Automatic control of intraluminal data acquisition and related devices, systems and methods

Abstract

The present invention provides systems, devices, and methods for controlling intravascular data acquisition. For example, a registration process can be used to control the start and / or stop of intravascular data acquisition. In one embodiment, a system includes a processor circuit configured to: generate a roadmap of a vessel, identify a region of interest of the vessel on the roadmap, determine whether an intravascular data acquisition device has entered the region of interest, and control the intravascular data acquisition device to acquire intravascular data of the region of interest. The processor can then output a graphical representation of the intravascular data of the region of interest to a display device.

Description

Technical Field

[0001] The present invention generally relates to the acquisition of intraluminal data, and more particularly to the automatic acquisition of intraluminal data. More specifically, the present disclosure relates to methods, systems, and apparatus for automatically acquiring intraluminal data using external image data. Background Art

[0002] Intraluminal data acquisition is a widely used technique in interventional cardiology as a diagnostic tool for evaluating diseased tubes (such as arteries) in the human body to determine the need for treatment, guide intervention, and / or evaluate its effectiveness. For example, pressure and / or flow measurements can be obtained at different locations along the blood vessel to evaluate the performance of the tube and identify areas of narrowing and potential blockages. Intravascular devices (such as pressure sensing guidewires and / or catheters) can be used to make pressure measurements from within the blood vessel. In another example, intraluminal imaging (such as intravascular ultrasound (IVUS) imaging or optical coherence tomography (OCT)) can be used to obtain imaging data of the tube to identify lesions or blockages.

[0003] During an intravascular diagnostic procedure, an intravascular device is navigated to a region of the vascular system, such as a coronary artery, under external imaging (e.g., angiography and / or fluoroscopy). The physician typically guides the device to a specific region of interest in the vascular system for evaluation. For example, the physician may want to focus the evaluation on an area of the vascular system that shows signs of narrowing or blockage. Once the pressure sensing device has been advanced past the region of interest, the physician initiates a pullback procedure, in which the intravascular device is slowly pulled back through the vessel. During the pullback, the physician monitors the position of the intravascular device in external imaging to determine when to initiate and / or terminate the data collection process. When the physician observes that the intravascular device has entered the region of interest, the physician manually initiates intravascular data acquisition. This may include pausing the pullback procedure to press a button or otherwise issue a command to begin acquiring intravascular data. Similarly, when the physician observes that the intravascular device has exited the region of interest, the physician manually terminates intravascular data acquisition. This process is repeated for each region of interest identified at the beginning of the procedure.

[0004] Therefore, current workflows for intravascular data acquisition may involve multiple operators to control the movement of the intravascular device and start / stop data acquisition. Alternatively, current workflows for data acquisition may involve a tedious process in which the physician pauses and restarts the pullback operation while visually monitoring the position of the intravascular device. Summary of the Invention

[0005] The present disclosure is directed to automated acquisition of intraluminal data. For example, a registration process can be used to automatically start and / or stop acquisition of intraluminal data, thereby streamlining the diagnostic workflow. For example, according to one embodiment of the present disclosure, a processor circuit is configured to generate a roadmap of a vessel based on external image data (e.g., angiographic image data). The roadmap can be associated with a predetermined region of interest (ROI) within the vessel. The processor is further configured to track the position of an intravascular data acquisition device (e.g., a pressure-sensing guidewire) as the device moves through the vessel. When the processor determines that the device has entered the ROI within the vessel, the processor circuit is configured to automatically initiate data acquisition. In some embodiments, intraluminal data acquisition can also be automatically terminated by the processor circuit once the intraluminal device leaves the ROI. While the device is tracked in the angiographic data, the processor circuit simultaneously registers the intraluminal data with the external image data. This process continues until all selected ROIs have been evaluated. This automated method can be applied and repeated to evaluate multiple ROIs identified within a vessel. In some embodiments, the ROIs are identified by a user using a user interface device (e.g., a mouse, keyboard, or touchscreen display). In other embodiments, the processor circuit is configured to automatically identify one or more regions of interest of the tube in the roadmap.

[0006] According to one embodiment of the present disclosure, a system for controlling intravascular data acquisition includes a processor circuit configured to: generate a roadmap of a tube using first extravascular image data of the tube; identify a region of interest of the tube on the roadmap of the tube; receive second extravascular image data representing an intravascular data acquisition device positioned within the tube; determine whether the intravascular data acquisition device has entered the region of interest based on the second extravascular image data; and in response to determining that the intravascular data acquisition device has entered the region of interest, control the intravascular data acquisition device to obtain intravascular data of the region of interest; and output a first graphical representation of the intravascular data of the region of interest to a display device in communication with the processor circuit.

[0007] In some embodiments, the processor circuit is configured to: identify a radiopaque marker of an intravascular data acquisition device using the second extravascular image data; determine a position of the intravascular data acquisition device relative to a roadmap of the vessel based on the identified radiopaque marker; and determine whether the intravascular data acquisition device has entered a region of interest based on the determined position. In some embodiments, the processor circuit is configured to output a screen display to a display device, the screen display including: a roadmap; a first graphical representation of intravascular data of the region of interest; a second graphical representation of the region of interest on the roadmap; and a third graphical representation of the position of the intravascular data acquisition device.

[0008] In some embodiments, the processor circuit is further configured to: receive user input from a user interface device indicating a region on the roadmap; and identify a region of interest for the vessel based on the user input. In some embodiments, the user input indicates a length of the vessel on the roadmap. In some embodiments, the first extravascular image data includes angiographic data, and the processor circuit is further configured to identify the region of interest based on image processing of the angiographic data. In some embodiments, the intravascular data includes at least one of pressure data or flow data, and the processor circuit is further configured to calculate a functional indicator of the vessel at the region of interest based on at least one of the pressure data or flow data.

[0009] In some embodiments, the functional indicator includes at least one of a fractional flow reserve (FFR) or an instantaneous wave-free ratio (iFR). In some embodiments, the intravascular data includes intravascular image data. In some embodiments, the processor circuit is further configured to: determine whether the intravascular data acquisition device has left the area of interest based on the second extravascular image data; and in response to determining that the intravascular data acquisition device has left the area of interest, stop receiving intravascular data of the area of interest of the tube from the intravascular data acquisition device. In some embodiments, the system also includes the intravascular data acquisition device. In some embodiments, the intravascular data acquisition device includes a flexible, elongated member having a proximal portion and a distal portion, and a sensing component connected to the distal portion. In some embodiments, the distal portion and the sensing component are configured to be positioned within the tube.

[0010] In some embodiments, the processor circuit is further configured to: identify another region of interest of the vessel on the roadmap of the vessel; determine whether the intravascular data acquisition device has entered the other region of interest based on the second extravascular image data; and in response to determining that the intravascular data acquisition device has entered the other region of interest, control the intravascular data acquisition device to obtain intravascular data of the other region of interest; and output a fourth graphical representation of the intravascular data of the other region of interest to a display device in communication with the processor circuit.

[0011] According to another embodiment of the present disclosure, a method includes: generating a roadmap of a vessel using first extravascular image data of the vessel; identifying a region of interest of the vessel on the roadmap of the vessel; receiving second extravascular image data representing an intravascular data acquisition device positioned within the vessel; determining whether the intravascular data acquisition device has entered the region of interest based on the second extravascular image data; and receiving intravascular data of the region of interest of the vessel from the intravascular data acquisition device in response to determining that the intravascular data acquisition device has entered the region of interest.

[0012] In some embodiments, the method further includes: identifying a radiopaque marker of an intravascular data acquisition device using the second extravascular image data; determining a position of the intravascular data acquisition device relative to a roadmap of the vessel; and determining whether the intravascular data acquisition device has entered a region of interest based on the determined position. In some embodiments, the method further includes: outputting a screen display to a display device, the screen display including: the roadmap; a graphical representation of the region of interest on the roadmap; and a second graphical representation of the position of the intravascular data acquisition device. In some embodiments, the method further includes: receiving user input from a user interface device indicating a region on the roadmap; and identifying the region of interest for the vessel based on the user input.

[0013] In some embodiments, the first extravascular image data includes angiographic data. In some embodiments, identifying the region of interest includes identifying the region of interest based on image processing of the angiographic data. In some embodiments, the intravascular data includes at least one of pressure data or flow data. In some embodiments, the method further includes: calculating a functional indicator of the vessel at the region of interest based on at least one of the pressure data or the flow data. In some embodiments, the functional indicator includes at least one of a fractional flow reserve (FFR) or an instantaneous wave-free ratio (iFR). In some embodiments, the method further includes: determining whether the intravascular data acquisition device has entered the region of interest based on the second extravascular image data; and in response to determining that the intravascular data acquisition device has left the region of interest, stopping receiving intravascular data of the region of interest of the vessel from the intravascular data acquisition device.

[0014] Other aspects, features, and advantages of the present disclosure will become apparent from the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Illustrative embodiments of the present disclosure will be described with reference to the accompanying drawings, in which:

[0016] Figure 1 A diagrammatic perspective view of a tube having a narrowing is shown according to an embodiment of the present disclosure.

