Patent Description:
Assessing the functional significances of cardiovascular and peripheral vascular diseases by intraluminal pressure and/or flow measurements can be beneficial to guide treatments of atherosclerotic diseases. Intraluminal devices with sensing and functional measurement (FM) capabilities have been developed to perform various types of measurements. For example, an intraluminal device may include a pressure sensor and/or a flow sensor at the tip of the intraluminal device. The intraluminal device may be inserted into a vessel of a patient body and the pressure sensor and/or the flow sensor may measure pressure and/or flow within the vessel. In particular, indices have been developed for coronary arteries to guide cardiologists in the decision of treating lesions. Examples of pressure-based indices may include fractional flow reserve (FFR) and instantaneous wave free ratio (iFR). An example of flow-based indices may include coronary flow reserve (CFR). An example of a combination of pressure-based and flow-based indices may include hyperemic stenosis resistance (HSR). These pressure-based and/or flow-based indices can provide better guidance to treatment decisions compared to angiographic assessment alone.

The operations of an intraluminal sensing device may require several wire connections, for example, for receiving power and for communication with a console for display and control and/or with a computing system for various physiologic data computations. For example, the sensors may receive power via the wire connections for operating the sensors and the sensor signals may be processed (e.g., amplified and/or filtered) and output to the console via the wire connections and/or further computations and processing at the computing system to obtain meaningful and/or useful data for diagnosis.

Intraluminal procedures may be performed in catheter labs and office-based labs (OBLs). The use of intraluminal devices in catheter labs and OBLs increases the number of cables in the catheter labs and OBLs and may clutter the workspace of the catheter labs and the OBLs. In some instances, it may be desirable to output sensor data signals to multiple diagnostic systems for various aspects of a workflow, and which further increasing the amount of cabling. These conditions can make a physician's ability to gather medical data for patient diagnosis more challenging. <CIT> relates to a patient communication system including a housing, a first socket disposed on the housing and configured to receive first medical data associated with a first modality from a first medical sensing device communicatively coupled thereto, and a controller disposed within the housing and configured to digitize the first medical data if it is received by the first socket in analog form. The system also includes a network communication module disposed within the housing and configured to transmit the digitized first medical data onto a data network and a first power module disposed within the housing and configured to provide a first dynamic amount of power to the first medical sensing device through the first socket based on the power requirements of the first medical sensing device. <CIT> relates to subject monitoring with a system configured to determine a first body state of a subject, based on an image data of the subject, and to determine a second body state of the subject, based on physiological data of the subject, wherein the subject monitoring system is operable, when it is determined that one of the first and second body states of the subject is not abnormal, to re-perform a corresponding one of the determinations, and then determine whether or not a notification indicating that the subject is in an abnormal state should be issued, based on a result of the re-performed determination about the one of the first and second body states. <CIT> relates to a notification system that appropriately notifies a healthcare provider of a change in the state of a patient in a sickroom. <CIT> relates to locating invasive intravascular devices within a vascular system. In one embodiment, an invasive medical sensing system is disclosed. The system comprises a flexible elongate member having a plurality of radiation-sensitive components arranged around an outer circumferential surface of the flexible elongate member. The plurality of radiation-sensitive components is arranged such that an orientation of the flexible elongate member can be determined when the sensors are exposed to radiation produced by a radiation source. The system further comprises a watchdog component communicatively coupled to the plurality of radiation-sensitive components and operable to detect radiation-induced changes in behavior of the plurality of radiation-sensitive components caused by the radiation and to determine the orientation of the flexible elongate member relative to the radiation source based on the detected radiation-induced changes in behavior.

The object of the present invention is solved by the subject-matter of the independent claims; further embodiments are incorporated in the dependent claims. While existing intraluminal sensing systems have proved useful, there remains a need for improved systems and techniques for reducing the amount of cabling between intraluminal sensing devices and systems in catheter labs or OBLs. Embodiments of the present disclosure provide a FM-PIM that computes physiologic data based on sensor signals collected from physiologic sensors and distributes the physiologic data wirelessly to multiple systems via a power over Ethernet (PoE) connection to a wireless router. For example, the FM-PIM is coupled to an intraluminal sensing device including at least one physiologic sensor, which may be a pressure sensor or a flow sensor, and a wireless router via an Ethernet cable providing the PoE connection. The FM-PIM includes a processing component coupled to the physiologic sensor and a PoE component coupled to the Ethernet cable. The PoE component receives power from the Ethernet cable to power the FM-PIM and the intraluminal sensing device. During a medical treatment or diagnostic procedure, the intraluminal sensing device can be inserted into a vessel of a patient and the physiologic sensor can obtain measurements associated with the vessel. The processing component receives sensor signals from the sensor and applies physiologic analytic algorithms to determine physiologic data from the received sensor signals. The processing component formats the physiologic data into a format suitable for display. The PoE component transmits and distributes the physiologic data to one or more systems that are in wireless communication with the wireless router. The PoE component can also receive control and/or data signals from one or more systems to facilitate the physiologic measurements and/or physiologic data computations.

