Theoretical and experimental evaluation of the radial force of self-expanding braided bioabsorbable stents

This study was carried out to evaluate if the analytical model developed by Jedwab and Clerc for calculating the mechanical properties of metallic braided stents is also valid for bioabsorbable braided stents. An analytical model could be used to shorten the development cycle of stents by reducing the amount of in vitro testing. Jedwab and Clerc derived formulae for longitudinal stiffness and radial pressure stiffness. The longitudinal stiffness was defined by measuring the stent elongation under load. The radial pressure stiffness was defined from the slope of the load-displacement curve measured with the testing method described by Agrawal and Clark where a collar is placed around the stent to compress it. The radial pressure stiffness was measured with and without lubrication to evaluate the effects of friction between the stent and collar and in the stent structure itself. Two bioabsorbable braided stents and one metallic braided stent were used in the measurements. The metal stent test results were consistent with what was reported by Jedwab and Clerc. However, the analytical model was not applicable to bioabsorbable stents. This was mainly due to the larger fibre diameter of the bioabsorbable stents, which prevents the fibres from freely collapsing when the stent diameter decreases. The analytical model is based on an assumption that the fibres behave independently. However, the testing method described by Agrawal and Clark provided a useful tool to compare the radial force of self-expanding stents.     

Theoretical and experimental evaluation of the radial force of self-expanding braided bioabsorbable stents

This study was carried out to evaluate if the analytical model developed by Jedwab and Clerc for calculating the mechanical properties of metallic braided stents is also valid for bioabsorbable braided stents. An analytical model could be used to shorten the development cycle of stents by reducing the amount of in vitro testing. Jedwab and Clerc derived formulae for longitudinal stiffness and radial pressure stiffness. The longitudinal stiffness was defined by measuring the stent elongation under load. The radial pressure stiffness was defined from the slope of the load-displacement curve measured with the testing method described by Agrawal and Clark where a collar is placed around the stent to compress it. The radial pressure stiffness was measured with and without lubrication to evaluate the effects of friction between the stent and collar and in the stent structure itself. Two bioabsorbable braided stents and one metallic braided stent were used in the measurements. The metal stent test results were consistent with what was reported by Jedwab and Clerc. However, the analytical model was not applicable to bioabsorbable stents. This was mainly due to the larger fibre diameter of the bioabsorbable stents, which prevents the fibres from freely collapsing when the stent diameter decreases. The analytical model is based on an assumption that the fibres behave independently. However, the testing method described by Agrawal and Clark provided a useful tool to compare the radial force of self-expanding stents.     

Mechanical design of an intracranial stent for treating cerebral aneurysms

Endovascular treatment of cerebral aneurysms using stents has advanced markedly in recent years. Mechanically, a cerebrovascular stent must be very flexible longitudinally and have low radial stiffness. However, no study has examined the stress distribution and deformation of cerebrovascular stents using the finite element method (FEM) and experiments. Stents can have open- and closed-cell structures, and open-cell stents are used clinically in the cerebrovasculature because of their high flexibility. However, the open-cell structure confers a risk of in-stent stenosis due to protrusion of stent struts into the normal parent artery. Therefore, a flexible stent with a closed-cell structure is required. To design a clinically useful, highly flexible, closed-cell stent, one must examine the mechanical properties of the closed-cell structure. In this study, we investigated the relationship between mesh patterns and the mechanical properties of closed-cell stents. Several mesh patterns were designed and their characteristics were studied using numerical simulation. The results showed that the bending stiffness of a closed-cell stent depends on the geometric configuration of the stent cell. It decreases when the stent cell is stretched in the circumferential direction. Mechanical flexibility equal to an open-cell structure was obtained in a closed-cell structure by varying the geometric configuration of the stent cell.     

