Abstract: A device useful for treating an aneurysm having a neck comprises a first inflatable disc and a second inflatable disc, said second inflatable disc being adjacent to said first inflatable disc and in fluid communication therewith. The inflatable discs are sized and constructed such that when the inflatable discs are inflated, the aneurysm neck is engaged therebetween. The inflatable discs may include at least one wall that is substantially inelastic and may include an internal member limiting expansion of the inflatable disc in a direction parallel to the device axis. The inflatable discs may have an aspect ratio greater than 3.

Abstract: A bifurcated vascular prosthesis implanted using a combined laparoscopic/open and endovascular technique for curing aneurysms of the abdominal aorta includes two stents on distal arms of the prosthesis. A delivery system and surgical kit for the release of the vascular prosthesis includes a pair of balloon release catheters, to be inserted within each corresponding stent and to remain adhering thereto throughout the time prior to release until reinflated with an inflating syringe, and a pair of balloon guide catheters, each including a dilator and a sheath. A method for implanting the prosthesis is also provided.

Abstract: This invention provides modified rapamycins that have specific monosaccharide(s), oligosaccharide(s), pseudosugar(s) or derivatives thereof attached through a linker to create rapamycin carbohydrate derivatives having enhanced pharmacokinetic and/or pharmacodynamic profiles. For example, administration of the rapamycin carbohydrate derivative results in altered pharmacokinetic profiles and reduced toxicities. Thus, the present invention provides compounds with characteristics that are distinct from other drugs in its class such as rapamycin.

Abstract: A device for treating an aneurysm including an aneurysm liner expandable to form an inner cavity and a plurality of extender segments supported in the aneurysm liner. The device includes an axial constraint coupled to the plurality of extender segments in the liner to axially constrain extender segments in end to end alignment to bias the liner in a collapsed profile.

Abstract: A medical device comprises a catheter having a catheter shaft and a balloon located at the distal end of the catheter shaft, and a bifurcated stent. The bifurcated stent comprises a trunk and at least two joined cylindrical parts extending from the trunk. A first part is capable of radially self-expanding and a second part is radially expandable only by means of a force applied thereto. At least a portion of the second part is disposed about the balloon prior to being radially expanded.

Abstract: An expandable stent having a covering which exhibits the characteristic of upon being activated by applying an agent to the covering, dissolving to expose a portion of the underlying stent. The stent may be placed across the neck of an aneurysm to seal the aneurysm and thereafter a selected region of the covering may be dissolved by an activating agent to permit blood to flow to adjacent vessels.

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: A delivery system includes a sheath and a handle. The handle includes: a slide shaft having a threaded outer surface; and a hub assembly coupled to the sheath. The hub assembly includes: an inner slider having a thread tooth pivot support; a thread tooth pivotably mounted to the thread tooth pivot support; and a sleeve having a thread tooth press member pressing on the thread tooth, where motion of the sleeve relative to the inner slider pivots the thread tooth on the thread tooth pivot support to engage and disengage the hub assembly with the threaded outer surface.

Abstract: The present invention is directed to a positioning apparatus for use during a surgical procedure, which may involve the repair of a vessel. The positioning apparatus in accordance with an embodiment of the present invention may comprise a delivery assembly and a distensible member having at least one expansible member. The expansible member has a distal end and a proximal end, wherein the proximal end is interposed with the delivery assembly. The positioning apparatus, by way of the at least one expansible member, is used to position an object within a vessel that may or may not be aneurismal.

Abstract: An embodiment of the present invention relates to methods for performing a surgical procedure. In particular, an embodiment of the present invention is directed to methods for performing a surgical procedure, using a delivery catheter containing a laser fiber assembly. In accordance with an embodiment of the present invention, a method of performing a surgical procedure comprises the steps of: advancing a delivery catheter to a procedure specific area; activating a laser fiber assembly disposed within the delivery catheter; and advancing the laser fiber assembly to create a treatment specific hole at the procedure specific area.

