Stentdesign und FEA

Stent-Design (Lasercut)

Unsere Stärken

  • Stent Konzeption 
  • Stent Konstruktion (2D and 3D) 
  • Stent nummerisch validieren und qualifizieren mit Hilfe Finite Elemente Simulation
  • Fertigungszeichnungen bereitstellen (Lasercut-drawing)

Stent Optimierung und Validierung

Folgende Parameter können optimiert werden: 

  • Radialkraft 
  • Flexibilität im Gefäß
  • Distale und Proximale Stent-Seite
  • Crimpverhalten 
  • Expansionsverhalten 
  • Fatigue (Lebensdauer)

Folgende Internationalen Normen und Regelwerke werden in diesem Rahmen verwendet:

 

ISO 25539-1: Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses

ISO 25539-2: Cardiovascular implants – Endovascular devices – Part 2: Vascular stents

ISO 25539-3: Cardiovascular implants – Endovascular devices – Part 3: Vena cava filters

ASTM F2514: Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

ASTM F2477: Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

ASTM F2942: Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

ASTM F3067: Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents

ASTM F2079: Elastic Recoil of Balloon-Expandable Stents

ASTM F3211: Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices.

 

FDA Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems. April 18, 2010

 

FDA Guidance for Industry and FDA Staff: Reporting of Computational Modeling Studies in Medical Device Submissions. September 21, 2016

 

Heart Valves:

 

ISO 5840-3: Cardiovascular implants – Cardiac valve prostheses – Part 3: Heart valve substitutes implanted by transcatheter techniques

ISO 5910: Cardiovascular implants and extracorporeal systems – Cardiac valve repair devices


Stent FEA (Braided and Lasercut)

Wir übernehmen den nummerischen Nachweis Ihres Stents und führen folgende Simulationen durch: 

  • Radialkraft (im intended used Bereich des Stents) 
  • Crimpen (radial comprimieren bis Katheter ID)

 Wärmebehandelte Materialparameter verwenden (zB: NiTinol wärmebehandelt) !!!

Expandieren (bis zum gewünschten Durchmesser)

  • Stent Fatigue ( Stent-Dauerfestigkeit im menschlischen Gefäß) 
  • Stent deployment (Freisetzung)
  • Stent foreshortening (Stent axial komprimieren)
  • Virtual Stenting (Stentimplantation)

Folgende Internationalen Normen und Regelwerke werden in diesem Rahmen verwendet: 

 

ISO 25539-1: Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses

ISO 25539-2: Cardiovascular implants – Endovascular devices – Part 2: Vascular stents

ISO 25539-3: Cardiovascular implants – Endovascular devices – Part 3: Vena cava filters

ASTM F2514: Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

ASTM F2477: Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

ASTM F2942: Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

ASTM F3067: Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents

ASTM F2079: Elastic Recoil of Balloon-Expandable Stents

ASTM F3211: Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices.

 

FDA Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems. April 18, 2010

 

FDA Guidance for Industry and FDA Staff: Reporting of Computational Modeling Studies in Medical Device Submissions. September 21, 2016

 

Heart Valves:

 

ISO 5840-3: Cardiovascular implants – Cardiac valve prostheses – Part 3: Heart valve substitutes implanted by transcatheter techniques

ISO 5910: Cardiovascular implants and extracorporeal systems – Cardiac valve repair devices