A new double-cone nitinol device for PDA occlusion: design, manufacturing and initial in vivo results

ASAIO J. 2009 Jul-Aug;55(4):309-13. doi: 10.1097/MAT.0b013e3181a4f77d.

Abstract

Use of occluder devices for a patent ductus arteriosus (PDA) closure is restricted to small diameter PDAs and involves high device costs. The objective of this study was to develop a new nitinol implant for the closure of a PDA and to evaluate its safety and efficacy in an animal model. The design consists of a device that promotes thrombus formation in the PDA. The device has a double-cone shape with their vertices joined. The cones are made of a nitinol wire helix with dacron fibers attached. The proximal end of the helix can be screwed to a conventional catheter release wire. In vitro testing was performed to verify the effectiveness of the implantation of the device and its releasing system; all trials (n = 30) were successful, showing accurate placement and release of the device. Complete and successful implantation of the device was achieved in all in vivo experiments (n = 5). There was one case of embolization due to premature detachment; a second device was successfully implanted. Histological evaluation after 42.3 +/- 3.1 days demonstrated complete PDA occlusion. The retrieved PDA showed total closure of the defect, endothelization of the PDA outlets and proper lodging of the device.

MeSH terms

  • Alloys / pharmacology
  • Animals
  • Animals, Newborn
  • Biocompatible Materials / chemistry
  • Catheterization
  • Cattle
  • Ductus Arteriosus, Patent / surgery*
  • Ductus Arteriosus, Patent / therapy*
  • Embolization, Therapeutic / instrumentation
  • Embolization, Therapeutic / methods
  • Equipment Design
  • Models, Animal
  • Prostheses and Implants
  • Prosthesis Design / instrumentation
  • Thrombosis

Substances

  • Alloys
  • Biocompatible Materials
  • nitinol