Abstract: Method and apparatus implementing and using techniques for controlling flow in a body lumen, including use of an implantable medical device. The device includes a membrane implantable in a body lumen and invertibly deformable between a first position and a second position. The membrane is invertible in response to the direction of fluid flow through the lumen and can be deformable by fluid flow in the body lumen.

Abstract: A first stent delivery system provided with a sheath for covering the stent, the sheath including proximal sheath portion adapted to be movable in a proximal direction and a distal sheath portion adapted to be moveable in a distal direction. A second stent delivery system including an outer and intermediate tubular members covering a chamber with a preloaded stent, the outer tubular member being retractable prior to the retraction of the intermediate sheath and release of the stent. A third stent delivery system including with an inflatable balloon at a distal end of the system for fixing the system in place within the vessel prior to the release of the stent thereby insure accurate stent deployment.

Abstract: An implantable prosthesis for placement in hollow tubular organs is described alongwith an instrument for deploying the said prosthesis. On radial compaction, the prosthesis has a low profile, allowing introduction into the body with a deployment instrument of low calibre. The prosthesis has a longitudinal strut to provide longitudinal support. One or more, outwardly biased, flexible curvilinear members with good shape-memory, symmetrically attached to the leading end of the prosthesis help unroll the prosthesis during deployment. Magnetized wires or powder may be attached to the prosthesis to facilitate this process and provide in addition radial elasticity to the prosthesis. The prosthesis may have tubular extensions to allow the treating lesions that involve the parent tubular organ and its branches. Alternatively, the prosthesis may be provided with apertures which can be widened in vivo. For implantation in branches, the prosthesis may be provided with a flange at its trailing end.

Abstract: Graft delivery systems and methods for performing a cardiac by-pass procedure using a graft or a mammary artery are described. A combination of catheters and guide devices through the aorta, coronary artery, and the thoracic region can be used to accomplish these procedures.

Abstract: A composition and method for detecting the presence, location and uniformity of a lubricious coating on a medical device. The method includes the steps of preparing a mixture of a biocompatible hydrophilic fluorescent dye and a hydrophobic lubricant, applying the mixture to the surface of a medical device to form a coating capable of exhibiting fluorescence, and subjecting the surface of the medical device to a source of energy capable of inducing a fluorescent emission. The coating composition may further comprise a surfactant. This method finds particular utility for catheters, especially stent delivery catheters.

Abstract: A multi-sheath delivery catheter and method for introducing a prosthesis into a body lumen involving use of (a) an outer sheath adapted to contain a portion of the prosthesis and having an inner surface with a non-round cross-section; (b) a middle sheath slideably disposed at least partly within the outer sheath and adapted to contain another portion of the prosthesis, the middle sheath having a distal end with a first handle attached to it that has a non-round cross-section corresponding to and engaging the non-round cross-section of the inner surface of the outer sheath; and (c) a pusher slideably disposed at least partly within the middle sheath and adapted to engage the prosthesis, relative rotational movement between the outer sheath and the middle sheath is prevented by virtue of the engagement of the non-round cross-section of the first handle with the non-round cross-section of the inner surface of the outer sheath.

Abstract: The present invention provides anchoring mechanisms for tissue implants. The anchors are integrated as part of the structure of the implant and serve to resist migration of the implant from highly dynamic muscle tissue such as the myocardium of the heart. In implant devices configured as a flexible coil, various attributes of the coil may be altered to increase the anchoring capability of the device. The flexibility of the device may be increased to resist migration by changing the coil filament thickness, pitch or filament material. Alternatively, the end coil may be altered to have a broader cross-sectional profile in engagement with the tissue or may include an anchoring barb. Additionally, methods of implanting a tissue implant device are provided.

Abstract: The present invention is directed to implantable medical device assemblies. The assemblies are primarily used to introduce and deposit implantable medical devices in the vasculatures of implant recipients. The principle implantable medical device used in the assembly is an expandable element in the form of an endovascular device. The expandable element is maintained in a compacted configuration during introduction of the device into the vasculature with a confinement means. The expandable element is released from the confinement means at an implantation site with a control line. The control line has high tensile strength, high modulus, structural rigidity, and low compressibility. These features of the control line provide a practitioner with tactile feedback of the release of the expandable element from the confinement means. The tactile feedback is present during the entire deployment of the expandable element.

