Percutaneous coronary intervention (pci) planning interface and associated devices, systems, and methods

Abstract

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

Description

[0001] This application is a divisional application of patent application 201580061751.7, filed on November 3, 2015, entitled "Percutaneous Coronary Intervention (PCI) Planning Interface and Associated Devices, Systems and Methods". Technical Field

[0002] This disclosure generally relates to the assessment of blood vessels for planning percutaneous coronary intervention (PCI). For example, some embodiments of this disclosure are adapted to visualize and modify the properties of a graphical representation of a stent positioned within a blood vessel using a graphical user interface to determine physiological parameters for PCI, such as stent location, stent length, stent diameter, etc. Background Technology

[0003] Innovation in the process of diagnosing and validating the success of disease management has evolved from purely external imaging procedures to include internal diagnostic processes. In addition to conventional external imaging techniques such as X-rays, MRI, CT scans, fluoroscopy, and angiography, small sensors can now be placed directly inside the body. For example, diagnostic instruments and procedures have been developed for diagnosing vascular occlusion and other vascular diseases using ultra-miniature sensors placed at the distal end of flexible, elongated components such as catheters or guidewires used in catheter insertion procedures. Known medical sensing techniques include, for example, intravascular ultrasound (IVUS), forward-looking IVUS (FL-IVUS), fractional flow reserve (FFR) determination, coronary flow reserve (CFR) determination, optical coherence tomography (OCT), transesophageal echocardiography, and image-guided therapy.

[0004] A typical procedure involves intravascular pressure measurement. The currently accepted technique for assessing the severity of stenosis in a blood vessel (including lesions caused by localized ischemia) is the fractional flow reserve (FFR). FFR is a calculation of the ratio of distal pressure measurements (obtained distal to the stenosis) to proximal pressure measurements (obtained proximal to the stenosis). FFR provides an index of stenosis severity, allowing determination of whether the blockage restricts blood flow within the vessel to the extent requiring intervention. The normal FFR value in healthy blood vessels is 1.00, while values ​​less than approximately 0.80 are generally considered significant and require intervention. Another technique used for vascular assessment utilizes the Instant Wave-Free Ratio. TM Functionality Functionality (iFR) includes the determination of the pressure ratio across the stenosis during the waveless period when the resistance is naturally constant and minimized during the cardiac cycle. The iFR modality does not require the administration of a vasodilator. The normal value for iFR in healthy blood vessels is 1.00, while values ​​less than approximately 0.89 are generally considered significant and require intervention.

[0005] When an obstructed blood vessel requiring treatment is identified, percutaneous coronary intervention (PCI) is a treatment procedure that can be used to manage the vessel. PCI includes angioplasty and stent placement across the stenosis to open the vessel. Clinicians typically rely on angiography and physiological measurements of pressure and / or flow (which are not meaningfully connected) to plan the intervention. Planning the intervention can involve selecting various stent-related parameters, such as location, length, and diameter. Developing a treatment plan is challenging due to the difficulty of integrating various data sources. Furthermore, there is very little ability to predict the effectiveness of the intervention based on available data. For example, clinicians often cannot use the clinical certainty supported by the collected data to determine how altering the stent's location and / or length affects the effectiveness of stent placement.

[0006] Therefore, there remains a need for improved devices, systems, and methods for assessing the severity of occlusions in blood vessels, and particularly stenosis in blood vessels. There also remains a need for improved devices, systems, and methods for planning PCI by connecting angiography and physiological data in a manner that allows clinicians to efficiently plan and evaluate proposed treatments. Furthermore, there remains a need to provide visual depictions of the blood vessels and proposed therapeutic interventions (such as stents) within them that allow clinicians to plan, evaluate, and modify proposed treatments in a manner supported by the collected physiological data. Summary of the Invention

[0007] Embodiments of this disclosure are configured to provide a graphical user interface illustrating a stent positioned within a blood vessel, allowing physicians to efficiently plan a surgical procedure known as percutaneous coronary intervention (PCI). The location and length of the stent within the vessel can be changed based on user input. The image of the vessel can include various annotations to assist the physician, including one or more pressure ratios calculated along the length of the vessel, the location of the vessel along the pressure ratio(s), and the name of the vessel. In some embodiments, a menu of stents is provided to the physician, enabling the physician to select stents that are in stock and available for hospital use when planning the surgical procedure.

[0008] In an exemplary embodiment, a method for evaluating a patient's blood vessels is provided. The method includes: outputting a screen display to a display device, the screen display including: a visualization of pressure measurements obtained from the first and second instruments positioned within the patient's blood vessel while a second instrument is longitudinally moved through the blood vessel and a first instrument remains fixed within the blood vessel, and a visual representation of the blood vessel; receiving user input to modify the visualization to simulate a treatment process; and updating the screen display in response to the user input, including modifying the visualization based on the user input.

[0009] In some embodiments, the method further includes: acquiring angiographic data simultaneously with acquiring the pressure measurement result, wherein the visual representation of the vessel includes an angiographic image of the vessel, and wherein the visualization includes a graphic overlay on the angiographic image. In some embodiments, acquiring the pressure measurement result includes moving the second device through the vessel at a constant or non-constant speed. In some embodiments, the visualization includes a graphic representation of a stent positioned in the visual representation of the vessel, and wherein the treatment procedure is a percutaneous coronary intervention. In some embodiments, the method further includes determining physiological parameters for a stent to be deployed in the vessel based on characteristics of the graphic representation of the stent. In some embodiments, the physiological parameters include at least one of: stent location, stent length, and stent diameter; and the characteristics of the graphic representation of the stent include at least one of: location, length, and diameter.

[0010] In some embodiments, the method further includes automatically calculating at least one of the stent length and the length of a graphical representation of the stent based on at least one of the angiography data, obtained pressure measurements, and a pressure ratio calculated based on the obtained pressure measurements, wherein the visualization includes a graphical representation of the stent having the calculated length. In some embodiments, the method further includes determining at least one of the stent length and the length of the graphical representation of the stent based on user input, wherein the visualization includes a graphical representation of the stent having the determined length. In some embodiments, the method further includes determining at least one of the stent diameter and the diameter of the graphical representation of the stent based on at least one of the angiography data and intravascular imaging data obtained within the blood vessel. In some embodiments, receiving user input includes receiving user input to move the graphical representation of the stent within the visual representation of the blood vessel, and wherein modifying the visualization includes outputting a graphical representation of the stent at the location based on the user input. In some embodiments, receiving user input includes receiving user input to change the length of the graphical representation of the stent within the visual representation of the blood vessel, and wherein modifying the visualization includes outputting a graphical representation of the stent having the length based on the received user input.

[0011] In some embodiments, the method further includes outputting multiple graphical representations of the stent. In some embodiments, the method further includes editing the multiple graphical representations of the stent based on a stent inventory database associated with a clinical setting. In some embodiments, the method further includes at least one of the following: receiving user input to select one of the multiple graphical representations of the stent, wherein the visualization includes the selected graphical representation of the stent positioned in a visual representation of the blood vessel; and automatically selecting a graphical representation of the stent from the multiple graphical representations of the stent based on at least one of the following: the angiographic data, the obtained pressure measurements, and the pressure ratio calculated based on the obtained pressure measurements, wherein the visualization includes the graphical representation of the stent automatically selected from the multiple graphical representations of the stent.

[0012] In some embodiments, the method further includes calculating a pressure ratio within the blood vessel based on the obtained pressure measurement, wherein the visualization further includes the calculated pressure ratio. In some embodiments, the visualization further includes at least one of: a marker indicating the location within the blood vessel associated with the obtained pressure measurement; and the calculated pressure ratio positioned adjacent to the marker indicating the location within the blood vessel. In some embodiments, the method further includes automatically identifying the blood vessel, wherein the visualization further includes a label indicating a determined identifier of the blood vessel.

[0013] In another exemplary embodiment, a system for evaluating a patient's blood vessels is provided. The system includes: a first instrument sized and shaped for insertion into a patient's blood vessel; a second instrument sized and shaped for insertion into the patient's blood vessel; and a processing system communicatively coupled to the first and second instruments and a display device, the processing system being configured to: receive pressure measurements from the first and second instruments positioned within the patient's blood vessel while the second instrument is longitudinally moved through the blood vessel and the first instrument remains fixed within the blood vessel; output a screen display to the display device, the screen display including: a visualization based on the pressure measurements received from the first and second instruments and a visual representation of the blood vessel; receive user input to modify the visualization to simulate a treatment process; and update the screen display in response to the user input, including modifying the visualization based on the user input.

[0014] In some embodiments, the visual representation of the blood vessel includes an angiographic image of the blood vessel, and the visualization includes a graphical overlay on the angiographic image. In some embodiments, the visualization includes a graphical representation of a stent positioned within the visual representation of the blood vessel, and the treatment procedure is a percutaneous coronary intervention. In some embodiments, the processing system is further configured to determine physiological parameters for a stent to be deployed in the blood vessel based on characteristics of the graphical representation of the stent. In some embodiments, the physiological parameters include at least one of the following: stent location, stent length, and stent diameter; and the properties of the graphical representation of the stent include at least one of the following: location, length, and diameter.

[0015] In some embodiments, the processing system is further configured to automatically calculate at least one of the stent length and the length of a graphical representation of the stent based on at least one of the angiography data, received pressure measurements, and a pressure ratio calculated based on the received pressure measurements, wherein the visualization includes a graphical representation of the stent having the calculated length. In some embodiments, the processing system is further configured to determine at least one of the stent length and the length of the graphical representation of the stent based on the user input, wherein the visualization includes a graphical representation of the stent having the determined length.

[0016] In some embodiments, the processing system is further configured to automatically calculate at least one of the stent diameter and the diameter of the graphic representation of the stent based on at least one of angiographic data and intravascular ultrasound (IVUS) data. In some embodiments, the processing system is configured to receive user input to move the graphic representation of the stent within the visual representation of the blood vessel, and wherein the processing system is configured to modify the visualization by outputting the graphic representation of the stent at a location based on the user input. In some embodiments, the processing system is configured to receive user input to change the length of the graphic representation of the stent within the blood vessel, and wherein the processing system is configured to modify the visualization by outputting the graphic representation of the stent having the received length based on the received user input.

[0017] In some embodiments, the processing system is further configured to output multiple graphical representations of the stent. In some embodiments, the processing system is further configured to edit the multiple graphical representations of the stent based on a stent inventory database associated with a clinical setting. In some embodiments, the processing system is further configured to perform at least one of the following: receiving user input to select one of the multiple graphical representations of the stent, wherein the visualization includes the graphical representation of the stent selected from the multiple graphical representations of the stent; and automatically selecting a graphical representation of the stent from the multiple graphical representations of the stent based on at least one of the angiographic data, received pressure measurements, and a pressure ratio calculated based on the received pressure measurements, wherein the visualization includes the graphical representation of the stent automatically selected from the multiple graphical representations of the stent.

[0018] In some embodiments, the processing system is further configured to calculate a pressure ratio within the vessel based on received pressure measurements, wherein the visualization further includes the calculated pressure ratio. In some embodiments, the visualization further includes at least one of: a marker indicating a location within the vessel associated with the obtained pressure measurements; and the calculated pressure ratio positioned adjacent to the marker indicating the location within the vessel. In some embodiments, consecutive markers are positioned at unequal intervals along the visual representation of the vessel. In some embodiments, the processing system is further configured to automatically identify the vessel, wherein the visualization further includes a label indicating a determined identifier of the vessel.

[0019] Additional aspects, features, and advantages of this disclosure will become apparent from the following detailed description. Attached Figure Description

[0020] Illustrative embodiments of the present disclosure will now be described with reference to the accompanying drawings, in which:

[0021] Figure 1 This is a schematic perspective view of a narrow blood vessel according to an embodiment of the present disclosure.

[0022] Figure 2 It is along Figure 1 The section line 2-2 was obtained Figure 1 A schematic partial cross-sectional perspective view of a portion of a blood vessel.

[0023] Figure 3 The instrument is positioned therein according to an embodiment of this disclosure. Figure 1 and Figure 2 A partial cross-sectional perspective view of a blood vessel.

[0024] Figure 4 This is a schematic diagram of a system according to an embodiment of the present disclosure.

[0025] Figure 5 This is a flowchart of a method for evaluating a patient's blood vessels according to embodiments of the present disclosure.

[0026] Figure 6 This is a flowchart of a method for evaluating a patient's blood vessels according to another embodiment of the present disclosure.

[0027] Figure 7 This is a screen display according to an embodiment of the present disclosure.

[0028] Figure 8a This is a screen display according to another embodiment of the present disclosure.

[0029] Figure 8b This is a screen display according to another embodiment of the present disclosure.

[0030] Figure 9 This is a screen display according to another embodiment of the present disclosure.

[0031] Figure 10 This is a screen display according to another embodiment of the present disclosure.

[0032] Figure 11 This is a screen display according to another embodiment of the present disclosure.

[0033] Figure 12 This is a screen display according to another embodiment of the present disclosure.

[0034] Figure 13 This is a screen display according to another embodiment of the present disclosure.

[0035] Figure 14 This is a screen display according to another embodiment of the present disclosure.

[0036] Figure 15 This is a screen display according to another embodiment of the present disclosure.

[0037] Figure 16 This is a screen display according to another embodiment of the present disclosure.

[0038] Figure 17 This is a screen display according to another embodiment of the present disclosure.

[0039] Figure 18 This is a screen display according to another embodiment of the present disclosure.

[0040] Figure 19 This is a screen display according to another embodiment of the present disclosure.

[0041] Figure 20 This is a screen display according to another embodiment of the present disclosure.

[0042] Figure 21 This is a screen display according to another embodiment of the present disclosure.

[0043] Figure 22 This is a screen display according to another embodiment of the present disclosure.

[0044] Figure 23 This is a screen display according to another embodiment of the present disclosure.

[0045] Figure 24 This is a screen display according to another embodiment of the present disclosure.

[0046] Figure 25 This is a screen display according to another embodiment of the present disclosure.

[0047] Figure 26 This is a screen display according to another embodiment of the present disclosure.

[0048] Figure 27 This is a screen display according to another embodiment of the present disclosure.

[0049] Figure 28 This is a screen display according to another embodiment of the present disclosure. Detailed Implementation

[0050] For the purpose of facilitating an understanding of the principles of this disclosure, reference will now be made to embodiments illustrated in the accompanying drawings, and specific language will be used to describe the same content. However, it should be understood that this is not intended to limit the scope of this disclosure. Any changes and other modifications to the described devices, systems, and methods, as well as any other applications of the principles of this disclosure, are fully contemplated and are included within the scope of this disclosure, as will generally occur to those skilled in the art to which this disclosure pertains. Specifically, it is fully contemplated that features, components, and / or steps described with respect to one embodiment can be combined with features, components, and / or steps described with respect to other embodiments of this disclosure. However, for the sake of brevity, a variety of iterations of these combinations will not be described independently.

