title: Design and verification of a shape memory polymer peripheral occlusion device.
abstract: Shape memory polymer foams have been previously investigated for their safety and efficacy in treating a porcine aneurysm model. Their biocompatibility, rapid thrombus formation, and ability for endovascular catheter-based delivery to a variety of vascular beds makes these foams ideal candidates for use in numerous embolic applications, particularly within the peripheral vasculature. This study sought to investigate the material properties, safety, and efficacy of a shape memory polymer peripheral embolization device in vitro. The material characteristics of the device were analyzed to show tunability of the glass transition temperature (Tg) and the expansion rate of the polymer to ensure adequate time to deliver the device through a catheter prior to excessive foam expansion. Mechanical analysis and flow migration studies were performed to ensure minimal risk of vessel perforation and undesired thromboembolism upon device deployment. The efficacy of the device was verified by performing blood flow studies that established affinity for thrombus formation and blood penetration throughout the foam and by delivery of the device in an ultrasound phantom that demonstrated flow stagnation and diversion of flow to collateral pathways.
authors.affiliation: Department of Biomedical Engineering, Texas A&M University, MS 3120, 5045 Emerging Technologies Building, College Station, TX 77843-3120, USA.
authors.forename: Todd L
authors.initials: TL
authors.lastname: Landsman
authors.affiliation: College of Medicine, Texas A&M University Health Science Center, MS 1359, 8447 State Highway 47, HPEB 3060, Bryan, TX 77807-3260, USA.
authors.forename: Ruth L
authors.initials: RL
authors.lastname: Bush
authors.affiliation: Texas A&M Institute for Preclinical Studies, Texas A&M University, MS 4478, College Station, TX 77845-4478, USA.
authors.forename: Alan
authors.initials: A
authors.lastname: Glowczwski
authors.affiliation: Department of Biomedical Engineering, Texas A&M University, MS 3120, 5045 Emerging Technologies Building, College Station, TX 77843-3120, USA.
authors.forename: John
authors.initials: J
authors.lastname: Horn
authors.affiliation: Department of Biomedical Engineering, Texas A&M University, MS 3120, 5045 Emerging Technologies Building, College Station, TX 77843-3120, USA.
authors.forename: Staci L
authors.initials: SL
authors.lastname: Jessen
authors.affiliation: College of Medicine, Texas A&M University Health Science Center, MS 1359, 8447 State Highway 47, HPEB 3060, Bryan, TX 77807-3260, USA.
authors.forename: Ethan
authors.initials: E
authors.lastname: Ungchusri
authors.affiliation: Department of Biomedical Engineering, Texas A&M University, MS 3120, 5045 Emerging Technologies Building, College Station, TX 77843-3120, USA.
authors.forename: Katelin
authors.initials: K
authors.lastname: Diguette
authors.affiliation: Department of Biomedical Engineering, Texas A&M University, MS 3120, 5045 Emerging Technologies Building, College Station, TX 77843-3120, USA.
authors.forename: Harrison R
authors.initials: HR
authors.lastname: Smith
authors.affiliation: Department of Biomedical Engineering, Texas A&M University, MS 3120, 5045 Emerging Technologies Building, College Station, TX 77843-3120, USA.
authors.forename: Sayyeda M
authors.initials: SM
authors.lastname: Hasan
authors.affiliation: Maverick Regional Anesthesia Education, LLC, 10592 County Road 175, Iola, TX 77861, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Nash
authors.affiliation: Department of Biomedical Engineering, Texas A&M University, MS 3120, 5045 Emerging Technologies Building, College Station, TX 77843-3120, USA; Department of Veterinary Pathobiology, Cardiovascular Pathology Laboratory, College of Veterinary Medicine, Texas A&M University, MS 4467, College Station, TX 77843-4467, USA.
authors.forename: Fred J
authors.initials: FJ
authors.lastname: Clubb
authors.affiliation: Department of Biomedical Engineering, Texas A&M University, MS 3120, 5045 Emerging Technologies Building, College Station, TX 77843-3120, USA. Electronic address: djmaitland@tamu.edu.
authors.forename: Duncan J
authors.initials: DJ
authors.lastname: Maitland
mesh_terms: D000783:Aneurysm / Q000628:therapy*; D000818:Animals; D001672:Biocompatible Materials; D004621:Embolization, Therapeutic / Q000295:instrumentation*; D011108:Polymers / Q000737:chemistry*; D013552:Swine; D044366:Transition Temperature
chemical_list: D001672:Biocompatible Materials; D011108:Polymers
keywords: Embolization; Pelvic congestion syndrome; Shape memory polymer; Varicocele; Varicose veins