Blood pump with EKG monitoring, defibrillation and pacing capabilities

Abstract

The blood pump system includes a catheter, a pump housing disposed distal to the distal end of the catheter, a rotor disposed at least partially within the pump housing, a controller, and electrodes coupled to a distal region of the blood pump. The electrodes can be used to sense electrocardiogram (EKG) signals and send signals to a blood pump controller. Operation of the blood pump can be adjusted based on the EKG signals and cardiac parameters derived from the EKG signals. The controller can further determine the need for defibrillation or pacing of the patient's heart based on the signals and can administer electrical shock therapy to the heart via the electrodes coupled to the blood pump. Using the electrodes and blood pump already in place within the heart allows for more efficient and safe treatment of serious cardiac conditions. TIFF2022539362000002.tif187155

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 868,403, filed June 28, 2019, the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] background Cardiovascular disease is a major cause of morbidity, mortality, and healthcare burden worldwide. A variety of treatments have been developed for cardiovascular disease, ranging from pharmaceuticals to mechanical devices and ultimately transplantation. Temporary cardiac assist devices, such as ventricular assist devices, provide hemodynamic support and promote cardiac recovery. Several intracardiac heart pump assemblies can be introduced surgically or percutaneously into the heart 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. An intracardiac pump can be driven by a motor located outside the patient's body or a motor located within 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 cardiac components. Examples of such systems include the IMPELLA® family of devices (Abiomed, Inc., Danvers, Massachusetts).

[0003] Cardiac arrhythmias, or irregular heartbeats, are common among the patient population who require hemodynamic support from mechanical circulatory support systems such as intracardiac blood pumps. If the arrhythmia is severe, it may be necessary to correct the cardiac rhythm with a pacing or defibrillation device.

[0004] In critical care settings, patients suffering from life-threatening cardiac arrhythmias or irregular rhythms are often defibrillated by manual or automated external defibrillators, which apply a constant amount of electrical current to the heart by placing large pads or electrodes against the patient's skin to depolarize the heart and terminate the irregular heartbeat. Defibrillation is only used when certain types of arrhythmias are detected, and improper defibrillation can cause dangerous irregularities and other injury.

[0005] Adjustments to cardiac pacing are similarly addressed in critical care settings through 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 electrical current to stimulate heart contractions. Pacing is indicated when an abnormally slow heart rate, called bradycardia, is detected.

[0006] In situations where pacing or defibrillation is indicated, the clinician must first recognize that treatment is required, diagnose the cardiac irregularity, and determine the appropriate treatment. If defibrillation is indicated, the clinician must then place electrodes or pads on the patient, determine the voltage and timing of the shock, and deliver the shock to the patient. If pacing is indicated, the clinician must place electrodes or pads on the patient, select the heart rate, and adjust the current to the appropriate level.

[0007] A delay in pacing or defibrillating a patient when needed can be detrimental to the patient's condition and can result in a reduced survival rate. Furthermore, defibrillation and transcutaneous pacing can be uncomfortable for the patient. Unfortunately, electrical shocks for defibrillation and pacing in life-saving or emergency care are most often administered externally, requiring large electrical charges that can cause serious injury to the patient. Thus, new techniques are needed to provide efficient and safe pacing and defibrillation to patients. Summary of the Invention

[0008] overview The methods, systems, and devices described herein enable the use of a circulatory assist device including electrodes having transmitting, sensing, and charge transferring capabilities to provide circulatory assistance, detect electrocardiogram (EKG) signals, detect changes in cardiac function based on the EKG signals, and in response to the changes, modify the amount of assistance provided by the device, and provide defibrillation and pacing of the heart when necessary.

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

[0010] Generally, the mechanical circulatory support system includes a mechanical circulatory support device, a controller communicatively coupled to the mechanical circulatory support device and designed to control the level of assistance provided by the mechanical circulatory support device, and electrodes coupled to the mechanical support device. The mechanical circulatory support system may 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 support device includes an intravascular blood pump system including a catheter having a proximal end and a distal end, a blood pump disposed distal to 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 distal to the distal end of the catheter, and a rotor disposed at least partially 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 speed of the rotor, thereby controlling the level of assistance provided by the intravascular blood pump.

[0012] In another aspect, a method of providing circulatory assistance using a circulatory assist device, such as an intravascular blood pump, includes positioning the device (e.g., an intravascular blood pump) within a patient's vasculature and operating the intravascular blood pump by rotating a rotor within a pump housing at a pump speed. The method further includes measuring an EKG signal within the vasculature using electrodes 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 support includes positioning a circulatory assist device in the patient's vasculature, the circulatory assist device including electrodes 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 electrodes.

[0014] In another aspect, a method of providing pacing of a patient's heart while providing circulatory assistance includes positioning a circulatory assist device within the patient's vasculature, the circulatory assist device including electrodes coupled to the circulatory assist device, 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 pacing of the patient's heart based on the EKG signal, and delivering an electrical charge for delivery by the electrodes to pace the patient's heart.

[0015] In another aspect, a method of providing defibrillation of a patient's heart while providing circulatory support includes positioning a circulatory assist device within the patient's vasculature, the circulatory assist device including electrodes coupled to the circulatory assist device, 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 delivering an electrical charge for delivery at the electrodes to defibrillate the patient's heart. [Brief description of the drawings]

