Abstract: An introducer apparatus and a method for forming an introducer apparatus. The apparatus comprises an inner liner having a passageway extending longitudinally therethrough. A coil in a stressed, radially expanded condition is positioned longitudinally around said inner tube. A polymeric outer tube is positioned longitudinally around the coil and the inner liner, and is bonded to the inner liner through the spaces between the turns of the coil. The polymeric outer tube is formed in a manner such that it maintains the coil in its stressed radially expanded condition. In a preferred embodiment, the inner liner and outer tube comprise a polyimide.

Abstract: Disclosed is an anchoring element for an implantable prosthesis that includes a barb, wherein the anchoring element, which includes a basal portion, comprises a thin layer of material, such as a cannula or sheet of metal, that extends or wraps at least partially around the strut of the prosthesis to which it is attached. The barb is configured to extend outward from the basal portion to penetrate adjacent tissue. The anchoring element is either permanently affixed to the strut, such as by laser or spot welding, crimping, or some other method of bonding, or allowed to slide longitudinally over the strut between two points or stops in order to relieve any excessive loads placed upon the barb that could cause fracture. The anchoring element and strut may be configured to limit axial rotation of the barb, while still allowing longitudinal movement. In another embodiment, the slidable anchoring element may be manipulated following initial deployment to reorient the barb toward the implantation site.

Abstract: A medical device (10) includes a structure (12) adapted for introduction into a patient, the structure (12) being formed of a preferably non-porous base material (14) having a roughened or textured surface (16). The structure (12) is conveniently configured as a vascular stent with a base material (14) of stainless steel, nitinol or another suitable material. The medical device (10) also includes a layer (18) of a bioactive material posited directly upon the roughened or textured surface (16) of the base material (14) of the structure (12). The surface (16) of the base material (14) is roughened or textured by etching or by abrasion with sodium bicarbonate or another suitable grit. A preferred roughened or textured surface (16) is thought to have a mean surface roughness of about 10 ?in. (about 250 nm) and a surface roughness range between about 1 ?in. and about 100 ?in. (about 25 nm and about 2.5 ?m).

Abstract: 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; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material.

Abstract: A stent (10) formed from cannula and having flexible segments (11) and high hoop strength segments (12) alternating therealong. Axial tie bars (21,22) interconnect the segments; minimal length reduction would occur upon expansion. In the high hoop strength segment (12), struts (16) are initially parallel in the unexpanded strut condition, while in the flexible segment (11), struts (14) extend from a respective bight (15) to converge at distal ends when unexpanded. In one embodiment, certain adjacent struts (16) of the hoop segment are spaced apart by a large gap (20) while others are spaced apart by a small gap (18). In another embodiment all the struts (16) of the hoop segment are spaced apart uniformly from each other (or from an axial tie bar) by a small gap (23), resulting in minimizing the occurrence of fatigue of high-stress sites upon expansion/contraction cycles from continuous pulsatile events.

Abstract: 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; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer is includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material.

Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Abstract: An expandable stent prosthesis is disclosed in which the apices of the bends located at at least one end of the stent are individually twisted at an angle to the circumference of the stent to form a fan blade-like arrangement when viewed from that end. The fan blade-like arrangement allows the stent to expand from the compressed condition during deployment such that likelihood of a strut or bend of the stent become entangled with a barb or adjacent strut or bend, is reduced. In one embodiment of the invention, the fan blade-like arrangement results from plastically deforming the individual apices, while in another embodiment, the apices are twisted into the fan blade-like arrangement during the loading process, such as by use of a suture thread to pull the apices into alignment.

Abstract: 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.

Abstract: An easy-to-produce and mechanically strong tube of an implantable graft prosthesis has been developed which is manufactured in any desired length, wall thickness, or diameter. The construct produced by the method of the invention may be used as grafts for arteries, veins, ureters, urethras, shunts, or in any application where a compliant, tissue-compatible tube is needed. The manufacture of the graft prosthesis generally involves wrapping multiple sheets of a purified, collagen-based matrix structure around a mandrel, compressing and drying the tissue on the mandrel before removing the construct for eventual use.

Abstract: 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; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer is includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material.

Abstract: A catheter apparatus (20) and radiation dosimetry unit indicator (21) for delivery of a prescribed radiation dose to a patient. The catheter is filled with a radiation carrier material such as an inert radioactive gas (12) for the treatment of, for example, restenosis after angioplasty, and malignancies. The inflated catheter includes a plurality of discrete chambers such as balloon sections (22, 24, 26) for transporting the radioactive carrier material, and a plurality of discrete chambers (32, 34, 36) enabling substantial blood flow through the artery during treatment with the prescribed radiation. The inflated catheter can also comprise a one-unit balloon. A specific metal coating enhances the radiation dose delivered to the target. The wall (25) of the inflation lumen attenuates transmission dose to the blood circulating through the hollow inner lumen of the catheter device.

