“Automated Cardiac Defibrillator Pacer With Integrated Cardiac Assist Device” in Patent Application Approval Process (USPTO 20230080043): Patent Application

2023 APR 05 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- A patent application by the inventors Broder, Avi (Caesarea, IL); Fishel, Robert (Caesarea, IL); Strommer, Gera (Caesarea, IL), filed on January 20, 2021, was made available online on March 16, 2023, according to news reporting originating from Washington, D.C., by NewsRx correspondents.

This patent application has not been assigned to a company or institution.

The following quote was obtained by the news editors from the background information supplied by the inventors: “A ventricular assist device or cardiac assist device provides cardiac assist functionality. Non-limiting examples of such cardiac assist devices include cardiac assist pumps, pacemakers, heart monitors, cardiac central pressure monitor, cardiac oximetry sensor and so forth. For example, a cardiac assist pump is an electromechanical device that assists in cardiac circulation to partially or to completely replace the pumping function of a failing heart. Current technology allows for insertion of small axially driven cardiac assist pumps into the heart. Some cardiac assist devices are built in a form of a catheter pump inserted percutaneously, typically via the femoral artery, into the ascending aorta, across the valve and into the left ventricle. Once in position inside the heart, the cardiac assist device draws blood out of the left ventricle and pumps it into the ascending aorta thereby adding pressure to this blood flow. Cardiac assist devices can be used to support both the right ventricle and the left ventricle. Instances of use of these types of devices include high risk angioplasty, acute coronary syndromes such as acute myocardial infarction and weaning of the heart from the heart lung machine after open heart surgery. Non-limiting examples of such cardiac assist devices in a form of a pump catheter are the Abbott HeartMate® PHP, the AbioMed Impella® and the Terumo iVAC2L™.

“Cardiac arrhythmias such as ventricular tachycardia (VT) and ventricular fibrillation (VF) are common causes of death, especially in patients with heart failure or in the period immediately surrounding acute coronary occlusions or coronary interventions.

“Many patients who undergo cardiac assist device implantation suffer from malignant ventricular arrhythmias such as VT or VF and require external electrical shocks from a defibrillator to restore a normal heart rhythm. These shocks are typically delivered using a standard automated external defibrillator (AED) in which a high energy, high voltage shock is initiated by the AED after personnel operating the defibrillator position the AED patches on the patient’s body. Patients in this state may require cardiopulmonary resuscitation (CPR) but the need for resuscitation is often not identified immediately and the delivery of an external defibrillating shock is thus delayed. This delay in recognition and delivery of defibrillation therapy for treating VT/VF in these patients causes both increased morbidity and mortality.

“A wearable automatic defibrillator such as the LifeVest® device manufactured by Zoll Medical® can be offered to such patients but currently is not used as patients with cardiac assist devices are not typically ambulatory. In the future however, longer term use of cardiac assist devices will require these patients, all of whom are at increased risk of arrhythmic death, to be protected from arrhythmic sudden death with immediately available defibrillation. Many such patients do not already have an internal cardiac defibrillators (ICD) prior to their cardiac assist device insertion. Furthermore, current Centers for Medicare & Medicaid Services (CMS) guidelines do not allow implantation of a permanent ICD in these patients until after a mandated waiting period, which can be as long as 3 months after a coronary intervention. Thus, there is a real clinical need for patients with cardiac support devices to have back-up rescue automatic defibrillation.

“Further, patients who need a cardiac assist device typically suffer from or are at risk of conduction system disease including complete heart block. For example, an acute anterior wall myocardial infarction can result in necrosis of the conduction system and cause cardiac asystole. In addition, many patients with active heart failure often will already have a left bundle branch block (LBBB) and resultant ventricular desynchrony. In addition, insertion of a cardiac assist device in a patient with a pre-existing right bundle branch block (RBBB) can result in trauma to the remaining left bundle branch and cardiac asystole. Finally, insertion of a right sided cardiac assist device in a patient with a LBBB can in turn traumatize the remaining right bundle branch and also result in cardiac asystole.”

