Abstract: The invention generally relates to devices and methods that provide for guided delivery of a heart replacement valve or other implant into the vasculature. In certain embodiments, a delivery device of the invention includes an outer sheath and an inner sheath moveably disposed within the outer sheath. The outer sheath includes a first imaging element and defining a center lumen that leads to an opening. The outer sheath is further configured to releasably hold an implant within the center lumen. The first imaging element is configured to at least partially surround the center lumen such that the implant is deployable through the first imaging element. The inner sheath is configured to engage with and deploy the implant out of the opening of the elongate body and into a body lumen.

Abstract: Intraluminal medical devices, systems and methods are provided. In one embodiment, an intraluminal medical system includes a handheld interface device in communication with an intraluminal device to be positioned within a body lumen of a patient. The intraluminal device includes a sensor configured to obtain physiology data associated with the body lumen. The handheld interface device includes a housing sized and shaped for handheld use, a controller core disposed within the housing and configured to control a plurality of sensor types respectively associated with a plurality of intraluminal devices, a computing core disposed within the housing, and a first display integrated in the housing. The controller core is operable to identify the sensor of the intraluminal device, and control the sensor to obtain the physiology data associated with the body lumen.

Abstract: Aspects of the invention include ultrasound systems that suppress grating lobe artifacts arising due to high frequency operation of an array transducer probe which is operated at a frequency higher than its pitch limitation.

Abstract: In an embodiment, a medical system is disclosed. One embodiment of the medical system comprises a medical processing unit in communication with an intravascular instrument configured to be moved longitudinally within a body lumen and in further communication with a radiographic imaging source configured to obtain radiographic images of the intravascular instrument while the intravascular instrument is moved longitudinally within the body lumen. The medical processing unit is configured to receive radiographic images obtained by the radiographic imaging source, track the intravascular instrument within the radiographic images while the intravascular instrument is moved longitudinally within the body lumen, calculate a movement speed based on the tracking, compare the calculated movement speed to a predefined target movement speed, generate a speed-adjustment suggestion based on the comparison, and output the speed-adjustment suggestion to a display for review by a user.

Abstract: Systems, methods, and devices that perform flow scan sequences are provided. In one embodiment, an ultrasound imaging system includes an intraluminal catheter or guidewire, an annular array of acoustic elements positioned around a circumference of the catheter or guidewire, and a processor in communication with the annular array. The processor is configured to activate a first subaperture of the annular array at a first time, thereafter, activate a second interleaving subaperture, and activate the first subaperture again at a different, second time such that the scan sequence moves around the circumference of the catheter or guidewire. Temporal differences between the received ultrasound signals obtained by the first subaperture at the first and second times are determined to detect motion around the annular array. By interleaving subaperture firings, the total number of firings to form an image frame can be reduced.

Abstract: The invention provides methods and devices for treating liver cirrhosis or portal hypertension by creating an intrahepatic shunt, or new passage, from a portal vein of a patient to a hepatic vein using a device with intravascular imaging capabilities and pressure sensing capabilities or positioning mechanisms. The integration of intravascular imaging aids in the precise placement of the shunt and pressure measurement may verify successful shunt creation. An apparatus may include a catheter with an extended body for insertion into a hepatic vein of a patient, an intravascular imaging device and a needle exit port on the distal portion of the extended body, and a needle disposed within a lumen in the catheter and configured to be pushed out of the exit port and extend away from a side of the extended body, in which the needle includes a pressure sensor.

Abstract: Embolism treatment devices, systems, and methods are provided. In one embodiment, an embolism treatment system includes a flexible elongate member configured to be positioned within a blood vessel of a patient, the flexible elongate member comprising a distal portion and a proximal portion; an ultrasound imaging component positioned at the distal portion and configured to emit ultrasound energy towards a blood clot within the blood vessel and collect an image signal representative of the blood clot; a treatment component positioned at the distal portion and configured to treat the blood clot; and a flow sensing component positioned at the distal portion and configured to determine a blood flow measurement within the blood vessel associated with the blood clot.

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: Intravascular devices, systems, and methods are disclosed. In some instances, the intravascular device is a guide wire with electrical conductors embedded within a core wire. In some instances, the electrical conductors are coupled to conductive bands adjacent a proximal portion of the guide wire and a sensing element adjacent a distal portion of the guide wire. Methods of making, manufacturing, and/or assembling such intravascular devices and associated systems are also provided.

Abstract: An intravascular ultrasound (IVUS) device that includes a flexible elongate member having a proximal portion and a distal portion; a controller coupled to the distal portion of the flexible elongate member; an ultrasound transducer disposed at the distal portion of the flexible elongate member and in communication with the controller; a pressure transducer disposed at the distal portion of the flexible elongate member and in communication with the controller; and plurality of conductors extending from the controller to the proximal portion of the catheter, at least one conductor of the plurality of conductors being configured to carry both the signals representing information captured by the ultrasound transducer and information captured by the pressure transducer.

