Abstract: A catheter apparatus and radiation dosimetry unit indicator for delivery of a prescribed radiation dose to a patient. A radiotherapy source vial (700) includes a fluid container (701) of radioactive fluid with a seal (702,731) disposed about the container. Seal (702,731) is moveable with respect to container (701) to change the contained volume therein. A radioactive fluid transport site (703) is in communication with the contained volume and with an exterior (726) of the container (701), and may include a septum (707) or a valve (711). An engagement mechanism (704) is connectable to an external control mechanism (706) whereby the contained volume in the radioactive fluid container can be decreased and increased by actuation of the external control mechanism.

Abstract: 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).

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 &mgr;in. (about 250 nm) and a surface roughness range between about 1 &mgr;in. and about 100 &mgr;in. (about 25 nm and about 2.5 &mgr;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 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 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.

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 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 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.

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 method of filtering blood in a blood vessel of a patient wherein a catheter is initially introduced into the blood vessel and then advanced to a desired location within the blood vessel. Subsequently, a portion of a positioning assembly having a filter distally attached thereto is guided through the catheter. The filter is then positioned at a location beyond the distal end of the catheter within the blood vessel with the positioning assembly. The positioning assembly is then locked to the catheter. The catheter is then anchored to an object located outside of the blood vessel. Thereafter, an amount of blood is filtered within the blood vessel with the filter. The filter can be readily repositioned by unlocking the positioning assembly from the catheter, repositioning the filter within the blood vessel with the positioning assembly and then relocking the positioning assembly to the catheter.

Abstract: A medical device for localizing a nonpalpable breast lesion. The device includes a tubular introducer needle and a wire guide positioned therein for inserting into a breast to the site of the lesion. The wire guide includes a distal portion having a preformed, resilient helical coil configuration for locking into position about the lesion. The distal portion includes a superelastic metallic alloy for maintaining the helical coil configuration after repeated extensions from and retractions into the needle passageway. The needle is inserted with the wire guide positioned therein into the breast to the site of the lesion and from the distal portion of the needle. The distal end of the needle includes a plurality of indentations for enhancing the ultrasound visualization thereof. As the distal portion of the wire guide emerges from the needle, the acuate distal end of the wire guide cuts into and scribes a helical path about the tissue distal to the lesion.

Abstract: A wire guide comprising an elongate central core and a coil formed of radiopaque material which is positioned substantially concentrically with the elongate central core. The wire guide also comprises a polymer sleeve which encloses the elongated central core. The guide wire further comprises a hydrophilic coating which substantially encloses the polymer sleeve.

Abstract: 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.

Abstract: A dual lumen hemodialysis catheter. The catheter includes a tube having a circular external cross section which is rotatably received within a fitting. The fitting may be attached to the patient by sutures or the like and rotatably mounts the tube of the catheter. Stop means are provided on opposite sides of the fitting preventing the tube of the catheter from moving longitudinally relative to the fitting. The catheter may be rotated relative to the fitting in order to readjust the rotational position of the tube inside the patient's blood vessel without longitudinal movement of the tube. The catheter is cut off at its distal end perpendicularly to the length of the tube in order to define the mouth of one lumen. The tube is tapered from the cut off distal end to a point proximal of the distal end, said point being approximately 3 cm from the distal end. The taper of the tube defines at least a portion of the mouth of the second lumen.

Abstract: A apparatus and method for percutaneous catheterization of a blood vessel permitting use of a small gauge needle is shown. A 22 gauge needle is used for making the initial entry into the blood vessel. A wire guide is then introduced into the blood vessel through the introducer needle, the needle then being withdrawn. A catheter and an inner cannula are passed in unison over the wire guide, through the skin and into the blood vessel. The cannula is provided with a tapered tip which extends through the distal opening of the catheter, thereby providing a diametrical transition between the small wire guide and the relatively larger catheter, resulting in a minimum of trauma during insertion. Once the catheter is in place, the inner cannula and wire guide are withdrawn, leaving the catheter in place with a relatively large distal opening, thereby promoting good fluid flow characteristics of the catheter.

Abstract: A dual lumen hemodialysis catheter. The catheter includes a tube having a circular external cross section which is rotatably received within a fitting. The fitting may be attached to the patient by sutures or the like and rotatably mounts the tube of the catheter. Stop means are provided on opposite sides of the fitting preventing the tube of the catheter from moving longitudinally relative to the fitting. The catheter may be rotated relative to the fitting in order to readjust the rotational position of the tube inside the patient's blood vessel without longitudinal movement of the tube. The catheter is cut off at its distal end perpendicularly to the length of the tube in order to define the mouth of one lumen. The tube is tapered from the cut off distal end to a point proximal of the distal end, said point being approximately 3 cm from the distal end. The taper of the tube defines at least a portion of the mouth of the second lumen.