Cuffless blood pressure determination with a patient specific, variable calibration
11395596 · 2022-07-26
Assignee
Inventors
- David E. Quinn (Auburn, NY)
- Matthew Banet (San Diego, CA)
- Marshal Dhillon (San Diego, CA)
- Lauren Nicole Miller Hayward (La Jolla, CA, US)
Cpc classification
A61B5/0285
HUMAN NECESSITIES
A61B5/053
HUMAN NECESSITIES
A61B5/0002
HUMAN NECESSITIES
A61B2560/0223
HUMAN NECESSITIES
A61B5/022
HUMAN NECESSITIES
International classification
A61B5/00
HUMAN NECESSITIES
Abstract
A method for estimating blood pressure of a care recipient includes establishing a pre-maneuver reference value of blood pressure and a companion nonreference value of blood pressure, subjecting the care recipient to a maneuver, establishing a post-maneuver reference value of blood pressure and a companion post-manuever nonreference value of blood pressure, establishing an operational post-maneuver nonreference value of blood pressure, and adjusting the operational value as a function of the pre-maneuver and post-maneuver values. An associated apparatus includes a sensor, a processor and a memory which contains instructions. The instructions, when executed, cause the processor to estimate blood pressure as a function of a pre-maneuver reference value of blood pressure, a companion pre-maneuver nonreference value of blood pressure, a post-maneuver reference value of blood pressure, a companion post-manuever nonreference value of blood pressure, and an operational value of blood pressure based on information sensed by the sensor.
Claims
1. A method for estimating blood pressure of a care recipient, comprising: establishing a pre-maneuver reference value of blood pressure and a companion pre-maneuver nonreference value of blood pressure; subjecting the care recipient to a maneuver; establishing a post-maneuver reference value of blood pressure and a companion post-maneuver nonreference value of blood pressure; establishing an operational value of blood pressure that is determined: based on sensed parameter signals, and independent of at least the pre-maneuver reference value and the post-maneuver reference value; adjusting the operational value as a function of the pre-maneuver reference value, the pre-maneuver nonreference value, the post-maneuver reference value, and the post-maneuver nonreference value, wherein adjusting the operational value comprises generating an adjusted value, and the pre-maneuver reference value is held constant to generate the adjusted value; and designating the adjusted value as the estimated blood pressure of the care recipient.
2. The method of claim 1 wherein the post-maneuver reference value is derived from the pre-maneuver reference value and a known or presumed effect of the maneuver.
3. The method of claim 1 wherein the post-maneuver reference value is based on subjecting the recipient to a single maneuver.
4. The method of claim 1 wherein the adjusting step is a linear function of the pre-maneuver and post-maneuver nonreference values.
5. The method of claim 1 wherein the pre-maneuver and post maneuver reference values are cuff-based values.
6. The method of claim 1 wherein the pre-maneuver and post-maneuver nonreference values are cuffless based values.
7. The method of claim 1 wherein the maneuver is passive with respect to the care recipient.
8. The method of claim 1 wherein the maneuver is selected from the group consisting of: A) transitioning the care recipient between a) lying with his or her head at a first elevation which is not lower than an elevation of his or her lower limbs and b) lying with his or her head at a second elevation which is lower than the elevation of his or her lower limbs; and B) transitioning the care recipient between lying with his or her arms at his or her sides and sitting with his or her arms at his or her sides.
9. The method of claim 8 wherein transitioning the care recipient between lying and sitting comprises an active maneuver in which the care recipient takes a seated position with his or her arms at his or her sides.
10. The method of claim 8 wherein transitioning the care recipient between lying and sitting comprises a passive maneuver in which the care recipient is maneuvered to a seated position with his or her arms at his or her sides.
11. The method of claim 1 wherein the pre-maneuver reference value and the post-maneuver reference value are established with the use of a cuff on one of the care recipient's arms, and the maneuver is transitioning the care recipient to a state in which the elevation of his or her heart is lower than the elevation of his or her head and arms.
