Why Fatigue to Fracture is needed
Although most new medical device standards and regulatory guidelines require Fatigue to Fracture (FtF) testing, the most important reason to develop a Fatigue to Fracture program is to ensure that your new product lifetime enhances the company’s reputation and financial success. Properly executed Fatigue to Fracture testing can predict the lifetime of your product. It can also identify locations of future failure and verify Finite Element Analysis (FEA) predictions.
Dynatek Labs offers a real solution
Dynatek Labs has always cast an eye forward to the needs of the future. Although the fundamentals of Fatigue to Fracture are well established, the real innovations center on experimental protocols that result in successful predictions of endurance limits and sites of future failures. Dynatek has developed an instrument, testing protocols, and testing envelopes that address properties of all implantable tubular elements such as stents and endovascular prostheses.
Dynatek Labs radial Fatigue to Fracture device tester can, along with novel mock arteries, deliver cyclic pressures up to 50 psi (2500 mmHg).
Testing Advantage
A properly designed and executed Fatigue to Fracture evaluation can predict:
1. Endurance limits by varying the load, frequency of test, temperature or pH
2. Predict potential failure locations of the device
3. Verify (or not) the validity of a Finite Element Analysis
- Learn more
- The Durability Testing of Porous Bifurcated Stent/Grafts …
- The High Frequency Testing of Vascular Grafts and Vascular Stents: Influence …
- Sources of Error in Monitoring High Speed Testing of Vascular Grafts
- Design Considerations for the In Vitro Testing of Cardiovascular Prosthesis
- High Speed Vascular Graft Testing: The Influence of Varying Structural…
- Compliant Silicone Vessels
- High Speed Photographic Verification of Stent Deflection
- UC3-HD Controller
Fatigue to Fracture (FtF) has
• Extremely strong stainless manifold capable of 2000 psi loading
• Unique bellows design allowing lifetimes of up to 1 billion cycles before failure
• Components that can withstand up to 60 °C temperature and pH 12.0
• High pressure capacitance tank with a view window and electronic fluid level monitor
• Custom designed electromagnetic motor that delivers years of service
• State of the art explosion proof case (optional), that cannot be tampered with, to maximize the safety of the operators or observers
• Handy computer and controller cart that lets the user choose options for comfort and useability
Software
Perhaps the most impressive component of the Fatigue to Fracture instrument is our Universal Software that controls and monitors all experimental parameters and records them as frequently as once per minute. LabView-based programming coupled to a powerful SBRIO and FPGA has extraordinary capabilities to control, monitor and record each moment of an experiment.
As you can see in the photos, the Dynatek Fatigue to Fracture tester is an impressive, strong and powerful instrument. Not just built for endurance testing, it includes a safety enclosure that ensures operator safety.
The second part of the story is focused on the unique mock artery system that we have developed. By using a combination of outer and/or inner mock vessel you can:
1. Produce agressive contraction only loading
2. Produce agressive expansion only loading
3. Produce agressive expansion and contraction loading
The Dynatek Fatigue to Fracture tester is a unique and effective way to carry out predictory Fatigue to Fracture testing on vascular stents, endovascular prothesis (or other tubular elements that may not be a medical device). This instrument is the latest in a series of historic contributions that Dynatek Labs has been responsible for over the past 30 years.
Dynatek personnel will custom design any protocol or instrument to meet your needs.
Dynatek Labs FtF Product Specifications
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Description
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Specifications
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|---|---|
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# of samples
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≤ 6 |
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Sample diameter
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1-8 mm ID
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Sample length (straight)
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≤ 250 mm
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Sample configuration
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linear for easy photography |
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Manifolds
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stainless steel, proximal and distal
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Capacitance tank
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reinforced stainless steel with observation window and float switch |
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Pressure transducer
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high pressure / high resolution
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Temperature range
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room temp to 60 °C |
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pH range
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5.0 to 12.0
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Sample temperature control
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24v circulatory pump
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Systemic pressure
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up to 28 psi
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Control system
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Dynatek’s Universal Controller
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Variables controlled and/or monitored
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temp, cycle rate, cycle count, systemic pressure, sample pressure
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Certification
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CE mark
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Safety enclosure
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Optional
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Cleaning
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Alcoholic cleaner and sterilant
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Freq. of pertinent data stored
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≥ 1 min
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Test samples of various dimension
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yes
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Power required
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120/240 V 60/50 Hz
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Unattended operation
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yes
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Ionic solution restriction
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chloride levels < 0.2 M
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Testing modes
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sample deflection or pressure 1
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Sound
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< 60 dBA
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1Sample deflection monitoring requires optional high speed camera.
Specifications are subject to change without notice.
Dynatek Labs, Inc.
105 East 4th Street
Galena, MO 65656
417.357.6155
800.325.8252
fax 417.357.6327
