Abstract: The invention provides improved devices, systems, and methods for tissue approximation and repair at treatment sites. The invention provides devices, systems, and methods that may more successfully approximate and repair tissue by improving the capture of tissue into the devices. The invention may be a one-way mechanism that allows tissue to enter the mechanism but not easily exit, such as a leaf-spring, a protrusion, a pivoting arm and one or more frictional elements.

Abstract: The present invention provides an intravascular blood pump comprising an expandable and collapsible region distal to a pump assembly. In some embodiments, the expandable and collapsible region may comprise expandable and collapsible proximal and/or distal transition sections adjacent a central expandable and collapsible region. Support structure, e.g., an expandable and collapsible stent may comprise at least a part of the expandable and collapsible region. In some embodiments, a distal portion of the housing comprises the expandable and collapsible region, wherein an inversion of the distal housing results in a collapsed configuration and eversion of the distal housing results in an expanded configuration.

Abstract: Disclosed is a guidewire stop configured to lock a medical device onto a guidewire. The guidewire stop comprises a locking element, an actuator coupled to the locking element and a locking tube, wherein at least a section of the guidewire and at least part of the locking element or actuator pass through the locking tube. Further disclosed is that the locking tube comprises an unlocking element configured to unlock the medical device from the guidewire. The disclosed guidewire stop has at least the following three configurations: —an initial unlocked configuration in which the guidewire stop and the medical device are movable relative to the guidewire; —a first locked configuration in which the guidewire stop and the medical device are not movable relative to the guidewire; and—a first unlocked configuration in which the guidewire stop and the medical device are movable relative to the guidewire.

Abstract: A method of making a medical guidewire including providing a wire having a length that includes a proximal length and a distal length. The method further includes applying cold work to the distal length and not applying cold work to the proximal length, thereby imparting to the distal length a diameter that is smaller than the proximal length diameter; and applying a reducing process to the wire whereby the proximal length is reduced to have an outer diameter that is the same as the outer diameter of the distal length. The proximal length has an inner diameter and the distal length has an inner diameter that is less than the inner diameter of the proximal length.

Abstract: A lubricated tubular graft is implanted in the inferior vena cava and the superior vena cava in order to control the inflow of blood to the right atrium. A bifurcated leg with a non-collapsing stent extends across the tricuspid valve. A bioprosthetic valve is positioned proximal of the stent in the bifurcated leg in order to regulate flow through the tricuspid valve and to eliminate tricuspid regurgitation.

Abstract: A closure device for closing an opening in tissue is provided. The closure device includes an elongate member through which needles may be deployed. The closure device also includes a closure element having a foot portion and a needle guide portion. The foot portion and the needle guide portion are each movable between a delivery configuration and a deployed configuration. The foot portion includes cuffs removably mounted thereon and having sutures connected therebetween. The needle guide portion includes needle guide apertures that guide the needles to the cuffs. The needles securely engage the cuffs and draw the cuffs and suture through the lumen wall so that the opening in the lumen wall can be closed with the sutures.

Abstract: A method for managing a guidewire in preparation for a surgical operation, comprising attaching a block of resilient polymer to a coiled tube which contains a guidewire; attaching to the block of resilient polymer a card having printed information concerning the guidewire on a planar surface of the card; removing the guidewire from the coiled tube; removing the block of resilient polymer from the coiled tube while keeping the card having printed information attached to the block of resilient polymer; coiling the guidewire into a flat spiral form; capturing, in a slot formed in the block of resilient polymer, a plurality of portions of the guidewire, which portions are adjacent to and parallel with each other, thereby maintaining the guidewire in the flat spiral form.

Abstract: A method for managing a guidewire in preparation for a surgical operation, comprising attaching a block of resilient polymer to a coiled tube which contains a guidewire; attaching to the block of resilient polymer a card having printed information concerning the guidewire on a planar surface of the card; removing the guidewire from the coiled tube; removing the block of resilient polymer from the coiled tube while keeping the card having printed information attached to the block of resilient polymer; coiling the guidewire into a flat spiral form; capturing, in a slot formed in the block of resilient polymer, a plurality of portions of the guidewire, which portions are adjacent to and parallel with each other, thereby maintaining the guidewire in the flat spiral form.

Abstract: The present invention provides an intravascular blood pump comprising an expandable and collapsible region distal to a pump assembly and proximal in certain embodiments to inlet apertures in the pump housing. In some embodiments, the expandable and collapsible region may comprise expandable and collapsible proximal and/or distal transition sections adjacent a central expandable and collapsible region. Support structure, e.g., an expandable and collapsible stent may comprise at least a part of the expandable and collapsible region.

