Abstract: Intravascular devices, systems, and methods are disclosed. In some embodiments, the intravascular devices are guide wires that include a capacitive pressure-sensing component disposed at a distal portion of the guide wire. Methods of making such intravascular devices, including various manufacturing and assembling techniques, are disclosed. Systems associated with such intravascular devices and methods of using such devices and systems are also disclosed.

Abstract: An imaging device for imaging a portion of a patient's vasculature with an imaging element may include a proximal portion having a relatively higher stiffness that provides rigidity for pushing the imaging device through a patient's vasculature, and may include a distal portion having a relatively lower stiffness that enables threading through a curved vasculature of the patient. The imaging device also may include a transition region disposed between the proximal portion and the distal portion.

Abstract: An endoluminal filter, comprising a first support member having a first end and a second end; and a second support member attached to the first end of the first support member or the second end of the first support member and forming a crossover with the first support member to form two loops one on either side of the crossover, wherein at least a portion of the first or second support member is modified to provide an enhanced echogenic characteristic. A system for positioning a filter within a vasculature including an endoluminal filter, a user interface, a display, and a processor is also provided. A method for positioning a filter within a lumen is also provided wherein the steps are performed using an intravascular ultrasound system and the filter is modified to provide at least one echogenic characteristic.

Abstract: The invention generally relates to intraluminal procedures, and, more particularly, to a contra-rotating cutting assembly for use with an atherectomy device to remove occlusive material from an occluded lumen, such as a blood vessel or other body lumen. The contra-rotating cutting assembly includes a rotatable housing having a distal end, an opposing proximal end and a lumen extending between the distal and proximal ends. The housing is configured to rotate about a longitudinal axis in a first direction. The cutting assembly further includes a rotatable cutter head positioned within at least a portion of the lumen of the housing and in coaxial alignment with the housing. The cutter head is configured to rotate about the longitudinal axis in a second direction opposite the first direction.

Abstract: Solid-state ultrasound imaging devices, systems, and methods are provided. Some embodiments of the present disclosure are particularly directed to identifying and removing artifacts in ultrasound data due to side lobes, grating lobes, and/or other effect. In some embodiments, an ultrasound processing system includes an interface operable to receive A-line signal data and a focusing engine operable to perform a focusing process on the received A-line signal data to produce focused A-line signal data. The ultrasound processing system also includes a coherency unit operable to determine a measurement of coherency of the received A-line signal data. The ultrasound processing system further includes an adjustment unit operable to determine an adjustment to the focused A-line signal data based on the measurement of coherency, and a compensation unit operable to apply the adjustment to the focused A-line signal data.

Abstract: The invention relates to evaluation of maturity of arteriovenous (AV) fistula using guidewires that measure intravascular blood flow and/or pressure. The invention provides methods of evaluating AV fistula maturation using an instrumented guidewire to measure intravascular flow and/or pressure. By using a small diameter guidewire that does not interfere substantially with the flow, an accurate measurement can be made that is useful for identifying when a fistula is mature and therefore ready to be used for hemodialysis. The flow of blood through the fistula is measured using the guidewire and the measured flow and/or pressure of blood is used to determine if the fistula is mature.

Abstract: Intravascular devices, systems, and methods are disclosed. In some embodiments, a method of assembling an intravascular device is provided that includes positioning a first tubular member around a plurality of conductors and a core member; advancing a first of the plurality of conductors through an opening of the first tubular member; positioning a first conductive member around the first tubular member; and electrically coupling the first of the plurality of conductors to the first conductive member. In some embodiments, an intravascular device is provided that includes an insulating member positioned around a plurality of conductors and a core member and a conductive member positioned around the insulating member, wherein at least one of the plurality of conductors extends through an opening in the insulating member and is electrically coupled to the first conductive member.

Abstract: The invention generally relates to catheter systems and methods for guided formation of vascular access sites (such as fistulas and grafts). According to certain aspects, a catheter system for forming a vascular access site include an elongate body comprising a distal end and configured to be inserted into a first vessel. The elongate body includes an exit port along its side that is proximal to the distal end. An imaging assembly is associated with the elongate body and configured to generate image data of the first vessel and a second vessel positioned next to the first vessel. For vascular access formation, a penetrating member of the catheter system extends out of the exit port and through a wall of the first vessel and a wall of the second vessel.

Abstract: Intravascular devices, systems, and methods are disclosed. In some embodiments, the intravascular devices include at least one pressure sensing component within a distal portion of the device. In that regard, one or more electrical, electronic, optical, and/or electro-optical pressure-sensing components is secured to an elongated substrate such that the pressure-sensing component is mounted perpendicular to a central longitudinal axis of the device. In some implementations, the elongated substrate has a cylindrical profile. Methods of making, assembling, and/or using such intravascular devices and associated systems are also provided.

