Method and apparatus for non-invasively measuring hemodynamic parameters using parametrics

• US 8,597,195 B2
• Filed: 01/10/2011
• Issued: 12/03/2013
• Est. Priority Date: 02/05/2002
• Status: Expired due to Fees

• Current Assignee: United States GTM Medical Devices
• Original Assignee: Tensys Medical Inc. (Recorders & Medicare Systems Pvt Ltd.)
• Inventors: Gallant, Stuart L., Voss, Gregory I., Markle, William H.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US12/987,928
• Publication Number:
  US 20110166458A1
• Time in Patent Office: 1,058 Days
• Field of Search: 600/481, 600483-486, 600/488, 600490-504
• US Class Current: 600/485
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure

Abstract

An improved method and apparatus for non-invasively assessing one or more hemodynamic parameters associated with the circulatory system of a living organism. In one aspect, the invention comprises a method of measuring a hemodynamic parameter (e.g., arterial blood pressure) by applanating or compressing portions of tissue proximate to the blood vessel of concern until a desired condition is achieved, and then measuring the hemodynamic parameter. Such applanation effectively mitigates transfer and other losses created by the tissue proximate to the blood vessel, thereby facilitating accurate and robust tonometric measurement. An algorithm adapted to maintain optimal levels of applanation is also described. Methods and apparatus for scaling such hemodynamic parameter measurements based on subject physiology, and providing treatment to the subject based on the measured parameters, are also disclosed.

Claims

1. Apparatus adapted to measure pressure of a blood vessel of a living subject, comprising:

a digital processor;

a pressure sensor adapted to generate a signal relating to pressure applied thereto; and

wherein said digital processor is configured to receive said signal from said pressure sensor and scale said signal using a scaling factor based at least in part on a body mass index (BMI) of said subject.

2. The apparatus of claim 1, further comprising a bias element disposed proximate to said pressure sensor and adapted to mitigate effects of tissue interposed between said sensor and said blood vessel, said bias element substantially surrounding at least a portion of said pressure sensor.

3. The apparatus of claim 2, further comprising an applanation apparatus adapted to controllably press at least a portion of said pressure sensor and said bias element against said tissue.

4. The apparatus of claim 2, wherein said living subject comprises a human being, and said bias element uses at least said pressure sensor to at least partly applanate a radial artery of said human being, said at least partial applanation being performed while said signal is being generated.

5. The apparatus of claim 1, wherein said signals relating to said pressure comprise a measurement of systolic and diastolic pressure of said subject.

6. The apparatus of claim 1, wherein said digital processor is further configured to scale said signal using said scaling factor based at least in part on said BMI via said digial processor being further configured to:

determine said BMI said subject; and

identify a relationship between said BMI and said scaling factor; and

using said scaling factor to scale said signal relating to pressure applied to said pressure sensor.

7. The apparatus of claim 1, further comprising a user interface operative to receive data entered by a user, said data relating to at least said body mass index.

8. A method of measuring pulse pressure of a living subject, comprising:

utilizing a pressure sensor to obtain a plurality of pressure values associated with a systolic and diastolic pressure of a blood vessel of said living subject;

utilizing said plurality of pressure values to determine a pulse pressure of said living subject;

deriving a scaling factor based at least in part on a body mass index (BMI) of said subject;

scaling said determined pulse pressure using said scaling factor using at least a processor associated with said pressure sensor; and

presenting said scaled pulse pressure to a user.

9. The method of claim 8, further comprising determining a mean pulse pressure, and said act of scaling said determined pulse pressure comprises applying said scaling factor to pressure values above and below said mean.

10. The method of claim 9, wherein said act of applying said scaling factor to said pressure values above and below said mean comprises applying a positive (+) scaling factor to systolic pressures above said mean, and a negative (−

) scaling factor to diastolic pressures below said mean.

11. The method of claim 8, wherein said act of determining said derivation of said scaling factor comprises utilizing one or more inputs received from a user via a user interface.

12. A method of measuring pulse pressure of a living subject, comprising:

obtaining via pressure sensor a plurality of pressure values associated with a blood vessel of said living subject;

deriving a scaling factor based on body mass index (BMI);

using at least a processor associated with said pressure sensor to scale said plurality of pressure values using said scaling factor; and

utilizing at least said scaled pressure values to generate a pulse pressure value of said living subject.

13. The method of claim 12, wherein said act of obtaining said plurality of pressure values comprises applanating said blood vessel of said living subject via said pressure sensor.

14. The method of claim 13, wherein said living subject comprises a human being, and said act of applanating is performed substantially contemporaneously with said act of measuring said plurality of pressure values.

15. The method of claim 13, further comprising:

varying a level of applanation applied to said blood vessel by said pressure sensor over time;

determining a level of compression where a desired condition of said plurality of pressure values associated with said blood vessel exists; and

maintaining said pressure sensor at or near said level of compression where said desired condition exists.

16. A method of measuring pulse pressure of a living subject, comprising:

utilizing a pressure sensor to measure a plurality of pressure values of a blood vessel of said living subject;

determining a physiological parameter of said living subject;

deriving a scaling factor based at least in part on said physiological parameter via a processor in communication with said pressure sensor, said physiological parameter comprising a ratio of body mass index (BMI) to wrist circumference (WC);

said processor scaling said plurality of pressure values using said scaling factor; and

utilizing said scaled pressure values to generate at least one pulsatile pressure value via said processor.

17. The method of claim 16, wherein said act of utilizing a pressure sensor measure said plurality of pressure values of a blood vessel comprises obtaining a tonometric measurement of a systolic and diastolic pressure of said living subject.

18. The method of claim 16, wherein said act of utilizing a pressure sensor to measure a plurality of pressure values comprises applanating said blood vessel of said living subject via said pressure sensor.

19. The method of claim 18, further comprising:

varying a level of applanation applied to said blood vessel by said pressure sensor over time;

determining a level of compression where a desired condition of said plurality of pressure values associated with said blood vessel exists; and

maintaining said pressure sensor at or near said level of compression where said desired condition exists.

20. Apparatus for measuring the pulse pressure of a living subject, comprising:

a first means for generating a signal relating to pressure in a blood vessel of said subject,

said signal being affected at least in part by tissue interposed between said first means and a blood vessel of said subject;

a second means for scaling said signal using a scaling factor, said scaling factor comprising a value derived from at least a wrist circumference (WC) of said subject;

a third means for outputting a value for said pulse pressure based on said scaled signal; and

a fourth means for mitigating the effects of said tissue on said signal, said first and fourth means being disposed proximate to one another.

21. The apparatus of claim 20, further comprising a means for controllably pressing at least a portion of said first and fourth means against said tissue.

22. The apparatus of claim 20, wherein further comprising a bias element substantially enveloping at least a portion of said first means.

23. The apparatus of claim 22, wherein said living subject comprises a human being, and said apparatus uses at least said bias element to at least partly applanate the radial artery of said human being, said at least partial applanation being performed while said signal is being generated.

24. The apparatus of claim 20, wherein said scaling factor further comprises a value derived from at least a body mass index (BMI) of said subject, and said apparatus further comprises a means for receiving data relating to said subject'"'"'s weight and said subject'"'"'s height from a user, said BMI being calculated from said weight and height data.

25. The apparatus of claim 20, further comprising a fifth means for receiving data entered by a user, said data relating to at least said WC.