This invention is related to a blood pressure meter and cuff.
Blood pressure is one of the vital signs (i.e. blood pressure, breathe, temperature, heart pulse etc.) in humans or animals, and it is one of the strongest parameters to monitor and to diagnose the medical conditions and the diseases such as heart diseases and hypertension. For a reliable medical evaluation and treatment, blood pressure measurement accuracy less than ±5 mmHg is necessary from a body portion. Since, the blood pressure value is strongly dependent on the vertical distance from the heart level; blood pressure measurement from upper arm at the level of heart is universally recognized by medical professionals for a more reliable and accurate measurement. This is generally achieved by a structure called “cuff”, which is wrapped (or placed) around upper arm of human.
Usual cuffs are composed of bags or bladders inflated/deflated (or pressurized/depressurized) by air through a pressure control unit. In order to measure the blood pressure, there can be different methods such as (i) detection of Korotkoff sounds usually achieved by a stethoscope by medical professionals, (ii) oscillometric techniques detecting the oscillations in the inflatable air bag due to pressure oscillations caused by artery, and (iii) techniques depending on Doppler Effect. Korotkoff sounds and oscillometric detections are widely accepted and employed in commercial blood pressure monitors, meters or devices (i.e. sphygmomanometer). In the case of automatic or electronic blood pressure meter, oscillometric methods are usually employed due to its improved signal to noise ratio capabilities and no need of detection of Korotkoff (blood flow) sounds. Furthermore, this method allows visualizing blood pressure wave or pulse wave, and it improves the medical evaluation of a subject.
The cuff size for an upper arm type blood pressure monitor is an important consideration. The ideal cuff should have a bag width at least 40% of the arm circumference, and double of the width is recommended for the length of the bag. For a small adult with an arm circumference of 22 to 26 cm, 12 cm bag width is recommended, while for a standard adult with an arm circumference of 27 to 34 cm (or more), 16 cm bag width is recommended [NPL (Non Patent Literature) 1, page 705]. However, these considerations are probably based on cuffs composed of single air bag (bladder) suffering from cuff-edge problems.
A cuff with a bag having 12 cm width is used in most of the medical checks. These checks are usually fast and less than 5 minutes. Even though, comfortability is not an issue during medical checks, a cuff width around 12 cm is not comfortable for daily uses and/or for continuous blood pressure measurements, i.e. ambulatory blood pressure measurement (ABPM). It is a known fact that blood pressure measurement results can be affected by white-coat hypertension and cause erroneous results and treatments. The blood pressure measurements out of hospitals, at homes or during daily life are recommended for more reliable results especially to predict the risks of cardiovascular events and to diagnose the white-coat hypertension [NPL 1]. However, current cuffs have large width and they are stressful to the user during daily life. A smaller cuff width without sacrificing the accuracy is appreciated for daily life measurements and it remains as a problem.
Mercury type upper arm blood pressure monitor has been accepted as a gold standard [NPL 1]. Typical commercially available cuff of mercury type blood pressure monitor has an inflatable/deflatable air bag (or occlusion component) width around 12 cm, and its cross section on a body portion (e.g. an arm or leg) of human (or animal) is similar to ellipsoid. The proximal side (near to the heart) is called as upstream side and the distal side (near to the hand or foot) is called as downstream side. The occlusion component is pressurized to occlude the artery and the blood pressure is measured based on the oscillations caused by oscillations in the underlying artery.
During the pressurization of the cuff, however, the heart continues to pump the blood and it hits to the walls of the occluded artery under the cuff. The blood flow from the heart side reflects back and causes upstream flows in the proximal side. The cuff under the pressurization resembles an ellipsoid in cross-section, and it loses the efficiency of the contact with skin at the edges. This is known as cuff-edge effect. It causes a non-uniform pressure distribution over the artery leading to a partial occlusion or a narrower occlusion of the artery around the center of the cuff. Due to cuff-edge effects, the effective occlusion width is smaller than that of the cuff along the axis around which the cuff is wrapped.
Although the aforementioned width with its pressure distribution characteristic in typical cuffs is tolerable, decreasing the width enhances cuff-edge effect, and this will probably cause erroneously high readings [NPL 2] due to probably incompletely and/or non-uniformly transmitted pressure to the artery under a narrower cuff or mis-cuffing. Therefore, if the pressure can be completely or uniformly transmitted to or distributed over the artery under the cuff by reducing those cuff-edge effects, smaller cuff width for standard adults is realizable and applicable with enough measurement accuracy.
We previously presented to reduce significantly the foregoing problem and to enable smaller cuff width (for a standard adult) leading to relatively more comfortable, low volume and compact wearable medical devices from ABPM applications to consumer applications. It is achieved such that a blood pressure cuff comprising a relatively low volume (narrower) occlusion component is configured to occlude the artery, a pulse wave detection component is configured to detect pulse wave or blood pressure oscillations, and a compliance material is configured to be placed between said occlusion component and said pulse wave detection component in order to disperse the pressure over the artery to reduce cuff-edge problems (or mis-cuffing) caused by said occlusion component to achieve a low volume or narrower cuff width.
