Medical Devices

Projects

  • Failure analysis of a line of stainless steel stents for a medical device manufacturer. The project included review of the manufacturing process, metallography, electron microscopy and finite element analysis.

  • Fatigue analysis of a stent design for a medical device manufacturer. The objective of the project was to determine if cracking in the stent could occur from normal pulsating blood pressure after insertion. The project included finite element analysis.

  • Review of current tribological problems (wear and friction) in polymeric, metallic and ceramic implantable devices and an assessment of the materials and design approaches being utilized to solve these problems, for a manufacturer of hip and knee implants. This program included review of the literature and contacts/meetings with medical device industry organizations.

  • Assessment of the market for a new, high temperature ceramic material and coating process for an automotive component developer.

  • Review of manufacturing and quality control testing operations, particularly those related to mechanical reliability, for the manufacturer of heart catheters.

  • Analysis of manufacturing methods used to produce surgical staples of various cross sections in support of a patent litigation for a law firm.

  • Failure analysis of a fetal monitor spiral electrode for a medical device manufacturer. The project included review of the design and manufacturing process, metallography and scanning electron microscopy and finite element analysis.

  • Design analysis of a syringe component to reduce product cost substantially for a manufacturer of medical products. This project included substantial finite element analysis, durability assessment, and mechanical testing of syringe and seal.

  • Assessment of the structural integrity of a disposable blood separation bowl for a medical product manufacturer. This project included finite element analysis and validation testing using instrumented bowls.

  • Modeling of a novel, polymer drug release device taken orally. Analytical models were developed and an experimental study was carried out to determine the stiffness, recovery and degradation properties of a set of degradable polymers for a drug company.

  • Development of a new metal forming process, including design of manufacturing equipment, to reduce the cost of a stainless steel surgical blade for a medical device manufacturer. The project included finite element simulation, mechanical testing and failure modes and effects analysis.

  • Determination of the mechanism of fatigue in methacrylate bone cement used for knee and hip implants for an implant device manufacturer. Detailed electron microscopy and mechanical testing were conducted.

Stent Deformation

Stents used for treating coronary artery disease are required to satisfy numerous mechanical requirements. Deployment by balloon catheters must result in relatively uniform expansion at modest pressures. Details must be carefully designed to minimize the risk of cracking where individual elements meet. Meeting these and other requirements, such as flexibility during insertion and resistance to collapse from the arterial wall pressure, can be accomplished with simulation and an understanding of the mechanical behavior of the materials.

 

Unexpanded Stent Segment (4 mm OD)

 

Stent Segment Expanded to About 6 mm

 

Strains in the Corners Remain Well Below the Failure Value

 

Shortening During Expansion Is Relatively Low

 

 

 

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