[0016] [Figure 1] 1 illustrates an exemplary blood pump system including an electrode according to an aspect of the present disclosure. [Diagram 2] FIG. 1 illustrates an exemplary blood pump system including an electrode positioned in the left heart according to aspects of the present disclosure. [Diagram 3] FIG. 1 illustrates an exemplary blood pump system including an electrode positioned in the right heart according to aspects of the present disclosure. [Figure 4] 1 is a flow chart illustrating an exemplary method for operating an intravascular blood pump based on an EKG signal measured with electrodes coupled to the intravascular blood pump according to an aspect of the present disclosure. [Diagram 5] 1 is a flow chart illustrating an exemplary method for providing cardiac assistance using an intravascular blood pump including electrodes according to aspects of the present disclosure. [Figure 6] 1 is a flow chart illustrating an exemplary method for measuring an EKG signal while providing circulatory assistance according to aspects of the present disclosure. [Figure 7] 1 is a flow chart illustrating an exemplary method for providing pacing of a patient's heart according to aspects of the present disclosure. [Figure 8] 1 is a flow chart illustrating an exemplary method for providing defibrillation of a patient's heart according to aspects of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] Detailed Description FIG. 1 illustrates an exemplary blood pump system 100 according to aspects of the 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 coupled to a distal end of the catheter 102. The rotor 106 is coupled to a drive shaft 118 and disposed within the pump housing 104. In addition, as shown in the example of FIG. 1, the rotor 106 may also extend beyond the distal end of the pump housing 104 to a proximal end of the cannula 108. In some aspects of the technology, the drive shaft 118 may extend through the catheter 102 and be configured to rotatably drive the rotor 106 via a motor disposed outside the patient's body. In some aspects of the 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 a 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 a proximal end of the cannula 108, but may alternatively be formed in a wall of the pump housing 104. Similarly, the inlet opening 122 is shown in FIG. 1 as being formed at a distal end of the cannula 108, but may alternatively 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] A flexible projection 114 extends from the distal end 110 of the cannula 108. The electrode 112 is coupled to the blood pump system 100. The blood pump system can be utilized in a right heart configuration or a left heart configuration, as described below in Figures 2 and 3, respectively.

[0019] The electrodes 112 are disposed on the distal end 110 of the cannula, e.g., on a flexible protrusion 114. The flexible protrusion 114 may 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 comprises a ball or sphere. A distal portion 116 of the flexible protrusion 114 may provide guidance and positioning of the blood pump system 100 within the heart. For example, the flexible protrusion may be used to space the inlet opening 122 of the blood pump system 100 and the wall of the heart, or to guide the blood pump system 100 through the vasculature.

[0020] Disposed within the blood pump system 100 are electrical wires 120 that connect the electrodes 112 to a controller (not shown). The electrical wires 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 and / or optical sensor 126 disposed on the catheter 102 as shown or disposed elsewhere on the blood pump system 100. The electrical wires 120 coupled to the electrodes 112 may follow the same path through the catheter 102 as the electrical wires, pressure wires, and optical fibers coupled to the pressure and / or optical sensor 126 of the blood pump system 100. The electrical wires 120 provide an electrical connection and power supply from the controller to the electrodes 112. The electrodes 112 may be designed to function as pacing and / or defibrillation electrodes 112 equipped to deliver an electrical charge to the heart, and also function as sensing electrodes 112 that measure EKG signals and transmit signals to the controller via the electrical wires 120. The functions of the controller and electrodes 112 together are described in more detail below with reference to FIGS.

[0021] In the example of FIG. 1, the reference electrode 107 is located on the catheter 102 connecting the blood pump system 100 to the controller near the distal end of the catheter 102 so as to be located within the patient's vasculature. However, the reference electrode 107 may alternatively be located 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 through the catheter 102. The measured EKG signal reflects the difference in electrical potential 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 electrodes 112 for sensing, pacing, and defibrillation directly on the blood pump system 100, no additional catheters for EKG sensing are required and no external pacing and defibrillation methods are required. Time delays in providing treatment for severe arrhythmias are reduced compared to conventional methods utilizing external manual defibrillation or transcutaneous pacing because the necessary electrodes 112 are already in position to deliver charge to the heart. Because the electrodes 112 are within the heart and can deliver an electrical shock directly to the heart tissue, the amount of charge required is reduced, providing a more efficient system and reducing the possibility of causing further injury that may occur with external defibrillation or pacing, which require larger currents and charges.

[0023] 2 illustrates an exemplary blood pump system 200 according to aspects of the disclosure, including an electrode 212 disposed on a blood pump 201 at 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 enters the cannula 208 (as indicated by arrow 223), at least one outlet opening 224 through which blood exits the cannula 208 (as indicated by arrow 225), a reference electrode 207, a catheter 202, and a flexible protrusion 214 at a 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. Again, the at least one outlet opening 224 may be formed in the proximal end of the cannula 208 or in a pump housing structure attached to the proximal end of the cannula 208. Similarly, the at least one inlet opening 222 may be formed in the distal end of the cannula 208 or in a blood inflow cage structure (which may be considered part of the cannula 208) attached to the distal end of the cannula 208.

[0024] The pump 204 is coupled to a first catheter 202 that extends through a second catheter 203. Both the first catheter 202 and the second catheter 203 extend through the vasculature to attach the blood pump 201 to the controller 238. The first catheter 202 may 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. In some implementations, the blood pump 201 can be compressed by retracting it into the second catheter 203.

[0025] The electrode 212 is positioned on the flexible projection 214 as shown, or elsewhere at the distal end of the blood pump 201, such as at the distal end of the cannula 208. The blood pump 201 is positioned 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 projection 214 or at the distal end of the cannula 208, is positioned in the left ventricle 249 where it can be used to administer an electrical shock to the heart for defibrillation or pacing, if desired. The electrode 212 may also be positioned at the most distal portion of the flexible projection 216. The flexible projection 214 may help provide spacing between the inlet opening 222 and the wall of the left ventricle 249. The electrode 212 does not need to be in contact with heart tissue, as blood in the heart is also conductive. The reference electrode 207 is located near the blood pump 201 so as to be 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 located on the skin outside the patient's body. The reference electrode 207 may 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 through the catheter 202. The measured EKG signal reflects the difference in electrical 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) communicatively coupled to the electrodes 212 for controlling the operation of the blood pump 218. 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, chimes, etc.). For example, the controller 238 may be an Automated Impella Controller (AIC) from Abiomed, Inc. or any other suitable controller. The electrodes 212 are coupled to the controller 238 by electrical wires 219 that extend through the cannula 208 and the first catheter 202. As described above with respect to FIG. 1, the electrical wires 219 may be embedded in the wall of the cannula 208 and may extend through the catheter 202 to the controller 238. The electrical wires 219 provide an electrical connection and power supply from the controller 238 to the electrodes 212. In some implementations, the electrodes 212 can be coupled to a wireless transmitter and designed to function on the blood pump system 200 without wires 219 directly connecting the electrodes 212 to the controller 238.

