Abstract: The present technology includes systems and methods for invasively adjusting implantable devices for selectively controlling fluid flow between a first body region and a second body region of a patient. For example, in many of the embodiments described herein, a catheter can be used to mechanically and/or electrically engage an implanted medical device. Once the catheter engages the medical device, the catheter can (i) increase a dimension associated with the medical device, such as through mechanical expansion forces, and/or (ii) decrease a dimension associated with the medical device, such as by heating a shape memory component of the medical device above a phase transition temperature.

Abstract: The present technology includes systems and methods for invasively adjusting implantable devices for selectively controlling fluid flow between a first body region and a second body region of a patient. For example, in many of the embodiments described herein, a catheter can be used to mechanically and/or electrically engage an implanted medical device. Once the catheter engages the medical device, the catheter can (i) increase a dimension associated with the medical device, such as through mechanical expansion forces, and/or (ii) decrease a dimension associated with the medical device, such as by heating a shape memory component of the medical device above a phase transition temperature.

Abstract: Devices and methods are described for delivering aneurysm stabilizing substances that may act in more than one pathway to the aneurysmal wall to prevent further enlargement of an aneurysm while allowing blood flow through the treatment area. Methods, devices and features for removal of the delivery device after the treatment are also disclosed.

Abstract: Aspects of the present invention provide apparatuses and methods for closing an apical hole in a heart of a subject, including a hole-closure device that includes a tissue-attachment portion configured to attach to cardiac tissue around the apical hole, and a collapsible portion coupled to the tissue-attachment portion and configured to close the hole by collapsing inwardly inside the apical hole.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Abstract: An implant and method for repairing and/or replacing functionality of a native mitral valve are in various embodiments configured to reduce or eliminate mitral regurgitation and residual mitral valve leakage. A coiled anchor with a central turn that reduces in size upon implantation is used to approximate the amount of reduction in the size and the reshaping of the native mitral annulus to reduce valve leakage. A clip can be further applied to the native valve leaflets to reduce the size of the native mitral annulus and leakage therethrough. A prosthetic heart valve can be implanted in the coiled anchor to replace and further improve functionality of the valve. In some cases, the prosthetic valve can be implanted in a clipped valve, where the clip is detached from one of the native valve leaflets to provide space for the prosthetic valve to expand.

Abstract: Among other things, a tool to attach a support to a heart valve annulus includes a stabilizing body that includes features to stabilize an axial position of the tool relative to the annulus, and an attachment device connected to the stabilizing body, the stabilizing body and the attachment device being movable relative to one another under control from a location remote from the tool. The support may have an expandable tubular body having a plurality of struts, a plurality of tissue anchors extending from distally facing apexes in a distal direction post-deployment, wherein axial distal advance of the implantable annulus support causes the plurality of tissue anchors to axially engage tissue, and the implantable annulus support is self-contractible from a radially enlarged engagement configuration for engaging tissue of the mitral valve annulus, to a reduced, deployed configuration for modifying mitral valve annulus geometry.

Abstract: Bioresorbable polymer vascular scaffolds made of combinations of polylactide and polycaprolactone having a high molecular weight polymer, thin struts in a selected range and sufficient radial strength to support a vessel upon deployment. The scaffolds have degradation behavior of molecular weight, radial strength, and mass that are conducive to healing of a vessel including providing patency to a vessel, reduction of radial strength, breaking up, and resorbing to allow return of the vessel to a natural state.

Abstract: A vascular closure device includes a frame to which there is fitted a plurality of anchor elements, spaced radially around the frame. The closure device includes a radial compression feature, which may be a memorized shape of the frame or non-sprung condition of the frame, having a small radius. The closure device is deployed in a vessel such that the anchor elements are embedded into the vessel wall. The radial compression feature causes the frame to compress radially, as a result of which the anchor elements will pull the vessel wall inwardly, thereby closing the vessel.

