Blood pump with capability of electrocardiogram (EKG) monitoring, defibrillation and pacing

Abstract

To provide technologies for providing efficient and safe pacing and defibrillation to patients.SOLUTION: A blood pump system 200 includes: a catheter 202; a pump housing disposed distal to a distal end of the catheter 202; a rotor positioned at least partially in the pump housing; a controller 238; and an electrode 212 coupled to a distal region of the blood pump 201. The electrode 212 can be used to sense electrocardiogram (EKG) signals and transmit the signals to a controller 238 of the blood pump 201. The operation of the blood pump 201 can be adjusted based on the EKG signal and on cardiac parameters derived from the EKG signal. Further, the controller 238 can determine a need for defibrillation or pacing of the patient's heart based on the signal and can administer treatment with electrical shocks to the heart via the electrode 212 coupled to the blood pump 201.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 62 / 868,403, filed Jun. 28, 2019, the entire disclosure of which is incorporated herein by reference.

Background Art

[0002] Background Cardiovascular diseases are a major cause of morbidity, mortality, and healthcare burden worldwide. A variety of treatment methods have been developed for cardiovascular diseases, ranging from pharmaceuticals to mechanical devices and ultimately transplantation. Temporary heart assist devices such as ventricular assist devices provide hemodynamic assistance and promote heart recovery. Some intracardiac heart pump assemblies can be introduced into the heart surgically or percutaneously and used to deliver blood from one location in the heart or circulatory system to another location in the heart or circulatory system. For example, when deployed within the heart, an intracardiac pump can pump blood from the left ventricle of the heart to the aorta or from the inferior vena cava to the pulmonary artery. The intracardiac pump can be driven by a motor located outside the patient's body or a motor located inside the patient's body. Some intracardiac blood pump systems can operate in parallel with the native heart to supplement cardiac output and partially or completely relieve the burden on the components of the heart. Examples of such systems include devices of the IMPELLA® family (Abiomed, Inc., Danvers, Massachusetts).

[0003] Among patient populations that require hemodynamic assistance by mechanical circulatory support systems such as intracardiac blood pumps, it is common to experience cardiac arrhythmias or irregular heartbeats. In severe cases of arrhythmia, it may be necessary to correct the heart rhythm with a pacing device or a defibrillator.

[0004] In a life-saving treatment scenario, patients suffering from life-threatening cardiac arrhythmias or cardiac rhythm disorders are often defibrillated by a manual external defibrillator or an automated external defibrillator by delivering a certain amount of electric current to the heart through applying large pads or electrodes to the patient's skin to depolarize the heart and terminate the irregular heartbeat. Defibrillation is only used when a specific type of arrhythmia is detected, and inappropriate defibrillation can cause dangerous rhythm disorders and other injuries.

[0005] Adjustments for cardiac pacing are also similarly addressed in a life-saving treatment scenario by the use of transcutaneous or external pacing. In transcutaneous pacing, clinicians typically use pads or electrodes placed on the patient's chest to deliver pulses of electric current to stimulate the contraction of the heart. Pacing is necessary when an abnormally slow heartbeat called bradycardia is detected.

[0006] In situations where pacing or defibrillation is required, the clinician must first recognize that treatment is needed, diagnose the irregularity of the heart, and determine the appropriate treatment. If defibrillation is indicated, the clinician then places electrodes or pads on the patient, determines the voltage and timing of the electrical shock, and administers the electrical shock to the patient. If pacing is indicated, the clinician places electrodes or pads on the patient, selects the heart rate, and adjusts the current to an appropriate level.

[0007] Delaying the administration of pacing or defibrillation to the patient when needed can be harmful to the patient's condition and can lead to a decrease in survival rate. Furthermore, defibrillation and transcutaneous pacing can be uncomfortable for the patient. Unfortunately, since electrical shocks for defibrillation and pacing in life-saving treatment or emergencies are most often applied externally, a large amount of electric charge is required, which can cause serious injury to the patient. Therefore, new technologies are needed to provide efficient and safe pacing and defibrillation to patients.

Summary of the Invention

[0008] Summary The methods, systems, and devices described herein provide circulatory assistance, detect electrocardiogram (EKG) signals, detect changes in cardiac function based on the EKG signals, change the amount of assistance provided by the device in response to the changes, and provide defibrillation and pacing of the heart when needed, using a circulatory assist device that includes an electrode having a transmission function, a sensing function, and a charge transfer function.

[0009] By integrating pacing and defibrillation functions into a circulatory assist device, a system for treating arrhythmias in real time during circulatory assistance becomes available, thereby reducing treatment delays and severity of arrhythmia symptoms. Electrodes for pacing and defibrillation (or other similar devices for sensing or stimulation, or both) can be implemented in a circulatory assist device (e.g., a blood pump). Such devices can also be utilized as EKG (sometimes referred to as ECG) electrodes. The EKG data can be provided by the electrodes to the controller of the circulatory assist device to provide additional information to the clinician regarding the patient's condition. The EKG data can further enhance the ability of the assist device controller to rapidly identify and respond to cardiac events or changes in cardiac function.

[0010] Generally, a mechanical circulatory assist system includes a mechanical circulatory assist device, a controller communicatively coupled to the mechanical circulatory assist device and designed to control the level of assistance provided by the mechanical circulatory assist device, and electrodes coupled to the mechanical assist device. The mechanical circulatory assist system can include one or more of an intravascular blood pump, an extracorporeal membrane oxygenation (ECMO) device, an intra-aortic balloon pump, a surgically implanted left ventricular assist device (LVAD), or a percutaneous expandable blood pump disposed in the right or left heart. In one aspect, the circulatory assist device includes an intravascular blood pump system having a catheter with a proximal end and a distal end, a blood pump disposed distally of the distal end of the catheter, and electrodes coupled to a distal region of the blood pump.

[0011] In another aspect, an intravascular blood pump system includes an intravascular blood pump, a controller, and an electrode coupled to the intravascular blood pump. The intravascular blood pump includes a catheter having a proximal end and a distal end, a pump housing disposed distally of the distal end of the catheter, and a rotor at least partially disposed within the pump housing and designed to be rotationally driven. The controller is communicatively coupled to the intravascular blood pump and is designed to control the level of assistance provided by the intravascular blood pump by controlling the speed of the rotor.

[0012] In another aspect, a method of providing circulatory assistance using a circulatory assist device, such as an intravascular blood pump, includes disposing the device (e.g., an intravascular blood pump) within a patient's vasculature and operating the intravascular blood pump by rotating a rotor within the pump housing at a pump speed. The method further includes measuring an EKG signal within the vasculature using an electrode coupled to the intravascular blood pump and adjusting the pump speed of the rotor based on the EKG signal.

[0013] In another aspect, a method of measuring an EKG signal while providing circulatory assistance includes disposing within a patient's vasculature a circulatory assist device that includes an electrode coupled to the circulatory assist device. The method also includes operating the circulatory assist device within the patient's vasculature and measuring an EKG signal within the vasculature using the electrode.

[0014] In another aspect, a method of providing cardiac pacing of a patient while providing circulatory assistance includes disposing within a patient's vasculature a circulatory assist device that includes an electrode coupled to the circulatory assist device. The method includes operating the circulatory assist device within the vasculature, measuring an EKG signal within the vasculature using the electrode, determining a need for cardiac pacing of the patient based on the EKG signal, and sending a charge for delivery by the electrode to pace the patient's heart.

[0015] In another aspect, a method of providing defibrillation of a patient's heart while providing circulatory assistance includes disposing within the patient's vasculature a circulatory assist device that includes electrodes coupled to a circulatory assist apparatus. The method further includes operating the circulatory assist device within the vasculature, measuring an EKG signal within the vasculature using the electrodes, determining a need for defibrillation of the patient's heart based on the EKG signal, and sending a charge for delivery by the electrodes to defibrillate the patient's heart.

