Abstract: Intraluminal ultrasound devices, systems and methods are provided. In one embodiment, an intraluminal ultrasound device includes a flexible elongate member configured to be positioned within a body lumen of a patient, the flexible elongate member including a distal portion and a longitudinal axis; and a transducer array disposed at the distal portion of the flexible elongate member and circumferentially positioned around the longitudinal axis of the flexible elongate member. The transducer array includes a plurality of micromachined ultrasound transducers (MUTs). In addition, the transducer array is configured to obtain ultrasound imaging data of the body lumen in response to a first electrical signal, and apply an ultrasound therapy within the body lumen in response to a second electrical signal.

Abstract: A wireless intraluminal device (102) and an associated system for treating and diagnosing patients are provided. In one embodiment, the wireless intraluminal device (102) includes a flexible elongate member (158) including a proximal portion (106) and a distal portion (108); a sensor assembly (116) coupled to the distal portion of the flexible elongate member; a cable (117) coupled to the sensor assembly and extending along the flexible elongate member; and a wireless transceiver (252) positioned within the flexible elongate member, wherein the wireless transceiver is in communication with the sensor assembly via the cable. A wireless communication component (104) wirelessly transmits a sensor measurement collected by the sensor assembly to a sensor measurement processing system (132) via a wireless link (150) for physiological data generation at the sensor measurement processing system.

Abstract: Intravascular ultrasound (IVUS) imaging devices, systems, and method are provided. In one embodiment, an IVUS imaging device includes a flexible elongate member configured to be positioned within a lumen of a patient, the flexible elongate member comprising a proximal portion and a distal portion; and an imaging assembly disposed at the distal portion of the flexible elongate member. The imaging assembly includes a first ultrasound transducer operating at a first center frequency; and a second ultrasound transducer operating at a second center frequency different from the first center frequency.

Abstract: An intravascular ultrasound probe is disclosed, incorporating features for utilizing an advanced transducer technology on a rotating transducer shaft. In particular, the probe accommodates the transmission of the multitude of signals across the boundary between the rotary and stationary components of the probe required to support an advanced transducer technology. These advanced transducer technologies offer the potential for increased bandwidth, improved beam profiles, better signal to noise ratio, reduced manufacturing costs, advanced tissue characterization algorithms, and other desirable features. Furthermore, the inclusion of electronic components on the spinning side of the probe can be highly advantageous in terms of preserving maximum signal to noise ratio and signal fidelity, along with other performance benefits.

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: Devices, systems, and methods of imaging a blood vessel are provided. For example, the method can include obtaining fluoroscopic image data of a region of interest in a blood vessel using an x-ray source; obtaining intravascular ultrasound (IVUS) data at a plurality of positions across the region of interest using an IVUS component disposed on an intravascular device; processing the fluoroscopic image data and IVUS data, including: determining, using the fluoroscopic image data, a position of the intravascular device with respect to the x-ray source at each of the plurality of positions across the region of interest; co-registering the fluoroscopic image data and the IVUS image data; and generating, a model of the region of interest including position information of a border of a lumen of the blood vessel at each of the plurality of locations; and outputting a visual representation of the model of the region of interest.

Abstract: Systems and methods for suppressing off-axis sidelobes and/or clutter, near-field reverberation clutter, and/or grating lobe contributions are disclosed. A dual apodization with median (DAM) filtering technique is disclosed. The dual apodization technique may include summing aligned channel data with apodization functions (406, 412, 414) with complementary apertures applied. Median values for a zero function (RF3) and the resulting signals (RF1, RF2) from the complementary apertures are determined to generate a median value signal (416, MVS). The median value signal is used to generate an ultrasound image with enhanced image contrast. A method of image smoothing of the ultrasound image with enhanced image contrast is also disclosed. The smoothed image may include low frequency components of the ultrasound image with enhanced image contrast and high frequency components of an original image.

Abstract: Ultrasound image devices, systems, and methods are provided. In one embodiment, an intraluminal ultrasound imaging system includes a patient interface module (PIM) in communication with an intraluminal imaging device comprising an ultrasound imaging component, the PIM comprising a processing component configured to detect device information associated with the intraluminal imaging device, the device information identifying an ultrasound attribute associated with the ultrasound imaging component; and determine a waveform for ultrasound wave emissions at the ultrasound imaging component based on the identified ultrasound attribute; and a trigger signal generation component in communication with the processing component and configured to generate a trigger signal based on the determined waveform to control the ultrasound wave emissions at the ultrasound imaging component.

