System and methods for generating and displaying information indicative of disease in a blood vessel

Abstract

A medical system for generating and displaying information indicative of disease in a blood vessel includes a controller and a display. The controller is configured to generate and display on the display, a graph including a trace indicative of a pressure ratio between a distal and an aortic blood pressure over time. The controller is configured to identify a first region and a second region of the trace during which the pressure ratio is substantially constant over a first period and second period of time, respectively and calculate a difference between the pressure ratio at the first and second regions. The controller controls the display to display the graph, a first indicator indicating the first region, a second indicator indicating the second region, and an indication of the calculated difference between the pressure ratio at the second region and the pressure ratio at the first region of the trace.

Description

SYSTEM AND METHODS FOR GENERATING AND DISPLAYING INFORMATION INDICATIVE OF DISEASE IN A BLOOD VESSELCROSS-REFERENCE TO RELATED PATENT APPLICATION

[0000] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 656,517, filed on June 5, 2024, which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0001] The present disclosure relates to a medical system for generating and displaying information indicative of disease in a blood vessel of a patient.BACKGROUND

[0002] In many medical procedures, various physiological conditions present within a body cavity need to be monitored. These physiological conditions are typically physical in nature — such as pressure, temperature, rate-of-fluid flow, and provide a physician or medical technician with critical information as to the status of a patient's condition.

[0003] One device that is widely used to monitor conditions is the blood pressure sensor. A blood pressure sensor senses the magnitude of a patient's blood pressure, and converts it into a representative signal that is transmitted to the exterior of the patient.

[0004] In the prior art, it is known to mount a sensor at a distal portion of a sensor wire or sensor catheter and to position the sensor in a blood vessel in a living body to detect a physical parameter, such as pressure, temperature, or flow. The sensor includes at least one sensor element that is directly or indirectly sensitive to the parameter.

[0005] One known sensor wire has a typical length of 1.5 to 2 meters, and comprises a hollow tube running along a major part of the wire. The hollow tube has an outer diameter in a range of 0.25 to 0.5 mm, typically approximately 0.35 mm. In some sensor wires, a core wire is arranged within the tube so as to extend within the tube and out from a distal opening of the tube, and one or more sensors are arranged at a distal portion of the sensor wire, e.g. mounted at a distal portion of the core wire. In other sensor wires, no core wire isincluded. The sensor may be an electrical sensor, or an optical sensor (e.g., using light to measure deflection of a membrane).

[0006] In the case of an electrical sensor, the sensor comprises an electrical circuitry, which generally is connected in a Wheatstone bridge-type of arrangement to one or several piezoresistive elements provided on a membrane. As is known in the art, a certain pressure exerted on the membrane from the surrounding medium will cause stretching or deflection of the membrane, and thereby cause a change in the resistance of the piezoresistive elements mounted thereon.

[0007] Known sensor catheters may be similarly arranged, except without the core wire, and with the sensor being mounted to the tube.

[0008] In order to power the sensor (in the case of an electrical sensor) and to communicate signals representing the measured physiological variable to an external controller (in the case of both an electrical sensor and an optical sensor), one or more cables or fibers, such as microcables or optical fibers are connected to the sensor. The cables or fibers are routed along the sensor wire to be passed out from the vessel to an external controller, or to an external transmitter or transceiver that sends a wired or wireless signal to the external controller.

[0009] In U.S. Pat. Pub. No. 2006 / 0009817, which is incorporated by reference in its entirety for the medical devices, methods and techniques disclosed therein, and which is assigned to the present assignee, an example of such a sensor and guide wire assembly is disclosed. The system comprises a sensor arranged to be disposed in the body, a control unit arranged to be disposed outside the body and a wired connection between the sensor and the control unit, to provide a supply voltage from the control unit to the sensor and to communicate a signal therebetween. The control unit further has a modulator, for modulating the received sensor signal and a communication interface for wireless communication of the modulated signal.

[0010] In U.S. Pat. No. 7,724,148, which is incorporated by reference in its entirety for the medical devices, methods and techniques disclosed therein,, and which also is assigned to the present assignee, another example of such a pressure measurement system isdisclosed. The pressure sensor wire is adapted to be connected, at its proximal end, to a transceiver unit that is adapted to wirelessly communicate via a communication signal with a communication unit arranged in connection with an external device.

[0011] In U.S. Pat. No. 6,112,598, U.S. Pat. No. 7,207,227, and U.S. Pat. No.6,615,667, which are incorporated by reference in their entireties for the medical devices, methods and techniques disclosed therein, and assigned to the present assignee, further examples of pressure sensors, sensor wires, and sensor catheters are disclosed.

[0012] The human vascular system may suffer from a number of problems. These may broadly be characterized as cardiovascular and peripheral vascular disease. Atherosclerosis, in which atherosclerotic plaque develops in a patient's cardiovascular system, is a particularly common problem. The plaque can be quite extensive and occlude a substantial length of the vessel.

[0013] The sensor wires and sensor catheters of the type described above may be used to measure distal pressure Pa (i.e., distal blood pressure) in the coronary vessels to identify a constriction (for example, a single stenosis, a series of stenoses, a lesion, or diffuse disease). The extent of the constriction, may be determined by determining a pressure ratio between the measured distal pressure Pa and a measured aortic pressure Pa(i.e., aortic blood pressure). The sensor wire is typically inserted by use of an insertion catheter. The insertion catheter is inserted into the femoral artery or the radial artery, and the sensor wire is then guided by the inserted catheter to the measurement site at which the constriction is located. The distal blood pressure Pa is then measured at a location distal of the constriction. Simultaneously, the aortic blood pressure Pais measured using, for example, a fluid filled pressure catheter connected to an external pressure transducer. Thus, a pressure ratio based on Pa and Pacan be calculated.

[0014] One such pressure ratio is Fractional Flow Reserve (FFR), which is an index based on the ratio between distal blood pressure Pa and aortic blood pressure Paduring maximum hyperemia. FFR is described in detail in U.S. Pat. No. 6,565,514, which is incorporated by reference in its entirety for the medical devices, methods and techniques disclosed therein. Another such pressure ratio is Resting Full-cycle Ratio (RFR), which is a non-hyperemic index based on the lowest sub-cycle ratio of Pd / Paover diastole and systole,calculated as a moving average. A third is Instantaneous Wave-free Ratio (iFR), which is a non-hyperemic index based on the ratio of Pd / Pa during the wave-free period of diastole.

[0015] In some known systems, the distal blood pressure sensor is moved from a first position in the blood vessel on a first side of the constriction to a second position in the blood vessel on a second side of the constriction, while the aortic blood pressure sensor remains stationary. The distal blood pressure Pd and the aortic blood pressure Paare measured continuously during this movement. This may be referred to as a “pull-back procedure,” because the distal blood pressure sensor is typically pulled back from a first position distal of a constriction, to a second position proximal of the constriction. U.S. Pat. Pub No. 2006 / 0052700 describes one example of such a system and method.SUMMARY

[0016] A medical system may generate and display information indicative of disease in a blood vessel of a patient based on the calculated pressure ratio during a pull-back procedure. For example, a medical system may include a controller, and a display configured to display information generated by the controller. The controller may be configured to receive data indicative of a distal blood pressure measured by a distal blood pressure sensor of a sensor wire or sensor catheter, receive data indicative of an aortic blood pressure measured by an aortic blood pressure sensor, and generate a graph containing a trace indicative of a pressure ratio between the distal blood pressure and the aortic blood pressure over time, while the distal blood pressure sensor is moved from a first position in the blood vessel to a second position in the blood vessel.

[0017] However, the present inventors have determined that there is a need for improved systems and methods for displaying information indicative of disease in a blood vessel of a patient based on the calculated pressure ratio or other metric during a pull-back procedure. Certain embodiments described in the present application address this need.

[0018] In some embodiments, a medical system for generating and displaying information indicative of disease in a blood vessel of a patient, comprises: a controller; and a display configured to display information generated by the controller. The controller is configured to: receive data indicative of a distal blood pressure measured by a distal bloodpressure sensor of a sensor wire or sensor catheter, receive data indicative of an aortic blood pressure measured by an aortic blood pressure sensor, generate a graph containing a trace indicative of a pressure ratio or other metric between the distal blood pressure and the aortic blood pressure over time while the distal blood pressure sensor is moved from a first position in the blood vessel to a second position in the blood vessel, identify a first region of the trace during which the pressure ratio is substantially constant over a first period of time, identify a second region of the trace during which the pressure ratio is substantially constant over a second period of time, calculate a difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace, control the display to display the graph, control the display to display, on the graph, a first indicator indicating the first region of the trace, and a second indicator indicating the second region of the trace, and control the display to display an indication of the calculated difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace.

[0019] In some embodiments, a medical system for generating and displaying information indicative of disease in a blood vessel of a patient, comprises: a controller; and a display configured to display information generated by the controller. The controller is configured to: receive data indicative of a distal blood pressure measured by a distal blood pressure sensor of a sensor wire or sensor catheter, receive data indicative of an aortic blood pressure measured by an aortic blood pressure sensor, generate a graph containing a trace indicative of a pressure ratio between the distal blood pressure and the aortic blood pressure over time while the distal blood pressure sensor is moved from a first position in the blood vessel to a second position in the blood vessel, identify a first region of the trace during which the pressure ratio is substantially constant over a first period of time, identify a second region of the trace during which the pressure ratio is substantially constant over a second period of time, calculate a difference between the pressure ratio at a trailing end of the first region of the trace and the pressure ratio at a leading end of the second region of the trace, and control the display to display the graph, control the display to display a first region starting point indicator at the trailing end of the first region of the trace, control the display to display a second region starting point indicator at the leading end of the second region of the trace, control the display to display an indication of the calculated difference between the pressure ratio at the trailing end of the first region of the trace and the pressure ratio at the leading end of the second region of the trace.

[0020] In some embodiments, a medical system for generating and displaying information indicative of disease in a blood vessel of a patient, comprises: a controller; and a display configured to display information generated by the controller. The controller is configured to: receive data indicative of a distal blood pressure measured by a distal blood pressure sensor of a sensor wire or sensor catheter, receive data indicative of an aortic blood pressure measured by an aortic blood pressure sensor, generate a graph containing a trace indicative of a pressure ratio between the distal blood pressure and the aortic blood pressure over time while the distal blood pressure sensor is moved from a first position in the blood vessel to a second position in the blood vessel, identify a first region of the trace during which the pressure ratio is substantially constant over a first period of time, identify a second region of the trace during which the pressure ratio is substantially constant over a second period of time, calculate a difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace, generate a drawing of a blood vessel that includes a constricted region corresponding to a region between the first region of the trace and the second region of the trace, where an extent of constriction in the constricted region is based on the calculated difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace, control the display to display the graph, and control the display to display, above or below the trace, the generated drawing of the blood vessel, such that the constricted region of the blood vessel is aligned above or below the region between the first region of the trace and the second region of the trace.

