Method of continuously monitoring blood pressure

• US 5,261,412 A
• Filed: 11/20/1992
• Issued: 11/16/1993
• Est. Priority Date: 11/20/1992
• Status: Expired due to Term

• Current Assignee: Carefusion 303 Incorporated (Becton, Dickinson & Co)
• Original Assignee: Ivax Corporation (Teva Pharmaceutical Industries, Ltd.)
• Inventors: Butterfield, Robert D., Martin, Stephen A.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Sykes, Angela D.
• Application Number:
  US07/980,931
• Time in Patent Office: 361 Days
• Field of Search: 128/672, 128/676, 128/677-683, 128/687-688, 128/690-691
• US Class Current: 600/485
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02255 the pressure being controlled by plethysmographic signals, e.g. derived from optical sensors

Abstract

A method, for use in a non-invasive blood pressure monitoring system, of operating a tissue stress sensor at an off-optimum arterial applanation state. The system uses a stress sensor including a stress sensitive element for detecting stress of tissue overlying an artery of interest. The tissue stress sensor is placed in communication with tissue overlying the artery of interest and at least one electrical signal is obtained therefrom representing stress data across the length of the stress sensitive element. The data represents stress datum communicated to preselected portions of the stress sensitive element. From the stress datum, various techniques are used to determine the optimum applanation state and the actual applanation state. A waveform scaling factor function is created which compensates for the errors associated with operating the tissue stress sensor at an off-optimum applanation state. Thus, the disclosed method provides the benefits associated with operating a tissue stress sensor at an off-optimum state without sacrificing measurement accuracy.

Claims

1. For use in a non-invasive blood pressure monitoring system, a method of operating a tissue stress sensor at an off-optimum arterial applanation state, said tissue stress sensor of the type for measuring the stress of tissue overlying an artery of interest, said method including the steps of:

(A) placing said stress sensor in communication with said tissue overlying said artery of interest, and collecting stress datum from said sensor,

(B) determining which of said datum corresponds to an optimum artery applanation state,

(C) using said stress sensor for applanating said artery at said off-optimum applanation state,

(D) obtaining from said tissue stress sensor stress datum associated with said tissue overlying said artery while said artery is in said off-optimum applanation state,

(E) using said datum obtained in step (B) and step (D) and deriving correction factors, and

(F) combining said stress data obtained in step (D) with said correction factors derived in step (E) to yield corrected stress data that approximates the intra-arterial blood pressure.

2. The method of claim 1, wherein step (B) includes the substeps of:

(i) computing an applanation optimization factor (AOP) and an applanation state parameter (ASP),

(ii) relating said AOP as a function of said ASP, and

(iii) optimizing the relationship of substep (ii) according to a predetermined optimization rule.

3. The method of claim 2, wherein said AOP of substep (i) is a pulsatile stress parameter (PPAR) which is calculated according to the following formula:

##EQU14## where;

b, c=limits of integration;

σ

_SCS =systolic contact stress;

σ

_DCS =diastolic contact stress;

x=distance along stress sensitive element.

4. The method of claim 3, wherein the limits of integration b, c bound a continuous region of said stress sensor.

5. The method of claim 3, wherein said limits of integration b, c bound at least two discontinuous regions of said stress sensor.

6. The method of claim 2, wherein said ASP of substep (i) is an average contact stress parameter (AASI) which is calculated according to the following formula:

##EQU15## where;

σ

_AVG (AAS₁)=average stress value across the length of the stress sensitive element while the artery of interest undergoes the first artery applanation state;

AAS₁ =First Artery Applanation State;

AASI₁ =First Artery Applanation State Index;

σ

(x)_AAS.sbsb.1 =stress data sensed by stress sensing element at location x while the artery of interest undergoes the first artery applanation state.

7. The method of claim 1, wherein step (F) includes combining stress data with said correction factors according to the following formula:

space="preserve" listing-type="equation">σ

.sub.EFF (t)=σ

.sub.S.P. (t)·

m+b

where;

σ

_EFF (t)=spatially corrected effective contact stress;

σ

_S.P. (t)=stress data obtained in step (C);

m=slope correction factor;

b=offset correction factor.

