Surgery – Diagnostic testing – Cardiovascular
Reexamination Certificate
1999-06-29
2002-10-29
Nasser, Robert L. (Department: 3736)
Surgery
Diagnostic testing
Cardiovascular
C600S500000
Reexamination Certificate
active
06471655
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to methods and apparatus for monitoring the blood pressure of a living subject, and specifically to the non-invasive monitoring of arterial blood pressure using acoustic techniques.
2. Description of the Related Art
Three well known techniques have been used to non-invasively monitor a subject's arterial blood pressure waveform, namely, auscultation, oscillometry, and tonometry. Both the auscultation and oscillometry techniques use a standard inflatable arm cuff that occludes the subject's bronchial artery. The auscultatory technique determines the subject's systolic and diastolic pressures by monitoring certain Korotkoff sounds that occur as the cuff is slowly deflated. The oscillometric technique, on the other hand, determines these pressures, as well as the subject's mean pressure, by measuring actual pressure changes that occur in the cuff as the cuff is deflated. Both techniques determine pressure values only intermittently, because of the need to alternately inflate and deflate the cuff, and they cannot replicate the subject's actual blood pressure waveform. Thus, true continuous, beat-to-beat blood pressure monitoring cannot be achieved using these techniques.
Occlusive cuff instruments of the kind described briefly above generally have been effective in sensing long-term trends in a subject's blood pressure. However, such instruments generally have been ineffective in sensing short-term blood pressure variations, which are of critical importance in many medical applications, including surgery.
The technique of arterial tonometry is also well known in the medical arts. According to the theory of arterial tonometry, the pressure in a superficial artery with sufficient bony support, such as the radial artery, may be accurately recorded during an applanation sweep when the transmural pressure equals zero. The term “applanation” refers to the process of varying the pressure applied to the artery. An applanation sweep refers to a time period during which pressure over the artery is varied from overcompression to undercompression or vice versa. At the onset of a decreasing applanation sweep, the artery is overcompressed into a “dog bone” shape, so that pressure pulses are not recorded. At the end of the sweep, the artery is undercompressed, so that minimum amplitude pressure pulses are recorded. Within the sweep, it is assumed that an applanation occurs during which the arterial wall tension is parallel to the tonometer surface. Here, the arterial pressure is perpendicular to the surface and is the only stress detected by the tonometer sensor. At this pressure, it is assumed that the maximum peak-to-peak amplitude (the “maximum pulsatile”) pressure obtained corresponds to zero transmural pressure. This theory is illustrated graphically in FIG.
1
. Note that in
FIG. 1
, bone or another rigid member is assumed to lie under the artery.
One prior art device for implementing the tonometry technique includes a rigid array of miniature pressure transducers that is applied against the tissue overlying a peripheral artery, e.g., the radial artery. The transducers each directly sense the mechanical forces in the underlying subject tissue, and each is sized to cover only a fraction of the underlying artery. The array is urged against the tissue, to applanate the underlying artery and thereby cause beat-to-beat pressure variations within the artery to be coupled through the tissue to at least some of the transducers. An array of different transducers is used to ensure that at least one transducer is always over the artery, regardless of array position on the subject. This type of tonometer, however, is subject to several drawbacks. First, the array of discrete transducers generally is not anatomically compatible with the continuous contours of the subjects tissue overlying the artery being sensed. This has historically led to inaccuracies in the resulting transducer signals. In addition, in some cases, this incompatibility can cause tissue injury and nerve damage and can restrict blood flow to distal tissue.
Prior art tonometry systems are also quite sensitive to the orientation of the pressure transducer on the subject being monitored. Specifically, such systems show a degradation in accuracy when the angular relationship between the transducer and the artery is varied from an “optimal” incidence angle. This is an important consideration, since no two measurements are likely to have the device placed or maintained at precisely the same angle with respect to the artery.
Perhaps the most significant drawback to arterial tonometry systems in general is their inability to continuously monitor and adjust the level of arterial wall compression to an optimum level of zero transmural pressure. Generally, optimization of arterial wall compression has been achieved only by periodic recalibration. This has required an interruption of the subject monitoring function, which sometimes can occur during critical periods. This disability severely limits acceptance of tonometers in the clinical environment.
It is also noted that the maximum pulsatile theory described above has only been demonstrated to date in excised canine arteries, and not in vivo. See, for example, Drzewiecki, G. M, et al, “Generalization of the transmural pressure-area relation for the femoral artery”, 7
th
Annual IEEE EMBS Conference
, 1985, pp.507-510. Accordingly, the maximum peak-to-peak amplitude in vivo may not occur at the arterial pressure at which the transmural pressure equals zero. In fact, during anecdotal studies performed by the applicant herein using two prior art tonometry systems (with which several hundred applanation sweeps were recorded under numerous test conditions), the maximum pulsatile theory described above never yielded measured mean arterial pressure (MAP) that was consistently similar to the average of two cuff pressure measurements taken immediately before and after the sweep. These factors suggest that prior art maximum pulsatile theory devices may produce significant errors in measured MAP.
Based on the foregoing, there is a clear need for an apparatus, and related method, for non-invasively and continually monitoring a subject's arterial blood pressure, with reduced susceptibility to noise and subject movement, and relative insensitivity to placement of the apparatus on the subject. Such an improved apparatus and method would also obviate the need for frequent recalibration of the system while in use on the subject. Furthermore, it would be desirable to make certain components of the apparatus in contact with the subject disposable, thereby allowing for the cost effective replacement of these components at regular intervals.
SUMMARY OF THE INVENTION
The invention disclosed herein addresses the foregoing needs by providing an improved apparatus and method for non-invasively monitoring the arterial blood pressure of a subject.
In a first aspect of the invention, a method of measuring the blood pressure within a blood vessel of a subject is disclosed. The method generally comprises: compressing at least a portion of the blood vessel to a varying degree as a function of time; transmitting an acoustic wave into the blood vessel during compressing; receiving an echo of the acoustic wave from the blood vessel during compressing; estimating at least one parameter based on the echo by forming a time-frequency distribution of the echo; and determining the pressure within the blood vessel when the parameter is estimated to satisfy a predetermined condition. In one exemplary embodiment, both pressure and ultrasonic transducers are placed over the blood vessel. Blood velocity and time-frequency distribution are determined as a function of time and the peak time-frequency distribution is correlated to the mean arterial pressure (MAP).
In a second aspect of the invention, the foregoing acoustic pulses are used to assist in placement of the transducers on the subject's wrist so as to max
Gazdzinski & Associates
Nasser Robert L.
VitalWave Corporation
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