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

Abstract

A blood pump system includes a catheter, a pump housing disposed distal of a distal end of the catheter, a rotor positioned at least partially in the pump housing, a controller, and an electrode coupled to a distal region of the blood pump. The electrode can be used to sense an electrocardiogram (EKG) signal and transmit the signal to the controller of the blood pump. Operation of the blood pump can be adjusted based on the EKG signal and cardiac parameters derived from the EKG signal. Further, the controller can determine a need for defibrillation or pacing of a heart of a patient based on the signal and can administer an electrical shock therapy to the heart via the electrode coupled to the blood pump. The use of the electrode with the blood pump already placed in the heart allows for more effective and safer treatment of serious cardiac conditions.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 868,403, filed on June 28, 2019, the disclosure of which is incorporated herein by reference in its entirety. Background Art

[0003] Cardiovascular disease is a leading cause of morbidity, mortality, and healthcare burden worldwide. Various treatment modalities have been developed for cardiovascular disease, ranging from medications to mechanical devices and ultimately transplantation. Temporary cardiac support devices (such as ventricular assist devices) provide hemodynamic support and promote cardiac recovery. Some intracardiac heart pump assemblies can be introduced into the heart surgically or percutaneously for transporting blood from one location in the heart or circulatory system to another location in the heart or circulatory system. For example, when deployed in the heart, an intracardiac pump can pump blood from the left ventricle of the heart into the aorta, or pump blood from the inferior vena cava to the pulmonary artery. The intracardiac pump can be powered 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 unload the heart's components. Examples of such systems include Series of devices (Abiomed, Inc., Danvers MA).

[0004] Arrhythmias, or irregular heartbeats, are common in patients who require hemodynamic support via mechanical circulatory support systems, such as intracardiac blood pumps. When arrhythmias are severe, they may require the use of pacing or defibrillation devices to correct the heart rhythm.

[0005] In critical care settings, patients with life-threatening arrhythmias, or dysrhythmias, are typically defibrillated with a manual external defibrillator or an automated external defibrillator, which delivers a measured amount of current to the heart through large pads or electrodes applied to the patient's skin, depolarizing the heart and ending the irregular heartbeat. Defibrillation is only used when specific types of arrhythmias are detected, and inappropriate defibrillation can lead to dangerous dysrhythmias and other injuries.

[0006] Regulation of the heart's pace is similarly addressed in critical care settings using 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 the heart's contractions. Pacing is required when an abnormally slow heart rate, known as bradycardia, is detected.

[0007] In cases where pacing or defibrillation is required, the clinician must first recognize the need for treatment, diagnose the cardiac irregularity and determine the appropriate treatment. When defibrillation is indicated, the clinician must place electrodes or electrode pads on the patient, determine the voltage and timing of the shock and administer the shock to the patient. When pacing is indicated, the clinician places electrodes or electrode pads on the patient and selects the heart rate and adjusts the current to the appropriate level.

[0008] The delay in administering pacing or defibrillation to a patient when needed can be detrimental to the patient's condition and can result in decreased survival rates. In addition, defibrillation and transcutaneous pacing can be uncomfortable for the patient. Unfortunately, because shocks for defibrillation and pacing in intensive care or emergency situations are most often applied externally, a large amount of charge is required, sometimes causing severe injury to the patient. Therefore, there is a need for new technology for providing effective and safe pacing and defibrillation to a patient. SUMMARY

[0009] The methods, systems, and devices described herein are capable of using a circulatory assist device including electrodes with the ability to transmit, sense, and deliver charge to provide circulatory support, detect electrocardiogram (EKG) signals, and based on the EKG signals detecting changes in heart function and reacting to them by varying the amount of support provided by the device as well as providing defibrillation and pacing of the heart when necessary.

[0010] By integrating pacing and defibrillation functionality into a circulatory assist device, the system becomes available to treat arrhythmias in real time during circulatory assist, reducing treatment delay and the severity of the arrhythmia indication. Electrodes (or other similar devices for sensing or stimulation or both) can be implemented on a circulatory assist device (e.g., a blood pump) for pacing and defibrillation. Such a device can also be used as an EKG (sometimes also referred to as ECG) electrode. EKG data can be provided by the electrodes to the controller of the circulatory assist device to provide additional information to the clinician about the patient's condition. EKG data can also enhance the ability of the assist device controller to quickly identify and respond to cardiac events or changes in heart function.

[0011] Generally, a mechanical circulatory support system includes a mechanical circulatory support device, a controller communicatively coupled to the mechanical circulatory support device and designed to control a level of support provided by the mechanical circulatory support device, and an electrode coupled to the mechanical support device. The mechanical circulatory support 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 positioned in the right or left heart. In an aspect, a circulatory assist device includes an intravascular blood pump system having a catheter having a proximal end and a distal end, a blood pump disposed distal of the distal end of the catheter, and an electrode coupled to a distal region of the blood pump.

[0012] 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 of the distal end of the catheter, and a rotor positioned at least partially in the pump housing, the rotor designed to be rotatably driven. The controller is communicatively coupled to the intravascular blood pump and designed to control a level of support provided by the intravascular blood pump by controlling a speed of the rotor.

[0013] In another aspect, a method of providing circulatory support using a circulatory assist device, such as an intravascular blood pump, includes placing the device (e.g., an intravascular blood pump) within a vasculature of a patient 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 an electrode coupled to the intravascular blood pump and adjusting the pump speed of the rotor based on the EKG signal.

[0014] In another aspect, a method for measuring an EKG signal while providing circulatory support includes placing a circulatory support device within a vasculature of a patient, where the circulatory support device includes an electrode coupled to the circulatory support device. The method further includes operating the circulatory support device within the vasculature of the patient and measuring an EKG signal within the vasculature using the electrode.

[0015] In another aspect, a method for providing pacing of a heart of a patient while providing circulatory support includes placing a circulatory support device within a vasculature of a patient, where the circulatory support device includes an electrode coupled to the circulatory support device. The method further includes operating the circulatory support device within the vasculature; measuring an EKG signal within the vasculature using the electrode; determining a need for pacing of the heart of the patient based on the EKG signal; and transmitting a charge for delivery at the electrode to pace the heart of the patient.

[0016] In another aspect, a method for providing defibrillation of a patient's heart while providing circulatory support includes placing a circulatory support device within a vasculature of the patient, where the circulatory support device includes an electrode coupled to the circulatory support device. The method also includes operating the circulatory support device within the vasculature; measuring an EKG signal within the vasculature using the electrode; determining a need for defibrillation of the patient's heart based on the EKG signal; and transmitting an electrical charge for delivery at the electrode to defibrillate the patient's heart. BRIEF DESCRIPTION OF DRAWINGS

[0017] Figure 1 An exemplary blood pump system including an electrode is shown in accordance with aspects of the present disclosure;

[0018] Figure 2 An exemplary blood pump system including an electrode positioned in the left heart is shown in accordance with aspects of the present disclosure;

[0019] Figure 3 An exemplary blood pump system including an electrode positioned in the right heart is shown in accordance with aspects of the present disclosure;

[0020] Figure 4 A flowchart illustrating an exemplary method for operating an intravascular blood pump based on an EKG signal measured at an electrode coupled to the intravascular blood pump in accordance with aspects of the present disclosure is shown;

[0021] Figure 5 A flowchart illustrating an exemplary method for providing cardiac support using an intravascular blood pump including an electrode in accordance with aspects of the present disclosure is shown;

[0022] Figure 6 A flowchart illustrating an exemplary method for measuring an EKG signal while providing circulatory support in accordance with aspects of the present disclosure is shown;

[0023] Figure 7 A flowchart illustrating an exemplary method for providing pacing of a patient's heart in accordance with aspects of the present disclosure is shown; and

[0024] Figure 8 A flowchart illustrating an exemplary method for providing defibrillation of a patient's heart in accordance with aspects of the present disclosure is shown. DETAILED DESCRIPTION

[0025] Figure 1An exemplary blood pump system 100 according to aspects of the present disclosure is shown, including a catheter 102, a pump housing 104, a rotor 106, a drive shaft (or drive cable) 118, a sleeve 108, a flexible tab 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 the drive shaft 118 and is positioned within the pump housing 104. Further, as shown in the example of Figure 1 , the rotor 106 can also extend beyond the distal end of the pump housing 104 into the proximal end of the sleeve 108. In some aspects of the technology, the drive shaft 118 can extend through the catheter 102 and can be configured to rotatably drive the rotor 106 via a motor located outside of the patient. In some aspects of the technology, the rotor 106 can be driven by a motor located within the patient, such as by a motor located within the pump housing 104. The sleeve 108 extends from the distal end of the pump housing 104. The blood pump system 100 includes inlet holes 122 and outlet holes 124. While the outlet holes 124 are shown in Figure 1 as being formed in the proximal end of the sleeve 108, they can instead be formed in the wall of the pump housing 104. Likewise, while the inlet holes 122 are shown in Figure 1 as being formed in the distal end of the sleeve 108, they can instead be formed in a blood inflow cage structure attached to the distal end of the sleeve 108 (which can be considered a part of the sleeve 108).

