Pressure-based structural cardiac assessment system and method

Abstract

The system evaluates a heart valve, such as a deployed heart valve. The system utilizes pressure sensor calibration, waveform adjustment, feature detection, and / or valve condition generation for valve evaluation. A graphical user interface displays a measure related to valve evaluation. A graphical user interface simultaneously displays two recorded graphical, physiological parameters and / or heart valve condition indicator values (e.g., gradient, regurgitation index, regurgitation ratio, etc.).

Description

[0001] Incorporation by reference of any priority application

[0002] This application claims the U.S. Provisional Patent Application Serial No. 63 / 269,770, filed on March 22, 2022, entitled “Pressure Based Structural Heart Assessment Systems and Methods,” which is incorporated herein by reference in its entirety. Technical Field

[0003] The present application relates to devices, user interfaces, algorithms, and systems associated with a structural heart guidewire configured to sense blood pressure to provide information about blood flow through a heart valve before, during, and / or immediately after a structural heart procedure. Background Art

[0004] Guidewires are known for delivering catheters to many vascular locations in the body. A combination of mechanical properties such as flexibility, pushability, and torquability facilitates access to vascular locations. Coronary procedures are known to include pressure sensors to provide information about blood flow through static occlusions to help cardiologists determine whether to treat a patient.

[0005] Although pressure sensing around static lesions in the coronary vessels is known, these ideas have not been applied to structural heart surgery, such as treating heart valves and improving the heart's pumping function. The pumping function of the heart has been addressed with various types of mechanical pumps. Heart valves have been treated in the past through open heart surgery. However, currently, heart valves are increasingly being replaced by cardiologists using catheters, and percutaneous heart valves are mounted on and delivered through a catheter. Summary of the invention

[0006] For the purpose of summarizing the present disclosure, certain aspects, benefits and novel features are discussed herein. It should be understood that not all such aspects, benefits or features will be implemented in any specific embodiment of the present invention, and the skilled person will recognize various combinations of such aspects, benefits or features from the disclosure herein.

[0007] According to one embodiment, a method is disclosed, which includes: determining a first plurality of pressure values ​​by a first pressure sensor located in a first part of the heart; determining a second plurality of pressure values ​​by a second pressure sensor located in a cardiovascular region adjacent to the first part of the heart; determining a heart rate of the heart; calculating (i) a first end-diastolic pressure (force) of the first part of the heart and (ii) a systolic pressure (force) of the first part of the heart from the first plurality of pressure values; calculating a second end-diastolic pressure of the cardiovascular region adjacent to the first part of the heart from the second plurality of pressure values; determining a reflux index, wherein determining the reflux index also includes: calculating a pressure difference between the first end-diastolic pressure and the second end-diastolic pressure; and calculating a standardized pressure difference value based at least in part on the systolic pressure and the heart rate; and displaying the reflux index in a user interface.

[0008] According to one embodiment, a method is disclosed, which includes: controlling a heart rate of a heart; determining a first plurality of pressure values ​​by a first pressure sensor located in a first part of the heart; determining a second plurality of pressure values ​​by a second pressure sensor located in a cardiovascular area adjacent to the first part of the heart; determining a reflux index based at least in part on (i) a first value from the first plurality of pressure values ​​and (ii) a second value from the second plurality of pressure values; and displaying the reflux index in a user interface.

[0009] According to one aspect, the method may further include: calculating (i) a first end-diastolic pressure of a first part of the heart and (ii) a systolic pressure of the first part of the heart from a first plurality of pressure values; and calculating a second end-diastolic pressure of a cardiovascular region adjacent to the first part of the heart from a second plurality of pressure values, wherein determining the regurgitation index is further based at least in part on the first end-diastolic pressure, the second end-diastolic pressure, and the systolic pressure.

[0010] According to another aspect, controlling the heart rate may further include pacing the ventricles of the heart to a predetermined heart rate interval.

[0011] According to another aspect, controlling the heart rate may further include administering a medication to the patient.

[0012] According to another aspect, the method may further include: calculating a time constant from the first plurality of pressure values ​​and the second plurality of pressure values; and causing the time constant to be displayed in a user interface.

[0013] According to another aspect, the regurgitation index may further include a time-integrated regurgitation index.

[0014] According to one embodiment, a method is disclosed, which includes: causing an extrasystole of the heart in which the ventricular heartbeat does not eject blood in the aorta; determining a first plurality of pressure values ​​by a first pressure sensor located in a first portion of the heart; determining a second plurality of pressure values ​​by a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart; calculating (i) a first end-diastolic pressure of the first portion of the heart and (ii) a systolic pressure of the first portion of the heart from the first plurality of pressure values; calculating a second end-diastolic pressure of the cardiovascular region adjacent to the first portion of the heart from the second plurality of pressure values; determining a regurgitation index based at least in part on the first end-diastolic pressure, the second end-diastolic pressure, and the systolic pressure; and causing the regurgitation index to be displayed in a user interface.

[0015] According to one aspect, inducing an extrasystole of the heart may further include programming a pacemaker coupled to the heart to induce the extrasystole.

[0016] According to another embodiment, a system is disclosed, comprising: a non-transitory computer storage medium configured to store at least computer-executable instructions; and one or more hardware processors in communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer-executable instructions to at least: determine a first plurality of pressure values ​​by (i) a first pressure sensor located in a first portion of the heart and (ii) a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart before a cardiac procedure; calculate a first regurgitation index from the first plurality of pressure values; determine a second plurality of pressure values ​​by (i) the first pressure sensor located in the first portion of the heart and (ii) the second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart after the cardiac procedure; calculate a second regurgitation index from the second plurality of pressure values; determine a regurgitation difference value based at least in part on the second regurgitation index and the first regurgitation index; and cause the regurgitation difference value to be displayed on a user interface.

[0017] According to one aspect, determining the reflux difference value may further include: calculating a normalized difference value by dividing (i) the difference between the second reflux index and the first reflux index by (ii) the first reflux index; and designating the normalized difference value as the reflux difference value.

[0018] According to one embodiment, a method is disclosed, which includes: determining a time series of pressure values ​​by a pressure sensor located in a portion of the heart; identifying a subset of the time series pressure values ​​corresponding to at least a portion of the diastole; calculating a first slope from the subset of the time series pressure values; identifying a first reflux index based at least in part on the first slope, wherein identifying the first reflux index also includes: searching for the first reflux index associated with the first slope; and displaying the first reflux index in a user interface.

[0019] According to one aspect, the method may further include: accessing a plurality of pressure measurements, wherein each of the plurality of pressure measurements corresponds to a patient; for each of the plurality of pressure measurements, calculating a pair including a diastolic slope and a regurgitation index from the pressure measurement; determining a correlation between the diastolic slope and the regurgitation index based at least in part on the paired diastolic slope and regurgitation index, wherein finding a first regurgitation index further includes: applying the correlation between the diastolic slope and the regurgitation index to the first slope.

[0020] According to another aspect, the portion of the heart may include at least the left ventricle, such that, for example, the first pressure sensor is positioned in the left ventricle during at least a portion of the method.

[0021] According to another aspect, calculating the first slope from the subset of the time series pressure values ​​may further include: determining a linear fit from the subset of the time series pressure values; and calculating the first slope from the linear fit.

[0022] According to another aspect, calculating the first slope from the subset of the time series pressure values ​​may further include: determining a polynomial function from the subset of the time series pressure values; and calculating the first slope from the polynomial function.

[0023] According to another aspect, calculating the first slope from the subset of the time series pressure values ​​may further include: determining an exponential function from the subset of the time series pressure values; and calculating the first slope from the exponential function.

[0024] According to one embodiment, a method is disclosed, which includes: determining a first time series pressure value by a first pressure sensor located in a first part of the heart; determining a second time series pressure value by a second pressure sensor located in a cardiovascular area adjacent to the first part of the heart; identifying a subgroup of the first time series pressure values ​​corresponding to at least a portion of the diastole; identifying a subgroup of the second time series pressure values ​​corresponding to at least the portion of the diastole; calculating (i) a first slope of the subgroup of the first time series pressure values ​​and (ii) a second slope of the subgroup of the second time series pressure values; determining a reflux index based at least in part on the first slope and the second slope; and displaying the reflux index in a user interface.

[0025] According to one aspect, the first portion of the heart may include at least the left ventricle, and a cardiovascular region adjacent to the first portion includes at least the aorta, such that, for example, during at least a portion of the method, the first pressure sensor is located in the left ventricle and the second pressure sensor is located in the aorta.

[0026] According to another aspect, the method may further include: calculating a first plurality of slopes from a subgroup of first time series pressure values, the first plurality of slopes including a first slope; calculating a second plurality of slopes from a subgroup of second time series pressure values, the second plurality of slopes including a second slope; and determining a slope angle (degrees) of each of the first plurality of slopes and the second plurality of slopes, wherein determining the reflux index further includes: determining a first statistical metric from the slope angle of each slope in the first plurality of slopes; determining a second statistical metric from the slope angle of each slope in the second plurality of slopes; calculating a combined statistical metric from the first statistical metric and the second statistical metric; and designating the combined statistical metric as the reflux index.

[0027] According to another aspect, calculating the combined statistical metric may further include adding or subtracting at least one of the first statistical metric and the second statistical metric.

[0028] According to another aspect, the method may further include: determining a first slope angle of the first slope; and determining a second slope angle of the second slope, wherein determining the regurgitation index further includes: calculating a combined slope angle from the first slope angle and the second slope angle; and designating the combined slope angle as the regurgitation index.

[0029] According to another aspect, calculating the combined slope angle may further include at least one of adding, subtracting, multiplying, or dividing the first slope angle and the second slope angle.

[0030] According to another aspect, calculating the second slope may further include: determining an initial slope from a subset of the second time series pressure values; determining a correction factor from the second time series pressure values; calculating a corrected diastolic slope from the initial slope, wherein calculating the corrected diastolic slope also includes applying the correction factor to the initial slope; and designating the corrected diastolic slope as the second slope.

[0031] According to another aspect, determining the correction factor may further include: calculating at least one of an Augmentation Index or a pressure augmentation from the second time series of pressure values; and identifying the correction factor based at least in part on one of the Augmentation Index or the pressure augmentation.

[0032] According to another embodiment, a system is disclosed, comprising: a non-transitory computer storage medium configured to store at least computer-executable instructions; and one or more hardware processors in communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer-executable instructions to at least: determine a first set of time series pressure values ​​by (i) a first pressure sensor located in a first portion of the heart and (ii) a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart before a cardiac procedure; calculate a first time constant from the first set of time series pressure values; determine a second set of time series pressure values ​​by (i) the first pressure sensor located in the first portion of the heart and (ii) the second pressure sensor located in the cardiovascular region adjacent to the first portion of the heart after the cardiac procedure; calculate a second time constant from the second set of time series pressure values; determine a time constant difference based at least in part on the first time constant and the second time constant; and cause the time constant difference to be displayed in a user interface.

[0033] According to one aspect, a first portion of the heart may include at least a left ventricle, and a cardiovascular region adjacent to the first portion includes at least the aorta, such that when the one or more hardware processors execute the computer-executable instructions, a time constant difference is determined based on a pressure value sensed by the first pressure sensor when the first pressure sensor is located in the left ventricle and a pressure value sensed by the second pressure sensor when the second pressure sensor is located in the aorta.

[0034] According to another aspect, calculating the first time constant from the first set of time series pressure values ​​may include determining a relationship τ that is essentially: Where area (P–R) 12 is an area between (i) a first time series of pressure values ​​from a first part of the heart and (ii) a second time series of pressure values ​​from a cardiovascular region adjacent to the first part of the heart and between a first time and a second time, P1 is a first pressure value at the first time from the first time series of pressure values, R1 is the first pressure value at the first time from the second time series of pressure values, P2 is a second pressure value at the second time from the first time series of pressure values, and R2 is a second pressure value at the second time from the second time series of pressure values.

[0035] According to another aspect of the method, the first time and the second time may be within a diastolic period.

[0036] According to another embodiment, a system is disclosed that includes: a non-transitory computer storage medium configured to store at least computer-executable instructions; and one or more hardware processors in communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer-executable instructions to at least: determine a set of time-series pressure values ​​from (i) a first pressure sensor located in a first portion of the heart and (ii) a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart; calculate a time constant from the set of time-series pressure values, wherein calculating the time constant further includes determining a relationship τ, substantially: Where area (P–R) 12 is an area between (i) a first time series of pressure values ​​from a first part of the heart and (ii) a second time series of pressure values ​​from a cardiovascular region adjacent to the first part of the heart and between a first time and a second time, P1 is a first pressure value at the first time from the first time series of pressure values, R1 is a first pressure value at the first time from the second time series of pressure values, P2 is a second pressure value at the second time from the first time series of pressure values, and R1 is a second pressure value at the second time from the second time series of pressure values; and causing the time constant to be displayed in a user interface.

[0037] According to one aspect of a system including a non-transitory computer storage medium, the first time and the second time may be within diastole.

[0038] According to another embodiment, a system is disclosed, comprising: a non-transitory computer storage medium configured to store at least computer-executable instructions; and one or more hardware processors in communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer-executable instructions to at least: determine a first time series of pressure values ​​by a pressure sensor located in a portion of the heart before a cardiac procedure; calculate a first time constant from the first time series of pressure values; determine a second time series of pressure values ​​by the pressure sensor located in the portion of the heart after the cardiac procedure; calculate a second time constant from the second time series of pressure values; determine a time constant difference based at least in part on the first time constant and the second time constant; and cause the time constant difference to be displayed in a user interface.

[0039] According to one aspect, the portion of the heart may include a left ventricle or an aorta, such that when one or more hardware processors execute computer-executable instructions, the determined time constant difference is based on a pressure value sensed by the first pressure sensor when the first pressure sensor is located in the left ventricle and a pressure value sensed by the second pressure sensor when the second pressure sensor is located in the aorta.

[0040] According to another aspect, wherein calculating the first time constant from the first time series of pressure values ​​comprises determining a relationship τ which is essentially: The area (P) 12 is the area between the first time and the second time below the first time series pressure value, P1 is the first pressure value at the first time from the first time series pressure value, and P2 is the second pressure value at the second time from the first time series pressure value.

[0041] According to another aspect, the first time and the second time may be in diastole.

[0042] According to another embodiment, a system is disclosed, comprising: a non-transitory computer storage medium configured to store at least computer executable instructions; and one or more hardware processors in communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer executable instructions to at least: determine a first time series of pressure values ​​by a first pressure sensor located in a first portion of the heart; determine a second time series of pressure values ​​by a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart; identify a first heartbeat and a second heartbeat from the first time series and the second time series; and identify a first characteristic of the first heartbeat based at least in part on a first characteristic of the first heartbeat. A heartbeat is associated with a first category, wherein the first category indicates that the first heartbeat has been rejected; based at least in part on a second feature of the second heartbeat, the second heartbeat is associated with a second category, wherein the second category indicates that the second heartbeat has been accepted; a reflux index is determined, wherein determining the reflux index further comprises: excluding the first heartbeat based at least in part on the first category and the rejection of the first heartbeat; accepting the second heartbeat based at least in part on the second category and the acceptance of the second heartbeat; calculating the reflux index based at least in part on (i) a first portion of a first time series associated with the second heartbeat and (ii) a second portion of a second time series associated with the second heartbeat; and displaying the reflux index in a user interface.

[0043] According to one aspect, the first characteristic of the first heartbeat may correspond to a transit time of the first heartbeat, and associating the first heartbeat with the first category based at least in part on the first characteristic may further include determining that the transit time of the first heartbeat is outside of a threshold range.

[0044] According to another aspect, the first characteristic of the first heartbeat may correspond to an elapsed time of a diastole of the first heartbeat, and associating the first heartbeat with the first category based at least in part on the first characteristic further comprises determining that the elapsed time of the diastole of the first heartbeat exceeds a threshold time.

[0045] According to another aspect, the first characteristic of the first heartbeat may correspond to a pressure of a systolic period of the first heartbeat, and associating the first heartbeat with the first category based at least in part on the first characteristic may further include determining that the pressure of the systolic period of the first heartbeat exceeds a threshold.

[0046] According to another aspect, the first portion of the heart may include the aorta or the left ventricle, such that when one or more hardware processors execute the computer-executable instructions, the calculated regurgitation index is based on a pressure value sensed by the first pressure sensor when the first pressure sensor is located in the aorta or the left ventricle.

[0047] According to another embodiment, a system is disclosed, comprising: a non-transitory computer storage medium configured to store at least computer-executable instructions; and one or more hardware processors in communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer-executable instructions to at least: receive a first set of time-series pressure values ​​by (i) a first pressure sensor located in a first part of the heart and (ii) a second pressure sensor located in a cardiovascular region adjacent to the first part of the heart during a first time period; calculate a first regurgitation index from the first set of time-series pressure values; receive a second set of time-series pressure values ​​by (i) the first pressure sensor located in the first part of the heart and (ii) the second pressure sensor located in the cardiovascular region adjacent to the first part of the heart during a second time period; calculate a second regurgitation index from the second set of time-series pressure values; and cause display in a user interface: a first set of graphs of the first set of time-series pressure values, a first visual representation of the first regurgitation index on the first set of graphs, a second set of graphs of the second set of time-series pressure values, and a second visual representation of the second regurgitation index on the second set of graphs.

[0048] According to another embodiment, a system is disclosed, comprising: a non-transitory computer storage medium configured to store at least computer-executable instructions; and one or more hardware processors in communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer-executable instructions to at least: receive a first set of time-series pressure values ​​by (i) a first pressure sensor located in a first portion of the heart and (ii) a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart during a first time period; calculate a first hemodynamic parameter from the first set of time-series pressure values; receive a second set of time-series pressure values ​​by (i) the first pressure sensor located in the first portion of the heart and (ii) the second pressure sensor located in the cardiovascular region adjacent to the first portion of the heart during a second time period; calculate a second hemodynamic parameter from the second set of time-series pressure values; and cause to be displayed in a user interface: a first set of graphs of the first set of time-series pressure values, a first visual representation of the first hemodynamic parameter, a second set of graphs of the second set of time-series pressure values, and a second visual representation of the second hemodynamic parameter.

[0049] According to one aspect, the first time period can correspond to before a cardiac procedure and the second time period can correspond to after the cardiac procedure.

[0050] According to another aspect, the cardiac procedure may include a balloon aortic valvuloplasty (BAV) procedure or a prosthesis insertion procedure.

[0051] In various embodiments, a system and / or computer system is disclosed, which includes a computer-readable storage medium having program instructions implemented therethrough; and one or more processors configured to execute the program instructions so that the one or more processors perform operations including one or more aspects of the above and / or following embodiments (including one or more aspects of the appended claims).

[0052] In various embodiments, a computer-implemented method is disclosed in which one or more aspects of the above and / or below described embodiments (including one or more aspects of the appended claims) are implemented and / or performed by one or more processors executing program instructions.

[0053] In various embodiments, a computer program product is disclosed that includes a computer-readable storage medium having program instructions implemented therein, the program instructions being executable by one or more processors to cause the one or more processors to perform operations including one or more aspects of the above-described and / or below-described embodiments (including one or more aspects of the appended claims). BRIEF DESCRIPTION OF THE DRAWINGS

[0054] These and other features, aspects and benefits are described below with reference to the accompanying drawings, which are intended to be for illustrative purposes only and should not be interpreted in any way as limiting the scope of the embodiments. In addition, the various features of the different embodiments disclosed can be combined to form additional embodiments, which are part of the present disclosure. In the accompanying drawings, the same reference characters represent features that correspond consistently throughout similar embodiments. The following is a brief description of each figure.

[0055] Figures 1A-1F is a schematic diagram of a pressure guidewire deployed within the heart.

[0056] Figure 2A is a schematic diagram of a system including a console and a guidewire configured to facilitate delivery of a structural heart device.

[0057] Figure 2B Can be incorporated Figure 2A A plan view of the coiled distal tip of the pressure sensing guidewire of the system.

[0058] Figure 2C is a transverse cross-sectional view of a system including an aortic pigtail catheter and a TAVR delivery system guide catheter.

[0059] Figure 2D is a transverse cross-sectional view of a system including a guide catheter for a TMVR delivery system.

[0060] Figure 2E is an illustration of another system including a console for facilitating delivery of a structural heart device.

[0061] Figure 3 yes Figure 2B A schematic diagram of a variation of a pressure sensing guidewire is shown.

[0062] Figure 4 yes Figure 2B A cross-sectional view of another variation of a pressure sensing guidewire is shown.

[0063] Figure 5 yes Figure 2B A schematic diagram of another variation of a pressure sensing guidewire is shown.

[0064] Fig. 6A yes Figure 2B A cross-sectional view of another variation of a pressure sensing guidewire is shown.

[0065] Figure 6B yes Figure 2B A cross-sectional view of another variation of a pressure sensing guidewire is shown.

[0066] Figure 6C yes Figure 2BA cross-sectional view of another variation of a pressure sensing guidewire is shown.

[0067] Figure 7 yes Figure 2B A schematic diagram of another variation of a pressure sensing guidewire is shown.

[0068] Figure 8 yes Figure 2B A schematic diagram of another variation of a pressure sensing guidewire is shown.

[0069] Fig. 9 yes Figure 2B A cross-sectional view of another variation of a pressure sensing guidewire is shown.

[0070] Figures 10A-10E It is the user interface of the Heart Valve Assessment System.

[0071] Figures 11A-11E It is an additional user interface of the Heart Valve Assessment System.

[0072] Fig.12 It is the configuration user interface of the Heart Valve Assessment System.

[0073] Fig.13 It is a flowchart of the user interface generation process.

[0074] Fig.14 is a diagram of the heart valve assessment system.

[0075] Fig.15 is a flow chart of the heart valve evaluation process.

[0076] Fig.16 is a flow chart of the calibration process.

[0077] Fig.17 This is an example waveform analysis diagram.

[0078] Fig.18 are additional example waveforms and / or example waveform analysis graphs.

[0079] Fig.19 is a flow chart of the calibration process.

[0080] Figure 20-26 are graphs of additional example waveforms and / or example waveform analyses.

[0081] Fig. 27 is a flow chart of another calibration process.

[0082] Fig.28 is a flow chart of an additional heart valve evaluation process.

[0083] Fig.29is another diagram of a heart valve assessment system in which the various methods and systems discussed herein may be implemented. DETAILED DESCRIPTION

[0084] The present application relates to systems and methods for providing pressure curves during cardiac procedures, including valvuloplasty procedures, transcatheter aortic valve replacement (TAVR) procedures (sometimes also referred to as transcatheter aortic valve implantation (TAVI) procedures), transcatheter mitral valve replacement (TAMR) procedures, and other catheter-based procedures. The system and method can be used to assist cardiologists in completing key aspects of structural heart procedures. The embodiments herein can be used to convey the condition of a heart valve immediately before, during, and / or after the deployment of a structural heart device (such as an aortic valve, mitral valve, or other heart valve) through a user interface output (e.g., graphically). The embodiments herein can be used to convey the condition of a heart valve long after the deployment of such a device. The embodiments herein can be used to convey the properties of blood flow through a heart valve before, during, and / or after (e.g., immediately or long after) the deployment of a structural heart device such as an aortic valve, mitral valve, or other heart valve. The embodiments described herein can simultaneously display two recorded graphs, physiological parameters, and / or values ​​indicating the condition of a heart valve (e.g., gradient, regurgitation index, regurgitation ratio, etc.). For example, a first record may be of a patient before a procedure, and a second record may be of the same patient after a procedure. As another example, a first record may be from a first portion of a procedure, and a second record may be from a second portion of the procedure. The new display may provide an intuitive and / or immediate sense of the patient's condition to simplify and expedite the procedure and increase its success rate. Further discussion of user interface outputs may be found in Section III of this application.

[0085] The pressure measurements obtained from the systems and methods described herein can be used to calculate a heart valve or blood flow index, such as a valve regurgitation index or a pressure gradient across a native heart valve, a previously placed replacement heart valve, or a currently implanted replacement heart valve. The valve regurgitation index and pressure gradient enable a cardiologist to size a heart valve. During systole, a higher pressure gradient across the aortic valve (or lower pressure within the aorta) may indicate more severe valve calcification. A lower end-diastolic regurgitation index may indicate more severe regurgitation. Further discussion of such calculations may be found in Sections III and IV of this application.

[0086] I. Instance Methods

[0087] Figures 1A-1FVarious methods of accessing the heart during a structural heart procedure are illustrated. One of the pressure guidewire 30 or the pressure sensing device (e.g., the pigtail catheter 10 or the access catheter 20) can be used to calculate an upstream pressure curve (with respect to flow), and the other of the pressure guidewire 30 or the pressure sensing device can be used to calculate a downstream pressure curve (with respect to flow). Although certain methods are described below with respect to specific heart valves and access routes, similar systems can be used to evaluate other valves, such as the tricuspid valve or the pulmonary (arterial) valve. In addition, although specific examples may refer to a pressure sensing guidewire, a pressure sensing device, or a pigtail catheter, it should be understood that the device can be any elongated structure having a similar structure and / or function, such as a guidewire, a pigtail catheter, a diagnostic catheter, or a guide catheter.

[0088] Figure 1A Systems and methods for measuring the performance of an existing or replacement aortic heart valve are illustrated. The existing heart valve may be a natural but diseased valve or a previously implanted replacement heart valve (which is being evaluated in a subsequent procedure). As shown, the pigtail catheter 10 may be located downstream of the treatment site, such as in the aorta A downstream of the aortic valve, to provide a downstream pressure curve. The pigtail catheter 10 may also be used to deliver contrast media to facilitate visualization of the treatment site. The access catheter 20 may be delivered to the heart from the same or different access site as the pigtail catheter 10. The access catheter 20 or a separate delivery catheter exchanged with the access catheter 20 may be used to advance a pressure guidewire 30. The pressure guidewire 30 may be used to advance a valve dilation balloon, a replacement valve, and / or other devices to the treatment site. The pressure guidewire 30 may be extended through the access catheter 20 to a position upstream of the treatment site, such as in the left ventricle LV, to provide an upstream pressure curve. The pressure guidewire 30 may include a pressure sensor 40 at any location along the distal segment of the pressure guidewire 30, such as within the curved portion of the guidewire 30 (sometimes referred to herein as the atraumatic curvature), at the transition to the atraumatic curvature, or proximal to the atraumatic curvature (see Figure 2B Prior to entering the heart, access is provided using an arterial approach (eg, femoral or radial access). Figure 1B Example with Figure 1A A similar configuration, except that one or both of the pigtail catheter 10 and / or the access catheter 20 can be used to provide a pressure reading (result) by utilizing external pressure sensing. The catheter 20 can achieve a measurement of downstream pressure, similar to the pressure read by the pressure guidewire 30. This configuration can be used to equalize the external pressure sensor with the pressure guidewire. Alternatively, any other delivery catheter exchanged with the access catheter can be used to provide a downstream pressure curve. In some cases, the downstream pressure output can be received by a console, which can be coupled (coupled) with the pressure signal of one or both of the pigtail catheter 10 and the access catheter 20.