8. The method of claim 7, wherein said slope correction factor m and said offset correction factor b are derived according to the following formulas:

##EQU16## where;

(σ

*_DIAS)_EFF =effective diastolic contact stress associated with selected regions of the stress sensitive element;

(σ

*_PULSE)_EFF =effective pulsatile contact stress associated with selected regions of the stress sensitive element;

(σ

*_DIAS)_S.P. =diastolic contact stress associated with a specific sampling point along the stress sensitive element;

(σ

*_PULSE)_S.P. =pulsatile contact stress associated with a specific sampling point along the stress sensitive element.

9. The method of claim 8, wherein (o*_DIAS)_EFF and (o*_PULSE)_EFF are calculated according to the following formulas:

##EQU17## where;

o*_DIAS (x)=diastolic contact stress;

o*_PULSE (x)=pulsatile contact stress;

x=location along stress sensitive element;

b, c=limits of integration;

i=discrete location along stress sensitive element.

10. The method of claim 1, wherein step (F) includes combining said stress data with said correction factors according to the following formula:

##EQU18## where;

(o(t))_A =effective contact stress waveform from selected region acquired at known off-optimum applanation;

##EQU19##

11. The method of claim 10, wherein said scaling factors are derived according to the following formulas:

##EQU20## where;

(o_DIAS (ASP)_EFF)_OPT =effective diastolic contact stress at the optimum applanation state;

o_DIAS (ASP)_EFF =effective diastolic contact stress at the actual off optimum applanation state;

(o_PULSE (ASP)_EFF)_OPT =effective pulsatile contact stress at the optimum applanation state;

o_PULSE (ASP)_EFF =effective pulsatile contact stress at the actual off optimum applanation state;

(o_DIAS)_OPT =diastolic contact stress at optimum applanation state.

12. For use in a non-invasive blood pressure monitoring system, a method of operating a tissue stress sensor at a non-optimum arterial applanation state, said tissue stress sensor including a stress sensitive element for measuring the stress of tissue overlying an artery of interest, said stress sensitive element having a length that exceeds the diameter of the lumen of said artery of interest, said method including the steps of:

(A) placing said stress sensitive element of said tissue stress sensor in communication with said tissue overlying said artery of interest,

(B) orienting said stress sensitive element such that said stress sensitive element spans beyond the diameter of the lumen of said artery of interest,

(C) using said stress sensitive element to act upon said artery of interest thereby applanating said artery of interest through a plurality of applanation states, and at each applanation state,

(D) obtaining from said tissue stress sensor at least one electrical signal representing stress data across the length of said stress sensitive element, each stress datum of said stress data representing stress datum communicated to a predetermined portion of said stress sensitive element from said tissue overlying said artery of interest, and from said data obtained in at least one of said plurality of applanation states,

(E) determining an optimum arterial applanation state,

(F) computing an error value associated with said non-optimum arterial applanation state wherein said non-optimum arterial applanation state is different from said optimum arterial applanation sate,

(G) applanating said artery of interest to said non-optimum arterial applanation state,

(H) while said artery is applanated to said non-optimum applanation state, obtaining tissue stress data from said tissue stress sensor, and

(I) combining said stress data obtained in step (H) with said error value computed in step (F) to yield corrected stress data that approximates stress data associated with said tissue overlying said artery of interest when said artery is applanated to said optimum arterial applanation state.

13. The method of claim 12, wherein step (E) includes the substeps of:

(i) computing an applanation optimization factor (AOP) and an applanation state parameter (ASP),

(ii) relating said AOP as a function of said ASP, and

(iii) optimizing the relationship of substep (ii) according to a predetermined optimization rule.

14. The method of claim 13, wherein said AOP of substep (i) is a pulsatile stress parameter (PPAR) which is calculated according to the following formula:

##EQU21## where;

b, c=limits of integration;

σ

_SCS =systolic contact stress;

σ

_DCS =diastolic contact stress;

x=distance along stress sensitive element.

15. The method of claim 14, wherein the limits of integration b,c bound a continuous region of said stress sensor.

16. The method of claim 14, wherein said limits of integration b,c bound at least two discontinuous regions of said stress sensor.

17. The method of claim 13, wherein said ASP of substep (i) is an average contact stress parameter (AASI) which is calculated according to the following formula:

##EQU22## where;

σ

_AVG(AAS.sbsb.1.sub.) =average stress value across the length of the stress sensitive element while the artery of interest undergoes the first artery applanation state;

AAS₁ =First Artery Applanation State;

AASI₁ =First Artery Applanation State Index;

σ

(x)_AAS.sbsb.1 =stress data sensed by stress sensing element at location x while the artery of interest undergoes the first artery applanation state.