[0051] refer to Figure 1 and Figure 2 The illustration shows a narrowed blood vessel 100 according to an embodiment of the present disclosure. In this aspect, Figure 1 It is a perspective view of the vascular 100, and Figure 2 It is along Figure 1 Section line 2-2 shows a partial cross-sectional perspective view of a portion of the vessel 100. See section line 2-2 for more details. Figure 1 The blood vessel 100 includes a proximal portion 102 and a distal portion 104. A lumen 106 extends along the length of the blood vessel 100 between the proximal portion 102 and the distal portion 104. In this aspect, the lumen 106 is configured to allow fluid flow through the blood vessel. In some instances, the blood vessel 100 is a blood vessel. In some specific instances, the blood vessel 100 is a coronary artery. In such instances, the lumen 106 is configured to facilitate blood flow through the blood vessel 100.

[0052] As shown, the blood vessel 100 includes a stenosis 108 between a proximal portion 102 and a distal portion 104. The stenosis 108 generally represents any obstruction or other structural arrangement that results in restriction of fluid flow through the lumen 106 of the blood vessel 100. Embodiments of this disclosure are suitable for use in a wide variety of vascular applications, including, but not limited to, coronary arteries, peripheral arteries (including, but not limited to, lower extremity, carotid, and neurovascular arteries), kidneys, and / or veins. Where the blood vessel 100 is a vascular vessel, the stenosis 108 may be the result of plaque buildup, including, but not limited to, plaque components such as fibrous tissue, fibrous grease (fibrinous lipids), necrotic core, calcification (dense calcium), blood, fresh thrombus, and mature thrombus. Typically, the composition of the stenosis will depend on the type of blood vessel being evaluated. In this respect, it should be understood that the concepts of this disclosure are applicable to virtually any type of obstruction or other narrowing of a blood vessel resulting in reduced fluid flow.

[0053] For more specific reference Figure 2The lumen 106 of the vessel 100 has a diameter 110 at the proximal end of a stenosis 108 and a diameter 112 at the distal end of the stenosis. In some instances, diameters 110 and 112 are substantially equal to each other. In this respect, diameters 110 and 112 are intended to represent healthy portions of the lumen 106, or at least healthier portions compared to the stenosis 108. Thus, these healthier portions of the lumen 106 are illustrated as having a substantially constant cylindrical profile, and therefore, the height or width of the lumen has been referred to as the diameter. However, it should be understood that in many instances, these portions of the lumen 106 will also have plaque buildup, asymmetrical profiles, and / or other irregularities, but to a lesser degree than the stenosis 108, and therefore will not have a cylindrical profile. In such instances, diameters 110 and 112 are understood to represent the relative size or cross-sectional area of ​​the lumen and do not imply a circular cross-sectional profile.

[0054] As in Figure 2 As shown, stenosis 108 includes plaque buildup 114 that narrows the lumen 106 of the blood vessel 100. In some instances, plaque buildup 114 does not have a uniform or symmetrical profile, making the angiographic evaluation of such stenosis unreliable. In the illustrated embodiment, plaque buildup 114 includes an upper portion 116 and an opposing lower portion 118. In this aspect, the lower portion 118 has an increased thickness relative to the upper portion 116, resulting in an asymmetrical and non-uniform profile relative to the proximal and distal portions of the lumen of stenosis 108. As shown, plaque buildup 114 reduces the available space for fluid flow through the lumen 106. Specifically, the cross-sectional area of ​​the lumen 106 is reduced by the plaque buildup. At the narrowest point between the upper portion 116 and the lower portion 118, the lumen 106 has a height 120, which represents the reduced size or cross-sectional area of ​​the diameters 110 and 112 relative to the proximal and distal ends of stenosis 108. Note that the stenosis 108, including plaque buildup 114, is exemplary and should not be considered restrictive in any way. In this respect, it should be understood that in other instances, the stenosis 108 has other shapes and / or compositions that restrict fluid flow through the lumen 106. Although the vascular 100 is... Figure 1 and Figure 2 The following embodiments are described in the illustration with a single stenosis 108 and primarily in the context of a single stenosis; however, it should be understood that the devices, systems and methods described herein have similar applications for blood vessels with multiple stenotic regions.

[0055] Now for reference Figure 3According to embodiments of this disclosure, a blood vessel 100 is shown having instruments 130 and 132 positioned therein. Generally, instruments 130 and 132 can be any type of device, instrument, or probe sized and shaped for positioning within the blood vessel. In the illustrated embodiment, instrument 130 typically represents a guidewire, while instrument 132 typically represents a catheter. In this aspect, instrument 130 extends through the central lumen of instrument 132. However, in other embodiments, instruments 130 and 132 take other forms. In this aspect, in some embodiments, instruments 130 and 132 have similar forms. For example, in some instances, both instruments 130 and 132 are guidewires. In other instances, both instruments 130 and 132 are catheters. On the other hand, in some embodiments, such as in the illustrated embodiment, instruments 130 and 132 have different forms, wherein one of the instruments is a catheter and the other is a guidewire. Furthermore, in some instances, instruments 130 and 132 are arranged coaxially with each other, as in... Figure 3 The illustrated embodiment is shown. In other instances, one of the devices extends through the eccentric lumen of the other device. In still other instances, devices 130 and 132 extend side-by-side. In some specific embodiments, at least one of the devices serves as a rapid exchange device, such as a rapid exchange catheter. In such embodiments, the other device is a partner connector, or another device is configured to facilitate the introduction and removal of the rapid exchange device. Furthermore, in other instances, instead of two separate devices 130 and 132, a single device is utilized. In some embodiments, the single device incorporates aspects of the functionality (e.g., data acquisition) of both devices 130 and 132.

[0056] The device 130 is configured to obtain diagnostic information about a blood vessel 100. In this aspect, the device 130 includes one or more sensors, transducers, and / or other monitoring elements configured to obtain diagnostic information about the blood vessel. The diagnostic information includes one or more of the following: pressure, flow rate (velocity and / or volume), images (including images obtained using ultrasound (e.g., IVUS), OCT, thermal and / or other imaging techniques), temperature, and / or combinations thereof. In some instances, the one or more sensors, transducers, and / or other monitoring elements are positioned adjacent to the distal portion of the device 130. In this aspect, in some instances, 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 134 of the device 130. In some instances, at least one of the one or more sensors, transducers, and / or other monitoring elements is positioned at the distal tip of the device 130.

[0057] The device 130 includes at least one element configured to monitor pressure within the blood 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 being connected to a fluid column sensor separate from the device and positioned at the proximal end of the fluid column), an optical pressure sensor, and / or combinations thereof. In some instances, one or more features of the pressure monitoring element are implemented as solid-state components manufactured using semiconductor and / or other suitable manufacturing techniques. Examples of commercially available guidewire products including suitable pressure monitoring elements include, but are not limited to, those available from Volcano. Pressure guide wire, PrimeWire PLUS pressure guidewire, and XT pressure and flow guidewires, and their respective PressureWires, available from St. Jude Medical. TM Certus guidewire and PressureWire TM Aeris guidewire. Typically, the device 130 is sized such that it can be positioned through the narrow 108 without significantly affecting fluid flow across the narrow, which will affect distal pressure readings. Therefore, in some instances, 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. In some embodiments, the device 130 has an outer diameter of 0.035” or less.

[0058] Device 132 is also configured to obtain diagnostic information about the blood vessel 100. In some instances, device 132 is configured to obtain the same diagnostic information as device 130. In other instances, device 132 is configured to obtain different diagnostic information than device 130, which may include additional diagnostic information, less diagnostic information, and / or alternative diagnostic information. The diagnostic information obtained by device 132 includes one or more of the following: pressure, flow rate (velocity and / or volume), images (including images obtained using ultrasound (e.g., IVUS), OCT, thermal and / or other imaging techniques), temperature, and / or combinations thereof. Device 132 includes one or more sensors, transducers, and / or other monitoring elements configured to obtain this diagnostic information. In this aspect, in some instances, the one or more sensors, transducers, and / or other monitoring elements are positioned adjacent to the distal portion of device 132. In some instances, 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 tip 136 of the instrument 132. In some instances, at least one of the one or more sensors, transducers, and / or other monitoring elements is positioned at the distal tip of the instrument 132.

[0059] Similar to device 130, device 132 also includes at least one element configured to monitor pressure within the blood 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 being connected to a fluid column sensor separate from the device and positioned at a portion of the proximal end of the fluid column), an optical pressure sensor, and / or combinations thereof. In some instances, one or more features of the pressure monitoring element are implemented as solid-state components manufactured using semiconductor and / or other suitable manufacturing techniques. In some instances, currently available catheter products suitable for use with one or more of the Siemens AXIOM Sensis, Mennen Horizon XVu, and Philips Xper IM Physiomonitoring 5, and including a pressure monitoring element, can be used in device 132.

[0060] According to various aspects of this disclosure, at least one of device 130 and device 132 is configured to monitor pressure distal to stenosis 108 within blood vessel 100, and at least one of device 130 and device 132 is configured to monitor pressure proximal to stenosis within blood vessel 100. In this aspect, devices 130 and 132 are sized and shaped to allow for the positioning of at least one element, said at least one element being configured to monitor pressure within blood vessel 100 to be positioned proximal and / or distal to stenosis 108 as needed, based on the device configuration. Figure 3 The illustration shows a position 138 suitable for measuring the distal pressure of the stenosis 108. In this respect, in some instances, the position 138 is 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 from the distal end of the stenosis 108 (as shown in...). Figure 2 (As shown in the image). Figure 3 Several suitable locations for measuring proximal pressure of stenosis 108 are also illustrated. In this aspect, in some instances, locations 140, 142, 144, 146, and 148 each represent a location suitable for monitoring proximal pressure of the stenosis. In this aspect, locations 140, 142, 144, 146, and 148 are positioned at different distances from the proximal end of stenosis 108, ranging from more than 20 cm downwards to approximately 5 mm or less. Typically, proximal pressure measurements are spaced apart from the proximal end of the stenosis. Therefore, in some instances, proximal pressure measurements are taken at a distance equal to or greater than the internal diameter of the vessel lumen from the proximal end of the stenosis. In the context of coronary artery pressure measurement, proximal pressure measurements are typically taken at the proximal location of the stenosis within the proximal portion of the vessel and at the distal location of the aorta. However, in some specific instances of coronary artery pressure measurement, proximal pressure measurements are taken from a location within the aorta. In other instances, proximal pressure measurements are taken at the root or ostium of the coronary artery.

[0061] In some embodiments, at least one of instruments 130 and 132 is configured to monitor pressure within the blood vessel 100 during movement through lumen 106. In some instances, instrument 130 is configured to move through lumen 106 and across stenosis 108. In this aspect, in some instances, instrument 130 is positioned distal to stenosis 108 and moved (i.e., pulled back) proximally across stenosis to a proximal position of stenosis. In other instances, instrument 130 is positioned proximally to stenosis 108 and moved distally across stenosis to a distal position of stenosis. In some embodiments, movement of instrument 130 (either proximally or distally) is manually controlled by a medical professional (e.g., a surgeon's hand). In other embodiments, movement of instrument 130 (either proximally or distally) is controlled by a movement control device (e.g., a pull-back device, such as the Trak available from Volcano). II. The movement is automatically controlled. In some instances, 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 instances, the movement of the instrument 130 through the blood vessel is continuous with respect to each pull-back or push-through. In other instances, the instrument 130 is moved stepwise through the blood vessel (i.e., repeatedly moved a fixed amount of distance and / or a fixed amount of time). Some aspects of the visual description 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 instances, the aspects of the visual description discussed below are particularly suitable for embodiments in which a single instrument is moved through the lumen 106 with or without the presence of a second instrument.

[0062] Device 130 and / or device 132 can be used to perform Instant Wave-Free Ratio TM Functionality The medical sensing procedures associated with Functionality (two trademarks of Volcano Corporation) and those disclosed in U.S. Patent Application No. 13 / 460296 entitled "DEVICES, SYSTEMS, AND METHODS FOR ASSESSING A VESSEL," which are incorporated herein by reference in their entirety, disclose the use of pressure ratios available without the application of emphysema. Furthermore, devices 130 and / or 132 can be used to perform procedures suitable for estimating pressure ratios as disclosed in U.S. Provisional Patent Application No. 62 / 024005, filed July 14, 2014, entitled "DEVICES, SYSTEMS, AND METHODS FOR TREATMENT OF VESSELS." The medical sensing process associated with FFR and / or other accepted diagnostic pressure ratios, compensation Pd / Pa ratios, is incorporated herein by reference in its entirety.

[0063] Now for reference Figure 4 A system 150 according to an embodiment of the present disclosure is shown therein. In this aspect, Figure 4This is a schematic diagram of system 150. As shown, system 150 includes device 152. In some instances, device 152 is adapted to function as at least one of device 130 and device 132 discussed below. Thus, in some instances, device 152 includes features similar to those discussed above with respect to devices 130 and 132 in some instances. In the illustrated embodiment, device 152 is a guidewire having a distal portion 154 and a housing 156 positioned adjacent to the distal portion. In this aspect, housing 156 is spaced approximately 3 cm from the distal tip of device 152. Housing 156 is configured to house one or more sensors, transducers, and / or other monitoring elements configured to obtain diagnostic information about the blood vessel. In the illustrated embodiment, housing 156 includes at least a pressure sensor configured to monitor pressure within the lumen in which device 152 is positioned. Shaft 158 ​​extends proximally from housing 156. Torque device 160 is positioned on and coupled to the proximal portion of shaft 158. Proximal portion 162 of device 152 is coupled to connector 164. Cable 166 extends from connector 164 to connector 168. In some instances, connector 168 is configured to be inserted into interface 170. In this aspect, in some instances, interface 170 is a patient interface module (PIM). In some instances, wireless connectivity is used to replace cable 166. In this aspect, it should be understood that various communication paths can be used between device 152 and interface 170, including physical connections (including electrical, optical, and / or fluid connections), wireless connections, and / or combinations thereof.

[0064] Interface 170 is communicatively coupled to computing device 172 via connection 174. Computing device 172 generally refers to any device suitable for performing the processing and analysis techniques discussed herein. In some embodiments, computing device 172 includes a processor, random access memory, and storage medium. In this aspect, in certain specific instances, computing device 172 is programmed to perform steps associated with data acquisition and analysis as described herein. Therefore, it should be understood that any steps related to data acquisition, data processing, device control, and / or other processing or control aspects of this disclosure can be implemented by computing device using corresponding instructions stored on or in a non-transient computer-readable medium accessible by said computing device. In some instances, computing device 172 is a console device. In some specific instances, computing device 172 is associated with an S5, each available from Volcano Corporation. TM Imaging system or The imaging system is similar. In some instances, the processing device 172 is portable (e.g., handheld, on a trolley, etc.). In some instances, all or part of the computing device 172 can be implemented as a bedside controller, such that one or more processing steps described herein can be performed by one or more processing components of said bedside controller. An exemplary bedside controller is described in U.S. Provisional Application No. 62 / 049265, filed September 11, 2014, entitled “Bedside Controller for Assessment of Vessels and Associated Devices, Systems, and Methods,” which is incorporated herein by reference in its entirety. Furthermore, it should be understood that in some instances, the computing device 172 comprises 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 this disclosure separately or within a predefined group. Any division and / or combination of processing and / or control aspects across multiple computing devices described below is within the scope of this disclosure.