[0026] The flexible tab 114 extends from the distal end 110 of the sleeve 108. The electrode 112 is coupled to the blood pump system 100. The blood pump system can be used in a right heart configuration or a left heart configuration, as will be described below in Figure 2 and Figure 3 , respectively.

[0027] The electrode 112 is positioned at the distal end 110 of the sleeve, for example on the flexible tab 114. The flexible tab 114 can be implemented as a pigtail or straight tab from the distal end 110 of the sleeve. In some implementations, the flexible tab 114 includes a bulb or bulbous shape. The distal portion 116 of the flexible tab 114 can provide guidance and positioning for the blood pump system 100 within the heart. For example, the flexible tab can be used to space the inlet holes 122 of the blood pump system 100 from the walls of the heart, or to guide the blood pump system 100 through the vasculature.

[0028] Electrical wires 120 are positioned in the blood pump system 100 to connect the electrodes 112 to a controller (not shown). The electrical wires 120 can be embedded in the wall of the cannula 108 and can extend through the catheter 102 to the controller. The blood pump system 100 can also include pressure sensors and / or optical sensors 126 as shown positioned on the catheter 102 or elsewhere on the blood pump system 100. The electrical wires 120 coupled to the electrodes 112 can follow the same path through the catheter 102 as the electrical wires, pressure lines, and optical fibers coupled to the pressure sensors and / or optical sensors 126 of the blood pump system 100. The electrical wires 120 provide electrical connection and power supply from the controller to the electrodes 112. The electrodes 112 can be designed to function as pacing and / or defibrillation electrodes 112 equipped to deliver electrical charges to the heart and also as sensing electrodes 112 to measure EKG signals and transmit the signals through the electrical wires 120 to the controller. The functionality of the controller and electrodes 112 together will be described in more detail below with reference to Figure 2 and Figure 3 described in more detail.

[0029] In the example of Figure 1 the reference electrode 107 is positioned on the catheter 102 that connects the blood pump system 100 to the controller and proximate to the distal end of the catheter 102 so that it is positioned within the vasculature of the patient. However, the reference electrode 107 can instead be positioned outside the patient, such as on the skin of the patient. This reference electrode 107 can be connected to the controller by electrical wires that can be the same electrical wires 120 that connect the electrodes 112 to the controller through the catheter 102. The measured EKG signal reflects the difference in electrical potential between the electrodes 112 on the blood pump system 100 and the reference electrode 107. When pacing or defibrillation therapy is administered, the voltage is delivered between the electrodes 112 mounted on the blood pump system 101 and the reference electrode 107.

[0030] By providing electrodes 112 for sensing, pacing, and defibrillation directly on the blood pump system 100, no additional catheter is needed for EKG sensing and no external pacing and defibrillation methods are needed. The time delay in providing therapy for severe arrhythmias is reduced compared to conventional methods that use external manual defibrillation or transcutaneous pacing because the electrodes 112 needed are already in position to provide electrical charges to the heart. Because the electrodes 112 are within the heart and are able to provide electrical shocks directly to the heart tissue, the amount of electrical charge needed can be reduced, providing a more effective system and reducing the chance of additional harm that can occur due to the need for larger currents and charges for external defibrillation or pacing.

[0031] Figure 2An exemplary blood pump system 200 is shown that includes an electrode 212 positioned on a blood pump 201 positioned in a left heart in accordance with aspects of the present disclosure. The blood pump system 200 includes the blood pump 201 and a controller 238. The blood pump 201 includes a cannula 208, a pump 204, at least one inlet hole 222 through which blood flows into the cannula 208 (as shown by arrows 223), at least one outlet hole 224 through which blood flows out of the cannula 208 (as shown by arrows 225), a reference electrode 207, a catheter 202, and a flexible tab 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 Figure 1 . The blood pump 201 can be the device or any other suitable blood pump. Here as well, the at least one outlet hole 224 can be formed at a proximal end of the cannula 208, or can be formed in a pump housing structure attached to the proximal end of the cannula 208. Likewise, the at least one inlet hole 222 can be formed at a distal end of the cannula 208, or can be formed in a blood inflow cage structure (which can be considered a part of the cannula 208) attached to the distal end of the cannula 208.

[0032] 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 can be movable within the second catheter 203. The second catheter 203 is a non-rotating catheter. In some embodiments, the blood pump 201 can be withdrawn into the second catheter 203 to insert or remove the blood pump 201 through the vasculature. In some embodiments, the blood pump 201 can be compressed by being withdrawn into the second catheter 203.

[0033] As shown, the electrode 212 is positioned on the flexible tab 214 or elsewhere on the distal end of the blood pump 201, such as the distal end of the cannula 208. The blood pump 201 is positioned across the aortic valve 248 such that the at least one inlet hole 222 is in the left ventricle 249 and the at least one outlet hole 224 is in the aorta 247. Whether on the flexible tab 214 or on the distal end of the cannula 208, the electrode 212 is positioned within the left ventricle 249, which can be used to administer an electrical shock to the heart for defibrillation or pacing, if needed. The electrode 212 can also be positioned on the distal-most portion of the flexible tab 216. The flexible tab 214 can be used to space the inlet hole 222 from the wall of the left ventricle 249. The electrode 212 does not need to be in contact with the heart tissue because the blood within the heart is also conductive. The reference electrode 207 is positioned on the catheter 202 that connects the blood pump 201 to the controller 238 and is positioned within the patient’s vasculature proximate to the blood pump 201. The reference electrode 207 can alternatively be positioned on the skin of the patient outside of the body. The reference electrode 207 can be connected to the controller 238 by an electrical wire, which can be the same electrical 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 administering pacing or defibrillation therapy, a voltage is delivered between the electrode 212 mounted on the blood pump 201 and the reference electrode 207.

[0034] 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 and is communicatively coupled to the electrode 212. The controller 238 also includes a memory 242 and a display 244 (which can also include one or more audio devices, such as a speaker, a buzzer, etc.). For example, the controller 238 can be an Automated Impeller Controller (AIC) by Abiomed or any other suitable controller. The electrode 212 is coupled to the controller 238 by an electrical wire 219 that extends through the cannula 208 and the first catheter 202. As described above with reference to Figure 1 the electrode 212 can be embedded in the wall of the cannula 208 and extends through the catheter 202 to the controller 238. The electrical wire 219 provides an electrical connection and power supply from the controller 238 to the electrode 212. In some embodiments, the electrode 212 can be coupled to a wireless transmitter and can be designed to function on the blood pump system 200 without the electrical wire 219 directly connecting the electrode 212 to the controller 238.

