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

Abstract: A method of fabricating miniature ultrasound transducers includes receiving a wafer on which a plurality of miniature ultrasound transducers is formed. The miniature ultrasound transducers each includes: a transducer membrane that contains a piezoelectric material and a first bond pad and a second bond pad each electrically coupled to the transducer membrane. A protective layer is conformally deposited over the plurality of miniature ultrasound transducers from a front side of the wafer. A first etching process is performed to form a plurality of first trenches that extend into the wafer from the front side. The first trenches are etched through the protective layer. The first trenches are disposed between adjacent miniature ultrasound transducers. A second etching process is performed to remove portions of the protective layer disposed over the first and second bond pads, thereby exposing the first and second bond pads.

Abstract: A method for acoustic tomography within a patient may include generating a focused ultrasonic signal using a transducer is provided; the ultrasonic signal forming a path within the patient. The method includes directing the ultrasonic signal on a spot within the patient; scanning the spot in a predetermined pattern about a volume within the patient; receiving an ultrasonic echo in the transducer; converting the ultrasonic echo into a voltage; selecting a frequency band from the voltage; amplifying the voltage in the selected frequency band with a processing circuit; and generating an image of the volume within the patient structure utilizing the amplified voltage. A method for recanalization of a blood vessel including the above acoustic tomography steps is also provided.

Abstract: A method and system is provided for using backscattered data and known parameters to characterize vascular tissue. Specifically, methods and devices for identifying information about the imaging element used to gather the backscattered data are provided in order to permit an operation console having a plurality of Virtual Histology classification trees to select the appropriate VH classification tree for analyzing data gathered using that imaging element. In order to select the appropriate VH database for analyzing data from a specific imaging catheter, it is advantageous to know information regarding the function and performance of the catheter, such as the operating frequency of the catheter and whether it is a rotational or phased-array catheter. The present invention provides a device and method for storing this information on the imaging catheter and communicating the information to the operation console.

Abstract: An integrated therapeutic and imaging device that uses at least two balloons to provide a guarded zone that can be evacuated and replaced with a fluid that is sufficiently clear to permit optical coherence tomography (or even high resolution ultrasound) imaging that would otherwise be of poor quality or impossible. Methods of making and operating the imaging device to obtain clear, high quality images, as well as treating a patient's tissue with the device within a living body in association with obtaining an image of the patient's tissue, are included.

Abstract: A method and system for imaging, diagnosing, and/or treating an area of interest in a patient's body is provided. More particularly, a manually steered “rapid exchange” type catheter for a system for imaging, diagnosing, and/or treating an area of interest in a patient's body is provided. The catheter comprises a catheter body configured to be introduced to an area of interest in a patient's body, a device for imaging, diagnosing, and/or treating the area of interest contained within the catheter body, and a manual steering device attached to the imaging, diagnosing, and/or treating device to allow an operator to manually steer the imaging, diagnosing, and/or treating device, wherein the catheter is configured to be mounted on a commercially available guidewire.

Abstract: The invention generally relates to intravascular imaging catheters and methods of making catheters for imaging systems. The invention provides a connector for an imaging catheter that includes a unitary body with very thin electrical contacts that are formed on the surface of the body. Due to the scale of the contacts, the connector operates essentially as a single unitary piece of material. Each of the leads may be less than about 100 ?m wide and less than about 8 ?m thick, and further the leads may be spaced apart by less than about 160 ?m.

Abstract: Embodiments of the invention relate generally to systems and methods for providing embolic protection to a medical procedure by filtration of debris generated by the medical procedure. The system and methods include an embolic protection device having an ultrasound transducer for assisting in intravascular navigation of the device.

Abstract: The present disclosure involves a method and apparatus for attaching two electrical dies by wire bonding and then encasing the assembly in a protective casting that works by arranging two dies into a fixture conducive to wire bonding. Doped epoxy may be immediately dispensed over the assembly to form a near-net-shape protective cover, or Drive Can.

Abstract: The present disclosure provides a method of fabricating an ultrasound transducer. A substrate having a first side and a second side opposite the first side is provided. A bottom electrode is formed over the first side of the substrate. A piezoelectric element is formed over the bottom electrode. The piezoelectric element has a chamfered sidewall. A top electrode is formed over the piezoelectric element. A step metal element is formed over a portion of the top electrode proximate to the chamfered sidewall of the piezoelectric element.

Abstract: Sold-state intravascular ultrasound (IVUS) imaging devices, systems, and methods are provided. Some embodiments of the present disclosure are particularly directed to flexible and efficient systems for focusing IVUS echo data received from transducers including polymer piezoelectric micro-machined ultrasound transducers (PMUTs). In one embodiment, an ultrasound processing system includes first and second aperture engines coupled to an engine controller, which provides aperture assignments to the first and second aperture engines. The aperture engines receive the assignment and a portion of A-line data, perform one or more focusing process on the received A-line data, and produce focused data in accordance with the aperture assignment. In some embodiments, once an aperture engine has produced focused data, the engine controller clears the aperture engine and assigns another aperture.

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: Devices, systems, and methods for controlling an intravascular imaging device are provided. For example, in one embodiment a method includes communicating a control signal to an actuator of the intravascular imaging device to cause oscillation of an imaging element of the intravascular imaging device, wherein the intravascular imaging device further includes an acoustic marker; receiving imaging data from the imaging element of the intravascular imaging device; identifying the acoustic marker in the imaging data by determining a correlation between the imaging data and a template representative of the acoustic marker; adjusting an aspect of the control signal based on identifying the acoustic marker; and communicating the adjusted control signal to the actuator of the intravascular imaging device.

Abstract: The invention provides methods for detecting features of interest in cardiovascular images by receiving information from a first modality and transforming information from the first modality into a first coordinate space, receiving information from a second modality and transforming information from the second modality into a second coordinate space. The first coordinate space is aligned to the second coordinate space to combine information from the first modality and the second modality into a combined data set. The method can also involve detecting the feature of interest in a vascular image based on the combined data set.

Abstract: The present invention provides for an improved combination sensor tip that includes an ultrasound transducer and a pressure sensor both disposed at or in close proximity to the distal end of the combination sensor tip. The present invention also provides for an improved connector to couple a guide wire to a physiology monitor that reduces torsional resistance when maneuvering the guide wire.

Abstract: A system and method for providing a vascular image are disclosed wherein a single composite display simultaneously provides a first view of a patient including an angiogram image and a second view including an intravascular image rendered from information provided by an imaging probe mounted on a distal end of a flexible elongate member. A cursor, having a position derived from image information provided by a radiopaque marker proximate the imaging probe, is displayed within the angiogram image to correlate the position of the imaging probe to a presently displayed intravascular image and thus provide an easily discernable identification of a position within a patient corresponding to a currently displayed intravascular image. The resulting composite display simultaneously provides: an intravascular image that includes information about a vessel that is not available from an angiogram and a current location within a vessel of a source of intravascular image data from which the intravascular image is rendered.