[0017] Figure 2 Shown along Figure 1 The section line 2-2 is taken Figure 1 Diagrammatic partial cross-sectional perspective view of a portion of a tube.

[0018] Figure 3 An embodiment according to the present disclosure is shown Figure 1 and Figure 2 Diagrammatic partial cross-sectional perspective view of a tube with an instrument positioned within the tube.

[0019] Figure 4AA diagrammatic representation of an intraluminal imaging system with a pressure guidewire according to an embodiment of the present disclosure is shown.

[0020] Figure 4B A diagrammatic schematic diagram of an intravascular ultrasound (IVUS) imaging system is shown in accordance with an embodiment of the present disclosure.

[0021] Figure 5 is a diagrammatic schematic diagram of a processor circuit according to an embodiment of the present disclosure.

[0022] Figure 6 is a decision flow chart of an automatic method for acquiring intraluminal data according to an embodiment of the present disclosure.

[0023] Figure 7 is a flow chart illustrating method steps of a processor performing automatic acquisition of intraluminal data according to an embodiment of the present disclosure.

[0024] Figure 8 is a diagrammatic view of an angiographic image with multiple regions of interest identified by a user according to an embodiment of the present disclosure.

[0025] Figure 9 is a diagrammatic view of an angiographic image with a region of interest identified by a user according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0026] For the purpose of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments shown in the accompanying drawings, and specific language will be used to describe the embodiments. Nevertheless, it will be understood that no limitation of the scope of the present disclosure is intended. Any changes and further modifications to the apparatus and any other applications of the principles of the present disclosure are fully contemplated and included in the present disclosure as would be generally conceivable to one skilled in the art. In particular, it is fully contemplated that the features, components and / or steps described with respect to one embodiment may be combined with the features, components and / or steps described with respect to other embodiments of the present invention. However, for the purpose of brevity, multiple repetitions of these combinations will no longer be described separately.

[0027] refer to Figure 1 and Figure 2 , which shows a tube 100 having a narrow portion according to an embodiment of the present disclosure. In this regard, Figure 1 is a diagrammatic perspective view of tube 100, and Figure 2 It is along Figure 1 A partial cross-sectional perspective view of a portion of the tube 100 taken along section line 2-2 is shown. Figure 1, tube 100 includes a proximal portion 102 and a distal portion 104. A lumen 106 extends along the length of tube 100 between proximal portion 102 and distal portion 104. In this regard, lumen 106 is configured to allow fluid to flow through the tube. In some cases, tube 100 is a blood vessel. In such cases, lumen 106 is configured to facilitate blood flow through tube 100. In some cases, tube 100 is a coronary artery. In other cases, the tube is a peripheral tube, such as a peripheral vein or artery.

[0028] As shown, tube 100 includes a stenosis 108 between proximal portion 102 and distal portion 104. Stenosis 108 generally represents any blockage or other structural arrangement that causes restriction fluid flow through the lumen 106 of tube 100. Embodiments of the present disclosure are applicable to a variety of vascular applications, including but not limited to coronary, peripheral (including but not limited to lower limbs, carotid arteries and neurovascular), renal and / or venous. In the case where tube 100 is a blood vessel, stenosis 108 can be the result of plaque accumulation, and plaque includes but not limited to plaque components such as fiber, fiber-lipid (fibrous fat), necrotic cells, calcification (dense calcium), blood, fresh thrombus and mature thrombus. Typically, the composition of the stenosis will depend on the type of tube being assessed. In this respect, it should be understood that the concept of the present disclosure is actually applicable to any type of blockage or other narrowing that causes fluid flow to decline of the tube.

[0029] More specifically refer to Figure 2 , the lumen 106 of the tube 100 has a diameter 110 proximal to the stenosis 108 and a diameter 112 distal to the stenosis. In some cases, diameters 110 and 112 are substantially equal to each other. In this regard, diameters 110 and 112 are intended to represent healthy portions of the lumen 106, or at least portions that are healthier than the stenosis 108. Therefore, these healthier portions of the lumen 106 are shown as having a substantially constant cylindrical profile, and thus, the height or width of the lumen is referred to as the diameter. However, it should be understood that in many cases, these portions of the lumen 106 may also have plaque accumulation, asymmetric profiles, and / or other irregularities, but to a lesser extent than the stenosis 108 and therefore will not have a cylindrical profile. In such cases, diameters 110 and 112 should be understood to represent the relative size or cross-sectional area of the lumen and do not imply a circular cross-sectional profile.

[0030] like Figure 2As shown, the stenosis 108 includes a plaque accumulation 114 that narrows the lumen 106 of the tube 100. In some cases, the plaque accumulation 114 does not have a uniform or symmetrical profile, making angiographic assessment of such a stenosis potentially unreliable. In the illustrated embodiment, the plaque accumulation 114 includes an upper portion 116 and an opposing lower portion 118. In this regard, the lower portion 118 has an increased thickness relative to the upper portion 116, resulting in an asymmetric and uneven profile relative to the portions of the lumen proximal and distal to the stenosis 108. As shown, the plaque accumulation 114 reduces the space available for fluid flow through the lumen 106. In particular, the plaque accumulation 114 reduces the cross-sectional area of the lumen 106. At its narrowest point between the upper portion 116 and the lower portion 118, the lumen 106 has a height 120, which represents a reduced size or cross-sectional area relative to the diameters 110 and 112 proximal and distal to the stenosis 108. It should be noted that the stenosis 108 including the plaque buildup 114 is exemplary in nature and should not be considered limiting in any way. In this regard, it should be understood that in other cases the stenosis 108 has other shapes and / or compositions that restrict fluid flow through the lumen 106. Although in Figure 1 and Figure 2 A tube 100 having a single stenosis 108 is shown in FIG, and the following embodiments are described primarily in the context of a single stenosis, but it should be understood that the devices, systems, and methods described herein have similar applications for tubes having multiple stenosis areas.

[0031] Now refer to Figure 3 , shows tube 100 having instruments 130 and 132 according to embodiments of the present disclosure positioned therein. Generally, instruments 130 and 132 can be any form of device, instrument, or probe that is sized and shaped to be positioned within a tube. In the illustrated embodiment, instrument 130 generally represents a guidewire, while instrument 132 generally represents a catheter. In this regard, instrument 130 extends through a central lumen of instrument 132. However, in other embodiments, instruments 130 and 132 take other forms. In this regard, in some embodiments, instruments 130 and 132 are of similar forms. For example, in some cases, instruments 130 and 132 are both guidewires. In other cases, instruments 130 and 132 are both catheters. On the other hand, in some embodiments, such as the illustrated embodiment, instruments 130 and 132 are of different forms, where one instrument is a catheter and the other instrument is a guidewire. Furthermore, in some cases, such as Figure 3In the illustrated embodiment, the instruments 130 and 132 are arranged coaxially with each other. In other cases, one instrument extends through an eccentric lumen of the other instrument. In other cases, the instruments 130 and 132 extend side by side. In some specific embodiments, at least one of the instruments is a rapid-change device, such as a rapid-change catheter. In such embodiments, the other instrument is a double guidewire or other device configured to facilitate the introduction and removal of a rapid-change device. In addition, in other cases, a single instrument is utilized instead of two separate instruments 130 and 132. In some embodiments, a single instrument combines the various functions (e.g., data acquisition) of the two instruments 130 and 132.

[0032] The instrument 130 is configured to obtain diagnostic information about the tube 100. In this regard, the instrument 130 includes one or more sensors, transducers, and / or other monitoring elements configured to obtain diagnostic information about the tube. The diagnostic information includes one or more of: pressure, flow (velocity), images (including images obtained using ultrasound (e.g., IVUS), OCT, thermal and / or other imaging techniques), temperature, and / or a combination thereof. In some cases, the one or more sensors, transducers, and / or other monitoring elements are positioned at a distal portion of the instrument 130. In this regard, in some cases, the one or more sensors, transducers, and / or other monitoring elements are positioned at a distance of less than 30 cm, less than 10 cm, less than 5 cm, less than 3 cm, less than 2 cm, and / or less than 1 cm from the distal end 134 of the instrument 130. In some cases, at least one of the one or more sensors, transducers, and / or other monitoring elements is positioned at the distal end of the instrument 130.

[0033] The device 130 includes at least one element configured to monitor pressure within the vessel 100. The pressure monitoring element can take the form of a piezoresistive pressure sensor, a piezoelectric pressure sensor, a capacitive pressure sensor, an electromagnetic pressure sensor, a fluid column (the fluid column is connected to a fluid column sensor that is separate from the device and / or located at a portion of the device proximal to the fluid column), an optical pressure sensor, and / or a combination thereof. In some cases, one or more features of the pressure monitoring element are implemented as a solid-state component manufactured using semiconductors and / or other suitable manufacturing techniques. Examples of commercially available guidewire products that include suitable pressure monitoring elements include, but are not limited to, the PrimeWire available from Volcano Corporation. Pressure guide wire, Pressure guidewire and XT pressure and flow guidewires, as well as PressureWire™ Certus and PressureWire™ Aeris guidewires available from St. Jude Medical, Inc. Typically, the device 130 is sized so that it can be positioned through the stenosis 108 without significantly affecting fluid flow through the stenosis, which would affect distal pressure readings. Thus, in some cases, the device 130 has an outer diameter of 0.018" or less. In some embodiments, the device 130 has an outer diameter of 0.014" or less.