[0035] The electrode 212 is used to measure an EKG signal as described above with reference to Figure 1The electrodes 212 function to measure EKG signals within the heart and, if necessary, provide electrical charges to the heart for pacing and defibrillation. The electrodes 212 transmit the EKG signals to the controller 238. The controller 238 can display the signals to a clinician on a display 244 to allow the clinician to diagnose arrhythmias. The controller 238 can also record the EKG signals in a memory 242. The controller 238 can also include software in the processor 240 and / or memory 242 for analyzing the EKG signals to detect and diagnose arrhythmias, and can also be configured to alert the clinician on the display 244 of detected arrhythmias and recommended treatments determined by the processor 240. Because the electrodes 212 are coupled to the blood pump 201 that is already positioned in the heart, administering treatment through pacing or defibrillation becomes more effective. For example, a clinician can transmit an electrical shock to the heart via the electrodes 212 by inputting a command on the controller 238. Additionally, the controller 238 can include software that determines the appropriate voltage, timing, and / or heart rate and current to administer and prompts the clinician to administer the treatment. Analyzing the EKG signals at the controller 238 enables a faster response to arrhythmias and cardiac events compared to current practices that can use external manual defibrillation and pacing.

[0036] After the controller 238 receives the EKG signals from the electrodes 212, the controller 238 generates the EKG signals and / or cardiac characteristics derived from the signals for display on the display 244. Displaying the EKG signals to the clinician allows the clinician to easily see the morphology and timing of the EKG waves for diagnostic purposes.

[0037] Based on the EKG information transmitted by the electrodes 212, the controller 238 can determine the heart function of the patient, which aids in the operation of the blood pump 201. The controller 238 receives digital signals including the EKG signals at the processor 240 and uses this information, along with other signals and data available to the controller 238, to extract cardiac parameters and characteristics indicative of heart function.

[0038] The controller 238 extracts cardiac parameters from the EKG data transmitted by the electrodes 212 and uses this data to determine the effect of the support provided by the blood pump 201. Based on the EKG data transmitted to the controller 238, the controller can extract cardiac parameters such as the left ventricular end diastolic pressure (LVEDP), which can be used to better understand heart function. The LVEDP is indicative of the pressure in the left ventricle of the heart at the end of diastole and is a key value in determining patient health and heart function, which can be derived from signal processing of the pressure and motion characteristics from the blood pump. A low LVEDP is indicative of patient health, while a higher LVEDP can be indicative of disease or illness.

[0039] For example, the EKG signal provided to the controller is a trace of the R wave. When the pressure measurement indicates the LVEDP, the top of the R wave indicates the timing in the cardiac cycle. Because the EKG signal makes the timing of the pressure measurement clearer, the controller 238 can extract information from the EKG signal about the timing of the LVEDP in the cardiac cycle and can take the LVEDP measurement at the precise timing in the cycle that the LVEDP occurs. With the information from the EKG signal, the LVEDP can be more accurately determined.

[0040] Alternatively or additionally, the EKG signal can be used to determine the appropriate timing in 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 power output, native cardiac output, native cardiac power output, cardiac contractility, cardiac relaxation, fluid responsiveness, volume status, and cardiac unloading or recovery index.

[0041] The controller 238 uses the EKG signal to time the measurement of the aortic pressure to accurately estimate the LVEDP (or other cardiac parameters) based on the pressure measurement and the motion parameters and present that information to the clinician on the display 244. The controller can further process the data to determine whether the circulatory support provided by the blood pump 201 should be changed to provide more or less support to the patient. By using the EKG signal from the electrodes 212 to accurately measure the LVEDP, the controller 238 can better respond to changes in cardiac function. In particular, the controller 238 can use the extracted cardiac parameters, including the LVEDP, to determine whether the circulatory support should be increased or decreased and, in response, can change the support by changing the speed of the rotor or prompting the clinician to do so.

[0042] In some implementations, the controller 238 can be used to automatically operate the blood pump 201 and the support 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 the cardiac parameters extracted from the EKG and other signals available to the controller 238, the controller 238 can adjust the rotor speed in order to provide more or less support. Alternatively, the controller 238 can prompt the clinician to change the speed of the rotor by displaying a suggestion on the display 244.

[0043] The controller 238 is also able to 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 can adjust the support as needed or provide additional therapy options using the electrodes 212 incorporated in the blood pump 201.

[0044] The controller 238 can also use the EKG signal to determine if there is an irregular heartbeat that indicates a need for pacing or defibrillation of the heart. The need for pacing can be determined by comparing the EKG signal to a reference signal, comparing the current EKG signal to a patient's historical EKG signals, or comparing the number of heartbeats per minute extracted from the EKG signal to a threshold (e.g., 60 beats per minute (BPM) for an adult human). The detection of an irregular heartbeat or a heartbeat that is too fast can indicate a cardiac rhythm disorder, such as ventricular fibrillation or pulseless ventricular tachycardia, for which defibrillation is an appropriate treatment. The irregular heartbeat for which defibrillation is needed can be determined by comparing the EKG signal to a reference signal, comparing the current EKG signal to a patient's historical EKG signals, comparing the number of heartbeats per minute extracted from the EKG signal to a threshold, or comparing the EKG signal to a reference rhythm of heartbeats associated with cardiac arrest. Alternatively, the irregularity can be determined by software programmed to recognize irregular or too-fast heartbeats, or by a machine learning algorithm trained to recognize these events.

[0045] When a need for pacing or defibrillation is detected, the controller 238 can alert the clinician by displaying a warning or recommendation on the display 244. The controller 238 can further determine which of pacing or defibrillation is needed and determine 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 the heart to defibrillate the heart can be determined by the controller 238. In some embodiments, 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 embodiments, the timing, current, heart rate, and other parameters of the electrical charge are determined by the controller 238. In some embodiments, the relevant parameters associated with pacing of the heart are input into the system by the clinician or can be determined by the controller 238 and approved by the clinician. An amount of electrical current is then delivered to the heart through the electrodes 212 to depolarize the myocardium and end the arrhythmia. Because the electrodes 212 are already in place and the electrical charge can be delivered directly to the heart, using the blood pump system 200 including the electrodes 212 to pace or defibrillate the heart is more effective and less dangerous than using a manual external defibrillator or a percutaneous pacing device to treat the condition.

[0046] Blood pump systems including electrodes can also be used with blood pumps that support the heart in a right heart configuration. Figure 3 An exemplary blood pump system 300 according to aspects of the present disclosure is shown, including electrodes 312 positioned in the right heart and capable of measuring an EKG signal and providing an electrical charge to the heart for pacing and defibrillation. The blood pump system 300 includes a blood pump 301 and a controller 338.

[0047] The blood pump 301 includes a cannula 308, a pump 304, at least one inlet hole 324 through which blood flows into the cannula 308 (as indicated by arrow 325), at least one outlet hole 321 through which blood flows out of the cannula 308 (as indicated by arrow 323), and a flexible tab 314 at a distal end of the cannula 308. For example, the blood pump 301 can be a blood pump system 100 of Figure 1 . The blood pump 301 can be a device or any other suitable blood pump. Similarly as described above, the at least one inlet hole 324 can be formed in a proximal end of the cannula 308, or can be formed in a pump housing structure attached to the proximal end of the cannula 308. Likewise, the at least one outlet hole 321 can be formed in a distal end of the cannula 308, or can be formed in a blood outflow cage structure (which can be considered a part of the cannula 308) attached to the distal end of the cannula 308.

[0048] 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 such that the at least one inlet hole 324 is in the inferior vena cava 317 and the at least one outlet hole expels blood into the pulmonary artery 350, the electrode 312 is positioned within the pulmonary artery. The electrode 312 can be coupled to the cannula 308 of the blood pump 301 such that the electrode 312 is positioned in the right ventricle 349 when the blood pump 301 is positioned in the right heart 351. The electrode 312 can be placed on the cannula 308 and positioned in the right ventricle 349, on the flexible tab 314 (or the distal or tip of the mechanical circulatory support system if there is no flexible tab), or positioned on the catheter 302 to be proximate to the right heart 351 in the inferior vena cava 317. It can be preferable for a portion of the cannula 308 to be positioned in the right ventricle 349 because it is closer to the myocardium. If the electrode 312 is not in the right ventricle 349 (e.g., if the electrode 312 is on the flexible tab 314), the blood pump 301 can be temporarily repositioned to place the electrode 312 in the right ventricle 349 before applying pacing or defibrillation.

