Detection of right ventricular systolic dysfunction

Abstract

A system for monitoring right ventricular systolic dysfunction includes a hemodynamic sensor that generates a hemodynamic sensor signal representing the patient's right ventricular pressure waveform, a display, one or more processors, and computer-readable memory. The computer-readable memory is encoded using instructions, which, when executed by one or more processors, cause the system to receive the hemodynamic sensor signal representing the patient's right ventricular pressure waveform, extract the right ventricular peak systolic pressure and right ventricular end-diastolic pressure from the patient's right ventricular pressure waveform, determine the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure, and output the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure to the display in order to monitor for the presence of right ventricular systolic dysfunction based on the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 505,679, entitled "DETECTION OF RIGHT VENTRICULAR SYSTOLIC DYSFUNCTION," filed on June 1, 2023. The disclosure of U.S. Provisional Application No. 63 / 505,679 is hereby incorporated by reference in its entirety.

[0002] The present disclosure generally relates to right ventricular (RV) systolic dysfunction, and more particularly to the detection of RV systolic dysfunction in patients.

Background Art

[0003] RV systolic dysfunction is a major problem in the ICU and OR, especially in patients who have undergone cardiopulmonary bypass. RV systolic dysfunction may indicate future cardiovascular events such as myocardial infarction and heart failure. Current methods for detecting RV systolic dysfunction utilize ultrasound technology, which requires a skilled physician and available resources. Means for detecting RV systolic dysfunction that require fewer resources would enable the improvement of patient care.

Summary of the Invention

Means for Solving the Problems

[0004] A system for monitoring right ventricular systolic dysfunction in a patient includes a hemodynamic sensor that continuously generates a hemodynamic sensor signal representing the patient's right ventricular pressure waveform, a display, one or more processors, and computer-readable memory. The computer-readable memory is encoded using instructions, which, when executed by one or more processors, cause the system to receive a hemodynamic sensor signal representing the patient's right ventricular pressure waveform, extract the right ventricular peak systolic pressure and right ventricular end-diastolic pressure from the patient's right ventricular pressure waveform, and output the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure to the display in order to monitor for the presence of right ventricular systolic dysfunction based on the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure.

[0005] A method for detecting right ventricular systolic dysfunction in a patient includes the steps of: receiving detected hemodynamic data representing the patient's right ventricular pressure waveform using a hemodynamic monitor; performing waveform analysis of the hemodynamic data using the hemodynamic monitor to determine the right ventricular peak systolic pressure and right ventricular end-diastolic pressure from the patient's right ventricular pressure waveform; and detecting right ventricular systolic dysfunction by determining the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure using the hemodynamic monitor.

[0006] A system for detecting right ventricular systolic dysfunction in a patient includes a hemodynamic sensor that generates a hemodynamic sensor signal representing the patient's right ventricular pressure waveform, a display, one or more processors, and computer-readable memory. The computer-readable memory is encoded using instructions, which, when executed by one or more processors, cause the system to receive the hemodynamic sensor signal representing the patient's right ventricular pressure waveform, extract the right ventricular peak systolic pressure and right ventricular end-diastolic pressure from the patient's right ventricular pressure waveform, determine the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure, and output the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure to the display in order to detect right ventricular systolic dysfunction based on the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure. [Brief explanation of the drawing]

[0007] [Figure 1] This is an exemplary perspective view of a hemodynamic monitor that analyzes the RV pressure waveform to provide the ratio of RV peak systolic pressure to RV end-diastolic pressure, which can detect RV systolic dysfunction in patients. [Figure 2] This is a perspective view of a catheter that can be inserted into a patient and connected to one or more hemodynamic sensors. [Figure 3] This is a perspective view of an exemplary minimally invasive pressure sensor for detecting hemodynamic data representing a patient's pulmonary artery pressure or right ventricular pressure. [Figure 4] This is a perspective view of an oximetry module for receiving oximetry data from a catheter inserted into a patient. [Figure 5A] This is a schematic diagram of a tissue oximetry sensor used to determine oxygen saturation in a patient's brain tissue. [Figure 5B] This is a diagram of a tissue oximetry module that can be used with a tissue oximetry sensor to determine the oxygen saturation level in a patient's brain tissue. [Figure 6] This block diagram shows an exemplary hemodynamic monitoring system that analyzes RV pressure waveforms to provide the ratio of peak RV systolic pressure to end-diastolic RV pressure and detects patient RV systolic dysfunction based on hemodynamic data. [Figure 7] This graph shows an exemplary trace of the RV pressure waveform, including exemplary indices corresponding to the peak RV systolic pressure and end-diastolic pressure. [Figure 8] This flowchart illustrates exemplary operations for extracting a set of features from a patient's RV pressure waveform to detect and evaluate the progression of RV contraction dysfunction. [Modes for carrying out the invention]

[0008] Generally, this disclosure describes a hemodynamic monitoring system that utilizes a Swan-Ganz catheter and hemodynamic sensors to generate right ventricular pressure (RV) waveforms and continuously monitor the ratio of peak RV systolic pressure to end-diastolic RV pressure to detect and assess the progression of RV systolic dysfunction in patients, for example, in an operating room (OR), intensive care unit (ICU), or other patient care environment. The system is easier to implement, more cost-effective, and can inform healthcare professionals of the presence and severity of RV systolic dysfunction in patients to support patient care.

