Abstract: Disclosed herein is a blood flow restriction device, that includes an elongate member configured for advancement along a blood vessel, having an actuator at a proximal end and a restriction mechanism at a distal end. The restriction mechanism is configured to transition between a various states of blood-flow restriction that includes deploying and/or retracting one or more restriction members between a collapsed state and a distally expanded state by the actuator. One or more restriction members may be cone shaped having conical wall which may include a number of apertures extending therethrough. The restriction mechanism may be transitionable either discreetly or variably between two or more blood-flow restriction states. The actuator may include a microprocessor controlled electro-mechanical actuator coupled with a sensor configured to measure a blood flow parameter, and logic of the controller may adjust a blood flow restriction amount based on a signal from the sensor.

Abstract: An apparatus for cutting a wall of a vessel (V), such as scoring or slicing a lesion (L) associated therewith. The device includes a cutter (10) with a single shaft (12) having a branched portion including at least two radially expandable arms. A first (16) of the expandable arms includes at least one blade (20) for slicing or scoring the lesion (L) when expanded. A second (18) of the expandable arms may also include a blade (20), or may have no blade. A sheath (S) may also be provided. The arm or arms with blades may also include a limiter (22) for limiting the cutting depth of the blade (20). An anchor may also be provided for anchoring the cutter (10) in the vessel (V).

Abstract: A surgical guidewire and snare apparatus comprising of an elongated sheath that has a central, longitudinal bore, proximal and distal sheath ends. A head is at the sheath distal end. A wire or cable occupies the central, longitudinal bore, and the wire or cable has a proximal wire or cable and a distal wire or cable end. The wire or cable distal end has an engagement with the head. Slotted portions are on the sheath at the sheath distal end. Spaced apart sections of the sheath are next to the slotted portions. Tension is applied to the wire or cable proximal end that pulls the head proximally to enlarge the slotted portions and curve the spaced apart sheath sections next to the slotted portions.

Abstract: A thrombectomy device for removing a material from a subject includes a catheter, a diaphragm, and a vacuum. The catheter includes an outer body defining a lumen extending therethrough. The diaphragm is coupled to the catheter and is moveable between an open diaphragm configuration and a closed diaphragm configuration. The diaphragm allows movement of the material through the lumen when in the open diaphragm configuration and prevents movement of the material through the lumen when in the closed diaphragm configuration. The vacuum is in communication with the lumen and is operable to exert a vacuum pressure on the diaphragm. The vacuum pressure is operable to move the diaphragm from the open diaphragm configuration to the closed diaphragm configuration.

Abstract: A vena cava filter is described, having one or more frame members or an elongated member arranged in helical fashion. A plurality of filaments connect frame members or portions of the elongated member. The filaments may be made of suture material. Hooks may be placed on a free end of the filaments, along the length thereof, or on one or more frame members to engage the blood vessel wall and anchor the filter. A retrieval member may be positioned on the filter to facilitate withdrawal of the filter from the blood vessel.

Abstract: In one aspect, a system for endovascular treatment of a blood vessel includes a control unit, an ultrasound device, an actuator, and a catheter having a treatment portion. The ultrasound device is communicatively coupled to the control unit. The ultrasound device includes an ultrasound probe having a subject contact surface. The actuator is coupled to the ultrasound probe and is operable to move the subject contact surface of the ultrasound prove relative to a treatment zone of a subject. The control unit is configured to determine a position of the treatment portion of the catheter as the catheter is advanced through the blood vessel, and move the subject contact surface of the ultrasound probe relative to the treatment zone of the subject with the actuator to follow the position of the catheter as the catheter is advanced through the blood vessel.

Abstract: A method of preparing a filter for delivery into a body vessel. The filter includes a hub disposed along a longitudinal axis and a plurality of anchor members extending from the hub. Each anchor member includes either a cranial extension or a caudal extension at a distal end thereof. At least one anchor member distal end may be spaced from the hub at each of a first, second, and third distance along the longitudinal axis. The filter also includes a plurality of locator members extending from the hub, the locator members alternatingly interposed between the anchor members.

Abstract: A stent delivery system includes an inner tubular member, a stent disposed over a distal section of the inner tubular member, a locking member positioned over the inner tubular member proximal of the stent, and an outer tubular member covering the stent and the locking member in a delivery configuration. A portion of the stent can be positioned in the locking member in the delivery configuration. The locking member can include a tubular proximal section, and a plurality of fingers extending distally from the tubular proximal section. The plurality of fingers can include a first finger and a second finger. The plurality of fingers can have a locked configuration with each of the first finger and the second finger parallel to a longitudinal axis, and an unlocked configuration with one of the first finger and/or the second finger forming an angle with respect to the longitudinal axis.

Abstract: A wearable device for monitoring a tissue swelling condition of a user is disclosed that includes a device attachment mechanism for securing the device to the user, and a sensing mechanism coupled to the attachment mechanism. The sensing mechanism can be configured to provide an electrical signal in accordance with the tissue swelling condition of the user to a console, where the console can be configured to: (i) receive the electrical signal from the sensing mechanism, and (ii) provide swelling information to the user in accordance with the electrical signal. Various tissue swelling sensing mechanisms are disclosed, as well as a system including the wearable device and storage, where the storage includes executable instructions that when executed by one or more processors causes the one or more processors to perform operations, including receiving tissue swelling data from the wearable device, and rendering tissue swelling information on a display.

