Abstract: An implantable device for regulating blood flow through a blood vessel includes an elongated support. The support includes axially spaced apart first and second substantially annular support portions, and an x-shaped linking member linking the axially spaced apart portions to one another. The device also includes a valve membrane extending between the axially spaced apart support portions and having an upper portion, a lower portion and an intermediate portion. The valve membrane includes a first region and a second lower region. The first region is folded over the linking member for attachment and the second region is adjacent the first region and unattached to the linking member. The second region is movable between a first position to enable blood flow and a second position to inhibit blood flow.

Abstract: A method of making a self-expanding stent includes disposing a stent comprising a shape memory alloy about an inflatable body, and applying a coolant to a surface of the stent. The inflatable body is inflated to radially expand the stent to an expanded diameter from an initial diameter, and the coolant is reapplied to the surface of the stent. The inflatable body is deflated, and the stent is positioned about a mandrel sized to accommodate the expanded diameter of the stent, where the stent reaches a mandrel-defined diameter. The stent is heat set at the mandrel-defined diameter so as to impart a memory of an expanded configuration of the stent to the shape memory alloy.

Abstract: An implantable device for regulating blood flow through a blood vessel comprising an elongated support dimensioned and configured to be implanted in a blood vessel. The support includes a linking member linking axially spaced apart portions to one another. A valve membrane extends between the axially spaced apart support portions and includes first region folded over the first linking member and attached thereto and a second region adjacent the first region and unattached to the first linking member. The second region is movable between a first position to enable blood flow and a second position to inhibit blood flow.

Abstract: A stent graft for reinforcement of a vascular abnormalities and an associated method are provided. According to one embodiment, the stent graft includes a flexible tubular structure comprising a proximal end and a distal end and having an expanded heat set configuration. The tubular structure is configured to be constrained to a smaller diameter than the expanded heat set configuration, and the tubular structure is heat set such that at least a portion of the proximal and/or distal ends is configured to fold over on itself when unconstrained.

Abstract: A stent made of nitinol having improved axial or radial stiffness, the stent having a support structure which comprises peripheral struts around the circumference, wherein the peripheral struts are linked to one another in the axial direction via connection struts. The support structure may assume a first compressed state and a second expanded state. The nitinol is in the support structure in a martensitic microstructure in the compressed state and largely in an austenitic microstructure in the second expanded state. One or more support structure sections, however, are entirely or partially in a martensitic microstructure in the second expanded state.

Abstract: A method of bonding a first component of a medical device to a second component of the medical device, where at least one of the components comprises a shape memory material, includes positioning the components in close proximity to each other to obtain an assembled configuration, and heating the assembled configuration at a temperature in the range of from about 800° C. to about 1100° C. to obtain a diffusion bond at a region of contact between the two components. The assembled configuration is formed into a desired set shape and heat-set at a temperature in the range of from about 350° C. to about 550° C. to impart a memory of the desired set shape to the shape memory materials without substantially impairing the diffusion bond.

Abstract: Apparatus and methods are described including a mechanical support element that is placed inside a first vein of a subject. At least one electrode disposed on the mechanical support element is placed inside the first vein, in a vicinity of a site upstream of a bifurcation with a second vein of the subject. A control unit enhances downstream blood flow from the first vein by driving the at least one electrode to divert blood downstream into the second vein by constricting the first vein at the upstream site, by driving the at least one electrode to apply a current to the vicinity of the site. The mechanical support element prevents the first vein from collapsing by providing mechanical support to the vein. Other embodiments are also described.

Abstract: The present invention relates to a device comprising a substrate based essentially on nitinol and, arranged thereon at least partially, a covering or a coating based on at least one polyphosphazene derivative having the general formula (I), a process for its production, and the use of the device as an artificial implant, vascular or nonvascular stent, catheter, thrombolectomy or embolectomy catheter, fragmentation spindle or catheter, filter, vascular connector, hernia patch, oral, dental or throat implant or urether.