[0009] Figure 1 is a perspective view of a hemodynamic monitor 10 that analyzes RV pressure waveforms and provides a ratio of RV peak systolic pressure to RV end-diastolic pressure to detect RV systolic dysfunction in a patient. As shown in Figure 1, the hemodynamic monitor 10 includes a display 12, which in the embodiment of Figure 1 presents a graphical user interface including control elements (e.g., graphical control elements), the control elements enabling interaction between the hemodynamic monitor 10 and the user. The hemodynamic monitor 10 also includes a plurality of input and / or output (I / O) connectors configured for wired connections (e.g., electrical and / or communication connections) to one or more peripheral components such as one or more hemodynamic sensors, as will be further described below. For example, as shown in Figure 1, the hemodynamic monitor 10 may include I / O connectors 14. While the embodiment of Figure 1 shows five separate I / O connectors 14, it should be understood that in other embodiments, the hemodynamic monitor 10 may include fewer than five or more I / O connectors. In further embodiments, the hemodynamic monitor 10 may not include the I / O connector 14 and may communicate wirelessly with various graphical devices.

[0010] As further described below, the hemodynamic monitor 10 includes one or more processors and a computer-readable memory storing RV systolic dysfunction software code, which can execute the RV systolic dysfunction software code to determine RV systolic dysfunction in a patient based on detected hemodynamic data of the patient. The hemodynamic monitor 10 can receive detected hemodynamic data representing the patient's right ventricular pressure waveform, for example, via one or more hemodynamic sensors connected to the hemodynamic monitor 10 via an I / O connector 14. The hemodynamic monitor 10 executes the RV systolic dysfunction software code and uses the detected hemodynamic data and RV systolic dysfunction profiling parameters (e.g., input features) to obtain the severity of the patient's RV systolic dysfunction, as further described below.

[0011] As shown in Figure 1, the hemodynamic monitor 10 can present a graphical user interface on the display 12. The display 12 can be a liquid crystal display (LCD), a light-emitting diode (LED) display, an organic light-emitting diode (OLED) display, or other display device suitable for providing information to the user in a graphical form. In some embodiments, such as the embodiment in Figure 1, the display 12 can be a touch-sensitive and / or presence-sensing display device configured to receive user input in the form of gestures, such as touch gestures, scroll gestures, zoom gestures, swipe gestures, or other gesture inputs.

[0012] The hemodynamic monitor 10 receives hemodynamic data from the patient via one or more hemodynamic sensors 16A, 16B, 16C, and 16D (collectively, hemodynamic sensor 16) (shown in Figures 2 to 5). In response to receiving the patient's hemodynamic data, the hemodynamic monitor 10 runs RV systolic dysfunction software code to determine RV systolic dysfunction in the patient and displays the presence or absence of RV systolic dysfunction and the severity of the RV systolic dysfunction on the display 12. In some embodiments, the hemodynamic monitor 10 can activate sensory alarms, such as auditory alarms, tactile alarms, or other sensory alarms, in response to the determination that RV systolic dysfunction has occurred in the patient. Thus, the hemodynamic monitor 10 can alert healthcare personnel to RV systolic dysfunction in the patient and whether the RV systolic dysfunction is becoming more severe or less severe.

[0013] Figure 2 shows a catheter 18 that can be connected to one or more hemodynamic sensors 16 to provide hemodynamic data to a hemodynamic monitor 10. For example, the catheter 18 may be connected to one or more hemodynamic sensors 16A that detect blood pressure to detect the patient's right ventricular pressure, pulmonary artery pressure, or both right ventricular pressure and pulmonary artery pressure. In addition, the catheter 18 may interact with an oximetry module 62 for detecting the patient's mixed venous blood oxygen saturation. The catheter 18 is protected by a sheath 20 and includes multiple lumens 22 that communicate a fluid connector 24, an optical connector 26, a thermistor connector 28, and a thermal filament connector 30 with one of the following: a port 32, an implanted hemodynamic sensor 16D (e.g., a thermistor), or an implanted hemodynamic sensor 16E (e.g., a thermal filament). To facilitate insertion of the catheter 18 into the patient, or for specific hemodynamic measurements, the catheter 18 includes a balloon 34 located at the tip 36 of the catheter 18.

[0014] As shown in Figure 2, the catheter 18 includes a distal port connector 24A that communicates with a port 32A at the tip 36. A proximal infusion connector 24B communicates with the proximal port 32B, located approximately 30 cm from the tip 36, and can be used to inject fluids and drugs into the patient's heart. A right ventricular pacing connector 24C communicates with the right ventricular port 32C, which may be located approximately 19 cm or 12-13 cm from the tip 36. The right ventricular pacing connector 24C can be used to detect the right ventricular pressure of the patient's heart. A thermistor connector 28 is electrically connected to a hemodynamic sensor 16D (e.g., a thermistor) located near the tip 36 of the catheter 18 to measure core body temperature in the pulmonary artery. In some embodiments of the catheter 18, a thermal filament connector 30 is electrically connected to a hemodynamic sensor (16E) (e.g., a thermal filament) embedded in the catheter 18 and located in the patient's right ventricle. In some examples, the catheter 18 does not include a thermal filament or a corresponding thermal filament connector 30. The balloon connector 24D communicates with the balloon 34, and the balloon 34 can be inflated and deflated using the balloon connector 24D by using a syringe 38.

