WO2017033090A1

WO2017033090A1 - Intravascular measurement system with interface to hemodynamic monitoring system

Info

Publication number: WO2017033090A1
Application number: PCT/IB2016/054888
Authority: WO
Inventors: Dale Gene Dorando; Howard David Alpert; Hao DO; Yannick KUO; Chris Elliott
Original assignee: Koninklijke Philips N.V.
Priority date: 2015-08-21
Filing date: 2016-08-15
Publication date: 2017-03-02

Abstract

Devices, systems, and methods for evaluating a physiological condition of a vessel are disclosed. In an embodiment, an intravascular interface device is disclosed. One embodiment of the intravascular interface device comprises a processor and three modules each in communication with the processor: an aortic pressure module, a distal pressure module, and an electrocardiogram module. The aortic pressure module receives aortic pressure data from an intravascular instrument and communicates the aortic pressure data to a hemodynamic system and to a computing device. The distal pressure module receives distal pressure data from the computing device and communicates the distal pressure data to the hemodynamic system. The electrocardiogram module receives electrocardiogram data from the hemodynamic system and communicates the electrocardiogram data to the computing device.

Description

INTRAVASCULAR MEASUREMENT SYSTEM WITH INTERFACE TO

HEMODYNAMIC MONITORING SYSTEM

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to and the benefit of U. S. Provisional Patent Application No. 62/208,411, filed August 21, 2015, which is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

[0002] The present disclosure relates generally to the field of medical devices. More particularly, the present disclosure relates to the assessment of vessels, including 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 suitable for use in the evaluation of biological vessels; for example, some particular embodiments of the present disclosure are specifically configured for use in the evaluation of a stenosis of a human blood vessel, including focal and diffuse blockages.

BACKGROUND

[0003] Heart disease is a serious health condition affecting millions of people worldwide. One major cause of heart disease is the presence of flow reducing blockages or lesions within blood vessels. For example, accumulation of plaque inside blood vessels can eventually cause occlusion of the blood vessels through the formation of a partial or even a complete blockage. The formation of such blockages can be life-threatening, and surgical intervention is often required to save the lives of afflicted individuals.

[0004] Common treatment options available to open up an occluded vessel include balloon angioplasty, rotational atherectomy, and intravascular stents. Traditionally, surgeons have relied on X-ray fluoroscopic images, which are planar images showing the external shape of the silhouette of the lumen of blood vessels, to guide treatment. Unfortunately, with X-ray fluoroscopic images, there is a great deal of uncertainty about the exact extent and orientation of the stenosis responsible for the occlusion, making it difficult to find the exact location of the stenosis. In addition, though it is known that restenosis can occur at the same place, it is difficult to check the post-surgical condition inside the vessels with X-ray. [0005] A currently accepted technique for assessing the severity of a stenosis in a blood vessel, including ischemia causing lesions, is fractional flow reserve (FFR). FFR is a calculation of the ratio of a distal pressure measurement (taken on the distal side of the stenosis (e.g., downstream portion of the vessel relative to the stenosis)) relative to a proximal pressure measurement (taken on the proximal side of the stenosis). FFR provides an index of stenosis severity that allows determination as to whether the blockage limits blood flow within the vessel to an extent that treatment is required. The normal value of FFR in a healthy vessel is 1.00, while values less than about 0.80 are generally deemed significant and require treatment.

[0006] Diagnostic and corrective procedures are frequently performed in a catheterization laboratory as intravascular catheters and guide wires are often utilized to measure the pressure within a blood vessel. For example, intravascular catheters and guide wires may be used to obtain pressure data from both a proximal and distal side of a blockage inside a blood vessel and that pressure data may be used in calculating an FFR used to diagnose the severity of the blockage. Intravascular catheters and guide wires can also be utilized to visualize the inner lumen of a blood vessel and/or otherwise obtain data related to a blood vessel. Vessel data, such as the foregoing, is typically sent to a computer for processing and display so that physicians are able to conveniently reference the vessel data during performance of a procedure.

[0007] Given the severity and widespread occurrence of heart disease, there remains a need for improved devices, systems, and methods for assessing the severity of a blockage in a vessel and, in particular, a stenosis in a blood vessel. The devices, systems, and associated methods of the present disclosure overcome one or more of the shortcomings of the prior art.

SUMMARY

[0008] The present disclosure is directed to devices, systems, and methods for vascular assessment. Aspects of the present disclosure utilize an intravascular measurement system with an interface to a hemodynamic monitoring system.

[0009] For example, in an embodiment, an intravascular interface device is disclosed that comprises a processor and three modules in communication with the processor: an aortic pressure module, a distal pressure module, and an electrocardiogram module. The aortic pressure module receives aortic pressure data from an intravascular instrument and communicates the aortic pressure data to a hemodynamic system and a computing device. The distal pressure module receives distal pressure data from the computing device and communicates the distal pressure data to the hemodynamic system. The electrocardiogram module receives

electrocardiogram data from the hemodynamic system and communicates the electrocardiogram data to the computing device.

[00010] In one aspect, a power isolation barrier separates the aortic pressure module and distal pressure module from the electrocardiogram module. In one aspect, the intravascular interface device comprises a wireless transceiver in communication with the processor. The wireless transceiver can include at least one of a Bluetooth transceiver, a Bluetooth low energy transceiver, a Wi-Fi transceiver, a ZigBee transceiver, or other suitable wireless transceiver (e.g., infrared, Wibree (Baby Bluetooth), GSM, SPRS, EDGE, UMTS, WAP, etc.). The aortic pressure module may communicate the aortic pressure data to the computing device via the wireless transceiver. The distal pressure module may receive distal pressure data from the computing device via the wireless transceiver. The electrocardiogram module may communicate the electrocardiogram data to the computing device via the wireless transceiver. In one aspect, the intravascular interface device comprises a universal serial bus (USB) port in communication with the processor. In that regard, the aortic pressure module may communicate the aortic pressure data to the hemodynamic system and/or to the computing device via the USB port and/or an analog connection.

[00011] In another embodiment, an intravascular processing system is disclosed that comprises a patient interface module (PFM) in communication with a first intravascular instrument and a computing device; a hemodynamic interface module in communication with a second intravascular instrument, a hemodynamic system, and the computing device; and the computing device. The PFM receives distal pressure data from the first intravascular instrument, processes the received distal pressure data, and digitally communicates the processed distal pressure data to the computing device.

[00012] The hemodynamic interface module can include a processor and three modules in communication with the processor: an aortic pressure module, a distal pressure module, and an electrocardiogram module. The aortic pressure module receives aortic pressure data from the second intravascular instrument and communicates the aortic pressure data to the hemodynamic system and the computing device. The distal pressure module receives distal pressure data from the computing device and communicates the distal pressure data to the hemodynamic system. The electrocardiogram module receives electrocardiogram data from the hemodynamic system and communicates the electrocardiogram data to the computing device.

