Method and apparatus for the noninvasive assessment of hemodynamic parameters including blood vessel location

• US 7,503,896 B2
• Filed: 03/22/2001
• Issued: 03/17/2009
• Est. Priority Date: 06/29/1999
• Status: Expired due to Fees

• Current Assignee: Tensys Medical Inc. (Recorders & Medicare Systems Pvt Ltd.)
• Original Assignee: Tensys Medical Inc. (Recorders & Medicare Systems Pvt Ltd.)
• Inventors: Baura, Gail D., Miele, Frank R., Mucci, Ronald
• Primary Examiner(s): Smith; Ruth S
• Assistant Examiner(s): CWERN, JONATHAN
• Application Number:
  US09/815,982
• Publication Number:
  US 20020055680A1
• Time in Patent Office: 2,917 Days
• Field of Search: 600437-472, 600/301, 600/485, 600/500
• US Class Current: 600/454
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/489 Blood vessels
• CPC Class Codes: A61B 5/6806 Gloves
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/7225 Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• CPC Class Codes: A61B 8/04 Measuring blood pressure
• CPC Class Codes: A61B 8/4227 characterised by straps, belts, cuffs or braces

Abstract

A method and apparatus for determining the mean arterial blood pressure (MAP) of a subject during tonometric conditions. In one embodiment, the apparatus comprises one or more pressure and ultrasound transducers placed over the radial artery of a human subject'"'"'s wrist, the latter transmitting and receiving acoustic energy so as to permit the measurement of blood velocity during periods of variable compression of the artery. In another aspect of the invention, a wrist brace useful for measuring blood pressure using the aforementioned apparatus is disclosed. In yet another aspect of the invention, backscattered acoustic energy is used to identify the location of the blood vessel of interest, and optionally control the position of measurement or treatment equipment with respect thereto.

Claims

1. A method of positioning a blood pressure sensor including locating a blood vessel disposed within surrounding tissue, comprising:

transmitting acoustic energy into said tissue including said blood vessel;

evaluating reflections of said acoustic energy from said tissue and said blood vessel,

identifying at least one region of reduced energy reflection within said tissue, said at least one region corresponding to said blood vessel,

said act of identifying comprising automatically detecting a local minimum indicative of both lateral position and depth; and

positioning said blood pressure sensor based at least in part on said act of identifying.

2. The method of claim 1, wherein said blood pressure sensor comprises a tonometric sensor, and said act of evaluating comprises analyzing at least one A-mode line.

3. The method of claim 2, further comprising correlating said at least one region to a depth location within said tissue based on said act of analyzing said at least one A-mode line.

4. The method of claim 2, wherein said act of identifying comprises:

forming at least one integrated power representation based on said reflections; and

identifying at least one artifact within said at least one integrated power representation, said at least one artifact corresponding to the lumen of said blood vessel.

5. The method of claim 4, wherein said act of identifying at least one artifact comprises identifying at least one plateau within a normalized integrated power profile.

6. The method of claim 1, wherein said act of identifying comprises:

measuring the signal level of said reflections as a function of depth within said tissue; and

identifying the lumen of said blood vessel based on at least one feature identified during said act of measuring.

7. The method of claim 1, wherein the act of identifying comprises:

determining a power metric from said reflections;

integrating said power metric to produce a power function;

normalizing said power function;

dividing said normalized power function into a plurality of intervals; and

evaluating at least one of said intervals to identify an artifact.

8. The method of claim 1, wherein said act of evaluating further comprises detecting an envelope associated with said reflections.

9. The method of claim 8, wherein said act of envelope detecting comprises:

providing an A-mode representation of said reflections;

multiplying at least a portion of said A-mode representation by a sine and a cosine function to produce a demodulated signal; and

lowpass filtering said demodulated signal.

10. The method of claim 9, wherein said act of lowpass filtering comprises filtering with a FIR filter, said FIR filter having a plurality of coefficients associated therewith.

11. The method of claim 9, further comprising applanating at least a portion of said tissue in order to reduce interference.

12. The method of claim 1, wherein said blood pressure sensor comprises a tonometric pressure sensor, and said act of transmitting comprises transmitting from an ultrasonic device, said pressure sensor and said ultrasonic device being substantially co-located.