Abstract: A intraluminal stent comprises a reticulated tube having an un-deployed diameter and expandable to an enlarged diameter. The tube includes a structural beam extending between first and second ends. The structural beam changes from a first geometry to a second geometry when the tube changes from the un-deployed diameter to the enlarged diameter. The structural beam includes first and second longitudinal elements each extending at least partially between the first and second ends and with a spacing between the first and second elements. Each of said first and second elements changes from the first geometry to the second geometry when the tube changes from the un-deployed diameter to the enlarged diameter for the spacing to remain substantially unchanged as the tube changes from the un-deployed diameter to the enlarged diameter.

Abstract: The present invention is directed to a vessel support member having opposing ends adapted to move in a circumferential plane, the support member configured for deployment in a substantially radial direction to support a substantial portion of the circumference of a vessel, the support member adapted to change between a first configuration and at least a second configuration, such that when in the first configuration, the support member is substantially linear or substantially planar, and as the support member is deployed and changes to at least the second configuration, one opposing end moves in a radial direction relative to the other opposing end, such that when in the second configuration the support member is substantially non-linear or substantially prismatic with a curved portion or region. Also provided is a method of supporting, and a kit for providing support to, a human or animal vessel, and a deployment means for deploying a support member.

Abstract: An anchor for an implantable medical device, for example, and implantable physiologic sensor, includes a proximal hub portion, an intermediate portion extending radially and distally from the hub portion, and a distal portion extending distally from the proximal portion and adapted to engage an inner surface of a target vessel for securing the implantable medical device therein. The anchor can assume a collapsed configuration for delivery through a catheter, and an expanded configuration for fixation within the vessel once deployed. The intermediate portion extends from the proximal portion at an oblique angle, allowing the anchor to be retracted and re-collapsed within the delivery catheter after initial deployment, if re-positioning or removal of the implantable medical device is necessary or desired.

Abstract: A tubular endoprosthesis including a polymeric material is disclosed. The endoprosthesis has a collapsed position that can be reverted to a first expanded position larger than the collapsed position by heating to a first temperature subsequent to insertion of the endoprosthesis into a cavity or lumen in a mammal. The endoprosthesis can be further expanded to a second expanded position within the cavity or lumen.

Abstract: A catheter-based annuloplasty system for use in repairing a heart valve having leaflets and a valve annulus, includes a delivery catheter having a proximal end and a distal end, and an expandable stent disposed on the distal end of the catheter. An adjustable annuloplasty ring is disposed on the expandable stent and is configured to expand and contract in response to expansion and contraction of the stent.

Abstract: A stent comprises a tubular member having openings therein and having a plurality of interconnected members and one or more frangible restraining members. The frangible restraining members break upon partial expansion of the stent. Thereafter, the stent self-expands.

Abstract: A method for manufacturing a stent, includes the steps of winding stent wire around the outer surface of a longitudinal axis of a mandrel into a desired final shape that is polygonal in an elevation orthogonal to the longitudinal axis, and forming a stent by setting the wound stent wire in the desired polygonal final shape. The outside diameter of the stent formed will be in co-columnar apposition with a blood vessel in which it is implanted. The mandrel employed in the methods can have a multiple-sided outer surface and a longitudinal axis.

Abstract: Described herein are devices and methods fabricating devices having nanostructures that allow adhesion or growth of one cell type, such as endothelial cells, more than another cell type, such as smooth muscle cells. In particular, stent covers having such nanostructures are described, and methods for fabricating these stent covers. Also described herein are methods for optimizing the nanostructures forming the devices.

Abstract: An intravascular stent especially suited for implanting in curved arterial portions or ostial regions. The stent can include an end region which is fabricated to have a greater radial strength than the remaining axial length of the stent. Such a stent is particularly suited for use in ostial regions, which require greater support near the end of the stent. The stent alternatively can include sections adjacent the end of the stent with greater bending flexibility than the remaining axial length of the stent. Such a stent is particularly suited for use in curved arteries. The stent can also be constructed with an end that has greater radial strength and sections adjacent the end with greater bending flexibility. Such a stent prevents flaring of the stent end during insertion.