Mechanical properties and in vitro degradation of bioabsorbable self-expanding braided stents

The aim of this study was to characterize the mechanical and self-expansion properties of braided bioabsorbable stents. In total four different stents were manufactured from PLLA fibres using a braiding technique. The changes in radial pressure stiffness and diameter recovery of the stents were determined initially, and after insertion and release from a delivery device. The braided stents were compared to three commercially available metallic braided stents. The changes in physical and mechanical properties of the PLLA fibres and stents during in vitro degradation were investigated. After release from the delivery device, the PLLA stents did not fully recover to their original diameter. The radial pressure stiffness of the bioabsorbable stents was similar to that of the metallic stents. The in vitro degradation study showed that the stents would keep at least half of their initial radial pressure stiffness for more than 22 weeks.     

Mechanical properties and in vitro degradation of bioabsorbable self-expanding braided stents

The aim of this study was to characterize the mechanical and self-expansion properties of braided bioabsorbable stents. In total four different stents were manufactured from PLLA fibres using a braiding technique. The changes in radial pressure stiffness and diameter recovery of the stents were determined initially, and after insertion and release from a delivery device. The braided stents were compared to three commercially available metallic braided stents. The changes in physical and mechanical properties of the PLLA fibres and stents during in vitro degradation were investigated. After release from the delivery device, the PLLA stents did not fully recover to their original diameter. The radial pressure stiffness of the bioabsorbable stents was similar to that of the metallic stents. The in vitro degradation study showed that the stents would keep at least half of their initial radial pressure stiffness for more than 22 weeks.     

Effects of Stent Structure on Stent Flexibility Measurements

Adequate delivery and placement of intracoronary artery stents is dependent on various properties of the stent itself, including flexibility and high-radial strength. Although these properties can be assessed via determination of the bending stiffness and radial stiffness of a stent, the mesh structure of the stent does not lend easily to such measurements. The goal of the present study was to determine an optimal method for determining stent bending stiffness. The four-points bending test was used to evaluate stent flexibility, and the finite element method (FEM) was employed to assess the effect of stent structure on flexibility in stents with differing link structures. The four-points bending test yielded the following bending stiffness values: 85.28 N mm² for the stent with an S-shaped link; 41.67 N mm² for the stent with an N-shaped link; 78.79 N mm² for the stent with a modified W-shaped link; and 188.67 N mm² for the stent with a W-shaped link. The stent with the point symmetric link configuration (S-, N- and modified W-shaped link) had high flexibility. FEM analysis revealed that low flexibility resulted from interference between the struts at the compressive side. Further, the flexibility predicted from FEM analysis correlated with bending stiffness of the stents. We conclude that use of the four-points bending test yields information that is critical for the design of flexible stents.     

Virtual optimization of self-expandable braided wire stents

At present, the deployment of self-expandable braided stents has become a common and widely used minimally invasive treatment for stenotic lesions in the cardiovascular, gastrointestinal and respiratory system. To improve these revascularization procedures (e.g. increase the positioning accuracy) the optimal strategy lies in the further development of the stent design. In the context of optimizing braided stent designs, computational models can provide an excellent research tool complementary to analytical models. In this study, a finite element based modelling strategy is proposed to investigate and optimize the mechanics of braided stents. First a geometrical and finite element model of a braided Urolume endoprosthesis was built with the open source pyFormex design tool. The results of the reference simulation of the Urolume stent are in close agreement with both analytical and experimental data. Subsequently, a simplex-based design optimization algorithm automatically adjusts the reference Urolume geometry to facilitate precise positioning by reducing the foreshortening with 20% while maintaining the radial stiffness. Therefore, the proposed modelling strategy appears to be a promising optimization methodology in braided stent design.     

Partially polyurethane-covered stent for cerebral aneurysm treatment

Partially polyurethane-covered stent (PPCS) is proposed for the treatment of cerebral aneurysms. The PPCSs were observed to substantially modify the flow entering the aneurysm in a patient-specific aneurysm phantom (PSAP). These stents can act as flow modulators and the polyurethane (PU) membrane can provide a smooth scaffold for restoring the structural integrity of the diseased vessel. Partial coating of the stent aids in sealing only the entrance to the aneurysm while keeping the perforators around the aneurysm open and patent. Biocompatibility of the PU membrane was monitored using contact angle measurements to show that critical surface tension (CST) values remained in the thromboresistant range of 20-30 mN/m. Stent flexibility, stiffness, and pressure-diameter relationship showed no significant change after asymmetric PU film application. No delamination of the PU membrane from the stent was observed within the working strains of the stent. The flow modulating capability of the PPCS was monitored by intentionally orienting the stent to cover either the proximal or the distal regions along the neck of the PSAP. Time density curves (TDCs) compared the relative metrics of input rate, washout rate, residence time, and influx in the aneurysm before and after the stent placement.     

