Abstract: Intravascular ultrasound (IVUS) imaging devices, systems, and methods are provided. Embodiments of the present disclosure provide intravascular ultrasound (IVUS) devices with robust, four-wire electrical interconnects. In some embodiments, an intravascular ultrasound (IVUS) device is provided. The IVUS device comprises: a catheter body; an ultrasound assembly coupled to a distal portion of the catheter body; and four conductors extending along a length of the catheter body, wherein a distal section of each of the four conductors has a flattened profile and wherein the flattened distal section of each of the four conductors is electrically coupled to a respective electrical contact of the ultrasound assembly. The ultrasound assembly can be a phased-array ultrasound assembly or a rotational ultrasound assembly.

Abstract: What is described is an apparatus for intravascular pressure measurement, comprising an elongate body, a first pressure sensor and a centering assembly disposed adjacent the sensor. In one aspect, the elongate body has a uniform diameter from the distal end to the proximal end. In another aspect, the uniform diameter is 0.035 inches or less. In still a further aspect, the elongated body is a catheter having a plurality of reinforcing filaments and the filaments are utilized to electrically connect the sensor to the proximal end.

Abstract: Embodiments of the present disclosure are configured to visualize severe blockages in a vessel and, in particular, chronic total occlusions in blood vessels. In some particular embodiments, the devices, systems, and methods of the present disclosure are configured to visualize the blockage to facilitate safe crossing of the blockage.

Abstract: An intraluminal imaging device is provided that includes a flexible elongate member configured for positioning within a vessel of a patient, a support member coupled to the flexible elongate member; and an imaging assembly coupled to the support member. The support member can include a proximal section with a first cross-sectional profile configured to interface with a distal portion of the flexible elongate member and a distal section with a second cross-sectional profile configured to interface with a proximal portion of the imaging assembly, wherein the first cross-sectional profile is different than the second cross-sectional profile. Associated devices, systems, and methods are also provided.

Abstract: Intraluminal ultrasound imaging devices, methods, and systems are provided. Some embodiments of the present disclosure sure include intraluminal devices configured to navigate and maneuver tortuous vasculature of a patient. For example, an intravascular imaging device can include a flexible support member at a distal portion of the imaging device. The flexible support member may support a plurality of ultrasound transducers and a plurality of control circuits. The flexible support member includes a flexible joint portion between a transducer portion and a controller portion. Introducing a flexible joint portion between the transducer portion and the controller portion can provide for greater flexibility of the imaging device and enable the device to navigate tortuous regions of a patients anatomy.

Abstract: An intraluminal device is provided. In on embodiment, an intraluminal device includes a flexible elongate member including a proximal portion and a distal portion; an imaging component coupled to the distal portion of the flexible elongate member; and a plurality of radiopaque markers positioned at the distal portion of the flexible elongate member, wherein the plurality of radiopaque markers are separated from each other, wherein the plurality of radiopaque markers are arranged on the flexible elongate member at two different orientations with respect to the imaging component, and wherein at least a first radiopaque marker of the plurality of radiopaque markers includes an arc-shaped portion and an extended portion extending from the arc-shaped portion.

Abstract: Intravascular ultrasound (IVUS) imaging devices, systems, and methods are provided. Embodiments of the present disclosure provide intravascular ultrasound (IVUS) devices with robust, four-wire electrical interconnects. In some embodiments, an intravascular ultrasound (IVUS) device is provided. The IVUS device comprises: a catheter body; an ultrasound assembly coupled to a distal portion of the catheter body; and four conductors extending along a length of the catheter body, wherein a distal section of each of the four conductors has a flattened profile and wherein the flattened distal section of each of the four conductors is electrically coupled to a respective electrical contact of the ultrasound assembly. The ultrasound assembly can be a phased-array ultrasound assembly or a rotational ultrasound assembly.

Abstract: The invention generally relates to devices and methods for imaging and aspirating biological material from inside a vessel. In certain embodiments, the invention provides devices that include a body configured to fit within a lumen of a vessel. The body includes an opening. Devices of the invention also include an aspiration channel within the body. The aspiration channel includes a distal end that is connected to the opening. Devices of the invention also include an imaging assembly coupled to the body.

Abstract: A medical device including both an intraluminal imaging apparatus and dual guidewire lumens is provided, allowing more accurate and stable catheter navigation and treatment delivery. The dual lumen catheter may also include members for increased torsional rigidity, distally located functional measurement sensors, and patterned radioopaque markers for orientation of the dual lumen exits.

Abstract: An intravascular imaging device is provided. In one embodiment, the intravascular imaging device includes a flexible elongate member sized and shaped for insertion into a vessel of a patient, the flexible elongate member having a proximal portion and a distal portion; a conductor extending between the proximal and distal portions of the flexible elongate member; an imaging assembly disposed at the distal portion of the flexible elongate member, the imaging assembly including: a flex circuit including a body and a tab extending therefrom, the tab having a conductive portion coupled to the conductor; and a support member around which the flex circuit is disposed, the support member including a shelf on which tab is positioned.