12. A blood pressure monitoring system comprising: a sensor; a processor; a memory containing instructions which, when executed, cause the processor to: estimate blood pressure as a function of a pre-maneuver reference value of blood pressure, a companion pre-maneuver nonreference value of blood pressure, a post-maneuver reference value of blood pressure, a companion post-maneuver nonreference value of blood pressure, and an operational value of blood pressure, wherein the operational value of blood pressure is: established based on parameter signals sensed by the sensor, determined independent of at least the pre-maneuver reference value and the post-maneuver reference value, and adjusted as a function of the pre-maneuver reference value, pre-maneuver nonreference value, the post-maneuver reference value, and the post-maneuver nonreference value, and wherein: adjusting the operational value comprises generating an adjusted value, the pre-maneuver reference value is held constant to generate the adjusted value, and the adjusted value is designated as the estimated blood pressure.
13. The system of claim 12 wherein the instructions, when executed, cause the estimated blood pressure to be a linear function of the pre-maneuver and post-maneuver non-reference values.
14. The system of claim 12 wherein the system comprises a patch and wherein the sensor is mounted on the patch.
15. The system of claim 14 wherein the processor and/or the memory are mounted on the patch.
16. The system of claim 12 comprising a patient support element and wherein the instructions, when executed, cause the patient support element to carry out the maneuver.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The foregoing and other features of the various embodiments of the method and system for blood pressure determination described herein will become more apparent from the following detailed description and the accompanying drawings in which:
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
DETAILED DESCRIPTION
(14) Referring to
(15) During operation, and with the patch adhered to a patient, each sensor senses a physiological signal which corresponds to a parameter useful for determining blood pressure. Operating under instructions 36, the processor calculates an estimate of the patient's blood pressure from those parameter signals. Those skilled in the art will recognize that instructions 36 may be expressed in terms of parameters related to blood pressure rather than in terms of blood pressure itself. However, in the interest of explanatory simplicity this specification describes the calculations and concepts in terms of blood pressure.
(16)
(17) At time t.sub.CAL1, block 100 establishes a pre-maneuver reference value of blood pressure, P.sub.1,REF. Unless stated otherwise, examples and explanations in this specification are based on using a cuff-based method as the reference.
(18) At block 104, also at time t.sub.CAL1, the method establishes a pre-maneuver nonreference value of blood pressure, P.sub.1,NON. The nonreference value is based on a cuffless technique. One example of a cuffless technique is one that relies on one or more cardiac parameters such as pulse transit time, impedance measurements, and heart sounds.
(19) Blocks 100 and 104 are a pre-maneuver calibration step carried out at pre-maneuver calibration time t.sub.CAL1. The pre-maneuver calibration step corresponds to the single calibration described in the “Background” section of this application. That is: P.sub.1,REF corresponds to P.sub.REFERENCE; P.sub.1,NON corresponds to P.sub.CUFFLESS(t.sub.reference); and t.sub.CAL1 corresponds to t.sub.reference.
(20) The pre-maneuver reference and nonreference values need not be established at exactly the same time, provided they are companion values established at equivalent times as already described above in connection with determining a static offset at t.sub.reference. Accordingly, t.sub.CAL1 as used in this specification can refer to either a single time at which both P.sub.1,REF and P.sub.1,NON are established or to distinct times within a time interval that satisfies the above criterion of a constant state of the patient. In addition, the readings at blocks 100 and 104 can be taken in the opposite order of that shown.
(21) At block 108 the patient is subjected to a maneuver, examples of which are described below. The phrase “is subjected to” includes maneuvers in which the patient is passive and the maneuver is the result of an external influence acting on the patient (passive maneuvers), maneuvers that are undertaken by the patient himself without the action of an external influence (active maneuvers), and maneuvers that are partly passive and partly active. The maneuver is one which will cause the patient's actual blood pressure to change. The time at which the maneuver takes place is t.sub.MAN. Because the maneuver is not instantaneous, t.sub.MAN may be considered to be an interval of time corresponding to the conduct of the maneuver rather than a discrete point in time.
