Abstract: Disclosed is a stent graft prosthesis comprising a graft portion that includes a main body portion and an cuff portion, the cuff portion generally located at or near the proximal end of the main body portion and extending circumferentially therealong. Stents comprising the graft supporting structure are also attached to graft portion about the proximal end. In one embodiment, the cuff portion comprises material that is folded over the outside surface of the main body portion with an anchoring stent being attached over the cuff and main body portions, extending proximally therefrom. In another series of embodiments, the cuff portion comprises an external sealing zone that extends around the outer main body portion to help prevent leakage of fluids. In one example, the material of the second edge of the cuff portion is frayed to better engage the vessel walls and promote thrombus and/or tissue growth.

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: An apparatus and method for measuring the compliance of the lower esophageal sphincter (LES), the apparatus including a catheter having a plurality of extendable members for both measuring the compliance of the LES and stimulating the esophagus which relaxes the LES to obtain a more clinically relevant measurement of LES compliance. In one embodiment, the plurality of extendable members include a first balloon which is located and inflated within the esophagus to trigger esophageal motility, a second, non-elastic balloon that is positioned within the LES, and a third balloon which is inflated within the stomach to help align the second balloon with LES. Incrementally increasing volumes of air are introduced into the second balloon, with the resulting pressures exerted by the LES calculated and compared to normative values to assess the condition of the LES.

Abstract: Disclosed is a heart lead removal apparatus for removing an range of different sized implanted cardiac pacemaker or defibrillator leads from the heart, typically through a blood vessel leading to the heart. The lead removal apparatus comprises a stylet, an expandable portion, and an actuator portion which is manually advanced by the operator to cause the expandable portion to engage the coils within a pacemaker coil lumen. In one preferred embodiment, the expandable portion comprises a multifilar wire bundle that is helically wound around the stylet and attached about the tip thereof. The actuator portion, which comprises an elongate metal cannula attached to a first handle, is urged forward to contact the proximal end of the expandable portion, thereby causing the individual wires of the multifilar wire bundle to deform outward in a random fashion.

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: An introducer apparatus (10) comprising a pair of co-extending splittable introducer sheaths (11), (12) is disclosed. The unique properties (pushability, torqueability, length, shape, etc.) of the individual introducer sheaths yields an introducer apparatus with the additional navigational flexibility to reach a remote target that whose access would be more difficult or impossible with a single introducer sheath. One embodiment include a coaxial pair of introducer sheaths made of made of molecularly oriented (non-isotropic) polytetrafluoroethylene PTFE which are used for placement of a pacemaker or defibrillator lead into the coronary sinus. In this embodiment, the first introducer sheath (11) is introduced over a wire guide into ostium of the coronary sinus, which represents the first target site. The outer introducer sheath includes preformed bends (20) to facilitate passage through the vasculature.

Abstract: A medical apparatus assembly (10) comprises a medical device (11) that includes a side port assembly 13 adapted to combine a first pathway (37) for infusion of fluids with a second pathway (38) for wire guide (12) into a first passageway (26) while the second passageway (27) includes the third pathway (39), which comprises a control member (24), such as an electrical wire. The side port assembly is configured such that the first passageway communicates with both a first port (16), such as a fitting for connecting to a syringe, and a second port (15) which includes a sealing mechanism (32), such as a Tuohy-Borst fitting, thereby allowing the wire guide to be preloaded, instead of requiring it to be removed prior to infusing fluids. Optionally, a third port (43) may be included when external communication with the second passageway, is desired, such as balloons or baskets.

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: 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 medical device (10) such as a radio frequency dilator sheath for separating an encapsulated elongated structure (11) such as an electrical cardiac lead implanted in biological tissue (12) such as a vessel leading to or from a patient's heart. The radio frequency dilator sheath includes inner and outer coaxial dilator sheaths (13 and 28) with respective beveled distal ends (18 and 36) for mechanically loosening and separating encapsulating tissue from an implanted electric cardiac lead. The beveled distal end of the inner sheath is truncated to form a transverse face or surface (89) that is approximately perpendicular to the longitudinal axis of the sheath. Electrical conductors (16 and 17) are positioned about the distal end (14) and passage (15) of the inner dilator sheath.

Abstract: An esophageal prosthesis (10) for preventing reflux of gastric fluids through the esophagus. The esophageal prosthesis process includes a tubular frame (11) with a sleeve (13) disposed around and longitudinally along the tubular frame as well as extending from the distal end (14) of the frame. The lower portion (28) of the sleeve has a readily collapsible lumen (15) that forms a one-way valve for preventing the reflux of gastric fluids in an antegrade manner through the esophagus. Fluids however readily flow through the sleeve in a antegrade direction. In response to a pressure build up in the stomach of a patient wanting to belch or vomit, the lower portion of the sleeve inverts through the passage (12) of the tubular frame, thereby relieving the pressure build up or voiding the patient's stomach.

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.