[0034] Instrument 132 is also configured to obtain diagnostic information about tube 100. In some cases, instrument 132 is configured to obtain the same diagnostic information as instrument 130. In other cases, instrument 132 is configured to obtain different diagnostic information than instrument 130, which may include additional diagnostic information, less diagnostic information, and / or alternative diagnostic information. The diagnostic information obtained by instrument 132 may include one or more of pressure, flow (velocity), images (including images obtained using ultrasound (e.g., IVUS), OCT, thermal, and / or other imaging techniques), temperature, and / or combinations thereof. Instrument 132 includes one or more sensors, transducers, and / or other monitoring elements configured to obtain this diagnostic information. In this regard, in some cases, the one or more sensors, transducers, and / or other monitoring elements are positioned at a distal portion of instrument 132. In this regard, in some cases, the one or more sensors, transducers, and / or other monitoring elements are positioned less than 30 cm, less than 10 cm, less than 5 cm, less than 3 cm, less than 2 cm, and / or less than 1 cm from the distal tip 136 of instrument 132. In some cases, at least one of one or more sensors, transducers, and / or other monitoring elements is positioned at the distal tip of instrument 132 .

[0035] With respect to the illustrated embodiment, similar to instrument 130, instrument 132 also includes at least one element configured to monitor the pressure within tube 100. The pressure monitoring element may take the form of a piezoresistive pressure sensor, a piezoelectric pressure sensor, a capacitive pressure sensor, an electromagnetic pressure sensor, a fluid column (the fluid column is in communication with the fluid column sensor, the fluid column sensor is separate from the instrument and / or is located at a portion of the instrument proximal to the fluid column), an optical pressure sensor, and / or combinations thereof. In some cases, one or more features of the pressure monitoring element are implemented as a solid-state component manufactured using semiconductor and / or other suitable manufacturing technologies. In some cases, currently available catheter products that can be used with one or more of the Siemens AXIOM Sensis, Mennen Horizon XVu, and Philips Xper IM Physiomonitoring 5 and include a pressure monitoring element may be used with instrument 132. Additionally, in other embodiments, instrument 132 and / or instrument 130 include, for example, a flow sensor or an imaging sensor.

[0036] According to various aspects of the present disclosure, at least one of the instruments 130 and 132 is configured to monitor pressure within the tube 100 distal to the stenosis 108 and at least one of the instruments 130 and 132 is configured to monitor pressure within the tube proximal to the stenosis. In this regard, the instruments 130, 132 are sized and shaped to allow positioning of the at least one element configured to monitor pressure within the tube 100 to be positioned proximal and / or distal to the stenosis 108, as desired based on the configuration of the device. In this regard, Figure 3 A location 138 is shown suitable for measuring pressure distal to the stenosis 108. In this regard, in some cases, the location 138 is aligned with the stenosis 108 (e.g., Figure 2 The distal ends of the devices (as shown) are less than 5 cm, less than 3 cm, less than 2 cm, less than 1 cm, less than 5 mm and / or less than 2.5 mm apart. Figure 3Also shown are a number of suitable locations for measuring pressure proximal to the stenosis 108. In this regard, locations 140, 142, 144, 146, and 148 each represent a location suitable for monitoring pressure proximal to the stenosis in some cases. In this regard, locations 140, 142, 144, 146, and 148 are positioned at varying distances from the proximal end of the stenosis 108, ranging from greater than 20 centimeters down to approximately 5 millimeters or less. Typically, proximal pressure measurements are performed at a distance from the proximal end of the stenosis that is equal to or greater than the inner diameter of the tube lumen. In the case of coronary pressure measurements, proximal pressure measurements are typically performed within the proximal portion of the tube, proximal to the stenosis and distal to the aorta. However, in some specific cases of coronary pressure measurements, proximal pressure measurements are performed from a location within the aorta. In other cases, proximal pressure measurements are performed at the root or ostium of the coronary artery.

[0037] In some embodiments, at least one of instruments 130 and 132 is configured to monitor the pressure within tube 100 while moving through lumen 106. In some cases, instrument 130 is configured to move through lumen 106 and across stenosis 108. In this regard, in some cases, instrument 130 is positioned distal to stenosis 108 and is moved proximally (i.e., pulled back) across the stenosis to a position proximal to the stenosis. In other cases, instrument 130 is positioned proximal to stenosis 108 and is moved distally across the stenosis to a position distal to the stenosis. In some embodiments, movement of instrument 130, whether proximally or distally, is manually controlled by medical personnel (e.g., the hands of a surgeon). In other embodiments, movement of instrument 130, whether proximally or distally, is controlled by a movement control device (e.g., a pullback device, such as a Trak II device). In this regard, in some cases, the movement control device controls the movement of the instrument 130 at a selectable and known speed (e.g., 2.0 mm / s, 1.0 mm / s, 0.5 mm / s, 0.2 mm / s, etc.). In some cases, the movement of the instrument 130 through the tube is continuous with each pullback or push. In other cases, the instrument 130 is moved through the tube in a stepwise manner (i.e., repeatedly moved a fixed amount of distance and / or a fixed amount of time). Some aspects of the visual representation discussed below are particularly suitable for embodiments in which at least one of the instruments 130 and 132 is moved through the lumen 106. Furthermore, in some specific cases, many aspects of the visual representation discussed below are particularly suitable for embodiments in which a single instrument is moved through the lumen 106, regardless of whether a second instrument is present.

[0038] In some cases, using a single instrument has the advantage that it can avoid or reduce problems associated with variations in pressure measurements of one instrument relative to another instrument. For example, in some cases, relative changes in pressure are obtained using a single instrument as it is moved through the tube so that the time period between pressure measurements is sufficiently short (e.g., less than 500 ms, less than 100 ms, less than 50 ms, less than 10 ms, less than 5 ms, less than 1 ms, or other) to prevent any effect of any variations in the pressure sensitivity of the instrument.

[0039] Physicians can use a variety of tools to evaluate and / or diagnose blood vessels. In this regard, physiological data (such as pressure, flow, temperature, or other physiological measurements) can be used to evaluate the function or performance of the blood vessel. In addition, intravascular imaging (including IVUS and OCT) can be used to obtain more details of the size and structure within the blood vessel to determine, for example, the risk of blockage. When evaluating the vessel, the physician may wish to focus the evaluation on specific areas of the vasculature that are associated with narrowing or lesions in the vessel. These areas of interest can be identified or designated using external imaging (such as angiography) for further analysis. In this regard, Figure 4A and Figure 4B Different intravascular data acquisition devices that can be used to evaluate the vessel are shown.

[0040] Now refer to Figure 4A , which shows a system 150 according to an embodiment of the present disclosure. In this regard, Figure 4Ais a schematic diagram of system 150. As shown, system 150 includes an instrument 152. In some cases, instrument 152 is suitable for use as at least one of instruments 130 and 132 discussed above. Thus, in some cases, instrument 152 includes features similar to those discussed above with respect to instruments 130 and 132. In the illustrated embodiment, instrument 152 is a guidewire having a distal portion 154 and a housing 156 positioned adjacent the distal portion. Housing 156 is spaced approximately 3 centimeters from the distal end of instrument 152. Housing 156 is configured to house one or more sensors, transducers, and / or other monitoring elements configured to obtain diagnostic information about the vessel. In the illustrated embodiment, housing 156 includes at least one pressure sensor configured to monitor the pressure within the lumen of the vessel in which instrument 152 is positioned. A shaft 158 extends proximally from housing 156. A torque device 160 is positioned on and coupled to the proximal portion of shaft 158. The proximal portion 162 of the instrument 152 is coupled to a connector 164. A cable 166 extends from the connector 164 to a connector 168. In some cases, the connector 168 is configured to be plugged into an interface 170. In this regard, the interface 170 can be a patient interface module (PIM). In some cases, the cable 166 is replaced with a wireless connection. In this regard, it should be understood that various communication paths between the instrument 152 and the interface 170 can be utilized, including physical connections (including electrical, optical, and / or fluid connections), wireless connections, and / or combinations thereof.

