Abstract: A prosthetic device for sustaining a vessel or hollow organ lumen (a stent) has a tubular wire frame (1) with rows of elongate cells (2) having a larger axis and a smaller axis. The cells are arranged with the larger axis in the circumferential direction of the frame (2) and the smaller axis parallel to the axial direction thereof. Each cell is formed by two U-shaped wire sections, and in a plane perpendicular to the longitudinal axis one of the branches of the U-shaped wire sections in one row form together a closed ring shape (4) which provides the frame (1) with large radial stiffness. In the axial direction the frame (1) has only low stiffness so that it easily conforms to the vascular wall even if this deforms due to external loads. The interconnection between the cells (2) may be flexible.

Abstract: An endovascular graft prosthesis for arrangement at an aneurysm positioned in the vicinity of a bifurcation in an arterial system having a main lumen and a first and a second branch lumen. The endovascular graft prosthesis includes a prosthetic device with at least one expandable tubular frame body for arrangement in the main lumen and a first and a second graft limb. The frame body is contractible into a first shape with a smaller diameter for introduction to a vascular site upstream of the aneurysm and is radially expandable into a second shape having a larger diameter and an inner lumen. The frame body is provided with a covering which extends across the inner lumen of the tubular frame body and has two apertures each of which has a diameter of less than half the larger diameter of the frame body. The first and second limbs have a cranial end for mounting at one of the apertures and a caudal end for arrangement in one of the branch lumens.

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: Radiopaque marker elements for attachment to ends of a radially expandable surgical stent are disclosed. Each radiopaque marker element is homogeneously formed from a radiopaque material and attached through an attachment means to ends of the stent. The radiopaque marker elements enhance the visibility of the stent when the stent is viewed with a medical imaging device, such as a fluoroscope. The marker elements extend beyond ends of the stent. The marker elements are attached to the stent before radial expansion and are configured to radially expand along with the stent during surgical implantation thereof within a body lumen, such as an artery. The radiopaque marker elements can either be attached to an unmodified radially expandable surgical stent or to a prepped stent which includes receivers at ends of the stent particularly configured to attach to the radiopaque marker elements.

Abstract: A preformed anchoring wire guide (10) for medical procedures such as renal angioplasty. The wire guide (10) is comprised of a superelastic memory alloy mandril (11), such as a nickel-titanium alloy, and includes a preformed bend (14) having an angle (15) with respect to the longitudinal axis (28) that corresponds with the takeoff angle of the renal artery (23) relative to the aorta (33). This preformed bend (14) allows easier access to the ostium (22) of the renal artery (23) and allows the distal portion (27) of the wire guide to anchor within the artery (23) and resist dislodgement and deformation, thereby improving trackability of a balloon angioplasty catheter (21), reducing the need for a guiding catheter, and reducing the likelihood of vessel damage or thrombus shear due to forces that are normally exerted against the wall of the vessel (33) by a standard wire guide.

Abstract: A back-up retention member drainage catheter (10) for insertion in the bladder and urethra of a patient undergoing a radical prostatectomy surgical procedure. The drainage catheter includes an elongated tubular member (11) having a drainage lumen (14) extending longitudinally therein with an external drainage port (15, 16) disposed near the distal end (12) of the tubular member. A back-up retention member (18) and, in particular, a first balloon (20) is disposed on the elongated tubular member near the distal end and proximal the external drainage port. A primary retention member (19) and, in particular, a second retention balloon (22) is also disposed on the elongated tubular member around the first retention balloon. First and second inflation lumens (21, 23) extend longitudinally through the elongated tubular member and communicate internally with the first and second retention balloons, respectively.

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 brachytherapy device 10 for exposing to radioactivity a patient includes an elongate member such as a needle or cannula 12 adapted for introduction into the patient and also includes a stylet 14 slideably receivable in a longitudinal throughbore 16 in the needle 12. The device 10 also includes a portion 64 near either the proximal end 18 of the needle 12 or the distal end 24 of the stylet 14 which provides a local, defined amount of friction between the needle 12 and the stylet 14. The device 10 further includes an anti-static handle 34 connected to the needle 12. The handle 34 has an interior ramp surface 40 in communication with the throughbore 16 of the needle 12, frustoconical in shape and possessing an included apical angle of at least about 16°. The localized friction portion 64 can be a crimp or flange 48 on the stylet 14, or a crimp 44 or deformation 46 in or of the needle 12.

