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Amanda, Mary, & Makayla May 10th, 2013 The Phenomenon of Pacemakers Purpose: To inform peers about the

titanium alloy Ti-6Al-4V, as well as how its used in the manufacturing of pacemakers. I. Introduction: If you place two fingers on your wrist or your neck, youre able to feel your heartbeat. Your heartbeat is caused by the chambers of the heart contracting, allowing blood to be pumped through them. This happens because the body has a natural pacemaker to regulate this. However, this natural pacemaker may either malfunction or break down, so man-made pacemakers can be implemented into the body to keep the heart on track. Overview of pacemakers A. What they are 1. Electronic biomedical device thats able to regulate the human heartbeat 2. Small box thats surgically implanted into the chest cavity with electrodes that are in direct contact with the heart 3. Implemented in tens of thousands of patients annually B. How theyre used 1. Necessary when bodys natural pacemaker malfunctions or breaks down a. Pumping of the heart synchronized by the sinoatrial node located in right atrium b. Natural pacemaker able to create electrical energy, impulse travels throughout the heart, causing different chambers to contract 2. Not a permanent solution, need to be replaced before they have the chance to wear out 3. Have become easier to implant into body C. Brief history 1. First pacemaker developed in 1952 by Paul Zoll, was portable version of cardiac resuscitator 2. C. Walton Lillehei improved Zolls pacemaker by making leads attach directly to outer wall of heart 3. In 1958, a battery was added as the power source, allowing patients to be mobile and for the continuous use of a pacemaker 4. First implantable pacemaker invented by William Chardack and Wilson Greatbatch, implanted in a living patient in 1960 5. Modern technique for implanting pacemakers developed by Seymour Furman a. Leads inserted into vein and threaded into the ventricles, meaning that chest cavity isnt opened in the process b. Since the leads are inside heart, lower voltages are now needed to regulate heartbeat so pacemakers can be implemented for longer periods of time D. Different designs 1. North American Society of Pacing and Electrophysiology (NASPE) classifies pacemakers according to which heart chamber is paced, which chamber is sensed, how the pacemaker responds to a sensed beat, and whether it is programmable 2. Numerous different models, all essentially composed of battery, lead wires, and circuitry 3. Common characteristics

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Amanda, Mary, & Makayla May 10th, 2013 a. Must be able to generate about five volts of power b. Must retain power over many years, with a minimum time frame of four years c. Must have a predictable life cycle so that doctors know when to replace them d. Must be able to function when theyre hermetically sealed, making them airtight E. How theyre made 1. Components constructed individually before being pieced together to form the final product a. Battery is made b. Leads are made c. Motherboard is made d. Final assembly includes the circuitry being connected to the battery before both of them are inserted into the metal casing 1) Focus on casing 2) Casing constructed in multiple pieces, sealed together after other pacemaker components are manufactured 3) Casing pieces are a stamped product made from sheets e. Final product packaged along with accessories 2. Quality control is very important because peoples lives depend on these devices 3. Ti-6Al-4V used to make the casing a. High resistance to corrosion b. Low weight c. Biocompatible d. Greater yield and ultimate strengths than pure titanium e. Durable f. Main titanium alloy thats used, different designs may use different titanium alloys Overview of Ti-6Al-4V A. Other applications 1. Biomedical implants 2. Bone screws 3. Bone plates 4. Heart valves 5. Peripheral stents 6. Used in a lot of biomedical applications because of characteristics and properties B. Composition 1. Alloying Elements a. Aluminum 1) 6% 2) Alpha stabilizer b. Vanadium 1) 4% 2) Beta stabilizer

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Amanda, Mary, & Makayla May 10th, 2013 c. Titanium: Makes up the balance 2. Impurities a. Carbon 1) 0.10% 2) Hard material, not intentionally added b. Iron 1) 0.40% 2) Beta stabilizer, not intentionally added c. Hydrogen 1) 0.015% 2) Added due to air exposure d. Nitrogen 1) 0.05% 2) Increases strength, reduces ductility and toughness e. Oxygen 1) 0.20% 2) Increases strength, reduces ductility and toughness C. Naming system 1. Unified Numbering System (UNS) 2. Symbols of largest alloying elements listed next to average percent composition Properties of Ti-6Al-4V A. Density is 4.43 g/cm3 B. Mechanical properties 1. High fracture toughness 2. Ultimate tensile strength is 170 ksi 3. Brinell Hardness is 379 4. Shear strength is 110 ksi 5. Fatigue strength is 102 ksi C. Additional properties 1. Corrosion resistance 2. Resistance to aqueous salt solutions 3. Resistance to body fluids and other internal chemicals 4. Resistance to wear (especially when in contact with bone and tissue) D. Heat treatment (solution treated and aged) 1. Process a. Heated at a solution temperature of 955C-970C for one hour ( transition temperature is 955C) b. Cooled in water (can be air cooled from the annealing temperature without impairing its stability) c. Aging temperature is 480C-595C for four to eight hours 2. Reason for heat treatment a. Reduce stresses built up during fabrication (stress relieving) b. Produce the optimal ductility, machinability, and structural stability (annealing) c. Increase the strength (solution treating and aging) d. Produce the optimal fracture toughness and fatigue strength E. Thermal Oxidation

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Amanda, Mary, & Makayla May 10th, 2013 1. Preformed at 650C in Air 2. Process takes 48 hours 3. Increases the hardness and the corrosion resistance Conclusion: In the end, this type of alloy is the best choice to utilize in the manufacturing of pacemaker casings. Titanium alloys are widely used in biomedical applications because of their characteristics and properties, and theres no reason to use a different material or alloy for this application.

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Amanda, Mary, & Makayla May 10th, 2013 Reference Page

Basu, Debabrata, et al. "In vivo bone response and interfacial properties of titanium-alloy implant with different designs in rabbit model with time." Indian Journal of Dental Research 22.2 (2011): 277. Academic OneFile. Web. 24 Apr. 2013. Collings, E.W. Ti-Al-4V. Materials Properties Handbook Titanium Alloys. Ohio: ASM International. 1994. Print. Donachie, Matthew. "Biomedical alloys." Advanced Materials & Processes 154.1 (1998): 63+. Academic OneFile. Web. 23 Apr. 2013. Geng, Hwaiyu. Manufacturing Engineering Handbook. New York: The McGraw-Hill Companies, Inc., 2004. Print. How Pacemaker is Made. How Products Are Made. Advameg, Inc., n.d. Web. 17 Apr. 2013. Li, Rui, et al. Metallurgical Analysis and Nonoindentation Characterization of Ti-6Al-4V Work Piece and Chips in High-Throughput Drilling. Materials Science & Engineering A. Philidelphia: Elsevier B.V., 2007. Print. Precision Metal Forming and Micromolding Madehow. Greatbatch Medical. Web. 7 May 2013. Schuler, Martin, et al. "Biomedical interfaces: titanium surface technology for implants and cell carriers." Nanomedicine 1.4 (2006): 449+. Academic OneFile. Web. 23 Apr. 2013. Section 1 Metallurgy. Titanium Alloys Handbook. Battelle Columbus Laboratories. 1972. Print. Titanium Ti-6Al-4V (Grade 5), Annealed MatWeb. MatWeb, LLC, 2013. Web. 24 Apr. 2013. Wang, Qiang, Yang Zhang, Ke Yang, and Lili Tan. "Preparation of Bioactive Film on Ti6Al4V." Surface Review and Letters 16.05 (2009)

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