[0041] The interface 170 is communicatively coupled to a computing device 172 via a connection 174. The computing device 172 generally represents any device suitable for performing the processing and analysis techniques discussed in the present disclosure. In some embodiments, the computing device 172 includes a processor, random access memory, and storage media. In this regard, in some specific cases, the computing device 172 is programmed to perform the steps associated with the data acquisition and analysis described herein. Therefore, it should be understood that any steps related to data acquisition, data processing, instrument control, and / or other processing or control aspects of the present disclosure can be implemented by the computing device using corresponding instructions stored on or within a non-transitory computer-readable medium accessible to the computing device. In some cases, the computing device 172 is a console device. In some specific cases, the computing device 172 is similar to an s5 TM Imaging system or s5i TMimaging system, each of which is available from Volcano Corporation, or a CORE, CORE MOBILE, CORE M2, or IntraSight system available from Koninklijke Philips, NV, in some cases, the computing device 172 is portable (e.g., handheld, on a cart, etc.). Furthermore, it should be understood that in some cases, the computing device 172 includes multiple computing devices. In this regard, it should be particularly understood that multiple computing devices can be used to implement different processing and / or control aspects of the present disclosure, either individually or within predefined groupings. For example, in some embodiments, the computing device 172 includes two different computing components or devices that communicate with each other. Any division and / or combination of the processing and / or control aspects described below across multiple computing devices is within the scope of the present disclosure.

[0042] Connector 164, cable 166, connector 168, interface 170, and connection 174 together facilitate communication between one or more sensors, transducers, and / or other monitoring elements of apparatus 152 and computing device 172. However, this communication path is exemplary in nature and should not be considered limiting in any way. In this regard, it should be understood that any communication path between apparatus 152 and computing device 172 can be utilized, including physical connections (including electrical, optical, and / or fluid connections), wireless connections, and / or combinations thereof. In this regard, it should be understood that in some cases, connection 174 is wireless. In some cases, connection 174 includes a communication link through a network (e.g., an intranet, the Internet, a telecommunications network, and / or other network). In this regard, it should be understood that in some cases, computing device 172 is located away from the operating area where apparatus 152 is being used. Enabling connection 174 to include a connection through a network can facilitate communication between apparatus 152 and remote computing device 172, regardless of whether the computing device is in an adjacent room, adjacent building, or in a different state / country. Additionally, it should be understood that in some cases, the communication path between the appliance 152 and the computing device 172 is a secure connection. Still further, it should be understood that in some cases, data communicated on one or more portions of the communication path between the appliance 152 and the computing device 172 is encrypted.

[0043] System 150 also includes an instrument 175. In this regard, in some cases, instrument 175 is suitable for use as at least one of instruments 130 and 132 described above. Thus, in some cases, instrument 175 includes features similar to those discussed above with respect to instruments 130 and 132. In the illustrated embodiment, instrument 175 is a catheter-type device. In this regard, instrument 175 includes one or more sensors, transducers, and / or other monitoring elements located adjacent to a distal portion of the instrument, configured to obtain diagnostic information about the tube. In the illustrated embodiment, instrument 175 includes a pressure sensor configured to monitor the pressure within the lumen of the tube in which instrument 175 is positioned. Instrument 175 communicates with interface 176 via connection 177. In some cases, interface 176 is a hemodynamic monitoring system or other control device, such as a Siemens AXIOM Sensis, Mennen Horizon XVu, or Philips Xper IM Physiomonitoring 5. In one particular embodiment, instrument 175 is a pressure-sensing catheter comprising a column of fluid extending along its length. In such an embodiment, the interface 176 includes a hemostatic valve fluidically coupled to the fluid column of the catheter, a manifold fluidically coupled to the hemostatic valve, and tubing extending between the components as needed to fluidically couple the components. In this regard, the fluid column of the catheter is in fluid communication with the pressure sensor via the valve, manifold, and tubing. In some cases, the pressure sensor is part of the interface 176. In other cases, the pressure sensor is a separate component positioned between the instrument 175 and the interface 176. The interface 176 is communicatively coupled to the computing device 172 via connection 178.

[0044] Similar to the connection between instrument 152 and computing device 172, interface 176 and connections 177 and 178 facilitate communication between one or more sensors, transducers, and / or other monitoring elements of instrument 175 and computing device 172. However, this communication path is exemplary in nature and should not be considered limiting in any way. In this regard, it should be understood that any communication path between instrument 175 and computing device 172 can be utilized, including physical connections (including electrical, optical, and / or fluidic connections), wireless connections, and / or combinations thereof. In this regard, it should be understood that in some cases, connection 178 is wireless. In some cases, connection 178 comprises a communication link via a network (e.g., an intranet, the Internet, a telecommunications network, and / or other network). In this regard, it should be understood that in some cases, computing device 172 is located remotely from the operating area where instrument 175 is being used. Enabling connection 178 to comprise a connection via a network can facilitate communication between instrument 175 and remote computing device 172, regardless of whether the computing device is in an adjacent room, adjacent building, or in a different state / country. Additionally, it should be understood that in some cases, the communication path between the device 175 and the computing device 172 is a secure connection. Still further, it should be understood that in some cases, data communicated on one or more portions of the communication path between the device 175 and the computing device 172 is encrypted.

[0045] Computing device 172 also communicates with an extraluminal imaging system 180, which obtains extraluminal images of body lumens. Extraluminal imaging system 180 communicates with computing device 172 via a communication link 184, which can be wireless or wired, as similarly described above. In some embodiments, extraluminal imaging system 180 includes imaging device 182 and / or processing hardware and software to control the operation of the imaging device and / or generate extraluminal images. Extraluminal imaging system 180 may be an extravascular imaging system that obtains extravascular images of blood vessels. In some embodiments, computing device 172 is contained within a single housing. This single housing may include processing hardware and software associated with both intravascular data and extravascular imaging. In some embodiments, computing device 172 includes multiple housings that communicate with each other. One housing may include processing hardware and software associated with intravascular data, while another housing may include processing hardware and software associated with extravascular imaging. In this case, one processing system may be associated with intravascular data, while another processing system may be associated with extravascular imaging.

[0046] Computing device 172 receives extravascular images from extravascular imaging system 180. Extravascular imaging device 182 can obtain images of body lumens when positioned outside the patient's body. Computing device 172 can generate extravascular images from data obtained by extravascular imaging device 182. For example, computing device 172 can receive and process electrical signals from extravascular imaging device 182 that represent anatomical structures in the extravascular image and output the extravascular image. In some cases, extravascular imaging device 182 and / or a processing system associated with extravascular imaging device 182 generates the extravascular image and transmits the extravascular image to computing device 172. Examples of extravascular imaging devices include external ultrasound, x-ray, angiography, fluoroscopy, computed tomography (CT), and / or magnetic resonance imaging (MRI) devices. Angiographic or arteriographic imaging techniques are used to visualize the interior of the lumens of blood vessels and other organs of the body, with particular attention to arteries, veins, and ventricles. This is traditionally done by injecting a radiopaque contrast agent into the blood vessels and imaging them using x-ray based techniques. An angiogram is an image of a tube with a contrast agent so that the outline of the tube is visible in the x-ray image. For example, an angiogram can be of any suitable type, including digital subtraction angiography. Fluoroscopy uses x-rays to obtain real-time moving images of the inside of the tube. In some cases, fluoroscopy is performed without the injection of a contrast agent. One or more of these techniques allow the interventional radiologist or cardiologist to see stenosis (blockage or narrowing) inside the tube, which may inhibit blood flow and cause pain.

[0047] It should be understood that in other embodiments of the present disclosure, one or more components of system 150 are not included, are implemented in a different arrangement / order, and / or are replaced by alternative devices / mechanisms. For example, in some cases, system 150 does not include interface 170 and / or interface 176. In this case, connector 168 (or other similar connector that communicates with instrument 152 or instrument 175) can be plugged into a port associated with computing device 172. Alternatively, instruments 152, 175 can communicate wirelessly with computing device 172. In general, the communication path between one or both of instruments 152, 175 and computing device 172 can have no intermediate nodes (i.e., a direct connection), one intermediate node between the instrument and the computing device, or multiple intermediate nodes between the instrument and the computing device.

[0048] Figure 4Bis a diagrammatic illustration of an ultrasound imaging system 500 according to aspects of the present disclosure. The ultrasound imaging system 500 can be an intraluminal imaging system. In some cases, the system 500 can be an intravascular ultrasound (IVUS) imaging system. The system 500 can include an intraluminal imaging device 502 (e.g., a catheter, guidewire, or guide catheter), a patient interface module (PIM) 504, a processing system or console 506, an extraluminal imaging system 503, and a monitor 508. The intraluminal imaging device 502 can be an ultrasound imaging device. In some cases, the device 502 can be an IVUS imaging device, such as a solid-state IVUS device.

[0049] At a high level, the IVUS device 502 transmits ultrasonic energy or ultrasonic signals from a transducer or transducer array 524 included in a scanner assembly 510 mounted near the distal end of the catheter device 502. In some embodiments, the transducer or transducer array comprises a single transducer element. In other embodiments, the transducer array comprises multiple transducer elements. The ultrasonic energy is reflected by tissue structures (such as a tube 520 or another body lumen) in the medium surrounding the scanner assembly 510, and the ultrasonic echo signals are received by the transducer array 524. In this regard, the device 502 can be sized, shaped, or otherwise configured to be positioned within a patient's body lumen. The PIM 504 transmits the received echo signals to a console or computer 506, where an ultrasound image (including flow information) is reconstructed and displayed on a monitor 508. The console or computer 506 can include a processor and memory. The computer or computing device 506 can be operable to facilitate the features of the IVUS imaging system 500 described herein. For example, a processor may execute computer-readable instructions stored on a non-transitory tangible computer-readable medium.