[0049] The controller 338 includes a processor 340 (or a set of one or more processors 340) for controlling the operation of the blood pump and communicatively coupled to the electrode 312. The controller also includes a memory 342 and a display 344 (which can also include one or more audio devices, such as a speaker, a buzzer, etc.). As described above with respect to Figure 2The electrode 312 is coupled to the controller 338 by wires 319 that provide electrical connections and power supply from the controller 338 to the electrode 312. As described above, the electrode 312 transmits EKG signals to the controller 338 that the controller can use to perform a number of tasks related to the assessment of the patient's cardiac function. For example, the controller 338 can use the EKG signals to display the signals to a clinician, extract cardiac parameters from the signals and other signals available to the controller 338, and determine cardiac events or characteristics that indicate a need for pacing or defibrillation. When pacing or defibrillation is needed, the controller 338 can sound an alarm and / or display a warning and / or recommendation to the clinician on the display 344, or can determine the optimal settings and parameters for administering an electrical shock to the patient's heart as part of pacing or defibrillation and present these parameters to the clinician. The clinician then only needs to approve the recommended treatment to allow the electrode 312 to administer the electrical shock to regulate the patient's heartbeat. As described above with respect to Figure 2 The blood pump 301 can also include a reference electrode (not shown) positioned on the catheter 302. Pacing or defibrillation of the heart is provided by applying a voltage between the electrode 312 and the reference electrode.

[0050] As the controller 338 extracts cardiac parameters from the signals and other signals available to the controller 338, these cardiac parameters can be presented to the clinician to aid in the diagnosis and monitoring of the patient's health. Alternatively or additionally, the cardiac parameters can be used to determine whether to recommend a change in the circulatory support being provided. The controller 338 can use the extracted cardiac parameters to determine whether pump support should be increased or decreased. The controller 338 can make this determination and provide a recommendation to the clinician via the display 344, or the controller 338 can automatically adjust the support provided by the blood pump 301. When the electrode 312 is positioned within the right ventricle 349, the EKG data provided by the electrode 312 can better reveal conditions of right heart infarction. The EKG signals from the electrode 312 within the right ventricle 349 can also better reveal cardiac conduction blockage 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, the EKG signals from the electrode 312 positioned within the right heart 351 enable the clinician to better understand the patient's condition and adjust the treatment accordingly.

[0051] The incorporation of the electrode 312 into the blood pump 301 enables faster detection and response to cardiac events, including cardiac arrhythmias that require pacing or defibrillation and changes in cardiac function that require a change in the circulatory support provided by the blood pump 301.

[0052] Figure 4 An illustration is shown for use in conjunction with an electrode (e.g., the electrode 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112) coupled to an intravascular blood pump (e.g., the blood pump 101, 201, 301, 401, 501, 601, 701, 801, 901, 1001, 1101) to provide pacing or defibrillation of a heart. Figure 1 the electrode 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112) coupled to an intravascular blood pump (e.g., the blood pump 101, 201, 301, 401, 501, 601, 701, 801, 901, 1001, 1101) to provide pacing or defibrillation of a heart.Figure 2 electrodes 212 of the blood pump system 100 of FIG. 1, Figure 3 electrodes 312 of the blood pump system 300 of FIG. 3. Figure 1 an exemplary method 400 of operating an intravascular blood pump based on an EKG signal measured at electrodes 212 of the blood pump system 100 of FIG. 1, Figure 2 an exemplary method 400 of operating an intravascular blood pump based on an EKG signal measured at electrodes 212 of the blood pump system 100 of FIG. 1, Figure 3 an exemplary method 400 of operating an intravascular blood pump based on an EKG signal measured at electrodes 212 of the blood pump system 100 of FIG. 1, Figure 4 Figure 1 an exemplary method 400 of operating an intravascular blood pump based on an EKG signal measured at electrodes 212 of the blood pump system 100 of FIG. 1, Figure 2 an exemplary method 400 of operating an intravascular blood pump based on an EKG signal measured at electrodes 212 of the blood pump system 100 of FIG. 1, Figure 3 an exemplary method 400 of operating an intravascular blood pump based on an EKG signal measured at electrodes 212 of the blood pump system 100 of FIG. 1.

[0053] at step 408, adjusting the pump speed of the rotor 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 a cardiac parameter determined from the EKG signal. The controller can determine from 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 can then automatically adjust the pump speed of the rotor to reduce the pump speed or can alert the clinician that the patient should be weaned and prompt the clinician to manually adjust the rotor pump speed.

[0054] at step 410, identifying a cardiac event based on the EKG signal. The controller can 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 can further determine a treatment method for the identified cardiac event. At step 412, generating a warning for display based on the identified cardiac event. The controller can alert the clinician and display a notification that a cardiac event was detected. In addition, the controller can display a recommendation for a treatment method and / or can prompt the clinician to administer the recommended treatment method through the electrodes coupled to the intravascular heart pump.

[0055] ​By combining the electrodes with an intravascular blood pump, the signals detected by the electrodes can be used by the blood pump to control the operation of the blood pump and can also be analyzed to provide clinicians with critical information about cardiac function and cardiac events more quickly than would otherwise be available. Figure 5 - Figure 8 As described, 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.

[0056] Figure 5 Shown are diagrams for use with electrodes (e.g., Figure 1 Electrode 112, Figure 2 Electrode 212, Figure 3 of electrodes 312) of an intravascular blood pump (e.g., Figure 1 Blood pump system 100, Figure 2 Blood pump 201, Figure 3 Flowchart of an exemplary method 500 for providing cardiac support using a blood pump 301 ). Figure 5 The method described in is applicable to intravascular blood pump systems (e.g., Figure 1 Blood pump system 100, Figure 2 Left heart blood pump system 200, Figure 3 1 . The right heart blood pump system 300 of FIG. 1 is shown in FIG. 1 . At step 502, an intravascular blood pump is placed within the patient's vascular system. At step 504, the intravascular blood pump is operated by rotating a rotor within the pump housing at a pump speed. At step 506, an EKG signal in the vascular system is measured 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 can be analyzed to determine whether there is an irregular heartbeat or a heartbeat that is too fast or too slow, thereby requiring defibrillation or pacing to normalize the heartbeat. At step 512, based on the identified cardiac event, an electrical charge is provided to the vascular system via the electrodes to defibrillate or pace the heart.

[0057] Although Figure 4 and Figure 5 The methods are described with respect to an intravascular blood pump coupled to electrodes, but these methods can also be applied to any mechanical circulatory support device with attached electrodes that can be placed into the vasculature by surgery or percutaneous insertion through the patient's vasculature. For example, Figure 4 and Figure 5 The method is applicable to mechanical circulatory support devices such as IABP, ECMO devices, surgically implanted LVADs, percutaneous expandable blood pumps, and intravascular blood pump systems positioned in the right or left heart.

[0058] Figure 6A flowchart illustrating an exemplary method 600 for measuring an EKG signal while providing circulatory support is shown. Figure 6 The methods described in the Summary are applicable to any mechanical circulatory support device, including IABP, ECMO devices, LVADs, expandable blood pumps, and intravascular blood pumps (e.g., Figure 2 blood pump 201 of the VentrAssist®, Figure 3 blood pump 301 of the HeartWare®, and blood pump systems (e.g., Figure 1 blood pump system 100 of the Impella®, Figure 2 left heart blood pump system 200 of the Jarvik®, Figure 3 right heart blood pump system 300 of the Levacor®). At step 602, a circulatory support device including electrodes (e.g., Figure 1 electrodes 112 of the Impella®, Figure 2 electrodes 212 of the Jarvik®, Figure 3 electrodes 312 of the Levacor®) is placed within the vasculature of a patient. At step 604, the circulatory support device is operated within the vasculature of the patient. For example, the circulatory support device can be operated to pump blood through the heart of the patient to provide continuous or pulsatile heart 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 support device.

[0059] At step 610, a cardiac characteristic is determined from the EKG signal by the controller. For example, a cardiac characteristic extracted from the EKG signal can be a characteristic of a heartbeat, such as an irregular beat, a too slow or too fast beat, or a missed beat. As another example, a timing of a measurement of LVEDP can be determined from a peak of an R-wave shown in the EKG signal, based on which an accurate LVEDP value can be measured. Other cardiac parameters and characteristics can be extracted from the EKG signal and other signals and information available to the circulatory support device, such as pressure measurements and pump or motor parameters. After the cardiac characteristic is determined, the cardiac characteristic can be displayed to a clinician, or can be used by the controller to determine and implement a treatment method, such as administering a shock to correct an irregular heartbeat, or reducing a level of circulatory support provided by the circulatory support device to de-activate support for a patient whose heart function is improving.