[00013] In one aspect, the hemodynamic interface module of the intravascular processing system further comprises a wireless transceiver in communication with the processor. In that regard, the aortic pressure module may communicate the aortic pressure data to the computing device via the wireless transceiver, the distal pressure module may receive the distal pressure data from the computing device via the wireless transceiver, and the electrocardiogram module may communicate the electrocardiogram data to the computing device via the wireless transceiver. The wireless transceiver can include at least one of a Bluetooth transceiver, a Bluetooth low energy transceiver, a Wi-Fi transceiver, a ZigBee transceiver, or other suitable wireless transceiver (e.g., infrared, Wibree (Baby Bluetooth), GSM, SPRS, EDGE, UMTS, WAP, etc.). The computing device may calculate a fractional flow reserve (FFR) value based on the cardiovascular data received and output the calculated FFR value to a display. The computing device may calculate an instant wave-free ratio (iFR) value based on the

cardiovascular data received and output the calculated iFR value to a display. In one aspect, the intravascular processing system comprises a portable control device in communication with the computing device. In one aspect, the intravascular processing system further comprises a maneuverable cart to which the computing device is mounted.

[00014] In another embodiment, a method is disclosed. The method comprises receiving, at an interface device, aortic pressure data from an intravascular instrument; communicating, from the interface device, the aortic pressure data to a computing device; communicating, from the interface device, the aortic pressure data to a hemodynamic system; and receiving, at the interface device, electrocardiogram data from the hemodynamic system. The method further comprises communicating, from the interface device, the electrocardiogram data to the computing device; receiving, at the interface device, distal pressure data from the computing device; and communicating, from the interface device, the distal pressure data to the

hemodynamic system.

[00015] In one aspect, the interface device communicates the aortic pressure data and the electrocardiogram data to the computing device and receives the distal pressure data from the computing device through a wireless connection. The wireless connection can include at least one of a standard Bluetooth connection, a Bluetooth low energy connection, a Wi-Fi connection, a ZigBee connection, or other suitable wireless transceiver (e.g., infrared, Wibree (Baby

Bluetooth), GSM, SPRS, EDGE, UMTS, WAP, etc.).

[00016] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In that regard, additional aspects, features, and advantages of the present disclosure will be apparent to one skilled in the art from the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Illustrative embodiments of the present disclosure will be described with reference to the accompanying drawings, of which:

[0011] FIG. 1 is a diagrammatic perspective view of a vessel having a stenosis according to an embodiment of the present disclosure.

[0012] 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.

[0013] FIG. 3 is a diagrammatic, partial cross-sectional perspective view of the vessel of FIG. 1 and FIG. 2 with instruments positioned therein according to an embodiment of the present disclosure.

[0014] FIG. 4 is a diagrammatic, schematic view of a system according to an embodiment of the present disclosure.

[0015] FIG. 5 is a diagrammatic, schematic view of a system according to an embodiment of the present disclosure.

[0016] FIG. 6 is a diagrammatic, schematic view of a system according to an embodiment of the present disclosure.

[0017] FIG. 7 is a flowchart of a method according to an embodiment of the present disclosure.

DETAILED DESCRD7TION

[0018] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It is nevertheless understood that no limitation to the scope of the disclosure is intended. Any alterations and further modifications to the described devices, systems, and methods, and any further application of the principles of the present disclosure are fully contemplated and included within the present disclosure as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and/or steps described with respect to one embodiment may be combined with the features, components, and/or steps described with respect to other embodiments of the present disclosure. In addition, dimensions provided herein are for specific examples and it is contemplated that different sizes, dimensions, and/or ratios may be utilized to implement the concepts of the present disclosure. For the sake of brevity, the numerous iterations of these combinations will not be described separately.

[0019] Referring to FIG. 1 and FIG. 2, shown therein is a vessel 100 having a stenosis according to an embodiment of the present disclosure. In that regard, FIG. 1 is a diagrammatic perspective view of the vessel 100, and 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. Referring more specifically to 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. In some instances, the vessel 100 is a systemic blood vessel. In some particular instances, the vessel 100 is a coronary artery. In such instances, the lumen 106 is configured to facilitate the flow of blood through the vessel 100.

[0020] As shown, 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. Where the vessel 100 is a blood vessel, 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. Generally, the composition of the stenosis will depend on the type of vessel being evaluated. 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.

[0021] Referring more particularly to FIG. 2, the lumen 106 of the vessel 100 has a diameter 110 proximal of the stenosis 108 and a diameter 112 distal of the stenosis 108. In some instances, the diameters 110 and 112 may be substantially equal to one another. In that regard, 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. However, it is understood that in many instances 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. In such instances, 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.

[0022] As shown in FIG. 2, stenosis 108 includes plaque buildup 114 that narrows the lumen 106 of the vessel 100. In some instances, the plaque buildup 114 may not have a uniform or symmetrical profile, making angiographic evaluation of such a stenosis potentially unreliable. In the illustrated embodiment, 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. As shown, the plaque buildup 114 decreases the available space for fluid to flow through the lumen 106. In particular, the cross- sectional area of the lumen 106 is decreased by the plaque buildup 114. At the narrowest point between the upper and lower portions 116, 118 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. Note that the stenosis 108, including plaque buildup 114, is exemplary in nature and should not 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. While the vessel 100 is illustrated in FIG. 1 and FIG. 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.

[0023] Referring now to FIG. 3, the vessel 100 is shown with instruments 130 and 132 positioned therein according to an embodiment of the present disclosure. In general, instruments 130 and 132 may comprise any form of device, instrument, or probe sized and shaped to be positioned within a vessel. In the illustrated embodiment, instrument 130 is generally

representative of a guide wire, and instrument 132 is generally representative of a catheter. In that regard, instrument 130 may extend through a central lumen of instrument 132. However, in other embodiments, the instruments 130 and 132 may take other forms. The instruments 130 and 132 may take similar form in some embodiments. For example, in some instances, both instruments 130 and 132 may comprise guide wires. In other instances, both instruments 130 and 132 may comprise catheters. On the other hand, the instruments 130 and 132 may take different forms in some embodiments, such as the illustrated embodiment, where one of the instruments comprises a catheter and the other a guide wire. Further, in some instances, the instruments 130 and 132 may be disposed coaxial with one another, as shown in the illustrated embodiment of FIG. 3. In other instances, one of the instruments may extend through an off-center lumen of the other instrument. In yet other instances, the instruments 130 and 132 may extend side-by-side. In some particular embodiments, at least one of the instruments may comprise a rapid-exchange device, such as a rapid-exchange catheter. In such embodiments, the other instrument may comprise a buddy wire or other device configured to facilitate the introduction and removal of the rapid-exchange device. Further still, in other instances, a single instrument may be utilized instead of two separate instruments 130 and 132. In that regard, the single instrument may incorporate aspects of the functionalities (e.g., data acquisition) of both instruments 130 and 132 in some embodiments.

