Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
  • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
  • A61B5/021—Measuring pressure in heart or blood vessels
  • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
  • A61B5/02158—Measuring pressure in heart or blood vessels by means inserted into the body provided with two or more sensor elements
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
  • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
  • A61B5/6852—Catheters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/74—Details of notification to user or communication with user or patient ; user input means
  • A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
  • A61B5/7435—Displaying user selection data, e.g. icons in a graphical user interface
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/74—Details of notification to user or communication with user or patient ; user input means
  • A61B5/7475—User input or interface means, e.g. keyboard, pointing device, joystick
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
  • A61B5/026—Measuring blood flow

Definitions

• the present disclosure relates generally to the assessment of vessels and, in particular, the assessment of the severity of a blockage or other restriction to the flow of fluid through a vessel. Aspects of the present disclosure are particularly suited for evaluation of biological vessels in some instances. For example, some particular embodiments of the present disclosure are specifically configured for the evaluation of a stenosis of a human blood vessel.
• FFR fractional flow reserve
• Coronary blood flow is unique in that it is affected not only by fluctuations in the pressure arising proximally (as in the aorta) but is also simultaneously affected by fluctuations arising distally in the microcirculation. Accordingly, it is not possible to accurately assess the severity of a coronary stenosis by simply measuring the fall in mean or peak pressure across the stenosis because the distal coronary pressure is not purely a residual of the pressure transmitted from the aortic end of the vessel. As a result, for an effective calculation of FFR within the coronary arteries, it is necessary to reduce the vascular resistance within the vessel.
• pharmacological hyperemic agents such as adenosine, are administered to reduce and stabilize the resistance within the coronary arteries.
• Embodiments of the present disclosure are configured to assess the severity of a blockage in a vessel and, in particular, a stenosis in a blood vessel.
• the devices, systems, and methods of the present disclosure are configured to assess the severity of a stenosis in the coronary arteries without the administration of a hyperemic agent.
• a method of normalizing pressure measurements of two different intravascular pressure sensing devices can include: obtaining pressure measurements from first and second pressure sensing instruments while the first and second pressure sensing instruments are positioned within the vessel of the patient and adjacent to one another; and normalizing the pressure measurements of the first and second pressure sensing instruments to one another utilizing at least one cardiac cycle following activation of a normalization button by a user.
• the at least one cardiac cycle can include at least three cardiac cycles, such as five cardiac cycles.
• normalizing the pressure measurements includes calculating a normalization adjustment using an average, calculated for a plurality of samples of the pressure measurements.
• the method can further include temporally aligning the pressure measurements of the first and second pressure sensing instruments. Temporally aligning the pressure measurements can include calculating a time shift between the pressure
• the time shift can be calculated using a cross- correlation function and/or an auto-correlation function.
• a system in some instances, includes a first pressure sensing instrument sized and shaped for introduction into a vessel of the patient; a second pressure sensing instrument sized and shaped for introduction into the vessel of the patient; a processing unit in communication with the first and second instruments, the processing unit configured to: obtain pressure measurements from the first and second pressure sensing instruments while the first and second pressure sensing instruments are positioned within the vessel of the patient and adjacent to one another; and normalizing the pressure measurements of the first and second pressure sensing instruments to one another utilizing at least one cardiac cycle following activation of a normalization button by a user.
• a method of evaluating a vessel of a patient includes obtaining pressure measurements from at least one pressure sensing instrument while the at least one pressure sensing instrument is positioned within the vessel of the patient over a plurality of cardiac cycles; identifying an outlier cardiac cycle from the plurality of cardiac cycles; excluding the identified outlier cardiac cycle from calculations; and displaying the obtained pressure measurements to a user, wherein the display of the obtained pressure measurements identifies the outlier cardiac cycle. Identifying the outlier cardiac cycle from the plurality of cardiac cycles can include analyzing the obtained pressure measurements to identify the outlier cardiac cycle, such as comparing the obtained pressure measurements to a threshold.
• the threshold is a relative change in pressure ratio compared to at least one of the other cardiac cycles or compared to an average of at least two of the other cardiac cycles.
• the display of the obtained pressure measurements identifies the outlier cardiac cycle utilizing text, utilizing a distinguishable color, or omitting the pressure measurements for the outlier cardiac cycle from the display.
• FIG. 1 is a diagrammatic perspective view of a vessel having a stenosis according to an embodiment of the present disclosure.
• FIG. 2 is a diagrammatic, partial cross-sectional perspective view of a portion of the vessel of Fig. 1 taken along section line 2-2 of Fig. 1.
• FIG. 3 is a diagrammatic, partial cross-sectional perspective view of the vessel of Figs. 1 and 2 with instruments positioned therein according to an embodiment of the present disclosure.
• FIG. 4 is a diagrammatic, schematic view of a system according to an embodiment of the present disclosure.
• FIG. 5 is a graphical representation of measured pressure, velocity, and resistance within a vessel according to an embodiment of the present disclosure.
• FIG. 6 is a magnified view of a portion of the graphical representation of Fig. 5 corresponding to a resting state of a patient.
• FIG. 7 is a magnified view of a portion of the graphical representation of Fig. 5 corresponding to a hyperemic state of a patient.
• FIG. 8 is the portion of the graphical representation of Fig. 6 annotated to identify a diagnostic window according to an embodiment of the present disclosure.
• FIG. 9 is a graphical representation of measured pressure and velocity within a vessel according to an embodiment of the present disclosure.
• FIG. 10 is a graphical representation of a derivative of the measured velocity of Fig. 9 according to an embodiment of the present disclosure.
• FIG. 11 is the graphical representation of Fig. 9 annotated to identify a diagnostic window according to an embodiment of the present disclosure.
• FIG. 12 is a graphical representation of wave intensity within a vessel according to an embodiment of the present disclosure.
• FIG. 13 is a graphical representation of proximal and distal originating pressure waves within a vessel corresponding to the wave intensity of Fig. 12 according to an embodiment of the present disclosure.
• FIG. 14 is a graphical representation of pressure and velocity within a vessel corresponding to the wave intensity of Fig. 12 and the proximal and distal originating pressure waves of Fig. 13 according to an embodiment of the present disclosure.
• FIG. 15 is a graphical representation of a resistance within a vessel corresponding to the wave intensity of Fig. 12, the proximal and distal originating pressure waves of Fig. 13, and the pressure and velocity of Fig. 14 according to an embodiment of the present disclosure.
• FIG. 16 is a graphical representation of an identification of a starting point of a diagnostic window based on a proximal pressure measurement according to an embodiment of the present disclosure.
• FIG. 17 is a graphical representation of an identification of a starting point of a diagnostic window based on a proximal pressure measurement according to another embodiment of the present disclosure.
• FIG. 18 is a graphical representation of an identification of a starting point of a diagnostic window based on a proximal pressure measurement according to another embodiment of the present disclosure.
• FIG. 19 is a graphical representation of an identification of a starting point of a diagnostic window based on a distal pressure measurement according to an embodiment of the present disclosure.
• FIG. 20 is a graphical representation of an identification of a starting point of a diagnostic window based on a distal pressure measurement according to another embodiment of the present disclosure.
• FIG. 21 is a graphical representation of an identification of a starting point of a diagnostic window based on a distal pressure measurement according to another embodiment of the present disclosure.
• FIG. 22 is a graphical representation of an identification of a starting point of a diagnostic window based on a distal pressure measurement according to another embodiment of the present disclosure.
• FIG. 23 is a graphical representation of an identification of an ending point of a diagnostic window based on a starting point of the diagnostic window according to an embodiment of the present disclosure.
• FIG. 24 is a graphical representation of an identification of an ending point of a diagnostic window based on a proximal pressure measurement according to an embodiment of the present disclosure.
• FIG. 25 is a graphical representation of an identification of an ending point of a diagnostic window based on a distal pressure measurement according to an embodiment of the present disclosure.
• FIG. 26 is a graphical representation of an identification of an ending point of a diagnostic window based on a distal pressure measurement according to an embodiment of the present disclosure.
• FIG. 27 is a graphical representation of a diagnostic window relative to proximal and distal pressure measurements according to an embodiment of the present disclosure.
• FIG. 28 is a graphical representation of a diagnostic window relative to proximal and distal pressure measurements according to another embodiment of the present disclosure.
• FIG. 29 is graphical representation of an ECG signal according to an embodiment of the present disclosure.
• FIG. 30 is a graphical representation of a diagnostic window relative to proximal and distal pressure measurements according to another embodiment of the present disclosure.
• FIG. 31 is a graphical representation of a diagnostic window relative to proximal and distal pressure measurements according to an embodiment of the present disclosure.
• FIG. 32 is a magnified view of a portion of the graphical representation of Fig. 30 illustrating a temporal adjustment of the distal pressure measurement relative to the proximal pressure measurement.
• FIG. 33 is a graphical representation of proximal and distal pressure measurements within a vessel according to an embodiment of the present disclosure.
• FIG. 34 is a pair of graphical representations, where the top graphical representation illustrates proximal and distal pressure measurements within a vessel and the bottom graphical representation illustrates a ratio of the proximal and distal pressure measurements and a fit between the proximal pressure waveform and the distal pressure waveform according to an embodiment of the present disclosure.
• FIG. 35 is a pair of graphical representations similar to that of Fig. 33, but where the distal pressure measurement waveform of the top graphical representation has been shifted relative the distal pressure waveform of Fig. 33 and the bottom graphical representation illustrates the corresponding ratio of the proximal and distal pressure measurements and the fit between the proximal pressure waveform and the distal pressure waveform based on the shifted distal pressure measurement waveform.
• FIG. 36 is a graphical representation of pressure measurements obtained by first and second pressure sensing instruments positioned within a vessel and showing aspects of a normalization procedure according to an embodiment of the present disclosure.
• FIG. 37 is a graphical representation illustrating aspects of the technique for evaluating a vessel that excludes outlier cardiac cycles according to an embodiment of the present disclosure.
• Fig. 1 is a diagrammatic perspective view of the vessel 100
• Fig. 2 is a partial cross-sectional perspective view of a portion of the vessel 100 taken along section line 2-2 of Fig. 1.