[0050] The PIM 504 facilitates signal communication between the IVUS console 506 and the scanner assembly 510 included in the IVUS device 502. This communication includes the following steps: (1) providing commands to an integrated circuit controller chip included in the scanner assembly 510 to select specific transducer array elements or acoustic elements for transmission and reception, (2) providing a transmit trigger signal to an integrated circuit controller chip included in the scanner assembly 510 to activate the transmitter circuit to generate an electrical pulse for stimulating the selected transducer array element, and / or (3) receiving amplified echo signals received from the selected transducer array element via an amplifier on the integrated circuit controller chip included in the scanner assembly 510. In some embodiments, the PIM 504 performs preliminary processing of the echo data before forwarding the data to the console 506. In an example of such an embodiment, the PIM 504 performs amplification, filtering, and / or aggregation of the data. In one embodiment, the PIM 504 also provides high-voltage and low-voltage DC power to support the operation of the device 502, including the circuits located within the scanner assembly 510.

[0051] IVUS console 506 receives echo data from scanner assembly 510 via PIM 504 and processes the data to reconstruct an image of tissue structures located in the medium surrounding scanner assembly 510. Console 506 outputs the image data, such that an image of tube 520, such as a cross-sectional image of tube 120, is displayed on monitor 508. Tube 520 can represent a structure filled or surrounded by fluid, both natural and artificial. Tube 520 can be within a patient's body. Tube 520 can be a blood vessel, such as an artery or vein, of the patient's vasculature, including the cardiac vasculature, peripheral vasculature, neural vasculature, renal vasculature, and / or any other suitable lumen within the body. For example, device 502 can be used to examine any number of anatomical locations and tissue types, including, but not limited to: organs, including the liver, heart, kidneys, gallbladder, pancreas, and lungs; ducts; intestines; nervous system structures, including the brain, dural sac, spinal cord, and peripheral nerves; the urinary tract; and valves within the bloodstream, chambers, or other parts of the heart, and / or other systems of the body. In addition to natural structures, device 502 may also be used to inspect artificial structures such as, but not limited to, heart valves, stents, shunts, filters, and other devices.

[0052] The processing system 506 also communicates with the extraluminal imaging system 503, which obtains extraluminal images of the body lumen. The extraluminal imaging system 503 communicates with the processing system 506 via a communication link, which can be wireless or wired, as similarly described above. In some embodiments, the extraluminal imaging system 503 includes an imaging device and / or processing hardware and software to control the operation of the imaging device and / or generate extraluminal images. The extraluminal imaging system 503 can be an extravascular imaging system that obtains extravascular images of blood vessels. In some embodiments, the processing system 506 is contained within a single housing. The single housing can include processing hardware and software associated with both intravascular data and extravascular imaging. In some embodiments, the processing system 506 includes multiple housings that communicate with each other. One housing can include processing hardware and software associated with intravascular data, while another housing can include processing hardware and software associated with extravascular imaging. In this case, one processing system can be associated with intravascular data, while another processing system can be associated with extravascular imaging.

[0053] The processing system 506 receives the extravascular image from the extravascular imaging system 503. The extravascular imaging device can obtain images of the body lumen when positioned outside the patient's body. The processing system 506 can generate the extravascular image from the data obtained by the extravascular imaging device. For example, the processing system 506 can receive and process electrical signals from the extravascular imaging device that represent anatomical structures in the extravascular image and output the extravascular image. In some cases, the extravascular imaging device generates the extravascular image and transmits the extravascular image to the processing system 506. Examples of extravascular imaging devices include external ultrasound, x-ray, angiography, fluoroscopy, computed tomography (CT), and / or magnetic resonance imaging (MRI) devices. Angiographic or arterial imaging techniques are used to visualize the interior of the lumen of blood vessels and other organs of the body, with particular attention to arteries, veins, and ventricles. This is traditionally performed by injecting a radiopaque contrast agent into the blood vessels and imaging using x-ray-based techniques. Angiography is an image of a tube with a contrast agent so that the outline of the tube is visible in an x-ray image. For example, angiography can be of any suitable type, including digital subtraction angiography. Fluoroscopy uses x-rays to obtain real-time moving images of the inside of a tube. In some cases, fluoroscopy is performed without the injection of a contrast agent. One or more of these techniques allow an interventional radiologist or cardiologist to see a stenosis (blockage or narrowing) inside the tube, which can inhibit blood flow and cause pain.

[0054] In some embodiments, the IVUS device includes features similar to those of conventional solid-state IVUS catheters, such as those available from Koninklijke Philips NV. Catheter and those disclosed in U.S. Patent No. 7,846,101, which is hereby incorporated by reference in its entirety. For example, the IVUS device 502 includes a scanner assembly 510 near the distal end of the device 502 and a transmission line bundle 512 extending along the longitudinal body of the device 502. The transmission line bundle or cable 512 may include multiple conductors, including one, two, three, four, five, six, seven or more conductors. It should be understood that the wire of any suitable size can be used for the conductor. In one embodiment, the cable 512 may include a four-conductor transmission line arrangement with a wire of, for example, 41 American wire gauge (AWG). In one embodiment, the cable 512 may include a seven-conductor transmission line arrangement using a wire of, for example, 44AWG. In some embodiments, a wire of 43AWG may be used.

[0055] The transmission harness 512 terminates in a PIM connector 514 at the proximal end of the device 502. The PIM connector 514 electrically couples the transmission harness 512 to the PIM 504 and physically couples the IVUS device 502 to the PIM 504. In one embodiment, the IVUS device 502 also includes a guidewire exit port 516. Thus, in some cases, the IVUS device is a rapid exchange catheter. The guidewire exit port 516 allows for the distal insertion of a guidewire 518 to guide the device 502 through the tube 520.

[0056] In one embodiment, the processing system 506 generates flow data by processing the echo signals from the IVUS device 502 into Doppler power or velocity information. The processing system 506 can also generate B-mode data by applying envelope detection and logarithmic compression to the conditioned echo signals. The processing system 506 can also generate images in various views based on the flow data or B-mode data, such as 2D and / or 3D views. The processing system 506 can also perform various analyses and / or assessments. For example, the processing system 506 can apply virtual histology (VH) technology, such as analyzing or assessing plaques within a tube (e.g., tube 520). An image can be generated to display a reconstructed color-coded tissue map formed by plaque components superimposed on a cross-sectional view of the tube.

[0057] In one embodiment, the processing system 506 can apply a blood flow detection algorithm (e.g., ChromaFlo) to determine the movement of blood flow, for example, by repeatedly acquiring image data of a target region (e.g., vessel 520) and determining the movement of blood flow based on the image data. The blood flow detection algorithm operates on the principle that the signal measured from vascular tissue is relatively static between each acquisition, while the signal measured from blood flow changes at a characteristic rate corresponding to the flow velocity. Therefore, the blood flow detection algorithm can determine the movement of blood flow based on the change in the signal measured from the target region between repeated acquisitions. To repeatedly acquire image data, the processing system 506 can control the device 502 to transmit repeated pulses at the same aperture.

[0058] Although the present disclosure describes embodiments related to intravascular ultrasound (IVUS) imaging using an intravascular catheter or guidewire, it should be understood that one or more aspects of the present disclosure can be implemented in any suitable ultrasound imaging system, including a synthetic aperture ultrasound imaging system, a phased array ultrasound imaging system, or any other array-based ultrasound imaging system. For example, various aspects of the present disclosure can be implemented in an intraluminal ultrasound imaging system using an intracardiac (ICE) echocardiography catheter and / or a transesophageal echocardiography (TEE) probe, and / or an external ultrasound imaging system using an ultrasound probe configured for imaging when positioned adjacent to and / or in contact with a patient's skin. In some embodiments, the ultrasound imaging device can be a transthoracic echocardiography (TTE) imaging device.

[0059] The ultrasonic transducer array of the ultrasound imaging device includes an array of acoustic elements configured to transmit ultrasonic energy and receive echoes corresponding to the transmitted ultrasonic energy. In some cases, the array may include any number of ultrasonic transducer elements. For example, the array may include values between 2 acoustic elements and 100,000 acoustic elements, including values such as 2 acoustic elements, 4 acoustic elements, 64 acoustic elements, 128 acoustic elements, 500 acoustic elements, 812 acoustic elements, 3,000 acoustic elements, 10,000 acoustic elements, 20,000 acoustic elements, 50,000 acoustic elements, 65,000 acoustic elements, and / or other values that are larger or smaller. In some cases, the transducer elements of the array can be arranged in any suitable configuration, such as a linear array, a planar array, a curved array, a curvilinear array, a circular array, an annular array, a phased array, a matrix array, a one-dimensional (1D) array, a 1.x-dimensional array (e.g., a 1.5D array), or a two-dimensional (2D) array. The array of transducer elements (e.g., one or more rows, one or more columns, and / or one or more orientations) can be controlled and activated uniformly or independently. The array can be configured to obtain one-dimensional, two-dimensional, and / or three-dimensional images of the patient's anatomical structure.