Abstract: Aspects of the present invention provide apparatuses and methods for closing an apical hole in a heart of a subject, including a hole-closure device that includes a tissue-attachment portion configured to attach to cardiac tissue around the apical hole, and a collapsible portion coupled to the tissue-attachment portion and configured to close the hole by collapsing inwardly inside the apical hole.

Abstract: Apparatus (10) is provided, which includes an endovascular stent-graft (20) and a heating device (22) that is coupled to the stent-graft (20). The stent-graft (20) is configured to be implanted in at least one blood vessel in a vicinity of an aneurysm (102). The heating device (22) is configured to apply, to a region (24) external to the stent-graft (20), thermal energy sufficient to coagulate blood flowing into the aneurysm (102). Other embodiments are also described.

Abstract: The present invention provides, in one embodiment, a vascular filter device for capturing dislodged blood clots within a vessel. The vascular filter device includes an expandable framework for securing the device within a vessel. The device also includes a pathway extending through the framework. The device further includes at least one filter in alignment with the pathway for capturing dislodged clots or emboli. In an embodiment, the filter can be given form by a material that can be easily eliminated in situ to permit reestablishment of the pathway.

Abstract: Guidewires and thin-film catheter-sheaths, fabricated using vacuum deposition techniques, which are monolayer or plural-layer members having ultra-thin wall thicknesses to provide very-low profile delivery assemblies for introduction and delivery of endoluminal devices.

Abstract: Superelastic and/or shape memory nickel-titanium alloys having an increased fatigue life that is superior to known nickel-titanium alloys are disclosed. The nickel-titanium alloys have a minimum fatigue life that may be at least about 10 million strain cycles at a strain greater than about 0.75%. The minimum fatigue life may be due, at least in part, to the nickel-titanium alloy having at least one of an oxygen concentration of less than about 200 ppm, a carbon concentration of less than about 200 ppm, the absence of oxide-based and/or carbide-based inclusions having a size greater than about 5 microns (?m), the presence of an R-phase, or combinations of the foregoing. Articles manufactured from such fatigue-resistant nickel-titanium alloys can be more durable because they are more resistant to repetitive strain and crack propagation.

Abstract: One aspect is a method for the production of a three-dimensional structure of successive layers producing a multitude of successive layers wherein, with the exception of a first layer, each of the successive layers is arranged on a preceding layer. Each of the successive layers includes at least two materials wherein one material is a sacrificial material and one material is a structure material. Each of the successive layers defines a successive cross-section through the three-dimensional structure. Producing each of the layers includes depositing the sacrificial material by means of an electrochemical process and depositing the structure material by means of physical gas phase deposition. After a multitude of successive layers has been produced, the three-dimensional structure is uncovered by removing at least a part of the sacrificial material. The sacrificial material is at least one of a group consisting of nickel, silver, palladium, and gold.

Abstract: Bioabsorbable scaffolds having high crush recoverability, high fracture resistance, and reduced or no recoil due to self expanding properties at physiological conditions are disclosed. The scaffolds are made from a random copolymer of PLLA and a rubbery polymer such as polycaprolactone.

Abstract: A medical device-includes a polymer stent crimped to a catheter having an expansion balloon. The stent is crimped to the balloon by a process that includes heating the stent to a temperature below the polymer's glass transition temperature to improve stent retention without adversely affecting the mechanical characteristics of the stent when later deployed to support a body lumen.

Abstract: A method is provided, including, delivering into a heart of a patient an annuloplasty ring structure including a body portion and an adjusting mechanism configured to adjust a size of the body portion of the annuloplasty ring structure, the adjusting mechanism including a housing, and following the delivering, moving the housing with respect to the body portion. Other applications are also described.

Abstract: A radiopaque nitinol stent for 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 including tungsten. The added tungsten in specified amounts improve the radiopacity of the nitinol stent comparable to that of a stainless steel stent of the same strut pattern coated with a thin layer of gold. Furthermore, the nitinol stent has improved radiopacity yet retains its superelastic and shape memory behavior and further maintains a thin strut/wall thickness for high flexibility.