[0021] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the subject matter disclosed herein. In particular, all sub combinations and combinations of claimed subject matter appearing at the end of this disclosure are contemplated as being part of the subject matter disclosed herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The foregoing and other features of the present disclosure will become more fully apparent from the following description and appended claims taken in conjunction with the accompanying drawings. Understanding that these drawings depict only severalimplementations in accordance with the disclosure and are therefore not to be considered limiting of its scope, the disclosure will be described with additional specificity and detail through use of the accompanying drawings.

[0023] FIG. l is a schematic illustration of a medical system including a controller configured generate and display information indicative of disease in a blood vessel of a patient, according to an embodiment.

[0024] FIG. 2 is a schematic block diagram of a controller that may be included in the medical system of FIG. 1, according to an embodiment.

[0025] FIG. 3 is a graphical user interface (GUI) generated on a display of the medical system of FIG. 1 by the controller that shows a trace corresponding to a pressure ratio between distal and aortic blood pressures determined during a pull-back procedure, and a table indicating pressure ratios at various locations, according to an embodiment.

[0026] FIG. 4 is a GUI generated on the display of the medical system of FIG. 1 by the controller that shows a trace corresponding to raw pressure ratio data and filtered data, according to an embodiment.

[0027] FIG. 5 is a GUI generated on the display of the medical system of FIG. 1 by the controller that shows a trace corresponding to a pressure ratio between distal and aortic blood pressures determined during a pull-back procedure, and a drawing of a blood vessel showing location of constrictions therein determined based on the pressure ratios, according to an embodiment.

[0028] FIG. 6 is a GUI generated on the display of the medical system of FIG. 1 by the controller that shows a trace corresponding to raw and filtered pressure ratio data, and indicate numerical values of difference in the pressure ratio, according to an embodiment.

[0029] FIG. 7 is a GUI generated on the display of the medical system of FIG. 1 by the controller that shows a trace corresponding to raw pressure ratio data, and a shape bound on a top side by the trace, on a bottom side by a horizontal line corresponding to a pressure ratio value at the trailing end of the first region of the trace, and on a right side by a verticalline corresponding to a time value at the leading end of the second region of the trace, according to an embodiment.

[0030] FIG. 8 is a GUI generated on the display of the medical system of FIG. 1 by the controller that shows a trace corresponding to raw pressure ratio data, and rectangles overlaid on the trace that are indicative of the difference of the pressure ratio, according to an embodiment.

[0031] FIG. 9 is a GUI generated on the display of the medical system of FIG. 1 by the controller that shows a trace corresponding to raw pressure ratio data, and circles overlaid on the trace that are indicative of the difference of the pressure ratio, according to an embodiment.

[0032] FIG. 10 is a GUI generated on the display of the medical system of FIG. 1 by the controller that shows a trace corresponding to raw pressure ratio data, and triangles overlaid on the trace that are indicative of the difference of the pressure ratio, according to an embodiment.

[0033] FIG. 11 is a GUI generated on the display of the medical system of FIG. 1 by the controller that shows a trace corresponding to raw pressure ratio data, and relatively thicker portions of the trace that are indicative of the difference of the pressure ratio, according to an embodiment.

[0034] FIG. 12 is a GUI generated on the display of the medical system of FIG. 1 by the controller that shows a trace corresponding to raw pressure ratio data, and bars located below the trace that are indicative of the difference of the pressure ratio, according to an embodiment.

[0035] FIG. 13 is a GUI generated on the display of the medical system of FIG. 1 by the controller that shows a trace corresponding to raw pressure ratio data, and circles located below the trace that are indicative of the difference of the pressure ratio, according to an embodiment.

[0036] FIG. 14 is a schematic flow diagram of a method for generating and displaying information indicative of disease in a blood vessel of a patient, according to an embodiment.

[0037] FIG. 15 is a schematic flow diagram of a method for generating and displaying information indicative of disease in a blood vessel of a patient, according to another embodiment.

[0038] FIG. 16 is a schematic flow diagram of a method for generating and displaying information indicative of disease in a blood vessel of a patient, according to yet another embodiment.

[0039] FIG. 17 is a side cross-section view of a sensor guide wire that may be used as a sensor assembly in the medical system of FIG. 1, according to an embodiment.

[0040] Reference is made to the accompanying drawings throughout the following detailed description. In the drawings, similar symbols typically identify similar components unless context dictates otherwise. The illustrative implementations described in the detailed description, drawings, and claims are not meant to be limiting. Other implementations may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here. It will be readily understood that the aspects of the present disclosure, as generally described herein and illustrated in the figures, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are explicitly contemplated and made part of this disclosure.DETAILED DESCRIPTION

[0041] Embodiments described herein relate generally to medical systems and methods for generating a graph including a trace corresponding to a pressure ratio between a distal blood pressure Pa and an aortic blood pressure Pameasured during a pull-back procedure. A controller of the medical system is configured to control a display of the medical system to display information corresponding to the pressure ratio and one or more constrictions present in a blood vessel of the patient through which a pressure sensor configured to measure the distal pressure Pa is being moved. Such indicators may include, for example, calculated difference between pressure ratios, regions of a pressure ratio trace corresponding to a location of one or more constrictions in the blood vessel, a drawing of the blood vessel showing location of the constriction, and / or various visual indicators overlaid on the trace to indicate the difference between pressure ratios.

[0042] Various embodiments of the systems and methods described herein for generating and displaying information on a display that corresponds to a pressure ratio determined during a pull-back procedure as described herein may provide one or more benefits including, for example: (1) providing a user friendly visual display of pressure ratios determined during a pull-back procedure (e.g., during an RFR pull-back procedure) that is intuitive and easy for a physician to readily grasp; (2) providing visual representation of a blood vessel of a patient and location of constrictions therein that facilitate a user such as a physician in determining an extent of constriction in the corresponding blood vessel; and (3) allowing the user to manipulate a GUI displayed on a display further facilitating the user in diagnosing extent of the constriction and thereby, the health of the patient.

[0043] FIG. 1 is a schematic illustration of a medical system 100, according to an embodiment. The medical system 100 includes a pressure sensor assembly 102, an aortic blood pressure sensor 103, a controller 170, and a display 120, and may also include a temperature sensor 104, a heart rate sensor 106, an electrocardiogram (ECG) sensor 108, and a blood oxygen sensor 110. The controller 170 is configured to determine a pressure ratio between a distal blood pressure Pa and aortic blood pressure Pain a blood vessel V of a patient based on pressure data received from a sensor assembly 102 and the aortic blood pressure sensor 103, as described in detail herein. The controller 170 is configured to generate a trace indicative of the pressure ratio, calculate difference between pressure ratios and generate various GUIs on a display 120 thereof that is indicative of the extent and / or location of a first constriction Cl, a second constriction C2, or any number of constrictions present in the blood vessel V of the patient. The patient may include a human or an animal.

[0044] The sensor assembly 102 may be, for example, a sensor guide wire or a sensor catheter, and, for example, may be any of the sensor assemblies and associated components described in U.S. Pat. Pub. No. 2006 / 0009817, or U.S. Pat. Nos. 7,724,148, 6,112,598, 7,207,227, and 6,615,667, which are incorporated by reference herein in their entireties for such devices and methods of use thereof. In some embodiments, the sensor assembly 102 may be, for example, a sensor guide wire 1 as shown in FIG. 17. FIG. 17 shows a cross section of a prior art guide wire 1. The guide wire 1 includes a solid core wire 16 disposed in a portion of a proximal tubing portion 17. The core wire 16 may, for example, be machined by centering grinding. The solid core wire 16 may form the distalportion of the guide wire 1 and extend beyond the distal end of the proximal tubing portion 17. The proximal tubing portion 17 may be connected to or integrally formed with an optional proximal coil 18. A pressure sensor element 19 is mounted on the wire 16. The pressure sensor element 19 may be an absolute pressure sensor. The pressure sensor element 19 may include a transducer 29 which may be made of, for example, poly silicon and a pi ezoresi stive element.

[0045] Between the wire 16 and the proximal coil 18, one or more leads 30 may run from the electronic circuitry of the pressure sensor element 19. The wire 16, may act as a portion of one of the leads 30, as in FIG. 17. The transducer of the pressure sensor element 19 may be mounted such that bending artifacts are minimized or eliminated (e.g., ensuring that the edges of the pressure sensor element 19 do not come into contact with the surrounding tube). The pressure sensor element 19 is protected by a short section of a tube 21, having an aperture 22 through which a surrounding medium interacts with the pressure sensor element 19. The guide wire 1 further includes, at the very distal end of the guide wire, an X-ray non-transparent distal coil 23 (also referred to as a "radiopaque coil"), made, for example, of platinum, and used for location purposes, and a safety wire 24 for securing the distal part of the coil 23. In one embodiment, the wire 16 is made of stainless steel. In other embodiments, the wire 16 may be made of a shape memory metal. The proximal tubing 17 and the proximal coil 18 may be coupled so as to be utilized as an electrical shield.

[0046] The sensor assembly 102 is configured to be coupled to the controller 170 of the medical system 100. The sensor assembly 102 includes a distal blood pressure sensor 101 located at a distal end of sensor assembly 102. The distal blood pressure sensor 101 can be any type of pressure sensor, for example, a mechanical pressure sensor or an optical pressure sensor. The sensor assembly 102 is configured to be inserted into the blood vessel V of the patient beyond a location where a first constriction Cl (e.g., a stenosis or lesion) and / or a second constriction is located. The distal blood pressure sensor 101 is configured to measure the distal blood pressure Pa in the blood vessel over time, for example, as the sensor assembly 102 is moved back (e.g., while performing a pull-back procedure) from the location beyond where the first constriction Cl is present. The sensor assembly 102generates a distal blood pressure signal indicative of the distal blood pressure Pa. In FIG. 1, the blood flow in the blood vessel V is from right to left.

[0047] The aortic blood pressure sensor 103 is configured to measure an aortic blood pressure Paof the patient over time. The aortic blood pressure sensor 103 may include a fluid filled pressure catheter connected to an external pressure transducer, or any other suitable aortic blood pressure sensor. The aortic blood pressure sensor 103 is configured to generate an aortic blood pressure signal indicative of the aortic blood pressure Pa.

[0048] In some embodiments, the medical system 100 may be configured to determine various health parameters of the patient. For example, the temperature sensor 104 is configured to measure a body temperature of the patient and generate a temperature signal indicative of the body temperature of the patient. The heart rate sensor 106 is configured to measure a heart rate of the patient and generate a heart rate signal indicative of the heart rate of patient. Similarly, the ECG sensor 108 is configured to measure an ECG of the patient, and generate an ECG signal indicative of the ECG of the patient. Furthermore, the blood oxygen sensor 110 is configured to measure a blood oxygen level of the patient and generate a blood oxygen signal indicative of the blood oxygen level of the patient.

[0049] The controller 170 is communicatively coupled to the sensor assembly 102 and the aortic blood pressure sensor 103, and is configured to receive the distal blood pressure signal and the aortic blood pressure signal therefrom. In some embodiments, the controller 170 is also communicatively coupled to the temperature sensor 104, the heart rate sensor 106, the ECG sensor 108, and / or the blood oxygen sensor 110 and configured to receive the temperature signal, the heart rate signal, the ECG signal, and the blood oxygen signal, respectively therefrom.

