1、Designation: F2079 09 (Reapproved 2017)Standard Test Method forMeasuring Intrinsic Elastic Recoil of Balloon-ExpandableStents1This standard is issued under the fixed designation F2079; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision
2、, 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 The purpose of this test method is to quantify thepercentage by which the diameter of a stent decreases
3、from itsexpanded diameter while still on the delivery balloon to itsrelaxed diameter after deflating the balloon. This test method isappropriate for stents manufactured from a material that isplastically deformed when the stents diameter is increasedfrom its predeployed size to its postdeployed size
4、 by mechani-cal means. This test method may be performed in air at roomtemperature unless there is a known temperature dependence ofthe material, in which case, the temperature at which the test isconducted shall be stated in the report.1.2 The values stated in SI units are to be regarded asstandard
5、. No other units of measurement are included in thisstandard.1.3 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-
6、bility of regulatory limitations prior to use.1.4 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the
7、 World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Terminology2.1 Definitions:2.1.1 labeled diameter, nthe nominal deployed size of astent as indicated on its manufacturers label.2.1.2 stent recoil, nthe amount, expressed as a percentage,by which the diameter of a stent changes
8、from the expandeddiameter measured with the stent on the inflated deliveryballoon to the final value measured after deflating the balloon.3. Summary of Test Method3.1 A sample device representative of product that will bemarketed is either premounted or mounted on the deliveryballoon at the time of
9、use. The delivery balloon is inflated tothe nominal expansion pressure indicated for the labeled stent.The outer diameter of the stent is measured in at least threeaxial locations while the stent is still on the inflated deliveryballoon. At each axial location, measurements are taken in twoapproxima
10、tely orthogonal rotational positions. The balloon isdeflated and the outer diameter of the stent is remeasured in thesame positions at approximately the same locations.4. Significance and Use4.1 Minimal stent recoil is a desirable feature of a stentbecause it minimizes the maximum diameter to which
11、a stentmust be expanded to achieve its final relaxed diameter. A stenthaving a high recoil must be expanded to a greater diameter toachieve its final relaxed diameter than a stent having lowrecoil. Practically, excessive expansion of the vessel into whichthe stent is to be implanted may cause tissue
12、 damage resultingin a poor immediate result or poor long-term outcome. Stentrecoil is affected by intrinsic properties of the material used toconstruct the stent and the specific geometric design of thestent; therefore, measuring stent recoil is an essential part ofevaluating the design.5. Apparatus
13、5.1 A means to inflate with noncompressible fluid, typicallywater, the delivery balloon on which the stent is mounted. Themeans used must be capable of achieving the pressure requiredto maintain the expanded diameter of the stent until it can bemeasured and may include a device to monitor pressure.5
14、.2 A means to measure the outer diameter of the stentwithout deforming the stent. Typically, a calibrated opticalsystem, which does not require contact with the stent, is used.The resolution of the measurement system shall be 0.01 mm orbetter. The accuracy of the system shall be 2 % of reading orbet
15、ter.6. Sampling, Test Specimens, and Test Units6.1 Unless otherwise justified, all samples selected fortesting should be taken from fully processed, clinical quality1This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct respon
16、sibility of SubcommitteeF04.30 on Cardiovascular Standards.Current edition approved Sept. 1, 2017. Published September 2017. Originallyapproved in 2001. Last previous edition approved in 2013 as F2079 09 (2013).DOI: 10.1520/F2079-09R17.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700
17、, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the Wor
18、ld Trade Organization Technical Barriers to Trade (TBT) Committee.1product. It is not required that these devices undergo terminalsterilization. Cosmetic rejects or other nonclinical samples maybe used if the cause for rejection has been shown not to affectstent recoil.6.2 The number of specimens te
19、sted for each unique stentgeometry should be sufficient to meet sampling requirementsfor desired specification limits. In general, a minimum of tenspecimens is recommended. If a single stent geometry isintended to be used for more than one labeled diameter, recoilshall be evaluated for test specimen