[0065] 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 device 152 and computing device 172. However, this communication path is merely exemplary and should not be considered limiting in any way. In this respect, it should be understood that any communication path between device 152 and computing device 172 may be utilized, including physical connections (including electrical, optical, and / or fluid connections), wireless connections, and / or combinations thereof. In this respect, it should be understood that in some instances, connection 174 is wireless. In some instances, connection 174 includes a communication link over a network (e.g., an intranet, the Internet, a telecommunications network, and / or other networks). In this respect, it should be understood that in some instances, computing device 172 is located remotely from the operating area where device 152 is used. Enabling connection 174 to include a connection over a network enables communication between device 152 and remote computing device 172, regardless of whether the computing device is in an adjacent room, adjacent building, or different state / country. Furthermore, it should be understood that in some instances, the communication path between device 152 and computing device 172 is a secure connection. Even further, it should be understood that in some instances, data transmitted over one or more portions of the communication path between device 152 and computing device 172 is encrypted.

[0066] System 150 also includes device 175. In some instances, device 175 is adapted to be used as at least one of devices 130 and 132 discussed above. Thus, in some instances, device 175 includes features similar to those discussed above with respect to devices 130 and 132 in some instances. In the illustrated embodiment, device 175 is a catheter-type device. In this aspect, device 175 includes one or more sensors, transducers, and / or distal portions adjacent to the device, and other monitoring elements configured to obtain diagnostic information about the blood vessel. In the illustrated embodiment, device 175 includes a pressure sensor configured to monitor pressure within the lumen in which device 175 is positioned. Device 175 communicates with interface 176 via connection 177. In some instances, interface 176 is a hemodynamic monitoring system or other control device, such as the Siemens AXIOM Sensis, Mennen Horizon XVu, and Philips XperIM Physiomonitoring 5. In one specific embodiment, device 175 is a pressure-sensing catheter comprising a fluid column extending along its length. In such an embodiment, interface 176 includes: a hemostatic valve fluidly coupled to the fluid column of the catheter; a multi-branch tube fluidly coupled to the hemostatic valve; and tubing extending between the components as needed to fluidly couple the components. In this aspect, the fluid column of the catheter is in fluid communication with the pressure sensor via the valve, the multi-branch tube, and the tubing. In some instances, the pressure sensor is part of interface 176. In other instances, the pressure sensor is a separate component positioned between device 175 and interface 176. Interface 176 is communicatively coupled to computing device 172 via connection 178.

[0067] Computing device 172 is communicatively coupled to display device 180 via connection 182. In some embodiments, display device 172 is a component of computing device 172, while in other embodiments, display device 172 is distinct from computing device 172. In some embodiments, display device 172 is implemented as a bedside controller having a touchscreen display as described, for example, in U.S. Provisional Application No. 62 / 049265, filed September 11, 2014, entitled "Bedside Controller for Assessment of Vessels and Associated Devices, Systems, and Methods," which is incorporated herein by reference in its entirety. Computing device 172 is capable of generating screen displays including data collected by instruments 152 and 175, as well as other instruments; quantities calculated based on the collected data; visualization of the vessels in which the data is collected; and visualization of the quantities based on the collected data and the calculated quantities. Figure 7-28 The diagram illustrates an exemplary screen display. Computing device 172 is capable of providing display data associated with the screen display to display device 180. Computing device 172 can be additionally communicatively coupled to a user interface device. The user interface device allows a user to interact with the screen display on display device 180. For example, a user can use the user interface device to provide user input to modify all or part of the screen display. Figure 7-28 The illustration shows exemplary user input and corresponding modifications to the screen display. In some embodiments, the user interface device is a separate component from the display device 180. In other embodiments, the user interface device is part of the display device 180. For example, the user interface device can be implemented as a bedside controller having a touchscreen display as described, for example, in U.S. Provisional Application No. 62 / 049265, filed September 11, 2014, entitled "Bedside Controller for Assessment of Vessels and Associated Devices, Systems, and Methods," which is incorporated herein by reference in its entirety. In such an embodiment, user input can be touch input received on a touch-sensitive display of the bedside controller.

[0068] Similar to the connection between device 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 device 175 and computing device 172. However, this communication path is merely exemplary and should not be considered limiting in any way. In this respect, it should be understood that any communication path between device 175 and computing device 172 may be utilized, including physical connections (including electrical, optical, and / or fluid connections), wireless connections, and / or combinations thereof. In this respect, it should be understood that in some instances, connection 178 is wireless. In some instances, connection 178 includes a communication link over a network (e.g., an intranet, the Internet, a telecommunications network, and / or other networks). In this respect, it should be understood that in some instances, computing device 172 is located remotely from the operating area where device 175 is used. Connection 178, including network connectivity, enables communication between device 175 and remote computing device 172, regardless of whether the computing devices are in adjacent rooms, adjacent buildings, or different states / countries. Furthermore, it should be understood that in some instances, the communication path between device 175 and computing device 172 is a secure connection. Even further, it should be understood that in some instances, data transmitted over one or more portions of the communication path between device 175 and computing device 172 is encrypted.

[0069] It should be understood that one or more components of system 150 may not be included, may be implemented in a different arrangement / sequence, and / or may be replaced using alternative devices / mechanisms from other embodiments of this disclosure. For example, in some instances, system 150 may not include interface 170 and / or interface 176. In such instances, connector 168 (or other similar connector communicating with device 152 or device 175) may be inserted into a port associated with computing device 172. Alternatively, devices 152, 175 may communicate wirelessly with computing device 172. Generally, the communication path between any one or both of devices 152, 175 and computing device 172 may be without intermediate nodes (i.e., direct connection), have intermediate nodes between the device and the computing device, or have multiple intermediate nodes between the device and the computing device.

[0070] In some embodiments, system 150 may additionally include a bedside controller, such as the bedside controller described in U.S. Provisional Application No. 62 / 049265 entitled “Bedside Controller for Assessment of Vessels and Associated Devices, Systems, and Methods”, filed September 11, 2014, which is incorporated herein by reference in its entirety. The bedside controller may be used by a clinician to control devices 152 and 175 to acquire pressure data during procedures; view real-time medical pressure measurements (e.g., visual representations of pressure data, such as pressure waveforms, numerical values, etc.); calculate pressure ratio(s) based on the collected pressure data; and interact with acquired medical sensing data, visual representations of the acquired medical sensing data and / or the calculated pressure ratio(s), visualizations based on the acquired medical sensing data and / or the calculated pressure ratio(s), and / or visual representations of the blood vessels 100. In this respect, the bedside controller can be communicatively coupled to computing device 172, interface 170 and interface 176 and / or device 152 and device 175.

[0071] In some embodiments, system 150 may include an inventory database 190 associated with a clinical setting, such as a hospital or other healthcare facility where PCI will be performed on a patient. The inventory database may store various data regarding stents available for clinicians. This data may include manufacturer name, length, diameter, material, quantity available at the hospital, quantity available for immediate use, resupply frequency, next shipment date, and other suitable information. (As relative to...) Figure 27 and Figure 28 As described, computing device 172 is capable of editing multiple stent options based on inventory database 190 and providing a selection menu to clinicians. Computing device 172 is capable of providing automatically recommended specific stents (e.g., stents from a specific manufacturer with specific length, diameter, and / or material) based on PCI planning performed using a graphical user interface. Computing device 172 is also capable of receiving user input selecting a specific stent and providing it to the graphical user interface, enabling clinicians to assess the efficiency of treatment using the selected stent. Computing device 172 is communicatively coupled to inventory database 190 via connection 192. Connection 192 can represent one or more network connections that communicatively couple computing device 172 to the computing systems of a healthcare facility.

[0072] Diagnostic information within a vascular system of interest can be obtained using one or more of devices 130, 132, 152, and 175. For example, diagnostic information can be obtained for one or more coronary arteries, peripheral arteries, cerebral blood vessels, etc. The diagnostic information can include pressure-related values, flow-related values, etc. The pressure-related values ​​can include FFR (e.g., the pressure ratio calculated when at least one stenosis across the blood vessel is moved through the blood vessel by the first device relative to the second device), Pd / Pa (e.g., the ratio of pressure distal to the lesion to pressure proximal to the lesion), iFR (e.g., the pressure ratio calculated using a diagnostic window relative to the distance at which at least one stenosis across the blood vessel is moved through the blood vessel by the first device relative to the second device), etc. Flow-related values ​​can include coronary flow reserve or CFR (e.g., the maximum increase in blood flow through a coronary artery above its normal resting volume), basic stenosis resistance index (BSR), etc.

[0073] Diagnostic information and / or data obtained by devices 130, 132, 152, and / or 175 are correlated or co-registered with (one or more) angiographic images and / or other two-dimensional or three-dimensional depictions of the patient's vascular system obtained by an external imaging system. In various embodiments, the diagnostic information obtained by the external imaging system can include externally acquired angiographic images, X-ray images, CT images, PET images, MRI images, SPECT images, and / or other two-dimensional or three-dimensional external luminal depictions of the patient's vascular system. Spatial co-registration can be performed using the techniques disclosed in U.S. Patent No. 7,930,014 entitled "VASCULAR IMAGE CO-REGISTRATION," based on known pull-back speed / distance, known starting point, known ending point, and / or combinations thereof. For example, a mechanical pull-back device can be used to perform a pressure sensing procedure. The mechanical pull-back device is capable of moving the pressure sensing device through the blood vessel at a fixed, known rate. The location of pressure measurements and / or (one or more) pressure ratios can be determined based on the ratio of the pull-back of the pressure sensing device to a known location (e.g., from the start, midpoint, and end locations available from angiographic data). In some embodiments, techniques similar to those described in U.S. Provisional Patent Application No. 61 / 747480, filed December 31, 2012, entitled “SPATIAL CORRELATION OF INTRAVASCULAR IMAGES AND PHYSIOLOGICALFEATURES,” are used to correlate diagnostic information and / or data with vascular images, which are incorporated herein by reference in their entirety. In some embodiments, co-registration and / or correlation can be performed as described in U.S. Provisional Patent Application No. 61 / 856509, filed July 19, 2013, entitled “DEVICES, SYSTEMS, AND METHODSFOR ASSESSMENT OF VESSELS,” which are incorporated herein by reference in their entirety.

[0074] In some embodiments, techniques similar to those described in U.S. Patent Application No. 14 / 144280, filed December 31, 2012, entitled “DEVICES, SYSTEMS, AND METHODS FOR ASSESSMENT OF VESSELS,” are used to correlate diagnostic information and / or data with vascular images, which are incorporated herein by reference in their entirety. In some embodiments, co-registration and / or correlation can be performed as described in U.S. Provisional Patent Application No. 61 / 856509, filed July 19, 2013, entitled “DEVICES, SYSTEMS, AND METHODS FOR ASSESSMENT OF VESSELS,” which are incorporated herein by reference in their entirety. In other embodiments, co-registration and / or correlation can be performed, as described in International Application No. PCT / IL2011 / 000612, filed July 28, 2011, entitled “CO-USE OF ENDOLUMINAL DATA AND EXTRALUMINAL IMAGING,” which is incorporated herein by reference in its entirety. Furthermore, in some embodiments, co-registration and / or correlation can be performed, as described in International Application No. PCT / IL2009 / 001089, filed November 18, 2009, entitled “IMAGEPROCESSING AND TOOL ACTUATION FOR MEDICAL PROCEDURES,” which is incorporated herein by reference in its entirety. In other embodiments, co-registration and / or correlation can be achieved as described in U.S. Patent Application No. 12 / 075244, entitled “IMAGING FOR USE WITH MOVING ORGANS”, filed March 10, 2008, which is incorporated herein by reference in its entirety.

[0075] Figure 5 This is a flowchart illustrating a method 500 for evaluating a patient's blood vessels. Method 500 will be described in the context of a pressure sensing procedure (such as iFR, Pd / Pa, or FFR procedure). It should be understood that method 500 can also be performed in the context of a flow sensing procedure (such as CFR procedure). References can be made to... Figure 7 , Figure 9 , Figure 11 , Figure 13 , Figure 15 , Figure 17 , Figure 19 , Figure 21 , Figure 23 , Figure 25 and Figure 27To better understand method 500: At block 510, method 500 includes obtaining a pressure measurement result. At block 520, method 500 includes acquiring angiographic data. In some embodiments, the pressure measurement result is obtained simultaneously with the acquisition of angiographic data. Simultaneous collection of pressure measurement results and angiographic data facilitates co-registration, as described above. For example, the collected pressure data can be co-registered such that the location of the pressure sensing element of an intravascular device within the blood vessel is known. The processing system is able to associate the location with the pressure measurement result and / or (one or more) pressure ratios at that location. The processing system is also able to generate a screen display including the pressure measurement result and / or pressure ratio at its associated location, as described relative to block 530.

[0076] Clinicians can insert one or more pressure-sensing intravascular devices (such as catheters or guidewires) into a patient. In some embodiments, clinicians can use angiographic data to guide the intravascular device within the patient to the desired location. After the pressure-sensing intravascular device has been properly positioned in the patient, the clinician can initiate the collection of pressure measurements. Pressure measurements can be collected during one or more of the following processes: FFR “spot” measurements, where the pressure sensor remains in one location while causing congestion; FFR pull-back, where the congestion is prolonged and the sensor is pulled back to the opening; iFR “spot” measurements, which are similar to FFR spot measurements but without congestion; and iFR pull-back, which is FFR pull-back but without congestion. In various embodiments, physiological measurement collection can be performed through a combination of one or more of the processes described above. Physiological measurements can be continuous, such as during a pull-back process. Physiological measurements can occur as the intravascular device is moved in one direction. Measurement collection can be a discontinuous process, such as when an intravascular device is selectively moved through a blood vessel (e.g., when movement of the intravascular device begins and stops, or when the intravascular device is held at various points along a blood vessel longer than others). Physiological measurements can occur when the intravascular device is moved in two directions (e.g., proximal and distal within the blood vessel). Co-registration can be used to ensure that the location of the measurement can be identified on the angiographic images of the blood vessel, regardless of how the physiological measurements are collected. For example, based on co-registration data, a composite of the collected physiological measurements can be generated.