[0024] Instrument 130 may be configured to obtain diagnostic information about the vessel 100. While, in some contexts, diagnostic information may comprise diagnostic data, biological information, biological data, cardiovascular information, cardiovascular data, and/or other information or data, for the purposes of the present disclosure, the term "diagnostic information" will be used. Diagnostic information may be gathered continuously, approximately every .0001 seconds, approximately every .005 seconds, approximately every .01 seconds, approximately every .25 seconds, approximately every .5 seconds, approximately once per second,

approximately once every two seconds, approximately once every 5 seconds, approximately once every 10 seconds, approximately once per heartbeat, and/or over some other timeframe. It is also contemplated that diagnostic information may be gathered in response to a trigger, in response to a command, or in response to a request. The diagnostic information may include one or more of pressure, flow (velocity), images (including images obtained using ultrasound (e.g., IVUS), OCT, thermal, and/or other imaging techniques), temperature, heart rate, electrical activity, and/or combinations thereof.

[0025] Accordingly, the instrument 130 may include one or more sensors, transducers, and/or other monitoring elements configured to obtain the diagnostic information about the vessel. The one or more sensors, transducers, and/or other monitoring elements may be positioned adjacent a distal portion of the instrument 130. The sensors, transducers, and/or other monitoring elements may be described with reference to an aspect of their implementation. For example, a pressure sensor may comprise a sensor configured to measure a pressure. In another example, an aortic transducer may comprise a transducer located in the aorta and/or interacting with diagnostic information pertaining to the aorta. In some instances, the one or more sensors, transducers, and/or other monitoring elements may be 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 an embodiment, at least one of the one or more sensors, transducers, and/or other monitoring elements may be positioned at the distal tip of the instrument 130.

[0026] The instrument 130 may include 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. In some instances, one or more features of the pressure monitoring element may be implemented as a solid-state component manufactured using semiconductor and/or other suitable manufacturing techniques. Examples of commercially available guide wire products that include suitable pressure monitoring elements include, without limitation, the Prime Wire PRESTIGE® pressure guide wire and the ComboWire® XT pressure and flow guide wire, each available from Volcano Corporation, as well as the PressureWire™ Certus guide wire and the Pressure Wire™ Aeris guide wire, each available from St. Jude Medical, Inc. The instrument 130 may be 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 may have an outer diameter of 0.018" or less. In some

embodiments, the instrument 130 may have an outer diameter of 0.014" or less.

[0027] Instrument 132 may also be configured to obtain diagnostic information about the vessel 100. In some instances, instrument 132 may be configured to obtain the same diagnostic information as instrument 130. In other instances, instrument 132 may be configured to obtain different diagnostic information than instrument 130, which may include additional diagnostic information, less diagnostic information, and/or alternative diagnostic information. Diagnostic information may be gathered continuously, approximately every .0001 seconds, approximately every .005 seconds, approximately every .01 seconds, approximately every .1 seconds, approximately every .25 seconds, approximately every .5 seconds, approximately once per second, approximately once every two seconds, approximately once every 5 seconds, approximately once every 10 seconds, approximately once per heartbeat, and/or over some other timeframe. It is also contemplated that diagnostic information may be gathered in response to a trigger, in response to a command, and/or in response to a request. The diagnostic information obtained by instrument 132 may include one or more of pressure, flow (velocity), images (including images obtained using ultrasound (e.g., IVUS), OCT, thermal, and/or other imaging techniques), temperature, or combinations thereof

[0028] Instrument 132 may include one or more sensors, transducers, and/or other monitoring elements configured to obtain this diagnostic information. In an embodiment, the one or more sensors, transducers, and/or other monitoring elements may be positioned adjacent a distal portion of the instrument 132. The sensors, transducers, and/or other monitoring elements may be described with reference to an aspect of their implementation. For example, a pressure sensor may comprise a sensor configured to measure a pressure. In another example, an aortic transducer may comprise a transducer located in the aorta and/or interacting with diagnostic information pertaining to the aorta. The one or more sensors, transducers, and/or other monitoring elements may be 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 may be positioned at the distal tip of the instrument 132.

[0029] Similar to instrument 130, instrument 132 may also include 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. In some instances, one or more features of the pressure monitoring element may be implemented as a solid-state component manufactured using semiconductor and/or other suitable manufacturing techniques. Millar catheters may be utilized in some embodiments. Currently available catheter products suitable for use with one or more of Philips's Xper Flex Cardio Physiomonitoring System, GE's Mac-Lab XT and XTi hemodynamic recording systems, Siemens's AXIOM Sensis XP VC11, McKesson's Horizon Cardiology Hemo, and Mennen's Horizon XVu Hemodynamic Monitoring System and include pressure monitoring elements can be utilized for instrument 132 in some instances.

[0030] In accordance with aspects of the present disclosure, at least one of the instruments 130 and 132 may be configured to monitor a pressure, e.g., a blood pressure, within the vessel 100 distal of the stenosis 108 and at least one of the instruments 130 and 132 may be configured to monitor a pressure within the vessel proximal of the stenosis. In that regard, the instruments 130, 132 may be 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 appropriate 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 may be 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.

[0031] 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 may be 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 can be spaced from the proximal end of the stenosis. Accordingly, in some instances, the proximal pressure measurement may be 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. In the context of coronary artery pressure measurements, the proximal pressure measurement may be taken at a position proximal of the stenosis and distal of the aorta, within a proximal portion of the vessel. However, in some particular instances of coronary artery pressure measurements, the proximal pressure measurement may be taken from a location inside the aorta. In such instances, the pressure data obtained may be referred to as aortic pressure data. In other instances, the proximal pressure measurement may be taken at the root or ostium of the coronary artery. [0032] Referring now to FIG. 4, shown therein is an intravascular processing system 200 according to an embodiment of the present disclosure. In that regard, FIG. 4 is a diagrammatic, schematic view of the intravascular processing system 200. As shown, the intravascular processing system 200 comprises an intravascular instrument 202, an intravascular instrument 204, a patient interface module (PIM) 206, a hemodynamic interface module 208, a

hemodynamic system 210, a computing device 212, and a controller 214. Some embodiments of the intravascular processing system 200 may comprise one or more additional elements and/or may lack one or more of the elements shown in FIG. 4. For example, though FIG. 4 depicts the intravascular processing system 200 as comprising the controller 214, alternate embodiments of the intravascular processing system 200 that lack the controller 214 are contemplated. Though not shown in FIG. 4, it is contemplated that the intravascular processing system 200 may further comprise a maneuverable cart to which the computing device 212 may be mounted, secured, affixed, or otherwise attached. Accordingly, a particular implementation of the intravascular processing system 200 may lack the controller 214 while comprising a maneuverable cart.