[0015] For example, after insertion into the patient via the introducer, the distal port connector 24A and the right ventricular pacing connector 24C can be connected to separate pressure transducer sensors 16A. The first pressure transducer sensor 16A provides the hemodynamic monitor 10 with pulmonary artery pressure waveform data detected at the distal port 32A located in the pulmonary artery, while the second transducer sensor 16A provides right ventricular pressure waveform data detected at the right ventricular port 32C located in the right ventricle of the patient's heart. Pulmonary artery blood oxygen saturation data can be provided by the oximetry module 62 based on light pulses emitted from the oximetry module 62 into the pulmonary artery and reflected light received by the oximetry module 62 via the optical connector 26 of the catheter 18. Additionally, using the thermal filament connector 30 and thermistor connector 28 and associated cable wiring, the hemodynamic monitor 10 can receive patient cardiac output data, for example, using a thermodilution technique. Cardiac output measured via the thermal filament and the corresponding thermal filament connector 30 can be considered continuous cardiac output. If the catheter 18 does not contain a thermal filament, cardiac output can be determined using the thermistor connector 28 after injecting a fluid bolus (or set of boluses) of known volume and temperature via the proximal infusion port 32B using a thermodilution technique. Cardiac output measured via the thermistor and the corresponding thermistor connector 28 after injecting the fluid bolus can be considered intermittent cardiac output. Intermittent cardiac output measurements can be taken at intervals of approximately several minutes, several hours, or possibly longer, depending on the level of monitoring required by the patient. For example, a clinician may administer a bolus set of 3-4 fluid boluses, with one fluid bolus in the set administered approximately every minute, thereby making the complete bolus set last approximately 3 minutes. In one example, fluid boluses may be administered very frequently, such as every minute or every few minutes, when a clinician is evaluating the patient's response to medication or another medical intervention.In another example, if the patient is relatively stable in the ICU, the fluid bolus can be administered at a lower frequency, such as every hour or every six hours. Catheter 18 is one embodiment of a catheter that can be used to measure right ventricular pressure waveform data. In other embodiments, any catheter configured to measure right ventricular pressure waveform data can be used.

[0016] Figure 3 is a perspective view of a hemodynamic sensor 16A that can be attached to a patient to detect hemodynamic data representing the patient's right ventricular pressure or pulmonary artery pressure. As shown in Figure 3, the hemodynamic sensor 16A includes a housing 40, a fluid input port 42, a catheter-side fluid port 44, and an I / O cable 46. The fluid input port 42 is configured to connect to a fluid source, such as a saline bag or other fluid input source, via tubing or other hydraulic connections. The catheter-side fluid port 44 is configured to connect via tubing or other hydraulic connections to a catheter inserted in the patient's arm (i.e., a radial artery catheter) or a catheter inserted in the patient's leg (a femoral artery catheter). The I / O cable 46 is configured to connect to a hemodynamic monitor 10 via one or more of the I / O connectors 14 (Figure 1). The housing 40 of the hemodynamic sensor 16A encloses one or more pressure transducers, communication circuits, processing circuits, and corresponding electronic components to detect fluid pressure corresponding to the patient's right ventricular pressure or pulmonary artery pressure, which is transmitted to the hemodynamic monitor 10 (Figure 1) via the I / O cable 46.

[0017] During operation, a fluid column (e.g., saline) is introduced from a fluid source (e.g., a saline bag) through a hemodynamic sensor 16A and fluid input port 42 to the catheter-side fluid port 44, and then to the catheter inserted into the patient. Right ventricular pressure or pulmonary artery pressure is transmitted through the fluid column to a pressure sensor, which is located within the housing 40 and detects the pressure in the fluid column. The hemodynamic sensor 16A converts the detected pressure in the fluid column into an electrical signal via a pressure transducer and outputs the corresponding electrical signal to the hemodynamic monitor 10 (Figure 1) via the I / O cable 46. Thus, the hemodynamic sensor 16 transmits analog sensor data (or a digital representation of analog sensor data) to the hemodynamic monitor 10 (Figure 1) that represents substantially continuous heartbeat-by-heartbeat monitoring of the patient's right ventricular pressure or pulmonary artery pressure.

[0018] Figure 4 shows an oximetry module 62 used to receive oximetry data from a catheter inserted into the patient. As shown in Figure 4, the hemodynamic sensor 16B includes an optical transmitter and optical receiver, which are housed within a housing 50 and arranged to communicate with the catheter via an input / output connector 48 accessible through a protective door 52. Within the housing 50, the hemodynamic sensor 16B includes a communication circuit, a processing circuit, and corresponding electronic components, as shown in Figure 4, to detect blood oxygen saturation data derived from light emitted into the patient via the catheter and corresponding reflected light received from the patient via the catheter. The electrical signal indicating the patient's blood oxygen saturation is transmitted to the hemodynamic monitor 10 via a cable 54 and connector 56, which interacts with one of the I / O connectors 14 (Figure 1).

[0019] FIG. 5A is a schematic diagram of a tissue oximetry sensor 16C for determining blood oxygen saturation in a patient's brain tissue. FIG. 5B is an isometric view of a tissue oximetry module 62 that can be used with the tissue oximetry sensor 16C to determine oxygen saturation in a patient's brain tissue. The determined blood oxygen saturation in the brain tissue can be provided to the hemodynamic monitor 10. The tissue oximetry sensor 16C includes a light emitter 58 and one or more detectors 60. The oximetry module 62 shown in FIG. 5B is connected to one or more tissue oximetry sensors 16C via a cable 64 and includes a communication circuit, a processing circuit, and corresponding electronic components, and emits light pulses into the patient's brain tissue by the tissue oximetry sensor 16C or the oximetry sensor 16C. The return light received by one or more detectors 60 of each tissue oximetry sensor 16C is received via the cable 64 and processed by the oximetry module 62. An electrical signal indicating the patient tissue oxygen saturation is transmitted to the hemodynamic monitor 10 via a cable 66, and the cable 66 interacts with the I / O connector 14 (FIG. 1).