In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors’ summary information for this patent application: “Exemplary embodiments disclosed herein relate to a percutaneous transvenous defibrillator and/or pacing device with an integrated cardiac assist device and method of use. More specifically, different aspects disclosed herein provide for one or more external devices attached to an insertable assembly having internal components, such as electrodes and sensors, that may provide sensing, pacing and/or defibrillation as well as cardiac assist functionality. The internal components for providing sensing, pacing and/or defibrillation are advantageously compact components for integration with internal cardiac assist functionality.

“Embodiments disclosed herein may be configured to provide variations of the internal components, external devices and cardiac assist functionality and include: a percutaneous transvenous defibrillator with an integrated cardiac assist device or “defibrillating cardiac assist device” (DCAD), a percutaneous transvenous pacer with an integrated cardiac assist device or “pacing cardiac assist device” (PCAD), or a combined “defibrillating and pacing cardiac assist device” (DPCAD). In some embodiments, an insertable percutaneous transvenous defibrillator/pacer (IDP) may be used with an implanted cardiac assist device. In the disclosed embodiments the cardiac assist device/component may be any of a cardiac assist pump, a pacemaker, a heart monitor, a cardiac central pressure monitor, a cardiac oximetry sensor and so forth.

“In some embodiments, the DCAD, DPCAD or IDP includes an external AED and internal defibrillator assembly having high voltage anode and cathode coils and for performing sensing of ventricular arrhythmias and for automated delivery of defibrillation shocks provided by the external AED during periods of detected VT/VF.

“In some embodiments, a PCAD, DPCAD or IDP includes an external pacing controller and internal pacing assembly having unipole and bipole electrode configurations. In some embodiments, a PCAD, DPCAD or IDP includes unipolar electrodes that may be positioned at the distal end of the cardiac assist device, at the aortic arch (or IVC/RA/RV in the case of a right sided cardiac assist device), and in the descending aorta. In some embodiments, a PCAD, DPCAD or IDP includes a distal bipolar pacing electrode pair that may be positioned at the very distal portion of the cardiac assist device. In some embodiments, a PCAD, DPCAD or IDP includes a dedicated screw in pacing lead originating at the distal end of the cardiac assist device and screwed into an appropriate location in the left ventricle (LV) or right ventricle (RV).

“In some embodiments, an IDP utilizes the catheter and assist port of an implanted cardiac assist device for implanting of the defibrillator assembly and/or pacer assembly into a patient.

“Integration of automated defibrillator and/or pacer functionality with cardiac assist functionality may provide several advantages and alternate functionality including:

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“Single implantation procedure for all devices;

“Single device and single exit port from patient’s body reduces discomfort such as when wearing a wearable defibrillator;

“Fast automated detection of VT/VF and immediate activation of defibrillation shocks;

“Rapid detection of ventricular tachycardia via intracardiac sensing;

“Discrimination of VT from atrial arrhythmias with aberration via sensing of atrial activity utilizing an atrial sensing dipole place on the shaft of the device;

“Lower defibrillating thresholds are possible using the internal shocking coils than possible via external AEDs thus resulting in lower concurrent pain and patient trauma from a given shock;

“Ability to sense whether a given arrhythmia results in hemodynamic compromise using pressure sensors integrated the defibrillating cardiac assist device;

“Ability to deliver anti-bradycardia pacing of ventricular tachycardia via the distal electrode of the device as an anode and either a common ground or another cathodal electrode on a more proximal section of the device;

“Ability to deliver anti-tachycardia pacing of ventricular tachycardia via the distal electrode of the device as an anode and either a common ground or another cathodal electrode on a more proximal section of the device;

“Anti-tachycardia pacing delivery via any unipolar or bipolar pacing pair to help terminate monomorphic VT prior to degeneration into ventricular fibrillation;

“Dynamically anticipative resynchronization pacing of either the LV or RV (in the setting of a right bundle branch block) using sensing from either surface electrodes or any of the various unipolar and/or bipolar electrodes integrated into the device;

“Integrated LV/RV pacing and high voltage shocking therapy using the same high voltage coil electrodes in the heart as a source of power for both pacing and shock delivery;

“Selectable shocking and pacing bipoles including pacing and shocks between the distal coil or electrode pair of the cardiac assist device and the coils in the more proximal portions of the device which, in an LV placement, would be at the aortic arch and descending aorta;