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 multiple-sided medical device comprises a closed frame of a single piece of 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 that comprises a self-expanding stent. The stent is pushed from a delivery catheter into the lumen of a duct or vessel. One or more barbs are attached to the frame of the device for anchoring or to connect additional frames. A covering of fabric or other flexible material such as DACRON, PTFE, or collagen, is sutured or attached to the frame to form an occlusion device, a stent graft, or an artificial valve such as for correcting incompetent veins in the lower legs and feet. A partial, triangular-shaped covering over the lumen of the device allows the valve to open with normal blood flow and close to retrograde flow.

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: Heart lead removal apparatus for removing an implanted cardiac pacemaker lead from the wall of a heart through a blood vessel leading to the heart. The lead removal apparatus comprises an outer tube sized for insertion into the coiled structure passageway of the pacemaker lead; an anchoring projection positioned proximate the distal end of the outer tube; and a stylet positioned through the passageway of the outer tube for urging the anchoring projection between relaxed and hooked positions. In the hooked position, the projection extends outwardly from the outer tube and when also positioned in the coiled structure passageway, hooks into the coiled structure for facilitating removal of the lead from the heart. In the relaxed position, the anchoring projection is insertable into the coiled structure passageway. The apparatus preferably includes a laterally flexible member constituted by a folded back portion of the stylet.

Abstract: A conically helically shaped embolization coil (10) for occluding a blood vessel, aneurysm, and the like. The embolization coil includes a continuous platinum-tungsten alloy wire strand (11) wound into a longitudinally extending coil (12) having a plurality of tightly spaced turns (13). The longitudinally extending coil is wound into a conically helically shaped coil (15) with a plurality of radially expanding turns (16). Distal turn (17) of the radially expanding turns has a minor diameter (18) less than a minimum diameter (34) of a vessel (32) of which the embolization is to be positioned therein. Uncompressed proximal turn (19) of the radially expanding turns has a major diameter (20) greater than a maximum diameter (33) of the vessel in which the coil to be positioned.

Abstract: A catheter apparatus filled with a radiation carrier material such as an inert radioactive gas for the treatment of 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 may also comprise one unit balloon. A specific metal coating enhances the radiation dose delivered to the target. The wall of the 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 method for predetermining the controlled and uniform discharge rate of a fluid from a single lumen tubular body having passageways radially extending through the wall of the tubular body has been developed and is described. The method involves predetermining such parameters as the transverse cross-sectional areas of the passageways extending through the wall of the tubular body, the spacing of the passageways, the pressure at each of the passageways, and the rate of flow at each of the passageways. One specific preferred application of such a tubular body is an infusion catheter for delivering various fluids to designated areas of the body for either a therapeutic treatment and/or diagnostic purposes. For example, such a catheter may be adapted to deliver controlled and uniform quantities of thrombolytic agents, chemotherapeutic agents as well as such diagnostic agents as fluorescent dyes and radioactive agents.

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 method for polishing radially expandable surgical stents is disclosed where fluid abrasive media M flows over surfaces of the stent 10 causing the surfaces of the stent 10 to be polished and streamlined. The stent 10 is temporarily provided with cylindrical support ends 20, which are not radially expandable to support the stent 10 during the polishing process. An interior polishing fixture 100 is provided which has cylindrical chambers 135 therein adapted to receive a stent 10 therein. Fluid abrasive media M then flows into bores 108 in the fixture 100 leading to the cylindrical chambers 135 and adjacent the inner diameter surfaces of the stent 10. Surfaces of the stent 10 forming the outer diameter are polished by placing the stent 10 within an exterior polishing fixture 200 which has a cylindrical recess 220 therein.