Abstract: Systems, devices, and methods for using an intraluminal sensing device are provided. The intraluminal sensing device may include a ferrous element disposed at a distal portion of an elongate flexible member configured to be placed in a body lumen of a patient. An external electromagnetic field device may be used to produce an electromagnetic field that may be used to direct the movement of the flexible elongate member within the body lumen.

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: 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: 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: A system for the remote management of head mounted vision assist devices used by patients, is provided. The system includes head mounted vision assist devices located at various patient locations, at least one computing device used by a clinician supervising the usage of the vision assist devices by the patients, and a server communicatively coupled with each of the vision assist devices and the computing device used by the clinician. The server executes stored instructions to enable the clinician to remotely monitor the results of one or more diagnostic tests conducted by a patient at predefined time intervals and monitor a display of a head mounted vision assist device being used by the patient by mirroring the patient's display on the clinician's computing device.

Abstract: Systems and methods for diagnosing a user's vision condition by combining results of one or more vision tests taken by the user via a head-mounted vision device (HMVD) are provided. A user is provided with a first vision test and a second vision test via the HMVD and takes each test a predefined number of times and in a predefined order. Results are obtained from each test taken by the user, combined to obtain a combined test result for the user, and then used to diagnose the user's vision condition.

Abstract: Systems, devices, and methods for using an intraluminal sensing device are provided. The intraluminal sensing device may include a ferrous element disposed at a distal portion of an elongate flexible member configured to be placed in a body lumen of a patient. An external electromagnetic field device may be used to produce an electromagnetic field that may be used to direct the movement of the flexible elongate member within the body lumen.

Abstract: Devices, systems, and methods for evaluating a vessel and tracking progression of an intravascular procedure are disclosed. In an embodiment, a medical system is disclosed. One embodiment of the medical system comprises a medical processing unit in communication with an intravascular device configured to obtain intravascular ultrasound (IVUS) data and with an external ultrasound device configured to obtain external ultrasound data. The medical processing unit is configured to receive the IVUS data from the intravascular device, wherein the intravascular device is positioned proximate to an aneurysm, receive the external ultrasound data from the external ultrasound device, wherein the external ultrasound device is positioned to image the aneurysm, and track progression of a coil embolization of the aneurysm based on the IVUS data and the external ultrasound data.

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: 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: Disclosed is an occlusion device for use in a body lumen such as the left atrial appendage. The occlusion device includes an occlusion member and may also include a stabilizing member. The stabilizing member inhibits compression of the left atrial appendage, facilitating tissue in-growth onto the occlusion member. Methods are also disclosed.

Abstract: Disclosed is an occlusion device for use in a body lumen such as the left atrial appendage. The occlusion device includes an occlusion member and may also include a stabilizing member. The stabilizing member inhibits compression of the left atrial appendage, facilitating tissue in-growth onto the occlusion member. Methods are also disclosed.

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: 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: Disclosed is a method of preventing atrial appendage thrombus from entering the blood stream in which an occlusion device placed within the left atrial appendage inhibits compression of the left atrial appendage and facilitates tissue in-growth onto the occlusion member. The occlusion device includes an occlusion member, a plurality of supports and a plurality of barbs associated with the plurality of supports.

Abstract: Clot disruption and dissolution are achieved using a catheter having the ability to infuse a thrombolytic agent, aspirate clot and fluid, and allow passage of a guidewire. Optionally, the catheter may also include a mechanical agitator for further disrupt clot in the presence of the thrombolytic agent. A flow resistor in the catheter provides for infusion and/or aspiration to be concentrated primarily at a clot treatment area in a blood vessel while also providing optional infusion and/or aspiration distal to the treatment area. In some embodiments, infusion, aspiration and guidewire passage occur through a common lumen. The thrombolytic agent, such as tPA, streptokinase, or urokinase, is directly released into the clot at the point where the agitator is engaging the clot. In this way, the thrombolytic activity of the agent is enhanced and the dissolution of the clot is improved.

Abstract: Disclosed is an occlusion device for use in a body lumen such as the left atrial appendage. The occlusion device includes an occlusion member and may also include a stabilizing member. The stabilizing member inhibits compression of the left atrial appendage, facilitating tissue in-growth onto the occlusion member. Methods are also disclosed.

Abstract: A device and method for obliterating or occluding a body cavity or passageway, in particular, the left atrial appendage of a patient's heart. The procedure can be carried out intraoperatively, but is preferably carried out percutaneously by use of a delivery catheter to position an occluding device adjacent a patient's left atrial appendage. The occluding device may prevent the passage of embolic or other material to or from the left atrial appendage by volumetrically filling the appendage, closing the opening of the appendage with an occluding member, or pulling the tissue around the opening of the appendage together and fixing it in a closed state.

Abstract: Clot disruption and dissolution are achieved using a catheter having the ability to infuse a thrombolytic agent, aspirate clot and fluid, and allow passage of a guidewire. Optionally, the catheter may also include a mechanical agitator for further disrupt clot in the presence of the thrombolytic agent. A flow resistor in the catheter provides for infusion and/or aspiration to be concentrated primarily at a clot treatment area in a blood vessel while also providing optional infusion and/or aspiration distal to the treatment area. In some embodiments, infusion, aspiration and guidewire passage occur through a common lumen. The thrombolytic agent, such as tPA, streptokinase, or urokinase, is directly released into the clot at the point where the agitator is engaging the clot. In this way, the thrombolytic activity of the agent is enhanced and the dissolution of the clot is improved.