Abstract: An endoventricular injection catheter with integrated echocardiographic capability enables injections into heart tissue under visualization. The catheter includes an elongated body having a distal end and an imaging core arranged to be inserted into a heart. The imaging core is arranged to transmit ultrasonic energy and to receive reflected ultrasonic energy at the distal end to provide electrical signals representing echocardiographic images to enable cardiac visualization. The catheter further includes an injector carried on the elongated body with the imaging core. The injector is arranged to inject a therapeutic agent into tissue of the heart visualized by the imaging core.

Abstract: An improved catheter is provided. The catheter may include a deflectable member located at a distal end of a catheter body. The deflectable member may comprise an ultrasound transducer array. The deflectable member may be interconnected to the catheter body by a live hinge. The catheter may include a lumen extending from a proximal end of the catheter body to the distal end. The lumen may be used to deliver an interventional device to a point distal to the distal end of the catheter body. The deflectable member may be selectively deflectable in a pivot-like manner through an arc of at least 90 degrees. In embodiments where the deflectable member includes an ultrasound transducer array, the ultrasound transducer array may be operable to image both when aligned with the catheter body and when pivoted relative to the catheter body.

Abstract: An improved catheter is provided. The catheter may include a deflectable member located at a distal end of the catheter. The deflectable member may comprise an ultrasound transducer array. The catheter may include a lumen extending from a proximal end of the catheter to the distal end. The lumen may be used to deliver an interventional device to a point distal to the distal end of the catheter. The deflectable member may be selectively deflectable in a pivot-like manner through an arc of at least 90 degrees. In embodiments where the deflectable member includes an ultrasound transducer array, the ultrasound transducer array may be operable to image both when aligned with the catheter and when pivoted relative to the catheter. When pivoted relative to the catheter, the ultrasound transducer array may have a field of view distal to the distal end of the catheter.

Abstract: Presenting intravascular images and angiographic images co-registered on a display. As an imaging catheter is pushed through an occlusion, a center point of the catheter and an outline of the vessel wall can be displayed. A physician can see where the catheter is crossing the occlusion within the vessel. The physician can determine what path the catheter is taking the through occlusion. Methods include extending an imaging catheter through the occlusion, determining a location of a wall of the vessel relative to a center point of the catheter, obtaining a position of the catheter within a lumen of the vessel via angiography, and displaying the catheter crossing the occlusion by co-registering the location of the wall, the position of the catheter within the lumen, and the lumen on a display.

Abstract: The invention provides devices and methods for crossing total chronic occlusions. In certain aspects, a device for imaging a vessel includes an elongate body defining a first lumen and comprising a distal end; a housing operably associated with the distal end and comprising a forward-looking imaging element; and a member at least partially disposed within the first lumen of the elongate body; the member configured to extend beyond the distal end of the elongate body to advance into an occluded vessel.

Abstract: The invention generally relates to intravascular intervention catheters and provides catheters for performing an intravascular procedure that use a mechanism to control an operation at the end of the catheter. The mechanism can be used to steer the distal tip of the catheter from a controller at a proximal end of the catheter. The mechanism may include one or more pull wires extending along the catheter. The mechanism may optionally be manually or computer controlled.

Abstract: Devices and methods of the invention provide for imaging an object within a body lumen. In certain aspects, a device for intraluminal imaging of the invention includes an elongate body defining a longitudinal axis, and a linear-array of imaging elements located on the body along the longitudinal axis.

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: The invention is an imaging catheter chamber having a plurality of openings to allow easy passage of fluids, e.g., saline from the interior of the chamber to the exterior of the catheter. The invention is useful for both IVUS and OCT imaging.

Abstract: The invention includes patient interface modules that guide the workflow of an intravascular medical imaging procedure. In some instances a Patient Interface Modules (PIM) connected to the imaging catheter has one or more indicators that guide the workflow. Some modules may be adapted to connect to multiple imaging devices, or an imaging device and a pressure sensing device, or other treatment device.

Abstract: The invention relates to systems and methods for three dimensional imaging of tissue. The invention provides systems and methods to provide a representation of tissue from three-dimensional data that includes intravascular imaging data as well as data representing a shape of the intravascular imaging probe. Device of the invention combine a shape-sensing mechanism with an intravascular intervention catheter.

Abstract: A device for the transfer of radiopaque material within the body comprises a valvuloplasty or other balloon coated with the radiopaque material. The balloon is inflated in the aortic valve for marking the site of an aortic annulus to enable accurate placement of prosthetic valves under fluoroscopic imaging.

