Endovascular Stents

Mark DeAngelis, Hector Baez, Amanda Johnston,

Justin Eng
Background
Developed in late 1980s.
Hold open blood vessels at sites of percutaneous
transluminal coronary angioplasty (PCTA) or vascular
injury.
PCTA is a form of percutaneous cardiovascular
intervention (PCI), used for patients with
atherosclerotic plaque or thrombotic deposits (Ratner et
al, 2013).
Diagram of PCTA
Figure 1. A diagram of PCTA: A) the location of the coronary arteries, B) the artery before the
balloon is expanded, C) the artery as the balloon is expanding, D) the stent in place. (NIH)
Background (cont.)
Can be balloon inflated or self-inflated.
Three main types:
Coil
Circular tubes of metallic wire or strips in coil shape.
Tubular mesh
Wires wound together in a mesh network.
Slotted tube
Metal tubes that have a laser-cut design (Butany et al,
2005).
Materials
Metals are ideal for stents.
Many choices for grades and alloys.
Allows tailoring to different needs.
Excellent mechanical properties.
Typically bioinert.
Fairly inexpensive and easy to fabricate.
Can be coated with polymeric coatings (Ratner et al,
2013; Stent Manufacturing).
Fabrication
Can be laser fabricated using computer numerical
control (CNC).
Produces slotted tube type.
Laser cuts pattern from metal tube.
Mask is applied to allow different heat treatment for
bands and connectors.
Mask is removed after heat treatment (Gregorich).
Fabrication (cont.)
Alternative method:
Liquid or powder stent material is poured into
female mold.
Mold is rotated with forces of at least 1G as stent
solidifies (Mirizzi).
Argon furnaces allow annealing temps of 11oo C for
316L stainless steel.
Stents can be electropolished after heat treatment.
Inspected for quality control and packaged in clean
rooms (Stent Manufacturing).
316L Stainless Steel
Low carbon grade of 316 stainless steel.
Unaffected by sensitization, the precipitation of
carbides at grain boundaries.
Contains molybdenum.
Provides corrosion resistance in chloride
environments.
Austenitic structure.
Provides excellent strength (Stainless Steel).
316L Stainless Steel
Element Percent
Composition
Iron Balance
Carbon <0.03%
Chromium 16-18.5%
Nickel 10-14%
Molybdenum 2-3%
Manganese <2%
Silicon <1%
Phosphorus <0.045%
Sulphur <0.03
Figure 2. A table of the chemical
composition of 316L stainless
steel (Stainless Steel).
Figure 3. The Medtronic beStent2, a
balloon expandable, slotted tube stent
made of 316L stainless steel. The arrow is
pointing to gold radiopaque marker.
(Butany et al, 2005)
UNIMET L-605 Cobalt
Chromium
Super-alloy
Can withstand high temps and mechanical stress.
Solid strengthened.
Excellent resistance to:
Oxidation
Sulfidation
Wear
Galling
Stronger than steel, better radiopacity (AZoM, Kereiakes et al,
2003).
UNIMET L-605 Cobalt
Chromium
Element Percent Composition
Cobalt 46.38-56.95%
Chromium 19-21%
Tungsten 14-16%
Nickel 9-11%
Iron <3%
Other Balance
Figure 4. A table of
UNIMET L-605s
chemical composition
(AZoM).
Comparison of Metals
Metal
Elastic
modulus
(GPa)
Yield
strength
(MPa)
Tensile
strength
(MPa)
Density
(g/cm3)
316L stainless steel (ASTM F138
and F139; annealed) 190 331 586 7.9
Cobalt chromium 210 448-648 951-1220 9.2
Pure iron 211.4 120-150 180-210 7.87
Mg alloy (WE43) 44 162 250 1.84
Figure 4. A comparison of the mechanical properties of metals, including
316L and cobalt chromium (Mani et al, 2007).
Optimizing the Device
Desirable characteristics:
Low cross sectional area
High flexibility
High biocompatibility
High radial strength
Low metallic surface area
Favorable radiographic properties
Easy deployment (Butany et al, 2005)
Figure 5. Features of a commercial cobalt chromium stent (Sahajanand
Medical Technologies Pvt. Ltd.).
Interaction
Minimal interaction with the host tissue
(blood)
Withstand corrosion
Cobalt Chromium
316L Stainless Steel
Engineering Solutions
Drug-Eluting stents
anti-proliferative drug (Maisel)
prevents neointima
Biodegradable stents
short term support
absorbed or dissolved
match the radial strength of traditional materials
Why Stents?
