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Medical Device Consulting:
IVC Filter DesignBy Remy Doucet, Austin Shima, and
Jason Trimble
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Objectives
• Analyze a current medical device (IVC filter) and determine pros and cons in treating disease (pulmonary embolism)
• Develop a design that improves upon the current medical device
• Analyze proposed design and explain mechanical forces that act upon the device and possible failure modes.
• Explain possible biological and chemical interactions with the body (biocompatibility)
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Relevant Class Material
• Stress - normalization of forces through area
• Strain - the deformation of a material
• Fatigue - weakening of a material caused by repeated loading
• Biocompatibility - property of not eliciting response from living tissue
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Important Definitions• Percutaneous - Done through the skin
s
• Endothelial cells - The cells that line the inside of blood vessels s
• Thrombosis - Formation of a blood clot that obstructs the flow of blood s
• Embolism - Any blockage of a blood vessel s
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Background Pathology
• Deep Vein Thrombosis - A condition where blood clots form in the leg. h
• Pulmonary Embolism - A blood clot gets lodged in the lungs preventing blood flow from the lungs to the body.
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Risk Factors
Risk Factors for DVT and Pulmonary Embolism include…• Prolonged bed rest or paralysis
• Sitting for long periods of time
• Being overweight
• Supplemental Estrogen
• Smoking
• Cancer
• Age
Personal or Family History of Deep Vein Thrombosis
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Treatment Options • There are two major treatments for DVT and PE
- Blood Thinners or an IVC
• Blood thinners are the prefered treatment for DVT s
• If the patient cannot take blood thinners or they are not effective a doctor may advise the use of the Inferior Vena cava Filter as a last resort
- The filter is placed in the Inferior Vena Cava and any clots that may break off of the embolism will be caught by the Filter
• Usually removed after 5 years or may be removed if risk of DVT or PE is significantly reduced or if complications occur.
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Current Device Faulty Loading Scenario
Multiple modes of failure to look out for with an IVC Filter.• Migration
• Tilting
• Fractures
• Perforation
• Embedding
https://www.youtube.com/watch?v=1djRpPxNGrA
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Novel Design
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Free Body Diagram
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Design Considerations
• Integrated IVC is shaped into a bell-like shape vs traditional bacteriophage.
Conical bell shape provides more room for blood to flow around caught embolisms
• Outer stent structure for increased durability and greatly decreases chance of dislocation. Also provides increased blood flow.
• Stent structure can be equipped with localized blood thinning drugs
• IVC located near end of stent to allow for ease of placement and removal
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Deployment Procedure
• Percutaneous deployment through femoral or jugular vein
• Advance rod through vein
• Release filter and device is ejected from catheter
• Insertion takes about 30 minutes
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Material Properties of Invention● Nitinol or cobalt chromium alloy are good metals to use
○ Nitinol biocompatible and flexible with shape memory
○ Cobalt chromium corrosion resistant
● polymers
● Use drug - eluting stent
○ For preventing clots from blocking the vessel
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Modes of Failure• Nitinol is flexible so will not fracture easily ( at about 250 MPa)
• Fatigue is more likely
- Stents are subjected to cyclic stresses following deployment
- Nitinol endurance limit of about 7 MPa at around 1 x 10^7 cycles
• Vessel can also be worn down
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Importance of Retrievability
• Retrievability good for temporary high risk such as after surgery or trauma
• Can be a long-term risk of recurrent DVT
• Retrieved by clasping filter at end of catheter
• Retrieval rate affected by an inability to capture (device tilting, wall narrow)
• IVC filters have a lifetime of less than 5 years
• Stents are mainly permanent- for this design, endothelial cells can’t grow over it.
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ReferencesAng, Hui Ying, 2017. Bioresorbable stents: Current and upcoming bioresorbable technologies.
International Journal of Cardiology 228, 931-939
Dixon, Austin, 2013. Improving retrieval rates for retrievable inferior vena cava filters. Expert Rev. Med. Devices 10(1), 135-141
Garcia, A., 2012. Evaluation of migration forces of a retrievable filter: Experimental setup and finite element study. Medical Engineering and Physics 34, issue 8, 1167 - 1176
Rundback, John H., 2010. Permanent or temporary IVC filtration with a novel double-ring anchoring technology optional nitinol filter. Expert Rev. Med. Devices 7(1), 11-19
Symptoms and causes - Pulmonary embolism. Retrieved from http://www.mayoclinic.org/diseases-conditions/pulmonary-embolism/symptoms-causes/dxc-20234744
Xiong, Yonggang, 2016. Study of the Mechanical Properties and Biocompatibility of the Stents. Journal of Nanoscience and Nanotechnology vol. 16, 12214-12222
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Questions?