In one embodiment, an intraluminal sensing system is provided. The intraluminal sensing system includes a patient interface module (PIM) in communication with an intraluminal device comprising a physiologic sensor and positioned within a body lumen of a patient, a wireless router via a signal link, and a computing device in wireless communication with the wireless router, wherein the PIM comprises a processing component configured to receive a sensor signal from the physiologic sensor; and determine physiologic data based on at least the sensor signal; and a power and communication component configured to receive power from the signal link; and transmit, to the computing device via the signal link and the wireless router, the physiologic data.

In some embodiments, the power and communication component is further configured to receive a control signal from the computing device via the signal link and the wireless router, and wherein the processing component is further configured to receive the sensor signal based on at least the control signal. In some embodiments, the power and communication component is further configured to receive a control signal from the computing device via the signal link and the wireless router, and wherein the processing component is further configured to determine the physiologic data based on the control signal. In some embodiments, the power and communication component is further configured to provide the power received from the signal link to the physiologic sensor of the intraluminal device. In some embodiments, the power and communication component is further configured to provide the power received from the signal link to the processing component. In some embodiments, the PIM further includes a memory coupled to the processing component and configured to store the physiologic data. In some embodiments, the PIM further includes a display coupled to the processing component and configured to display the physiologic data. In some embodiments, the power and communication component is further configured to receive, from a hemodynamic system via the signal link and the wireless router, a proximal pressure measurement, and wherein the processing component is further configured to determine the physiologic data by determining a distal pressure measurement based on the sensor signal; and determine a pressure ratio based on the proximal pressure measurement and the distal pressure measurement. In some embodiments, the processing component is further configured to determine the physiologic data by determining, based on the sensor signal, a flow-related value associated with the body lumen. In some embodiments, the intraluminal sensing system further comprises the intraluminal device. In some embodiments, the physiologic sensor comprises at least one of a pressure sensor or a flow sensor. In some embodiments, the PIM further comprises a patient isolation circuit coupled between the power and communication component and the processing component. In some embodiments, the processing component is configured to format the physiologic data into a format usable by the computing device to display the physiologic data, and wherein the power and communication component is configured to transmit the physiologic data in the format usable by the computing device to display the physiologic data. In some embodiments, the PIM is in communication with a second computing device in wireless communication with the wireless router, and wherein the power and communication component is further configured to transmit, to the second computing device via the signal link and the wireless router, the physiologic data.

In one embodiment, a method of performing physiologic sensing is provided. The method includes receiving, by a patient interface module (PIM) from an intraluminal sensing device, a sensor signal associated with a body lumen of a patient; determining, by the PIM, physiologic data based on at least the sensor signal; receiving, by the PIM, power from a wireless router via a signal link; and transmitting, by the PIM to a computing device via the signal link and the wireless router, the physiologic data.

In some embodiments, the method further includes receiving, by the PIM from the computing device via the signal link and the wireless router, a control signal, wherein the receiving the sensor signal includes receiving the sensor signal based on at least the control signal. In some embodiments, the method further includes receiving, by the PIM from the computing device via the signal link and the wireless router, a control signal, wherein the determining the physiologic data includes determining the physiologic data further based on at least the control signal. In some embodiments, the method further includes receiving, by the PIM from a hemodynamic system via the signal link and the wireless router, a proximal pressure measurement, wherein the determining the physiologic data includes determining a distal pressure measurement based on the sensor signal; and determining a pressure ratio based on the proximal pressure measurement and the distal pressure measurement. In some embodiments, the determining the physiologic data includes determining a flow-related value associated with the body lumen. In some embodiments, the method further includes formatting, by the PIM, the physiologic data according to a display format of the computing device, wherein the transmitting the physiologic data includes transmitting the physiologic data in the display format of the computing device.