• the vessel 100 includes a proximal portion 102 and a distal portion 104.
• a lumen 106 extends along the length of the vessel 100 between the proximal portion 102 and the distal portion 104.
• the lumen 106 is configured to allow the flow of fluid through the vessel.
• the vessel 100 is a systemic blood vessel.
• the vessel 100 is a coronary artery.
• the lumen 106 is configured to facilitate the flow of blood through the vessel 100.
• the vessel 100 includes a stenosis 108 between the proximal portion 102 and the distal portion 104.
• Stenosis 108 is generally representative of any blockage or other structural arrangement that results in a restriction to the flow of fluid through the lumen 106 of the vessel 100.
• Embodiments of the present disclosure are suitable for use in a wide variety of vascular applications, including without limitation coronary, peripheral (including but not limited to lower limb, carotid, and neurovascular), renal, and/or venous.
• the stenosis 108 may be a result of plaque buildup, including without limitation plaque components such as fibrous, fibro-lipidic (fibro fatty), necrotic core, calcified (dense calcium), blood, fresh thrombus, and mature thrombus.
• plaque components such as fibrous, fibro-lipidic (fibro fatty), necrotic core, calcified (dense calcium), blood, fresh thrombus, and mature thrombus.
• the composition of the stenosis will depend on the type of vessel being evaluated. In that regard, it is understood that the concepts of the present disclosure are applicable to virtually any type of blockage or other narrowing of a vessel that results in decreased fluid flow.
• the lumen 106 of the vessel 100 has a diameter 110 proximal of the stenosis 108 and a diameter 112 distal of the stenosis.
• the diameters 110 and 112 are substantially equal to one another.
• the diameters 110 and 112 are intended to represent healthy portions, or at least healthier portions, of the lumen 106 in comparison to stenosis 108. Accordingly, these healthier portions of the lumen 106 are illustrated as having a substantially constant cylindrical profile and, as a result, the height or width of the lumen has been referred to as a diameter.
• these portions of the lumen 106 will also have plaque buildup, a non-symmetric profile, and/or other irregularities, but to a lesser extent than stenosis 108 and, therefore, will not have a cylindrical profile.
• the diameters 110 and 112 are understood to be representative of a relative size or cross- sectional area of the lumen and do not imply a circular cross-sectional profile.
• stenosis 108 includes plaque buildup 114 that narrows the lumen 106 of the vessel 100.
• the plaque buildup 114 does not have a uniform or symmetrical profile, making angiographic evaluation of such a stenosis unreliable.
• the plaque buildup 114 includes an upper portion 116 and an opposing lower portion 118.
• the lower portion 118 has an increased thickness relative to the upper portion 116 that results in a non-symmetrical and non-uniform profile relative to the portions of the lumen proximal and distal of the stenosis 108.
• the plaque buildup 114 decreases the available space for fluid to flow through the lumen 106.
• the cross-sectional area of the lumen 106 is decreased by the plaque buildup 114.
• the lumen 106 has a height 120, which is representative of a reduced size or cross-sectional area relative to the diameters 110 and 112 proximal and distal of the stenosis 108.
• the stenosis 108, including plaque buildup 114 is exemplary in nature and should be considered limiting in any way. In that regard, it is understood that the stenosis 108 has other shapes and/or
• compositions that limit the flow of fluid through the lumen 106 in other instances are illustrated in Figs. 1 and 2 as having a single stenosis 108 and the description of the embodiments below is primarily made in the context of a single stenosis, it is nevertheless understood that the devices, systems, and methods described herein have similar application for a vessel having multiple stenosis regions.
• instruments 130 and 132 may be any form of device, instrument, or probe sized and shaped to be positioned within a vessel.
• instrument 130 is generally representative of a guide wire
• instrument 132 is generally representative of a catheter.
• instrument 130 extends through a central lumen of instrument 132.
• the instruments 130 and 132 take other forms.
• the instruments 130 and 132 are of similar form in some embodiments.
• both instruments 130 and 132 are guide wires.
• both instruments 130 and 132 are catheters.
• the instruments 130 and 132 are of different form in some embodiments, such as the illustrated embodiment, where one of the instruments is a catheter and the other is a guide wire. Further, in some instances, the instruments 130 and 132 are disposed coaxial with one another, as shown in the illustrated embodiment of Fig. 3. In other instances, one of the instruments extends through an off-center lumen of the other instrument. In yet other instances, the instruments 130 and 132 extend side-by-side. In some particular embodiments, at least one of the instruments is as a rapid-exchange device, such as a rapid-exchange catheter. In such embodiments, the other instrument is a buddy wire or other device configured to facilitate the introduction and removal of the rapid- exchange device. Further still, in other instances, instead of two separate instruments 130 and 132 a single instrument is utilized. In that regard, the single instrument incorporates aspects of the functionalities (e.g. , data acquisition) of both instruments 130 and 132 in some embodiments.
• the single instrument incorporates aspects of the functionalities (e.g. , data acquisition)
• Instrument 130 is configured to obtain diagnostic information about the vessel 100.
• the instrument 130 includes one or more sensors, transducers, and/or other monitoring elements configured to obtain the diagnostic information about the vessel.
• the diagnostic information includes one or more of pressure, flow (velocity), images (including images obtained using ultrasound (e.g. , IVUS), OCT, thermal, and/or other imaging techniques), temperature, and/or combinations thereof.
• the one or more sensors, transducers, and/or other monitoring elements are positioned adjacent a distal portion of the instrument 130 in some instances.
• the one or more sensors, transducers, and/or other monitoring elements are positioned less than 30 cm, less than 10 cm, less than 5 cm, less than 3 cm, less than 2 cm, and/or less than 1 cm from a distal tip 134 of the instrument 130 in some instances.
• at least one of the one or more sensors, transducers, and/or other monitoring elements is positioned at the distal tip of the instrument 130.
• the instrument 130 includes at least one element configured to monitor pressure within the vessel 100.
• the pressure monitoring element can take the form a piezo-resistive pressure sensor, a piezo-electric pressure sensor, a capacitive pressure sensor, an
• the pressure monitoring element is implemented as a solid-state component manufactured using semiconductor and/or other suitable manufacturing techniques.
• suitable pressure monitoring elements include, without limitation, the Prime Wire PRESTIGE® pressure guide wire, the Prime Wire® pressure guide wire, and the ComboWire® XT pressure and flow guide wire, each available from Volcano
• the instrument 130 is sized such that it can be positioned through the stenosis 108 without significantly impacting fluid flow across the stenosis, which would impact the distal pressure reading. Accordingly, in some instances the instrument 130 has an outer diameter of 0.018" or less. In some embodiments, the instrument 130 has an outer diameter of 0.014" or less.
• Instrument 132 is also configured to obtain diagnostic information about the vessel 100. In some instances, instrument 132 is configured to obtain the same diagnostic information as instrument 130. In other instances, instrument 132 is configured to obtain different diagnostic information than instrument 130, which may include additional diagnostic information, less diagnostic information, and/or alternative diagnostic information.
• the diagnostic information obtained by instrument 132 includes one or more of pressure, flow (velocity), images (including images obtained using ultrasound (e.g. , IVUS), OCT, thermal, and/or other imaging techniques), temperature, and/or combinations thereof.
• Instrument 132 includes one or more sensors, transducers, and/or other monitoring elements configured to obtain this diagnostic information.
• the one or more sensors, transducers, and/or other monitoring elements are positioned adjacent a distal portion of the instrument 132 in some instances.
• the one or more sensors, transducers, and/or other monitoring elements are positioned less than 30 cm, less than 10 cm, less than 5 cm, less than 3 cm, less than 2 cm, and/or less than 1 cm from a distal tip 136 of the instrument 132 in some instances.
• at least one of the one or more sensors, transducers, and/or other monitoring elements is positioned at the distal tip of the instrument 132.
• instrument 132 also includes at least one element configured to monitor pressure within the vessel 100.
• the pressure monitoring element can take the form a piezo-resistive pressure sensor, a piezo-electric pressure sensor, a capacitive pressure sensor, an electromagnetic pressure sensor, a fluid column (the fluid column being in communication with a fluid column sensor that is separate from the instrument and/or positioned at a portion of the instrument proximal of the fluid column), an optical pressure sensor, and/or combinations thereof.
• one or more features of the pressure monitoring element are implemented as a solid-state component manufactured using semiconductor and/or other suitable manufacturing techniques. Millar catheters are utilized in some embodiments.
• At least one of the instruments 130 and 132 is configured to monitor a pressure within the vessel 100 distal of the stenosis 108 and at least one of the instruments 130 and 132 is configured to monitor a pressure within the vessel proximal of the stenosis.
• the instruments 130, 132 are sized and shaped to allow positioning of the at least one element configured to monitor pressure within the vessel 100 to be positioned proximal and/or distal of the stenosis 108 as necessary based on the configuration of the devices.
• Fig. 3 illustrates a position 138 suitable for measuring pressure distal of the stenosis 108.
• the position 138 is less than 5 cm, less than 3 cm, less than 2 cm, less than 1 cm, less than 5 mm, and/or less than 2.5 mm from the distal end of the stenosis 108 (as shown in Fig. 2) in some instances.
• Fig. 3 also illustrates a plurality of suitable positions for measuring pressure proximal of the stenosis 108.
• positions 140, 142, 144, 146, and 148 each represent a position that is suitable for monitoring the pressure proximal of the stenosis in some instances.
• the positions 140, 142, 144, 146, and 148 are positioned at varying distances from the proximal end of the stenosis 108 ranging from more than 20 cm down to about 5 mm or less.
• the proximal pressure measurement will be spaced from the proximal end of the stenosis. Accordingly, in some instances, the proximal pressure measurement is taken at a distance equal to or greater than an inner diameter of the lumen of the vessel from the proximal end of the stenosis.
• the proximal pressure measurement is generally taken at a position proximal of the stenosis and distal of the aorta, within a proximal portion of the vessel.
• the proximal pressure measurement is taken from a location inside the aorta. In other instances, the proximal pressure measurement is taken at the root or ostium of the coronary artery.
• Fig. 4 is a diagrammatic, schematic view of the system 150.
