ASTM F2606-2008(2014) Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems《三点弯曲血管球囊膨胀型支架和支架装置的标准指南》.pdf

《ASTM F2606-2008(2014) Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems《三点弯曲血管球囊膨胀型支架和支架装置的标准指南》.pdf》由会员分享，可在线阅读，更多相关《ASTM F2606-2008(2014) Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems《三点弯曲血管球囊膨胀型支架和支架装置的标准指南》.pdf（6页珍藏版）》请在麦多课文档分享上搜索。

1、Designation: F2606 08 (Reapproved 2014)Standard Guide forThree-Point Bending of Balloon Expandable Vascular Stentsand Stent Systems1This standard is issued under the fixed designation F2606; the number immediately following the designation indicates the year oforiginal adoption or, in the case of re

2、vision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide provides guidelines for quantitatively char-acterizing balloon-expandable stent and ste

3、nt system flexibilityusing three-point bending procedures. Guidelines are providedfor characterizing deployed stent flexibility, and for character-izing pre-deployment stent system flexibility in the region ofthe stent and balloon.1.2 This guide is not recommended for test articles thatcannot be app

4、ropriately evaluated using a span length to stentouter diameter (as tested) ratio of at least 4:1. Test articles thatdo not meet this requirement are likely to exhibit appreciabledeformation by modes other than bending.1.3 This guide does not provide procedures for characteriz-ing the bending flexib

5、ility of self-expanding stents, self-expanding stent systems, endoprostheses (stent-grafts), or en-doprostheses systems. However, some aspects of this guidemay be useful for developing appropriate three-point bendingcharacterization procedures for these devices. While this guidewas developed with va

6、scular stents and stent systems in mind,it may be useful for characterizing the bending flexibility ofballoon-expandable stents and stent systems used in non-vascular applications.1.4 The values stated in SI units are to be regarded as thestandard. The values given in parentheses are mathematicalcon

7、versions to inch-pound units that are provided for informa-tion only and are not considered standard.2. Terminology2.1 Definitions:2.1.1 bending flexibility, na measure of the ability of a testspecimen to bend.2.1.2 bending stiffness, na measure of the ability of a testspecimen to resist bending.2.1

8、.3 conformability, nthe degree to which a stent or stentsystem matches the native curvature of the vasculature.2.1.4 deflection, ndisplacement of the dynamic support(loading anvil) at any point in the test.2.1.5 delivery system, ncatheter that is used to deliver anddeploy a stent at the target site.

9、 A delivery system forballoon-expandable stents may be similar to a balloon-dilatation (angioplasty) catheter.2.1.6 midspan bending moment, na linear estimate of thebending moment at the center of the span. See 8.5.2.1.7 midspan curvature, na linear estimate of the curva-ture of the center of the sp

10、an. See 8.5.2.1.8 span length, ndistance between the centers of thesupports.2.1.9 stent system, ndelivery system with a pre-mountedstent.2.1.10 stent, vascular, nsynthetic structure that is perma-nently implanted in the native or grafted vasculature and that isintended to provide mechanical radial s

11、upport to enhancevessel patency.3. Significance and Use3.1 This guide can be used to obtain force versus deflectionor midspan bending moment versus midspan curvature curvesfor stents and stent systems subjected to three-point bendingconditions. Bending flexibility of a stent system may be afactor in

12、 its ability to track through the vascular anatomy, andmay be a factor in vascular trauma along the delivery pathwaydistal to the guide catheter. Bending flexibility of a deployedstent may be one measure of its ability to flex with a vessel, orto conform to the natural curvature of a vessel. Bending

13、flexibility of a delivery system may also be of interest if it isdesired to assess the separate contributions of the deliverysystem and the mounted stent to the overall flexibility of thestent system.3.2 This guide is not intended to determine materialproperties, stent system trackability (ability o

14、f a stent system tofollow a guide wire and/or guide catheter through vasculartortuosity), or stent system deliverability (ability of a stentsystem to deliver a stent to the implantation site(s) or throughparticular level(s) of vascular tortuosity). While this guide doesnot determine stent system tra

15、ckability or deliverability, it canprovide quantitative insight into how stent system bending1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.30 on Cardiovascular Standards.Current edition app

16、roved March 1, 2014. Published April 2014. Originallyapproved in 2008. Last previous edition approved in 2008 as F2606 08. DOI:10.1520/F2606-08R14.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1flexibility affects trackability and de