Abstract: A medical imaging assembly includes an elongated catheter having a connector at the proximal end; an array of transducers on the distal end of the catheter; conductors electrically coupled to the array of transducers and in electrical communication with the connector of the catheter; and a control unit coupleable to the catheter to send and receive electrical signals between the control unit and the array of transducers through the connector of the catheter. The control unit has a processor to execute instructions including 1) selecting a first subset of M transmitting transducers and a second subset of N receiving transducers from the array of transducers, where N>M; and 2) for each of at least N transmit/receive cycles, a) directing the first subset of M transmitting transducers to transmit an acoustic signal; and b) directing the second subset of N receiving transducers to receive corresponding echo signals.

Abstract: Devices, systems, and methods for ultrasonically acquiring far-field and near-field images within a body are disclosed. An ultrasound imaging device adapted for insertion within a body includes a first ultrasonic sensor configured to transmit ultrasonic waves at a first frequency for acquiring far-field images within the body, and a second ultrasonic sensor configured to transmit ultrasonic waves at a higher frequency than the first frequency for acquiring near-field images within the body. The ultrasound imaging device can be connected to a control device and user interface for visualizing far-field and near-field images acquired by the ultrasonic sensors.

Abstract: An imaging system comprises a catheter having a lumen, a rotatable imaging probe within the catheter lumen including a distal transducer and first and second conductors coupled to the transducer, and a coupler that couples the rotatable first and second conductors to non-rotatable third and fourth conductors, respectively. The coupler includes a rotary capacitive coupler.

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 various embodiments of an ultrasound catheter for use in intravascular ultrasound (IVUS) imaging. An exemplary IVUS device includes an flexible elongate member having a lumen extending therethrough, and a rotatable imaging core disposed within the lumen. The imaging core is further configured to transmit and receive ultrasound signals through a distal portion of the flexible elongate member. The distal portion of the flexible elongate member includes a first set of material layers, while the proximal portion includes a second set of material layers different than the first set of material layers. The first set of material layers and the second material layers minimize distortion of the ultrasound signals. The first set of material layers further facilitates an average speed of sound through the first set of material layers that is substantially equivalent to a speed of sound through blood.

Abstract: A field programmable gate array (FPGA) circuit including a quadrature internal conditioning circuit is provided. The circuit having a buffer circuit; and a reconstruction engine circuit, wherein the reconstruction engine circuit includes: a circuit to measure a phase of a signal; and a flavor interpolation circuit; wherein: the circuit to measure the phase of a signal includes digitization points forming two complex numbers for each cycle of the center frequency of the signal. A system for collecting tissue images including a patient interface module (PIM); a pulse transmitter circuit; an analog to digital converter circuit; and an FPGA circuit as above; and a catheter having a sensing head is also provided. A method for using the above system to provide an image reconstruction is also provided.

Abstract: Hood 2 is formed to extend forward from the outer periphery of the tip of the tubular body 1. The tubular body is provided with at least a fluid delivery channel 11, an imaging channel 12 and a bending mechanism. Hood 2 has a basic shape of a cylindrical shape or a hollow circular truncated cone shape enlarging toward the tip, the tip of the hood has an obliquely-cut shape, and the hollow of the hood opens in the tip face 21 thereof. A hood tip 22 located at the tip of the wall part of the outer periphery of the tip of the hood bends to the inside of the hood and acts to stay the fluid.

Abstract: A male and female connectors and a method for providing electrical connection between a patient interface module (PIM) and an intravascular sensing device carrying more than two signal leads. A four-electrical-contacts male connector includes three elongated hollow tubular male bodies concentrically disposed around one another in an expanded telescopic fashion to define three stepped banded outer surfaces, where one electrical contact is formed on an inner surface of the innermost male body, and the rest on the stepped bands. The female connector includes three spaced-apart hollow tubular female bodies concentrically disposed around one another and a shaft disposed within the innermost female body, being sized and configured, respectively, to mate with the three stepped bands and a central cavity defined by the innermost male body of the male connector.

Abstract: A patient interface module (PIM) for an intra-vascular ultrasound (IVUS) imaging system and a method for using it are provided. The PIM may include a motor having position sensors; a motor controller circuit providing a signal to the motor; and a clock and timing circuit to provide a trigger signal to a pulse transmitter circuit and a reference clock signal to an analog to digital converter (ADC) circuit, the trigger signal and the reference clock signal synchronized to a local oscillator; wherein the motor is configured to provide a relative phase value between a motor shaft and the local oscillator to a data processing circuit.