[0027] The electrodes 212 function as described above with respect to FIG. 1 to measure EKG signals in the heart and to deliver electrical charges for pacing and defibrillation to the heart as needed. The electrodes 212 transmit the EKG signals to the controller 238. The controller 238 may display the signals to a clinician on a display 244 to allow the clinician to diagnose arrhythmias. The controller 238 may also record the EKG signals in the memory 242. The controller 238 may also include software in the processor 240 and / or memory 242 used to analyze the EKG signals to detect and diagnose arrhythmias, and may be further configured to alert the clinician on the display 244 of detected arrhythmias and recommended therapy determined by the processor 240. Because the electrodes 212 are coupled to the blood pump 201 already positioned in the heart, application of therapy by pacing or defibrillation becomes much more efficient. For example, the clinician may deliver an electrical shock to the heart via the electrodes 212 by inputting a command on the controller 238. Additionally, the controller 238 may include software that determines the appropriate voltage, timing, and / or heart rate and current to be administered and prompts the clinician to administer therapy. Analysis of the EKG signal by the controller 238 allows for much more rapid response to arrhythmias and cardiac events than is currently possible using external manual defibrillation and pacing.

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

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

[0030] The controller 238 extracts cardiac parameters from the EKG data sent by the electrodes 212 and uses the data to make decisions regarding the effectiveness of the assistance provided by the blood pump 201. Based on the EKG data sent to the 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 in the left ventricle of the heart at end diastole and is a critical value in determining the health and cardiac function of a patient that can be derived from signal processing from the pressure and motor characteristics of the blood pump. A low LVEDP indicates a healthy patient, while 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 top of the R wave indicates the timing of the cardiac cycle when the pressure measurement indicates the LVEDP. Because the EKG signal makes the timing of the pressure measurement more specific, the controller 238 can extract information about the timing of the LVEDP in the cardiac cycle from the EKG signal and make an LVEDP measurement at the exact moment in the cycle where the LVEDP occurs. With information from the EKG signal, the LVEDP can be more accurately determined.

[0032] Alternatively or additionally, the EKG signal can also 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, pressure gradient, heart rate, cardiac output, cardiac output, intrinsic cardiac output, intrinsic cardiac output, cardiac contractility, cardiac relaxation, fluid responsiveness, volume status, and cardiac unloading or recovery index.

[0033] The controller 238 times the measurements of the aortic pressure using the EKG signal to accurately estimate the LVEDP (or other cardiac parameter) based on the pressure measurements and the motor parameters, and presents the information to the clinician on the display 244. The controller can also further process the data to determine whether the circulatory support provided by the blood pump 201 should be altered to provide more or less assistance to the patient. Accurate measurement of the LVEDP using the EKG signal from the electrodes 212 allows the controller 238 to respond more quickly to changes in cardiac function. In particular, the controller 238 can use the extracted cardiac parameters, including the LVEDP, to determine whether circulatory support should be increased or decreased, and can alter the support accordingly by altering the rotor speed or prompting the clinician to do so.

[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 allows the controller 238 to better predict and quickly identify changes in cardiac function. Based on the EKG signal and cardiac parameters extracted from the EKG signal and other signals available to the controller 238, the controller 238 may adjust the rotor speed to provide more or less assistance. Alternatively, the controller 238 may prompt the clinician to change the rotor speed by displaying a recommendation on the display 244.

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

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

[0037] If a 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 required and the appropriate parameters of the electrical shock to be administered as a treatment for the condition. For example, the timing and voltage of the electrical shock to be administered to defibrillate the heart may be determined by the controller 238. In some implementations, the timing and voltage of the electrical shock may be entered 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, relevant parameters related to pacing the heart may be entered into the system by the clinician or determined by the controller 238 and approved by the clinician. A certain amount of electrical current is then sent to the heart via the electrodes 212 to depolarize the myocardium and terminate the arrhythmia. Because the electrodes 212 are already in place and can deliver an electrical charge directly to the heart, defibrillating or pacing 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] A blood pump system including electrodes can also be used with a blood pump that assists the heart in a right-heart configuration. Figure 3 shows an exemplary blood pump system 300 according to aspects of the disclosure that includes an electrode 312 positioned on the right heart and capable of measuring EKG signals and supplying an electrical charge to the heart for pacing and defibrillation. The blood pump system 300 includes a blood pump 301 and a controller 338.

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

[0040] The pump 304 is coupled 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 a controller 338. For example, when the blood pump 301 is positioned in the right heart 351 with at least one inlet opening 324 in the inferior vena cava 317 and at least one outlet opening draining blood into the pulmonary artery 350, the electrode 312 is positioned in the pulmonary artery. The electrode 312 can be coupled to the cannula 308 of the blood pump 301 such that the electrode 312 is located in the right ventricle 349 when the blood pump 301 is positioned in the right heart 351. The electrode 312 may be located on a cannula 308 located in the right ventricle 349, on a flexible protrusion 314 (or at the distal or tip of the mechanical circulatory assist system if there is no flexible protrusion), or on a catheter 302 located near the right heart 351 in the inferior vena cava 317. The portion of the cannula 308 located in the right ventricle 349 may be preferred due to its proximity to the myocardium. If the electrode 312 is not in the right ventricle 349 (e.g., if the electrode 312 is on a flexible protrusion 314), the blood pump 301 may be temporarily repositioned to position the electrode 312 in 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 electrodes 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, chimes, etc.). As described above with respect to FIG. 2, the electrodes 312 are coupled to the controller 338 by wires 319 that provide an electrical connection and power supply from the controller 338 to the electrodes 312. The electrodes 312 transmit EKG signals to the controller 338 that the controller can use to perform several tasks related to the assessment of the patient's cardiac function, as described above. For example, the EKG signals can be used by the controller 338 to display the signals to a clinician, extract cardiac parameters from the EKG signals 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 may sound an alarm and / or display a warning and / or recommendation to the clinician on the display 344, or may determine optimal settings and parameters for delivering an electrical shock to the patient's heart as part of the pacing or defibrillation and present those parameters to the clinician. The clinician then need only approve the recommended therapy and enable the electrode 312 to deliver an electrical shock to regulate the patient's heart rate. 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. Pacing or defibrillation of the heart is provided by applying a voltage between the electrode 312 and the reference electrode.