Brief Description of the Drawings

[0016]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Mode for Carrying Out the Invention

[0017] Detailed Description FIG. 1 shows an exemplary blood pump system 100 according to aspects of the present disclosure, including a catheter 102, a pump housing 104, a rotor 106, a drive shaft (or drive cable) 118, a cannula 108, a flexible protrusion 114, an electrode 112, and a reference electrode 107. The pump housing 104 of the blood pump system 100 is connected to the distal end of the catheter 102. The rotor 106 is connected to the drive shaft 118 and is disposed within the pump housing 104. Additionally, as shown in the example of FIG. 1, the rotor 106 may also extend beyond the distal end of the pump housing 104 to the proximal end of the cannula 108. In some aspects of the present technology, the drive shaft 118 may extend through the catheter 102 and may be configured to rotationally drive the rotor 106 via a motor disposed outside the patient's body. In some aspects of the present technology, the rotor 106 may be driven by a motor disposed within the patient's body, such as by a motor disposed within the pump housing 104. The cannula 108 extends from the distal end of the pump housing 104. The blood pump system 100 includes an inlet opening 122 and an outlet opening 124. The outlet opening 124 is shown in FIG. 1 as being formed at the proximal end of the cannula 108, but alternatively may be formed in the wall of the pump housing 104. Similarly, the inlet opening 122 is shown in FIG. 1 as being formed at the distal end of the cannula 108, but alternatively may be formed in a blood inflow cage structure (which may be considered part of the cannula 108) attached to the distal end of the cannula 108.

[0018] The flexible protrusion 114 extends from the distal end 110 of the cannula 108. The electrode 112 is connected to the blood pump system 100. The blood pump system can be utilized in a right heart configuration or a left heart configuration, as will be described hereinafter with reference to FIGS. 2 and 3, respectively.

[0019] The electrode 112 is disposed on the distal end 110 of the cannula, for example, on the flexible protrusion 114. The flexible protrusion 114 can be implemented as a pigtail or as a straight protrusion from the distal end 110 of the cannula. In some implementations, the flexible protrusion 114 includes a ball or sphere. The distal portion 116 of the flexible protrusion 114 can provide guidance and positioning of the blood pump system 100 within the heart. For example, the flexible protrusion can be used to space the inlet opening 122 of the blood pump system 100 from the heart wall or to guide the blood pump system 100 through the vasculature.

[0020] Within the blood pump system 100, a wire 120 that connects the electrode 112 to a controller (not shown) is disposed. The wire 120 may be embedded in the wall of the cannula 108 and may extend through the catheter 102 to the controller. The blood pump system 100 may further include a pressure sensor and / or an optical sensor 126 disposed on the catheter 102 as shown or at other locations on the blood pump system 100. The wire 120 connected to the electrode 112 may follow the same path through the catheter 102 as the wires, pressure lines, and optical fibers connected to the pressure sensor and / or optical sensor 126 of the blood pump system 100. The wire 120 provides an electrical connection and power supply from the controller to the electrode 112. The electrode 112 can be designed to function as a pacing and / or defibrillation electrode 112 equipped to send an electric charge to the heart and also function as a sensing electrode 112 that measures an EKG signal and transmits the signal to the controller via the wire 120. The functions of the controller and the electrode 112 will be described in more detail below with reference to FIGS. 2 and 3.

[0021] In the example of FIG. 1, the reference electrode 107 is disposed near the distal end of the catheter 102 on the catheter 102 connecting the blood pump system 100 to the controller so as to be located within the patient's vasculature. However, the reference electrode 107 may alternatively be disposed outside the patient's body, for example, on the patient's skin. The reference electrode 107 may be connected to the controller by a wire, which may be the same wire 120 that connects the electrode 112 to the controller via the catheter 102. The measured EKG signal reflects the potential difference between the electrode 112 on the blood pump system 100 and the reference electrode 107. When pacing or defibrillation therapy is administered, a voltage is sent between the electrode 112 attached to the blood pump system 101 and the reference electrode 107.

[0022] By providing the electrodes 112 for sensing, pacing, and defibrillation directly on the blood pump system 100, no additional catheter for EKG sensing is required and no external pacing and defibrillation methods are required. The time delay in providing treatment for severe arrhythmias is reduced compared to conventional methods that utilize external manual defibrillation or transcutaneous pacing because the required electrode 112 is already in a position to supply charge to the heart. Since the electrode 112 is within the heart and can directly deliver an electrical shock to the heart tissue, the amount of charge required is reduced, a more efficient system is provided, and the potential for further injury that can occur with external defibrillation or pacing that requires larger currents and charges is reduced.

[0023] FIG. 2 shows an exemplary blood pump system 200 according to aspects of the present disclosure, including an electrode 212 disposed on a blood pump 201 in the left heart. The blood pump system 200 includes a blood pump 201 and a controller 238. The blood pump 201 includes a cannula 208, a pump 204, at least one inlet opening 222 through which blood flows as it enters the cannula 208 (as indicated by arrow 223), at least one outlet opening 224 through which blood flows as it exits the cannula 208 (as indicated by arrow 225), a reference electrode 207, a catheter 202, and a flexible protrusion 214 at the distal end of the cannula 208. For example, the blood pump 201 including the electrode 212 can be the blood pump system 100 of FIG. 1. The blood pump 201 can be an IMPELLA® device or any other suitable blood pump. Here also, at least one outlet opening 224 may be formed at the proximal end of the cannula 208 or may be formed in a pump housing structure attached to the proximal end of the cannula 208. Similarly, at least one inlet opening 222 may be formed at the distal end of the cannula 208 or may be formed in a blood inflow cage structure (which can be considered part of the cannula 208) attached to the distal end of the cannula 208.

[0024] The pump 204 is connected to a first catheter 202 that extends through a second catheter 203. Both the first catheter 202 and the second catheter 203 extend through a vasculature structure to attach the blood pump 201 to the controller 238. The first catheter 202 can be movable within the second catheter 203. The second catheter 203 is a non-rotating catheter. In some implementations, the blood pump 201 can be retracted into the second catheter 203 to insert or remove the blood pump 201 through the vasculature structure. In some implementations, the blood pump 201 can be compressed by retracting it into the second catheter 203.

[0025] The electrode 212 is disposed on the flexible protrusion 214 as shown in the figure, or at other locations at the distal end of the blood pump 201 such as the distal end of the cannula 208. The blood pump 201 is disposed across the aortic valve 248 such that at least one inlet opening 222 is in the left ventricle 249 and at least one outlet opening 224 is in the aorta 247. The electrode 212, whether on the flexible protrusion 214 or at the distal end of the cannula 208, is disposed within the left ventricle 249 where it can be used to deliver an electrical shock to the heart for defibrillation or pacing as needed. The electrode 212 may be further disposed at the most distal portion of the flexible protrusion 216. The flexible protrusion 214 may serve to space the inlet opening 222 from the wall of the left ventricle 249. Since the blood within the heart is also conductive, the electrode 212 need not be in contact with the heart tissue. The reference electrode 207 is disposed near the blood pump 201 such that it is located within the patient's vasculature on the catheter 202 that connects the blood pump 201 to the controller 238. The reference electrode 207 may alternatively be disposed on the skin outside the patient's body. This reference electrode 207 can be connected to the controller 238 by a wire, which may be the same wire 219 that connects the electrode 212 to the controller 238 via the catheter 202. The measured EKG signal reflects the difference in potential between the electrode 212 on the blood pump 201 and the reference electrode 207. When pacing or defibrillation therapy is administered, a voltage is sent between the electrode 212 attached to the blood pump 201 and the reference electrode 207.

[0026] The controller 238 includes a processor 240 (or a set of one or more processors 240) for controlling the operation of the blood pump 218 communicatively coupled to the electrode 212. The controller 238 also includes a memory 242 and a display 244 (which may further include one or more audio devices such as a speaker, chime, etc.). For example, the controller 238 can be an Automated Impella Controller (AIC) from Abiomed, Inc. or any other suitable controller. The electrode 212 is coupled to the controller 238 by a wire 219 that extends through the cannula 208 and the first catheter 202. As described above with respect to FIG. 1, the wire 219 may be embedded in the wall of the cannula 208 and extend through the catheter 202 to the controller 238. The wire 219 provides an electrical connection and power supply from the controller 238 to the electrode 212. In some implementations, the electrode 212 can be coupled to a wireless transmitter and designed to function on the blood pump system 200 without the wire 219 directly connecting the electrode 212 to the controller 238.

