US2011077542A1PendingUtilityA1

Methods, Systems and Devices for Detecting and Diagnosing Heart Diseases and Disorders

Assignee: DYNACARDIA INCPriority: Jul 9, 2007Filed: Dec 3, 2010Published: Mar 31, 2011
Est. expiryJul 9, 2027(~0.9 yrs left)· nominal 20-yr term from priority
A61B 5/7225A61B 5/341A61B 5/364A61B 5/7257A61B 5/366
38
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Claims

Abstract

Disclosed herein methods, devices, and systems for detecting and diagnosing a heart disease or disorder in a subject from a prime electrocardiogram which comprises calculating at least one distribution function of the prime electrocardiogram and determining whether the distribution function is indicative of the presence of absence of the heart disease or disorder.

Claims

exact text as granted — not AI-modified
1 . A method for determining a distribution function of a prime electrocardiogram which comprises
 obtaining a prime electrocardiogram;   obtaining density functions for the harmonics in a range of harmonics of the prime electrocardiogram; and   summing the density functions.   
     
     
         2 . The method of  claim 1 , wherein the prime electrocardiogram is a prime morphological electrocardiogram. 
     
     
         3 . The method of  claim 2 , wherein the prime morphological electrocardiogram is obtained by
 obtaining a raw electrocardiogram as electronic data;   selecting at least one characteristic segment or at least one characteristic window; and   isolating the characteristic segment or the characteristic window by removing information extraneous to the characteristic segment or the characteristic window.   
     
     
         4 . The method of  claim 3 , wherein the characteristic segment is a QT segment, an RT segment, or a PR segment. 
     
     
         5 . The method of  claim 3 , wherein the characteristic window includes part or all of a T-wave or part or all of a PQRST interval. 
     
     
         6 . The method of  claim 3 , which further comprises refining the characteristic segment or the characteristic window by averaging the characteristic segment or the characteristic window. 
     
     
         7 . The method of  claim 6 , which further comprises repeating the averaged characteristic window or the averaged characteristic segment by N times, wherein N is any positive integer. 
     
     
         8 . The method of  claim 3 , wherein the isolated characteristic segment is a plurality of isolated characteristic segments in series. 
     
     
         9 . The method of  claim 3 , wherein the isolated characteristic window is a plurality of isolated characteristic windows in series. 
     
     
         10 . The method of  claim 1 , wherein the prime electrocardiogram is a prime arrhythmological electrocardiogram. 
     
     
         11 . A method for diagnosing or detecting a heart disease or disorder in a subject which comprises
 acquiring a prime electrocardiogram from the subject,   obtaining a plurality of density functions for the harmonics in a range of harmonics of the prime electrocardiogram;   summing the plurality of density functions to give at least one distribution function; and   determining the presence or absence of the heart disease or disorder based on whether the distribution function is indicative of the heart disease or disorder.   
     
     
         12 - 20 . (canceled) 
     
     
         21 . The method of  claim 11 , wherein a combination of distribution functions selected from the group consisting of
 a) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , and H II [6]≦θ 3 ;   b) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , H II [6]>θ 3 , H V1 [30]>θ 4 , and H aVL [499]>θ 5 ;   c) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , H II [6]>θ 3 , H V1 [30]≦θ 4 , and H III [30]≦θ 6 ;   d) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , H II [6]>θ 3 , H V1 [30]≦θ 4 , H III [30]>θ 6 , and H V5 [499]>θ 7 ; and   e) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , H II [6]>θ 3 , H V1 [30]≦θ 4 , and H III [30]>θ 6 , H V5 [499]≦θ 7 , H V5 [6]≦θ 8 , H aVR [6]>θ 9 , and H III [6]>θ 10      
       is indicative of the absence of the heart disease or disorder. 
     
     
         22 . The method of  claim 11 , wherein a combination of distribution functions selected from the group consisting of
 a) H aVL [30]>θ 1 ;   b) H aVL [30]≦θ 1 , and H V2 [6]≦θ 2 ;   c) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , H II [6]>θ 3 , H V1 [30]>θ 4 , and H aVL [499]≦θ 5 ;   d) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , H II [6]>θ 3 , H V1 [30]>θ 4 , H III [30]>θ 6 , H V5 [499]≦θ 7 , and H V5 [6]≦θ 8 .   e) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , H II [6]>θ 3 , H V1 [30]≦θ 4 , H III [30]>θ 6 , H V5 [499]≦θ 7 , H V5 [6]>θ 8 , and H aVR [6]≦θ 9 ; and   f) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , H II [6]>θ 3 , H V1 [30]≦θ 4 , H III [30]>θ 6 , H V5 [499]≦θ 7 , H V5 [6]>θ 8 , H aVR [6]>θ 9 , and H III [6]≦θ10   
       is indicative of the presence of the heart disease or disorder. 
     
