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 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:
An expandable frame for an embolic filtering device used to capture embolic debris in a body vessel includes a first half frame having a first control arm connected to a second control arm by a partial loop and a second half frame having a first control arm connected to a second control arm by a partial loop. The partial loops cooperatively form a composite loop for attachment of a filtering element which will expand in the body vessel to capture embolic debris entrained in the fluid of the vessel. The lengths and positioning of the first and second control arms of each half frame can be varied to create an expandable frame which conforms to the size and shape of the body vessel in which the filtering device is deployed. Additionally, the radius of the partial loops, along with the length of the arc of the partial loops, can be varied on each of the frames to create a composite filtering assembly that can easily adapt to the size and shape of the body vessel. Additionally, the control arms of the half frames can be disposed either proximally or distally of the composite loop to create a distinct filtering structure.
摘要:
A drug eluting stent can include a stent body having a polymeric coating with a lipophilic and/or hydrophilic element. A drug that has a bioactivity that inhibits cell proliferation can be disposed in the polymeric coating. The drug can be present in the polymer at an amount greater than or equal to about 150 ug/cm2. The polymeric coating and drug are configured to cooperate so as to form a diffusion pathway with tissue when the stent is disposed in a body lumen such that the drug preferentially diffuses into the tissue over a body fluid passing through the body lumen such that a maximum systemic blood concentration of the drug is less than about 40 ng/ml.
摘要翻译:药物洗脱支架可以包括具有亲脂和/或亲水元件的聚合物涂层的支架体。 具有抑制细胞增殖的生物活性的药物可以设置在聚合物涂层中。 药物可以以大于或等于约150μg/ cm 2的量存在于聚合物中。 聚合物涂层和药物被配置为配合以便当支架设置在体腔中时与组织形成扩散路径,使得药物优先地通过穿过体腔的体液扩散到组织中,使得最大系统 药物的血液浓度小于约40ng / ml。
摘要:
An expandable frame for an embolic filtering device used to capture embolic debris in a body vessel includes a first half frame having a first control arm connected to a second control arm by a partial loop and a second half frame having a first control arm connected to a second control arm by a partial loop. The partial loops cooperatively form a composite loop for attachment of a filtering element which will expand in the body vessel to capture embolic debris entrained in the fluid of the vessel. The lengths and positioning of the first and second control arms of each half frame can be varied to create an expandable frame which conforms to the size and shape of the body vessel in which the filtering device is deployed. Additionally, the radius of the partial loops, along with the length of the arc of the partial loops, can be varied on each of the frames to create a composite filtering assembly that can easily adapt to the size and shape of the body vessel. Additionally, the control arms of the half frames can be disposed either proximally or distally of the composite loop to create a distinct filtering structure.
摘要:
A deployment control system provides controlled deployment of an embolic protection device which may include a guide wire, an expandable filter attached to the guide wire near its distal end, and a restraining sheath that maintains the expanded filter in a collapsed position. The deployment control system includes a torque control device which allows the physician to torque the guide wire into the patient's anatomy and a mechanism for preventing the guide wire from buckling as the restraining sheath is being retracted to deploy the expandable filter. A recovery control system for recovering the embolic protection device includes an inner catheter which extends within a lumen of an outer recovery sheath in a coaxial arrangement. A distal portion of the inner catheter extends beyond another recovery sheath during advancement of the recovery system into the vasculature. The recovery sheath can be advanced over the inner catheter to collapse the expandable filter. The proximal ends of the inner catheter and recovery sheath include handle portions having snap mechanisms which hold the components together as the recovery system is being advanced into the patient's vasculature.
摘要:
A deployment control system provides controlled deployment of an embolic protection device which may include a guide wire, an expandable filter attached to the guide wire near its distal end, and a restraining sheath that maintains the expanded filter in a collapsed position. The deployment control system includes a torque control device which allows the physician to torque the guide wire into the patient's anatomy and a mechanism for preventing the guide wire from buckling as the restraining sheath is being retracted to deploy the expandable filter. A recovery control system for recovering the embolic protection device includes an inner catheter which extends within a lumen of an outer recovery sheath in a coaxial arrangement. A distal portion of the inner catheter extends beyond another recovery sheath during advancement of the recovery system into the vasculature. The recovery sheath can be advanced over the inner catheter to collapse the expandable filter. The proximal ends of the inner catheter and recovery sheath include handle portions having snap mechanisms which hold the components together as the recovery system is being advanced into the patient's vasculature.
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.