Occlusion component to occlude the artery and pulse wave detection component to detect blood pressure oscillations are different in volume. While continuous pumping improves inflation of occlusion component having relatively bigger size, it causes over-inflation of pulse wave detection component due to excessive delivery of fluid to a smaller volume. This situation in pulse wave detection component causes inaccurate or over-estimated blood pressure readings due to big changes in small volume.
Fluidic connection between occlusion component and pulse wave detection component or to the pulse wave detection component is controlled and adjusted.
With its narrower width and so the low volume, the blood pressure cuff according to the present invention achieves medically accurate and precise blood pressure readings similar to its commercial counterparts, i.e. 12 cm width, with great potentials of more comfortable medical devices and ABPM applications.
Exemplary embodiments for carrying out the present invention will be described using drawings in the following. However, although exemplary technical limitations for carrying out the present invention are applied to the exemplary embodiments described below, the scope of the invention is not limited to below.
The structure of the blood pressure cuff containing occlusion component to occlude the artery to block the blood flow, which is preferably an inflatable/deflatable bag or bladder, and a pulse wave detection component to detect or sense pulse wave or blood pressure waves or oscillations in the artery, which is preferably an inflatable/deflatable bag or bladder, is shown in
Both occlusion component and pulse wave detection component can be designed such that they can be connected as independent systems (
In
The blood pressure cuff of the first exemplary embodiment with independent pumping sources is shown in
Occlusion component 103-a may have a branch or braches like occlusion support component 103-b, to support the suppression of the upstreams at proximal (heart) side for a better pulse wave detection and improvement of signal to noise ratio. It is connected to occlusion component 103-a via a fluidic connection 103-c. Pulse wave or blood pressure oscillations in the underlying artery is detected by pulse wave detection component 105, which is preferably an inflation/deflation bag. The pulse wave detection component 105 is significantly smaller in size compared to occlusion component 103, and therefore they are pressurized and depressurized by independent sources via 106 and 108.
Between occlusion component 103 and pulse wave detection component 105, compliance fluid bag 104 is placed. It contains fluids, preferably liquids or gels. The compliance fluid bag 104 improves the compliance between occlusion component 103 and the body portion 101, and it enhances uniform pressure distribution on underlying artery. By using the compliance fluid bag 104, it is possible to use smaller volumes for occlusion component 103 which leads to lower space, lower pumping necessities on the pumps, and more compact ABPMs.
To improve the compliance between occlusion component 103 and the body portion 101, the compliance fluid bag 104 is appreciated to have a bigger width and length compared to occlusion component 103.
In order to achieve a better occlusion, it is necessary to limit the freedom of the occlusion component 103 and compliance fluid bag 104 against the body portion 101. This is achieved by a flexible hard support 102 place on occlusion component 103, compliance fluid bag 104 and pulse wave detection component 105.
Referring to
Pulse wave detection component 105 can be positioned on the distal side or downstream side of the blood pressure cuff to achieve an improved signal to noise ratio. However, it is preferably positioned under the compliance fluid bag 104.
The second exemplary embodiment of the blood pressure cuff is shown in
Occlusion component 203-a may have a branch or braches like occlusion support component 203-b, to support the suppression of the upstreams at proximal (heart) side for a better pulse wave detection and improvement of signal to noise ratio. It is connected to occlusion component 203-a via a fluidic connection 203-c. Pulse wave or blood pressure oscillations in the underlying artery is detected by pulse wave detection component 205, which is preferably an inflation/deflation bag.
Between occlusion component 203 and pulse wave detection component 205, compliance fluid bag 204 is placed. It contains fluids, preferably liquids or gels. The compliance fluid bag 204 improves the compliance between occlusion component 203 and the body portion 201, and it enhances uniform pressure distribution on underlying artery. By using the compliance fluid bag 204, it is possible to use smaller volumes for occlusion component 203 which leads to lower space, lower pumping necessities on the pumps, and more compact ABPMs.
To improve the compliance between occlusion component 203 and the body portion 201, the compliance fluid bag 104 is appreciated to have a bigger width and length compared to occlusion component 203.
In order to achieve a better occlusion, it is necessary to limit the freedom of the occlusion component 203 and compliance fluid bag 204 against the body portion 201. This is achieved by a flexible hard support 202 placed on occlusion component 203, compliance fluid bag 204 and pulse wave detection component 205.
Referring to
Pump 206 can be electrical or mechanical such as a manual handbulb. The pressure inside pulse wave detection component 205 can be measured by a pressure sensor 212 via tube 211.
Pulse wave detection component 205 can be positioned on the distal side or downstream side of the blood pressure cuff to achieve an improved signal to noise ratio. However, it is preferably positioned under the compliance fluid bag 204.
