Non-invasive method and apparatus for diagnosing and monitoring aortic valve abnormalities, such as aortic regurgitation

Abstract

A method and device is provided for determining aortic valve abnormalities. The method first includes the step of providing a sphygmomanometer device for inducing a pressure on a body part of a patient. A data stream receiver is provided for receiving a stream of data relating to the pressure response of the pulsed fluid flowing through the cardiovascular system of the patient. A data processor is provided for processing the data to create a series of time dependant pulse wave forms. The data can be converted by Fast Fourier Transformation (FFT) to obtain Power Spectrum (PS) which comprises a frequency dependant array of pulse signals. Both of the time dependant and frequency dependant (Power Spectrum) data can be displayed and analyzed to help determine the condition of the aortic valve and the percentage of regurgitation of the patient. With the Power Spectrum display, the determination is made based on first, identifying the existence of an additional second series of harmonically occurring regurgitation signals that have a frequency different from the main signals indicative of the forward flow of fluid through the aortic valve. The ratio of the amplitude or density of the regurgitation signal peak can be divided by the amplitude or density of the associated main signal peak, to determine the ratio of the associated “Regurgitation” flow to and “Main” flow, to thereby semi-quantitatively determine the percent of regurgitation flow of the patient.

What is claimed is:  
     
       1. A method for identifying the existence of aortic valve abnormalities in a patient comprising the steps of: 
       (1) providing a non-invasive pressure inducing means for inducing a pressure on a body part of a patient and applying pressure to the body part;  
       (2) providing a data receiving means;  
       (3) using the data receiving means to receive a stream of pulsation signal data from the patient relating to the pressure response of pulsed fluid flowing through the cardiovascular system of the patient;  
       (4) providing a data processing means;  
       (5) using the data processing means for processing the stream of pulsation signal data to create an array of pulse wave forms; and  
       (6) identifying wave form characteristics that denote the presence of aortic valve abnormalities.  
     
     
       2. The method of  claim 1  wherein the step of using the data processing means comprises the step of using the data processing means to create a time dependant array of pulse wave forms. 
     
     
       3. The method of  claim 2  wherein each of the pulse wave forms of the time dependant array of pulse wave forms includes a peak, and the step of identifying wave form characteristics includes the step of comparing the height of a series of adjacent wave form peaks. 
     
     
       4. The method of  claim 3  wherein the step of comparing the height of a series of adjacent wave form peaks includes the step of comparing the height of at least four adjacent peaks, P 1 , P 2 , P 3  and P 4 , having heights of H 1 , H 2 , H 3  and H 4 , respectively. 
     
     
       5. The method of  claim 4  further comprising the step of detecting the presence of aortic valve abnormalities if at least one of (1): H 1 >H 2 , H 2 <H 3 , and H 3 >H 4 ; and (2): H 1 <H 2 , H 2 >H 3  and H 3 <H 4  occurs. 
     
     
       6. The method of  claim 1  wherein the array of pulse wave forms comprises a series of at least four adjacent pulse wave forms including a first wave form having a peak P 1 , and a height H 1 ; a second pulse wave form having a peak P 2  and a height H 2 ; a third pulse wave form having a peak P 3  and a height H 3 ; and a fourth pulse wave form having a peak P 4  and a height H 4 ; further comprising the step of detecting the presence of aortic valve abnormalities if at least one of: (1) H 1 >H 2 , H 2 <H 3 , and H 3 >H 4 ; and (2) H 1 <H 2 , H 2 >H 3  and H 3 <H 4  occurs. 
     
     
       7. The method of  claim 1  further comprising the step of graphically displaying the array of pulse wave forms. 
     
     
       8. The method of  claim 7  wherein 
       (1) the step of using the data processing means comprises the step of using the data processing means to create a time dependant array of pulse wave forms,  
       (2) the time dependant array of pulse wave forms are graphically displayed,  
       (3) the time dependant array of pulse wave forms being graphically displayed include a series of pulse wave forms each having a peak,  
       (4) the step of graphically displaying the time dependant array includes the step of displaying an envelope line that extends between the peaks of adjacent wave forms, and  
       (5) the step of identifying wave form characteristics includes the step of identifying the slope of the envelope line to determine whether it denotes the presence of aortic valve abnormalities.  
     
