Stent Tester: Design and Application

Author

Dharam Botadra, Southern Illinois University Carbondale

Date of Award

5-2012

Degree Name

Master of Science

Department

Biomedical Engineering

First Advisor

Filip, Peter

Second Advisor

Botros, Nazeih

Third Advisor

Chen, Ada

Abstract

Cardiovascular diseases which include high blood pressure, coronary heart diseases, heart failure, stroke and peripheral arterial diseases (PAD) affect one out of three American adults or 105 million people. By 2030, the prevalence of cardiovascular disease is estimated to rise 10 percent to more than 40 percent of American adults, or 116 million people. Approximately 8 million people in the United States have PAD, including 12-20% of individuals older than age 60. The main reason of PAD is obstruction of blood flow through lower extremities causing Atherosclerosis. The major artery affected in the lower extremities due to PAD is superficial femoral artery (SFA). Huge numbers of clinical procedures like superficial femoral artery stenting, balloon angioplasty, and percutaneous transluminal intervention are done to treat the disease. Thorough in vitro (biological phenomena made to occur outside the human body) testing of this kind should reduce the risk of in vivo (biological phenomena occurring inside the human body) stent failure and thus lead to increased survivability for patients suffering with cardiovascular diseases and PAD. It has been recognized that a metal subjected to a repetitive or fluctuating stress will fail at a stress much lower than that required to cause failure on a single application of load. As per literature review, typically SFA stents survive no more than 12-18 months until the first fracture is detected in MRI. There was a need of a customized designed device such that it would simulate realistic blood pressure conditions and test the capacity the SFA stents. Commercially, the stents are tested under accelerated cyclic loading conditions at different frequencies for longer cycle periods. In order to demonstrate how stents perform once deployed into an artery, a testing device was required which will simulate arterial blood pressure variations and compressive loads over artery as close as possible to human body. The stent tester documented in this report is capable of subjecting a stent to appropriate physiological loading by deploying it in a simulated vessel and subjecting it to external compression. Loading of this kind was performed at frequencies at 60 Hz and, as such, simulating one million heartbeats of artery pulsation. The primary purpose of this thesis was to successfully design stent tester which cycles artificial fluid simulating blood pressure in arteries and superimposing cyclic compression of stent deployed in an artificial artery. The goal was to obtain a test machine that allows for a cost effective testing of cardiovascular and peripheral stents. Another goal was to externally compress the arterial wall subjected to compressive load with the help of an air controlled mechanical piston attached with load cell assembly. The load cell measures the amount of load applied over the silicone tubing. The design of the device contains two peristaltic pumps which alternate pressure every second by pumping distilled water via plastic tubing. The stent was crimped with the guide wire catheter and deployed in the silicone artery (diameter 11mm O.D) from Dynatek labs. Wall and bridge stents (Medtronic, Schneider Inc.) 10 x 39 mm were used for testing with and without external load. Industrial pressure transducer S-10 (Wika Instruments Corporation) ranging from 0-5 PSI (0-259mmHg) is used to monitor the pressure in the artificial artery. The pressure transducer is connected to the data logger (Omega om320) which serially communicates with computer. The silicon mock test artery was 20cm long so that stents used in various arterial interventions can be tested. The silicon artery has primary advantages over rubber latex artery which are clarity and close resemblance to human artery and durable (ideal for long term durability tests). Preliminary results from literature review show that stent materials, based on its mechanical properties survive for more than one million heartbeats. To demonstrate the capacity of current design a nitinol stent was tested under physiological conditions at 60Hz frequency. A load of 980 grams for 2001 - 5000 heartbeats, 1.98 kg for 5001 - 10000 heartbeats, 4.25 kg for 10001 - 25000 heartbeats and 6.54 kg for 25001 - 50000 heartbeats was applied over the artificial artery. The mechanical piston with load cell assembly was allowed to externally compress the artificial artery. Partial functionality of device was demonstrated by running it for one million heartbeats and 48000 compressive cycles. The device was successfully designed and has the capacity to cycle artificial fluid simulating blood pressure changes in arteries and have demonstrated the ability to test any type of stents. The device was designed efficient which was simulated in an acceptable pressure range as compared to human blood pressure and allow for compression of stent in a cyclic testing pattern. The system was maintained to as close as between diastolic value of 76mmHg to diastolic 122mmHg pressure range. The device was run for about one million heartbeats and it was observed that the NiTi stent successfully survived. The stent was observed visually with a magnifying glass for any cracks or failure at intervals of 500, 1000, 2000, 5000, 10000, 25000, 50000 and one million heartbeats respectively. After running the device for one week at a frequency of 60Hz, no fractures on the stent were visually observed. However, the stent was deformed from the center. Data analysis showed that the mean diastolic and systolic pressure measurements for intervals with no load were found to be statistically significant i.e. in acceptable range. However, the device design lacks stability due to various reasons like device operates in an open looped system, has bubbles in the artificial artery which might be producing varying pressure values and variation in applying load. The device was partly unable to simulate arterial blood pressure changes under no loading conditions. Efforts are being made to improve the design of the device to make it realistic simulation of variation in arterial blood pressure for long term durable testing of the stents.