13. A method of positioning a pressure transducer including locating a blood vessel in tissue, comprising:

generating at least one beam of acoustic waves;

transmitting said at least one beam of acoustic waves into said tissue, said beam moving with respect to said tissue so as to ensonify different portions of said tissue as a function of time;

receiving energy backscattered by said tissue and said blood vessel;

analyzing said backscattered energy to identify at least one plateau therein, said at least one plateau resulting from the lumen of said blood vessel;

correlating said at least one plateau to the location of said blood vessel; and

positioning said pressure transducer based at least in part on said location of said blood vessel.

14. Blood pressure sensor positioning apparatus, comprising:

a pressure sensor;

apparatus adapted to move said pressure sensor;

at least one transducer capable of transmitting an acoustic wave into tissue containing a blood vessel and receiving a plurality of echoes therefrom, said at least one transducer configured to generate first signals related to said echoes;

a processor, operatively connected to said at least one transducer, and configured to process said first signals to determine the location of the lumen of said blood vessel by comparing a region of reduced energy reflection within said tissue as compared with higher levels of energy reflection in surrounding tissue; and

a controller, operatively coupled to said apparatus adapted to move, said controller positioning said pressure sensor based at least in part on said location of the lumen;

wherein said transmitting an acoustic wave further comprises sweeping transversely across said tissue.

15. The apparatus of claim 14, wherein said processor is adapted to determine a power profile associated with said echoes, and identify at least one artifact therein, said at least one artifact corresponding at least in part to said lumen.

16. The apparatus of claim 15, wherein said power profile is integrated over a variable corresponding to the propagation of said acoustic wave, and said at least one artifact comprises a plateau within said integrated power profile.

17. The apparatus of claim 14, wherein said processor is adapted to determine a Doppler shift associated with blood present in said blood vessel.

18. The apparatus of claim 14, wherein said processor is adapted to compare the signal level of at least a portion of said echoes and identify at least one artifact therein.

19. The apparatus of claim 18, wherein said signal level comprises an envelope-squared metric, and said at least one artifact comprises a reduction in the magnitude of said envelope-squared metric, said reduction corresponding to said lumen of said blood vessel.

20. A method of positioning a blood pressure sensor including locating a blood vessel disposed within surrounding tissue, comprising the steps of:

transmitting acoustic energy into said tissue including said blood vessel to generate reflections thereof;

receiving said reflections of said acoustic energy from said tissue and said blood vessel;

forming at least one integrated power representation to identify at least one region of reduced energy reflection within said tissue, said at least one region corresponding to the lumen of said blood vessel;

locating said blood vessel based on the location of said lumen; and

positioning said sensor based at least in part on said act of locating.

21. Blood vessel locating apparatus, comprising:

at least one first transducer capable of transmitting an acoustic wave into a blood vessel and receiving a plurality of echoes therefrom, said first transducer configured to generate first signals related to said echoes;

at least one pressure transducer capable of obtaining a plurality of pressure signals from said blood vessel;

at least one signal converter, operatively coupled to said at least one first transducer and adapted to produce second signals from said first signals;

at least one digital processor, operatively coupled to an analog-to-digital converter, and configured to process said second signals; and

a computer program running at least in part on said digital processor, said computer program being adapted to determine a power profile based on said second signals, and to determine the location of the lumen of said blood vessel based at least in part on one or more artifacts present within said power profile;

said computer program further being adapted to measure pressure within said blood vessel based at least in part on said pressure signals.

22. A method of positioning a pressure sensor by locating a blood vessel disposed within surrounding tissue, comprising:

transmitting acoustic energy into said tissue including said blood vessel;

receiving reflections of said acoustic energy from said tissue and said blood vessel;

basebanding at least a portion of said received reflections to produce baseband data;

developing an envelope squared representation of said baseband data;

applying a depth-dependent gain to at least a portion of said envelope squared representation;

identifying said blood vessel based at least in part on an output of said act of applying; and

positioning said sensor based at least in part on said act of identifying.