[0077] In this respect, in some instances, the pressure measurement result represents the pressure ratio between a fixed position within the blood vessel and a moving position as the device is moved through the blood vessel. For example, in some instances, a proximal pressure measurement result is obtained at a fixed position within the blood vessel, while the device is pulled back to a second position closer to the first position (i.e., closer to the fixed position for proximal measurement) from a position where the proximal pressure measurement result is obtained via the blood vessel. For clarity, this arrangement will be used to describe many embodiments of the present disclosure when understanding the concepts of the present disclosure. However, it should be understood that the concept is equally applicable to other arrangements. For example, in some instances, the device is pushed through the blood vessel from a first position distal to the proximal pressure measurement position to a second position further distal (i.e., further away from the fixed position for proximal pressure measurement). In other instances, a distal pressure measurement result is obtained at a fixed position within the blood vessel, and the device is pulled back to a second position closer to the first position (i.e., further away from the fixed position for distal pressure measurement) from a first position proximal to the fixed position for distal pressure measurement via the blood vessel. However, in other instances, distal pressure measurements are obtained at a fixed location within the blood vessel, and the device is propelled through the blood vessel from a first location proximal to the fixed location of the distal pressure measurement to a second location no closer than the first location (i.e., closer to the fixed location of the distal pressure measurement).

[0078] In a typical embodiment, the processing system is capable of collecting raw pressure data from an intravascular device and processing the data to calculate one or more pressure differences or one or more pressure ratios. In some instances, the pressure difference between two intravascular pressure measurements (e.g., a fixed-position pressure measurement and a moving pressure measurement) is calculated as a ratio of the two pressure measurements (e.g., a moving pressure measurement divided by a fixed-position pressure measurement). In some instances, the pressure difference is calculated for each cardiac cycle of the patient. In this aspect, in some embodiments, the calculated pressure difference is the average pressure difference across cardiac cycles. For example, in some instances where a vasodilator is applied to the patient, the average pressure difference across cardiac cycles is used to calculate the pressure difference. In other embodiments, only a portion of the cardiac cycle is used to calculate the pressure difference. In some instances, the pressure difference is a portion of the cardiac cycle or an average over a diagnostic window.

[0079] In some embodiments, one or more of the techniques described in U.S. Patent Application No. 13 / 460296, filed April 30, 2012, entitled “DEVICES, SYSTEMS, AND METHODS FOR ASSESSING A VESSEL,” are used to select a diagnostic window, which is incorporated herein by reference in its entirety. As discussed therein, the diagnostic window and associated techniques are particularly suitable for use in situations where a congestive agent is not applied to the patient. Generally, a diagnostic window for evaluating differential pressure across a stenosis without the use of a congestive agent is identified based on one or more of the properties and / or components of: proximal pressure measurements, distal pressure measurements, proximal velocity measurements, distal velocity measurements, ECG waveforms, and / or other identifiable and / or measurable aspects of vascular performance. In this regard, various signal processing and / or computational techniques can be applied to one or more of the following properties and / or components to identify a suitable diagnostic window: proximal pressure measurement results, distal pressure measurement results, proximal velocity measurement results, distal velocity measurement results, ECG waveforms, and / or other identifiable and / or measurable aspects of vascular performance.

[0080] Refer again Figure 5 At box 530, method 500 includes determining whether PCI is an appropriate treatment for the blood vessel. Angiographic data, pressure measurements, and / or other data can be used to determine the presence of blood vessel stenosis and that treatment of the blood vessel is necessary. An exemplary embodiment for determining the need for blood vessel treatment is described in U.S. Provisional Application No. 62 / 089039, which is incorporated herein by reference in its entirety.

[0081] Method 500 includes planning PCI at step 540. Planning PCI can include interacting with the graphical user interface described herein to determine physiological parameters for PCI, such as stent location, stent length, stent diameter, etc. Using the screen display described herein, a graphical representation of the stent positioned within the blood vessel can be visualized. The screen display can include various co-registered physiological data, such as pressure ratios(one or more) superimposed on the blood vessel at its associated location. The graphical representation of the stent can have various analog or virtual properties, such as location, length, diameter, etc., such that it is appropriately adapted within the visual representation of the blood vessel. For example, the properties of the graphical representation of the stent can be manually selected by a clinician, for example, based on user input, and / or automatically determined by a computing device. The properties of the graphical representation of the stent can be changed in response to user input. As described with respect to box 580, based on the analog or virtual properties of the graphical representation of the stent, true physiological parameters for PCI, such as stent location, stent length, stent diameter, etc., can be determined. In this way, angiographic data and physiological measurements can be combined in a meaningful manner to plan and evaluate the outcome of PCI. Treatment planning and any modifications to stent parameters, as well as the predicted / expected outcomes of treatment, can be supported by the collected data.

[0082] Planning PCI (box 540) can include one or more of boxes 550, 560, and / or 570. At box 550, method 500 includes an output screen display. The screen display includes visualization based on pressure measurement results and a visual representation of the vessel. In some embodiments, the visual representation of the vessel is a two-dimensional or three-dimensional angiographic image of the vessel, such as an angiographic image generated based on angiographic data collected at box 520. In some embodiments, the visual representation of the vessel is a two-dimensional or three-dimensional graphical representation of the vessel, such as a stylized image or reconstruction of the vessel. The visualization based on pressure measurement results can include numerical, graphical, textual, and / or other suitable visualizations. For example, the visualization can include one or more of the following: a stent positioned within the visual representation of the vessel, a calculated pressure ratio(s), a marker indicating the location within the vessel of the obtained pressure measurement result or the calculated pressure ratio(s), a label identifying the vessel, etc. Figure 7-28The visual representation of blood vessels and visualization based on pressure measurement results are described in the context of this study. In some embodiments, visualization based on pressure measurement results can include a heatmap, wherein the visual representation of the blood vessels is colored or otherwise progressively transformed to show changes in the obtained pressure measurement results or calculated pressure ratio(s). Examples of screen displays including heatmaps, calculated pressure ratios, markers indicating locations associated with the obtained pressure measurement results or calculated pressure ratios are described in U.S. Provisional Application No. 61 / 895909, filed October 25, 2013, entitled "Devices, Systems, and Methods for Vessel Assessment," which are incorporated herein by reference in their entirety. In various embodiments, other collected data, calculated quantities, such as ECG waveforms and values, can be provided on a screen display, as described in U.S. Provisional Application No. 62 / 049265, filed September 11, 2014, entitled "Bedside Controller for Assessment of Vessels and Associated Devices, Systems, and Methods," which is incorporated herein by reference in its entirety. In method 600 ( Figure 6 Other exemplary screen displays were described in the discussion.

[0083] At block 560, method 500 includes receiving user input to modify the visualization. The user input may be inserting a stent into the visual representation of a blood vessel and / or moving the stent within the blood vessel. The user input may be changing one or more properties of the stent, such as length, diameter, material, etc. For example, the user input may be increasing or decreasing the length of the stent within the blood vessel. The user input may be received at a user interface device. In some embodiments, the user input is touch input received at a touch-sensitive display of a bedside controller. At block 570, method 500 includes modifying the visualization based on the user input. For example, in response to the user input, the stent may be inserted into the visual representation of a blood vessel, the position of the stent within the blood vessel may be changed, and one or more properties of the stent (e.g., length, diameter, material, etc.) may be changed.

[0084] At box 580, method 500 includes performing PCI using physical parameters identified during PCI planning. True physiological parameters (e.g., stent location, stent length, stent diameter, etc.) can be determined based on the location, length, diameter, etc., of the stent's graphical representation within a visual representation of the blood vessel. For example, computing device 172 can correlate the virtual / simulated properties of the stent's graphical representation with co-registered angiographic data to determine the stent's true physiological parameters. For example, the length of the stent's graphical representation can be correlated with the actual length within the blood vessel traversed by the stent using angiographic images. Similarly, the location, diameter, and other virtual / simulated properties of the stent's graphical representation can be correlated with corresponding true physiological parameters within the blood vessel using angiographic images. In some embodiments, quantitative coronary angiography (QCA), known pull-back velocity, etc., can be used to determine the blood vessel size in the co-registered angiographic data. PCI can then be performed on a patient to treat the blocked blood vessel using a stent with the determined true physiological parameters.

[0085] Figure 6 This is a flowchart illustrating method 600 for evaluating a patient's blood vessels. Method 600 is similar to other methods, and will be described similarly within the context of pressure sensing procedures (such as iFR, Pd / Pa, or FFR procedures). It should be understood that method 600 can be performed within the context of flow sensing procedures such as CFR procedures. Reference Figure 7-28 This will allow for a better understanding of method 600. Boxes 610, 620, and 630 are similar to boxes 510, 520, and 530 of method 500 described above.

[0086] Method 600 includes planning PCI at step 640. Planning PCI may include interacting with the graphical user interface described herein to determine physiological parameters for PCI, such as stent location, stent length, stent diameter, etc. Using the screen display described herein, a graphical representation of a stent positioned within a blood vessel or along a pressure curve can be visualized. The screen display can include various co-registered physiological data, such as pressure ratios (one or more) superimposed on the blood vessel or pressure curve at its associated location. The graphical representation of the stent can have various analog or virtual properties, such as location, length, diameter, etc., such that it is appropriately adapted to the visual representation of the blood vessel. For example, the properties of the graphical representation of the stent can be manually selected by a clinician, for example, based on user input, and / or automatically determined by a computing device. The properties of the graphical representation of the stent can vary in response to user input. As described with respect to box 690, based on the analog or virtual properties of the graphical representation of the stent, the actual physiological parameters for PCI, such as stent location, stent length, stent diameter, etc., can be determined. In this way, angiographic data and physiological measurements can be meaningfully combined to plan and evaluate PCI outcomes. Treatment planning for stent parameters and any modifications, as well as the anticipated outcomes of the intervention, can be supported by the collected angiographic and / or pressure data.

[0087] Planning a PCI (box 640) can include one or more of boxes 650, 660, 670, and / or 680. At box 650, method 600 includes an output screen display. The screen display includes a visual representation of the pressure ratio and a visual representation of the blood vessels. In some embodiments, the screen display can include both a visual representation of the pressure ratio and a visual representation of the blood vessels, such as arranged side-by-side. In various embodiments, other acquired data, calculated quantities, such as ECG waveforms and values, can be provided on the screen display as described in U.S. Provisional Application No. 62 / 049265, filed September 11, 2014, entitled “Bedside Controller for Assessment of Vessels and Associated Devices, Systems, and Methods,” which is incorporated herein by reference in its entirety. Regarding method 500 ( Figure 5 Other exemplary screen displays are described in the discussion of ( ). As similarly described relative to box 550, the visual representation of blood vessels can include two-dimensional or three-dimensional angiographic images or graphical representations of blood vessels.

[0088] A visual representation of the pressure ratio can include a graph of the calculated pressure ratio over time or relative to a location / position within an anatomical structure, such as blood vessels. Figure 8a, Figure 8b , Figure 10 , Figure 12 , Figure 14 , Figure 16 , Figure 18 , Figure 20 , Figure 22 , Figure 24 , Figure 26 and Figure 28 The diagram illustrates an exemplary embodiment of a visual representation of pressure ratios. The graph can show pressure ratios calculated, such as during pull-back, within the time it takes to obtain a pressure measurement, or relative to a location / position within the blood vessel. For example, the graph can show iFR or FFR pressure ratio values. In this respect, the iFR pressure ratio can be calculated as described in one or more of the following: PCT patent application publication No. WO2012 / 093260, filed January 6, 2012, entitled "APPARATUS AND METHOD OF CHARACTERISING A NARROWING IN A FLUID FILLED TUBE"; PCT patent application publication No. WO 2012 / 093266, filed January 6, 2012, entitled "APPARATUS AND METHOD OF ASSESSING ANARROWING IN A FLUID FILLED TUBE"; U.S. patent application No. 13 / 460296, filed April 30, 2012, entitled "DEVICES, SYSTEMS, AND METHODS FOR ASSESSING A VESSEL"; and U.S. patent application No. 13 / 460296, filed August 20, 2012, entitled "DEVICES, SYSTEMS, AND METHODS FOR ASSESSING A VESSEL". PCT patent application publication No. WO 2013 / 028612 entitled “VISUALLY DEPICTING A VESSEL AND EVALUATING TREATMENT OPTIONS”, U.S. Provisional Patent Application No. 61 / 856509 entitled “DEVICES, SYSTEMS, AND METHODS FOR ASSESSMENT OF VESSELS”, filed July 19, 2013, and U.S. Patent Application No. 61 / 856518 entitled “DEVICES, SYSTEMS, AND METHODS FOR ASSESSING AVESSEL WITH AUTOMATED DRIFT CORRECTION”, filed July 19, 2013, are all incorporated herein by reference in their entirety.

[0089] It should be understood that the visual representation of pressure ratios can illustrate pressure ratios and / or baseline pressure measurements obtained from multiple sensing components in any suitable manner. Generally, the representation of data in the visual representation of pressure ratios can be used to identify gradients / changes in the pressure ratios and / or baseline pressure measurements that can indicate significant lesions in the blood vessels. In this aspect, the visual representation of the data can include (one or more) pressure measurements; ratios of pressure measurements; differences in pressure measurements; gradients in (one or more) pressure measurements; ratios of pressure measurements and / or differences in pressure measurements; first or second derivatives of (one or more) pressure measurements; ratios of pressure measurements and / or differences in pressure measurements; and / or combinations thereof.

[0090] At block 660, method 600 includes receiving user input to modify a visual representation of a pressure ratio or a visual representation of a blood vessel. The user input may be inserting a stent into the visual representation of the blood vessel or the visual representation of the pressure ratio. The user input may be moving the stent within the blood vessel or along the visual representation of the pressure ratio. The user input may be changing one or more properties of the stent, such as length, diameter, material, etc. For example, the user input may be increasing or decreasing the length of the stent within the blood vessel or along the visual representation of the pressure ratio. The user input can be received from a user interface device. In some embodiments, the user input is touch input received at a touch-sensitive display of a bedside controller. For example, user input modifying the visual representation of the pressure ratio can be received directly on a graph of the pressure ratio over time. For example, user input modifying the visual representation of the blood vessel can be received directly on an angiographic image of the blood vessel.

[0091] At box 670, method 600 includes modifying one of the selected visual representation of the pressure ratio and the visual representation of the vessel. At box 680, method 600 includes correspondingly modifying the unselected visual representation of the pressure ratio and the visual representation of the vessel. For example, in response to user input modifying the visual representation of the vessel, a stent can be inserted into the visual representation of the vessel. For example, the stent can be a graphic overlay positioned on an angiographic image of the vessel. The corresponding stent can also be inserted into the visual representation of the pressure ratio. Similarly, in response to user input modifying the visual representation of the pressure ratio, a stent can be inserted along a graph of the pressure ratio over time. The corresponding stent can also be inserted into the visual representation of the vessel. User-guided modifications and automatic corresponding modifications can be performed using various properties of the stent or other visualizations. For example, the screen display can be modified to change the position of the stent along the visual representation of the pressure ratio, and the position of the stent within the vessel can be changed accordingly, and vice versa. It is possible to change one or more properties of the stent (e.g., length, diameter, material, etc.) in the visual representation of the pressure ratio, and to correspondingly change one or more properties in the visual representation of the blood vessel, and vice versa.