<FIG> is a schematic diagram of a distributed wireless intraluminal sensing system <NUM>, according to aspects of the present disclosure. The system <NUM> may include an intraluminal sensing device <NUM>, a FM-PIM <NUM>, a wireless router <NUM>, a plurality of distributed systems <NUM>, for example, including a hemodynamic system 134a, an FM control system 134b, and an FM console system 134c. The FM-PIM <NUM> is in communication with the intraluminal sensing device <NUM> and the wireless router <NUM>. The FM-PIM <NUM> is connected to the wireless router <NUM> via an Ethernet cable <NUM>. The Ethernet cable <NUM> functions as a signal link or PoE link delivering power to the FM-PIM <NUM> and the intraluminal sensing device <NUM> as shown by the arrow <NUM> and transporting data between the FM-PIM <NUM> and the wireless router <NUM> as shown by the arrow <NUM>. The wireless router <NUM> is in wireless communication with the systems <NUM> as shown by the radio frequency (RF) signals <NUM>. Thus, the FM-PIM <NUM> can communicate with one or more of the systems <NUM> via the wireless router <NUM>.

The intraluminal sensing device <NUM> may include a flexible elongate member <NUM>, which may be a catheter, a guide wire, or a guide catheter. The flexible elongate member <NUM> includes a distal portion <NUM>, a proximal portion <NUM>, and a housing <NUM> positioned adjacent to the distal portion <NUM>. The housing <NUM> may be positioned at a distance (e.g., about <NUM> centimeters (cm)) from a distal tip of the intraluminal sensing device <NUM>. The housing <NUM> may include sensor assembly (sensor assembly <NUM> shown in <FIG>), which may include one or more physiologic sensors, transducers, and/or other monitoring elements configured to obtain diagnostic information about a body lumen or vessel <NUM>. For example, the flexible elongate member <NUM> can be inserted into a vessel <NUM> of a patient and the sensors can measure physiological characteristics, which may be pressure, flow, temperature, and/or volume, of fluid in the vessel <NUM>.

Vessel <NUM> may represent fluid filled or surrounded structures, both natural and man-made. The vessel <NUM> may be within a body of a patient. The vessel <NUM> may be a blood vessel, as an artery or a vein of a patient's vascular system, including cardiac vasculature, peripheral vasculature, neural vasculature, renal vasculature, and/or any suitable lumen inside the body. The intraluminal device <NUM> is an intravascular device in some embodiments. The intraluminal imaging device <NUM> may be used to examine any number of anatomical locations and tissue types, including without limitation, organs including the liver, heart, kidneys, gall bladder, pancreas, lungs; ducts; intestines; nervous system structures including the brain, dural sac, spinal cord and peripheral nerves; the urinary tract; as well as valves within the blood, chambers or other parts of the heart, and/or other systems of the body. The intraluminal device <NUM> may be used to examine any lumen in the above anatomical locations. In addition to natural structures, the intraluminal device <NUM> may be used to examine man-made structures such as, but without limitation, heart valves, stents, shunts, filters and other devices.

The intraluminal sensing device <NUM> may further include a cable (a cable <NUM> shown in <FIG>) coupled to the sensor assembly in the housing <NUM> to provide communication between the sensor assembly and the FM-PIM <NUM>. For example, the communication cable can transfer the sensor measurements to the FM-PIM <NUM> and transfer power from the FM-PIM <NUM> to the sensor assembly. Electrical signals can be transmitted between the FM-PIM <NUM> and the intraluminal sensing device <NUM> via a cable <NUM>.

The FM-PIM <NUM> includes a processing component (a processing component <NUM> shown in <FIG> and <FIG>), which may include hardware and/or software, configured to determine and compute physiologic data based on the sensor measurements, for example, by applying signal processing algorithms and/or physiologic analytic algorithms to the sensor measurements. Some examples of physiologic data may include a pressure ratio, fractional flow reserve (FFR), instantaneous wave free ratio (iFR), coronary flow reserve (CFR), flow volume, thermal flow, temperature, and/or other suitable values. The physiologic data may aid in treatment decisions and or guide treatment procedures.