Abstract: An apparatus is provided for scoring a treatment location in a vessel. A catheter includes an expandable element or inflatable balloon for achieving dilatation. A scoring element includes an elongated scoring wire having at least one ring for selective positioning over the inflatable balloon, which may then be inflated to provide scoring function in both a longitudinal and transverse direction. A plurality of the rings may be provided, and may be adapted for use with a variety of different sizes or lengths of balloons. Related methods are also disclosed.

Abstract: Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure.

Abstract: An apparatus is provided for scoring a treatment location in a vessel. A catheter includes an expandable element or inflatable balloon for achieving dilatation. A scoring element includes an elongated scoring wire having at least one ring for selective positioning over the inflatable balloon, which may then be inflated to provide scoring function in both a longitudinal and transverse direction. A plurality of the rings may be provided, and may be adapted for use with a variety of different sizes or lengths of balloons. Related methods are also disclosed.

Abstract: A blood filter extraction system for extracting a blood filter from within a blood vessel. The system includes an extraction wire, or plurality of such wires, positioned within an elongated tubular member. A plurality of extraction wires coupled to the distal end of the extraction member each include a hook for engaging filter members. Alternatively, the extraction wires may be one or more wires configured in a helical shape which engage filter members when the extraction member is rotated. The system may also include an elongated tubular member with the distal end having a conical shape. To extract a filter, the extraction wires are then pushed out of the tubular member and into the filter members. The extraction member is then withdrawn or rotated so the wires engage and draw in the filter members, after which the catheter is pushed over the conical portion of the tubular member.

Abstract: A thrombi removal catheter includes a sheath having a distal axial opening at a distal end in fluid communication with a lumen, and a lateral opening that extends through a side wall to the lumen. The lateral opening is proximally spaced from the distal end. An elongate member is disposed in the lumen of the sheath and is configured for longitudinal movement relative to the sheath. The elongate member has a proximal position and a distal position relative to the sheath. When the elongate member is in the proximal position, the distal axial opening of the sheath is closed by a distal blocker element of the elongate member and the lateral opening of the sheath is open, and when the elongate member is in the distal position, the lateral opening of the sheath is closed by the proximal blocker element and the distal axial opening of the sheath is open.

Abstract: An endovascular implant for forming a fistula includes a body including a wall forming a lumen having a distal opening and a proximal opening. An anchor is coupled to a distal end of the body adjacent the distal opening. The anchor may include a first anchor extending from a first side of a distal end of the body, and a second, separate anchor may extending from a second side of the distal end of the body. A retriever may be coupled to a proximal end of the body adjacent the proximal opening.

Abstract: An orbital atherectomy system includes a handheld driver having a motor. An elongate flexible driveshaft has a proximal end portion and a distal end portion. The proximal end portion is drivably coupled to the motor. The distal end portion defines a rotational axis. An abrasive element is fixedly disposed on the distal end portion of the elongate flexible driveshaft. The abrasive element includes a first flat side, a second flat side, a leading tapered end portion having a leading end, and a trailing tapered end portion having a trailing end. The first flat side and the second flat side are on opposite sides of the rotational axis.

Abstract: Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure.

Abstract: A method of preparing a filter for delivery into a body vessel. The filter includes a hub disposed along a longitudinal axis and a plurality of anchor members extending from the hub. Each anchor member includes either a cranial extension or a caudal extension at a distal end thereof. At least one anchor member distal end may be spaced from the hub at each of a first, second, and third distance along the longitudinal axis. The filter also includes a plurality of locator members extending from the hub, the locator members alternatingly interposed between the anchor members.

Abstract: Disclosed herein is a vessel shaping device configured to reshape a vessel along a single axis and regulate a blood flow therethrough. The vessel reshaping device generally consists of a frame that can transition to an expanded configuration and can temporarily reshape a vessel, e.g. the inferior vena cava (“IVC”), in a single axis extending perpendicular to a longitudinal axis. The greater the expansion of the reshaping device, the greater the reduction in cross-sectional area and the greater the reduction in flow through the vessel. Modifying a blood flow to the heart as such can improve the symptoms of hypervolemia, leading to increased diuretic efficiency and improve symptoms of congestive heart failure.

Abstract: A fistula formation device includes a first engagement member and a second engagement member. The first engagement member is configured to be positioned within a first vessel. The first engagement member includes a plate defining a first opening therethrough. The second engagement member is configured to be positioned within a second vessel. The second engagement member includes a base plate having a second opening extending therethrough, and one or more retention members extending from the base plate around the second opening, wherein the one or more retention members are configured to extend through the plate of the first engagement member to secure the first engagement member to the second engagement member and form an open conduit through the first engagement member and the second engagement member between the first vessel and the second vessel.