[0020] FIG. 6 is a block diagram of a hemodynamic monitoring system 68 that analyzes the RV pressure waveform to determine the RV peak systolic pressure and the RV end-diastolic pressure, provides the ratio of the RV peak systolic pressure to the RV end-diastolic pressure, and detects a patient's RV systolic dysfunction based on hemodynamic data. As shown in FIG. 6, the hemodynamic monitoring system 68 includes a hemodynamic monitor 10 and hemodynamic sensors 16 (including hemodynamic sensors 16A, 16B, 16C, 16D). The hemodynamic monitoring system 68 can be implemented in a patient care environment such as an ICU, an OR, or other patient care environments. As shown in FIG. 6, the patient care environment can include a patient 70 and a healthcare provider 72 trained to use the hemodynamic monitoring system 68.

[0021] Regarding FIG. 1, the hemodynamic monitor 10 described above can be an integrated hardware unit including a system processor 74, a system memory 76, a display 12, an analog-to-digital converter (ADC) 78, and a digital-to-analog converter (DAC) 80. In other embodiments, any one or more components of the hemodynamic monitor 10 and / or the aforementioned functions can be distributed among multiple hardware units. For example, in some embodiments, the display 12 can be a separate display device that is remote from the hemodynamic monitor 10 and operatively coupled to the hemodynamic monitor 10. Similarly, at least a portion of the data processing within the hemodynamic monitoring system 68 can be performed via a smart cable connected between the catheter or sensor and the hemodynamic monitor 10. Generally, although illustrated and described as an integrated hardware unit in the embodiment of FIG. 6, it should be understood that the hemodynamic monitor 10 can include any combination of devices and components that are electrically, communicatively, or otherwise operatively connected to perform the functions attributable to the hemodynamic monitor 10 herein.

[0022] As shown in FIG. 6, the system memory 76 stores RV systolic dysfunction software code 82. The RV systolic dysfunction software code 82 includes a waveform analysis module 84 and a ratio generation module 86. The display 12 provides a user interface 88, and the user interface 88 includes control elements 90 that enable interaction between the user and the hemodynamic monitor 10 and / or other components of the hemodynamic monitoring system 68. The user interface 88 shown in FIG. 6 also provides a sensory alarm 92 to alert medical personnel of the exacerbation of the patient 70's RV systolic dysfunction.

[0023] The hemodynamic sensor 16 can be attached to patient 70 to detect hemodynamic data representing the patient's right ventricular pressure waveform, pulmonary artery pressure waveform, blood oxygen saturation (SyO2), cerebral tissue oxygen saturation (StO2), or cardiac output (CO), or any combination of these hemodynamic data. The hemodynamic sensor 16 is operably connected to the hemodynamic monitor 10 to provide the detected hemodynamic data to the hemodynamic monitor 10 (for example, electrically and / or communicably connected via wired, wireless, or both). In some embodiments, the hemodynamic sensor 16 provides the hemodynamic data of patient 70 to the hemodynamic monitor 10 as an analog signal, which is converted by the ADC 80 into digital hemodynamic data representing the right ventricular pressure waveform. In other embodiments, the hemodynamic sensor 16 provides the detected hemodynamic data to the hemodynamic monitor 10 in digital form, in which case the hemodynamic monitor 10 does not need to include or utilize the ADC 78. In yet another embodiment, the hemodynamic sensor 16 can provide the hemodynamic data of patient 70 to the hemodynamic monitor 10 as an analog signal, which is then analyzed by the hemodynamic monitor 10 in analog form.

[0024] The hemodynamic sensor 16 may include one or more non-invasive, minimally invasive, or invasive sensors attached to the patient 70. For example, the hemodynamic sensor 16 may take the form of an invasive hemodynamic sensor 16A, such as a second pressure transducer sensor 16A that provides right ventricular pressure waveform data detected at the right ventricular port 32C located in the right ventricle of the patient 70's heart (Figure 3). The hemodynamic sensor 16 may take the form of an invasive hemodynamic sensor 16B, such as an oximetry module 62 that provides blood oxygen saturation data in the pulmonary artery based on light pulses radiated from the oximetry module 62 into the pulmonary artery, reflected and returned, and received by module 16B via the optical connector 26 of the catheter 18 (Figure 4). Furthermore, the hemodynamic sensor 16 may take the form of a non-invasive hemodynamic sensor 16C, such as a tissue oximetry sensor 16C that provides oxygen saturation data in the brain tissue of the patient 70 (Figures 5A and 5B). In some embodiments, the hemodynamic sensor 16 can be non-invasively attached to the limbs of the patient 70, such as the patient's forehead, wrists, arms, fingers, ankles, toes, or other limbs. The hemodynamic sensor 16 can also take the form of other invasive hemodynamic sensors, minimally invasive hemodynamic sensors, or non-invasive hemodynamic sensors.

[0025] In one embodiment, the hemodynamic sensor 16 can be configured to detect the right ventricular pressure, pulmonary artery pressure, or both of the right ventricular pressure and pulmonary artery pressure of the patient 70. In some cases, the hemodynamic sensor 16 can be used to detect the patient's cardiac output, blood oxygen saturation in the pulmonary artery, or both cardiac output and blood oxygen saturation, in addition to the right ventricular pressure waveform and pulmonary artery pressure waveform. For example, one or more hemodynamic sensors 16 can be attached to the patient 70 via a radial artery catheter inserted in the patient 70's arm. In another embodiment, one or more hemodynamic sensors 16 can be attached to the patient 70 via a femoral artery catheter inserted in the patient 70's leg. In yet another embodiment, one or more of the hemodynamic sensors 16 may provide tissue oxygen saturation in the patient 70's brain tissue via an oximetry sensor attached to the patient 70's forehead. Such techniques also enable multiple hemodynamic sensors 16 to perform substantially continuous heartbeat-by-heart rate monitoring of right ventricular pressure and pulmonary artery pressure, as well as monitoring of the patient's cardiac output, blood oxygen saturation, and tissue oxygen saturation, or any combination of these hemodynamic data, over a period of time such as several minutes or several hours.