The FM-PIM <NUM> further includes a power and communication component (a PoE component <NUM> shown in <FIG>) coupled to the wireless router <NUM> by the Ethernet cable <NUM>. For example, the wireless router <NUM> functions as a power sourcing equipment and the FM-PIM <NUM> function as a power device. The Ethernet cable <NUM> includes multiple twisted pairs. The Ethernet cable <NUM> can transport power and data over different twisted pairs or the same twisted pairs as described in Institute of Electrical and Electronics Engineers (IEEE) <NUM> standards. The internal components of the FM-PIM <NUM> are described in greater detail herein with respect to <FIG> and <FIG>. The FM-PIM <NUM> communicates the physiologic data to the wireless router <NUM> via the Ethernet cable <NUM>.

The wireless router <NUM> may be any wireless communication device or access point configured with support for transporting data and power (e.g., PoE support). The wireless router <NUM> may include transceivers and antennas configured to communicate with the systems <NUM> according to any suitable wireless communication protocols, such as IEEE <NUM> (WiFi) standards, Bluetooth, Zigbee, and ultra-wideband (UWB). For example, the wireless router <NUM> may forward signals received from the systems <NUM> to the FM-PIM <NUM>. In a reverse direction, the wireless router <NUM> may forward signals received from the FM-PIM <NUM> to the system <NUM>. The wireless router <NUM> may include a power and communication component configured to deliver power to the FM-PIM <NUM> and to transport data via the Ethernet cable <NUM>, for example, according to the IEEE <NUM> standards.

The systems <NUM> may include computing devices including hardware and/or software, consoles, keyboards, display monitors, and/or touchscreens for controlling and/or monitoring physiologic assessments and measurements. The systems <NUM> may further include wireless communication devices including transceivers and antennas for wireless communication with the wireless router <NUM>. The wireless communication devices may implement a similar wireless communication protocol as the wireless router <NUM> for communication with the wireless router <NUM>. Thus, in some embodiments, the systems <NUM> may be wireless computer workstations, wireless tablets, and/or any mobile devices.

The FM control system 134b can send control signals carrying commands for performing a medical diagnostic or treatment procedure using the intraluminal sensing device <NUM> and the wireless router <NUM> can forward the control signals to the FM-PIM <NUM>. For example, the FM control system 134b may function similar to a bedside controller. The FM-PIM <NUM> can control the sensor assembly in the intraluminal sensing device <NUM> and/or compute physiologic measurement data according to the control commands. For example, during a medical diagnostic or treatment procedure, a clinician may operate the FM control system 134b by sending a start command to begin acquiring sensor measurements, a recording command to record the sensor measurements, and/or a stop command to stop the acquisition. The FM-PIM <NUM> may send the computed physiologic measurement data to the FM control system 134b for display via the wireless router <NUM>. In some embodiments, the FM-PIM <NUM> may simultaneously send the computed physiologic measurement data to the FM control system 134b and the FM console system 134c for display via the wireless router <NUM>. In some embodiments, the FM console system 134c may function as another controller performing different aspects of the workflow than the FM control system 134b.

The hemodynamic system 134a can perform hemodynamic measurements and hemodynamic analysis and facilitate various physiologic measurements. For example, the hemodynamic system 134a may include instruments for performing aortic or proximal pressure measurements and/or electrocardiography (ECG) measurements. The hemodynamic system 134a can send the aortic or proximal pressure measurements and/or ECG measurements to the FM-PIM <NUM> via the wireless router <NUM> to facilitate the computation of physiologic data at the FM-PIM <NUM>, as described in greater detail herein.

<FIG> is a perspective view of the intraluminal sensing device <NUM>, according to aspects of the present disclosure. The intraluminal sensing device <NUM> includes an internal sensor mount <NUM>, the external housing <NUM>, sensor assembly <NUM>, a proximal flexible member <NUM>, a distal flexible member <NUM>, and a proximal electrical interface <NUM>.

The proximal electrical interface <NUM> is configured to electrically connect the sensor assembly <NUM> to the FM-PIM <NUM> for communicating signals (e.g., power and data). In accordance with this, the electrical interface <NUM> is in electrical communication with the sensor assembly <NUM>. The electrical interface <NUM> may include a series of conductive contacts on its outer surface that engage and communicate with corresponding contacts on the FM-PIM <NUM>.

