JP2017505685A - Sphygmomanometer and cuff - Google Patents

Abstract

The sphygmomanometer cuff of the present invention has an occluding member configured to occlude an artery and a compliance fluid bag containing an incompressible fluid and superimposed on the occluding member, the compliance fluid bag being a sphygmomanometer cuff. The occlusion member overlaps the occlusion member in the width direction of the occlusion member at least upstream of the artery from the center of the width of the occlusion member, which is the length of the occlusion member along the axis on which the occlusion is wound.

Description

  The present invention relates to a sphygmomanometer and a cuff.

  Blood pressure is one of the vital signs of humans or animals (ie, blood pressure, breathing, body temperature, heart rate, etc.) and is the most important parameter for monitoring and diagnosing medical conditions and diseases such as heart disease and hypertension It is one of. For reliable medical evaluation and treatment, blood pressure measurement accuracy of less than ± 5 mmHg from the body part is required. Since blood pressure values strongly depend on the vertical distance from the heart height, as a more reliable and accurate measurement method, blood pressure measurement from the upper arm at the heart height is widely accepted by medical professionals. This is typically done by a structure called a “cuff” that is wrapped around the upper arm of the human (ie, placed on the upper arm).

  A typical cuff consists of a bag (or bladder) that is inflated / deflated (or pressurized / depressurized) by air from a pressure control unit. In order to measure blood pressure, the detection of Korotkoff sounds that are generally performed with a stethoscope by medical professionals, the oscillometric method that detects vibration in the inflatable bladder caused by the pressure vibration of the arteries, the method using the Doppler effect, There can be various ways. Blood pressure measurement by Korotkoff sounds and oscillometric methods is widely accepted and used in commercial blood pressure monitors, blood pressure meters, or blood pressure devices (ie, blood pressure monitors). For automatic sphygmomanometers (or electronic sphygmomanometers), oscillometric methods are commonly used because of their improved signal to noise ratio performance. Furthermore, this method makes it possible to visualize the blood pressure wave or blood pressure pulse wave and improve the medical evaluation of the subject.

  The cuff size for the brachial blood pressure monitor is an important consideration. The ideal cuff has a bag width of at least 40% around the arm and a recommended bag length of twice this width is recommended. 12cm bag width is recommended for small adults with arms around 22-26cm, while 16cm bag width is recommended for standard adults with arms around 27-34cm (or more) [Page 705 of Non-Patent Document 1]. However, for cuffs consisting of a single bladder, the cuff edge problem should be considered.

  In most medical tests, a cuff with a 12 cm wide bag is used. In general, such testing is immediate and takes less than 5 minutes. Even if comfort is not an issue during a medical test, a cuff width of about 12 cm is not comfortable for daily use or continuous blood pressure measurement, ie, Ambient Blood Pressure Monitoring (ABPM). Absent. It is a well-known fact that the results of blood pressure measurements can be affected by white coat hypertension and can cause false results and treatments. Blood pressure measurements outside the hospital, at home, or during daily life are particularly recommended for predicting the risk of cardiovascular accidents and diagnosing white coat hypertension and obtaining more reliable results [Patent Document 1]. . However, current cuffs are wide and stressful for users in daily life. A smaller cuff width without sacrificing accuracy is desirable in everyday life measurements, but remains a challenge.

  As a standard measurement of blood pressure, a mercury-type upper arm blood pressure monitor is used [Patent Document 1]. A typical commercially available cuff in a mercury-type blood pressure monitor has a bag width of about 12 cm, and FIG. 28 shows a cross-sectional view 10 of a human (or animal) body part (eg, arm or leg). Yes. FIG. 28 shows a pressurized cuff cross-section along the axis around which the cuff is wound, and the closure member 11, usually an inflatable bag, is attached to the axis, ie the arm or leg (human or animal). The body part 12 is wound around the body. The side near the heart 13 is called the upstream side (or proximal) and the side near the hand or foot is called the downstream side (or distal). The occlusion member 11 is used to occlude the underlying artery 14 and measure blood pressure by pressure vibration. The blood flow 15 in the artery is blocked by the pressurized occlusion member 11.

US Patent Application Publication No. 2010/0106029 US Pat. No. 6,969,356

Thomas G. Pickering, outside, "Recommendations for blood pressure measurement in humans and experimental animals Part 1:. Blood pressure measurement in humans: A statement for professionals from the subcommittee of professional and public education of the American Heart Association council of high blood pressure research", Circulation, 111, 697-716, 2005 M.M. Ramsey, “Blood pressure monitoring: Automated oscillometric devices”, J. Am. Clin. Monitor. 56-67, 1991

  However, during the pressurization of the cuff, the heart continues to pump blood, and the blood strikes the wall of the occluded artery under the cuff. Blood flow from the heart side is bounced, causing upstream flow 16 proximally. A cuff in a pressurized state has an elliptical cross section, thereby losing the efficiency of contact with the skin at the edges. This is known as the cuff edge effect 17. This effect results in a non-uniform pressure distribution 18 to the artery and a partial or narrow occlusion 19 of the artery around the center of the cuff. Due to the cuff edge effect 17, the effective closure width is smaller than the width of the cuff along the axis around which the cuff is wound.

  The object of the present invention is to greatly reduce the above mentioned problems and to allow a smaller cuff width leading to a relatively more comfortable and more compact wearable medical device.