     
         23 . The method of  claim 11 , which further comprises determining a secondary factor. 
     
     
         24 . The method of  claim 23 , wherein the secondary factor is the subject's age or whether the subject suffers from diabetes mellitus. 
     
     
         25 . The method of  claim 24 , wherein a combination of age and distribution functions selected from the group consisting of
 a) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , age≦θ 3 , and H aVR [30]≦θ 4 ;   b) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , age>θ 3 , H V5 [6]>θ 5 , H V1 [499]>θ 6 , and H aVR [499]>θ 10 ; and   c) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , age>θ 3 , H V5 [6]>θ 5 , H V1 [499]≦ 6 , H V2 [499]>θ 7 , H aVL [30]>θ 7 , H aVL [30]>θ 8 , and H V4 [6]>θ 9      
       is indicative of the absence of the heart disease or disorder. 
     
     
         26 . The method of  claim 24 , wherein a combination of age and distribution functions selected from the group consisting of
 a) H aVL [30]>θ 1 ;   b) H aVL [30]>θ 1  and H V2 [6]≦θ 2 ;   c) H aVL [30]>θ 1 , H V2 [6]≦θ 2 , age≦θ 3 , and H aVR [30]>θ 4 ;   d) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , age>θ 3 , and H V5 [6]θ 5 ;   e) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , age>θ 3 , H V5 [6]>θ 5 , H V1 [499]>θ 6 , and H aVR [499]≦θ 10 ;   f) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , age>θ 3 , H V5 [6]>θ 5 , H V1 [499]≦ 6 , and H V2 [499]≦θ 7 ;   g) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , age>θ 3 , H V5 [6]>θ 5 , H V1 [499]≦θ 6 , H V2 [499]>θ 7 ; H aVL [30]>θ 7 , and H aVL [30]≦θ 8 ; and   h) H aVL [30]≦θ 1 , H V2 [6]>θ 2 , age>θ 3 , H V5 [6]>θ 5 , H V1 [499]≦θ 6 , H V2 [499]>θ 7 ; H aVL [30]>θ 7 , H aVL [30]>θ 8 , and H V4 [6]≦θ 9      
       s indicative of the presence of the heart disease or disorder. 
     
     
         27 . The method of  claim 24 , wherein a combination of distribution functions and the presence or absence of diabetes mellitus (DM) selected from the group consisting of
 a) H aVL [6]≦θ 1 , DM is positive, and H V6 [499]≦θ 2 ; and   b) H aVL [6]≦θ 1 , DM is negative, H aVF [6]>θ 3 , H 1 [6]>θ8 4  SH 1 [6]>θ 4 , H II [6]≦θ 5 , H III [6]≦θ 6 ; H V5 [30]≦θ 7 , and H V3 [6]≦θ 8      
       is indicative of the absence of the heart disease or disorder. 
     
     
         28 . The method of  claim 24 , wherein a combination of distribution functions and the presence or absence of diabetes mellitus (DM) selected from the group consisting of
 a) H aVL [6]>θ 1 ;   b) H aVL [6]≦θ 1 , DM is positive, and H V6 [499]>θ 2 ;   c) H aVL [6]≦θ 1 , DM is negative, and H aVF [6]≦θ 3 ;   d) H aVL [6]≦θ 1 , DM is negative, and H aVF [6]>θ 3 , and H I [6]≦θ 4 ;   e) H aVL [6]≦θ 1 , DM is negative, H aVF [6]>θ 3 , H I [6]>θ 4 , and H II [6]>θ 5 ;   f) H aVL [6]≦θ 1 , DM is negative, H aVF [6]>θ 3 , H I [6]>θ 4 , H II [6]≦θ 5 , and H III [6]>θ 6 ,   g) H aVL [6]≦θ 1 , DM is negative, H aVF [6]>θ 3 , H I [6]>θ 4 , H II [6]≦θ 5 , H III [6]≦θ 6 , and H V5 [30]>θ 7 ; and   h) H aVL [6]≦θ 1 , DM is negative, H aVF [6]>θ 3 , H I [6]>θ 4  SH I [6]>θ 4 , H II [6]≦θ 5 , H III [6]≦θ 6 , H V5 [30]≦θ 7 , and H V3 [6]>θ 8      
       is indicative of the absence of the heart disease or disorder. 
     
     
         29 . A system or device for detecting or diagnosing a subject as suffering from a heart disease or disorder comprising
 an electrocardiograph for obtaining a raw electrocardiogram from the subject;   a data acquisition module for converting the raw electrocardiogram into a raw digital electrocardiogram;   a prime electrocardiogram converter for converting the raw digital electrocardiogram into a prime electrocardiogram; and   a computer to calculate at least one distribution function of the prime electrocardiogram.   
     
     
         30 . (canceled)

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