“P-wave and QRS complex sensing via various electrode unipolar and bipolar pairs to find a combination with optimized P and QRS sensing for effective anticipative resynchronization pacing;

“An external automated pacing controller capable of sensing malignant ventricular and atrial arrhythmias and delivering automated high voltage therapy, anti-tachycardia pacing, backup pacing and resynchronization pacing as needed by the individual patient;

“An external pacing controller with automated electrode pair selection for ideal pacing efficiency or hemodynamic benefit;

“An external pacing controller with automated electrode pair selection for ideal sensing of P wave for atrial activity and QRS complexes for ventricular activity including ventricular capture during pacing;

“An implantable device with automated electrode pair selection for ideal pacing efficiency or hemodynamic benefit;

“An implantable device with automated electrode pair selection for ideal sensing of P wave for atrial activity and QRS complexes for ventricular activity including ventricular capture during pacing.

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“In various embodiments, there is provided a device, comprising a shared catheter, a defibrillator assembly, an AED and a cardiac assist assembly, wherein the defibrillator assembly includes at least two defibrillation coils in communication with the AED and wherein the defibrillator assembly and the cardiac assist assembly use the shared catheter for percutaneous and intravenous implantation into a patient.

“In some embodiments, the device further comprises an external pump controller, wherein the cardiac assist assembly comprises an internal flow pump adapted for pumping of blood from the patient’s heart, and wherein the internal flow pump is in communication with the external pump controller.

“In some embodiments, the defibrillator assembly further comprises at least one cardiac rhythm sensor in communication with the AED In some embodiments, the device further comprises at least one pressure sensor in communication with the AED. In some embodiments, the AED is configured to detect sustained ventricular arrhythmia in the heart of the patient and to deliver a high voltage shock via the at least two defibrillation coils when the sustained ventricular arrhythmia is detected. In some embodiments, the arrhythmia detection is based on a signal sensed from the at least two defibrillation coils, from the at least one cardiac rhythm sensor or the at least one pressure sensor. In some embodiments, the at least one cardiac rhythm sensor comprises a first cardiac rhythm sensor and a second cardiac rhythm sensor.

“In some embodiments, the cardiac assist assembly is selected from the group consisting of a heart monitor, cardiac central pressure monitor, and a cardiac oximetry sensor.

“In various embodiments, there is provided a device, comprising a shared catheter, a pacing assembly, a pacing controller, and a cardiac assist assembly, wherein the pacing assembly includes at least two electrodes in communication with the pacing controller, and wherein the pacer assembly and the cardiac assist assembly use the shared catheter for percutaneous and intravenous implantation into a patient. In some embodiments, one of the at least two electrodes is a pacing lead. In some embodiments, the pacing lead is a screw-in pacing lead. In some embodiments, the device is configured to use the at least two electrodes for both pacing and sensing.

“In some embodiments, the device further comprises an external pump controller, wherein the cardiac assist assembly comprises an internal flow pump adapted for pumping of blood from the patient’s heart, wherein the internal flow pump is in communication with the external pump controller.

“In some embodiments, the pacing controller is configured for selecting an electrode pair for pacing and an electrode pair for sensing.

“In some embodiments, the device further comprises an external electrode for adhering to the skin of the patient. In some embodiments, any combination of the at least two electrodes and the external electrode may be used to form a common ground.

“In some embodiments, the device is configured to provide dynamically anticipative resynchronization pacing.

“In some embodiments, the device further comprises an AED, wherein at least two of the electrodes are high voltage (HV) electrodes, wherein the AED is in communication with the HV electrodes and configured to use the HV electrodes to provide defibrillation. In some embodiments, the AED is configured to detect a sustained ventricular arrhythmia in the heart of the patient and to deliver a high voltage shock via the HV electrodes when the sustained ventricular arrhythmia is detected. In some embodiments, the AED is integrated into the pacing controller or vice versa.”

There is additional summary information. Please visit full patent to read further.”