  The sphygmomanometer cuff includes an occluding member configured to occlude the artery and a compliance fluid bag containing an incompressible fluid and superimposed on the occluding member, the compliance fluid bag being wrapped with the sphygmomanometer cuff. The occlusion member overlaps the occlusion member in the width direction of the occlusion member at least upstream from the center of the width of the occlusion member, which is the length of the occlusion member along the axis.

  The sphygmomanometer cuff of the present invention can reduce the cuff edge effect, thereby allowing a smaller cuff width that can make the medical device more comfortable.

A sphygmomanometer structure having a single fluid connection with a sphygmomanometer cuff. A sphygmomanometer structure having a plurality of fluid connections with a sphygmomanometer cuff. 1 is a top view of a first embodiment of a sphygmomanometer cuff. FIG. 1 is a cross-sectional view of a first embodiment of a sphygmomanometer cuff along the axis of a sphygmomanometer cuff around which the cuff is wound. It is an experimental result of the pressure distribution along the axis | shaft on which the cuff was wound of the cuff air bag provided with the compliance fluid bag (or compliance improving member) and the cuff air bag not provided. FIG. 6 is a cross-sectional view of a second embodiment of a sphygmomanometer cuff along the axis of the sphygmomanometer cuff around which the cuff is wound. FIG. 6 is a cross-sectional view of a second embodiment of a sphygmomanometer cuff along the axis of the sphygmomanometer cuff around which the cuff is wound. FIG. 6 is another cross-sectional view of the second embodiment of the sphygmomanometer cuff along the axis of the sphygmomanometer cuff around which the cuff is wound. It is sectional drawing in the pressurization state of 2nd Embodiment of the blood pressure meter cuff with which the upper arm was mounted | worn (however, it is in the state which the artery opened for easy visibility). FIG. 6 is a cross-sectional view of a second embodiment of a sphygmomanometer cuff attached to the upper arm in a pressurized state, where the compliance fluid bag may include a plurality of bags (although the artery is open for clarity). It is sectional drawing. It is sectional drawing of 3rd Embodiment of the blood pressure meter cuff by which the pulse-wave detection member is arrange | positioned under the compliance fluid bag of the downstream. FIG. 12 is a cross-sectional view of a fourth embodiment of a sphygmomanometer cuff, wherein the closure member at the top of the compliance fluid bag toward the body part is supported at the lower part upstream by the closure support member via the fluid connection. . It is sectional drawing of 4th Embodiment of the blood pressure meter cuff by which the obstruction | occlusion member is supported in the lower part of an upstream by attaching the obstruction | occlusion support member. It is sectional drawing of the 4th Embodiment of the sphygmomanometer cuff by which the obstruction | occlusion member is supported by attaching the obstruction | occlusion support member to a test subject's body part in direct contact. It is sectional drawing of the compliance fluid bag provided with the flexible sheet | seat, and the compliance fluid bag which is not provided. It is sectional drawing of the compliance fluid bag provided with the flexible sheet | seat, and the compliance fluid bag which is not provided. It is a top view of a compliance fluid bag. It is a top view of a compliance fluid bag. It is a three-dimensional arrangement of flexible sheets in a compliance fluid bag. It is a three-dimensional arrangement of flexible sheets in a compliance fluid bag. FIG. 10 is a cross-sectional view of a fifth embodiment of a sphygmomanometer cuff along the axis around which the cuff is wound. FIG. 11 is a cross-sectional view of a sixth embodiment of a sphygmomanometer cuff along the axis around which the cuff is wound. FIG. 10 is a cross-sectional view of a seventh embodiment of a sphygmomanometer cuff along the axis around which the cuff is wound. FIG. 10 is a cross-sectional view of an eighth embodiment of a sphygmomanometer cuff along the axis around which the cuff is wound. FIG. 10 is a cross-sectional view of a ninth embodiment of a sphygmomanometer cuff along the axis around which the cuff is wound. FIG. 12 is a cross-sectional view of a tenth embodiment of a sphygmomanometer cuff along the axis around which the cuff is wound. FIG. 25 is a cross-sectional view of an eleventh embodiment of a sphygmomanometer cuff along the axis around which the cuff is wound. It is sectional drawing of Example 1 of 12th Embodiment of the blood pressure meter cuff along the axis | shaft in which the cuff was wound. FIG. 29 is a cross-sectional view of Example 2 of the twelfth embodiment of the sphygmomanometer cuff along the axis around which the cuff is wound. It is sectional drawing of Example 3 of 12th Embodiment of the blood pressure meter cuff along the axis | shaft in which the cuff was wound. FIG. 29 is a cross-sectional view of Example 4 of the twelfth embodiment of the sphygmomanometer cuff along the axis around which the cuff is wound. FIG. 24 is a cross-sectional view of a thirteenth embodiment of a sphygmomanometer cuff along the axis around which the cuff is wound. It is sectional drawing of the blood pressure meter cuff of the prototype used for experiment. It is a schematic external view which shows the mode of blood pressure measurement. It is a pie chart which shows the measurement accuracy of the whole blood pressure measurement result by a prototype. It is a pie chart which shows the measurement accuracy of SBP measured by the prototype. It is a pie chart which shows the measurement accuracy of DBP measured by the prototype. It is a bar graph which shows the measurement precision of a prototype, a reference | standard blood pressure meter cuff, and a comparative example. FIG. 3 is a pressurized cross-sectional view of a commercially available cuff air bag along the axis around which the cuff is wound.

  Hereinafter, embodiments for carrying out the present invention will be described with reference to the drawings. However, exemplary technical limitations for carrying out the present invention are applied to the embodiments described below, but the scope of the present invention is not limited to the following.