[0027] Electrode 212 functions as described above with respect to FIG. 1 to measure the EKG signal within the heart and supply charge for pacing and defibrillation of the heart as needed. Electrode 212 transmits the EKG signal to controller 238. Controller 238 may display the signal to the clinician on display 244 to enable the clinician to diagnose arrhythmias. Controller 238 may also record the EKG signal in memory 242. Controller 238 may also include software used to analyze the EKG signal to detect and diagnose arrhythmias in processor 240 and / or memory 242, and may be further configured to alert the clinician on display 244 about the detected arrhythmias and the recommended treatment determined by processor 240. Since electrode 212 is connected to blood pump 201 already disposed within the heart, the application of treatment by pacing or defibrillation is much more efficient. For example, the clinician may send an electrical shock to the heart via electrode 212 by entering a command on controller 238. Additionally, controller 238 may include software that determines the appropriate voltage, timing, and / or heart rate and current to be applied and prompts the clinician to perform the treatment. By analyzing the EKG signal at controller 238, a response to arrhythmias and cardiac events can be made much more quickly than is currently possible using external manual defibrillation and pacing.

[0028] After controller 238 receives the EKG signal from electrode 212, controller 238 generates the EKG signal and / or cardiac characteristics derived from the signal for display on display 244. By displaying the EKG signal to the clinician, the clinician can easily view the morphology and timing of the EKG waves for diagnostic purposes.

[0029] Based on the EKG information sent by electrode 212, controller 238 can make a determination regarding the patient's cardiac function to assist the operation of blood pump 201. Controller 238 receives a digital signal including the EKG signal at processor 240 and uses that information along with other signals and data available to controller 238 to extract cardiac parameters and characteristics indicative of cardiac function.

[0030] Controller 238 extracts cardiac parameters from the EKG data sent by electrode 212 and uses that data to make a determination regarding the effect of the assistance provided by blood pump 201. Based on the EKG data sent to controller 238, the controller can extract cardiac parameters such as left ventricular end-diastolic pressure (LVEDP) that can be used to better understand cardiac function. LVEDP indicates the pressure within the left ventricle of the heart at the end of diastole and is a critical value in determining a patient's health and cardiac function that can be derived from signal processing of the pressure of the blood pump and motor characteristics. A low LVEDP indicates a healthy patient, and a high LVEDP can be a sign of disease or illness.

[0031] For example, the EKG signal provided to the controller is a trace of the R wave. The peak of the R wave indicates the timing of the cardiac cycle when the pressure measurement indicates LVEDP. Since the EKG signal clarifies the timing of the pressure measurement, controller 238 can extract information regarding the timing of LVEDP in the cardiac cycle from the EKG signal and perform the LVEDP measurement at the exact timing within the cycle when LVEDP occurs. The information from the EKG signal enables a more accurate determination of LVEDP.

[0032] Alternatively or additionally, the EKG signal can be used to determine the appropriate timing of the cardiac cycle for measurements used to determine other cardiac parameters such as left ventricular volume, aortic pulse pressure, mean aortic pressure, pump flow rate, pressure gradient, heart rate, cardiac output, stroke volume, stroke work, self-cardiac output, self-stroke work, contractility, cardiac relaxation, fluid responsiveness, volume status, and cardiac unloading or recovery index.

[0033] The controller 238 measures the time of aortic pressure measurement using the EKG signal, accurately estimates the LVEDP (or other cardiac parameters) based on the pressure measurement and motor parameters, and presents information to the clinician on the display 244. The controller can also further process the data to determine whether the circulatory assistance provided by the blood pump 201 should be changed to increase or decrease the assistance to the patient. With the accurate measurement of LVEDP using the EKG signal from the electrodes 212, the controller 238 can respond earlier to changes in cardiac function. In particular, the controller 238 can use the extracted cardiac parameters including LVEDP to determine whether to increase or decrease the circulatory assistance, and accordingly change the speed of the rotor or prompt the clinician to do so to change the assistance.

[0034] In some implementations, the controller 238 can be used to automate the operation of the blood pump 201 and the assistance provided by the blood pump 201. The EKG signal provided to the controller 238 enables the controller 238 to better predict and quickly identify changes in cardiac function. Based on the EKG signal and the cardiac parameters extracted from the EKG signal and other signals available to the controller 238, the controller 238 can adjust the rotor speed to provide more or less assistance. Alternatively, the controller 238 may prompt the clinician to change the speed of the rotor by displaying a recommendation on the display 244.

[0035] The controller 238 can also use the EKG signal to detect premature ventricular contractions and other cardiac conditions when the heart skips a beat. The controller 238 can then alert the clinician and, if necessary, adjust the assistance or provide additional treatment options using the electrodes 212 incorporated in the blood pump 201.

[0036] The controller 238 can also use the EKG signal to determine whether there is an irregular heartbeat indicating a need for cardiac pacing or defibrillation. The need for pacing can be determined by comparing the EKG signal with a reference signal, comparing the patient's current EKG signal with a past EKG signal, or comparing the heart rate extracted from the EKG signal with a threshold value, e.g., 60 beats per minute (BPM) for an adult. Detection of an irregular heartbeat, or a heart rate that is too fast, can indicate an arrhythmia for which defibrillation is the appropriate treatment, such as ventricular fibrillation or pulseless ventricular tachycardia. An irregular heartbeat that requires defibrillation can be determined by comparing the EKG signal with a reference signal, comparing the patient's current EKG signal with a past EKG signal, comparing the heart rate extracted from the EKG signal with a threshold value, or comparing the EKG signal with a reference heart rhythm associated with cardiac arrest. Alternatively, the irregularity may be determined by software programmed to identify irregular or too-fast heartbeats, or by a machine learning algorithm trained to identify these events.

[0037] When the need for pacing or defibrillation is detected, the controller 238 may alert the clinician by displaying a warning or recommendation on the display 244. The controller 238 may further determine whether pacing or defibrillation is needed and determine the appropriate parameters for the electrical shock to be administered as treatment for the condition. For example, the controller 238 may determine the timing and voltage of the electrical shock to be administered to defibrillate the heart. In some implementations, the timing and voltage of the electrical shock are input into the system by the clinician or determined by the controller 238 and approved by the clinician. In other implementations, the timing of the charge, current, heart rate, and other parameters are determined by the controller 238. In some implementations, the relevant parameters related to cardiac pacing may be input into the system by the clinician or determined by the controller 238 and approved by the clinician. Then, a certain amount of current is sent to the heart through the electrodes 212 to depolarize the myocardium and terminate the arrhythmia. Since the electrodes 212 are already in place and can supply charge directly to the heart, defibrillation or pacing of the heart using the blood pump system 200 including the electrodes 212 is more efficient and less risky than treatment using a manual external defibrillator or a transcutaneous pacing device.

[0038] The blood pump system including the electrodes can also be used with a blood pump that assists the heart in a right heart configuration. FIG. 3 shows an exemplary blood pump system 300 according to aspects of the present disclosure that includes electrodes 312 disposed on the right heart and capable of measuring an EKG signal and supplying charge to the heart for pacing and defibrillation. The blood pump system 300 includes a blood pump 301 and a controller 338.

[0039] The blood pump 301 includes a cannula 308, a pump 304, at least one inlet opening 324 through which blood flows as it enters the cannula 308 (as indicated by arrow 325), at least one outlet opening 321 through which blood flows as it exits the cannula 308 (as indicated by arrow 323), and a flexible protrusion 314 at the distal end of the cannula 308. For example, the blood pump 301 can be the blood pump system 100 of FIG. 1. The blood pump 301 can be an IMPELLA® device, or any other suitable blood pump. Similarly, at least one inlet opening 324 may be formed at the proximal end of the cannula 308, or may be formed in a pump housing structure attached to the proximal end of the cannula 308. Similarly, at least one outlet opening 321 may also be formed at the distal end of the cannula 308, or may be formed in a blood outflow cage structure (which can be considered part of the cannula 308) attached to the distal end of the cannula 308.

[0040] The pump 304 is connected to a first catheter 302 that extends through a second catheter 303. Both the first catheter 302 and the second catheter 303 extend through the vasculature to attach the blood pump 301 to the controller 338. For example, when the blood pump 301 is disposed within the right heart 351 such that at least one inlet opening 324 is within the inferior vena cava 317 and at least one outlet opening discharges blood into the pulmonary artery 350, the electrode 312 is disposed within the pulmonary artery. The electrode 312 can be connected to the cannula 308 of the blood pump 301 such that the electrode 312 is positioned within the right ventricle 349 when the blood pump 301 is disposed within the right heart 351. The electrode 312 can be disposed on the cannula 308 positioned within the right ventricle 349, on the flexible projection 314 (or, in the absence of a flexible projection, at the distal end or tip of the mechanical circulatory support system), or on the catheter 302 positioned near the right heart 351 within the inferior vena cava 317. The portion of the cannula 308 positioned within the right ventricle 349 may be preferred because it is close to the myocardium. If the electrode 312 is not within the right ventricle 349 (e.g., if the electrode 312 is on the flexible projection 314), the blood pump 301 can be temporarily repositioned to place the electrode 312 within the right ventricle 349 before applying pacing or defibrillation.