[0089] Equalizing the pressure readings between the downstream and upstream pressure sensing devices can be very important. Equalization can be done in terms of pressure accuracy (gain and offset), but can also be done in terms of the phase delay between the two pressure curves. For example, pressure readings can be taken from downstream and upstream pressure sensing devices in the same general anatomical region, and the pressure measurements can be adjusted manually or automatically for the phase delay between the two pressure curves. Figure 1B As shown, equalized pressure measurements can be obtained from the left ventricle LV. In this method, the downstream pressure output is provided by the access catheter 20, and the upstream pressure output is provided by the pressure guidewire 30. The sensing portion (sensing feature) of the access catheter 20 (e.g., the distal end of the fluid column in the catheter 20) is advanced adjacent to the sensing portion of the pressure guidewire 30. The sensing portions of the access catheter 20 and the pressure guidewire 30 can be confirmed to be located in the left ventricle LV. The sensing portions of the access catheter 20 and the pressure guidewire 30 can be confirmed to be located in similar locations in the left ventricle LV.

[0090] Figure 1C Example with Figure 1A A similar configuration is provided, except that the pressure sensor 40 is located proximal to the atraumatic bend of the pressure guidewire 30. For example, the sensing portion of the pigtail catheter 10 (e.g., the distal end of the fluid column in the catheter 10) is advanced adjacent to the sensor 40 or other pressure sensing portion of the pressure guidewire 30. The pigtail catheter 10 and the sensing portion of the pressure guidewire 30 can be confirmed to be located in the aorta A. In this configuration, pressure equalization can be performed in the aorta A. After pressure equalization, the pressure guidewire 30 can be advanced into the left ventricle LV to provide an upstream pressure curve, while the pigtail catheter 10 remains in the aorta A to provide a downstream pressure curve.

[0091] exist Figure 1D In the embodiment, the pigtail catheter 10 can be positioned in the aorta A to provide a downstream pressure curve. In the present embodiment, the pressure guidewire 30 extends through the pigtail catheter 10 to provide an upstream pressure curve. In this configuration, pressure equalization can be performed in the aorta A. For example, the sensing portion of the pressure guidewire 30 can be advanced to the end of the fluid column in the pigtail catheter 10 or just distal to it. The signals of the sensing portion of the pressure guidewire 30 and the fluid column can be compared to equalize them (as further discussed in Part IV below). After pressure equalization, the pressure guidewire 30 can be removed from the aortic pigtail and inserted into the left ventricle through the access catheter 20, while the pigtail catheter 10 remains in the aorta A to provide a downstream pressure curve.

[0092] The system described herein can also be used to measure the performance of an existing or replacement mitral valve. For example, as shown in FIG. IE, the access catheter 20 can be advanced through the venous vascular system, such as through the inferior vena cava or the superior vena cava VC, such as from the femoral artery approach to the right atrium RA. Then, the access catheter 20 can be advanced through the atrial septum to a position in the left atrium LA. In some variations, the access catheter 20 can be configured to provide access through a patent foramen ovale, or can be configured to follow a guidewire or device that provides such access. The access catheter 20 or a separate delivery catheter exchanged with the access catheter 20 can be used to advance a valve expansion balloon, a replacement valve, and / or other devices to a treatment site. The pressure guidewire 30 can extend through the catheter 20 to the left ventricle LV. The catheter 20 can provide a pressure signal that can be used to generate an upstream pressure curve, while the pressure guidewire 30 can provide a pressure signal that can be used to generate a downstream pressure curve. Alternatively, any other delivery catheter exchanged with the access catheter can be used to provide an upstream pressure curve.

[0093] Similar systems can be used for apical approaches to aortic or mitral valve procedures. Figure 1F As shown, the access catheter 20 can access the left ventricle LV through the apex P of the heart. A separate device (not shown) can be used to open a path through the apex P. The access catheter 20 can be advanced through such a device. The access catheter 20 or a separate delivery catheter exchanged with the access catheter 20 can be used to advance a valve dilation balloon, a replacement valve, and / or other devices to the treatment site. In an aortic valve procedure, a pressure guidewire 30 can be extended to the aorta A through the access catheter 20. The access catheter 20 can provide a pressure signal that can be used to calculate an upstream pressure curve, and the pressure guidewire 30 can provide a signal that can be used to calculate a downstream pressure curve. Alternatively, any other delivery catheter exchanged with the access catheter can be used to provide the upstream pressure curve.

[0094] although Figure 1F An aortic valve assessment or procedure is shown via the apex P of the heart, but the pressure guidewire 30 can be advanced through the mitral valve M so that its sensing portion is in the left atrium. In this way, the pressure guidewire can provide a pressure signal that can be used to calculate the left atrial pressure curve (the proximal or upstream pressure curve in terms of flow). The access catheter 20 can generate a pressure signal that can be used to calculate the left ventricular pressure curve (the distal or downstream pressure curve in terms of flow).

[0095] During a valve dilation procedure (sometimes referred to as valvuloplasty) or a valve implantation procedure, the natural circulation through the heart valve may be blocked by a valvuloplasty balloon, a valve replacement delivery system, or other therapeutic device. However, when the heart is pumping, pressure from the left ventricle (LV) or myocardial compression may push the therapeutic device back to the aorta A, making it difficult to properly position the therapeutic device. Rapid pacing or defibrillation of the left ventricle LV can reduce the pressure gradient between the aorta A and the left ventricle LV and the myocardial force, and allow the clinician to complete the procedure. Conventional rapid pacing may involve the introduction of a temporary pacemaker into the heart, but this usually requires a separate access point, such as a venous access point. A temporary pacemaker may also puncture the heart, causing other complications. Instead, a pressure guidewire 30 may be used for rapid pacing. As described above, the pressure guidewire 30 may be introduced through the same access point as the access catheter 20 or other delivery catheter, which reduces the total number of access points. The current may be delivered to the proximal segment pressure guidewire and transmitted to the distal segment of the pressure guidewire through the connecting tube and / or the core wire, as described in further detail below. The access catheter 20 or other delivery catheter can isolate at least the middle section of the rapid pacing pressure guidewire 30 from the patient to prevent the loss of current through the access to the ventricle. Alternatively or additionally, the pressure guidewire 30 can include an isolation portion to isolate the pressure guidewire 30. Figure 2B As shown, the distal segment of the pressure guidewire may include a bend that allows the current to contact the ventricular wall at multiple locations.

[0096] II. Overview of Pressure Wire Systems and Their Uses

[0097] Figure 2A A diagnostic system 200 is illustrated that may be used to monitor a patient's vasculature. The diagnostic system 200 is configured to determine whether the extent of valve damage is significant enough to indicate that balloon dilation (eg, valvuloplasty), valve replacement, or other catheter intervention should be performed.

[0098] The diagnostic system 200 may include a monitor assembly 204 configured to couple to a pressure guidewire 208. The diagnostic system 200 may include a connection (represented by dashed line A) that facilitates connection and disconnection of the pressure guidewire 208 to the monitor assembly 204. Connection and disconnection to the monitor assembly 204 may be used to allow a clinician to initially assess the effects of a heart valve injury using the pressure guidewire 208. The pressure guidewire 208 may also be used to deliver a therapeutic device, such as a balloon catheter or a valve delivery system.

[0099] Fiber optic interface cable 202 can be used to connect pressure guide wire 208 to monitor assembly 204 via handle 207. In some embodiments, system 200 receives input from a tubular catheter body for accessing a vascular system. For example, access catheter 20 can be an access catheter. The pressure sensing of access catheter 20 or the distal tip of the pressure sensing in access catheter 20 can be positioned adjacent to the treatment site, so that a pressure signal corresponding to the pressure of the first side of the treatment site (e.g., in the aorta) can be obtained. This pressure measurement result is sometimes referred to as Pa in this article. In other configurations, system 200 may include a pressure sensing device, such as a pigtail catheter, which is delivered separately from the pressure guide wire to obtain Pa.

[0100] The pressure guidewire 208 can take any suitable form. For example, the pressure guidewire 208 can include a proximal segment having a proximal end located outside the patient's body and a distal end that can be advanced into the vascular system through the access catheter 20. The pressure guidewire 208 can be configured to be flexible to navigate in a tortuous vascular system while maintaining structural integrity for pushability and twistability. For example, at least the proximal segment of the pressure guidewire 208 can be supported by a connecting tube and / or a core for structural integrity, while the distal segment of the pressure guidewire 208 can be shaped to include a non-invasive curved portion 250 (such as Figure 2B The coiled end shown in the figure) can be provided to provide greater flexibility and prevent puncture. In other configurations, the curved distal segment can be joined to the pressure guide wire 208 to provide an atraumatic bend 250.

[0101] Any sensing method can be used. For example, an optical sensor can be configured to sense pressure when exposed to blood. The optical sensor can be disposed in the internal space of the pressure guide wire 208 and communicated with the external fluid of the pressure guide wire 208. The sensor can be an optical or electrical pressure sensor. The sensor can be selectively arranged to communicate with the monitor assembly 204-through a pressure wire lead (pressure wire lead(s)) disposed between the sensor and the proximal end of the pressure guide wire 208. The pressure wire lead (one or more) can be an optical fiber or an electrical wire (electrical wire).

[0102] like Figure 2BAs shown, the pressure sensor can be located anywhere along the distal segment of the pressure guidewire 208. For example, the pressure sensor can be positioned at position 206D near the distal-most tip of the guidewire, at position 206C along the guidewire bend 250, at position 206B at the transition portion of the guidewire bend 250, or at position 206A proximal to the guidewire bend 250. For example, position 206C can be at about 270 degrees around the bend 250 from the straight region of the pressure guidewire (near position 206A), and position 206D can be at about 540 degrees around the bend from the straight region of the pressure guidewire. However, the pressure sensor can be located anywhere in the curved distal region of the pressure guidewire, for example between about 0 degrees to about 90 degrees, including about 0 degrees and about 90 degrees, between about 90 degrees to about 180 degrees, including about 90 degrees and about 180 degrees, between about 180 degrees to about 270 degrees, including about 180 degrees and about 270 degrees, between about 270 degrees to about 360 degrees, including about 270 degrees and about 360 degrees, between about 360 degrees to about 450 degrees, including about 360 degrees and about 450 degrees, or between about 450 degrees to about 540 degrees, including about 450 degrees and about 540 degrees.

[0103] When the distal portion is coiled, the pressure sensor can be positioned at about 270 degrees along the curved portion 250 from the straight segment of the pressure guidewire 208. The position of the pressure sensor in the distal segment of the guidewire can affect the accuracy of the pressure measurement results. For example, when the pressure sensor is in the more distant position 206C, 206D, the pressure sensor can be more centrally positioned in a chamber of the heart, such as the left ventricle LV, and away from the chamber wall. In addition, at the more distant position 206C, 206D, the pressure sensor is less likely to be blocked by an access catheter or other delivery catheter during a valvuloplasty or heart replacement procedure. At the more proximal position 206A, 206B, the pressure measurement results will be obtained closer to the heart valve, but can be equalized in the aorta A while keeping the distal tip of the pressure guidewire 208 in the left ventricle LV. In some procedures, the manipulation of the pigtail catheter or other pressure sensing device required for equalization in the aorta A is less. For example, during the aortic valve procedure, the pigtail catheter has been positioned in the aorta. Although the pressure sensor may be proximal to the bend 250, the pressure sensor is distal enough to obtain pressure measurements distal to the heart valve. The distal tip of the pressure guidewire 208 is left within the left ventricle LV, maintaining access to the left ventricle LV.

[0104] Figure 2CA cross-section of a TAVR system within a patient's descending aorta is illustrated, with anatomical structures removed for clarity. The TAVR system may be used in conjunction with a monitor display 204. For example, a pressure guidewire 208 extends through an access catheter 210 and / or other sheaths such as a delivery system 212. The same access catheter 210 may be used to advance the delivery system 212 over the pressure guidewire 208. The delivery system 212 may be used to advance a valve replacement or other therapeutic device. Other configurations are also possible. For example, the catheter of the access catheter 210 may be exchanged with the delivery system 212 and then advanced over the pressure guidewire 208. As shown, the pressure sensing device for providing a pressure signal of aortic blood pressure is an aortic pigtail catheter 214 that is delivered separately from the access catheter 210. For more details on the relative positions of the aortic pigtail catheter and the pressure guidewire, see Figures 1A-1C Access catheter 210 may be similar to access catheter 20 and advanced over pressure guidewire 208 after access catheter 20 has been removed.

[0105] In other configurations, the access catheter 210 or delivery system 212 may be used to obtain a pressure signal of aortic blood pressure and may therefore be a pressure sensing device for aortic pressure. Figure 2D As shown, for mitral valve replacement, access catheter 211 can be a pressure sensing device. Pressure guidewire 208 extends through access catheter 211. Access catheter can be removed and exchanged for delivery system 213 by advancing delivery system 213 over pressure guidewire 208. Delivery system 213 can be used to deliver a mitral valve or other replacement or therapeutic device.

[0106] Figure 2E A portion of another diagnostic system 251 is illustrated. Figure 2E The diagnostic system 251 may be similar to Figure 2A Diagnostic system 200. Figure 2E The diagnostic system 251 may include a monitor assembly 254 configured to be coupled to the pressure guidewire 208 (not shown). Figure 2E The monitor component 254 may be similar to Figure 2A Monitor component 204.

[0107] a. Pressure guide wire based on wire material

[0108] Figure 3 and Figure 4 Different pressure guidewires 308, 408 that can be used for any of the above methods are illustrated. Numbers used to identify features of pressure guidewire 308 are incremented by a factor of one hundred (100) to identify similar features of pressure guidewire 408. This numbering convention generally applies to the remaining figures. Any components of pressure guidewires 308, 408 can be interchanged.

[0109] In general, the pressure guidewire 308, 408 includes an outer tube 310, 410 defining an inner lumen, a core wire 316, 416 extending at least partially through the inner lumen of the outer tube 310, 410, a pressure sensor assembly 318, 418 disposed within the inner lumen of the outer tube 310, 410, and / or a distal tip 432. The pressure guidewire 308 may also include a distal tip that may be the same or similar to the tip 432 or any other tip disclosed herein. The outer diameter of the pressure guidewire 308, 408 may be uniform or substantially uniform along substantially the entire or entire working length of the pressure guidewire 308, 408. For example, the outer diameter of the pressure guidewire 308 may be uniform or substantially uniform along the entire working length - excluding the distal tip 432 or the atraumatic bend 250. The pressure guidewire 308, 408 may include an outer diameter of up to 0.035 inches, such as between 0.018 inches and 0.035 inches. In some configurations, the distal portion of the pressure guidewire 308, 408 may form an atraumatic bend 250, such as Figure 2B The coiled portion is shown. In other configurations, the distal portion of the pressure guidewire 308, 408 can remain straight from at least the pressure sensor of the pressure sensor assembly to the distal tip of the pressure guidewire.

[0110] Figure 3 310 is a schematic diagram of a variation of the pressure sensing guidewire 308. As shown, at least the distal portion of the outer tube 310 can be coiled. For example, the coil portion 312 can be a flat ribbon coil or a rounded coil. The coil portion 312 can extend as follows: along most of the working length of the pressure guidewire 308, along substantially the entire working length of the pressure guidewire 308, or along the entire working length of the pressure guidewire 308. In the case of a significant length of the outer tube 310 being coiled, the coil portion 312 provides sufficient flexibility and softness to avoid any trauma (e.g., puncture and / or cutting) during use. The coil portion 312 also promotes safety in the event of a distal tip failure. The coil portion 312 can also ensure electrical contact with the heart when pacing rapidly.

[0111] like Figure 3 As shown, at least the proximal portion 328 of the core wire 316 can be concentric with the outer tube 310 and extend through at least a portion of the lumen of the outer tube 310. For example, the core wire 316 can extend along most of the working length of the pressure guide wire 308, along substantially the entire working length of the pressure guide wire 308, or along the entire working length of the pressure guide wire 308. The core wire 316 provides sufficient rigidity for the pressure guide wire 308 to achieve pushability and prevent kinking. It also provides sufficient rigidity to support the delivery catheter during valve implementation.

[0112] At least a portion of the core wire 316 may include a reduced diameter portion 326 to provide space for the pressure sensor 322 within the lumen of the outer tube 310. For example, Figure 3 As shown, the reduced diameter portion 326 may be tapered toward the distal end of the pressure guidewire 308. The transition between the proximal portion 328 of the core wire 316 and the reduced diameter portion 326 may be located at the atraumatic bend 250 ( Figure 2B The core wire 316 will extend proximally of at least a portion or all of the non-invasive curved portion 250 of the pressure guide wire 308 to facilitate a flexible transition to the non-invasive curved portion 250 of the pressure guide wire 308. The core wire 316 will continue to extend through at least a portion of the non-invasive curved portion 250. This flexible transition acts as a force absorber and ensures that no kinks are formed in the proximal segment of the non-invasive curved portion 250 of the pressure guide wire 308. Kinks can complicate procedures such as advancing another catheter over the guide wire 308 or removing the guide wire 308 from the patient's body without trauma.

[0113] The proximal portion 328 of the core wire 316 may include an outer diameter of up to 0.03 inches, such as between 0.015 inches and 0.03 inches. The reduced diameter portion 326 of the core wire 316 may include an outer diameter that is less than one-third or one-quarter of the outer diameter of the proximal portion 328 of the core wire 316. For example, the reduced diameter portion 326 of the core wire 316 may include an outer diameter that is less than 0.01 inches or less than 0.0075 inches.

[0114] The core wire 316 may include a conductive material such as stainless steel to provide a conductive path for the current applied to the guide wire 308 in conjunction with the above-described rapid pacing techniques. The proximal end of the core wire 316 may be exposed from the proximal end of the outer tube 310 to connect to the monitor display 204 and / or to a current generator. Less than 10% or less than 5% of the length of the core wire 316 may be exposed from the proximal end of the outer tube 310 to connect to a current source for rapid pacing.

[0115] The pressure sensor assembly 318 may include a pressure sensor 322 and one or more pressure wire leads 320 extending from the pressure sensor 322. The pressure wire leads 320 may extend along the core wire 316. For example, the pressure sensor 322 may be an optical or electrical sensor, a membrane-based sensor, a MEMS sensor, or other device capable of generating a signal in response to pressure levels or fluctuations. The one or more pressure wire leads 320 may be optical fibers or electrical wires. Figure 3 As shown, the pressure sensor assembly 318 may also include a sensor housing 324, which is disposed on the pressure sensor 322 and positioned between the outer tube 310 and the core wire 316. The sensor housing 324 may include a ring-like or short tubular member or cylinder in which the membrane is supported. The sensor housing 324 may enhance handling during assembly in the coil portion 312.

[0116] The pressure sensor assembly 318 can be radially disposed between the core wire 316 and the outer tube 310, wherein the pressure sensor 322 is radially disposed between the reduced diameter portion 326 of the core wire 316 and the coil portion 312 of the outer tube 310. At least a portion of the pressure sensor assembly 318 can be off-axis relative to the longitudinal axis L of the pressure guidewire 308. In some configurations, the entire pressure sensor assembly 318 can be off-axis relative to the longitudinal axis L of the pressure guidewire 308.

[0117] The pressure sensor 322 can be exposed to blood or other fluids through the spacing or gap 314 in the coil portion 312. However, in other variations, the outer tube 310 may include a sensor housing segment having one or more openings to expose the pressure sensor 322 to blood or other fluids. The sensor housing segment can be harder than the rest of the coil portion 312. For example, the sensor housing segment can be a metal tube that divides the coil portion 312 into two segments. The sensor housing segment can be mounted to the distal portion of the first coil segment of the coil portion 312 and the proximal portion of the second coil segment of the coil portion 312. As another example, the coil portion 312 may include two coils that are welded together to produce a hardened segment.

[0118] At least a portion of the pressure guidewire 308 may be covered by a lubricated insulator, such as a polymer layer, such as PTFE. The insulator may secure one or more pressure wire leads 320 in place. The insulator may also electrically isolate the core wire 316 from the patient along the length of the insulator when rapid pacing is induced through the core wire 316. The insulator may replace the need for a separate catheter to electrically isolate the pressure guidewire 308.

[0119] Figure 4Another variation of the pressure guidewire 408 is illustrated. The pressure guidewire 408 may include any features described with respect to the pressure guidewire 308. In this variation, the distal portion of the outer tube 410 may be formed by the coil portion 412. The proximal portion of the outer tube 410 may be formed by the connecting tube 430. The connecting tube 430 may include a conductive material to facilitate rapid pacing. For example, the connecting tube 430 may be formed with a metal structure such as a stainless steel tube. The connecting tube 430 is not covered with a coating or other isolator to achieve rapid pacing. In some configurations, the current may flow through one or more pressure wire leads 420, optionally or additionally. The connecting tube 430 may be directly or indirectly connected to the coil portion 412 and / or the distal tip 432. For example, the coil portions 412, 414 may be indirectly connected to the connecting tube 430 via an isolating portion. The isolating portion may provide isolation from the patient and may therefore be the length of the isolating body portion 434 in some embodiments. The isolating body portion 434 may isolate the patient from the core wire 416. In some configurations, the separator portion 434 can include a polymer layer, such as PTFE.

[0120] At least one non-reduced diameter portion of the core wire 416 can be concentric with the outer tube 410. The core wire 416 can extend through at least the coil portion 412. In addition, the core wire 416 can also extend through the spacer portion 434 of the outer tube 410 and / or at least a portion of the connecting tube 430. For example, the proximal end of the core wire 416 can be sealed to the distal end of the connecting tube 430 (e.g., using an adhesive 436) and extend distally from the distal end of the connecting tube 430.

[0121] Core wire 416 may include any features of core wire 316. For example, a distal portion of core wire 416 may include reduced diameter portion 426. The proximal end of coil portion 412 may be distal to the transition between non-reduced diameter portion 428 and reduced diameter portion 426 of core wire 416.

[0122] The pressure sensor assembly 418 can be radially disposed between the core wire 416 and the outer tube 410, wherein the pressure sensor 422 is radially positioned between the reduced diameter portion 426 of the core wire 416 and the coil portion 412. At least a portion of the pressure sensor assembly 418 can be off-axis relative to the longitudinal axis L of the pressure guidewire 408. For example, a first segment 438a of at least one pressure wire lead 420 can be concentric with the outer tube 410, and a second segment 438b of the pressure wire lead 420 can be off-axis relative to the longitudinal axis of the outer tube 410. The outer tube 410 can include an opening 440 to allow the pressure wire lead 420 to transition from a first segment 438a concentric with the outer tube 410 to a second segment 438b off-axis relative to the longitudinal axis of the outer tube 410. The opening 440 can be partially cut away in thickness, or extend through the full thickness of the outer tube 410. If the opening 440 extends through the full thickness of the outer tube 410, the opening 440 can be sealed (e.g., with an adhesive 436) to prevent blood or other fluids from flowing into the pressure guidewire through the opening 440. Figure 4 As shown, the opening 440 is provided in the connecting tube 430. However, in other configurations, the opening 440 may be provided in the isolator portion 434.

[0123] In lieu of opening 440, core wire 416 may be sized or offset relative to the longitudinal axis of pressure guidewire 408 to allow pressure wire lead 420 to transition from a first segment 438a that is concentric with outer tube 410 to a second segment 438b that is off-axis relative to the longitudinal axis of outer tube 410. Core wire 416 may have a groove on one side that is configured to receive the span of pressure wire lead 420 so that the lead may transition from first segment 438a to second segment 438b.

[0124] The pressure guide wire 408 may include a distal tip 432 that is rounded to form an atraumatic tip. For example, the distal tip 432 may have a hemispherical shape. The tip 432 may also reduce or even prevent unwanted foreign matter from entering through the distal end of the pressure guide wire 408.

[0125] In some configurations, the distal tip 432 is a separate component that is adhered, welded and / or otherwise joined to the coil portion 412 and / or the core wire 416. The distal tip may be joined to the inner surface of the coil portion 412 and / or the most distal edge of the coil portion 412. The core wire 416 may be bent up to 180 degrees in the outer tube 410 to strengthen the adhesive bonding with the distal tip 432. In other configurations, the distal tip 432 may be the expanded distal end of the core wire 416 at the distal end of the diameter reduction portion 426. The distal end of the core wire 416 may be adhered, welded and / or otherwise joined to the inner surface and / or the most distal edge of the coil portion 412. In one method, the distal tip 432 is formed by converting the expanded section of the core wire 416 into a hemispherical member. The expanded section may be melted to form a hemispherical member. The hemispherical member may be joined to the distal portion of the coil portion 412. In either of these configurations, the atraumatic portion of the distal tip 432 may be formed by the core wire 416, adhesive, and / or weld.

[0126] b. Tube-based pressure guidewire

[0127] Figures 5 to 9 Further variations of pressure guidewires that can be used in any of the above methods are illustrated. The pressure guidewires described below may include any of the features of the pressure guidewires 308, 408 described above. In general, Figures 5 to 9 The pressure guidewire shown includes an outer tube defining an inner lumen, a connecting tube located radially inwardly of the outer tube, a pressure sensor assembly disposed within the inner lumen of the outer tube, and / or a distal tip. The outer diameter of the pressure guidewire can be uniform or substantially uniform along substantially the entire or entire working length of the pressure guidewire. For example, the outer diameter of the pressure guidewire can be uniform or substantially uniform along the entire working length - excluding the distal tip or ground bend. The pressure guidewire may include an outer diameter of up to 0.035 inches, for example between 0.018 inches and 0.035 inches. In some configurations, the distal portion of the pressure guidewire can be formed as Figure 2B Atraumatic curve 250 is shown. In other configurations, the distal portion of the pressure guidewire can remain straight.