     
       9. A method for identifying the existence of aortic valve abnormalities, comprising the steps of: 
       (1) providing a non-invasive pressure inducing means for inducing a pressure on a body part of a patient and applying pressure to the body part;  
       (2) providing a data receiving means;  
       (3) using the data receiving means to receive a stream of pulsation signal data from the patient relating to the pressure response of pulsed fluid flowing through the cardiovascular system of the patient having a cardiovascular system;  
       (4) providing a data processing means;  
       (5) processing the stream of pulsation signal data to create an array of time dependant wave form data;  
       (6) converting the array of time dependant wave form data to an array of frequency dependant wave form data; and  
       (7) identifying characteristics of the frequency dependant wave form data that denote the presence of aortic valve abnormalities.  
     
     
       10. The method of  claim 9  wherein the steps of converting the time dependant wave form data comprises the step of using a Fourier transformation to convert the time dependant wave form data to frequency dependant wave form data. 
     
     
       11. The method of  claim 9  wherein the step of identifying the characteristics of the frequency dependant wave form data includes the step of identifying a first series of harmonically occurring flow signals corresponding to a flow of fluid forwardly through the aortic valve, and detecting the presence or absence of a second series of harmonically occurring flow signals corresponding to aortic regurgitation. 
     
     
       12. The method of  claim 11  wherein the flow signals of the first series each have a corresponding flow signal of the second series, each of the flow signals of the first series has an amplitude A 1 , and each of the flow signals of the second series has an amplitude A 2  and further comprising the step of comprising the amplitude A 2  of a flow signal of the second series to the amplitude A 1  of a flow signal of the first series to obtain a semi-quantitative analysis of the aortic regurgitation. 
     
     
       13. The method of  claim 12  wherein the step of comparing the amplitudes comprises the step of determining a ratio A 2 /A 1  of the amplitudes of corresponding flow signals of the second and first series to approximate the ratio of aortic regurgitation flow to forward fluid flow through the aortic valve. 
     
     
       14. The method of  claim 11  wherein the flow signals of the first series each have a corresponding flow signal of the second series, 
       each of the flow signals of the first series has a density, D 1    
       each of the flow signals of the second series has a density, D 2  and  
       further comprising the step of comprising the density D 2  of the flow signal of the second series to the density D 1  of the flow signal of the first series to obtain a semi-quantitative value of the aortic regurgitation.  
     
     
       15. The method of  claim 14  wherein the step of comparing the densities comprises the step of determining the ratio D 2 /D 1  of corresponding flow signals of the second and first series to approximate the ratio of aortic regurgitation flow, to the flow of fluid forward through the aortic valve. 
     
     
       16. The method of  claim 11  further comprising the step of evaluating the frequency shift between the flow signals of the first series and the flow signals of the second series. 
     
     
       17. The method of  claim 16  wherein the step of evaluating the frequency shift comprises the step of evaluating the frequency shift between the flow signals of the first series and the flow signals of the second series to determine at least one of the nature, type and characteristics of the aortic regurgitation of the patient. 
     
     
       18. A device for identifying the existence of aortic valve abnormalities in a patient comprising: 
       (1) a non-invasive pressure inducing means for inducing a pressure to a body part of a patient;  
       (2) a data receiving means for receiving a stream of pulsation signal data from the patient relating to the pressure response of pulsed fluid flowing through the cardiovascular system of the patient;  
       (3) a data processing means for processing the stream of pulsation signal data to create a time dependant array of pulse wave forms; and  
       (4) means for aiding in the identification of wave form characteristics that denote the presence of aortic valve abnormalities.  
     
     
       19. The device of  claim 18  further comprising graphic display means for displaying the time dependant array of pulse wave forms. 
     