• the system 150 includes an instrument 152.
• instrument 152 is suitable for use as at least one of instruments 130 and 132 discussed above.
• the instrument 152 includes features similar to those discussed above with respect to instruments 130 and 132 in some instances.
• the instrument 152 is a guide wire having a distal portion 154 and a housing 156 positioned adjacent the distal portion.
• the housing 156 is spaced approximately 3 cm from a distal tip of the instrument 152.
• the housing 156 is configured to house one or more sensors, transducers, and/or other monitoring elements configured to obtain the diagnostic information about the vessel.
• the housing 156 contains at least a pressure sensor configured to monitor a pressure within a lumen in which the instrument 152 is positioned.
• a shaft 158 extends proximally from the housing 156.
• a torque device 160 is positioned over and coupled to a proximal portion of the shaft 158.
• a proximal end portion 162 of the instrument 152 is coupled to a connector 164.
• a cable 166 extends from connector 164 to a connector 168.
• connector 168 is configured to be plugged into an interface 170.
• interface 170 is a patient interface module (PIM) in some instances.
• the cable 166 is replaced with a wireless connection.
• PIM patient interface module
• communication pathways between the instrument 152 and the interface 170 may be utilized, including physical connections (including electrical, optical, and/or fluid connections), wireless connections, and/or combinations thereof.
• the interface 170 is communicatively coupled to a computing device 172 via a connection 174.
• Computing device 172 is generally representative of any device suitable for performing the processing and analysis techniques discussed within the present disclosure.
• the computing device 172 includes a processor, random access memory, and a storage medium.
• the computing device 172 is programmed to execute steps associated with the data acquisition and analysis described herein. Accordingly, it is understood that any steps related to data acquisition, data processing, instrument control, and/or other processing or control aspects of the present disclosure may be implemented by the computing device using corresponding instructions stored on or in a non-transitory computer readable medium accessible by the computing device.
• the computing device 172 is a console device.
• the computing device 172 is similar to the s5TM Imaging System or the s5iTM Imaging System, each available from Volcano Corporation. In some instances, the computing device 172 is portable (e.g. , handheld, on a rolling cart, etc.). Further, it is understood that in some instances the computing device 172 comprises a plurality of computing devices. In that regard, it is particularly understood that the different processing and/or control aspects of the present disclosure may be implemented separately or within predefined groupings using a plurality of computing devices. Any divisions and/or combinations of the processing and/or control aspects described below across multiple computing devices are within the scope of the present disclosure.
• connection 174 facilitate communication between the one or more sensors, transducers, and/or other monitoring elements of the instrument 152 and the computing device 172.
• this communication pathway is exemplary in nature and should not be considered limiting in any way.
• any communication pathway between the instrument 152 and the computing device 172 may be utilized, including physical connections (including electrical, optical, and/or fluid connections), wireless connections, and/or combinations thereof.
• the connection 174 is wireless in some instances.
• the connection 174 includes a communication link over a network (e.g. , intranet, internet, telecommunications network, and/or other network).
• the computing device 172 is positioned remote from an operating area where the instrument 152 is being used in some instances. Having the connection 174 include a connection over a network can facilitate communication between the instrument 152 and the remote computing device 172 regardless of whether the computing device is in an adjacent room, an adjacent building, or in a different state/country. Further, it is understood that the communication pathway between the instrument 152 and the computing device 172 is a secure connection in some instances. Further still, it is understood that, in some instances, the data communicated over one or more portions of the communication pathway between the instrument 152 and the computing device 172 is encrypted.
• the system 150 also includes an instrument 175. In that regard, in some instances instrument 175 is suitable for use as at least one of instruments 130 and 132 discussed above.
• the instrument 175 includes features similar to those discussed above with respect to instruments 130 and 132 in some instances.
• the instrument 175 is a catheter-type device.
• the instrument 175 includes one or more sensors, transducers, and/or other monitoring elements adjacent a distal portion of the instrument configured to obtain the diagnostic information about the vessel.
• the instrument 175 includes a pressure sensor configured to monitor a pressure within a lumen in which the instrument 175 is positioned.
• the instrument 175 is in communication with an interface 176 via connection 177.
• interface 176 is a hemodynamic monitoring system or other control device, such as Siemens AXIOM Sensis, Mennen Horizon XVu, and Philips Xper IM Physiomonitoring 5.
• instrument 175 is a pressure-sensing catheter that includes fluid column extending along its length.
• interface 176 includes a hemostasis valve fluidly coupled to the fluid column of the catheter, a manifold fluidly coupled to the hemostasis valve, and tubing extending between the components as necessary to fluidly couple the components.
• the fluid column of the catheter is in fluid communication with a pressure sensor via the valve, manifold, and tubing.
• the pressure sensor is part of interface 176.
• the pressure sensor is a separate component positioned between the instrument 175 and the interface 176.
• the interface 176 is communicatively coupled to the computing device 172 via a connection 178.
• interface 176 and connections 177 and 178 facilitate communication between the one or more sensors, transducers, and/or other monitoring elements of the instrument 175 and the computing device 172.
• this communication pathway is exemplary in nature and should not be considered limiting in any way.
• any communication pathway between the instrument 175 and the computing device 172 may be utilized, including physical connections (including electrical, optical, and/or fluid connections), wireless connections, and/or combinations thereof.
• the connection 178 is wireless in some instances.
• the connection 178 includes a communication link over a network (e.g. , intranet, internet, telecommunications network, and/or other network).
• the computing device 172 is positioned remote from an operating area where the instrument 175 is being used in some instances. Having the connection 178 include a connection over a network can facilitate communication between the instrument 175 and the remote computing device 172 regardless of whether the computing device is in an adjacent room, an adjacent building, or in a different state/country. Further, it is understood that the communication pathway between the instrument 175 and the computing device 172 is a secure connection in some instances. Further still, it is understood that, in some instances, the data communicated over one or more portions of the communication pathway between the instrument 175 and the computing device 172 is encrypted.
• the system 150 does not include interface 170 and/or interface 176.
• the connector 168 (or other similar connector in communication with instrument 152 or instrument 175) may plug into a port associated with computing device 172.
• the instruments 152, 175 may communicate wirelessly with the computing device 172.
• the communication pathway between either or both of the instruments 152, 175 and the computing device 172 may have no intermediate nodes (i.e. , a direct connection), one intermediate node between the instrument and the computing device, or a plurality of intermediate nodes between the instrument and the computing device.
• Fig. 5 is a graphical representation of measured pressure, velocity, and resistance within a vessel
• Fig. 6 is a magnified view of a portion of the graphical representation of Fig. 5 corresponding to a resting state of a patient
• Fig. 7 is a magnified view of a portion of the graphical representation of Fig. 5 corresponding to a hyperemic state of a patient
• Fig. 8 is the portion of the graphical representation of Fig. 6 annotated to identify a diagnostic window according to an embodiment of the present disclosure.
• the graphical representation 180 includes a graph 182 plotting pressure within the vessel over time, a graph 184 plotting velocity of the fluid within the vessel over time, and a graph 186 plotting resistance within the vessel over time.
• the resistance (or impedance) shown in graph 186 is calculated based on the pressure and velocity data of graphs 182 and 184.
• the resistance values shown in graph 186 are determined by dividing the pressure measurement of graph 182 by the velocity measurement 184 for the corresponding point in time.
• the graphical representation 180 includes a time period 188 that corresponds to a resting state of the patient's heart and a time period 190 that corresponds to a stressed state of the patient's heart.
• the stressed state of the patient's heart is caused by the administration of a hyperemic agent in some instances.
• window 192 of the graphical representation 180 includes graph portions 196, 198, and 200 that correspond to graphs 182, 184, and 186, respectively.
• the resistance within the vessel has an average value of approximately 0.35 on the scale of graph 200, as indicated by line 202.
• window 194 of the graphical representation 180 includes graph portions 204, 206, and 208 that correspond to graphs 182, 184, and 186, respectively.
• the resistance within the vessel is significantly less than the resting state with a value of approximately 0.20 on the scale of graph 208, as indicated by line 210.
• current FFR techniques rely on the average pressures across an entire heartbeat cycle, it is necessary to stress the patient's heart to achieve this reduced and relatively constant resistance across the entire heartbeat so that the data obtained is suitable for use with FFR techniques.
• section 212 of the heartbeat cycle of the patient corresponds to the portion of the heartbeat cycle of the patient where the resistance is reduced without the use of a hyperemic agent or other stressing technique. That is, section 212 is a portion of the heartbeat cycle of a resting patient that has a naturally reduced and relatively constant resistance. In other instances, section 212 of the heartbeat cycle encompasses the portion the heartbeat cycle that is less than a fixed percentage of the maximum resistance of the heartbeat cycle.
• the fixed percentage of the maximum resistance of the heartbeat cycle is less than 50%, less than 30%, less than 25%, less than 20%, less than 15%, less than 10%, and less than 5% in some embodiments.
• section 212 of the heartbeat cycle encompasses the portion the heartbeat cycle that is less than a fixed percentage of the average resistance of the heartbeat cycle.
• the fixed percentage of the average resistance of the heartbeat cycle is less than 75%, less than 50%, less than 25%, less than 20%, less than 15%, less than 10%, and less than 5% in some embodiments.
• the portion of the heartbeat cycle coinciding with section 212 is utilized as a diagnostic window for evaluating a stenosis of the vessel of a patient without the use of a hyperemic agent or other stressing of the patient's heart.
• the pressure ratio distal pressure divided by proximal pressure
• the calculated pressure ratio is an average over the diagnostic window defined by section 212 in some instances.
• a calculated pressure ratio above a threshold value is indicative of a first treatment mode (e.g. , no treatment, drug therapy, etc.), while a calculated pressure ratio below the threshold value is indicative of a second, more invasive treatment mode (e.g. , angioplasty, stent, etc.).
• the threshold value is a fixed, preset value.
• the threshold value is selected for a particular patient and/or a particular stenosis of a patient.
• the threshold value for a particular patient may be based on one or more of empirical data, patient characteristics, patient history, physician preference, available treatment options, and/or other parameters.