Abstract: Methods and devices are disclosed for manipulating the airway, such as to treat obstructive sleep apnea. An implant is positioned within the body with respect to the airway. The spatial orientation of the airway is manipulated, directly or indirectly, to affect the configuration of the airway. In general, the implant is manipulated to displace the trachea in an inferior direction, resist superior displacement of the trachea and/or to alter the tracheal wall tension. The implant restrains the trachea in the manipulated configuration.

Abstract: A connection socket (12) for an end of a stent graft or a side arm (10) of a stent graft. The connection socket has a first resilient ring (14) around the arm at its end, a second resilient ring (16) spaced apart along the arm from the first ring and optionally a zig zag resilient stent (20) between the first and second rings. Each of the rings is of slightly lesser diameter than the side arm. The zig-zag resilient stent can be a compression stent.

Abstract: This invention relates to medical devices comprising shape memory alloys which have been subjected to a thermal and mechanical treatment to increase the austenite start temperature As to As? such that the shape memory alloy is martensitic at body temperature and when subsequently subjected to a controlled deformation, the shape memory alloy preferentially reverts to the parent phase. The shape memory alloy comprises nickel, titanium and a ternary element, preferably 3 at. % to about 20 at. %. The ternary element is insoluble in a Ni—Ti matrix. In a preferred embodiment, the element is selected from the group consisting of niobium, tantalum and zirconium.

Abstract: An intravascular stent especially suited for implanting in curved arterial portions or ostial regions. The stent can include an end region which is fabricated to have a greater radial strength than the remaining axial length of the stent. Such a stent is particularly suited for use in ostial regions, which require greater support near the end of the stent. The stent alternatively can include sections adjacent the end of the stent with greater bending flexibility than the remaining axial length of the stent. Such a stent is particularly suited for use in curved arteries. The stent can also be constructed with an end that has greater radial strength and sections adjacent the end with greater bending flexibility. Such a stent prevents flaring of the stent end during insertion.

Abstract: A process for inducing a two-way shape memory effect in a device forward of a shape memory alloy and a device made by the process are disclosed. The two-way memory effect occurs in the device in a temperature range of between about 5° C. to 25° C. wherein the training process is based on B2R phrase transformations. An R-phase formation or reorientation takes place in the device under stress whereupon the R-phase transforms into stress induced martenite. The device is subjected to thermocycling.

Abstract: A radiopaque nitinol medical device such as a stent for use with or implantation in a body lumen is disclosed. The stent is made from a superelastic alloy such as nickel-titanium or nitinol, and includes a ternary element selected from the group of chemical elements consisting of iridium, platinum, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, or hafnium. The added ternary element improves the radiopacity of the nitinol stent comparable to that of a stainless steel stent of the same and strut pattern coated with a thin layer of gold. The nitinol stent has improved radioplacity yet retains its superelastic and shape memory behavior and further maintains a thin strut/wall thickness for high flexibility.

Abstract: A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

Abstract: A method for manufacturing a stent, includes the steps of winding stent wire around the outer surface of a longitudinal axis of a mandrel into a desired final shape that is polygonal in an elevation orthogonal to the longitudinal axis, and forming a stent by setting the wound stent wire in the desired polygonal final shape. The outside diameter of the stent formed will be in co-columnar apposition with a blood vessel in which it is implanted. The mandrel employed in the methods can have a multiple-sided outer surface and a longitudinal axis.

Abstract: A luminal endoprosthesis for treating aneurysms, particularly aneurysms located at an arterial bifurcation. One feature of the endoprosthesis is a tubular armature that can expand radially from a compressed state to an expanded state. A further feature of the endoprosthesis, when in the expanded state, is a lenticular head whom axis coincides with that of the tubular armature, and which can be inserted into an aneurysm pocket. A method of manufacturing such an endoprosthesis is also described.

Abstract: Apparatus (20) is provided for creating a connection between a first body lumen (114) of a subject and a second body lumen (116) of the subject. The apparatus (20) includes a first engagement portion (102) configured to engage a wall of a first body lumen (114), a second engagement portion (104) that engages a wall of a second body lumen (116), and a cylindrical connecting portion (106) connecting the first engagement portion (102) to the second engagement portion (104). The connecting portion (106) defines a channel therethrough for passage of fluid from the inner space of the lumen (114), through the flow channel, and into the inner space of the body lumen (116). The apparatus also includes a projection (200) coupled to the second engagement portion (104), and surrounds an external surface of the wall of the lumen (116). Other embodiments are also described.