Abstract: Bioabsorbable scaffolds having high crush recoverability, high fracture resistance, and reduced or no recoil due to self expanding properties at physiological conditions are disclosed. The scaffolds are made from a random copolymer of PLLA and a rubbery polymer such as polycaprolactone.

Abstract: A method for making a device for causing thrombosis of an aneurysm, wherein said device comprises a single elastic filament configurable between (i) an elongated, substantially linear configuration, and (ii) a longitudinally-contracted, substantially three-dimensional configuration, said method comprising: providing a sheet of shape memory material; producing a single filament, two-dimensional interim structure from said sheet of shape memory material; mounting said single filament, two-dimensional interim structure to a fixture so that said single filament, two-dimensional interim structure is transformed into said longitudinally-contracted, substantially three-dimensional configuration; and heat treating said single filament, two-dimensional interim structure while it is mounted to said fixture so as to produce said device in its longitudinally-contracted, substantially three-dimensional configuration.

Abstract: A dual valve prosthesis having first and second prosthetic valve sections is disclosed. The first prosthetic valve section includes a stent structure with a first prosthetic valve secured therein and the second prosthetic valve section includes an annular frame with a second prosthetic valve secured therein. When the dual valve prosthesis is in an expanded configuration, the annular frame extends from the stent structure such that the first and second prosthetic valves are laterally offset from each other. In a method in accordance herewith, the first and second prosthetic valve sections include prosthetic aortic and mitral valves, respectively, and the dual heart valve prosthesis is configured to replace both the native aortic and mitral valves of the heart in a single transcatheter heart valve implantation procedure.

Abstract: A medical implant (20) includes first and second ring members (22, 24), each including a resilient framework (26) having a generally cylindrical form. A tubular sleeve (28) is fixed to the first and second ring members so as to hold the ring members in mutual longitudinal alignment, thereby defining a lumen (32) passing through the ring members. A constricting element (30) is fit around the sleeve at a location intermediate the first and second ring members so as to reduce a diameter of the lumen at the location.

Abstract: A medical device- includes a polymer stent crimped to a catheter having an expansion balloon. The stent is crimped to the balloon by a process that includes heating the stent to a temperature below the polymer's glass transition temperature to improve stent retention without adversely affecting the mechanical characteristics of the stent when later deployed to support a body lumen.

Abstract: A method of removing slag formed during laser cutting a hypotube may include flowing cooling gas into a laser nozzle, directing flow of the cooling gas onto an external surface of the hypotube, and injecting cooling fluid into an inner lumen of the hypotube at a velocity. Flowing the cooling gas and injecting the cooling fluid may at least partially remove slag from the external surface of the hypotube.

Abstract: A medical device includes a balloon catheter having an expandable member, e.g., an inflatable balloon, at its distal end and a stent or other endoprosthesis. The stent is, for example, an apertured tubular member formed of a polymer and is assembled about the balloon. The stent has an initial diameter for delivery into the body and can be expanded to a larger diameter by inflating the balloon.

Abstract: According to one aspect of the present invention, a fatigue resistant stent comprises a flexible tubular structure having an inside diameter, an outside diameter, and a sidewall therebetween and having apertures extending through the sidewall. According to other aspects of the invention, processes for making a fatigue resistant stent are disclosed. According to further aspects of the invention, delivery systems for a fatigue resistant stent and methods of use are provided.

Abstract: The present invention relates generally to stents for insertion into bodily lumens that include at least one strand that forms a self-expanding tubular structure. Specifically, these strands form a plurality of intersections at which one portion of the strand is in proximity to another portion of the same or different strand. More specifically, at least some of those intersections include a plurality of reinforcement members.