• section 212 is identified by monitoring pressure and fluid flow velocity within the vessel using one or more instruments and calculating the resistance within the vessel based on the measured pressure and velocity.
• the instrument 130 includes one or more sensing elements configured to monitor at least pressure and flow velocity
• instrument 132 includes one or more sensing elements configured to monitor at least pressure. Accordingly, with the one or more sensing elements of instrument 130 positioned distal of the stenosis and the one or more sensing elements of instrument 132 positioned proximal of the stenosis, the pressure and flow velocity measurements obtained by instrument 130 are utilized to identify section 212.
• the corresponding distal pressure measurements are compared to the proximal pressure measurements (as obtained by the one or more sensing elements of instrument 132) to calculate the pressure ratio across the stenosis during the diagnostic window defined by section 212.
• Additional examples of evaluating a vessel based on pressure and flow velocity measurements are described in UK Patent Application No. 1003964.2 filed March 10, 2010 and titled “METHOD AND APPARATUS FOR THE MEASUREMENT OF A FLUID FLOW RESTRICTION IN A VESSEL", which is hereby incorporated by reference in its entirety.
• section 212 is identified without monitoring fluid velocity.
• diagnostic window is identified solely based on characteristics of the pressure measurements obtained by instruments positioned within the vessel. Accordingly, in such instances, the instruments utilized need only have elements configured to monitor a pressure within the vessel, which results in reduced cost and simplification of the system.
• Exemplary techniques for evaluating a vessel based on pressure measurements are described in UK Patent Application No. 1100137.7 filed January 6, 2011 and titled "APPARATUS AND METHOD OF ASSESSING A NARROWING IN A FLUID FILLED TUBE", which is hereby incorporated by reference in its entirety.
• the diagnostic window for evaluating differential pressure across a stenosis without the use of a hyperemic agent in accordance with the present disclosure may be identified based on characteristics and/or components of one or more of proximal pressure measurements, distal pressure measurements, proximal velocity measurements, distal velocity measurements, ECG waveforms, and/or other identifiable and/or measurable aspects of vessel performance.
• various signal processing and/or computational techniques can be applied to the characteristics and/or components of one or more of proximal pressure measurements, distal pressure measurements, proximal velocity measurements, distal velocity measurements, ECG waveforms, and/or other identifiable and/or measurable aspects of vessel performance to identify a suitable diagnostic window.
• the determination of the diagnostic window and/or the calculation of the pressure differential are performed in approximately real time or live to identify the section 212 and calculate the pressure ratio.
• calculating the pressure ratio in "real time” or “live” within the context of the present disclosure is understood to encompass calculations that occur within 10 seconds of data acquisition. It is recognized, however, that often "real time” or “live” calculations are performed within 1 second of data acquisition.
• the "real time” or “live” calculations are performed concurrent with data acquisition.
• the calculations are performed by a processor in the delays between data acquisitions. For example, if data is acquired from the pressure sensing devices for 1 ms every 5 ms, then in the 4 ms between data acquisitions the processor can perform the calculations.
• the pressure ratio calculation is performed 10 or more seconds after data acquisition.
• the data utilized to identify the diagnostic window and/or calculate the pressure ratio are stored for later analysis.
• Figs. 9-11 shown therein are graphical representations of diagnostic information illustrating aspects of another embodiment of the present disclosure.
• Fig. 9 is a graphical representation of measured pressure and velocity within a vessel
• Fig. 10 is a graphical representation of a differential of the measured velocity of Fig. 9
• Fig. 11 is the graphical representation of measured pressure and velocity within the vessel annotated to identify a diagnostic window according to an embodiment of the present disclosure.
• graphical representation 220 includes a plot 222 representative of pressure (measured in mmHg) within a vessel over the time period of one cardiac cycle and a plot 224 representative of velocity (measured in m/s) of a fluid within the vessel over the same cardiac cycle.
• Fig. 10 in turn, is a graphical representation 230 of a differential of the velocity plot 224 of graphical representation 220 of Fig. 9. In that regard, in some instances, the velocity differential or change in velocity (dU) is calculated as
• variable t is equal to the sample rate of the velocity measurements of the system such that the differential is calculated for all data points. In other instances, the variable t is longer than the sample rate of the velocity measurements of the system such that only a subset of the obtained data points are utilized.
• the differential of the velocity plot 224 is relatively stabilized around zero.
• the velocity of the fluid within the vessel and/or the vascular resistance is relatively constant during time period 232.
• the velocity is considered stabilized when it varies between -0.01 and +0.01, and in some specific instance is considered stabilized when it varies between about -.005 and about +0.005.
• the velocity is considered stabilized with values outside of these ranges.
• time period 234 extending from about 200 ms to about 350 ms the differential of the velocity plot 224 is relatively stabilized around zero representing that the velocity of the fluid within the vessel is substantially constant during time period 234 as well.
• time period 234 can be highly variable, as valvular disease, dyssynchrony within a ventricle, regional myocardial contractile differences, microvascular disease can all lead to large variations of timing of the time period 234.
• all or portions of the time periods 232 and/or 234 are utilized as a diagnostic window for evaluating pressure ratio across a stenosis in some embodiments of the present disclosure.
• the diagnostic window is selected by identifying a portion of the cardiac cycle corresponding to the time period in which the change in velocity (i.e. , dU) fluctuates around zero.
• Fig. 11 shows the graphical representation 220 of Fig. 9 annotated to identify a diagnostic window 236 corresponding to the time period 232 of Fig. 10.
• the diagnostic window is selected by identifying a portion of the cardiac cycle corresponding to a period in which the change in velocity (i. e. , dU) is relatively small compared to the maximum change in velocity (i. e. , dUm a x) during a cardiac cycle.
• the maximum change in velocity i.e.
• the diagnostic window is selected by identifying the portion(s) of the cardiac cycle where the change in velocity (i.e. , dU) is less than 25%, less than 20 %, less than 15%, less than 10%, and/or less than 5% of the maximum change in velocity (i. e. , dU max ) for the cardiac cycle.
• time period 232, time period 234, and/or other time periods where the change in velocity is relatively constant and approximately zero such as variation or standard deviation from the mean, minimum threshold offset, or otherwise.
• time periods 232 and 234 have been identified using a differential of the velocity measurement, in other instances first, second, and/or third derivatives of the velocity measurement are utilized. For example, identifying time periods during the cardiac cycle where the first derivative of velocity is relatively constant and approximately zero allows the localization of time periods where velocity is relatively constant. Further, identifying time periods during the cardiac cycle where the second derivative of velocity is relatively constant and approximately zero allows the localization of a time period where acceleration is relatively constant and near zero, but not necessarily zero.
• Time periods 232, 234, and/or other time periods where the change in velocity is relatively constant and approximately zero are suitable diagnostic windows for evaluating a pressure differential across a stenosis of a vessel without the use of a hyperemic agent in accordance with the present disclosure.
• the severity of a stenosis within the vessel can be evaluated based on pressure measurements taken proximal and distal of the stenosis.
• an evaluation of the severity of the stenosis can be made. For example, the forward-generated pressure
• a forward-generated pressure differential is utilized to evaluate a stenosis in some instances.
• the forward-generated pressure differential is calculated based on proximally originating (i.e. , originating from the aorta) separated forward pressure waves and/or reflections of the proximally originating separated forward pressure waves from vascular structures distal of the aorta in some instances.
• a backward-generated pressure differential is utilized in the context of the coronary arteries to evaluate a stenosis.
• the backward-generated pressure differential is calculated based on distally originating (i.e. , originating from the microvasculature) separated backward pressure waves and/or reflections of the distally originating separated backward pressure waves from vascular structures proximal of the microvasculature.
• a pressure wave is introduced into the vessel by an instrument or medical device.
• the instrument or medical device is utilized to generate a proximally originating forward pressure wave, a distally originating backward pressure wave, and/or combinations thereof for use in evaluating the severity of the stenosis.
• an instrument having a movable membrane is positioned within the vessel. The movable membrane of the instrument is then activated to cause movement of the membrane and generation of a corresponding pressure wave within the fluid of the vessel. Based on the configuration of the instrument, position of the membrane within the vessel, and/or the orientation of the membrane within the vessel the generated pressure wave(s) will be directed distally, proximally, and/or both. Pressure measurements based on the generated pressure wave(s) can then be analyzed to determine the severity of the stenosis.
• FIG. 12 is a graphical representation of wave intensity within a vessel
• Fig. 13 is a graphical representation of proximal and distal originating pressure waves within the vessel corresponding to the wave intensity of Fig. 12
• Fig. 14 is a graphical representation of pressure and velocity within the vessel corresponding to the wave intensity of Fig. 12 and the proximal and distal originating pressure waves of Fig. 13
• FIG. 15 is a graphical representation of a resistance within the vessel corresponding to the wave intensity of Fig. 12, the proximal and distal originating pressure waves of Fig. 13, and the pressure and velocity of Fig. 14.
• a graphical representation 240 plotting the intensities associated with proximally and distally originating waves of a cardiac cycle over time.
• plot 242 is representative of proximally originating waves
• plot 244 is representative of distally originating waves.
• six predominating waves are associated with the cardiac cycle of a patient.
• wave 246 is a backward-traveling pushing wave
• wave 248 is a dominant forward-traveling pushing wave
• wave 250 is a backward-traveling pushing wave
• wave 252 is a forward-traveling suction wave
• wave 254 is a dominant backward-traveling suction wave
• wave 256 is a forward- traveling pushing wave.
• no waves are generated during a time period 258 late in the cardiac cycle.
• the time period 258 is referred to as a wave-free period of the cardiac cycle. Additional details regarding pressure waves in the context of the coronary arteries can be found in "Evidence of a Dominant Backward-Propagating 'Suction' Wave Responsible for Diastolic Coronary Filling in
• a graphical representation 260 of proximal and distal originating pressure waves within a vessel over a time period associated with a cardiac cycle correspond to the wave intensities of Fig. 12.
• the graphical representation 260 includes a plot 262 representative of a proximally-originating pressure, a plot 264 representative of a distally-originating pressure, and a plot 265 representative of the total pressure (proximally-originating pressure plus the distally-originating pressure).
