Non-invasive methods and systems for assessing cardiac filling pressure

• US 9,549,678 B2
• Filed: 07/01/2009
• Issued: 01/24/2017
• Est. Priority Date: 07/08/2008
• Status: Active Grant

• Current Assignee: Johns Hopkins University
• Original Assignee: Johns Hopkins University
• Inventors: Silber, Harry A.
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): Alter, Mitchell E
• Application Number:
  US13/003,076
• Publication Number:
  US 20110245691A1
• Time in Patent Office: 2,764 Days
• Field of Search: 600/485
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02116 of pulse wave amplitude A61B5/02225 takes precedence
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips

Abstract

Featured are methods and systems for assessing cardiac filing pressure non-invasively. Such methods include, inter alia, arranging a photoplethysmography (PPG) transducer on a finger of a patient and fluidly coupling a pressure transducer to the patient'"'"'s mouth so that the pressure transducer measures expiratory pressure. The PPG transducer provides an output of a pulse volume signal of cardiac circulatory flow. Such methods also including determining a pulse amplitude ratio, using the pulse volume near the end of the expiratory effort and a baseline pulse volume, and assessing the pulse amplitude ratio so as to determine a filing pressure condition for the heart of the patient.

Claims

1. A method, comprising:

displaying to the user (1) a target expiratory pressure for the user, (2) a target time period for maintaining by the user the target expiratory pressure, and (3) a representation of a target location for the user to place an optical pulse volume sensing device;

sensing a change in pulse volume using the optical pulse volume sensing device coupled to a finger of the user, the optical pulse volume sensing device including a photoplethysmography (PPG) transducer, the optical pulse volume sensing device configured to sense a change in volume caused by a volume pulse by illuminating skin with light from a light emitting diode (LED), and is configured to provide an output of a pulse pressure signal of cardiac circulatory flow;

measuring an expiratory pressure for a predetermined period of time using a pressure transducer fluidly coupled to a mouth;

determining a pulse amplitude ratio, which is a ratio of the pulse amplitude near an end of the predetermined period of time and a baseline pulse amplitude; and

assessing the determined pulse amplitude ratio based on a correlation to determine a filling pressure condition of a heart, the correlation being associated with a graphical plot of a plurality of left ventricular end diastolic pressure (LVEDP) measurements of a plurality of patients using a catheter, and a graphical plot of the plurality of LVEDP measurements against a plurality of pulse amplitude ratios of the plurality of patients.

2. The method of claim 1, wherein the pressure transducer is disposed in one of a mouth piece or a tubing so the pressure transducer is located remote from the mouth.

3. The method of claim 1, further comprising:

communicatively coupling a microprocessor to each of the pressure transducer and the optical pulse volume sensing device; and

determining the pulse amplitude ratio includes determining the pulse amplitude ratio using the microprocessor and output signals from the pressure transducer and the optical pulse volume sensing device.

4. The method of claim 3, wherein the microprocessor includes an applications program including program segments and instructions and criteria for determining the pulse amplitude ratio from the output signals from the pressure transducer and the optical pulse volume sensing device.

5. The method of claim 4, wherein the applications program includes program segments and instructions and criteria for periodically deter mining the pulse amplitude ratio.

6. The method of claim 4, further comprising:

storing in a storage device operably coupled to said microprocessor the determined pulse amplitude ratios, a pulse volume near the end of the predetermined period of time, the baseline pulse volume and measured pressures during the predetermined period of time.

7. The method of claim 3, further comprising:

printing data associated with the determined pulse amplitude ratios using a printing device operably coupled to said microprocessor.

8. The method of claim 6, further comprising:

disposing the microprocessor and storage device in an enclosure of a device.

9. The method of claim 8, wherein the device further includes one of a display device or a printing device;

and wherein said method further includes one of displaying determined information using the display device or outputting a hard copy of the determined information.

10. The method of claim 8, wherein the device microprocessor is communicatively coupled to each of the optical pulse volume sensing device and the pressure transducer.

11. The method of claim 1, wherein:

the optical pulse volume sensing device further includes a communication interface module that is configured to form a communication link with a communications system that is external to said device and to output signals to the communications system that are appropriate for transmission over the communications system.

12. The method of claim 11, further comprising communicating information acquired by the optical pulse volume sensing device to one of a practitioner or a monitoring apparatus.

16. The method of claim 1, wherein said fluidly coupling a pressure transducer to the patient'"'"'s mouth so that the pressure transducer measures an expiratory pressure further comprises maintaining an expiratory pressure condition in the range of from about 20 mmHg to about 35 mmHg.