[0050] The controller 170 is also communicatively coupled to the display 120. The display 120 is configured to display information generated by the controller 170, for example, display GUIs that include graphs, traces, tables, shapes, features, numbers, letters, indicators, any other visual indicators, or any suitable combination thereof that is indicative of disease in the blood vessel, for example, presence, size and / or location of one or more constrictions C in the blood vessel V. In some instances, the display 120 may also display one or more health parameters of the patient (e.g., body temperature, heart rate, ECG, and / orblood oxygen level). The display 120 may include a liquid crystal display (LCD), light emitting diode (LED) display, a hand held display (e.g., a tablet display, a cell phone display, a laptop display, or a desktop display etc.), or any other suitable display. While shown in FIG. 1 as being separate from the controller 170, in some embodiments, the controller 170 and the display 12 may be integrated into a single housing.

[0051] The controller 170 may be operably coupled to the various components of the medical system 100 using any type and any number of wired or wireless connections. For example, a wired connection may include a serial cable, a fiber optic cable, a CAT5 cable, or any other form of wired connection. Wireless connections may include the Internet, Wi-Fi, cellular, radio, Bluetooth, ZigBee, etc.

[0052] In some embodiments, the controller 170 is configured to receive data indicative of the distal blood pressure Pa measured by the distal blood pressure sensor 101 of the sensor assembly 102. The controller 170 is also configured to receive data indicative of the aortic blood pressure Pameasured by the aortic blood pressure sensor 103. The controller 170 is configured to generate a graph containing a trace indicative of a pressure ratio or other metric between the distal blood pressure Pa and the aortic blood pressure Paover time while the sensor assembly 102 including distal blood pressure sensor 101 is moved from a first position in the blood vessel V to a second position in the blood vessel V, for example, during a pull-back procedure from left to right in FIG. 1.

[0053] For example, FIG. 3 shows a GUI 130 including a graph 140 that is displayed on the display 120 by the controller 170. The graph 140 includes a trace 142 indicative of the pressure ratio between the distal blood pressure Pa and the aortic blood pressure Paover time while the sensor assembly 102 is moved from the first position in the blood vessel V to the second position in the blood vessel V. As shown in FIG. 3, the trace 142 represents a raw pressure ratio of the distal blood pressure Pa measured by the distal blood pressure sensor 101 and aortic blood pressure Pameasured by the aortic blood pressure sensor 103 over time. The Y-axis of the trace corresponds to the pressure ratio Pa / Pa, and the X-axis corresponds to time.

[0054] The controller 170 is configured to identify a first region R1 of first constriction Cl of the trace 142 during which the pressure ratio is substantially constant (e.g., is within +10% of a mean value) over a first period of time. For example, the first region R1 of the trace 142 corresponds to a distal blood pressure Pa measured by the distal blood pressure sensor 101 at a location distal of the first constriction Cl present in the blood vessel V. As the sensor assembly 102 is pulled-back from the first constriction Cl the pressure ratio remains substantially constant while the distal blood pressure sensor 101 remains distal to the left in FIG. 1 of the first constriction Cl, and the pressure ratio during this time corresponds to the first region R1 of the trace 142.

[0055] The controller 170 is also configured to identify a second region R2 of the trace 142 during which the pressure ratio is substantially constant (e.g., is within + 10% of a mean value) over a second period of time. For example, as the sensor assembly 102 is pulled-back through the blood vessel V, the distal blood pressure sensor 101 gradually moves through the first constriction Cl . This results in an increase in the pressure ratio because the distal blood pressure experiences a progressively lesser pressure as the distal blood pressure sensor 101 is gradually pulled-back from the first constriction Cl. This is indicated on the trace 142 as an increase in the pressure ratio. Once the distal blood pressure sensor 101 reaches a location in the blood vessel V that is proximal of the first constriction, the distal blood pressure becomes substantially constant.

[0056] As the sensor assembly 102 continues to be pulled-back in the blood vessel V, the pressure ratio remains relatively constant until the distal blood pressure sensor 101 reaches the second constriction C2. The pressure ratio determined by the controller 170 between the first constriction Cl and the second constriction C2 corresponds to the second region R2 of the trace 142. The controller 170 is also configured to calculate a difference between the pressure ratio at the second region R2 of the trace 142 and the pressure ratio at the first region R1 of the trace 142.

[0057] The controller 170 is configured to control the display 120 to display, on the graph 140, a first indicator INDI indicating the first region R1 of the trace 142, and a second indicator IND2 indicating the second region R2 of the trace 142. In some embodiments, the first indicator INDI includes a first label or symbol located adjacent to the first region R1 of the trace 142, and the second indicator IND2 includes a second label or symbol located adjacent to the second region R2 of the trace. For example, as shown in FIG. 3, the firstindicator INDI may include the number 1 that may be inscribed in a circle, and the second indicator IND2 may include the number 2 that may also be inscribed in a circle. In other embodiments, the first indicator INDI may include a first color (e.g., red, cyan, orange, or any other suitable color) or line style (e.g., have a first thickness) of the first region R1 of the trace 142, and the second indicator IND2 includes a second color (e.g., yellow, maroon, purple, or any other suitable color) or line style (e.g., having a second thickness) of the second region R2 of the trace 142, the second color or line style being different from the first color (e.g., first color being red and second color being yellow) or line style (e.g., second thickness being less than or more than the first thickness).

[0058] In some embodiments, the controller 170 is further configured to identify a third region R3 of the trace 142 during which the pressure ratio is substantially constant (e.g., is within + 10% of a mean value) over a third period of time, as shown in FIG. 3. The third region R3 corresponds to a region proximal of the second constriction C2. As the sensor assembly 102, and thereby the distal blood pressure sensor 101 continues to be pulled-back through the second constriction C2 the distal blood pressure Pa, and thereby, the pressure ratio continues to increase. Once the distal blood pressure sensor 101 reaches a location completely proximal of the second constriction C2, the distal blood pressure Pa becomes substantially equal to the aortic blood pressure Pa(e.g., within + 2%) provided that another constriction is not present proximal of the second constriction C2. The region proximal of the second constriction C2 corresponds to the third region R3 of the trace 142 at which the pressure ratio is about 1.0.

[0059] In such embodiments, the controller 170 is configured to calculate a difference between the pressure ratio at the third region R3 of the trace 142 and the pressure ratio at the second region R2 of the trace 142. The controller 170 may also be configured to calculate a difference between the pressure ratio at the third region R3 of the trace 142 and the pressure ratio at the first region R1 of the trace 142. The controller 170 is configured to control the display 120 to display, on the graph 140, a third indicator IND3 indicating the third region R3 of the trace 142. In some embodiments, the third indicator IND3 includes the letter 3 that may be inscribed in a circle. In other embodiments, the second indicator includes a third color or line style of the third region R3 of the trace 142 that is different from the first color or line style and the second color or line style. For example, the third color mayinclude green, or the third line style may include a third thickness of the third region R3 of the trace 142 that is less than or greater than the first and second thicknesses.

[0060] The controller 170 is configured to control the display 120 to display an indication of the calculated difference between the pressure ratio at the second region R2 of the trace 142 and the pressure ratio at the first region R1 of the trace 142. The controller 170 may also be configured to control the display 120 to display an indication of the calculated difference between the pressure ratio at the third region R3 of the trace 142 and the pressure ratio at the second region R2 of the trace 142, as well as an indication of the calculated difference between the pressure ratio at the third region R3 of the trace 142 and the pressure ratio at the first region R1 of the trace 142. The term pressure ratio includes any of the pressure ratios of FFR, RFR, iFR or any other cardiovascular metric.

[0061] In some embodiments, the indication of the calculated difference between the pressure ratio at the second region R2 of the trace 142 and the pressure ratio at the first region R1 of the trace 142 includes a table showing the first label or symbol (i.e., the first indicator INDI) and the second label or symbol (i.e., the second indicator IND2), along with a value of the calculated difference between the pressure ratio at the second region R2 of the trace 142 and the pressure ratio at the first region R1 of the trace 142.

[0062] For example, as shown in FIG. 3, the indication of the calculated difference between the pressure ratio at the second region R2 of the trace 142 and the pressure ratio at the first region R1 of the trace 142 includes a table 150 that may be located below the graph 140 as shown in FIG. 3, or in other embodiments, above, right side, or left side of the graph 140. The table 150 includes a first row 152 including the first label or symbol (e.g., the first indicator INDI as shown in FIG. 3), and the second label or symbol (e.g., the second indicator IND2 as shown in FIG. 3), along with a value of the calculated difference between the pressure ratio at the second region R2 of the trace 142 and the pressure ratio at the first region R1 of the trace 142. The table 150 also includes a second row 154 including the second label or symbol and the third label or symbol (e.g., the second indicator IND2 and the third indicator IND 3), along with a value of the calculated difference between the pressure ratio at the third region R3 of the trace 142 and the pressure ratio at the second region R2 of the trace 42. Further, the table 150 includes a third row 156 including the firstlabel or symbol and the third label or symbol (e.g., the first indicator INDI and the third indicator IND 3), along with a value of the calculated difference between the pressure ratio at the third region R3 of the trace 142 and the pressure ratio at the first region R1 of the trace 142.

[0063] In some embodiments, the controller 170 is configured to change a location and / or an extent of the first region R1 of the trace 142, the second region R2 and / or the third region R3 of the trace based on an input received from a user (e.g., a physician) via an input device (e.g., a computer mouse, a track pad, or the display 120 in implementations in which the display 120 is touch sensitive, etc.). For example, in some embodiments, as shown in FIG. 3, the location and / or extents of the first region R1 of the trace 142 are indicated on the graph 140 by a first region first marker 141 located at a leading edge of the first region Rl, and a first region second marker 143 located at a trailing edge of the first region Rl.Similarly, the location and / or extents of the second region R2 are indicated on the graph 140 by a second region first marker 145 located at a leading edge of the second region R2 and a second region second marker 147 located at a trailing edge of the second region R2, and the location and / or extents of the third region R3 are indicated on the graph 140 by a third region first marker 149 located at a leading edge of the third region R3 and a third region second marker 151 located at a trailing edge of the third region R3.

[0064] While FIG. 3 shows each of the markers 141, 143, 145, 147, 149, 151 as including solid filled circles, in other embodiments, the controller 170 may be configured to display one or more of the markers 141, 143, 145, 147, 149, 151 on the graph 140 as hollow circles, pattern filled circles, or any other solid, hollow or pattern filled shape (e.g., square, triangle, rectangle, polygon, oval, ellipse, etc.) The user may use the input device input a command configured to move one or more of the markers 141, 143, 145, 147, 149, 151 along the trace 142 so as to control a location and / or extent of each of the regions Rl, R2, R3. In some embodiments, the user may also use the input device to zoom in or out of a desired location or region of the trace 142.

[0065] While not shown in FIG. 3, in various embodiments, the GUI 130 or any other GUIs generated by the controller 170 and displayed on the display may also include other graphs, traces, indicators, or information corresponding to other health parameters of thepatient. Such information may include but is not limited to patient temperature (e.g., determined by the temperature sensor 104), patient heart rate (e.g., determined by the heart rate sensor 106), patient ECG (e.g., determined by the ECG sensor 108) and / or patient blood oxygen level (e.g., determined by the blood oxygen sensor 110).

