Abstract: Embodiments of the present disclosure are configured to assess effectiveness of an endovascular aneurysm coiling procedure. A system is provided that can include a flow-sensing intravascular device with a flexible elongate member which is sized and shaped for insertion into a vasculature, and a flow sensing element secured to a distal portion of the flexible elongate member. A computer can be in communication with the flow-sensing intravascular device. With a coil is positioned within an aneurysm, the computer can detect a flow measurement of fluid entering the aneurysm based on data obtained by the flow sensing element positioned within the aneurysm, and can determine that the fluid flow measurement is at or below an acceptable level. If flow is at an unacceptable level, additional coils can be added to further restrict flow. Also, a second source of fluid into the aneurysm can be indicated by the flow measurements.

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 generally relates to catheter systems and methods for guided formation of vascular access sites (such as fistulas and grafts). According to certain aspects, a catheter system for forming a vascular access site include an elongate body comprising a distal end and configured to be inserted into a first vessel. The elongate body includes an exit port along its side that is proximal to the distal end. An imaging assembly is associated with the elongate body and configured to generate image data of the first vessel and a second vessel positioned next to the first vessel. For vascular access formation, a penetrating member of the catheter system extends out of the exit port and through a wall of the first vessel and a wall of the second vessel.

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: 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 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: Devices, systems, and methods for evaluating blood flow with vascular perfusion imaging are disclosed. In an embodiment, a medical system is disclosed. One embodiment of the medical system comprises a perfusion imaging system configured to obtain perfusion imaging data associated with movement of contrast through a vessel of a patient, a graphical user interface, and a medical processing unit in communication with the perfusion imaging system and the graphical user interface. The medical processing unit is configured to receive a first set of perfusion imaging data from the perfusion imaging system, determine at least one parameter representative of the movement of the contrast through the vessel of the patient, generate a first graphical representation of the first set of perfusion imaging data and the at least one parameter determined based on the first set of perfusion imaging data, and output the first graphical representation to the graphical user interface.

Abstract: The invention provides methods for diagnosing and treating deep vein thrombosis and other conditions associated with occluded or constricted vessels. According to certain aspects, methods of the invention involve inserting a sensing device into a vessel having a thrombus therein, assessing, with the sensing device, one or more functional parameters within the vessel, determining an interventional therapy for treating the thrombus based on the assessing step; and performing the interventional therapy.

Abstract: The invention provides methods and systems for increasing the open cross-section of a vascular fistula that is obstructed by thrombus. Using a catheter having an imaging element and a thrombus disrupting element, the thrombus can be disrupted and removed, and the fistula evaluated with the imaging element. The imaging element is preferably an ultrasound imaging element.

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: Devices, systems, and methods for evaluating blood flow with vascular perfusion imaging are disclosed. In an embodiment, a medical system is disclosed. One embodiment of the medical system comprises a perfusion imaging system configured to obtain perfusion imaging data associated with movement of contrast through a vessel of a patient, a graphical user interface, and a medical processing unit in communication with the perfusion imaging system and the graphical user interface. The medical processing unit is configured to receive a first set of perfusion imaging data from the perfusion imaging system, determine at least one parameter representative of the movement of the contrast through the vessel of the patient, generate a first graphical representation of the first set of perfusion imaging data and the at least one parameter determined based on the first set of perfusion imaging data, and output the first graphical representation to the graphical user interface.

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: The invention generally relates to catheter systems and methods for guided formation of vascular access sites (such as fistulas and grafts). According to certain aspects, a catheter system for forming a vascular access site include an elongate body comprising a distal end and configured to be inserted into a first vessel. The elongate body includes an exit port along its side that is proximal to the distal end. An imaging assembly is associated with the elongate body and configured to generate image data of the first vessel and a second vessel positioned next to the first vessel. For vascular access formation, a penetrating member of the catheter system extends out of the exit port and through a wall of the first vessel and a wall of the second vessel.

Abstract: The invention generally relates to catheter systems and methods for guided formation of vascular access sites (such as fistulas and grafts). According to certain aspects, a catheter system for forming a vascular access site include an elongate body comprising a distal end and configured to be inserted into a first vessel. The elongate body includes an exit port along its side that is proximal to the distal end. An imaging assembly is associated with the elongate body and configured to generate image data of the first vessel and a second vessel positioned next to the first vessel. For vascular access formation, a penetrating member of the catheter system extends out of the exit port and through a wall of the first vessel and a wall of the second vessel.

Abstract: Embodiments of the present disclosure are configured to assess effectiveness of an endovascular aneurysm coiling procedure. A system is provided that can include a flow sensing element supported by a structure that can position and retain the sensing element within the aneurysm. A computer in communication with the sensing element can detect a measurement of fluid flow entering the aneurysm based on data obtained by the sensing element after positioning the structure and element within an aneurysm. A wire segment can pass through the elongate member and form a coil in the aneurysm as the wire segment is passed through the elongate member. The sensing element can provide fluid flow measurements from within the aneurysm after the elongate member is removed from the vasculature.

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: Embodiments of the present disclosure are configured to assess effectiveness of an endovascular aneurysm coiling procedure. A system is provided that can include a flow-sensing intravascular device with a flexible elongate member which is sized and shaped for insertion into a vasculature, and a flow sensing element secured to a distal portion of the flexible elongate member. A computer can be in communication with the flow-sensing intravascular device. With a coil is positioned within an aneurysm, the computer can detect a flow measurement of fluid entering the aneurysm based on data obtained by the flow sensing element positioned within the aneurysm, and can determine that the fluid flow measurement is at or below an acceptable level. If flow is at an unacceptable level, additional coils can be added to further restrict flow. Also, a second source of fluid into the aneurysm can be indicated by the flow measurements.

Abstract: A component for a machine is disclosed. The component may include an interior frame, a protruding member extending from the interior frame, and a carbon fiber wrapped over the interior frame and around the protruding member. A method of manufacturing a component for a machine is also disclosed. The method may include supplying an interior frame with a protruding member extending from the interior frame. The method may further include wrapping a carbon fiber around the interior frame and the protruding member, and curing the carbon fiber to the interior frame.

Abstract: Devices, systems, and methods automatically detecting anomalous waveforms and eliminating these waveforms from physiologic measurements are disclosed. For example, in some instances a method includes collecting a pressure data from an intravascular device positioned within the vessel of the patient, the pressure data including a pressure waveform for each cardiac cycle of the patient; comparing the pressure waveform for each cardiac cycle of the patient to a reference pressure waveform to identify an anomalous pressure waveform; and calculating a pressure ratio utilizing the pressure data from the intravascular device, wherein data from the anomalous pressure waveform is excluded from the calculation.

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.