Innovation Trends & Research
Opportunities in Safety Critical Coronary
Artery Stents
By

L Ramanan
Predictive & Robust Med...
HEART… The Pump!!!
• Heart beats 72 times per minute…
103,680 times a Day…
1.9 Billion
beats in a 50 year adult….
• Normal...
Coronary Artery
• Heart is made of muscles require
oxygenated blood for their working.
• Heart muscles are surrounded by
a...
Burden of Cardio Vascular Disease

Projections for CHD Mortality in India

Principal Causes 58 Million Deaths of
All Ages ...
Atherosclerosis – Mechanism & Physics
• Atherosclerosis – (Block)
• Build-up of fat & plaque
• Obstructs Blood flow

Ref: ...
Treatment Method of CAD

http://www.nhlbi.nih.gov/health/healthtopics/topics/angioplasty/howdone.html

Angioplasty
Stentin...
Benefit of Stenting… Recovers Blood Flow

Before Stenting

After Stenting
Blockage in artery
What is Stent?

• A small meshed metal tube
• Structural Support to artery

Driver Sprint from Medtronic

Coronary Stent f...
Coronary Stent System
Expanded Balloon
Radio Marker
Folded Balloon

Stent

Driver® from Medtronic Picture Ref from Medtron...
Stent Deployment

GE’s Cath Lab
Picture GE’s Innova Biplane at Cath Lab In Hospital - Ref:
L Ramanan, 2010, “Six Sigma – A...
Origin of Stent Development
• Angioplasty in 1970s was
developed
by
Andreas
Gruentzig
• Coronary Angioplasty later
referen...
Stent Pyramid
Ref: A Survey of Stent Designs - Stoeckel,
Bonsignore, Duda, Min Invas Ther &
Allied Technol, 11(4) pp. 137‐...
Additions, Coatings
• Bare Metal Stent vs
Drug eluting Stents
• Endothelialisation &
Drug Coating
• Radiopaque Coating
• R...
Geometry & Design
•
•
•
•
•
•
•
•
•

Open Cell
Closed Cell
Hybrid
Rings
Helical
AMG
Coil
Peak-Peak
Abbott
SMTPL
Peak-valle...
Stent Manufacturing
•
•
•
•
•
•
•
•
•

Laser Machining
EDM
Photo Chemical Etching
Braiding
Nitting
Stranding
Water Jet Cut...
Stent Material
•
•
•
•
•
•
•
•

Stainless Steel
Tantalum
Cobalt Chromium Alloy
Platinum
Nitinol, Magnesium…
Bio absorbable...
Bio Absorbable Stent

Leap Frog Innovation in Stent
Click Here on Picture - Absorb from Abbott
Innovation & Research Opportunities
•
•
•
•
•
•
•
•
•
•
•
•

New Drug – Chemistry, Biology
Drug Coating – Nano Technology
...
Key for Successful Product
• Marry Technology &
Domain Expertise

• Be

in

Customer

Shoes

Dream to Innovate
Innovate and Make a Difference
• Dreamt of Contributing to Design
a Coronary Artery Stent
• Delivered a little in recent t...
Acknowledgements
• Sincere Thanks to Prof. K Chandrasekaran, Sri Srinivasan,
President PDMA India, Ms Christina President ...
RAISE Wishes
You, Family,
Friends, Loved
ones A HAPPY
&
PAROSPEROUS
NEW YEAR
2014
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Innovation trends and Opportunities in safety critical coronary artery stents

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A presentation that is intended for Researchers for giving an overview of Coronary Stents, Its importance to mankind, its deployment procedure and modality and the the opportunities for Research and Innovation

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Innovation trends and Opportunities in safety critical coronary artery stents