[0060] The ultrasonic transducer elements may include piezoelectric / piezoresistive elements, piezoelectric micromachined ultrasonic transducer (PMUT) elements, capacitive micromachined ultrasonic transducer (CMUT) elements, and / or any other suitable type of ultrasonic transducer element. The ultrasonic transducer elements of the array communicate with (e.g., are electrically coupled to) an electronic circuit. For example, the electronic circuit may include one or more transducer control logic chips. The electronic circuit may include one or more integrated circuits (ICs), such as application specific integrated circuits (ASICs). In some embodiments, one or more ICs may include a microbeamformer (μBF). In other embodiments, one or more ICs include a multiplexer circuit (MUX).

[0061] Figure 5 is a schematic diagram of a processor circuit 600 according to an embodiment of the present disclosure. The processor circuit 600 may be Figure 4A The computing device 172, interfaces 170 and 176, intraluminal device 152 and / or extraluminal imaging system 175 are shown, or Figure 4B The processing circuit 600 is implemented in the processing system 506 or extraluminal imaging system 506 as shown. As shown, the processor circuit 600 may include a processor 602, a memory 604, and a communication module 608. These elements may communicate with each other directly or indirectly, such as via one or more buses.

[0062] The processor 602 may include a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, an FPGA, another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein. The processor 602 may also be implemented as a combination of computing devices, for example, a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0063] The memory 604 may include cache memory (e.g., cache memory of the processor 602), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, solid-state storage, a hard drive, other forms of volatile and non-volatile memory, or a combination of different types of memory. In one embodiment, the memory 604 includes a non-transitory computer-readable medium. The memory 604 may store instructions 606. The instructions 606 may include instructions that, when executed by the processor 602, cause the processor 602 to perform the operations referred to herein. Figure 4A The computing device 172, the extraluminal imaging system 180 and / or the intraluminal device 152 or Figure 4BInstructions 606 may also be referred to as code. The terms "instructions" and "code" should be interpreted broadly to include any type of computer-readable statements. For example, the terms "instructions" and "code" may refer to one or more programs, routines, subroutines, functions, procedures, etc. "Instructions" and "code" may include a single computer-readable statement or many computer-readable statements.

[0064] The communication module 608 may include any electronic circuitry and / or logic circuitry to facilitate direct or indirect communication of data between the processor circuit 600 and the computing device 172, the intraluminal device 152 or the processing system 506, the imaging device 502, and / or the monitor 508. In this regard, the communication module 608 may be an input / output (I / O) device. In some cases, the communication module 608 facilitates communication between various elements of the processor circuit 600 and / or the Figure 4A and Figure 4B Direct or indirect communication between components of the system shown in .

[0065] Figure 6 is a flow chart of a method for controlling the acquisition of intraluminal data according to an embodiment of the present disclosure. The decision method 700 includes exemplary steps that can simplify the workflow of a characterization laboratory by automating a portion of the data acquisition process. In some embodiments, the steps of the method 700 can be performed by Figure 3 、 Figure 4A and Figure 4B One or more components of the apparatus explained in Figure 5 It should be understood that the steps of method 700 may be performed in the same manner as described above. Figure 6The steps described herein may be performed in a different order than shown, additional steps may be provided before, during, or after the steps described, and / or some of the steps described may be replaced or eliminated in other embodiments. In step 702, the processor circuit receives extravascular image data (e.g., angiographic image data) representing the patient's vasculature. In some embodiments, the processor circuit may receive the extravascular image data from an extravascular imaging device (e.g., an X-ray imaging device, a computed tomography (CT) device, or any other suitable imaging device). For example, the extravascular image data may include one or more angiographic image frames in which a contrast agent has been introduced into the patient's vasculature. In some embodiments, the processor circuit receives a plurality of extravascular image frames acquired at corresponding times. For example, the plurality of extravascular image frames may represent the patient's vasculature at different times during cyclical motion of the patient, such as heartbeat, respiration, etc. Accordingly, the processor circuit may identify or designate one of the image frames as a roadmap image based on various parameters of the image frames (including contrast, intensity, amount of contrast agent, etc.). Furthermore, the processor circuit may identify or designate a roadmap image for a plurality of different time points during the patient's cyclical motion (e.g., heartbeat, respiration, etc.). In some embodiments, once a roadmap image has been specified, the processor circuit performs image processing on the roadmap image to identify vessels in the image. For example, the processor circuit can be configured to perform segmentation, QCA, or any other suitable image processing technique to identify vessel shapes and paths in the roadmap image.

[0066] At step 704, the processor circuit identifies a region of interest (ROI) for the vessel. In some embodiments, the processor circuit identifies or specifies the ROI based on input received from a user input device. For example, a user may select a region of the vascular system using a mouse, trackball, touchpad, keyboard, or any suitable peripheral interface device. In some embodiments, the user interface device includes a touchscreen display, and the user inputs the selection of the ROI by touching a location or area on the screen. In some embodiments, the user input identifies a proximal point and a distal point on the vessel, and the processor circuit identifies the length of the vessel between the proximal and distal points as the ROI. In some embodiments, the user traces the length of the vessel on the touchscreen display to identify the ROI. Furthermore, it should be understood that the processor circuit can be configured to receive multiple inputs corresponding to multiple ROIs. For example, a first ROI may be identified by a first user input associated with a first position of the vessel, while a second ROI may be identified by a second user input associated with a second position of the vessel. In some embodiments, the first and second ROIs may correspond to different vessels or branches of the vascular system.

[0067] In other embodiments, the processor circuit is configured to automatically identify one or more ROIs. For example, based on image processing (e.g., segmentation, QCA), the processor circuit can identify tubes that are at higher risk due to lesions or stenosis. In some embodiments, the processor circuit can evaluate the tube diameter or cross-sectional area at multiple locations to identify narrowed areas of the tube that may include a stenosis or lesion. The processor circuit can then specify one or more ROIs corresponding to the identified stenosis. For example, the processor circuit can specify the ROI as the length of the tube including the stenosis.

[0068] Step 706, inserting an intravascular data acquisition device into the patient's vascular system. The intravascular data acquisition device can be configured to acquire one or more types of data about the tube, such as pressure data, flow data, temperature data, and / or image data. For example, the intravascular data acquisition device can include one or more of a pressure sensing guidewire, a pressure sensing catheter, a flow sensing guidewire, a flow sensing catheter, a temperature sensor, an IVUS imaging catheter, an OCT imaging catheter, a FLIVUS imaging device, or any other suitable device type. The device can include a sensor coupled to a distal end of a flexible, elongated member configured to be positioned within the patient's vascular system. In this regard, the device can include Figure 4A The one or more devices shown in , for example, include instrument 175 and / or instrument 152.

[0069] The device can be inserted under extravascular imaging (e.g., external ultrasound, fluoroscopy, angiography, or any other suitable extravascular imaging modality). For example, the processor circuit can be configured to receive second extravascular imaging data of the vessel from the intravascular data acquisition device. The processor circuit can then register the second extravascular imaging data (e.g., fluoroscopy image data) to the roadmap to provide image-based guidance for the intravascular data acquisition operation. In some embodiments, the intravascular data acquisition device includes one or more markers that are visible in the second extravascular image data. In some embodiments, the processor circuit is configured to provide a screen display to the physician that includes a roadmap image and an indicator of the position of the intravascular data acquisition device in the vessel. In some embodiments, the screen display includes superimposing a current fluoroscopy image on the roadmap image. The screen display can be continuously updated so that the current or real-time position of the marker of the intravascular data acquisition device is displayed at the corresponding position in the roadmap image. In some embodiments, the processor circuit is configured to generate a graphical representation of the intravascular imaging device based on the second extravascular image data. The processor circuit may then generate a screen display to include the graphical representations positioned at the corresponding locations on the roadmap image.In some embodiments, the screen display includes an additional graphical representation of the area of interest identified in step 704.

[0070] At step 708, a pullback operation is initiated. In some embodiments, the pullback is manually performed by the physician. For example, the physician may manually retract or pull the intravascular data acquisition device in a proximal direction. In some embodiments, the pullback is initiated by the physician but automatically controlled by a mechanical actuator (e.g., an electric motor). During the pullback operation, the processor circuit may track the position of the intraluminal device within the vascular system using the second extravascular image data. For example, the position of the intravascular data acquisition device may be tracked using the registered fluoroscopic image data.

