Surgery – Diagnostic testing – Cardiovascular
Reexamination Certificate
1998-05-08
2001-03-13
Lacyk, John P. (Department: 3736)
Surgery
Diagnostic testing
Cardiovascular
C600S490000, C073S753000
Reexamination Certificate
active
06200270
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a sensor for non-invasive and continuous determination of the duration of arterial pulse waves.
2. Description of the Related Art
A desirable goal for many manufacturers of blood-pressure measuring devices is continuous non-invasive measurement of human blood pressure without the aid of uncomfortable compression cuffs.
It has been known for quite some time that human blood pressure, differing from individual to individual, correlates to the velocity of pulse waves. Hitherto this fact could not be exploited for continuous measurement of blood pressure, because there are no reliable, inexpensive sensors available for determination of the pulse-wave velocity.
Hitherto, attempts have been made to determine the pulse-wave velocity, which is about 10 m/s at the wrist, via the change in the color, the form or in the electric resistance of the skin. Attempts have also been made to measure the pulse-wave velocity with the aid of the ultrasonic Doppler method, a reliable but not exactly inexpensive method. One such attempt is described in DE-OS-1 905 620. Two spaced apart piezoelectric oscillator systems, the conical-shaped sound of which irradiates a to-be-examined vessel and a Doppler reception device permit determination of the vessel-wall velocity with which the vessel wall is extended by the blood-pressure waves flowing through the vessel. Ultimately information on the pulse-wave velocity is obtained via a special evaluation algorithm.
Another example for determining the pulse-wave velocity is indicated in U.S. Pat. No. 4,245,648 describing a process and a device for measuring blood pressure and for determining the pulse rate. Two pressure-sensitive sensors housed in an arm cuff are placed along a blood-conducting vessel. The increase-in-pressure values determined in intervals can be utilized for calculating the pressure-wave velocity. However, disadvantageous is the large size of the device making it impossible to use at sites that are difficult to reach. Furthermore, application of the device involves considerable motoric impediment.
DESCRIPTION OF THE INVENTION
The object of the present invention is to further improve the sensor known from U.S. Pat. No. 4,245,648 in such a manner that it is designed so small and compact that it can be combined, by way of illustration, with a wristwatch.
The solution to the object of the present invention is set forth in claim
1
. Advantageous embodiments are the subject matter of the subclaims.
An element of the present invention is that a sensor for non-invasive and continuous determination of the duration of arterial pulse waves, in which at least two piezoelectric pressure sensors are placed at intervals in succession in the running direction of the arteries, with the sensor being provided with pressure sensitive surfaces and integrated in a casing, is designed in such a manner that the piezoelectric pressure sensors have a pressure-sensitive, strip-shaped surface which are each placed in their longitudinal extension perpendicular to the running direction of the arteries, and that the casing is provided with at least two recesses adapted to the contours of the strip-shaped surfaces into which the pressure-sensitive, strip-shaped surfaces of the pressure sensors are disposed flush to the casing surface.
The invented sensor determines non-invasively the pressure pulsations of the arteria radialis preferably at the wrist level at two closely adjacent positions of which the one is located more proximally and the other more distally at the measuring point of the arteria radialis in the wrist region. The pulse-wave velocity and therefore, using previously patient related calibration, the average blood pressure can be determined from the time lag of the pulse maximum of the two measuring positions. The level of the systolic and diastolic pressure can be immediately determined from the measured difference between the pulse-pressure maximum and pulse-pressure minimum at one of the positions. The device is so small that it can be constantly worn on the wrist like a wristwatch, thereby largely avoiding any discomfort to the patient.
The sensor immediately determines the difference in the duration of the pulse wave propagating in the artery thereby setting stricter measurement criteria so that the invented sensor works more accurately than hitherto known measurement methods in which the indirect determination of the pulse wave occurs via the color, resistance, form of the skin. Inexpensive mass production of the sensor is also feasible.
For determination of the pressure, the invented sensor is provided with at least two separately operating pressure sensors which each are provided with a pressure-sensitive, strip-shaped surface and which are disposed in their longitudinal extension perpendicular to the running direction of the artery. The individual pressure sensors composed of piezoelectric material are integrated in a semi-cylindrical casing in such a manner that they are inserted in the angular running recesses in the casing wall at the convex, hemispherical nappe of the semi-cylinder.
Therefore, the individual pressure-sensitive surfaces essentially follow the convex-shaped hemispherical surface contour of the semi-cylinder which is pressed against the surface of the skin in such a manner that the curved pressure-sensitive surfaces intersect perpendicularly the running direction of the artery with radial polarization.
The purpose of the convex curvature of the semi-cylinder and the pressure sensitive surfaces connected thereto is to ensure, upon lightly pressing the sensor casing against the natural form of the surface of the skin, improved adaptation to the measuring site and therewith improved mechanical contacting of the measuring object. Furthermore, the purpose of the semi-cylindrical surface contour of the sensor casing is largely insensitive to overturning at the longitudinal axis.
Moreover, the pressure-sensitive surfaces of the pressure sensor has to be designed narrow in the direction of the running direction of the artery so that a small as possible duration of the pulse wave at each individual sensor area can be attained, thereby permitting obtaining high temporal resolution. The distance between the two pressure sensitive surface areas has to be selected so small that both pressure sensors still lie close to the surface in the region of the course of the arteria radialis. Only in this manner, can both pressure sensors detect the same temporal pulse duration. On the other hand, the distance has to be large enough in order to be able to still pick up the time lag of the pulse maximum between the two pressure sensors. Tests have shown that these conditions can be realized if the individual pressure-sensitive surfaces have a width of 1 mm and are spaced 1 cm apart.
The individual piezoelectric pressure sensors are composed of piezoelectric material and their surface facing the artery projects through the aforementioned recesses worked into the convex shaped casing wall. In this way. the individual piezo electric pressure sensors assume a hemispherical shape, in which upon external pressure polarization charges, which lead to an electric voltage between the pressure sensor surfaces, are released between their external and their internal surface proportional to the application of mechanical pressure or tension.
In view of the fact that when pressure is applied, a high voltage is generated between the surfaces of the piezoelectric pressure sensors by relatively small charges, low-frequency pressure fluctuations, such as arterial pressure pulsations, can no longer be detected if the receiver is directly connected to a low-ohmic signal processing system. Therefore a preamplifier with a high as possible input resistor and a low as possible output resistor is required which is placed as close as possible to the piezoelectric element.
Preferably, a simple, as small as possible to-be-realized impedance converter circuit, which by way of illustration is composed o
Biehl Margit
Kiefer Stefan
Astorino Michael
Fraunhofer-Gesellschaft zur Foerderung der angewandten Forschung
Lacyk John P.
Staas & Halsey , LLP
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