{"title":"Shape-Setting of Self-Expanding Nickel–Titanium Laser-Cut and Wire-Braided Stents to Introduce a Helical Ridge","authors":"","doi":"10.1007/s13239-024-00717-2","DOIUrl":null,"url":null,"abstract":"<h3>Abstract</h3> <span> <h3>Purpose</h3> <p>Altered hemodynamics caused by the presence of an endovascular device may undermine the success of peripheral stenting procedures. Flow-enhanced stent designs are under investigation to recover physiological blood flow patterns in the treated artery and reduce long-term complications. However, flow-enhanced designs require the development of customised manufacturing processes that consider the complex behaviour of Nickel-Titanium (Ni-Ti). While the manufacturing routes of traditional self-expanding Ni–Ti stents are well-established, the process to introduce alternative stent designs is rarely reported in the literature, with much of this information (especially related to shape-setting step) being commercially sensitive and not reaching the public domain, as yet.</p> </span> <span> <h3>Methods</h3> <p>A reliable manufacturing method was developed and improved to induce a helical ridge onto laser-cut and wire-braided Nickel–Titanium self-expanding stents. The process consisted of fastening the stent into a custom-built fixture that provided the helical shape, which was followed by a shape-setting in air furnace and rapid quenching in cold water. The parameters employed for the shape-setting in air furnace were thoroughly explored, and their effects assessed in terms of the mechanical performance of the device, material transformation temperatures and surface finishing.</p> </span> <span> <h3>Results</h3> <p>Both stents were successfully imparted with a helical ridge and the optimal heat treatment parameters combination was found. The settings of 500 °C/30 min provided mechanical properties comparable with the original design, and transformation temperatures suitable for stenting applications (<em>A</em><sub>f</sub> = 23.5 °C). Microscopy analysis confirmed that the manufacturing process did not alter the surface finishing. Deliverability testing showed the helical device could be loaded onto a catheter delivery system and deployed with full recovery of the expanded helical configuration.</p> </span> <span> <h3>Conclusion</h3> <p>This demonstrates the feasibility of an additional heat treatment regime to allow for helical shape-setting of laser-cut and wire-braided devices that may be applied to further designs.</p> </span>","PeriodicalId":54322,"journal":{"name":"Cardiovascular Engineering and Technology","volume":"26 1","pages":""},"PeriodicalIF":1.6000,"publicationDate":"2024-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cardiovascular Engineering and Technology","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.1007/s13239-024-00717-2","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose
Altered hemodynamics caused by the presence of an endovascular device may undermine the success of peripheral stenting procedures. Flow-enhanced stent designs are under investigation to recover physiological blood flow patterns in the treated artery and reduce long-term complications. However, flow-enhanced designs require the development of customised manufacturing processes that consider the complex behaviour of Nickel-Titanium (Ni-Ti). While the manufacturing routes of traditional self-expanding Ni–Ti stents are well-established, the process to introduce alternative stent designs is rarely reported in the literature, with much of this information (especially related to shape-setting step) being commercially sensitive and not reaching the public domain, as yet.
Methods
A reliable manufacturing method was developed and improved to induce a helical ridge onto laser-cut and wire-braided Nickel–Titanium self-expanding stents. The process consisted of fastening the stent into a custom-built fixture that provided the helical shape, which was followed by a shape-setting in air furnace and rapid quenching in cold water. The parameters employed for the shape-setting in air furnace were thoroughly explored, and their effects assessed in terms of the mechanical performance of the device, material transformation temperatures and surface finishing.
Results
Both stents were successfully imparted with a helical ridge and the optimal heat treatment parameters combination was found. The settings of 500 °C/30 min provided mechanical properties comparable with the original design, and transformation temperatures suitable for stenting applications (Af = 23.5 °C). Microscopy analysis confirmed that the manufacturing process did not alter the surface finishing. Deliverability testing showed the helical device could be loaded onto a catheter delivery system and deployed with full recovery of the expanded helical configuration.
Conclusion
This demonstrates the feasibility of an additional heat treatment regime to allow for helical shape-setting of laser-cut and wire-braided devices that may be applied to further designs.
期刊介绍：
Cardiovascular Engineering and Technology is a journal publishing the spectrum of basic to translational research in all aspects of cardiovascular physiology and medical treatment. It is the forum for academic and industrial investigators to disseminate research that utilizes engineering principles and methods to advance fundamental knowledge and technological solutions related to the cardiovascular system. Manuscripts spanning from subcellular to systems level topics are invited, including but not limited to implantable medical devices, hemodynamics and tissue biomechanics, functional imaging, surgical devices, electrophysiology, tissue engineering and regenerative medicine, diagnostic instruments, transport and delivery of biologics, and sensors. In addition to manuscripts describing the original publication of research, manuscripts reviewing developments in these topics or their state-of-art are also invited.
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