[0128] The connecting tube may include an inner diameter that may be less than one-third or one-quarter of the outer diameter of the connecting tube. For example, the connecting tube may include an outer diameter of up to 0.035 inches, such as between 0.018 inches and 0.035 inches, and an inner diameter of less than 0.01 inches, such as less than 0.007 inches. The connecting tube may have a uniform outer diameter (see Figure 5 ) or uneven diameter (see Fig. 6A). In the non-uniform configuration, the outer diameter of the reduced diameter portion of the connecting tube can be less than or equal to about 0.033 inches. The connecting tube can extend along most or substantially the entire working length of the pressure guidewire. For example, the connecting tube can extend at least 80%, or at least 90% of the working length of the pressure guidewire.

[0129] The connecting tube can be made of a conductive metal. For example, the connecting tube can be a stainless steel tube. The proximal tube of the connector can be exposed from the proximal end of the outer tube to connect to a monitor display and / or to a current generator. Therefore, at least the proximal end of the connecting tube can be uncoated.

[0130] The pressure guide wire may also include a core wire distal to the connecting tube. In venous or transapical aortic valve applications, the portion with the core wire may be disposed downstream of the blood flow of the portion with the connecting tube. In arterial or transapical mitral valve applications, the portion with the core wire may be disposed upstream of the blood flow of the portion with the connecting tube. The core wire may include an outer diameter of up to 0.03 inches, for example between 0.018 inches and 0.03 inches. The reduced diameter portion of the core wire may include an outer diameter that is less than one-third or one-quarter of the outer diameter of the remaining portion of the core wire. For example, the reduced diameter portion of the core wire may include an outer diameter that is less than 0.01 inches or less than 0.0075 inches. The core wire may extend along only the distal portion of the pressure guide wire, for example, extending along less than 20% or less than 10% or less than 5% of the working length of the pressure guide wire.

[0131] Figure 5 5 is a schematic diagram of another variation of the pressure sensing guidewire 508. As shown, at least the distal portion of the outer tube 510 can be coiled. For example, the coiled portion can be a flat ribbon coil or a rounded coil. Figure 5 As shown, the coiled portion may include two coiled segments 512a, 512b separated from each other by a sensor housing 542. In some embodiments, a plastic layer may be provided in place of the coil portion 512b. The plastic layer may be made of or include polytetrafluoroethylene (PTFE) or an elastomer. Additional details about the plastic layer will be described below. Fig. 9 Description. Coil portions 512a, 512b can extend together along most of the working length of pressure guidewire 508 or along substantially the entire working length of pressure guidewire 508. For example, coil portions 512a, 512b can extend together at least 80% or at least 90% of the working length of pressure guidewire 508. In the case where a significant length of outer tube 510 is coiled, coil portions 512a, 512b provide sufficient flexibility to navigate tortuous vascular systems. Distal coil portion 512a also promotes safety in the event of a failure along the coil portion (e.g., a distal tip failure). When used for rapid pacing, distal coil portion 512a can also ensure electrical contact with the inner wall of the patient's heart (e.g., the inner wall of the left ventricle).

[0132] like Figure 5 As shown, at least the proximal portion 528 of the core wire 516 may be concentric with the outer tube 510 and extend through at least a portion of the lumen of the outer tube 510. The diameter of the proximal portion 528 of the core wire 516 may be the same as the outermost diameter of the connecting tube 530. At least a portion of the core wire 516 may include a reduced diameter portion 526, such as a tapered portion that tapers toward the distal end of the pressure guidewire 508. The transition between the proximal portion 528 of the core wire 516 and the reduced diameter portion 526 may be positioned proximal to the atraumatic bend 250 in the distal segment of the pressure guidewire 508 to facilitate a flexible transition toward the atraumatic bend 250 of the pressure guidewire 508. This flexible transition acts as a force absorber and ensures that no kinks are formed in the proximal segment of the atraumatic bend 250 of the pressure guidewire 508. Kinks may complicate procedures such as advancing another catheter over the guidewire 508 or removing the guidewire 308 from the patient's body without trauma. The core wire 516 may include a conductive material such as stainless steel to provide rapid pacing as described above.

[0133] The pressure sensor assembly 508 may include a pressure sensor 522 and one or more pressure wire leads 520 extending from the pressure sensor 522. For example, the pressure sensor 522 may be an optical or electrical sensor, a membrane-based sensor, or other sensor. The pressure wire lead (one or more) 520 may be an optical fiber or an electric wire. The pressure wire lead (one or more) 520 may extend through the lumen of the connecting tube 530. The connecting tube 530 positions the pressure wire lead (one or more) 520 along the central longitudinal axis L of the pressure guide wire 508. The pressure wire lead (one or more) 520 may be fixed to and in some cases also sealed to the connecting tube 530, for example using an adhesive. In some cases, the adhesive provides a seal to prevent fluid from flowing proximally through the connecting tube 530. The adhesive may also be used at the proximal end of the connecting tube 530 to concentrically fix the optical fiber 520 to the connecting tube 530.

[0134] like Figure 5 As shown, the pressure sensor 522 can be disposed within a pressure sensor housing 542 of the outer tube 510. The sensor housing 542 protects the pressure sensor 522 and also provides a connection between the coil portions 512a, 512b. The pressure sensor 522 can be exposed to blood or other fluids through at least one opening 544 in the sensor housing 542. As shown, the sensor housing 542 can be a metal tube that joins the two coil portions 512a, 512b, but in other variations, the sensor housing 542 can be formed by welding several coils together to form a welded portion that joins the coil portions 512a, 512b.

[0135] The sensor housing 542 and the pressure sensor 522 may be positioned Figure 2B The non-invasive bend 250 is shown proximal to the guidewire 508, for example at location 206A. However, as described above, the pressure sensor may also be positioned anywhere along the bend 250 in the distal segment of the pressure guidewire 508.

[0136] At least a portion of the pressure guidewire 508 may be covered by a lubricated spacer, such as a polymer layer such as PTFE. The spacer may also electrically isolate portions of the pressure guidewire 508 when rapid pacing is induced via the connecting tube 530 and / or the core wire 516. The spacer may replace the need for a separate catheter body to electrically isolate the pressure guidewire 508.

[0137] Fig. 6A 608. The pressure sensing guidewire 608 may include a pressure sensor 622 and one or more pressure wire leads 620 extending from the pressure sensor 622. The diameter of the proximal portion 628 of the core wire 616 may be the same as the outermost diameter of the connecting tube 630. The pressure sensor 622 may be disposed in a pressure sensor housing 642 of the outer tube 610. The sensor housing 642 may protect the pressure sensor 622. The sensor housing 642 may provide a connection between the coil portions 612a, 612b. The pressure sensor 622 may be exposed to blood or other fluids through at least one opening 644 in the sensor housing 642. As shown, the sensor housing 642 may be a metal tube that joins the two coil portions 612a, 612b. In other embodiments, the sensor housing 642 may be formed by welding a plurality of coils together to form a welded portion that joins the coil portions 612a, 612b.

[0138] Pressure sensing guidewire 608 is similar to pressure sensing guidewire 508 except for the differences described below. Fig. 6A The public content is Figure 5 The pressure sensing guidewire 608 includes a distal tip 632. The distal tip 632 is similar to the distal tip 432, except for the differences described below. The distal tip 632 can achieve non-invasive interaction with blood vessels, valves, and heart wall chambers. The tip 632 can also reduce or prevent foreign matter (such as components or fluids) from entering through the distal end of the pressure guidewire 608. The distal tip 632 can have a hemispherical shape.

[0139] In some configurations, the distal tip 632 is a separate component that is adhered, welded, and / or otherwise bonded to the coil portion 612a and / or the core wire 616. The distal tip 632 can be bonded to the inner surface of the coil portion 612a and / or the distal-most edge of the coil portion 612a. The core wire 616 can be bent up to 180 degrees within the outer tube 610 to enhance the adhesive bond with the distal tip 632, which will be discussed below with respect to Figure 6CFurther detailed description. In other configurations, the distal tip 632 can be an enlarged distal end of the core wire 616 distal to the diameter reduction portion 626. The distal end of the core wire 616 can be adhered, welded and / or otherwise bonded to the inner surface and / or the distalmost edge of the coil portion 612a. In any of these configurations, the atraumatic portion of the distal tip 632 can be formed by the core wire 616, such as by melting or otherwise reshaping the enlarged section of the core wire 616 to produce a desired shape.

[0140] Figure 6B is a cross-sectional view of another variation of pressure sensing guidewire 608'. Pressure sensing guidewire 608' may be similar to pressure sensing guidewire 608, except Figure 6B In place of coil portion 612b, isolator portion 634 is included. Isolator portion 634 may include a polymer layer such as PTFE.

[0141] Figure 6C is a cross-sectional view of another variation of a pressure sensing guidewire 608". The pressure sensing guidewire 608" may include any of the features of the pressure sensing guidewires 608 or 608'. Figure 6C In the embodiment, the distal end of the core wire 616" may include a curved configuration to strengthen the adhesive joint with the distal tip 632". For example, the distal end of the core wire 616" may be bent up to 180 degrees relative to the rest of the core wire 616" to form a U-shaped distal end.

[0142] Figure 7 708. The pressure sensing guidewire 708 may include a pressure sensor 722 and one or more pressure wire leads 720 extending from the pressure sensor 722. The core wire 716 may have a proximal portion 728. At least a portion of the core wire 716 may include a reduced diameter portion 726, such as a tapered portion that tapers toward the distal end of the pressure guidewire 708. The pressure sensor 722 may be disposed within a pressure sensor housing 742 of the outer tube 710. The sensor housing 742 may protect the pressure sensor 722. The sensor housing 742 may provide a connection between the coil portions 712a, 712b. The pressure sensor 722 may be exposed to blood or other fluids through at least one opening 744 in the sensor housing 742. As shown, the sensor housing 742 may be a metal tube that joins the two coil portions 712a, 712b. In other embodiments, the sensor housing 742 may be formed by welding a plurality of coils together to form a welded portion that joins the coil portions 712a, 712b.

[0143] Pressure sensing guidewire 708 is similar to pressure sensing guidewire 508, except that sensor housing 742 and pressure sensor 722 may be positioned more distally in distal bend 250 of pressure guidewire 708, e.g., at Figure 2BHowever, as described above, it may be beneficial to reduce the diameter of the inner core wire to promote flexibility at the transition to the distal bend 250. Thus, the sensor housing 742 and pressure sensor 722 may be positioned in an area where the connecting tube 730 and / or the core wire 716 have transitioned to a reduced diameter. For example, Figure 7 As shown, the connecting tube 730 can have a reduced diameter section 746 at the distal end of the connecting tube 730. The connecting tube 730 can taper toward the reduced diameter section 746 at the tapered portion 754. The diameter of the proximal end of the core wire 716 can also be smaller than the outermost diameter of the connecting tube 730, such as at its distal end or distal region. In this configuration, the outer diameter of the sensor housing 742 can also be reduced compared to the sensor housing 542.

[0144] Figure 8 808. The core wire 816 may have a proximal portion 828. The connecting tube 830 may have a reduced diameter section 846 at the distal end of the connecting tube 830. The pressure sensing guidewire 808 is similar to the pressure sensing guidewire 708, except that the sensor housing 842 and the pressure sensor 822 may be positioned more distally in the distal bend 250 of the pressure guidewire 808, for example, at Figure 2B However, as described above, it may be beneficial to reduce the diameter of the inner core wire to promote flexibility at the transition to the distal bend 250. Therefore, in the region of the location 206D in the distal bend 250, the reduced diameter portion 826 of the core wire 816 may have a sufficiently reduced diameter to allow the sensor 822 to be radially positioned between the distal coil portion 812a and the reduced diameter portion 826 of the core wire 816. Figure 8 As shown, the sensor 822 can have a separate sensor housing 842 located around the sensor 822.

[0145] In place of a sensor housing along the outer tube 810, the pressure guidewire 808 includes a connector 848 extending between the coil portions 812a, 812b. The connector 848 may include an opening 852 to allow at least one pressure wire lead 820 to transition from a first segment 838a concentric with the outer tube 810 and within the connector tube 830 to a second segment 838b offset from the longitudinal axis L of the outer tube 810. The opening 852 may be partially cut away in thickness, or extend through the full thickness of the outer tube 810. If the opening 852 extends through the full thickness of the outer tube 810, the opening 852 may be sealed (e.g., with an adhesive) to prevent fluid from flowing into the pressure guidewire through the opening 852.

[0146] Fig. 9908 is a cross-sectional view of another variation of the pressure sensing guidewire 908. The pressure guidewire 908 may include a connector 948 extending between the isolator portion 934 and the coil portion 912a. The connector 948 may include an opening 952 to allow at least one pressure wire lead 920 to transition from a first segment 938a concentric with the outer tube 910 and located within the connector tube 930 to a second segment 938b. The opening 952 may be partially cut away in thickness, or extend through the full thickness of the outer tube 810. If the opening 952 extends through the full thickness of the outer tube 810, the opening 952 may be sealed (e.g., with an adhesive) to prevent fluid from flowing into the pressure guidewire through the opening 952. The core wire 916 may have a proximal portion 928, a reduced diameter portion 926, and a distal portion 922. The pressure sensing guidewire 908 may include a pressure sensor. The pressure sensing guidewire 908 is similar to the pressure sensing guidewire 808. Fig. 9 Includes a distal tip 932. The distal tip 932 may include Figures 6A-6C Any features of the distal tip 632 shown.

[0147] The outer tube 910 includes a spacer portion 934 and a coil portion 912a joined by a connector 948. The spacer portion 934 surrounds at least a portion of the connecting tube 930. The spacer portion 934 may include a polymer layer such as PTFE to electrically isolate the connecting tube 930 from the patient during rapid pacing. The proximal end 956 of the connecting tube 930 may be exposed from the proximal end of the spacer portion 934 to connect to a monitor display and / or to a current generator. Therefore, at least the proximal end of the connecting tube 930 may be uncoated.

[0148] As shown, connector 948 can be a metal tube that joins isolator portion 934 and coil portion 912a, but in other variations, connector 948 can be a welded portion that joins isolator portion 934 and coil portion 912a.

[0149] The one or more pressure wire leads 920 may be sealed to the lumen of the connecting tube 930 (eg, with an adhesive) to prevent proximal flow of fluid and to ensure concentricity of the optical fiber used for signal transmission.

[0150] The pressure sensor can be exposed to blood or other fluids by the spacing or gap in the coil part 912a. The outer tube 910 may also include a sensor housing segment 924. The sensor housing segment can be harder than the rest of the coil part 912a. For example, the sensor housing segment 924 can be a metal tube that divides the coil part 912a into two segments. The sensor housing segment 924 can be mounted to the distal portion of the first coil segment of the coil part 912a and the proximal portion of the second coil segment of the coil part 912a. The sensor housing segment 924 may include one or more openings to expose the pressure sensor to blood or other fluids. As another example, the coil part 912a may include two coils that are welded together to produce a hardened segment to serve as the sensor housing segment 924.

[0151] III. Heart Valve Assessment User Interface System

[0152] Existing user interfaces may be unable or insufficient to immediately indicate the condition of a heart valve before, during, and / or after deployment of a structural heart device. During a structural heart procedure, existing user interfaces may not provide one or more pressure curves or indicators of heart valve condition, such as a valve regurgitation index or a pressure gradient. In addition, existing structural heart procedure user interfaces may have limited user interaction capabilities, such as a lack of options to allow a user to customize one or more user interfaces. Existing patient monitors and / or displays may have limited visual space to display indicators, such as values ​​indicating heart valve condition, diagnostics, physiological parameters, or other data.

[0153] Therefore, the user interface of the heart valve assessment system disclosed herein can be improved relative to existing user interfaces. During a structural heart procedure, one or more indicators of the heart valve condition can be provided to a clinician through a user interface. The user interface can be organized so as to provide information in an effective manner. The user can display or select a specific graphical representation or indicator that allows the clinician to quickly assess the heart valve condition or problem. The systems and techniques described herein can enable clinicians to access data faster, perform analysis faster, and / or interact with one or more user interfaces faster (such as by reducing the number of clicks or selections by the user) compared to existing graphical user interface systems. The user interface described herein can be improved relative to existing user interfaces by more efficient use of limited visual space on a small monitor or display. For example, visual indicators, graphical representations, and / or combinations thereof can provide information related to the heart valve condition to the user in an effective manner (configured for a monitor or display with limited space). Therefore, the systems and techniques described herein can be improved relative to conventional user interfaces.

[0154] As used herein, in addition to its conventional meaning, "cardiovascular region" also refers to any area related to or surrounding the heart, such as the left ventricle or right ventricle, aorta, left atrium or right atrium, inferior vena cava, and / or blood flow channels adjacent to a portion of the heart (such as blood flow chambers, blood vessels, pulmonary arteries).

[0155] The heart valve assessment system described herein can beneficially provide an indicator of the condition of the heart valve, such as a pressure gradient or a valve regurgitation index. As used herein, in addition to its usual meaning, "pressure gradient" or "gradient" can also refer to the severity or measurement of the narrowing (or stenosis) of the valve accompanied by the pressure enhancement behind it. Exemplary gradients are provided here, such as peak-to-peak gradients, area gradients, or instantaneous gradients. The peak-to-peak gradient can indicate the pressure difference between the maximum or local maximum systolic pressure of a first cardiovascular region (such as the left ventricle LV) and a second cardiovascular region (such as the aorta Ao). The area gradient can indicate the area between two graphs (such as a pressure curve). The instantaneous gradient can indicate the maximum or local maximum pressure between the first cardiovascular region and the second cardiovascular region during the cardiac cycle. As used herein, in addition to its conventional meaning, "valve regurgitation index", "regurgitation index" or "regurgitation" can also refer to the leakage measurement of the valve. The regurgitation calculation can include the pressure difference at the end of the diastolic cycle divided by the systolic pressure or normalized by the systolic pressure. The aortic regurgitation calculation may correspond to the following equation: Aortic regurgitation index = (aortic diastolic blood pressure - left ventricular end-diastolic pressure) / aortic systolic blood pressure. The systems, techniques, and / or graphical user interfaces described herein may provide clinicians with additional data upon which to base treatment / procedural decisions. For example, values ​​indicative of a heart valve condition and / or an associated user interface may provide clinicians with additional information to address valve disease, modify a replacement valve during a procedure, and / or make recommendations after a valve procedure.

[0156] Regurgitation can occur when blood leaks back through the valve. Regurgitation can be caused by valve disease or, in the case of prosthetic replacement, it can be caused by a malapposition of the replacement valve to the native valve.

[0157] a. Example User Interface

[0158] Figures 10A-10E , 11A-11C and 12 depict example heart valve assessment user interfaces. The heart valve assessment system may be used with the above Figure 2A The diagnostic system 200 described in the foregoing may be the same, similar, or may include similar components thereto. For convenience, the user interface will be described as being Figure 2A200 including a monitor 204, although other computing systems may display user interfaces. These user interfaces may be displayed by the monitor 204 described above - using, for example, data received from a pressure guidewire 208, a pressure sensing access catheter 20, or a pressure sensing pigtail catheter 10. Thus, each of the user interfaces shown may be displayed as a graphical user interface output by electronic hardware.

[0159] Each user interface shown includes one or more user interface elements or controls that can be selected by a user. The user interface can be capable of receiving user input. The user interface elements shown are merely illustrative examples and can be changed in other embodiments. For example, aspects of the user interface can be rearranged from the situations shown and described below, and / or specific aspects can be included or not included. In addition, the user interfaces shown can be combined or split into other user interfaces, so that similar functionality or the same functionality can be provided. Figures 10A-10E The user interfaces of the present invention (such as user interfaces 1000, 1020, 1040, 1060 and / or 1080) can have similar user interface elements and / or capabilities. In addition, each user interface element can be selected by a user using one or more input options (such as a mouse, touch screen input (e.g., finger or pen) or keyboard input and other user interface input options).

[0160] Figures 10A-10E Depicted is an example user interface that may be presented by the monitor 204 of the system 200 described above and / or the system 1400 described herein. Fig. 10A In the embodiment of the present invention, the user interface 1000 can be displayed immediately before, during and / or after a cardiac procedure. The user interface 1000 may include one or more graphics 1002, 1004, 1006, 1008 and one or more physiological parameters 1010, 1012. Example graphics 1002, 1004, 1006, 1008 may include or be pressure waves. Graphics 1002, 1004, 1006, 1008 may represent pressure values ​​corresponding to cardiovascular region measurements. The pressure values ​​may include a series of pressure values ​​that vary over time. The cardiovascular region may include a portion of the heart (such as the left ventricle LV, the right ventricle RV, or the mitral valve) and / or a blood flow channel adjacent to a portion of the heart (such as the aorta Ao, the vena cava, or the pulmonary artery). The one or more graphics 1002, 1004, 1006, 1008 and / or the one or more physiological parameters 1010, 1012 may be updated in near real time or real time when pressure measurements are captured from the patient.

[0161] As shown, the user interface 1000 may include a first graphic 1002 of a first cardiovascular region, such as the aorta Ao, and a second graphic 1006 of a second cardiovascular region, such as the left ventricle LV. Additional graphics 1004, 1008 may correspond to statistical measures of pressure values ​​of the cardiovascular regions, such as average or mean pressure values ​​of the aorta Ao or the left ventricle LV. The statistical measure may be based on a configuration parameter that may be selected by the user to indicate a period of the statistical measure, such as the number of heartbeats or the time period over which the statistical measure is calculated. In some embodiments, the one or more graphics 1002, 1004, 1006, 1008 may have an indicator to indicate the corresponding cardiovascular region of the graphic (e.g., the aorta Ao graphics 1002, 1004 may be coded in red, and the left ventricle LV graphics 1006, 1008 may be coded in blue).

[0162] As shown, the user interface 1000 may include a first physiological parameter 1010 of a first cardiovascular region, such as the aorta Ao, and a second physiological parameter 1012 of a second cardiovascular region, such as the left ventricle LV. The physiological parameters 1010, 1012 may include systolic blood pressure, diastolic blood pressure, and / or a statistical measure of blood pressure (such as the average or mean systolic blood pressure or diastolic blood pressure or a certain combination thereof for a specific cardiovascular region). The statistically measured physiological parameters may correspond to additional graphics 1004, 1008.

[0163] The user interface 1000 may include one or more user interface options, such as a record option 1014. The clinician may select the record option 1014 to record blood pressure values, other measurements, and / or other values ​​related to the procedure. The clinician may then playback the recorded data. In some embodiments, values ​​indicative of a heart valve condition, such as, but not limited to, a gradient or regurgitant index, may be displayed to the user during playback mode.

[0164] Go to Fig. 10B , depicting another user interface 1020. The other user interface 1020 may be similar to Fig. 10A However, the additional user interface 1020 may include a stop recording option 1022 that may enable the user to stop recording of patient data. In some embodiments, after stopping, the user may enter a playback mode to view values ​​indicating a heart valve condition, such as, but not limited to, a gradient or regurgitation index.

[0165] Go to Fig. 10C , depicting another user interface 1040. The other user interface 1040 may be similar to Fig. 10A The additional user interface 1040 may include a first graphic 1002 and a second graphic 1006, which are similar to Fig. 10AHowever, the additional user interface 1040 may display one or more gradient representations 1042a, 1042b, 1042c that visually display the gradient measurement between the first peak in the first graph 1002 and the second peak in the second graph 1006. The one or more gradient representations 1042a, 1042b, 1042c may correspond to a gradient type such as a peak-to-peak gradient type.

[0166] The user interface 1040 may include a first numerical value 1046 corresponding to a gradient type such as a peak-to-peak gradient type. The first numerical value 1046 may correspond to a pressure difference between a maximum or local maximum systolic pressure of a first cardiovascular region (such as the left ventricle LV) and a second cardiovascular region (such as the aorta Ao). In some embodiments, the first numerical value 1046 may include a statistical measure, such as an average or mean pressure difference between the maximum or local maximum systolic pressures of multiple cardiac cycles. As shown, the first numerical value 1046 (here 28) may be a statistical measure of a multi-beat peak-to-peak measurement corresponding to the three graphical peak-to-peak measurements 1042a, 1042b, 1042c.

[0167] The user interface 1040 may display one or more regurgitation indications 1044a, 1044b, 1044c. As shown, the one or more regurgitation indications 1044a, 1044b, 1044c may visually display the regurgitation measurement result between the first point in the first graph 1002 and the second point in the second graph 1006. The one or more regurgitation indications 1044a, 1044b, 1044c may correspond to the pressure difference at the end of the diastolic cycle (here, the end diastolic blood pressure of the aorta Ao minus the end diastolic blood pressure of the left ventricle LV) divided by the systolic blood pressure (here, the aortic systolic blood pressure) or a calculation result normalized by it.

[0168] The user interface 1040 may include a second numerical value 1048 corresponding to the regurgitation index. The second numerical value 1048 may correspond to the pressure difference at the end of the diastolic cycle divided by or normalized by the systolic pressure. In some embodiments, the second numerical value 1048 may include a statistical measure, such as an average or mean regurgitation over a plurality of cardiac cycles. As shown, the second numerical value 1048 (here 22) may be a statistical measure of the regurgitation calculation results for a plurality of cardiac cycles corresponding to the three regurgitation representations 1044a, 1044b, 1044c.

[0169] The user interface 1040 may include an electrocardiogram (ECG) 1050. The ECG 1050 may be disabled or enabled by the user. Thus, the ECG 1050 may be removed or omitted from the user interface 1040. Although not illustrated, in some embodiments, if the ECG 1050 is removed or omitted, the stress graphic display 1051 may be enlarged in size in the user interface 1040.

[0170] The user interface 1040 may include playback controls 1052 and a gradient type selector 1056. As shown, the playback controls 1052 may display the time (here 0:01:18) and the current playback position 1054. In some embodiments, the user may interact with the playback controls 1052 to advance or rewind the playback of one or more graphics and corresponding indicators of the heart valve condition(s). The user may change the gradient type of the user interface 1040 by selecting the gradient type selector 1056, which may result in displaying an updated user interface instead of the current user interface 1040 being displayed.

