US-20260124454-A1 - BLOOD PUMP WITH CAPABILITY OF ELECTROCARDIOGRAM (EKG) MONITORING, DEFIBRILLATION AND PACING

US20260124454A1US 20260124454 A1US20260124454 A1US 20260124454A1US-20260124454-A1

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 a distal region of the blood pump. The electrode can be used to sense electrocardiogram (EKG) signals and transmit the signals to a controller of the blood pump. The operation of the blood pump can be adjusted based on the EKG signal and on cardiac parameters derived from the EKG signal. Further, the controller can determine a need for defibrillation or pacing of the patient's heart based on the signal and can administer treatment with electrical shocks to the heart via the electrode coupled to the blood pump. The use of an electrode with a blood pump already in place in the heart allows for more efficient and safer treatment of serious cardiac conditions.

Inventors

Qing Tan
Ahmad El Katerji

Assignees

ABIOMED, INC.

Dates

Publication Date: 20260507
Application Date: 20250915

Claims (20)

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 positioned at least partially in the pump housing, the rotor configured to be rotatably driven; a cannula coupled to the pump housing; and a flexible projection coupled to a distal end of the cannula; and an electrode coupled to the intravascular blood pump, and configured to sense an electrocardiogram (EKG) signal of a patient's heart, wherein the electrode is positioned on the flexible projection.
2 . The intravascular blood pump system of claim 1 , further comprising: a controller communicatively coupled to the intravascular blood pump and the electrode, and 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 . (canceled)
4 . The intravascular blood pump system of 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.
5 . 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.
6 . The intravascular blood pump system of claim 2 , wherein the controller is further configured to: process an EKG signal from the electrode; and determine a left ventricular end diastolic pressure (LVEDP) based on the EKG signal.
7 . The intravascular blood pump system of claim 6 , wherein the controller is further configured to display at least one of the EKG signal and the LVEDP on a display.
8 . The intravascular blood pump system of claim 2 , wherein the controller is further configured to: process a first EKG signal from the electrode; determine a first LVEDP based on the first EKG signal; store the first LVEDP in memory; process a second EKG signal from the electrode; determine a second LVEDP based on the second EKG signal; compare the second LVEDP to the first LVEDP accessed in the memory; and determine 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 a support recommendation for the intravascular blood pump based on the difference between the second LVEDP and the first LVEDP.
10 . The intravascular blood pump system of claim 9 , 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.
11 . The intravascular blood pump system of claim 9 , wherein the controller is further configured to determine a support recommendation to decrease the support provided by the intravascular blood pump when the difference between the second LVEDP and the first LVEDP is negative.
12 . The intravascular blood pump system of claim 9 , wherein the controller is further configured to display the support recommendation on a display.
13 . The intravascular blood pump system of claim 9 , wherein the controller is further configured to automatically implement the support recommendation by adjusting the speed at which the rotor is rotatably driven.
14 . (canceled)
15 . (canceled)
16 . (canceled)
17 . The intravascular blood pump system of claim 141 , wherein the electrode is further configured to provide pacing or defibrillation of the patient's heart by producing an electric charge within the patient's heart.
18 . (canceled)
19 . (canceled)
20 . (canceled)

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a continuation of U.S. application Ser. No. 18/665,080, filed May 15, 2024, now allowed, which is a continuation of U.S. application Ser. No. 17/981,039, filed Nov. 4, 2022, now U.S. Pat. No. 12,017,076, which is a continuation of U.S. application Ser. No. 16/910,690, filed Jun. 24, 2020, now U.S. Pat. No. 11,524,165, which claims priority to U.S. Provisional Application No. 62/868,403, filed Jun. 28, 2019, the entire disclosures of which are incorporated by reference herein. BACKGROUND Cardiovascular diseases are a leading cause of morbidity, mortality, and burden on healthcare around the world. A variety of treatment modalities have been developed for cardiovascular disease, ranging from pharmaceuticals to mechanical devices and finally transplantation. Temporary cardiac support devices, such as ventricular assist devices, provide hemodynamic support, and facilitate heart recovery. Some intracardiac heart pump assemblies can be introduced into the heart either surgically or percutaneously and used to deliver blood from one location in the heart or circulatory system to another location in the heart or circulatory system. For example, when deployed 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. Intracardiac pumps can be powered by a motor located outside of 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 fully unload components of the heart. Examples of such systems include the IMPELLA® family of devices (Abiomed, Inc., Danvers MA). Among the population of patients who require hemodynamic support by a mechanical circulatory support system, such as an intracardiac blood pump, it is common to experience heart arrhythmia, or irregular heartbeats. When the arrhythmia is severe, it may be necessary to correct the heart rhythm with a pacing or defibrillation device. In a critical care setting, a patient suffering from life-threatening cardiac arrhythmia or dysrhythmia is often defibrillated by a manual external defibrillator or automated external defibrillator to deliver a dose of electric current to the heart through the application of large pads or electrodes to the patient's skin to depolarize the heart and end the irregular heartbeat. Defibrillation is used only when specific kinds of arrhythmias are detected, and improper defibrillation can cause dangerous dysrhythmia and other injuries. Adjustments to the heart's pacing are similarly addressed in critical care settings by use of transcutaneous, or external, pacing. In transcutaneous pacing, a clinician typically uses pads or electrodes placed on the patient's chest to provide pulses of electrical current to stimulate contraction of the heart. Pacing is required when an abnormally slow heartrate is detected, called bradycardia. In situations in which pacing or defibrillation are required, the clinician must first recognize that treatment is required, diagnose the cardiac irregularity, and determine the proper treatment. When defibrillation is indicated, the clinician must then place the electrodes or pads on the patient, determine the voltage and timing for the electrical shock, and administer the electric shock to the patient. When pacing is indicated, the clinician places the electrodes or pads on the patient, and selects a heart rate and adjusts the current to the appropriate level. Delay in administering the pacing or defibrillation to a patient, when necessary, can be detrimental to a patient's condition and may result in lowered survival rate. Further, defibrillation and transcutaneous pacing may be uncomfortable for the patient. Unfortunately, because electrical shocks for defibrillation and pacing in a critical care or emergency setting are most often applied externally, high amounts of electrical charge are required, sometimes resulting in serious injury to the patient. Accordingly, there is a need for new technologies providing efficient and safe pacing and defibrillation to patients. SUMMARY The methods, systems, and devices described herein enable use of a circulatory assist device including an electrode with transmission, sensing, and electrical charge delivery capabilities to provide circulatory support, detect an electrocardiogram (EKG) signal, and detect and react to changes in heart function based on the EKG signal by changing an amount of support provided by the device and providing defibrillation and pacing of the heart when necessary. By integrating a pacing and defibrillation function into a circulatory assist device, a system becomes available for treating arrhythmia in real-time during circulatory assist, thereby reducing treatment delay and severity of the arrhythmia indication. An electrode (or other si