Abstract: A sleeve device, system and method are provided for restricting and/or constricting aneurysms. More particularly, a sleeve and/or a double-walled sleeve is located in or on a vessel in the location of an aneurysm. When placed around the outside of a vessel, is used to restrict and/or constrict the aneurysm containing portion of the vessel. If desired, the sleeve may be constructed as a double-walled sleeve that can be inflated to apply pressure to and/or in the vessel.

Abstract: Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leaden Methods of making and using the devices are also disclosed.

Abstract: An endoluminal prosthesis system deployable in a region of a patient's vasculature having one or more branch vessels, having a main graft body having a first opening in a wall portion of the main graft body and a pre-loaded guidewire positioned inside the main graft body and advanced through the first opening. One or more branch grafts can be attached to the main graft body to cover one or more openings in the main graft body.

Abstract: An implantable shunt device for draining cerebrospinal fluid from a patient's subarachnoid space includes a shunt having opposed first and second ends and a one-way valve located at the first end of the shunt. A hollow passageway extends between the tip and one-way valve such that fluid can be drained through the tip and out through the valve. The endovascular cerebrospinal fluid shunt of the present invention can be placed into a patient percutaneously via a catheter inserted into the venous system of the body through a needle hole, without the need for open surgery. The device allows for more physiologic drainage of cerebrospinal fluid since the device shunts cerebrospinal fluid into the same cerebral venous system that occurs naturally in normal people.

Abstract: Storage and loading systems for expandable intraluminal medical devices are described. The systems include a container that defines an opening that tapers from a relatively large first diameter to a relatively small second diameter. A neck region includes structure adapted to engage an outer sheath of a delivery system such that an intraluminal medical device within the chamber of the container can be advanced through the tapered opening to effect compression of the intraluminal medical device and, ultimately, loading of the device into the delivery system. Methods of preparing and intraluminal medical device for implantation in a patient and kits useful in such methods are also described.

Abstract: The present invention relates to devices, articles, coatings, and methods for controlled active agent release and/or for providing a hemocompatible surface. More specifically, the present invention relates to copolymer compositions and devices, articles, and methods regarding the same for controlled active agent release. In an embodiment, the present invention includes a copolymer composition. The copolymer composition can include a copolymer and an active agent. In an embodiment, the copolymer includes an effective portion of a monomeric unit including a polar moiety. The active agent can be polar. The active agent can be charged. The active agent can be non-polar. In an embodiment, the copolymer composition includes a random copolymer. In an embodiment, the random copolymer includes butyl methacrylate-co-acrylamido-methyl-propane sulfonate copolymer, which can provide reduced platelet adhesion.

Abstract: This disclosure describes decellularized, biologically-engineered tubular grafts and methods of making and using such decellularized, biologically-engineered tubular grafts.

Abstract: An expandable stent is implanted in a body lumen, such as a coronary artery, peripheral artery, or other body lumen for treating an area of vulnerable plaque. The invention provides for a an intravascular stent having a plurality of cylindrical rings connected by undulating links. The stent has a high degree of flexibility in the longitudinal direction, yet has adequate vessel wall coverage and radial strength sufficient to hold open an artery or other body lumen. A central section is positioned between distal and proximal sections and is aligned with the area of vulnerable plaque to enhance growth of endothelial cells over the fibrous cap of the vulnerable plaque to reinforce the area and reduce the likelihood of rupture.

Abstract: The present invention is a vascular stent comprising a cylindrical wall radially expandable from a compressed state to an expanded state and including a plurality of cells. At least one cell includes a first primary member having a first restrainer member and a second primary member having a second restrainer member. When the cylindrical wall is in the expanded state, the first and second primary members are located a greater distance from each other than when the cylindrical wall is in the compressed state. The first and second restrainer members join to maintain the cylindrical wall in the compressed state. An expansion force applied to the cylindrical wall causes the first and second restrainer members to separate, thereby freeing the cylindrical wall to expand from the compressed state to the expanded state.

Abstract: Described are medical devices which are or can be used to form tubular medical devices, and related methods. Preferred devices include tubular grafts of biomaterial having lumen walls which present no seam edge that traverses the entire length of the lumen, illustratively including devices having lumen walls which have a discontinuous seam presenting multiple seam edges. Such a device may include a tubular structure formed by inserting a plurality of extensions of a biomaterial sheet through a plurality of corresponding apertures of the sheet.