[0041] The controller 338 includes a processor 340 (or a set of one or more processors 340) communicatively coupled to the electrode 312 for controlling the operation of the blood pump. The controller also includes a memory 342 and a display 344 (which may further include one or more audio devices such as a speaker, chime, etc.). As described above with respect to FIG. 2, the electrode 312 is coupled to the controller 338 by a wire 319 that provides an electrical connection and power supply from the controller 338 to the electrode 312. The electrode 312 transmits to the controller 338 an EKG signal that can be used by the controller to perform several tasks related to the assessment of the patient's cardiac function, as described above. For example, the EKG signal can be used by the controller 338 to display the signal to a clinician, extract cardiac parameters from the EKG signal and other signals available to the controller 338, and determine cardiac events or characteristics that indicate the need for pacing or defibrillation. If pacing or defibrillation is required, the controller 338 can sound an alarm and / or display warnings and / or recommendations to the clinician on the display 344, or determine optimal settings and parameters for delivering an electrical shock to the patient's heart as part of pacing or defibrillation and present those parameters to the clinician. The clinician may then simply approve the recommended treatment and enable the electrode 312 to deliver an electrical shock to regulate the patient's heartbeat. As described above with respect to FIG. 2, the blood pump 301 may also include a reference electrode (not shown) disposed on the catheter 302. Cardiac pacing or defibrillation is provided by applying a voltage between the electrode 312 and the reference electrode.

[0042] When the controller 338 extracts cardiac parameters from its signals and other signals available to the controller 338, these cardiac parameters can be presented to the clinician to assist in the diagnosis and monitoring of the patient's health. Alternatively or additionally, the cardiac parameters can be used to determine whether a change in the provided circulatory assistance is recommended. The controller 338 can determine whether the pump assistance should be increased or decreased using the extracted cardiac parameters. The controller 338 may make this determination and provide a recommendation to the clinician via the display 344, or the controller 338 may automatically make an adjustment to the assistance provided by the blood pump 301. When the electrode 312 is disposed within the right ventricle 349, the EKG data provided by the electrode 312 can clarify the state of right ventricular infarction. The EKG signal from the electrode 312 within the right ventricle 349 can also clarify a cardiac conduction disorder within the right heart 351 better than an electrode 312 disposed on the left side of the heart. When these types of right heart conditions are detected, the EKG signal from the electrode 312 disposed within the right heart 351 enables the clinician to better know the patient's condition and adjust the treatment accordingly.

[0043] By incorporating the electrode 312 into the blood pump 301, more rapid detection and response to cardiac events, including arrhythmias requiring pacing or defibrillation and changes in cardiac function requiring a change in the circulatory assistance provided by the blood pump 301, becomes possible.

[0044] FIG. 4 shows a flowchart of an exemplary method 400 for operating an intravascular blood pump (e.g., the blood pump system 100 of FIG. 1, the blood pump 201 of FIG. 2, the blood pump 301 of FIG. 3) based on an EKG signal measured by electrodes (e.g., the electrode 112 of FIG. 1, the electrode 212 of FIG. 2, the electrode 312 of FIG. 3) coupled to the intravascular blood pump. The method described in FIG. 4 is applicable to an intravascular blood pump system (e.g., the blood pump system 100 of FIG. 1, the left heart blood pump system 200 of FIG. 2, the right heart blood pump system 300 of FIG. 3). This method includes, in step 402, placing an intravascular blood pump, including electrodes, within a patient's vasculature. The blood pump can be a left heart blood pump disposed across the aortic valve such that the electrodes are located within the left ventricle. Alternatively, the blood pump can be a right heart blood pump disposed such that the electrodes are located within the pulmonary artery. In step 404, the intravascular blood pump is operated by rotating a rotor within the pump housing at a pump speed. In step 406, an EKG signal within the vasculature is measured using electrodes coupled to the intravascular blood pump. In some implementations, the EKG signal is used by a controller of the blood pump to extract other cardiac parameters indicative of cardiac function. For example, a cardiac parameter may be determined directly from the EKG signal, or the EKG signal may be used in combination with other signals and data available to the controller, such as aortic pressure or motor current, to extract a cardiac parameter. The EKG signal can be used to determine the timing of another measurement, such as LVEDP.

[0045] In process 408, the pump speed of the rotor is adjusted based on the EKG signal. The pump speed of the rotor can be adjusted by the controller based on the EKG signal itself or based on cardiac parameters determined from the EKG signal. The controller can determine, based on the EKG signal and other cardiac parameters, that the health of the patient's heart is improving and that the patient should be weaned from circulatory support. The controller can then automatically adjust the pump speed of the rotor to decrease the pump speed or alert the clinician that the patient should be weaned and prompt the clinician to manually adjust the rotor pump speed.

[0046] In process 410, cardiac events are identified based on the EKG signal. The controller can include software for analyzing the EKG signal and determining cardiac events such as irregular heartbeats or heartbeats that are too fast or too slow. The controller can further determine a treatment method for the identified cardiac event. In process 412, a warning for display is generated based on the identified cardiac event. The controller can alert the clinician and display a notification that a cardiac event has been detected. Further, the controller can display a recommended treatment method and / or prompt the clinician to perform the treatment method recommended by the electrodes connected to the intravascular heart pump.

[0047] By incorporating electrodes into the intravascular blood pump, the signals detected by the electrodes can be utilized when the blood pump controls the operation of the blood pump and analyzed to provide the clinician with important information regarding cardiac function and cardiac events much more quickly than may be available by other means. Further, as will be described later with respect to FIGS. 5-8, since the electrodes are already within the heart, the electrodes can be used to provide treatments such as defibrillation and pacing of the heart with minimal delay.

[0048] FIG. 5 shows a flowchart of an exemplary method 500 for providing cardiac assistance using an intravascular blood pump (e.g., blood pump 100 of FIG. 1, blood pump 201 of FIG. 2, blood pump 301 of FIG. 3) including electrodes (e.g., electrode 112 of FIG. 1, electrode 212 of FIG. 2, electrode 312 of FIG. 3). The method described in FIG. 5 is applicable to an intravascular blood pump system (e.g., blood pump system 100 of FIG. 1, left heart blood pump system 200 of FIG. 2, right heart blood pump system 300 of FIG. 3). In step 502, an intravascular blood pump is placed within a patient's vasculature. In step 504, the intravascular blood pump is operated by rotating a rotor within the pump housing at a pump speed. In step 506, an EKG signal within the vasculature is measured using electrodes coupled to the intravascular blood pump. In step 508, the pump speed of the rotor is adjusted based on the EKG signal. In step 510, a cardiac event is identified based on the EKG signal. For example, the EKG signal can be analyzed to determine if there is an irregular heartbeat that requires defibrillation or pacing to normalize the heartbeat, or a heartbeat that is too fast or too slow. In step 512, based on the identified cardiac event, a charge is supplied to the vasculature via the electrodes to defibrillate or pace the heart.

[0049] Although the methods of FIGS. 4 and 5 are described with respect to an intravascular blood pump coupled to electrodes, these methods can also be applied to any mechanical circulatory assist device having electrodes attached thereto that can be placed within the vasculature surgically or via percutaneous insertion through the patient's vasculature. For example, the methods of FIGS. 4 and 5 are applicable to mechanical circulatory assist devices such as an IABP, an ECMO device, a surgically implanted LVAD, a percutaneous expandable blood pump, and an intravascular blood pump system placed in the right or left heart.

[0050] FIG. 6 shows a flowchart depicting an exemplary method 600 for measuring an EKG signal while providing circulatory assistance. The method described in FIG. 6 is applicable to any mechanical circulatory assist device including an IABP, an ECMO device, an LVAD, an expandable blood pump, and an intravascular blood pump (e.g., blood pump 201 of FIG. 2, blood pump 301 of FIG. 3) and blood pump systems (e.g., blood pump system 100 of FIG. 1, left heart blood pump system 200 of FIG. 2, right heart blood pump system 300 of FIG. 3). In step 602, a circulatory assist device including electrodes (e.g., electrode 112 of FIG. 1, electrode 212 of FIG. 2, electrode 312 of FIG. 3) is placed within the patient's vasculature. In step 604, the circulatory assist device is operated within the patient's vasculature. For example, the circulatory assist device may operate to pump blood through the patient's heart to provide continuous or pulsatile cardiac assistance. In step 606, an EKG signal is measured within the vasculature using the electrodes, and in step 608, the EKG signal is transmitted to a controller of the circulatory assist device.

