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: 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: An apparatus for demonstrating the use of a medical device includes a body adapted for receiving the medical device. The body includes at least a portion adapted for viewing the medical device when positioned in the body. A cover is provided for selectively covering the portion of the body adapted for viewing the medical device. A kit and related methods are also disclosed.

Abstract: A catheter for actively scoring or slicing a lesion. A catheter body includes first and second lateral openings. A selectively deployable cutter is connected to the catheter body. The cutter has a retracted configuration in which it does not perform a slicing or scoring function, such as while tracking through the vasculature, and a deployed configuration for slicing or scoring an obstruction. The cutter may include a plurality of retractable blades, such that when deployed, each blade projects in a different direction, such as from one of the lateral openings. Related methods are also disclosed.

Abstract: A detachable guidewire assembly (10) is provided with multiple diameter compatibility. The assembly (10) includes a first guidewire (12) and second guidewire (14) a diameter less than that of the first guidewire. The second guidewire (14) is adapted for insertion and removal within and from the first catheter (12) via a receiver in form of an open lateral channel (16) or a longitudinal bore. A releasable coupling (18) is provided for selectively connecting the first guidewire (12) to the second guidewire (14). The releasable coupling may be formed by a magnetic coupling or a mechanical coupling. The second guidewire (14) may be equal to or greater in length than the first guidewire (12). In a coupled configuration, the distal tips of the first and second guidewires may align, but a proximal end portion of the second guidewire (14) may extend proximally of the first guidewire (12).

Abstract: A catheter (10) including a shaft (14), a balloon (12) positioned at the distal end of the shaft, and at least one scoring wire (30) to score a vascular lesion. A distal end portion of the scoring wire is retractable and includes an atraumatic tip (32). The device includes an actuator (40), such as a thumb wheel (44), for advancing the at least one scoring wire to a location such that a portion thereof is alongside the balloon, thereby allowing for selective use in a scoring configuration. When the balloon expands when fluid is delivered to the balloon through the inflation lumen, this expansion pushes the scoring wire against the vascular lesion.

Abstract: A medical balloon includes a base balloon layer and at least one cellulose fiber applied to the base balloon layer, such as by an adhesive. The cellulose fiber may include hydro-dynamically focused, cellulose nano fibers. The cellulose fiber may be a longitudinal fiber extending along the base balloon substantially parallel to the longitudinal axis, at least one hoop fiber over the at least one longitudinal fiber, or both, including possibly as a single continuous fiber. The at least one fiber may further include silk proteins, and at least one silk fiber may also be included. An outer layer, such as a polymer film or spray coating, may be applied over the at least one cellulose fiber. Related methods are also disclosed.

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: Systems and methods are disclosed for restoring venous valve function. In some embodiments, for example, a system includes an implantable coil and a deployment device therefor. The implantable coil has a non-coiled configuration in a first state and a coiled configuration in a second state configured to compress incompetent valves. The deployment device includes a handle, an outer sheath, a needle, and a mandrel. The handle includes a first actuator and a second actuator. The outer sheath includes a side opening proximate a distal end. The needle is operatively coupled to the first actuator. The mandrel is operatively coupled to the second actuator. The mandrel is configured to push the implantable coil through a needle tip of the needle, which allows the implantable coil to transition from the first state within the deployment device to the second state outside of the deployment device such as around a vein.

Abstract: A catheter (10) is provided for relieving compression among blood vessels by introducing a filler into an intravascular space to form a bridge connecting the vessels in order to relieve the compression. The catheter is provided with a shaft (14), expandable elements (16,18) supported by the shaft for reliving compression in the vessel temporarily, and a retractable needle (30) located between the expandable elements. When deployed, such as by using an actuator (40), the needle may deliver the filler to the intervascular space to form a bridge between the vessels for relieving the compression once the catheter is removed.

Abstract: A catheter (10) for introduction into a body vessel includes a shaft, a balloon (12) positioned at the distal end of the shaft, and at least one scoring wire (30) to score a vascular lesion. A distal end portion of the scoring wire is detachably connected to the catheter, such as by way of magnetic coupling (30a), thereby allowing for selective use of the catheter in a scoring or non-scoring configuration. The balloon expands when fluid is delivered to the balloon through an inflation lumen. This expansion pushes the scoring wire against the vascular lesion.

Abstract: A system for forming a fistula includes a first catheter, a second catheter, one or more magnetic field sensors, a user output device, and a control unit. The first catheter includes one or more first catheter magnetic elements and a fistula-forming element. The second catheter includes one or more second catheter magnetic elements. The one or more magnetic field sensors are configured to output a magnetic field signal. The control unit is configured to determine a distance of separation of the first catheter from the second catheter based the magnetic field signal from the one or more magnetic field sensors and output a ready signal with the user output device in response to determining that the distance of separation of the first catheter from the second catheter is a predetermined distance or less.

Abstract: A catheter for actively scoring or slicing a lesion. A catheter body includes first and second lateral openings. A selectively deployable cutter is connected to the catheter body. The cutter has a retracted configuration in which it does not perform a slicing or scoring function, such as while tracking through the vasculature, and a deployed configuration for slicing or scoring an obstruction. The cutter may include a plurality of retractable blades, such that when deployed, each blade projects in a different direction, such as from one of the lateral openings. Related methods are also disclosed.

Abstract: An apparatus for demonstrating the use of a medical device includes a body adapted for receiving the medical device. The body includes at least a portion adapted for viewing the medical device when positioned in the body. A cover is provided for selectively covering the portion of the body adapted for viewing the medical device. A kit and related methods are also disclosed.