20、s expanded to the smallestand largest diameters intended for that geometry.6.3 Most stents are comprised of a repetitious continuouspattern or of repeating subunits. If stents are made longer byadditional repetition of the basic geometric pattern or byadding identical subunits, then recoil need be m
21、easured on onlya single length of each diameter stent. If, however, dimensionsof the substructure of the repeating pattern or of the subunits isaltered to change the length, then recoil must be measured foreach unique geometry.7. Procedure7.1 Corresponding paired outer diameter measurements,(that is
22、, Diameterinflatedand Diameterfinal) shall be obtainedwith the stent in approximately the same rotational positionwith respect to the measurement system.7.2 The number of locations along the length of the stent atwhich recoil is measured should be determined by initialassessment of the stent geometr
23、y. Measurements should bemade at multiple axial locations, including one location nearmidlength and locations near either end of the stent. Additionalmeasurements may be warranted by the stent design. Forexample, if the stent is specifically designed to recoil differ-ently at specific locations alon
24、g its length, additional measure-ments should be taken at these locations.7.3 Inflate the balloon to the nominal expansion pressureindicated on the stent labeling. To allow for full expansion ofthe stent, maintain the expansion pressure for 15 to 30 s beforetaking diameter measurements.7.4 For each
25、axial measurement location identified in 7.2,measure the outer diameter of the stent in two approximatelyorthogonal rotational positions.7.5 Deflate the balloon.7.6 Measure the outer diameter of the stent at the samelocations and in the same rotational positions with respect tothe measurement system
26、 as in 7.4. These measurements shouldbe taken no sooner than 10 s after deflating the balloon.8. Calculation8.1 Calculate the stent recoil for the locations measured in7.4 for each stent using the following equation:Stent Recoil %! 5S1 2SDiameterfinalDiameterinflatedDD*100 (1)where:Diameterinflated=
27、 outer diameter of stent while on inflateddelivery balloon andDiameterfinal= outer diameter of stent after deflating de-livery balloon.8.2 Calculate the average and standard deviation of stentrecoil for each axial location at which recoil is measured.9. Report9.1 Report the following information for
28、 each labeled diam-eter of each unique stent geometry:9.1.1 Labeled stent diameter, in millimetres.9.1.2 Labeled stent length.9.1.3 Number of samples measured.9.1.4 Locations at which measurements were taken.9.1.5 Diameterinflated(mean 6 standard deviation, to thenearest 0.01 mm).9.1.6 Diameterfinal
29、(mean 6 standard deviation, to the near-est 0.01 mm).9.1.7 Stent recoil average (mean 6 standard deviation, tothe nearest 0.5 %) for each location measured.9.1.8 Temperature at which test is performed.10. Precision and Bias10.1 PrecisionThe precision of this test method has notyet been established.
30、An interlaboratory comparison to deter-mine the precision is being planned.10.2 BiasNo information can be presented on the bias ofthis test method because no material having an acceptablereference value is available.11. Keywords11.1 recoil; stentF2079 09 (2017)2APPENDIXES(Nonmandatory Information)X1
31、. RATIONALEX1.1 Balloon-expandable stents typically are deployed forpermanent implant by plastically deforming the material ofconstruction. Upon release of the balloon pressure, the diam-eter will decrease, the exact amount of which depends on thematerial used to construct the stent and the specific
32、 design ofthe stent. For optimal clinical results, it is critical that the finaldeployed diameter be appropriate for the exact location ofdeployment. Moreover, a stent with excessive recoil must beinflated to a larger diameter to achieve the desired finaldiameter. This larger required initial inflat
33、ion diameter maycause more damage to the vessel than would the lower inflationdiameter required for a stent with a lower recoil. The implant-ing physician must have guidance as to how much any givenstent design will recoil so that the balloon may be inflated tothe expanded diameter required to achie
34、ve the desired finaldiameter. This test method provides a standardized procedureto determine the recoil characteristics of stents so that consis-tent labeling can be written. Note that this test methodmeasures the intrinsic recoil of the stent and may not predicthow the stent will perform when impla
35、nted in a vessel in whichstent recoil, stent stiffness, and vessel stiffness interact todetermine the final diameter.X2. REVISION HISTORYX2.1 This standard was originally approved in 2001. It wasrevised in 2002 to clarify terminology, measurementprocedures, and reporting requirements.ASTM Internatio
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39、, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 09 (2017)3
