US-12623067-B2 - Electroporation delivery systems and methods of using electroporation delivery systems

US12623067B2US 12623067 B2US12623067 B2US 12623067B2US-12623067-B2

Abstract

The present disclosure relates generally to electroporation systems and utilizing algorithms for electroporation pulse delivery including a patient's EKG/EGM monitoring. In some embodiments, an electroporation delivery system may include an electrocardiogram operatively connected to a processing device and a memory. One or more sensors may be operatively connected to the electrocardiogram for measuring electrical activity QRS complex of a patient's heart. One or more electrodes for treatment may be disposed in, at, or near the patient's heart, the one or more electrodes operatively connected to a pulse delivery mechanism. The electroporation delivery system may be configured to determine whether an electroporation pulse is deliverable to a patient based on the electrocardiogram.

Inventors

Samuel J. Asirvatham
Suraj Kapa
Sarah M. Gruba
Douglas D. Pagoria
James P. Rohl
Chance M. Witt
Ammar M. Killu
Niyada Naksuk

Assignees

CARDIAC PACEMAKERS, INC.
MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH

Dates

Publication Date: 20260512
Application Date: 20220606

Claims (20)

1 . An electroporation delivery system, comprising: an electrocardiogram monitor operatively connected to a processing device and a memory; one or more sensors operatively connected to the electrocardiogram monitor for measuring an electrocardiogram of a heart of a patient; and one or more electrodes configured to deliver treatment in, at, or near the patient's heart, the one or more electrodes operatively connected to a pulse delivery mechanism, wherein, in order to account for irregular heartbeats of the patient's heart, the electroporation delivery system is configured to determine whether an electroporation pulse is to be delivered from the pulse delivery mechanism to the patient using a rolling average of the electrocardiogram.
2 . The electroporation delivery system according to claim 1 , wherein the processing device is configured to execute the following steps: measuring and averaging approximately 30 initial heartbeat durations of the patient's heart; calculating the rolling average by averaging a series of four heartbeat durations; comparing the rolling average to the averaged initial heartbeat durations including a standard deviation; and if the rolling average is equal to the average initial heartbeat durations within the standard deviation, delivering the electroporation pulse during a fifth heartbeat duration following the averaged series of four heartbeat durations, and if the rolling average is not equal to the average initial heartbeat durations within the standard deviation, not delivering the electroporation pulse during the fifth heartbeat duration following the averaged series of four heartbeat durations.
3 . The electroporation delivery system according to claim 1 , wherein the processing device is configured to execute the following steps: calculating a rolling average by averaging a series of four heartbeat durations; setting the rolling average to a heartbeat average including a standard deviation; and comparing the rolling average to a fifth heartbeat duration following the averaged series of four heartbeat durations, wherein if the fifth heartbeat duration following the averaged series of four heartbeat durations is equal to the rolling average within the standard deviation, delivering an electroporation pulse during a sixth heartbeat duration following the fifth heartbeat duration, and if the fifth heartbeat duration following the averaged series of the four heartbeat durations is not equal to the rolling average within the standard deviation, not delivering the electroporation pulse during the sixth heartbeat duration following the fifth heartbeat duration.
4 . The electroporation delivery system according to claim 3 , wherein delivery of the electroporation pulse during the sixth heartbeat duration occurs at a time determined by the averaged series of four heartbeat durations divided by two after a Q wave of a QRS complex of the sixth heartbeat duration.
5 . The electroporation delivery system according to claim 1 , wherein the processing device is configured to execute the following steps: measuring and averaging approximately 30 initial R wave amplitudes in a QRS complex of the patient's heart; calculating a rolling average by averaging a series of four R wave amplitudes; and comparing the rolling average to the average initial R wave amplitudes including a standard deviation, wherein if the rolling average is equal to the average initial R wave amplitudes within the standard deviation, delivering the electroporation pulse during a fifth heartbeat duration following the averaged series of four R wave amplitudes, and if the rolling average is not equal to the average initial R wave amplitudes within the standard deviation, not delivering the electroporation pulse during the fifth heartbeat duration following the averaged series of four R wave amplitudes.