[0042] Once the controller 338 extracts cardiac parameters from that signal and other signals available to the controller 338, these cardiac parameters can be presented to a clinician to assist in diagnosing and monitoring the health of the patient. Alternatively or additionally, the cardiac parameters can be used to determine whether a change in the circulatory support being provided is recommended. The controller 338 may use the extracted cardiac parameters to determine whether pump support should be increased or decreased. 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 adjustments to the support provided by the blood pump 301. If the electrode 312 is placed in the right ventricle 349, the EKG data provided by the electrode 312 may be more revealing of a right heart infarction condition. The EKG signal from the electrode 312 in the right ventricle 349 may also be more revealing of cardiac conduction disorders in the right heart 351 than an electrode 312 placed on the left side of the heart. When these types of right heart conditions are detected, EKG signals from electrodes 312 placed in the right heart 351 allow the clinician to better understand the patient's condition and adjust treatment accordingly.

[0043] Incorporating electrodes 312 into blood pump 301 enables more rapid detection and response to cardiac events, including arrhythmias requiring pacing or defibrillation, as well as changes in cardiac function requiring modification of the circulatory support provided by blood pump 301.

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

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

[0046] At step 410, a cardiac event is identified based on the EKG signal. The controller may include software for analyzing the EKG signal and determining a cardiac event, such as an irregular heartbeat or a heartbeat that is too fast or too slow. The controller may further determine a method of treatment for the identified cardiac event. At step 412, an alert is generated for display based on the identified cardiac event. The controller may alert the clinician and display a notice that a cardiac event has been detected. Additionally, the controller may display a recommended treatment and / or prompt the clinician to administer the recommended treatment via electrodes coupled to an intravascular heart pump.

[0047] By incorporating electrodes into an intravascular blood pump, signals detected by the electrodes can be utilized by the blood pump in controlling the operation of the blood pump and can also be analyzed to provide clinicians with important information regarding cardiac function and events much more quickly than might otherwise be available. Additionally, as described below with respect to Figures 5-8, because the electrodes are already within the heart, they can be used to provide therapy such as defibrillation and pacing of the heart with minimal delay.

[0048] FIG. 5 shows a flow chart illustrating an exemplary method 500 for providing cardiac assistance using an intravascular blood pump (e.g., blood pump system 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 of FIG. 5 is applied 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). At step 502, the intravascular blood pump is positioned in the vasculature of a patient. At step 504, the intravascular blood pump is actuated by rotating a rotor in a pump housing at a pump speed. At step 506, an EKG signal is measured in the vasculature using electrodes coupled to the intravascular blood pump. At step 508, the pump speed of the rotor is adjusted based on the EKG signal. At step 510, a cardiac event is identified based on the EKG signal. For example, the EKG signal may be analyzed to determine whether there is an irregular heartbeat or a heartbeat that is too fast or too slow that requires defibrillation or pacing to normalize the heartbeat. Based on the identified cardiac events, an electrical charge is delivered to the vasculature via the electrodes to defibrillate or pace the heart.

[0049] Although the methods of Figures 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 with attached electrodes that can be placed within the vasculature, either surgically or by percutaneous insertion through the patient's vasculature. For example, the methods of Figures 4 and 5 are applicable to mechanical circulatory assist devices such as IABPs placed in the right or left heart, ECMO devices, surgically implanted LVADs, percutaneous expandable blood pumps, and intravascular blood pump systems.

[0050] FIG. 6 shows a flow chart illustrating an exemplary method 600 for measuring an EKG signal while providing circulatory support. The method of FIG. 6 applies to any mechanical circulatory support device, including IABP, ECMO device, LVAD, expandable blood pump, and intravascular blood pump (e.g., blood pump 201 of FIG. 2, blood pump 301 of FIG. 3) and 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). At step 602, a circulatory support device including electrodes (e.g., electrode 112 of FIG. 1, electrode 212 of FIG. 2, electrode 312 of FIG. 3) is positioned in the patient's vasculature. At step 604, the circulatory support device is activated in the patient's vasculature. For example, the circulatory support device may operate to pump blood through the patient's heart to provide continuous or pulsatile cardiac support. At step 606, an EKG signal is measured within the vasculature using the electrodes, and at step 608, the EKG signal is transmitted to a controller of the circulatory assist device.

[0051] At 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, the timing of the measurement of the LVEDP may be determined from the peak of the R wave shown in the EKG signal, based on which an accurate LVEDP value may be determined. Other cardiac parameters and cardiac characteristics may be extracted from the EKG signal and other signals and information that may be available to the circulatory support device, such as pressure measurements and pump or motor parameters. After the cardiac characteristics are determined, they may be displayed to a clinician or used by the controller to determine and implement a therapeutic method, such as application of an electric shock to correct an irregular heartbeat or reducing the level of circulatory support provided by the circulatory support device to wean a patient whose cardiac function is improving from the support.

[0052] FIG. 7 shows a flow chart illustrating an exemplary method 700 for providing pacing of a patient's heart. The method of FIG. 7 applies to any mechanical circulatory assist device, including IABP, ECMO device, LVAD, expandable blood pump, and intravascular blood pump (e.g., blood pump 201 of FIG. 2, blood pump 301 of FIG. 3) and 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). At step 702, a circulatory assist device including electrodes (e.g., electrodes 112 of FIG. 1, electrodes 212 of FIG. 2, electrodes 312 of FIG. 3) is positioned in the patient's vasculature. At step 704, the circulatory assist device is activated in 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. At step 706, an EKG signal is measured in the vasculature using the electrodes.