[0171] Go to Fig. 10D , depicting another user interface 1060. The other user interface 1060 may be similar to Fig. 10C The additional user interface 1040 may include, in addition to other similar user interface elements, similar to Fig. 10C However, the additional user interface 1060 may display one or more gradient representations 1062a, 1062b, 1062c that visually display a gradient measurement between a first point in the first graphic 1002 and a second point in the second graphic 1006. The one or more gradient representations 1062a, 1062b, 1062c of the additional user interface 1060 may be responsive to a user selection (e.g., Fig. 10C 1056 ).

[0172] The one or more gradient representations 1062a, 1062b, 1062c may correspond to a gradient type such as an instantaneous gradient type. The instantaneous gradient representations 1062a, 1062b, 1062c may indicate a maximum or local maximum pressure difference between a first cardiovascular region and a second cardiovascular region during a cardiac cycle. The user interface 1060 may include a numerical value 1064 (here 64) corresponding to a gradient type such as an instantaneous gradient type. The numerical value 1064 may indicate a maximum or local maximum pressure difference between a first cardiovascular region (such as a left ventricle LV) and a second cardiovascular region (such as aorta Ao) during a cardiac cycle. In some embodiments, the numerical value 1064 may include a statistical measure, such as an average or mean maximum or local maximum pressure difference over multiple cardiac cycles. As shown, the numerical value 1064 may be a statistical measure of a multi-heartbeat instantaneous gradient measurement corresponding to the three graphical instantaneous measurements 1062a, 1062b, 1062c.

[0173] Go to Fig.10E , depicting another user interface 1080. The other user interface 1080 may be similar to Fig. 10CThe additional user interface 1080 may include, in addition to other similar user interface elements, Fig. 10C The first graphic 1002 and the second graphic 1006 are similar to the first graphic 1002 and the second graphic 1006. However, the additional user interface 1080 can display one or more gradient representations 1082a, 1082b, 1082c, which visually display the area between the first graphic 1002 and the second graphic 1006. The one or more gradient representations 1082a, 1082b, 1082c of the additional user interface 1060 can be responsive to user selections (e.g., Fig. 10C 1054 and 1055 ) based on one or more user selections of a gradient type selector 1056 .

[0174] The one or more gradient representations 1082a, 1082b, 1082c may correspond to a gradient type such as an area gradient type. The area gradient representations 1082a, 1082b, 1082c may indicate a pressure difference between a first cardiovascular region and a second cardiovascular region. The user interface 1080 may include a numerical value 1084 (here 56), which corresponds to a gradient type such as an area gradient type. The numerical value 1084 may indicate the area between two graphics corresponding to a first cardiovascular region (such as the left ventricle LV) and a second cardiovascular region (such as the aorta Ao). In some embodiments, the numerical value 1084 may include a statistical measure, such as an average or mean area between two graphics or pressure curves for multiple cardiac cycles. As shown, the numerical value 1084 may be a statistical measure of a multi-heartbeat area gradient measurement result corresponding to the three graphic instantaneous measurement results 1082a, 1082b, 1082c.

[0175] Figures 11A-11C Depicted are additional example user interfaces that may be presented by the monitor 204 of the system 200 described above and / or the system 1400 described herein. Fig.11A , 11B , 11C user interfaces 1100, 1120, 1140 may be similar to Fig. 10C , 10D , user interfaces 1040, 1060, 1080 of 10E. In particular, Fig.11A , Fig. 11B , Fig. 11C The user interfaces 1100, 1120, and 1140 can respectively display Fig. 10C , Fig. 10D , Fig.10E An alternative gradient representation of the gradient representation of the user interface 1040, 1060, 1080. In addition, Fig.11A , 11B, 1100 , 1120 , 1140 of FIG. 11C may depict a user interface displaying values ​​indicative of a heart valve condition(s) of a mitral valve.

[0176] exist Fig.11A In the embodiment of the present invention, the user interface 1100 may include a gradient representation 1102. The gradient representation 1102 may be used for a peak-to-peak gradient type, which may be similar to Fig. 10C However, instead of visualizing the measurement between two peaks, the gradient representation 1102 can depict one or more pressure values ​​corresponding to the peak-to-peak gradient in graphical form. Fig.11A A benefit of the gradient representation 1102 is that it may enable a clinician to quickly view relative peak-to-peak pressure changes over time, which may include past and current measurements.

[0177] Fig.11A The regurgitation representation 1104 may be similar to Fig. 10C However, similar to the gradient representation 1102, the regurgitant representation 1104 may depict one or more pressure values ​​corresponding to valve regurgitation in graphical form, instead of visualizing the measurement between two points.

[0178] Go to Fig. 11B , the user interface 1120 may include another gradient representation 1112. The gradient representation 1112 may be used for a transient gradient type, which may be similar to Fig. 10D However, instead of visualizing the measurement results between two points, the gradient representation 1112 can depict one or more pressure values ​​corresponding to the peak-to-peak gradient in graphical form. Fig.11A The gradient representation 1102 is similar, Fig. 11B A benefit of the gradient representation 1112 is that it may enable a clinician to quickly view the relative instantaneous pressure changes over time, including past and current measurements.

[0179] Go to Fig. 11C , the user interface 1140 may include another gradient representation 1142. The gradient representation 1142 may be used for an area gradient type, which may be similar to Fig.10E However, instead of or in addition to depicting the area between two graphics as the only visual representation, the gradient representation 1142 may depict one or more pressure values ​​corresponding to the area gradient in graphical form. Fig.11A The gradient representation 1102 is similar, Fig. 11C A benefit of the gradient representation 1142 is that it may enable a clinician to quickly view relative pressure changes over time, including past and current measurements.

[0180] Fig.11D and 11E Depicted are additional example user interfaces that may be presented by the monitor 204 of the system 200 described above and / or the system 1400 described herein. Fig.11D , 11E The user interfaces 1150, 1170 in the example may be similar to those described herein with respect to Fig. 10A , 10B , 10C, 10D, 10E, 11A, 11B, 11C. In particular, Fig.11D , 11E The user interfaces 1150, 1170 in can be comparison user interfaces. As used herein, a "comparison user interface" is a user interface in which graphs, physiological parameters, heart valve condition indicators (e.g., gradients, regurgitant index, regurgitant ratio, etc.), and / or other metrics of two records (e.g., pre-procedural and post-procedural records) are displayed simultaneously. As described herein, the first record can be of a patient before a procedure, and the second record can be of the same patient after a procedure. As another example, the first record can be from a first portion of a procedure, and the second record can be from a second portion of a procedure. Fig.11D The user interfaces 1150, 1170 in the HE may beneficially allow a clinician to quickly compare hemodynamic information from two different recordings.

[0181] exist Fig.11D , the user interface 1150 may include a first area 1152A and a second area 1152B. As shown, the first area 1152A and the second area 1152B may include one or more first graphics and / or indicators 1154A and one or more second graphics and / or indicators 1154B, which may be similar to the graphics and indicators described herein. For example, the one or more first graphics and / or indicators 1154A may include pressure waves of one or more cardiovascular regions (such as the left ventricle LV, the right ventricle RV, the aorta Ao, the inferior vena cava, or the pulmonary artery) and / or values ​​indicating the condition of the heart valve, such as but not limited to the gradient or regurgitation index of any cardiovascular region of the first record (which may be a pre-procedural record of the patient). Similarly, the second graphics and / or indicators 1154B may be of the same type (one or more) as the first graphics and / or indicators 1154A but may be used for a second record (which may be a post-procedural record of the same patient).

[0182] The user interface 1150 may include a parameter area 1156. The parameter area 1156 may display parameters of the first record and the second record simultaneously. For example, the parameter area 1156 may display pre-procedural and post-procedural parameters of the same patient simultaneously. Example parameters may include physiological parameters such as pressure values ​​of the aorta Ao and the left ventricle LV - for two records (such as pre-procedural and post-procedural records). Another example parameter may include a gradient value (such as the mean or average area between two graphs) of two records (such as pre-procedural and post-procedural records). The mean or average gradient may be calculated by the heartbeat shown in the graph of the first area 1152A or the second area 1152B. Other example parameters (for two records) may include a time-integrated regurgitation index (TIARI), a regurgitation ratio, and / or a patient's heart rate. Regurgitation indexes and / or indicators (such as regurgitation ratios) may be calculated by the heartbeat shown in the graph of the first area 1152A or the second area 1152B. Any other indices, gradients, and / or metrics described herein for two records (eg, pre-procedure and post-procedure records) may be presented in parameter area 1156 and / or user interface 1150 .

[0183] The user interface 1150 may include record selectors 1158A, 1158B and / or parameter selectors 1160, 1162. The first and second record selectors 1158A, 1158B may allow the clinician to select corresponding records displayed in the first region 1152A and the second region 1152B, respectively. The selection of a record may also cause the parameter region 1156 to be updated accordingly. The first parameter selector 1160 may allow the clinician to select and change the parameter type of the gradient (such as the peak-to-peak gradient type, the instantaneous gradient type, or the area gradient type), which may cause the first region 1152A, the second region 1152B, and the parameter region 1156 to be updated accordingly. Similarly, the second parameter selector 1162 may allow the clinician to select and change the parameter type of the regurgitation (such as the aortic regurgitation index (ARI) or the time-integrated aortic regurgitation index (TIARI)), which may cause the first region 1152A, the second region 1152B, and the parameter region 1156 to be updated accordingly.

[0184] Fig.11E Another comparison user interface 1170 may be presented. Fig.11E The user interface 1170 may be similar to Fig.11D 1150. However, instead of displaying the graphics side by side, Fig.11E The user interface 1170 may display the graphics in a stacked state, for example, one graphic vertically overlaying another graphic on the screen, and / or larger than Fig.11D 1150. In some embodiments, a stacked graph can be displayed with one or more features of a heartbeat aligned in a left-to-right direction.

[0185] Fig.12 A configuration user interface 1200 of a heart valve assessment system is depicted. A clinician may configure one or more user interfaces using the configuration user interface 1200. The configuration user interface 1200 may enable a clinician to select a procedure type, a default regurgitation type, a time scale, a pressure scale, and / or other customizable user interface options. The configuration user interface 1200 may include a statistical metric period selector 1202, which may allow a user to select a number of heart beats for statistical metric calculations.

[0186] b. User interface generation process

[0187] Go to Fig.13 , shows an example user interface generation process 1300. Although process 1300 is in conjunction with a heart valve assessment system (e.g., Figure 2A System 200 or the following description Fig.14 1400), but any system configured to perform the process in any order is within the scope of the present disclosure. Process 1300 may be performed by a system as discussed herein. Figure 2A System 200 or Fig.14 The various components of the system 1400 are performed. Depending on the implementation, the process 1300 may include fewer or additional blocks and / or the blocks may be performed in a different order than the example. Other implementations of the process 1300 may include fewer blocks than the example, or the blocks may be performed in a different order than the example.

[0188] Beginning at block 1302, pressure values ​​may be received. In particular, the systems 200, 1400 may receive pressure values. The systems 200, 1400 may receive a first set of pressure values ​​and a second set of pressure values. Each pressure value in the first set of pressure values ​​may correspond to a first signal received from a first pressure sensor measuring a first cardiovascular region (e.g., a first portion of the heart). Each pressure value in the second set of pressure values ​​may correspond to a second signal received from a second pressure sensor measuring a second cardiovascular region (e.g., a blood flow channel adjacent to the first portion of the heart). Thus, the systems 200, 1400 may determine first and second sets of pressure values ​​by the first and second sensors, respectively. As described above in Sections I and / or II, the pressure sensor may be included in a pressure guidewire, an access catheter, a pigtail catheter, or a treatment device (e.g., a heart valve dilation balloon, a heart valve delivery device configured to sense pressure, or other pressure sensing device). Additional details regarding receiving pressure values ​​may be found in the following section regarding Fig.15 Process 1500 (such as blocks 1502 and / or 1504 of process 1500) is described in greater detail.

[0189] At block 1304, configuration parameters may be received. In particular, the system 200, 1400 may receive configuration parameters. Example configuration parameters may include the number of heartbeats displayed in the user interface or the default gradient type. Additional details regarding configuration parameters are provided above with respect to Fig.12 is described in further detail.

[0190] At block 1306, a user selection may be received. Example user selections may include a change in gradient type. The user may select Fig. 10C The gradient type selector 1056 can be used to change between gradient types, such as Fig. 10D The instantaneous gradient type or Fig.10E Other user selections can include the area gradient type for biomass Fig.12 The configuration parameters of the configuration user interface 1200 described herein may be modified. For example, the user selection may include a user heartbeat selection. The user heartbeat selection may specify the number of heartbeats used for the statistical measurement (such as, for example, 2, 3, or 4 heartbeats). The user heartbeat selection may also include the selection of one or more specific heartbeats. For example, a user may interact with the user interface described herein to select a portion of a graphic corresponding to a specific heartbeat and / or may select an identifier(s) of a specific heartbeat(s).

[0191] At box 1308, a value indicative of a heart valve condition may be determined. As described herein, example values ​​indicative of a heart valve condition may include a regurgitant index or a gradient pressure. The system 200, 1400 may determine a value indicative of a heart valve condition based on data from previous boxes 1302, 1304, 1306. For example, the system 200, 1400 may calculate a specific value indicative of a heart valve condition from a received pressure value based on a configuration parameter or user selection (which may specify a specific gradient type, a number of heartbeats to be calculated, and / or specific heartbeats to be used or excluded). As described herein, a statistical measure of a value indicating a specific heart valve condition, such as a regurgitant index or gradient, may be calculated using the number of heartbeats. The system 200, 1400 may detect rapid pacing from one of the first set of pressure values ​​or the second set of pressure values, such as by detecting whether a certain number of heartbeats have exceeded a threshold time period. More details on determining a value indicative of a heart valve condition will be described in Section IV below, such as regarding Fig.15 The process of 1500 and Fig.28 Process 2800. Fig.15 Some blocks in process 1500 may further describe determining a value indicative of a heart valve condition, such as blocks 1504 , 1506 , 1508 , 1510 .

[0192] At block 1310, a user interface may be displayed. The system 200, 1400 may display a user interface on the monitor 204. The example user interface is described above with respect to Figures 10A-10E The first displayed user interface may include a first graphic and a second graphic, the first graphic being based at least in part on the first set of pressure values, and the second graphic being based at least in part on the second set of pressure values. The first displayed user interface may correspond to Fig. 10C , 10D , 10E, 11A, 11B, 11C. The first illustrated user interface may also include a gradient representation indicating a valve gradient such as a peak-to-peak gradient, an instantaneous gradient, and / or an area gradient. For example, the first gradient representation may visually depict an area between the first graphic and the second graphic (e.g., Fig.10E The displayed area may indicate a pressure difference between the first cardiovascular region and the second cardiovascular region. The first user interface may also include a numerical value indicating the amount of valve regurgitation (e.g., Fig. 10C The first user interface may also include a reflux representation that visually displays the reflux measurement result between the first point in the first graph and the second point in the second graph (e.g., Fig. 10C The first user interface may also include a numerical value of the first gradient of the valve according to the statistical metric (e.g., Fig.10E The first user interface may also include an electrocardiogram, which is described above with respect to Fig. 10C In some embodiments, if rapid pacing is detected, the first user interface can present a rapid pacing warning.

[0193] In some embodiments, the first user interface may include multiple values ​​of different gradient types but on the same graphical display. For example, two or more values ​​may be selected from: peak-to-peak gradient values, instantaneous gradient values, and / or area gradient values, and are displayed simultaneously on the same graphical display.

[0194] As shown, after the display box 1310 is executed, the previous box can be returned to receive additional pressure value data, user selections and / or configuration parameter updates (which result in one or more user interface updates). For example, the system 200, 1400 can receive a user selection of a second gradient type (such as a peak-to-peak gradient type) via the first user interface. Therefore, the system 200, 1400 can display a second user interface regarding the second gradient type (such as a peak-to-peak gradient type) instead of the first user interface. The second user interface may include a first graph, a second graph, and a second gradient representation - which visually displays the gradient measurement result between the first peak in the first graph and the second peak in the second graph (such as Fig. 10C The gradients are represented by 1042a, 1042b, 1042c).

[0195] The user may make any number of changes to the user interface. For example, another user interface selection of a third gradient type (e.g., a transient gradient type) may be received. Thus, the system 200, 1400 may display a third user interface of a third gradient type (e.g., a transient gradient type) in place of the second user interface. The third user interface may include the first graphic and the second graphic and a third gradient representation that visually displays a second gradient measurement result (e.g., a first point in the first graphic and a second point in the second graphic) between. Fig. 10D 1062a, 1062b, 1062c). Although a specific order of gradient type changes has been described herein, the heart valve assessment system can accept any order of gradient type changes.

[0196] IV. Heart Valve Assessment Systems and Methods

[0197] The systems and methods described herein can evaluate heart valves. Pressure values ​​can be used to evaluate valves. The valve can be diagnosed by various signal processing methods involving pressure gradients across the valve. The pressure gradient across the valve during systole can indicate the pressure loss caused by blood flowing through the valve, which can indicate blood flow restriction. The pressure gradient at the end of diastole (e.g., after the valve closes) can indicate the amount of blood leaking across the valve when closed. As described herein, normalizing the gradient with systolic pressure from a cardiovascular region such as the aorta, or dividing the gradient by systolic pressure from a cardiovascular region such as the aorta, can be referred to as regurgitation (result). The various techniques described herein can be used to improve the accuracy of valve evaluation or diagnostic methods, such as but not limited to pressure sensor calibration, waveform adjustment, feature detection and / or valve condition generation.

[0198] a. Overview of Heart Valve Assessment System and Method

[0199] Go to Fig.14 , depicts a block diagram of a heart valve system 1400. Fig.14, a heart valve assessment environment 1402 includes inputs 1404 such as pressure signals (one or more), a heart valve assessment system 1400, and outputs 1406 such as valve conditions, valve diagnostic indices, and / or waveforms. Example waveforms may include time series data, such as a series of corresponding pressure and timestamp pairs. Fig.14 The heart valve assessment system 1400 may be similar to Figure 2A Components of the system 200 and / or heart valve assessment system 1400 may be implemented in the monitor 204. The pressure signal(s) 1406 may be received by one or more pressure sensors described herein, such as the pressure guidewire 208, the pressure sensing access catheter 20, or the pressure sensing pigtail catheter 10.

[0200] The heart valve assessment system 1400 may include a calibration service 1408, a waveform adjustment service 1410, a feature detection service 1412, and / or a valve condition determination service 1414. The calibration service 1408 may calibrate one pressure sensor relative to another pressure sensor. The waveform adjustment service 1410 may adjust one or more pressure waveforms so that two or more pressure waveforms may be generally synchronized. The feature detection service 1412 may detect one or more features in the pressure waveform, such as detecting systole, diastole, dicrotic notch, end of diastole, and / or beginning of systole. The valve condition determination service 1414 may determine one or more valve conditions. The valve condition determination service 1414 may include an index calculator 1416 and / or a gradient calculator 1418. The index calculator 1416 may generate an index such as a valvular regurgitation index, a time-integrated regurgitation index (TIARI), and / or an indicator such as an aortic regurgitation ratio or a time constant. The gradient calculator 1418 may generate a pressure gradient and / or a statistical measure of the pressure gradient. The generated output data 1406 such as valve condition, valve diagnostic index, and / or waveform may be provided in a user interface as described herein, or may be provided to another device or system.

[0201] Go to Fig.15 , an example valve assessment process 1500 is shown. Although process 1500 is used in conjunction with a heart valve assessment system such as Figure 2A System 200 or Fig.14 The process 1500 is described with reference to the system 1400 of FIG. 1 , however, any system configured to perform the process in any order is within the scope of the present disclosure. The process 1500 may be performed as discussed herein by Figure 2A System 200 or Fig.14The various components of the system 1400 are performed. Depending on the implementation, the process 1500 may include fewer or more blocks and / or the blocks may be performed in a different order than the example. Other implementations of the process 1500 may include fewer blocks than the example, or the blocks may be performed in a different order than the example.

[0202] Beginning at block 1502, a pressure value or signal may be received or determined. In particular, the heart valve assessment system 1400 may receive a pressure signal from a pressure sensor such as a pressure guidewire 208, a pressure sensing access catheter 20, or a pressure sensing pigtail catheter 10. The heart valve assessment system 1400 may determine a first set of pressure values ​​and a second set of pressure values ​​from the received pressure signal. Each pressure value in the first set of pressure values ​​may correspond to a first signal received by a first pressure sensor measuring a first cardiovascular region. Each pressure value in the second set of pressure values ​​may correspond to a second signal received by a second pressure sensor measuring a second cardiovascular region, which may be the same or different from the first cardiovascular region. The heart valve assessment system 1400 may determine the first and second sets of pressure values ​​from the first and second sensors, respectively. As described in Part I and / or Part II above, the pressure sensor may be included in a pressure guidewire or other pressure sensing device. In some embodiments, such as in the case of calibration, the first pressure sensor and the second pressure sensor may be located in the same or different cardiovascular regions. In this case, the process may proceed to block 1504.

[0203] At block 1504, calibration may be performed. Calibration service 1408 may perform calibration. The second sensor may be calibrated relative to the first sensor to determine a more accurate pressure measurement. Similarly, the first sensor may be calibrated relative to the second sensor to determine a more accurate pressure measurement. In some embodiments, each of the first sensor and the second sensor may be calibrated together. The pressure value determined by the second sensor may be adjusted based on the calibration. Calibration of the first sensor and the second sensor may result in the generation of one or more calibration parameters. The one or more calibration parameters may be used to adjust one or more pressure values ​​determined by the calibrated pressure sensor. More details on calibration will be provided below with respect to Fig.16 Course 1600 and / or Fig. 27 The process 2700 is described in further detail. As used herein, the terms "calibration" and "equalization" may be used interchangeably.

[0204] The process can return to box 1502. After calibration is completed, one or more pressure sensors can be moved to different cardiovascular regions, and additional pressure signals can be received at box 1502. The pressure signals can be received by two or more pressure sensors located in different cardiovascular regions. Examples of different cardiovascular regions can include adjacent blood channels, such as but not limited to opposite sides of a heart valve, such as the left ventricle and aorta, the left ventricle and left atrium, the right ventricle and pulmonary artery, the right atrium and right ventricle, the inferior vena cava and right atrium, etc. The heart valve assessment system 1400 can determine a first set of pressure values ​​and a second set of pressure values ​​from the pressure signals, such as by applying the determined calibration parameters.

[0205] At block 1506, waveform adjustment can be performed. Because some valve conditions (e.g., diagnosis) can be based on intra-beat waveform analysis where a particular portion of the cardiac cycle is available, it is important to adjust one or more pressure waveforms so that two or more pressure waveforms are generally synchronized or aligned. The adjustment of the waveform can correspond to a time shift of one or more waveforms so that their corresponding features are aligned. In some embodiments, the waveform adjustment service 1410 can automatically adjust one or more waveforms. In other embodiments, some aspects of the waveform adjustment can include receiving user input, such as an operator manually adjusting one or more waveforms.

[0206] The waveform adjustment service 1410 can adjust the phase between one or both pressure waveforms by adding a delay to one or both pressure waveforms during installation, maintenance, or use with a specific patient. This technique can assume that the setup process during installation or maintenance is representative of the setup process during a procedure such as TAVI. For example, the aortic pressure signal time delay can represent the aortic pressure line delay caused by the TAVI procedure. The waveform adjustment service 1410 can adjust the phase for each specific patient.

[0207] The waveform adjustment service 1410 may include or communicate with an automatic phase delay identification system that may advise an operator to verify and adjust the phase delay between the two pressure signals. The waveform adjustment service 1410 may verify such a time delay upon request or perform equalization, such as when the two pressure signals have the same source (e.g., are located at the same location so that they will experience similar pressures) or when the pressure signals are from different locations.

[0208] The waveform adjustment service 1410 can detect phase delay based on the time delay between one or more pressure waveform features. The pressure waveform features can include one or more of systolic relative position, dicrotic notch relative position, or end of diastole relative position. The waveform adjustment service 1410 can use the feature of the relative position of the maximum slope of the systolic rising edge, which is a reliable feature.

[0209] Additionally or alternatively, the waveform adjustment service 1410 can systematically adjust time delays when pressure equalization is requested. Similar to techniques for detecting phase delays, time adjustments can be measured by comparing the relative positions of specific pressure waveform features. For example, the waveform adjustment service 1410 can delay pressure sampling times (timing) based on the identification of pressure waveform features during the equalization process. The waveform adjustment service 1410 can exploit cross-correlations between two signals, i.e., such as by calculating the correlation between one signal and another signal when shifted in time. The time shift can cause the correlation value between the two signals to be enhanced or even maximized, which can correspond to a time shift that can be added to one or the other pressure signal.

[0210] At block 1508, feature detection may be performed. Feature detection service 1412 may perform feature detection. Example features that may be detected from the pressure waveform may include systole, diastole, dicrotic notch, end of diastole, and / or start of systole. More details on feature detection are provided below with respect to FIG. Fig.19 The process 1900 is described in further detail.

[0211] At block 1510, a value indicative of a heart valve condition may be determined. The valve condition determination service 1414 may determine the valve condition. In particular, the index calculator 1416 may generate an index such as a valve regurgitation index, and the gradient calculator 1418 may generate a pressure gradient and / or a statistical measure of the pressure gradient. The index calculator 1416 and / or the gradient calculator 1418 may generate the valve condition using a waveform or detected feature of a calibration or adjustment of the previous block. The index calculator 1416 may calculate the regurgitation index based at least in part on a first subset of a first set of pressure values ​​according to systole or diastole and a second subset of adjusted pressure values ​​according to systole or diastole. For example, the index calculator 1416 may calculate the regurgitation index using the following equation: aortic regurgitation index = (aortic diastolic blood pressure - left ventricular diastolic blood pressure) / aortic systolic blood pressure. The gradient calculator 1418 can calculate a gradient value (such as an area gradient value, a peak-to-peak gradient value, and / or an instantaneous gradient value, which are described in further detail in Section III above) based at least in part on the difference (value) between the pressure value of the first subset during systole and the adjusted pressure value of the second subset during systole. Further details on determining valve condition are described in further detail in Section IV above and Section IV below.

