TINA:
• AAA: static CT images
• Looking at anatomical variations across patients
• Series of charts:  maximum dimensions – giving range of data
• Report on 50^th percentile, 75^th percentile diameters
• CRAIG:  sounds very complementary – should be able to learn from each other
• February 5 submission

 

Computational Modeling Protocol

• Addition of Solid Modeling (T. Morrison edits)
• Added FDA perspective on solid mechanics modeling
• Construction of a solid model of a vessel (instead of a rigid cylinder) to be used for bench and simulated testing of an SFA stent design
• Interaction of stent with vessel/plaque/fluid – many years to address all of this
• Future:  complex fluid/structure interactions
• CRAIG:  one key piece is for someone to take ownership and pull it all together  so Tina’s work on this is greatly appreciated
• Website keeps a history of everything that you do
• WIKI:  let’s “re-factor” and make a clean version of this (history will be maintained)
• SOLID MODEL:  tangible translation of anatomic clinical information into engineering terms (like Solidworks) so that it can be used
• Model:  deformable – may take a long time to do this practically
• 1^st set of examples = v. helpful to show
• Integrate images so that they are accessible to engineering community (physical tests, boundary conditions for FEM)
• TINA:  important to think about what data to share with engineers to do future modeling themselves
• CRAIG:  share data in as raw a form as possible (DICOM dataset); tabular numbers (e.g., bend radii)
• Often see numbers in tables in publications
• Hope to also have 3D data available to engineering community
• BRIAN – two important goals
• Get and distribute raw data
• An example of a model built from the data – an interpretation of all the data that was collected – informs what the mechanical environment is that the stents will “see”
• TINA:  NIH meeting today – high level discussion of model and data repositories
• AHMET:  heard Tina’s talk – v. good
• 2 NIH grants
• Disseminated some data
• Can send some example pages (including DICOM data sets)
• CCF:  can collect, can bring it into a usable form to distribute, can develop models and make them available
• Can make data available through some remote (non-CCF sites), such as Stanford Biomedical Computing Center for NIH [SIMTK]
• NIH has spent millions on these sites – will help with grant application
• üACTION (Ahmet):  during the meeting he sent the ASPECT group the web-site they use for their CCF projects (foot/musculoskeletal modeling) -https://simtk.org
• Can track who downloaded data that was disseminated
• In R01: 
• collect data,
• bring into a usable format (DICOM doesn’t require special software),
• build models – generate and disseminate geometries, and
• use for simulation,
• what will be shared & when
• CRAIG:  agree that we don’t want to reinvent infrastructure

 

Outstanding ACTION Items

• Tech Transfer Agreements – FDA is drafting
• Meeting on Friday – hope to have progress soon, so we can start sharing information
• ACTION (Paul):  give Achim a wish list for what sizes and how many stents they’d like to have  (Melissa will help)
• ACTION (Tina):  update the references to include expanded references that she is referring to (on ASPECT site) - done
• ACTION (Alexander):  Wedge discussion – Alex should FU with Paul to finalize how to fund and design what is needed;  Paul will coordinate a FU discussion with Alexander and other CCF folks who will be appropriate to build
• ACTION (Paul):  estimation of costs (if dividing by multiple companies)

 

Next Meeting:  1/06/09