(22) The method then proceeds to block 112 where, at time t.sub.CAL2, it establishes a post-maneuver reference value of blood pressure P.sub.2,REF. Time t.sub.CAL2 is later than time t.sub.CAL1 and is a time after which any blood pressure transients associated with the maneuver have dissipated.
(23) After the reading at block 112 has been obtained, the equipment used to establish reference values P.sub.1,REF and P.sub.2,REF is no longer needed, and so can be removed from the patient (or its readings disregarded).
(24) At block 116, also at time t.sub.CAL2, the method determines a post-maneuver nonreference value of blood pressure, P.sub.2,NON. The nonreference value is based on a cuffless technique.
(25) Blocks 112 and 116 are a post-maneuver calibration step carried out at post-maneuver calibration time t.sub.CAL2. Neither the maneuver nor the post-maneuver calibration step have a counterpart in the above described prior art method.
(26) The post-maneuver reference and nonreference values need not be established at exactly the same time, provided they are companion values established at equivalent times as already described above in connection with determining the pre-maneuver values at t.sub.CAL1. Accordingly, t.sub.CAL2 as used in this specification can refer to either a single time at which both P.sub.2,REF and P.sub.2,NON are established or to distinct times within a time interval that satisfies the above criterion of a constant state of the patient. In addition, the readings at blocks 112 and 116 can be taken in the opposite order of that shown.
(27) At block 120 the method establishes an operational value of blood pressure P.sub.NON(t) (equivalent to P.sub.CUFFLESS(t) based on the parameter signals sensed by sensors 26. The value established at block 120 is referred to as “operational” because it forms the basis for determining the blood pressure value to be communicated to display module 44 for continuous use by the patient's caregivers. The operational value may be established with the same equipment used to establish the pre-maneuver and post-maneuver nonreference values at blocks 104 and 116.
(28) At block 124 the method adjusts the operational value as a function of the pre-maneuver reference value, the pre-maneuver nonreference value, the post-maneuver reference value, and the post-maneuver nonreference value. At block 128 the method designates the adjusted value as the estimated blood pressure of the patient. The communications module 42 (
(29) After block 124 the method also follows a path back to block 120 and continues to loop through blocks 120 and 124. As a result the operational value is periodically updated, and the updated value is adjusted by the functional relationship determined from the pre-maneuver and post-maneuver reference and nonreference values. The operations at blocks 120, 124, and 128 may be repeated at a low frequency or may be repeated at a high enough frequency that the output of block 128 approximates a continuous, analogue output.
(30)
(31) Block 1243 calculates Δ.sub.2, the difference between post-maneuver reference pressure P.sub.2,PEF and post-maneuver nonreference pressure P.sub.2,NON. Δ.sub.2 may be referred to as a post-maneuver static offset, but, unlike the premaneuver static offset Δ.sub.1, has no counterpart in the conventional calibration described in the “Background” section of this specification.
(32) Block 124C calculates m, the extent to which the static offset Δ.sub.1 changes in response to changes in blood pressure indicated by the cuffless system.
(33) Block 124D calculates an estimate of cuffless blood pressure, P.sub.CUFFLESS,EST at any time t as a function of 1) P.sub.1,REF the pre-maneuver reading obtained from the reference system at the calibration time t.sub.CAL1, 2) slope m, 3) P.sub.NON(t), the readings at any time t obtained from the cuffless (nonreference) system and 4) P.sub.NON(t.sub.CAL1), (or, equivalently, P.sub.1,NON) the cuffless pressure determined at the pre-maneuver calibration point. The relationship used at block 124D is reproduced below:
P.sub.CUFFLESS,EST(t)=P.sub.1,REF+m[P.sub.NON(t)−P.sub.NON(t.sub.CAL1)]. (3)
(34) In view of the fact that P.sub.NON(t) is the same as P.sub.CUFFLESS(t), equation (3) can also be expressed as:
P.sub.CUFFLESS,EST(t)=P.sub.1,REF+m[P.sub.CUFFLESS(t)−P.sub.CUFFLESS(t.sub.CAL1)]. (4)
The subtrahend in the above equations is the same as P.sub.1,NON.