6 . The electroporation delivery system according to claim 1 , wherein the processing device is configured to execute the following steps: calculating a rolling average by averaging a series of four R wave amplitudes in a QRS complex of the patient's heart; setting the rolling average to the averaged R wave amplitudes including a standard deviation; and comparing the rolling average to a fifth R wave amplitude of a fifth heartbeat duration following the averaged series of four R wave amplitudes, wherein if the fifth R wave amplitude following the averaged series of four R wave amplitudes is equal to the rolling average within the standard deviation, delivering the electroporation pulse during a sixth heartbeat duration following the fifth R wave amplitude, and if the fifth R wave amplitude following the averaged series of the four R wave amplitudes is not equal to the rolling average within the standard deviation, not delivering the electroporation pulse during the sixth heartbeat duration following the fifth R wave amplitude.
7 . The electroporation delivery system according to claim 1 , further comprising one or more signal filters for extracting at least one of an R wave and a T wave of a QRS complex; wherein the electroporation pulse is deliverable in response to a positive value of the R wave and a negative value of the T wave output from the one or more filters; wherein the electroporation pulse is not deliverable in response to the positive value of the R wave and a positive value of the T wave output from the one or more filters; and wherein the electroporation pulse is deliverable in response to the R wave being within 70 ms and the negative value of the T wave output from the one or more filters.
8 . The electroporation delivery system according to claim 1 , wherein pacing of the patient's heart is adjustable for electroporation pulse delivery by induced pacing, including the following steps: pacing a portion of the patient's heart; detecting an evoked potential, wherein if no evoked potential is detected, the pacing of the portion of the patient's heart is continued and no electroporation pulse is delivered, and: in response to detecting evoked potential, determining if the detection occurs during a vulnerable period of a T wave; wherein in response to the detection occurring during the vulnerable period of the T wave, the pacing of the portion of the patient's heart is continued and no electroporation pulse is delivered; and wherein in response to the detection not occurring during the vulnerable period of the T wave, delivering the electroporation pulse.
9 . The electroporation delivery system according to claim 1 , wherein pacing of the patient's heart is adjustable for electroporation pulse delivery by continuous pacing, including the following steps: (a) sending a continuous pacing signal to the patient's heart to maintain the heart in a contracted state; (b) during the continuous pacing, delivering one or more electroporation pulses; and (c) monitoring heart rhythms of the patient for irregularities, wherein in response to detecting an irregularity, pacing the patient's heart to a normal rhythm; and wherein in response to detecting a regular heartbeat, repeating steps (a), (b), and (c) if additional treatment is needed.
10 . The electroporation delivery system according to claim 1 , wherein electroporation pulse delivery is paused for monitoring the electrocardiogram for regular heart rhythms.
11 . The electroporation delivery system according to claim 1 , wherein an electroporation pulse shape is at least one of square-shaped and defibrillation-like shaped, and wherein the electroporation pulse shape is at least one of monopolar and bipolar.
12 . The electroporation delivery system according to claim 1 , wherein the electroporation delivery system is operational for treating at least one of atrial fibrillation and cancer disposed in, at, or near the heart.
13 . A method for delivering an electroporation pulse by an electroporation delivery system for treatment in, at, or near a patient's heart, comprising: measuring electrical activity QRS complex of the patient's heart using an electrocardiogram monitor and one or more sensors operatively connected to a processing device and a memory; calculating, by the processing device, a rolling average by averaging a series of four heartbeat parameters; and delivering, based on the rolling average, the electroporation pulse by one or more electrodes operatively connected to a pulse delivery mechanism of the electroporation delivery system.
14 . The method according to claim 13 , wherein the delivering, based on the rolling average, the electroporation pulse comprises: measuring and averaging approximately 30 initial heartbeat parameters of a patient's heart; and including a standard deviation to the average initial heartbeat parameters.
15 . The method according to claim 13 , wherein the delivering, based on the rolling average, the electroporation pulse comprises using a fifth heartbeat parameter following the averaged series of four heartbeat parameters, and the rolling average is set to a heartbeat average including a standard deviation.
16 . The method according to claim 15 , further comprising: delivering the electroporation pulse during a fifth heartbeat duration following the averaged series of four heartbeat parameters; and not delivering the electroporation pulse during the fifth heartbeat duration following the averaged series of four heartbeat parameters in response to the rolling average not equaling a determined value.
17 . The method according to claim 15 , further comprising: delivering the electroporation pulse during a sixth heartbeat duration following a fifth heartbeat duration; and not delivering the electroporation pulse during the sixth heartbeat duration following the fifth heartbeat duration in response to the fifth heartbeat parameter not equaling the rolling average within the standard deviation.