Abstract: The present invention embodies delivery systems and methods for delivering modular endovascular graft devices that allow one portion of the repair device to be deployed while maintaining control of the other portions. The delivery systems are simpler to use, easier to manufacture and facilitate better packing of the repair device.

Abstract: Method and apparatus for implanting radially expandable prostheses in the body lumens rely on tacking or anchoring of the prostheses with separately introduced fasteners. The prostheses may be self-expanding or balloon expandable. After initial placement, a fastener applier system is introduced within the expanded prostheses to deploy a plurality of fasteners at at least one prosthesis end, usually as each end of the prosthesis. The fasteners are usually helical fasteners which are delivered from a helical track in the fastener applier by rotation with a rotator wire. The fasteners will be applied singly, typically in circumferentially spaced-apart patterns about the interior of each end of the prosthesis.

Abstract: An implantable medical device and methods for making the implantable medical device are disclosed. The implantable medical device includes a substrate. At least a portion of the substrate is coated with a first layer including a polymer containing a drug. A barrier overlies the first layer. The barrier significantly reduces the rate of release of the drug from the polymer, thereby sustaining release of the drug from the medical device for a longer time. The barrier may be a homogeneous layer overlying the first layer, or a number of discrete deposits over the first layer. Alternatively, the barrier may be intermixed with an outer portion of the first layer. The barrier material is biocompatible, and typically has a thickness ranging from about 50 angstroms to about 20,000 microns.

Abstract: A stent-graft deployment system (10) includes a stent-graft (15), a flexible catheter tip (12) attached to a catheter shaft (25), a retractable primary sheath (20) containing the stent-graft in a first constrained small diameter configuration around the catheter shaft near the flexible tip. The stent-graft deployment system further includes a flexible secondary sheath (14) disposed within the retractable primary sheath and also containing the stent-graft, wherein when the primary sheath is removed from around the stent-graft, the flexible secondary sheath contains the stent-graft in a second constrained small diameter configuration around the catheter shaft near the flexible tip. The removal of the secondary sheath releases the stent-graft from a radial constraint so that stent-graft deployment may proceed.

Abstract: An intraluminal graft assembly is provided. In one embodiment, the assembly comprises a support frame having first, radially smaller and second, radially larger configurations. A graft is attached to the support frame at one end by connectors and is not connected to the other end. The graft extends along only a fractional length of the support frame when in the first configuration, and substantially along the entire length of the support frame when in the second configuration. A vessel repair system is also provided. In the system, a driving member is positioned to force the support frame from the first configuration to the second configuration.

Abstract: A device 10 and method for replacing or restoring competence to incompetent valves. The device 10 is inserted percutaneously or surgically and is preferably constructed of a material capable of promoting cellular ingrowth such that, eventually, native biologic tissue completely covers the device 10 insulating the blood flow therefrom. The material is preferably bioabsorbable over time, allowing the device to harbor the regeneration of a valve structure and to later become absorbed by the body. The device is sized and arranged to mimic the valve it is replacing or repairing.

Abstract: Endoluminal stent-grafts include several features which restrict dilation subsequent to installation but which allow the stent-grafts to be installed in the same manner as a conventional stent-graft. According to one embodiment, sutures are attached to an expanded stent-graft. The suture material is preferably braided PET or polypropylene and sutures are interwoven into the stent at substantially regular intervals. A second embodiment utilizes a band material in lieu of suture material. A third embodiment utilizes a warp knit tubular sheath with inlay yarn. The warp knit tubular sheath with inlay yarn may also act as the graft material. The invention includes a method of using these stent-grafts to prevent the dislodgment of an endoluminal stent-graft after deployment. The method includes the step of determining the maximum stent-graft diameter and related size of dilation restriction means to prevent excessive stent-graft shortening after initial deployment.

