Endovascular stents are small mesh tubes that are placed inside blood vessels to hold them open after procedures like angioplasty. They are commonly made of metals like stainless steel or cobalt-chromium alloys. Stents are fabricated using methods like laser cutting or molding and must have properties like flexibility, strength and biocompatibility. While stents help treat blocked arteries, they also carry risks, so researchers are working on drug-eluting and biodegradable stent designs to reduce complications over time. Stents are a major medical device market with over $2.5 billion spent annually in the US.
Endovascular stents are small mesh tubes that are placed inside blood vessels to hold them open after procedures like angioplasty. They are commonly made of metals like stainless steel or cobalt-chromium alloys. Stents are fabricated using methods like laser cutting or molding and must have properties like flexibility, strength and biocompatibility. While stents help treat blocked arteries, they also carry risks, so researchers are working on drug-eluting and biodegradable stent designs to reduce complications over time. Stents are a major medical device market with over $2.5 billion spent annually in the US.
Endovascular stents are small mesh tubes that are placed inside blood vessels to hold them open after procedures like angioplasty. They are commonly made of metals like stainless steel or cobalt-chromium alloys. Stents are fabricated using methods like laser cutting or molding and must have properties like flexibility, strength and biocompatibility. While stents help treat blocked arteries, they also carry risks, so researchers are working on drug-eluting and biodegradable stent designs to reduce complications over time. Stents are a major medical device market with over $2.5 billion spent annually in the US.
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?