The sensor assembly <NUM> may include one or more sensors. The sensor assembly <NUM> is arranged and configured to measure a physiological characteristic of a patient. When used on the intraluminal sensing device <NUM>, the sensor assembly <NUM> is arranged and configured to measure a physiological characteristic of a vessel itself, such as a vascular vessel. In one embodiment, the sensor assembly <NUM> may include a pressure monitoring element configured to monitor a pressure within a lumen of the vessel <NUM>. The pressure monitoring element can take the form of a piezo-resistive pressure sensor, a piezo-electric pressure sensor, a capacitive pressure sensor, an electromagnetic pressure sensor, an optical pressure sensor, and/or combinations thereof. In some instances, 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.

In another embodiment, the sensor assembly <NUM> may include a flow monitoring element configured to monitor a flow within a lumen of the vessel <NUM>. The flow monitoring element may be a flow velocity sensor or a flow volume sensor. In another embodiment, the sensor assembly <NUM> may include a temperature sensor configured to monitor the temperature within a lumen of the vessel <NUM>.

In yet other embodiments, the sensor assembly <NUM> includes a plurality of sensors arranged to detect one or more characteristics of the patient and provide feedback or information relating to the detected physiological characteristic(s). The sensor assembly <NUM> may be disposed, for example, less than about <NUM> from a distal-most end <NUM> of the intraluminal sensing device <NUM>. In one embodiment, the sensor assembly <NUM> is disposed about <NUM> from the distal-most end <NUM> of the intraluminal sensing device <NUM>.

The intraluminal sensing device <NUM> includes a cable <NUM> extending from the sensor assembly <NUM> to the proximal electrical interface <NUM>. The cable <NUM> may include conductors, which may be electrical cables or wires configured to carry signals and/or power between the sensor assembly <NUM> and the proximal electrical interface <NUM>. In some embodiments, the conductors are integrated with a core wire <NUM>, which can extend along a length of the intraluminal sensing device <NUM> with the core wire <NUM>. In some embodiments, three conductors are provided; however, the number of conductors in any particular embodiment may depend in part on the type or number of sensors disposed within the intraluminal sensing device <NUM>. For example, the number of conductors can be in the range of about one to twenty conductors, one to ten conductors, one to five conductors, one to four conductors, one to three conductors, etc..

The external housing <NUM> is positioned between the proximal flexible member <NUM> and the distal flexible member <NUM>, and is configured to cover and protect the sensor assembly <NUM>. In an embodiment, the sensor assembly <NUM> may be mounted within the internal sensor mount <NUM>, which may be a short tube or a hypotube, using epoxy.

The proximal flexible member <NUM> extends proximally from the internal sensor mount <NUM> towards the proximal electrical interface <NUM>. The proximal flexible member <NUM> may be a polymer tube, a coil-embedded polymer tube, or a coil. The distal flexible member <NUM> may be similar to the proximal flexible member <NUM> and may include a radiopaque coil. The intraluminal sensing device <NUM> further includes a distal-most end <NUM>. The distal-most end <NUM> may be rounded end that can smoothly slide against tissue as the intraluminal sensing device <NUM> is fed through the vasculature of a patient.

<FIG> illustrates a use case scenario <NUM> for the distributed wireless intraluminal sensing system <NUM>, according to aspects of the present disclosure. The scenario <NUM> includes a catheter lab <NUM> and a control room <NUM>. The catheter lab <NUM> is an examination room in a hospital or clinic where a physician or a clinician may perform a medical treatment or diagnostic procedure on a patient, for example, using the intraluminal sensing device <NUM>. The control room <NUM> may be another room in the hospital or clinic where anther physician or clinician may monitor the physiologic data obtained from the medical procedure during the procedure. For example, the intraluminal sensing device <NUM>, the FM-PIM <NUM>, the wireless router <NUM>, the hemodynamic system 134a, and the FM control system 134b are located in the catheter lab <NUM>, while the FM console system 134c is located in the control room <NUM>.

During a medical procedure, a physician may insert the intraluminal sensing device <NUM> into a patient vessel (e.g., the vessel <NUM>) of interest. The physician may normalize and/or calibrate the intraluminal sensing device <NUM> by operating the FM control system 134b and/or the hemodynamic system 134a prior to the insertion. The physician may operate the FM control system 134b for performing the medical procedure. For example, the physician may start, record, and/or stop data acquisition. The physician may press a start button, for example, via a graphical user interface (GUI) display on the FM control system <NUM>, to begin data acquisition. The FM control system <NUM> sends a control signal carrying a start command to the wireless router <NUM>. The wireless router <NUM> forwards the control signal to the FM-PIM <NUM>. The FM-PIM <NUM> begins to collect sensor measurements from the sensors on the intraluminal sensing device <NUM>. The FM-PIM <NUM> computes physiologic data, for example, representative of a certain diagnostic modality. The FM-PIM <NUM> transmits the physiologic data to the FM control system 134b and/or the FM console system 134c for display. The physician or clinician may also initiate recording and/or stopping the data acquisition using similar mechanisms as the starting of the data acquisition.

