IP Library Granted Patent US 12,642,472
Granted Patent B2
US 12,642,472 · App. 17/331,576 · Granted Jun 2, 2026

Systems, devices, components and methods for detecting the locations of sources of cardiac rhythm disorders in a patient's heart and generating an estimate or probability of the patient being free from atrial fibrillation

Inventors: Peter Ruppersberg (Blonay, CH); Philip Haeusser (Munich, DE); Melissa Huang Szu-Min Kong (West Lake Hills, TX); David Emanuel Luksic (Munich, DE); Kostiantyn Serhiyovich Ahapov (Munich, DE)
Assignee: Boston Scientific Scimed, Inc.
A61B5/361A61B5/343A61B5/7275A61B5/742
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Quick Facts
Patent No.
US 12,642,472
App. No.
17/331,576
Granted
Jun 2, 2026
Kind
B2
Abstract

Disclosed are various examples and embodiments of systems, devices, components and methods configured to detect the locations of sources of cardiac rhythm disorders in a patient's heart, and then to generate an estimate or probability of the patient being free from atrial fibrillation. The various embodiments employ at least one computing device to process a plurality of electrogram surfaces through time to generate at least one electrographical flow (EGF) map, representation, pattern, or data set, and then process the at least one EGF map, representation, pattern, or data set to determine at least two of source activity levels, flow angle variability (FAV) levels, and active fractionation (AFR) levels corresponding thereto. On the basis of a combination of the determined at least two of source activity levels, FAV levels, and AFR levels, an electrographical volatility index (EVI) score or metric representative of the estimate or probability of the patient being free from AF is generated.

Claims (51)

1 . A system configured to generate an estimate or probability of a patient being free from atrial fibrillation (AF) so that an appropriate ablation therapy can be delivered to the patient, comprising:

at least one computing device comprising at least one non-transitory computer readable medium configured to store instructions executable by at least one processor to determine the source and location of the atrial fibrillation in the patient's heart, the computing device being operably connected to a display or monitor, the computing device being configured to:

(a) receive electrogram signals;

(b) assign positions of electrodes on a mapping electrode assembly employed to acquire the electrogram signals to their corresponding electrogram signals;

(c) provide or generate a map, representation, or data set of the electrode positions;

(d) process the electrogram signals to generate a plurality of at least one interpolated, fitted, smoothed and estimated electrogram surfaces for discrete times of the electrogram signals corresponding at least partially to the map, representation, or data set;

(e) process the plurality of electrogram surfaces through time using optical flow analysis and estimation techniques to generate at least one electrographical flow (EGF) map, representation, pattern, or data set;

(f) process the at least one EGF map, representation, pattern, or data set to determine at least two of source activity levels, flow angle variability (FAV) levels, and active fractionation (AFR) levels corresponding thereto;

(g) determine and generate, on the basis of a combination of the determined at least two of source activity levels, FAV levels, and AFR levels, an electrographical volatility index (EVI) representative of the estimate or probability of the patient being free from AF, wherein at least one of the EVI and the estimate or probability of the patient being free from AF is presented on a display, monitor, or printer to one or more users, and further wherein on the basis of the estimate or probability the one or more users can determine whether to deliver an ablation therapy to the patient.

2 . The system of claim 1 , wherein the computing device convolves at least two of the determined source activity levels, the determined flow angle variability levels, and the determined active fractionation levels with one another to provide the estimate or probability of the patient being free from AF.

3 . The system of claim 1 , wherein the determined source activity levels correspond to at least one of Type A atrial behavior exhibiting stable rotors and drivers and Type B atrial behavior where rotors switch on and off.

4 . The system of claim 1 , wherein the determined flow angle variability levels correspond to Type D atrial behavior exhibiting stable reentry patterns with low FAV.

5 . The system of claim 1 , wherein the determined active fractionation levels correspond to Type E atrial behavior exhibiting a combination of active fractionation and action potential flow origins.

