ASTM F2394 PDF

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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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Calcium alginate hydrogel as the vessel model showed the highest PTX delivery upon dilation. Drug adherence and loss on the way to the vessel was tested in vitro by Kelsch et al. Thus, solubility is very important for drug release and delivery. The entire guiding catheter was then flushed with 20 mL of 0. The balloon was almost completely unloaded.

Catheter Torque Test

Thus, the drug diffused into the vessel model or adhered on the vessel wall and was not released in one minute 2f394 the medium. Table 2 Particle quantification after simulated anatomic passage. The simulated vessel models chosen were important for an effective drug transfer. The residual loads of PTX on the balloon catheter were also determined Fig. However, expansion of the balloon in calcium alginate yielded only 0. 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 PTX transfer into the vessel models are listed in Table 1. Similar transfer rates for PTX upon dilation were aatm with calcium alginate as the vessel model 6.

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Torque Sensor Application – Catheter Torque Test

Thus, the highest drug wash-off after 1 min was achieved in case of calcium alginate as the vessel model. Balloon catheters were coated with paclitaxel using the ionic liquid cetylpyridinium salicylate as aastm novel carrier. Paclitaxel may dissolve on contact with the hydrogel compartment and diffuse into the gel.

Consequently, there was still It is intended to provide a starting point from which to select and investigate securement test options. Alternatively, with PAAm as the vessel wall, only 2. Over a period of one minute, a contact between the expanded balloon and simulated vessel wall is established, thus allowing transfer of PTX particles. As before, a short wash-off time drug release after one minute was chosen to simulate the drug behavior after pass through the tracking model. A hydrogel is a network of polymer chains that are hydrophilic and should be more appropriate.

Remember me for one month. Within the first hour, the concentration decreases dramatically. Table 1 Total PTX delivery upon dilation in different vessel models after simulated use in an in vitro zstm model a. In vivo characteristics may also differ from in vitro results.

The degree of crystallization is important; Afari et al. After complete gelation, the metal rod was removed from the flow-through cell and a simulated artificial vessel wall was obtained. Drug residue on the balloon.

ASTM F2394 – 07(2017)

E Practice for Conducting Ruggedness Tests. The poly VEImBr hydrogel shows strong swelling behavior in methanol which was used to extract the drug from the hydrogel. Poly vinylethylimidazolium bromide hydrogel poly VEImBr. Considerably lower PTX was delivered into hydrogel-based vessel models. Drug delivered in the silicone tube was extracted with methanol A shorter dilation time results in partial drug release.

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ASTM-F, –

Another drug transfer pathway may occur by particle transfer of PTX due to prevailing mechanical forces during balloon expansion onto the vessel wall. Silicone tube only balloon type 2calcium alginate trial 1: Calcium alginate, poly vinylethylimidazolium bromide and polyacrylamide hydrogels were used as vessel models in this in vitro study.

The wash-off from the alginate hydrogel was high drug release after 1 min by a simulated blood stream: There were no books found for the applied search filters.

All samples were quantified by means of HPLC after a 1: It is intended to provide a starting point from which to select and investigate securement test options.

No items in cart. During balloon inflation, the blood flow in the vessel is interrupted and therefore expansion can only be maintained up to one minute.

It is intended to provide c2394 starting point from which to select and investigate securement test options. This could be overcome by using other drug candidates or models showing, for example, fluorescence.