In some embodiments, the hemodynamic system 134a may facilitate physiologic data computation at the FM-PIM <NUM>. As described above, the hemodynamic system 134a can include instruments for collecting aortic or proximal pressure measurements and/or ECG measurements. For example, the hemodynamic system 134a can collect aortic or proximal pressure and/or ECG measurements from the patient while the intraluminal sensing device <NUM> is taking distal pressure measurements from the patient. The hemodynamic system 134a may send data signals carrying the aortic proximal pressure and/or ECG measurements to the wireless router <NUM>. The wireless router <NUM> forwards the data signals to the FM-PIM <NUM>. The FM-PIM <NUM> may compute an FFR based on the distal pressure measurement measured by the intraluminal sensing device <NUM> and the aortic or proximal pressure measurement received from the hemodynamic system 134a. In some instances, the FM-PIM <NUM> may identify a diagnostic window during the cardiac cycle (e.g., when resistance is naturally constant and minimized, such as based on ECG signal waveforms) and compute an iFR value based the proximal and distal pressure measurements obtained during the diagnostic window.

<FIG> is a schematic diagram illustrating an architecture of the FM-PIM <NUM>, according to aspects of the present disclosure. <FIG> is a schematic diagram illustrating functional blocks of the FM-PIM <NUM>, according to aspects of the present disclosure. The FM-PIM <NUM> includes a processing component <NUM>, a patient isolation circuit <NUM>, a PoE component <NUM>, a memory <NUM>, and a display <NUM> encased in a housing <NUM>. The housing <NUM> may be constructed from a rigid material, such as plastic and/or metal. The processing component <NUM> is coupled to the memory <NUM>, the display <NUM>, and the sensor assembly <NUM> of the intraluminal sensing device <NUM>. The processing component <NUM> includes a microcontroller <NUM>, a field programmable gate array (FPGA) <NUM>, and an application processing component <NUM>. The patient isolation circuit <NUM> couples the PoE component <NUM> to the processing component <NUM>.

The PoE component <NUM> is configured to draw power and communicate data via the Ethernet cable <NUM>. For example, the PoE component <NUM> may include a PoE controller, an Ethernet device, a direct current (DC)/DC converter. The PoE controller draws or requests power from the wireless router <NUM> via the Ethernet cable <NUM>. The PoE device controller may also handle signaling required for PoE communication. The DC/DC converter converts input voltage received from the wireless router <NUM> into a suitable voltage level for operating the processing component <NUM> and the sensor assembly <NUM>. For example, the PoE component <NUM> is coupled to the power circuitry within the FM-PIM <NUM> and the electrical interface <NUM> of the intraluminal sensing device <NUM>. The Ethernet device may include transceivers and medium access control (MAC) processors configured to communicate data with the wireless router <NUM> according to an Ethernet protocol. The transportations of the data and power may be over the same twisted pair or different twisted pairs.

The patient isolation circuit <NUM> includes circuitry configured to provide electrical isolation between the PoE component <NUM> and the intraluminal sensing device <NUM>, which is in contact with a patient body when in use. For example, in an event where a short or electrical malfunction occurs, the patient isolation circuit <NUM> may restrict the line voltage from passing from the PoE component <NUM> to the patient undergoing an intraluminal sensing procedure. The patient isolation circuit <NUM> may also restrict the amount of low-level RF signals that may be passed to the patient body.

The memory <NUM> may include volatile memory and non-volatile memory of any suitable memory types, including random access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), dynamic random-access memory (DRAM), static random-access memory (SRAM), and combinations thereof. The memory <NUM> is configured to store physiologic data computed by the processing component <NUM>.

The display <NUM> may be any suitable displaying device having a display panel integral with the housing <NUM>. The display <NUM> is configured to display physiologic data computed by the processing component <NUM>, such as FFR, iFR, CFR, and/or other suitable quantity.