  1A and 1B show the structure of a sphygmomanometer 150 having a single fluid connection 153 with the sphygmomanometer cuff 152 and a plurality of fluid connections 153 and 154 with the sphygmomanometer cuff 152. It is shown. The sphygmomanometer 150 includes a measurement unit 155 and a sphygmomanometer cuff 152. The sphygmomanometer cuff 152 is attached to the body part 151 of the subject whose blood pressure is to be measured. The measurement unit 155 includes a pressure increase / decrease unit 156, a blood pressure measurement unit 157, a control operation unit 158, and a display unit 159. The pressure increasing / decreasing unit 156 may include a pump, a valve, and a fluid element necessary for pressurizing and depressurizing the sphygmomanometer cuff 152, and the blood pressure measuring unit 157 may include a pressure sensor. In FIG. 1A, the pressure increasing / decreasing unit 156 is connected to the sphygmomanometer cuff 152 via a single fluid connection 153. The measurement is performed by the blood pressure measurement unit 157 via the fluid connection unit 160. The pressure increasing / decreasing unit 156 and the blood pressure measuring unit 157 are in electronic communication with the control operation unit 158. The control operation unit 158 stores and processes measurement signals using a CPU (Central Processing Unit), a ROM (Read-Only Memory), and a RAM (Random Access Memory). And control of the entire device. The result is displayed on the display unit 159 by an LED (Light-Emitting Diode, light emitting diode) or an LCD (Liquid Crystal Display, liquid crystal display) monitor. FIG. 1B shows another possible sphygmomanometer, in which a sphygmomanometer cuff 152 is connected to the measurement unit via a plurality of fluid connections 153,154. In FIG. 1B, the pressure increasing / decreasing unit 156 is connected to the sphygmomanometer cuff 152 via the fluid connection part 153, and the blood pressure measurement unit 157 is connected to the sphygmomanometer cuff 152 via the fluid connection part 154. Both the units 156 and 157 are in communication with each other via the fluid connection portion 160. Although not shown in the figure, the control operation unit 158 includes an energy unit.

[First Embodiment]
2 and 3 show a sphygmomanometer cuff 100 according to the first embodiment. FIG. 2 is a top view of the sphygmomanometer cuff. The width of the closure member 101 is less than or equal to the width of the compliance fluid bag 102 along the axis around which the cuff is wound (or the axis around which the cuff is wound). The length of the compliance fluid bag 102 may be shorter or longer than the length of the occlusion member 101 along the outer circumference of the blood pressure measurement site of the subject, such as a human or animal arm or leg. The length of the occlusion member 101 may be from half the circumference of the body part to the whole body part. Occlusion member 101 needs to apply sufficient pressure to the artery to prevent blood flow. The occlusion member 101 is desirably 80% of the circumference of the body part (Non-patent Document 1). The peripheral length of the body portion of the compliance fluid bag 102 may be approximately 40% of the peripheral length, or may be longer than the length of the occlusion member 101. However, the circumferential length of the compliance fluid bag 102 is preferably longer than the length of the closing member 101.

  FIG. 3 shows a cross-sectional view of the cuff of the present invention along the axis around which the cuff is wound. FIG. 3 shows a pressurized cuff 100 in which an occluding member 101 is wrapped around the axis of a subject's body part 103, such as a human or animal arm or leg.

  The occlusion member 101 may be an electrically actuated polymeric material, may be pressurized / depressurized with a liquid, or may be a typical air (or gas) inflatable bag that is most commonly used. May be used. In consideration of practicality, an air pressurization / depressurization (inflatable / shrinkable) closing member (that is, an air bag or a bladder) is preferable.

  The compliance material (compliance fluid bag) 102 is below the occlusion member 101 toward the subject's body part 103 and provides more appropriate compliance between the subject's body part 103 and the occlusion member 101. That is, the compliance fluid bag 102 has a function as a compliance improvement member. The width of the compliance fluid bag 102 is equal to or greater than the width of the closure member 101 along the axis around which the cuff is wound. The width of the compliance fluid bag 102 can be increased up to 150% of the width of the closure member 101.

  The width of the closing member 101 in the pressurized state is shown as w1. The elongation of the upstream and downstream compliance fluid bags 102 when in a pressurized state may be equal to or greater than zero. Although not described in detail, a plurality of compliance fluid bags can be used under the closure member 101. In this case, the outermost width, that is, the distance from the proximal side to the distal side of the compliance fluid bag under the closing member 101, regardless of whether or not the plurality of compliance fluid bags overlap each other, Preferably, it is equal to or greater than the width of the occluding member 101 along. Thereby, at least one of the influence of the fluid pressure difference and the influence of gravity on the upstream side and the downstream side in the sphygmomanometer cuff due to the liquid contents in the compliance fluid bag can be reduced to some extent, and the blood pressure measurement error is reduced. be able to.

  The side closer to the heart 104 is upstream (or proximal) and the side closer to the hand or foot is downstream (ie distal). The occlusion member 101 is used to occlude the underlying artery 105. A blood flow 106 in the artery is blocked by the pressurized occlusion member 101.