Abstract: Devices, systems, and methods of evaluating risk associated with a condition of the vessel and providing an objective intervention recommendation based on the evaluated risk are disclosed. The method includes steps of obtaining physiologic measurements from a first instrument and a second instrument positioned within the vessel of the patient while the second instrument is moved longitudinally through the vessel from a first position to a second position, obtaining image data from an image of a vessel system, co-registering the physiologic measurements with the image data to produce co-registered physiologic measurements, and determining whether to perform a first surgical procedure or a second surgical procedure, wherein the determining is based on the co-registered physiologic measurements. Other associated methods, systems, and devices are also provided herein.

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

Abstract: The invention generally relates to medical imaging systems that instantly and/or automatically detect borders. Embodiments of the invention provide an imaging system that automatically detects a border at a location within a vessel in response only to navigational input moving the image to that location. In some embodiments, systems and methods of the invention operate such that when a doctor moves an imaging catheter to a new location with in tissue, the system essentially instantly finds, and optionally displays, the border(s), calculates an occlusion, or both.

Abstract: The invention relates to restricting flow through a vascular access site such as an arteriovenous (AV) fistula or a graft using intravascular measurements to guide the procedure. The invention provides systems and methods for using intravascular detection to guide the restriction of flow through an AV fistula or graft. An intravascular instrument such as an imaging catheter or guidewire with measuring capabilities is inserted into a vessel proximal to an access site and used to evaluate the access site, which is banded to obtain healthy flow as indicated by the intravascular instrument. In certain aspects, the invention provides a method for improving a hemodialysis fistula or graft by inserting an intravascular instrument into a vessel proximal to the fistula or graft, making a measurement with the intravascular instrument, and restricting flow through the fistula or graft until the measurement obtains a predetermined value.

Abstract: The invention generally relates to intravascular imaging system and particularly to processing in multimodal systems. The invention provides an imaging system that splits incoming image data into two signals and performs the same processing step on each of the split signals. The system can then send the two signals down two processing pathways. Methods include receiving an analog image signal, transmitting the received signal to a processing system, splitting the signal to produce a first image signal and a second image signal, and performing a processing operation on the first image signal and the second image signal. The first and second signal include substantially the same information as one another.

Abstract: The present disclosure is directed to intravascular devices, systems, and methods having a core wire with multiple flattened sections. In one aspect, a sensing guide wire is provided. The guide wire includes a first flexible elongate member; a sensing element positioned at a distal portion of the first flexible elongate member; and a second flexible elongate member coupled to the first flexible elongate member such that the second flexible elongate member extends distally from the first flexible elongate member; and wherein a distal portion of the first flexible elongate member includes at least two flattened sections, and wherein the first and second flexible elongate members are coupled along a portion of one of the at least two flattened sections. In other aspects, methods of forming a sensing guide wire are provided.

Abstract: Embodiments of the present disclosure are related to intravascular devices having improved rapid-exchange configurations and associated systems and methods. In some particular embodiments, the devices of the present disclosure include a reinforced rapid-exchange port, an offset rapid-exchange port, and/or combinations thereof. For example, in some implementations an intravascular imaging device is provided that includes a main catheter body; a rotational imaging element positioned within a lumen of the main catheter body; a distal portion extending from the main catheter body, the distal portion having a rapid-exchange port in communication with a guidewire lumen, the rapid-exchange port and the guidewire lumen sized and shaped to receive a guidewire; and at least one reinforcing element positioned adjacent to the rapid-exchange port.

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: Solid-state ultrasound imaging devices, systems, and methods are provided. Some embodiments of the present disclosure are particularly directed to compact and efficient ultrasound transducer scanner formed from a substantially cylindrical semiconductor substrate. In some embodiments, an intravascular ultrasound (IVUS) device includes: an ultrasound scanner assembly disposed at a distal portion of the flexible elongate member, the ultrasound scanner assembly including a semiconductor substrate having a plurality of transistors formed thereupon. The semiconductor substrate is curved to have a substantially cylindrical form when the ultrasound scanner assembly is in a rolled form, and the plurality of transistors are arranged in a cylindrical arrangement when the ultrasound scanner assembly is in the rolled form.

Abstract: A method of evaluating a vessel of a patient is provided. The method includes outputting, to a display device, a screen display including: a visualization based on pressure measurements obtained from a first instrument and a second instrument positioned within the vessel of the patient while the second instrument is moved longitudinally through the vessel and the first instrument remains stationary within the vessel; and a visual representation of a vessel; receiving a user input to modify the visualization to simulate a therapeutic procedure; and updating the screen display, in response to the user input, including modifying the visualization based on the user input. A system for evaluating a vessel of a patient is also provided. The system includes first and second instruments sized and shaped for introduction into the vessel of the patient; and a processing system communicatively coupled to the first and second instruments and a display device.