[0033] In an embodiment, the intravascular instrument 202 and/or the intravascular instrument 204 comprises at least one of instruments 130 and 132 discussed above. Accordingly, one or both of the intravascular instruments 202 and 204 may include features similar to those discussed above with respect to instruments 130 and 132. For example, the intravascular instrument 202 and/or the intravascular instrument 204 may comprise a pressure sensor and/or a transducer. In an embodiment, the intravascular instrument 202 may be positioned in the vasculature of a patient and may gather diagnostic information. The intravascular instrument 202 and/or other elements of the intravascular processing system 200, e.g., the intravascular instrument 204, may gather diagnostic information in accordance with the periodicity discussed hereinabove with reference to FIG. 3, over some other interval, in response to a trigger, in response to a command, in response to a request, or according to any combinations thereof.

[0034] In some instances, the intravascular instrument 202 may gather pressure data obtained at a location distal of a stenosis. For example, the intravascular instrument 202 may be positioned within the vessel 100 and may gather pressure data from the position 138 distal of the stenosis 108. For the purposes of the present disclosure, data gathered distal of a stenosis or other point of reference will be referred to as distal data; however, additional descriptors may be added to the general term in order to convey additional information. Thus, as used herein, the term "distal pressure data" refers to pressure data obtained at a location distal to a point of reference such as a stenosis.

[0035] The intravascular instrument 202 may be communicatively linked the PF 206 via a Universal Serial Bus (USB) port or other connection and may communicate diagnostic information to the PIM 206. For example, the intravascular instrument 202 may perform pressure measurements distal of a stenosis, e.g., the stenosis 108, and may subsequently communicate the obtained distal pressure data to the PIM 206 via the USB port. Diagnostic information may be communicated continuously, approximately every .01 seconds, approximately every .1 seconds, approximately every .25 seconds, approximately every .5 seconds, approximately once per second, approximately once every two seconds, approximately once every 5 seconds, approximately once every 10 seconds, instantly upon receipt, approximately once per heartbeat, in accordance with some other timeframe, in response to a trigger, in response to a command, in response to a request, or combinations thereof For the sake of brevity, the preceding sentence will not be repeated with respect to each communicative element of the intravascular processing system 200; however, it is understood that each such element may likewise communicate diagnostic information continuously, approximately every .01 seconds, etc., as described above. It is further understood that a request and/or a command may emanate from an element of the intravascular processing system 200 and/or from a user of an element of the intravascular processing system 200.

[0036] The term "communicate" and its variants are used herein to describe the process of conveying information between a first location/component and a second location/component using any suitable technique. It is understood that in some embodiments and/or contexts the terms transmit, transfer, send, channel, forward, relay, and/or terms may alternatively be used to describe aspects of the present disclosure. It is further noted that any element of the intravascular processing system 200 described in an embodiment as comprising a USB port and/or communicating via a USB port or connection may, in some instances, comprise and

communicate via a Thunderbolt connection, a Fire Wire connection, some other high-speed data bus connection, including custom and/or standardized connections, or via combinations thereof.

[0037] In an embodiment, the intravascular instrument 204 may be positioned in the vasculature of a patient and may gather diagnostic information. In some instances, the intravascular instrument 204 may gather pressure data obtained at a location proximal of a stenosis. For example, the intravascular instrument 204 may be positioned within the vessel 100 and may gather pressure data from one or more of the positions 140, 142, 144, 146, and 148 proximal of the stenosis 108. For the purposes of the present disclosure, data gathered proximal or upstream of a stenosis or other point of reference will be referred to as proximal data;

however, additional descriptors may be added to the general term in order to convey additional information. Thus, as used herein, the term "proximal pressure data" refers to pressure data from a location proximal to a point of reference such as a stenosis. The intravascular instrument 204 may be communicatively linked to the hemodynamic interface module 208 via an analog connection or other connection and may communicate diagnostic information to the

hemodynamic interface module 208. For example, the intravascular instrument 204 may perform pressure measurements proximal of a stenosis, e.g., the stenosis 108, and may subsequently communicate the obtained proximal pressure data, e.g., aortic pressure data, to the hemodynamic interface module 208, which can further communicate the obtained proximal pressure data using a USB connection, bluetooth low energy, and/or other suitable connection.

[0038] The PEVI 206 may serve as an interface between the intravascular instrument 202 and other elements of the intravascular processing system 200. The PIM 206 may receive diagnostic information from the intravascular instrument 202 and may communicate the diagnostic information to the computing device 212. In an embodiment, the diagnostic information communicated to the computing device 212 may comprise distal pressure data. In some instances, the diagnostic information may be received from the intravascular instrument 202 in analog form. In an embodiment, the PEVI 206 may comprise an analog to digital converter (A/D) and may process and digitize the diagnostic information and communicate the diagnostic information to the computing device 212 in a digital format. The diagnostic information may be communicated via a USB connection with the computing device 212 and/or via a wireless connection with the computing device 212.

[0039] The PEVI 206 may be designed so as to resist the ingress of fluids and other substances. It is specifically contemplated that the PIM 206 may be designed such that splashing water, blood, and/or other fluids have little to no adverse effect on the successful operation of the PEVI 206. In an embodiment, the PEVI 206 may perform one or more self-assessing diagnostic tests upon powering on, in response to input, once per day, once per use, and/or at some other interval. It is understood that different diagnostic tests may be performed either at the same time or at different times and intervals. Results of the diagnostic tests may be communicated to the computing device 212, displayed on a display of the PIM 206, displayed on a remote display, or subjected to combinations thereof. Further, the PIM 206 may be updated with new and/or revised software code and/or programming to update the functionality of the PIM over time.