Abstract: The present invention, in an exemplary embodiment, provides a stent, which combines many of the excellent characteristics of both silicone and metal stents while eliminating the undesirable ones. In particular, a principal objective in accordance with the present invention is to provide a family of stents where the relative hardness/softness of regions of the stent can differ from other regions of the stent to provide additional patient comfort and resistance to radial forces. An exemplary embodiment also provides a family of stents with obstruction clearance and/or radiation therapy capabilities.

Abstract: A process for assembling a medical device made from a nickel-titanium alloy for use in a mammalian body while avoiding the formation of stress-induced martensite and a medical device used in combination with a delivery system for deployment into the mammalian body are disclosed. By heating the nickel-titanium alloy of the medical device to a temperature above Md, and deforming and installing the device into a delivery system or holding capsule, it is possible to avoid the formation of stress-induced martensite in the stent, which stays in the austenitic phase throughout.

Abstract: A fatigue-resistant implantable medical device. The fatigue-resistant implantable medical device includes a tubular stent. The tubular stent can have a laser-cut length and a shape-set length that is either longer or shorter than the laser-cut length. Such stents will tend to return to their laser-cut length when they are compressed for delivery. A stent that is shape-set longer than its laser-cut/delivery length that is deployed in a vessel that is shortened for stent delivery will tend to return to its shape-set length when the vessel returns to its neutral (i.e., elongated) length. Likewise, a stent that is shape-set shorter than its laser-cut/delivery length that is deployed in a vessel that is elongated for stent delivery will tend to return to its shape-set length when the vessel returns to its neutral (i.e., shortened) length. Such stents will experience reduced axial loading and reduced mean strain, thereby improving fatigue life.

Abstract: The invention relates to a sealing device for repair of cardiac and vascular defects or tissue opening such as a patent foramen ovale (PFO) or shunt in the heart, the vascular system, etc. and particularly provides an occluder device and trans-catheter occluder delivery system. The sealing device would have improved conformity to heart anatomy and be easily deployed, repositioned, and retrieved at the opening site.

Abstract: A vascular graft prosthesis comprising a tubular member having a luminal wall defining a lumen and an inner luminal diameter; and means for non-invasively constricting at least a portion of the luminal wall to reduce the inner luminal diameter and reduce a volumetric flow rate through the tubular member at the site of implantation of the vascular graft prosthesis, and during normal operating conditions, the means for constricting being operable to therefore facilitate an increase in a volumetric flow rate through the target limb to treat various symptoms manifesting themselves as a result of the implanted graft prosthesis, such as those resulting from an arteriovenous graft access and indicative of Steal syndrome.

Abstract: A vascular device comprising a plurality of vessel engaging members and a valve. The device is movable from a collapsed insertion position having a first diameter to a second expanded position having a second diameter larger than the first diameter. The plurality of vessel engaging members extend outwardly from the device for securely engaging the internal wall of a vessel upon expansion of the device to the second expanded position, wherein the vessel engaging members pull the internal wall of the vessel radially inwardly upon movement of the device from the second expanded position toward a first expanded position having a third diameter greater than the first diameter and less than the second diameter. In the first expanded position the valve is movable between an open position to allow blood flow therethrough to a closed position to prevent blood flow.

Abstract: Disclosed is an antithrombotic neurovascular device useful for the treatment of brain aneurysms and/or acute ischemic stroke. The device comprises a mechanical structure, which may be a stent, stent-like structure, or flow diverter, and a drug-eluting coating. This device is designed for local delivery of antiplatelet medication to the site of device implantation in order to improve outcomes for the population of brain aneurysm and/or acute ischemic stroke patients currently being treated with stents, and for use with patients presenting with ruptured aneurysms, in whom systemic dual antiplatelet therapy is contraindicated. The coating comprises an antiplatelet drug, preferably, a GPIIb/IIIa receptor inhibitor, more preferably, abcixmab, and optionally comprises a polymeric binder that functions as a drug modulating polymer. Also disclosed are methods for producing the antithrombotic neurovascular device, and using the device for the treatment of brain aneurysms and/or acute ischemic stroke.