[0092] In some instances, either a visual representation of the pressure ratio or a visual representation of the blood vessel can be better suited for PCI planning. One or more methods described herein allow clinicians to use the visual representation best suited to the situation. For example, angiographic images can indicate that a stent of a specific length is sufficient to remedy pressure changes caused by lesions in the blood vessel. However, because pressure sensing devices take a relatively direct route through the blood vessel, angiographic images may underestimate the actual length of the stent required. Conversely, a visual representation of the pressure ratio can more accurately suggest the length of the stent required to address the pressure drop. Therefore, the screen display of the visual representation of the pressure ratio can be modified to include stents with increased lengths. The visual representation of the blood vessel can be modified accordingly to include longer stents. In other embodiments, the visual representation of the blood vessel can provide more accurate information for PCI planning and can be modified accordingly to adjust the visual representation of the pressure ratio.

[0093] At box 690, method 600 includes performing PCI using physical parameters identified during PCI planning. True physiological parameters (e.g., stent location, stent length, etc.) can be determined based on the location, length, diameter, etc., of the stent in a visual representation of the blood vessel and / or in a graphical representation of the stent along a pressure curve. For example, computing device 172 can correlate the properties of the stent's graphical representation with co-registered angiographic data to determine the stent's true physiological parameters. For example, the length of the stent's graphical representation can be correlated with the actual length of the blood vessel traversed by the stent using known intravascular distances (e.g., pressure ratios) between data points on an angiographic image or pressure curve. Similarly, the location, diameter, and other virtual / simulated properties of the stent's graphical representation can be correlated with corresponding true physiological parameters within the blood vessel using known intravascular dimensions (e.g., pressure ratios) between data points on an angiographic image or pressure curve. In some embodiments, quantitative coronary angiography (QCA), known pull-back velocities, etc., can be used to determine the vessel size in co-registered angiography. It enables the performance of PCI on patients to treat blocked blood vessels using stents with defined real physiological parameters.

[0094] The following discussion is largely based on... Figure 7-28 . Figure 7-28 This is an exemplary screen display (or partial screen display) according to embodiments of the present disclosure. Figure 7 , Figure 9 , Figure 11 , Figure 13 , Figure 15 , Figure 17 , Figure 19 , Figure 21 , Figure 23 , Figure 25 and Figure 27 The illustration shows a screen display that includes a visual representation of blood vessels. Figure 8a , Figure 8b , Figure 10 , Figure 12 , Figure 14 , Figure 16 , Figure 18 , Figure 20 , Figure 22 , Figure 24 , Figure 26 and Figure 28 The illustration shows a screen display that includes a visual representation of the pressure ratio. Figure 7-28 Display devices capable of being displayed on systems assessing a patient's vascular system, such as computing devices 172 ( Figure 4 The associated display device 180. That is, one or more components (e.g., processor and / or processing circuitry) of the system (e.g., computing device 172) are able to provide display data to enable... Figure 7-28The image is displayed on a display device (e.g., display device 180). Figure 7-28 The pressure ratio values ​​shown in the figure are illustrative.

[0095] Figure 7 The illustration shows a screen display 700 (or a partial screen display) including a visual representation of blood vessels. In screen display 700 ( Figure 7 The data described in ) corresponds to screen displays 800 and 850 ( Figure 8a and Figure 8b The data shown in the image. The screen displays a visual representation of a blood vessel 702, including an intravascular device with pressure sensing components, being guided therein. Angiographic and pressure data can be collected using the intravascular device within the blood vessel 702. For example, the pressure data can be collected during a pullback procedure, which... Figure 7 In this embodiment, the flow is from right to left of the blood vessel 702. The collected angiography data can be used to generate angiography images including blood vessel 702 and other branch blood vessels 704. One or more visualizations described herein can be graphic overlays on angiography images. Screen display 700 includes a label field 706 that identifies one or more specific blood vessels. In some embodiments, a computing device (e.g., Figure 4 The computing device 172) uses angiographic data, such as the outline, location, branching, and other features of (one or more) blood vessels, to automatically identify them. The position and / or viewing angle of an external imaging system (e.g., angiography or X-ray system) can also be used to identify blood vessels. The computing device is capable of generating display data associated with label 706, including letters, numbers, alphanumeric, and / or symbolic characters. Figure 7 In one embodiment, label 706 includes abbreviations for the identified blood vessel, such as "RCA" for the right coronary artery and "PLA" for the posterior coronary artery. Although abbreviations and specific blood vessels are used... Figure 7 However, it should be understood that any suitable label can be used. In some embodiments, the user can selectively activate or deactivate one or more of the labels 706, such that some, all, or no labels 706 are included in the screen display 700.

[0096] The screen display 700 also includes a marker 708 indicating the location within the vessel 700 associated with the collected pressure measurements or calculated pressure ratios. For example, marker 708 could indicate the location of the pressure sensor when pressure measurements are collected. Figure 7In this embodiment, marker 708 is a line segment traversing the blood vessel 702. Other examples of markers indicating location are described in U.S. Provisional Application No. 61 / 895909, entitled “Devices, Systems, and Methods for Vessel Assessment,” filed October 25, 2013, and are incorporated herein by reference in their entirety. In one embodiment, such as during an iFR procedure, a pressure ratio is calculated per heartbeat cycle. Therefore, each marker 708 indicates the data collected and / or the calculated pressure ratio during the heartbeat cycle. In some embodiments, a user can selectively activate or deactivate one or more of the markers 708, such that some, all, or no markers 708 are included in the screen display 700. The markers 708 can be separated by different distances within the blood vessel 702, as indicated by distances 710 and 712. Furthermore, distances 710 and 712 can correspond to the speed at which the pressure sensing device is guided through the blood vessel 702. In embodiments where the pressure sensing device is guided through the blood vessel 702 at a constant speed, the distances between the markers 708 are equal or nearly equal, such that consecutive markers 702 are positioned at equal or nearly equal intervals. In embodiments where the pressure sensing device is guided through the blood vessel 702 at a non-constant speed, the distances between the markers 708 will vary to a greater extent, such that consecutive markers 708 are positioned at unequal intervals. For example, the pressure sensing device can decelerate near a blockage, allowing data to be collected from a relatively larger number of heartbeat cycles. Figure 7 As illustrated, there is a smaller distance between successive markers 708 around the area attributable to pressure changes caused by blockage in the blood vessel 702. Co-registration is possible, allowing the location of the pressure-sensing intravascular device within the blood vessel 702 to be known during each cardiac cycle. Therefore, the pressure-sensing intravascular device can be guided through the blood vessel 702 at a non-constant speed (e.g., during a pull-back procedure), allowing the pace of data collection within the blood vessel 702 to be controlled by the clinician. For example, the clinician can slow down to obtain more information near clinically significant portions of the blood vessel 702, such as lesions. Conversely, the clinician can accelerate through non-clinically significant portions of the blood vessel 702.

[0097] Pressure changes in vessel 702 are indicated by pressure ratio field 714. Adjacent marker 708 provides the pressure ratio field. Figure 7In this embodiment, only a portion of the pressure ratio field 714 is shown. In various embodiments, a portion, all, or no pressure ratio field 714 can provide a calculated pressure ratio associated with a given location. For example, a user can selectively activate or deactivate one or more of the pressure ratio fields 714. In various embodiments, the pressure ratio field 714 includes letters, numbers, alphanumeric characters, and / or symbol characters. Figure 7 In this context, field 714 includes a numerical value associated with the iFR calculation. In other embodiments, field 714 may include labels such as “FFR,” “iFR,” “Pd / Pa,” or others to identify the type of quantity being displayed. For example, such an embodiment is described in U.S. Provisional Application No. 61 / 895909, entitled “Devices, Systems, and Methods for Vessel Assessment,” filed October 25, 2013, which is incorporated herein by reference in its entirety. The value in field 714 indicates a change in pressure. For example, in… Figure 7 In the mean 702, blockages may exist between values ​​of 0.93 and 0.81.

[0098] The screen display 700 additionally includes a stent insertion field 716. The selection of the stent insertion field 716 can be a user input that modifies the visual representation of the blood vessel and / or a visualization based on pressure measurement results. In some embodiments, the selection of the stent insertion field 716 enables a computing device (e.g., computing device 172) to determine one or more recommended characteristics for a stent to be deployed within the blood vessel 702, including location, diameter, length, material, etc. The determination of one or more characteristics can be based on collected pressure data, calculated pressure ratio(s), angiographic data, threshold pressure ratio, target pressure ratio, ideal pressure ratio, etc. In this aspect, the stent can be described as a visualization based on pressure measurement results. For example, stent characteristics, such as location and length, can be selected to remedy a decrease in the pressure ratio across the occlusion. The computing device can determine the stent characteristics and generate display data such that the stent is displayed within the blood vessel 702 (e.g., in...). Figure 9(As illustrated in the figure). As described below, clinicians can modify the recommended characteristics of the stent. In some embodiments, the selection of the insertion stent field 716 is provided without determining its characteristics based on collected pressure data, calculated pressure(s) and / or angiographic data. In this way, clinicians can customize the characteristics of the stent. For example, clinicians can provide user input along the blood vessel 702 (such as clicks and drags or other suitable inputs), and the computing device can provide a graphical representation of the stent with a length corresponding to the distance traversed by the user input along the blood vessel 702. In some embodiments, multiple stent options can be provided when selecting the insertion stent field 716, such as relative to... Figure 25 A more detailed description.

[0099] Figure 8a and Figure 8b The illustration shows screen displays 800 and 850 (or partial screen displays) including a visual representation of the pressure ratio. In screen displays 800 and 850 (… Figure 8a and Figure 8b The data described in ) corresponds to screen display 700 ( Figure 7 The data shown in the figure. Screen displays 800 and 850 respectively include curves 802 and 852 representing the pressure ratio within the blood vessel 702. Except for the x-axis, curves 802 and 852 represent the same data. Screen display 800 ( Figure 8a This includes time or distance on the x-axis and pressure ratios (such as iFR, FFR, Pd / Pa, etc.) on the y-axis. For example, in Figure 7 In the illustrated embodiment, a moving pressure sensing device can be guided from right to left within the vessel 702 during the pull-back process, while a stationary pressure sensing device remains fixed on the left side of the vessel 702. Values ​​along the x-axis of the display 800 can correspond to the duration of the pull-back process and / or the distance traveled by the moving pressure sensing device during the pull-back process. The display 850 includes the position corresponding to the physical orientation of the vessel 702 along the x-axis and pressure ratio quantities (such as iFR, FFR, Pd / Pa, etc.) on the y-axis. That is, the display 850 shows the pressure ratio associated with the left side of the vessel 702 on the left side of curve 852 and the pressure ratio associated with the right side of the vessel 702 on the right side of curve 852. In some instances, providing a pressure ratio plot corresponding to the physical location along the vessel can facilitate easier PCI planning. The following discussion generally refers to the display 850, but it should be understood that the display 800 can be used equivalently.

[0100] Displays 800 and 850 include an ideal pressure ratio line 806. The ideal line 806 represents a pressure ratio equal to -1 (1), indicating a non-blocked blood vessel. Physiologically, a pressure ratio equal to -1 (1) is the maximum possible pressure ratio and occurs when proximal and distal pressure measurements are equal. During PCI planning, clinicians attempt to determine stent parameters that will bring the patient's pressure ratio back as close as possible to the ideal line 806.

[0101] Displays 800 and 850 include a threshold pressure ratio 804. The threshold 804 can be set at a value indicating the transition between a pressure ratio representing a healthy blood vessel and a pressure ratio representing a blocked blood vessel. A pressure ratio greater than the threshold 804 can indicate a vessel not recommended for treatment, while a pressure ratio less than the threshold 804 can indicate a vessel recommended for treatment. The threshold 804 can vary depending on the pressure ratio scale (e.g., iFR, FFR, Pd / Pa, etc.) used in displays 800 and 850. For example, the threshold 804 for FFR can be 0.80, and the threshold 804 for iFR can be 0.89. For example, if a blood vessel has an FFR value greater than 0.80, the clinician can determine that the blood vessel should not be treated. If a blood vessel has an FFR value less than 0.80, the clinician can determine that PCI should be used to treat the blood vessel.

[0102] Displays 800 and 850 include a target line 820. The target line 820 can correspond to a pressure ratio value associated with clinically beneficial outcomes for the patient. In some embodiments, the target line 820 can correspond to a pressure ratio value higher than a threshold 804. That is, the threshold 804 can represent a minimum pressure ratio value that can be considered healthy, while the target line 820 can represent a higher pressure ratio value associated with effective treatment. The target line 820 can vary depending on the pressure ratio scale (e.g., iFR, FFR, Pd / Pa, etc.) used in displays 800 and 850. For example, the target line 820 for FFR can be 0.93. A graphical user interface for PCI planning allows clinicians to set pressure ratio values ​​for the threshold 804 and / or the target line 820. For example, clinicians can access setting options that allow modification of the threshold 804 and / or the target line 820. One of the goals during stent insertion in PCI is to return the actual pressure ratio values ​​of curves 802 and 852 as close as possible to the value indicated by the ideal line 806. However, recreating perfect flow within a stenotic blood vessel may be medically impossible. In such cases, the target line 820 represents a medically acceptable pressure ratio value indicating effective treatment. Therefore, during PCI planning, clinicians determine stent parameters to return the patient's pressure ratio value as close as possible to the ideal line 806 and at least above the target line 820. In response to user input showing / hiding the visualization, threshold 804, target line 820, and / or ideal line 806 can be selectively provided on screen displays 800 and 850. Although threshold 804 and target line 820 are shown on... Figure 10 , Figure 12 , Figure 14 , Figure 16 , Figure 18 , Figure 20 , Figure 22 , Figure 24 , Figure 26 and Figure 28 However, it should be understood that no or any one or more thresholds 804, target lines 820 and / or ideal lines 806 can be provided on the screen display.

[0103] In some embodiments, various colors and / or other visual indicators are provided on screen displays 800 and 850 to indicate the difference between threshold 804 and the actual pressure ratio. For example, a first color (e.g., green, white, or others) can be used to represent values ​​much greater than the threshold (e.g., where the threshold is 0.80 on a scale of 0.00 to 1.00, values ​​greater than 0.90), a second color (e.g., yellow, gray, or others) can be used to represent values ​​close to but greater than the threshold (e.g., where the threshold is 0.80 on a scale of 0.00 to 1.00, values ​​between 0.80 and 0.90), and a third color (e.g., red, black, or others) can be used to represent values ​​equal to or less than the threshold (e.g., where the threshold is 0.80 on a scale of 0.00 to 1.00, values ​​of 0.80 and below). It should be understood that any number of color combinations, scales, categories, and / or other characteristics can be used to visually represent the relative value of the pressure difference to the threshold. However, for the sake of brevity, the applicant will not explicitly describe many variations in this document.