Comparison of Two Stents in Modifying Cerebral Aneurysm Hemodynamics

There is a general lack of quantitative understanding about how specific design features of endovascular stents (struts and mesh design, porosity) affect the hemodynamics in intracranial aneurysms. To shed light on this issue, we studied two commercial high-porosity stents (Tristar stent and Wallstent) in aneurysm models of varying vessel curvature as well as in a patient-specific model using Computational Fluid Dynamics. We investigated how these stents modify hemodynamic parameters such as aneurysmal inflow rate, stasis, and wall shear stress, and how such changes are related to the specific designs. We found that the flow damping effect of stents and resulting aneurysmal stasis and wall shear stress are strongly influenced by stent porosity, strut design, and mesh hole shape. We also confirmed that the damping effect is significantly reduced at higher vessel curvatures, which indicates limited usefulness of high-porosity stents as a stand-alone treatment. Finally, we showed that the stasis-inducing performance of stents in 3D geometries can be predicted from the hydraulic resistance of their flat mesh screens. From this, we propose a methodology to cost-effectively compare different stent designs before running a full 3D simulation.     

Alteration of hemodynamics in aneurysm models by stenting: Influence of stent porosity

Recent developments in minimally invasive approach to cerebrovascular diseases include the placement of stents in arteries for treatment of aneurysms. Preliminary clinical observations and experimental studies have shown that intravascular stents traversing the orifice may lead to thrombosis and subsequent occlusion of the aneurysm. The alterations in vessel local hemodynamics due to the introduction of a stent are not yet well understood. We investigated changes in local hemodynamics resulting from stent implantation. Pulsatile flow patterns in an experimental flow appraratus were visualized using laser-induced fluorescence of rhodamine dye. The test cells were constructed in a rectangular shape to facilitate an undisturbed longitudinal view of flow patterns in parent vessel and aneurysm models with and without porous stents. Woven nitinol stents of various porosities (76%, 80%, 82%, and 85%) were investigated. The selected fluid dynamic similarity parameters (Reynolds and Womersley numbers) represented conditions usually found in high-flow, larger arteries in humans (such as the carotid artery) and low-flow, smaller arteries (such as the vertebral artery). The mean Reynolds number for the larger arteries was 180, with maximum/minimum values of 490/−30 and the Womersley number was 5.3. The mean Reynolds number for the smaller arteries was 90, with maximum/minimum values of 230/2, and the Womersley number was 2.7. For the larger arteries modeled, placement of a stent of the lowest porosity across the aneurysm orifice resulted in reduction of aneurysmal vortex speed and decreased interaction with parent vessel flow. For smaller arteries, a stent of the same porosity led to a substantial reduction of parent vessel/aneurysmal flow interaction and the appearance of a nonrecirculating crescent of fluid rich in rhodamine dye in the aneurysm dome. Our results can help explainin vivo thrombus formation within an aneurysm after placement of a stent that is compatible with local hemodynamics.     