6 . The system of claim 1 , wherein the activity level corresponds to a percentage of time a detected source is determined to be on or active.

7 . The system of claim 6 , wherein when the percentage of time the detected source is on or active is greater than about 25% the activity level is deemed to be high, and the probability the patient is free from AF is lower.

8 . The system of claim 6 , wherein the percentage of time the detected source is on or active is greater than between about 26% and about 30% the activity level is deemed to be high.

9 . The system of claim 6 , wherein when the percentage of time the detected source is on or active is less than about 30% the activity level is deemed to be low, and the probability the patient is free from AF is deemed to be higher.

10 . The system of claim 6 , wherein when the percentage of time the detected source is on or active is less than between about 26% and about 30% the activity level is deemed to be low, and the probability the patient is free from AF is deemed to be higher.

11 . The system of claim 1 , wherein the flow angle variability level corresponds to one or more EGF flow angles computed over a predetermined period of time.

12 . The system of claim 11 , wherein a flow angle level exceeding a range between about 4 and 5 degrees measured over about 20 milliseconds is deemed to be high, and the probability the patient is free from AF is deemed to be higher.

13 . The system of claim 11 , wherein a flow angle level less than a range between about 4 and 5 degrees measured over about 20 milliseconds is deemed to be low, and the probability the patient is free from AF is deemed to be lower.

14 . The system of claim 1 , wherein the active fractionation level corresponds to a combination of measuring divergence in EGF flow patterns indicative of action potential origins and measuring a percentage of a surface area of the patient's atrium determined to be fractionated on the basis of divergent EGF flow patterns.

15 . The system of claim 14 , wherein when the active fractionation level exceeds a level between about 27 percent and about 31 percent of a surface area of an analyzed portion of the patient's atrium exhibiting divergence in EGF flow patterns over a predetermined period of time, the probability the patient is free from AF is lower.

16 . The system of claim 14 , wherein when the active fractionation level falls below a level between about 27 percent and about 31 percent of a surface area of an analyzed portion of the patient's atrium exhibiting divergence in EGF flow patterns over a predetermined period of time, the probability the patient is free from AF is higher.

17 . The system of claim 1 , wherein the EVI is generated in accordance with the formula: EVI=(1−p (source activity))α·p (flow angle variability)β·(1−p (active fractionation))γ, where the symbol “·” denotes convolution.

18 . A method of generating an estimate or probability of a patient being free from atrial fibrillation (AF) so that an appropriate ablation therapy can be delivered to the patient, the method employing at least one computing device comprising at least one non-transitory computer readable medium configured to store instructions executable by at least one processor to determine the source and location of the atrial fibrillation in the patient's heart, the computing device being operably connected to a display or monitor, the method comprising:

(a) receiving electrogram signals acquired from electrodes located inside the patient's heart;

(b) using the computing device, assigning positions of the electrodes on a mapping electrode assembly employed to acquire the electrogram signals to their corresponding electrogram signals;

(c) using the computing device, providing or generating a map, representation, or data set of the electrode positions;

(d) using the computing device, processing the electrogram signals to generate a plurality of at least one of interpolated, fitted, smoothed and estimated three-dimensional electrogram surfaces for discrete times of the electrogram signals corresponding at least partially to the map, representation, or data set;

(e) using the computing device, processing the plurality of three-dimensional electrogram surfaces through time using optical flow analysis and estimation techniques to generate at least one electrographical flow (EGF) map, representation, pattern, or data set;

(f) using the computing device, processing the at least one EGF map, representation, pattern, or data set to determine at least two of source activity levels, flow angle variability (FAV) levels, and active fractionation (AFR) levels corresponding thereto;

(g) using the computing device, determining and generating, on the basis of a combination of the determined at least two of source activity levels, FAV levels, and AFR levels, an electrographical volatility index (EVI) representative of the estimate or probability of the patient being free from AF;

(h) presenting at least one of the EVI and the estimate or probability of the patient being free from AF on a display, monitor, or printer to one or more users, and

(i) on the basis of the estimate or probability the one or more users determine whether to deliver an ablation therapy to the patient.