[0066] As shown in FIG. 3, the controller 170 is configured to generate the graph 140 such that the trace 142 shows a raw pressure ratio over time. In some embodiments, the controller 170 may be configured to generate the graph 140 or any other graph described herein such that the trace 142 or any other trace described herein additionally, or alternately, shows a filtered pressure ratio over time. The pressure ratio is filtered such that the trace does not indicate that the pressure ratio decreases over any given period of time. Other filtering may also be performed.

[0067] For example, FIG. 4 shows a GUI 230 displayed on the display 120 by the controller 170 that includes the graph 240. While not shown, the GUI 230 may also include the table 150 shown in FIG. 3, any other indicator of the difference in pressure ratios, or any other suitable information as described herein. The graph 240 displays a trace 242 that shows raw pressure ratio over time. Furthermore, the controller 170 is configured to generate a second trace 244 showing filtered pressure ratio. For example, the controller 170 may include a software or hardware filter including but not limited to a band-pass filter, a low pass filter, a high pass filter, median filter, or any other suitable filter to obtain the filtered pressure ratio and generate the second trace.

[0068] As shown in FIG. 4, the controller 170 may be configured to display the first trace 242 corresponding to the raw pressure ratio as a dotted line, and second trace 244 corresponding to the filtered pressure ratio as a solid line. In other embodiments, the controller 170 may display the first trace 242 in a first color, a first thickness or a dotted line of a first type, and display the second trace 244 in a second color, a second thickness or a dotted line of a second type that is different from the first color, the first thickness and / or the first type of dotted line.

[0069] As shown in FIG. 4, the second trace 244 does not indicate or show the pressure ratio decreasing over any given period of time. Expanding further, as the sensor assembly 102 is pulled-back through the blood vessel V, the pressure ratio should continue to increaseas the sensor assembly 102 is pulled proximal of the constrictions Cl, C2 and eventually become substantially equal to 1 (e.g., in a range of 0.95 to 1) proximal of the constrictions Cl, C2 where the distal blood pressure Pa becomes substantially equal to the aortic blood pressure Pa. This is because the decay in the aortic blood pressure Padue to the constrictions Cl, C2 that causes the distal blood pressure Pa to be smaller than the aortic blood pressure Pacontinues to decrease as the sensor assembly 102 is pulled back to a location proximal of the constrictions Cl, C2. However, the raw filtered data shown by the first trace 242 also shows the pressure decreasing over time at certain locations, which may be due to electrical noise or mechanical noise (e.g., due to the distal blood pressure sensor 101 contacting the first or second constriction Cl, C2, or fluid vortexes generated around a tip of the sensor assembly 102). These anomalies are removed in the filtered pressure ratio shown in the second trace 244.

[0070] In some embodiments, the controller 170 is further configured to generate a drawing of a blood vessel that includes a constricted region (e.g., the constrictions Cl and C2 of the blood vessel V) corresponding to a region between the first region R1 of the trace 142 and the second region R2 of the trace 142. An extent of constriction in the constricted region is based on the calculated difference between the pressure ratio at the second region R2 of the trace 142 and the pressure ratio at the first region R1 of the trace 142.

[0071] For example, FIG. 5 shows a GUI 330 generated and displayed on the display 120 by the controller 170. The GUI 330 includes the graph 140 showing the trace 142. Additionally, the controller 170 controls the display 120 to display below the trace 142, the generated drawing 350 of a blood vessel 352 through which the sensor assembly 102 is being moved, and showing a first constriction 354 and a second constriction 356 present in the blood vessel 352. In other embodiments, the generated drawing 350 of the blood vessel 352 may be displayed above the trace 142.

[0072] The drawing 350 is generated such that a first constriction 354 of the blood vessel 352 is aligned below a first transition region T1 between the first region R1 and the second region R2 of trace 142. The first transition region T1 corresponds to the increase in pressure ratio as the sensor assembly 102 is pulled through the first constriction 354. Similarly, a second constricted region 356 of the blood vessel 352 is aligned below a secondtransition region T2 between the second region R2 and the third region R3 of trace 142. The second transition region T2 corresponds to the increase in pressure ratio as the sensor assembly 102 is pulled proximally through the second constriction 356.

[0073] In some embodiments, the controller 170 may also be configured to display a dimension of the first and / or second constriction 354, 356 in the blood vessel 352 on the drawing 350. For example, the controller 170 may be configured to visualize the sensor assembly 102 (e.g., a sensor guide wire such as the sensor guide wire shown in FIG. 17) at the same time that the pull-back procedure is being performed. The visualization may be performed via X-rays, ultrasound, or any other suitable method. The controller 170 may be configured to determine the length, size and / or other dimension of the constrictions 354, 356 based on the location of the sensor assembly 102 and the pressure ratio at the location.

[0074] Furthermore, the controller 170 may also be configured to determine a diameter of the blood vessel 352 at the first and / or the second constriction 354, 356 based on the change in distal blood pressure Pa or the pressure ratio in the first transition region T1 and the second transition region T2. In a variation of this embodiment, the general drawing 350 may be localed within the graph 140

[0075] Referring again to FIG. 3, in some embodiments, the controller 170 may be configured to calculate a difference between the pressure ratio at a trailing end of the first region R1 of the trace 142, and the pressure ratio at a leading end of the second region R2 of the trace. In such embodiments the controller 170 may be configured to control the display 120 to display the graph 140, and further control the display 120 to display a first region end point indicator, for example, the first region second marker 143, at the trailing end of the first region R1 of the trace 142, and display a second region starting point indicator, for example, the second region first marker 145, at the leading end of the second region R2 of the trace 142.

[0076] The controller 170 is further configured to control the display 120 to display an indication of the calculated difference between the pressure ratio at the trailing end (e.g., the pressure ratio at the first region second marker 143) of the first region R1 of the trace 142 and the pressure ratio at the leading end (e.g., the second region first marker 145) of thesecond region R2 of the trace 142. In some embodiments, the indication may be shown via the table 150 as shown in FIG. 3 and previously described in detail herein.

[0077] In some embodiments, the indication of the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 and the pressure ratio at the leading end of the second region R2 of the trace 142 includes a numerical value of the calculated difference. In some embodiments, the numerical value may be shown in the Table 150. In other embodiments, the controller 170 may be configured to display the numerical value in the GUI displayed on the display 120.

[0078] For example, FIG. 6 shows a GUI 430 generated by the controller 170 for the display 120. The GUI 430 includes a graph 440 that shows the raw pressure ratio trace 242, and may also include the filtered pressure ratio trace 244, as previously described herein. The GUI 430 also includes a first indicator INDI indicating the first numerical value (0.09) of the difference in the pressure ratio at the trailing end of the first region R1 of the trace 242 indicated by the first region second marker 143, and the pressure ratio at the leading end of the second region R2 of the trace 242 indicated by the second region first marker 145. In some embodiments, the first indicator INDI may also include a first vertical dimension line (e.g., extending vertically from the first region R1 to the second region R2) displayed adjacent to the first numerical value and having a length corresponding to the first numerical value. In some embodiments, the GUI 430 also includes a second indicator IND2 indicating a second numerical value (0.17) of the difference in the pressure ratio at the trailing end of the second region R2 of the trace 242 indicated by the second region second marker 147, and the pressure ratio at the leading end of the third region R2 of the trace 242 indicated by the third region first marker 149. In some embodiments, the second indicator IND2 may also include a second vertical dimension line (e.g., extending vertically from the second region R2 to the third region R3) displayed adjacent to the second numerical value and having a length corresponding to the second numerical value.

[0079] In some embodiments, the indication of the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 of FIG. 3 or any other pressure ratio trace described herein, and the pressure ratio at the leading end of the second region R2 of the trace 142 includes a shape bound on a top side by the trace 142 at theleading end of the second region R2, on a bottom side by a horizontal line corresponding to a pressure ratio value at the trailing end of the first region of the trace 142, and on a right side by a vertical line corresponding to a time value at the leading end of the second region of the trace 142.

[0080] For example, FIG. 7 shows a GUI 530 generated by and displayed on the display 120 by the controller 170, according to an embodiment. The GUI 530 includes a graph 450 that shows the trace 142 previously described herein with respect to FIG. 3. A first indicator INDI of the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 that is indicated by the first region second marker 143, and the pressure ratio at the leading end of the second region R2 of the trace 142 that is indicated by the second region first marker 145 comprises a first shape 542 bound on a top side by the trace 142 at the leading end of the second region R2, on a bottom side by a first horizontal line 541 corresponding to a pressure ratio value at the trailing end of the first region of the trace 142, and on a right side by a first vertical line 543 corresponding to a time value at the leading end of the second region R2 of the trace 142. In some embodiments, the first shape 542 includes a right triangle located on a right side of the trace 142. In particular embodiments, the first indicator INDI may also include a numerical value of the calculated pressure ratio difference between the trailing end of the first region R1 and the leading end of the second region R2 displayed adjacent to the first shape 542, for example, on a left side thereof as shown in FIG. 7, but in other embodiments, may be displayed on a right side, above or below the first shape 542.

[0081] Similarly, a second indicator IND2 of the calculated difference between the pressure ratio at the trailing end of the second region R2 of the trace 142 that is indicated by the second region second marker 147, and the pressure ratio at the leading end of the third region R3 of the trace 142 that is indicated by the third region first marker 149 comprises a second shape 546 bound on a top side by the trace 142, at the leading end of the third region R3 on a bottom side by a second horizontal line 545 corresponding to a pressure ratio value at the trailing end of the second region R2 of the trace 142, and on a right side by a second vertical line 547 corresponding to a time value at the leading end of the third region R3 of the trace 142. In some embodiments, the second shape 546 also includes a right triangle located on a right side of the trace 142. In particular embodiments, the second indicatorIND2 may also include a numerical value of the calculated pressure ratio difference between the trailing end of the second region R2 and the leading end of the third region R3 displayed adjacent to the second shape 546, for example, on a left side thereof as shown in FIG. 7, but in other embodiments, may be displayed on a right side, above or below the second shape 546.

[0082] In some embodiments, the indication of the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 or any other trace described herein, and the pressure ratio at the leading end of the second region R2 of the trace 142 includes a rectangle having a lower side corresponding to a pressure ratio value at the trailing end of the first region R1 of the trace 142, and an upper side corresponding to a pressure ratio value at the leading end of the second region R2 of the trace 142.

[0083] For example, FIG. 8 shows a GUI 630 generated by and displayed on the display 120 by the controller 170, according to an embodiment. The GUI 630 includes a graph 640 that shows the trace 142. A first indicator INDI of the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 and the pressure ratio at the leading end of the second region R2 of the trace 142 includes a first rectangle 642 having a lower side corresponding to a pressure ratio value at the trailing end of the first region R1 of the trace 142, and an upper side corresponding to a pressure ratio value at the leading end of the second region R2 of the trace 142. The first rectangle 642 may overlap the trace 142 such that a lower left corner 641 of the first rectangle 642 is located at trailing end of the first region Rl, and an upper right comer 643 thereof is located proximate to the leading edge of the second region R2. In particular embodiments, the first indicator INDI may also include a numerical value of the calculated pressure ratio difference between the trailing end of the first region Rl and the leading end of the second region R2 displayed adjacent to the first rectangle 642, for example, on a left side thereof as shown in FIG. 8, but in other embodiments, may be displayed on a right side, above or below the first rectangle 642.

