Abstract: A vascular prosthesis configured for direct connection to an artery. The vascular prosthesis may include a tube of material other than autologous vascular tissue, having an end formation, which is configured for surgical connection to an opening formed in the artery, and a narrower portion prior to commencement of the end formation. The end formation may have an enlarged chamber adapted to induce a concave section in said blood vessel upon attachment thereto.

Abstract: An endoluminal stent contains a hollow passageway for the circulation of fluids to treat vascular walls affected with malignant growths or experiencing restenosis. The hollow passageway stent can have one or a plurality of passageways and is configured in a tubular shape with numerous coils, providing an empty tubular lumen through the center of the stent to allow blood flow. The stent is connected to a removable catheter that conducts fluid to the stent. Fluid flow may be regulated by valves incorporated in either the stent and/or the catheter. The stent and catheter are connected to avoid leakage of the fluid. Cryogenic, heated or radioactive fluids are circulated through the stent to treat the affected sites. A method of delivering drugs to the vascular wall is also provided by creating a stent with porous outer walls to allow diffusion of the drug.

Abstract: Extruded, stretched, sintered tubular PTFE materials are produced which are suited for use in the medical field as liners and covers for expandable stents. The PTFE materials have an unusually low REC (Radial Expansion Coefficient) and RER (Radial Expansion Ratio).

Abstract: An anchoring device for incorporation into an endoluminal prosthesis to prevent migration thereof in a reliable way without the problems associated with intraluminal delivery of the prosthesis. The anchoring device allows smooth, efficient delivery of the prosthesis by providing an anchoring system that does not engage the delivery catheter or sheath upon deployment of the prosthesis within a body lumen.

Abstract: A vascular prosthesis (50) comprises a tube (52) of material other than autologous vascular tissue, the tube having an end formation for surgical connection direct to an opening formed in an artery, the formation comprising an enlarged chamber (54) having a heel (56) and a toe (58) at opposite ends of a first longer diameter parallel to the axis of the tube and a second shorter transverse diameter the enlarged chamber serving to promote localised movement of blood having a non-laminar nature with a shear stress inducing relationship to receiving arterial wall.

Abstract: A delivery system and device for re-lining bodily vessels. A stent is attached to a distal end of a tubular lining made of biocompatible material and loaded into a hollow atraumatic tip. A semi-rigid shaft connects the atraumatic tip to a stopper and runs through the center of the tubular lining. The proximal end of the tubular lining is attached to a sliding hub. Optionally, a balloon is positioned near the stent in fluid communication with the shaft. The assembled device is introduced into a bodily vessel following an endarterectomy or atherectomy procedure. The atraumatic tip is delivered to a predetermined location and upon reaching that destination, the stent is released from the tip to expand against the vessel wall. If a balloon is utilized, it is inflated to ensure that the stent is fully deployed within the vessel. The balloon is then deflated arid the tip and shaft are pulled through the expanded stent and tubular lining.

Abstract: Partially encapsulated stents are made using strips and bands of covering material. In one embodiment ringed stents are placed over an inner ePTFE tube (e.g., supported on a mandrel) and are covered by a series of longitudinal strips. A series of spaced apart ePTFE circumferential bands can then be placed over the top of the longitudinal strips and ringed stents; alternatively bands alone or strips alone may be employed. All of the components of the structure are then laminated to the inner ePTFE tube to capture the stent. By selecting the size and position of the ePTFE bands, it is possible to leave critical parts of the stent unencapsulated to facilitate flexibility and expansion. The longitudinal strips can be woven about the stent and later laminated into position to provide an anti-compression function as well as overall structural stability. Although a single stent can be used, these approaches lend themselves to use of a plurality of individual ring stents spaced apart along the inner ePTFE tube.

Abstract: A method for selectively bonding layers of polymeric material, especially expanded polytetrafluoroethylene (ePTFE), to create endoluminal vascular devices. In a preferred method the selective bonding is achieved by applying pressure to selected areas using a textured mandrel. This permits a stent device to be encapsulated between two layers of ePTFE with unbonded slip pockets to accommodate movement of the structural members of the stent. This allows stent compression with minimal force and promotes a low profile of the compressed device. Unbonded regions of ePTFE allow enhanced cellular penetration for rapid healing and can also contain bioactive substance that will diffuse through the ePTFE to treat the vessel wall.

Abstract: A delivery mechanism for an implantable stent which provides a high mechanical advantage to the surgeon and convenient operation so as to facilitate smooth withdrawal of an outer catheter sheath following placement of the stent in the desired location within the patient's vessel. Preferred embodiments include a moving rail actuated by a V-shaped lever, a hydraulic actuator, a rack and pinion drive, and a power screw system. The delivery mechanism has a movable member that is attached to the outer catheter sheath so that actuating the mechanism results in an incremental movement of the moveable member, which in turn results in an incremental movement of the outer catheter sheath. Once the outer catheter sheath is retracted from the stent, the stent is deployed into the patient's vessel and the remaining parts of the mechanism, including an inner tube, an atraumatic tip, and a stabilizing element, are easily removed.

Abstract: Shape memory alloy and elastically self-expanding endoluminal stents which are at least partially encapsulated in a substantially monolithic expanded polytetrafluoroethylene (“ePTFE”) covering. An endoluminal stent, which has a reduced diametric dimension for endoluminal delivery and a larger in vivo final diametric diameter, is encapsulated in an ePTFE covering which circumferentially covers both the luminal and abluminal walls along at least a portion of the longitudinal extent of the endoluminal stent. The shape memory endoluminal stent is fabricated from a shape memory alloy which exhibits either shape memory or pseudoelastic properties or from an elastic material having an inherent spring tension.