[0104] Screen displays 800 and 850 additionally include a flag 808 and a pressure ratio field 814. The flag 808 and pressure ratio field 814 are related to... Figure 7 Those similar to those described in the context. Although curves 802 and 852 are in Figure 8a and Figure 8b The curves are depicted as continuous, but marker 808 can represent actual data points on curves 802 and 852. Based on the pressure ratio associated with marker 808, interpolation can be performed on the values ​​of curves 802 and 852 between markers 808. Computing devices (e.g., Figure 4 The computing device 172) is capable of providing data processing, data interpolation, smoothing, and performing other calculations to generate pressure ratio curves 802 and 852. It is capable of selectively activating and deactivating the ideal pressure ratio line 806, threshold 804, flag 808, and pressure ratio field 814, so that some, all, or none of them appear on screen displays 800 and 850.

[0105] Screen displays 800 and 850 additionally include an insertion bracket field 816. Selection of the insertion bracket field 816 allows for user input that modifies the visual representation of the pressure ratio. (Relative to...) Figure 7 Similarly described, in some embodiments, the selection of the insertion bracket field 816 enables the computing device (e.g., Figure 4The computing device 172) determines one or more recommended characteristics of the stent to be deployed along curve 802 or curve 852, including stent location, diameter, length, material, etc. The determination of one or more characteristics can be based on collected pressure data, calculated pressure ratio(s), angiographic data, threshold pressure ratio, target pressure ratio, ideal pressure ratio, etc. In this respect, the stent can be described as a visualization based on pressure measurement results. For example, stent characteristics, such as location and length, can be selected to traverse the descent of the pressure ratio curve. The computing device is able to determine the stent characteristics and generate display data such that the stent is displayed along curves 802 and 852 (e.g., in...). Figure 10 (As illustrated in the figure). As described below, clinicians can modify the recommended characteristics of the stent. In some embodiments, the selection of the insertion stent field 816 provides the stent without determining its characteristics based on acquired pressure data, calculated pressure(s) ratio(s), and / or angiographic data. In this way, clinicians can customize the characteristics of the stent. For example, clinicians can provide user input (such as clicks or drags or other suitable inputs) along curves 802 and / or 852, and the computing device can provide a graphical representation of the stent having a length corresponding to the distance traversed by the user input along curves 802 and / or 852. In some embodiments, multiple stent options can be provided when selecting the insertion stent field 816, such as relative to... Figure 26 A more detailed description.

[0106] Figure 9 The illustration shows a screen display 900 (or a partial screen display) including a visual representation of blood vessels. Screen display 900 ( Figure 9 The data described in ) corresponds to 1000 displayed on the screen. Figure 10The data shown in the figure. The graphic representation of stent 902 is positioned within the visual representation of blood vessel 702. In response to modifications to the visual representation of blood vessel and / or modifications to the visualization based on pressure measurements, stent 902 can be inserted into the blood vessel. As described above, location, length, diameter, material, and / or other characteristics can be automatically generated by a computing device, and corresponding display data can be provided to a display device. For example, the diameter of the stent can be automatically set to match the diameter of the blood vessel in the angiographic image. Graphical characteristics of stent 902 that determine how stent 902 appears in screen display 900 can be selected, such that stent 902 is visually distinguishable within blood vessel 702. The image characteristics can include color, shadow, pattern, transparency, borders, and other relevant characteristics. In some embodiments, image characteristics of stent 902 are selected to match the physical appearance of the actual stent. In some embodiments, image characteristics of stent 902 are selected to highlight the area within blood vessel 702 in which the stent is inserted. Based on the location, length, diameter, material, and / or other virtual / simulated properties of the stent 902, the true physiological values ​​of the stent to be positioned within the blocked blood vessel of a human patient can be determined.

[0107] Figure 10 The illustration shows a screen display 1000 (or a portion of the screen display) including a visual representation of the pressure ratio. In screen display 1000 ( Figure 10 The data described in ) corresponds to the display on the screen at 900 ( Figure 9 The data shown in the figure. A graphical representation of the stent 1002 is positioned along the visual representation of the pressure ratio curve 852. The characteristics of the graphical representation of stent 1002, such as position and length, correspond to the characteristics of the graphical representation of stent 902 positioned within the blood vessel 702. Figure 9In response to modifications to the visual representation of the pressure ratio and / or user input modifying the visualization based on pressure measurements, a stent 1002 can be inserted along the pressure ratio curve 852. As described above, location, length, diameter, material, and / or other physical characteristics can be automatically generated by a computing device, and corresponding display data can be provided to a display device. Image characteristics of the stent 1002 that determine how it appears in the screen display 100 can be selected, such that the stent 1002 is visually distinguishable along curve 852. Image characteristics can include color, shadow, pattern, transparency, borders, and other relevant properties. In some embodiments, image characteristics of the stent 1002 are selected to match the physical appearance of an actual stent. In some embodiments, image characteristics of the stent 1002 are selected to highlight the area along curve 852 in which the stent is inserted. Based on the location, length, diameter, material, and / or other virtual / simulated characteristics of the graphical representation of the stent 1002, the true physiological values ​​of the stent to be positioned within an obstructed blood vessel in a human patient can be determined.

[0108] The screen display 1000 includes a corrected pressure curve 1004. The corrected pressure curve 1004 represents the expected change in pressure curve 852 due to the deployment of the support 1002 at its current position and with current characteristics (such as length). No pressure change across the length of the support 1002 is expected, as illustrated in the corrected pressure curve 1004. That is, the placement of the support 1002 is ideally designed to create perfect or near-perfect flow across that portion of the support 702. The end of the support 1002 can be indicated by a support end annotation 1006. In different embodiments, various other graphical representations of the support end can be utilized. The support end annotation 1006 can be selectively provided to the screen display 1000, for example, based on user input showing / hiding the visualization. The support end annotation 1006 indicates a point beyond which the corrected pressure curve 1004 is expected to behave like pressure curve 852. As shown, after stent tip annotation 1006, the shape of the corrected pressure curve 1004 is set to resemble that of pressure curve 852. However, because stent 1002 corrects for at least a portion of the pressure drop across the lesion in the vessel, the pressure value indicated by the corrected pressure curve 1004 is higher.

[0109] The screen display 1000 additionally includes a corrected pressure ratio value 1010. The corrected pressure ratio value 1010 can correspond to a value in the corrected pressure ratio curve 1004. One or both of the corrected pressure ratio value 1010 and the corrected pressure ratio curve 1004 can provide clinical validation that the selected treatment will achieve the clinical goal of reducing pressure loss in the blood vessels. For example, a threshold 804 can correspond to an iFR value of 0.89, greater than which the blood vessel can be considered healthy. If the corrected pressure ratio value 1010 provides an iFR value greater than 0.89 (rather than in...), the blood vessel will be considered healthy. Figure 10 As in the embodiments described herein, clinicians can understand that the placement of a stent with given parameters (e.g., length, diameter, location, etc.) will provide some benefit during the treatment of the blood vessel. Clinicians can also understand that the proposed stent parameters do not result in a corrected pressure ratio curve 1004 or a corrected pressure ratio value 1004 equal to or exceeding the target line 820, where the clinical benefit may arise from the treatment intervention. Therefore, as described herein, clinicians can change stent parameters to move the stent, modify the stent length, etc., thereby planning a PCI that results in a corrected pressure ratio exceeding the target line 820. In some embodiments, clinicians can make sufficient medical determination that it is not feasible for the corrected pressure ratio curve 1004 to reach the target line 820 and to raise the corrected pressure ratio curve 1004 above the threshold 804. The corrected pressure ratio value 1010 can be associated with the distal portion of the corrected pressure ratio curve 1004 (e.g., the most distal value, the average value of the corrected pressure ratio curve, etc.). The corrected pressure ratio value 1010 can be provided adjacent to the corrected pressure ratio curve 1004. In response to user input that shows / hides the visualization, a calibrated pressure ratio value of 1010 can be selectively provided.

[0110] The computing device (e.g., computing device 172) can calculate the value of the corrected pressure curve 1004 based on the obtained pressure measurements, the calculated pressure ratio, the target pressure ratio, the ideal pressure ratio, etc. The corrected pressure curve 1004 can be calculated and provided in real time, allowing adjustment of curve 1004 based on modifications made by clinicians to other physical characteristics such as the position and length of the stent 1002. Clinicians can modify the physiological characteristics of the stent so that the corrected pressure value is close to the ideal pressure ratio. Figure 8b Such an ideal pressure ratio line (806) and / or at least greater than the target pressure ratio (such as Figure 8b Target line 820).

[0111] In some embodiments, a graphical representation of the bracket is inserted into the screen display 900 ( Figure 9The 702 vascular tract enables the graphical representation of the stent to be displayed along the screen. Figure 10 The pressure ratio curve 852 is correspondingly inserted. Similarly, along the screen display 1000 ( Figure 10 The pressure ratio curve 852 allows the stent to be inserted into the corresponding blood vessel 702 of the display 900. In this way, clinicians can perform PCI planning while directly interacting with one of the selected displays 900 and 1000, and automatically view corresponding changes in the unselected display 900 and 1000.

[0112] Figure 11-14 The motion of a stent within a blood vessel and along a pressure ratio curve is described. Figure 11 The illustration shows a screen display 1100 (or a partial screen display) including a visual representation of blood vessels. In screen display 1100 ( Figure 11 The data described in ) corresponds to the display on the screen at 1200 ( Figure 12 The data shown in the figure. A graphical representation of the ability to move the stent 902 within the vessel 702. That is, in response to user input to move the stent 902, the position of the stent 902 relative to the vessel 702 can be changed. User input to move the stent 902 can be described as user input that modifies a visualization based on pressure ratio or a visual representation of the vessel. In some embodiments, the stent option menu 1104 can provide options 1106 and 1108 to move the stent 902 left or right within the vessel 702. In some embodiments, such as when the screen display 1100 is provided on a touch-sensitive display, the user can move the stent within the vessel 702 using one or more touch inputs on the stent 902 itself. For example, the user can touch and drag the stent 902 to different positions. Figure 11 In one embodiment, screen display 1100 is shown in an intermediate stage, wherein bracket 902 is moved to the left side of new position 1102 in response to corresponding user input. Figure 13 The screen display 1300 shows the stent 1302 at its new location in the blood vessel 702. The screen display 1300 ( Figure 13 The data described in ) corresponds to the display on the screen at 1400 ( Figure 14 The data shown in the figure.

[0113] Figure 12 The illustration shows a screen display 1200 (or a portion of the screen display) including a visual representation of the pressure ratio. In screen display 1200 ( Figure 12 The data described in ) corresponds to the display on the screen at 1100 ( Figure 11The data shown in the figure. A graphical representation of the ability to move the bracket 1002 along the pressure ratio curve 852. That is, in response to user input to move the bracket 1002, the position of the bracket 1002 along the curve 852 can be changed. User input to move the bracket 1002 can be described as user input that modifies a visualization based on the pressure ratio or a visual representation of the pressure ratio. In some embodiments, the bracket option menu 1204 can provide options 1206 and 1208 to move the bracket 1002 left or right along the curve 852. In some embodiments, such as when the screen display 1200 is provided on a touch-sensitive display, the user can use one or more touch inputs on the bracket 1002 itself to move the bracket along the curve 852. For example, the user can touch and drag the bracket 1002 to different positions. Figure 12 In some embodiments, the screen display 1200 is shown in an intermediate phase, wherein the support 1002 is moved to the left of the new position 1202 in response to a corresponding user input. In some embodiments, the corrected pressure ratio curve 1004 can be updated in real time, such that as the support 1002 is being moved, the curve 1004 is adjusted to reflect the predicted pressure ratio of the support 1002 at the concurrent position. Figure 14 The screen display 1400 shows the bracket 1402 at its new position along curve 852. The screen display 1400 ( Figure 14 The data described in ) corresponds to screen display 1300 ( Figure 13 The data shown in the figure. Screen display 1400 also provides an updated, corrected pressure ratio curve 1004 based on the new position of the support 1402. For example, Figure 14 Curve 1004 is above the target line 820, indicating that stent 1402 is better positioned relative to the blockage in vessel 702 (as opposed to...). Figure 12 The pressure changes caused by the blockage are remedied by comparing the original position of stent 1002 (within the target line 820). A corrected pressure ratio curve 1004, at least above the target line 820, can serve as a target for the clinician during PCI planning. In response to the selected virtual / simulation characteristics of stent 1402, the computational device predicts the target to be achieved based on the acquired pressure data. The virtual / simulation properties of stent 1402 can be correlated with the actual physiological parameters of the stent to be positioned within the human blood vessel for PCI-based treatment of the patient. Therefore, the graphical representation of the stent's movement allows clinicians to select the appropriate physiological location for stent deployment to maximize clinical efficiency during PCI planning.

[0114] In some embodiments, the mobile screen displays 1100 ( Figure 11 The stent in the 702 vascular vessel enables the stent to be displayed along the screen at 1200 ( Figure 12The pressure ratio curve 852 shifts accordingly. Similarly, along the screen display 1200 ( Figure 12 The pressure ratio curve of 852 movable bracket allows the bracket to be positioned on the screen at 1100 ( Figure 11 The stent can be moved correspondingly within the vessel 702. In this way, clinicians can perform PCI planning while directly interacting with one of the selected displays 1100 and 1200, while automatically viewing corresponding changes in the unselected display 1100 and 1200. For example, clinicians can work directly on display 1200, which illustrates the pressure ratio curve 852 and the stent's positioning relative to the pressure ratio curve. The stent can be moved along the pressure ratio curve 852 so that the calibrated pressure ratio curve 1004 more closely matches or exceeds the target line 820. The stent can be moved within the vessel's display 1100 (…). Figure 11 The stent position can be adjusted accordingly to help clinicians understand where to deploy the stent in the blood vessel to achieve the corrected pressure ratio curve.

[0115] Figure 15-24 The length of the stent, varying within the blood vessel and along a pressure ratio curve, is described. Specifically, Figure 17-20 The shortened stent is described, and Figure 21-24 The extension stent is described. Figure 15 The illustration shows a screen display 1500 (or a partial screen display) including a visual representation of blood vessels. In screen display 1500 ( Figure 15 The data described in ) corresponds to a display of 1600 on the screen. Figure 16 The data shown in the figure. The length of the graphical representation of the stent 1502 within the vessel 702 can be decreased or increased. That is, in response to user input to shorten or lengthen the stent 1502, the stent 1502 within the vessel 702 can be shortened or lengthened accordingly. User input to shorten or lengthen the stent 1502 can be described as user input modifying a pressure ratio-based visualization or a visual representation of the vessel. In some embodiments, the stent option menu 1504 can provide options 1506 and 1508 to increase or decrease the length of the stent 1502 accordingly. In some embodiments, such as when the screen display 1500 is provided on a touch-sensitive display, the user can use one or more touch inputs on the stent 1502 itself to change the length of the stent within the vessel 702. For example, the user can touch and drag one, the other, or both ends of the stent 1502 (e.g., relative to...). Figure 17 and Figure 21 (A more detailed description follows). Figure 15 The illustration shows bracket 1502 before receiving user input to change the length of the bracket.