[0212] At block 1512, a value indicative of a heart valve condition may be displayed in the user interface. The heart valve assessment system 1400 may display a value indicative of a heart valve condition. Further details regarding the display of valve status are described above with respect to Fig.13 Block 1310 and Figures 10A-10E and 11A-11C are described in detail.

[0213] b. Pressure sensor calibration

[0214] As described herein, the first sensor can be calibrated relative to the second sensor to determine a more accurate pressure measurement result, which can also be referred to as equalization. For example, a pressure guidewire can be located at or near the valve position together with another pressure equipment. The other pressure equipment can be a catheter, a pigtail equipment, or other equipment for delivering a valve and including an inner cavity connected to a pressure transducer. The pressure equipment can be another pressure guidewire or a catheter including a distal pressure sensor. The pressure guidewire and the pressure equipment are positioned to measure the same pressure. The pressure sensor can be positioned in the same cardiovascular region, such as the aorta, ventricle, atrium or other position. Although it can be understood that the pressure sensors in the same position should show the same pressure, there may be differences between the first and second pressures (such as aortic pressure Pa and distal pressure Pd). Therefore, after being in the same position, one pressure sensor can be calibrated relative to another pressure sensor.

[0215] The systems and methods described herein for pressure sensor calibration can improve the accuracy of pressure devices. For example, as described above, even if two pressure devices are located in the same cardiovascular region, the pressure may be different based on the proximal or distal location of each pressure device. In addition, pressure differences may be caused by other factors, such as different device types of multiple pressure devices. Therefore, the systems and methods described herein for calibration can improve pressure device technology by being able to provide more accurate pressure readings (results).

[0216] Go to Fig.16 , an example calibration process 1600 is shown. Although process 1600 is used in conjunction with a heart valve assessment system such as Figure 2A System 200 or Fig.14 The system 1400 is described in detail, but any system configured to perform the process in any order is within the scope of the present disclosure. The process 1600 may be performed by a system as discussed herein. Figure 2A System 200 or Fig.14 The various components of the system 1400 are performed. Depending on the implementation, the process 1600 may include fewer or more blocks and / or the blocks may be performed in a different order than the example. Other implementations of the process 1600 may include fewer blocks than the example, or the blocks may be performed in a different order than the example.

[0217] Beginning at block 1602, one or more calibration pressure values ​​may be determined by one or more pressure sensors. The calibration service 1600 may determine one or more calibration pressure values ​​by one or more pressure sensors. The calibration service 1600 may receive a first calibration pressure value corresponding to a first calibration signal received from a first pressure sensor measuring a cardiovascular region and a second calibration pressure value corresponding to a second calibration signal received from a second pressure sensor measuring the same cardiovascular region. The calibration service 1600 may receive a first set of calibration pressure values ​​determined by the first pressure sensor and a second set of calibration pressure values ​​determined by the second pressure sensor.

[0218] At block 1604, calibration parameters may be calculated. The calibration service 1600 may calculate one or more calibration parameters. The calibration service 1600 may calculate calibration parameters, such as an offset or gain (G), using one or more techniques. The calibration service 1600 may determine an offset or gain (G). The calibration service 1600 may calculate an offset using the following offset equation: P1=P2+offset, where P1 may be Pd and P2 may be Pa. The calibration service 1600 may use the offset to determine that the pressures between the two pressure sensors are equal (e.g., average pressure). Additionally or alternatively, the calibration service 1600 may adjust the gain (G) of a pressure sensor so that the pressures between the two sensors (e.g., average pressure) become equal. The calibration service 1600 may calculate a gain (G) using the following gain equation: P1=G*P2, where P1 may be Pd and P2 may be Pa.

[0219] The calibration service 1600 can determine the calibration parameters using a linear fit. The first set of pressure values ​​and the second set of pressure values ​​can be or include a first vector or a second vector, respectively. The calibration service 1600 can determine a linear fit between the first vector and the second vector. The first vector can correspond to [P1] (such as [Pd]), and the second vector can correspond to [P2] (such as [Pa]). The calibration service 1600 can calculate the offset using the following offset equation: [P1] = K*[P2] + b. The calibration service 1600 can apply a linear fit between multiple pressure measurements of one pressure sensor relative to multiple pressure measurements of another pressure sensor to determine calibration parameters K and b. Linear fit calibration is desirable when equalizing two pressure measurements when positioned in a heart chamber (e.g., a ventricle). In contrast to aortic pressure, ventricular pressure (and atrial pressure) has a wide range of pressure variations, from close to venous pressure to aortic systolic pressure (and even to higher pressures, given the pressure loss across the aortic valve), so the risk of obtaining a linear fit with a significant offset (b) is minimized. [P1] may correspond to a vector containing a plurality of P1 pressure values, such as Pd, and [P2] may correspond to a vector containing a plurality of P2 pressure values, such as Pa. The pressure measurements that calibration service 1600 may use to calculate a linear fit may be a subset of pressure measurements, e.g., it may include only systolic measurements, diastolic measurements, or other portions of the cardiac cycle.

[0220] At block 1606, calibration parameters may be applied. The calibration service 1600 may apply one or more calibration parameters to the pressure values. The calibration service 1600 may apply an offset, gain (G), or linear fit parameters (K and b) to the one or more pressure values ​​to determine one or more adjusted pressure values.

[0221] c. Feature Detection

[0222] The heart valve assessment system 1400 can rely on the phase (phase) of the cardiac cycle to determine the valve condition, such as the regurgitation index. Therefore, the heart valve assessment system 1400 can detect one or more features, such as but not limited to systole, diastole, dicrotic notch, end of diastole, and / or onset of systole. The dicrotic notch is a feature that can indicate a phase change from diastole to systole. The end of diastole or the onset of systole is another detectable feature. The end of diastole can be identified by an electrocardiogram (ECG). In some embodiments, it may be desirable to use pressure to identify the end of diastole because the ECG signal may be unavailable or the ECG signal may not be clean enough. The transition (period) from diastole to systole is generally not clearly discernible because it may be quite rounded and / or the transition (period) may also include various pressure features that may lead to insufficient positioning. The heart valve assessment system 1400 can rely on features such as a systolic pressure rise zone. The heart valve assessment system 1400 can identify the location of the maximum or local maximum slope of the rising portion of systolic pressure, which can be more reliable than other features. In particular, the heart valve assessment system 1400 can identify the location of the maximum slope of the conditioned pressure signal.

[0223] Go to Fig.17 , depicting a waveform analysis environment 1700. The waveform analysis environment 1700 includes a first set of pressure data points 1702 and a second set of pressure data points 1704. The heart valve analysis system 1400 can analyze the data points in the environment 1700 to detect the dicrotic notch feature. The heart valve analysis system 1400 can detect the dicrotic notch feature by calculating and identifying the data point that forms the smallest angle with nearby data points. Fig.17 An example of angle calculation is shown. With respect to the first set of data points 1702, the heart valve analysis system 1400 can obtain the angle α(i) by calculating the angle formed by a first line extending from a center point P(i) and a previous point P(il) and a second line extending from the same center point P(i) and a subsequent point P(i+1). With respect to the first and second sets of data points 1702, 1704, the angle α(i+l) around point P(i+1) can be smaller than the angle α(i) around P(i). Therefore, the heart valve analysis system 1400 can identify the dicrotic notch feature at point P(i+1). In this example, although adjacent points are used to calculate the angle, the technique may include using non-adjacent points. In some embodiments, the technique may include using another n data points (such as another 2 or 3 data points) for the calculation of a line formed on a portion of the angle. Depending on the embodiment, the signal of the data point may be preconditioned or may not be preconditioned.

[0224] Go to Fig.18 , depicts another waveform analysis environment 1800. The heart valve analysis system 1400 can analyze data points in the environment 1800 to detect the end of diastole and / or the start of systole. The environment 1800 can include a waveform 1806. Fig.18 The slope 1802 extending from the maximum or local maximum slope position of the rising portion of the systolic period 1801 is illustrated. The heart valve analysis system 1400 can track a horizontal line 1804 that intersects the minimum or local minimum pressure value 1803. The intersection 1805 between the slope (line) 1802 and the horizontal line 1804 can provide a reliable location for the intermediate position of the transition (period) from the end of diastole to the beginning of systole. In some embodiments, when using aortic pressure to identify the end of diastole or the beginning of systole, a more accurate end of diastole location can be obtained by moving the position for a period of time 1807 (which can be predetermined). Providing a movement of about 40 to 100 ms from the intersection 1805, the end of diastole can be obtained. In some embodiments, a position moved by 60 ms can achieve a good estimate of the end of diastole. The heart valve analysis system 1400 can use other techniques such as moving the intersection of a percentage of the heart cycle, such as between 8% and 12%, or 5% and 8%.

[0225] The technology (one or more) described herein may be configured to identify the end of diastole when using aortic pressure. This technology may be configured in the case where the pressure being processed is ventricular pressure. Ventricular pressure may result in a more accurate determination of the end of diastole because the position of the intersection 1805 does not need to be moved. After the position of the first intersection 1805 is determined, a more accurate determination of the end of diastole may include changing the slope (line) extending from the maximum slope position to a new slope (line) extending from a position between the maximum slope position and the first intersection 1805. In particular, the determination of the end of diastole may include changing the slope (line) extending from the maximum slope position to a new slope (line) extending from a position closer to the first intersection 1805. The new slope (line) extending from a position closer to the first intersection 1805 may then extend to intersect with the horizontal line. The new intersection may be found and used as the end of diastole.

[0226] Go to Fig.19 , showing a feature detection process 1900. Although process 1900 is combined with a heart valve assessment system such as Figure 2A System 200 or Fig.14 The system 1400 is described as a system of the present disclosure, but any system configured to perform the process in any order is within the scope of the present disclosure. The process 1900 may be performed by a system as discussed herein. Figure 2A System 200 or Fig.14The various components of the system 1400 are performed. Depending on the implementation, the process 1900 may include fewer or more blocks and / or the blocks may be performed in a different order than the example. Other implementations of the process 1900 may include fewer blocks than the example or the blocks may be performed in a different order than the example.

[0227] Beginning at block 1902, the signal may be conditioned. The heart valve analysis system 1400 may condition the signal. The heart valve analysis system 1400 may filter the pressure signal, such as by convolving the signal with a window. The window may be square or other, and the duration may be two samples or more. Conditioning the signal may be preferred in certain situations, such as finding the location of the maximum slope, because there may be oscillatory features caused by bubbles or other factors.

[0228] At block 1904, a dicrotic notch feature may be detected. A feature detection service 1412 may detect a dicrotic notch feature. Various techniques may be utilized to determine the features of the dicrotic notch. The feature detection service 1412 may calculate a second-order derivative of one of the pressure signals, and may identify the location of the zero crossing. More specifically, the feature detection service 1412 may calculate a second-order derivative value from a first set of pressure values, and may identify a zero crossing point based at least in part on the second-order derivative value, wherein the zero crossing point corresponds to a first dicrotic notch feature. These techniques may enable the positioning of the dicrotic notch feature in the absence of a clear notch (i.e., a notch visible on a graphical representation of the pressure waveform itself). When a clear notch is present, i.e., when the notch includes a short pressure signal feature that rises upward that is visible in a graphical representation of the pressure waveform, the feature detection service 1412 may search for a nearby first-order derivative zero crossing. These techniques may be performed on an unconditioned pressure signal, but they may also be performed on a conditioned pressure signal.

[0229] The feature detection service 1412 can detect the dicrotic notch feature by calculating and identifying a data point that forms a minimum angle with nearby data points. The feature detection service 1412 can calculate a first angle for a first point from a set of pressure values—based at least in part on a first front point and a first rear point. The feature detection service 1412 can calculate a second angle for a second point from the first set of pressure values—based at least in part on a second front point and a second rear point. The feature detection service 1412 can determine that the second angle is less than the first angle, and can identify the second point as a first dicrotic notch feature. More details on detecting the dicrotic notch feature are provided above with respect to Fig.17 is described.

[0230] At block 1906, an end of diastole feature or a start of systole feature may be detected. Feature detection service 1412 may detect an end of diastole feature or a start of systole feature. Feature detection service 1412 may identify a first subset of rising pressure values ​​from the first set of pressure values. Feature detection service 1412 may identify a local minimum pressure value from the first plurality of pressure values. Feature detection service 1412 may determine a tangent from the first subset. Feature detection service 1412 may then identify a horizontal line that intersects the local minimum pressure value and identify a first intersection between the tangent and the horizontal line. Based at least in part on the first intersection, feature detection service 1412 may identify a first point in the first set of pressure values ​​as the end of a first diastole or the start of a first systole. Identifying the first point may further include adjusting the first intersection by a predetermined time period. The predetermined time period may be or may include approximately 60 ms. The predetermined time period may include between approximately 40 ms and approximately 100 ms. Identifying the first point may further include adjusting the first intersection by a percentage of a cardiac cycle. The percentage may include or may be between about 8% and 12% of the cardiac cycle. The percentage may include or may be between 5% and 8% of the cardiac cycle. More details on detecting the end of diastole features or the onset of systole are provided above with respect to Fig.18 is described.

[0231] At block 1908, systole or diastole may be determined. The feature detection service 1412 may detect a diastolic feature or a systolic feature. The feature detection service 1412 may utilize the dicrotic notch feature to identify a phase change from diastole to systole. The end of diastole or the start of systole is another feature that may be detected.

[0232] d. Other valve conditions

[0233] Additional valve conditions may be determined by the heart valve assessment system 1400. Additional example valve conditions may include, but are not limited to, transvalvular dysfunction diagnosis, stenosis severity index, aortic regurgitation index, corrected aortic regurgitation index, time-integrated regurgitation index, aortic regurgitation ratio, and / or time constant.

[0234] i. Valvular stenosis severity index

[0235] Although the aortic valve is used to describe certain embodiments, it should be understood that the techniques described herein can be applied to other valves, such as the mitral valve, the pulmonary (arterial) valve, and the tricuspid valve. Fig. 20 , depicting the left ventricular pressure waveform (LVEP) 2010 and the aortic pressure waveform (AOP) 2011. Fig. 20In an example of aortic stenosis, there may be aortic stenosis. Aortic stenosis can impede blood flow through the valve, which in turn causes a loss or drop in pressure. The pressure loss can occur during the systolic period. In particular, the pressure loss can occur during the period when blood is ejected from the left ventricle into the aorta (ejection phase). The ejection phase 2012 is defined as the period defined by the point in time when the left ventricular pressure exceeds the aortic pressure.

[0236] In normal healthy subjects, left ventricular and aortic pressures should be equal during the ejection phase. However, in the presence of aortic stenosis, left ventricular pressure can be higher than aortic pressure. The pressure loss can increase with the severity of aortic stenosis. Techniques for assessing the severity of aortic stenosis (AS) include calculating the pressure gradient between LVP and AOP during the entire ejection phase. In particular, the severity of aortic stenosis (AS) can be based on the gradient between the mean LVP and the mean AOP during the ejection phase ( <lvsp> - <asp>) as shown in area 2013. As described below, <lvsp>can be the mean left ventricular systolic pressure during ejection, and <asp>It can be the average aortic systolic pressure of the ejection period. An improved technique can include eliminating the edge portion of the ejection period and calculating the pressure gradient in the area where the instantaneous pressure gradient is more constant. This can be achieved by calculating the average pressure gradient of the central 50% of the ejection period to reject 25% of the cycles at the two edges. Other percentages of the central portion are also possible, such as 30%, 40%, 60%, 70% or 80%.

[0237] However, this technique may be sensitive to pressure amplitude. Another technique consists of normalizing the aortic stenosis index (AS) by dividing the mean pressure gradient by the mean LVEP, as shown in the following equation:

[0238]

[0239] <lvsp>can be the mean left ventricular systolic pressure during ejection, and <asp>It can be the mean aortic systolic pressure during the ejection phase.

[0240] At rest, it can be assumed that the total blood supply is adequate, i.e., the aortic pressure during the ejection phase allows adequate total perfusion. In the absence of aortic stenosis, it can be reasonably assumed that the left ventricular pressure during the ejection phase can be equal to the aortic pressure in the presence of aortic stenosis. Total vascular resistance may not change with or without aortic stenosis. The value of corresponds to the loss of available perfusion caused by the presence of aortic stenosis. In normal healthy subjects without aortic stenosis, will be equal to 0. The equivalent of fractional flow reserve (FFR) is modified as follows index: In this case, It can express the percentage of perfusion available in a stenotic valve relative to a normal valve. and It can be calculated by taking the average pressure over the entire ejection phase, or the pressure can be calculated by taking a portion of the ejection phase.Another index involves taking the maximum instantaneous gradient between the LVSP and ASP during the ejection phase.

[0241] ii. Aortic regurgitation index

[0242] Regurgitation can occur when blood flows back through a leaky valve. Regurgitation can be caused by valve disease or, in the case of a prosthetic replacement, by a poor fit of the replacement valve to the native valve. The post-procedural outcome of patients after valve replacement can be negatively affected by valve regurgitation. Therefore, diagnosing post-TAVI and possibly pre-TAVI valve regurgitation is very important for valve adjustment.

[0243] Fig.21 The pressure waveform of a normal healthy subject is illustrated. Fig. 22 A similar pressure waveform but with aortic regurgitation is illustrated. Blood flowing through the valve and back into the left ventricle can cause the left ventricular diastolic pressure to rise. It can also cause the aortic diastolic pressure to fall due to the loss of blood volume through the closed aortic valve. Systolic pressure can increase to compensate for the loss of available blood perfusion.

[0244] The aortic regurgitation index (ARI) can be composed by calculating the gradient between the end-diastolic aortic pressure (AEDP) 2220 and the end-diastolic ventricular pressure (LVEDP), normalized by the aortic systolic pressure (ASP), which is shown in the following equation.

[0245]

[0246] In some embodiments, the calculation may include multiplying the initial result by 100, which is shown in the following equation.

[0247]

[0248] Multiplying the initial result by 100 can make the aortic regurgitation index (ARI) easier to understand and / or compare. For example, if the end-diastolic aortic pressure (AEDP) is 65, the left ventricular end-diastolic pressure (LVEDP) is 10, and the aortic systolic pressure (ASP) is 160, then the first aortic regurgitation index (ARI) can be calculated as 34.375 (or 34.38, 34.4, 34, etc., depending on the rounding convention used). Similarly, if the end-diastolic aortic pressure (AEDP) is 40, the left ventricular end-diastolic pressure (LVEDP) is 20, and the aortic systolic pressure (ASP) is 130, then the second aortic regurgitation index (ARI) can be calculated as 15.384 (or 15.38, 15.4, 15, etc., depending on the rounding convention used). Therefore, multiplying by 100 in the above calculation can facilitate the comparison of the first and second aortic regurgitation indexes.

[0249] Another index that may provide better stability and reproducibility includes calculating the gradient of mean left ventricular diastolic pressure (LVDP) and mean aortic diastolic pressure (ADP) 2221 divided by aortic systolic pressure (ASP). Another index consists of calculating the same gradient over a portion of diastole, for example, calculating the gradient over a period of time when the left ventricular pressure is below a certain value 2222 (more specifically, in a region where the LVDP is relatively flat). A predetermined portion of diastole may also be used to calculate the regurgitation index, such as, for example, taking 75% of the left portion of diastole. Instead of (or in addition to) using end-diastolic aortic pressure (AEDP) 2220 and end-diastolic ventricular pressure (LVEDP) to calculate the regurgitation index, a time-integrated regurgitation index (TIARI) may be calculated by integrating systolic time and diastolic time; in other words, the time-integrated regurgitation index (TIARI) may be determined by calculating the area between the aortic and left ventricular pressure curves divided by the area of ​​the aortic systolic pressure curve.

[0250] As described above, only a portion of the diastole period can be used to calculate the aortic regurgitation index (ARI) or time-integrated aortic regurgitation index (TIARI). After the valve closes, there can be (and typically are) some pressure oscillations. Beneficially, in some embodiments, the start of diastole can be removed from the data used to calculate the index (to avoid this noisy portion of the signal). In addition, patients undergoing cardiac procedures such as transcatheter aortic valve replacement (TAVR) often have additional heartbeats (ectopic heartbeats) preceding regular heartbeats, and / or significantly adjusted heart rates. Therefore, some of the improved algorithms described herein can beneficially reduce or eliminate the effects of heart rate variations on the calculation of the aortic regurgitation index.

[0251] In some embodiments, the aortic regurgitation index can be standardized through the heartbeat length. For example, the aortic regurgitation index can be calculated using a specific heart rate, such as 60 beats per minute (BPM), which can be a normal resting heart rate for an adult. In other embodiments, ventricular pacing can be used to make the heart beat at a predetermined heart rate. In some embodiments, the heart rate can be changed (such as 60BPM, 100BPM, 140BPM, etc.), and the aortic regurgitation index can be calculated at one or more of the heart rates.

[0252] In some embodiments, a reduction in heart rate can beneficially provide a longer diastolic portion of the aortic pressure signal. For example, in some cases, the diastolic portion of the pressure curve can be described by an exponential decay curve; therefore, by reducing the heart rate, the diastolic portion of the pressure curve can be extended, thereby improving the calculated regurgitant index. In some embodiments, the heart rate can be reduced using methods other than standard ventricular pacing (e.g., electrical stimulation provided by a pacemaker to the ventricles of the heart). For example, drugs such as adenosine or other types of drugs with similar pacing effects can be administered to reduce the heart rate. Therefore, in some embodiments, the heart rate can be changed (e.g., 60BPM, 50BPM, 40BPM, 30BPM, 20BPM, etc.), and the aortic regurgitant index can be calculated at one or more of the heart rates.

[0253] In some embodiments, inducing an extrasystole (also known as a premature beat, premature contraction, or short beat) can beneficially provide a longer diastolic portion of the aortic pressure signal. Some pacemakers can be configured / programmed to induce an extrasystole. For example, the pacemaker can be set to a relatively low heart rate, such as 60 BPM. In some embodiments, higher or lower heart rates can be utilized. The goal can be to induce an extrasystole that produces a ventricular contraction but is not sufficient to open the aortic valve, which can result in a longer diastolic portion of the aortic pressure signal. Therefore, this beneficial technique can be used to calculate an improved regurgitation index.

[0254] exist Fig.23A , a left ventricular pressure waveform (LVEP) 2302 and an aortic pressure waveform (AOP) 2306 depict a situation where an extrasystole has occurred, which can be used to calculate an improved regurgitation index. As shown, an extrasystole 2304 (a short beat) close to the preceding heartbeat will produce a ventricular contraction, but not enough to open the aortic valve. Also as shown, the extrasystole 2304 can result in a longer portion 2308 of the aortic pressure waveform 2306, where there is a distinctive curve relative to other portions of the aortic pressure waveform 2306. As discussed herein, the longer diastolic portion 2308 of the aortic pressure waveform 2306 can be used to calculate an improved regurgitation index.

[0255] In some embodiments, wire manipulation during the procedure can be beneficially used to calculate an improved regurgitation index. For example, during a procedure such as transcatheter aortic valve replacement (TAVR), wire manipulation within the ventricle can cause some instability in the patient's heart rate. Therefore, there may be a longer diastolic portion of the aortic pressure signal and / or a longer pulsation, which can be used to calculate the regurgitation index. As described herein, the length of the heartbeat and / or diastole can be used to classify the heartbeat or diastole as included or excluded as part of the index or indicator calculation. The regurgitation index can be calculated for a longer diastolic portion and / or a longer pulsation of the aortic pressure signal, while excluding a shorter diastolic portion and / or a shorter pulsation of the aortic pressure signal. In some embodiments, the system can automatically select a longer diastolic portion and / or a longer pulsation of the aortic pressure signal for calculating the regurgitation index.

[0256] exist Fig. 23B , a left ventricular pressure waveform (LVEP) 2310 and an aortic pressure waveform (AOP) 2312 are depicted, which may correspond to pressure waveforms generated during a procedure such as transcatheter aortic valve replacement (TAVR), which may be used to calculate an improved regurgitation index. As described above, wire manipulation within the ventricle may cause some instability in the patient's heart rate during the procedure. As shown, heart rate instability may result in longer portions 2314A, 2314B, 2314C of the aortic pressure waveform 2312, where there is a distinctive curve relative to other portions of the aortic pressure waveform 2312. According to an embodiment, one or more methods may be used to select portions of the aortic pressure waveform 2312 for regurgitation index calculation. The length of the heartbeat may be used to identify portions of the aortic pressure waveform 2312 to be included or excluded from the calculation. For example, if the time between two systoles of adjacent heartbeats of the pressure waveform or signal is too short or too long, these portions of the signal may be discarded. Additionally or alternatively, the length of the diastole may be used. As discussed herein, these longer diastolic portions 2314A, 2314B, 2314C of the aortic pressure waveform 2306 may be used to calculate an improved regurgitation index.

[0257] In some embodiments, a regurgitation index can be calculated from beats that meet a threshold (e.g., beats with a predetermined length in diastole). Beats that are insufficient in length (e.g., ectopic beats) can be rejected by the system and not used to calculate one or more regurgitation indices.

[0258] iii. Aortic regurgitation index

[0259] The regurgitation index can be used for various purposes, such as diagnostic and / or assessment purposes. In particular, the above-described system 200 and / or system 1400 can be used to generate an index from the regurgitation index, which may also be referred to herein as a "combined valve condition." For example, the index can be useful to a clinician to help answer the following question: Is the regurgitation improving, remaining stable, or worsening after a procedure (such as a transcatheter aortic valve, mitral valve, tricuspid valve, or pulmonary (arterial) valve replacement procedure)?

[0260] The above-mentioned system 200 and / or system 1400 can calculate the index by any index (post-procedure and pre-procedure) described in this article, such as calculating the index by the aortic regurgitation index or the time-integrated aortic regurgitation index (post-procedure and pre-procedure). An example index is the ratio calculated by the post-procedure and pre-procedure indices. The aortic regurgitation ratio can serve as a powerful predictor of mortality one year after a transcatheter aortic valve replacement procedure. The above-mentioned system 200 and / or system 1400 can calculate the aortic regurgitation ratio by dividing the post-procedure aortic regurgitation index value by the pre-procedure aortic regurgitation index value. An example formula for calculating the aortic regurgitation ratio index is provided below.