[0040] In an embodiment, the hemodynamic interface module 208 may comprise a hemodynamic converter box (HCB). The hemodynamic interface module 208 may serve as an interface between elements of the intravascular processing system 200. The hemodynamic interface module 208 may receive diagnostic information, e.g., proximal pressure data, from the intravascular instrument 204 or associated component (e.g., a pressure transducer associated with the intravascular instrument 204) and may communicate the received diagnostic information to the hemodynamic system 210 and/or to the computing device 212. In embodiments in which the diagnostic information is sent to both the hemodynamic system 210 and the computing device 212, the diagnostic information may be communicated to the hemodynamic system 210 and the computing device 212 at approximately the same time or at different times. In some instances, the diagnostic information may be received from the intravascular instrument 204 by the hemodynamic interface module 208 in analog form. The hemodynamic interface module 208 may comprise an A/D converter and may digitize the diagnostic information before the diagnostic information is communicated to the hemodynamic system 210 and/or to the computing device 212. In some instances, the hemodynamic interface module 208 samples a signal from the intravascular instrument 204 without causing interference with the signal that would disrupt interpretation of the signal by the hemodynamic system 210.

[0041] The hemodynamic interface module 208 may receive diagnostic information from the hemodynamic system 210. In an embodiment, the diagnostic information received may comprise electrocardiogram data. The hemodynamic interface module 208 may subsequently communicate the diagnostic information received from the hemodynamic system 210 to the computing device 212. Further, the hemodynamic interface module 208 may receive diagnostic information, e.g., distal pressure data, from the computing device 212. The diagnostic information received from the computing device 212 may be communicated to the hemodynamic system 210.

Communication of diagnostic information to and from the hemodynamic interface module 208 may occur via a USB port and/or via a wireless connection. Elements of the intravascular processing system 200 in wireless communication with each other may engage in wireless handshaking. For example, it is understood that the hemodynamic interface module 208 and/or other elements of the intravascular processing system 200 may engage in wireless handshaking with the computing device 212. In some particular implementations, the hemodynamic interface module 208 has a wireless connection to the computing device 212 and a wired connection to the hemodynamic system 210. However, the hemodynamic interface module 208 can utilize any suitable combination of wireless and/or wired connections to communicate with the other devices of the intravascular processing system 200.

[0042] Wireless connections that can be utilized include Institute of Electrical and

Electronics Engineers (IEEE) standards 802.15.1 (Bluetooth/Bluetooth low energy), 802.11 (Wi- Fi), 802.15.4 (ZigBee), and other suitable wireless transceiver (e.g., infrared, Wibree (Baby Bluetooth), GSM, SPRS, EDGE, UMTS, WAP, etc.). Safety measures may be taken in order to protect the integrity of wireless communications. For example, information communicated wirelessly may be encrypted, the information may be hashed, e.g., with a cryptographic hash function, a cyclic redundancy check may be performed upon receipt of a communication, and/or other safety measures or combinations thereof may be taken. The foregoing discussion is not intended to limit implementation of the disclosed wireless connections and safety measures to embodiments of the hemodynamic interface module 208; rather, it is understood that other elements of the intravascular processing system 200 may implement one or more of the wireless connections and/or safety measures discussed hereinabove.

[0043] These and other aspects of the hemodynamic interface module 208 will be described in detail with respect to FIG. 6 below.

[0044] In an embodiment, the hemodynamic system 210 comprises a hemodynamic monitoring system or other control device, such as Siemens AXIOM Sensis, Mennen Horizon XVu, and Philips Xper IM Physiomonitoring 5. The hemodynamic system 210 may receive diagnostic information from the hemodynamic interface module 208. In an embodiment, the hemodynamic system 210 may receive distal pressure data and proximal pressure data, e.g., aortic pressure data, from the hemodynamic interface module 208. Accordingly, the

hemodynamic system 210 may process the diagnostic information and perform calculations similar to those described below with reference to the computing device 212. The hemodynamic system 210 may further receive input from one or more electrodes configured detect changes in electrical activity when placed on a patient's skin. When the electrodes are placed on the chest of a patient, information about changes in electrical activity detected by the electrodes may be useful in an assessment of the patient's heart. While also within the scope of the term "diagnostic information," information gathered by the electrodes may be herein referred to specifically as electrocardiogram data. The hemodynamic system 210 may receive electrocardiogram data from the electrodes and may communicate the electrocardiogram data to the hemodynamic interface module 208. Communication of diagnostic information to and from the hemodynamic system 210 may occur via an analog connection, digital connection, and/or via a wireless connection.

[0045] The computing device 212 may be generally representative of any device suitable for performing the processing and analysis techniques discussed within the present disclosure. In some embodiments, the computing device 212 may include a processor, random access memory, and a storage medium. In that regard, the computing device 212 may be 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 212 using corresponding instructions stored on or in a non-transitory computer readable medium accessible by the computing device 212.

[0046] It is understood that the communication pathways between elements of the intravascular processing system 200 may comprise physical connections (including electrical, optical, and/or fluid connections), wireless connections, and/or combinations thereof. In that regard, it is understood that the computing device 212 may comprise one or more physical connections, one or more wireless connections, and/or combinations thereof communicatively linking the computing device 212 with one or more elements of the intravascular processing system 200. In some instances, communication between elements of the intravascular processing system 200 includes a communication link over a network (e.g., intranet, internet,

telecommunications network, and/or other network). In that regard, it is understood that the computing device 212 may be positioned remote from an operating area where one or more other elements of the intravascular processing system 200 are implemented.

[0047] As discussed herein, the computing device 212 may receive diagnostic information from one or more elements of the intravascular processing system 200. The computing device 212 may process the diagnostic information so as to calculate an FFR, to calculate an instant wave-free ratio (iFR), e.g., a pressure ratio value calculated using a diagnostic window relative to a distance as a first instrument is moved through a vessel relative to a second instrument, including across at least one stenosis of the vessel, to calculate a coronary flow reserve (CFR), e.g., maximum increase in blood flow through the coronary arteries above the normal resting volume, to perform other calculations, to otherwise process the diagnostic information, or to perform combinations thereof. One or more of IPV (instanteous Peak Velocity), APV (average Peak velocity), DSVR (diastolic systolic velocity ratio), ASPV ( Average Systolic Peak

Velocity), ADPV (Average Diastolic Peak Velocity), PVi (Peak Velocity integral), MPV (Maximum Peak Velocity), CPI (Cardiometrics Pulsatility Index), RE (Resistance Index), HSR (Hyperemic Stenosis Resistance), HMR (Hyperemic Microvascular Resistance, FFR (Fractional Flow Reserv), iFR (Instant Wave Free Ratio), CFR (Coronary Flow Reserve), BSR (Basal Stenosis Resistance), CMR (Coronary Microvascular Resistance), CFI (antegrade flow), and/or other value(s) may be displayed on a display at the direction of the computing device 212. In some instances, the display may be remote from the operating room and/or from the computing device 212. In an embodiment, the computing device 212 comprises a display and may display one or more of the calculated FFR, iFR, and CFR values on the display. It is understood that, in some embodiments, "displaying" information, e.g., the calculated FFR, iFR, and/or CFR values, may involve displaying the information on multiple displays, e.g., on both a remote display and on a display of the computing device 212.