Abstract: A coated medical device, such as a stent, that elutes a taxane agent in a controlled manner is provided. In one embodiment, the taxane agent is paclitaxel and at least a portion of the paclitaxel is present in a dihydrate solid form. The medical device may be coated with a layer including a taxane agent and a layer of bioabsorbable elastomer over the layer including the taxane agent. Methods of manufacturing and using the coated medical device are also provided.

Abstract: An implantable medical device having enhanced endothelial migration features, generally comprises: a structural member including a leading edge and a trailing edge interconnected by a third surface region, the leading edge including a second surface region in a generally curvilinear cross-section, and the trailing edge including a fourth surface region in a generally curvilinear cross-section, whereby blood flow over the second surface region generate shear stress at the second surface region without an eddy region in the second surface region.

Abstract: This invention relates to poly(ester amide)s (PEAs) comprising inactivated terminal amino and carboxyl groups, methods of synthesizing the inactivated PEAs and uses for them in the treatment of vascular diseases.

Abstract: Treatment of aneurysmal blood vessels with local delivery of therapeutic agents thereby reduces or lessens the severity of an aneurysm, and, where used in conjunction with the placement of an excluding device, provides for more rapid recovery of the blood vessel from any disturbance occurring during placement of the excluding device. Therapeutic agents are placed in the aneurysmal site in a time-release carrier medium, such that the therapeutic agent is released into the aneurysmal site over a period of time without the need to provide systemic introduction of the therapeutic agent. The carrier may be introduced through the patient's dermis, such as with the use of a laparoscope, or intravascularly, through the use of a catheter. The carrier may be in a solid matrix, viscous liquid or liquid form.

Abstract: The present invention provides modified metal surfaces, methods of preparing the same, and intermediates thereto. These materials are useful in a variety of applications including biomaterials.

Abstract: Devices and methods for assessing the size, shape, and topography of vessel lumens and hollow portions of organs are described. The devices and methods are particularly adapted for determining the size, shape, topography, and compliance of the native heart valves to facilitate the later implantation of a prosthetic heart valve. The devices are typically catheter-based having an assessment mechanism fixed to a distal end of the catheter. The assessment mechanism generally includes an expandable member, such as a balloon. The assessment mechanism may also include an imaging member, a physical assessment member, an electronic mapping construction, an alignment mechanism, a valvuloplasty balloon, or any combinations thereof. The methods typically comprise deploying the balloon percutaneously to a target location, expanding the balloon, and determining one or more physical parameters associated with the target location.

Abstract: A nickel-free stainless steel stent using a stainless steel which does not substantially contain Ni in the stainless steel, has a metal allergy onset-preventing effect, and is excellent in terms of precision workability, strength, and ductility, is provided. The nickel-free stainless steel stent is characterized by using a stainless steel containing, as a chemical composition, from 15 to 30% by mass of Cr, from 0.97 to 2% by mass of Mo, and from 0.5 to 1% by mass of N, with the remainder being Fe, and optionally containing inevitable impurities.

Abstract: A method and apparatus for simultaneously polishing the inner and outer surfaces of an unpolished polymeric stent using a heat process. The unpolished stent can be mounted, for example, on a “spiral-mandrel,” a tubular helical structure with gaps in between a series of coils of the structure. Heat from a heat source can then applied to the spiral-mandrel at a range between the glass transition temperature and melting temperature of the polymer of the stent.

Abstract: The invention relates to scaffolds for artificial heart valves and vascular structures comprising a biocompatible block copolymer. A method and means for producing said scaffold are also provided.

Abstract: A variable zone high metal to vessel ratio stent includes a proximal high metal to vessel ratio zone, a central low metal to vessel ratio zone, and a distal high metal to vessel ratio zone. The proximal high metal to vessel ratio zone is deployed with fixation and sealing to healthy tissue of a main vessel superior to branch vessels and an aneurysm. The central low metal to vessel ratio zone is deployed directly on ostai of the branch vessels. However, as the central low metal to vessel ratio zone is highly permeable, blood flows from the main vessel through the central low metal to vessel ratio zone and into branch vessels.