17. The method of claim 16, wherein the expiratory pressure condition is maintained at about 20 mmHg for about 8 seconds to about 12 seconds.

18. The method of claim 1, wherein the determined correlation is a pulse amplitude ratio of less than or equal to 0.4 indicates a LVEDP of less than or equal to 15 or a pulse amplitude ratio of greater than or equal to 0.7 indicates a LVEDP of greater than or equal to 25.

13. A system for assessing cardiac filling pressure non-invasively, said system comprising:

a display module configured to display to a user (1) a target expiratory pressure for the user, (2) a target time period for maintaining by the user the target expiratory pressure, and (3) a representation of a target location for the user to place an optical pulse volume sensing device;

the optical pulse volume sensing device including a photoplethysmography (PPG) transducer, the optical pulse volume sensing device configured to be located on a finger or digit of the user such that the optical pulse volume sensing device senses a change in volume caused by a pressure pulse by illuminating skin with light from a light emitting diode (LED), the optical pulse volume sensing device configured to provide an output of a pulse pressure signal of cardiac circulatory flow;

a pressure transducer configured to be fluidly coupled to a mouth such that the pressure transducer measures expiratory pressure during a predetermined period of time; and

a processor configured to determine a pulse amplitude ratio, which is a ratio of the pulse pressure near an end of the predetermined period of time and a baseline pulse pressure; and

an output device configured to display the pulse amplitude ratio based on the correlation to determine a filling pressure condition for a heart, the correlation being associated with a graphical plot of a plurality of left ventricular end diastolic pressure (LVEDP) measurements of a plurality of patients using a catheter, and a graphical plot of the plurality of LVEDP measurements against a plurality of pulse amplitude ratios of the plurality of patients.

14. A device for assessing cardiac filling pressure non-invasively, said device comprising:

an optical pulse volume sensing device including a photoplethysmography (PPG) transducer, the optical pulse volume sensing device configured to be located on a finger or digit such that the optical pulse volume sensing device senses a change in volume caused by a pressure pulse by illuminating skin of the finger or digit with light from a light emitting diode (LED), the optical pulse volume sensing device configured to provide an output of a pulse pressure signal of cardiac circulatory flow;

a microprocessor configured to be communicatively coupled to the optical pulse volume sensing device and to a pressure transducer that is fluidly coupled to a mouth such that the pressure transducer measures expiratory pressure during a predetermined period of time, the pressure transducer operatively coupled to a display module configured to display to a user (1) a target expiratory pressure for the user, (2) a target time period for maintaining by the user the target expiratory pressure, and (3) a representation of a target location for the user to place the optical pulse volume sensing device; and

an applications program for execution on the microprocessor, the applications program including program segments and instructions and criteria for determining a pulse amplitude ratio, which is a ratio of the pulse volume near an end of the predetermined period of time and a baseline pulse volume; and

for determining a correlation between the pulse amplitude ratio and left ventricular end diastolic pressure (LVEDP) based on a graphical plot of a plurality of LVEDP measurements of a plurality of patients using a catheter and a graphical plot of the plurality of LVEDP measurements against a plurality of pulse amplitude ratios of the plurality of patients; and

for assessing the determined pulse amplitude ratio based on the correlation so as to determine a filling pressure condition for the heart of the patient.

15. A method for assessing cardiac filling pressure non-invasively, said method comprising:

displaying to the user a representation of a target location for the user to place an optical pulse volume sensing device, the optical pulse volume sensing device including a photoplethysmography (PPG) transducer;

sensing, using the optical pulse volume sensing device operably coupled to a finger or a digit of a patient or subject, a change in volume caused by a pressure pulse by illuminating skin with light from a light emitting diode (LED), the optical pulse volume sensing device configured to provide an output of a pulse pressure signal of cardiac circulatory flow;

providing a positive pressure delivery device;

fluidly coupling a pressure transducer to the patient'"'"'s mouth;

selectively fluidly coupling the positive pressure delivery device to the patient'"'"'s mouth so as to maintain a positive inspiratory pressure condition of about 20 mmHg to about 35 mmHg for about 8 to about 12 seconds;

determining a pulse amplitude ratio while the positive inspiratory pressure condition is maintained, which is a ratio of the pulse amplitude near the end of the predetermined period of time and a baseline pulse amplitude; and

determining a correlation between the determined pulse amplitude ratio and filling pressure, and using the correlation so as to determine a filling pressure condition for the heart of the patient.