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

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. 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. 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. 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. 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. Treatment Method of CAD
http://www.nhlbi.nih.gov/health/healthtopics/topics/angioplasty/howdone.html
Angioplasty
Stenting
Click to See a Movie

7. Benefit of Stenting… Recovers Blood Flow
Before Stenting
After Stenting
Blockage in artery

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. 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. 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. 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. 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. 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. Geometry & Design
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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. Stent Manufacturing
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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. Stent Material
•
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Stainless Steel
Tantalum
Cobalt Chromium Alloy
Platinum
Nitinol, Magnesium…
Bio absorbable Polymer
…..
…..
Shape Memory Alloy – Retention of Shape
Materials … Potential Research & Innovation Opportunities

17. Bio Absorbable Stent
Leap Frog Innovation in Stent
Click Here on Picture - Absorb from Abbott

18. Innovation & Research Opportunities
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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. Key for Successful Product
• Marry Technology &
Domain Expertise
• Be
in
Customer
Shoes
Dream to Innovate

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. 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. RAISE Wishes
You, Family,
Friends, Loved
ones A HAPPY
&
PAROSPEROUS
NEW YEAR
2014