Abstract: A radio frequency antenna is provided for use with a medical device for implantation into an animal. The antenna comprises a coil formed by a wire that includes a core formed of a shape-memory material with an electrically conductive first layer applied to an outer surface of the core. A second layer, of an electrically insulating and biologically compatible material, extends around the first layer. If necessary to reduce friction, a lubricant is placed between the first and second layers. If second layer is formed of a porous material or a non-biological compatible material, a biological compatible outer layer surrounds the second layer thereby providing a barrier that is impermeable to body fluids of the animal.

Abstract: An endovascular prosthesis includes a tubular body and a mobile external coupling. The tubular body includes a graft material and stents coupled thereto, a forms a lumen therethrough. The mobile external coupling extends outwardly from the tubular body. The mobile external coupling includes a graft material and is generally frustoconically shaped. The mobile external coupling includes a base coupled to the tubular body, a top spaced from the tubular body, and a coupling lumen disposed between the base and the top, wherein the coupling lumen is in flow communication with the body lumen. The coupling graft material is a woven fabric with warp yarn which run generally parallel to a longitudinal axis of the mobile external coupling including a shape memory material.

Abstract: An endovascular prosthesis includes a tubular body and a flexible springy mobile external coupling. The tubular body includes a graft material and stents coupled thereto with a forms a lumen therethrough. The mobile external coupling extends outwardly from the tubular body. The mobile external coupling includes a graft material and is generally frustoconically shaped. The mobile external coupling includes a base coupled to the tubular body, a top spaced from the tubular body, and a coupling lumen disposed between the base and the top, wherein the coupling lumen is in flow communication with the body lumen. A helically shaped stent may be coupled to the coupling graft material to make it flexible and springy.

Abstract: The present invention provides a stent and tubular organ treatment device that can flexibly deform according to a curved portion of a tubular organ, contracts less in the longitudinal direction during insertion, and is easy to handle. A stent (1) is formed into a tubular form by arranging five tubular unit bodies in an axial direction and connecting them by a connecting filament (F). Each tubular unit is formed into a closed loop by cutting a metal wire to a predetermined length, bending it in a zigzag manner in a peripheral direction, and securely connecting both ends thereof. A tubular unit body (W) having two bent portions projected in the axial direction is connected to and rockably retained by a tubular unit body (U1). Similarly, a tubular unit body (V) is rockably retained by the tubular unit body (W), whereby the entire stent can easily deform into a curved shape.

Abstract: A recoverable, safe and reliable valve stent for unidirectional flow of human lumen which can be implanted temporarily or for a long term and is used in the interventional therapy so as to obstruct from anisotropic flow, in the case of lung diseases. It comprises a cylindrical stent made up of memory alloy material. In particular, an elastic diaphragm is arranged inside the cylindrical stent and at least one gap is arranged on the diaphragm so that the spring piece is divided into a bendable section. One end of the cylindrical stent is provided with a fixed rear clip which is used to fix the alloy material making up the cylindrical stent. The rear clip is provided with screwthreads which can be connected with the conveyor. The stent in the present invention is in a structure without hook body, so the stent can be accurately positioned, adjusted and placed or recovered in double directions with strong anti-backflow ability.

Abstract: A method for determining the position of a stent within a body, comprising the steps of: providing a 3D dataset of voxels representing a 3D image containing the stent; determining a starting position for the determination of the stent position; determining the axis of symmetry of the stent in the 3D dataset; determining a second dataset representing at least one image containing the stent in its present position; and determining the positional offset of the stent by image fusion using the 3D dataset and the second dataset and by penalizing a rotation around the axis of symmetry as compared to the starting position.