Development of nanofiber-covered stents using electrospinning: in vitro and acute phase in vivo experiments

There are some technical difficulties in treating for a broad necked aneurysm and a higher incidence of recurrence. Because of these drawbacks, more innovative techniques for superior endovascular reconstructive treatment are required. We developed a novel covered stent employing electrospinning to deposit fine polyurethane (PU) fibers onto stents. An in vitro water leak test was designed and applied prior to animal testing to estimate the performance of covered stents and to determine the appropriate amount of PU fibers on a stent. Two tenths of a milligram of PU fibers proved to be sufficient to prevent water leakage. Then, the efficacy of the covered stents to that of bare stents was compared using 10 rabbits in which model aneurysms had been formed at the right common carotid artery by the elastase method. Angiographic evaluation on day 1 posttreatment (acute phase) revealed complete occlusion of the aneurysms and the patency of the parent arteries in animals treated with covered stents. At 10 days poststenting (subacute phase), the aneurysm neck was completely covered with neointimal layer as shown by scanning electron microscopic examination. The PU-covered stent holds promise as a device for treating cerebral aneurysms.     

The Effect of Stent Porosity and Strut Shape on Saccular Aneurysm and its Numerical Analysis with Lattice Boltzmann Method

The analysis of a flow pattern in cerebral aneurysms and the effect of stent strut shapes are presented in this article. The treatment of cerebral aneurisms with a porous stent has recently been proposed as a minimally invasive way to prevent rupture and favor coagulation mechanism inside the aneurism. The efficiency of stent is related to several parameters, including porosity and stent strut shapes. The goal of this article is to study the effect of the stent strut shape and porosity on the hemodynamic properties of the flow inside an aneurysm using a numerical analysis. In this study, we use the concept of flow reduction to characterize the stent efficiency. Also, we use the lattice Boltzmann method (LBM) of a non-Newtonian blood flow. To resolve the characteristics of a highly complex flow, we use an extrapolation method for the wall and stent boundary. To ease the code development and facilitate the incorporation of new physics, a scientific programming strategy based on object-oriented concepts is developed. Reduced velocity, smaller average vorticity magnitude, smaller average shear rate, and increased viscosity are observed when the proposed stent shapes and porosities are used. The rectangular stent is observed to be optimal and to decrease the magnitude of the velocity by 89.25% in the 2D model and 53.92% in the 3D model in the aneurysm sac. Our results show the role of the porosity and stent strut shape and help us to understand the characteristics of stent strut design.     

新型球扩式锥形血管支架的径向支撑力学行为

目的 探求支架锥度和连接筋形式对支架支撑性能的影响规律,为锥形支架的结构设计和临床选择提供重要的科学依据。方法 通过构建新型球囊扩张式锥形血管支架径向支撑性能的非线性有限元模型,采用平面压缩法分析血管支架在不同支架锥度(0°、0.565°、1.13°)和支架连接体结构形式(V、I、C、S、M型)下的支架径向刚度和应力分布规律,研究血管支架结构设计和其径向支撑性能之间的关系。结果 0°、0.565°、1.13°支架径向刚度分别为2.51、1.61、0.85 N/mm, 0.565°、1.13°支架分别比0°支架(圆直支架)下降了35.86%和66.14%;除了C型连接体支架径向刚度为1.48 N/mm外,I、M、S、V型连接体支架的径向刚度相差不大,分别为2.51、2.61、2.41、2.52 N/mm,表明这4种连接体支架在径向抗压缩性能上几乎相同。结论 相比于传统的圆直支架,锥形支架的径向刚度会减小,且随着锥度增加,支架的径向刚度会逐渐降低;在研究的所有支架类型中,除了C型连接体支架的径向刚度较差外,其余连接体形状对支架的径向刚度影响甚微。在不改变支架连接筋形式的情况下,通过降低锥形...     

考虑尺寸效应的聚合物血管支架力学性能

目的 研究考虑尺寸效应的聚合物血管支架力学性能,分析支架结构对支架力学性能和支架变形过程中尺寸效应的影响规律,为支架的结构设计提供理论依据。 方法 建立考虑尺寸效应的聚乳酸的 Cosserat 理论模型,并结合有限元法,通过三点弯和平板压获得支架弯曲刚度和径向刚度,进一步分析支架筋厚和筋宽、支撑单元曲率半径和轴向间距对支架径向支撑性能和尺寸效应的影响规律。 结果 聚合物血管支架在弯曲和压缩过程中均存在明显的尺寸效应现象;支架径向刚度与支撑单元曲率半径和轴向间距均呈负相关,与筋厚和筋宽均呈正相关;支撑单元曲率半径、轴向间距以及支架筋厚和筋宽越小,聚合物血管支架压缩过程中的尺寸效应越大。 结论 支架的径向支撑性能主要由结构的刚度决定,并受支架变形过程中尺寸效应的影响;支架几何结构的特征尺寸越小、支架弯扭变形的程度越大,则尺寸效应越明显,对支架径向支撑性能的增幅越大。     