[0048] The computing device 212 may further process the diagnostic information in other ways. The computing device 212 may graph diagnostic information, FFR, iFR, CFR, and/or combinations thereof and display the graph on a display. Displayed graphs and/or data may be updated continuously, approximately every .0001 seconds, approximately every .005 seconds, approximately every .01 seconds, approximately every .1 seconds, approximately every .25 seconds, approximately every .5 seconds, approximately once per second, approximately once every two seconds, approximately once every 5 seconds, approximately once every 10 seconds, approximately once every 30 seconds, instantly upon receipt of data, instantly upon calculation of a value, approximately once per heartbeat, in accordance with some other timeframe, in response to a trigger, in response to a command, in response to a request, or combinations thereof. It is understood that a request and/or a command may emanate from an element of the intravascular processing system 200 and/or from a user of the computing device 212. [0049] The computing device 212 may issue instructions to other elements of the intravascular processing system 200. Instructions may comprise requests, demands, commands, other communications, or combinations thereof. For example, the computing device 212 may issue a request for diagnostic information to the intravascular instrument 202 via the PIM 206. As discussed hereinabove, the intravascular instrument 202 may obtain diagnostic information in response to receiving the request. The diagnostic information may then be communicated from the intravascular instrument 202 to the computing device 212 as discussed hereinabove. In an embodiment, the computing device 212 may run a software application that dictates aspects of instructions issued by the computing device 212. For example, the software application may dictate the timing of issuance, the intended recipient, other aspects of instructions issued by the computing device 212, or combinations thereof.

[0050] In an embodiment, the computing device 212 may comprise one or more

touchscreens configured to allow a user of the computing device 212 to interact with the computing device 212. For example, a user of the computing device 212, e.g., a physician, may issue instructions to the computing device 212 via a touchscreen. The touchscreens may be capacitive, resistive, and/or other types of touchscreens. In some instances, one or more of the touchscreens may comprise a graphical user interface (GUI). The touchscreens may further serve as displays on which the computing device 212 may display information such as calculated FFR, iFR, and/or CFR values. The computing device 212 may be further designed such that splashing water, blood, and/or other fluids have little to no adverse effect on the successful operation of the computing device 212. Some embodiments of the computing device 212 may comprise a customized USB port that includes a locking feature. In some instances, the PEVI 206 may be communicatively coupled to the computing device 212 via the customized USB port. The locking feature may serve to help protect against unintended disconnection of the PEVI 206 from the computing device 212.

[0051] In some instances, the computing device 212 may comprise a console device. In some particular instances, the computing device 212 may be similar to the s5™ Imaging System or the s5i™ Imaging System, each available from Volcano Corporation. In some embodiments, the computing device 212 may be portable (e.g., handheld, on a rolling cart, etc.). Accordingly, the computing device 212 may comprise straps, clips, hooks, elastic bands, hook and loop fasteners, and/or other features or combinations thereof configured to facilitate mounting, affixing, securing, and/or otherwise attaching the computing device 212 to a maneuverable cart, a bedframe, a pole, and/or to some other structure. Further, it is understood that in some instances the computing device 212 may comprise 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 are within the scope of the present disclosure.

[0052] In an embodiment, the controller 214 may comprise a portable device in wireless communication with the computing device 212. The controller 214 may allow a user to communicate instructions to the computing device 212 without using a touchscreen, keyboard, etc., of the computing device 212. Accordingly, the controller 214 may allow a user to communicate instructions to the computing device 212 at a distance. In an embodiment, the controller 214 communicates with the computing device 212 via an infrared (T ) wireless connection and/or radiofrequency (RF) wireless connection.

[0053] Referring now to FIG. 5, shown therein is an intravascular processing system 250 according to an embodiment of the present disclosure. In that regard, FIG. 5 is a diagrammatic, schematic view of the intravascular processing system 250. As shown, the intravascular processing system 250 can include one or more of the intravascular instrument 202, the intravascular instrument 204, the PIM 206, the hemodynamic interface module 208, the hemodynamic system 210, the computing device 212, and the controller 214. The intravascular processing system 250 is also shown in the context of a patient 216 and a physician 218. In some instances, the intravascular processing system 250 may be an embodiment of the intravascular processing system 200. Accordingly, it is understood that the intravascular processing system 250 and elements thereof may, where feasible, implement aspects disclosed hereinabove. As shown, in some instances the patient interface module 206, the hemodynamic interface module 208, and the computing device 212 define an interface system 252.

[0054] Distal pressure data (Pd) may be obtained from a location, e.g., the position 138, distal of a stenosis, e.g., the stenosis 108, within the vasculature of the patient 216. In an embodiment, the distal pressure data may be obtained by the intravascular instrument 202, which may comprise a pressure-sensing guide wire. In some instances, the distal pressure data (Pd) is obtained as the intravascular instrument 202 is moved through the vasculature of the patient 216. Additionally, aortic pressure data (Pa) may be obtained from a location inside the aorta of the patient 216. In an embodiment, the aortic pressure data may be obtained by the intravascular instrument 204, which may comprise a pressure-sensing catheter and associated aortic pressure transducer.

[0055] As shown in FIG. 5, the distal pressure data (Pd) may be communicated to the PIM 206 and subsequently communicated to the computing device 212. In an embodiment, the distal pressure data (Pd) may be communicated from the computing device 212 to the hemodynamic interface module 208 and on to the hemodynamic system 210. The aortic pressure data (Pa) may be communicated to the hemodynamic interface module 208 and from the hemodynamic interface module 208 to the hemodynamic system 210 and to the computing device 212. The hemodynamic interface module 208 may receive electrocardiogram data (ECG) from the hemodynamic system 210 and may communicate the electrocardiogram data (ECG) to the computing device 212.

[0056] As discussed hereinabove, the computing device 212 may receive instructions via a wireless connection with the controller 214. The controller 214 may be operated by the physician 218 and/or by other hospital staff. The physician 218 and/or other hospital staff may also interact with the computing device 212 via a touchscreen as described hereinabove. The computing device 212 may display an FFR, an iFR, a CFR, and/or other information received by or calculated by the computing device 212. The physician 218 may use the displayed information to diagnose, treat, or aid in treating ailments of the patient 216, e.g., heart disease.