Abstract: A stent suitable for the repair of lesions in bifurcated blood vessels is provided, having a deformable end portion such that a free end of the end portion can be aligned with the surface of an abutting stent or angioplasty balloon in a main branch of the bifurcated vessel. A method of blood vessel repair using this stent is also provided.

Abstract: An implantable endoluminal device that is fabricated from materials that present a blood or body fluid and tissue contact surface that has controlled heterogeneities in material constitution. An endoluminal stent-graft and web-stent that is made of an monolithic material deposited into a monolayer and etched into regions of structural members and web regions subtending interstitial regions between the structural members. An endoluminal graft is also provided which is made of a biocompatible metal or metal-like material. The endoluminal stent-graft is characterized by having controlled heterogeneities in the stent material along the blood flow surface of the stent and the method of fabricating the stent using vacuum deposition methods.

Abstract: An implantable, radially distensible stent includes a tubular structure having opposed open ends. The wall of the stent is made from a shape memory polymeric material. Grooves may be disposed within an outer surface of stent wall to improve flexibility and drainage of the stent.

Abstract: A stent designed for catheter delivery to a target neurovascular site via a tortuous path, in a contracted state, and deployment at the target site, in an expanded state, is disclosed. The stent includes a plurality of expandable tubular members, where member is composed of a continuous wire element forming a plurality of wave segments, and segment contains a pair of opposite looped peaks having a wave shape such that the distance between adjacent sides of a wave, on proceeding from a peak toward opposite peaks, increases monotonically with an inflection point therebetween. The expandable tubular members are joined through adjacent peaks by axial connectors. Radial expansion of the stent from a contracted to expanded state is accommodated by movement of adjacent wave-segment peaks away from one another, without significant change in the axial dimension of the stent. Also disclosed are a system incorporating the stent, and a method of treating a neurovascular abnormality.

Abstract: A vacuum deposition method for fabricating high-strength nitinol films by sputter depositing nickel and titanium from a heated sputtering target, and controlling the sputter deposition process parameters in order to create high-strength nitinol films that exhibit shape memory and/or superelastic properties without the need for precipitation annealing to attenuate the transition conditions of the deposited material. A vacuum deposited nitinol film having high-strength properties equal to or better than wrought nitinol films and which are characterized by having non-columnar crystal grain structures.

Abstract: Embodiments of the present invention provide medical devices for treating a target site within the body and associated methods for fabricating and delivering medical devices. According to one embodiment, a medical device includes a tubular structure having proximal and distal ends and a side wall extending therebetween. At least a portion of the side wall can have a corrugated surface. The side wall further includes at least one layer of a metallic fabric configured to be compressed and heat set to define the corrugated surface. The tubular structure may comprise an expanded shape, and may be configured to be constrained to a smaller diameter than the expanded shape for delivery within a catheter to a target site and to assume the expanded shape upon release from the catheter.

Abstract: A process for inducing a two-way shape memory effect in a device forward of a shape memory alloy and a device made by the process are disclosed. The two-way memory effect occurs in the device in a temperature range of between about 5° C. to 25° C. wherein the training process is based on B2??R phrase transformations. An R-phase formation or reorientation takes place in the device under stress whereupon the R-phase transforms into stress induced martenite. The device is subjected to thermocycling.

Abstract: A medical device has a structure differentiated in terms of its stiffness or elasticity. Such stiffness differentiation is achieved through the use of superelastic or shape-memory materials which transition between a relatively malleable phase to a stiffer phase at a transition temperature which is adjustable by heat treatment. A differentiation of the stiffness of the structure forming the medical device is achieved by differentially adjusting the transition temperature of select portions of the medical device before the medical device is placed in its operational mode, usually implanted in a body at body temperature.

Abstract: The present invention concerns shape memory devices, methods of producing same and the use of these materials.

Abstract: An atraumatic heart valve prosthesis includes a prosthetic valve coupled to an expandable anchoring structure including a outflow portion configured to taper inwardly in a distal direction towards a central axis of the prosthesis. By this configuration, the distal end of the anchoring structure imparts less force upon the vessel wall (e.g., the aortic tunica intima) during continued expansion and contraction of the heart. The expandable anchoring structure can be balloon expandable or self-expanding.