[0060] Figure 7 A flowchart illustrating an exemplary method 700 for providing pacing of a heart of a patient is shown. Figure 7 The methods described in the Summary are applicable to any mechanical circulatory support device, including IABP, ECMO devices, LVADs, expandable blood pumps, and intravascular blood pumps (e.g., Figure 2 blood pump 201 of the VentrAssist®, Figure 3 blood pump 301 of the HeartWare®, and blood pump systems (e.g., Figure 1 blood pump system 100 of the Impella®, Figure 2 left heart blood pump system 200 of the Jarvik®, Figure 3At step 702, the right heart blood pump system 300 including electrodes (e.g., Figure 1 Electrode 112, Figure 2 Electrode 212, Figure 3 A circulatory support device (electrodes 312) is placed within the patient's vasculature. At step 704, the circulatory support device is operated within the patient's vasculature. For example, the circulatory support device can be operated to pump blood through the patient's heart to provide continuous or pulsatile cardiac support. At step 706, an EKG signal is measured within the vasculature using the electrodes.

[0061] At step 708, the need for pacing the patient's heart is determined based on the EKG signal. For example, an abnormally slow heartbeat may indicate bradycardia and require cardiac adjustments. The need for pacing can be determined by comparing the EKG signal to a reference signal, comparing the current EKG signal to the patient's historical EKG signals, or comparing the beats 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 can be determined by software programmed to identify bradycardia, or by a machine learning algorithm trained to recognize these events.

[0062] At step 710, an electrical charge is transferred for delivery at the electrodes to provide pacing to the patient's heart. The timing, current, heart rate, and other parameters of the charge can be input into the system by a clinician or can be determined by a controller and approved by the clinician. The charge is delivered at the electrodes within the heart. Because the electrodes are already in place and can deliver the charge directly to the heart, cardiac pacing using a circulatory support device that includes electrodes is more effective and less dangerous than treatment using transcutaneous pacing.

[0063] Figure 8 A flow chart illustrating an exemplary method 800 for providing defibrillation of a patient's heart is shown. Figure 8 The methods described in [ 15 ] are applicable to any mechanical circulatory support device, including IABP, ECMO devices, LVADs, expandable blood pumps, and intravascular blood pumps (e.g., Figure 2 Blood pump 201, Figure 3 Blood pump 301) and blood pump system (eg, Figure 1 Blood pump system 100, Figure 2 Left heart blood pump system 200, Figure 3 At step 802, the right heart blood pump system 300 including electrodes (e.g., Figure 1 Electrode 112, Figure 2 Electrode 212, Figure 3A circulatory support device including electrodes 312) is placed within the vasculature of a patient. At step 804, the circulatory support device is operated within the vasculature of the patient. For example, the circulatory support device can be operated to pump blood through the heart of the patient to provide continuous or pulsatile cardiac support. At step 806, an EKG signal is measured within the vasculature using the electrodes.

[0064] At step 808, a need for defibrillation of the heart of the patient is determined based on the EKG signal. For example, irregular heartbeats or heartbeats that are too fast can indicate a cardiac rhythm disorder, such as ventricular fibrillation or pulseless ventricular tachycardia, for which defibrillation is an appropriate treatment. Irregularity of the heartbeats can be determined by comparing the EKG signal to a reference signal, comparing a current EKG signal to a historical EKG signal of the patient, comparing a heart rate per minute extracted from the EKG signal to a threshold, or comparing the EKG signal to a reference rhythm of heartbeats associated with cardiac arrest. Alternatively, irregularity can be determined by software programmed to identify irregular or too-fast heartbeats, or by a machine learning algorithm trained to identify these events.

[0065] At step 810, an electrical charge is delivered at the electrodes to defibrillate the heart of the patient. The timing and voltage of the shock can be input into the system by a clinician or can be determined by the controller and approved by the clinician. An amount of current is then delivered to the heart by the electrodes to depolarize the myocardium and end the arrhythmia. Because the electrodes are already in place and can deliver the electrical charge directly to the heart, defibrillating the heart using the circulatory support device including the electrodes is more effective and less dangerous than treating with a manual external defibrillator.

[0066] The above description is merely illustrative of the principles of the technology. Thus, the devices and methods described herein can be practiced by other than the described implementations without departing from the spirit and scope of the technology.

[0067] Furthermore, 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 illustrated above (including any components thereof) can also be used in combination or integrated with other systems. Moreover, certain features can be omitted or not implemented.

[0068] The described systems and methods can be implemented locally on a heart pump system or a controller of a heart pump system, such as an AIC. The heart pump system can include a data processing device. The systems and methods described herein can be implemented remotely on a separate data processing device. The separate data processing device can be connected to the heart pump system directly or indirectly through a cloud application. The heart pump system can communicate in real-time (or near real-time) with the separate data processing device.

[0069] Processors suitable for the execution of a computer program include, by way of example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer. Generally, a processor will receive 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. Generally, a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto-optical disks, or optical disks. However, a computer need not have such devices.

[0070] Exemplary Embodiments

[0071] As has been described, the systems and methods disclosed herein can be implemented in various ways. In this regard, the above disclosure is intended to include, but not be limited to, systems, methods, and combinations and subcombinations thereof set forth in the following categories of exemplary embodiments.

[0072] Class A :

[0073] A1 : A mechanical circulatory support system comprising:

[0074] a mechanical circulatory support device; and

[0075] an electrode coupled to the mechanical circulatory support device.

[0076] A2: The mechanical circulatory support system of A1, wherein the mechanical circulatory support device is configured to be positioned at least partially in a heart of a patient.

[0077] 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 positioned in a right heart or a left heart.

[0078] A4: The mechanical circulatory support system of any of A1 -A3, wherein the electrical signal from the electrode is an electrocardiogram (EKG) signal.

[0079] A5: The mechanical circulatory support system of any of Al-Al4, wherein the electrode is configured to be positioned in the heart.

[0080] A6: The mechanical circulatory support system of any of Al-Al5, wherein the electrode is communicatively coupled to the controller, and wherein the controller is configured to receive the electrical signal from the electrode.

[0081] A7: The mechanical circulatory support system of A6, wherein the controller is configured to control a level of support provided by the mechanical circulatory support device.

[0082] A8: The mechanical circulatory support system of A7, wherein the controller is configured to:

[0083] process the electrical signal from the electrode; and

[0084] generate the electrical signal from the electrode for display.

[0085] A9: The mechanical circulatory support system of A8, wherein the controller is configured to extract a left ventricular end diastolic pressure (LVEDP) from the EKG signal.

[0086] A10: The mechanical circulatory support system of A9, wherein the controller is configured to display the EKG signal and the LVEDP on the display.

[0087] A11 : The mechanical circulatory support system of any of A6-A10, wherein the controller is configured to:

[0088] store the historical LVEDP in a memory;

[0089] compare the new LVEDP to the historical LVEDP accessed in the memory; and

[0090] determine a difference between the new LVEDP and the historical LVEDP.

[0091] A12: The mechanical circulatory support system of Al l, wherein the controller is further configured to determine a support recommendation based on the difference between the new LVEDP and the historical LVEDP.

[0092] A13: The mechanical circulatory support system of A12, wherein the controller is configured to determine the support recommendation to increase the support of the mechanical circulatory support device when the difference between the new LVEDP and the historical LVEDP is positive.

[0093] A14: The mechanical circulatory support system of A12, wherein the controller is configured to determine the support recommendation to decrease the support of the mechanical circulatory support device when the difference between the new LVEDP and the historical LVEDP is negative.

[0094] A15: The mechanical circulatory support system of any of A12-A14, wherein the controller is further configured to generate a support recommendation for display.

[0095] A16: The mechanical circulatory support system of any of A12-A15, wherein the controller is further configured to automatically implement the support recommendation.

