WO1993004625A1 - Ensemble capteur de la pression du sang de l'artere temporale sans introduction dans le corps - Google Patents

Ensemble capteur de la pression du sang de l'artere temporale sans introduction dans le corps Download PDF

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Publication number
WO1993004625A1
WO1993004625A1 PCT/US1992/007279 US9207279W WO9304625A1 WO 1993004625 A1 WO1993004625 A1 WO 1993004625A1 US 9207279 W US9207279 W US 9207279W WO 9304625 A1 WO9304625 A1 WO 9304625A1
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WO
WIPO (PCT)
Prior art keywords
bladder
patient
support base
inflatable
blood pressure
Prior art date
Application number
PCT/US1992/007279
Other languages
English (en)
Inventor
Alexander Borsanyi
Phillip D. Baker
Dwayne R. Westenskow
Nancy Smith
Original Assignee
Baxter International Inc.
University Of Utah
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baxter International Inc., University Of Utah filed Critical Baxter International Inc.
Publication of WO1993004625A1 publication Critical patent/WO1993004625A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6814—Head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/022—Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
    • A61B5/02233—Occluders specially adapted therefor
    • A61B5/02241—Occluders specially adapted therefor of small dimensions, e.g. adapted to fingers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/168—Fluid filled sensor housings

Definitions

  • This invention relates generally to measurement of a person's blood pressure and more specifically to a device and related method for measuring blood pressure in the superficial temporal artery without the discomfort, inaccuracies and inherent dangers of using a standard occlusive blood pressure arm cuff.
  • occlusive arm cuff Perhaps the most common of these devices is the occlusive arm cuff, wherein the arm is modeled as a cylindrical structure composed of an incompressible fluid. Pressure in the occlusive cuff is assumed to be transmitted through the tissue of the arm without attenuation and thus to deliver a calibrated, uniformly distributed, and variable pressure to the wall of the artery. However, validation of this assumption is very difficult and there appears to be indirect evidence that it is at least partly invalid.
  • the occlusive arm cuff is a relatively simple device comprising a rubber bladder enclosed in a fabric cover. The cuff is wrapped around the arm and secured with suitably fasteners.
  • the occlusive cuff is not a complicated device, its use is complicated by the fact that failure to select the proper size cuff for a patient can result in significant errors in blood pressure measurements. For example, it has been observed that there is a minimum cuff width beyond which further narrowing of the cuff results in an increasing overestimation of blood pressure. This phenomenon has been related to pressure dissipation, i.e.
  • the transducer which transfers the force of the pressurized blood vessel to a measuring device, must be centered directly over the blood vessel. Otherwise, an inaccurate reading is registered.
  • the '708 device is unduly susceptible to environmental elements such as temperature and moisture, which affect the performance of the material in the transducer.
  • this device does not take into account exterior noise and artifacts, such as patient movement and pulsation of other nearby arteries, which can have a dramatic adverse effect on measurement readings.
  • noninvasive methods of estimating blood pressure are generally not traumatic and present little risk to the patient, they are often used instead of the invasive method, which requires that a catheter or needle be inserted into an artery.
  • a major disadvantage associated with noninvasive methods has been their lack of close agreement with actual blood pressure as would be measured by invasive methods.
  • lack of close agreement also exists among the different noninvasive methods, further adding to the uncertainty of any particular reading derives.
  • Oscillometry has become the preferred method for automatic, noninvasive blood pressure monitoring, as described in United States Patents 3,903,872; 4,009,709; and 4,074,711 each of which is incorporated herein by reference. It has been estimated that there are well over one hundred and fifty thousand (150,000) automatic oscillometric noninvasive blood pressure devices in the United States alone.
  • One advantage of the oscillometric method over other noninvasive methods is its ability to estimate not only diastolic and systolic pressures, but also mean pressure.
  • oscillometric blood pressure monitors use an inflatable air filled occlusive cuff that is placed around a limb, usually the upper arm. Small oscillations in the cuff pressure, which correspond to intraarterial pulses in the artery underlying the- cuff, are recorded while the cuff pressure is increased from a pressure below diastolic to a pressure above systolic. As is characteristic of oscillometric waveforms, the cuff pressure oscillations initially increase in amplitude with increasing cuff pressure.
  • Oscillometric waveforms have been found to be susceptible to artifacts and noise from a variety of sources. It is readily apparent that the processing of artifacts and noise interfering with quality signals decreases the accuracy of any estimation of blood pressure. Such, noises and artifacts can be caused not only'by patient movement during the test but by signals sent out by peripheral blood vessels also contained within the test zone.