[0261]

[0262] Additional example regurgitation indicators are described below that may be useful to clinicians in determining whether regurgitation is improving or worsening after a procedure. If a patient's aortic regurgitation ratio remains stable or improves, some studies suggest that the patient may perform better or have fewer adverse events after the procedure. Similarly, if other aortic regurgitation indicators (such as those described below) remain stable or improve, the patient may perform better or have fewer adverse events after the procedure.

[0263] Another example indicator is the difference between the post-procedural and pre-procedural indices (difference). For example, the system can calculate the aortic regurgitation difference by subtracting the pre-procedural aortic regurgitation index value from the post-procedural aortic regurgitation index value. An example formula for calculating the aortic regurgitation difference indicator is provided below.

[0264] Aortic regurgitation difference = AR 后 -AR 前

[0265] Another example indicator can be the standardized difference between the post-procedural and pre-procedural indices. For example, the system can calculate the standardized aortic regurgitation difference by subtracting the pre-procedural aortic regurgitation index value from the post-procedural aortic regurgitation index value and dividing by the pre-procedural aortic regurgitation index value. An example formula for calculating the aortic regurgitation difference indicator is provided below.

[0266]

[0267] In some embodiments, the system can display information other than the aortic regurgitation indicator that can be helpful for diagnostic and / or assessment purposes. For example, the system can display the patient's heart rate (such as resting heart rate) after the procedure and before the procedure.

[0268] iv. Corrected aortic regurgitation index

[0269] Arterial stiffness, which may be common in patients with valve replacement, affects the pressure waveform in a manner similar to aortic regurgitation. In these cases, the aortic regurgitation index described above may lead to a false determination of positive regurgitation, which in turn may lead to unnecessary valve adjustments. More specifically, arterial stiffness has the effect of increasing systolic blood pressure. Fig.23C In the present invention, this pressure increase 2330 can be caused by a reflected pressure wave of the hardened vascular system, which occurs earlier than in the normal vascular system. In the normal vascular system, the reflected wave occurs later in the diastole, so there can be an increase in the early stage of diastolic pressure.

[0270] Pressure during diastole is maintained by the compliance of the vascular system. The extensibility of the arteries (primarily the aorta) maintains pressure within the vascular system by retracting toward an unsolicited state. Stiffened arteries do not have the same degree of compliance, so the arteries are not able to maintain prolonged pressure during diastole. When diastolic pressure falls faster, aortic end-diastolic pressure (AEDP) also falls faster, so there is less aortic regurgitation.

[0271] Diastolic pressure can be represented by a two-component model including vascular system compliance (C) and total vascular resistance (R). Diastolic pressure relaxation provides the following diastolic period equation representation.

[0272]

[0273] If compliance is known, this equation will allow calculation of total vascular resistance (R). End-aortic diastolic pressure can be recalculated using generally normal compliance and the previously calculated total vascular resistance.

[0274] Compliance can be referred to as the increase in arterial capacity / volume for a given change in pressure, as shown in the following equation.

[0275]

[0276] ΔV can be obtained by measuring the relative change in arterial diameter. It can be more easily measured by measuring the left ventricular stroke volume / volume obtained from the difference in angiographic left ventricular contour measurements between systole and diastole. ΔP is the gradient of aortic systolic to diastolic pressure.

[0277] Arterial stiffness may be well correlated with pressure augmentation (PA) 2330, or conversely, compliance may be well correlated with the inverse of pressure augmentation. Correction of aortic regurgitation may be preferably performed by pressure augmentation because it may be more easily implemented in a clinical setting. Pressure augmentation may be accompanied by visible changes in the ascending portion of systole 2331, allowing estimation of pressure augmentation. Another method may include injecting nitroglycerin into the patient because it relaxes the arterial system, resulting in a decrease in pressure augmentation. The change in aortic systolic pressure caused by nitroglycerin may provide pressure augmentation. Compliance may be provided with the following relationship in the form of the compliance equation using pressure augmentation or adjusted assuming a generally normal compliance C n Any relationship f(PA) can be estimated.

[0278] C=f(PA)=C n -k·PA

[0279] R can be calculated by substituting C from the above equation into the Diastolic Equation using the diastolic aortic pressure measurement. The calculated R and C are then converted to the corrected aortic diastolic pressure (CADP). n The corrected aortic regurgitation was calculated by replacing the aortic diastolic pressure (ADP) with the corrected aortic diastolic pressure (CADP) as shown in the following equation.

[0280]

[0281] Another approach consists of replacing the measured aortic systolic pressure with the corrected aortic systolic pressure, ie removing the pressure enhancement contribution from the ASP. Corrected aortic regurgitation can also be made using the above-mentioned mean diastolic pressure calculation result, rather than using only the end-diastolic pressure value.

[0282] The increased pressure during left ventricular diastole caused by abnormal venous pressure can also lead to errors in the calculated aortic regurgitation index. Another improvement method involves subtracting the contribution of venous or atrial pressure from the left ventricular diastolic pressure component, as shown in the following equation.

[0283]

[0284] v. Regurgitation index based on diastolic slope(s)

[0285] When there is regurgitation, blood from the aorta returns to the left ventricle during the diastolic portion of the cycle. This can occur due to paravalvular leak. When blood from the aorta returns to the left ventricle, the aortic pressure decreases, that is, the downward slope of the graph of the aortic pressure values ​​over time will change more dramatically than in the absence of regurgitation. In contrast, the slope of the graph of left ventricular diastolic pressure over time will increase compared to the absence of regurgitation. This occurs because the pressure of the blood entering the left ventricle is higher than the blood inside the ventricle during this portion of the beat. Left ventricular diastolic pressure (LVDP) may not vary that much from patient to patient - even when different factors or conditions are taken into account. In contrast, the aortic slope can have relatively large variations in view of one or more factors or conditions, such as vascular stiffness (e.g., stiffness of the aorta or vasculature). Therefore, the regurgitation index can be corrected by taking into account vascular stiffness.

[0286] exist Fig.23D 2344, the left ventricular pressure waveform (LVEP) 2340 and the aortic pressure waveform (AOP) 2342 can depict the situation in which regurgitation exists. As described above, during the diastolic portion of the cycle 2344, blood from the aorta returns to the ventricles, and the aortic pressure can decrease, and the downward slope (as shown) generally changes more sharply than in the absence of regurgitation. Conversely, during the diastolic portion of the cycle 2344, the left ventricular pressure 2340 can increase with a generally upward slope (as shown).

[0287] During the diastolic portion of cycle 2344, some of the oscillations shown may be caused by the fluid filling the pressure line. In particular, the oscillations may be caused by sudden pressure differences caused by the fluid filling the line. In some embodiments, the use of a pressure transducer included in the pressure device can reduce these oscillations. For example, the pressure transducer can be configured to generate an electrical signal or an optical signal indicative of pressure. For example, a smoother pressure tracing (such as Fig.23A or the waveform shown in 23B). These improved pressure tracings can be used to calculate an improved reflux index.

[0288] As described herein, one way to assess vascular stiffness is through pressure enhancement. Fig.23E , depicts an aortic pressure waveform 2350 when there is some vessel stiffness. As shown, the aortic valve opens at time "t1". Due to the stiffness, instead of the aortic dilation due to increased pressure, a pressure wave can be generated that can return to the aortic root, valve area and / or ventricle. As shown, the pressure of the positive wave "p f ” and the enhanced pressure "p" of the reflected wave arriving at time "t2" aug ” are added to produce the first shoulder in waveform 2350. In late systole, the pressure decreases and reaches the second shoulder - which ends with the closure of the aortic valve at time "t3". Fig.23E The aortic pressure waveform 2350 (where some vascular stiffness is present) is compared to Fig.23D This contrasts with the aortic pressure waveform 2342 (in which the vascular system has greater compliance).

[0289] The mathematical derivation of pressure augmentation - known as the augmentation index (AI) - can indicate aortic or vascular stiffness and can be used to analyze the physical state of the arterial system. The augmentation index can be calculated as the pressure change from the first shoulder to the peak of the rising portion of the aortic waveform (p aug ) as a percentage of the pressure pulse (PP). PP is the pressure from the minimum value just before the aortic valve opens to p f With p aug The total pressure change of the pressure maximum value is added. An example formula for calculating the enhancement index is provided below.

[0290]

[0291] exist Fig.23F , the pressure change of the aortic pressure waveform 2350 is shown (p aug ) and pressure pulse (PP).

[0292] In some cases, there may be problems with measuring the pressure in one or more cardiovascular regions, which may affect the calculation of the augmentation index. For example, the measured pressure and / or the recorded pressure waveform may be inaccurate in some cases. In particular, some existing procedures use a short guidewire with a distal pigtail tip for contrast injection and pressure measurement. This method can lead to inaccurate pressure measurements and therefore inaccurate waveforms. Therefore, it is very important to use a sensor configured to accurately measure the pressure of one or more cardiovascular regions (such as the aorta or one or more other cardiovascular regions). As described herein, one or more pressure equipment (such as a pressure guidewire, an aortic wire, a catheter including a distal pressure sensor, and / or a catheter that can measure distal pressure) can be used to measure the pressure in the aorta and / or at a location near the valve. Preferably, the pressure equipment (one or more) can be configured or used to greatly improve the accuracy of pressure measurement to calculate the augmentation index. For example, as an improvement to existing procedures, a guidewire configured to more accurately measure pressure can be included in the distal end of the aortic pigtail.

[0293] As described herein, vascular stiffness can cause pressure reverberation, which can lead to pressure enhancement (p aug ), and the augmentation index can be used to estimate the stiffness of the vessel. Stiffer vessels do not deform as much as normal vessels during the systolic phase of the cycle, resulting in less stored energy. The stored energy can be transferred as pressure during diastole. Therefore, the augmentation index (Al) and / or pressure augmentation (p aug ) can be used to at least partially correct the aortic diastolic (pressure) slope. For example, the aortic diastolic slope can be based on the augmentation index (AI) and / or the pressure augmentation (p aug ) value applies a correction factor to the aortic diastolic slope.

[0294] One or more methods may be used to calculate the aortic diastolic pressure slope. The aortic diastolic pressure slope may be calculated from the slope of two points during diastole (e.g., the dicrotic notch and the minimum). The aortic diastolic pressure slope may be calculated from the slope of a linear fit of (partial or full) left ventricular diastolic pressure. For example, Fig.23D , a linear fit of the left ventricular pressure waveform (LVEP) 2340 during the diastolic portion (part or all) of the cycle 2344 can be calculated. For example, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the diastolic period can be utilized. As another example, pressure data at the midpoint of the diastolic period can be utilized, and 20% or 75% of the diastolic period can be used by removing the proximal (early pulsating) and distal (late pulsating) portions from the midpoint. The aortic diastolic pressure slope can be calculated by the slope of a linear fit of the filtered pressure signal of the aortic diastolic pressure (part or all). The aortic diastolic pressure slope can be calculated by the slope of a polynomial or exponential distribution of the aortic diastolic pressure (part or all).

[0295] The left ventricular diastolic pressure slope can be used (in some cases exclusively) to evaluate regurgitation. For example, a pressure tracing that identifies regurgitation can be used to establish a correlation between the left ventricular diastolic pressure slope and regurgitation. One or more methods can be used to calculate the left ventricular diastolic pressure slope. The left ventricular diastolic pressure slope can be calculated by the slope between each point of the left ventricular diastolic pressure (LVDP) and / or the end-diastolic ventricular pressure (LVEDP). The left ventricular diastolic pressure slope can be calculated by the slope of a linear fit of the left ventricular diastolic pressure (part or all). The left ventricular diastolic pressure slope can be calculated by the slope of a linear fit of a filtered pressure signal of the left ventricular diastolic pressure (part or all). The left ventricular diastolic pressure slope can be calculated by the slope of a polynomial or exponential distribution of the left ventricular diastolic pressure (part or all).

[0296] Some regurgitation calculations can be based on the left ventricular diastolic pressure slope and the aortic diastolic pressure slope. One or more methods can be used to calculate regurgitation from the diastolic pressure slope. Regurgitation can be calculated by at least adding and / or adding (possibly averaging) the left ventricular diastolic pressure angle slope and the aortic diastolic pressure angle slope (partially or completely). As used herein, "slope" refers to the slope angle of the slope line in addition to its conventional meaning. The regurgitation index can be calculated by at least multiplying and / or dividing the left ventricular diastolic pressure slope and the aortic diastolic pressure slope. As described herein, the corrected aortic diastolic slope can be used to perform regurgitation calculations based on the augmentation index and / or pressure augmentation.

[0297] vi. Time constant index

[0298] Changes in the time constant of the pressure decay during diastole (pre-procedure and post-procedure) can be correlated with the patient's outcome after the procedure. In other words, the time constant metric can be useful to clinicians in determining whether regurgitation is improving or worsening after a procedure such as a transcatheter aortic valve replacement (TAVR) procedure.

[0299] An example formula is provided below to estimate the time constant τ (which may be expressed in seconds).

[0300] τ=A 12 / (P1-P2)

[0301] In this example formula, A 12 is the pressure integral of the arterial pressure wave in diastole between time t1 and time t2, P1 is the arterial pressure at time t1, and P2 is the arterial pressure at time t2. Time t1 can be selected to be a time shortly after the end of ejection, and time t2 can be selected to be a time before the next ejection begins. The example formula for estimating the time constant can be used to estimate arterial compliance in the ternary Windkessel model.

[0302] Advantageously, the time constant may be independent of heart rate (which may be different from the aortic regurgitation index (ARI) and / or the time-integrated aortic regurgitation index (TIARI)). On the other hand, the time constant is sensitive to aortic stiffness because it is measured on the aortic pressure signal. Therefore, the time constant variation may be more meaningful with respect to the results of the evaluation procedure than the time constant itself.

[0303] The time constant (and / or changes therein) between aortic pressure and ventricular pressure during diastole may also be useful. An example formula for estimating the time constant (which may be in seconds) between aortic pressure and ventricular pressure is provided below.

[0304]

[0305] In this example formula, the area (AO-LV) 12 is the area between the aortic pressure wave and the left ventricular pressure wave between time t1 and time t2 during diastole; AO1, AO2, LV1 and LV2 are the aortic pressure and left ventricular pressure at time t1 and t2, respectively. As described herein, aortic and left ventricular pressure measurements can be obtained by pressure sensing devices, such as diagnostic catheters, guide catheters, pigtail catheters and / or pressure guidewires in the aorta and / or left ventricle.

[0306] The time constant of left ventricular pressure during diastole (and / or its changes) may also be useful. Because left ventricular diastolic pressure may be greatly affected by regurgitation, an example formula for estimating the time constant of ventricular pressure (which may be measured in seconds) is provided below.

[0307]

[0308] In this example formula, the area (LV) 12 is the area under the left ventricular pressure wave between time t1 and time t2 during diastole, and LV1 and LV2 are the left ventricular pressures at time t1 and t2, respectively. Again, as described herein, left ventricular pressure measurements may be obtained by a pressure sensing device such as a catheter or pressure guidewire.

[0309] vii. Heartbeat Selection

[0310] The diastolic phase can be a target area or cardiac phase when evaluating a patient's regurgitation (e.g., a patient's regurgitation index calculation can utilize the diastolic phase). In addition, procedures such as transcatheter aortic valve replacement (TAVR) can often result in extrasystoles and / or multiple ectopic heartbeats, which can significantly reduce the diastolic portion of the cycle. Therefore, with respect to one or more of the indices and / or indicators described herein, it can be beneficial to use appropriate or sufficient heartbeat(s) when calculating the corresponding index or indicator. In other words, it can be beneficial to exclude inappropriate heartbeats (such as extrasystoles and / or multiple ectopic heartbeats) when calculating one or more of the indices and / or indicators described herein.

[0311] In some embodiments, the system can utilize the length of the heartbeat to classify the heartbeat. Then, the system can utilize the classification of the heartbeat to determine whether the heartbeat should be included in or excluded from the index or indicator calculation. For example, if the system identifies a heartbeat based on the length of the heartbeat as inappropriate, the system can exclude the heartbeat from being used for the index or indicator calculation. The system can exclude heartbeats above or below a specific threshold time. For example, the patient's average (or other statistical measure) heart rate can be 65 beats / minute, which can be converted into heartbeat length in seconds. In some embodiments, the system can reject heartbeats that are 10%, 20%, or 30% longer or shorter than a specific heartbeat length (such as an average heartbeat length, for example, at a resting heart rate or a program-induced heart rate).

[0312] In some embodiments, the system can use the length of the aortic or left ventricular pressure tracing during diastole to classify the heartbeat. The system can then use the heartbeat classification to determine whether the heartbeat should be included or excluded from the index or indicator calculation. For example, if the system identifies a heartbeat as inappropriate based on the length of the aortic or left ventricular pressure tracing during diastole of the heartbeat, the system can exclude the heartbeat from being used for the index or indicator calculation. The system can exclude heartbeats whose aortic diastolic length or left ventricular diastolic length is above or below a specific threshold time. For example, the average (or other statistical measure) aortic diastolic length or left ventricular diastolic length (in seconds) can be predetermined, determined during the procedure, and / or received. In some embodiments, the system can reject heartbeats whose aortic or left ventricular diastolic (length) is 10%, 20%, or 30% longer or shorter than a specific aortic diastolic length or left ventricular diastolic length (such as the average aortic diastolic length or the average left ventricular diastolic length).

[0313] In some embodiments, the system can utilize the aortic or left ventricular pressure value during the heartbeat contraction to classify the heartbeat. Then, the system can utilize the heartbeat classification to determine whether the heartbeat should be included in or excluded from the index or indicator calculation. For example, if the system identifies the heartbeat based on the aortic or left ventricular systolic pressure of the heartbeat as inappropriate, the system can exclude the heartbeat from being used for the index or indicator calculation. The system can exclude heartbeats whose aortic or left ventricular systolic pressure is above or below a specific threshold pressure. For example, the average (or other statistical measure) aortic or left ventricular systolic pressure can be predetermined, determined during the procedure, and / or received. In some embodiments, the system can reject heartbeats whose aortic or left ventricular systolic pressure is 10%, 20%, or 30% longer or shorter than a specific aortic or left ventricular systolic pressure (such as the average aortic systolic pressure or left ventricular systolic pressure).

[0314] Additional techniques based on pressure measurements and / or ECG tracings can be used to identify irregular heart beats for potential exclusion. For example, an ECG tracing can be compared with an ECG tracing of a first library associated with a normal heart cycle. Similarly, an ECG tracing can be compared with an ECG tracing of a second library associated with an irregular heart cycle. The system can determine whether the ECG tracing matches (or does not match) an ECG tracing from a library - using one or more mathematical techniques, such as but not limited to partial least squares regression, linear regression, nonlinear regression and / or other comparative analysis techniques. In some embodiments, a threshold for determining how close (or far away) an ECG tracing must be to an ECG tracing from a library to be considered a match (or mismatch) can be selected based on user preferences, empirical results and / or a combination thereof. In some embodiments, an ECG tracing can be compared with an objective measurement standard to determine whether the associated heart cycle will be considered normal or irregular. For example, in some embodiments, an ECG tracing can be evaluated using heart rate. If the heart rate is faster or slower than the normal range, the corresponding heart cycle (one or more) can be considered irregular.

[0315] Similar matching and comparison methods can be used for pressure measurements. For example, the waveform of the obtained pressure measurement can be compared with a library of pressure measurement waveforms for normal and / or irregular heart cycles, respectively. The system can determine whether the pressure waveform matches (or does not match) a pressure waveform from the library, which can be determined using any of the techniques described herein, such as but not limited to partial least squares regression, linear regression, nonlinear regression, and / or other comparative analysis techniques.

[0316] In some embodiments, the pressure measurement results and / or ECG tracings can be compared with other pressure measurements and / or ECG tracings. In this regard, if the pressure measurement results and / or ECG tracings deviate too far from other pressure measurements and / or ECG tracings, respectively, the heartbeats associated with the pressure measurement results and / or ECG tracings can be considered as irregular heartbeat cycles. Whether the pressure measurement results and / or ECG tracings deviate too far from other pressure measurements and / or ECG tracings, respectively, can be evaluated using statistical analysis techniques, such as but not limited to deviations from the mean, deviations from the median, and / or other suitable deviation analysis techniques.

[0317] e. Additional Pressure Sensor Calibration

[0318] As described herein, the first sensor can be calibrated relative to the second sensor to determine a more accurate pressure measurement result, which can also be referred to as equalization. For example, the pressure guidewire can be at or near the valve position together with another pressure device. Another pressure device can be a catheter, a pigtail or other device for delivering a valve and including an inner cavity connected to a pressure transducer. The pressure device can be another pressure guidewire or a catheter including a distal pressure sensor. Additional pressure equipment can include a piezoelectric sensor and / or an optical sensor. The example pressure equipment that can be equalized can be selected from, but not limited to, a pressure guidewire, a catheter, a pigtail, a distal pressure sensor, a piezoelectric sensor, and / or an optical sensor. Therefore, an example combination of pressure equipment that can be equalized can include two pigtails, two piezoelectric sensors, two optical sensors, and / or any other combination of pressure equipment. However, unlike some calibration techniques described herein (wherein the pressure equipment is located in the same cardiovascular region for calibration), other calibration techniques described herein can be performed when the pressure equipment is located in different cardiovascular regions, such as the first equipment is located in the left ventricle and the second equipment is located in the aorta. As described herein, the calibration of the pressure equipment when the equipment is located in different cardiovascular regions of the heart can be achieved by detecting one or more features of the pressure waveform. In particular, one or more features detected in the pressure waveform may be used to time adjust and / or gain adjust the pressure waveform to achieve equalization purposes.

[0319] The systems and methods described herein for calibrating a pressure sensor when a pressure device is in different positions can improve the efficiency of pressure readings. For example, as described above, pressure calibration can be performed when the pressure devices are positioned in the same cardiovascular region. However, ensuring that both pressure devices are positioned in the same cardiovascular region can add additional steps to the cardiac procedure. The techniques described herein for calibrating by waveform features with time adjustment and / or gain adjustment can be beneficially performed when the pressure device is in different positions required for a cardiac procedure. Therefore, the systems and methods described herein for calibrating when the pressure device is in different positions can improve pressure device technology - by being able to provide more accurate pressure readings (results) without adding additional steps to the cardiac procedure.

[0320] The aortic pressure waveform may be different from the ventricular pressure waveform. Fig. 20 , the aortic pressure may begin to increase at the onset of systole, as shown in the aortic pressure waveform 2011. In particular, the aortic pressure may begin to increase when the aortic valve opens - at the beginning of time period 2012 (wherein the aortic valve opens). The aortic pressure waveform 2011 increases until it reaches at least a local maximum, i.e., the systolic pressure, within time period 2012, and then suddenly decreases until it reaches the dicrotic notch at the end of time period 2012. The dicrotic notch represents the moment when the aortic valve closes. These two moments, when the aortic valve opens and closes, may be useful for equalization because they may represent the only (time) points at which ventricular pressure and aortic pressure may be equal. These two moments, the opening and closing of the aortic valve, may generally correspond to the beginning and end of time period 2012, respectively. The left ventricular pressure waveform 2010 may intersect the aortic pressure waveform 2011 at the beginning and end of time period 2012.

[0321] exist Fig.24 , pressure waveforms that may include phase delays are depicted. In particular, left ventricular pressure waveform 2402 and aortic pressure waveform 2404 are depicted. Fig. 20 The cross-sectional view of the left ventricular pressure waveform 2010 and the aortic pressure waveform 2011 in FIG. Fig.24 The left ventricular pressure waveform 2402 may intersect the aortic pressure waveform 2404 at different times - with respect to the characteristics of the aortic pressure waveform 2404. In particular, Fig.24 In the example, the left ventricular pressure waveform 2402 does not cross the aortic pressure waveform 2404 at the time of valve opening 2406 or at the time of the dicrotic notch 2408. The calibration techniques described herein can be applied to Fig.24 In particular, the time adjustment can be applied to Fig.24 The pressure waveform(s) of FIG.

[0322] exist Fig.25 , pressure waveforms that may include gain errors are depicted. In particular, left ventricular pressure waveform 2502 and aortic pressure waveform 2504 are depicted. Fig.25 In the pressure waveform of , there may be a gain error, which may cause amplitude variations. For example, the left ventricular pressure waveform 2502 may include a gain error of approximately 1.3, which may cause the point where the left ventricular pressure waveform 2502 crosses the aortic pressure waveform 2504 to be widened. In particular, at the dicrotic notch feature of the aortic pressure waveform 2504, the pressure value 2508 of the left ventricular pressure waveform 2502 may be higher than the pressure value 2506 of the aortic pressure waveform 2504. In other examples, if the gain is less than 1, the intersection points will be closer together (not shown). The calibration techniques described herein may be applied to Fig.25 In particular, gain adjustment can be applied to Fig.25 The pressure waveform(s) of FIG.

[0323] exist Fig.26 , pressure waveforms that may contain phase delay and gain errors are depicted. In particular, left ventricular pressure waveform 2602 and aortic pressure waveform 2604 are depicted. The calibration techniques described herein may be applied to Fig.26 In particular, time adjustment and / or gain adjustment may be applied to Fig.26 The pressure waveform(s) of FIG.

[0324] exist Fig. 27 , another example calibration process 2700 is shown. Although process 2700 is used in conjunction with a heart valve assessment system such as Figure 2A System 200 or Fig.14 The process 2700 may be performed by a system 1400 as discussed herein, and any system configured to perform the process in any order is within the scope of the present disclosure. Figure 2A System 200 or Fig.14 The various components of the system 1400 are performed. Depending on the implementation, the process 2700 may include fewer or more blocks and / or the blocks may be performed in a different order than the example. Other implementations of the process 2700 may include fewer blocks than the example or the blocks may be performed in a different order than the example.