  1. 1. Innovation Trends & Research Opportunities in Safety Critical Coronary Artery Stents By L Ramanan Predictive & Robust Medical Device Design Subject Matter Expert - RAISE Consultancy 16th Dec 2013 @ IC&SR, IITM - Chennai
  2. 2. HEART… The Pump!!! • Heart beats 72 times per minute… 103,680 times a Day… 1.9 Billion beats in a 50 year adult…. • Normal Heart pumps ~73ml of Blood per beat… 7568Litres of Blood in a Day… pumped 139 Million Litres of Blood in a 50 year Adult (Blood forms ~8% of human mass, ~5 Litres in Vol) • Blood Circulatory system of veins and artery of an adult is about 100,000Km in length • Arteries carry oxygenated blood • Veins carry de-oxygenated blood Reliability Number!!?? God’s Best Gift
  3. 3. Coronary Artery • Heart is made of muscles require oxygenated blood for their working. • Heart muscles are surrounded by arteries and Veins • Coronary Artery Size varies approximately between 0.6mm to 4.5mm • Systolic Pressure in artery (when heart contracts/pumps) 100 – 140mm of Hg • Diastolic Pressure in artery (when heart relaxes) 60 – 90 mm of Hg • Blood pressure in smallest artery (arterioles) is ~35mm of Hg Pic Ref: 3dscience.com
  4. 4. Burden of Cardio Vascular Disease Projections for CHD Mortality in India Principal Causes 58 Million Deaths of All Ages in 2005 – Worldwide One of CVD / CHD / CAD is ? Projections for CHD Mortality in India Source: Burden of Cardio Vascular Disease in India by Dr. Rajeev Gupta, India
  5. 5. Atherosclerosis – Mechanism & Physics • Atherosclerosis – (Block) • Build-up of fat & plaque • Obstructs Blood flow Ref: Atherosclerosis (Source: Human Physiology, 7th Edition) http://www.nhlbi.nih.gov/health/health-topics/topics/cad/
  6. 6. Treatment Method of CAD http://www.nhlbi.nih.gov/health/healthtopics/topics/angioplasty/howdone.html Angioplasty Stenting Click to See a Movie
  7. 7. Benefit of Stenting… Recovers Blood Flow Before Stenting After Stenting Blockage in artery
  8. 8. What is Stent? • A small meshed metal tube • Structural Support to artery Driver Sprint from Medtronic Coronary Stent from Abbott Promus Premier from Boston Scientific http://www.nhlbi.nih.gov/health/health-topics/topics/stents/ Supralimus Core from Sahajanand Involves – High Precision, Technology & Safety
  9. 9. Coronary Stent System Expanded Balloon Radio Marker Folded Balloon Stent Driver® from Medtronic Picture Ref from Medtronic Stent Crimped on Delivery System – Secure Technology of Medtronic
  10. 10. Stent Deployment GE’s Cath Lab Picture GE’s Innova Biplane at Cath Lab In Hospital - Ref: L Ramanan, 2010, “Six Sigma – An Ingredient of Innovative Product Design”, IndoUS Workshop on – “Product Design – Impact from Research to Education to Practice” Pict Ref: L Ramanan (2008) CAE Simulation - An Inspiring Technology in Medical Device Design, 2008 ANSYS India Keynote Address To See a Angiogram Procedure in Cath Lab Click on Above Picture Ramanan is Grateful to his Past Employer GE, for Opportunity to Work in Cath Lab… Passion to Cath Lab, Sowed His Dream on Working for Stents
  11. 11. Origin of Stent Development • Angioplasty in 1970s was developed by Andreas Gruentzig • Coronary Angioplasty later referenced as PTCA • PTCA had the issues of ~40% Restenosis within 6 Months • First Bare Metal stent was invented by Dr. Julio Palmaz in 1990s and reduced restenosis to 20 - to 25% Dr. Andreas Gruentzig (1929-85) Dr. Julio Palmaz Continuous Innovations Keep Happening In Stent!!!
  12. 12. Stent Pyramid Ref: A Survey of Stent Designs - Stoeckel, Bonsignore, Duda, Min Invas Ther & Allied Technol, 11(4) pp. 137‐147, 2002 Stent Throws Lots of Challenges & Opportunities For Research, Innovation & Business