Abstract: A device and method for treating bodily diseases and/or conditions, for example, varicose veins, tumors and aneutisms including for example insertion of a blocking device toward a target destination using a catheter and delivery of sclerosing or other agents to the vessel while maintaining minimal, for example zero pressure in the treatment area, The blocking device may prevent treatment materials, embolisms, debris etc., from entering the upstream section of vessel. The blocking device may include, for example, a cap or other concave shape and may be expandable or extendible towards the vessel walls.

Abstract: According to an aspect of the present invention, medical devices are provided that contain at least one polymeric region which contains (a) at least one block copolymer that contains at least three polymer blocks that differ from one another and (b) at least one therapeutic agent.

Abstract: The present invention provides devices and methods for use in the perfusion of organs and anatomical regions. In one aspect the present method provides a percutaneously deliverable device for supporting a vessel in a human or animal subject including means for supporting the vessel during delivery of a fluid thereto or collection of a fluid therefrom. In another aspect the invention provides a method for delivery or collection of a fluid to or from an organ or anatomical region in a human or animal subject, the method including the step of supporting a vessel associated with the organ or anatomical region. The devices and methods may be used to deliver, remove or recirculate a therapeutic agent to an organ or anatomical region.

Abstract: An implant and process for manufacturing the implant for a joint of a patient comprises determining a dimension of a bone in the joint, generating a three-dimensional image of the bone, converting the image into a CAD model, determining a three-dimensional design for the implant according to the dimension of the bone, activating an electron beam melter, and additive-manufacturing the implant with the electron beam melter, the implant having a dimension equal to the dimension of the bone, the implant comprising a porous material. The porous material can be an osteoconductive material or an osteoinductive material or a combination thereof.

Abstract: Medical devices, such as stents, fabricated at least in part from a polymer composite including a biodegradable elastomeric phase dispersed within a biodegradable polymeric matrix are disclosed. The composite is composed of a polyurethane block copolymer including soft polymer blocks and a hard polymer blocks.

Abstract: Methods of fabricating an implantable medical devices such as stents made from biodegradable polymers are disclosed that reduce or minimize chain scission and monomer generation during processing steps. The method includes processing a poly(L-lactide) resin having an number average molecular weight between 150 to 200 kD in an extruder in a molten state. A poly(L-lactide) tube is formed from the processed resin and a stent is fabricated from the tube. The number average molecular weight of the poly(L-lactide) of the stent after sterilization is 70 to 100 kD.

Abstract: The present invention refers to medical devices comprising a modified Co-Polymer or to the modified Co-Polymer itself having high flexibility and high stress resistance, especially tensile strength or tear resistance, in addition to the good physical characteristics of a Block-Co-Polymers of a polyamide and a polycarbonate diamine.

Abstract: According to one aspect of the present invention, implantable and insertable medical devices are provided which contain one or more particle-containing regions that comprise silicate particles and carbon particles.

Abstract: Implantable devices, such as stents, having a surface modified with TiNxCy are disclosed.

Abstract: Methods, apparatuses, computer program products, devices and systems are described that include accepting one or more blood vessel sleeve dimensions based on blood vessel data from an individual; and making a rapid-prototyped blood vessel sleeve at least partly based on the one or more blood vessel sleeve dimensions.

Abstract: The present invention relates to medical devices and in particular to frameless grafting prostheses and methods of making and using such devices. The frameless grafting prostheses include a stiffening member useful in the attachment of the frameless grafting prostheses to a wall of a body lumen.

Abstract: An implantable medical device, such as a sensor for monitoring a selected internally detectable physiological parameter of a patient, is attached to a fixation member that is deployable within the patient to position and orient the sensor to enable it to perform its function. The fixation member may be configured to lie in a single plane when deployed or may be tubular in shape. The attachment of the housing and fixation member includes providing the fixation member with a linear attachment strut that is non-circular in cross section and providing the housing with external members that define an elongate channel, non-circular in cross section and receptive to the attachment strut. The attachment strut can be inserted transversely into the channel and the external member can be crimped over the strut to secure the housing and fixation member together.

Abstract: The present invention relates to a medical device or implant made at least in part of a high strength, low modulus metal alloy comprising Niobium, Tantalum, and at least one element selected from the group consisting of Zirconium, Tungsten, and Molybdenum. The medical devices according to the present invention provide superior characteristics with regard to bio-compatibility, radio-opacity and MRI compatibility.