18. The method of claim 12, wherein step (I) includes combining stress data with said error value according to the following formula:

space="preserve" listing-type="equation">σ

.sub.EFF (t)=σ

.sub.S.P. (t)·

m+b

where;

σ

_EFF (t)=spatially corrected effective contact stress;

σ

_S.P. (t)=stress data obtained in step (C);

m=slope correction factor;

b=offset correction factor.

19. The method of claim 18, wherein said slope correction factor m and said offset correction factor b are derived according to the following formulas:

##EQU23## where;

(σ

*_DIAS)_EFF =effective diastolic contact stress associated with selected regions of the stress sensitive element;

(σ

*_PULSE)_EFF =effective pulsatile contact stress associated with selected regions of the stress sensitive element;

(σ

*_DIAS)_S.P. =diastolic contact stress associated with a specific sampling point along the stress sensitive element;

(σ

*_PULSE)_S.P. =pulsatile contact stress associated with a specific sampling point along the stress sensitive element.

20. The method of claim 12, wherein step (I) includes combining said stress data with said error value according to the following formula:

##EQU24## where;

(σ

(t)_A =effective contact stress waveform from selected region acquired at known off-optimum applanation;

##EQU25##

21. The method of claim 20, wherein said scaling factors are derived according to the following formulas:

##EQU26## where;

(σ

_DIAS (ASP)_EFF)_OPT =effective diastolic contact stress at the optimum applanation state;

σ

_DIAS (ASP)_EFF =effective diastolic contact stress at the actual off-optimum applanation state;

(σ

_PULSE (ASP)_EFF)_OPT =effective pulsatile contact stress at the optimum applanation state;

σ

_PULSE (ASP)_EFF =effective pulsatile contact stress at the actual off-optimum applanation state;

(σ

_DIAS)_OPT =diastolic contact stress at optimum applanation state.

22. For use in a non-invasive blood pressure monitoring system, an apparatus for operating a tissue stress sensor at an off-optimum arterial applanation state, said tissue stress sensor of the type for measuring the stress of tissue overlying an artery of interest, said apparatus comprising:

means for placing said stress sensor in communication with said tissue overlying said artery of interest, and means for collecting stress datum from said sensor,

means for determining which of said datum corresponds to an optimum artery applanation state,

means for applanating said artery at said off-optimum applanation state,

means for obtaining from said tissue stress sensor stress datum associated with said tissue overlying said artery while said artery is in said off-optimum applanation state,

means for deriving correction factors using said datum corresponding to said optimum applanation state and said off-optimum applanation state, and

means for combining said stress data corresponding to said off-optimum applanation state with said correction factors to yield corrected stress data that approximates the intra-arterial blood pressure.

23. The apparatus of claim 22, wherein said combining means combines stress data with said correction factors according to the following formula:

space="preserve" listing-type="equation">σ

.sub.EFF (t)=σ

.sub.S.P. (t)·

m+b

where;

σ

_EFF (t)= spatially corrected effective contact stress;

σ

_S.P. (t)= stress data obtained in step (C);

m= slope correction factor;

b= offset correction factor.

24. The apparatus of claim 22, wherein said combining means combines said stress data with said correction factors according to the following formula:

(σ

(t))_E.O. =(σ

(t))_A -σ

_DIAS (e_A))·

ƒ

_PULSE (e_A)+σ

_DIAS (e_A)·

ƒ

_DIAS (e_A)

where;

(σ

(t))_A = effective contact stress waveform from selected region acquired at known off-optimum applanation;

##EQU27##

25. The apparatus of claim 24, wherein said combining means uses scaling factors derived according to the following formula:

##EQU28## where;

(σ

_DIAS (ASP)_EFF)_OPT = effective diastolic contact stress at the optimum applanation state;

σ

_DIAS (ASP)_EFF = effective diastolic contact stress at the actual off optimum applanation state;

(σ

_PULSE (ASP)_EFF)_OPT = effective pulsatile contact stress at the optimum applanation state;

σ

_PULSE (ASP)_EFF = effective pulsatile contact stress at the actual off optimum applanation state;

(σ

_DIAS)_OPT = diastolic contact stress at optimum applanation state.