  However, during the pressurization of the cuff, the heart continues to pump blood, and the blood strikes the wall of the occluded artery under the cuff. Blood flow from the heart side is bounced, causing upstream flow 107 proximally. Since the cuff in the pressurized state has an elliptical cross section, the efficiency of contact with the skin at the end is lost. This is known as the cuff edge effect 17 (FIG. 28). However, in this design, the compliance fluid bag improves compliance between the occlusion member 101 and the body part 103 of the subject. This leads to a reduction 108 of the cuff edge effect and leads to a more uniform pressure distribution 109 for the artery under the cuff. By making the pressure distribution uniform, pressure can be effectively transmitted to the underlying artery, and the artery 105 is occluded 110. This approach provides a method that can eliminate inappropriate cuff edge effects and reduce the cuff width along the axis around which the cuff is wound without sacrificing measurement accuracy.

  The compliance fluid bag 102 improves the compliance between the occlusion member 101 and the body part 103 of the subject. The compliance fluid bag 102 may or may not contain a fluid. However, to improve practicality, an enclosed compliance fluid bag is preferred. To improve compliance, incompressible fluids such as liquids or gels are preferred.

  A flexible bag material such as polyethylene, polyvinyl chloride, or latex free plastic is preferred.

  Elastic materials or expandable materials are also conceivable for the bags, in particular for the compliance fluid bag 102. It is such that the width of the compliance fluid bag along the axis around which the cuff is wound can be made smaller than the width of the closure member. During pressurization, the compliance fluid bag extends or expands along the axis around which the cuff is wound. During measurement, the width of the compliance fluid bag 102 is preferably equal to or greater than the width of the closure member 101.

  The boundary surface 113 may include an adhesive or a double-sided adhesive layer that secures the closure member 101 to the compliance fluid bag 102 for more stable operation. The interface 112 between the compliance fluid bag 102 and the subject's body part 103 may include a fabric cover (not shown) that covers the sphygmomanometer cuff.

  Next, the experimental results of the present inventors will be described. The measurement is performed by a cuff having a compliance fluid bag (or a compliance strengthening member) and a cuff having no compliance fluid bag (or a compliance reinforcing member). The measurement is performed at eight points along the axis around which a commercially available cuff is wound by a flexible pressure sensor having a diameter of 1 cm. FIG. 4 shows data with and without the compliance fluid bag. Commercial cuffs have a width of about 13.5 cm including the fabric cover. The data shows that the pressure is low at the end of the cuff and is relatively uniform around the center. The pressure value measured by the pressure sensor is scaled as a ratio of the output of the sensor when 200 mmHg is read from a mercury meter of a commercially available sphygmomanometer. (The cuff is fixed between two plates larger than the cuff and the pressure sensor is placed on the cuff.) 75% of the mercury meter to occlude the artery for reliable blood pressure measurement ( In other words, assuming that 3/4) is insufficient (ie, 150 mmHg is insufficient), the arteries under the cuff are approximately 4 to 5 cm from both ends (corresponding to one third of the cuff). It is thought that sufficient pressure is not applied to For typical cuff pressure distribution characteristics, this width is acceptable. However, reducing the width increases the cuff edge effect, with high probability due to incomplete and / or non-uniform transmission of pressure to the artery under the narrow cuff. Inadvertently, a high reading (that is, erroneous measurement of blood pressure) will occur [Non-Patent Document 2]. Therefore, if the cuff edge effect can be reduced so that pressure can be transmitted completely or evenly to the artery under the cuff (or if it can be distributed completely or evenly), standard measurement with sufficient measurement accuracy can be achieved. A smaller cuff width for adults becomes feasible and applicable.

  FIG. 4 shows further experimental data. Square dots on the graph indicate the pressure distribution along the width of the compliance fluid bag (compliance improving member) disposed on the closing member 101. In fact, the compliance fluid bag is placed on a fabric cover on a commercially available cuff. The compliance improving member is a water-filled bag in this preliminary experiment, and has a width of about 15 cm, which is larger than a commercially available cuff. In this experiment, water is used because it is easily available. However, any liquid or gel may be used. The pressure sensor is placed on a compliance enhancing member placed on a commercially available cuff and the experiment is repeated. FIG. 4 shows that the pressure distribution uniformity is improved by the compliance fluid bag compared to the case without the compliance fluid bag, and the fitting result shows that the cuff edge effect is clearly reduced. Is shown. For example, the pressure sensor readings at locations corresponding to 6% and 94% of the commercial cuff width (ie, the end) are approximately 2 and 4 times, respectively, for the compliance fluid bag (or compliance enhancing member). Has been enhanced. These results may not be possible with a commercial cuff by maintaining sufficient pressure uniformity on the artery for occlusion by using a compliance enhancement member for the body part of the subject whose blood pressure is to be measured. This means that the cuff width can be reduced. This technique can reduce blood pressure error measurement in a hospital or emergency, and can realize a more comfortable blood pressure monitor and ABPM with high blood pressure measurement accuracy.

  Here, with reference to the graph of FIG. 4, characteristics common to the sphygmomanometer cuff of the first and second embodiments and the sphygmomanometer cuff of the third to fourteenth embodiments (described later) will be described.

  The characteristic configuration of the sphygmomanometer cuff of the present invention is that the closing member and the compliance fluid bag overlap. The term “the closing member and the compliance fluid bag overlap” means a state where there is at least a portion where the closing member and the compliance fluid bag overlap in a direction substantially perpendicular to the contact surface of the measurement object. The compliance fluid bag may be laminated on the closure member, or the closure member may be laminated on the compliance fluid bag. Further, the fact that the closure member and the compliance fluid bag overlap includes the case where an incompressible component material is provided between the closure member and the compliance fluid bag as in a third embodiment described later. Yes.

