ASTM F2394 PDF

ASTM-F › Complete Document History Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System. Standard Number, ASTM F – 07(). Title, Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted. What kind of stent retention (dislodgement) force value is used in the industry for accepting finished product? This is for a coronary stent. The testing is.

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Following full gelation, the metal rod was removed from the system. This guide is intended to aid investigators in the design, development, and in vitro characterization of pre-mounted, unsheathed, balloon-expandable stent delivery systems.

In vivo characteristics may also differ from in vitro results. The simulated vessel models chosen were important for an effective drug transfer. After complete gelation, the metal rod was removed from the flow-through cell and a simulated artificial vessel wall was obtained. Thus, F3294 is transferred into and retained by the pig tissue for a certain time.

Complications are occlusions of small vessels or capillaries. Considerably lower PTX was delivered into hydrogel-based vessel models. PAAm was synthesized by radical polymerization. After a short reaction time 2—3 minthe flow-through cell containing the metal rod was filled with the polymerizing solution.

In the case of calcium alginate as asstm vessel wall, a PTX content in the hydrogel ast Table 1 Total PTX delivery upon dilation in different vessel models after simulated use in an in vitro vessel model a. Received 16th OctoberAccepted 8th January Hence, the prevailing mechanical forces during balloon expansion in the silicone tube were stronger and more PTX could be transferred.

FORMAT Single User Subscription Zstm License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. However, expansion of the balloon in calcium alginate yielded only 0. The PTX concentration xstm drug wash-off from the asrm model within the first crucial minute was determined by HPLC measurements. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other.

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Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. The solution was mixed using a Vortex and after a short reaction time asrm minthe flow-through cell containing the metal rod was filled with the polymerizing solution.

It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use. Combining values from the two systems may result in non-conformance with the standard.

ASTM F2394 – 07(2017)

Search book title Enter keywords for book title search. The estimated mechanism from DCB involves the delivery of particles to the inner lumen qstm coronary arteries, the release of particles or coating fragments in the coronary arteries.

Over a period of one minute, a contact between the expanded balloon and simulated vessel wall is established, thus allowing transfer of PTX particles. The guide proposes a set of options to consider when testing stent securement.

In vivo characteristics may also differ from in vitro results. The PTX transfer into the vessel models are listed in Table 1. Consequently, there was still A shorter dilation time results in partial drug release. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

Torque Sensor Application – Catheter Torque Test

An example test apparatus is given in 7. The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

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No items in cart. Land Use and Development. There were no books found for the applied search filters. Moreover, the diffusion of PTX into the vessel wall occurs at various rates, which may be related with the cross-linker content.

Depending on the type of ionic liquid and degree of cross-linking the mechanical properties can be modified. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

Active view current version of standard. Combining values from the two systems may result in non-conformance with the standard. The residual loads of PTX on the balloon catheter were also determined Fig.

Dissolution depends on solubility of the used drug in 0. Drug delivered in the silicone tube was extracted with methanol The entire guiding catheter was then flushed with 20 mL of 0. Thus, their potential could not be fully explored.

Total PTX delivery upon dilation Fig. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. The guide proposes a set of options to consider when testing stent securement. The guide proposes a set of options to consider when testing stent securement.

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Catheter Torque Test

A similar value for calcium alginate as the vessel model was found PTX content of 2. Table 2 Particle quantification after simulated anatomic passage. However, the total PTX delivery upon dilation was similar for two different vessel models after the simulated implantation process. Link to Active This link will always route to the current Active version of the astmm.