As shown in <FIG>, the FPGA <NUM> includes one or more analog-to-digital converters (ADCs) <NUM> coupled to a signal conditioning component <NUM>. The ADCs <NUM> includes circuitry configured to receive analog sensor signals, for example, from pressure and/or flow sensors on the sensor assembly <NUM>, and convert the analog sensor signals to digital sensor signals. The signal conditioning component <NUM> is coupled to the ADCs <NUM>. The signal conditioning component <NUM> is configured to perform signal conditioning on the digital sensor signals. Signal conditioning may include signal amplification, filtering, and/or noise reduction.

The microcontroller <NUM> is coupled to the FPGA <NUM>. For example, a control firmware may be stored on the memory <NUM> and executed by the microcontroller <NUM>. The control firmware may include state machines <NUM> configured to control the operations of the FPGA <NUM>. For example, the state machines <NUM> may control the starting and ending of a particular signal conditioning circuitry. While the microcontroller <NUM> is illustrated as a separate component from the FPGA <NUM>, in some embodiments, the microcontroller <NUM> can be implemented as part of the FPGA <NUM>.

The application processing component <NUM> is coupled to the FPGA <NUM>. The application processing component <NUM> can include hardware and/or software. In some embodiments, the application processing component <NUM> may include a general purpose processor, a digital signal processor, and/or an application-specific integrated circuit (ASIC). The application processing component <NUM> is configured to generate physiologic data from the conditioned sensor signals. The application processing component <NUM> may apply signal processing algorithms and/or physiologic analytic algorithms on the conditioned sensor signals. For example, the application processing component <NUM> may include a plurality of FM components <NUM>. The FM component <NUM> may be configured to determine physiologic data of various modalities, which may be flow-related and/or pressure-related. The application processing component <NUM> may further include a data formatting component <NUM> configured to format the physiologic data according to display formats suitable for display on the systems <NUM>. The data formatting component <NUM> can also packetize the physiologic data for transmission to the systems <NUM> via the wireless router <NUM>.

In an embodiment, one of the FM components <NUM> is configured to compute FFRs. FFRs operate based on a physiologic principle, where pressures are proportional to changes in flow velocity when the vascular resistance is constant. To effectively measure FFR, a hyperemic agent is administered to a patient under test to reduce and stabilize the vascular resistance within the coronary arteries. FFR is a calculation of the ratio of a distal pressure measurement (taken on the distal side of a stenosis) relative to a proximal pressure measurement (taken on the proximal side of the stenosis). For example, the distal pressure measurement can be taken by inserting the intraluminal sensing device <NUM> equipped with a pressure sensor into a blood vessel and the proximal pressure measurement can be taken using the hemodynamic system 134a. In an embodiment, the FM-PIM <NUM> may receive a data signal carrying the proximal pressure measurement from the hemodynamic system 134a via the Ethernet cable <NUM> and the wireless router <NUM>. 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 FFR values can be formatted and/or packetized and simultaneously sent to one or more of the systems <NUM> and/or the display <NUM> for display. The FFR values can also be recorded and stored in the memory <NUM>.

In an embodiment, one of the FM components <NUM> is configured to compute iFRs. The iFR modality does not rely on hyperemic agents to stabilize the vasculature pressure. The iFR refers to an instantaneous pressure ratio across a stenosis during a wave-free period. A wave-free period refers to a restful interval of a cardiac cycle where the vascular resistance is naturally constant. For example, a diagnostic window representing a restful interval in a cardiac cycle is identified based on proximal pressure measurements and/or distal pressure measurements and subsequently iFRs are determined based on flow velocity measurements of fluid flow in the blood vessel during the diagnostic window. Details of vessel assessment mechanisms are described in <CIT>, titled "DEVICES, SYSTEMS, AND METHODS FOR ASSESSING A VESSEL. The iFR values can be simultaneously sent to one or more of the systems <NUM> and/or the display <NUM>. The iFR modality allows for real-time or live measurements and monitoring. The iFR values can also be recorded and stored in the memory <NUM>.

In an embodiment, one of the FM components <NUM> is configured to compute CFRs. CFRs are ratios between resting and maximal possible coronary blood flow. For example, a measurement of a fluid velocity within a blood vessel can be taken by advancing the intraluminal sensing device <NUM> equipped with a flow sensor into the blood vessel. CFR can be computed based on the fluid velocity measurement and the cross-sectional area of the blood vessel. The vessel area can be estimated or measured based on angiography and/or optical coherence tomography measurements. The CFR values can be simultaneously sent to one or more of the systems <NUM> and/or the display <NUM>. The CFR values can also be recorded and stored in the memory <NUM>.