Abstract: A system for treating an aneurysm includes an expandable barrier positionable to bridge an aneurysm neck. The barrier may comprise a fiber mesh, a balloon or a molly anchor member, and may unroll, unfold, or inflate from a compact configuration to an expanded configuration. Expansion of the barrier may be greater radially than axially. A vaso-occlusive member comprising a coil or balloon may be deposited in the aneurysm. Another aneurysm treatment system comprises an outer fenestrated stent and/or an inner fenestrated sleeve, which may be implanted together adjacent an aneurysm neck to regulate blood flow to the aneurysm. The sleeve may be movable relative to the stent to open or occlude the fenestrations, which may vary in size, shape, and distribution. An intra-luminal vessel occlusion device comprises a stent and a sheath. A drawstring may be actuated to gradually close a sheath orifice to control blood flow through the vessel.

Abstract: The invention relates to an intraluminal device, in particular an intraluminal prosthesis, shunt, catheter or local drug delivery device. In order to increase the bio-compatibility of this device, it is provided with at least one coating. The coating contains a therapeutic agent which is comprised in a matrix that sticks to the intraluminal device. Instead of being formed by a little bio-compatible polymer, the matrix is formed by a bio-compatible oil or fat, such as cod-liver oil or olive oil. Preferably, the bio-compatible oil or fat further comprises alfa-tocopherol.

Abstract: A tubular conduit is disclosed. The tubular conduit comprises a tubular portion made from a flexible material and an axially extending external helical formation located around the outside of the tubular portion. The external helical formation is for supporting the tubular portion. Optionally the tubular portion also comprises an axially extending internal helical protrusion, which imparts a helical flow to a fluid passing through the tubular portion. It is preferred that the tubular conduit is a vascular graft.

Abstract: An endovascular conduit device and method for use during cardiac lead extraction and other vascular procedures is presented. The endovascular conduit device includes an outer-sheath, a conduit member, a lumen member, and an inflation member to control the flow of fluid within the conduit member. The endovascular conduit device may be positioned intravascularly as cardiac lead extraction or other procedures are performed. If necessary, as in the case of a vascular tear, the endovascular conduit device further includes expandable members that are activated to allow blood to be forced into the channel of the conduit member. Blood may then be contained and directed safely to bypass the area of vessel injury. In doing so, a catastrophic circulatory collapse or shock is prevented.

Abstract: A vascular occlusion device deployment system for placing an occlusion device at a preselected site within the vasculature of a patient. The deployment system employing a pusher having a lumen with an opening at the distal end of the pusher. A vascular occlusion device is connected to the distal end of the pusher by a portion that is removeably disposed within the opening. The portion of the occlusion device is forced out of the opening by an expandable reaction chamber, thereby deploying the occlusion device. The expandable reaction chamber, prior to deployment, has multiple chambers separated by a heat-dissolvable membrane. When the membrane is dissolved, components from the chambers react and expand, leading to deployment.

Abstract: An expandable stent is implanted in a body lumen, such as a coronary artery, peripheral artery, or other body lumen for treating an area of vulnerable plaque. The invention provides for a an intravascular stent having a plurality of cylindrical rings connected by undulating links. The stent has a high degree of flexibility in the longitudinal direction, yet has adequate vessel wall coverage and radial strength sufficient to hold open an artery or other body lumen. A central section is positioned between distal and proximal sections and is aligned with the area of vulnerable plaque to enhance growth of endothelial cells over the fibrous cap of the vulnerable plaque to reinforce the area and reduce the likelihood of rupture.

Abstract: Various embodiments of the present invention provide a conduit device including an attaching device configured for defining a helical pathway through a tissue wall and complementary ring in cooperation for securing the device within an aperture defined in the tissue wall. Some embodiments of the present invention further provide a system for implanting a conduit device in a tissue wall. More specifically, some embodiments provide a system including a coring device for defining an aperture in a tissue by removing and retaining a tissue core and securely implanting a conduit device therein so as to provide fluid communication between a first and second surface of the tissue wall via the conduit device.

Abstract: The endovascular graft includes a tubular structure having a first end and a second end. The tubular structure has a wall which defines a lumen between the first and second ends. A fenestration is located between the first and second ends to extend through the wall of the tubular structure. A sealing ring is circumferentially disposed within or on, including without limitation secured to, the tubular structure. The sealing ring is adjacent to the fenestration. The sealing ring may be inflatable.