[0053] At step 708, the 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 the need for cardiac regulation. The need for pacing may be determined by comparing the EKG signal to a reference signal, comparing the patient's current EKG signal to past EKG signals, or comparing the heart rate per minute extracted from the EKG signal to a threshold value, such as 60 beats per minute (BPM) for an adult. Alternatively, the 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] At step 710, a charge is sent for delivery at the electrodes to provide pacing to the patient's heart. The timing, current, heart rate, and other parameters of the charge may be entered into the system by the clinician or may be determined by the controller and approved by the clinician. The charge is delivered at electrodes within the heart. Because the electrodes are already in place and the charge can be delivered directly to the heart, pacing the heart using a circulatory assist device that includes electrodes is more efficient and less risky than treatments that use transcutaneous pacing.

[0055] FIG. 8 shows a flow chart illustrating an exemplary method 800 for providing defibrillation of a patient's heart. The method of FIG. 8 applies to any mechanical circulatory assist device, including IABP, ECMO device, LVAD, expandable blood pump, and intravascular blood pump (e.g., blood pump 201 of FIG. 2, blood pump 301 of FIG. 3) and 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). At step 802, a circulatory assist device including electrodes (e.g., electrodes 112 of FIG. 1, electrodes 212 of FIG. 2, electrodes 312 of FIG. 3) is positioned in the patient's vasculature. At step 804, the circulatory assist device is activated in 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. At step 806, an EKG signal is measured in the vasculature using the electrodes.

[0056] At step 808, the need for defibrillation of the patient's heart is determined based on the EKG signal. For example, an irregular heartbeat or a heartbeat that is too fast may indicate a cardiac rhythm disorder for which defibrillation is an appropriate treatment, such as ventricular fibrillation or pulseless ventricular tachycardia. Heartbeat irregularity may be determined by comparing the EKG signal to a reference signal, comparing the patient's current EKG signal to past EKG signals, comparing a heart rate extracted from the EKG signal to a threshold value, or comparing the EKG signal to a reference heart rhythm associated with cardiac arrest. Alternatively, 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.

[0057] At step 810, a charge is sent for delivery at the electrodes to defibrillate the patient's heart. The timing and voltage of the electric shock can be entered into the system by the clinician or can be determined by the controller and approved by the clinician. A fixed amount of current is then sent to the heart via the electrodes to depolarize the myocardium and terminate the arrhythmia. Because the electrodes are already in place and the charge can be delivered directly to the heart, defibrillation of the heart using a circulatory assist device that includes electrodes is more efficient and less risky than treatment using a manual external defibrillator.

[0058] The foregoing description is merely illustrative of the principles of the technology. Thus, the apparatus and methods described herein can be practiced in other than described implementations, which are presented for purposes of illustration and not limitation.

[0059] In addition, the disclosed features may be implemented in any combination or subcombination (including multiple subcombinations and subcombinations) with one or more other features described herein. The various features described or illustrated above, including any components thereof, may be combined or integrated into other systems. Furthermore, certain 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 the heart pump system or on a controller of the 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 in real time (or near real time) with the separate data processing device.

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

[0062] Exemplary Implementations As previously discussed, the systems and methods disclosed herein may be implemented in a variety of ways. In that regard, the above disclosure is intended to include, but is not limited to, the systems, methods, and combinations and subcombinations thereof set forth in the following exemplary implementation categories:

[0063] Category A: A1: A mechanical circulatory assist device; an electrode connected to a mechanical assist device; Mechanical circulatory support systems, including: A2: The mechanical circulatory support system of A1, wherein the mechanical circulatory support device is configured to be positioned at least in part within the patient's heart. A3: The mechanical circulatory support system of A1 or A2, wherein the mechanical circulatory support 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 placed in the right or left heart. A4: Any of the mechanical circulatory support systems A1 to A3, in which the electrical signal from the electrodes is an electrocardiogram (EKG) signal. A5: Any of the mechanical circulatory support systems A1 to A4, configured so that an electrode is placed within the heart. A6: Any of the mechanical circulatory assist systems of A1 to A5, wherein the electrodes are communicatively coupled to a controller, the controller being configured to receive electrical signals from the electrodes. A7: The mechanical circulatory support system of A6, wherein the controller is configured to control the level of assistance provided by the mechanical circulatory support device. A8: The controller is Processing electrical signals from the electrodes; Generating said electrical signals from the electrodes for display. A7 mechanical circulatory support system configured as follows: A9: The mechanical circulatory assist system of A8, wherein the controller is configured to extract 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 Stored in past LVEDP memory, comparing the new LVEDP with the previous LVEDP accessed in memory; Determine the difference between the new LVEDP and the previous LVEDP A mechanical circulatory support system according to any one of A6 to A10, configured as described above. A12: The mechanical circulatory support system of A11, wherein the controller is further configured to determine the support recommendation based on a difference between the new LVEDP and the historical LVEDP. A13: The mechanical circulatory support system of A12, wherein the controller is configured to determine an assistance recommendation for increasing assistance by the mechanical circulatory support device when a difference between the new LVEDP and the past LVEDP is positive. A14: The mechanical circulatory support system of A12, wherein the controller is configured to determine an assistance recommendation for reducing assistance when a difference between the new LVEDP and the past LVEDP is negative. A15: The mechanical circulatory support system of any of A12 to A14, wherein the controller is further configured to generate an assistance recommendation for display. A16: Any of the mechanical circulatory support systems of A12 to A15, wherein the controller is further configured to automatically implement the support recommendation. A17: Any of the mechanical circulatory support systems of A1 to A16, further comprising a reference electrode connected to the mechanical circulatory support device.