• a graphical representation 270 that includes a plot 272 representative of pressure (measured in mmHg) within a vessel over time and a plot 274 representative of velocity (measured in cm/s) of a fluid within the vessel over time.
• the pressure and velocity plots 272, 274 of Fig. 14 correspond to the wave intensities and pressure waves of Figs. 12 and 13, respectively.
• the slopes of the pressure plot 272 and the velocity plot 274 are relatively constant.
• the resistance within the vessel is relatively constant and reduced during the time period 258.
• the graphical representation 280 of Fig. 15 includes a plot 282 of the resistance within the vessel over the time of a cardiac cycle.
• the resistance values of graphical representation 280 are calculated using the pressure and velocity measurements of Fig. 14, where resistance is equal to pressure divided by velocity for a particular point in time along the cardiac cycle. Due to the reduced and relative constant resistance during time period 258, all or a portion of the time period 258 is suitable for use as a diagnostic window for evaluating pressure differential across a stenosis in some
• the diagnostic window is the period of minimum resistance that corresponds to the wave-free period at the end of the backward-travelling suction wave, running to shortly before the end of the cardiac cycle.
• Figs. 16-26 shown therein are various graphical representations of techniques for determining start and/or end points for a diagnostic window in accordance with the present disclosure.
• Figs. 16-18 generally illustrate identification of a starting point of a diagnostic window based on a proximal pressure measurement
• Figs. 19-22 generally illustrate identification of a starting point of a diagnostic window based on a distal pressure measurement
• Fig. 23 illustrates identification of an end of a diagnostic window based on a starting point of the diagnostic window
• Fig. 24 illustrates identification of an ending point of a diagnostic window based on a proximal pressure measurement
• a graphical representation 300 includes a proximal pressure reading 302 and a distal pressure reading 304 each plotted over time relative to a cardiac cycle.
• the proximal pressure reading 302 is representative of a pressure proximal of a stenosis of a vessel.
• the proximal pressure reading 302 is based upon a partial pressure (e.g. , forward generated or backward generated) in some instances.
• the distal pressure reading 304 is representative of a pressure distal of the stenosis.
• the distal pressure reading 304 is based upon a partial pressure (e.g. , forward generated or backward generated) in some instances.
• proximal and distal pressure readings 302 and 304 provided in Fig. 16 will be utilized in describing the techniques associated with Figs. 17-28 as well.
• the proximal and distal pressure readings 302 and 304 are exemplary and should not be considered limiting in any way.
• the pressure readings will vary from patient to patient and even between cardiac cycles of a single patient. Accordingly, it is understood that the techniques described herein for identifying a diagnostic window based on these pressure readings are suitable for use with a wide variety of pressure reading plots. Further, it is understood that the techniques described below are calculated or determined over a plurality of cardiac cycles in some instances.
• the diagnostic window is identified by making calculations over a plurality of cardiac cycles and calculating an average or mean value, identifying overlapping areas common to the plurality of cardiac cycles, and/or otherwise identifying a suitable time period for a diagnostic window. Further still, it is understood that two or more of the techniques described below may be utilized together to identify a starting point, ending point, and/or other aspect of a diagnostic window.
• the starting point of the diagnostic window is determined by identifying a dicrotic notch and adding a fixed amount of time in some instances.
• a dicrotic notch 306 has been identified and a fixed time period 308 has been added to determine the starting point 310 of a diagnostic window.
• the fixed time period 308 is between about 1 ms and about 500 ms in some instances. In some particular instances, the time period 308 is between about 25 ms and about 150 ms.
• the amount of time added to the start of diastole is selected based on a percentage of the cardiac cycle or a percentage of the length of diastole. For example, in some instances, the amount of time added is between about 0% and about 70% of the length of the cardiac cycle. In yet other instances, no time is added to the dicrotic notch, such that the dicrotic notch 306 is the starting point 310.
• a start of diastole is identified based on the proximal pressure measurements and a fixed time period is added to determine the starting point of a diagnostic window.
• the fixed time period is between about 1 ms and about 500 ms. In some particular embodiments, the fixed time period is between the beginning of diastole and the start of the diagnostic window is between about 25 ms and about 200 ms.
• the amount of time added to the start of diastole is selected based on a percentage of the cardiac cycle or a percentage of the length of diastole. For example, in some instances, the time added to the start of diastole is between about 0% and about 70% of the cardiac cycle.
• the time added to the start of diastole is between about 0% and about 100% of the total length of the diastole portion of the cardiac cycle. In some instances, the time added to the start of diastole is between about 2% and about 75% of the total length of the diastole portion of the cardiac cycle. In yet other instances, no time is added to the start of diastole, such that the start of diastole is also the starting point of the diagnostic window.
• the starting point of the diagnostic window is determined by identifying a peak proximal pressure and adding a fixed amount of time in some instances.
• a peak pressure 314 has been identified and a fixed time period 316 has been added to determine the starting point 318 of a diagnostic window.
• the fixed time period 316 is between about 1 ms and about 550 ms in some instances. In some instances, the fixed time period 316 is between about 25 ms and about 175 ms.
• the amount of time added to the peak proximal pressure is selected based on a percentage of the cardiac cycle or a percentage of the length of diastole. For example, in some instances, the amount of time added is between about 0% and about 70% of the length of the cardiac cycle. In yet other instances, no time is added to the peak proximal pressure, such that the peak pressure 314 is the starting point 318.
• the starting point of the diagnostic window is determined by identifying the start of a cardiac cycle and adding a fixed amount of time in some instances.
• a start 322 of the cardiac cycle has been identified and a fixed time period 324 has been added to determine the starting point 326 of a diagnostic window.
• the fixed time period 324 is between about 150 ms and about 900 ms in some instances. In some instances, the fixed time period 324 is between about 300 ms and about 600 ms. In some particular embodiments, the fixed time period 324 is calculated as a percentage of the length 328 of a cardiac cycle of the patient. As shown in Fig.
• an end 330 of the cardiac cycle has been identified such that the length 328 of the cardiac cycle extends between the start 322 and the end 330.
• the percentage of the length 328 of the cardiac cycle utilized for calculating the starting point 356 is between about 25% and about 95% in some instances. In some instances, the percentage of the length 328 of the cardiac cycle is between about 40 % and about 75%. In yet other instances, no time is added to the start of the cardiac cycle, such that the start of the cardiac cycle 322 is the starting point 326.
• the starting point of the diagnostic window is determined by identifying a dicrotic notch and adding a fixed amount of time in some instances.
• a dicrotic notch 334 has been identified and a fixed time period 336 has been added to determine the starting point 338 of a diagnostic window.
• the fixed time period 336 is between about 1 ms and about 500 ms in some instances. In some instances, the fixed time period 336 is between about 25 ms and about 150 ms.
• a peak pressure 339 is identified based on the distal pressure measurements and a fixed time period is added to determine the starting point of a diagnostic window.
• the fixed time period relative to the peak pressure is between about 1 ms and about 550 ms in some instances. In some instances, the fixed time period is between about 25 ms and about 175 ms. In yet other instances, no time is added to the dicrotic notch, such that the dicrotic notch 334 is the starting point 338.
• a start of diastole is identified based on the distal pressure measurements and a fixed time period is added to determine the starting point of a diagnostic window.
• the fixed time period is between about 1 ms and about 500 ms.
• the fixed time period between the beginning of diastole and the start of the diagnostic window is between about 25 ms and about 200 ms.
• the amount of time added to the start of diastole is selected based on a percentage of the cardiac cycle or a percentage of the length of diastole. For example, in some instances, the time added to the start of diastole is between about 0% and about 70% of the cardiac cycle.
• the time added to the start of diastole is between about 0% and about 100% of the total length of the diastole portion of the cardiac cycle. In some instances, the time added to the start of diastole is between about 2% and about 75% of the total length of the diastole portion of the cardiac cycle. In yet other instances, no time is added to the start of diastole, such that the start of diastole is the starting point of the diagnostic window. Referring now to Fig. 20, the starting point of the diagnostic window is determined by identifying a maximum change in pressure and adding a fixed amount of time in some instances. In some particular instances, the maximum change in pressure after a peak distal pressure is utilized as the basis point from which the fixed amount of time is added.
• the point having a maximum change in pressure (i.e. , dP/dt) is identified by point 344.
• a fixed time period 346 has been added to point 344 to determine the starting point 348 of a diagnostic window.
• the fixed time period 346 is between about 1 ms and about 500 ms in some instances. In some instances, the fixed time period 346 is between about 25 ms and about 150 ms. In some particular embodiments, the fixed time period 346 is calculated as a percentage of the length of the cardiac cycle of the patient. The percentage of the length of the cardiac cycle utilized for calculating the starting point 348 is between about 0% and about 70% in some instances. In yet other instances, no time is added to the point 344 representative of the maximum change in pressure, such that the point 344 is the starting point 348.
• the starting point of the diagnostic window is determined by identifying the start of a cardiac cycle and adding a fixed amount of time in some instances.
• a start 352 of the cardiac cycle has been identified and a fixed time period 354 has been added to determine the starting point 356 of a diagnostic window.
• the fixed time period 354 is between about 150 ms and about 900 ms in some instances. In some instances, the fixed time period 354 is between about 300 ms and about 600 ms. In some particular embodiments, the fixed time period 354 is calculated as a percentage of the length 358 of the cardiac cycle of the patient. As shown in Fig.
• an end 360 of the cardiac cycle has been identified such that the length 358 of the cardiac cycle extends between the start 352 and the end 360.
• the percentage of the length 358 of the cardiac cycle utilized for calculating the starting point 356 is between about 25% and about 95% in some instances. In some particular instances, the percentage of the length 358 of the cardiac cycle is between about 40 % and about 75 %. In yet other instances, no time is added to the start of the cardiac cycle, such that the start of the cardiac cycle 352 is the starting point 356.
