Abstract
Objective: We have already developed Masamune, double-lumen balloon microcatheter. Because of double lumen, it can be used not only as neck plasty balloon, but also as the catheter for coil insertion. We recently developed Super-Masamune, a new type of Masamune.
Method: The concept of development is that compliance of the Super-Masamune is equal to that of single-lumen balloon microcatheters, which is already commercially available. Material of the balloon is switched from silicone to styrene elastomer to improve compliance. Super-Masamune has a purge hole because styrene elastomer is not a semipermeable membrane. Then, animal experimentation using swines was performed. Effectiveness of Super-Masamune for neck plasty technique is evaluated in the aneurysm model of the swine. Vessel damage due to balloon inflation was evaluated by histological observations, and was compared with that of HyperForm, single lumen balloon microcatheter.
Result: Profile of Super-Masamune is similar to Masamune in spite of changing to styrene elastomer. The total length of Super-Masamune is 150 cm, distal diameter is 2.8F, proximal diameter is 3.4F, and inner diameter of recommended guiding catheter is 0.059 inch or more. Inner diameter is 0.40 mm, balloon length is 4 mm, and balloon diameter is 7 mm at recommended volume of 0.2 ml. Super-Masamune is more compliant than Masamune. Animal experimentation showed that Super-Masamune gives less damage to the vessel than HyperForm.
Conclusions: Super-Masamune is a very compliant double-lumen balloon microcatheter. It would extend the indication of intra-aneurysmal coil embolization. Super-Masamune has recently become commercially available in Japan.