Abstract: Described herein is a sensing wire for locating a blood vessel in a patient. The sensing wire comprises a hollow, rigid tube including a lumen extending from a proximal portion to a distal portion, an ultrasonic sensor coupled to the distal portion of the tube, and a communication assembly positioned at the distal portion and coupled to the ultrasound sensor. Also described is a system for accessing and evaluating a blood vessel in a patient. The system comprises an access sensor wire, an access needle sized to receive the access sensor wire, and a second sensing wire configured to be positioned within the access needle. A method is also disclosed for accessing a blood vessel with an introduction needle, where a short access sensing wire is replaced by a much longer second sensing wire after the needle is positioned in the vessel.

Abstract: Disclosed herein is a system and method for characterizing adventitial tissue. In one aspect, a system and method is disclosed that characterizes tissue types within the adventitial tissue including nerve bundles and blood vessels. In a further aspect, the adventitia is imaged and characterized to provide guidance for crossing lesions within an occluded vessel.

Abstract: An intravascular measurement system is provided. The system includes a catheter having a plurality of visible markers on a proximal portion that are proportional to a plurality of radiopaque markers on a distal portion. In at least one aspect, the system includes an imaging device adjacent the distal end.

Abstract: Devices, systems, and methods for visually depicting a vessel and evaluating treatment options are disclosed.

Abstract: The invention provides a guidewire with a centering mechanism. The mechanism lifts the guidewire from a vessel wall and biases it towards the center of the vessel. Since the guidewire can be selectively lifted away from the vessel wall, scraping the catheter against the wall can be avoided, the tip can be guided into the correct branch of a bifurcation, and an imaging device can be used to its full potential. In certain aspects, the invention provides a guidewire with an elongated shaft with a proximal portion and a distal portion comprising a distal tip. One or more centering mechanism can be provided on a guidewire.

Abstract: There are described a variety of intravascular filters wherein at least a portion of the filter has been modified to provide an enhanced echogenic characteristic of the filter. Also described are systems for positioning a variety of intravascular filters within the vasculature wherein the systems include an intravascular filter, an intravascular ultrasound transducer, a user interface configured to receive input from an operator regarding a surgical procedure including an insertion site and a destination site for positioning the filter according to the surgical procedure, a display, and a processor. The filter can include a hub and a plurality of legs or wires or segments extending from the hub, wherein at least a portion of the hub or a portion of one or more of the legs or wires or segments is modified to provide an enhanced echogenic characteristic of the filter or a portion of the filter.

Abstract: The invention relates to an apparatus for in vivo imaging. More specifically, the present invention relates to a catheter that incorporates an Optical Coherence Tomography (OCT) system and an Intravascular Ultrasound (“IVUS) system for concurrent imaging of luminal systems, such as imaging the vasculature system, including, without limitation, cardiac vasculature, peripheral vasculature and neural vasculature.

Abstract: Embodiments of the present disclosure are configured to assess the severity of a blockage in a vessel and, in particular, a stenosis in a blood vessel. In some particular embodiments, the devices, systems, and methods of the present disclosure are configured to assess the severity of a stenosis in the coronary arteries by monitoring fluid flow. In some embodiments, the devices, systems, and methods of the present disclosure include a flow-sensing element within a distal portion of an intravascular device that is mounted at an oblique angle with respect to a central longitudinal axis of the intravascular device. The angled flow-sensing element can be oriented away from a vessel wall and towards the center of the vessel lumen through rotation of the intravascular device.

Abstract: The disclosed automatic calibration systems and methods provide a repeatable way to detect internal catheter reflections and to shift the internal catheter reflections to calibrate an image.

Abstract: A steerable sheath for a catheter delivery system and associated devices and methods are disclosed. In some embodiments, the catheter delivery system includes a catheter sheath having a steerable distal portion and a flexible elongate member connecting to a steering unit. The flexible elongate member has a central lumen through which a therapeutic or diagnostic device of a first modality can be inserted, used to perform a procedure, and then removed and replaced by a different therapeutic or diagnostic device while the catheter sheath remains substantially at the same location within a patient.

Abstract: Improved wiring arrangements for sensor catheters are provided to reduce wire-to-wire cross-talk wherein wires connecting the sensor of the sensor catheter to a processing unit are divided into a plurality of wire bundles contained within respective sheaths, with the wires in wire bundle twisted together reduce electromagnetic signal interference among the individual wires, or between wire bundles.