[0084] Similarly, a second indicator IND2 of the calculated difference between the pressure ratio at the trailing end of the second region R2 of the trace 142 and the pressure ratio at the leading end of the third region R3 of the trace 142 comprises a second rectangle646 having a lower side corresponding to a pressure ratio value at the trailing end of the second region R2 of the trace 142, and an upper side corresponding to a pressure ratio value at the leading end of the third region R3 of the trace 142. The second rectangle 646 may overlap the trace 142 such that a lower left corner 645 of the second rectangle 646 is at the trailing end of the second region R2, and a top right corner 647 of the second rectangle 646 is at the leading edge of the third region R3. In particular embodiments, the second indicator IND2 may also include a numerical value of the calculated pressure ratio difference between the trailing end of the second region R2 and the leading end of the third region R3 displayed adjacent to the second rectangle 646, for example, on a left side thereof as shown in FIG. 8, but in other embodiments, may be displayed on a right side, above or below the second rectangle 646.

[0085] In some embodiments, the indication of the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 and the pressure ratio at the leading end of the second region R2 of the trace 142 comprises a circle having a lowermost point corresponding to a pressure ratio value at the trailing end of the first region R1 of the trace 142, and an uppermost point corresponding to a pressure ratio value at the leading end of the second region R2 of the trace 142.

[0086] For example, FIG. 9 shows a GUI 730 generated by and displayed on the display 120 by the controller 170, according to an embodiment. The GUI 730 includes a graph 740 that shows the trace 142. A first indicator INDI of the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 and the pressure ratio at the leading end of the second region R2 of the trace 142 includes a first circle 742 having a lower most point 741 corresponding to a pressure ratio value at the trailing end of the first region R1 of the trace 142, and an uppermost point 743 corresponding to a pressure ratio value at the leading end of the second region R2 of the trace 142. The first circle 742 may overlap the trace 142. In particular embodiments, the first indicator INDI may also include a numerical value of the calculated pressure ratio difference between the trailing end of the first region R1 and the leading end of the second region R2 displayed adjacent to the first circle 742, for example, on a left side thereof as shown in FIG. 9, but in other embodiments, may be displayed on a right side, above or below the first circle 742.

[0087] Similarly, a second indicator IND2 of the calculated difference between the pressure ratio at the trailing end of the second region R2 of the trace 142 and the pressure ratio at the leading end of the third region R3 of the trace 142 comprises a second circle 746 having a lowermost point 745 side corresponding to a pressure ratio value at the trailing end of the second region R2 of the trace 142, and an uppermost point 747 corresponding to a pressure ratio value at the leading end of the third region R3 of the trace 142. The second circle 746 may overlap the trace 142. In particular embodiments, the second indicator IND2 may also include a numerical value of the calculated pressure ratio difference between the trailing end of the second region R2 and the leading end of the third region R3 displayed adjacent to the second circle 746, for example, on a left side thereof as shown in FIG. 9, but in other embodiments, may be displayed on a right side, above or below the second circle 746. In a variation of this embodiment, the first and second circles 742, 746 are separated (e.g., above or below or to the left or the right) from the trace 142.

[0088] In some embodiments, the indication of the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 and the pressure ratio at the leading end of the second region R2 of the trace 142 comprises a triangle having a lower side corresponding to a pressure ratio value at the trailing end of the first region R1 of the trace 142, and an uppermost point corresponding to a pressure ratio value at the leading end of the second region R2 of the trace 142.

[0089] For example, FIG. 10 shows a GUI 830 generated by and displayed on the display 120 by the controller 170, according to an embodiment. The GUI 830 includes a graph 840 that shows the trace 142. A first indicator INDI of the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 and the pressure ratio at the leading end of the second region R2 of the trace 142 includes a first triangle 842 having a lower side 841 corresponding to a pressure ratio value at the trailing end of the first region R1 of the trace 142, and an uppermost point 843 corresponding to a pressure ratio value at the leading end of the second region R2 of the trace 142. The first triangle 842 may overlap the trace 142, and the uppermost point 843 may be at the leading edge of the second region R2 of the trace 142. In particular embodiments, the first indicator INDI may also include a numerical value of the calculated pressure ratio difference between the trailing end of the first region R1 and the leading end of the second region R2 displayedadjacent to the first triangle 842, for example, on a left side thereof as shown in FIG. 10, but in other embodiments, may be displayed on a right side, above or below the first triangle 842.

[0090] Similarly, a second indicator IND2 of the calculated difference between the pressure ratio at the trailing end of the second region R2 of the trace 142 and the pressure ratio at the leading end of the third region R3 of the trace 142 comprises a second triangle 846 having a lower side 845 corresponding to a pressure ratio value at the trailing end of the second region R2 of the trace 142, and an uppermost point 847 corresponding to a pressure ratio value at the leading end of the third region R3 of the trace 142. The second triangle 846 may overlap the trace 142, and the uppermost point 847 may be at the leading edge of the third region R3 of the trace 142. In particular embodiments, the second indicator IND2 may also include a numerical value of the calculated pressure ratio difference between the trailing end of the second region R2 and the leading end of the third region R3 displayed adjacent to the second triangle 846, for example, on a left side thereof as shown in FIG. 10, but in other embodiments, may be displayed on a right side, above or below the second triangle 846.

[0091] In some embodiments, the indication of the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 and the pressure ratio at the leading end of the second region R2 of the trace 142 comprises a relatively thick portion of the trace 142 that extends between the indication of the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 and the pressure ratio at the leading end of the second region R2 of the trace 142.

[0092] For example, FIG. 11 shows a GUI 930 generated by and displayed on the display 120 by the controller 170, according to an embodiment. The GUI 930 includes a graph 940 that shows the trace 142. A first indicator INDI includes a first trace portion 942 of the trace 142 that extends between the indication of the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 and the pressure ratio at the leading end of the second region R2 of the trace 142, and a second indicator IND2 includes a second trace portion 946 that extends between the indication of the calculated difference between the pressure ratio at the trailing end of the second region R2 of the trace142 and the pressure ratio at the leading end of the third region R3 of the trace 142. Each of the first trace portion 942 and the second trace portion 946 are relatively thicker than the remaining portions of the trace 142. In some embodiments, the first trace portion 942 and the second trace portion 946 have the same thickness. In other embodiments, the first trace portion 942 and the second trace portion may have different thicknesses based on a magnitude of the calculated pressure difference corresponding to each of the first trace portion 942 and the second trace portion 946.

[0093] In particular embodiments, the first indicator INDI may also include a numerical value of the calculated pressure ratio difference between the trailing end of the first region R1 and the leading end of the second region R2 displayed adjacent to the first trace portion 942, for example, on a left side thereof as shown in FIG. 11, but in other embodiments, may be displayed on a right side, above or below the first trace portion 942. Moreover, the second indicator IND2 may also include a numerical value of the calculated pressure ratio difference between the trailing end of the second region R2 and the leading end of the third region R3 displayed adjacent to the second trace portion 946, for example, on a left side thereof as shown in FIG. 11, but in other embodiments, may be displayed on a right side, above or below the second trace portion 946.

[0094] In some embodiments, the indication of the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 and the pressure ratio at the leading end of the second region R2 of the trace 142 comprises a bar located above or below the trace 142 and having a height that is proportional to the calculated difference.

[0095] For example, FIG. 12 shows a GUI 1030 generated by and displayed on the display 120 by the controller 170, according to an embodiment. The GUI 1030 includes a graph 1040 that shows the trace 142. The graph 1040 also includes a first indicator INDI including a first bar 1042 located below the trace 142, for example, below the first transition region T1 of the trace 142 where the trace 142 transitions from the first region R1 to the second region R2. The first bar 1042 has a first height that is proportional to the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 and the pressure ratio at the leading end of the second region R2 of the trace 142. The graph 1040 also includes a second indicator IND2 including a second bar 1046 located below thetrace 142, for example, below the second transition region T2 of the trace 142, where the trace 142 transitions from the second region R2 to the third region R3. The second bar 1046 has a second height that is proportional to the calculated difference between the pressure ratio at the trailing end of the second region R2 of the trace 142 and the pressure ratio at the leading end of the third region R3 of the trace 142. While shown as being positioned below the trace 142, in other embodiments, the bars 1042, 1046 may be located above the trace 142.

[0096] In particular embodiments, the first indicator INDI may also include a numerical value of the calculated pressure ratio difference between the trailing end of the first region R1 and the leading end of the second region R2 displayed adjacent to the first bar 1042, for example, on a left side thereof as shown in FIG. 12, but in other embodiments, may be displayed on a right side of the first bar 1042. Moreover, the second indicator IND2 may also include a numerical value of the calculated pressure ratio difference between the trailing end of the second region R2 and the leading end of the third region R3 displayed adjacent to the second bar 1046, for example, on a left side thereof as shown in FIG. 12, but in other embodiments, may be displayed on a right side of the second bar 1046.

[0097] In some embodiments, the indication of the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 and the pressure ratio at the leading end of the second region R2 of the trace 142 comprises a circle located above or below the trace 142 and having a size that is proportional to or related to the calculated difference.

[0098] For example, FIG. 13 shows a GUI 1130 generated by and displayed on the display 120 by the controller 170, according to an embodiment. The GUI 1130 includes a graph 1140 that shows the trace 142. The GUI 1130 also includes an indication portion 1150 located below the graph 1140. The indication portion 1150 includes a first indicator INDI including a first circle 1152 located below the trace 142, for example, below the first transition region T1 of the trace 142 where the trace 142 transitions from the first region R1 to the second region R2. The first circle 1152 has a first size (e.g., diameter) that is proportional to the calculated difference between the pressure ratio at the trailing end of the first region R1 of the trace 142 and the pressure ratio at the leading end of the second regionR2 of the trace 142. The indication portion 1150 also includes a second indicator IND2 including a second circle 1156 located below the trace 142, for example, below the second transition region T2 of the trace 142 where the trace 142 transitions from the second region R2 to the third region R3. The second circle 1156 has a second size (e.g., diameter) that is proportional to the calculated difference between the pressure ratio at the trailing end of the second region R2 of the trace 142 and the pressure ratio at the leading end of the third region R3 of the trace 142. While shown as located below the graph 1140, in some embodiments, the indication portion 1150 may be positioned within the graph 1140, for example displayed above or below the trace 142 within the graph 1140.

[0099] In particular embodiments, the first indicator INDI may also include a numerical value of the calculated pressure ratio difference between the trailing end of the first region R1 and the leading end of the second region R2 displayed adjacent to the first circle 1152, for example, on a left side thereof as shown in FIG. 13, but in other embodiments, may be displayed on a right side, above or below the first circle 1152. Moreover, the second indicator IND2 may also include a numerical value of the calculated pressure ratio difference between the trailing end of the second region R2 and the leading end of the third region R3 displayed adjacent to the second circle 1156, for example, on a left side thereof as shown in FIG. 13, but in other embodiments, may be displayed on a right side, above or below the second circle 1156.