• the starting point of the diagnostic window is determined by identifying a ventricularization point in some instances. As shown in the graphical representation 362 of Fig. 22, a ventricularization point 364 of the cardiac cycle has been identified. In some instances, the ventricularization point 364 is identified based on the change in slope of the distal pressure reading. In the illustrated embodiment, the starting point 366 of the diagnostic window substantially coincides with the ventricularization point 364. In other instances, the starting point 366 is set to be a fixed amount of time before or after the ventricularization point. In that regard, the fixed time period is between about -250 ms and about 400 ms in some instances. In some instances, the fixed time period is between about -50 ms and about 100 ms.
• a graphical representation 370 illustrating a technique for identifying an ending point of a diagnostic window based on a starting point 372 of the diagnostic window.
• the diagnostic window has an ending point 374 that is spaced from the starting point 372 by a fixed amount of time 376.
• the fixed time period 376 is between about 1 ms and about 700 ms in some instances. In some instances, the fixed time period 376 is between about 200 ms and about 500 ms. In some particular embodiments, the fixed time period 376 is calculated as a percentage of the length of the cardiac cycle of the patient. The percentage of the length of the cardiac cycle utilized for calculating the time period 376 is between about 0% and about 70% in some instances.
• the percentage of the length of the cardiac cycle is between about 25% and about 50%.
• the diagnostic window is a specific point in the cardiac cycle such that time 376 is zero.
• the techniques described for identifying the starting point and/or the ending point of a diagnostic window are suitable for identifying such a diagnostic point in the cardiac cycle for evaluating pressure differential.
• a diagnostic window for a single cardiac cycle is comprised of a plurality of discrete diagnostic points along the single cardiac cycle.
• a graphical representation 380 illustrating a technique for identifying an ending point of a diagnostic window based on identifying the end of a cardiac cycle according to a proximal pressure measurement, which is an aortic pressure measurement in some instances, and subtracting a fixed amount of time.
• a proximal pressure measurement which is an aortic pressure measurement in some instances
• subtracting a fixed amount of time As shown, an end 382 of the cardiac cycle has been identified and a fixed time period 384 has been subtracted to determine the ending point 386 of a diagnostic window.
• the fixed time period 384 is between about 1 ms and about 600 ms in some instances. In some particular embodiments, the fixed time period 384 is calculated as a percentage of the length of the cardiac cycle of the patient.
• the percentage of the length of the cardiac cycle utilized for calculating the time period 384 is between about 0% and about 70% in some instances. In some instances, the percentage of the length of the cardiac cycle is between about 1% and about 25%. In yet other instances, no time is subtracted from the end of the cardiac cycle, such that the end of the cardiac cycle 382 is the ending point 386.
• Figs. 25 and 26 shown therein are techniques for identifying an ending point of a diagnostic window based on a distal pressure measurement. Referring more specifically to Fig. 25, shown therein is a graphical representation 390 illustrating a technique for identifying an ending point of a diagnostic window based on identifying the end of a cardiac cycle according to a distal pressure measurement and subtracting a fixed amount of time.
• the fixed time period 394 is between about 1 ms and about 600 ms. In some instances, the fixed time period 394 is between about 5 ms and about 100 ms. In some particular embodiments, the fixed time period 394 is calculated as a percentage of the length of the cardiac cycle of the patient. The percentage of the length of the cardiac cycle utilized for calculating the time period 394 is between about 0% and about 70%. In some instances, the percentage of the length of the cardiac cycle is between about 1% and about 25%. In yet other instances, no time is subtracted from the end of the cardiac cycle, such that the end of the cardiac cycle 392 is the ending point 396.
• a graphical representation 400 illustrating a technique for identifying an ending of a diagnostic window based on identifying the ventricularization point of a distal pressure measurement.
• a ventricularization point 402 of the cardiac cycle has been identified.
• the ventricularization point 402 is identified based on the change in slope of the distal pressure reading.
• an ending point 404 of the diagnostic window substantially coincides with the ventricularization point 402.
• the ending point 404 is set to be a fixed amount of time before or after the ventricularization point.
• the fixed time period is between about -200 ms and about 450 ms.
• the fixed time period is between about -50 ms and about 100 ms.
• Figs. 27 and 28 shown therein are graphical representations of exemplary diagnostic windows relative to proximal and distal pressure measurements.
• Fig. 27 illustrates a diagnostic window that begins shortly after ventricularization
• Fig. 28 illustrates a diagnostic window that begins before ventricularization.
• graphical representation 410 shows a diagnostic window 412 that includes a starting point 414 and an ending point 416.
• the starting point 414 is selected using one or more of the techniques described above for identifying a starting point of a diagnostic window.
• the ending point 416 is selected using one or more of the techniques described above for identifying an ending point of a diagnostic window.
• the diagnostic window 412 begins after the ventricularization point of the distal pressure reading 304 and ends before the end of the cardiac cycle.
• graphical representation 420 shows a diagnostic window 422 that includes a starting point 424 and an ending point 426.
• the starting point 424 is selected using one or more of the techniques described above for identifying a starting point of a diagnostic window.
• the ending point 426 is selected using one or more of the techniques described above for identifying an ending point of a diagnostic window. As shown, the diagnostic window 422 begins before the
• ventricularization point of the distal pressure reading 304 ends before the end of the cardiac cycle such that the ventricularization point is included within the diagnostic window 422.
• Fig. 29 shown therein is graphical representation of an ECG signal annotated with exemplary diagnostic windows according embodiments of the present disclosure.
• at least one identifiable feature of the ECG signal is utilized to select that starting point and/or ending point of the diagnostic window.
• a diagnostic window is identified using the decline of the T-wave as the starting point and the start of the R-wave as the ending point.
• the starting point and/or ending point of the diagnostic window is determined by adding a fixed amount of time to an identifiable feature of the ECG signal.
• the fixed amount time is a percentage of the cardiac cycle in some instances.
• a diagnostic window 456 has been identified that includes a starting point 458 and an ending point 460 for a cardiac cycle 462.
• the diagnostic window 456 is defined by the starting point 458 and the ending point 460.
• the starting point 458 is selected to be positioned at a fixed percentage of the total diastole time of the cardiac cycle 462 after a maximum decline in pressure.
• the fixed percentage of the total diastole time added to the point of maximum pressure decline to determine the starting point 458 is between about 10% and about 60%, with some particular embodiments having a percentage between about 20% and about 30%, and with one particular embodiment having a percentage of about 25%.
• the ending point 560 is selected to be positioned at a fixed percentage of the total diastole time or diastolic window from the beginning of diastole for the cardiac cycle 462.
• the fixed percentage of the total diastole time added to the beginning of diastole to determine the ending point 460 is between about 40% and about 90%, with some particular embodiments having a percentage between about 60% and about 80%, and with one particular embodiment having a percentage of about 70%.
• the ending point 560 is selected to be positioned at a fixed percentage of the total diastole time or diastolic window from the end of diastole for the cardiac cycle 462.
• the fixed percentage of the total diastole time subtracted from the end of diastole to determine the ending point 460 is between about 10% and about 60%, with some particular embodiments having a percentage between about 20% and about 40%, and with one particular embodiment having a percentage of about 30%. Accordingly, in the illustrated embodiment, both the starting point 458 and ending point 460 are selected based on a proportion of diastole of the cardiac cycle 462.
• diagnostic windows defined using such techniques for multiple cardiac cycles may vary from cardiac cycle to cardiac cycle because the length of diastole may vary from cardiac cycle to cardiac cycle.
• a diagnostic window 466 has been identified that includes a starting point 468 and an ending point 470 for a cardiac cycle 472 that follows cardiac cycle 462.
• the diagnostic window 466 will be longer or shorter than the diagnostic window 456, in some instances, because of differences in the length of diastole between cardiac cycle 462 and cardiac cycle 472.
• the diagnostic window is determined using one or more techniques selected from: identifying a feature of a waveform or other data feature and selecting a starting point relative to the identified feature (e.g. , before, after, or simultaneous with the feature); identifying a feature of a waveform or other data feature and selecting an ending point relative to the identified feature (e.g.
• the starting point and/or ending point of a maximum diagnostic window is identified (using one or more of the techniques described above, for example) and then a portion of that maximum diagnostic window is selected for use in evaluating the pressure differential across a stenosis.
• the portion selected for use is a percentage of the maximum diagnostic window. In some particular embodiments, the portion is between about 5 % and about 99% of the maximum diagnostic window.
• the portion selected for use is a centered portion of the maximum diagnostic window. For example, if the maximum diagnostic window was found to extend from 500 ms to 900 ms of a cardiac cycle and a centered portion comprising 50% of the maximum diagnostic window was to be utilized as the selected portion, then the selected portion would correspond with the time from 600 ms to 800 ms of the cardiac cycle. In other instances, the portion selected for use is an off-centered portion of the maximum diagnostic window.
• the selected portion would correspond with the time from 700 ms to 800 ms of the cardiac cycle.
• the diagnostic window is selected for each cardiac cycle such that the location and/or size of the diagnostic window may vary from cycle to cycle. In that regard, due to variances in the parameter(s) utilized to select the beginning, end, and/or duration of the diagnostic window from cardiac cycle to cardiac cycle, there is a corresponding variance in the diagnostic window in some instances.
• FIG. 31 shows a diagnostic window relative to proximal and distal pressure measurements
• FIG. 32 illustrates a temporal adjustment of the distal pressure measurement relative to the proximal pressure measurement.
• a diagnostic window 506 has been identified that includes a starting point 508 and an ending point 510.
• the diagnostic window 506 is suitable for evaluating the severity of a stenosis of the vessel without the need to use a hyperemic agent.
• the diagnostic window 506, starting point 508, and/or ending point 510 are calculated using one or more the techniques described above in some instances.
• the proximal pressure 502 includes a portion 512 coinciding with the diagnostic window 506.
• the distal pressure 504 includes a portion 514 that coincides with the diagnostic window 506.
• the proximal pressure 502 and distal pressure 504 are not temporally aligned in some instances.
• the differences can come from physical sources (such as cable length and/or varying electronics) and/or can be due to signal processing differences (such as filtering techniques).
• the proximal pressure measurement signal is acquired by and routed through a hemodynamic monitoring system and may take significantly longer to reach the processing hardware or computing device compared to the distal pressure measurement signal that is sent more directly to the processing hardware or computing device.