[0325] In some embodiments, one set of pressure values ​​can come from a pressure sensor located in the left ventricle (e.g., a pressure fluid-filled line), and another set of pressure values ​​can come from a different pressure sensor located in the aorta (e.g., a pressure guidewire). In addition, in some embodiments, the heart valve assessment system 1400 can adjust the pressure values ​​of the left ventricle based on the output of the calibration process 2700. In some cases, the pressure fluid-filled line has a relatively large delay compared to the pressure guidewire due to the pressure propagation time in the fluid-filled line. Therefore, it can be beneficial to adjust the left ventricular pressure instead of the aortic pressure. As described herein, multiple options are possible. For example, additionally or alternatively, the heart valve assessment system 1400 can adjust the pressure values ​​of the aorta based on the output of the calibration process 2700.

[0326] Beginning at block 2702, the pressure device(s) may be zeroed. In particular, the heart valve assessment system 1400 may zero one or more pressure devices. As used herein, "zeroing" may refer to the process of eliminating external pressure, such as atmospheric pressure, to the system 1400. The system 1400 may zero the one or more pressure devices to exclude pressure signals other than the actual pressure from the patient. Zeroing may produce more accurate data upon which to base treatment / operation decisions.

[0327] At block 2704, a pressure value or signal may be received or determined. In particular, the heart valve assessment system 1400 may receive a pressure signal from a pressure sensor such as a pressure guidewire 208, a pressure sensing access catheter 20, a pressure sensing pigtail catheter 10, a distal pressure sensor, a piezoelectric sensor, and / or an optical sensor. The heart valve assessment system 1400 may determine a first set of pressure values ​​and a second set of pressure values ​​from the received pressure signals. Each pressure value of the first set of pressure values ​​may correspond to a first signal received from a first pressure sensor measuring a first cardiovascular region. Each pressure value of the second set of pressure values ​​may correspond to a second signal received from a second pressure sensor measuring a second cardiovascular region different from the first cardiovascular region. For example, the first pressure sensor may be positioned at a first portion of the heart, and the second pressure sensor may be positioned at a cardiovascular region adjacent to the first portion of the heart. The heart valve assessment system 1400 may determine the first and second sets of pressure values ​​by the first and second sensors, respectively. The current block 2704 for receiving pressure values ​​or signals may be similar to Fig.15 Block 1502 of receiving a pressure value or signal.

[0328] At block 2706, feature detection may be performed. The feature detection service 1412 may perform feature detection. Example features that may be detected from the pressure waveform may include systole, diastole, dicrotic notch, end of diastole, and / or start of systole. The feature detection service 1412 may identify Figure 24-26 In particular, feature detection service 1412 can determine a substantial start (point) of a systolic period in a set of pressure values. As another example, feature detection service 1412 can determine a dicrotic notch feature in a set of pressure values. More details on feature detection are provided above with respect to Fig.19 The current block 2706 for performing feature detection may be similar to Fig.15 Block 1508 performs feature detection.

[0329] In some embodiments, the feature detection service 1412 may perform feature detection by applying one or more thresholds. In some pressure waveforms, the valve opening intersection may not be exactly at the start of systole, but slightly later or earlier. For example, the pressure required to open a highly calcified leaflet may delay pressure transmission in the aorta, resulting in a flatter aortic pressure curve, which may change the intersection. For example, the feature detection service 1412 may identify that systole substantially starts within a certain percentage of the cardiac cycle before or after the end of diastole in a set of pressure values. As another example, the feature detection service 1412 may identify a timestamp corresponding to a dicrotic notch feature, where the timestamp may be within a certain percentage of the cardiac cycle before or after the dicrotic notch in a set of pressure values. Example threshold percentages may include between approximately 0% to 1%, 0% to 2%, 0% to 5%, and 0% to 10% of the cardiac cycle.

[0330] At block 2708, a time adjustment may be calculated. In particular, the calibration service 1408 may calculate the time adjustment. The calibration service 1408 may calculate a time adjustment that causes a set of pressure values ​​to intersect with a baseline set of pressure values ​​at substantially the beginning of the systolic period of the baseline set of pressure values. For example, Fig.24 In the context of a pressure waveform of 2402, the calibration service 1408 can calculate a time adjustment that causes the left ventricular pressure waveform 2402 to intersect the aortic pressure waveform 2404 at a time substantially beginning of systole / valve opening 2406. An example time adjustment can be a time value expressed in time units such as milliseconds or seconds. At block 2710, the time adjustment can be applied. In particular, the calibration service 1408 can apply the time adjustment to a set of pressure values ​​so that values ​​from the set of pressure values ​​correspond to values ​​in the base set of pressure values ​​at substantially beginning of systole.

[0331] At block 2712, a gain adjustment may be calculated. In particular, the calibration service 1408 may calculate the gain adjustment. The calibration service 1408 may measure the pressure differential at the dicrotic notch location and calculate the required gain correction. In particular, the calibration service 1408 may use the detected dicrotic notch feature for a reference set of pressure values. The calibration service 1408 may identify a timestamp corresponding to the dicrotic notch feature and determine a first value at the timestamp from the reference set of pressure values. The calibration service 1408 may further determine a second value at the timestamp from another set of pressure values. Where the first value corresponds to V1, the second value corresponds to V2, and the gain adjustment may include g, an example equation for calculating the gain adjustment may include determining a relationship substantially as follows: For example, in Fig.25 In the context of a pressure waveform of , the calibration service 1408 may calculate the gain adjustment (i.e., gain 2506 ) by dividing the pressure value 2506 of the aortic pressure waveform 2504 by the pressure value 2508 of the left ventricular pressure waveform 2502 . 校正 =Ao 重搏 / Lv 重搏 ).

[0332] At block 2714, a gain adjustment may be applied. In particular, the calibration service 1408 may apply the gain adjustment to a set of pressure values ​​to achieve a gain correction. In some implementations, the calibration service 1408 may multiply the gain adjustment by each value of the set of pressure values ​​to modify the magnitude of the pressure value.

[0333] In block 2716, it may be determined whether an end condition of the calibration process 2700 has been met. In particular, the calibration service 1408 may determine whether an end condition has been met. An example end condition may include determining whether an intersection point (one or more) of a set of pressure values ​​is within a threshold of one or more detected features of a reference set of pressure values. For example, the calibration service 1408 may determine that an intersection point of the left ventricular pressure waveform is within a threshold of substantially the beginning (point) of the systolic phase of the aortic pressure value. As another example, the calibration service 1408 may determine that an intersection point of the left ventricular pressure waveform is within a threshold of a dicrotic notch feature of the aortic pressure value. If the condition is not met, the process may return to previous blocks 2708, 2710, 2712, 2714 to recalculate and apply calibration parameters, such as time adjustment and / or gain adjustment. Thus, the calibration service 1408 may operate in a loop until an end condition is met. For example, the calibration service 1408 may operate in a loop until, in some embodiments, a pressure waveform intersection point matches a valve opening indicated by a feature in the pressure waveform. If the end conditions are met, the process continues to box 2718.

[0334] At block 2718, the determined calibration parameter(s) may be stored and / or used. In particular, the calibration service 1408 may store and / or use the time adjustment and / or gain adjustment. For example, the calibration service 1408 applies the time adjustment and / or gain adjustment to a set of pressure values ​​and / or signals received from the pressure equipment after calibration is completed.

[0335] f. Other heart valve assessment methods

[0336] Go to Fig.28 , shows an example valve assessment process 2800. Although process 2800 is used in conjunction with a heart valve assessment system such as Figure 2A System 200 or Fig.14 The process 2800 may be performed by a system 1400 as discussed herein, but any system configured to perform the process in any order is within the scope of the present disclosure. Figure 2A System 200 or Fig.14 The various components of the system 1400 are performed. Depending on the implementation, the process 2800 may include fewer or more blocks and / or the blocks may be performed in a different order than the example. Other implementations of the process 2800 may include fewer blocks than the example or the blocks may be performed in a different order than the example.

[0337] At box 2802, it can be determined whether to control the heart rate. In particular, the clinician can determine whether to control the patient's heart rate. For example, reducing the heart rate can beneficially provide a longer diastolic portion of the aortic pressure signal, which (as described herein) can be used to calculate an improved index or indicator, such as an improved regurgitation index. In some embodiments, controlling the heart rate can be incorporated as a step performed for other reasons in a cardiac procedure. For example, adenosine can be given to reduce the risk of causing myocardial ischemia during the procedure. Therefore, there can be a variety of reasons for controlling the heart rate during the procedure. If it is determined that the heart rate should be controlled, the process 2800 proceeds to box 2804 to control the heart rate. Otherwise, the process 2800 proceeds to the next box 2806.

[0338] At box 2804, the heart rate can be controlled. In particular, the clinician can control the patient's heart rate. For example, the clinician can administer a drug such as adenosine or other drug types having a similar pacing effect to reduce the patient's heart rate. Additionally or alternatively, ventricular pacing can be applied to the heart (e.g., electrical stimulation provided to the ventricles of the heart by a pacemaker) to a predetermined heart rate interval. In some applications, guide wire 308 or other guide wires configured for pacing as described above can be used to induce ventricular pacing at box 2804.

[0339] At box 2806, it can be determined whether an extrasystole is induced. In particular, the clinician can determine whether an extrasystole is induced in the patient. For example, an extrasystole without ejection of blood in the aorta can have the same effect as reducing the heart rate. This will increase the diastolic length of the pressure signal, which (as described herein) can be used to calculate an improved index or indicator, such as an improved regurgitation index. If it is determined that an extrasystole without ejection of blood should be induced, process 2800 proceeds to box 2808 to induce an extrasystole. Otherwise, process 2800 proceeds to the next box 2810.

[0340] At block 2808, an extrasystole may be induced. In particular, the pacemaker may be configured / programmed to induce an extrasystole that does not eject blood in the aorta. The pacemaker may be configured / programmed to induce a relatively low heart rate, such as 60 BPM or other heart rate, which may result in an extrasystole. The pacemaker may cause an extrasystole in which the ventricular heartbeat does not eject blood in the aorta, which may result in a prolonged diastolic portion of the aortic pressure signal. In some applications, guidewire 308 or other guidewires described above that are configured for pacing may be used in the process to induce an extrasystole at block 2808.

[0341] At block 2810, a pressure value or signal may be received or determined. In particular, the system 200, 1400 may receive a pressure signal from a pressure sensor such as a pressure guidewire 208, 308, 408, a pressure sensing access catheter 20, a pressure sensing pigtail catheter 10, a distal pressure sensor, a piezoelectric sensor, and / or an optical sensor. The system 200, 1400 may determine a first set of pressure values ​​and a second set of pressure values ​​from the received pressure signal. Each pressure value in the first set of pressure values ​​may correspond to a first signal received from a first pressure sensor measuring a first portion of the heart. Each pressure value in the second set of pressure values ​​may correspond to a second signal received from a second pressure sensor measuring a cardiovascular region adjacent to the first portion of the heart. For example, the first pressure sensor may be positioned in at least the left ventricle, and the second pressure sensor may be positioned in at least the aorta. The system 200, 1400 may determine a first and second set of pressure values ​​from the first and second sensors, respectively. In some embodiments, the system 200, 1400 may determine or receive one or more time series pressure values. For example, the system 200, 1400 may determine a time series of pressure values ​​from a pressure sensor located in a portion of the heart. As another example, the system 200, 1400 may determine or receive a first set of time series of pressure values ​​from a first pressure sensor located in a first portion of the heart and a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart. The example time series of pressure values ​​may include pairs of pressure values ​​and times. The current block 2810 of receiving pressure values ​​or signals may be similar to Fig.15 Block 1502 of receiving a pressure value or signal.

[0342] At box 2812, it can be determined whether a heartbeat is selected. In particular, the system 200, 1400 can determine whether a heartbeat is selected. A configuration setting can indicate whether the system 200, 1400 should select a heartbeat. In some embodiments, the configuration setting can be user-selected. As described herein, when the system 200, 1400 determines an index or indicator, it can be beneficial to exclude inappropriate heartbeats. If it is determined that a heartbeat should be selected, the process 2800 proceeds to box 2814 to select a heartbeat. Otherwise, the process 2800 proceeds to the next box 2816.

[0343] At box 2814, a heartbeat or a series or other multiple heartbeats can be selected. In one example, system 200, 1400 can select a heartbeat. For example, system 200, 1400 can identify a first heartbeat and a second heartbeat by a first time series and / or a second time series. System 200, 1400 can determine the characteristics of the first heartbeat and the second heartbeat. System 200, 1400 can associate the first heartbeat with a first category based at least in part on a first characteristic of the first heartbeat. Similarly, system 200, 1400 can associate the second heartbeat with a second category based at least in part on a second characteristic of the second heartbeat. The first category and the second category can indicate that the first heartbeat and the second heartbeat have been accepted or rejected, respectively. System 200, 1400 can include heartbeat (one or more) in the calculation (wherein the heartbeat (one or more) has been accepted), and can exclude heartbeat (one or more) that has been rejected.

[0344] Example features of a heartbeat may correspond to the elapsed time of a heartbeat, the elapsed time of a heartbeat during diastole, and the systolic pressure of a heartbeat. In some embodiments, the system 200, 1400 may classify the heartbeat based on the length of the heartbeat. For example, the system 200, 1400 may determine that the elapsed time of a heartbeat is outside a threshold range and reject the heartbeat. In other words, the system 200, 1400 may determine that the length of the heartbeat is too long or too short, and therefore reject it. In some embodiments, the system 200, 1400 may classify the heartbeat based on the length of the heartbeat during diastole. For example, the system 200, 1400 may determine that the elapsed time of a heartbeat during diastole exceeds a threshold time and rejects the heartbeat. In some embodiments, the system 200, 1400 may classify the heartbeat based on the pressure value of the heartbeat. For example, the system 200, 1400 may determine that the systolic pressure of the heartbeat exceeds a threshold and rejects the heartbeat.

[0345] At block 2816, a heart rate may be determined. In particular, the system 200, 1400 may determine or receive the patient's heart rate. For example, the system 200, 1400 may determine the patient's heart rate from an electrocardiogram (ECG). In other embodiments, the heart rate may be determined by other physiological sensors (one or more) that monitor the patient, such as heart rate monitoring based on photoplethysmography (PPG).

[0346] At block 2818, a value indicative of a heart valve condition, such as an index or indicator, can be determined. In particular, the system 200, 1400 can determine the heart valve condition based on data from previous blocks. As described herein, example values ​​indicative of a heart valve condition can include a regurgitation index, a time-integrated regurgitation index, a time constant, hemodynamics, and other indices and indicators described herein. In some embodiments, the system 200, 1400 can determine the regurgitation index based at least in part on (i) a first value from a first pressure value and (ii) a second value from a second pressure value. The current block 2810 for determining a value indicative of a heart valve condition can be similar to the method for determining a value indicative of a heart valve condition. Fig.13 Block 1308 and / or Fig.15 Block 1510. Further details regarding determining a value indicative of a heart valve condition are described above in Sections III and IV.

[0347] In some embodiments, the system 200, 1400 can determine a regurgitation index normalized by heart beat length. The system 200, 1400 can calculate (i) a first end-diastolic pressure of a first portion of the heart and (ii) a systolic pressure of the first portion of the heart from a first pressure value. The system 200, 1400 can calculate a second end-diastolic pressure of a cardiovascular region adjacent to the first portion of the heart from a second pressure value. The system 200, 1400 can determine the regurgitation index by: calculating a pressure difference between the first end-diastolic pressure and the second end-diastolic pressure; and calculating a normalized pressure difference value based at least in part on systolic pressure and heart rate. For example, the system 200, 1400 can calculate the aortic regurgitation index using a heart rate (e.g., 60 beats per minute (BPM)). As described in the previous box 2804 for controlling heart rate, one or more techniques can be used to control heart rate (e.g., administering medication or initiating ventricular pacing) - before the system 200, 1400 calculates an index or indicator.

[0348] In some embodiments, the system 200, 1400 can determine a regurgitation index as described herein. The system 200, 1400 can calculate (i) a first end-diastolic pressure of a first portion of the heart and (ii) a systolic pressure of the first portion of the heart from a first pressure value. The system 200, 1400 can calculate a second end-diastolic pressure of a cardiovascular region adjacent to the first portion of the heart from a second pressure value. The system 200, 1400 can determine the regurgitation index based at least in part on the first end-diastolic pressure, the second end-diastolic pressure, and the systolic pressure.

[0349] In some embodiments, the system 200, 1400 may determine a regurgitation index based at least on a diastolic slope, as described herein. The system 200, 1400 may identify a subset of time series pressure values ​​corresponding to at least a portion of the diastolic period. The system 200, 1400 may calculate a first slope from the subset of time series pressure values. An example method for the system 200, 1400 to calculate the first slope may include: determining a linear fit from the subset of time series pressure values; and calculating the first slope from the linear fit. Another example method for the system 200, 1400 to calculate the first slope may include: determining a polynomial function from the subset of time series pressure values; and calculating the first slope from the polynomial function. Another example method for the system 200, 1400 to calculate the first slope may include: determining an exponential function from the subset of time series pressure values; and calculating the first slope from the exponential function. The system 200, 1400 can identify a first regurgitation index based at least in part on the first slope, wherein identifying the first regurgitation index can include: finding the first regurgitation index associated with the first slope. As described herein, a time series of pressure values ​​can be obtained from a sensor position in at least a portion of the left ventricle. More details about using the diastolic slope are discussed in more detail in Section IV above.

[0350] In some embodiments, the system 200, 1400 can determine a correlation between a slope and a regurgitation index. The system 200, 1400 can access pressure measurements, where each of the pressure measurements corresponds to a patient. For each of the pressure measurements, the system 200, 1400 can calculate a pair including a diastolic slope and a regurgitation index from the pressure measurements. The system 200, 1400 can determine a correlation between a diastolic slope and a regurgitation index based at least in part on the paired diastolic slope and regurgitation index. Thus, the system 200, 1400 can look up the regurgitation index from the first slope—by applying the determined correlation between the diastolic slope and the regurgitation index to the first slope.

[0351] In some embodiments, the system 200, 1400 can determine the regurgitation index based on at least two diastolic slopes, as described herein. The system 200, 1400 can identify a subset of first time series pressure values ​​corresponding to at least a portion of the diastolic period; and identify a subset of second time series pressure values ​​corresponding to at least the portion of the diastolic period. As described herein, the first and second time series can come from sensors located at least in the left ventricle and the aorta, respectively. The system 200, 1400 can (i) calculate a first slope from a subset of the first time series pressure values ​​and (ii) calculate a second slope from a subset of the second time series pressure values. The system 200, 1400 can determine the regurgitation index based at least in part on the first slope and the second slope. More details about using multiple diastolic slopes are discussed in more detail in Section IV above.

[0352] In some embodiments, the system 200, 1400 may determine the regurgitation index from a plurality of diastolic slopes using a statistical metric, such as a mean. The system 200, 1400 may calculate a first slope (multiple) from a subset of the first time series pressure values, wherein the first slope (multiple) includes a first slope; and calculate a second slope (multiple) from a subset of the second time series pressure values, wherein the second slope (multiple) includes a second slope. The system 200, 1400 may determine a slope angle for each of the first slope (multiple) and the second slope (multiple). The system 200, 1400 for determining the regurgitation index may include: determining a first statistical metric from a slope angle for each of the first slopes; determining a second statistical metric from a slope angle for each of the second slopes; and calculating a combined statistical metric from the first statistical metric and the second statistical metric. The system 200, 1400 may designate the combined statistical metric as a regurgitation index. In some embodiments, the system 200, 1400 can calculate the combined statistical metric by at least one of adding or subtracting the first statistical metric and the second statistical metric. In particular, the system 200, 1400 can calculate the example combined statistical metric by at least adding and / or subtracting (possibly averaging) a first angular slope (e.g., left ventricular diastolic pressure slope) and a second angular slope (e.g., aortic diastolic pressure slope).

[0353] In some embodiments, the system 200, 1400 can determine the regurgitation index by combining multiple diastolic slopes. The system 200, 1400 can determine a first slope angle of a first slope and a second slope angle of a second slope. The system 200, 1400 can determine the regurgitation index by at least: calculating a combined slope angle from the first slope angle and the second slope angle; and designating the combined slope angle as the regurgitation index. In some embodiments, the system 200, 1400 calculating the combined slope angle can include at least one of adding, subtracting, multiplying, or dividing the first slope angle and the second slope angle. For example, the system 200, 1400 can calculate the regurgitation index by at least multiplying and / or dividing the left ventricular diastolic pressure slope and the aortic diastolic pressure slope.

[0354] In some embodiments, the system 200, 1400 may correct the diastolic slope. The system 200, 1400 may determine an initial slope from a subset of the second time series pressure values. The system 200, 1400 may determine a correction factor from the second time series pressure values. The system 200, 1400 may calculate a corrected diastolic slope from the initial slope by applying the correction factor to the initial slope. The system 200, 1400 may designate the corrected diastolic slope as the second slope, which may be used as described above. As described herein, the system 200, 1400 may determine the correction factor by: calculating at least one of an enhancement index or pressure enhancement from the second time series pressure values; and determining the correction factor based at least in part on one of the enhancement index or pressure enhancement.

[0355] In some embodiments, the system 200, 1400 can determine the regurgitation index based at least on the beat selection. For example, the system 200, 1400 can determine the regurgitation index by: excluding the first heartbeat based at least in part on the first category and the first heartbeat being rejected; and including the second heartbeat based at least in part on the second category and the second heartbeat being accepted. The system 200, 1400 can calculate the regurgitation index based at least in part on (i) a first portion of the first time series associated with the second heartbeat and (ii) a second portion of the second time series associated with the second heartbeat.

[0356] In some embodiments, the system 200, 1400 can determine a time constant and / or an indicator based on the time constant as a value indicating a heart valve condition. In particular, the system 200, 1400 can calculate the time constant from a set of time series pressure values. As described herein, the system 200, 1400 calculating the time constant can include at least determining a relationship τ, substantially as follows:

[0357]

[0358] Area (PR) 12 It can be an area between (i) a first time series pressure value from a first portion of the heart and (ii) a second time series pressure value from a cardiovascular region adjacent to the first portion of the heart and between a first time and a second time. P1 is a first pressure value at a first time from a first time series pressure value. R1 is a first pressure value at a first time from a second time series pressure value. P2 is a second pressure value at a second time from a first time series pressure value. R2 is a second pressure value at a second time from a second time series pressure value. As described herein, the first portion of the heart may include at least a left ventricle, and a cardiovascular region adjacent to the first portion may include at least an aorta. The first time and the second time may be within a diastolic period.

[0359] In some embodiments, the system 200, 1400 can determine the time constant from a time series from a pressure sensor positioned at a single portion of the heart. In particular, the system 200, 1400 can calculate the time constant from a set of time series pressure values ​​obtained from a single portion of the heart. As described herein, the system 200, 1400 calculating the time constant can include at least determining the relationship τ, substantially as follows:

[0360]

[0361] Area (P) 12 It can be the area under the time series pressure values ​​between the first time and the second time. P1 is the first pressure value at the first time from the time series pressure values. P2 is the second pressure value at the second time from the time series pressure values. As described herein, a single portion of the heart can include at least the left ventricle or the aorta. The first time and the second time can be in diastole.

[0362] At block 2820, it may be determined whether multiple values ​​indicating heart valve conditions (one or more) should be determined. In particular, the system 200, 1400 may determine whether multiple values ​​indicating heart valve conditions (one or more) should be determined based on specific configuration settings of the system 200, 1400 and / or user selections through a graphical user interface. Some graphical user interfaces described herein may display multiple indices or indicators from different time periods and / or heart valve condition indication values ​​including multiple indices or indicators. For example, the graphical user interface of the system 200, 1400 may display the regurgitation difference of the first and second regurgitation indices from different time periods (such as before a cardiac procedure and after a cardiac procedure). If multiple valve conditions should be determined and the valve conditions are not yet ready, the process 2800 returns to the first block 2802. If multiple valve conditions should be determined and the valve conditions are ready, the process 2800 proceeds to block 2824 to determine the combined valve condition (when applicable). Otherwise, the process 2800 proceeds to block 2822 to display the value indicating the heart valve condition.

[0363] In some embodiments, the system 200, 1400 allows a user to mark the reflux calculation results for comparison. For example, the graphical user interface of the system 200, 1400 can receive a user selection to mark the reflux value for later comparison. Then, the later graphical user interface (which can be similar to Fig. 10A A graphical user interface 1000 may display a combined value indicating a heart valve condition using a labeled regurgitation value. For example, a graphical user interface (which may be displayed during a real-time program) may display a regurgitation ratio using a labeled value.

[0364] At block 2822, a value indicative of a heart valve condition may be displayed. In particular, the system 200, 1400 may display a value (such as an index or indicator) indicative of a heart valve condition in a user interface. The value indicative of a heart valve condition may be displayed in a user interface as described herein. More details on valve condition display are provided above with respect to Fig.13 Block 1310 and Figures 10A-10E The user interfaces of 11A-11E are described in further detail.

[0365] As described above, if multiple valve conditions should be determined and the valve conditions are not yet ready, the process 2800 returns to the first box 2802. Therefore, in some embodiments, the previous boxes 2802, 2804, 2806, 2808, 2810, 2812, 2814, 2816, 2818 can correspond to a first time period, such as a time period before a cardiac procedure. Therefore, before the cardiac procedure, the system 200, 1400 can determine a first pressure value (such as a first set of time series pressure values) from at least (i) a first pressure sensor located in a first part of the heart and (ii) a second pressure sensor located in a cardiovascular region adjacent to the first part of the heart. The system 200, 1400 can calculate a first value indicating a heart valve condition, such as a first regurgitation index and / or a second time constant, from the first pressure value of the first time period.

[0366] Thus, process 2800 may perform blocks 2802, 2804, 2806, 2808, 2810, 2812, 2814, 2816, 2818 a second time. For example, system 200, 1400 may determine a second value indicative of a heart valve condition for a second time period (e.g., after a cardiac procedure). Thus, after the cardiac procedure, system 200, 1400 may determine a second pressure value (e.g., a second set of time series pressure values) from at least (i) a first pressure sensor located at a first portion of the heart and (ii) a second pressure sensor located at a cardiovascular region adjacent to the first portion of the heart. System 200, 1400 may calculate a second value indicative of a heart valve condition, such as a second regurgitant index and / or a second time constant, from the second pressure values ​​for the second time period.