[0051] In step 610, cardiac characteristics are determined from the EKG signal by the controller. As an example, cardiac characteristics extracted from the EKG signal may be characteristics of the heartbeat such as irregular beats, beats that are too slow or too fast, or skipped beats. As another example, based on the peak of the R wave shown in the EKG signal, the timing of measurement of LVEDP, from which an accurate LVEDP value can be measured, may be determined. Other cardiac parameters and cardiac characteristics can be extracted from the EKG signal and other signals and information that may be available to the circulatory assist device, such as pressure measurements and pump parameters or motor parameters. After the cardiac characteristics are determined, the cardiac characteristics may be displayed to a clinician or used by the controller to determine and implement treatment methods such as the application of an electrical shock to correct an irregular heartbeat or a reduction in the level of circulatory assistance provided by the circulatory assist device to wean a patient with improving cardiac function from assistance.

[0052] FIG. 7 shows a flowchart illustrating an exemplary method 700 for providing pacing of a patient's heart. The method described in FIG. 7 is applicable to any mechanical circulatory assist device including an IABP, an ECMO device, an LVAD, an expandable blood pump, and an intravascular blood pump (e.g., blood pump 201 of FIG. 2, blood pump 301 of FIG. 3) and blood pump systems (e.g., blood pump system 100 of FIG. 1, left heart blood pump system 200 of FIG. 2, right heart blood pump system 300 of FIG. 3). In step 702, a circulatory assist device including electrodes (e.g., electrode 112 of FIG. 1, electrode 212 of FIG. 2, electrode 312 of FIG. 3) is placed within the patient's vasculature. In step 704, the circulatory assist device is operated within the patient's vasculature. For example, the circulatory assist device may operate to pump blood through the patient's heart to provide continuous or pulsatile cardiac assistance. In step 706, an EKG signal is measured within the vasculature using the electrodes.

[0053] In step 708, a need for pacing of the patient's heart is determined based on the EKG signal. For example, an abnormally slow heart rate may indicate bradycardia and a need for cardiac regulation. The need for pacing may be determined by comparison of the EKG signal with a reference signal, comparison of the patient's current EKG signal with a past EKG signal, or comparison of the heart rate extracted from the EKG signal with a threshold, e.g., a pulsation of 60 beats per minute (BPM) for an adult. Alternatively, an abnormally slow heart rate may be determined by software programmed to identify bradycardia or by a machine learning algorithm trained to identify these events.

[0054] In step 710, a charge is sent to supply the electrodes to provide pacing to the patient's heart. The timing of the charge, the current, the heart rate, and other parameters may be input into the system by a clinician or determined by a controller and approved by a clinician. The charge is supplied by electrodes within the heart. Since the electrodes are already in place and can supply the charge directly to the heart, pacing of the heart using a circulatory assist device including electrodes is more efficient and less risky than a treatment using transcutaneous pacing.

[0055] FIG. 8 shows a flowchart illustrating an exemplary method 800 for providing defibrillation of a patient's heart. The method described in FIG. 8 is applicable to any mechanical circulatory assist device including an IABP, an ECMO device, an LVAD, an expandable blood pump, and an intravascular blood pump (e.g., blood pump 201 of FIG. 2, blood pump 301 of FIG. 3) and a blood pump system (e.g., blood pump system 100 of FIG. 1, left heart blood pump system 200 of FIG. 2, right heart blood pump system 300 of FIG. 3). In step 802, a circulatory assist device including electrodes (e.g., electrode 112 of FIG. 1, electrode 212 of FIG. 2, electrode 312 of FIG. 3) is placed within the patient's vasculature. In step 804, the circulatory assist device is operated within the patient's vasculature. For example, the circulatory assist device may operate to pump blood through the patient's heart to provide continuous or pulsatile cardiac assistance. In step 806, an EKG signal is measured within the vasculature using the electrodes.

[0056] In step 808, a determination is made as to the need for defibrillation of the patient's heart based on the EKG signal. For example, an irregular heartbeat, or a heartbeat that is too fast, may indicate an arrhythmia for which defibrillation is the appropriate treatment, such as ventricular fibrillation or pulseless ventricular tachycardia. The irregularity of the heartbeat may be determined by comparison of the EKG signal to a reference signal, comparison of the patient's current EKG signal to a past EKG signal, comparison of the heart rate per minute extracted from the EKG signal to a threshold value, or comparison of the EKG signal to a reference heart rhythm associated with cardiac arrest. Alternatively, the irregularity may be determined by software programmed to identify an irregular or too-fast heartbeat, or by a machine learning algorithm trained to identify these events.

[0057] In operation 810, charge is sent to supply the patient's heart via electrodes to defibrillate it. The timing and voltage of the electrical shock can be input into the system by a clinician or determined by a controller and approved by a clinician. Then, a certain amount of current is sent through the electrodes to the heart to depolarize the myocardium and terminate the arrhythmia. Since the electrodes are already in place and can supply the charge directly to the heart, defibrillation of the heart using a circulatory assist device including the electrodes is more efficient and less risky than treatment using a manual external defibrillator.

[0058] The above description is merely for the purpose of exemplifying the principles of the present technology. Therefore, the devices and methods described herein can be implemented by other implementations presented for illustrative purposes rather than limitations.

[0059] In addition, the disclosed features can be implemented in any combination or sub - combination (including multiple dependent combinations and sub - combinations) with one or more other features described herein. The various features described or exemplified above, including any of their components, may be combined or integrated with other systems. Further, specific features may be omitted or not implemented without departing from the spirit of the present technology.

[0060] The described systems and methods may be implemented locally on a heart pump system or on a controller of a heart pump system such as an AIC. The heart pump system may include a data processing device. The systems and methods described herein may be implemented remotely on a separate data processing device. The separate data processing device may be connected directly to the heart pump system or indirectly via a cloud application. The heart pump system may communicate with the separate data processing device in real - time (or near real - time).

[0061] Processors suitable for the execution of a computer program include, for example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer. In general, a processor receives instructions and data from a read-only memory or a random access memory or both. Essential elements of a computer are a processor for executing instructions and one or more memory devices for storing instructions and data. In general, a computer includes one or more mass storage devices for storing data, such as magnetic disks, magneto-optical disks, or optical disks, or is operatively coupled to receive data from or transfer data to one or more mass storage devices, or both. However, a computer need not have such devices.

[0062] Exemplary Implementations As already described, the systems and methods disclosed herein can be implemented in various ways. In that regard, the foregoing disclosure is intended to include, but is not limited to, systems, methods, and combinations and sub-combinations thereof described in the categories of the following exemplary implementations.