[0096] A17: The mechanical circulatory support system of any of A1-A16, further comprising a reference electrode coupled to the mechanical circulatory support device.

[0097] Class B :

[0098] B1: An intravascular blood pump system, comprising:

[0099] a catheter having a proximal end and a distal end;

[0100] a pump housing disposed distal of the distal end of the catheter;

[0101] a rotor positioned at least partially in the pump housing; and

[0102] an electrode coupled to a distal region of the blood pump.

[0103] B2: The intravascular blood pump of B1, further comprising:

[0104] a flexible protrusion disposed distal of the pump housing.

[0105] B3: The intravascular blood pump of B1 or B2, wherein the electrode is positioned on the flexible protrusion.

[0106] B4: The intravascular blood pump of any of B1-B3, wherein the electrode is configured to function as a sensor.

[0107] B5: The intravascular blood pump of any of B1-B4, further comprising:

[0108] a sleeve coupled to the pump housing.

[0109] B6: The intravascular blood pump of B5, wherein the flexible protrusion is positioned on a distal end of the sleeve.

[0110] B7: The intravascular blood pump of any of B1-B6, further comprising:

[0111] a drive cable extending from the rotor through the catheter to the proximal end of the catheter, wherein the drive cable is configured to drive the rotor within the pump housing.

[0112] B8: The intravascular blood pump of any of B1-B7, further comprising:

[0113] an electrical wire extending from the electrode through the catheter to a proximal end of the catheter.

[0114] B9: The intravascular blood pump of B8, wherein the electrical wire is embedded in a sidewall of the pump housing.

[0115] B10: The intravascular blood pump of B8 or B10, wherein the electrical wire is configured to transmit a signal from the electrode to a proximal end of the catheter.

[0116] B11 : The intravascular blood pump of any of B7-B10, wherein the electrical wire is configured to transmit an electrical charge from the proximal end of the catheter for delivery at the electrode.

[0117] B12: The intravascular blood pump of any of B1-B11, wherein the electrode is configured to be positioned within a heart.

[0118] B13: The intravascular blood pump of any of B1-B12, further comprising:

[0119] a plurality of inlet holes formed in the pump housing; and

[0120] a plurality of outlet holes formed in the pump housing.

[0121] B14: The intravascular blood pump of B13, further comprising a reference electrode coupled to the catheter.

[0122] B15: The intravascular blood pump of B13 or B14, wherein the plurality of inlet holes are configured to be positioned in a left ventricle of a heart, and wherein the outlet hole is proximal to the inlet holes and is configured to be positioned in an aorta of the heart.

[0123] B16: The intravascular blood pump of B15, wherein the electrode is configured to be positioned in the left ventricle.

[0124] B17: The intravascular blood pump of B16, wherein the electrode is configured to defibrillate the heart by transmitting an electrical charge within the left ventricle.

[0125] B18: The intravascular blood pump of B16, wherein the electrode is configured to provide pacing to the heart by transmitting an electrical charge within the left ventricle.

[0126] B19: The intravascular blood pump of B13, wherein the plurality of inlet holes are configured to be positioned in an inferior vena cava of a heart, and wherein the plurality of outlet holes are distal to the inlet holes and are configured to be positioned in a pulmonary artery of the heart.

[0127] B20: The intravascular blood pump of B19, wherein the electrode is configured to be positioned in a right ventricle.

[0128] B21 : The intravascular blood pump of B20, wherein the electrode is configured to defibrillate the heart by transmitting an electrical charge within the right ventricle.

[0129] B22: The intravascular blood pump of B20, wherein the electrode is configured to pace the heart by transmitting an electrical charge within the right ventricle.

[0130] B23: The intravascular blood pump of any of B1-B22, further comprising a pressure sensor coupled to the catheter.

[0131] Class C :

[0132] C1 : A mechanical circulatory support system, comprising:

[0133] a mechanical circulatory support device;

[0134] a controller communicatively coupled to the mechanical circulatory support device and configured to control a level of support provided by the mechanical circulatory support device; and

[0135] an electrode coupled to the mechanical circulatory support device.

[0136] C2: The mechanical circulatory support system of C1, wherein the electrode is communicatively coupled to the controller, and wherein the controller is configured to receive an electrical signal from the electrode.

[0137] C3: The mechanical circulatory support system of C2, wherein the controller is configured to:

[0138] process the electrical signal from the electrode; and

[0139] generate the electrical signal from the electrode for display.

[0140] C4: The mechanical circulatory support system of C2 or C3, wherein the electrical signal from the electrode is an electrocardiogram (EKG) signal.

[0141] C5: The mechanical circulatory support system of any of C1-C4, wherein the electrode is configured to be positioned in a heart.

[0142] C6: The mechanical circulatory support system of C4, wherein the controller is configured to extract a left ventricular end diastolic pressure (LVEDP) from the EKG signal.

[0143] C7: The mechanical circulatory support system of C6, wherein the controller is configured to display the EKG signal and the LVEDP on a display.

[0144] C8: The mechanical circulatory support system of C6 or C7, wherein the controller is configured to:

[0145] storing the historical LVEDP in a memory;

[0146] comparing the new LVEDP to the accessed historical LVEDP in the memory; and

[0147] determining a difference between the new LVEDP and the historical LVEDP.

[0148] C9: The mechanical circulatory support system of C8, wherein the controller is further configured to determine a support recommendation based on the difference between the new LVEDP and the historical LVEDP.

[0149] C10: The mechanical circulatory support system of C9, wherein the controller is configured to determine a support recommendation to increase support when the difference between the new LVEDP and the historical LVEDP is positive.

[0150] C11: The mechanical circulatory support system of C9, wherein the controller is configured to determine a support recommendation to decrease support when the difference between the new LVEDP and the historical LVEDP is negative.

[0151] C12: The mechanical circulatory support system of any of C9-C11, wherein the controller is further configured to generate the support recommendation for display.

[0152] C13: The mechanical circulatory support system of any of C9-C12, wherein the controller is further configured to automatically implement the support recommendation.

[0153] C14: The mechanical circulatory support system of any of C9-C13, further comprising a reference electrode.

[0154] Class D :

[0155] D1: An intravascular blood pump system, comprising:

[0156] an intravascular blood pump comprising:

[0157] a catheter having a proximal end and a distal end;

[0158] a pump housing disposed distal of the distal end of the catheter; and

[0159] a rotor positioned at least partially in the pump housing, the rotor configured to be rotatably driven;

[0160] a controller communicatively coupled to the intravascular blood pump and configured to control a level of support provided by the intravascular blood pump by controlling a speed of the rotor; and

[0161] an electrode coupled to the intravascular blood pump.

[0162] D2: The intravascular blood pump system of Dl, further comprising:

[0163] a flexible protrusion disposed distal of the pump housing.

[0164] D3: The intravascular blood pump system of Dl or D2, wherein the electrode is positioned on the flexible protrusion.

[0165] D4: The intravascular blood pump system of any of Dl-D3, wherein the electrode is configured to function as a sensor.

[0166] D5: The intravascular blood pump system of any of Dl-D4, further comprising:

[0167] a cannula coupled to the pump housing.

[0168] D6: The intravascular blood pump system of D5, wherein the flexible protrusion is positioned on a distal end of the cannula.

[0169] D7: The intravascular blood pump system of any of Dl-D6, further comprising:

[0170] a drive cable extending from the rotor through the catheter to a proximal end of the catheter, wherein the drive cable is configured to drive the rotor within the pump housing.

[0171] D8: The intravascular blood pump system of any of Dl-D7, further comprising:

[0172] an electrical wire extending from the electrode through the catheter to a proximal end of the catheter.

[0173] D9: The intravascular blood pump system of D8, wherein the electrical wire is embedded in a sidewall of the pump housing.

[0174] D10: The intravascular blood pump system of D8 or D9, wherein the electrode is communicatively coupled to the controller by the electrical wire, and wherein the controller is configured to receive electrical signals from the electrode by the electrical wire.

[0175] Dl l: The intravascular blood pump system of any of D8-D10, wherein the controller is configured to:

[0176] process the electrical signals from the electrode; and

[0177] display the electrical signals from the electrode on a display.

