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 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 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 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 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 medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. The scaffold, after being deployed by the balloon, provides a crush recovery of about 90% after the diameter of the scaffold has been pinched or crushed by 50%. The scaffold also has a reduced crimped profile and a modification of the scaffold's ring structure at the crowns that contributes to the reduced crimped profile.
摘要:
An embolic filtering system includes a guide wire, a filter device disposed on the guide wire, a sheath adapted to maintain the filter device in an unexpanded position and a torque device having a lumen for receiving the guide wire and a locking mechanism for locking the torque device to the guide wire. The torque device may include a side port adapted to receive the proximal end of the sheath to allow a portion of the guide wire to shear the sheath from the guide wire through retraction of the sheath through the side port. The torque device may include an extension arm having a distal opening adapted to receive both the guide wire and the sheath. A second lumen may be used to allow a portion of the guide wire to shear the sheath away from the guide wire through retraction of the sheath through the second lumen.