[0063] Category A: A1: A mechanical circulatory assist device, and An electrode coupled to the mechanical assist device A mechanical circulatory assist system comprising the same. A2: The mechanical circulatory assist system of A1, wherein the mechanical circulatory assist device is configured to be at least partially disposed within the patient's heart. A3: The mechanical circulatory assist system of A1 or A2, wherein the mechanical circulatory assist device is one of an intravascular blood pump, an extracorporeal membrane oxygenation (ECMO) device, an intra-aortic balloon pump, a surgically implanted left ventricular assist device (LVAD), or a percutaneous expandable blood pump disposed in the right or left heart. A4: A mechanical circulatory assist system of any one of A1 to A3, wherein the electrical signal from the electrode is an electrocardiogram (EKG) signal. A5: A mechanical circulatory assist system of any one of A1 to A4, wherein the electrode is configured to be disposed within the heart. A6: A mechanical circulatory assist system of any one of A1 to A5, wherein the electrode is communicably coupled to the controller, and the controller is configured to receive an electrical signal from the electrode. A7: The mechanical circulatory assist system of A6, wherein the controller is configured to control the level of assistance provided by the mechanical circulatory assist device. A8: The controller is configured to process the electrical signal from the electrode and generate the electrical signal from the electrode for display in the mechanical circulatory assist system of A7. A9: The mechanical circulatory assist system of A8, wherein the controller is configured to extract the left ventricular end-diastolic pressure (LVEDP) from the EKG signal. A10: The mechanical circulatory assist system of A9, wherein the controller is configured to display the EKG signal and the LVEDP on a display. A11: The controller is configured to store in a past LVEDP memory, compare the new LVEDP with the past LVEDP accessed in the memory, and determine the difference between the new LVEDP and the past LVEDP in the mechanical circulatory assist system of any one of A6 to A10. A12: The mechanical circulatory assist system of A11, wherein the controller is further configured to determine a recommendation for assistance based on the difference between the new LVEDP and the past LVEDP. A13: The mechanical circulatory assist system of A12, wherein the controller is configured to determine a recommendation for assistance to increase the assistance by the mechanical circulatory assist device when the difference between the new LVEDP and the past LVEDP is positive. A14: The mechanical circulatory assist system of A12, wherein the controller is configured to determine a recommendation for reducing assistance when the difference between the new LVEDP and the past LVEDP is negative. A15: The mechanical circulatory assist system according to any one of A12 to A14, wherein the controller is further configured to generate a recommendation for assistance for display. A16: The mechanical circulatory assist system according to any one of A12 to A15, wherein the controller is further configured to automatically implement the recommendation for assistance. A17: The mechanical circulatory assist system according to any one of A1 to A16, further including a reference electrode connected to the mechanical circulatory assist device.

[0064] Category B: B1: A catheter having a proximal end and a distal end, A pump housing disposed distally of the distal end of the catheter, A rotor at least partially disposed within the pump housing, And an electrode connected to the distal region of the blood pump An intravascular blood pump system. B2: The intravascular blood pump of B1, further including a flexible protrusion disposed distally of the pump housing. B3: The intravascular blood pump of B1 or B2, wherein the electrode is disposed on the flexible protrusion. B4: The intravascular blood pump according to any one of B1 to B3, wherein the electrode is configured to function as a sensor. B5: The intravascular blood pump according to any one of B1 to B4, further including a cannula connected to the pump housing. B6: The intravascular blood pump of B5, wherein the flexible protrusion is disposed at the distal end of the cannula. B7: The intravascular blood pump according to any one of B1 to B6, further including a drive cable configured to drive the rotor within the pump housing and extending from the rotor through the catheter to the proximal end of the catheter. An intravascular blood pump of any one of B1 - B7, further comprising a wire extending from the electrode through the catheter to the proximal end of the catheter. B9: The intravascular blood pump of B8, wherein the wire is embedded in the side wall of the pump housing. B10: The intravascular blood pump of B8 or B10, wherein the wire is configured to transmit a signal from the electrode to the proximal end of the catheter. B11: The intravascular blood pump of any one of B7 - B10, wherein the wire is configured to send charges from the proximal end of the catheter for supply by the electrode. B12: The intravascular blood pump of any one of B1 - B11, wherein the electrode is configured to be disposed within the heart. B13: A plurality of openings formed in the pump housing, and A plurality of outlet openings formed in the pump housing and The intravascular blood pump of any one of B1 - B12, further comprising. B14: The intravascular blood pump of B13, further comprising a reference electrode connected to the catheter. B15: The plurality of inlet openings are configured to be disposed in the left ventricle of the heart, and The outlet opening is proximal to the inlet opening and is configured to be disposed within the aorta of the heart, The intravascular blood pump of B13 or B14. B16: The intravascular blood pump of B15, wherein the electrode is configured to be disposed within the left ventricle. B17: The intravascular blood pump of B16, wherein the electrode is configured to defibrillate the heart by sending charges within the left ventricle. B18: The intravascular blood pump of B16, wherein the electrode is configured to provide pacing to the heart by sending charges within the left ventricle. B19: The plurality of inlet openings are configured to be disposed in the inferior vena cava of the heart, and The plurality of outlet openings are distal to the inlet openings and are configured to be disposed within the pulmonary artery of the heart, The intravascular blood pump of B13. B20: An intravascular blood pump of B19, configured such that the electrodes are disposed within the right ventricle. B21: An intravascular blood pump of B20, configured such that the electrodes defibrillate the heart by sending electric charges within the right ventricle. B22: An intravascular blood pump of B20, configured such that the electrodes provide pacing to the heart by sending electric charges within the right ventricle. B23: An intravascular blood pump according to any one of B1 to B22, further including a pressure sensor connected to a catheter.

[0065] Category C: C1: A mechanical circulatory assist device, and A controller communicably connected to the mechanical circulatory assist device and configured to control the level of assistance provided by the mechanical circulatory assist device, and An electrode connected to the mechanical circulatory assist device A mechanical circulatory assist system including the above. C2: A mechanical circulatory assist system of C1, configured such that the electrode is communicably connected to the controller and the controller is configured to receive an electrical signal from the electrode. C3: The controller Processes the electrical signal from the electrode and Generates the electrical signal from the electrode for display A mechanical circulatory assist system of C2 configured as above. C4: A mechanical circulatory assist system of C2 or C3, wherein the electrical signal from the electrode is an electrocardiogram (EKG) signal. C5: A mechanical circulatory assist system according to any one of C1 to C4, configured such that the electrode is disposed within the heart. C6: A mechanical circulatory assist system of C4, configured such that the controller extracts the left ventricular end-diastolic pressure (LVEDP) from the EKG signal. C7: A mechanical circulatory assist system of C6, configured such that the controller displays the EKG signal and the LVEDP on a display. C8: The controller Stored in the past LVEDP memory, The new LVEDP is compared with the past LVEDP accessed in the memory, Determine the difference between the new LVEDP and the past LVEDP A mechanical circulatory assist system of C6 or C7, configured as follows. C9: A mechanical circulatory assist system of C8, further configured such that the controller determines an assist recommendation based on the difference between the new LVEDP and the past LVEDP. C10: A mechanical circulatory assist system of C9, configured such that the controller determines an assist recommendation to increase the assist when the difference between the new LVEDP and the past LVEDP is positive. C11: A mechanical circulatory assist system of C9, configured such that the controller determines an assist recommendation to decrease the assist when the difference between the new LVEDP and the past LVEDP is negative. C12: A mechanical circulatory assist system of any of C9 - C11, further configured such that the controller generates an assist recommendation for display. C13: A mechanical circulatory assist system of any of C9 - C12, further configured such that the controller automatically implements the assist recommendation. C14: A mechanical circulatory assist system of any of C9 - C13, further including a reference electrode.