Abstract: An ultrasound transducer for use in intra-vascular ultrasound (IVUS) imaging systems including a single crystal composite (SCC) layer is provided. The transducer has a front electrode on a side of the SCC layer; and a back electrode on the opposite side of the SCC layer. The SCC layer may have a dish shape including pillars made of a single crystal piezo-electric material embedded in a polymer matrix. Also provided is an ultrasound transducer as above, with the back electrode split into two electrodes electrically decoupled from one another. A method of forming an ultrasound transducer as above is also provided. An IVUS imaging system is provided, including an ultrasound transducer rotationally disposed within an elongate member; an actuator; and a control system controlling activation of the ultrasound transducer to facilitate imaging.

Abstract: The invention generally relates to a rotational imaging apparatus with a monolithic shaft and methods of use thereof. In certain aspects, the apparatus includes a rotatable monolithic hollow elongate shaft. A rotatable elongate drive member is disposed within the shaft, and a rotatable elongate electrical signal transmission member is disposed within the drive member. The apparatus further includes an imaging device, and the shaft, the drive member and the signal transmission member are coupled to the imaging device.

Abstract: The invention generally relates to a rotational imaging apparatus and methods of use thereof. In certain aspects, the apparatus includes a hollow elongate body. The hollow body includes a proximal and a distal end, and the proximal end includes a connector. A rotatable drive member is disposed within the body, and a rotatable electrical signal transmission member is disposed within the drive cable. The drive member and the electrical signal transmission member are coupled to an imaging device within the body and a portion of the electrical signal transmission member is attached to the drive member distal to the connector.

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: The invention provides an intravascular catheter with an expandable member such as a balloon with an imaging device on a surface of the expandable member. The imaging device can use an optical fiber on a surface of the expandable member to image a treatment site. Since an image can be captured directly from the surface of the expandable member, an operator can examine the treatment site while positioning the expandable member. With the treatment site in view, the operator can deliver the treatment (e.g., inflate the balloon or deploy the stent) with confidence that it will be located properly.

Abstract: An ultrasound transducer for use in intravascular ultrasound (IVUS) imaging systems including a single crystal composite (SCC) layer is provided. The transducer has a front electrode on a side of the SCC layer; and a back electrode on the opposite side of the SCC layer. The SCC layer may have a bowl shape including pillars made of a single crystal piezoelectric material embedded in a polymer matrix. Also provided is an ultrasound transducer as above, with the back electrode split into two electrodes electrically isolated from one another. A method of forming an ultrasound transducer as above is also provided. An IVUS imaging system is provided, including an ultrasound emitter and receiver rotationally disposed within an elongate member; an actuator; and a control system controlling emission of pulses and receiving ultrasound echo data associated with the pulses. The ultrasound emitter and receiver include an ultrasound transducer as above.

Abstract: Intraluminal devices, especially catheters having variable flexibility elements in a midsection of the device. The devices offer improved deliverability in an intraluminal environment, especially when used in imaging and treatment catheters.

Abstract: In one embodiment, a catheter imaging device includes an elongated catheter shaft having a forward looking ultrasonic transducer disposed at a distal end thereof. A first device is coupled to the transducer for sweeping an ultrasonic beam produced by the transducer in a first plane and through a first angle therein, and a second device is coupled to the transducer for sweeping the ultrasonic beam in a second plane and through a second angle therein, the second plane being disposed orthogonal to the first plane. In one aspect, the ultrasonic transducer includes a plurality of transducer elements.

Abstract: Using the disclosed intravascular devices it is possible to image tissues, deliver therapy, and evaluate the tissue after the therapy is delivered. One embodiment is a catheter configured to provide ultrasound imaging, drug delivery, and Doppler flow analysis. The devices can use ultrasound imaging as well as optical coherence tomography (OCT).

Abstract: The present invention generally relates to a rapid exchange configuration that reduces the profile of a catheter riding on a guidewire and minimizes guidewire resistance. According to certain embodiments, a body of the catheter includes a distal portion and a proximal portion. The distal portion defines a guidewire lumen and includes a guidewire exit port being open in a proximal direction and leading to the guidewire lumen. A proximal section of the guidewire lumen is straight.

Abstract: The present invention generally relates to devices for imaging the interior of a vessel. The device can involve an elongated body configured to fit within the lumen of a vessel, a rotatable shaft positioned inside the elongated body, and a telescoping element, wherein a portion of the elongated body extends through the telescoping element, in which the elongated body is configured to contain the rotatable shaft inside the telescoping element.