[0100] While the graphs 540, 640, 740, 840, 940, 1040, 1140 show the trace 142 including raw pressure ratio over time, in other embodiments, each of the graphs 540, 640, 740, 840, 940, 1040, 1140 may additionally, or alternately show a filtered pressure ratio over time, as described with respect to FIG. 4. While not shown, the controller 170 may be configured to generate one or more traces, numerical values, graphs, symbols, indicators, etc., corresponding to various health parameters of the patient on any one of the GUIs shown in FIGS. 3-13. Such parameters may include but are not limited to patient body temperature, heart rate, ECG, blood oxygen level, or any other health parameter of the patient that is undergoing the procedure.

[0101] In particular embodiments, the controller 170 may include a plurality of modules or circuitries configured to perform various operations and functions of the controller 170.For example, FIG. 2 is a schematic block diagram of the controller 170 that may be included in the medical system 100 of FIG. 1, according to an embodiment. The controller 170 comprises a processor 172, a memory 174, or any other non-transitory computer readable medium, and a communication interface 176. Furthermore, the controller 170 includes a distal blood pressure determination circuitry 174a, an aortic blood pressure determination circuitry 174b, a pressure ratio and difference determination circuitry 174c, a display generation circuitry 174d, and in some embodiments, a patient health parameter determination circuitry 174e. It should be understood that the controller 170 shows only one embodiment of the controller 170 and any other controller capable of performing the operations described herein can be used.

[0102] The processor 172 can comprise a microprocessor, programmable logic controller (PLC) chip, an ASIC chip, or any other suitable processor. The processor 172 is in communication with the memory 174 and configured to execute instructions, algorithms, commands, or otherwise programs stored in the memory 174.

[0103] The memory 174 comprises any of the memory and / or storage components discussed herein. For example, the memory 174 may comprise a RAM and / or cache of processor 172. The memory 174 may also comprise one or more storage devices (e.g., hard drives, flash drives, computer readable media, etc.) either local or remote to controller 170. The memory 174 is configured to store look up tables, algorithms, programs or instructions.

[0104] In one configuration, the distal blood pressure determination circuitry 174a, the aortic blood pressure determination circuitry 174b, the pressure ratio and difference determination circuitry 174c, the display generation circuitry 174d, and the patient health parameter determination circuitry 174e are embodied as machine or computer-readable media (e.g., stored in the memory 174) that are executable by a processor, such as the processor 172. As described herein and amongst other uses, the machine-readable media (e.g., the memory 174) facilitates performance of certain operations to enable reception and transmission of data. For example, the machine-readable media may provide an instruction (e.g., command, etc.) to, e.g., acquire data. In this regard, the machine-readable media may include programmable logic that defines the frequency of acquisition of the data (or, transmission of the data). Thus, the computer readable media may include code, which maybe written in any programming language including, but not limited to, Java or the like and any conventional procedural programming languages, such as the "C" programming language or similar programming languages. The computer readable program code may be executed on one processor or multiple remote processors. In the latter scenario, the remote processors may be connected to each other through any type of network.

[0105] In another configuration, the distal blood pressure determination circuitry 174a, the aortic blood pressure determination circuitry 174b, the pressure ratio and difference determination circuitry 174c, the display generation circuitry 174d, and the patient health parameter determination circuitry 174e are embodied as hardware units, such as electronic control units. As such, the distal blood pressure determination circuitry 174a, the aortic blood pressure determination circuitry 174b, the pressure ratio and difference determination circuitry 174c, the display generation circuitry 174d, and the patient health parameter determination circuitry 174e may be embodied as one or more circuitry components including, but not limited to, processing circuitry, network interfaces, peripheral devices, input devices, output devices, sensors, computers, etc.

[0106] In some embodiments, the distal blood pressure determination circuitry 174a, the aortic blood pressure determination circuitry 174b, the pressure ratio and difference determination circuitry 174c, the display generation circuitry 174d, and the patient health parameter determination circuitry 174e may take the form of one or more analog circuits, electronic circuits (e.g., integrated circuits (IC), discrete circuits, system on a chip (SOCs) circuits, microcontrollers, etc.), telecommunication circuits, hybrid circuits, and any other type of “circuit.” In this regard, the distal blood pressure determination circuitry 174a, the aortic blood pressure determination circuitry 174b, the pressure ratio and difference determination circuitry 174c, the display generation circuitry 174d, and the patient health parameter determination circuitry 174e may include any type of component for accomplishing or facilitating achievement of the operations described herein. For example, a circuit as described herein may include one or more transistors, logic gates (e.g., NAND, AND, NOR, OR, XOR, NOT, XNOR, etc.), resistors, multiplexers, registers, capacitors, inductors, diodes, wiring, and so on.

[0107] Thus, the distal blood pressure determination circuitry 174a, the aortic blood pressure determination circuitry 174b, the pressure ratio and difference determination circuitry 174c, the display generation circuitry 174d, and the patient health parameter determination circuitry 174e may also include programmable hardware devices such as field programmable gate arrays, programmable array logic, programmable logic devices or the like. In this regard, the distal blood pressure determination circuitry 174a, the aortic blood pressure determination circuitry 174b, the pressure ratio and difference determination circuitry 174c, the display generation circuitry 174d, and the patient health parameter determination circuitry 174e may include one or more memory devices for storing instructions that are executable by the processor(s) of the distal blood pressure determination circuitry 174a, the aortic blood pressure determination circuitry 174b, the pressure ratio and difference determination circuitry 174c, the display generation circuitry 174d, and the patient health parameter determination circuitry 174e. The one or more memory devices and processor(s) may have the same definition as provided herein with respect to the memory 174 and the processor 172.

[0108] In the example shown, the controller 170 includes the processor 172 and the memory 174. The processor 172 and the memory 174 may be structured or configured to execute or implement the instructions, commands, and / or control processes described herein with respect to the distal blood pressure determination circuitry 174a, the aortic blood pressure determination circuitry 174b, the pressure ratio and difference determination circuitry 174c, the display generation circuitry 174d, and the patient health parameter determination circuitry 174e. Thus, the depicted configuration represents the aforementioned arrangement in which the distal blood pressure determination circuitry 174a, the aortic blood pressure determination circuitry 174b, the pressure ratio and difference determination circuitry 174c, the display generation circuitry 174d, and the patient health parameter determination circuitry 174e are embodied as machine or computer-readable media. However, as mentioned above, this illustration is not meant to be limiting as the present disclosure contemplates other embodiments such as the aforementioned embodiment where the distal blood pressure determination circuitry 174a, the aortic blood pressure determination circuitry 174b, the pressure ratio and difference determination circuitry 174c, the display generation circuitry 174d, and the patient health parameter determination circuitry 174e, or at least one circuit of the distal blood pressure determination circuitry174a, the aortic blood pressure determination circuitry 174b, the pressure ratio and difference determination circuitry 174c, the display generation circuitry 174d, and the patient health parameter determination circuitry 174e are configured as a hardware unit. All such combinations and variations are intended to fall within the scope of the present disclosure.

[0109] The processor 172 may be implemented as one or more general -purpose processors, an application specific integrated circuit (ASIC), one or more field programmable gate arrays (FPGAs), a digital signal processor (DSP), a group of processing components, or other suitable electronic processing components. In some embodiments, the one or more processors may be shared by multiple circuits (e.g., the distal blood pressure determination circuitry 174a, the aortic blood pressure determination circuitry 174b, the pressure ratio and difference determination circuitry 174c, the display generation circuitry 174d, and the patient health parameter determination circuitry 174e) may comprise or otherwise share the same processor which, in some example embodiments, may execute instructions stored, or otherwise accessed, via different areas of memory. Alternatively, or additionally, the one or more processors may be structured to perform or otherwise execute certain operations independent of one or more co-processors. In other example embodiments, two or more processors may be coupled via a bus to enable independent, parallel, pipelined, or multi-threaded instruction execution. All such variations are intended to fall within the scope of the present disclosure. The memory 174 (e.g., RAM, ROM, Flash Memory, hard disk storage, etc.) may store data and / or computer code for facilitating the various processes described herein. The memory 174 may be communicably connected to the processor 172 to provide computer code or instructions to the processor 172 for executing at least some of the processes described herein. Moreover, the memory 174 may be or include tangible, non-transient volatile memory or non-volatile memory. Accordingly, the memory 174 may include database components, object code components, script components, or any other type of information structure for supporting the various activities and information structures described herein.

[0110] The communication interface 176 may include wireless interfaces (e.g., jacks, antennas, transmitters, receivers, communication interfaces, wire terminals, etc.) for conducting data communications with various systems, devices, or networks. For example,the communication interface 176 may include an Ethernet card and port for sending and receiving data via an Ethernet-based communications network and / or a Wi-Fi communication interface for communicating with the sensor assembly 102, the aortic blood pressure sensor 103, the display 120, the temperature sensor 104, the heart rate sensor 106, the ECG sensor 108, and the blood oxygen sensor 110. The communication interface 176 may be structured to communicate via local area networks or wide area networks (e.g., the Internet, etc.) and may use a variety of communications protocols (e.g., IP, LON, Bluetooth, ZigBee, radio, cellular, near field communication, etc.).

[0111] The distal blood pressure determination circuitry 174a is configured to receive the distal blood pressure signal from the distal blood pressure sensor 101 that is indicative of or representative of the distal blood pressure in the blood vessel V of the patient, and determine the distal blood pressure therefrom.

[0112] The aortic blood pressure determination circuitry 174b is configured to receive the aortic blood pressure signal from the aortic blood pressure sensor 103 and determine the aortic blood pressure of the patient therefrom.

[0113] The pressure ratio and difference determination circuitry 174c is configured to determine the pressure ratio over time based on the distal blood pressure and aortic blood pressure, as previously described herein. For example, FFR, RFR, iFR, or any other suitable techniques may be used. Furthermore, the pressure ratio and difference determination circuitry 174c is configured to identify the first region R1 of the trace 142 or any other trace described herein corresponding to the pressure ratio during which the pressure ratio is substantially constant over a first period of time, identify the second region R2 of the trace 142 or any other trace described herein during which the pressure ratio is substantially constant over a second period of time, and calculate a difference between the pressure ratio at the second region R2 of the trace 142 and the pressure ratio at the first region R1 of the trace 142. In some embodiments, the pressure ratio and difference determination circuitry 174c may be configured to calculate a difference between the pressure ratio at a trailing end of the first region R1 of the trace 142 and the pressure ratio at a leading end of the second region R2 of the trace 142, as previously described herein.

[0114] The display generation circuitry 174d is configured to generate the GUI 130, 230, 330, 430, 530, 630, 730, 830, 930, 1030, 1130 or any other GUI described herein, and generate a display generation signal configured to cause the display 120 to display the corresponding GUI thereon.