(35)
(36)
(37) Table 1 below and
(38) The triangular symbols connected by the dashed line are the values of P.sub.CUFFLESS,EST that would be calculated by the prior art method in which the change in the cuffless reading relative to its value at the calibration point is added to the reference (i.e. reference) value at the calibration point (equation (1)) or, alternatively but equivalently, the unadjusted readings, P.sub.CUFFLESS(t), are biased by the constant calibration offset (equation (2)). In the example, the numerical value of the bias is 6. The oval border around the leftmost triangular symbol indicates that P.sub.CUFFLESS,EST(t.sub.CAL1)=P.sub.1,NON.
(39) The square symbols connected by the solid line are the values of P.sub.CUFFLESS,EST(t) calculated based on equation (3) or (4). In this specific example, the relationship of equation (3) is
P.sub.CUFFLESS,EST(t)=136+1.5[P.sub.CUFFLESS(t)−130] (6)
where 136 is P.sub.1,REF, 1.5 is slope m of block diagram block 124C (the slope of
(40) As is evident from
(41) TABLE-US-00001 TABLE 1 D P.sub.CUFFLESS,EST(t) = B C P.sub.1,REF + A P.sub.CUFFLESS(t) P.sub.CUFFLESS,EST(t) m[P.sub.NON(t) − Reading No (unadjusted) (Prior Art) P.sub.NON(t.sub.CAL1)] 1 130 136 136 2 132 138 139 3 133 139 140.5 4 138 144 148 5 140 146 151 6 138 144 148 7 135 141 143.5 8 130 136 136 9 119 125 119.5 10 122 128 124 11 120 126 121 12 120 126 121 13 122 128 124 14 118 124 118 15 122 128 124 16 123 129 125.5 17 120 126 121 18 122 128 124 19 127 133 131.5 20 122 128 124 21 132 138 139 22 144 150 157 23 140 146 151 24 140 146 151 25 133 139 140.5
(42)
(43) In the pre-maneuver state the patient is lying with his head at a first elevation E.sub.H1 which is not lower than the elevation E.sub.LL1 of his lower limbs (thighs and calves) as a result of support element 58 being at an essentially horizontal orientation. In the post maneuver state the patient is lying with his head at a second elevation E.sub.H2 which is lower than the lowest elevation E.sub.LL2 of his lower limbs (i.e. the approximate elevation of the patient's gluteal sulcus). The maneuver is considered to be a passive maneuver because it is carried out with little or no active involvement of the patient. Instead the patient merely remains lying in the bed while its orientation is changed. The maneuver is believed to increase the patient's actual blood pressure because extra blood volume is drained to the patient's torso at the elevation of the heart, which is approximately the elevation of the blood pressure cuff. In both the pre-maneuver state and the post-maneuver state the cuff is approximately at the same elevation as the patient's heart. As a result the hydrostatic component of blood pressure is the same in both the pre-maneuver state and the post-maneuver state.
(44)
(45)
(46) The maneuvers of
(47)
(48)
(49)
(50) Each of the foregoing examples subjects the patient to a single maneuver. However multiple maneuvers can be used to establish multiple post-maneuver static offsets. In the example of
(51) The adjusting step 124 of
(52) It may also be possible to establish the post maneuver reference value from the pre-maneuver reference value and an estimate of how the reference value changes as a function of P.sub.NON. This is indicated in
(53) The block diagram of
(54) Once the caregiver initiates the event sequence the method automatically acquires the pre-maneuver blood pressure readings at block 150. The automated sequence then proceeds to block 152 where the bed is commanded to undergo a maneuver, for example the maneuver of
(55) Although this disclosure refers to specific embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made without departing from the subject matter set forth in the accompanying claims.