  Referring to FIG. 4, the sensor output value is high when the sensor position is in the range of 6% to 35% and in the range of 65% to 94%. In this experiment, the sensors are not provided at the positions of 0% and 100%, but from the graph of FIG. 4, the pressure can be improved at the positions of 0% and 100% as compared with the case without the compliance fluid bag. Guessed.

  Here, in the axial direction around which the sphygmomanometer cuff is wound, if the central position of the closing member is defined as 0% and the positions of both ends of the closing member are redefined as 50%, the range of 15-50% It can be seen that when the fluid bag overlaps the closing member at 10% or more of the entire width, the effect of improving the closing property is high. Thus, if the fluid bag and the closing member partially overlap, the closing characteristic of the end of the closing member can be improved.

  Next, the reason why the effect of the above operation is obtained by overlapping the closing member and the fluid bag will be described.

  When air is fed into the closing member, the cross section of the bag swells into an elliptical shape due to the tension of the bag. That is, the central part swells greatly and the end part swells slightly. At this time, the fluid in the fluid bag moves due to the deformation of the closing member. The movement of the fluid proceeds in a direction in which the pressure between the measurement site and the closing member becomes uniform.

  For example, if the fluid bag is not present, the central portion of the closing member swells greatly and the end portion slightly swells. The pressure in between increases, but the pressure decreases because the close contact is not good. When the fluid bag is present, the fluid moves from the central part where the pressure is high to the end where the pressure is low. When the fluid moves to the end, the adhesion between the blocking member and the measurement site is improved, and the pressure near the end is improved. As described above, the fluid moves from a portion where the pressure between the blocking member and the measurement site is high toward a portion where the pressure is low. Thus, fluid movement continues to minimize pressure imbalance, thereby reducing pressure imbalance.

  Next, the effect of the difference between the contents of the closing member and the fluid bag will be described.

  The contents of the fluid bag are preferably an incompressible fluid (such as a liquid, gel, or particulate).

  When the content of the fluid bag is an incompressible fluid, the volume of the fluid bag hardly changes with respect to the external pressure. As a result, even if the compression pressure applied to the measurement site is increased, the adhesion between the closing member and the measurement site can be improved without substantially reducing the volume of the fluid bag. Therefore, the pressure imbalance can be reduced more effectively.

  On the other hand, the content of the closing member is preferably air.

  Since air has low viscosity, fluid resistance is low even if a large amount of air is sent and discharged. Therefore, even if the closing member is pressurized and depressurized, the pressure inside the bag can be controlled uniformly and accurately. In addition, when the content of the fluid bag is an incompressible fluid, it is possible to effectively eliminate an imbalance in pressurization due to insufficient adhesion between the closing member and the site to be measured. Accordingly, it is possible to accurately control the pressure applied to the measurement site, thereby improving the accuracy of blood pressure measurement.

  In addition, when the contents of the closing member are air and the contents of the fluid bag are an incompressible fluid, when blood flows into the closing part, the volume of the fluid bag does not change and only the volume inside the closing member remains. fluctuate. As a result, the S / N of the volume variation of the occlusion member due to blood flow is improved. Therefore, the pulse wave can be detected with high accuracy, and blood pressure measurement accuracy is improved.

  The experimental results showing the improvement in blood pressure measurement accuracy by the sphygmomanometer cuff of one embodiment of the present invention will be described later.

  US Patent Application Publication No. 2010/0106029 [Patent Document 1] describes a liquid bag in a cuff structure. However, the liquid bag width is smaller than the width of the cuff (or occlusion member) along the axis around which the cuff is wound, and this liquid bag improves the mechanical coupling between the cuff and the pulse wave in the artery. Used for. In our design, the liquid bag (or compliance fluid bag) has a width equal to or greater than the width of the closure member, the purpose of which is to improve compliance and eliminate the cuff edge effect; Or to reduce.

  US Pat. No. 6,969,356 [Patent Document 2] describes a liquid element in a cuff structure to improve compliance. However, the liquid element is only a fraction of the entire cuff, which directs the lower part of the cuff to a body part such as the ankle of the leg. The liquid only provides compliance to a limited area, and its width is about the size of a small bag that measures pulse waves. In our design, the liquid (or compliance fluid bag) covers the space under the closure member and improves the reduction of the cuff edge effect.

[Second Embodiment]
FIG. 5 shows a sphygmomanometer cuff 200 according to the second embodiment. FIG. 5 shows a cross section of the cuff of the present invention along the axis around which the cuff is wound. FIG. 5 shows a pressurized cuff 200 with an occluding member 201 wrapped around the axis of a subject's body part 203, such as an arm or leg (human or animal). In the sphygmomanometer cuff 200, a flexible hard support 211 having flexibility is further placed on the closing member and the compliance fluid bag. Other members are the same as those of the sphygmomanometer cuff 100 of the first embodiment.

  The degree of freedom or mobility of the occlusion member 201 is limited between the flexible hard support 211 and the body part 203 of the subject. The flexible hard support 211 may be a plastic material having sufficient flexibility and hardness, for example, a 1 mm PET sheet.

  The boundary surface 214 may include an adhesive or a double-sided adhesive layer that secures the closure member to the flexible hard support 211 for more stable operation.

  The sphygmomanometer cuff 200 of the present embodiment can also reduce the cuff edge effect.

  FIG. 6 shows an example of a second embodiment of a sphygmomanometer cuff, and the closure member 201 may be placed in a compliance fluid bag 222. The closure member 201 may be secured to the inner wall of the compliance fluid bag 222 by an adhesive or double-sided adhesive layer at the interface 224, and the outer compliance fluid bag 222 is similarly secured to the flexible hard support 211. May be.