     
       20. The device of  claim 18  wherein each of the pulse wave forms of the time dependant array of pulse wave forms includes a peak, and the means for aiding in the identification of wave form characteristics includes means for aiding in the comparison of the height of a series of adjacent wave form peaks. 
     
     
       21. The device of  claim 20  wherein the means for aiding in the comparison includes means for aiding in the comparison of the height of at least four adjacent peaks, P 1 , P 2 , P 3  and P 4 , having heights of H 1 , H 2 , H 3  and H 4 , respectively. 
     
     
       22. The device of  claim 21  further comprising means for detecting the presence of aortic valve abnormalities if at least one of: H 1 >H 2 , H 2 <H 3 , and H 3 >H 4 ; and H 1 <H 2 , H 2 >H 3  and H 3 <H 4  occurs. 
     
     
       23. The device of  claim 18  wherein the time dependant array of pulse wave forms comprises a series of at least four adjacent pulse wave forms including a first wave form having a peak P 1 , and a height H 1 ; a second pulse wave form having a peak P 2  and a height H 2 ; a third pulse wave form having a peak P 3  and a height H 3 ; and a fourth pulse wave form having a peak P 4  and a height H 4 ; further comprising means for detecting the presence of aortic valve abnormalities if at least one of: H 1 >H 2 , H 2 <H 3 , and H 3 >H 4 ; and H 1 <H 2 , H 2 >H 3  and H 3 <H 4  occurs. 
     
     
       24. The device of  claim 18  further comprising means for graphically displaying the time dependant array of pulse wave forms, wherein the time dependant array of pulse wave forms displayed by the graphic display means includes a series of pulse wave forms each having a peak, and the graphic display means includes means for displaying an envelope line that extends between the peaks of adjacent wave forms, and 
       the means for aiding in the identification of wave form characteristics includes means for identifying the slope of the envelope line to determine whether it denotes the presence of aortic valve abnormalities.  
     
     
       25. The device of  claim 24  wherein the means for identifying the slope of the envelope line comprises means for determining whether the envelope line has an undulating slope, thereby suggesting the presence of aortic valve abnormalities. 
     
     
       26. A device for identifying the existence of aortic valve abnormalities, comprising: 
       (1) a non-invasive pressure inducing means for inducing a pressure to a body part of a patient;  
       (2) a data receiving means for receiving a stream of pulsation signal data from the patient relating to the pressure response of pulsed fluid flowing through a cardiovascular system of the patient;  
       (3) a data processing means for processing the stream of pulsation signal data to create an array of time dependant wave form data;  
       (4) means for converting the array of time dependant wave form data to an array of frequency dependant wave form data; and  
       (5) means for aiding in the identification of characteristics of the frequency dependant wave form data that denote the presence of aortic valve abnormalities.  
     
     
       27. The device of  claim 26  wherein the means of converting the time dependant wave form data comprises a program means using a Fourier transformation to convert the time dependant wave form data to frequency dependant wave form data. 
     
     
       28. The device of  claim 26  wherein the means for aiding in the identification of the characteristics of the frequency dependant wave form data includes means for aiding in the identification of a first series of harmonically occurring flow signals corresponding to a flow of fluid forwardly through the aortic valve, and in the detection of the presence or absence of a second series of harmonically occurring flow signals corresponding to aortic regurgitation. 
     
     
       29. The device of  claim 28  wherein the flow signals of the first series each have a corresponding flow signal of the second series, each of the flow signals of the first series has an amplitude A 1 , and each of the flow signals of the second series has an amplitude A 2  and further comprising means for comparing the amplitude A 2  of a flow signal of the second series to the amplitude A 1  of a flow signal of the first series to obtain a semi-quantitative analysis of the aortic regurgitation. 
     
     
       30. The device of  claim 29  wherein the means for comparing the amplitudes comprises means for determining a ratio A 2 /A 1  of the amplitudes of corresponding flow signals of the second and first series to approximate the ratio of aortic regurgitation flow to forward fluid flow through the aortic valve. 
     