[0367] At box 2824, a combined valve condition can be determined. In particular, the system 200, 1400 can determine a combined value indicating a heart valve condition (when applicable). In some embodiments, the system 200, 1400 can determine a regurgitation difference based at least in part on a second regurgitation index and a first regurgitation index. For example, the system 200, 1400 can calculate the regurgitation difference by calculating a standardized difference by dividing (i) the difference between the second regurgitation index and the first regurgitation index by (ii) the first regurgitation index, and designating the standardized difference as the regurgitation difference. More details about the combined value indicating the heart valve condition are described in Section IV above. In other embodiments, instead of determining a value indicating the heart valve condition, the process 2800 can skip box 2824 of determining the combined valve condition, and can proceed to the next box 2826. For example, if the previously determined value(s) indicating the heart valve condition(s) are sufficient, the process can proceed to the next box 2826, such as when the current user interface does not display a combined value indicating the heart valve condition but can display multiple values ​​previously determined to indicate the heart valve condition(s).

[0368] In some embodiments, the system 200, 1400 can determine the time constant difference as a combined value indicative of a heart valve condition. For example, the system 200, 1400 can determine the time constant difference based at least in part on a first time constant and a second time constant. In some embodiments, the system 200, 1400 can calculate the time constant difference by subtracting at least one of the first time constant and the second time constant from the other. In some embodiments, the system 200, 1400 allows a user to mark time constants for comparison. For example, a graphical user interface of the system 200, 1400 can receive a user selection to mark time constants for later comparison. Then, a later graphical user interface (which can be similar to Fig. 10A The graphical user interface 1000 of the embodiment of the present invention can display the combined value indicating the condition of the heart valve using the marked time constant. For example, the graphical user interface (which can be displayed during the real-time program) can display the time constant difference using the marked value.

[0369] At block 2826, a combined value indicative of a heart valve condition and / or multiple values ​​indicative of a heart valve condition(s) may be displayed. In particular, the system 200, 1400 may display a combined value indicative of a heart valve condition (e.g., a regurgitation difference value or a time constant difference value) and / or multiple values ​​indicative of a heart valve condition(s) (e.g., a pre-procedural regurgitation index and a post-procedural regurgitation index) in the user interface. The display of the combined value indicative of a heart valve condition and / or multiple values ​​indicative of a heart valve condition(s) may be similar to that described above with respect to Fig.13 Block 1310 and Figures 10A-10E The presentation of value(s) indicative of heart valve condition(s) may be similar or identical to the presentation of value(s) indicative of heart valve condition(s) described in further detail in the user interfaces of FIGS. 11A-11E .

[0370] In some embodiments, the systems 200, 1400 can display a combined value indicating a heart valve condition (such as a regurgitation difference or a time constant difference) and / or multiple values ​​indicating a heart valve condition (one or more) (such as a pre-procedural regurgitation index and a post-procedural regurgitation index) in a comparison user interface. As described herein, the systems 200, 1400 can determine the first and second regurgitation indexes, the first and second hemodynamics, and / or other physiological parameters from the first and second time periods, respectively. As described herein, the first time period can be before the cardiac procedure, and the second time period can be after the cardiac procedure. Example cardiac procedures may include a balloon aortic valvuloplasty (BAV) procedure or a prosthesis insertion procedure. As described herein, the comparison user interface may include: a first set of graphics of a first set of time series pressure values, a first visual representation of a first regurgitation index on the first set of graphics, a second set of graphics of a second set of time series pressure values, and a second visual representation of a second regurgitation index on the second set of graphics. Another example comparison user interface displayed by the system 200, 1400 may include: a first set of graphs of a first set of time series pressure values, a first visual representation of a first hemodynamic parameter, a second set of graphs of a second set of time series pressure values, and a second visual representation of a second hemodynamic parameter. More details about the display of the comparison user interface are provided above with respect to Fig.11D and 11E is described in more detail.

[0371] As described in this article, a graphical user interface (similar to Fig. 10A A graphical user interface 1000 (shown in a real-time program) can display a combination of values ​​indicative of a heart valve condition. For example, a graphical user interface (which can be displayed during a real-time program) can display a regurgitation ratio or aortic regurgitation difference using labeled regurgitation values. As another example, a graphical user interface (which can be displayed during a real-time program) can display a time constant difference using labeled time constants. Although Fig. 10A Not shown, the user interface 1000 may additionally display a combination of values ​​indicative of a heart valve condition (eg, a regurgitant ratio and / or a time constant difference).

[0372] Implementing agencies

[0373] Fig.29 is a block diagram of example components of an example heart valve assessment system 1400. Fig.29 The heart valve assessment system 1400 is depicted as a single device, but the heart valve assessment system 1400 can be implemented in a server cluster, a server farm, a data center, a mainframe, a cloud computing environment, etc. The heart valve assessment system 1400 can include any number of devices operating as a distributed computing resource that provides services such as storage, computing, networking, etc.

[0374] The heart valve assessment system 1400 may include a hardware processor 2902, a data storage device 2904, a memory device 2906, a bus 2908, a display 2912, and one or more input / output devices 2914. The processor 2902 may also be implemented as a combination of computing devices, such as a combination of a digital signal processor and a microprocessor, a plurality of microprocessors, one or more microprocessors in combination with a digital signal processor, or any other such configuration. The processor 2902 may be configured to process data or execute instructions to perform one or more functions, etc. The data storage device 2904 may include a magnetic disk, an optical disk, or a flash drive, etc., and may be provided and connected to the bus 2908 for storing information and instructions. The memory 2906 may include one or more memory devices for storing data, including but not limited to random access memory (RAM) and read-only memory (ROM). The heart valve assessment system 1400 may be connected to a display 2912 (such as an LCD display or a touch screen) via the bus 2908 to display information to a user such as a patient. The heart valve assessment system 1400 may be coupled to one or more input / output devices 2914 via a bus 2908. The input devices 2914 may include, but are not limited to, a keyboard, a mouse, a digital pen, a microphone, a touch screen, a gesture recognition system, a voice recognition system, an imaging device (which may capture eye, hand, head, or body tracking data and / or position), a joystick, an accelerometer, or a gyroscope.

[0375] The heart valve assessment system 1400 may include one or more software engines (or services) for performing the processes and functions described herein. The software engine may include programming instructions for performing the processes described herein (and exemplified in the flow chart) for detecting input conditions (such as pressure signals) and generating output conditions (such as values ​​indicating heart valve conditions). The engine may be executed by one or more hardware processors 2902. The programming instructions may be stored in a data storage device 2904 and / or loaded into a memory 2906. The programming instructions may be implemented in C, C++, JAVA, or any other suitable programming language. In some embodiments, some or all parts of the heart valve assessment system 1400 (including the engine) may be implemented in a hardware processor (such as an ASIC and FPGA) of a dedicated circuit. The functions of some aspects of the heart valve assessment system 1400 may be remotely performed on a server (not shown) via a network. In addition, the functions of some aspects of the heart valve assessment system 1400 may be performed in one or more sensors or external devices.

[0376] The heart valve assessment system 1400 can communicate with one or more sensor devices 2916 described herein, such as a pressure guidewire 208 , a pressure sensing access catheter 20 , or a pressure sensing pigtail catheter 10 .

[0377] the term

[0378] As used herein, the relative terms "proximal" and "distal" should be defined from the perspective of a user of the system. Thus, proximal refers to a direction toward a user of the system, and distal refers to a direction away from a user of the system.

[0379] The relative terms "upstream" and "downstream" used herein should be defined from the perspective of blood flow. Thus, downstream refers to the direction toward the aorta relative to the left ventricle.

[0380] Conditional language, such as "may," "can," "might," or "could," unless expressly stated otherwise or understood otherwise in the context of use, is generally intended to convey that certain embodiments include, while other embodiments do not, certain features, elements, and / or steps. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any way essential to one or more embodiments.

[0381] The terms "comprises," "includes," "having," etc. are synonymous and are used inclusively and open-endedly and do not exclude additional elements, features, actions, operations, etc. In addition, the term "or" is used in its inclusive sense (not in its exclusive sense), so when used, for example, to connect listed elements, the term "or" means one, some, or all of the elements in the list.

[0382] As used herein, the terms "approximately," "about," "generally," and "substantially" refer to an amount that is close to a stated amount and still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "generally," and "substantially" may refer to an amount that is within less than 5% of a stated amount, as the context may dictate.

[0383] The ranges disclosed herein also encompass any and all overlaps, subranges, and combinations thereof. Language such as "up to," "at least," "greater than," "less than," and "between" include the stated values. Values ​​preceded by terms such as "about" or "approximately" include the stated values. For example, "about 4" includes "4."

[0384] Any method disclosed herein need not be performed in the order described. The methods disclosed herein include certain actions taken by the practitioner; however, they may also include any third-party instructions of those actions, whether explicit or implicit. For example, an action such as "moving the locking element distally" includes "instructing the locking element to move distally."

[0385] Although certain embodiments and examples have been described herein, it will be appreciated by those skilled in the art that many aspects of the humeral assembly shown and described in this disclosure may be combined and / or modified in various ways to form further embodiments or acceptable examples. All such modifications and variations are intended to be included within the scope of this disclosure. A variety of designs and methods are possible. Any feature, structure, or step disclosed herein is not necessary or indispensable.

[0386] Some embodiments have been described in conjunction with the accompanying drawings. However, it should be understood that the drawings are not drawn to scale. Distances, angles, etc. are merely exemplary and do not necessarily have an exact relationship to the actual size and layout of the device shown. Components may be added, removed, and / or rearranged. In addition, the disclosure of any specific features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc. in conjunction with various embodiments herein may be used in all other embodiments set forth herein. In addition, it should be recognized that any method described herein may be practiced using any device suitable for performing the steps.

[0387] For the purposes of this disclosure, certain aspects, benefits, and novel features are described herein. It should be understood that not necessarily all such benefits can be achieved according to any specific embodiment. Thus, for example, one skilled in the art will recognize that the present disclosure can be implemented or performed in a manner that achieves one benefit or a group of benefits taught herein without necessarily achieving other benefits taught or suggested herein.

[0388] In addition, although exemplary embodiments have been described herein, those skilled in the art will understand the scope of any and all embodiments with equivalent elements, modifications, omissions, combinations (e.g., across aspects of various embodiments), adjustments and / or changes based on this disclosure. The limitations in the claims should be interpreted broadly based on the language used in the claims, and are not limited to the examples described in this specification or during the examination of this application, which examples should be interpreted as non-exclusive. In addition, the actions of the disclosed processes and methods may be modified in any way, including reordering actions and / or inserting additional actions and / or deleting actions. Therefore, it is intended that the description and examples be regarded as exemplary only, and the true scope and spirit are indicated by the claims and their full range of equivalents.< / asp> < / lvsp> < / asp> < / lvsp> < / asp> < / lvsp>

Claims

1. A method comprising: determining a first plurality of pressure values ​​by a first pressure sensor located in a first portion of the heart; determining a second plurality of pressure values ​​by a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart; determining a heart rate of the heart; calculating (i) a first end-diastolic pressure of the first portion of the heart and (ii) a systolic pressure of the first portion of the heart from the first plurality of pressure values; calculating a second end-diastolic pressure of the cardiovascular region adjacent to the first portion of the heart from the second plurality of pressure values; Determining a reflux index, wherein determining the reflux index further comprises: calculating a pressure difference between the first end-diastolic pressure and the second end-diastolic pressure; and calculating from the pressure differential a value normalized at least in part based on the systolic pressure and the heart rate; and The reflux index is caused to be displayed in a user interface.

2. A method comprising: Controls the heart's rate; determining a first plurality of pressure values ​​by a first pressure sensor located at a first portion of the heart; determining a second plurality of pressure values ​​by a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart; determining a regurgitation index based at least in part on (i) a first value from the first plurality of pressure values ​​and (ii) a second value from the second plurality of pressure values; as well as The reflux index is caused to be displayed in a user interface.

3. The method according to claim 2, further comprising: calculating (i) a first end-diastolic pressure of the first portion of the heart and (ii) a systolic pressure of the first portion of the heart from the first plurality of pressure values; as well as A second end-diastolic pressure of the cardiovascular region adjacent to the first portion of the heart is calculated from the second plurality of pressure values, wherein determining the regurgitation index is further based at least in part on the first end-diastolic pressure, the second end-diastolic pressure, and the systolic pressure.

4. The method according to claim 2 or 3, wherein controlling the heart rate of the heart further comprises: The heart is subjected to ventricular pacing to a predetermined heart rate interval.

5. The method according to one of claims 2-4, wherein controlling the heart rate of the heart further comprises: Administer medication to the patient.

6. The method according to one of claims 2 to 5, further comprising: calculating a time constant from the first plurality of pressure values ​​and the second plurality of pressure values; as well as The time constant is caused to be displayed in the user interface.

7. The method according to one of claims 2-6, wherein the reflux index comprises a time-integrated reflux index.

8. A method comprising: Causes extrasystole of the heart, in which the ventricles do not eject blood in the aorta; determining a first plurality of pressure values ​​by a first pressure sensor located in a first portion of the heart; determining a second plurality of pressure values ​​by a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart; calculating (i) a first end-diastolic pressure of the first portion of the heart and (ii) a systolic pressure of the first portion of the heart from the first plurality of pressure values; calculating a second end-diastolic pressure of the cardiovascular region adjacent to the first portion of the heart from the second plurality of pressure values; determining a regurgitation index based at least in part on the first end-diastolic pressure, the second end-diastolic pressure, and the systolic pressure; as well as The reflux index is caused to be displayed in a user interface.

9. The method of claim 8, wherein inducing an extrasystole of the heart further comprises: A pacemaker connected to the heart is programmed to induce the extrasystoles.

10. A system comprising: a non-transitory computer storage medium configured to store at least computer-executable instructions; as well as one or more hardware processors in communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer-executable instructions to at least: Prior to a cardiac procedure, determining a first plurality of pressure values ​​by (i) a first pressure sensor located in a first portion of the heart and (ii) a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart; calculating a first reflux index from the first plurality of pressure values; determining, after the cardiac procedure, a second plurality of pressure values ​​by (i) the first pressure sensor located in the first portion of the heart and (ii) the second pressure sensor located in the cardiovascular region adjacent to the first portion of the heart; calculating a second reflux index from the second plurality of pressure values; determining a reflux difference based at least in part on the second reflux index and the first reflux index; as well as The reflux difference is caused to be displayed in a user interface.

11. The system of claim 10, wherein determining the reflux difference further comprises: calculating a standardized difference by dividing (i) the difference between the second reflux index and the first reflux index by (ii) the first reflux index; as well as The standardized difference is designated as the regurgitation difference.

12. A method comprising: determining a time series of pressure values ​​by a pressure sensor located at a portion of the heart; identifying a subset of said time series of pressure values ​​corresponding to at least a portion of a diastolic period; calculating a first slope from a subset of the time series pressure values; Based at least in part on the first slope, identifying a first reflux index, wherein identifying the first reflux index further comprises: finding the first regurgitation index associated with the first slope; as well as The first reflux index is displayed in a user interface.

13. The method according to claim 12, further comprising: accessing a plurality of pressure measurements, wherein each pressure measurement from the plurality of pressure measurements corresponds to a patient; for each pressure measurement from the plurality of pressure measurements, calculating from the pressure measurement a pair comprising a diastolic slope and a regurgitation index; determining a correlation between the diastolic slope and the regurgitation index based at least in part on the pair of diastolic slope and regurgitation index, wherein finding the first regurgitation index further comprises: The correlation between the diastolic slope and the regurgitation index is applied to the first slope.

14. The method of claim 12 or 13, wherein the portion of the heart includes at least the left ventricle.

15. The method of one of claims 12-14, wherein calculating the first slope from a subset of the time series pressure values ​​further comprises: determining a linear fit from a subset of the time series pressure values; as well as The first slope is calculated from the linear fit.

16. The method of one of claims 12-14, wherein calculating the first slope from a subset of the time series pressure values ​​further comprises: determining a polynomial function from a subset of the time series pressure values; as well as The first slope is calculated from the polynomial function.

17. The method of one of claims 12-14, wherein calculating the first slope from a subset of the time series pressure values ​​further comprises: determining an exponential function from a subset of the time series pressure values; as well as The first slope is calculated from the exponential function.

18. A method comprising: determining a first time series of pressure values ​​by a first pressure sensor located in a first portion of the heart; determining a second time series of pressure values ​​by a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart; identifying a subset of said first time series of pressure values ​​corresponding to at least a portion of a diastolic period; identifying a subset of said second time series of pressure values ​​corresponding to at least a portion of said diastolic period; (i) calculating a first slope from a subset of the first time series pressure values ​​and (ii) calculating a second slope from a subset of the second time series pressure values; determining a regurgitation index based at least in part on the first slope and the second slope; as well as The reflux index is caused to be displayed in a user interface.

19. The method of claim 18, wherein the first portion of the heart includes at least the left ventricle and the cardiovascular region adjacent to the first portion includes at least the aorta.

20. The method according to claim 18 or 19, further comprising: calculating a first plurality of slopes from a subset of the first time series pressure values, the first plurality of slopes including the first slope; calculating a second plurality of slopes from a subset of the second time series pressure values, the second plurality of slopes including the second slope; as well as determining a slope angle of each of the first plurality of slopes and the second plurality of slopes, wherein determining the regurgitation index further comprises: determining a first statistical metric from a slope angle of each slope in the first plurality of slopes; determining a second statistical metric from a slope angle of each slope in the second plurality of slopes; calculating a combined statistical metric from the first statistical metric and the second statistical metric; and The combined statistical measure is designated as the reflux index.

21. The method of claim 20, wherein calculating the combined statistical metric further comprises at least one of adding or subtracting the first statistical metric and the second statistical metric.

22. The method according to claim 20 or 21, further comprising: determining a first slope angle of the first slope; as well as and determining a second slope angle of the second slope, wherein determining the regurgitation index further comprises: calculating a combined slope angle from the first slope angle and the second slope angle; as well as The combined slope angle is designated as the regurgitation index.

23. The method of claim 22, wherein calculating the combined slope angle further comprises at least one of adding, subtracting, multiplying, or dividing the first slope angle and the second slope angle.

24. The method of one of claims 18-23, wherein calculating the second slope further comprises: determining an initial slope from a subset of the second time series pressure values; determining a correction factor from the second time series pressure values; calculating a corrected diastolic slope from the initial slope, wherein calculating the corrected diastolic slope further comprises applying the correction factor to the initial slope; and The corrected diastolic slope is designated as the second slope.

25. The method of claim 24, wherein determining the correction factor further comprises: calculating at least one of an enhancement index or a pressure enhancement from the second time series pressure values; as well as The correction factor is identified based at least in part on one of an enhancement index or a pressure enhancement.

26. A system comprising: a non-transitory computer storage medium configured to store at least computer-executable instructions; as well as one or more hardware processors in communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer-executable instructions to at least: Prior to a cardiac procedure, determining a first set of time series pressure values ​​by (i) a first pressure sensor located in a first portion of the heart and (ii) a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart; calculating a first time constant from the first set of time series pressure values; determining, after the cardiac procedure, a second set of time-series pressure values ​​by (i) the first pressure sensor located in the first portion of the heart and (ii) the second pressure sensor located in the cardiovascular region adjacent to the first portion of the heart; calculating a second time constant from the second set of time series pressure values; determining a time constant difference based at least in part on the first time constant and the second time constant; as well as The time constant difference is caused to be displayed in a user interface.

27. The system of claim 26, wherein the first portion of the heart includes at least the left ventricle, and the cardiovascular region adjacent to the first portion includes at least the aorta.

28. The system of claim 26 or 27, wherein calculating the first time constant from the first set of time series pressure values ​​comprises determining the relationship τ, essentially: Area (PR) 12 is the area between (i) the first time series of pressure values ​​from the first portion of the heart and (ii) the second time series of pressure values ​​from the cardiovascular region adjacent to the first portion of the heart and between a first time and a second time, P1 is a first pressure value at the first time from the first time series of pressure values, R1 is a first pressure value at the first time from the second time series of pressure values, P2 is a second pressure value at the second time from the first time series of pressure values, and R2 is a second pressure value at the second time from the second time series of pressure values.

29. The system of claim 28, wherein the first time and the second time are within diastole.

30. A system comprising: a non-transitory computer storage medium configured to store at least computer-executable instructions; as well as one or more hardware processors in communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer-executable instructions to at least: determining a set of time series pressure values ​​by (i) a first pressure sensor located in a first portion of the heart and (ii) a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart; A time constant is calculated from the set of time series pressure values, wherein calculating the time constant further comprises determining a relationship τ, essentially: Area (PR) 12 is the area between (i) a first time series of pressure values ​​from the first portion of the heart and (ii) a second time series of pressure values ​​from the cardiovascular region adjacent to the first portion of the heart and between a first time and a second time, P1 is a first pressure value at the first time from the first time series of pressure values, R1 is a first pressure value at the first time from the second time series of pressure values, P2 is a second pressure value at the second time from the first time series of pressure values, and R2 is a second pressure value at the second time from the second time series of pressure values; and The time constant is caused to be displayed in a user interface.

31. The system of claim 30, wherein the first time and the second time are within diastole.

32. A system comprising: a non-transitory computer storage medium configured to store at least computer-executable instructions; as well as one or more hardware processors in communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer-executable instructions to at least: Prior to a cardiac procedure, determining a first time series of pressure values ​​by a pressure sensor located at a portion of the heart; Calculating a first time constant from the first time series pressure values; determining, after the cardiac procedure, a second time series of pressure values ​​by the pressure sensor located at the portion of the heart; Calculating a second time constant from the second time series pressure values; determining a time constant difference based at least in part on the first time constant and the second time constant; as well as The time constant difference is caused to be displayed in a user interface.

33. The system of claim 32, wherein the portion of the heart comprises the left ventricle or the aorta.

34. The system of claim 32 or 33, wherein calculating the first time constant from the first time series of pressure values ​​comprises determining the relationship τ, substantially: The area (P) 12 is the area below the first time series pressure value between the first time and the second time, P1 is a first pressure value at the first time from the first time series of pressure values, and P2 is a second pressure value at the second time from the first time series of pressure values.

35. The system of claim 34, wherein the first time and the second time are within diastole.

36. A system comprising: a non-transitory computer storage medium configured to store at least computer-executable instructions; as well as one or more hardware processors in communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer-executable instructions to at least: determining a first time series of pressure values ​​by a first pressure sensor located in a first portion of the heart; determining a second time series of pressure values ​​by a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart; identifying a first heartbeat and a second heartbeat from the first time series and the second time series; associating the first heartbeat with a first category based at least in part on a first characteristic of the first heartbeat, wherein the first category indicates that the first heartbeat has been rejected; associating the second heartbeat with a second category based at least in part on a second characteristic of the second heartbeat, wherein the second category indicates that the second heartbeat has been accepted; Determining a reflux index, wherein determining the reflux index further comprises: based at least in part on the first category and the first heartbeat being rejected, excluding the first heartbeat; including the second heartbeat based at least in part on the second category and the second heartbeat being accepted; calculating a regurgitation index based at least in part on (i) a first portion of the first time series associated with a second heartbeat and (ii) a second portion of the second time series associated with the second heartbeat; and The reflux index is caused to be displayed in a user interface.

37. The system of claim 36, wherein the first characteristic of the first heartbeat corresponds to a time of passage of the first heartbeat, and wherein associating the first heartbeat with the first category based at least in part on the first characteristic further comprises: It is determined that the elapsed time of the first heartbeat is outside a threshold range.

38. The system of claim 36, wherein the first characteristic of the first heartbeat corresponds to an elapsed time of a diastole period of the first heartbeat, and wherein associating the first heartbeat with the first category based at least in part on the first characteristic further comprises: It is determined that the elapsed time of the diastole period of the first heartbeat exceeds a threshold time.

39. The system of claim 36, wherein the first characteristic of the first heartbeat corresponds to pressure from a systolic phase of the first heartbeat, and wherein associating the first heartbeat with the first category based at least in part on the first characteristic further comprises: It is determined that a pressure from a systole phase of the first heartbeat exceeds a threshold.

40. The system of one of claims 36-39, wherein the first portion of the heart comprises the aorta or the left ventricle.

41. A system comprising: a non-transitory computer storage medium configured to store at least computer-executable instructions; as well as one or more hardware processors in communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer-executable instructions to at least: receiving, during a first time period, a first set of time series pressure values ​​by (i) a first pressure sensor located in a first portion of the heart and (ii) a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart; Calculating a first reflux index based on the first set of time series pressure values; receiving, during a second time period, a second set of time series pressure values ​​by (i) the first pressure sensor located in the first portion of the heart and (ii) the second pressure sensor located in the cardiovascular region adjacent to the first portion of the heart; calculating a second reflux index based on the second set of time series pressure values; as well as To display in the user interface: a first set of graphs of the first set of time series pressure values, a first visual representation of the first reflux index on the first set of graphs, a second set of graphs of the second set of time series pressure values, and A second visual representation of the second reflux index on the second set of graphs.

42. A system comprising: a non-transitory computer storage medium configured to store at least computer-executable instructions; as well as one or more hardware processors in communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer-executable instructions to at least: receiving, during a first time period, a first set of time series pressure values ​​by (i) a first pressure sensor located in a first portion of the heart and (ii) a second pressure sensor located in a cardiovascular region adjacent to the first portion of the heart; calculating a first hemodynamic parameter from the first set of time series pressure values; receiving, during a second time period, a second set of time series pressure values ​​by (i) the first pressure sensor located in the first portion of the heart and (ii) the second pressure sensor located in the cardiovascular region adjacent to the first portion of the heart; calculating a second hemodynamic parameter from the second set of time series pressure values; and To display in the user interface: a first set of graphs of the first set of time series pressure values, a first visual representation of the first hemodynamic parameter, a second set of graphs of the second set of time series pressure values, and A second visual representation of the second hemodynamic parameter.

43. The system of claim 41 or 42, wherein the first time period corresponds to before a cardiac procedure and the second time period corresponds to after the cardiac procedure.

44. The system of claim 43, wherein the cardiac procedure comprises a balloon aortic valvuloplasty (BAV) procedure or a prosthesis insertion procedure.

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