[0066] Category D: D1: A catheter having a proximal end and a distal end, A pump housing disposed distal to the distal end of the catheter, and A rotor at least partially disposed within the pump housing, configured to be rotationally driven including an intravascular blood pump; A controller communicably coupled to the intravascular blood pump and configured to control the level of assist provided by the intravascular blood pump by controlling the speed of the rotor; An electrode coupled to the intravascular blood pump An intravascular blood pump system including D2: The intravascular blood pump system of D1, further including a flexible protrusion disposed distally of the pump housing. D3: The intravascular blood pump system of D1 or D2, wherein an electrode is disposed on the flexible protrusion. D4: The intravascular blood pump system of any one of D1 to D3, wherein the electrode is configured to function as a sensor. D5: The intravascular blood pump system of any one of D1 to D4, further including a cannula connected to the pump housing. D6: The intravascular blood pump system of D5, wherein the flexible protrusion is disposed at the distal end of the cannula. D7: The intravascular blood pump system of any one of D1 to D6, further including a drive cable configured to drive a rotor in the pump housing and extending from the rotor through a catheter to the proximal end of the catheter. D8: The intravascular blood pump system of any one of D1 to D7, further including a wire extending from the electrode through the catheter to the proximal end of the catheter. D9: The intravascular blood pump system of D8, wherein the wire is embedded in the side wall of the pump housing. D10: The intravascular blood pump system of D8 or D9, wherein the electrode is communicably connected to a controller by the wire, and the controller is configured to receive an electrical signal from the electrode via the wire. D11: The controller processes the electrical signal from the electrode, and displays the electrical signal from the electrode on a display The intravascular blood pump system of any one of D8 to D10, configured as such. D12: The intravascular blood pump system of any one of D8 to D11, wherein the electrical signal from the electrode is an electrocardiogram (EKG) signal. D13: The intravascular blood pump system of D12, wherein the controller is configured to extract the left ventricular end-diastolic pressure (LVEDP) from the EKG signal. D14: The intravascular blood pump system of D13, wherein the controller is configured to display at least one of the EKG signal and the LVEDP on a display. D15: The controller stores in a past LVEDP memory, compares the new LVEDP with the past LVEDP accessed in the memory, and determines the difference between the new LVEDP and the past LVEDP The intravascular blood pump system of D13 or D14, configured as such. D16: The intravascular blood pump system of D15, wherein the controller is further configured to determine an auxiliary recommendation based on the difference between the new LVEDP and the past LVEDP. D17: The intravascular blood pump system of D16, wherein the controller is configured to determine an auxiliary recommendation for increasing the assistance when the difference between the new LVEDP and the past LVEDP is positive. D18: The intravascular blood pump system of D16, wherein the controller is configured to determine an auxiliary recommendation for decreasing the assistance when the difference between the new LVEDP and the past LVEDP is negative. D19: The intravascular blood pump system of any one of D16 - D18, wherein the controller is further configured to display the auxiliary recommendation on a display. D20: The intravascular blood pump system of any one of D16 - D19, wherein the controller is further configured to automatically implement the auxiliary recommendation. D21: The intravascular blood pump system of any one of D13 - D20, wherein the controller is further configured to determine a treatment recommendation based on the EKG signal. D22: The intravascular blood pump system of any one of D13 - D20, wherein the controller is further configured to display an instruction of the treatment recommendation on a display. D23: The intravascular blood pump system of D22, further including a reference electrode connected to the catheter. The intravascular blood pump system of D23, wherein the controller is configured to send a charge for supply at an electrode via a wire to provide cardiac pacing or cardioversion in response to a user input. The intravascular blood pump system of D23, wherein the controller is configured to automatically send a charge for supply at an electrode via a wire to provide cardiac pacing or cardioversion based on a treatment recommendation. The intravascular blood pump system according to any one of D1 to D25, wherein the electrode is configured to be disposed within the heart. D27: The intravascular blood pump further includes a plurality of inlet openings formed in the cannula and a plurality of outlet openings formed in the pump housing, and is the intravascular blood pump system according to any one of D1 to D26. D28: The plurality of inlet openings are configured to be disposed in the left ventricle of the heart, and the outlet openings are proximal to the inlet openings and are configured to be disposed within the aorta of the heart, and is the intravascular blood pump system of D27. D29: The intravascular blood pump system of D28, wherein the electrode is configured to be disposed within the left ventricle. D30: The intravascular blood pump system of D29, wherein the electrode is configured to cardiovert the heart by sending a charge within the left ventricle. D31: The intravascular blood pump system of D29, wherein the electrode is configured to provide pacing to the heart by sending a charge within the left ventricle. D32: The plurality of inlet openings are configured to be disposed in the inferior vena cava of the heart, and the plurality of outlet openings are distal to the inlet openings and are configured to be disposed within the pulmonary artery of the heart, and is the intravascular blood pump system of D27. D33: The intravascular blood pump system of D32, wherein the electrode is configured to be disposed within the right ventricle. D34: The intravascular blood pump system of D33, wherein the electrode is configured to send an electric charge within the right ventricle. D35: The intravascular blood pump system of D33, wherein the electrode is configured to provide pacing to the heart by sending an electric charge within the right ventricle. D36: The intravascular blood pump system according to any one of D1 to D35, further comprising a pressure sensor connected to the catheter.

[0067] Category E: E1: A method of providing circulatory assistance using an intravascular blood pump, the method comprising the following steps: Placing an intravascular blood pump within the patient's vasculature; Operating the intravascular blood pump by rotating a rotor of the intravascular blood pump within the pump housing at a pump speed; Measuring an electrocardiogram (EKG) signal within the vasculature using an electrode connected to the intravascular blood pump; and Adjusting the pump speed of the rotor based on the EKG signal. E2: The method of E1, wherein the step of placing the intravascular blood pump within the patient's vasculature further comprises placing the intravascular blood pump within the patient's heart such that the electrode is located within the heart. E3: Generating an EKG signal for display; and Receiving a user input for adjusting the pump speed The method of E2, further comprising. E4: The method of E3, further comprising generating a recommendation for adjusting the pump speed based on the EKG signal for display. E5: The method according to any one of E1 to E4, further comprising calculating a left ventricular end-diastolic pressure (LVEDP) from the EKG signal. E6: The method of E5, further comprising determining a recommendation for adjusting the pump speed based on the LVEDP calculated from the EKG signal. E7: The step of determining a recommendation for adjusting the pump speed comprises Accessing the patient's past LVEDP; Comparing a patient's current LVEDP with a past LVEDP; and Determining a difference between the current LVEDP and the past LVEDP The method of E6, further comprising. E8: The method of E7, further comprising determining a recommendation for increasing the pump speed when the difference between the current LVEDP and the past LVEDP is positive. E9: The method of E7, further comprising determining a recommendation for decreasing the pump speed when the difference between the current LVEDP and the past LVEDP is negative. E10: Determining a recommendation for providing cardiac pacing based on an EKG signal; Generating a recommendation for providing cardiac pacing to a user for display; and Sending a charge for delivery by an electrode to pace the patient's heart in response to an input received from the user The method of E1 - E9, further comprising. E11: The method of E10, wherein the step of sending a charge for delivery by an electrode to pace the heart further comprises applying a voltage between a reference electrode and the electrode. E12: Determining a recommendation for providing cardiac defibrillation based on an EKG signal; Generating a recommendation for providing cardiac defibrillation to a user for display; and Sending a charge for delivery by an electrode to defibrillate the patient's heart in response to an input received from the user The method of E1 - E9, further comprising. E12: The method of E11, wherein the step of sending a charge for delivery by an electrode to defibrillate the heart further comprises applying a voltage between a reference electrode and the electrode. E13: The method of E1 - E12, wherein the step of placing an intravascular blood pump within a patient's vasculature further comprises placing the intravascular blood pump within the vasculature such that an electrode coupled to the intravascular blood pump is within the left ventricle. E14: The method of E1 to E12, further comprising the step of placing an intravascular blood pump within the patient's vasculature such that the intravascular blood pump is placed within the vasculature with an electrode connected to the intravascular blood pump being within the right ventricle.

[0068] Category F: F1: A method of measuring an EKG signal while providing circulatory assistance, the method comprising the following steps: Placing a circulatory assistance device including an electrode connected to the circulatory assistance device within the patient's vasculature; Operating the circulatory assistance device within the patient's vasculature; and Measuring an electrocardiogram (EKG) signal within the vasculature using the electrode. F2: The method of F1, wherein the circulatory assistance device is an intravascular blood pump. F3: The method of F1 or F2, wherein the step of placing the circulatory assistance device within the patient's vasculature further comprises placing the circulatory assistance device within the patient's heart such that the electrode is positioned within the heart. F4: The method of any one of F1 to F3, further comprising the step of transmitting the EKG signal to a controller connected to the circulatory assistance device. F5: The method of F4, further comprising the step of generating the EKG signal for display. F6: The method of F4 or F5, further comprising the step of storing the EKG signal in the memory of the controller as a past EKG signal. F7: Calculating a left ventricular end-diastolic pressure (LVEDP) from the EKG signal; and Storing the LVEDP in the memory of the controller as a past LVEDP signal The method of any one of F4 to F6, further comprising. F8: The method of F6 or F7, further comprising the step of determining a treatment recommendation based on a comparison of the past LVEDP and the current LVEDP. F9: The method of F8, further comprising the step of generating a treatment recommendation to the user for display. F10: The method of F8, further comprising the step of automatically making a treatment recommendation. F11: Determining a recommendation to increase the assistance provided by the circulatory assist device when the current LVEDP is higher than the past LVEDP; and Determining a recommendation to decrease the assistance provided by the circulatory assist device when the current LVEDP is lower than the past LVEDP The method according to any one of F8 to F10, further comprising.