  • a principal object of the present invention is the provision of a blood pressure measuring device which is easily positioned over the superficial temporal artery, from which accurate representative measurement is taken.
  • Another important object of this invention is to create a device which is not susceptible to common environmental changes.
  • Another principal object is to provide a blood pressure measurement device which suppresses exterior noises and artifacts to provide a more accurate signal.
  • Another major object of this invention is the provision of a more comfortable method of measuring blood pressure which avoids venous congestion and nerve trauma.
  • the sensor assembly comprises generally a support base which defines a cavity, a sensor bladder contained in the cavity, a holding bladder disposed atop the support base, a compression plate, and a transducer.
  • the holding bladder is situated between the support base and rigid compression plate, the compression plate engaging the headband which secures the sensor assembly to the patient's scalp.
  • the holding bladder serves to isolate the support base and sensor bladder against the temporal artery, and also absorbs much of the exterior noise and artifacts associated with oscillometric monitoring.
  • the sensor bladder is formed of a nonelasti ⁇ material such as polyvinyl chloride and serves, when inflated, to sense pressure changes within the subject artery. In sensing pressure changes, the sensor bladder sends signals which vary according to pressure variations within the artery. The transducer detects the signals and converts them into readable oscillometric waveforms.
  • the support base also has two continuous hinged legs for contracting and conforming to the scalp of the patient to be tested.
  • FIGURE 1 is a front perspective view of a preferred embodiment of the sensor assembly for measuring blood pressure shown attached to a patient's superficial temporal artery by a flexible, non-stretching, adjustable headband;
  • FIGURE 2 is an enlarged, exploded plan view of the sensor assembly of Figure 1;
  • FIGURE 3 is a bottom plan view of the sensor assembly of Figure 1;
  • FIGURE 4A is a frontal cross-sectional view of a model illustrating the operating principles of the present invention.
  • FIGURE 4B is a side cross-sectional view of the model of Figure 4a;
  • FIGURE 5 is a side elevational view of a typical patient's head illustrating the proper placement of the preferred sensor over the superficial temporal artery;
  • FIGURE 6 is a front elevational view of the support base; and FIGURE 7 is a schematic representation of the sensor assembly of the present invention shown attached to exteriorly contained air pumps and transducer.
  • the device of the present invention comprises generally a support base 10, an inflatable sensor bladder 12, a transducer 13, a compression plate 14, and an inflatable holding bladder 16, each of which is hereinafter described in greater detail.
  • the device is secured against the patient's skin by means of a flexible, nonstretching, adjustable headband 62 ( Figure 1) .
  • Support base 10 is of rigid construction, preferably plastic, and comprises two continuous parallel legs 18 and 20. As shown in Figure 2, legs 18 and 20 may have continuous, inwardly slanting, raised skin contracting feet 22 and 24, respectively, which follow generally the contour of a patient's skull. Advantageously, each foot 22 and 24 is hingedly connected to legs 18 and 20 of bottom face 21, respectively, to permit accommodation to differently shaped skulls. As also seen in Figure 2, support base 10 defines a cavity 26 wherein sensor bladder 12 is contained. Cavity 26 is open at and accessed through bottom face 21 of support base 10.
  • support base 10 may include top and bottom notches 28 and 30, each of which allows the sensor assembly to fit around the patient's ear as it is placed in a proper position to measure blood pressure in the superficial temporal artery. Notches 28 and 30 are useful to properly position and orient the sensor bladder over the temporal artery. Obviously, these notches may not be necessary when the device is used over other superficial arteries.
  • Support base 10 further comprises a top face 27 oriented away from the patient, and apertures 32 and 34 drilled or otherwise formed in short ends 36 and 38, respectively, of base 10 and leading to cavity 26.
  • Inflatable sensor bladder 12 is disposed in cavity 26 of support base 10 so as to be responsive to arterial activity when placed on the skin of the patient.
  • the preferred material from which it is constructed is nonexpandable and advantageously comprises polyvinyl chloride.
  • inflatable sensor bladder 12 is actually two independently inflated bladders 40 and 42, or more, as shown in Figure 2, stacked, one on top of the other in a series, so constructed by heat sealing thin layers of material together using a metal stamp.
  • bladders 40 and 42 are each connected by way of a sufficient length of tubing 44 and 46, which exit through apertures 32 and 34, respectively, to a standard air pump 48 and pressure transducer 13, both of which are well-known in the art.
  • Sensor bladder 12 which fills cavity 26 when inflated, makes direct contact with the patient's skin and is used both to occlude the artery wherein blood pressure is to be measured and to respond to pressure variations in the artery in the form of varied signals.
  • the use of stacked sensor bladders 40 and 42 allows for more even expansion during inflation, which is necessary to completely fill the cavity 26 in base support 10 and uniformly contact the patient's skin.
  • sensor bladder 12 takes the shape of a single accordion bellows.