17、liverability. Similarly,while this guide does not determine conformability of adeployed stent, it can provide quantitative insight into howstent and/or stent system bending flexibility affects deployedstent conformability. Since this guide quantifies bendingflexibility, it may be useful in determini

18、ng the magnitude ofbending flexibility effects on bending-related performancedifferences between the test article and control devices.3.3 The three-point bending procedures provided in thisguide are intended to be used to characterize balloon-expandable stent and stent system flexibility during prod

19、uctdevelopment. They may not necessarily satisfy any particularrequirements of national or international regulatory bodies.4. Summary of Guide4.1 The specimen is loaded onto a three-point bend fixture.The specimen is supported from below by two static supportsseparated by a known span and bent by a

20、force applied on thetop and midway between the lower supports. The bendingflexibility of the stent is obtained from force-versus-deflectionplots and/or midspan bending moment versus midspan curva-ture plots. Bending flexibility evaluations may be made onballoon-expandable stent systems, and/or on de

21、ployed balloon-expandable stents. Bending flexibility of a delivery system mayalso be evaluated if it is desired to assess the separatecontributions of the delivery system and the mounted stent tothe overall flexibility of the stent system.4.2 Bending flexibility assessments may be made using afixed

22、 span between the lower supports or by using a span thatincreases with the specimen length.4.2.1 The fixed span length method permits force versusdeflection comparisons that are independent of stent length.This method may be useful when comparing the flexibility ofstents with different diameters or

23、structural designs, and it maypermit bending flexibility to be evaluated at multiple longitu-dinal positions along longer test articles.4.2.2 The variable span length method allows the bendingmoment arm length to be maximized for any given stent lengthin order to minimize the potential for non-bendi

24、ng deformationat a given applied load and/or deflection. Bending flexibilitycomparisons may be made at different span lengths by com-paring midspan bending moments at given midspan bendingcurvatures. The variable span length approach also permits thestudy of bending load variation with span length,

25、but thebending loads are not solely dependent on the inherent bendingstiffness of the test article.4.2.3 Both the fixed and variable span length methodspermit the study of bending load variation with test articlecurvature by varying deflection to cause variation in curvature.In the variable span len

26、gth method, test article curvature mayalso be varied by changing the span length.5. Apparatus5.1 The three-point bend test apparatus consists of a meansof applying and accurately measuring various loads anddeflections to a specimen mounted in a three-point bendingfixture. Stents can be tested in the

27、 deployed state and stentsystems can be tested prior to stent deployment. The three-point loading fixture consists of two lower static supports andone upper load applicator as shown in Fig. 1. As the stent isdeflected, the force and deflection values are recorded. The testsystem should include a com

28、puterized data acquisition system.5.1.1 The two lower static supports should be parallelcylinders with a diameter of 6.35 mm (14 in.), unless anothergeometric shape and/or diameter is more appropriate for thespan and/or to minimize adverse stent/support interaction, forexample, to minimize resistanc

29、e to stent movement over thesupport during loading. The static supports may containcircumferential grooves or shoulders to keep the test articleaxis perpendicular to the supports during testing. Alternativelower supports should be designed to ensure that the appliedloads result in bending, not kinki

30、ng, buckling or crushing, ofthe test article. It is recommended that the lower static supportsbe designed to minimize friction by using materials such aspolytetrafluoroethylene (for example, Teflon), acetal poly-oxymethylene (for example, Delrin) or other low-frictionmaterial, or by allowing support

31、 rotation with bearings. Theheight of the static supports needs to be sufficient to provideadequate distance for deflection.5.1.2 The upper dynamic load applicator should also be acylinder with a 6.35 mm (14 in.) diameter, unless anothergeometric shape and/or diameter is more appropriate for thespan

32、 and/or minimization of adverse stent/support interactions(for example, to minimize the potential local deformation(kinking or crushing), to minimize the resistance to movementof the specimen over the lower supports during specimenbending, to minimize the potential for the upper support toresist spe

33、cimen bending, and so forth). The upper load appli-cator should be parallel to, and horizontally centered between,the lower static supports.Alternative designs for the upper loadapplicator should ensure that the applied loads result inbending, not kinking, buckling or crushing, of the test article.5