Abstract: A medical device-includes a polymer scaffold crimped to a catheter having an expansion balloon. The scaffold is crimped to the balloon by a process that includes inflating the delivery balloon during a diameter reduction to improve scaffold retention. A crimping temperature is maintained at about the onset of glass transition of the polymer material to facilitate more rapid stabilization of mechanical properties in the scaffold following crimping.

Abstract: A medical device-includes a polymer stent crimped to a catheter having an expansion balloon. The stent is crimped to the balloon by a process that includes heating the stent to a temperature below the polymer's glass transition temperature to improve stent retention without adversely affecting the mechanical characteristics of the stent when later deployed to support a body lumen.

Abstract: A stent/stent graft for reinforcement of vascular abnormalities and an associated method are provided. According to on embodiment, the stent/stent graft includes a flexible tubular structure comprising proximal and distal ends and having a heat set configuration. The tubular structure is configured to engage a lumen upstream and downstream of a vascular abnormality, such as an aneurysm, and a portion between the proximal and distal ends of the tubular structure is configured to engage the aneurysm.

Abstract: A stent comprises a metallic, relatively radiolucent carrier structure and at least one marker element which includes comparatively radiopaque material. The radiopaque material is completely enclosed by a cover layer of a material other than the radiopaque material, the cover layer including metal or a metal compound. The stent may be used to treat a patient.

Abstract: A radiopaque nitinol stent for 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 including tungsten. The added tungsten in specified amounts improve the radiopacity of the nitinol stent comparable to that of a stainless steel stent of the same strut pattern coated with a thin layer of gold. Furthermore, the nitinol stent has improved radiopacity yet retains its superelastic and shape memory behavior and further maintains a thin strut/wall thickness for high flexibility.

Abstract: To provide a stent which holds various performances such as deliverability, prevention of restenosis, flexible shape conformability, and so on and is therefore adaptable not only to a bile duct but also to a blood vessel system such as a tortuous coronary artery substantially without causing restenosis. A stent with an autonomic function is made of a Ti—Ni based shape memory alloy and has a maximum expanding force at a center portion in its lengthwise direction.

Abstract: Bioabsorbable scaffolds having high crush recoverability, high fracture resistance, and reduced or no recoil due to self expanding properties at physiological conditions are disclosed. The scaffolds are made from a random copolymer of PLLA and a rubbery polymer such as polycaprolactone.

Abstract: A retrievable stent is a self-expandable or balloon-expandable stent which is very useful for treating intracranial sidewall aneurysms and can be retrieved especially when the stent is not deployed appropriately. The stent comprises a proximal retrieving structure and a distal self-expandable or balloon-expandable stent or covered stent for the treatment of sidewall aneurysms of cerebral blood vessels.

Abstract: The disclosure provides biodegradable implantable devices such as a stent comprising a biodegradable polymeric wherein the polymeric material is treated to control crystallinity and/or Tg. The stent is capable to expand at body temperature in a body lumen from a crimped configuration to a deployed diameter and have sufficient strength to support a body lumen.

Abstract: A guide wire includes a distal core member made of a ferrous alloy which has shape memory properties and superelasticity. The ferrous alloy preferably includes substantially two phases, and has a difference of 100° C. or less between an Af point and an Ms point in a thermal hysteresis of martensitic transformation and reverse transformation. The guide wire may include a proximal core member made of an iron-containing alloy and having a higher modulus of elasticity than the distal core member. The two core members may be joined together by welding to form a core of the guide wire.

Abstract: According to one aspect of the present invention, a fatigue resistant stent comprises a flexible tubular structure having an inside diameter, an outside diameter, and a sidewall therebetween and having apertures extending through the sidewall. According to other aspects of the invention, processes for making a fatigue resistant stent are disclosed. According to further aspects of the invention, delivery systems for a fatigue resistant stent and methods of use are provided.

Abstract: A stent for treating a physical anomaly. The stent includes a skeletal support structure for expanding in the physical anomaly and a shape memory material coupled to the skeletal support structure.