19 . The method of claim 18 , further comprising the computing device convolving at least two of the determined source activity levels, the determined flow angle variability levels, and the determined active fractionation levels with one another to provide the estimate or probability of the patient being free from AF.

20 . The method of claim 18 , wherein the determined source activity levels correspond to at least one of Type A atrial behavior exhibiting stable rotors and drivers and Type B atrial behavior where rotors switch on and off.

21 . The method of claim 18 , wherein the determined flow angle variability levels correspond to Type D atrial behavior exhibiting stable reentry patterns with low FAV.

22 . The method of claim 18 , wherein the determined active fractionation levels correspond to Type E atrial behavior exhibiting a combination of active fractionation and action potential flow origins.

23 . The method of claim 18 , wherein the activity level corresponds to a percentage of time a detected source is determined to be on or active.

24 . The method of claim 23 , wherein when the percentage of time the detected source is on or active is greater than about 25% the activity level is deemed to be high, and the probability the patient is free from AF is lower.

25 . The method of claim 23 , wherein when the percentage of time the detected source is on or active is greater than between about 26% and about 30% the activity level is deemed to be high.

26 . The method of claim 23 , wherein when the percentage of time the detected source is on or active is less than about 30% the activity level is deemed to be low, and the probability the patient is free from AF is deemed to be higher.

27 . The method of claim 23 , wherein when the percentage of time the detected source is on or active is less than between about 26% and about 30% the activity level is deemed to be low, and the probability the patient is free from AF is deemed to be higher.

28 . The method of claim 18 , wherein the flow angle variability level corresponds to one or more EGF flow angles computed over a predetermined period of time.

29 . The method of claim 28 , wherein a flow angle level exceeding a range between about 4 and 5 degrees measured over about 20 milliseconds is deemed to be high, and the probability the patient is free from AF is deemed to be higher.

30 . The method of claim 28 , wherein a flow angle level less than a range between about 4 and 5 degrees measured over about 20 milliseconds is deemed to be low, and the probability the patient is free from AF is deemed to be lower.

31 . The method of claim 18 , wherein the active fractionation level corresponds to a combination of measuring divergence in EGF flow patterns indicative of action potential origins and measuring a percentage of a surface area of the patient's atrium determined to be fractionated on the basis of divergent EGF flow patterns.

32 . The method of claim 31 , wherein when the active fractionation level exceeds a level between about 27 percent and about 31 percent of a surface area of an analyzed portion of the patient's atrium exhibiting divergence in EGF flow patterns over a predetermined period of time, the probability the patient is free from AF is lower.

33 . The method of claim 31 , wherein when the active fractionation level falls below a level between about 27 percent and about 31 percent of a surface area of an analyzed portion of the patient's atrium exhibiting divergence in EGF flow patterns over a predetermined period of time, the probability the patient is free from AF is higher.

34 . The method of claim 18 , further comprising generating the EVI is determined in accordance with the formula: EVI=(1−p (source activity))α·p (flow angle variability)β·(1−p (active fractionation))γ, where the symbol “·” denotes convolution.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 14, 2026
From: CORTEX, INC.
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 073468/0615 →
MERGER Recorded Aug 23, 2024
From: ABLACON INC.
To: CORTEX, INC.
Reel/Frame 068378/0725 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 4, 2022
From: RUPPERSBERG, PETER; HAEUSSER, PHILIP; KONG, MELISSA HUANG SZU-MIN; LUKSIC, DAVID EMANUEL; AHAPOV, KOSTIANTYN SERHIYOVICH
To: ABLACON INC.
Reel/Frame 059491/0456 →
Continuity (3)
Continuation In Part 16387873 · Apr 18, 2019
Provisional Application 63032238 · May 29, 2020
Related Publication 20210282693A1 · Sep 16, 2021
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