Abstract: The present invention provides an intravascular blood pump comprising a pump assembly without a flow inducer or diffuser, and proximal and distal flow rate or pressure sensors, wherein the distal flow rate or pressure sensor may be tracked distal to the impeller after placement of the blood pump within the patient's vasculature.

Abstract: A method for manufacturing a shaping structure having a generally helical profile and configured to support electrodes for delivering electric energy into a cylindrical lumen of a patient. The method comprises providing a mandrel with a circular cylindrical shape and forming a first hole in the mandrel along the elongate axis, such that opposing ends of a bore of the first hole emerge at the proximal end and at the distal end; forming a second hole in the mandrel to extend from the curved surface to connect with the first hole; wrapping a metal wire around the mandrel; and inserting opposing ends of the metal wire into the second and the third hole respectively, and threading the opposing ends of the metal wire until they emerge from the opposing ends of the bore of the first hole; finally, heating the mandrel and the wire.

Abstract: The invention provides improved devices, systems, and methods for tissue approximation and repair at treatment sites. The invention provides devices, systems, and methods that may more successfully approximate and repair tissue by improving the capture of tissue into the devices. The invention may be a one-way mechanism that allows tissue to enter the mechanism but not easily exit, such as a leaf-spring, a protrusion, a pivoting arm and one or more frictional elements.

Abstract: A guidewire for use in intravascular procedures has an inner coil that is radiopaque and an outer coil that is non-radiopaque at the distal end of the guidewire. The radiopaque inner coil is visible under fluoroscopy so that the physician can monitor the location of the distal end of the guidewire during a procedure. The inner coil and the outer coil can be formed from a single wire or a multi-filar wire. The inner coil and the outer coil can have any of the following cross-sections for enhanced torquability: I-beam; vertical rectangular; vertical ellipse; square; peanut shape; vertical hexagonal; horizontal hexagonal; and horizontal ellipse.

Abstract: A shaping tool is used to form a bend in the distal end of a guidewire. The guidewire distal end is inserted through a channel and into a cavity of the shaping tool. Using hand pressure, a first member is moved axially relative to a second member of the shaping tool, thereby moving the cavity relative to the channel and imparting a bend in the distal end of the guidewire.

Abstract: The present disclosure describes tissue gripping devices, systems, and methods for gripping mitral valve tissue during treatment of a mitral valve and while a tissue fixation device is implanted in the mitral valve. The tissue gripping device includes a flexible member and one or more tissue gripping members coupled to one or more arms of the flexible member. The flexible member is formed from a shape-memory material, such as nitinol, and the tissue gripping member(s) are formed from a material that is more rigid than the shape-memory material. The tissue gripping member(s) are attached to the flexible member by threading or looping suture lines around and/or through the tissue gripping member(s) and the flexible member and/or by applying a cover material to the tissue gripping device to hold the tissue gripping member(s) against the flexible member.

Abstract: A mold is used to form a solder joint to join the distal end of the guidewire to a wire coil. The mold has a cavity that can have different configurations so that the solder joint can be any of bullet shaped, micro-J shaped, cone shaped, truncated cone shaped, or have a textured surface.

Abstract: A guidewire for use in intravascular procedures has a solder or weld joint at a distal end thereof. A plurality of dimples are formed on the solder/weld joint to increase the engagement and penetration of fibrous material including chronic total occlusions (CTO).

Abstract: A guidewire for use in intravascular procedures has an elongated core member including a proximal core section having a uniform diameter. One or more parabolic grind profile sections extend distally from the distal end of the proximal core section and provide a linear change in bending stiffness and a high degree of torque to the distal portion of the guidewire.

Abstract: A guidewire for use in intravascular procedures has an inner coil that is radiopaque and an outer coil that is non-radiopaque at the distal end of the guidewire. The radiopaque inner coil is visible under fluoroscopy so that the physician can monitor the location of the distal end of the guidewire during a procedure. The inner coil and the outer coil can be formed from a single wire or a multi-filar wire. The inner coil and the outer coil can have any of the following cross-sections for enhanced torquability: I-beam; vertical rectangular; vertical ellipse; square; peanut shape; vertical hexagonal; horizontal hexagonal; and horizontal ellipse.

Abstract: A closure device for closing an opening in tissue is provided. The closure device includes an elongate member through which needles may be deployed. The closure device also includes a foot portion having one or more feet slidably mounted relative thereto. The feet are movable between a deployed position and a delivery position. The feet include cuffs removably mounted therein, with sutures connected between the cuffs. When the feet are in the deployed position and the needles are advanced, the needles securely engage the cuffs and draw the cuffs and suture through the lumen wall so that the opening in the lumen wall can be closed with the sutures.