Treats stenosis, improving
blood flow
High complication rate
(Biomaterials Science 775)
~21% within the first 9
months
Room for improvement
Figure 6. Increase in carotid stenting
(Nallamothu)
FDA Approval
First coronary stent 1994
Classification
nature of expansion
stent design
Commercialization
As late as 2004, 16 models were approved
9 different manufacturers
Prefered treatment for Coronary Artery
Disease
$2.5 billion spent on stents in 2003 (Butany)
Competition
Currently 13 approved
coronary stents by FDA
Growing Market
Overuse debate
Figure 7. Market size and growth for
coronary stent devices (Ruchika BBC)
Work Cited
AZoM.com Staff Writers. "UDIMET Alloy L-605 (UNS R30605)." UDIMET Alloy L-605 (UNS R30605).
AZoM, 29 June 2013. Web. 08 Apr. 2014. <http://www.azom.com/article.aspx?ArticleID=9458>.
Butany, J., K. Carmichael, S. W. Leong, and M. J. Collins. "Coronary Artery Stents: Identification and
Evaluation." Journal of Clinical Pathology 58.8 (n.d.): 795-804. US National Library of Medicine. Web.
<http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1770873/>.
Gregorich, Daniel, and Jonathan Stinson. Medical Devices and Methods of Making the Same. Boston Scientific Scimed, Inc., assignee. Patent US 20080114449 A1. 23 Jan.
2008. Print.
"How Is Coronary Angioplasty Done?" - NHLBI, NIH. NIH, 01 Feb. 2012. Web. 08 Apr. 2014. <http://www.nhlbi.nih.gov/health/health-
topics/topics/angioplasty/howdone.html>.
Kereiakes, Dean J. "Usefulness of a Cobalt Chromium Coronary Stent Alloy." ScienceDirect. The American Journal of Cardiology, Aug.-Sept. 2003. Web. 8 Apr. 2014.
Maisel, William H., Dr. "Drug-Eluting Stents." American Heart Association Journals. Circulation, 2017. Web. 30 Apr. 2014.
Mani, Gopinath, Marc D. Feldman, Devang Patel, and C. Mauli Agrawal. "Coronary Stents: A Materials Perspective." Coronary Stents: A Materials Perspective.
Biomaterials Volume 28, Issue 9, Mar. 2007. Web. 08 Apr. 2014. <http://www.sciencedirect.com/science/article/pii/S0142961206010076>.
Mirizzi, Michael S. Stent Made by Rotational Molding or Centrifugal Casting and Method for Making the Same. Advanced Cardiovascular Systems, Inc., assignee.
Patent US 6574851 B1. 31 July 2000. Print.
Nallamothu, Brahmajee K., Dr., Mingrui Lu, Dr., Mary A. Rogers, Dr., Hitinder S. Gurm, Dr., and John D. Birkmeyer, Dr.
"Physician Speciality No Effect on Carotid Stenting Outcomes | HeartZine." Physician Speciality No Effect on Carotid Stenting Outcomes | HeartZine. Archives of
Internal Medicine, Aug. 2008. Web. 30 Apr. 2014.
Ratner, Buddy D. Hoffman, Allan S. Schoen, Frederick J. Lemons, Jack E. (2013). Biomaterials Science - An Introduction to Materials in Medicine (3rd Edition). (pp.
773-776). Elsevier.
Sahajanand Medical Technologies Pvt. Ltd. Design Features of Coronnium. Digital image. SMTPL - Coronnium - Cobalt Chromium Alloy Coronary Stent. Sahajanand
Medical Technologies Pvt. Ltd, n.d. Web. 30 Apr. 2014. <http://www.smtpl.com/coronnium.html>.
"Stainless Steel - Grade 316L - Properties, Fabrication and Applications (UNSS31603)." Stainless Steel - Grade 316L - Properties, Fabrication and Applications (UNS
S31603). AZoM, 18 Feb. 2004. Web. 08 Apr. 2014. <http://www.azom.com/article.aspx?ArticleID=2382>.
"Stent Manufacturing." Stent Manufacturing - Nitinol Stents. Norman Noble, Inc, n.d. Web. 08 Apr. 2014. <http://www.nnoble.com/Stent/Stents.htm>.
Questions?