• the resulting delay is between about 5 ms and about 150 ms in some instances. Because individual cardiac cycles may last between about 500 ms and about 1000 ms and the diagnostic window may be a small percentage of the total length of the cardiac cycle, longer delays between the proximal and distal pressure measurement signals can have a significant impact on alignment of the pressure data for calculating a pressure differential for a desired diastolic window of a cardiac cycle.
• a portion of the distal pressure 504 has been shifted to be temporally aligned with the portion 512 of the proximal pressure 502 coinciding with the diagnostic window 506.
• 32 illustrates a shift of only a portion of the distal pressure 504 into alignment with the proximal pressure, in other embodiments all or substantially all of the proximal and distal pressures are aligned before the portions corresponding to a selected diagnostic window are identified.
• Alignment of all or portion(s) of the proximal and distal pressures is accomplished using a hardware approach in some instances.
• one or more hardware components are positioned within the communication path of the proximal pressure measurement, the distal pressure measurement, and/or both to provide any necessary delays to temporally align the received pressure signals.
• alignment of all or portion(s) of the proximal and distal pressures is accomplished using a software approach.
• a cross-correlation function or matching technique is utilized to align the cardiac cycles in some embodiments.
• the alignment is based on a particular identifiable feature of the cardiac cycle, such as an ECG R-wave or a pressure peak.
• alignment is performed by a software user where adjustments are made to the delay time of at least one of the proximal and distal pressures until the cardiac cycles are visually aligned to the user.
• a further technique for aligning the signals is to apply a synchronized timestamp at the point of signal acquisition. Further, in some instances combinations of one or more of hardware, software, user, and/or time- stamping approaches are utilized to align the signals.
• each individual distal pressure measurement cardiac cycle is individually shifted to match the corresponding proximal pressure measurement cardiac cycle.
• an average shift for a particular procedure is calculated at the beginning of the procedure and all subsequent cardiac cycles during the procedure are shifted by that amount. This technique requires little processing power for implementation after the initial shift is determined, but can still provide a relatively accurate alignment of the signals over the course of a procedure because the majority of the signal delay is due to fixed sources that do not change from patient to patient or within the procedure.
• a new average shift is calculated each time that the proximal and distal pressure signals are normalized to one another during a procedure.
• the sensing element utilized for monitoring pressure distal of the stenosis is positioned adjacent the sensing element utilized for monitoring pressure proximal of the stenosis such that both sensing elements should have the same pressure reading. If there is a difference between the pressure readings, then the proximal and distal pressure signals are normalized to one another. As a result, the subsequently obtained proximal and distal pressure measurements are more consistent with each other and, therefore, the resulting pressure ratio calculations are more accurate.
• the pressure ratio for the diagnostic window 506 is calculated.
• the pressure ratio is calculated using average values for the proximal and distal pressure measurements across the diagnostic window.
• the pressure ratio calculations of the present disclosure are performed for a single cardiac cycle, in some instances. In other instances, the pressure ratio calculations are performed for multiple cardiac cycles. In that regard, accuracy of the pressure ratio can be improved by performing the pressure ratio calculations over multiple cardiac cycles and averaging the values and/or using an analysis technique to identify one or more of the calculated values that is believed to be most and/or least accurate.
• a graphical representation 550 of proximal and distal pressure measurements within a vessel includes a proximal pressure measurement waveform 552 and a distal pressure measurement waveform 554.
• the proximal pressure measurement waveform 552 is representative of pressure
• the proximal pressure measurement waveform 552 has a peak pressure at point 556 and the distal pressure measurement waveform 554 has a peak pressure at point 558.
• the peak pressures occur during systole of each heartbeat cycle at or around the systolic wave-free period.
• the difference 560 is calculated as the peak proximal pressure 556 minus the peak distal pressure 558.
• the difference is calculated as the peak distal pressure 558 minus the peak proximal pressure 556.
• this difference between the peak pressures is taken into account when calculating the ratio of the distal pressure to the proximal pressure during a selected diagnostic window using one or more of the techniques discussed above.
• the difference 560 between the peak proximal pressure 556 and the peak distal pressure 558 is determined and then compensated for in making the pressure ratio calculation.
• the difference 560 between the peak pressures is added to the distal pressure measurement during the diagnostic window such that the pressure ratio during the diagnostic window is calculated as (Poi sta i + Peak Pressure Difference)/Pp rox i ma i.
• the difference is calculated as the peak proximal pressure 556 minus the peak distal pressure 558.
• the difference 560 between the peak pressures is subtracted from the distal pressure measurement during the diagnostic window such that the pressure ratio during the diagnostic window is calculated as (Poi sta i - Peak Pressure
• the difference is calculated as the peak distal pressure 558 minus the peak proximal pressure 556.
• a ratio of the peak proximal and distal pressures is calculated.
• the ratio of peak pressures can then be used as a scaling factor to adjust the pressure ratio calculations made during the diagnostic window.
• the peak pressure ratio is calculated by dividing the peak proximal pressure by the peak distal pressure.
• the standard pressure ratio calculated across a diagnostic window using one or more of the techniques described above can be scaled by multiplying the standard pressure ratio calculation by the ratio of peak pressures. In this manner, the ratio of peak pressures can be used as a scaling factor for calculating the pressure ratio during the diagnostic window.
• differences in pressure present during systole can be compensated for when calculating the pressure ratio during the diagnostic window used to evaluate the vessel. This compensation can be particularly useful in situations where the diagnostic window is selected to be during a wave- free period in diastole following shortly after systole.
• Figs. 34 and 35 shown therein are aspects of a technique for evaluating a vessel according to another embodiment of the present disclosure.
• the technique described below with respect to Figs. 34 and 35 may be implemented using any of the diagnostic windows and associated techniques discussed above for evaluating a vessel using a pressure ratio across a lesion, stenosis, or region of interest.
• the technique associated with Figs. 34 and 35 is not dependent upon the accuracy of the pressure measurements to evaluate the stenosis.
• a graphical representation 600 illustrating aspects of the technique for evaluating a vessel according to the current embodiment of the present disclosure.
• the graphical representation 600 includes a graph 602 and a graph 604.
• Graph 602 illustrates a proximal pressure waveform 606 and a distal pressure waveform 608 of a patient over time.
• Graph 604 illustrates corresponding calculations based on those waveforms 606 and 608.
• plot 610 is representative of a pressure ratio of the distal pressure waveform 608 relative to the proximal pressure waveform 606 over time, which in some embodiments is during a wave free period of the heartbeat cycle.
• Plot 610 is representative of the pressure ratio calculation used in some of the vessel evaluation techniques described above.
• Plot 612 is representative of a slope comparison between the distal pressure waveform 608 and the proximal pressure waveform 606.
• the slope of the distal pressure waveform 608 is compared to the slope of the proximal pressure waveform 606 to provide an indication of the severity of a lesion or stenosis.
• a best fit regression slope is utilized.
• one or more of polynomial fitting, multiple line regression, estimation of the slope from points at either end of the waveforms, and/or other suitable fitting techniques are utilized. Further, the fitting may be performed over a single heartbeat or over multiple heartbeat cycles.
• the polyfit regression slope i.e. , a slope obtained through polynomial curve fitting
• the polyfit regression slope move towards 0.0, which is indicative of a severe lesion or stenosis (e.g. , total occlusion or severe blockage). Accordingly, the severity of the lesion or stenosis can be evaluated based on the polyfit regression slope.
• a predetermined threshold value can be utilized for the regression slope comparison.
• the predetermined threshold value is between about 0.70 and about 0.90, with some particular embodiments using a threshold value of 0.75, 0.80, 0.85, or otherwise. In other instances, the predetermined threshold value is less than 0.70 or greater than 0.90.
• Fig. 35 illustrates this point.
• Shown therein is a graphical representation 620 that includes a graph 622 and a graph 624.
• Graph 622 illustrates a proximal pressure waveform 626 and a distal pressure waveform 628 of a patient over time.
• proximal pressure waveform 626 is the same as proximal pressure waveform 606 of Fig. 34 and distal pressure waveform 628 is substantially the same as distal pressure waveform 608 of Fig.
• plot 630 is representative of a pressure ratio of the distal pressure waveform 628 relative to the proximal pressure waveform 626 over time.
• the values of plot 630 are substantially increased relative to the values of plot 610 of Fig. 34. This illustrates one of the potential problems of an inaccurate and/or non-normalized distal pressure measurement in the context of the pressure ratio calculation.
• plot 632 is representative of a slope comparison between the distal pressure waveform 628 and the proximal pressure waveform 626. As shown, plot 632 substantially matches plot 612 of Fig. 34. This is because plots 612 and 632 are based upon the shape of the proximal and distal waveforms, which are the same between Figs. 34 and 35. In that regard, the distal pressure waveform 628 has the same shape as distal pressure waveform 608, it has simply been shifted upward by a value of 10 mmHg. As a result, plots 612 and 632 based on the slopes of the waveforms are pressure-value independent and, therefore, drift independent. It is understood that this waveform shape and/or waveform slope based technique can be implemented using the waveforms from any of the diagnostic windows discussed above.
• One advantage of the techniques of the present disclosure for identifying diagnostic windows and evaluating pressure differentials is the concept of "beat matching".
• the proximal and distal waveforms for the same cardiac cycle are analyzed together with no averaging or individual calculations that span more than a single cardiac cycle.
• interruptions in the cardiac cycle such as ectopic heartbeats
• these interruptions that can be detrimental to current FFR techniques have minor effect on the techniques of the present disclosure.
• the effect of interruptions in the cardiac cycle and/or other irregularities in the data is further minimized and/or mitigated by monitoring the pressure differential calculations to detect these anomalies and automatically exclude the impacted cardiac cycles.
• pressure ratio is calculated on two sequential cardiac cycles and the individual pressure ratio values are averaged. The pressure ratio of a third cycle is then calculated. The average value of the pressure ratios is compared to the average pressure ratio using three cycles. If the difference between the averages is below a predetermined threshold value, then the calculated value is considered to be stable and no further calculations are performed. For example, if a threshold value of 0.001 is used and adding an additional cardiac cycle changes the average pressure ratio value by less than
• the threshold value for completing the analysis is typically selected to be small enough that adding a subsequent cardiac cycle will not change the pressure differential value. For example, in some instances the threshold value is selected to be between about 0.0001 and about 0.05.