Abstract: A method of authorizing a limited use intravascular device can include determining if the intravascular device is in communication with a clinical system; determining if the intravascular device is authorized for clinical operation without providing the clinical system access to intravascular device data stored on the intravascular device; and providing an authorization signal to the clinical system. An intravascular device can include a flexible elongate member including a sensing component at a distal portion and a connector at a proximal portion, the connector including: a memory component configured to store a parameter value; a processing component; and a charge storage component configured to power the memory component and/or the processing component; wherein the processing component is configured to determine if the flexible elongate member is authorized for clinical operation using the parameter value without providing the parameter value to a clinical system.

Abstract: Systems and methods for aiding users in viewing, assessing and analyzing images, especially images of lumens and medical devices contained within the lumens. Systems and methods for interacting with images of lumens and medical devices, for example through a graphical user interface.

Abstract: The invention provides devices with integrated intravascular imaging and methods for crossing a CTO within the true lumen of a vessel. An interventional catheter with intravascular imaging capabilities can be guided into an affected vessel and to a CTO. An included intravascular imaging device captures a 3D image of the environment. The catheter includes a crossing member that can be extended out from a distal tip of the catheter, causing the crossing member to directly cross through the CTO creating a new channel through the CTO.

Abstract: An intraluminal imaging device includes a flexible elongate shaft including a distal portion and a proximal portion, wherein the flexible elongate shaft is configured for insertion into a patient body; a distal tip that comprises an imaging element and is operably associated with the distal portion of the flexible elongate shaft; and a control handle coupled to the proximal portion of the flexible elongate shaft, wherein the control handle includes: a first actuator configured to position the imaging element within the patient body; and a first frictional member coupled to the first actuator and arranged to contact the first actuator to control positioning of the imaging element. Associated devices, systems, and methods are also provided.

Abstract: An imaging catheter assembly is provided. In one embodiment, the imaging catheter assembly includes a flexible elongate member including a distal portion and a proximal portion; a crown element coupled to the distal portion, wherein the crown element includes an annular ring, a first post and, a second post, and wherein the first post and the second post extend from the annular ring; a first pullwire anchored to the annular ring at the first post and extending along the flexible elongate member from the crown element to the proximal portion of the flexible elongate member; a second pullwire anchored to the annular ring at the first post and extending along the flexible elongate member from the crown element to the proximal portion of the flexible elongate member; and an imaging component coupled to the distal portion.

Abstract: Systems, devices, and methods for intraluminal ultrasound imaging are provided. An intraluminal ultrasound imaging system may include a patient interface module (PIM) in communication with an intraluminal device comprising an ultrasound imaging component and positioned within a body lumen of a patient. The PIM may receive ultrasound echo signals from the intraluminal device, transmit the ultrasound echo signals along a differential signal path, and digitize the ultrasound echo signals. The PIM may transmit the ultrasound wirelessly to a processing system. The PIM may be powered with a wireless charging system, such as an inductive charging system.

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: Disclosed herein is a system and method for characterizing adventitial tissue. In one aspect, a system and method are 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: The present disclosure relates generally to the imaging of blood vessels, and in particular, to the detection of one or more borders of a blood vessel. In some embodiments, a medical imaging system is configured to detect a primary border of a blood vessel and one or more alternative borders of the blood vessel. For example, in some embodiments, a medical imaging system includes an imaging device configured to obtain an image of a blood vessel, a processing unit, and a user display. The processing unit can be configured to receive the image of the blood vessel and perform an analysis of the image to identify a primary candidate border and an alternative candidate border of the blood vessel. The primary candidate border and alternative candidate border can represent candidates for a single boundary of the blood vessel.

Abstract: An imaging catheter assembly is provided. The imaging catheter assembly includes an interposer including a multi-layered substrate structure, wherein the multi-layered substrate structure includes a first plurality of conductive contact pads coupled to a second plurality of conductive contact pads via a plurality of conductive lines; an imaging component coupled to the interposer via the first plurality of conductive contact pads; and an electrical cable coupled to the interposer via the second plurality of conductive contact pads and in communication with the imaging component.

Abstract: Therapeutic ultrasound devices and methods are provided. In one embodiment, a therapeutic ultrasound device includes a housing configured for handheld operation by a user, an ultrasound assembly positioned within the housing and configured to generate ultrasound energy, a battery positioned in the housing and coupled to the ultrasound assembly to power the ultrasound assembly to generate the ultrasound energy, a flexible elongate member configured to be positioned within a body lumen of a patient, and an acoustic transmission member. The flexible elongate member includes a proximal portion, a distal portion, and a first lumen extending between the proximal portion and the distal portion. The housing is coupled to the proximal portion.

Abstract: Systems, devices, and methods provide a solid-state intravascular ultrasound (IVUS) imaging system that includes an array of ultrasound transducers mounted on a structural uni-body made of a polymeric substance doped with acoustic dampening material. The use of the polymeric substance doped with acoustic dampening material to fabricate the uni-body assists in improving the signal-to-noise ratio associated with the IVUS imaging signals.