Abstract: Methods and apparatus for delivering and installing a new length of tubing between two sections of a patient's existing body organ tubing and at least partly outside of that existing structure. For example, the new length of tubing may be for the purpose of providing the patient with a coronary bypass. The new tubing may be an artificial graft, a natural graft (harvested elsewhere from the patient), or both. The new tubing is installed at the operative site primarily by providing at least one graft location with instrumentation inserted through the patient's existing tubular body organ structure. Assistance in installing the new tubing may be provided by minimally invasive surgical access openings in the patient's chest. The tubing may be delivered through the patient's existing tubular body structure or, alternatively, through the surgical access openings.

Abstract: A stent-graft device for placement in the aortic arch comprises a graft having a main body sized for insertion in the aortic arch and defining a central lumen, the graft including a left branch and a right branch attached to the main body and arranged for flow communication with the central lumen, each of the main body, the left branch and the right branch including a stent and shiftable between a narrowed undeployed configuration and an expanded deployed configuration. The left and right branches each branch include a sheath arranged to constrain the branches in the undeployed configuration, and the left and right branches are arranged to be pulled into the left or right brachiocephalic artery exclusively under tension by respective pull wires.

Abstract: The artificial blood vessel A comprises a front end wire ring 101, a rear end wire ring 102 arranged facing to the front end wire ring 101, a tubular cover 7 which connects the end wire rings 101, 102, and a plurality of intermediate wire rings 12 arranged spaced apart from each other between the front end wire ring 101 and the rear end wire ring 102. Each of the front end wire ring 101, the rear end wire ring 102 and the intermediate wire rings 12 are given flexibly foldable elasticity. The circumference of the front end wire ring 101 is equally divided into four by dividing points 411, 421, 431, 441. Hooking means 13 are formed for a front pull string to be passed through at the dividing points 411, 431.

Abstract: A method of deploying a prosthesis includes restraining the prosthesis within a distal end of a sheath. A slide ring of a handle is rotated to initiate retraction of the sheath. In this manner, the prosthesis is initially very gradually released. The slide ring is then slid to complete retraction of the sheath and to deploy the prosthesis. In this manner, the sheath is easily and quickly retracted thus rapidly completing deployment of the prosthesis. Rapid deployment of the prosthesis facilitates faster procedure times, thus minimizing the period of time during which blood flow is occluded.

Abstract: An prosthesis for the repair of thoractic or abdominal aortic aneurysms (AAA) and a method for utilizing the prosthesis. Furthermore, an arrangement and method is provided for the repair of aortic aneurysms incorporating a device for the placement of the prosthesis in the corporeal lumen or body vessel of a patient, and wherein the prosthesis comprises a graft facilitating the exclusion of the aneurysm, and also provides for anastomotic structure for the attachment of the prosthesis in a laparoscopic surgical procedure.

Abstract: A medical device comprising a supporting structure having a coating on the surface thereof, the coating containing a therapeutic substance, such as, for example, a drug. Supporting structures for the medical devices that are suitable for use in this invention include, but are not limited to, coronary stents, peripheral stents, catheters, arterio-venous grafts, by-pass grafts, and drug delivery balloons used in the vasculature.

Abstract: With an insertion catheter for inserting a vascular prosthesis into a vessel, with an elongate, substantially tubular catheter cover having a proximal and a distal end, with an outlet for the vascular prosthesis provided at the distal end, in order to make insertion of the vascular prosthesis into the vessel particularly safe and simple, in particular, to provide the vascular prosthesis with protection against twisting, it is proposed that the outlet have a cross-sectional shape differing from a circular shape, and that the cross-sectional area defined by the outlet area be smaller than the cross-sectional area of the vascular prosthesis inserted in the vessel in the opened, unexpanded state.

