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    Final Presentation

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    api-520229867
    The document summarizes a design project for a left atrial appendage closure (LAA) device called UmbreLAA. Existing LAA occlusion devices have limited anatomical range. UmbreLAA aims to develop a non-pharmacological approach to reduce stroke risk from clots in patients with atrial fibrillation. The final design of UmbreLAA features a plug, anchoring system, and adjustable pacifier to improve sealing and conformability over current devices. Testing showed UmbreLAA conformed to larger anatomies and sealed more effectively than competitors in irregular shapes. The team conducted several design iterations and manufacturing methods to create prototypes for testing and requirements validation.

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    Final Presentation

    Uploaded by

    api-520229867
    280 views25 pages
    The document summarizes a design project for a left atrial appendage closure (LAA) device called UmbreLAA. Existing LAA occlusion devices have limited anatomical range. UmbreLAA aims to develop a non-pharmacological approach to reduce stroke risk from clots in patients with atrial fibrillation. The final design of UmbreLAA features a plug, anchoring system, and adjustable pacifier to improve sealing and conformability over current devices. Testing showed UmbreLAA conformed to larger anatomies and sealed more effectively than competitors in irregular shapes. The team conducted several design iterations and manufacturing methods to create prototypes for testing and requirements validation.

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    The document summarizes a design project for a left atrial appendage closure (LAA) device called UmbreLAA. Existing LAA occlusion devices have limited anatomical range. UmbreLAA aims to develop a non-pharmacological approach to reduce stroke risk from clots in patients with atrial fibrillation. The final design of UmbreLAA features a plug, anchoring system, and adjustable pacifier to improve sealing and conformability over current devices. Testing showed UmbreLAA conformed to larger anatomies and sealed more effectively than competitors in irregular shapes. The team conducted several design iterations and manufacturing methods to create prototypes for testing and requirements validation.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    280 views25 pages

    Final Presentation

    Uploaded by

    api-520229867
    The document summarizes a design project for a left atrial appendage closure (LAA) device called UmbreLAA. Existing LAA occlusion devices have limited anatomical range. UmbreLAA aims to develop a non-pharmacological approach to reduce stroke risk from clots in patients with atrial fibrillation. The final design of UmbreLAA features a plug, anchoring system, and adjustable pacifier to improve sealing and conformability over current devices. Testing showed UmbreLAA conformed to larger anatomies and sealed more effectively than competitors in irregular shapes. The team conducted several design iterations and manufacturing methods to create prototypes for testing and requirements validation.

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    © All Rights Reserved
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    of 25

    LAA

    LEFT ATRIAL
    APPENDAGE CLOSURE
    2.75 Final Presentation

    ● Gari Eberly
    ● Diego Alonso Quevedo Moreno
    ● Madison Reddie
    ● Aviva Levi

    Source: www.freepik.com
    CLINICAL NEED
    ● Atrial Fibrillation: irregular
    atrial contraction
    ○ ~37m people worldwide
    ○ Increased risk of clot
    formation
    ○ Subsequent 5-fold risk
    of ischemic stroke

    ● 90% of clots originate from


    left atrial appendage (LAA)
    Source: Created with biorender.com
    EXISTING SOLUTIONS

    ● Occlusion devices
    ○ Amulet
    ○ WATCHMAN FLX

    ● Limited anatomical range

    ● Still need to take blood


    thinners with WATCHMAN FLX
    Source: Diagnostic & Interventional
    Cardiology
    USE AND SERVICE

    ● TEE imaging and size


    selection

    ● Femoral vein catheter


    deployment
    Source: WATCHMAN DRT Brochure

    ● Endothelialization Source: Fairview Health Services


    MISSION STATEMENT

    “ Develop a non-pharmacological
    approach to reduce the risk of stroke
    from clots that originate from the left
    atrial appendage in patients with
    non-valvular atrial fibrillation
    FUNCTIONAL REQUIREMENTS
    Functional requirement Design parameter Analysis
    Prevent clot release Effective seal Leakage test

    Conformity
    Fit large anatomical range Beat current, on market device ranges
    Leakage test

    Minimally invasive delivery Fit inside 4mm catheter Geometric size

    Minimize embolization, trauma risk Establish secure fit with atraumatic features Tug test

    Promote endothelialization Use biocompatible materials

    Fatigue life Use materials with ductility, durability

    Easy, efficient deployment Avoid adding new steps to procedure


    DESIGN PROCESS STRATEGIES

    Ablation Ligation Endocardial plug


    FINAL DESIGN UmbreLAA
    Pacifier Plug Anchoring

    Adjustability

    TPU Cover

    Modular Design
    FINAL DESIGN UmbreLAA
    Isometric View Front View Lateral View
    SIZE OPTIMIZATION

    Effective
    diameter
    Effective
    length (mm)

    Effective
    length

    Effective
    diameter (mm)
    FINAL DESIGN UmbreLAA
    Isometric View Front View Lateral View
    DESIGN ITERATIONS
    DESIGN ITERATIONS

    FINAL
    FINAL PROTOTYPE
    Pacifier
    Plug Ostium model

    Anchors
    ADJUSTABILITY

    32mm
    MANUFACTURING
    PETG Nitrile Rubber Steel Thermoplastic

    Laser-cut Adhere Adhere Thermoform


    PETG frame nitrile rubber nut, steel wire TPU
    (Locktite 401) (Flexible Adhesive)
    MANUFACTURING
    TEST METHODS
    Conformability Sealing Stability

    31.5mm
    TEST METHODS
    TEST RESULTS Conformability

    32mm UmbreLAA 20mm WATCHMAN FLX

    31.5mm 14mm
    TEST RESULTS Sealing
    ● Round molds
    ○ Nearly no leakage when
    compression > 10%
    ● Extreme ovular molds
    ○ WATCHMAN:
    79% leakage
    ○ UmbreLAA (w/o pacifier):
    66% leakage
    ○ UmbreLAA (w/ pacifier):
    effectively no leakage 31.5mm
    TEST RESULTS Stability
    REQUIREMENTS REVIEW Pass
    Fail
    Maybe

    Functional requirement Design parameter Analysis


    Prevent clot release Effective seal Leakage test

    Conformity
    Fit large anatomical range Beat current, on market device ranges
    Leakage test

    Minimally invasive delivery Fit inside 4mm catheter Geometric size

    Minimize embolization, trauma risk Establish secure fit with atraumatic features Tug test

    Prototype with these


    Promote endothelialization Use biocompatible materials
    materials (known)
    Testing needed with final
    Fatigue life Use materials with ductility, durability
    intended material
    Exact deployment
    Easy, efficient deployment Avoid adding new steps to procedure
    procedure TBD
    OUR TEAM

    Gari Eberly Diego Madison Aviva Levi


    Quevedo Reddie
    HST PhD MechE - MechE - MechE -
    Student Graduate Graduate Student Graduate Student
    Student

    Special thanks to…


    Patrick Willoughby Brian Tischler Prof Ellen Roche
    BSC BSC Professor

    Dave Custer Keegan Mendez


    Communication Teaching Assistant

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