[0116] Figure 16The illustration shows a screen display 1600 (or a portion of the screen display) including a visual representation of the pressure ratio. In screen display 1600 ( Figure 16 The data described in ) corresponds to 1500 (displayed on the screen). Figure 15 The data shown in the figure. The length of the support 1602 can be increased or decreased along the pressure ratio curve 852. That is, in response to user input to shorten or lengthen the support 1602, the support 1602 along the curve 852 can be shortened or lengthened accordingly. The user input to shorten or lengthen the support 1602 can be described as user input that modifies a visualization based on the pressure ratio or a visual representation of the pressure ratio. In some embodiments, the support option menu 1604 can provide options 1606 and 1608 to increase or decrease the length of the support 1602 accordingly. In some embodiments, such as when the screen display 1600 is provided on a touch-sensitive display, the user can use one or more touch inputs on the support 1602 itself to change the length of the support along the curve 852. For example, the user can touch and drag one, the other, or both ends of the support 1602 (e.g., relative to the pressure ratio curve). Figure 18 and Figure 22 (A more detailed description follows). Figure 16 The illustration shows bracket 1602 before receiving user input to change the length of the bracket.

[0117] Figure 17 The illustration shows a screen display 1700 (or a partial screen display) including a visual representation of blood vessels. In screen display 1700 ( Figure 17 The data described in ) corresponds to the display on the screen at 1800 ( Figure 18 The data shown in the figure. Figure 17 In some embodiments, screen display 1700 is shown in an intermediate stage where the length of bracket 1702 decreases in response to corresponding user input. In some embodiments, user input is a selection of shortening option 1508. Selection of shortening option 1508 enables the length of bracket 1702 to be reduced by a fixed or variable amount at one, the other, or both of its ends 1706. In some embodiments, such as when user input is received on a touch-sensitive display, user input can include a touch on one, the other, or both of the ends 1706 and a drag towards the center of bracket 1702. Figure 17 In this embodiment, as a result of user input, the bracket 1702 can shorten its length 1704 at both ends of the bracket. Although the length 1704 at both ends 1706 of the bracket 1702 is... Figure 17 The lengths of the stent are approximately equal, but it should be understood that the stent can be shortened at different lengths at the distal end 1706. It should also be understood that the stent 1702 can be shortened at only one distal end 1706. Figure 19The screen display 1900 shows a modified, shorter stent 1902 with a vascular bundle 702. In the screen display 1900 ( Figure 19 The data described in ) corresponds to the data displayed on the screen in 2000 ( Figure 20 The data shown in the figure.

[0118] Figure 18 The illustration shows a screen display 1800 (or a portion of the screen display) including a visual representation of the pressure ratio. In screen display 1800 ( Figure 18 The data described in ) corresponds to the display on the screen at 1700 ( Figure 17 The data shown in the figure. Figure 18 In some embodiments, screen display 1800 is shown in an intermediate stage where the length of bracket 1802 is shortened in response to a corresponding user input. In some embodiments, the user input is a selection of shortening option 1608. Selection of shortening option 1608 allows the length of bracket 1802 to be shortened by a fixed amount at one, the other, or both of its ends 1806. In some embodiments, such as when user input is received on a touch-sensitive display, the user input can include a touch on one, the other, or both of the ends 1806 and a drag towards the center of bracket 1802. Figure 18 In some embodiments, as a result of user input, the support 1802 can shorten its length 1804 at both ends. In some embodiments, shortening the length of the support 1802 on the side adjacent to the pressure curve 852 allows the support 1802 to be moved from its original position of the support 1602. That is, shortening the length of the support 1602 (in...) Figure 18 In some embodiments, shortening the length of the stent 1802 on the left side causes both a change in the length of the stent and a shift in the position of the stent to the right. In some embodiments, shortening the length of the stent 1802 on the side opposite to the pressure curve 852 can change the length of the stent without changing the position of the stent. In some embodiments, the corrected pressure ratio curve 1004 can be updated in real time such that when the stent 1802 is shortened, the curve 1004 is adjusted to reflect the predicted pressure ratio of the stent 1802 with the same length. Figure 20 The screen display 2000 shows a bracket 2002 with a modified, shorter length and a modified position along the pressure ratio curve 852. The screen display 2000 ( Figure 20 The data described in ) corresponds to the display on the screen at 1900 ( Figure 19 The data shown in the figure.

[0119] The screen display 2000 also provides an updated, corrected pressure ratio curve 1004 based on the reduced length of the support 2002. Figure 20In this embodiment, the shortened length of the stent 2002 does not provide improvement in the reduced pressure caused by blockage in the blood vessel 702. In fact, Figure 20 Curve 1004 is more accurate than when the support 1602 has its original length. Figure 16 The curve 1004 is further away from the target line 820. Figure 20 The fact that curve 1004 is further from the target line 820 indicates that stent 2002 does not adequately cross the blockage in vessel 702 and is insufficient to remedy the pressure changes caused by the blockage. To improve the predicted pressure ratio within vessel 702 during PCI planning, clinicians can increase the stent length, as described below.

[0120] Figure 21 The illustration shows a screen display 2100 (or a partial screen display) including a visual representation of blood vessels. In screen display 2100 ( Figure 21 The data described in ) corresponds to the display on the screen at 2200 ( Figure 22 The data shown in the figure. Figure 21 In some embodiments, screen display 2100 is shown in an intermediate stage where the length of bracket 2102 is increased in response to a corresponding user input. In some embodiments, the user input is a selection of extension option 1508. Selection of extension option 1508 allows the length of bracket 1702 to be increased by a fixed or variable amount at one, the other, or both ends 2106. In some embodiments, such as when user input is received on a touch-sensitive display, the user input can include a touch on one, the other, or both ends 2106 and a drag towards the center of bracket 2102. As a result of the user input, bracket 2106 can be extended by a length 2104 at both ends 2106 of the bracket. Figure 21 As shown, the stent is extended at the end closer to the change in pressure ratio (e.g., from 0.93 to 0.81) so that the stent covers the area of ​​the blood vessel 702 that may have a blockage causing the pressure change. Although the length 2104 at both ends 2106 is... Figure 21 The lengths are different, but it should be understood that in other embodiments, the length 2104 can be the same. It should also be understood that the support 2106 can be extended at only one end 2106. Figure 23 The screen display 2300 shows a modified, longer stent 2302 with a vascular bundle 702. In the screen display 2300 ( Figure 23 The data described in ) corresponds to the display on the screen at 2400 ( Figure 24 The data shown in the figure.

[0121] Figure 22The illustration shows a screen display 2200 (or a portion of the screen display) including a visual representation of the pressure ratio. In screen display 2200 ( Figure 22 The data described in ) corresponds to the data displayed on the screen in 2100 ( Figure 21 The data shown in the figure. Figure 22 In some embodiments, screen display 220 is shown in an intermediate stage where the length of bracket 2202 is increased in response to a corresponding user input. In some embodiments, the user input is a selection of extension option 1608. Selection of extension option 1608 allows the length of bracket 2202 to be increased by a fixed or variable amount at one, the other, or both ends 2206. In some embodiments, such as when user input is received on a touch-sensitive display, the user input can include a touch on one, the other, or both ends 2206 and a drag towards the center of bracket 2202. As a result of the user input, bracket 2202 can be extended by a length 2204 at both ends 2206 of the bracket. In some embodiments, extending bracket 2202 adjacent to pressure curve 852 allows bracket 2202 to be moved from its original position. That is, bracket 1602 (in Figure 22 In some embodiments, shortening the length of the left side of the support (as described in the example) results in both a change in the length of the support and a shift in its position to the left. In some embodiments, shortening the length of the support 2202 on the side opposite to the pressure curve 852 can change the length of the support without changing its position. Figure 22 As shown, the stent 2202 is extended and moved such that the stent covers the region of curve 852 indicating pressure changes caused by blockage in the blood vessels. Although the length 2204 at both ends 2206 is... Figure 22 The lengths are different, but it should be understood that in other embodiments, the length 2204 may be the same. It should also be understood that the stent 2206 can be extended at only one end 2206. In some embodiments, the corrected pressure ratio curve 1004 can be updated in real time such that as the stent 2202 is extended, the curve 1004 is adjusted to reflect the predicted pressure ratio with respect to the stent 2202 at the same length. Figure 24 The screen display 2400 shows a bracket 2402 with a modified, longer length and a modified position along the pressure ratio curve 852. The screen display 2400 ( Figure 24 The data described in ) corresponds to the display on the screen at 2300 ( Figure 23 The data shown in the figure.

[0122] The screen display 2400 also provides a corrected pressure ratio curve 1004 updated based on the increased length of the bracket 2402. For example, Figure 24 Curve 1004 and when the support 1602 has its original length Figure 16 The curve 1004 is closer to the target line 820 than the curve 1004. Figure 24 Curve 1004, being closer to the target line 820, indicates that stent 2402 is a better length relative to the blockage in blood vessel 702 to remedy the pressure changes caused by the blockage. Although curve 1004 is above the target line 820, clinicians can make a medical determination during PCI planning that the predicted outcome is the best possible clinical result. The virtual / simulated characteristics of stent 2402 can be correlated with the actual physiological parameters of the stent to be positioned within a human blood vessel for PCI-based patient management. Therefore, the graphical representation of stent lengthening and shortening allows clinicians to select the appropriate physiological length of the stent being deployed to maximize clinical efficiency during PCI planning.

[0123] In some embodiments, the screen display is changed to 1700 ( Figure 17 ) and screen display 2100 ( Figure 21 The length of the stent in the vascular 702 allows the stent to be displayed 1800 degrees along the screen accordingly. Figure 12 ) and screen display 2200 ( Figure 22 The pressure ratio curve 852 correspondingly shortens or lengthens. Similarly, along the 1800 (...) displayed on the screen... Figure 12 ) and screen display 2200 ( Figure 22 The pressure ratio curve 852 shows that changing the length of the bracket allows the bracket to be positioned accordingly on the screen at 1700 ( ). Figure 17 ) and screen display 2100 ( Figure 21 Correspondingly, the stent is shortened and lengthened in the blood vessel 702. In this way, clinicians can perform PCI planning while directly interacting with one of the selected screen displays 1700 and 1800, while automatically viewing the corresponding changes in the unselected screen display 1700 and 1800. Similarly, clinicians can perform PCI planning while directly interacting with one of the selected screen displays 2100 and 2200, while automatically viewing the corresponding changes in the unselected screen display 2100 and 2200. For example, clinicians can work directly on screen display 2200, which illustrates the pressure ratio curve 852 and the stent's positioning relative to the calculated pressure ratio curve. The stent can be lengthened along the pressure ratio curve 852 so that the corrected pressure ratio curve 1004 more closely matches the ideal pressure ratio line 806 and / or the target line 820. The screen display 2100 on the blood vessel can make corresponding changes to the length of the stent, allowing clinicians to understand the length of the stent to be deployed in the blood vessel to achieve the corrected pressure ratio curve 852. Figure 24 ).

[0124] although Figure 7-24 The description describes a modification (e.g., moving the support, changing the length of the support), but it should be understood that multiple operations can be performed on the support (e.g., one or more instances of moving the support and one or more instances of changing the length of the support).

[0125] Furthermore, despite Figure 7-24 The length and placement of stents have been described in the context of this disclosure, but it should be understood that this disclosure is similarly applicable to other stent characteristics, such as diameter and material. For example, the size of a physiological stent can be set based on both the lesion length and the vessel diameter. For example, a 16 mm stent can have a diameter in quarter-millimeter increments between 2.5 mm and 5.0 mm. In various embodiments, the diameter of a graphical representation of the vessel can be selected to fit appropriately within the visual representation of the vascular tract or along a pressure curve. A computing device can correlate the diameter of the graphical representation of the stent with the actual physiological diameter of the stent to be inserted into a human vessel. In some embodiments, a clinician can manually input the physiological stent diameter.

[0126] In some embodiments, the computing device can perform QCA (quantitative coronary angiography) to determine, for example, the diameter of the vessel in an angiographic image. For example, during PCI planning, a clinician can select the location and / or length of a graphical representation of a stent superimposed on an angiographic image or pressure curve of the blood vessel. Using QCA, the computing device can determine the true physiological vessel diameter at both ends of the proposed stent and determine physiological diameter parameters recommended for use in human vessels. For example, the computing device can select the larger of two diameters associated with the ends of the proposed stent. The clinician can guide the determination of the physiological stent diameter, or the computing device can automatically determine and provide the physiological stent diameter.

[0127] In some embodiments, intravascular imaging can be used to determine the physiological stent diameter. For example, the vessel can be imaged using intravascular ultrasound (IVUS), forward-looking IVUS (FL-IVUS), optical coherence tomography (OCT), and / or other imaging modalities. In this aspect, in some embodiments, methods 500 and 600 can include acquiring intravascular imaging data. The intravascular images can be co-registered with angiographic data and / or physiological data (e.g., pressure measurements, flow measurements, etc.), as described, for example, in U.S. Patent No. 7,930,014 entitled “VASCULAR IMAGE CO-REGISTRATION,” which is incorporated herein by reference in its entirety. For example, during PCI planning, a clinician can select the location and / or length of a graphical representation or pressure curve of the stent superimposed on an angiographic image of the vessel. The clinician can view intravascular images at both ends of the proposed stent and determine the physiological vessel diameter based on the intravascular images. In some embodiments, the computing device can automatically determine vessel boundaries and physiological vessel diameter using intravascular images, as described, for example, in U.S. Provisional Application No. 62 / 024339 entitled “DEVICES, SYSTEMS, AND METHODS FOR IMPROVED ACCURACY MODEL OF VESSELANATOMY”, filed July 14, 2014, which is incorporated herein by reference in its entirety. Based on the determined physiological vessel diameter, a clinician can determine the physiological stent diameter, or the computing device can automatically determine and provide the physiological stent diameter. For example, a clinician or the computing device can select the larger of two diameters associated with the ends of the proposed stent.

[0128] Furthermore, it should be understood that PCI planning can include the localization and individual adjustment of more than one stent within the blood vessel. In this respect, Figure 25 and Figure 26 The illustration shows a screen display with multiple graphic representations of a support. Figure 25 The illustration shows a screen display 2500 (or a partial screen display) of a visual representation of a blood vessel including two graphic representations of a stent 2502 and a stent 2504. Figure 26 The illustration shows a screen display 2600 (or a partial screen display) with two graphical representations of the pressure ratio, using supports 2602 and 2604. In screen display 2500 ( Figure 25 The data described in ) corresponds to the display on the screen at 2600 ( Figure 26 The data shown in the diagram, and vice versa. PCI planning can include multiple graphical representations of the stent when angiographic and / or physiological data indicate multiple blockages. For example, Figure 26The pressure curve 852 includes two pressure drops, 2610 and 2612, that could be attributed to different lesions. PCI planning can include determining one or both lesions to be treated. Although in Figure 25 and Figure 26 The discussion specifically addresses two supports, but it should be understood that PCI plans can include any number of supports, including one, two, three, four, five, six or more.