[0115] In some embodiments in which the controller 170 includes the patient health parameter determination circuitry 174e, the patient health parameter determination circuitry 174e is configured to receive a temperature signal from the temperature sensor 104, a heart rate signal from the heart rate sensor 106, an ECG signal from the ECG sensor 108, and / or a blood oxygen level signal from the blood oxygen sensor 110, and calculate a body temperature, a heart rate, an ECG, and a blood oxygen level, respectively of the patient therefrom. In such embodiments, the display generation circuitry 174d may also be configured to generate graphs, traces, numerical values, symbols or any other indicators or visual displays of the patient body temperature, heart rate, ECG, and blood oxygen level. The display generation circuitry 174d communicates the generated information to the display 120 via the display generation signal causing the display 120 to display the information within the corresponding GUI displayed thereon.

[0116] FIG. 14 is a schematic flow diagram of a method 1200, according to an embodiment, for displaying a determined pressure ratio between a distal blood pressure and aortic blood pressure in a blood vessel (e.g., the blood vessel V) of a patient as well as calculating and displaying a difference in pressure ratio corresponding to one or more constrictions (e.g., the constrictions Cl and C2) present in the blood vessel, as described herein. While the method 1200 is described with respect to the medical system 100 and the controller 170, it should be understood that the operations of the method 1200 or any other method described herein (e.g., the method 1300, 1400) may be performed with any other controller or control system.

[0117] The method 1200 includes receiving, by the controller 170, data indicative of a distal blood pressure measured by a distal blood pressure sensor Pd of a sensor wire or sensor catheter (e.g., the sensor assembly 102) and receiving data indicative of an aortic blood pressure Pameasured by an aortic blood pressure sensor (e.g., the aortic blood pressure sensor 103), at 1202.

[0118] At 1204, the controller 170 generates a graph (e.g., the graph 140) containing a trace (e.g., the trace 142) indicative of a pressure ratio between the distal blood pressure Pa and the aortic blood pressure Paover time while the distal blood pressure sensor 101 included in the sensor assembly 102 is moved from a first position in the blood vessel V to a second position in the blood vessel V.

[0119] At 1206, the controller 170 identifies a first region of the trace (e.g., the first region R1 of the trace 142) during which the pressure ratio is substantially constant over a first period of time, and identifies a second region of the trace (e.g., the second region R2 of the trace 142) during which the pressure ratio is substantially constant over a second period of time.

[0120] At 1208, the controller 170 calculates a difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace. At 1210, the controller 170 controls the display to display the graph, and display, on the graph, a first indicator indicating the first region of the trace, and a second indicator indicating the second region of the trace, and an indication of the calculated difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace (e.g., the table 150, or the first indicator INDI and the second indicator IND2 described with respect to any one of FIGS. 3-13).

[0121] In some embodiments, the trace generated by and displayed on the display 120 by the controller 170 includes a raw pressure ratio calculated by the controller 170. In some embodiments, the controller 170 is also configured to generate the graph such that the trace shows a filtered pressure ratio over time (e.g., the graph 240 includs the filtered pressure ratio trace 244), at 1212. The pressure ratio is filtered such that the filtered pressure ratio trace does not indicate that the pressure ratio decreases over any given period of time.

[0122] In some embodiments, the controller 170 is configured to generate a drawing of a blood vessel (e.g., the drawing 350 of the blood vessel 352) that includes a constricted region corresponding to a region between the first region of the trace and the second region of the trace (e.g., the first constriction 354 corresponding to transition region T1 of the trace 142), and control the display 120 to display, above or below the trace (e.g., the trace 142), the generated drawing of the blood vessel, such that the constricted region of the bloodvessel is aligned above or below the region between the first region of the trace and the second region of the trace, at 1214.

[0123] At 1216, the controller 170 is configured to determine if an input is received to change a location and / or an extent of the first region of the trace (e.g., the first region R1 of the trace 142) and / or the second region (e.g., the second region R2 of the trace 142) from a user via an input device. If such an input is not received (1216:NO), the controller 170 continues to maintain the GUI displayed by the controller 170 on the display. In response to receiving an input to change the location and / or extent of the first region and / or the second region of the trace 142 from the user via the input device (1216:YES), the controller 170 is configured to change the location and / or the extent of the first region and / or second region of trace based on the input. The method 1200 may then return to operation 1208.

[0124] FIG. 15 is a schematic flow diagram of a method 1300, according to another embodiment, for displaying a determined pressure ratio between a distal blood pressure and aortic blood pressure in a blood vessel (e.g., the blood vessel V) of a patient as well as calculating and displaying a difference in pressure ratio corresponding to one or more constrictions (e.g., the constrictions Cl and C2) present in the blood vessel, as described herein.

[0125] The method 1300 includes receiving, by the controller 170, data indicative of a distal blood pressure measured by a distal blood pressure sensor Pd of a sensor wire or sensor catheter (e.g., the sensor assembly 102) and receiving data indicative of an aortic blood pressure Pameasured by an aortic blood pressure sensor (e.g., the aortic blood pressure sensor 103), at 1302.

[0126] At 1304, the controller 170 generates a graph (e.g., the graph 140) containing a trace (e.g., the trace 142) indicative of a pressure ratio between the distal blood pressure Pd and the aortic blood pressure Paover time while the distal blood pressure sensor 101 included in the sensor assembly 102 is moved from a first position in the blood vessel V to a second position in the blood vessel V.

[0127] At 1306, the controller 170 identifies a first region of the trace (e.g., the first region R1 of the trace 142) during which the pressure ratio is substantially constant over afirst period of time, and identifies a second region of the trace (e.g., the second region R2 of the trace 142) during which the pressure ratio is substantially constant over a second period of time.

[0128] At 1308, the controller 170 calculates a difference between the pressure ratio at a trailing end of the first region of the trace (e.g., the end indicated by the first region second marker 143 of the trace 142 in FIG. 3) and the pressure ratio at a leading end of the second region of the trace (e.g., the end indicated by the second region first marker 145 of the trace 142 in FIG. 3).

[0129] At 1310, the controller 170 controls the display to display the graph, and display, on the graph, a first region ending point indicator at the trailing end of the first region of the trace and a second region starting point indicator at the leading end of the second region of the trace. For example, the first region ending point indicator may include the first region second marker 143 and the second region starting point indicator may include the second region first marker 145. In some embodiments, the controller 170 may also control the display to display a second region ending point indicator at the trailing end of the second region of the trace and a third region starting point indicator at the leading end of the third region of the trace. For example, the second region ending point indicator may include the second region second marker 147 and the third region starting point indicator may include the third region first marker 149.

[0130] At 1312, the controller 170 is configured to control the display 120 to display an indication of the calculated difference between the pressure ratio at the trailing end of the first region of the trace and the pressure ratio at the leading end of the second region of the trace. In some embodiments, the indicator may include a number inscribed in a circle and / or the table 150 as shown in FIG. 3. In other embodiments, indication may include any of the first indicator INDI described with respect to FIGS. 5-13. In some embodiments, the controller 170 is configured to control the display 120 to also display an indication of the calculated difference between the pressure ratio at the trailing end of the second region of the trace and the pressure ratio at the leading end of the third region of the trace, for example, within the table 150 or via any of the second indicators IND2 as shown and described with respect to any one of FIGS. 5-13.

[0131] In some embodiments, the controller 170 is configured to generate a drawing of a blood vessel (e.g., the drawing 350 of the blood vessel 352) that includes a constricted region corresponding to a region between the first region of the trace and the second region of the trace (e.g., the first constriction 354 corresponding to transition region T1 of the trace 142), and control the display 120 to display, above or below the trace (e.g., the trace 142), the generated drawing of the blood vessel, such that the constricted region of the blood vessel is aligned above or below the region between the first region of the trace and the second region of the trace, at 1314.

[0132] At 1316, the controller 170 is configured to determine if an input is received to change a location and / or an extent of the first region of the trace (e.g., the first region R1 of the trace 142) and / or the second region (e.g., the second region R2 of the trace 142) from a user via an input device. If such an input is not received (1316:NO), the controller 170 continues to maintain the GUI displayed by the controller 170 on the display. In response to receiving an input to change the location and / or extent of the first region and / or the second region of the trace 142 from the user via the input device (1316:YES), the controller 170 is configured to change the location and / or the extent of the first region and / or second region of trace based on the input. The method 1300 may then return to operation 1308.

[0133] FIG. 16 is a schematic flow diagram of a method 1400, according to still another embodiment, for displaying a determined pressure ratio between a distal blood pressure and aortic blood pressure in a blood vessel (e.g., the blood vessel V) of a patient as well as calculating and displaying a difference in pressure ratio corresponding to one or more constrictions (e.g., the constrictions Cl and C2) present in the blood vessel, as described herein.

[0134] The method 1400 includes receiving, by the controller 170, data indicative of a distal blood pressure measured by a distal blood pressure sensor Pa of a sensor wire or sensor catheter (e.g., the sensor assembly 102) and receiving data indicative of an aortic blood pressure Pa measured by an aortic blood pressure sensor (e.g., the aortic blood pressure sensor 103), at 1302.

[0135] At 1404, the controller 170 generates a graph (e.g., the graph 140) containing a trace (e.g., the trace 142) indicative of a pressure ratio between the distal blood pressure Paand the aortic blood pressure Paover time while the distal blood pressure sensor 101 included in the sensor assembly 102 is moved from a first position in the blood vessel V to a second position in the blood vessel V.

[0136] At 1406, the controller 170 identifies a first region of the trace (e.g., the first region R1 of the trace 142) during which the pressure ratio is substantially constant over a first period of time, and identifies a second region of the trace (e.g., the second region R2 of the trace 142) during which the pressure ratio is substantially constant over a second period of time.

[0137] At 1408, the controller 170 calculates a difference between the pressure ratio at the first region of the trace and the pressure ratio at the second region of the trace. At 1410, the controller 170 is configured to generate a drawing of a blood vessel that includes a constricted region corresponding to a region between the first region of the trace and the second region of the trace.

[0138] At 1412, the controller 170 controls the display to display the graph, and display, on the graph, a first indicator indicating the first region of the trace, and a second indicator indicating the second region of the trace, and an indication of the calculated difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace (e.g., the table 150, or the first indicator INDI and the second indicator IND2 described with respect to any one of FIGS. 3 or 5-13).

[0139] At 1414, the controller 170 is configured to display on the display 120 above or below the trace, the generated drawing of a blood vessel (e.g., the drawing 350 of the blood vessel 352) that includes a constricted region corresponding to a region between the first region of the trace and the second region of the trace (e.g., the first constriction 354 corresponding to transition region T1 of the trace 142), and control the display 120 to display, above or below the trace (e.g., the trace 142), the generated drawing of the blood vessel, such that the constricted region of the blood vessel is aligned above or below the region between the first region of the trace and the second region of the trace, at 1414.

[0140] At 1416, the controller 170 is configured to determine if an input is received to change a location and / or an extent of the first region of the trace (e.g., the first region R1 ofthe trace 142) and / or the second region (e.g., the second region R2 of the trace 142) from a user via an input device. If such an input is not received (1416:NO), the controller 170 continues to maintain the GUI displayed by the controller 170 on the display. In response to receiving an input to change the location and / or extent of the first region and / or the second region of the trace 142 from the user via the input device (1416:YES), the controller 170 is configured to change the location and / or the extent of the first region and / or second region of trace based on the input. The method 1400 may then return to operation 1408.