Abstract: An apparatus for assessing the severity of stenosis in a blood vessel includes an elongate body including a distal portion and a centering assembly. The centering assembly is actuatable to selectively center the elongate body in the vessel. A pressure sensor is disposed adjacent the centering assembly and is configured to detect fluid pressure in the vessel. A processing system receives the measured pressure from the pressure sensor, receives data representing the cross-sectional area of the vessel, receives data representing the size of the distal portion, calculates a offset correlation based on the size of the distal portion and based on the size of the vessel, and calculates a fractional flow reserve (FFR) for the vessel as an index of stenosis severity taking into account the offset correlation and the measured fluid pressure from the pressure sensor.

Abstract: An intravascular imaging device is provided. In one embodiment, the intravascular imaging device includes a flexible elongate member sized and shaped for insertion into a vessel of a patient, the flexible elongate member having a proximal portion and a distal portion; an imaging assembly disposed at the distal portion of the flexible elongate member, the imaging assembly including: a flex circuit; a conductor extending along the flexible elongate member and in electrical communication with the flex circuit; and a support member around which the flex circuit is positioned, the support member including a conductive portion electrically coupled to the support member.

Abstract: Imaging devices, systems, and methods are provided. Some embodiments of the present disclosure are particularly directed to imaging a region of interest in tissue with photoacoustic and ultrasound modalities. In some embodiments, a medical sensing system includes one or more optical emitters and a measurement apparatus configured to be placed within a vascular pathway. The measurement apparatus may be configured to receive sound waves created by the interaction between emitted optical pulses and tissue, and transmit and receive ultrasound signals. The medical sensing system may also include a processing engine operable to produce images of the region of interest and a display configured to visually display the image of the region of interest.

Abstract: Imaging devices, systems, and methods are provided. Some embodiments of the present disclosure are particularly directed to imaging a region of interest in tissue with photoacoustic and ultrasound modalities. In some embodiments, a medical sensing system includes one or more external optical emitters and a measurement apparatus configured to be placed within a vascular pathway. The measurement apparatus may include a sensor array comprising sensors of two or more types. The sensors may be configured to receive sound waves created by the interaction between emitted optical pulses and tissue, and transmit and receive ultrasound signals. The medical sensing system may also include a processing engine operable to produce images of the region of interest and a display configured to visually display the image of the region of interest.

Abstract: An intravascular imaging device (102) is provided. In some embodiments, the intravascular imaging device includes a flexible elongate member sized and shaped for insertion into a vessel of a patient, the flexible elongate member having a proximal portion and a distal portion; and an imaging assembly (110) disposed at the distal portion of the flexible elongate member, the imaging assembly including a flex circuit (214) positioned directly around the flexible elongate member. In some embodiments, a method of assembling an intravascular imaging device includes obtaining a flex circuit including a first layer having a plurality of transducers and a second layer having an acoustic backing material; and positioning the flex circuit directly around a distal portion of a flexible elongate member.

Abstract: Imaging devices, systems, and methods are provided. Some embodiments of the present disclosure are particularly directed to imaging a region of interest in tissue with photoacoustic and ultrasound modalities. In some embodiments, a medical sensing system (100) includes a measurement apparatus (102) configured to be placed within a vascular pathway. The measurement apparatus may include a sensor array (106) comprising two or more sensor modalities. The sensor array may be configured to receive sound waves created by the interaction between emitted optical pulses and tissue, transmit and receive ultrasound signals, and rotate around a longitudinal axis of the measurement device. The medical sensing system may also include a processing engine operable to produce images of the region of interest and a display configured to visually display the image of the region of interest.

Abstract: A method of assembling an intravascular imaging device (102) is provided. In one embodiment, the method includes obtaining a support member having a body portion including a plurality of recesses longitudinally spaced from one another (405); positioning a flex circuit around the support member such that the flex circuit is radially spaced from the body portion of the support member (410); and filling a space between the flex circuit and the support member with a backing material through the plurality of recesses of the body portion (420). In one embodiment, an intravascular imaging device includes a flexible elongate member; an imaging assembly including: a flex circuit; and a support member (330) around which the flex circuit is disposed, the support member having a body portion including plurality of recesses (339), wherein the support member defines lumen in fluid communication with a space between the flex circuit and the support member via the plurality of recesses.

Abstract: An intraluminal imaging device is provided. The device includes a flexible elongate member configured to be inserted into a lumen of a patient, the flexible elongate member comprising a proximal portion and a distal portion. The device includes an ultrasound imaging assembly disposed at the distal portion and configured to obtain ultrasound imaging data while positioned within the lumen of the patient. The device includes a tip member disposed at the distal portion of the flexible elongate member, the tip member comprising a cavity adjacent to the ultrasound imaging assembly and configured to be filled with an adhesive to couple the tip member and the ultrasound imaging assembly. The tip member can include first material and a second material. The tip member can include linear outer diameter and varying wall thickness, and/or a varying outer diameter and a constant wall thickness.

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 apparatus for assessing the severity of stenosis in a blood vessel includes an elongate body including a distal portion and a centering assembly. The centering assembly is actuatable to selectively center the elongate body in the vessel. A pressure sensor is disposed adjacent the centering assembly and is configured to detect fluid pressure in the vessel. A processing system receives the measured pressure from the pressure sensor, receives data representing the cross-sectional area of the vessel, receives data representing the size of the distal portion, calculates a offset correlation based on the size of the distal portion and based on the size of the vessel, and calculates a fractional flow reserve (FFR) for the vessel as an index of stenosis severity taking into account the offset correlation and the measured fluid pressure from the pressure sensor.