Abstract: A process for setting an angioplasty stent on a corresponding insertion element, such as a delivery catheter, in which the angioplasty stent is subjected to an action of radial contraction. The stent is in a radially contracted state before being placed on the insertion element. Preferably, radial contraction of the stent results in a diameter at least marginally smaller than the diameter of the insertion element, e.g., a balloon catheter. After the stent has been set on the insertion element, in the structure of the stent there remain residual states of constraint which act in the direction of securing the stent in the condition of coupling to the insertion element.

Abstract: INSERTER AND FITTER OF TUBING REPAIR SETS characterized by being a tubular shape mechanical device, rigid or flexible, having a receptacle for housing a tubing repair set(12) also called prosthesis(12) with handles (8)(9) to insert and fit the prosthesis(12) at a target place. Having a nose cone(1) which leads the way to the catheter; a hooking system(5)(11) of the prosthesis(12) with a trigger(10) to loose and place the prosthesis at the target place inside the tubing.

Abstract: A graft for repairing defects in arteries is formed from a flexible graft and at least one attachment system. A device and method is disclosed for implanting a graft within the vasculature of a patient, in which the graft is inserted into the patient at a different stage than the attachment systems, and which allows for direct percutaneous insertion of the graft and attachment systems. The method permits control over the position of the graft in the vasculature during the course of deployment of the graft and attachment systems by providing for traction forces to be applied to opposing ends of the graft.

Abstract: Anastomosis systems include fittings and compression mechanisms for effecting end—end or end-side couplings of biological or synthetic bypass grafts to vessel locations. The fittings are tubular and surround end regions of the graft. In some applications an end region of the graft is everted and surrounds an exterior of the fitting, in which case the preferred compression mechanism is a retaining ring. A tool is used to evert the graft end region. In other applications, the fitting has an interior groove that receives an expandable retaining ring that urges the graft end region radially outwardly against the fitting. A graft deploying and securing system includes a needle for puncturing vessel tissue, a dilator, and a sheath adapted for containing a graft/fitting combination and guiding the combination into the vessel through an opening formed by the needle and dilator.

Abstract: A method and apparatus for reducing the longitudinal aspect of the catheter to stent force comprises at least one grip member for use with a stent delivery system. The grip engages a stent in the unexpanded state prior to delivery of the stent by retracting a stent retaining sheath. The grip comprises a body region having an outer diameter, a first end and a second end. The outer diameter of the first end is greater than the outer diameter of the second end. The grip is at least partially constructed from a polymeric material.

Abstract: A tubular endoprosthesis (10) having a flexible tubular skirt (12) designed to channel a body fluid. The endoprosthesis includes a collar (14) for connection of the skirt (12) through a lateral wall (110) of a tubular conduit (108). The connection collar (14) is initially joined to one end of the skirt (12) and has, at its periphery, elements (34) for securing it to the wall (110). The securing elements (34) are deformable between an initial docking position and a final connection position.

Abstract: An endovascular graft having an improved positioning mechanism capable of positioning and securing a bifurcated graft into a bifurcated vessel described. The graft can include a sleeve affixed to graft that is used in combination with a contralateral wire loop for placement of the graft within vasculature. The graft may include a structure for post deployment positioning into the bifurcated aneurysm area. Furthermore, the endovascular graft may be configured to form a sealing pocket that expands with induced fluid pressure and prevents fluid leaks at an attachment site.

Abstract: Method and apparatus implementing and using techniques for controlling flow in a body lumen, including use of an implantable medical device. The device includes a membrane implantable in a body lumen and invertibly deformable between a first position and a second position. The membrane is invertible in response to the direction of fluid flow through the lumen and can be deformable by fluid flow in the body lumen.

Abstract: The stent having a flexible self-expandable braided tubular wall having a proximal segment having an outer diameter, and a distal segment having an outer diameter smaller than the outer diameter of the proximal segment. An intermediate segment is formed between the proximal and distal segments, which forms a truncated cone of which the base is forming the proximal end of the intermediate segment and of which the top is forming the distal end of the intermediate segment. A covering layer is arranged within the tubular wall.