[0071] In step 710, the processor circuit determines whether the device has entered the ROI based on the tracked position of the intravascular data acquisition device. In some embodiments, step 710 includes comparing the device's position relative to the ROI with respect to the roadmap. In some embodiments, tracking the device's position includes mapping the device's current position to the position of a vessel segment. For example, in some embodiments, vessel segmentation techniques are used to determine the vessel's centerline, and the device's current position is mapped to the nearest point on the centerline. If the device has entered the ROI, the processor circuit automatically begins receiving intravascular data in step 712. In some embodiments, step 712 includes causing the intravascular data acquisition device to begin acquiring intravascular data, such as pressure data, flow data, IVUS data, OCT data, or any other suitable type of intravascular data. In some embodiments, the intravascular data acquisition device is already acquiring data, and the processor circuit stores the data in memory in response to determining that the device has entered the ROI. In some embodiments, before the intravascular device enters the ROI, intravascular data is being acquired and saved to memory, and the processor circuit is configured to generate a timestamp indicating when the intravascular data acquisition device enters the ROI. This timestamp can then be used to identify intravascular data corresponding to the ROI and exclude intravascular data that does not correspond to the ROI. Referring again to step 710, if the processor instead determines that the intravascular data acquisition device has not entered the ROI, step 710 is repeated in a loop while continuing to pull back until the processor circuit determines that the device has entered the ROI.

[0072] In step 714, the processor circuit determines whether the intravascular data acquisition device has exited the ROI. In some embodiments, the processor circuit can determine whether the device has exited the ROI in a manner similar to that used to determine whether the device has entered the ROI. If the device has exited the ROI, the processor circuit automatically stops receiving intravascular data in step 716. In some embodiments, step 716 includes ceasing storage of the data in memory in response to determining that the device has exited the ROI. In some embodiments, step 716 includes generating a timestamp indicating when the intravascular data acquisition device exited the ROI. This timestamp can then be used along with earlier timestamps generated when the device entered the ROI to determine intravascular data corresponding to the ROI and exclude intravascular data that does not correspond to the ROI. Referring again to step 714, if the processor instead determines that the intravascular data acquisition device has not exited the ROI, step 714 is repeated in a loop while continuing to pull back until the processor circuit determines that the device has exited the ROI.

[0073] In step 718, the processor circuit determines whether intravascular data has been acquired for all identified ROIs. As described above, in some embodiments, the processor circuit identifies multiple ROIs corresponding to different segments of the same vessel and / or segments of different vessels. In an exemplary embodiment in which multiple ROIs are identified on a single vessel or vessel branch, once the processor circuit determines that the intravascular data acquisition device has acquired data for one ROI and exited that ROI, the processor circuit may determine whether there are additional ROIs that have not yet been examined. If all ROIs have been examined, the intravascular data acquisition operation is terminated in step 722. On the other hand, if the processor circuit determines that there are additional ROIs on the vessel that have not yet been examined, the processor circuit continues the pullback operation and repeats the portion of method 700 starting with step 710.

[0074] Figure 7 is a flow chart illustrating a method 800 for controlling intravascular data acquisition. It should be understood that the method 800 may be performed using one or more of the devices and / or systems described above, including the systems 150, 132 and / or the processor circuit 600.

[0075] In step 802, a processor circuit receives first external image data of a blood vessel, such as from an extravascular imaging device (e.g., Figure 4AIn some embodiments, the first external image data comprises one or more angiographic images. In some embodiments, the first external image data comprises 2D image data and / or 3D image data of the vessel. The first external image data may be obtained by various external imaging devices or systems, including an angiographic device, a computed tomography (CT) device, an x-ray imaging device, an ultrasound imaging device, or any other suitable imaging device or system.

[0076] At step 804, the processor circuit generates a roadmap of the vessel using the first external image data. In some embodiments, generating the roadmap includes selecting an image or image frame from the first external image data. For example, the first external image data may include an extravascular angiographic image of the vessel obtained when a contrast agent is introduced into the vessel. Thus, generating the roadmap may include selecting an image from the angiographic image data in which at least a portion of the vessel is visible through the contrast agent. In some embodiments, the processor circuit selects the roadmap image based on the amount of contrast agent observed, a brightness value, a contrast value, or other values derived using image processing. For example, in some embodiments, selecting the roadmap image includes deriving vesselness values for a plurality of angiographic images. For example, the processor circuit may be configured to segment the plurality of external image frames to determine which image frames include a sufficient number of vessels. In some embodiments, the roadmap is selected by identifying the external image that displays the greatest number of vessels or vessel branches. The processor circuit may employ one or more image processing techniques, including Hessian filters, Frangi filters, segmentation, QCA, etc., to identify the roadmap image. Furthermore, in some embodiments, once a roadmap image is selected, generating the roadmap may further include identifying tubes and / or tube branches in the image. For example, generating the roadmap may include identifying and / or specifying tube boundaries and / or centerlines. Tube boundaries and / or centerlines may be identified using, for example, Hessian filters, Frangi filters, segmentation, QCA, etc. Additional description and details regarding generating a roadmap may be found in U.S. Patent No. 9,770,172, issued September 26, 2017, and U.S. Patent No. 9,095,308, issued August 4, 2015, the entire contents of which are incorporated by reference.

[0077] In step 806, the processor circuit identifies or designates a region of interest (ROI) for the vessel on the roadmap. In some embodiments, the ROI may be a branch of the vessel or a length of the vessel associated with a stenosis, lesion, or collapse of the vessel wall. In some embodiments, the ROI may be manually selected by a user via a user interface device. For example, the user may select the ROI while viewing the roadmap image using a mouse, trackball, trackpad, keyboard, touchscreen display, or other user interface device. In some embodiments, identifying the ROI includes receiving one or more user inputs related to a proximal point and / or a distal point of the ROI. For example, in some embodiments, the user may designate or identify the ROI by selecting first and second points on the vessel in the roadmap image, such that the ROI is the length of the vessel between the first and second points. In some embodiments, the user input may include selecting a single point on the vessel in the roadmap image, such that the ROI is identified as the length of the vessel including the selected point. In some embodiments, the user input indicates an area of the image, and the processor circuit designates the length of the vessel near the indicated area as the ROI. In some embodiments, the user input indicates the length of the vessel to be designated as the ROI. For example, a user may track the length of the tube using a mouse, trackball, touchpad, or any other suitable user interface device.

[0078] In further embodiments, the processor circuit is configured to automatically identify or designate a ROI by performing image processing on the roadmap image. For example, the processor circuit may be configured to perform tube segmentation of the roadmap to identify a narrowed region or portion of the tube. For example, in some embodiments, the processor circuit may identify one or more ROIs based on identifying a narrowing of the tube. For example, the processor circuit may determine whether the ratio of the diameter change to the length of the tube exceeds a threshold. Furthermore, in some embodiments, the processor circuit is configured to identify more than one ROI. Multiple ROIs may be identified individually based on user input or automatically by the processor circuit. In some embodiments, the processor circuit is configured to output a graphical representation of one or more ROIs to a display device in communication with the processor circuit. In this regard, Figure 8 A roadmap image 900 of a tube 902 is shown with graphical markers 904, 906 associated with different ROIs superimposed on respective regions of the tube 902. In some embodiments, the processor circuit generates and outputs the graphical markers 904, 906 such that they are positioned on the centerline of the tube. In some embodiments, the processor circuit generates and outputs the markers 904, 906 such that they fill the lumen area of the respective regions of the tube. Figure 9 A roadmap image 1000 of a vessel branch 1002 is shown with a graphical marker 1004 associated with an ROI superimposed on the vessel branch 1004. In this case, the ROI includes a continuous and relatively long segment of the vessel 1002. Figure 8 and Figure 9 In the illustrated embodiment, the indicia 904, 906, and 1004 comprise solid lines. However, it should be understood that other types of indicia may be used. For example, the indicia 904, 906, and 1004 may comprise dashed lines, dotted lines, shapes, patterns, numbers, text, colors, highlights, and / or combinations thereof.

[0079] In step 808, the processor circuit receives second external image data representative of an intravascular data acquisition device positioned within the tube. For example, the second external image data may include fluoroscopic image data of the tube and the intravascular data acquisition device positioned within the tube. In some embodiments, the second external image data and the first external image data are acquired by the same external imaging device, such as an x-ray imaging device or an ultrasound imaging device. For example, in some embodiments, the first external image data includes angiographic image data of the tube acquired by an x-ray imaging device while a contrast agent is present within the vasculature. Thus, the second external image data may include a fluoroscopic image acquired by the same x-ray imaging device after the contrast agent has been removed from the imaged vasculature. In other embodiments, the first external image data and the second external image data are acquired by different imaging devices.

[0080] In step 810, the processor circuit determines whether the intravascular data acquisition device has entered the ROI based on the second external image data. In some embodiments, step 810 also includes registering, transforming, or otherwise modifying the second external image data to spatially match the roadmap. In some embodiments, multiple roadmap images are identified or designated and correspond to different times in the patient's physiological cycle (such as heartbeat or respiration). Therefore, the second external image data can be gated so that each image or image frame in the second external image data matches the roadmap image obtained at the same point in the physiological cycle. Step 810 may involve performing one or more image transformations on the second external image data, including distorting, stretching, compressing, rotating, magnifying, and / or any other suitable image transformation, so that the vasculature structure in the second external image data overlaps with the vasculature structure in the roadmap.