[0026] The system processor 74 executes the RV contraction dysfunction software code 82, which in turn executes the waveform analysis module 84 and the ratio generation module 86 to extract and utilize features of the RV pressure waveform to detect and evaluate RV contraction dysfunction in patient 70. Examples of the system processor 74 may include a microprocessor, controller, digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), or other equivalent discrete or integrated logic circuits.

[0027] The system memory 76 can be configured to store information within the hemodynamic monitor 10 during operation. In some examples, the system memory 76 is described as a computer-readable storage medium. In some examples, the computer-readable storage medium can include a non-temporary medium. The term “non-temporary” can indicate that the storage medium is not embodied in a carrier wave or propagating signal. In some examples, a non-temporary storage medium can store data that may change over time (for example, in RAM or a cache). The system memory 76 can include volatile computer-readable memory and non-volatile computer-readable memory. Examples of volatile memory can include random-access memory (RAM), dynamic random-access memory (DRAM), static random-access memory (SRAM), and other forms of volatile memory. Examples of non-volatile memory can include, for example, magnetic hard disks, optical disks, flash memory, or electrically programmable memory (EPROM) or electrically erasable and programmable (EEPROM) memory.

[0028] The display 12 can be a liquid crystal display (LCD), a light-emitting diode (LED) display, an organic light-emitting diode (OLED) display, or another display device suitable for providing information to the user in a graphical format. The user interface 88 may include graphical control elements and / or physical control elements that allow user input to interact with the hemodynamic monitor 10 and / or other components of the hemodynamic monitoring system 68. In some embodiments, the user interface 88 may take the form of a graphical user interface (GUI) that presents graphical control elements presented on the touch-sensitive and / or presence-sensing display screen of the display 12. In such embodiments, user input may be received in the form of gesture input, such as touch gestures, scroll gestures, zoom gestures, or other gesture inputs. In some embodiments, the user interface 88 may take the form of physical control elements, such as physical buttons, keys, knobs, or other physical control elements configured to receive user input for interacting with components of the hemodynamic monitoring system 68, and / or may include physical control elements.

[0029] During operation, the hemodynamic sensor 16A is connected to the hemodynamic monitor 10 and catheter 18 (Figure 2). The hemodynamic sensor 16A detects hemodynamic data representing the right ventricular pressure waveform of patient 70. The hemodynamic sensor 16A provides hemodynamic data (e.g., analog sensor data) to the hemodynamic monitor 10. The ADC 78 converts the analog hemodynamic data into digital hemodynamic data representing the right ventricular pressure waveform of patient 70.

[0030] The system processor 74 executes the RV systolic dysfunction software code 82 and uses the received hemodynamic data to detect the presence and severity of RV systolic dysfunction in patient 70. For example, the system processor 74 executes the RV systolic dysfunction software code 82 to perform waveform analysis of the received hemodynamic data. The RV systolic dysfunction software code 82 uses the waveform analysis module 84 to determine the characteristics of the RV pressure waveform, including RV peak systolic pressure and RV end-diastolic pressure. Subsequently, the system processor 74 further executes the RV systolic dysfunction software code 82 to generate the ratio of RV peak systolic pressure to RV end-diastolic pressure via the ratio generation module 86. The ratio of RV peak systolic pressure to RV end-diastolic pressure is used to detect and assess RV systolic dysfunction in patient 70.

[0031] RV systolic dysfunction is identified through the ratio of RV peak systolic pressure to RV end-diastolic pressure. Elevated end-diastolic pressure and / or decreased systolic pressure result from RV systolic dysfunction. Therefore, RV systolic dysfunction lowers the ratio of RV peak systolic pressure to RV end-diastolic pressure. A lower ratio indicates a higher severity of RV systolic dysfunction. A ratio greater than 3 indicates no RV systolic dysfunction. A ratio of 2.5 or less indicates RV systolic dysfunction. A ratio of 2 or less indicates severe RV systolic dysfunction.

[0032] The hemodynamic monitor 10 helps assess the patient's hemodynamic state using a hemodynamic sensor 16. Therefore, the hemodynamic monitor 10 notifies healthcare professionals 72 of the presence of RV systolic dysfunction in patient 70, thereby enabling timely and effective patient care. Unlike ultrasound, which cannot continuously assess right ventricular function, the hemodynamic monitor 10 continuously generates data (approximately every 2 seconds, or per heartbeat), enabling continuous monitoring of RV systolic dysfunction. Therefore, the hemodynamic monitor 10 enables real-time updates of RV systolic dysfunction to healthcare professionals. Unlike ultrasound, the use of the hemodynamic monitor 10 to detect RV systolic dysfunction does not require a skilled physician. Therefore, the resources and expertise required for the hemodynamic monitor 10 to monitor RV systolic dysfunction are fewer than those required by ultrasound, making it a simpler and more cost-effective method. Furthermore, because ultrasound methods exhibit significant inter-physician and inter-hospital variability, the hemodynamic monitor 10 offers improved accuracy.

[0033] Figure 7 is a graph showing an exemplary trace of the RV pressure waveform 94 corresponding to hemodynamic data detected by one of the hemodynamic sensors 16A and received by the hemodynamic monitor 10. As further shown in Figure 7, the RV pressure waveform 94 (represented, for example, via digital hemodynamic data) can include various indices corresponding to the presence and severity of RV systolic dysfunction in patient 70.