Abstract: An prosthesis for the repair of thoractic or abdominal aortic aneurysms (AAA) and a method for utilizing the prosthesis. Furthermore, an arrangement and method is provided for the repair of aortic aneurysms incorporating a device for the placement of the prosthesis in the corporeal lumen or body vessel of a patient, and wherein the prosthesis comprises a graft facilitating the exclusion of the aneurysm, and also provides for anastomotic structure for the attachment of the prosthesis in a laparoscopic surgical procedure.

Abstract: Graft delivery systems and methods for performing a cardiac by-pass procedure using a graft or a mammary artery are described. A combination of catheters and guide devices through the aorta, coronary artery, and the thoracic region can be used to accomplish these procedures.

Abstract: A endovascular graft having at least two thin wall graft members, with at least one of the thin wall graft members configured to be deployed within a lumen of another thin wall graft member. The thin wall graft members may be coupled or connected to each other so as to allow relative axial displacement of the sections, or they may be separate members that have dimensions and a configuration to allow coaxial deployment within inner lumens of each other. By having multiple thin wall graft member, the graft may be built up within a patient's vasculature in steps through a delivery catheter system that is smaller in profile and more flexible than a delivery catheter system configured to deliver a single component graft. The graft of the invention may be delivered percutaneously or intraoperatively.

Abstract: An improved reduced diameter intraluminal grafting system capable of deploying a bifurcated graft into a bifurcated vessel is described. The system having a pliable jacket guard configured to ensure atraumatic delivery and deployment of the bifurcated graft. The bifurcated graft is comprised of a main tubular member and two tubular legs with attachment systems configured into each of the three ends of the graft. The bifurcated graft along with the mechanisms required to position and attach the bifurcated graft fit within a single delivery catheter for intraluminal delivery. The bifurcated graft, positioning mechanisms and attaching mechanisms are configured such that a small diameter delivery catheter can be utilized. The methods of positioning and attaching the bifurcated graft are also described.

Abstract: The present disclosure involves devices and related methods involving the use of a graft conduit (autologous or synthetic) which, when deployed within a diseased or occluded vessel or duct, reestablishes sufficient flow therethrough and isolates the diseased or occluded region from the rest of the vessels by forming a lining along the interior surface of the diseased or occluded region.

Abstract: The present invention relates to an applicator for a prosthesis of the type having a tubular element and distal and proximal flange fingers which are arranged distributed around the periphery of the tubular element and can be brought into a straightened position under spring tension for fitting the prosthesis. The applicator comprises a carrier tube with, at the distal end thereof, a supporting ring that fits in the tubular element; a movable release rod that is housed in the carrier tube and has a distal release ring at the distal end. The distal release ring is provided with an undercut that opens in the proximal direction, extends around the periphery and has an internal peripheral surface facing inwards. This internal peripheral surface lies within or on the outer contour of the external peripheral surface of the supporting ring.

Abstract: A system for protecting a stent from contact during loading comprises a stent a protective sleeve disposed about the stent and a loading tool. The inner diameter of the protective sleeve is greater than the outer diameter of the stent. The protective sleeve has a length longer than that of the stent. The portion of the sleeve extending beyond the length of the stent defines a sleeve extension. The loading tool is positioned about at the stent retaining sleeve of a catheter. The tip region of the loading tool separates the protective sleeve and the stent from one another when the protective sleeve is pulled over the tip region of the loading tool. When the protective sleeve is pulled over the tip region of the loading tool the stent is advanced into a lumen defined by the stent retaining sleeve of the catheter.

Abstract: The present invention embodies delivery systems and methods for delivering modular endovascular graft devices that allow one portion of the repair device to be deployed while maintaining control of the other portions. The delivery systems are simpler to use, easier to manufacture and facilitate better packing of the repair device.

Abstract: A medical device includes a catheter having an expandable balloon, an expandable endoprosthesis positioned on the balloon, and an expandable sleeve. The endoprosthesis has a first end and a second end, and the expandable sleeve extends over an end of the endoprosthesis and a portion of the balloon adjacent to the end of the endoprosthesis. The sleeve is configured to separate into a plurality of portions.