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Related Experiment Video

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Mechanical Viability and Functionality Assessment of a New Sutureless Endoluminal Microvascular Device: A Preliminary

Jordi Descarrega1, Joan Fontdevila1, Erica Segura2

  • 1Plastic Surgery Department, Hospital Clínic de Barcelona, Barcelona 08036, Spain; VessConnect, Barcelona 08028, Spain.

Journal of Medical Devices
|October 28, 2024
PubMed
Summary

A novel nitinol endoluminal device for microvascular anastomosis showed promising immediate patency in rabbits. However, early thrombosis formation necessitates further development, potentially with heparin elution, for improved long-term functionality.

Keywords:
anastomosismicrospikesmicrosurgerynitinolshape memory

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Area of Science:

  • Biomedical Engineering
  • Vascular Surgery
  • Materials Science

Background:

  • Microvascular anastomosis traditionally relies on sutures, which can be time-consuming and technically demanding.
  • Endoluminal devices offer a potential sutureless alternative for vessel connection.
  • Nitinol's shape memory properties are suitable for self-expanding medical devices.

Purpose of the Study:

  • To evaluate the mechanical viability and immediate/early functionality of a new nitinol endoluminal self-expanding device for microvascular anastomosis.
  • To assess the safety and efficacy of the device in an in vivo animal model.
  • To identify potential limitations and areas for improvement in device design.

Main Methods:

  • A prototype nitinol endoluminal device with microspikes was implanted in the femoral artery of seven New Zealand White rabbits.
  • Anastomosis time, ease of placement, and need for complementary stitches were recorded.
  • Vessel patency was assessed immediately post-implantation and at 7-day follow-up.

Main Results:

  • The device demonstrated rapid implantation with an average anastomosis time of 18 minutes and 45 seconds.
  • Immediate post-implantation patency was achieved in all cases.
  • All seven rabbits exhibited negative patency at 7-day follow-up due to intraluminal blood clot formation (thrombosis).

Conclusions:

  • The developed nitinol endoluminal device is simple to use and provides immediate functional anastomosis.
  • Thrombosis remains a significant challenge, likely due to the foreign body presence within the endoluminal space.
  • Future iterations incorporating heparin elution may mitigate thrombosis and improve long-term patency, offering value for sutureless endoluminal devices.