     
       31. The device of  claim 28  wherein the flow signals of the first series each have a corresponding flow signal of the second series, 
       each of the flow signals of the first series has a density D 1    
       each of the flow signals of the second series has a density, D 2  and  
       further comprising means for comparing the density D 2  of the flow signal of the second series to the density D 1  of the flow signal of the first series to obtain a semi-quantitative value of the aortic regurgitation.  
     
     
       32. The device of  claim 31  wherein the means for comparing the densities comprises means for determining the ratio D 2 /D 1  of corresponding flow signals of the second and first series to approximate the ratio of aortic regurgitation flow, to the flow of fluid forward through the aortic valve. 
     
     
       33. A method for identifying the existence of aortic valve abnormalities in a patient wherein the patient employs a non- invasive pressure inducer for inducing a pressure on a body part of the patient by applying pressure to the body part, and generating a stream of pulsation signal data relating to the pressure response of pulsed fluid flowing through the cardiovascular system of the patient, the method comprising the steps of:    
       (   1   )  providing a data receiver;    
       (   2   )  using the data receiver to receive the stream of pulsation signal data;    
       (   3   )  providing a data processor;    
       (   4   )  using the data processor for processing the stream of pulsation signal data to create an array of wave forms; and    
       (   5   )  identifying wave form characteristics that denote the presence of aortic valve abnormalities.   
     
     
       34. The method of  claim 33  wherein the step of using the data processor comprises the step of using the data processor to create a time dependant array of wave forms. 
     
     
       35. The method of  claim 34  wherein each of the wave forms of the time dependant array of wave forms includes a peak, and the step of identifying wave form characteristics includes the step of comparing the height of a series of adjacent wave form peaks. 
     
     
       36. The method of  claim 35  wherein the step of comparing the height of a series of adjacent wave form peaks includes the step of comparing the height of at least four adjacent peaks, P 1   , P   2   , P   3    and P   4   , having heights of H   1   , H   2   , H   3    and H   4   , respectively.   
     
     
       37. The method of  claim 36  further comprising the step of detecting the presence of aortic valve abnormalities if at least one of (   1   ):  H   1   >H   2   , H   2   <H   3   , and H   3   >H   4   ; and  (   2   ):  H   1   <H   2   , H   2   >H   3    and H   3   <H   4    occurs.   
     
     
       38. The method of  claim 33  wherein the array of wave forms comprises a series of at least four adjacent wave forms including a first wave form having a peak P 1   , and a height H   1   ; a second wave form having a peak P   2    and a height H   2   ; a third wave form having a peak P   3    and a height H   3   ; and a fourth wave form having a peak P   4    and a height H   4   ; further comprising the step of detecting the presence of aortic valve abnormalities if at least one of:  (   1   )  H   1   >H   2   , H   2   <H   3   , and H   3   >H   4   ; and  (   2   )  H   1   <H   2   , H   2   >H   3    and H   3   <H   4    occurs.   
     
     
       39. The method of  claim 33  further comprising the step of graphically displaying the array of wave forms. 
     
     
       40. The method of  claim 39  wherein 
       (   1   )  the step of using the data processor comprises the step of using the data processor to create a time dependant array of wave forms including a series of waveforms each having a peak,    
       (   2   )  the step of graphically displaying the array of waveforms comprises the step of graphically displaying the time dependant array of wave forms includes the series of wave forms each having a peak,    
       (   4   )  the step of graphically displaying the time dependant array includes the step of displaying an envelope line that extends between the peaks of adjacent wave forms, and    
       (   5   )  the step of identifying wave form characteristics includes the step of identifying the slope of the envelope line to determine whether it denotes the presence of aortic valve abnormalities.   
     
     
       41. A method for identifying the existence of aortic valve abnormalities in a patient wherein the patient employs a non- invasive pressure inducer for inducing a pressure on a body part of the patient, and who exerts a pressure on the body part, thereby generating a stream of pulsation signal data relating to the pressure response of pulsed pressure flowing through the cardiovascular system of the patient, the method comprising the steps of:    
       (   1   )  providing a data receiver;    
       (   2   )  using the data receiver to receive the stream of pulsation signal data    
       (   3   )  providing a data processor;    
       (   4   )  processing the stream of pulsation signal data to create an array of time dependant wave form data;    
       (   5   )  converting the array of time dependant wave form data to an array of frequency dependant wave form data; and    
       (   6   )  identifying characteristics of the frequency dependant wave form data that denote the presence of aortic valve abnormalities.   
     