[0034] Before extracting indicators from the RV pressure waveform 94, the heart rate detection algorithm identifies the start and end points of individual heartbeats for the RV pressure waveform 94. The right ventricular pressure heart rate detection algorithm identifies the start point of the heartbeat based on the peak right ventricular pressure, the lowest right ventricular pressure, the maximum or minimum rate of change of right ventricular pressure, and / or the second derivative of right ventricular pressure with respect to time. After heartbeat identification within the RV pressure waveform 94, various indicators of RV systolic dysfunction can be successively extracted from the waveform for each heartbeat.

[0035] Figure 7 shows exemplary indices 96 and 98 corresponding to the end-diastolic pressure (indicator 96) and peak systolic pressure (indicator 98) of the patient's heartbeat, respectively. Additional indices may be extracted from the RV pressure waveform 94. The system processor 74 executes the RV systolic dysfunction software code 82 to determine the presence and / or severity of RV systolic dysfunction. Indicators 96 and 98 are extracted from the RV pressure waveform 94 by the waveform analysis module 84 of the RV systolic dysfunction software code 82. The ratio generation module 86 of the RV systolic dysfunction software code 82 calculates the ratio of peak systolic pressure (indicator 98) to end-diastolic pressure (indicator 96). The RV systolic dysfunction software code 82 may extract additional indices from the RV pressure waveform 94 that indicate the start of the heartbeat.

[0036] RV systolic dysfunction is detected and its progression is assessed based on the ratio of peak systolic pressure (index 98) to end-diastolic pressure (index 96). In RV systolic dysfunction, systolic function is lost, systolic pressure decreases, and / or end-diastolic pressure increases. When systolic pressure decreases and / or end-diastolic pressure increases, the ratio of RV peak systolic pressure to RV end-diastolic pressure decreases. Therefore, a lower ratio of RV peak systolic pressure to RV end-diastolic pressure indicates a higher severity of RV systolic dysfunction. Since a low ratio of RV peak systolic pressure to RV end-diastolic pressure is not seen in other hemodynamic conditions such as bleeding or fluid administration, using the ratio of RV peak systolic pressure to RV end-diastolic pressure allows for a more accurate assessment of RV systolic dysfunction.

[0037] Therefore, the hemodynamic monitor 10 provides healthcare professionals with information to detect RV systolic dysfunction, enabling timely and effective patient care. Furthermore, the hemodynamic monitor 10 allows for the assessment of the severity of RV systolic dysfunction. Since the hemodynamic monitor 10 can continuously provide information on the severity of RV systolic dysfunction in patient 70, the hemodynamic monitor 10 can continuously monitor RV systolic dysfunction. The usefulness of the hemodynamic monitor 10 is enhanced because the hemodynamic monitor 10 continuously monitors right ventricular systolic dysfunction in the patient and provides real-time updates of increases or decreases in the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure, which indicates the detection of RV systolic dysfunction and / or the severity of RV systolic dysfunction.

[0038] Figure 8 is a flowchart illustrating exemplary operation for extracting a set of features from a patient's RV pressure waveform to detect and evaluate the progression of RV systolic dysfunction. For the purpose of clarity and ease of explanation, the exemplary operation in the context of the hemodynamic monitoring system 68 in Figure 6 is described below.

[0039] The detected hemodynamic data of patient 70 is received by the hemodynamic monitor 10 (step 100). The detected hemodynamic data represents the RV pressure waveform 94 of patient 70. For example, the hemodynamic monitor 10 can receive an analog hemodynamic sensor signal from the hemodynamic sensor 16A that represents the RV pressure waveform of patient 70.

[0040] The hemodynamic monitor 10 performs waveform analysis of hemodynamic data to determine RV systolic dysfunction profiling parameters, RV peak systolic pressure, and RV end-diastolic pressure (step 102). For example, the hemodynamic monitor 10 can execute the RV systolic dysfunction software code 82 to perform waveform analysis on the RV pressure waveform via the waveform analysis module 84. The waveform analysis module 84 determines the RV peak systolic pressure and RV end-diastolic pressure of the RV pressure waveform. The RV peak systolic pressure (index 98) and RV end-diastolic pressure (index 96) indicate RV systolic dysfunction in patient 70.

[0041] The hemodynamic monitor 10 determines the ratio of peak systolic pressure to end-diastolic pressure via the RV systolic dysfunction software code 82 (step 104). For example, the hemodynamic monitor 10 can execute the ratio generation module 86 of the RV systolic dysfunction software code 82. The RV systolic dysfunction software code 82 determines the ratio of peak systolic pressure (indicator 98 in Figure 7) to end-diastolic pressure (indicator 96 in Figure 7). The ratio of RV peak systolic pressure (indicator 98 in Figure 7) to RV end-diastolic pressure (indicator 96 in Figure 7) indicates the presence and severity of RV systolic dysfunction.

[0042] The presence and / or severity of RV systolic dysfunction is determined based on the ratio of RV peak systolic pressure (indicator 98 in Figure 7) to RV end-diastolic pressure (indicator 96 in Figure 7) (step 106). A ratio of RV peak systolic pressure (indicator 98 in Figure 7) to RV end-diastolic pressure (indicator 96 in Figure 7) lower than 2.5 indicates RV systolic dysfunction. The lower the ratio of RV peak systolic pressure to RV end-diastolic pressure, the greater the severity of RV systolic dysfunction. The smaller the ratio of RV peak systolic pressure (indicator 98 in Figure 7) to RV end-diastolic pressure (indicator 96 in Figure 7), the more severe the RV systolic dysfunction. The larger the ratio of RV peak systolic pressure (indicator 98 in Figure 7) to RV end-diastolic pressure (indicator 96 in Figure 7), the less severe the RV systolic dysfunction. Therefore, the ratio of peak systolic pressure (index 98 in Figure 7) to end-diastolic pressure (index 96 in Figure 7) allows healthcare professionals to detect and assess the progression of RV systolic dysfunction in patients.