• the level of confidence calculation has different thresholds depending on the degree of stenosis and/or an initial calculated pressure ratio.
• pressure ratio analysis of a stenosis is typically based around a cutoff value(s) for making decisions as to what type of therapy, if any, to administer. Accordingly, in some instances, it is desirable to be more accurate around these cutoff points. In other words, where the calculated pressure ratio values are close to a cut-off, a higher degree of confidence is required. For example, if the cutoff for a treatment decision is at 0.80 and the initial calculated pressure ratio measurement is between about 0.75 and about 0.85, then a higher degree of confidence is needed than if the initial calculated pressure ratio measurement is 0.40, which is far from the 0.80 cutoff point.
• the threshold value is at least partially determined by the initial calculated pressure ratio measurement.
• the level of confidence or stability of the calculated pressure ratio is visually indicated to user via a software interface.
• the color of the calculated pressure ratio may change as the confidence level increases (e.g. , fading from a darker color to a brighter color)
• the user interface may include a confidence scale with a corresponding marker displayed for the particular calculation (e.g. , a sliding scale or a bullseye where an indicator of confidence moves closer to the bullseye as confidence increases)
• the pressure ratio value may transition from a fuzzy or unclear display to a sharp, clear display as confidence increase, and/or other suitable indicators for visually representing the amount of confidence or perceived preciseness of a measurement.
• the system includes at least two modes: a single-cardiac-cycle mode that facilitates pressure ratio calculations while moving the distal pressure measuring device through the vessel and a multi-cardiac-cycle mode that provides a more precise pressure ratio calculation at a discrete location.
• the software user interface is configured to provide the live pressure ratio value until the distal pressure measuring device is moved to the desired location and a measurement button is selected and/or some other actuation step is taken to trigger the multi-cardiac-cycle mode calculation.
• the sensing element utilized for monitoring pressure distal of the stenosis is positioned adjacent the sensing element utilized for monitoring pressure proximal of the stenosis such that both sensing elements should have the same pressure reading.
• a user can activate a normalization procedure of the system such that the system matches the pressure values obtained by the first and second pressure sensing instruments.
• the normalization procedure can be activated via the push of a button, either via software or hardware, and/or other suitable normalization actuation element.
• Normalization equates the magnitude of the mean distal pressure signal to the mean aortic pressure signal.
• Fig. 36 illustrates two different approaches to the normalization procedure.
• the command signal to set amplitude normalization is performed immediately utilizing the five cardiac cycles, corresponding to those occurring across arrow 658, preceding activation of the normalize button 656.
• this approach is subject to potentially significant errors if the user is not aware that the preceding cardiac cycles are being utilized for the normalization calculations.
• the rapid workflow of some physicians can cause variations in the pressure measurements.
• the instruments may not have been measuring the same pressures and/or movement of the sensing element(s) may impart unintended changes to the measured pressures due to contact to surrounding structures.
• the command signal to set amplitude normalization is delayed by five cardiac cycles, corresponding to those occurring across arrow 662, after activation of the normalize button 660.
• the rapid workflow of some physicians that might cause variations in the pressure measurements in the five heartbeats prior to activation is mitigated, ensuring that both the temporal and amplitude normalization of the pressure measurements are synchronized.
• using the five following cardiac cycles helps to ensure that the computations are performed on stable cardiac cycle data as the user will be aware that the normalization procedure is underway.
• a message indicating the current status of normalization e.g. , calculating, percentage complete, or other suitable indication
• the median amplitude difference for the cardiac cycles can be utilized to normalize the pressure measurements. Alternatively, the mean or mode of the amplitude difference of the cardiac cycles is utilized. Similarly, cardiac cycles with the highest and/or lowest amplitude differences can be excluded from the calculations and the mean, median, or mode of the remaining cardiac cycles can be utilized.
• the iFR pressure ratio measurement can be improved by alignment in the time domain of the pressure waveforms because the definition of the wave- free period or diagnostic window can be dependent on physiological markers and/or electrical configuration.
• the Pd and Pa pressure signals may not reach the signal processing software at the same time due to different signal paths.
• the Pd signal may pass through the patient interface module to the processing system, while the Pa signal travels from the transducer to the hemo system and then to the processing system, introducing a time delay that creates a misalignment between the paired Pa and Pd cardiac waveforms. Accordingly, in some implementations when the user selects
• Normalize an adjustment is calculated which represents a time shift between the paired waveforms.
• the adjustment may be calculated in any suitable manner, including those described above for aligning the proximal and distal waveforms.
• the time shift can be computed by employing a simplified cross-correlation function between the paired Pd and Pa waveforms.
• the dot product of the two waveforms can be computed using the simplified cross-correlation function.
• the distal waveform is then shifted by one position (5 ms) relative to the aortic waveform and the dot product is recomputed.
• the shift/dot product cycle repeats through all the distal waveform shift positions excluding the middle third of maximum shifts. In that regard, the middle third of the waveform is excluded in some instances because alignments this far out of range produce minimal dot products and adversely affect CPU cycle efficiency.
• the maximum value in the set of dot products indicates the best alignment between the two waveforms.
• the difference between the original position and the shift resulting in the maximum dot product represents the optimal time delay used to align the waveforms.
• an auto-correlation function is utilized.
• the cross-correlation function measures the similarity between two waveforms as a function of a time-lag applied
• the ⁇ ,, ⁇ ,! factor in the equation above will have minimal impact on the cross correlation function and can also be eliminated. Further still, the 1/n term in can be disregarded because the number of samples remains the same. As the sample shifts, the point that falls off one end is added to the other end. As a result of these assumption, the cross- correl
• next five cardiac cycles use the next five cardiac cycles to determine the appropriate time shift. Accordingly, the same five cardiac cycles can be used for determining the necessary amplitude adjustment and time shift. Alternatively, different cardiac cycles can be used for determining the necessary amplitude adjustment and the time shift.
• the median shift of the cardiac cycles is saved as the time shift. Alternatively, the mean or mode of the shift of the cardiac cycles is utilized. Similarly, cardiac cycles with the highest and/or lowest shift values can be excluded from the calculations and the mean, median, or mode of the remaining cardiac cycles can be utilized. The previously stored time shift is replaced with the new time offset value.
• the pressure values obtained by the pressure sensing instrument utilized for monitoring pressure distal of the stenosis is adjusted to match the pressure values of the pressure sensing instrument utilized for monitoring pressure proximal of the stenosis, as described above.
• the pressure values obtained by the pressure sensing instrument utilized for monitoring pressure proximal of the stenosis is adjusted to match the pressure values of the pressure sensing instrument utilized for monitoring pressure distal of the stenosis.
• the pressure values obtained by the pressure sensing instrument utilized for monitoring pressure proximal of the stenosis and the pressure sensing instrument utilized for monitoring pressure distal of the stenosis are adjusted to match an intermediate pressure measurement value (i.e., a pressure value between that measured by each of the pressure sensing instruments).
• the graphical representation 670 includes a graph including a proximal and distal pressure waveforms of a patient over time.
• the effect of interruptions in the cardiac cycle and/or other irregularities in the data is further minimized and/or mitigated by monitoring the pressure differential calculations to detect these anomalies and automatically exclude the impacted cardiac cycles.
• the graphical representation 670 shows an outlier cardiac cycle 672 that has been identified and excluded from corresponding calculations.
• the processing system can monitor the heart rate (HR) and iFR results for extreme and/or outlier values.
• Cardiac cycle outliers can be identified by absolute limits compared to previous cycles and/or heart rate. For example, in some implementations the following criteria are used to identify outlier cardiac cycles that will be excluded: (1) HR ⁇ 30 bpm; (2) HR > 180 bpm; (3) iFR ⁇ 0.85 of the mean of other cardiac waveforms (i.e., more than 15% decrease from the mean); and/or (4) iFR > 1.15 of the mean of other cardiac waveforms (i.e., more than 15% increase from the mean).
• any suitable criteria and corresponding threshold values can be utilized to identify outlier cardiac cycles, including without limitation heart rate (e.g., below a minimum heart rate threshold, above a maximum heart rate threshold, or otherwise outside of an accepted, expected heart rate range), iFR or other pressure ratio deviation (e.g., exceed a deviation threshold), and/or ECG features (e.g., shape and/or timing of ECG waves).
• heart rate e.g., below a minimum heart rate threshold, above a maximum heart rate threshold, or otherwise outside of an accepted, expected heart rate range
• iFR or other pressure ratio deviation e.g., exceed a deviation threshold
• ECG features e.g., shape and/or timing of ECG waves.
• a cardiac cycle may be excluded because a suitable diagnostic window cannot be identified for that cardiac cycle.
• the cardiac cycle is to begin a certain amount of time after a first waveform (e.g., pressure or ECG) landmark and stop a certain amount of time before a second waveform landmark
• the timing of the landmarks may result in the starting point occurring after the stopping point such that there is not a suitable diagnostic window for that cardiac cycle.
• that cardiac cycle can be excluded from calculations and/or other analyses.
• the particular threshold values utilized to identify outlier cardiac cycles can be default system values, user selected values, values based on patient specific variables, and/or other suitable way of defining the threshold values.
• An identified outlier can be excluded from the set of cardiac waveforms used in the iFR convergence calculation, the set of cardiac waveforms used to establish the relative mean, and/or other calculations.
• the visualization of the pressure waveforms can be modified or annotated to indicated that the identified outlier cardiac cycle is being omitted from the calculations.
• Fig. 37 shows an implementation where the excluded cardiac cycle 672 is identified with an "X" on the screen.
• the excluded cardiac cycle 672 can be identified to the user in an suitable manner, including using other text to identify the excluded cardiac cycle 672, using different colored waveforms for the excluded cardiac cycle 672, using faded/ghosted waveforms for the excluded cardiac cycle 672, deleting the waveforms for the excluded cardiac cycle 672 from the display entirely, and/or any other suitable way to signify that the cardiac cycle 672 is being excluded from the calculations.

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