Abstract: In a rotational intravascular catheter, a proximal section of the catheter sheath, within which an elongated flexible drive member portion of the catheter is movably disposed, is extended into a telescoping portion of the catheter. The proximal sheath section functions to support the section of the drive member positioned within the telescoping section whether the telescoping section is in an extended position, qa retracted position, or any position therebetween.

Abstract: An intravascular catheter has a telescope section including telescoped inner and outer tubular catheter members, a sheath having a proximal end anchored to an end of one of the inner and outer catheter members, and an elongated flexible drive member coaxially disposed within and being proximally and distally movable through the sheath. The drive member has a distal portion received in the sheath, and a second, unsheathed portion extending beyond the sheath into the interior of the telescope section. the unsheathed portion of the drive member has a stiffness greater than that of the sheath-disposed distal portion of the drive member and of a sufficient magnitude such that the unsheathed portion of the drive member is self-supporting within the telescope section.

Abstract: A method of performing measurements on medical images with a bedside controller includes receiving, through a touch-sensitive display on the bedside controller, a user measurement input on an image displayed on the display, the user measurement input including a start point defined by a point of initial contact with the touch-sensitive display and an end point defined by a point of last contact with the touch-sensitive display. The method also includes selecting a measurement mode based on a shape of the user measurement input and calculating a measurement value associated with the user measurement input based on the measurement mode.

Abstract: In one aspect, the invention relates to a probe. The probe includes a sheath, a flexible, bi-directionally rotatable, optical subsystem positioned within the sheath, the optical subsystem comprising a transmission fiber, the optical subsystem capable of transmitting and collecting light of a predetermined range of wavelengths along a first beam having a predetermined beam size. The probe also includes an ultrasound subsystem, the ultrasound subsystem positioned within the sheath and adapted to propagate energy of a predetermined range of frequencies along a second beam having a second predetermined beam size, wherein a portion of the first and second beams overlap a region during a scan.

Abstract: An intravascular catheter having an elongated sheath surrounding an elongated flexible inner structure movable relative thereto is provided with various representative embodiments of flushing apparatus carried by the inner structure. Such flushing apparatus is operative in response to movement of the inner structure relative to the sheath to induce a flow of flushing fluid from a source thereof through the interior of the sheath and then discharge the flushing fluid from the sheath. In one embodiment thereof the flushing apparatus includes an impeller structure disposed on the inner structure. In another embodiment thereof the flushing structure includes an annular seal disposed on the inner structure in sliding and sealing engagement with the interior surface of the sheath.

Abstract: Rotational shape-memory actuators and associated devices, systems, and methods are disclosed. In some embodiments, a rotational shape-memory actuator includes a first anchor, a second anchor, a spring element extending between the first and second anchors, a first shape memory element extending between the first and second anchors, a second shape memory element extending between the first and second anchors, and a communication line wrapped around the first and second shape memory elements. The first and second shape memory elements are configured to transition between a first configuration in which the first and second shape memory elements are twisted together and a second configuration in which the first and second shape memory elements are less twisted together such that transitions of the first and second shape memory elements between the first and second configurations cause the second anchor to rotate with respect to the first anchor.

Abstract: A multifunctional invasive cardiovascular diagnostic measurement host is disclosed that interfaces a variety of sensor devices, such as guide wire-mounted pressure sensors, flow sensors, temperature sensors, etc, and provides a multi-mode graphical user interface providing a plurality of displays in accordance with the various types of sensors and measurements rendered by the sensors.

Abstract: A dependency-based startup method in a multi-modality medical processing system that includes receiving initialization information about a plurality of executable components to be started, the plurality of executable components including an executable modality component configured to communicate with a medical device communicatively coupled to the multi-modality medical processing system. The method also includes receiving dependency information about the executable modality component, the dependency information identifying one or more of the executable components upon which the executable modality component depends and transforming the initialization information and the dependency information into a dependency map that represents the dependencies between the plurality of executable components.

Abstract: The present invention provides minimally invasive imaging probe having an optical encoder integrated therewith for accurately measuring or estimating the rotational velocity near the distal end of the medical device, such as an imaging probe which undergoes rotational movement during scanning of surrounding tissue in bodily lumens and cavities.

