The Lucina SystemPROJECT PROPOSAL

Timothy BachmanGarrett GrindleLeigh McClureScott Morley

University of PittsburghSenior Design - BioE1160

Lucina Medical

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.

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

Lucina (Latin): Roman Goddess of Childbirth

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

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 patient’s perfusion needs.

Product Description (projected)

NOT TO SCALE

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

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.

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.

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.

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

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

Team ResponsibilitiesAction 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

Acknowledgements

• Department of Bioengineering

• Dr. Frank Pigula

• Mr. Mark Gartner

• Ms. Sarah Wright