The Lucina System PROJECT PROPOSAL

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The Lucina SystemPROJECT PROPOSAL
University of Pittsburgh Senior Design - BioE1160

• Timothy BachmanGarrett GrindleLeigh
  McClureScott Morley

Lucina Medical
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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.

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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

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Lucina (Latin) Roman Goddess of Childbirth
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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
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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.
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Product Description (projected)
NOT TO SCALE
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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

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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.

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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.

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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.

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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

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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

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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
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Acknowledgements

• Department of Bioengineering
• Dr. Frank Pigula
• Mr. Mark Gartner
• Ms. Sarah Wright