Abstract: Embodiments of the present invention relate to a system and method for in vivo measurement of blood parameters by processing analog electrical signals from a plurality of photodetectors. In some embodiments, it is possible to determine one or more blood parameters according to (i) a first electrical signal from a first detector and (ii) a second electrical signal from a second photodetector. A difference analog electrical signal is generated, indicative of a difference between the light response signal at the first location and light response signal at the second location, is generated. One or more blood parameters may be detected according to the difference analog electrical signal.

Abstract: Among other things, there is disclosed structure and methods for registering images obtained through internal (e.g. intravascular) ultrasound devices. Embodiments of a device with a rotating ultrasound beam is provided, with a wall of the device being anisotropic in ultrasound passage. As examples, a cable opaque to ultrasound is attached along the wall of the device, so that the ultrasound beam at the location of the cable is blocked, reflected or scattered. As another example, a thin film of metallic material is placed on or in the wall to allow a portion of the beam to be blocked or attenuated. The imaging system recognizes the changes to the signals made by the anisotropic wall, and registers successive images according to those changes.

Abstract: A system for use with ultrasound procedures including an ultrasound control and/or imaging system which has a microminiature motor, a rotatable reflector and a stationary ultrasound transducer. The transducer may be placed between the motor and the reflector, so as to eliminate the need for placement of wires or other artifact-creating items in the path of ultrasound signals. In particular embodiments, such systems can be incorporated in or retrofitted to commercially standard diagnostic and therapeutic catheters or other housings. Examples can be used in variety of ultrasound procedures, e.g. to perform intravascular ultrasound (IVUS) imaging.

Abstract: There are disclosed embodiments of devices and methods for imaging the inside of a body part, particularly a blood vessel. In particular embodiments, a catheter has a tip chamber, within which is an ultrasound transducer mounted on a pivot mechanism, a motor for turning the transducer, and an implement for pivoting the transducer. Examples of such an implement are a linear motor, a shaft or filament, and the pivot mechanism may be biased to return to a base position when the implement is not pivoting the transducer. In other embodiments, a mirror reflecting ultrasound signals from the transducer may be rotated and/or pivoted, using similar mechanisms.

Abstract: The invention relates to systems and methods for the operation of three-dimensional imaging systems.

Abstract: A bedside controller includes an integrally formed housing and self-contained mounting structure disposed on the housing. The mounting structure includes a mounting channel defined in the housing and a retaining clamp disposed above the mounting channel and configured to releasably secure a mounting platform within the mounting channel such that the bedside controller is mounted to the mounting platform. The bedside controller also includes a touch-sensitive display disposed within a surface of the housing and configured to display images and receive user input on the surface, a processor disposed within the housing, a communication module disposed within the housing, communicatively coupled to the processor, and configured to transmit and receive medical data, and a battery disposed within the integrally formed housing and electrically coupled to the touch-sensitive display, the processor, and the communication module.

Abstract: A first tube is a medical tube provided with a first portion, a second portion and a third portion in this order from the proximal end side toward the distal end side and is made of a resin. At the second portion, the outer diameter is smaller than the outer diameter of the first portion and the inner diameter is substantially equal to the inner diameter of the first portion. At the third portion, the outer diameter and the inner diameter are respectively smaller than the outer diameter and the inner diameter of the second portion. In this manner, a medical tube in which the outer diameter of the proximal end side is relatively large and the outer diameter of the distal end side is relatively small while securing the inner diameter having a sufficient size at the distal end side can be provided.

Abstract: An imaging assembly for an intravascular ultrasound system includes a catheter, an imaging core, and at least one transducer conductor. The imaging core is insertable into the catheter and extendable from a distal end of the catheter. The imaging core includes a rotatable magnet, a tilted reflective surface, and at least one fixed transducer all disposed in a body. The rotatable magnet is configured and arranged to rotate by a magnetic field generated external to the catheter. The tilted reflective surface rotates with the magnet. The at least one transducer is configured and arranged for transforming applied electrical signals to acoustic signals and also for transforming received echo signals to electrical signals. The at least one transducer conductor is electrically coupled to the at least one transducer and is configured and arranged to extend into the catheter when the imaging core is extended from the catheter.

Abstract: In part, the invention relates to systems, methods, and devices that store and retrieve information associated with an imaging probe such as an ultrasound probe, an optical coherence tomography probe, a multimodal probe and other probes. The information that is stored relates to one or more measurable properties for a specific imaging probe. Thus, when each probe is manufactured there can be variations in its length, brightness, angular alignment of its constituent elements, and various other probe specific measurements. In turn, these measurements can be used to calibrate or otherwise use a given probe with a system that collects, stores, or otherwise processes information collected using each probe.