[0069] Category G: G1: A method of providing pacing of a patient's heart while providing circulatory assistance, the method comprising the following steps: Placing a circulatory assist device including an electrode connected to the circulatory assist device within the patient's vasculature; Operating the circulatory assist device within the vasculature; Measuring an electrocardiogram (EKG) signal within the vasculature using the electrode; Determining the need for pacing of the patient's heart based on the EKG signal; and Sending a charge for supplying with the electrode to pace the patient's heart. G2: The method of G1, wherein the circulatory assist device is an intravascular blood pump. The method of G1 or G2, wherein the step of placing the circulatory assist device within the patient's vasculature further comprises placing the circulatory assist device within the patient's heart such that the electrode is located within the heart. The method according to any one of G1 to G3, further comprising transmitting the EKG signal to a controller connected to the circulatory assist device. The method of G4, further comprising generating an EKG signal for display. The method of G4 or G5, further comprising storing the EKG signal in the memory of the controller as a past EKG signal. The method of G6, wherein the step of determining the need for pacing of the patient's heart further comprises comparing the past EKG signal with the current EKG signal. G8: The step of determining the need for pacing of the patient's heart is Extracting EKG signal characteristics from the current EKG signal; and Comparing the EKG signal characteristics with one or more thresholds Any of the methods G1 - G6, further comprising this. G9: The step of determining the need for pacing of the patient's heart comprises extracting EKG signal characteristics from the current EKG signal and a past EKG signal; and comparing the current EKG signal characteristics with the past EKG characteristics The method of G6, further comprising this. G10: The step of sending a charge for supplying with an electrode to pace the patient's heart comprises sending one or more charges for supplying to the heart to increase the heart rate Any of the methods G1 - G9, comprising this. G11: The step of placing a circulatory assist device within the patient's vasculature comprises placing the circulatory assist device within the patient's vasculature such that an electrode connected to the circulatory assist device is located in either the left ventricle or the right ventricle Any of the methods G1 - G10, further comprising this. G12: The step of sending a charge for supplying with an electrode to pace the patient's heart further comprises sending a voltage between the electrode and a reference electrode. Any of the methods G1 - G11.

[0070] Category H: H1: A method of providing defibrillation of a patient's heart while providing circulatory assistance, the method comprising the following steps: placing within the patient's vasculature a circulatory assist device comprising an electrode connected to the circulatory assist device; operating the circulatory assist device within the vasculature; and measuring an electrocardiogram (EKG) signal within the vasculature using the electrode; determining the need for defibrillation of the patient's heart based on the EKG signal; and sending a charge for supplying with an electrode to defibrillate the patient's heart. H2: The method of H1, wherein the circulatory assist device is an intravascular blood pump. H3: The method of H1 or H2, wherein the step of disposing the circulatory assist device within the patient's vasculature further comprises disposing the circulatory assist device within the patient's heart such that the electrodes are positioned within the heart. H4: The method of any one of H1 to H3, further comprising transmitting the EKG signal to a controller coupled to the circulatory assist device. H5: The method of H4, further comprising generating the EKG signal for display. H6: The method of H4 or H5, further comprising storing the EKG signal as a past EKG signal in the memory of the controller. H7: The method of H6, wherein the step of determining the need for pacing of the patient's heart further comprises comparing the past EKG signal and the current EKG signal. H8: The step of determining the need for defibrillation of the patient's heart comprises extracting EKG signal characteristics from the current EKG signal; and comparing the EKG signal characteristics with one or more thresholds The method of any one of H1 to H6, further comprising the above steps. H9: The step of determining the need for defibrillation of the patient's heart comprises extracting EKG signal characteristics from the current EKG signal and the past EKG signal; and comparing the current EKG signal characteristics with the past EKG characteristics The method of H6, further comprising the above steps. H10: The step of sending a charge for supplying with an electrode to defibrillate the patient's heart comprises sending one or more charges for supplying to the heart to resume the function of the heart The method of any one of H1 to H9, further comprising the above steps. H11: The step of disposing the circulatory assist device within the patient's vasculature comprises disposing the circulatory assist device within the patient's vasculature such that the electrodes coupled to the circulatory assist device are positioned in either the left ventricle or the right ventricle The method of any one of H1 to H10, further comprising the above steps. The method according to any one of H1 to H11, wherein the step of sending a charge for supplying an electrode to defibrillate a patient's heart further includes sending a voltage between the electrode and a reference electrode.

Claims

1. A catheter having a proximal end and a distal end, a pump housing coupled to the distal end of the catheter, a rotor configured to be rotationally driven and at least partially disposed within the pump housing, and a cannula coupled to the pump housing comprising an intravascular blood pump; an electrode coupled to the intravascular blood pump and configured to sense an electrocardiogram (EKG) signal of a patient's heart comprising an intravascular blood pump system.

2. A controller communicatively coupled to the intravascular blood pump and the electrode and configured to control the level of assistance provided by the intravascular blood pump by controlling the speed at which the rotor is rotationally driven further comprising the intravascular blood pump system according to claim 1.

3. The intravascular blood pump system according to claim 1, wherein the intravascular blood pump further comprises a flexible protrusion coupled to the distal end of the cannula, and the electrode is disposed on the flexible protrusion.

4. The intravascular blood pump system according to claim 1, wherein the intravascular blood pump further comprises a drive cable extending from the rotor through the catheter to the proximal end of the catheter, the drive cable being configured to rotationally drive the rotor.

5. The intravascular blood pump system according to claim 1, wherein the intravascular blood pump further comprises a motor disposed within the pump housing, the motor being configured to rotationally drive the rotor.

6. The controller is further configured to process the EKG signal from the electrode, determine a left ventricular end-diastolic pressure (LVEDP) based on the EKG signal the intravascular blood pump system according to claim 2.

7. The intravascular blood pump system according to claim 6, wherein the controller is further configured to display at least one of the EKG signal and the LVEDP on a display.

8. The controller is configured to process a first EKG signal from the electrode, determine a first LVEDP based on the first EKG signal, store the first LVEDP in a memory, process a second EKG signal from the electrode, determine a second LVEDP based on the first EKG signal, compare the second LVEDP with the first LVEDP accessed in the memory, Determine the difference between the second LVEDP and the first LVEDP The intravascular blood pump system according to claim 2, further configured to be like this.

9. The intravascular blood pump system according to claim 8, further configured such that the controller determines a recommendation for assistance for the intravascular blood pump based on the difference between the second LVEDP and the first LVEDP.

10. The intravascular blood pump system according to claim 9, further configured such that the controller determines a recommendation for assistance to increase the assistance provided by the intravascular blood pump when the difference between the second LVEDP and the first LVEDP is positive.

11. The intravascular blood pump system according to claim 9, further configured such that the controller determines a recommendation for assistance to decrease the assistance provided by the intravascular blood pump when the difference between the second LVEDP and the first LVEDP is negative.

12. The intravascular blood pump system according to claim 9, further configured such that the controller displays the recommendation for assistance on a display.

13. The intravascular blood pump system according to claim 9, further configured such that the controller automatically implements the recommendation for assistance by adjusting the speed at which the rotor is rotationally driven.

14. The controller is processing the EKG signal from the electrode, determining a recommendation for pacing or defibrillating the patient's heart based on the EKG signal The intravascular blood pump system according to claim 2, further configured to be like this.

15. The intravascular blood pump system according to claim 14, further configured such that the controller determines the recommendation based at least in part on whether the EKG signal indicates that the patient has an irregular heartbeat.

16. The intravascular blood pump system according to claim 14, further configured such that the controller displays the recommendation on a display.

17. The intravascular blood pump system according to claim 14, further configured such that the electrode provides pacing or defibrillation of the patient's heart by supplying an electric charge within the patient's heart.

18. The intravascular blood pump system according to claim 17, further configured such that the controller automatically implements the recommendation by supplying charge within the patient's heart to the electrodes.

19. A method of providing circulatory assistance to a patient using an intravascular blood pump, the method comprising the following steps: Controlling the intravascular blood pump to pump at a first pump speed by one or more processors of a controller; Receiving an electrocardiogram (EKG) signal of the patient's heart from an electrode connected to the intravascular blood pump by the one or more processors; Determining, by the one or more processors, a second pump speed different from the first pump speed based on the EKG signal; and Controlling the intravascular blood pump to pump at the second pump speed by the one or more processors.

20. A method of providing pacing or defibrillation of a patient's heart while providing circulatory assistance to the patient using an intravascular blood pump, the method comprising the following steps: Controlling the intravascular blood pump to pump at a first pump speed by one or more processors of a controller; Receiving an electrocardiogram (EKG) signal of the patient's heart from an electrode connected to the intravascular blood pump by the one or more processors; Determining, by the one or more processors, the need for pacing or defibrillation of the patient's heart based on the EKG signal; and Controlling the electrodes to supply charge within the patient's heart to provide pacing or defibrillation of the patient's heart by the one or more processors.

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