[0178] D12: The intravascular blood pump system of any of D8-Dl l, wherein the electrical signals from the electrode are electrocardiogram (EKG) signals.

[0179] D13: The intravascular blood pump system of D12, wherein the controller is configured to extract a left ventricular end diastolic pressure (LVEDP) from the EKG signal.

[0180] 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 the display.

[0181] D15: The intravascular blood pump system of D13 or D14, wherein the controller is configured to:

[0182] store the historical LVEDP in a memory;

[0183] compare the new LVEDP to the accessed historical LVEDP in the memory; and

[0184] determine a difference between the new LVEDP and the historical LVEDP.

[0185] D16: The intravascular blood pump system of D15, wherein the controller is further configured to determine a support recommendation based on the difference between the new LVEDP and the historical LVEDP.

[0186] D17: The intravascular blood pump system of D16, wherein the controller is configured to determine a support recommendation to increase support when the difference between the new LVEDP and the historical LVEDP is positive.

[0187] D18: The intravascular blood pump system of D16, wherein the controller is configured to determine a support recommendation to decrease support when the difference between the new LVEDP and the historical LVEDP is negative.

[0188] D19: The intravascular blood pump system of any one of D16-D18, wherein the controller is further configured to display the support recommendation on the display.

[0189] D20: The intravascular blood pump system of any one of D16-D19, wherein the controller is further configured to automatically implement the support recommendation.

[0190] D21: The intravascular blood pump system of any one of D13-D20, wherein the controller is further configured to determine a therapy recommendation based on the EKG signal.

[0191] D22: The intravascular blood pump system of any one of D13-D20, wherein the controller is further configured to display an indication of the therapy recommendation on the display.

[0192] D23: The intravascular blood pump system of D22, further comprising a reference electrode coupled to the catheter.

[0193] D24: The intravascular blood pump system of D23, wherein the controller is configured to deliver, in response to user input, the electrical charge through the electrical wire to be delivered at the electrode to provide pacing of the heart or defibrillation of the heart.

[0194] D25: The intravascular blood pump system of D23, wherein the controller is configured to automatically deliver, based on a therapy recommendation, the electrical charge through the electrical wire to be delivered at the electrode to provide pacing of the heart or defibrillation of the heart.

[0195] D26: The intravascular blood pump system of any of D1-D25, wherein the electrode is configured to be placed in the heart.

[0196] D27: The intravascular blood pump system of any of D1-D26, further comprising:

[0197] a plurality of inlet holes formed in the cannula; and

[0198] a plurality of outlet holes formed in the pump housing.

[0199] D28: The intravascular blood pump system of D27, wherein the plurality of inlet holes are configured to be positioned in a left ventricle of the heart, and wherein the outlet hole is proximal to the inlet holes and configured to be positioned in an aorta of the heart.

[0200] D29: The intravascular blood pump system of D28, wherein the electrode is configured to be positioned in the left ventricle.

[0201] D30: The intravascular blood pump system of D29, wherein the electrode is configured to defibrillate the heart by delivering the electrical charge within the left ventricle.

[0202] D31 : The intravascular blood pump system of D29, wherein the electrode is configured to provide pacing to the heart by delivering the electrical charge within the left ventricle.

[0203] D32: The intravascular blood pump system of D27, wherein the plurality of inlet holes are configured to be positioned in an inferior vena cava of the heart, and wherein the plurality of outlet holes are distal to the inlet holes and configured to be positioned in a pulmonary artery of the heart.

[0204] D33: The intravascular blood pump system of D32, wherein the electrode is configured to be positioned in a right ventricle.

[0205] D34: The intravascular blood pump system of D33, wherein the electrode is configured to deliver the electrical charge within the right ventricle.

[0206] D35: The intravascular blood pump system of D33, wherein the electrode is configured to provide pacing to the heart by delivering the electrical charge within the right ventricle.

[0207] D36: The intravascular blood pump system of any of D1-D35, further comprising a pressure sensor coupled to the catheter.

[0208] Class E :

[0209] E1: A method of providing circulatory support using an intravascular blood pump, the method comprising:

[0210] positioning the intravascular blood pump within a vasculature of a patient;

[0211] operating the intravascular blood pump by rotating a rotor of the intravascular blood pump within a pump housing at a pump speed;

[0212] measuring an electrocardiogram (EKG) signal within the vasculature using an electrode coupled to the intravascular blood pump; and

[0213] adjusting the pump speed of the rotor based on the EKG signal.

[0214] E2: The method of El, wherein positioning the intravascular blood pump within the vasculature of the patient further comprises positioning the intravascular blood pump into a heart of the patient such that the electrode is positioned in the heart.

[0215] E3: The method of E2, further comprising:

[0216] generating the EKG signal for display; and

[0217] receiving a user input to adjust the pump speed.

[0218] E4: The method of E3, further comprising:

[0219] generating a recommendation to adjust the pump speed based on the EKG signal for display.

[0220] E5: The method of El-E4, further comprising:

[0221] calculating a left ventricular end diastolic pressure (LVEDP) from the EKG signal.

[0222] E6: The method of E5, further comprising:

[0223] determining a recommendation to adjust the pump speed based on the LVEDP calculated from the EKG signal.

[0224] E7: The method of E6, wherein determining the recommendation to adjust the pump speed further comprises:

[0225] accessing a historical LVEDP of the patient;

[0226] comparing a current LVEDP of the patient to the historical LVEDP; and

[0227] determining a difference between the current LVEDP and the historical LVEDP.

[0228] E8: The method of E7, further comprising:

[0229] determining a recommendation to increase the pump speed when the difference between the current LVEDP and the historical LVEDP is positive.

[0230] E9: The method of E7, further comprising:

[0231] determining a recommendation to decrease the pump speed when the difference between the current LVEDP and the historical LVEDP is negative.

[0232] E10: The method of El- E9, further comprising:

[0233] determining a recommendation to provide pacing of the heart based on the EKG signal;

[0234] generating the recommendation to provide pacing of the heart for display to a user; and

[0235] transmitting a charge to be delivered at the electrode to pace the heart of the patient in response to received input from the user.

[0236] E11 : The method of E10, wherein transmitting a charge to be delivered at the electrode to pace the heart further comprises delivering a voltage between a reference electrode and the electrode.

[0237] E12: The method of El- E9, further comprising:

[0238] determining a recommendation to provide defibrillation of the heart based on the EKG signal;

[0239] generating the recommendation to provide defibrillation of the heart for display to a user; and

[0240] transmitting a charge to be delivered at the electrode to defibrillate the heart of the patient in response to received input from the user.

[0241] E12: The method of El 1, wherein transmitting a charge to be delivered at the electrode to defibrillate the heart further comprises delivering a voltage between a reference electrode and the electrode.

[0242] E13: The method of El- E12, wherein positioning the intravascular blood pump within the vasculature of the patient further comprises positioning the intravascular blood pump within the vasculature such that an electrode coupled to the intravascular blood pump is located within the left ventricle.

[0243] E14: The method of El-El2, wherein positioning the intravascular blood pump within the vasculature of the patient further comprises positioning the intravascular blood pump within the vasculature such that the electrode coupled to the intravascular blood pump is located within the right ventricle.

[0244] Class F :

[0245] Fl: A method for measuring an EKG signal while providing circulatory support, the method comprising:

[0246] positioning a circulatory support device within a vasculature of a patient, the circulatory support device comprising an electrode coupled to the circulatory support device;

[0247] operating the circulatory support device within the vasculature of the patient; and

[0248] measuring an electrocardiogram (EKG) signal within the vasculature using the electrode.

[0249] F2: The method of Fl, wherein the circulatory support device is an intravascular blood pump.

[0250] F3: The method of Fl or F2, wherein positioning the circulatory support device within the vasculature of the patient further comprises positioning the circulatory support device within a heart of the patient such that the electrode is positioned in the heart.

[0251] F4: The method of any of Fl-Fl, further comprising:

[0252] transmitting the EKG signal to a controller coupled to the circulatory support device.

[0253] F5: The method of F4, further comprising:

[0254] generating the EKG signal for display.