[0129] As in Figure 25 As shown, the graphical representations of stents 2502 and 2504 can each be inserted into the visual representation of the blood vessel 702. PCI planning can be performed by moving the graphical representations of stents 2502 and 2504, changing their length / diameter, etc., as described herein. In some embodiments, the characteristics of the graphical representations of stents 2502 and 2504 can be modified individually, such as by first receiving user input to select a particular stent and then receiving user input to modify the properties of the selected stent. In some embodiments, the characteristics of stents 2502 and 2504 can be inserted and / or modified together, such as by first receiving user input to select both stents and receiving user input to modify the properties of both stents.

[0130] As in Figure 26 As shown, the graphical representations of stents 2602 and 2604 can each be inserted along a visual representation of the pressure ratio. PCI planning can be performed by moving the graphical representations of stents 2602 and 2604, changing the length / diameter, etc., as described herein. In various embodiments, the characteristics of the graphical representations of stents 2602 and 2604 can be modified individually or collectively. A corrected pressure ratio curve can be associated with each graphical representation of the stent. For example, a corrected pressure ratio curve 2606 is associated with stent 2602, and a corrected pressure ratio curve 2604 is associated with stent 2604. Clinicians can insert the graphical representation of stent 2602 along pressure curve 852. The characteristics of the graphical representation of stent 2602 can be modified as described herein. Stent 2602 results in some clinical improvement, as indicated by the distal value of the corrected pressure ratio curve 2606 greater than threshold 804. Clinicians can insert the graphical representation of stent 2604 along the corrected pressure ratio curve 2606. The graphical representation of stent 2604 can be modified, as described herein. Stent 2604, together with stent 2602, can lead to beneficial clinical outcomes, as indicated by the distal value of the corrected pressure ratio curve 2608 above the target line 820. The virtual / simulated characteristics of stents 2602 and 2606 can be correlated with the actual physiological parameters of the stents to be positioned within the human blood vessel for PCI-based treatment of the patient.

[0131] As described in this article, the screen display was modified to 2500 ( Figure 25 The characteristics of one or both of the graphical representations of the stent in the vascular 702 of the ) enable the display of 2600 ( ) along the screen. Figure 26 The corresponding graphical representations of the pressure curves (one or more) of the supports (one or more) are similarly modified.

[0132] Figure 27 The illustration shows a screen display 2700 (or a partial screen display) including a visual representation of blood vessels. In screen display 2700 ( Figure 27 The data described in ) corresponds to the display on the screen at 2800 ( Figure 28 The data shown in the image. Screen display 2700 includes a bracket option menu 2704, which includes multiple brackets. Although in Figure 27 Three supports are shown, but it should be understood that more or fewer supports can be provided in different embodiments. Each of the multiple supports can have similar or different physical properties, including length, diameter, material, etc. In some embodiments, the supports provided in menu 2704 correspond to those supports that can be used by clinicians in a workflow room. For example, computing devices (e.g., Figure 4 The computing device 172) can access an inventory database of a hospital or other process location to determine the types of stents that are in stock and available for clinicians. In some embodiments, the stents provided in menu 2704 correspond to those stents that can be procured and used from one or more manufacturers. For example, the computing device can access an inventory database of one or more manufacturers to determine the types of stents that can be procured and used by clinicians or hospitals. Menu 2704 can include various representations 2706 of the various stents. Different materials and other properties of stents can be indicated by different colors, shading, patterns, etc. Description 2708 can also accompany each stent in menu 2704. For example, description 2708 can include the length of the stent.

[0133] As described above, user input regarding the insertion of a stent into the vessel 702 enables the computing device to automatically determine the recommended physical characteristics of the stent. In some instances, the recommended physical characteristics may not correspond to stents that are in stock and available to clinicians. For example, the recommended physiological length determined by the computing device might be 15.5 mm, while actual stents are only available in 1 mm increments. Furthermore, stents can be identified by both physiological length and physiological diameter. In such embodiments, the computing device can automatically determine which of the available stents best matches the recommended physical characteristics and provide the best-matching stent in the vessel 702. For example, when 15.5 mm is the recommended stent length, the computing device can provide a 16 mm long and 3.0 mm diameter stent that is in stock and available to clinicians in the vessel 702. The physiological stent diameter can be determined, as described herein. In some embodiments, clinicians can determine the length and / or diameter for a stent and provide this information to the computing device. The computing device can access an inventory database and recommend suitable stent(s) based on the input length and / or diameter. The user can change the recommended stent by selecting another option from menu 2704. The user can also modify stent characteristics such as position, diameter, and length, as described above. In some embodiments, menu 2704 only provides stents that are in stock and available, while in other embodiments, menu 2704 provides all stents in the hospital, regardless of their availability. Indicators such as symbols or colors can be set to visually distinguish them from other stents by placing them near those that are either available or unavailable. In other embodiments, the computing device does not automatically select from multiple stents. Instead, the clinician can individually select from menu 2704 to determine which stent is most suitable. The visual representation of the automatically recommended or clinician-selected stent 2702 inserted in the indwelling catheter 702 can be indicated by highlighting 2710 in menu 2704. The stent 2702 can be modified, as shown in… Figure 7-24 It is described in the context of [the subject].

[0134] Figure 28 The illustration shows a screen display 2800 (or a portion of the screen display) including a visual representation of the pressure ratio. In screen display 2800 ( Figure 28 The data described in ) corresponds to the display on the screen at 2700 ( Figure 27 The data shown in the image. Screen display 2800 includes a stand option menu 2804, which includes multiple stands. Although in Figure 28 Three supports are shown, but it should be understood that more or fewer supports can be provided in different embodiments. In some embodiments, the supports provided in menu 2804 correspond to those that can be used by clinicians in a workflow room. For example, computing devices (e.g., Figure 4 The computing device 172) can access an inventory database of a hospital or other process location to determine the types of stents that are in stock and available for clinicians. In some embodiments, the stents provided in menu 2804 correspond to those stents that can be procured and used from one or more manufacturers. For example, the computing device can access an inventory database of one or more manufacturers to determine the types of stents available for procurement and use by clinicians or hospitals. Menu 2804 can include various representations 2806 of various stents. Different materials and other properties of stents can be indicated by different colors, shading, patterns, etc. Description 2808 can also accompany each stent in menu 2804. For example, description 2808 can include stent length.

[0135] As described above, user input regarding stent insertion along the pressure ratio curve 852 enables the computing device to automatically determine the recommended physical characteristics of the stent. In some instances, the recommended physical characteristics may not correspond to stents that are in stock and available to clinicians. For example, the recommended physical length determined by the computing device might be 15.5 mm, while stents are only available in 1 mm increments. Furthermore, stents can be identified by both physiological length and physiological diameter. In some embodiments, clinicians can determine the length and / or diameter of the stent and provide it to the computing device. The computing device can access an inventory database and recommend suitable stent(s) based on the input length and / or diameter. In such embodiments, the computing device can automatically determine which of the available stents most closely matches the recommended physical characteristics and provide the most closely matching stent along curve 852. For example, when 15.5 mm is the recommended stent length, the computing device can provide a 16 mm long and 3.0 mm diameter stent that is in stock and available to clinicians along curve 852. The physiological stent diameter can be determined, as described herein. Users can change the recommended stent by selecting another option from menu 2804. Users can also modify stent characteristics such as position, diameter, and length, as described above. In some embodiments, menu 2804 only provides stents that are in stock and available, while in other embodiments, menu 2804 provides all stents in the hospital regardless of their availability. Indicators such as symbols or colorings can be set to visually distinguish them from other stents by placing them near those that are either available or unavailable. In other embodiments, the computing device does not automatically select from multiple stents. Instead, clinicians can individually select from menu 2804 to determine which stent is most suitable. A graphical representation of the automatically recommended or clinician-selected stent inserted along curve 852 can be indicated by highlighting 2510 in menu 2804. Stent 2802 can be modified, as shown in... Figure 7-24It is described in the context of [the subject].

[0136] In some embodiments, a bracket from menu 2704 is inserted into screen display 2700. Figure 27 The vascular 702 enables the stent to display 2800 ( ) along the screen. Figure 28 The pressure ratio curve 852 is inserted. Similarly, along the screen display 2800 ( Figure 28 The pressure ratio curve 852 allows the bracket from menu 2804 to be inserted into the screen display 2700 accordingly. Figure 27 In this way, clinicians can perform PCI planning while directly interacting with one of the selected displays in screens 2700 and 2800, while automatically viewing corresponding changes in the unselected display in screens 2700 and 2800. For example, clinicians can work directly on screen 2800, which illustrates the pressure ratio curve 852 and the position / length of the stent relative to the calculated pressure ratio curve. Stents from among multiple available stents can be selected and inserted along the pressure ratio curve 852, so that the corrected pressure ratio curve 1004 more closely matches the ideal pressure ratio line 806 and / or the target line 820. Corresponding stents can be inserted into the blood vessel 702 in the screen display 2700 of the blood vessel, allowing clinicians to understand which of the available stents should be deployed in the blood vessel to achieve the corrected pressure ratio curve 1004. In the embodiment of Figure 2800, a longer stent is required to bring the corrected pressure ratio curve 1004 closer to the threshold 804.

[0137] Those skilled in the art will also recognize that the apparatus, systems, and methods described above can be modified in various ways. Therefore, those skilled in the art will understand that the embodiments covered by this disclosure are not limited to the specific exemplary embodiments described above. In this respect, although illustrative embodiments have been shown and described, various modifications, alterations, and substitutions are contemplated in the foregoing disclosure. It should be understood that such variations can be made to the foregoing without departing from the scope of this disclosure. Therefore, it should be understood that the appended claims are interpreted broadly and in a manner consistent with this disclosure.

Claims

1. A system for evaluating a vessel of a patient, comprising: a first instrument sized and shaped for introduction into the vessel of the patient; a second instrument sized and shaped for introduction into the vessel of the patient; and a processing system communicatively coupled to the first and second instruments and to a display device, the processing system configured to: receive pressure measurements from the first and second instruments positioned within the vessel of the patient while the second instrument is moved longitudinally through the vessel and the first instrument remains fixed within the vessel; calculate pressure ratios based on pressure measurements from the first and second instruments; receive angiography data and co-register the calculated pressure ratios with the angiography data; output to the display device a visual representation comprising: a graphical representation of at least one stent and calculated pressure ratio curves associated with locations within the vessel based on the co-registered angiography data; receive user input to modify a position and / or length of the at least one stent to a virtual / simulated case; determine a predicted pressure ratio for the virtual / simulated case based on the modified position and / or length of the at least one stent, the calculated pressure ratios, and the associated angiography data; output to the display device the predicted pressure ratio and the modified position and / or length of the at least one stent; and update the visual representation in response to the predicted pressure ratio and the modified position and / or length of the at least one stent for an evaluation of a predicted outcome of a treatment; wherein the updated visual representation comprises a predicted pressure ratio curve for the virtual / simulated case, a threshold line for the predicted pressure ratio, and a target line for the predicted pressure ratio, the target line being higher than the threshold line. the visual representation further comprises a graphical representation of at least one stent positioned in the vessel and the calculated pressure ratios overlaid on the angiography data.

2. The system of claim 1, wherein, the visual representation further comprises a visualization based on pressure measurements received from the first and second instruments and a visual representation of a vessel, the visual representation of the vessel comprising an angiogram image of the vessel, and wherein the visualization comprises a graphical overlay on the angiogram image.

3. The system of claim 2, wherein, the visualization comprises a graphical representation of a stent positioned in the visual representation of the vessel, and wherein the therapeutic procedure is a percutaneous coronary intervention.

4. The system of claim 3, wherein, 5. The system of claim 4, wherein: the processing system is further configured to correlate virtual / simulated properties of the graphical representation of the stent with the co-registered angiography data to determine true physiological parameters of the at least one stent to be deployed into the vessel; the true physiological parameters comprise at least one of: a stent position, a stent length, and a stent diameter; and the properties of the graphical representation of the stent comprise at least one of: a position, a length, and a diameter. ​ 6. The system of claim 5, wherein, The processing system is further configured to automatically calculate at least one of the stent length and the length of the graphical representation of the stent based on at least one of the angiography data, the received pressure measurements, and a pressure ratio calculated based on the received pressure measurements, wherein the visualization includes a graphical representation of a stent having the calculated length.

7. The system of claim 5, wherein, The processing system is further configured to determine at least one of the stent length and the length of the graphical representation of the stent based on the user input, wherein the visualization includes a graphical representation of a stent having the determined length.

8. The system of claim 5, wherein, The processing system is further configured to automatically calculate at least one of the stent diameter and the diameter of the graphical representation of the stent based on at least one of angiography data and intravascular ultrasound (IVUS) data.

9. The system of claim 5, wherein, The processing system is configured to receive user input, to move the graphical representation of the stent within the visual representation of the vessel by receiving user input, and wherein the processing system is configured to modify the visualization by outputting the graphical representation of the stent at a position based on the user input.

10. The system of claim 5, wherein, The processing system is configured to receive user input, to change a length of the graphical representation of the stent within the vessel by receiving user input, and wherein the processing system is configured to modify the visualization by outputting the graphical representation of the stent having the length based on the received user input.

11. The system of claim 5, wherein, The processing system is further configured to output a plurality of graphical representations of stents.

12. The system of claim 11, wherein, The processing system is further configured to curate the plurality of graphical representations of stents based on an inventory database of stents associated with a clinical environment.

13. The system of claim 11, wherein, The processing system is further configured to at least one of: receive user input to select one of the plurality of graphical representations of stents, wherein the visualization includes a graphical representation of a stent selected from among the plurality of graphical representations of stents; and automatically select a graphical representation of a stent from among a plurality of graphical representations of stents based on at least one of the angiography data, the received pressure measurements, and a pressure ratio calculated based on the received pressure measurements, wherein the visualization includes a graphical representation of a stent automatically selected from among the plurality of graphical representations of stents.

14. The system of claim 5, wherein, The processing system is further configured to calculate a pressure ratio within the vessel based on the received pressure measurements, and wherein the visualization further includes the calculated pressure ratio.

15. The system of claim 14, wherein, The visualization further includes at least one of: a marker indicating a location within the vessel associated with an obtained pressure measurement; the calculated pressure ratio positioned proximate to the marker indicating the location within the vessel.

16. The system of claim 15, wherein, Consecutive markers are positioned at unequally spaced intervals along the visual representation of the vessel.

17. The system of claim 5, wherein, The processing system is further configured to automatically identify the vessel, and wherein the visualization further includes a label indicating a determined identity of the vessel.

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