摘要:
A coating device for coating a medical device with a drug-eluting material uses an in-process drying station between coats to improve a drug release profile. The drying station includes a dryer having a telescoping plenum which provides a drying chamber for the stent or scaffold to reside while a heated gas is passed over the stent/scaffold. The drying chamber improves efficiency in drying, predictability or drug release rate, uniformity of coating material properties lengthwise over the stent/scaffold and provides a platform that can effectively support stents that are over 40 mm in length.
摘要:
A coating device for coating a medical device with a drug-eluting material uses an in-process drying station between coats to improve a drug release profile. The drying station includes a dryer having a telescoping plenum which provides a shield and drying region for the stent or scaffold to reside while a heated gas is passed over the stent/scaffold. The shield and drying region improve efficiency in drying, predictability or drug release rate, uniformity of coating material properties lengthwise over the stent/scaffold and provide a platform that can effectively support stents that are over 40 mm in length.
摘要:
A system and method allows for processing of two groups of medical devices, both groups being alternatingly spray coated within the same enclosure. The two groups repeatedly move back and forth between a spray area and a drying area which is isolated from the spray area. One group moves into the spray area as the other group moves out and into the drying area. Thereafter, the group in the spray area moves out and into the drying area and the other group moves back into the spraying area for a second coating. The alternating process may be repeated any number of times. The spray area may be located inside a sealed spray isolator enclosure and surrounded by gas discharge nozzles.
摘要:
A coated implantable medical device and a method of coating an implantable medical device is disclosed, the method includes applying a composition onto the device and drying the composition at elevated temperature in an environment having increased relative humidity. A pre-screening method for a manufacturing lot of coated stents to determine the number of drug coating layers for a desired drug release rate is disclosed. The method including coating and testing small groups of stents, and applying the results of the tests to determine the number of drug coating layers to apply to the manufacturing lot of stents.
摘要:
A system and method allows for processing of two groups of medical devices, both groups being alternatingly spray coated within the same enclosure. The two groups repeatedly move back and forth between a spray area and a drying area which is isolated from the spray area. One group moves into the spray area as the other group moves out and into the drying area. Thereafter, the group in the spray area moves out and into the drying area and the other group moves back into the spraying area for a second coating. The alternating process may be repeated any number of times. The spray area may be located inside a sealed spray isolator enclosure and surrounded by gas discharge nozzles.
摘要:
A coating device for coating a medical device with a drug-eluting material uses an in-process drying station between coats to improve a drug release profile. The drying station includes a heat nozzle configured for applying a uniform drying gas. A coating process using the dryer includes a closed-loop control for the gas between drying steps and an improved nozzle for producing more consistent spray patterns.
摘要:
A system and method are disclosed for collapsing medical devices, such as self-expanding, drug-eluting stents for loading into delivery catheters. The collapsing apparatus may be used for crimping expandable stents and other devices onto a balloon catheter. The medical device is cooled below the austenitic phase transformation temperature of the material forming the device, such as stainless steel or nitinol, and may be cooled until the material has fully transformed to the martenstitic state. For coated medical devices, the device is warmed to a temperature just below the beginning of austenite phase transformation prior to collapsing. An apparatus having a plurality of offset blades, linear bearings, radial bearings and an actuator mechanism is provided for collapsing the medical device. The system is configured with a mandrel subassembly to push the medical device into a catheter sheath, and with a nozzle subassembly to direct cold gas to the medical device.
摘要:
A system used in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region to capture any embolic material which may be created and released into the bloodstream during the procedure. The system includes filtering elements which are capable of occluding a blood vessel distal to an interventional procedure site, while enabling the blood to flow past the occlusion and filtering the blood to capture embolic material which may be released into the blood during a therapeutic interventional procedure. The filtering elements include an expandable member which is capable of being expanded distal to the area of treatment at the interventional procedure site for occluding the blood vessel and for enabling the blood to pass therethrough while preventing emboli from passing therethrough. The system also includes a sheath movable distally and proximally to enable the filtering elements to expand into position distal to the interventional procedure site for capturing embolic material and to collapse the filtering elements to retain the captured embolic material therein.
摘要:
A ratcheting handle actuator provides for a tool to actuate an intraluminal catheter system for treatment at an intraluminal site by repeated movements of the handle. This allows for actuation over a greater distance than a physician might be able to perform in a single motion while preserving a direct correspondence between the movements of the ratcheting handle and the actuation of the intraluminal device.