  FIG. 7 shows another example of the second embodiment of the sphygmomanometer cuff. In this embodiment, the compliance fluid bag 232 is composed of two bags, that is, an inner bag (ie, the closed bag 201) and an outer bag. There is a compliance fluid in the space between the inner and outer bags. At the interface 226, the compliance fluid bag 232 is secured to the flexible hard support 211 with an adhesive or a double-sided adhesive layer to improve stability. The interface 227 is simply the surface of the inner bag so that the inner bag can move freely within the compliance fluid bag. In addition, the movement of the inner bag along the axis around which the cuff is wound can be limited.

  FIG. 8 shows a cross-sectional view of the sphygmomanometer cuff attached to the upper arm in the pressurized state of the second embodiment. For ease of viewing, artery 205 is shown close to bone 215 in an open state. The flexible hard support 211 is close to the outer periphery of the body part 203 of the subject. The flexible hard support may occupy 80% to 100% of the outer periphery of the body part 203. Fasteners 216, such as hook and loop fasteners, can be used to secure the cuff to the body part. A compliance fluid bag 202 that is longer than the closure member 201 along the outer periphery of the body part 203 is preferred. This is because when the closing member 201 is pressurized, it presses the compliance fluid bag and the internal fluid escapes toward the end. As a result, a blocking effect is also provided in these regions, and by using this, an effective blocking length longer than the length of the blocking member 201 can be obtained as shown in FIG. As a result, the volume of the occlusion member, and hence the required amount of air, is reduced, and a sphygmomanometer and cuff that are smaller than the commercially available product can be realized. This reduces the reliability of the pump specifications such as size and speed, makes it possible to apply a more compact and comfortable sphygmomanometer or ABPM, and improve the effects of the present invention.

  At the boundary surfaces 213 and 214, as described above, each part can be fixed using an adhesive or a double-sided adhesive layer for stable operation. In addition, at the interface 212, a fabric cover can be used.

  FIG. 9 shows another cross-sectional view of the sphygmomanometer cuff attached to the upper arm in the pressurized state of the second embodiment. The compliance fluid bag 202 can be divided into a plurality of bags similar to the example consisting of 202-a, 202-b, and 202-c. The plurality of bags may have different lengths, and the total length along the outer periphery of the body part 203 of the subject may be longer than the length of the blocking member 201. At the boundary surfaces 213 and 214, as described above, each part can be fixed using an adhesive or a double-sided adhesive layer for stable operation. In addition, at the interface 212, a fabric cover can be used.

[Third Embodiment]
FIG. 10 shows a third embodiment of the sphygmomanometer cuff. A flexible hard support 211 for limiting the freedom of movement of the underlying components, an occlusion member 201 for occluding the underlying artery, and a compliance fluid bag 202 for improving compliance A pulse wave detection member 223 is attached to the cuff of FIG. Although not described in detail, a plurality of compliance fluid bags can be used under the closure member 201. In this case, the outermost width, that is, the distance from the proximal side to the distal side of the compliance fluid bag under the closing member 201, regardless of whether or not the plurality of compliance fluid bags overlap each other, Preferably, it should be equal to or greater than the width of the occluding member 201 along. Thereby, at least one of the influence of the fluid pressure difference and the influence of gravity on the upstream side and the downstream side in the sphygmomanometer cuff due to the liquid contents in the compliance fluid bag can be reduced to some extent, and the blood pressure measurement error is reduced. be able to.

  The third embodiment is different from the second embodiment in that it includes a pulse wave detection member 223.

  The pulse wave detection member 223 may be a bag that can be inflated / deflated by gas or air, or may be a device or module that measures blood pressure with high accuracy. The pulse wave detection member 223 may include a single sensor, a plurality of sensors, or an array of sensors for measuring blood pressure. The pulse wave detection member 223 of FIG. 10 may be attached to a cuff including the flexible hard support 211, the closing member 201, and the compliance fluid bag 202, or may be disposed in the cuff. Alternatively, it may be arranged in the vicinity of the cuff on the body part 203 of the subject along the axis around which the cuff is wound.

  Instead of having an internal pressure sensor, the pulse wave detection member 223 may be connected to an external pressure sensor. The internal pressure of the pulse wave detection member 223 is measured by an internal or external pressure sensor.

  A preferable position of the pulse wave detection member 223 for measuring blood pressure more effectively and accurately is below the compliance fluid bag 202 and the occlusion bag 201 toward the body part 203 of the subject on the downstream side (FIG. 10). . A position close to the end of the closing member 201 can be an ideal position. Thereby, the probability that the pressure distribution with respect to the artery becomes uniform can be improved by arranging the pulse wave detection member 223 not near the center but near the end. This is because the space between the compliance fluid bag 202 and the pulse wave detection member 223 on the body part 203 of the subject deteriorates the uniform pressure distribution with respect to the space such as the left and right ends of the pulse wave detection member 223. Because there is. To improve the stability of the structure, an adhesive or double-sided adhesive layer can be used to secure the bag and components to the interface 217. (Although not shown, in order to improve the signal-to-noise ratio, an absorbing material is disposed between the compliance fluid bag and the pulse wave detection member, and is transmitted through at least one of the compliance fluid bag and the blocking member. (Noise and vibration can be absorbed. The absorber may be a plastic sheet, a composite material, a porous material, a foam, or an encapsulating fluid.)