Abstract: A predilation device may comprise a shaft portion and a distal tip having helical threadings. The predilation device may further include a rapid exchange element rotatably coupled to the shaft portion. A guidewire may slidably engage the rapid exchange element and may guide the predilation device to a lesion site. The predilation device may be positioned with the distal tip abutting the lesion. The shaft portion may be rotated, thereby rotating the tip and causing the tip to pass through the lesion and predilate the lesion. In some embodiments, the tip may remove lesion material.

Abstract: The present invention refers to medical devices comprising a modified Co-Polymer or to the modified Co-Polymer itself having high flexibility and high stress resistance, especially tensile strength or tear resistance, in addition to the good physical characteristics of a Block-Co-Polymers of a polyamide and a polycarbonate, either polycarbonate diol or polycarbonate diamine.

Abstract: Shunt devices and a method for continuously decompressing elevated intraocular pressure in eyes affected by glaucoma by diverting excess aqueous humor from the anterior chamber of the eye into Schlemm's canal where post-operative patency can be maintained with an indwelling shunt device which surgically connects the canal with the anterior chamber. The shunt devices provide uni- or bi-directional flow of aqueous humor into Schlemm's canal.

Abstract: A prosthetic aortic conduit for replacing a root portion of an aorta is provided. The conduit comprises a continuous tubular conduit along a substantially common axis. A portion of the tubular conduit does not substantially deform in a longitudinal direction and has resilient means which allow said another portion of the conduit to be expandable in a lateral direction. The portion that is able to deform laterally mimics the function of the sinuses of Valsalva. The method of manufacturing such a conduit comprises the steps of having a continuous weave of rows of yarn or the equivalent with a change in tightness of the rows so that in some portion of the conduit it is expandable in the lateral direction and in some portion of the conduit it is expandable in the longitudinal direction.

Abstract: In a compression sleeve for the local enclosure of a blood vessel or vein area comprising a retaining structure of a biocompatible material, the retaining structure is a flexible mat consisting of a mesh or net-like structure provided with an arrangement holding the retaining structure in a vein enclosing position.

Abstract: A molecular plasma deposition (MPD) method in combination with an atomic layer deposition (ALD) procedure is used to produce amorphous, nonconformal thin metal film coatings on a variety of substrates. The films are porous, mesh-like lattices with imperfections such as pinholes and pores, which are useful as scaffolds for cell attachment, controlled release of bioactive agents and protective coatings.

Abstract: An article cut from a metallic sheet, has a first pattern of struts forming a plurality of inner apexes situated substantially within a plane that contains the plurality of the inner apexes. There is a second pattern of struts forming a plurality of outer apexes that are situated substantially within the plane containing the inner apexes. Each outer apex has at least one strut in common with an adjacent inner apex. There is also described a method of forming a non-planar three dimensional structure by patterning a planar sheet of material to form an article having a plurality of inner apexes, a plurality of outer apexes with a common curvilinear strut between an inner apex and an adjacent outer apex. Thereafter, everting the article into a non-planar three dimensional structure with the inner apexes at one end of the structure and the outer apexes at another end of the structure.

Abstract: Stents and methods of using stents are provided. Stents of the invention provide external support structure for a blood vessel segment disposed within, wherein the stents are capable of resilient radial expansion in a manner mimicking the compliance properties of an artery. The stent may be formed of a knitted or braided mesh formed so as to provide the needed compliance properties. A venous graft with the stent and a vein segment disposed within is provided, wherein graft is capable of mimicking the compliance properties of an artery. Methods of selecting stents for downsizing and methods of using the stents of the invention in downsizing and smoothening are provided. Methods of replacing a section of an artery with a venous graft including a stent of the invention are provided. Methods of reducing intimal hyperplasia in implanted vein segment in a venous graft using stents of the invention are provided.

Abstract: Devices, systems and methods are disclosed for the formation of an arteriovenous fistula in the limb of the patient. Embodiments include an apparatus for the creation, modification and maintenance of a fistula, including the modification of an existing dialysis fistula; and a method of supplying oxygenated blood to the venous circulation of a patient. A kit of anastomotic implants is described which supports a broad base of patient anatomies and fistula locations. The devices, systems and methods can be used to treat patients with one or more numerous ailments including chronic obstructive pulmonary disease, congestive heart failure, hypertension, hypotension, respiratory failure, pulmonary arterial hypertension, lung fibrosis and adult respiratory distress syndrome.