Abstract: A vessel closure device for delivering immediate hemostasis at a puncture site in a wall of a blood vessel includes an intravascular anchor having one or more suture attachment points, an extravascular cap having a lumen, a sealant, and a suture connected to at least one of the one or more suture attachment points of the intravascular anchor and threaded through the lumen of the extravascular cap, wherein each of the intravascular anchor, extravascular cap, sealant, and suture are formed of bioabsorbable materials.

Abstract: A device for closing an opening in a body lumen, the device having a first elongate member with a first lumen, a second elongate member distal the first elongate member, and a needle assembly slidably cooperating with the first elongate member to position a plurality of sutures within the lumen of the first elongate member. The needle assembly includes a needle base and a plurality of needle portions extending from the needle base. Slidable movement of the needle assembly in relation to the first elongate member locates the plurality of sutures selectively mounted to the needle assembly within the first lumen.

Abstract: The present invention comprises at least sensing, monitoring, and display of motor current which is then used in various embodiments of a rotational atherectomy device to determine and/or predict, among other things, treatment progression, treatment completion, optimal rotational speed, optimal advancement or traversal speed during treatment, whether stall appears imminent, and/or reacting to stop motor rotation before a stall occurs. In some embodiments, the determination or prediction results in an automatic, or preprogrammed adjustment by the control unit of the rotational speed of the rotating drive shaft and associated tool.

Abstract: An access closure device for closing an opening in tissue is provided. The access closure device may comprise a balloon delivery system and a sealant delivery system. The balloon delivery system may comprise a suture, a delivery shaft, an inflatable balloon, and a balloon segment releasably attached to the delivery shaft. The sealant delivery system may comprise a sealant delivery shaft, an ejection tube, and a snare wire configured to snare a suture of the delivery system.

Abstract: The present disclosure is directed to a multi-segment device comprising an elongate first portion comprising a first metallic material, an elongate second portion comprising a different metallic material, the first and second elongate portions being directly joined together end to end, a heat affected zone surrounding an interface of the elongate first portion and the elongate second portion, a shapeable distal end formed from at least a portion of the elongate second portion, a coil disposed about a portion of the elongate second portion.

Abstract: A medical device with an implantable blood pump and a control and sensing unit configured to determine the flow rate generated by the blood pump when driven by an electric motor, wherein the flow rate is determined using peak-to-peak current data generated by the electric motor and, in some cases, associated heart rate data. In some embodiments, the validity of pulsatility of the resulting blood flow is determined and, if out of predetermined limits, an alarm may be actuated.

Abstract: A torque device for gripping and manipulating a guidewire for advancing the guidewire into a patient's vascular system. The torque device is configured for single-handed use and can be opened for repositioning the torque device relative to the guidewire and closed for gripping the guidewire to prevent axial and rotational movement relative to the guidewire. The torque device grips the guidewire at multiple spaced apart locations on the guidewire.

Abstract: A guidewire for use in penetrating through complex and stenosed lesions. The distal tip of the guidewire has a roughened surface to increase frictional engagement with calcified and fibrous tissue to increase the penetration of the distal tip and the guidewire into and through the lesion and reduce the likelihood of deflection of the guidewire tip. The average surface roughness of the distal tip is in the range from 1 micron to 200 microns.

Abstract: A guidewire formed from drawn filled tubing having an inner core member encased in an outer layer. The inner core member is formed from a linear elastic or superelastic material and the outer layer is formed from a metal alloy such as 35N LT. A portion of the outer layer is ground down to form a feather edged joint between the outer layer and the inner core member.

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 closure system for closing an opening in tissue, the closure system including a closure device and a knot replacement device configured to position a suture lock on a suture. The closure device includes a housing, a needle actuation handle cooperating with the housing, a first hollow needle selectively movable by the needle actuation handle and operatively cooperating with a suture anchor frictionally engaged with a slot and a lumen of the first hollow needle and coupled to a suture. A portion of the suture anchor rests along an outer surface of the first hollow needle as the first hollow needle is advanced through tissue adjacent the opening.

Abstract: A thrombectomy system is provided that, in various embodiments, a rotating impeller that may be translated within limits along a guidewire and within a catheter. The rotating impeller is, during operation, either located entirely inside or outside of the distal end of the catheter's lumen or at least partially outside of the distal end of the catheter's lumen. In some cases, the impeller may be prevented from rotating if at least partially inside the catheter's lumen. The rotating impeller may achieve a working diameter that is greater than its resting diameter.

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 torque device for gripping and manipulating a guidewire for advancing the guidewire into a patient's vascular system. The torque device is configured for single-handed use and can be opened for repositioning the torque device relative to the guidewire and closed for gripping the guidewire to prevent axial and rotational movement relative to the guidewire. The torque device grips the guidewire at multiple spaced apart locations on the guidewire.

Abstract: A medical apparatus that includes a distal member, a needle disposed in the distal member and proximally advanceable from the distal member, and a needle capture portion positioned proximal to the distal member and which includes a through-hole to direct the needle from the needle capture portion towards a graspable member at a trajectory narrower than a trajectory of the needle from the distal member to the needle capture portion.

Abstract: A guidewire formed from drawn filled tubing having an inner core member encased in an outer layer. The inner core member is formed from a linear elastic or superelastic material and the outer layer is formed from a metal alloy such as 35N LT. A portion of the outer layer is ground down to form a feather edged joint between the outer layer and the inner core member.

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 device for positioning suture through tissue, the device including a proximal elongate member having a longitudinal axis, the proximal elongate member being configured to receive a needle, and a tissue locator disposed distal the proximal elongate member, the tissue locator being coupled to an elongate member extending through the proximal elongate member and including a leg with a needle receiving opening configured to accommodate the needle. Proximal movement of the elongate member compresses the tissue locator and folds the leg of the tissue locator, the leg transitioning from extending longitudinally to extending outwardly in relation to a position of the leg in a pre-compressed state.