23. The method of claim 22, further comprising decimating at least a portion of said data or said envelope squared.

24. A method of locating at least one wall of a blood vessel, comprising:

purposely compressing tissue surrounding at least a portion of said vessel so as to collapse interposed vessels;

transmitting acoustic energy into the blood vessel;

receiving reflected energy from said blood vessel;

detecting at least one region associated with the lumen in said blood vessel from said reflected energy;

starting at said at least one region, computing an integrated power in a first direction;

evaluating said integrated power as a function of said direction; and

detecting the location of said at least one wall of the blood vessel based at least in part on said act of evaluating.

25. The method of claim 24, wherein said received reflected energy is used to form A-mode signals, and said act of computing an integrated power comprises summing consecutive samples of a square of an envelope of said A-mode signals in said first direction.

26. A method of locating a first blood vessel disposed within surrounding tissue, comprising:

applanating at least said tissue, said applanating comprising at least partly compressing one or more second blood vessels proximate to said first blood vessel;

transmitting acoustic energy into said tissue including said first blood vessel;

evaluating reflections of said acoustic energy from said tissue and said first blood vessel; and

identifying at least one region of reduced energy reflection within said tissue as compared with higher levels of energy reflection in surrounding tissue, said at least one region corresponding to said first blood vessel.

27. The method of claim 26, wherein said act of at least partly compressing results in reducing interference with said act of identifying, said reducing of interference resulting at least in part from compression of said one or more second blood vessels.

28. A method of positioning a blood pressure sensor including locating a blood vessel disposed within surrounding tissue, comprising:

a step for transmitting acoustic energy into said tissue including said blood vessel;

a step for evaluating reflections of said acoustic energy from said tissue and said blood vessel;

a step for identifying at least one region of reduced energy reflection within said tissue, said at least one region corresponding to said blood vessel, said step for identifying comprising at least a step for automatically detecting a local minimum indicative of both lateral position and depth; and

a step for positioning said blood pressure sensor based at least in part on said step for detecting.

29. A method of positioning a pressure transducer including locating a blood vessel in tissue, comprising:

generating acoustic waves;

transmitting said acoustic waves into said tissue so as to ensonify different portions of said tissue as a function of time;

receiving energy backscattered by said tissue and said blood vessel;

analyzing said backscattered energy to identify at least one plateau therein, said at least one plateau resulting from the lumen of said blood vessel;

correlating said at least one plateau to the a location of said blood vessel; and

positioning said pressure transducer based at least in part on said location of said blood vessel.

30. A method of positioning a tonometric blood pressure sensor including locating a blood vessel disposed within surrounding tissue, comprising:

transmitting acoustic energy into said tissue including said blood vessel to generate reflections thereof, and receiving said reflections of said acoustic energy from said tissue and said blood vessel;

forming at least one integrated power representation using at least said reflections;

identifying at least one region of reduced energy reflection within said tissue, said at least one region corresponding to the lumen of said blood vessel;

locating said blood vessel based on the location of said lumen; and

positioning said sensor based at least in part on said act of locating.

31. Blood vessel locating apparatus further adapted for measuring blood pressure, comprising:

apparatus for transmitting an acoustic wave into a blood vessel and receiving a plurality of echoes therefrom;

apparatus for generating first signals related to said echoes;

apparatus for obtaining pressure signals from said blood vessel;

apparatus for converting said first signals to second signals;

apparatus for processing said second signals, said apparatus for processing being operatively coupled to said apparatus for converting; and

apparatus for determining a power profile based on said second signals, and for determining the location of the lumen of said blood vessel based at least in part on one or more artifacts present within said power profile;

said apparatus for determining further comprising apparatus for determining pressure within said blood vessel based at least in part on said pressure signals.

32. A method of positioning a blood pressure sensor by locating a blood vessel disposed within surrounding tissue, comprising:

a step for transmitting acoustic energy into said tissue including said blood vessel;

a step for receiving reflections of said acoustic energy from said tissue and said blood vessel;

a step for producing basebanded data from at least a portion of said received reflections;

a step for developing an envelope squared representation of said baseband data;

a step for applying a depth-dependent gain to at least a portion of said envelope squared representation;

a step for identifying said blood vessel based at least in part on an output of said step of applying; and

a step for positioning said blood pressure sensor above said identified blood vessel.