1. The Lucina System PROJECT PROPOSAL Timothy Bachman Garrett Grindle Leigh McClure Scott Morley University of Pittsburgh Senior Design - BioE1160 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 100’s 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 completeMarch 12, 2004 Prototype completeApril 6, 2004 Testing completeApril 12, 2004

6. Features & Benefits (projected) FeaturesBenefit 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 flowReduces placental dysfunction. Variable flow rate Accommodates patient’s 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/ J&J’s pump) Commercial Competitors Blood pump companies: J&J, Medtronic, Cobe, etc No competing commercial products at this time Strengths and Weaknesses vs. Stanford/UCSF’s 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 Children’s 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

15. Team Responsibilities Action ItemBachmanGrindleMcClureMorley Pump DesignLead Current pump evaluationsXXXX Solid modelingX CFDif req. Cannula DesignLead Evaluation of available cannulas XXXX Solid modelingXX CFDif req. Console DesignX Regulatory and QSX HFEXX Fabrication and Procurement PumpX CannulasX ConsoleX Prototype EvaluationXXXX Business PlanX

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