  As shown in FIG. 10, the pulse wave detection member 223 is disposed at a position between the compliance fluid bag 202 and the subject 203. The pulse wave detection member is in close contact with the object to be measured by the compliance fluid bag. Further, since the compliance fluid bag is not disposed between the object to be measured and the pulse wave detecting member, the pressure inside the pulse wave detecting member is substantially equal to the pressure applied to the object to be measured. Therefore, the blood pressure can be accurately determined by referring to the pressure inside the pulse wave detection member.

  FIG. 10 shows a configuration in which the pulse wave detection member, the compliance fluid bag, the closing member, and the hard support are sequentially stacked from the side close to the subject, but the stacking order of these members is the same as this configuration. It is not limited. For example, a pulse wave detection member, an occlusion member, a compliance fluid bag, and a hard support may be sequentially stacked from the side close to the subject. In this case, as shown in FIG. 10, the pulse wave detection member is preferably arranged between the compliance fluid bag and the subject and between the closing member and the subject. By using this configuration, the pressure in the object to be measured can be accurately measured.

  The volume of the pulse wave detection member is preferably smaller than the volume of the closing member. If the volume of the pulse wave detection member is small, the S / N (signal to noise) ratio of the volume fluctuation of the pulse wave detection member is improved. Therefore, arterial pulsation can be detected with high accuracy, and blood pressure measurement accuracy can be improved.

  A width of the pulse wave detection member 223 smaller than the width of the closing member 201 along the axis around which the cuff is wound is preferable. However, a width of 10% to 50% of the closing member is more desirable.

  The pulse wave detection member may be an arbitrary device including a sensor. However, a bag with a pressure measuring function that can be expanded / contracted by gas or air is preferable. The bag material may be a flexible material such as plastic.

[Fourth Embodiment]
FIG. 11 shows a fourth embodiment of a sphygmomanometer cuff having a further improved cross-section of the occluding member along the axis around which the cuff is wound. The closing member 401-a is an improved type of the closing member 201 in FIG. The function of the closing member 401-a is improved by the closing support member 401-b via the fluid connection 401-b. Under this structure, a compliance fluid bag 202 is formed toward the body part 203 of the subject. In order to measure blood pressure more effectively, a pulse wave detection member 223 is configured under the compliance fluid bag directed toward the body part of the subject. (Although not shown, in order to improve the signal-to-noise ratio, an absorbing material is disposed between the compliance fluid bag and the pulse wave detection member, and is transmitted through at least one of the compliance fluid bag and the blocking member. (Noise and vibration can be absorbed. The absorber may be a plastic sheet, a composite material, a porous material, a foam, or an encapsulating fluid.)

  The closing support member 401-b is connected to the closing member 401-a through the fluid connection portion 401-c (FIG. 11). The connection side is preferably the lower side of the occlusion member toward the body part 203 of the subject. The connection can be made through a hole or tube provided in the bag. By performing circular sealing and opening of the holes later, a through hole can be created between the bags. For example, a hot drilling process with a pointed hot object (e.g., a solder gun) is possible, thereby opening a hole and simultaneously sealing the bag.

  The occlusion support member 401-b supports or strengthens the occlusion of the artery under the cuff. The closing support member is configured to be arranged on the lower side of the closing bag 401-a and on the upstream side of FIG. As explained earlier, the heart continues to pump blood during occlusion of the artery under the cuff. Blood flow strikes the walls of the occluded artery. As a result, the blood flow is rebounded to the upstream side of the artery, and the accuracy of blood pressure measurement is reduced (207, FIG. 5). In this design, the upstream support member 401-b is used to suppress or reduce these upstream effects.

  The upstream end of the occlusion support member 401-b is preferably closer to the heart than the upstream end of the occlusion member 401-a along the axis around which the cuff is wound (FIG. 11). Thereby, the closing support member 401-b may be slightly inclined along the above-described axis. This further improves upstream suppression and improves at least one of blood pressure measurement accuracy and signal to noise ratio.

  The closing support member 401-b has a width smaller than the width of the closing member 401-a along the axis around which the cuff is wound. It is preferable that the total width of the closing member 401-a and the closing support member 401-b is equal to or smaller than the width of the compliance fluid bag 202 in the shaft.

  The occlusion support member 401-b is preferably a bag that can be expanded / contracted by gas or air passing from the occlusion member 401-a to the fluid connection portion 401-c. A bag material having flexible properties such as plastic is preferred.

  The closing support member 411 in FIG. 12 has functions and dimensions similar to those of the closing support member 401-b in FIG. The compliance fluid bag 202 is configured to be disposed below the occlusion member 401-a and the occlusion support member 411 toward the body part 203 of the subject. However, the occlusion support member 401-b is non-fluid, which means that the occlusion support member cannot expand / contract. The occlusive support member may be a flexible material such as plastic, silicone rubber, porous plastic (eg, sponge), or an encapsulating fluid.

  The closing support member 411 has a width smaller than the width of the closing member 401-a along the axis around which the cuff is wound. The total width of the closing member 411 and the closing support member 401-a is preferably equal to or smaller than the width of the compliance fluid bag 202.

  The upstream end of the occlusion support member 411 is preferably closer to the heart than the upstream end of the occlusion member 411 along the axis around which the cuff is wound (FIG. 12). Thereby, the obstruction | occlusion support member 411 may incline slightly along the said axis | shaft. This further improves upstream suppression or reduction and improves blood pressure measurement accuracy and signal to noise ratio.