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

[0065] Category C: C1: A mechanical circulatory assist device; a controller communicatively coupled to the mechanical circulatory assist device and configured to control the level of assistance provided by the mechanical circulatory assist device; Electrodes connected to a mechanical circulatory support device Mechanical circulatory support systems, including: C2: The mechanical circulatory assist system of C1, wherein the electrodes are communicatively coupled to a controller, the controller configured to receive electrical signals from the electrodes. C3: The controller Processing electrical signals from the electrodes; Generating said electrical signals from the electrodes for display. The C2 mechanical circulatory support system is configured as follows: C4: A mechanical circulatory support system of C2 or C3, in which the electrical signal from the electrodes is an electrocardiogram (EKG) signal. C5: Any of the mechanical circulatory support systems C1 to C4 configured with electrodes placed within the heart. C6: The mechanical circulatory support system of C4, where the controller is configured to extract left ventricular end diastolic pressure (LVEDP) from the EKG signal. C7: The mechanical circulatory support system of C6, wherein the controller is configured to display the EKG signal and the LVEDP on a display. C8: The controller Stored in past LVEDP memory, comparing the new LVEDP with the previous LVEDP accessed in memory; Determine the difference between the new LVEDP and the previous LVEDP A C6 or C7 mechanical circulatory support system configured to: C9: The mechanical circulatory support system of C8, wherein the controller is further configured to determine a recommendation for support based on a difference between the new LVEDP and the historical LVEDP. C10: The mechanical circulatory support system of C9, wherein the controller is configured to determine a support recommendation for increasing support if the difference between the new LVEDP and the past LVEDP is positive. C11: The mechanical circulatory support system of C9, wherein the controller is configured to determine an assistance recommendation to reduce assistance if the difference between the new LVEDP and the past LVEDP is negative. C12: The mechanical circulatory support system of any of C9 to C11, wherein the controller is further configured to generate an assistance recommendation for display. C13: Any of the mechanical circulatory support systems C9 to C12, wherein the controller is further configured to automatically implement the support recommendation. C14: Any of the mechanical circulatory support systems C9 to C13, further comprising 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; A rotor disposed at least partially within the pump housing and configured to be driven in rotation. an intravascular blood pump; a controller communicatively coupled to the intravascular blood pump and configured to control a level of assistance provided by the intravascular blood pump by controlling the speed of the rotor; an electrode connected to an intravascular blood pump; An intravascular blood pump system comprising: D2: The intravascular blood pump system of D1, further comprising a flexible protrusion disposed distally of the pump housing. D3: An intravascular blood pump system of D1 or D2 with electrodes positioned on the flexible protrusions. D4: Any of the intravascular blood pump systems D1 to D3, in which the electrodes are configured to function as sensors. D5: An intravascular blood pump system of any of D1 to D4, further comprising a cannula connected to the pump housing. D6: The intravascular blood pump system of D5 with a flexible protrusion placed at the distal end of the cannula. D7: Any of the intravascular blood pump systems of D1 to D6, further including a drive cable extending from the rotor through the catheter to a proximal end of the catheter, configured to drive the rotor within the pump housing. D8: Any of the intravascular blood pump systems of D1 to D7, further including an electrical wire extending from the electrode through the catheter to the proximal end of the catheter. D9: The intravascular blood pump system of D8, with the electrical wires embedded in the side wall of the pump housing. D10: An intravascular blood pump system of D8 or D9, wherein the electrodes are communicatively coupled to the controller by electrical wires, and the controller is configured to receive electrical signals from the electrodes via the electrical wires. D11: The controller Processing electrical signals from the electrodes; The electrical signal from the electrode is displayed on a display. An intravascular blood pump system according to any one of D8 to D10, configured as described above. D12: Any of the intravascular blood pump systems of D8 to D11, wherein the electrical signal from the electrodes is an electrocardiogram (EKG) signal. D13: The intravascular blood pump system of D12, where the controller is configured to extract 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 an EKG signal and an LVEDP on the display. D15: The controller Stored in past LVEDP memory, comparing the new LVEDP with the previous LVEDP accessed in memory; Determine the difference between the new LVEDP and the previous LVEDP The present invention relates to an intravascular blood pump system, comprising: a D13 or D14 intravascular blood pump system configured as follows: D16: The intravascular blood pump system of D15, wherein the controller is further configured to determine the support recommendation based on a 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 assist recommendation to increase assist if a 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 assist recommendation to reduce assist if a difference between the new LVEDP and the past LVEDP is negative. D19: An intravascular blood pump system of any of D16 to D18, wherein the controller is further configured to display a recommendation for assistance on the display. D20: Any of the intravascular blood pump systems of D16 to D19, wherein the controller is further configured to automatically implement the assistance recommendation. D21: Any of the intravascular blood pump systems of D13 to D20, wherein the controller is further configured to determine a treatment recommendation based on the EKG signal. D22: An intravascular blood pump system of any of D13 to D20, wherein the controller is further configured to display instructions for recommended treatment on the display. D23: The intravascular blood pump system of D22, further comprising a reference electrode connected to the catheter. D24: The intravascular blood pump system of D23, wherein the controller is configured to send electrical charges for delivery at the electrodes via the wires to provide cardiac pacing or cardiac defibrillation in response to user input. D25: The intravascular blood pump system of D23, wherein the controller is configured to automatically send electrical charges for delivery at the electrodes via the wires to provide cardiac pacing or cardiac defibrillation based on a treatment recommendation. D26: Any of the intravascular blood pump systems D1 to D25 configured so that the electrodes are placed within the heart. D27: Intravascular blood pump a plurality of entrance openings formed in the cannula; a plurality of outlet openings formed in the pump housing; The intravascular blood pump system of any one of D1 to D26, further comprising: D28: a plurality of inlet openings configured to be positioned in a left ventricle of the heart; and an outlet opening proximal to the inlet opening and configured to be positioned within the aorta of the heart; D27 intravascular blood pump system. D29: The intravascular blood pump system of D28 configured with the electrode positioned within the left ventricle. D30: An intravascular blood pump system of D29, where the electrodes are configured to defibrillate the heart by delivering an electrical charge within the left ventricle. D31: An intravascular blood pump system of D29, in which the electrodes are configured to provide pacing to the heart by delivering an electrical charge within the left ventricle. D32: a plurality of inlet openings configured to be positioned in the inferior vena cava of the heart; and a plurality of outlet openings distal to the inlet opening and configured to be positioned within a pulmonary artery of the heart; D27 intravascular blood pump system. D33: The intravascular blood pump system of D32 configured with the electrode positioned within the right ventricle. D34: The intravascular blood pump system of D33, where the electrodes are configured to deliver an electrical charge within the right ventricle. D35: An intravascular blood pump system of D33, where the electrodes are configured to provide pacing to the heart by delivering an electrical charge within the right ventricle. D36: Any of the intravascular blood pump systems of D1 to D35, further including a pressure sensor connected to the catheter.