     
       42. The method of  claim 41  wherein the steps of converting the time dependant wave form data comprises the step of using a Fourier transformation to convert the time dependant wave form data to frequency dependant wave form data. 
     
     
       43. The method of  claim 41  wherein the step of identifying the characteristics of the frequency dependant wave form data includes the step of identifying a first series of harmonically occurring flow signals corresponding to a flow of fluid forwardly through the aortic valve, and detecting the presence or absence of a second series of harmonically occurring flow signals corresponding to aortic regurgitation. 
     
     
       44. The method of  claim 43  wherein the flow signals of the first series each have a corresponding flow signal of the second series, each of the flow signals of the first series has an amplitude A 1   , and each of the flow signals of the second series has an amplitude A   2    and further comprising the step of comparing the amplitude A   2    of a flow signal of the second series to the amplitude A   1    of a flow signal of the first series to obtain a semi - quantitative analysis of the aortic regurgitation.   
     
     
       45. The method of  claim 44  wherein the step of comparing the amplitudes comprises the step of determining a ratio A 2   /A   1    of the amplitudes of corresponding flow signals of the second and first series to approximate the ratio of aortic regurgitation flow to forward fluid flow through the aortic valve.   
     
     
       46. The method of  claim 41  wherein the flow signals of the first series each have a corresponding flow signal of the second series, 
       
         each of the flow signals of the first series has a density, D 
         1  
       
       
         each of the flow signals of the second series has a density, D 
         2  
         and  
       
         further comprising the step of comparing the density D   2    of the flow signal of the second series to the density D   1    of the flow signal of the first series to obtain a semi - quantitative value of the aortic regurgitation.   
     
     
       47. The method of  claim 46  wherein the step of comparing the densities comprises the step of determining the ratio D 2   /D   1    of corresponding flow signals of the second and first series to approximate the ratio of aortic regurgitation flow, to the flow of fluid forward through the aortic valve.   
     
     
       48. The method of  claim 43  further comprising the step of evaluating the frequency shift between the flow signals of the first series and the flow signals of the second series. 
     
     
       49. The method of  claim 48  wherein the step of evaluating the frequency shift comprises the step of evaluating the frequency shift between the flow signals of the first series and the flow signals of the second series to determine at least one of the nature, type and characteristics of the aortic regurgitation of the patient. 
     
     
       50. A device for identifying the existence of aortic valve abnormalities in a patient wherein a non- invasive pressure inducer has been employed for applying a pressure to a body part and for generating a stream of pulsation signal data relating to the pressure response of pulsed fluid flowing through the cardiovascular system of the patient, the device comprising:    
       (   1   )  a data receiver for receiving the stream of pulsation signal data; and    
       (   2   )  a data processor for processing the stream of pulsation signal data to create a time dependant array of wave forms, the data processor including a program for aiding in the identification of wave form characteristics that denote the presence of aortic valve abnormalities.   
     
     
       51. The device of  claim 50  further comprising a graphic display for displaying the time dependant array of wave forms. 
     
     
       52. The device of  claim 50  wherein each of the wave forms of the time dependant array of wave forms includes a peak, and the program for aiding in the identification of wave form characteristics includes a program for aiding in the comparison of the height of a series of adjacent wave form peaks. 
     
     
       53. The device of  claim 52  wherein the program for aiding in the comparison includes a program for aiding in the comparison of the height of at least four adjacent peaks, P 1   , P   2   , P   3    and P   4   , having heights of H   1   , H   2   , H   3    and H   4   , respectively.   
     
     
       54. The device of  claim 53  wherein the program includes programming for detecting the presence of aortic valve abnormalities if at least one of: H 1   >H   2   , H   2   <H   3   , and H   3   >H   4   ; and H   1   <H   2   , H   2   >H   3    and H   3   <H   4    occurs.   
     
