This book offers a historical account of the development of the On-X carbon mechanical heart valve, discussing the steps involved in developing the materials, and describes how the design of the valve has evolved over the years. It explores both the scientific and corporate problems researchers have encountered over the years in the journey of making a mechanical heart valve. The chapters provide a detailed description of the design of the mechanical leaflet-based prosthetic valve, with a particular focus on blood flow characteristics. This book includes an overview of the state-of-the-art in the chemistry and physics of carbon, and compiles the advances in carbon-based technology and its applications in cardiac and thoracic surgery.This is an ideal book for bioengineers working on the chemistry and physics of carbon, and other professionals involved with cardiac and thoracic surgery.
Author(s): Jack Bokros
Publisher: Springer
Year: 2023
Language: English
Pages: 290
City: Cham
Foreword by John D. Puskas, MD
Foreword by Mervyn Williams
Acknowledgments
Contents
Abbreviations
Contents
Contents
Chapter 1: Overview
Chapter 2: Nuclear Foundations
Grappling with a Serious Problem
A Brush with the Not Discovered Here Mentality
Another Rung on the Academic Ladder
More Experience with Reactors
The Final Rung of the Academic Ladder
Diving Back into Industry
References
Chapter 3: Origin and Characterization of Medical Carbons
Black Box Analysis
New Directions Based on New Evidence
References
Chapter 4: Gott’s Early Experience: A Lesson in Serendipity
The Artificial Heart Program
The Gordon Conference
General Atomic Enters the World of the Artificial Heart Program
Following the Evidence Where It Leads
Where the Studies Led
References
Chapter 5: First Carbon Heart Valve Replacement
Navigating Unforeseen Complications
Manufacturing the First Hollow Balls
The Valves that Took a Detour
DeBakey-Surgitool Valves In Vivo
References
Chapter 6: First All-Carbon Mitral Valve Replacement
The Beall Valves Advance the State of the Art
A Major Wake-Up Call
One Patient’s Three-Decade Track Record
At the Dawn of the Industry
References
Chapter 7: Monoleaflet Tilting Disc Valves
An Unforeseen New Problem Arises
Business Complexities Take Center Stage
Large Black Smudge on Laboratory Exterior Wall
An Invited Visit to the Italian Company Facility
Marshall Kriesel and Medical Incorporated
Shiley Laboratories Develops Its Valve Designs
Medical Inc. Designs an Improved Valve
Medical Incorporated’s Omnicarbon Valve
Shiley’s Struggles with Strut Failure
The Key to the Future
References
Chapter 8: First Bileaflet Valve: St. Jude Medical Inc. Start-Up
Accommodating Demands for an Inspection
Reference
Chapter 9: General Atomic Inc. Medical Products Division Sold to Intermedics Inc.
Chapter 10: CarboMedics Inc. Gets Acquainted with Intermedics Inc.
Chapter 11: CarboMedics Inc. Moves to Austin Texas
The New Facility in Austin
New Facility, New Problems
Reference
Chapter 12: The Hemex Inc. Venture
The Dawn of Hemex, Inc.
Reaching beyond Carbon Heart Valve Replacement
References
Chapter 13: The St. Jude Medical Inc. Litigation
Dirty Tricks That Backfired
Reference
Chapter 14: Broadening the Horizon
References
Chapter 15: Two Valves for China
“Call Me Ned”
Rollie Siegel Joins CarboMedics, Inc.
First Steps in China
Bringing Carbon to Beijing
First Human Implant of the CarboMedics, Inc. Replacement Valve
References
Chapter 16: Negotiating Chinese Joint Venture
Chapter 17: European Company Buys Intermedics Inc.
References
Chapter 18: Medtronic Inc. Project
A Key Technical Breakthrough
The Accuntius/Wilde Patent Makes a New Pure Carbon Valve
References
Chapter 19: Medical Carbon Research Institute LLC/On-X Life Technologies Inc.
Visit to a Vineyard
Chapter 20: Valve Design
A Flare for Valve Design
High-Impact Versus Low-Impact Valve Closure
References
Chapter 21: Clinical Trials
A Pause to Reflect Important Events
References
Chapter 22: Design Validation
Leonard da Vinci Lays Down the Law
“The Thrill Is Gone!”
References
Chapter 23: Studies Concurrent with FDA Trials
Mervyn Williams and the South African Study
Belgium Reports In
Putting the Pieces All Together
Promoting the On-X Valve
References
Chapter 24: Understanding Cardiac Blood Flow
Gerald Buckberg and the Advance of Heart Science
References
Chapter 25: Investigating the Viability of Bioprostheses
Reference
Chapter 26: On-X Valve Implantability
What’s in a Shape?
References
Chapter 27: Selling the On-X Valve
Encountering Unexpected Resistance
Chapter 28: The Leonardo da Vinci Video
Marketing Philosophies in Conflict
References
Chapter 29: Gerald Buckberg Joins the Video Project
Misconceptions That Could Have Been Prevented
Big News from the FDA
References
Chapter 30: A Surprise from Northwestern University
The Video Continues to Evolve
Too Little Too Late?
The Video and the In-House Critics
References
Chapter 31: CryoLife Inc. Buys On-X Life Technologies Inc.
Chapter 32: Mervyn Williams’s South African Trial of the On-X Valve
Introduction
Surgical Procedure
Results
Discussion
Conclusion
References
Chapter 33: Summary and Reflections
Appendix
Summary and Conclusions
Reliability of Pyrolytic Carbon for Heart Valve Application
Fatigue Crack Growth Threshold
Does Pyrolytic Carbon Fatigue At All?
Probability of Failure and Weibull Statistics
Micro Cracks
Microstructure of Pyrolytic Carbon
Conclusions
References
Index