Abstract: An improved drug delivery graft comprises a drug delivery device coupled to an outer wall of a porous graft. An agent is conducted by the drug delivery device from a source to the outer wall of the graft where it is released to diffuse into the lumen of the graft through porous interstices of the outer wall.

Abstract: Partially encapsulated stents are made using gaps cut into ePTFE covering material. Ring stents are placed over an inner ePTFE tube (e.g., supported on a mandrel) and are covered by a “lacey” graft sleeve, which is constructed by cutting apertures into an ePTFE tube so that a series of circumferential and longitudinal strips is created. This “lacey” sleeve is then laminated to the inner ePTFE tube to capture the stents. By selecting the size and position of the apertures in the ePTFE covering, it is possible to leave critical parts of the stent unencapsulated to facilitate flexibility and expansion. Alternatively, the gaps can consist of slits cut into the ePTFE covering material. These slits can be cut in any direction including longitudinally, radially, or diagonally. In addition, the slits can be spaced at varying intervals around the covering material to maximize flexibility and expandability.

Abstract: An encapsulated stent having a stent or structural support layer sandwiched between two biocompatible flexible layers. One preferred embodiment has a stent cover which includes a tubular shaped stent that is concentrically retained between two tubular shaped grafts comprised of expanded polytetrafluoroethylene. Another preferred embodiment has a stent graft which includes at least one stent sandwiched between the ends of two tubular shaped grafts wherein at least a portion of the grafts are unsupported by the stent. Still another embodiment includes an articulating stented graft which includes a plurality of stents spaced apart from one another at a predetermined distance wherein each stent is contained between two elongated biocompatible tubular members. The graft/stent/graft assemblies all have inseparable layers.

Abstract: An endoluminal stent contains a hollow passageway for the circulation of fluids to treat vascular walls affected with malignant growths or experiencing restenosis. The hollow passageway stent can have one or a plurality of passageways and is configured in a tubular shape with numerous coils, providing an empty tubular lumen through the center of the stent to allow blood flow. The stent is connected to a removable catheter that conducts fluid to the stent. Fluid flow may be regulated by valves incorporated in either the stent and/or the catheter. The stent and catheter are connected to avoid leakage of the fluid. Cryogenic, heated or radioactive fluids are circulated through the stent to treat the affected sites. A method of delivering drugs to the vascular wall is also provided by creating a stent with porous outer walls to allow diffusion of the drug.

Abstract: An improved ePTFE-based delivery graft is intended to dispense a bioactive agent such as a drug into the blood stream. A hollow tubing is infused with the agent from a source such as a drug delivery pump mechanism. The spiral hollow tubing is wrapped in a helical fashion around, or otherwise brought into contact with an outer wall of a porous ePTFE graft and adhered thereto. The agent is delivered to the lumen of the graft by infusing the agent through the porous interstices of the graft wall. Thus, the bioactive agent is conducted by the hollow tubing from a source to the outer surface of an ePTFE graft where it is released to diffuse into the graft to influence biological processes along both the inner and outer surfaces of the graft. The present invention allows the bioactive agent or drug to be renewed or changed after implant of the graft. In addition the present invention can be implanted in the same fashion as regular vascular grafts.

Abstract: Shape memory alloy and elastically self-expanding endoluminal stents which are at least partially encapsulated in a substantially monolithic expanded polytetrafluoroethylene (“ePTFE”) covering. An endoluminal stent, which has a reduced diametric dimension for endoluminal delivery and a larger in vivo final diametric diameter, is encapsulated in an ePTFE covering which circumferentially covers both the luminal and abluminal walls along at least a portion of the longitudinal extent of the endoluminal stent. The shape memory endoluminal stent is fabricated from a shape memory alloy which exhibits either shape memory or pseudoelastic properties or from an elastic material having an inherent spring tension.

Abstract: The device of the present invention comprises a bifurcated graft fabricated from expanded PTFE (ePTFE). The inventive device is double walled so that following insertion into an aneurysm, fluid can be injected between the walls to expand the device thereby opening the inner tubular graft for receiving blood flow and locking the device into place in the aorta. The injected fluid may polymerize so that the device is permanently held in its expanded form. One embodiment of the device is fabricated with pockets or channels. After the device is delivered and expanded additional stiffening struts can be inserted into these pockets. In this way the basic device can be furled and tightly compressed for delivery (something not possible with a stent containing device). After the device is expanded, a stent-like structure can be inserted endovascularly giving the strength and resiliency of a stent-containing prosthesis.

Abstract: An expanded polytetrafluoroethylene flanged vascular graft (10) suitable for end-to-side anastomosis grafting having an integral terminal polytetrafluoroethylene flanged skirt or cuff section (12) which facilitates an end-to-side anastomosis directly between an artery and the expanded polytetrafluoroethylene flanged bypass graft (10) without need for an intervening venous collar or venous patch.

Abstract: A method for selectively bonding layers of polymeric material, especially expanded polytetrafluoroethylene (ePTFE), to create endoluminal vascular devices. In a preferred method the selective bonding is achieved by applying pressure to selected areas using a textured mandrel. This permits a stent device to be encapsulated between two layers of ePTFE with unbonded slip pockets to accommodate movement of the structural members of the stent. This allows stent compression with minimal force and promotes a low profile of the compressed device. Unbonded regions of ePTFE allow enhanced cellular penetration for rapid healing and can also contain bioactive substance that will diffuse through the ePTFE to treat the vessel wall.