[0043] Any of the various systems, devices, and apparatus described herein can be sterilized (for example, using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use in patients, and the methods described herein may include sterilization of the relevant systems, devices, and apparatus (for example, using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0044] The processing techniques, methods, steps, etc. described or proposed in this specification or the literature incorporated herein may also be performed on living animals, or on corpses, corpse hearts, anthropomorphic ghosts, simulators (in which body parts, tissues, etc. are simulated), and other non-living simulations.

[0045] Detailed description of the embodiment Possible embodiments of the present invention are described non-exclusively below.

[0046] A system for monitoring right ventricular systolic dysfunction in a patient includes a hemodynamic sensor that continuously generates a hemodynamic sensor signal representing the patient's right ventricular pressure waveform, a display, one or more processors, and a computer-readable memory encoded using instructions. When an instruction is executed by one or more processors, the system receives the hemodynamic sensor signal representing the patient's right ventricular pressure waveform, extracts the right ventricular peak systolic pressure and right ventricular end-diastolic pressure from the patient's right ventricular pressure waveform, determines the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure, and outputs the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure to the display in order to monitor for the presence of right ventricular systolic dysfunction based on the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure.

[0047] The system described in the previous paragraph may optionally include, as an addition and / or alternative, one or more of the following features, configurations, and / or additional components:

[0048] Right ventricular systolic dysfunction is detected when the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure is 2.5 or less.

[0049] Severe right ventricular systolic dysfunction is detected when the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure is 2 or less.

[0050] The system continuously monitors right ventricular systolic dysfunction in patients and updates in real time any increase or decrease in the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure.

[0051] The hemodynamic sensor is configured to be attached to a catheter.

[0052] The catheter includes a right ventricular port configured to be located in the right ventricle of the patient's heart.

[0053] One or more processors are configured to identify individual heartbeats for right ventricular pressure waveforms, enabling heartbeat-by-heartbeat monitoring.

[0054] A method for detecting right ventricular systolic dysfunction in a patient includes the steps of: receiving detected hemodynamic data representing the patient's right ventricular pressure waveform using a hemodynamic monitor; performing waveform analysis of the hemodynamic data using the hemodynamic monitor to determine the right ventricular peak systolic pressure and right ventricular end-diastolic pressure from the patient's right ventricular pressure waveform; and detecting right ventricular systolic dysfunction by determining the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure using the hemodynamic monitor.

[0055] The method described in the previous paragraph is optional and may include, as an addition and / or alternative, one or more of the following features, configurations, and / or additional components:

[0056] Right ventricular systolic dysfunction is detected when the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure is 2.5 or less.

[0057] Severe right ventricular systolic dysfunction is detected when the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure is 2 or less.

[0058] The step of receiving detected hemodynamic data includes continuously receiving detected hemodynamic data representing the patient's right ventricular pressure waveform to continuously monitor right ventricular systolic dysfunction in the patient and detecting an increase or decrease in the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure.

[0059] Connecting a hemodynamic sensor to the catheter.

[0060] The catheter includes a right ventricular port configured to be located in the right ventricle of the patient's heart.

[0061] The step of performing waveform analysis of hemodynamic data includes identifying individual heartbeats for right ventricular pressure waveforms to enable heartbeat-by-heartbeat monitoring of right ventricular systolic dysfunction.

[0062] A system for detecting right ventricular systolic dysfunction in a patient includes a hemodynamic sensor that generates a hemodynamic sensor signal representing the patient's right ventricular pressure waveform, a display, one or more processors, and computer-readable memory, the computer-readable memory being encoded using instructions, which, when executed by one or more processors, cause the system to receive the hemodynamic sensor signal representing the patient's right ventricular pressure waveform, extract the right ventricular peak systolic pressure and right ventricular end-diastolic pressure from the patient's right ventricular pressure waveform, determine the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure, and output the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure to the display in order to detect right ventricular systolic dysfunction based on the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure.

[0063] The system described in the previous paragraph may optionally include, as an addition and / or alternative, one or more of the following features, configurations, and / or additional components:

[0064] Right ventricular systolic dysfunction is detected when the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure is 2.5 or less.

[0065] Severe right ventricular systolic dysfunction is detected when the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure is 2 or less.

[0066] The hemodynamic sensor is configured to be attached to a catheter.

[0067] The catheter includes a right ventricular port configured to be located in the right ventricle of the patient's heart.

[0068] One or more processors are configured to identify individual heartbeats for the right ventricular pressure waveform.

[0069] The above methods can be applied to living animals, or to corpses, corpse hearts, anthropomorphic ghosts, or simulations such as simulators (in which body parts, hearts, tissues, etc., are simulated).