[0067] Category E: E1: A method of providing circulatory assistance using an intravascular blood pump, comprising the steps of: placing an intravascular blood pump within the vasculature of a patient; operating the intravascular blood pump by rotating a rotor of the intravascular blood pump within the pump housing at a pump speed; measuring electrocardiogram (EKG) signals within the vasculature using electrodes coupled to the intravascular blood pump; and Adjusting the rotor pump speed based on the EKG signal. E2: The method of E1, wherein the step of positioning the intravascular blood pump within the patient's vasculature further comprises positioning the intravascular blood pump within the patient's heart such that the electrodes are located within the heart. E3: generating an EKG signal for display; and receiving a user input to adjust 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 of E1 to E4, further comprising the step of calculating 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; To compare the patient's current LVEDP with their past LVEDP; and To determine the difference between current and past LVEDP The method of E6, further comprising: E8: The method of E7, further comprising determining a recommendation to increase pump speed if the difference between the current LVEDP and the past LVEDP is positive. E9: The method of E7, further comprising determining a recommendation to decrease pump speed if the difference between the current LVEDP and the past LVEDP is negative. E10: determining a recommendation for providing cardiac pacing based on the EKG signal; generating a recommendation for providing cardiac pacing to a user for display; and Responsive to input received from a user, sending electrical charges for delivery at the electrodes to pace the patient's heart. The methods of E1-E9 further include: E11: The method of E10, wherein the step of sending a charge for delivery at the electrode to pace the heart further comprises applying a voltage between the reference electrode and the electrode. E12: determining a recommendation to provide cardiac defibrillation based on the EKG signal; generating a recommendation for providing cardiac defibrillation to a user for display; and Responsive to input received from a user, transmitting an electrical charge for delivery at the electrodes to defibrillate the patient's heart. The methods of E1-E9 further include: E12: The method of E11, wherein the step of sending a charge for delivery with the electrode to defibrillate the heart further comprises applying a voltage between the reference electrode and the electrode. E13: The method of E1-E12, wherein the step of positioning the intravascular blood pump within the patient's vasculature further includes positioning 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-E12, wherein the step of positioning the intravascular blood pump within the patient's vasculature further includes positioning the intravascular blood pump within the vasculature such that an electrode coupled to the intravascular blood pump is within the right ventricle.

[0068] Category F: F1: A method for measuring an EKG signal while providing circulatory support, the method comprising the steps of: positioning within the patient's vasculature a circulatory assist device including electrodes coupled to the circulatory assist device; operating the circulatory assist device within the patient's vasculature; and Measuring electrocardiogram (EKG) signals within the vasculature using electrodes. F2: The method of F1, wherein the circulatory assist device is an intravascular blood pump. F3: The method of F1 or F2, wherein the step of positioning the circulatory assist device within the patient's vasculature further comprises positioning the circulatory assist device within the patient's heart such that the electrodes are located within the heart. F4: Any of the methods of F1-F3, further comprising the step of transmitting the EKG signal to a controller coupled to the circulatory assist device. F5: The method of F4, further comprising generating an EKG signal for display. F6: The method of F4 or F5, further comprising storing the EKG signal in a memory of the controller as a past EKG signal. F7: calculating left ventricular end diastolic pressure (LVEDP) from the EKG signal; and The process of storing the LVEDP in the controller's memory as a past LVEDP signal. Any of the methods F4 to F6, further comprising: F8: The method of F6 or F7, further comprising determining a treatment recommendation based on a comparison of the past LVEDP to the current LVEDP. F9: The method of F8, further comprising 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 support provided by the circulatory support device if the current LVEDP is higher than the past LVEDP; and determining a recommendation to reduce the support provided by the circulatory support device if the current LVEDP is lower than the past LVEDP; Any of the methods F8 to F10, further including:

[0069] Category G: G1: A method of providing pacing of a patient's heart while providing circulatory support, the method comprising the steps of: positioning within the patient's vasculature a circulatory assist device including electrodes coupled to the circulatory assist device; operating a circulatory assist device within the vasculature; measuring an electrocardiogram (EKG) signal within the vasculature using electrodes; determining the need for pacing of the patient's heart based on the EKG signal; and Delivering an electrical charge for delivery at the electrodes to pace the patient's heart. G2: The method of G1, wherein the circulatory assist device is an intravascular blood pump. G3: The method of G1 or G2, wherein the step of positioning the circulatory assist device within the patient's vasculature further comprises positioning the circulatory assist device within the patient's heart such that the electrodes are located within the heart. G4: Any of the methods of G1 to G3, further comprising the step of transmitting the EKG signal to a controller coupled to the circulatory assist device. G5: The method of G4, further comprising the step of generating an EKG signal for display. G6: The method of G4 or G5, further comprising storing the EKG signal in the controller memory as a past EKG signal. G7: The method of G6, wherein the step of determining the need for pacing of the patient's heart further includes comparing the past EKG signal with the current EKG signal. G8: Determining the patient's need for cardiac pacing, Extracting EKG signal characteristics from the current EKG signal; and Comparing the EKG signal characteristics to one or more thresholds Any of the methods G1 to G6, further comprising: G9: Determining the patient's need for cardiac pacing, extracting EKG signal characteristics from the current EKG signal and the past EKG signal; and Comparing current EKG signal characteristics with past EKG characteristics The method of G6 further includes: G10: Delivering an electrical charge to be delivered to an electrode for pacing a patient's heart, Delivering one or more electrical charges to the heart to increase the heart rate Any of the methods G1 to G9, including: G11. Placing a circulatory assist device in the vasculature of a patient, Positioning the circulatory assist device within the patient's vasculature such that an electrode coupled to the circulatory assist device is located in one of the left or right ventricle. Any of the methods G1 to G10, further comprising: G12: Any of the methods of G1-G11, wherein the step of sending a charge for delivery at the electrode to pace the patient's heart further includes sending a voltage between the electrode and a reference electrode.