Construction of 3 animal experimental models in the development of honeycomb microporous covered stents for the treatment of large wide-necked cerebral aneurysms

The treatment of large or wide-necked cerebral aneurysms is extremely difficult, and carries a high risk of rupture, even when surgical or endovascular methods are available. We are developing novel honeycomb microporous covered stents for treating such aneurysms. In this study, 3 experimental animal models were designed and evaluated quantitatively before preclinical study. The stents were prepared using specially designed balloon-expandable stents (diameter 3.5–5.0 mm, length 16–28 mm) by dip-coating to completely cover their struts with polyurethane film (thickness 20 µm) and microprocessing to form the honeycomb pattern after expansion. (1) In an internal carotid artery canine model (n = 4), all stents mounted on the delivery catheter passed smoothly through the tortuous vessel with minimal arterial damage. (2) In an the large, wide-necked, outer-sidewall aneurysm canine model, almost all parts of the aneurysms had embolized immediately after stenting (n = 4), and histological examination at 2 months revealed neointimal formation with complete endothelialization at all stented segments and entirely organized aneurysms. (3) In a perforating artery rabbit model, all lumbar arteries remained patent (n = 3), with minimal change in the vascular flow pattern for over 1 year, even after placement of a second, overlapping stent (n = 3). At 2 months after stenting, the luminal surface was covered with complete thin neointimal formation. Excellent embolization performance of the honeycomb microporous covered stents without disturbing branching flow was confirmed at the aneurysms in this proof-of-concept study.     

Particle image velocimetry assessment of stent design influence on intra-aneurysmal flow

Endovascular stenting appears to be an appealing treatment modality to selected complex intracranial aneurysms. However, stents currently used for endovascular treatment are not specifically designed for the cerebrovasculature. Stent parameters, such as porosity and filament size, have to be carefully optimized for long-term successful treatment. We investigated the influence of the stent filament size on the intra-aneurysmal flow dynamics in a sidewall aneurysm model in vitro. Three helical stents with 76% porosity but different filament sizes of 178, 153, and 127 m were studied using particle image velocimetry. Twenty-four pulsatile flow conditions were investigated. The results show that stenting significantly reduces intra-aneurysmal vorticity and the mean circulation inside the aneurysm is reduced to less than 3% of its value before stenting. For constant porosity, a further reduction of the mean circulation, up to 30% can be obtained by reducing the filament diameter. For a constant Womersley number, this further reduction is accentuated with increase in the peak Reynolds number. Further reduction in the mean circulation inside the aneurysm was not achieved for the 127 m stent. With further reduction in filament diameter, the helical stent filaments positioned against the aneurysm neck started wavering with the flow transferring added momentum into the aneurysm. For stents of smaller filament diameter, a supporting ultrastructure is required. © 2002 Biomedical Engineering Society. PAC2002: 8719Uv, 8780Rb, 8719La, 0630Gv     

气道支架力学设计与数值模拟研究进展

气道狭窄是一种先天性或由感染、肿瘤、外伤、结核等疾病引起的临床常见疾病,国内常见的病因有气管支气管结核、良性或恶性肿瘤等,植入气道支架已经成为介入治疗气道狭窄的主要方式。气道支架由硅酮支架到激光雕刻、编织支架,其材料与构型一直在不断更替改进。气道支架植入后仍然存在支架发生移位、气管出现肉芽肿、再狭窄等问题未解决,这些问题往往与支架植入后对气管组织整体产生的力学作用相关。本文总结归纳气道支架的力学性能以及支架与气管的典型数值模拟研究。力学性能包括支架的径向力、扭结阻力与屈服应力,其常受支架材质、构型设计、制作工艺等综合影响;而数值模拟方法能高效地对支架研发提供技术支持,为支架材料选取、设计改进与制造工作提供参考。     