  • Such a shape provides fairly uniform expansion of bladder 12 within the cavity 26 during inflation, especially in light of the nonexpandable nature of the material from which it is constructed.
  • the gap or volume that sensor bladder 12 must expand and fill varies with each patient depending upon the particular geometry of that patient's head.
  • the ability of bladder 12 to expand with little or no increase in the internal pressure of the bladder is important in delivering a calibrated and uniform pressure to the surface of the skin.
  • the objective sought to be obtained is to keep the surface of the bladder as flat as possible so that the pressure applied across the bladder wall is equivalent to the pressure in the bladder and the contact area between the skin and the bladder remains constant as the bladder pressure is increased during a blood pressure determination. It has been found that the best results occur when the total inflated volume of sensor bladder 12 is less than five milliliter ⁇ ; more specifically, between one and three milliliters.
  • the transducer 13 detects the arterial activity of varied signals measured by the sensor bladders 40 and 42, denoting pressure variations in the subject artery. These signals are then converted into readable oscillometric waveforms by a standard Wheatstone-type bridge from which the systolic, diastolic and means aspects of the patient's blood pressure are measured.
  • inflatable holding bladder 16 is disposed adjacent the top face 27 of the support base 10 opposite feet 22 and 24.
  • Holding bladder 16 is advantageously constructed of any durable impervious material and has a capability of expanding approximately two centimeters in height when inflated. Its main function is to supply an evenly distributed force on the support base 10 to maintain support base 10 in an independent static condition against the patient's skin while a blood pressure determination is being made.
  • Holding bladder 16 is manually inflated through a tube 52, which is attached at its opposing end to an air pump 54 (see Figure 7) .
  • Air pump 54 is actuated to inflate holding bladder 16 just before a blood pressure determination is made, i.e., just before sensor bladder 12 is inflated, and deflated immediately thereafter to minimize discomfort to the patient.
  • Holding bladder 16 also functions as a noise suppressor. When inflated, the holding bladder 16 attenuates and absorbs noise and artifacts transmitted through a headband used to attach the sensor assembly to a patient's head. Sources of these noises and artifacts arise from patient motion, as well as peripheral arteries near the temporal artery pulsating beneath the headband 62. In prior art devices, pulsations from these arteries were apparently transmitted as changes in headband tension back through the headband to the transducer 13, causing inaccuracies in blood pressure readings.
  • a stiff compression plate 14 is disposed atop holding bladder 16.
  • the bottom surface 58 thereof, which is adjacent to and in contact with holding bladder 16, is relatively flat, whereas the top surface 60 is generally convex in complying with the curvature of the patient's head.
  • Convex top surface 60 of compression plate 14 is engaged by a headband 62, as shown in Figures 1 and 2, which securely maintain the sensor assembly firmly in a substantially fixed position relative to the patient's skin over the temporal artery.
  • Headband 62 is advantageously separated into first and second major sections 62a and 62b, and is made adjustable by selectively joining the first and second major sections 62a and 62b with cooperating detachable adhering strips, such as Velcro (not shown) .
  • the headband 62 is flexible to conform to the individual patient's head curvatures, and yet must necessarily be made of a non-stretching material in order to provide an accurate reading.
  • the sensor assembly In applications over the superficial temporal artery, the sensor assembly is placed over either of the patient's ears and secured in placed by the headband 62. Caution must be taken to position at least a portion of sensor bladder 12 directly over the superficial temporal artery, which passes upward along the side of the head just in front of the ear, the artery then bifurcating into a frontal and parietal branch.
  • the artery may be located prior to positioning of the sensor assembly by probing with the finger tips for a pulse in the described area. By using the referenced notches the approximate proper positioning can be accomplished by simply adjusting the notch 30 or 28 over the ear.
  • sensor bladder 12 When the sensor assembly is properly positioned, air is pumped into the holding bladder 16 by air pump 54 to inflate and emit a downward pressure on support base 10. Before legs 18 and- 20 of support base 10 dig into the patient's scalp as a result of the inflating of holding bladder 16 to cause discomfort, sensor bladder 12 is also inflated by air pump 48, which alleviates a substantial portion of the pressure felt by the patient as a result of the inflating holding bladder 16.
  • the holding bladder 16 is also deflated to minimize discomfort to the patient. If continuous readings are to be taken over an interval of time, the sensor assembly is advantageously left in place between the readings. However, when the desired number of blood pressure determinations have been made, the entire sensor assembly is removed.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Ophthalmology & Optometry (AREA)
  • Dentistry (AREA)
  • Physiology (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