     
       55. The device of  claim 50  wherein the time dependant array of wave forms comprises a series of at least four adjacent wave forms including a first wave form having a peak P 1   , and a height H   1   ; a second wave form having a peak P   2    and a height H   2   ; a third wave form having a peak P   3    and a height H   3   ; and a fourth wave form having a peak P   4    and a height H   4    wherein the program includes a program for detecting the presence of aortic valve abnormalities if at least one of: H   1   >H   2   , H   2   <H   3   , and H   3   >H   4   ; and H   1   <H   2   , H   2   >H   3    and H   3   <H   4    occurs.   
     
     
       56. The device of  claim 50  further comprising a graphic display for displaying the time dependant array of wave forms, wherein the time dependant array of wave forms displayed by the graphic display includes a series of wave forms each having a peak, and the graphic display is capable of displaying an envelope line that extends between the peaks of adjacent wave forms, and 
       
         the program for aiding in the identification of wave form characteristics includes a program for identifying the slope of the envelope line to determine whether it denotes the presence of aortic valve abnormalities. 
       
     
     
       57. The device of  claim 56  wherein the program for identifying the slope of the envelope line is capable of determining whether the envelope line has an undulating slope, thereby suggesting the presence of aortic valve abnormalities. 
     
     
       58. A device for identifying the existence of aortic valve abnormalities in a patient wherein a non- invasive pressure inducer has been employed for applying a pressure to a body part of the patient, and for generating a stream of pulsation signal data relating to the pressure response of pulsed fluid flowing through the cardiovascular system of the patient, the device comprising:    
       (   1   )  a data receiver for receiving the stream of pulsation signal data;    
       (   2   )  a data processor for processing the stream of pulsation signal data to create an array of time dependant wave form data;    
       (   3   )  a conversion program for converting the array of time dependant wave form data to an array of frequency dependant wave form data; and    
       (   4   )  a program for aiding in the identification of characteristics of the frequency dependant wave form data that denote the presence of aortic valve abnormalities.   
     
     
       59. The device of  claim 58  wherein the conversion program comprises a conversion program that uses a Fourier transformation to convert the time dependant wave form data to frequency dependant wave form data. 
     
     
       60. The device of  claim 58  wherein the program for aiding the identification of the characteristics of the frequency dependant wave form data includes a program for aiding in the identification of a first series of harmonically occurring flow signals corresponding to a flow of fluid forwardly through the aortic valve, and in the detection of the presence or absence of a second series of harmonically occurring flow signals corresponding to aortic regurgitation. 
     
     
       61. The device of  claim 60  wherein the flow signals of the first series each have a corresponding flow signal of the second series, each of the flow signals of the first series has an amplitude A 1   , and each of the flow signals of the second series has an amplitude A   2    and further comprising a comparison program for comparing the amplitude A   2    of a flow signal of the second series to the amplitude A   1    of a flow signal of the first series to obtain a semi - quantitative analysis of the aortic regurgitation.   
     
     
       62. The device of  claim 61  wherein the comparison program is capable of determining a ratio A 2   /A   1    of the amplitudes of corresponding flow signals of the second and first series to approximate the ratio of aortic regurgitation flow to forward fluid flow through the aortic valve.   
     
     
       63. The device of  claim 60  wherein the flow signals of the first series each have a corresponding flow signal of the second series, 
       
         each of the flow signals of the first series has a density, D 
         1  
       
       
         each of the flow signals of the second series has a density, D 
         2  
         and  
       
         further comprising a comparison program for comparing the density D   2    of the flow signal of the second series to the density D   1    of the flow signal of the first series to obtain a semi - quantitative value of the aortic regurgitation.   
     
     
       64. The device of  claim 63  wherein the comparison program for comparing the densities is capable of determining the ratio D 2   /D   1    of corresponding flow signals of the second and first series to approximate the ratio of aortic regurgitation flow, to the flow of fluid forward through the aortic valve.