[0081] The processor circuit tracks a position of the intravascular data acquisition device in the second external image data to determine whether the intravascular data acquisition device has entered the ROI. In this regard, the processor circuit can be configured to register the tracked position of the intravascular data acquisition device in the second external image data with the roadmap. Further details and examples regarding registration of extravascular images and / or intravascular data can be found in U.S. Patent No. 7,930,014, issued on April 19, 2011, U.S. Patent No. 8,298,147, issued on October 30, 2012, and U.S. Patent Application Publication No. 2014 / 0276085, filed on March 12, 2014, the entire contents of which are incorporated by reference.

[0082] Tracking the position of the intravascular data acquisition device may include identifying one or more markers of the device in the second external image data. For example, in some embodiments, the intravascular data acquisition device includes one or more radiopaque markers that appear in the fluoroscopic image of the second external image data. By performing image processing on the second external image data, the processor circuit identifies the markers to determine the position of the data acquisition device. Based on the identified markers, the processor circuit determines the position of the intravascular data acquisition device within the vessel relative to the roadmap. In some embodiments, the processor circuit determines the position of the device such that the device position is mapped to the vessel path in the roadmap image. The processor circuit then determines whether the device has entered a region of interest (ROI) based on the determined position of the intravascular data acquisition device. In some embodiments, determining whether the device has entered a ROI includes comparing the determined position of the device relative to the roadmap with the position of the ROI. For example, the processor circuit may use a coordinate system (e.g., a Cartesian coordinate system) in which coordinate values correspond to positions on the roadmap. The processor circuit may compare the coordinate values of the determined position of the device to a range of coordinate values associated with the ROI. If the determined position of the device corresponds to the position of the ROI, the processor circuit may determine that the device has entered the ROI.

[0083] In some embodiments, step 812 includes automatically instructing or controlling the intravascular data acquisition device to begin acquiring intravascular data. The intravascular data acquisition device can acquire intravascular data during a pullback operation in which the intravascular data acquisition device is pulled back through the segment of the tube. In some embodiments, step 812 includes initiating the reception of intravascular data when the intravascular data acquisition device is already acquiring intravascular data. In some embodiments, step 812 includes generating a timestamp to be assigned to the intravascular data to indicate which intravascular data is representative of the ROI and which intravascular data is not representative of the ROI. The intravascular data acquired by the intravascular data acquisition device can be registered to the roadmap by the processor circuit. Therefore, each portion or each point of the intravascular data is associated with a corresponding position of the tube with respect to the roadmap.

[0084] As described above, in some embodiments, the processor circuit is further configured to determine whether the intravascular data acquisition device has left the ROI. In some aspects, the processor circuit can determine whether the device has left the ROI in a similar manner to that used to determine whether the device has entered the ROI. Therefore, the processor circuit can continue to track the position of the intravascular data acquisition device and compare the tracked position of the device with the ROI. Once the position of the device is determined to be outside the position range associated with the ROI, the processor circuit determines that the device has left the ROI. Therefore, the processor circuit can stop receiving intravascular data from the device. In some embodiments, stopping receiving intravascular data includes stopping power to the sensor of the device, or sending a command signal to the device to stop acquiring data. In some embodiments, stopping receiving intravascular data includes sending a command signal to stop storing the intravascular data in a memory. In some embodiments, stopping receiving intravascular data includes generating a timestamp when the device leaves the ROI.

[0085] In step 814, the processor circuit generates a graphical representation of the intravascular data for the ROI of the vessel and outputs it to a display in communication with the processor circuit. In some embodiments, the intravascular data includes one or more of pressure data, flow data, intravascular image data, temperature data, or any other suitable type of data. In this regard, the graphical representation may include text, numbers, a chart, or any other suitable representation of the intravascular data. For example, in some embodiments, the intravascular data includes pressure data, and the processor circuit is configured to calculate a pressure ratio or functional index associated with the ROI. In some embodiments, the processor circuit is configured to calculate multiple pressure ratios or functional indexes at multiple locations on the ROI. In some embodiments, the functional index includes FFR, iFR, or any other suitable functional index or pressure ratio. In other embodiments, the intravascular data includes IVUS data or OCT data. The processor may be configured to output one or more cross-sectional images of the vessel to the display. Furthermore, the cross-sectional images may be registered to a roadmap by the processor circuit, such that a user may cause the processor circuit to update the displayed intravascular image by selecting a specific location or point within the ROI on the roadmap.

[0086] The present application advantageously addresses the problem of streamlining workflows by automating a portion of the data acquisition and the ability to control the intraluminal data acquisition performed by the intraluminal data acquisition device based on its tracked position. Automation can also span various systems for vessel assessment, assuming there are command and communication protocols between the systems. Furthermore, further workflow automation can be achieved by considering accurate automated vessel segmentation methods based on angiographic data. Such algorithms can be used to identify segments of interest within the vessel (as opposed to the user having to identify the segments of interest). Automation of intravascular data acquisition can then be based on these segments of interest.

[0087] Those skilled in the art will recognize that the above-described devices, systems, and methods can be modified in various ways. Therefore, it will be understood by those skilled in the art that the embodiments encompassed by this disclosure are not limited to the specific exemplary embodiments described above. In this regard, although exemplary embodiments have been shown and described, various modifications, variations, and substitutions are contemplated in the foregoing disclosure. It should be understood that such changes may be made to the foregoing without departing from the scope of this disclosure. Therefore, it is appropriate to interpret the appended claims broadly in a manner consistent with this disclosure.

Claims

1. A system for controlling intravascular data acquisition, comprising: a processor circuit configured to: generating a roadmap of the vessel using the first extravascular image data of the vessel; identifying a region of interest of the tube on the roadmap of the tube; receiving second extravascular image data representative of an intravascular data acquisition device positioned within the vessel; determining, based on the second extravascular image data, whether the intravascular data acquisition device has entered the region of interest; as well as In response to determining that the intravascular data acquisition device has entered the region of interest, controlling the intravascular data acquisition device to acquire intravascular data of the region of interest; as well as A first graphical representation of the intravascular data of the region of interest is output to a display device in communication with the processor circuit.

2. The system according to claim 1, wherein: The processor circuit is configured to: identifying a radiopaque marker of the intravascular data acquisition device using the second extravascular image data; determining a position of the intravascular data acquisition device with respect to the roadmap of the vessel based on identifying the radiopaque marker; and Based on the determined position, it is determined whether the intravascular data acquisition device has entered the region of interest.

3. The system according to claim 1, wherein: The processor circuit is configured to output a screen display to the display device, the screen display comprising: said roadmap; said first graphical representation of said intravascular data of said region of interest; a second graphical representation of the area of interest on the roadmap; and A third graphical representation of the location of the data acquisition device within the vessel.

4. The system according to claim 1, wherein: The processor circuit is further configured to: receiving user input from a user interface device indicating an area on the route map; and Based on the user input, the region of interest of the tube is identified.

5. The system according to claim 4, wherein: The user input indicates a length of the tube on the roadmap.

6. The system according to claim 1, wherein: The first extravascular image data comprises angiographic data, and the processor circuit is further configured to: The region of interest is determined based on image processing of the angiography data.

7. The system according to claim 1, wherein: The intravascular data includes at least one of pressure data or flow data, and the processor circuit is further configured to: A functional index of the vessel at the region of interest is calculated based on the at least one of the pressure data or the flow data.

8. The system according to claim 7, wherein: The functional indicator includes at least one of the blood flow reserve fraction FFR or the instantaneous wave-free ratio iFR.

9. The system according to claim 1, wherein: The intravascular data includes intravascular image data.

10. The system according to claim 1, wherein: The processor circuit is further configured to: determining, based on the second extravascular image data, whether the intravascular data acquisition device has left the region of interest; and In response to determining that the intravascular data acquisition device has left the region of interest, receiving the intravascular data of the region of interest of the vessel from the intravascular data acquisition device is stopped.

11. The system according to claim 1, wherein: The system also includes the intravascular data acquisition device, wherein the intravascular data acquisition device includes a flexible, elongated member having a proximal portion and a distal portion, and a sensing component coupled to the distal portion, wherein the distal portion and the sensing component are configured to be positioned within the tube.

12. The system according to claim 1, wherein: The processor circuit is further configured to: identifying another region of interest of the tube on the roadmap of the tube; determining, based on the second extravascular image data, whether the intravascular data acquisition device has entered the other region of interest; as well as In response to determining that the intravascular data acquisition device has entered the another region of interest, controlling the intravascular data acquisition device to acquire intravascular data of the another region of interest; as well as A fourth graphical representation of the intravascular data of the another region of interest is output to a display device in communication with the processor circuit.

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