[0070] While the present invention has been described with reference to exemplary embodiments, those skilled in the art will understand that various modifications can be made without departing from the scope of the invention, and that elements of the exemplary embodiments can be substituted with equivalents. In addition, numerous modifications can be made to adapt the teachings of the invention to specific situations or materials without departing from the basic scope of the invention. Accordingly, the present invention is not intended to be limited to the specific embodiments disclosed, and is intended to include all embodiments within the scope of the appended claims. [Explanation of symbols]

[0071] 10. Hemodynamic monitor 12 displays 14 I / O connectors 16A, 16B, 16C, 16D, 16E Hemodynamic Sensors 18 Catheter 20 sheaths 22 lumens 24 Fluid Connectors 24A distal port connector 24C connector 24D Balloon Connector 26 Optical Connectors 28 Thermistor Connector 30 Thermal Filament Connectors 32 Distal Port 32B Proximal Injection Port 32C Right Ventricular Port 34 Balloons 36 Tip 40 Housing 42 Fluid input ports 44 Catheter-side fluid port 46 I / O cables 50 Housing 52 protective doors 54 Cables 56 Connectors 58 Optical emitters 60 detectors 62 Oximetry Module 64 Cables 66 Cables 68 Hemodynamic monitoring system 70 patients 72 Medical professionals 74 System Processors 76 System Memory 78 Analog-to-Digital Converter (ADC) 80 Digital-to-Analog Converter (DAC) 82 RV contraction function failure software code 84 Waveform Analysis Module 86 Ratio Generation Module 88 User Interface 90 control elements 94 RV pressure waveform 96, 98 indicators

Claims

1. A system for monitoring right ventricular systolic dysfunction in a patient, wherein the system is A hemodynamic sensor attached to a right heart catheter, including a right ventricular port located approximately 30 cm from the tip of the right heart catheter and configured to be located in the right ventricle of the patient's heart, wherein the hemodynamic sensor continuously generates a hemodynamic sensor signal representing the right ventricular pressure waveform of the patient, The display and Sensory alarms and One or more processors, The system comprises a computer-readable memory encoded using instructions, wherein, when the instructions are executed by one or more processors, the system causes the system to receive the hemodynamic sensor signals representing the right ventricular pressure waveform of the patient. From the right ventricular pressure waveform of the patient, the right ventricular peak systolic pressure and right ventricular end-diastolic pressure are extracted. Determine the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure. In order to monitor for the presence of right ventricular systolic dysfunction based on the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure, the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure is output to the display. A system that activates a sensory alarm when the ratio is lower than a threshold.

2. The system according to claim 1, wherein the presence of right ventricular systolic dysfunction is detected when the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure is 2.5 or less.

3. The system according to claim 2, wherein severe right ventricular systolic dysfunction is detected when the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure is 2 or less.

4. The system according to claim 1, wherein the system continuously monitors right ventricular systolic dysfunction in the patient and updates in real time the increase or decrease in the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure.

5. The system according to claim 1, wherein the hemodynamic sensor is configured to be attached to the lumen of the right heart catheter leading to the right ventricular port.

6. The system according to claim 5, wherein the right heart catheter does not include a thermal filament or a corresponding thermal filament connector.

7. The system according to claim 1, wherein the one or more processors are configured to identify individual heartbeats with respect to the right ventricular pressure waveform, enabling monitoring of each heartbeat.

8. A method for detecting right ventricular systolic dysfunction in a patient, wherein the method is The steps include receiving detected hemodynamic data representing the right ventricular pressure waveform of the patient using a hemodynamic monitor, The steps include: performing waveform analysis of the hemodynamic data using the hemodynamic monitor to determine the right ventricular peak systolic pressure and right ventricular end-diastolic pressure from the right ventricular pressure waveform of the patient; The steps include: detecting right ventricular systolic dysfunction by determining the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure using the hemodynamic monitor; Methods that include...

9. The method according to claim 8, wherein the presence of right ventricular systolic dysfunction is detected when the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure is 2.5 or less.

10. The method according to claim 9, wherein severe right ventricular systolic dysfunction is detected when the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure is 2 or less.

11. The method according to claim 8, wherein the step of receiving detected hemodynamic data includes continuously receiving detected hemodynamic data representing the right ventricular pressure waveform of the patient to continuously monitor right ventricular systolic dysfunction in the patient and detecting an increase or decrease in the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure.

12. The method according to claim 8, further comprising the step of connecting a hemodynamic sensor to the catheter.

13. The method according to claim 12, wherein the catheter includes a right ventricular port configured to be located in the right ventricle of the patient's heart.

14. The method according to claim 8, wherein the step of performing waveform analysis of the hemodynamic data includes identifying individual heartbeats for the right ventricular pressure waveform to enable heartbeat-by-heartbeat monitoring of right ventricular systolic dysfunction.

15. A system for detecting right ventricular systolic dysfunction in a patient, wherein the system is A hemodynamic sensor that generates a hemodynamic sensor signal representing the right ventricular pressure waveform of the patient, The display and One or more processors, A computer-readable memory encoded using instructions, wherein when the instructions are executed by one or more processors, the system The hemodynamic sensor signal representing the right ventricular pressure waveform of the patient is received. From the right ventricular pressure waveform of the patient, the right ventricular peak systolic pressure and right ventricular end-diastolic pressure are extracted. Determine the ratio of right ventricular peak systolic pressure to right ventricular end-diastolic pressure. A system that outputs the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure to the display in order to detect right ventricular systolic dysfunction based on the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure.

16. The system according to claim 15, wherein right ventricular systolic dysfunction is detected when the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure is 2.5 or less.

17. The system according to claim 16, wherein severe right ventricular systolic dysfunction is detected when the ratio of the right ventricular peak systolic pressure to the right ventricular end-diastolic pressure is 2 or less.

18. The system according to claim 15, wherein the hemodynamic sensor is configured to be attached to a catheter.

19. The system according to claim 18, wherein the catheter includes a right ventricular port configured to be located in the right ventricle of the patient's heart.

20. The system according to claim 15, wherein the one or more processors are configured to identify individual heartbeats with respect to the right ventricular pressure waveform, enabling heartbeat-by-heartbeat monitoring.

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