The claims supplied by the inventors are:

“1-6. (canceled)

“7. A device, comprising: a shared catheter; an automated external defibrillator (AED); a defibrillator assembly comprising at least one cardiac rhythm sensor in communication with the AED, wherein the at least one cardiac rhythm sensor comprises a first cardiac rhythm sensor and a second cardiac rhythm sensor; and a cardiac assist assembly, wherein the defibrillator assembly includes at least two defibrillation coils in communication with the AED and wherein the defibrillator assembly and the cardiac assist assembly use the shared catheter for percutaneous and intravenous implantation into a patient.

“8-13. (canceled)

“14. A device, comprising: a shared catheter; a pacing assembly; a pacing controller; and a cardiac assist assembly, wherein the pacing assembly includes at least two electrodes in communication with the pacing controller, and wherein the pacer assembly and the cardiac assist assembly use the shared catheter for percutaneous and intravenous implantation into a patient, wherein one of the at least two electrodes is a pacing lead, wherein the device is configured to use the at least two electrodes for both pacing and sensing, and wherein the pacing controller is configured for selecting an electrode pair for pacing and an electrode pair for sensing.

“15. (canceled)

“16. A device, comprising: a shared catheter; a pacing assembly; a pacing controller; a cardiac assist assembly, wherein the pacing assembly includes at least two electrodes in communication with the pacing controller, wherein the pacer assembly and the cardiac assist assembly use the shared catheter for percutaneous and intravenous implantation into a patient, and wherein one of the at least two electrodes is a pacing lead; and an external electrode for adhering to the skin of the patient, wherein the device is configured to use the at least two electrodes for both pacing and sensing, and wherein any combination of the at least two electrodes and the external electrode may be used to form a common ground.

“17. A device, comprising: a shared catheter; a pacing assembly; a pacing controller; a cardiac assist assembly, wherein the pacing assembly includes at least two electrodes in communication with the pacing controller, wherein the pacer assembly and the cardiac assist assembly use the shared catheter for percutaneous and intravenous implantation into a patient, wherein one of the at least two electrodes is a pacing lead, wherein the device is configured to use the at least two electrodes for both pacing and sensing, and wherein the device is configured to provide dynamically anticipative resynchronization pacing.

“18. A device, comprising: a shared catheter; a pacing assembly; a pacing controller; a cardiac assist assembly, wherein the pacing assembly includes at least two electrodes in communication with the pacing controller, wherein one of the at least two electrodes is a pacing lead, wherein the pacer assembly and the cardiac assist assembly use the shared catheter for percutaneous and intravenous implantation into a patient, and wherein the device is configured to use the at least two electrodes for both pacing and sensing; and an automated external defibrillator (AED), wherein at least two of the electrodes are high voltage (HV) electrodes, wherein the AED is in communication with the HV electrodes and configured to use the HV electrodes to provide defibrillation.

“19. The device of claim 18, wherein the AED is integrated into the pacing controller or vice versa.

“20. The device of claim 19, wherein the pacing assembly further comprises at least one cardiac rhythm sensor in communication with the pacing controller.

“21. The device of claim 20, further comprising at least one pressure sensor in communication with the AED.

“22. The device of claim 21, wherein the AED is configured to detect a sustained ventricular arrhythmia in the heart of the patient and to deliver a high voltage shock via the HV electrodes when the sustained ventricular arrhythmia is detected.

“23. (canceled)

“24. The device of claim 20, wherein the at least one cardiac rhythm sensor comprises a first cardiac rhythm sensor and a second cardiac rhythm sensor.

“25. A device for use with a cardiac assist device for implantation into a patient, comprising: a pacing and defibrillation assembly; an automated external defibrillator (AED); and a pacing controller, wherein the AED and pacing controller are in data communication with the pacing and defibrillation assembly for providing sensing, pacing and defibrillation, wherein the cardiac device comprises a catheter and an assist port and wherein the pacing and defibrillation assembly is percutaneously and intravenously implanted into the patient using the catheter and the assist port of the cardiac device.”

URL and more information on this patent application, see: Broder, Avi; Fishel, Robert; Strommer, Gera. Automated Cardiac Defibrillator Pacer With Integrated Cardiac Assist Device. U.S. Patent Application Number 20230080043, filed January 20, 2021 and posted March 16, 2023. Patent URL (for desktop use only): https://ppubs.uspto.gov/pubwebapp/external.html?q=(20230080043)&db=US-PGPUB&type=ids

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