34、.1.3 The bending fixtures lower (static) support diametersand upper (dynamic) load applicator diameter should beappropriate for the span length and test article diameter (that is,FIG. 1 Schematic of Three-Point Bending Apparatus with StentSystemF2606 08 (2014)2span length lower support diameter + up

35、per support diameter+ 2 (test article diameter).5.1.4 Table 1 provides span length and maximum deflectionrecommendations for the variable span length method. Thedeflection listed in Table 1 is a maximum deflection recom-mendation. Actual test deflections should be lower, especiallyif it is desired t

36、o avoid plastic deformation. Alternative spanlengths and deflections for deployed stent flexibility character-izations may be based on stented vessel flexure conditionsanticipated for the intended implant location(s) or other appro-priate considerations. Alternative span lengths and deflectionsfor s

37、tent system flexibility characterizations may be based onvessel curvature conditions anticipated along the intendeddelivery pathway(s) or other appropriate considerations.5.1.5 The span length used for the fixed span method shouldbe small enough to permit evaluation of the minimum stentlength to be

38、tested using the selected maximum deflection. It isrecommended that span length be at least 4 mm smaller thanthe minimum stent length to be evaluated.5.1.6 The apparatus should have adequate displacement(deflection) rate control and the displacement rate should besufficiently slow to avoid excessive

39、 loads due to inertial effects. Consideration should also be given to the displacement rate(s)expected clinically if the test article is sensitive to strain ratevariations between the quasi-static strain rates used to avoidexcessive inertial loads and the strain rates associated withclinically relev

40、ant displacement rates. Use of similar displace-ment rates are recommend for device comparison purposes.5.1.7 The accuracy of the apparatus force and displacementmeters should be within 65 % of the maximum reported forceand displacement values.5.2 An inflation device for deploying the stent.5.3 Mean

41、s to preheat and maintain the temperature of thetest article at 37 6 2C, if appropriate.5.4 Means to hydrate and maintain the hydration of the testarticle, if appropriate.6. Test Specimens6.1 A minimum of three like specimens (same labeled stentdiameter and length) should be tested for each test con

42、dition(span length, rotational orientation, and so forth) in order toprovide some indication of bending stiffness variation for agiven device and test condition. More samples may be needed,depending on the claims to be made based on the test results.6.2 If using the variable span method, the shortes

43、t stent of agiven diameter may be used to determine the maximumbending load associated with a given deflection or curvature.Conversely, the longest stent of a given diameter may be usedto determine the minimum bending load for a given deflectionor curvature.6.2.1 If using the fixed span method, the

44、variation ofbending load with stent length at a given deflection cannot bedetermined. However, the variation in bending load withcurvature may be determined by varying deflection to causevariation in curvature.6.3 If bending stiffness may be sensitive to the rotationalorientation of the test article

45、 about its longitudinal axis, themaximum and minimum bending stiffness orientations shouldbe evaluated.7. Procedure7.1 If deformation of the stent and/or delivery system occursduring a test, the sample should not be re-tested. Even ifdeformation is not observed, retesting specimens is not recom-mend

46、ed as test results may still be affected by prior tests.7.2 Prepare the fixture as described in Section 5 with the testarticle positioned perpendicular to the lower static supports.7.3 Mount the upper load applicator parallel to the staticsupports and centered between them. The load applicatorshould

47、 be able to move vertically to the maximum testdeflection without crushing the test article.7.4 If the bending properties of the test article are affectedby temperature variation between ambient and 37C, the testshould be conducted while maintaining the specimen tempera-ture at 37 6 2C.7.5 If the be

48、nding properties of the test article are sensitiveto hydration, the test should be conducted while keeping thetest article fully hydrated.7.6 Mark the middle of the stent to indicate the position andorientation of the applied deflection.7.7 If a stent system is to be tested, cut the stent system jus

49、tproximal of the proximal balloon seal.7.8 If a deployed stent is to be tested, deploy the stent asindicated in the Instructions for Use. Deploy at 37 6 2C ifdeployment at temperatures between ambient and 37C mayaffect stent diameter or flexural stiffness.7.9 If testing is to be conducted at 37 6 2C, preheat the testfixture and test article to 37 6 2C.7.10 Place the test article in the center of the three-pointbending fixture and position it such that the dynamic loadapplicator will contact the midpoint of the stent as marked in7.6.7.11 Maintain the test article