  13. 13. Additions, Coatings • Bare Metal Stent vs Drug eluting Stents • Endothelialisation & Drug Coating • Radiopaque Coating • Radiopaque Markers Marker on Balloon Nano Coating – Ensures uniformity in drug coating Usually (Ti) Innovation Needs & Research Opportunities in Stents Keeps Growing
  14. 14. Geometry & Design • • • • • • • • • Open Cell Closed Cell Hybrid Rings Helical AMG Coil Peak-Peak Abbott SMTPL Peak-valley Fire Bird Biosensor are Referenced from Web Stent Thickness Note: Pictures of Stentnot Exhaustive / Covering alland link appended Geometry Shown are manufacturers. Ref: PhD Thesis of Computer Modelling of Coronary Bifurcation Stenting, - Peter Mortier, Universiteit, Gent First Patent on Bare Metal Stent was Issued in 1984… Between 1984 to 1994 the number of patents granted are 245… Innovation in Stents Keeps Growing…
  15. 15. Stent Manufacturing • • • • • • • • • Laser Machining EDM Photo Chemical Etching Braiding Nitting Stranding Water Jet Cutting Metal Injection Molding Assembly from Wire Laser Cutting Winding Inventions & Innovation Opportunities in Process…
  16. 16. Stent Material • • • • • • • • Stainless Steel Tantalum Cobalt Chromium Alloy Platinum Nitinol, Magnesium… Bio absorbable Polymer ….. ….. Shape Memory Alloy – Retention of Shape Materials … Potential Research & Innovation Opportunities
  17. 17. Bio Absorbable Stent Leap Frog Innovation in Stent Click Here on Picture - Absorb from Abbott
  18. 18. Innovation & Research Opportunities • • • • • • • • • • • • New Drug – Chemistry, Biology Drug Coating – Nano Technology Precision Machining - Manufacturing Tech Heat Treatment – Metallurgy,.. Finish – EDM, Tribology… Design, Geometry – Product Design Materials – CoCr, Ni, Mg, … Radiopaque – Coating, material… Delivery System – Self / Balloon Expanding Metrology – SEM, Quality - Process & Product Polymer Fibers …….. Stent Provides World of Opportunities… Research Outputs Will Live in Hearts… Makes a Difference
  19. 19. Key for Successful Product • Marry Technology & Domain Expertise • Be in Customer Shoes Dream to Innovate
  20. 20. Innovate and Make a Difference • Dreamt of Contributing to Design a Coronary Artery Stent • Delivered a little in recent times • Developed Passion for Stents, hoping to contribute more in other variants of Coronary Stents • Dreaming of contributing to other clinical needs of Stents & Implantable Medical Devices Dr.A.P.J.Abdul Kalam Dream, Dream, Dream. Dream….… Actions
  21. 21. Acknowledgements • Sincere Thanks to Prof. K Chandrasekaran, Sri Srinivasan, President PDMA India, Ms Christina President PDMA - US, Learned Organizing Committee Members of ICSISPD 2013 • To RAISE’s Customers, Partners, vendors, all past employers of Ramanan - GE, Lucas TVS, Indian Railways, IITM, Teachers, Mentors, all his professional associations ASQ, ASME, QCI, IEI, ASM, IUSSTF, IUCEE, BMSI & PDMA, luminary health care professionals, noble Doctors, Our Partners in Research - Minitab, ANSYS, my family, relatives & friends across global poles for the contributions, in my growth as a SME in DFSS for Predictive and Robust Design towards Medical Devices Note: • Opinion expressed here are only for academic purpose in enhancing knowledge. No other interpretations are implied or intended or shall be made. Examples picked-up are from the published / presented work in public domain. They are referenced and greatly acknowledged appropriately, • If I missed referencing any of the source, I sincerely apologize and is not intentional – Ramanan, RAISE
  22. 22. RAISE Wishes You, Family, Friends, Loved ones A HAPPY & PAROSPEROUS NEW YEAR 2014

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