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.

Used balloons during in vitro study. Enter your personal account email address to request a password reset: Drug transfer from coated balloons to the simulated vessel wall could occur in different ways.

Drug wash-off from various vessel models after 1 min Fig. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. Complications are occlusions of small vessels or capillaries.

No items in cart. Table 1 Total PTX delivery upon dilation in different vessel models after simulated use in an in vitro vessel model a. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Calculated curves for PTX tissue concentration as function of time are provided in the literature. This guide is intended to aid investigators in the design, development, and in vitro characterization of pre-mounted, unsheathed, balloon-expandable stent delivery systems.

The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other.

Torque Sensor Application – Catheter Torque Test

The guide proposes f23944 set of options to consider when testing stent securement. Drug residue on the balloon Fig. PAAm was synthesized by radical polymerization. Historical Version s – view previous versions of standard.

Thus, the highest drug wash-off after 1 min was achieved in case of calcium alginate as the vessel model.

ASTM F2394 – 07(2017)

Calcium alginate hydrogel as the vessel model showed the highest PTX delivery upon dilation. Within the first hour, the concentration decreases dramatically. This could be overcome by using other drug candidates or models showing, for example, fluorescence.

The balloon was almost completely unloaded. Furthermore, the hydrogel characteristics were important for PTX transfer and diffusion into hydrogels.

Calcium alginate, poly vinylethylimidazolium bromide and polyacrylamide hydrogels were used as vessel models in this in vitro study. Drug transfer from coated balloon catheters to different simulated vessel aetm was evaluated and compared to a silicone tube. Only small transferred fractions were observed for both vessel models after passage of the balloon catheter through a simulated anatomic model.

Moreover, c2394 diffusion of PTX into the vessel wall occurs at various rates, which may be related with the cross-linker content. Thus, the drug diffused into the vessel model or adhered on the vessel wall and was not released in one minute into the medium. In addition to mechanical properties flexibility of the vessel models, different adhesion properties were present.

Local drug delivery after balloon dilation in the first crucial minute was determined in a vessel-simulating flow-through cell by a simulated blood stream. Paclitaxel may dissolve on contact with the hydrogel compartment and diffuse into the gel. The vessel-simulating flow-through cell 2f394 combined with a model coronary artery pathway to estimate drug loss during simulated use in an in vitro model. Most of the solvent diffused into the polymer and thus the hydrogel rapidly swells.

Catheter Torque Test

Thus, PTX is transferred into and retained by the pig tissue for a certain time. After complete gelation, the metal rod was removed from the flow-through cell and a simulated artificial vessel wall was obtained. The wash-off from the alginate hydrogel was high drug release after 1 min by a simulated blood stream: It is intended to f23944 a starting point from which to select and investigate securement test options.

In vivo characteristics may also differ from in vitro results. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of f3294 other. The guide proposes a set of options to consider when testing stent securement.