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The Lucina System PROJECT PROPOSAL

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University of Pittsburgh Senior Design - BioE1160 The Lucina System PROJECT PROPOSAL Timothy Bachman Garrett Grindle Leigh McClure Scott Morley Lucina Medical – PowerPoint PPT presentation

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Title: The Lucina System PROJECT PROPOSAL


1
The Lucina SystemPROJECT PROPOSAL
University of Pittsburgh Senior Design - BioE1160
  • Timothy BachmanGarrett GrindleLeigh
    McClureScott Morley

Lucina Medical
2
Overview
  • The practice of fetal heart surgery to correct
    congenital heart defects has been limited by the
    lack of a fetal CPB system.
  • It is believed that if congenital heart defects
    are corrected early, that blood flow patterns can
    be restored and the heart will develop normally.
  • There is an extremely small demand for a fetal
    CPB system probably 100s of cases per year.

3
Overview (cont)
  • This group will design a fetal cardiac bypass
    system comprised of
  • Pump
  • Venous and arterial cannulas
  • Controller, Pressure and Flow Sensors
  • Existing pumps are being evaluated for
    suitability
  • Cannulas will be purchased and modified if
    necessary

4
Lucina (Latin) Roman Goddess of Childbirth
5
Project Goals
  • Develop a working prototype of a fetal CPB system
    which fulfills the requirements of the PDS.
  • Evaluate prototype in a mock loop.

Design complete March 12, 2004
Prototype complete April 6, 2004
Testing complete April 12, 2004
6
Features Benefits (projected)
Features Benefit
Complete fetal cardiac bypass capability Permits open heart surgery on fetuses for the correction of congenital defects
Low priming volume Eliminates hemodilution. Reduces blood contact with foreign SA.
Pulsatile flow Reduces placental dysfunction.
Variable flow rate Accommodates patients perfusion needs.
7
Product Description (projected)
NOT TO SCALE
8
Design Alternatives
  • Pump
  • Currently evaluating a pediatric centrifugal
    blood pump
  • Concept for bladder-style pump has been proposed
  • Cannulas
  • Commercially available cannulas will be sought
  • Custom cannulas are possible
  • Sensors
  • Commercially available pressure and flow sensors
    will be sought

9
Competitive Analysis
  • Research Competitors
  • Stanford/UCSF group (one case w/ JJs pump)
  • Commercial Competitors
  • Blood pump companies JJ, Medtronic, Cobe, etc
  • No competing commercial products at this time
  • Strengths and Weaknesses vs. Stanford/UCSFs
    Group
  • Stanford has not published their work. Our
    competitive advantage or disadvantage has not yet
    been determined.

10
Technology
  • Current pump design technology will be
    considered.
  • Miniaturization of existing concepts will be
    considered.
  • A novel pump design has been proposed and will be
    evaluated.
  • Solid modeling and computational fluid dynamics
    will be utilized throughout the design process.

11
Team/Resources
  • People
  • Design Team Wide variety of backgrounds
    including electronics, mass transport, flow
    visualization, and biomechanics.
  • Dr. Frank Pigula, Pediatric Cardiothoracic
    Surgeon Boston Childrens Hospital Offers
    medical and end user advice.
  • Mark Gartner, Instructor, BioE 1160 Offers
    engineering expertise and material resources.
  • Sarah Wright, Engineer, Ension Offers pump
    evaluation and design advice.
  • Department of Bioengineering Offers design
    space, equipment, and funding.
  • School of Engineering Offers prototyping and
    machining facilities.
  • Limitations
  • Time Schedule is very tight, especially if pump
    design is required.
  • Funding is limited.
  • Experience of team members.

12
Current Status
  • Completed analyses/documents
  • PDS
  • Function Means Analysis
  • Object Tree Analysis
  • Human Factors Plan
  • Initial Hazard Analysis
  • Project Schedule
  • Met with Dr. Pigula regarding design
    specifications.
  • Began preliminary analysis of Nimbus Pump

13
Schedule and Milestones
  • Conceptual Design Complete 1/17/04
  • Choose pump
  • Cannula size and insertion sites
  • Determine console requirements and electrical
    safe guards
  • Primary Design Complete 2/21/04
  • Apply engineering model to determine dimensions
  • Determine Specific Components
  • Preliminary drawing and parts list
  • Design Refinement Complete 3/13/04
  • Integrate components
  • Manufacturing protocol
  • Final drawings, parts list, and testing protocol
  • Prototype Fabricated 4/6/04
  • Testing Complete 4/12/04
  • Business Plan Complete 4/14/04

14
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15
Team Responsibilities
Action Item Bachman Grindle McClure Morley
Pump Design Lead
Current pump evaluations X X X X
Solid modeling X
CFD if req. if req.
Cannula Design Lead
Evaluation of available cannulas X X X X
Solid modeling X X
CFD if req. if req.
Console Design X
Regulatory and QS X
HFE X X
Fabrication and Procurement
Pump X
Cannulas X
Console X
Prototype Evaluation X X X X
Business Plan X
16
Acknowledgements
  • Department of Bioengineering
  • Dr. Frank Pigula
  • Mr. Mark Gartner
  • Ms. Sarah Wright
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