Referring to
This over-estimation problem is related to the continuous or excessive pumping of fluid into the pulse wave detection component 205. Due to excessive amount of fluid, and relatively smaller size or volume, small fluctuations can cause big pressure deviations increasing the error. If the amount of flow or the flow speed can be controlled or adjusted, accurate values can be reached. In addition, increasing the value of impedance can be another solution.
To control and adjust the fluid flow into pulse wave detection component, another embodiment is proposed next by employing a valve.
The third exemplary embodiment of the blood pressure cuff is shown in
Occlusion component 303-a may have a branch or braches like occlusion support component 303-b, to support the suppression of the upstreams at proximal (heart) side for a better pulse wave detection and improvement of signal to noise ratio. It is connected to occlusion component 303-a via a fluidic connection 303-c. Pulse wave or blood pressure oscillations in the underlying artery is detected by pulse wave detection component 305, which is preferably an inflation/deflation bag.
Between occlusion component 303 and pulse wave detection component 305, compliance fluid bag 304 is placed. It contains fluids, preferably liquids or gels. The compliance fluid bag 304 improves the compliance between occlusion component 303 and the body portion 301, and it enhances uniform pressure distribution on underlying artery. By using the compliance fluid bag 304, it is possible to use smaller volumes for occlusion component 303 which leads to lower space, lower pumping necessities on the pumps, and more compact ABPMs.
To improve the compliance between occlusion component 303 and the body portion 301, the compliance fluid bag 304 is appreciated to have a bigger width and length compared to occlusion component 303.
In order to achieve a better occlusion, it is necessary to limit the freedom of the occlusion component 303 and compliance fluid bag 304 against the body portion 301. This is achieved by a flexible hard support 302 placed on occlusion component 303, compliance fluid bag 304 and pulse wave detection component 305.
Referring to
Pump 306 can be electrical or mechanical such as a manual handbulb. The pressure inside pulse wave detection component 305 can be measured by a pressure sensor 310 via tube 309.
Pulse wave detection component 305 can be positioned on the distal side or downstream side of the blood pressure cuff to achieve an improved signal to noise ratio. However, it is preferably positioned under the compliance fluid bag 304.
Referring to
Here, the point where valve 308-d in bridge component 308 switched OFF has critical importance to control and adjust the fluid amount flowing into the pulse wave detection component 305. In this experiment, it is around 25 mmHg. This switching point (or the threshold value) of the valve to block the fluid is appreciated to be less that the DBP of the subject, i.e. preferably less than 50 mmHg.
The number of the experiments for blood pressure readings with another subject is increased to 29 (
The fourth exemplary embodiment of the blood pressure cuff is shown in
Occlusion component 403-a may have a branch or braches like occlusion support component 403-b, to support the suppression of the upstreams at proximal (heart) side for a better pulse wave detection and improvement of signal to noise ratio. It is connected to occlusion component 403-a via a fluidic connection 403-c. Pulse wave or blood pressure oscillations in the underlying artery is detected by pulse wave detection component 405, which is preferably an inflation/deflation bag.
Between occlusion component 403 and pulse wave detection component 405, compliance fluid bag 404 is placed. It contains fluids, preferably liquids or gels. The compliance fluid bag 404 improves the compliance between occlusion component 403 and the body portion 401, and it enhances uniform pressure distribution on underlying artery. By using the compliance fluid bag 404, it is possible to use smaller volumes for occlusion component 403 which leads to lower space, lower pumping necessities on the pumps, and more compact ABPMs.
To improve the compliance between occlusion component 403 and the body portion 401, the compliance fluid bag 404 is appreciated to have a bigger width and length compared to occlusion component 403.
In order to achieve a better occlusion, it is necessary to limit the freedom of the occlusion component 403 and compliance fluid bag 404 against the body portion 401. This is achieved by a flexible hard support 402 placed on occlusion component 403, compliance fluid bag 404 and pulse wave detection component 405.
Referring to
Pump 406 can be electrical or mechanical such as a manual handbulb. The pressure inside pulse wave detection component 405 can be measured by a pressure sensor 410 via tube 409.
Pulse wave detection component 405 can be positioned on the distal side or downstream side of the blood pressure cuff to achieve an improved signal to noise ratio. However, it is preferably positioned under the compliance fluid bag 404.
Usual 3-port valve opens one port in a given of time, and closes the other port at that time. Therefore, fluid pumping into both of the components (403 and 405) is not possible. Therefore, instead of parallel pumping or pumping fluid into both components at the same time, serial or alternating pumping can be considered.
The last 2 figures, 10-A and 10-B, show some pumping examples and control protocols of the pumping.
Example-1 (
Example-2 (
Example-3 (
Example-4 (
Example-5 (
Apart from those, it is possible to apply or to find different control protocols, and/or combination of the control protocols mentioned above. For example, a prototype shown in
This invention can be applied to the blood pressure meters and ABPMs.
Filing Document | Filing Date | Country | Kind |
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PCT/JP2014/071416 | 8/7/2014 | WO | 00 |