Abstract: A radially expandable stent (10) made from a cannula or sheet of biocompatible material that includes at least one longitudinal segment (14) comprised of a series of laterally interconnected closed cells (13). Each closed cell of a longitudinal segment is defined laterally by a pair of longitudinal struts (15, 16) that are interconnected at each end by a circumferentially adjustable member (19, 20). When the stent is expanded using a balloon (47), the opposing circumferentially adjustable members deform to allow circumferential expansion of the longitudinal segment, while the length of the segment, as defined by the longitudinal struts, is maintained. Self-expanding versions of the stent utilize a nickel-titanium alloy. Adjacent longitudinal segments are joined by flexible interconnection segments (21) that permit the stent to bend laterally. The flexible interconnection segment is comprised of curvilinear struts (22, 23) that form a series of serpentine bends (81) that distribute lateral bending forces.

Abstract: A graft prostheses (11), materials and method for implanting, transplanting, replacing, or repairing a part of a patient. The graft prosthesis includes a purified, collagen-based matrix structure removed from a submucosa tissue source. The submucosa tissue source is purified by disinfection and removal steps to deactivate and remove contaminants, thereby making the purified structure biocompatible and suitable for grafting on and/or in a patient.

Abstract: A minimally invasive medical retrieval device 10 useful for the removal of objects such as stones, calculi, concretions, foreign bodies and the like from the urinary, biliary, vascular or other systems includes a sheath 12 containing at least three wires 14 adjacently disposed in the sheath 12. At least one of the wires 14, and preferably all of them, can be moved longitudinally with respect to the sheath 12. The wires 14 have distal portions 16 which are formed so as to allow the engaging and removal of the object or objects. The distal portions 16 of the wires 14 preferably form a helical basket 22 or 40 particularly adapted for engaging urinary stones, calculi and concretions. Other grasping and manipulating shapes are useful as well. The wires 14 are substantially wedge-shaped in cross-section and substantially fill the entire cross-sectional area of the interior 26 of the sheath 12. The wedge-shaped wires 14 can be partly contained within a stainless steel cannula 28 positioned in the sheath 12.

Abstract: A catheter apparatus and radiation dosimetry unit indicator for delivery of a prescribed radiation dose to a patient. The catheter is filled with a radiation carrier material such as an inert radioactive gas for the treatment of, for example, restenosis after angioplasty, and malignancies. The inflated catheter includes a plurality of discrete chambers for transporting the radioactive carrier material, and a plurality of discrete chambers enabling substantial blood flow through the artery during treatment with the prescribed radiation. The inflated catheter can also comprise a one-unit balloon. A specific metal coating enhances the radiation dose delivered to the target. The wall of the inflation lumen attenuates transmission dose to the blood circulating through the hollow inner lumen of the catheter device. The system also creates increased by-product radiation, from the impact of beta particles and gamma protons traveling toward the lumen wall.

Abstract: A catheter apparatus (20) and radiation dosimetry unit indicator (21) for delivery of a prescribed radiation dose to a patient. The catheter is filled with a radiation carrier material such as an inert radioactive gas (12) for the treatment of, for example, restenosis after angioplasty, and malignancies. The inflated catheter includes a plurality of discrete chambers such as balloon sections (22, 24, 26) for transporting the radioactive carrier material, and a plurality of discrete chambers (32, 34, 36) enabling substantial blood flow through the artery during treatment with the prescribed radiation. The inflated catheter can also comprise a one-unit balloon. A specific metal coating enhances the radiation dose delivered to the target. The wall (25) of the inflation lumen attenuates transmission dose to the blood circulating through the hollow inner lumen of the catheter device.

Abstract: A pneumatic tissue dissector 10 useful for cutting or dissecting living tissue during endoscopic or laparoscopic procedures includes a dissector tip 16 for exuding a flow of pressurized gas, an inlet arrangement 24 for controlling the flow of gas from the tip 16, and an exhaust system 30 for exhausting the gas exuded from the tip 16. The exhaust system includes an inlet 32 adjacent to the tip 16 and an outlet spaced from the inlet 32. The outlet 34 is operable in coordination with the inlet arrangement 24 and is capable of exhausting a flow of gas about equal to that exuded by the tip 16, ensuring that the pressure in the cavity in which the procedure is performed does not increase or fluctuate. The flow of pressurized gas from the tip 16 is preferably compatible with an insufflation cavity pressure of no more than about 15 mm Hg, and the inlet arrangement 24 preferably supplies gas to the tip 16 at a pressure of no more than about 50 psi.

Abstract: 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; 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. 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. Also disclosed is the method of manufacture of the device 10, as well as a method of using it in medical treatments.

Abstract: 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.