基于非对称孔结构的高性能血管支架设计

目的 设计一种新型高性能血管支架,使其能够在保证足够径向刚度的前提下减小支架厚度及金属覆盖率,并具有较好的轴向柔顺性,以达到减少支架内再狭窄的目的。方法 基于对称结构孔及非对称孔结构变形能力的研究,通过数值模拟方法对支架结构进行分析设计,并利用实验方法对加工后的支架进行径向刚度及弯曲刚度的测试。结果 新的支架结构具有较高的径向刚度、较小的金属覆盖率和较好的轴向柔顺性,对减少支架内再狭窄的产生具有一定意义。结论 基于非对称孔结构的支架设计方法是有效的,并且能够借此设计出高性能的血管支架结构。     

A computational model based on fibrin accumulation for the prediction of stasis thrombosis following flow-diverting treatment in cerebral aneurysms

Flow diverters, the specially designed low porosity stents, have been used to redirect blood flow from entering aneurysm, which induces flow stasis in aneurysm and promote thrombosis for repairing aneurysm. However, it is not clear how thrombus develops following flow-diversion treatment. Our objective was to develop a computation model for the prediction of stasis-induced thrombosis following flow-diversion treatment in cerebral aneurysms. We proposed a hypothesis to initiate coagulation following flow-diversion treatment. An experimental model was used by ligating rat’s right common carotid artery (RCCA) to create flow-stasis environment. Thrombus formed in RCCA as a result of flow stasis. The fibrin distributions in different sections along the axial length of RCCA were measured. The fibrin distribution predicted by our computational model displayed a trend of increase from the proximal neck to the distal tip, consistent with the experimental results on rats. The model was applied on a saccular aneurysm treated with flow diverter to investigate thrombus development following flow diversion. Thrombus was predicted to form inside the sac, and the aneurysm was occluded with only a small remnant neck remained. Our model can serve as a tool to evaluate flow-diversion treatment outcome and optimize the design of flow diverters.     

覆膜支架在颅颈血管病变治疗中的应用

背景：随着微导管技术的不断完善和栓塞材料的改进,血管内介入治疗已成为治疗颅颈血管病变的首选方法,主要包括可脱球囊、弹簧圈、液体栓塞剂、覆膜支架。与其他血管内栓塞治疗技术相比,覆膜支架有2个突出优点：有较高的完全闭塞率和较低的再通率。 目的：介绍国内主要应用的几种覆膜支架,以及覆膜支架治疗颅颈动脉瘤和颈内动脉海绵窦瘘的临床效果。 方法：以“覆膜支架,生物相容性,动脉瘤,颈动脉海绵窦瘘”为关键词,采用计算机检索万方数据网1998-01/2010-12相关文章。纳入覆膜支架治疗颅颈血管病变方面的文献,排除重复研究或Mata分析类文章。 结果与结论：现在神经外科临床应用的覆膜支架,主要采用的是美国Abbott公司推出的Jostent覆膜支架和上海微创公司生产的Willis覆膜支架。Jostent覆膜支架优点是生物相容性和扩展性较好,其多微孔结构可减少细胞扩散,阻止血小板聚集、炎性细胞移动,从而降低了继发性血栓及血管狭窄的概率;其缺点是在颅内动脉中应用的范围比较狭窄,动脉不能过于迂曲,弯曲角度不能过于锐利,病变附近不能有不可闭塞的穿支或分支。专为颅内血管设计的Willis覆膜支架的应用,彻底改变了颅内动脉瘤血管内治疗的传统理念,整个支架系统具有一定的柔顺性,有助于其通过颅内弯曲的血管系统,尤其是颈内动脉虹吸段,由于其操作简单,效果满意,为血管内治疗技术的发展提供了新的方向。