18 . The method according to claim 13 , wherein a heartbeat parameter is at least one of a heartbeat duration and an R wave amplitude.
19 . The method according to claim 13 , further comprising adjusting a pace of the patient's heart at least one of before, during, and after delivering the electroporation pulse.
20 . A system for delivering an electroporation pulse by an electroporation delivery system for treatment in, at, or near a patient's heart, the system being configured to execute the following steps: measuring electrical activity QRS complex of the patient's heart using an electrocardiogram monitor and one or more sensors operatively connected to a processing device and a memory; calculating, by the processing device, a rolling average by averaging a series of four heartbeat parameters; and delivering, based on the rolling average, the electroporation pulse by one or more electrodes operatively connected to a pulse delivery mechanism of the electroporation delivery system.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 16/107,046 filed Aug. 21, 2018 (now U.S. Pat. No. 11,389,642), which is a non-provisional application of, and claims the benefit of priority to, U.S. Provisional Application Ser. No. 62/549,631 filed Aug. 24, 2017, entitled “Electroporation Delivery Systems and Methods of Using Electroporation Delivery Systems.” The entirety of the related applications are hereby expressly incorporated by reference herein. FIELD The present disclosure relates generally to electroporation systems, including reversible electroporation (RE) and irreversible electroporation (IRE) systems and methods for using electroporation systems and, more particularly, to utilizing algorithms for electroporation pulse delivery including a patient's EKG/EGM monitoring. BACKGROUND Reversible electroporation (RE) may be typically used for drug delivery to a selected tissue area by applying direct-current through electrodes. Irreversible electroporation (IRE) is typically used as a soft tissue ablation technique (e.g., tumor removal) by delivering direct-current energy in short pulses to the selected tissue. For patients with healthy heart rhythms, undergoing an electroporation procedure near the heart is generally acceptable, as the electroporation procedure may rely on an algorithm that utilizes the QRS complex to determine when a pulse is delivered to the patient (FIG. 1A). However, in a patient having an arrhythmia, for example, the Q wave, R wave, and/or the S wave may be uneven and irregular (e.g., a patient's heart rate may be irregular and/or faster than normal heart rates) (FIG. 1B). The algorithms currently utilized in electroporation systems do not take into account irregular QRS wave patterns, which could result in an electroporation pulse being delivered that may affect the QRS wave. For example, when an electroporation pulse is delivered at less than or equal to 1.7 cm from the heart, a patient may experience a fatal (major) event. Even when an electroporation pulse is delivered at a distance greater than 1.7 cm from the heart, a patient may experience a minor event. Known algorithms typically issue a pulse within a certain time frame after the R wave. As can be seen in FIG. 1A, an electroporation pulse signal sent during an R wave in a regular heartbeat may be delivered prior to the T wave in the refractory period, while FIG. 1B illustrates that an irregular heartbeat may have a wider R wave, thereby resulting in a pulse occurring during the T wave. If an electroporation pulse is delivered during the T wave, a patient may experience malignant atrial and ventricular arrhythmias. In some instances, up to 14% of electroporation cases may cause ventricular fibrillation. It is with respect to these and other considerations that the present improvements may be useful. SUMMARY This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter. According to an exemplary embodiment of the present disclosure, an electroporation delivery system may include an electrocardiogram operatively connected to a processing device and a memory, one or more sensors operatively connected to the electrocardiogram for measuring electrical activity QRS complex of a patient's heart, and one or more electrodes for treatment at, in, or near the patient's heart, the one or more electrodes operatively connected to a pulse delivery mechanism. The electroporation delivery system may be configured to determine whether an electroporation pulse is deliverable to a patient based on the electrocardiogram. According to an exemplary embodiment of the present disclosure, a method for delivering an electroporation pulse by an electroporation delivery system for treatment in, at, or near a patient's heart may include measuring electrical activity QRS complex of the patient's heart by an electrocardiogram and one or more sensors operatively connected to a processing device and a memory, calculating by the processing device a rolling average by averaging a series of four pulse parameters, comparing the rolling average to a determined value, and delivering an electroporation pulse by one or more electrodes operatively connected to a pulse delivery mechanism of the electroporation delivery system in response to the rolling average being equal to the determined value. According to an exemplary embodiment of the present disclosure, a system for delivering an electroporation pulse by an electroporation delivery system for treatment in, at, or near a patient's heart may be configured to execute steps that include measuring electrical activity QRS complex of the patient's heart by an electrocardiogram a