[0057] Referring now to FIG. 6, shown therein is an intravascular processing system 300 according to an embodiment of the present disclosure. In that regard, FIG. 6 is a diagrammatic, schematic view of the intravascular processing system 300. As shown, the intravascular processing system 300 comprises the intravascular instrument 204, the hemodynamic interface module 208, and the hemodynamic system 210. Though not shown in FIG. 6, it is contemplated that the intravascular processing system 300 may comprise additional elements. In some instances, the intravascular processing system 300 may be an embodiment of the intravascular processing system 200. Accordingly, it is understood that the intravascular processing system 300 and elements thereof may, where feasible, implement aspects disclosed hereinabove. Though not depicted in FIG. 6, it is understood that diagnostic information may be wirelessly communicated from the hemodynamic interface module 208 to the hemodynamic system 210 and from the hemodynamic system 210 to the hemodynamic interface module 208.

[0058] As shown in FIG. 6, the hemodynamic interface module 208 comprises a processor 302 and several elements in communication with the processor 302: a wireless transceiver (XCVR) 304, an aortic pressure module 306, a distal pressure module 308, an electrocardiogram (ECG) module 310, and a Universal Serial Bus (USB) port 312. It is understood that while a single USB port 312 is shown, the hemodynamic interface module 208 may comprise two or more USB ports 312. Capabilities of the USB port 312 may be divided among multiple USB ports 312 in embodiments comprising a plurality of USB ports 312. Alternatively, the comprehensive range of capabilities of the USB port 312 may be present in one, multiple, or all USB ports 312 of a plurality of USB ports 312 in an embodiment of the hemodynamic interface module 208. Further, as noted above the USB port(s) may, in some instances, comprise and communicate via a Thunderbolt connection, a Fire Wire connection, some other high-speed data bus connection, including custom and/or standardized connections, or via combinations thereof. The hemodynamic interface module 208 further comprises a power isolation barrier 314 that separates the electrocardiogram module 310 and the USB port 312 from the other depicted elements of the hemodynamic interface module 208.

[0059] In some instances, the aortic pressure module 306, the distal pressure module 308, and/or the electrocardiogram module 310 may comprise circuits or portions of circuits for the receipt and transmission of diagnostic information. In an embodiment, the aortic pressure module 306, the distal pressure module 308, and the electrocardiogram module 310 may each be configured to act as pathways and/or storage for the different forms of diagnostic information. For example, the aortic pressure module 306 may be dedicated to aortic pressure data while the distal pressure module 308 may be dedicated to distal pressure data and the electrocardiogram module 310 may be dedicated to electrocardiogram data. In some embodiments, the aortic pressure module 306, the distal pressure module 308, the electrocardiogram module 310, or combinations thereof may be dedicated to their respective forms of diagnostic information to the exclusion of all other forms of diagnostic information. In some embodiments, the aortic pressure module, the distal pressure module 308, and/or the electrocardiogram module 310 are portions or sections of a single, common module. In other embodiments, the aortic pressure module, the distal pressure module 308, and/or the electrocardiogram module 310 are separate, individual modules. In this context, it is understood that module can include hardware, software, firmware, and/or combinations thereof.

[0060] The intravascular instrument 204 may obtain aortic pressure data and may

communicate the aortic pressure data to the hemodynamic interface module 208. The

hemodynamic interface module 208 may receive the aortic pressure data at the aortic pressure module 306. The aortic pressure module 306 may comprise one, two, or more amplifiers. In some instances, during communication processes performed by the hemodynamic interface module 208, the aortic pressure data may be amplified by a factor of approximately 20, approximately 30, approximately 50, approximately 70, approximately 80, approximately 100, or by some other factor. The aortic pressure data may be communicated to the hemodynamic system 210 via the aortic pressure module 306. In some instances, the aortic pressure data may be communicated from the aortic pressure module 306 directly to the hemodynamic system 210 without being first communicated to the processor 302. In an embodiment, the aortic pressure data may be communicated to the hemodynamic system 210 via an analog port 312, a digital connection, and/or via a wireless connection. As described hereinabove, aortic pressure data may also be communicated to a computing device, e.g, the computing device 212. In embodiments in which the aortic pressure data is wirelessly communicated to a computing device, the aortic pressure module 306 may communicate the aortic pressure data to the processor 302 which may communicate the aortic pressure data to the computing device via the wireless transceiver 304. The wireless transceiver 304 may comprise a Bluetooth transceiver, a Bluetooth low energy transceiver, a Wi-Fi transceiver, a ZigBee transceiver, other suitable wireless transceiver, and/or combinations thereof.

[0061] The hemodynamic interface module 208 may receive distal pressure data from a computing device, e.g., the computing device 212. The distal pressure data may be received at the processor 302 via the wireless transceiver 304. The processor may subsequently

communicate the distal pressure data to the distal pressure module 308 which may then communicate the distal pressure data to the hemodynamic system 210. The distal pressure data may be communicated to the hemodynamic system 210, via the analog port 312, a digital connection, and/or via a wireless connection. In an embodiment, the hemodynamic system 210 may communicate electrocardiogram data to the electrocardiogram module 310. The

electrocardiogram module 310 may receive the electrocardiogram data from the hemodynamic system 210, via the analog port 312, a digital connection, and/or via a wireless connection. The electrocardiogram module 310 may comprise one or more amplifiers with one, two, or more levels of gain. In an embodiment, the processor 302 may control gain switches of the

electrocardiogram module 310. The electrocardiogram module 310 may communicate the electrocardiogram data to the processor 302 which may communicate the electrocardiogram data to a computing device, e.g., the computing device 212, via the wireless transceiver 304. The R- wave portion of an electrocardiogram waveform included in the electrocardiogram data may be flagged prior to communication of the electrocardiogram data to the computing device.

[0062] In some instances, a computing device, e.g., the computing device 212, may be in communication with the hemodynamic interface module 208 via the analog port 312. In such instances, the processor 302 may communicate aortic pressure data and/or electrocardiogram data to the computing device via the analog port 312 and may receive distal pressure data from the computing device via the analog port 312. The analog port 312 may also serve to connect the hemodynamic interface device 208 to a power supply. Power may also be drawn from excitation voltages within the hemodynamic interface module 208. The hemodynamic interface module 208 may be further designed so as to resist the ingress of fluids and other substances. It is specifically contemplated that the hemodynamic interface module 208 may be designed such that splashing water, blood, and/or other fluids have little to no adverse effect on the successful operation of the hemodynamic interface module 208.

[0063] Referring now to FIG. 7, shown therein is a flow chart of a method 400 according to embodiments of the disclosure. Portions of the method 400 may correspond to techniques discussed hereinabove with reference to FIGS. 1-6 and may be performed with hardware and/or software components of the intravascular processing systems 200, 250, and 300. The method 400 begins at block 402 where aortic pressure data is received at an interface device. The aortic pressure data may be received from an intravascular instrument. In an embodiment, the interface device may comprise a hemodynamic interface module such as the hemodynamic interface module 208. In some instances, the intravascular instrument may comprise the intravascular instrument 204.