Abstract: A stent formed of a metallic material having a two-way memory adapted to be retrieved or repositioned after delivery includes an elongated tubular body and at least one crown connected to a respective longitudinal end of the body, the crown including a plurality of unconnected leaves, each leaf having a longitudinally extending frame connected at one end to the end of the body. A method of manufacturing the stent so that the crown has a greater two-way memory effect than the body is disclosed.

Abstract: Exemplary non-woven helical stents are described that are efficient to fabricate in terms of labor and resources by being able to be manufactured by hand or machine while providing mechanical stability equivalent or close thereto of known braided or woven stents.

Abstract: The present disclosure provides a bifurcated stent for use in juxtaposition with an angiological bifurcation. The disclosure provides a bifurcated stent that includes a proximal portion adapted to be disposed within a blood vessel in juxtaposition with a bifurcation, a first distal stent portion adapted to extend across the bifurcation into one of the branched blood vessels, and a second distal stent portion adapted to allow blood to flow from the proximal portion into the other branch blood vessel. The disclosure also provides a bifurcated prosthesis including such a bifurcated stent and a tubular graft layer formed from a biocompatible fabric in juxtaposition with the stent. The disclosure also provides a stent joining means for joining two stents one to the other to define a continuous lumen through the two stents.

Abstract: A woven, self-expanding stent device has one or more strands and is configured for insertion into an anatomical structure. The device includes a coupling structure secured to two different strand end portions that are substantially aligned with each other. The two different strand end portions include nickel and titanium. The coupling structure is not a strand of the device.

Abstract: A radiopaque nitinol stent for 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 including tungsten. The added tungsten in specified amounts improve the radiopacity of the nitinol stent comparable to that of a stainless steel stent of the same strut pattern coated with a thin layer of gold. Furthermore, the nitinol stent has improved radiopacity yet retains its superelastic and shape memory behavior and further maintains a thin strut/wall thickness for high flexibility.

Abstract: Implantable in vivo sensors used to monitor physical, chemical or electrical parameters within a body. The in vivo sensors are integral with an implantable medical device and are responsive to externally or internally applied energy. Upon application of energy, the sensors undergo a phase change in at least part of the material of the device which is then detected external to the body by conventional techniques such as radiography, ultrasound imaging, magnetic resonance imaging, radio frequency imaging or the like. The in vivo sensors of the present invention may be employed to provide volumetric measurements, flow rate measurements, pressure measurements, electrical measurements, biochemical measurements, temperature, measurements, or measure the degree and type of deposits within the lumen of an endoluminal implant, such as a stent or other type of endoluminal conduit.

Abstract: A helical stent is provided that is wound in a zig-zag pattern along a pitch angle with respect to a plane transverse to the axis of the stent. A bisecting line extending through a bend and between two adjacent angular struts is also angled with respect to the longitudinal axis of the stent.

Abstract: Polymeric stents having fracture toughness and resistance to recoil after deployment are disclosed along with methods of manufacturing such stents. Improvements to mechanical characteristics and other improvements may be achieved by having polymer chains within individual stent struts oriented in a direction that is closer to or in line with the axis of the individual stent struts. The struts are connected to each other by hinge elements that are configured to bend during crimping and deployment of the stent. The hinge elements may be tangent or non-tangent to the adjoining struts so as to form W-shaped closed cells arranged in an offset brick pattern in which the size each W-shaped closed cell can be defined in part by a curvilinear length that is approximately 4.5 mm, which allows the stent to be crimped down to an OD of about 1.3 mm and expanded to an OD of at least about 3.5 mm.

Abstract: The invention provides a process by which tubular tissue supports (stents) can be removed from hollow organs of humans or of animals after heating to a temperature below the transition temperature Ttrans until softening occurs.

Abstract: Methods and systems of delivering a stent at an elevated temperature are disclosed herein.