[0141] As used herein, the terms “about” and “approximately” generally mean plus or minus 10% of the stated value. For example, about 0.5 would include 0.45 and 0.55, about 10 would include 9 to 11, about 1000 would include 900 to 1100.

[0142] It is important to note that the construction and arrangement of the various exemplary embodiments are illustrative only. Although only a few embodiments have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements; values of parameters, mounting arrangements;, colors, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter described herein. Additionally, it should be understood that features from one embodiment disclosed herein may be combined with features of other embodiments disclosed. Other substitutions, modifications, changes, and omissions may also be made in the design, operating conditions, and arrangement of the various exemplary embodiments without departing from the scope of the present embodiments.

[0143] While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any embodiments or of what may be claimed, but rather as descriptions of features specific to particular implementations of particular embodiments. Certain features described in this specification in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting incertain combinations and even initially claimed as such, one or more features from a claimed combination can be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

Claims

WHAT IS CLAIMED IS:

1. A medical system for generating and displaying information indicative of disease in a blood vessel of a patient, the medical system comprising: a controller; and a display configured to display information generated by the controller; wherein the controller is configured to: receive data indicative of a distal blood pressure measured by a distal blood pressure sensor of a sensor wire or sensor catheter, receive data indicative of an aortic blood pressure measured by an aortic blood pressure sensor, generate a graph containing a trace indicative of a pressure ratio between the distal blood pressure and the aortic blood pressure over time while the distal blood pressure sensor is moved from a first position in the blood vessel to a second position in the blood vessel, identify a first region of the trace during which the pressure ratio is substantially constant over a first period of time, identify a second region of the trace during which the pressure ratio is substantially constant over a second period of time, calculate a difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace, control the display to display the graph, control the display to display, on the graph, a first indicator indicating the first region of the trace, and a second indicator indicating the second region of the trace, and control the display to display an indication of the calculated difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace.

2. The medical system of claim 1, wherein:the controller is configured to change a location and / or an extent of the first region of the trace and / or the second region of the trace based on an input received from a user via an input device.

3. The medical system of claim 1, wherein: the first indicator comprises a first label or symbol located adjacent to the first region of the trace, and the second indicator comprises a second label or symbol located adjacent to the second region of the trace.

4. The medical system of claim 3, wherein: the indication of the calculated difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace comprises a table showing the first label or symbol and the second label or symbol, along with a value of the calculated difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace.

5. The medical system of claim 1, wherein: the controller is further configured to: identify a third region of the trace during which the pressure ratio is substantially constant over a predetermined period of time, calculate a difference between the pressure ratio at the third region of the trace and the pressure ratio at the second region of the trace, calculate a difference between the pressure ratio at the third region of the trace and the pressure ratio at the first region of the trace, control the display to display, on the graph, a third indicator indicating the third region of the trace, control the display to display an indication of the calculated difference between the pressure ratio at the third region of the trace and the pressure ratio at the second region of the trace, and control the display to display an indication of the calculated difference between the pressure ratio at the third region of the trace and the pressure ratio at the first region of the trace.

6. The medical system of claim 5, wherein: the indication of the calculated difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace comprises a table showing: a first row including a first label or symbol and a second label or symbol, along with a value of the calculated difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace, a second row including the second label or symbol and a third label or symbol, along with a value of the calculated difference between the pressure ratio at the third region of the trace and the pressure ratio at the second region of the trace, and a third row including the first label or symbol and the third label or symbol, along with a value of the calculated difference between the pressure ratio at the third region of the trace and the pressure ratio at the first region of the trace.

7. The medical system of claim 1, wherein: the first indicator comprises a first color or line style of the first region of the trace, and the second indicator comprises a second color or line style of the second region of the trace, the second color or line style being different from the first color or line style.

8. The medical system of claim 1, wherein: the controller is configured to generate the graph such that the trace shows a raw pressure ratio over time.

9. The medical system of claim 1, wherein: the controller is configured to generate the graph such that the trace shows a filtered pressure ratio over time, the pressure ratio being filtered such that the trace does not indicate that the pressure ratio decreases over any given period of time.

10. The medical system of claim 1, wherein: the controller is further configured to:generate a drawing of a blood vessel that includes a constricted region corresponding to a region between the first region of the trace and the second region of the trace, wherein an extent of constriction in the constricted region is based on the calculated difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace, and control the display to display, above or below the trace, the generated drawing of the blood vessel, such that the constricted region of the blood vessel is aligned above or below the region between the first region of the trace and the second region of the trace.

11. A medical system for generating and displaying information indicative of disease in a blood vessel of a patient, the medical system comprising: a controller; and a display configured to display information generated by the controller; wherein the controller is configured to: receive data indicative of a distal blood pressure measured by a distal blood pressure sensor of a sensor wire or sensor catheter, receive data indicative of an aortic blood pressure measured by an aortic blood pressure sensor, generate a graph containing a trace indicative of a pressure ratio between the distal blood pressure and the aortic blood pressure over time while the distal blood pressure sensor is moved from a first position in the blood vessel to a second position in the blood vessel, identify a first region of the trace during which the pressure ratio is substantially constant over a first period of time, identify a second region of the trace during which the pressure ratio is substantially constant over a second period of time, calculate a difference between the pressure ratio at a trailing end of the first region of the trace and the pressure ratio at a leading end of the second region of the trace, and control the display to display the graph,control the display to display a first region ending point indicator at the trailing end of the first region of the trace, control the display to display a second region starting point indicator at the leading end of the second region of the trace, control the display to display an indication of the calculated difference between the pressure ratio at the trailing end of the first region of the trace and the pressure ratio at the leading end of the second region of the trace.

12. The medical system according to claim 11, wherein: the controller is configured to change a location of the trailing end of the first region of the trace and / or a location of the leading end of the second region of the trace based on an input received from a user via an input device.

13. The medical system according to claim 11, wherein: the indication of the calculated difference between the pressure ratio at the trailing end of the first region of the trace and the pressure ratio at the leading end of the second region of the trace comprises a numerical value of the calculated difference.

14. The medical system according to claim 11, wherein: the indication of the calculated difference between the pressure ratio at the trailing end of the first region of the trace and the pressure ratio at the leading end of the second region of the trace comprises a shape bound on a top side by the trace, on a bottom side by a horizontal line corresponding to a pressure ratio value at the trailing end of the first region of the trace, and on a right side by a vertical line corresponding to a time value at the leading end of the second region of the trace.

15. The medical system according to claim 11, wherein: the indication of the calculated difference between the pressure ratio at the trailing end of the first region of the trace and the pressure ratio at the leading end of the second region of the trace comprises a rectangle having a lower side corresponding to a pressure ratio value at the trailing end of the first region of the trace, and an upper side corresponding to a pressure ratio value at the leading end of the second region of the trace.

16. The medical system according to claim 15, wherein: the lower left corner of the rectangle is at the trailing end of the first region of the trace, and the upper right comer of the rectangle is at the leading end of the second region of the trace.

17. The medical system according to claim 11, wherein: the indication of the calculated difference between the pressure ratio at the trailing end of the first region of the trace and the pressure ratio at the leading end of the second region of the trace comprises a circle having a lowermost point corresponding to a pressure ratio value at the trailing end of the first region of the trace, and an uppermost point corresponding to a pressure ratio value at the leading end of the second region of the trace.

18. The medical system according to claim 11, wherein: the indication of the calculated difference between the pressure ratio at the trailing end of the first region of the trace and the pressure ratio at the leading end of the second region of the trace comprises a triangle having a lower side corresponding to a pressure ratio value at the trailing end of the first region of the trace, and an uppermost point corresponding to a pressure ratio value at the leading end of the second region of the trace.

19. The medical system according to claim 18, wherein: the uppermost point of the triangle is at the leading end of the second region of the trace.

20. The medical system according to claim 11, wherein: the indication of the calculated difference between the pressure ratio at the trailing end of the first region of the trace and the pressure ratio at the leading end of the second region of the trace comprises a relatively thick portion of the trace that extends between the indication of the calculated difference between the pressure ratio at the trailing end of the first region of the trace and the pressure ratio at the leading end of the second region of the trace.

21. The medical system according to claim 11, wherein: the indication of the calculated difference between the pressure ratio at the trailing end of the first region of the trace and the pressure ratio at the leading end of the second region of the trace comprises a bar located above or below the trace and having a height that is proportional to the calculated difference.

22. The medical system according to claim 11, wherein the indication of the calculated difference between the pressure ratio at the trailing end of the first region of the trace and the pressure ratio at the leading end of the second region of the trace comprises a circle located above or below the trace and having a size that is proportional to the calculated difference.

23. The medical system of claim 11, wherein: the controller is configured to generate the graph such that the trace shows a raw pressure ratio over time.

24. The medical system of claim 11, wherein: the controller is configured to generate the graph such that the trace shows a filtered pressure ratio over time, the pressure ratio being filtered such that the trace does not indicate that the pressure ratio decreases over any given period of time.

25. The medical system of claim 11, wherein: the controller is further configured to: generate a drawing of a blood vessel that includes a constricted region corresponding to a region between the trailing end of the first region of the trace and the leading end of the second region of the trace, where an extent of constriction in the constricted region is based on the calculated difference between the pressure ratio at a trailing end of the first region of the trace and the pressure ratio at a leading end of the second region of the trace, and control the display to display, above or below the trace, the generated drawing of the blood vessel, such that the constricted region of the blood vessel is alignedabove or below the region between the trailing end of the first region of the trace and the leading end of the second region of the trace.

26. A medical system for generating and displaying information indicative of disease in a blood vessel of a patient, the medical system comprising: a controller; and a display configured to display information generated by the controller; wherein the controller is configured to: receive data indicative of a distal blood pressure measured by a distal blood pressure sensor of a sensor wire or sensor catheter, receive data indicative of an aortic blood pressure measured by an aortic blood pressure sensor, generate a graph containing a trace indicative of a pressure ratio between the distal blood pressure and the aortic blood pressure over time while the distal blood pressure sensor is moved from a first position in the blood vessel to a second position in the blood vessel, identify a first region of the trace during which the pressure ratio is substantially constant over a first period of time, identify a second region of the trace during which the pressure ratio is substantially constant over a second period of time, calculate a difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace, generate a drawing of a blood vessel that includes a constricted region corresponding to a region between the first region of the trace and the second region of the trace, wherein an extent of constriction in the constricted region is based on the calculated difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace, control the display to display the graph, and control the display to display, above or below the trace, the generated drawing of the blood vessel, such that the constricted region of the blood vessel is aligned above or below the region between the first region of the trace and the second region of the trace.27 The medical system of claim 26, wherein the controller is further configured to generate a drawing of a blood vessel that includes a constricted region corresponding to a region between the first region of the trace and the second region of the trace, wherein an extent of constriction in the constricted region is based on the calculated difference between the pressure ratio at the second region of the trace and the pressure ratio at the first region of the trace.

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