By implementing the FM components <NUM> and the data formatting component <NUM> in the PIM <NUM>, the processed physiologic data can be advantageously distributed in a format for display by any suitable display of the systems <NUM>. In prior configurations, data from a PIM would be transmitted to the particular computing device (e.g., a console) where the data would be processed. According to the present disclose, the data can be processed at the PIM <NUM> without being transmitted to a particular system, and the data can be transmitted in a display format to any number of systems <NUM>. For example, physiologic data processing and formatting can be completed entirely within the PIM <NUM> and the physiologic data for display can be transmitted from the PIM to any suitable computer/monitor for display. In this manner, the physiologic data processing and formatting can be decoupled from larger, bulky computer systems and completed within relatively smaller, lighter, and more mobile PIM <NUM>.

In some embodiments, FFR measurements, iFR measurements, and/or CFR measurements can be further correlated and/or analyzed in conjunction with angiography measurements to provide physician with clinical guidance to estimate stenosis severity and aid appropriate treatment. While <FIG> illustrates the FM components <NUM> being implemented on the application processing component <NUM>, in some embodiments, the FM components <NUM> can be implemented by the microcontroller <NUM> and/or the FPGA <NUM>.

In some embodiments, the FM-PIM <NUM> may receive a control signal carrying control commands, such as start, stop, and/or record, and the processing component <NUM> may control the sensor assembly <NUM> and/or the physiologic data computations at the FPGA <NUM> and/or the application processing components <NUM> accordingly.

<FIG> is a flow diagram of a method <NUM> of performing physiologic sensing, according to aspects of the present disclosure. Steps of the method <NUM> can be executed by a computing device (e.g., a processor, processing circuit, and/or other suitable component) of a PIM such as the FM-PIM <NUM>. The method <NUM> may employ similar mechanisms as described with respect to <FIG>, <FIG>, and <FIG>. As illustrated, the method <NUM> includes a number of enumerated steps, but embodiments of the method <NUM> may include additional steps before, after, and in between the enumerated steps. In some embodiments, one or more of the enumerated steps may be omitted or performed in a different order.

At step <NUM>, the method <NUM> includes receiving a sensor signal associated with a body lumen of a patient from an intraluminal sensing device (e.g., the intraluminal sensing device <NUM>. Then sensor signal may be a pressure sensor signal or a flow sensor signal.

At step <NUM>, the method <NUM> includes determining physiologic data (e.g., FFRs, iFRs, and/or CFRs) based on at least the sensor signal.

At step <NUM>, the method <NUM> includes receiving power (e.g., the power signal shown by the arrow <NUM>) from a wireless router (e.g., the wireless router <NUM>) via a signal link (e.g., the Ethernet cable <NUM>).

At step <NUM>, the method <NUM> includes formatting the physiologic data according to a display format of a computing device (e.g., the systems <NUM>).

At step <NUM>, the method <NUM> includes transmitting the physiologic data in the display format to the computing device (e.g., the systems <NUM>) via the signal link and the wireless router.

Aspects of the present disclosure may provide several benefits. For example, the use of the PoE link for both power and data communications can reduce the amount of cabling that is typically required in an intraluminal system. The coupling of the PoE link to a wireless router enables the distribution of physiologic data to multiple systems without additional cable connections. In addition, computing the physiologic data at the FM-PIM can offload FM algorithms that are typically computed at a target system with a direct wired connection to the intraluminal sensing device. Thus, other systems monitoring the physiologic data can be lightweight, low-cost wireless devices and systems.

Claim 1:
An intraluminal sensing system (<NUM>), comprising:
- a patient interface module (<NUM>), PIM, configured for communication with a wireless router (<NUM>) and an intraluminal device (<NUM>) comprising a physiologic sensor (<NUM>), wherein for the communication with the wireless router a signal link is provided, and
- a computing device configured for wireless communication with the wireless router,
wherein the PIM comprises:
a processing component (<NUM>) configured to:
receive a sensor signal from the physiologic sensor; and
determine physiologic data based on at least the sensor signal; and
a power and communication component (<NUM>) configured to:
receive power from the signal link; and
transmit, to the computing device via the signal link and the wireless router, the physiologic data;
wherein the processing component is configured to determine and compute the physiologic data based on the sensor measurements, comprising applying at least one of signal processing algorithms and physiologic analytic algorithms to the sensor measurements.