[0255] F6: The method of F4 or F5, further comprising:

[0256] storing the EKG signal as a historical EKG signal in a memory of the controller.

[0257] F7: The method of any of F4-F6, further comprising:

[0258] calculating a left ventricular end diastolic pressure (LVEDP) from the EKG signal; and

[0259] storing the LVEDP as a historical LVEDP signal in the memory of the controller.

[0260] F8: The method of F6 or F7, further comprising:

[0261] determining a therapy recommendation based on a comparison of the historical LVEDP and the current LVEDP.

[0262] F9: The method of F8, further comprising:

[0263] generating the therapy recommendation for display to a user.

[0264] F10: The method of F8, further comprising:

[0265] automatically executing the therapy recommendation.

[0266] F11 : The method of any of F8-F10, further comprising:

[0267] determining a recommendation to increase support provided by the circulatory support device when the current LVEDP is higher than the historical LVEDP; and

[0268] determining a recommendation to decrease support provided by the circulatory support device when the current LVEDP is lower than the historical LVEDP.

[0269] Class G

[0270] Gl : A method for providing pacing of a patient's heart while providing circulatory support, the method comprising:

[0271] placing a circulatory support device within a vasculature of a patient, the circulatory support device including an electrode coupled to the circulatory support device;

[0272] operating the circulatory support device within the vasculature;

[0273] measuring an electrocardiogram (EKG) signal within the vasculature using the electrode;

[0274] determining a need for pacing of the patient's heart based on the EKG signal; and

[0275] transmitting an electrical charge to be delivered at the electrode to pace the patient's heart.

[0276] G2: The method of Gl, wherein the circulatory support device is an intravascular blood pump.

[0277] G3: The method of Gl or G2, wherein placing the circulatory support device within the vasculature of the patient further comprises placing the circulatory support device within a heart of the patient such that the electrode is positioned in the heart.

[0278] G4: The method of any of Gl-G3, further comprising:

[0279] transmitting the EKG signal to a controller coupled to the circulatory support device. ​

[0280] G5: The method of G4, further comprising:

[0281] generating the EKG signal for display.

[0282] G6: The method of G4 or G5, further comprising:

[0283] storing the EKG signal as a historical EKG signal in a memory of the controller.

[0284] G7: The method of G6, wherein determining a need for pacing of the patient's heart further comprises comparing the historical EKG signal to the current EKG signal.

[0285] G8: The method of any of G1-G6, wherein determining a need for pacing of the patient's heart further comprises:

[0286] extracting an EKG signal characteristic from the current EKG signal; and

[0287] comparing the EKG signal characteristic to one or more thresholds.

[0288] G9: The method of G6, wherein determining a need for pacing of the patient's heart further comprises:

[0289] extracting an EKG signal characteristic from the current EKG signal and the historical EKG signal; and

[0290] comparing the current EKG signal characteristic to the historical EKG characteristic.

[0291] G10: The method of any of G1-G9, wherein transmitting a charge for delivery at the electrode to pace the patient's heart comprises:

[0292] transmitting one or more charges for delivery to the heart to increase a heart rate.

[0293] G11: The method of any of G1-G10, wherein placing a circulatory support device within the patient's vasculature further comprises:

[0294] placing a circulatory support device within the patient's vasculature such that an electrode coupled to the circulatory support device is positioned in one of a left ventricle or a right ventricle.

[0295] G12: The method of any of G1-G11, wherein transmitting a charge for delivery at the electrode to pace the patient's heart further comprises transmitting a voltage between the electrode and a reference electrode.

[0296] Class H :

[0297] H1 : A method for providing defibrillation of a patient's heart while providing circulatory support, the method comprising:

[0298] placing a circulatory support device within a vasculature of a patient, the circulatory support device comprising an electrode coupled to the circulatory support device;

[0299] operating the circulatory support device within the vasculature; and

[0300] measuring an electrocardiogram (EKG) signal within the vasculature using the electrode;

[0301] determining a need for defibrillation of the patient's heart based on the EKG signal; and

[0302] transmitting an electrical charge to be delivered at the electrode to defibrillate the patient's heart.

[0303] H2: The method of H1, wherein the circulatory support device is an intravascular blood pump.

[0304] H3: The method of H1 or H2, wherein placing the circulatory support device within the vasculature of the patient further comprises placing the circulatory support device within a heart of the patient such that the electrode is positioned in the heart.

[0305] H4: The method of any of H1 -H3, further comprising:

[0306] transmitting the EKG signal to a controller coupled to the circulatory support device.

[0307] H5: The method of H4, further comprising:

[0308] generating the EKG signal for display.

[0309] H6: The method of H4 or H5, further comprising:

[0310] storing the EKG signal as a historical EKG signal in a memory of the controller.

[0311] H7: The method of H6, wherein determining a need for pacing of the patient's heart further comprises comparing the historical EKG signal to a current EKG signal.

[0312] H8: The method of any of H1 -H6, wherein determining a need for defibrillation of the patient's heart further comprises:

[0313] extracting an EKG signal characteristic from the current EKG signal; and

[0314] comparing the EKG signal characteristic to one or more thresholds.

[0315] H9: The method of H6, wherein determining a need for defibrillation of the patient's heart further comprises:

[0316] extracting EKG signal characteristics from the current EKG signal and the historical EKG signal; and

[0317] comparing the current EKG signal characteristics to the historical EKG characteristics.

[0318] H10: The method of any of H1-H9, wherein delivering the electrical charge at the electrode to defibrillate the patient's heart comprises:

[0319] delivering one or more electrical charges for delivery to the heart to restart the function of the heart.

[0320] H11 : The method of any of H1-H10, wherein placing the circulatory support device within the patient's vasculature further comprises:

[0321] placing the circulatory support device within the patient's vasculature such that the electrode coupled to the circulatory support device is positioned in one of a left ventricle or a right ventricle.

[0322] H12: The method of any of H1-H11, wherein delivering the electrical charge at the electrode to defibrillate the patient's heart further comprises delivering a voltage between the electrode and a reference electrode.

Claims

1. An intravascular blood pump system, comprising: An intravascular blood pump comprising: a catheter having a proximal end and a distal end; a pump housing coupled to the distal end of the catheter; a rotor at least partially positioned within the pump housing, the rotor configured to be rotatably driven; a sleeve coupled to the pump housing; and a flexible protrusion coupled to the distal end of the cannula; and An electrode is mounted on the intravascular blood pump and positioned on the flexible protrusion or at the distal end of the cannula, wherein the electrode is configured to sense an electrocardiogram (EKG) signal of the patient's heart.

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

3. 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 rotatably drive the rotor.

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

5. The intravascular blood pump system according to claim 2, wherein the controller is further configured to: processing EKG signals from the electrodes; and The left ventricular end-diastolic pressure, or LVEDP, is determined based on the EKG signal. 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 intravascular blood pump system according to claim 2, wherein the controller is further configured to: processing a first EKG signal from the electrode; determining a first LVEDP based on the first EKG signal; storing the first LVEDP in a memory; processing a second EKG signal from the electrode; determining a second LVEDP based on the second EKG signal; comparing the second LVEDP with the first LVEDP accessed from the memory; as well as A difference between the second LVEDP and the first LVEDP is determined. 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 the 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 a support recommendation to increase the support provided by the intravascular blood pump when the difference between the second LVEDP and the first LVEDP is positive.

10. The intravascular blood pump system of claim 8, wherein the controller is further configured to determine a support recommendation to reduce the support provided by the intravascular blood pump when the difference between the second LVEDP and the first LVEDP is negative.

11. The intravascular blood pump system of claim 8, wherein the controller is further configured to display the support suggestion on a display. 12 . The intravascular blood pump system of claim 8 , wherein the controller is further configured to automatically implement the support recommendation by adjusting the speed at which the rotor is rotatably driven.

13. The intravascular blood pump system according to claim 2, wherein the controller is further configured to: processing EKG signals from the electrodes; and A recommendation to provide pacing or defibrillation of the patient's heart is determined based on the EKG signal.

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. 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 generating 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 generate an electrical charge within the patient's heart.

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