Only small transferred fractions were observed for both vessel models after passage of the balloon catheter through a simulated anatomic model. Torque Sensor Application — Catheter Torque Test A drug release time of only one minute was chosen to simulate a very fast PTX transfer and wash-off from the vessel model. Print 1 2 3 4 5 page sstarting from page current page. Drug wash-off from various vessel models after 1 min Fig. The guide proposes a set of options to consider when testing stent securement. Since the drug is poorly soluble in water and because of binding to tissue structures, the PTX may persist longer in the vessel wall.
|Published (Last):||23 September 2006|
|PDF File Size:||15.90 Mb|
|ePub File Size:||7.62 Mb|
|Price:||Free* [*Free Regsitration Required]|
Mezile Copyright Compu-tecture, Inc. The guide proposes a set of options to consider when testing stent securement. As already mentioned, PTX is characterized by its very low solubility. Register for a trial account. After complete gelation, the metal rod was removed from the flow-through cell and a simulated artificial vessel wall was obtained. Are you sure you want to empty the cart? The estimated mechanism from DCB involves the delivery of particles to the inner lumen of coronary arteries, the release of particles or coating fragments in the coronary arteries.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. 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 entire guiding catheter was then flushed with 20 mL of 0.
Drug delivered in the silicone tube was extracted with methanol In addition to mechanical properties flexibility of the vessel models, different adhesion properties were present. The degree of crystallization is important; Afari et al. 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. Thus, the drug delivery characteristic is dependent on the hydrogel compartment.
In vivo characteristics may also differ from in vitro results. Please login to your authorized staff account to use this feature. Furthermore, the hydrogel characteristics were important for PTX transfer and diffusion into astn. There are different possibilities for interpretation of the observed results. Enter your personal account email f to request a password reset: Drug-coated balloon catheters are a novel clinical treatment alternative for coronary and peripheral artery diseases.
The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints. A hydrogel is a network of polymer chains that are hydrophilic and should be more appropriate. Catheter Torque Test The vessel-simulating flow-through cell was combined with a model coronary artery pathway to estimate drug ast, during simulated use in an in vitro model. Drug residue on the balloon. However, considerably less drug on the balloon catheter surface were analyzed in the cases of dilation in calcium alginate In conclusion, the PTX transfer upon dilation depends on the coating of the balloon and the used vessel model simulating the vessel wall.
PAAm was synthesized by radical polymerization. An example test apparatus axtm given in 7. Today, some 12, ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence.
Link to Active This link will always route to the current Active version of the standard. Next to calcium alginate as a natural hydrogel, synthetic polymers with good mechanical and long-term stability were also used.
Table 2 Particle quantification after simulated anatomic passage. Total PTX delivery upon dilation Fig. Extraction of the balloon catheter in methanol resulted in a PTX content of 1. However, expansion of the balloon in calcium alginate yielded only 0. If you like to setup a quick demo, let us know at support madcad. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Over a period of one minute, a contact between the expanded balloon and simulated vessel wall is established, thus allowing transfer of PTX particles.
Table 1 Total PTX delivery upon dilation in different vessel models after simulated use in an in vitro vessel model a. Thus, the highest drug wash-off after 1 min was achieved in case of calcium alginate as the vessel model. Extraction of the balloon in methanol resulted in the highest PTX concentration for the silicone tube The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints.
Land Use and Development.
ASTM F2394 PDF