On décrit un ensemble capteur, sans introduction dans le corps, conçu pour mesurer la pression des artères temporales superficielles d'un patient. Le dispositif comprend généralement une base support (10), une poche de capteur (12) placée à l'intérieur de la base support (10), un transducteur (13), une poche de maintien (16), et un ruban serre-tête (62) permettant d'attacher le dispositif à la tête du patient. Eventuellement, on peut prévoir une plaque de compression (14), qui permet d'obtenir une surface de contact améliorée entre la base support (10) et le ruban serre-tête (62). La poche de maintien (16) sert à atténuer le bruit et les artefacts provenant de sources extérieures tout en isolant la base support (10) contre le cuir chevelu du patient.
PCT/US1992/007279 1991-08-30 1992-08-27 Ensemble capteur de la pression du sang de l'artere temporale sans introduction dans le corps WO1993004625A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US75242191A 1991-08-30 1991-08-30
US07/752,421 1991-08-30

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WO1993004625A1 true WO1993004625A1 (fr) 1993-03-18

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5406952A (en) * 1993-02-11 1995-04-18 Biosyss Corporation Blood pressure monitoring system
WO2010053448A1 (fr) * 2008-11-04 2010-05-14 Choon Meng Ting Procédé de détermination de la tension artérielle et appareil de détermination de la tension artérielle
USD739533S1 (en) * 2014-03-12 2015-09-22 Butterfleye SAL Waterproof heart rate measuring apparatus
US9501955B2 (en) 2001-05-20 2016-11-22 Simbionix Ltd. Endoscopic ultrasonography simulation
WO2018066680A1 (fr) * 2016-10-05 2018-04-12 京セラ株式会社 Dispositif de mesure, méthode de mesure et programme
CN113520355A (zh) * 2021-06-23 2021-10-22 健鹤宝医疗科技(南京)有限公司 一种用于心梗检测的可穿戴检测装置和方法

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3040737A (en) * 1959-12-10 1962-06-26 Honeywell Regulator Co Blood pressure measuring transducer
US3903871A (en) * 1974-05-01 1975-09-09 Us Navy Ophthalmodynamometer
DE3106315A1 (de) * 1981-02-20 1982-09-09 Battelle-Institut E.V., 6000 Frankfurt "vorrichtung zur unblutigen messung und ueberwachung des blutdrucks"
US4423738A (en) * 1977-11-04 1984-01-03 Sri International Noninvasive blood pressure monitoring transducer
EP0247880A2 (fr) * 1986-05-28 1987-12-02 BAXTER INTERNATIONAL INC. (a Delaware corporation) Dispositif de surveillance de la pression sanguine par méthode oscillométrique
BR8705629A (pt) * 1987-10-21 1989-05-16 Brauntex Ind E Comercio Ltda Processo de fabricacao de bolsas de ar para aparelhos de medir pressao arterial
US5094244A (en) * 1989-08-25 1992-03-10 Health Monitors, Inc. Apparatus and process for determining systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, pulse rate, pulse wave shape, respiratory pattern, and respiratory rate

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3040737A (en) * 1959-12-10 1962-06-26 Honeywell Regulator Co Blood pressure measuring transducer
US3903871A (en) * 1974-05-01 1975-09-09 Us Navy Ophthalmodynamometer
US4423738A (en) * 1977-11-04 1984-01-03 Sri International Noninvasive blood pressure monitoring transducer
DE3106315A1 (de) * 1981-02-20 1982-09-09 Battelle-Institut E.V., 6000 Frankfurt "vorrichtung zur unblutigen messung und ueberwachung des blutdrucks"
EP0247880A2 (fr) * 1986-05-28 1987-12-02 BAXTER INTERNATIONAL INC. (a Delaware corporation) Dispositif de surveillance de la pression sanguine par méthode oscillométrique
BR8705629A (pt) * 1987-10-21 1989-05-16 Brauntex Ind E Comercio Ltda Processo de fabricacao de bolsas de ar para aparelhos de medir pressao arterial
US5094244A (en) * 1989-08-25 1992-03-10 Health Monitors, Inc. Apparatus and process for determining systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, pulse rate, pulse wave shape, respiratory pattern, and respiratory rate

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DATABASE WPIL Week 8925, Derwent Publications Ltd., London, GB; AN 89-178647 & BR,A,8 705 629 (BRAUNTEX IND COM LT) *

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5406952A (en) * 1993-02-11 1995-04-18 Biosyss Corporation Blood pressure monitoring system
US9501955B2 (en) 2001-05-20 2016-11-22 Simbionix Ltd. Endoscopic ultrasonography simulation
WO2010053448A1 (fr) * 2008-11-04 2010-05-14 Choon Meng Ting Procédé de détermination de la tension artérielle et appareil de détermination de la tension artérielle
USD739533S1 (en) * 2014-03-12 2015-09-22 Butterfleye SAL Waterproof heart rate measuring apparatus
WO2018066680A1 (fr) * 2016-10-05 2018-04-12 京セラ株式会社 Dispositif de mesure, méthode de mesure et programme
CN113520355A (zh) * 2021-06-23 2021-10-22 健鹤宝医疗科技(南京)有限公司 一种用于心梗检测的可穿戴检测装置和方法

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