摘要:
A stent deployment device (10) includes a catheter (12), a stent (14) positioned on the catheter (12), and a sleeve (16) carried on the catheter (12). The sleeve (16) has a portion (18) extending fully over and containing the stent (14). The stent deployment device (10) also includes a mechanism (20) for splitting at least the portion (18) of the sleeve (16) extending over the stent (14) and, preferably, for splitting the entire sleeve (16). Splitting of the sleeve portion (18) permits expansion of the stent (14). The mechanism (20) can include an inflatable, nondistending balloon (22) carried on the catheter (12), the stent (14) and the sleeve portion (18) being positioned over the balloon (22). The stent (14) can be self-expanding or can be expanded by the balloon (22) itself. Alternatively, the mechanism (20) can include a bulbous end (24) on the catheter (12). Longitudinal movement of the bulbous catheter end (24) with respect to the sleeve (16) splits at least the sleeve portion (18), permitting expansion of the stent (14). As further alternatives, the mechanism (20) can include a garrote (66) connected to the sleeve or a partial segment (62) of the sleeve (16) folded back alongside the stent (14). The sleeve (16) can be the same length as the catheter (12) or can be shorter than the catheter (12). In the former case, the mechanism (20) can include a pair of graspable wings (56) for splitting the full length of the sleeve (16). It is preferred that at least the portion (18) of the sleeve (16) extending over the stent (14) includes a longitudinally extending structure 46 for ensuring that the sleeve portion (18) will in fact split upon operation of the mechanism (20).
摘要:
A multiple-sided medical device comprises a frame comprising wire or other resilient material and having a series of bends and interconnecting sides. The device has both a flat configuration and a second, folded configuration which a generally serpentine shape. The device is pushed from a delivery catheter into the lumen of a duct or vessel and may include one or more barbs for anchoring purposes. A full or partial covering of fabric or other flexible material such as DACRON, PTFE, or a collagen-based material such as small intestinal submucosa (SIS), may be sutured or attached to the frame to form an occlusion device, a stent graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.
摘要:
A medical device for endoscopic access of a body cavity and a method of percutaneously placing inner and outer access sheaths of the device into the body cavity. The medical device includes inner and outer access sheaths and a dilator which is inserted into the outer sheath and has a shoulder or a shoulder piece for abutting against the proximal end of the outer sheath. The device also includes a wire guide that is percutaneously inserted into the body cavity via an introducer needle. The dilator and outer sheath are placed over the wire guide to dilate the puncture site and introduce the dilator and outer sheath into the body cavity. The dilator comprises an elongated cylindrical member having a passageway opening distally from the conically-shaped distal end and from an outside lateral wall of the dilator about the proximal end. The dilator also includes an end cap which is utilized to force the dilator and the outer sheath through the puncture site and into the body cavity. After positioning in the body cavity, the dilator and wire guide are removed through the outer sheath. The inner sheath is then inserted through the outer sheath into the body cavity. The proximal ends of both the inner and outer sheaths include seals for maintaining insufflation of the body cavity. The inner sheath includes a shoulder piece having a chamber and a side port for connection to an insufflation gas line.
摘要:
A multiple-sided medical device comprises a frame comprising wire or other resilient material and having a series of bends and interconnecting sides. The device has both a flat configuration and a second, folded configuration which a generally serpentine shape. The device is pushed from a delivery catheter into the lumen of a duct or vessel and may include one or more barbs for anchoring purposes. A full or partial covering of fabric or other flexible material such as DACRON, PTFE, or a collagen-based material such as small intestinal submucosa (SIS), may be sutured or attached to the frame using heat or pressure welding crimping, adhesive, or other techniques to form an occlusion device, a stent graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.
摘要:
A silver implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one layer 18 of a bioactive material posited on one surface of structure 12; and at least one porous layer 20 posited over the bioactive material layer 18 posited on one surface of structure 12 and the bioactive-material-free surface. Also included is a layer or impregnation of silver 45. Preferably, the structure 12 is a coronary stent. The porous layer 20 is comprised of a polymer applied preferably by vapor or plasma deposition and provides a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, merely by condensation of a monomer vapor. Silver is included as a base material, coating or included in a carrier, drug, medicament material utilized with the implantable stent.
摘要:
Methods of delivering a bioactive material to a body vessel are disclosed. The method steps can include providing an expandable medical device with a coating having a bioactive layer, and providing a second layer of a biodegradable polymer positioned over the bioactive layer. The second layer provides for controlled release of the bioactive material from the bioactive layer. The medical device is inserted into a body vessel using a catheter such that the medical device contacts the body vessel.
摘要:
An introducer system for introducing a plurality of wire guides into a vessel of a patient includes first and second wire guides, and a catheter. The first wire guide has a curved proximal end, and a distal end sufficiently flexible for passage through the vessel to a target site for the procedure. The catheter has proximal and distal open ends, and a lumen extending therebetween. At least the distal end of the catheter has sufficient flexibility for passage over the first wire guide to the target site, and has an inwardly curved portion between the proximal and distal open ends. The catheter further has a side port proximally positioned along the inwardly curved portion. The side port is sized and arranged such that the curve of the first wire guide proximal end is passable therethrough when the catheter is passed over the first wire guide. The second wire guide is sized for passage through the lumen when the first wire guide is positioned in the lumen. The second wire guide has a stiffness greater than the stiffness of the first wire guide.
摘要:
A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract, and at least one layer 18 of an immunosuppressive agent posited over at least one surface of the structure 12. Optionally, the device 10 can include at least one porous, preferably polymeric layer 20 posited over the layer 18 of immunosuppressive agent, and can alternatively or additionally include at least one coating layer 16 posited on one surface of the structure 12, the at least one layer 18 of immunosuppessive agent being posited in turn on at least a portion of the coating layer 16. The porous layer 20 and the coating layer 16 each provide for the controlled release of the bioactive material from the device 10. The structure 12 is preferably configured as a coronary stent. The polymer of the porous layer 20 is preferably applied by vapor or plasma deposition. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative which is deposited without solvents, heat or catalysts, but rather by condensation of a monomer vapor.
摘要:
Methods of making coated implantable medical devices are provided. The methods include positioning a first layer comprising a bioactive on at least a portion of a structure, and positioning at least one porous layer over the first layer. The at least one porous layer has a thickness adequate to provide a controlled release of the bioactive.
摘要:
A silver implantable medical device 29 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one layer 18 of a bioactive material posited on one surface of structure 12; and at least one porous layer 20 posited over the bioactive material layer 18 posited on one surface of structure (12) and the bioactive-material-free surface. Also included is a layer or impregnation of silver 45. Preferably, the structure 12 is a coronary stent. The porous layer 20 is comprised of a polymer applied preferably by vapor or plasma deposition and provides a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, merely by condensation of a monomer vapor. Silver is included as a base material, coating or included in a carrier, drug, medicant material utilized with the implantable stent.