[0064] The method 400 continues at block 404 where the aortic pressure data is

communicated from the interface device to a computing device. In an embodiment, the computing device may comprise the computing device 212. The aortic pressure data may be communicated wirelessly, via a USB connection, or via a hard-wire connection as discussed herein. The interface device communicates, at block 406, the aortic pressure data to a hemodynamic system, such as the hemodynamic system 210 in some instances. The method 400 continues at block 408 where electrocardiogram data is received at the interface device from the hemodynamic system. The electrocardiogram data is communicated from the interface device to the computing device at block 410. The method proceeds to block 412 where distal pressure data is received at the interface device from the computing device. In some instances, the distal pressure data was gathered by the intravascular instrument 202 and communicated to the PEVI 206 and then to the computing device. The interface device communicates the distal pressure data to the hemodynamic system at block 414. In an embodiment, the interface device may communicate the aortic pressure data and the electrocardiogram data to the computing device and receive the distal pressure data from the computing device through a wireless connection. The wireless connection may comprise at least one of: a standard Bluetooth connection, a Bluetooth low energy connection, a Wi-Fi connection, or a ZigBee connection. Though not shown in FIG. 7, the method may further comprise additional steps consistent with the foregoing disclosure. Further, the method may omit some of the steps shown in FIG. 7 and/or perform the steps in various orders without departing from the scope of the present disclosure.

[0065] Persons skilled in the art will also recognize that the apparatus, systems, and methods described above can be modified in various ways. Accordingly, persons of ordinary skill in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the particular exemplary embodiments described above. In that regard, although illustrative embodiments have been shown and described, a wide range of modification, change, and substitution is contemplated in the foregoing disclosure. It is understood that such variations may be made to the foregoing without departing from the scope of the present disclosure.

Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the present disclosure.

Claims

CLAIMS What is claimed is:

1. An intravascular interface device, comprising:

a processor;

an aortic pressure module in communication with the processor, wherein the aortic pressure module receives aortic pressure data from an intravascular instrument and

communicates the aortic pressure data to a hemodynamic system and a computing device;

a distal pressure module in communication with the processor, wherein the distal pressure module receives distal pressure data from the computing device and communicates the distal pressure data to the hemodynamic system; and

an electrocardiogram module in communication with the processor, wherein the electrocardiogram module receives electrocardiogram data from the hemodynamic system and communicates the electrocardiogram data to the computing device.

2. The intravascular interface device of claim 1, further comprising a wireless transceiver in communication with the processor.

3. The intravascular interface device of claim 2, wherein the aortic pressure module communicates the aortic pressure data to the computing device via the wireless transceiver.

4. The intravascular interface device of claim 3, wherein the distal pressure module receives the distal pressure data from the computing device via the wireless transceiver.

5. The intravascular interface device of claim 4, wherein the electrocardiogram module communicates the electrocardiogram data to the computing device via the wireless transceiver.

6. The intravascular interface device of claim 2, wherein the wireless transceiver includes at least one of: a Bluetooth transceiver, a Bluetooth low energy transceiver, a Wi-Fi transceiver, or a ZigBee transceiver.

7. The intravascular interface device of claim 1, further comprising a universal serial bus (USB) port in communication with the processor.

8. The intravascular interface device of claim 7, wherein the aortic pressure module communicates the aortic pressure data to the hemodynamic system via an analog port.

9. The intravascular interface device of claim 7, wherein the aortic pressure module communicates the aortic pressure data to the computing device via the USB port.

10. The intravascular interface device of claim 1, further comprising a power isolation barrier separating the aortic pressure module and distal pressure module from the electrocardiogram module.

11. An intravascular processing system, comprising:

a patient interface module (PEVI) in communication with a first intravascular instrument and a computing device, wherein the PIM receives distal pressure data from the first intravascular instrument, processes the received distal pressure data, and digitally communicates the processed distal pressure data to the computing device;

a hemodynamic interface module in communication with a second intravascular instrument, a hemodynamic system, and the computing device, wherein the hemodynamic interface module includes:

a processor;

an aortic pressure module in communication with the processor, wherein the aortic pressure module receives aortic pressure data from the second intravascular instrument and communicates the aortic pressure data to the hemodynamic system and the computing device;

a distal pressure module in communication with the processor, wherein the distal pressure module receives distal pressure data from the computing device and

communicates the distal pressure data to the hemodynamic system; and

an electrocardiogram module in communication with the processor, wherein the electrocardiogram module receives electrocardiogram data from the hemodynamic system and communicates the electrocardiogram data to the computing device; and the computing device in communication with the PEVI and the hemodynamic interface module.

12. The intravascular processing system of claim 11, wherein the hemodynamic interface module further comprises a wireless transceiver in communication with the processor.

13. The intravascular processing system of claim 12, wherein the aortic pressure module communicates the aortic pressure data to the computing device via the wireless transceiver, the distal pressure module receives the distal pressure data from the computing device via the wireless transceiver, and the electrocardiogram module communicates the electrocardiogram data to the computing device via the wireless transceiver.

14. The intravascular processing system of claim 12, wherein the wireless transceiver includes at least one of: a Bluetooth transceiver, a Bluetooth low energy transceiver, a Wi-Fi transceiver, or a ZigBee transceiver.

15. The intravascular processing system of claim 11, wherein the computing device calculates a fractional flow reserve (FFR) value based on the aortic pressure data and the distal pressure data, and outputs the calculated FFR value to a display.

16. The intravascular processing system of claim 11, wherein the computing device calculates an instant wave-free ratio (iFR) value based on the aortic pressure data and the distal pressure data, and outputs the calculated iFR value to a display.

17. The intravascular processing system of claim 11, further comprising a portable control device in wireless communication with the computing device.

18. The intravascular processing system of claim 11, further comprising a

maneuverable cart to which the computing device is mounted.

19. A method, comprising

receiving, at an interface device, aortic pressure data from an intravascular instrument; communicating, from the interface device, the aortic pressure data to a computing device; communicating, from the interface device, the aortic pressure data to a hemodynamic system;

receiving, at the interface device, electrocardiogram data from the hemodynamic system; communicating, from the interface device, the electrocardiogram data to the computing device;

receiving, at the interface device, distal pressure data from the computing device; and communicating, from the interface device, the distal pressure data to the hemodynamic system.

20. The method of claim 19, wherein the interface device communicates the aortic pressure data and the electrocardiogram data to the computing device and receives the distal pressure data from the computing device through a wireless connection.

21. The method of claim 20, wherein the wireless connection comprises at least one of: a standard Bluetooth connection, a Bluetooth low energy connection, a Wi-Fi connection, or a ZigBee connection.