[0070] Category H: H1: A method for providing defibrillation of a patient's heart while providing circulatory support, the method comprising the steps of: positioning within the patient's vasculature a circulatory assist device including electrodes coupled to the circulatory assist device; operating the circulatory assist device within the vasculature; and measuring an electrocardiogram (EKG) signal within the vasculature using electrodes; determining the need for defibrillation of the patient's heart based on the EKG signal; and Delivering an electrical charge for delivery at the electrodes 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 positioning the circulatory assist device within the patient's vasculature further comprises positioning the circulatory assist device within the patient's heart such that the electrodes are located within the heart. H4: Any of the methods of H1 to H3, further comprising the step of transmitting the EKG signal to a controller coupled to the circulatory assist device. H5: The method of H4, further comprising generating an EKG signal for display. H6: The method of H4 or H5, further comprising storing the EKG signal in the controller memory as a past EKG signal. 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 with 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 to one or more thresholds Any of the methods H1-H6, further comprising: 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 current EKG signal characteristics with past EKG characteristics The method of H6, further comprising: H10: The step of delivering an electrical charge to an electrode to defibrillate a patient's heart comprises: Delivering one or more electrical charges to the heart to resume cardiac function. Any of the methods H1 to H9, including: H11: Placing a circulatory assist device in the vasculature of a patient, Positioning the circulatory assist device within the patient's vasculature such that an electrode coupled to the circulatory assist device is located in one of the left or right ventricle. Any of the methods H1-H10, further comprising: H12: Any of the methods of H1-H11, wherein the step of sending a charge for delivery at the electrode to defibrillate the patient's heart further comprises 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 disposed at least partially within the pump housing and configured to be driven in rotation; a cannula coupled to the pump housing; and a flexible protrusion coupled to the distal end of the cannula; an intravascular blood pump comprising: an electrode attached to the intravascular blood pump and configured to sense an electrocardiogram (EKG) signal of a patient's heart, the electrode being disposed on the flexible protrusion; An intravascular blood pump system comprising:

2. a controller communicatively coupled to the intravascular blood pump and the electrodes and configured to control a level of assistance provided by the intravascular blood pump by controlling the speed at which the rotor is rotationally driven. The intravascular blood pump system of claim 1 , further comprising:

3. 2. The intravascular blood pump system of claim 1, wherein the intravascular blood pump further includes a drive cable extending from the rotor through the catheter to the proximal end of the catheter, the drive cable configured to rotatably drive the rotor.

4. The intravascular blood pump system of claim 1 , wherein the intravascular blood pump further includes a motor disposed within the pump housing, the motor configured to rotatably drive the rotor.

5. The controller: processing EKG signals from said electrodes; Determine left ventricular end diastolic pressure (LVEDP) based on the EKG signal.

3. The intravascular blood pump system of claim 2, further comprising:

6. The intravascular blood pump system of claim 5 , wherein the controller is further configured to display at least one of the EKG signal and the LVEDP on a display.

7. The controller: Processing a first EKG signal from the electrodes; determining a first LVEDP based on the first EKG signal; storing the first LVEDP in a memory; Processing a second EKG signal from the electrodes; determining a second LVEDP based on the second EKG signal; comparing the second LVEDP to the first LVEDP accessed in memory; Determining the difference between the second LVEDP and the first LVEDP 3. The intravascular blood pump system of claim 2, further comprising:

8. The intravascular blood pump system of claim 7 , wherein the controller is further configured to determine a support recommendation for the intravascular blood pump based on a difference between the second LVEDP and the first LVEDP.

9. The intravascular blood pump system of claim 8 , wherein the controller is further configured to determine an assist recommendation for increasing the assist provided by the intravascular blood pump based on the difference between the second LVEDP and the first LVEDP.

10. The intravascular blood pump system of claim 8 , wherein the controller is further configured to determine an assistance recommendation for reducing assistance provided by the intravascular blood pump based on the difference between the second LVEDP and the first LVEDP.

11. The intravascular blood pump system of claim 8 , wherein the controller is further configured to display the assistance recommendation on a display.

12. The intravascular blood pump system of claim 8 , wherein the controller is further configured to automatically implement the assistance recommendation by adjusting the speed at which the rotor is rotationally driven.

13. The controller: processing EKG signals from said electrodes; Determining a recommendation to provide pacing or defibrillation of the patient's heart based on the EKG signal.

3. The intravascular blood pump system of claim 2, further comprising:

14. 14. The intravascular blood pump system of claim 13, wherein the controller is further configured to determine the recommendation based at least in part on whether the EKG signal indicates that the patient is experiencing an irregular heartbeat.

15. The intravascular blood pump system of claim 13 , wherein the controller is further configured to display the recommendation on a display.

16. 14. The intravascular blood pump system of claim 13, wherein the electrodes are further configured to provide pacing or defibrillation of the patient's heart by delivering an electrical charge within the patient's heart.

17. The intravascular blood pump system of claim 16 , wherein the controller is further configured to automatically implement the recommendation by causing the electrodes to apply an electrical charge within the patient's heart.

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