  The closing support member 421 in FIG. 13 has functions similar to the closing support member 401-b in FIG. 11 and the closing support member 411 in FIG. The occlusion support member 421 may be in direct contact with the subject's body part 203 without going through the compliance fluid bag 202 and is below the occlusion member 401-a toward the subject's body part 203. Compliance fluid bag 202 provides compliance between occlusion member 401-a, occlusion support member 421, pulse wave detection member 223, and body part 203 of the subject. The occlusion support member 421 is not necessarily fluid. The occlusive support member may be a flexible material such as plastic, silicone rubber, porous plastic (eg, sponge), or an encapsulating fluid. (Similar to FIG. 11, a fluid bag connected to the closing member via the fluid connecting portion is also possible.)

  The occlusion support member 421 in FIG. 13 is configured to be disposed below the occlusion member 401-a toward the body part 203 of the subject, and more effectively by the pulse wave detection member 223 while suppressing upstream influence. In order to measure blood pressure, it is preferably arranged upstream. (Although not shown, in order to improve the signal-to-noise ratio, an absorber is disposed between the compliance fluid bag and the pulse wave detection member, and noise transmitted through at least one of the compliance fluid bag and the occlusion member and (It can absorb vibration, which can be a plastic sheet, a composite material, a porous material, a foam, or an encapsulated fluid.)

  The closing support member 421 has a width smaller than the width of the closing member 401-a along the axis around which the cuff is wound. For the closing support member 421 in FIG. 13, a width of 30% to 70% of the width of the closing member 401-a along the axis is preferable (similar to 401-b in FIG. 11 and 411 in FIG. 12).

  The upstream end of the occlusion support member 421 is preferably closer to the heart than the upstream end of the occlusion member 401-a along the axis around which the cuff is wound (FIG. 13). As a result, the closing support member 421 may be slightly inclined along the axis. This further improves upstream suppression or reduction and improves blood pressure measurement accuracy and signal to noise ratio.

  At the interface 218, the closure member and the closure support member can be secured using an adhesive or a double-sided adhesive layer.

  The end of the downstream compliance fluid bag 202 along the axis around which the cuff is wound is preferably close to the distal side (hand or foot) or equidistantly similar to the occlusion member 401-a. .

  The compliance fluid bag 202 of FIGS. 11, 12, and 13 may or may not contain fluid. However, to improve practicality, an enclosed compliance fluid bag is preferred. To further improve compliance, incompressible fluids such as liquids or gels are preferred. Although not described in detail, a plurality of compliance fluid bags can be used under the closure member 401-a. In this case, regardless of whether or not a plurality of compliance fluid bags overlap each other, the outermost width, that is, the distance from the proximal side to the distal side of the compliance fluid bag under the closing member 401-a is It should be understood that it is equal to or greater than the width of the closure member along the axis. By doing so, it is possible to reduce to some extent at least one of the influence of the hydraulic pressure difference and the influence of gravity on the upstream side and the downstream side in the sphygmomanometer cuff due to the liquid contents in the compliance fluid bag, and blood pressure measurement error Can be reduced.

  The pulse wave detection member 223 of FIGS. 11, 12, and 13 may be attached to the cuff, or may be disposed within the cuff, or along the axis around which the cuff is wound, It may be arranged near the cuff on the body part 203 of the subject.

  A preferable position of the pulse wave detection member 223 for measuring blood pressure more effectively and accurately is below the compliance fluid bag 202 and the occlusion bag 401-a toward the body part 203 of the subject on the downstream side (see FIG. 11, 12, and 13). A position closer to the end of the closing member 401-a is preferable. Thereby, the probability that the pressure distribution with respect to the artery becomes uniform can be improved by arranging the pulse wave detection member 223 not near the center but near the end. This is because the space between the compliance fluid bag 202 and the pulse wave detection member 223 on the body part 203 of the subject deteriorates the uniform pressure distribution with respect to the space such as the left and right ends of the pulse wave detection member 223. Because there is.

  A width of the pulse wave detection member 223 smaller than the width of the blocking member 401-a along the axis around which the cuff is wound is preferable. However, a width of 10% to 50% of the closing member 401-a along the axis is more desirable.

  The pulse wave detection member may be an arbitrary device including a sensor. However, a bag with a pressure measuring function that can be expanded / contracted by gas or air is preferable. The bag material may be a flexible material such as plastic.

  The compliance fluid bag of FIG. 5 can have different shapes. 14A to 14D show different possibilities. In FIG. 14A, the compliance fluid bag 502 can be configured to be placed at the end of the closure member 501. The outermost width of the compliance fluid bag 502 is equal to or greater than the width of the closure member 501 along the axis around which the cuff is wound. The compliance fluid bag 502 can have an irregular cross-section.

  FIG. 14B illustrates another possibility, in which a flexible sheet 503 is configured between the compliance fluid bags 502. This structure improves the stability of the sphygmomanometer cuff when actually used.

  14C and 14D show top views of the compliance fluid bag of FIGS. 14A and 14B. FIG. 14C shows a top view in which the outer periphery of the closing member 501 is shaped like a donut. In order to obtain a better compliance fluid bag 521, a shape like a rectangular donut is preferred. However, a plurality of compliance fluid bags 522 below the end of the closure member 501 are also applicable.

  The flexible sheet shown in FIG. 14B can be variously configured. The flexible sheet may be an entire sheet 503-a as shown in FIG. 15A, or may be composed of a plurality of flexible sheets 503-b as shown in FIG. 15B.

  14A to 14D, 15A and 15B, a pulse wave detection member for measuring blood pressure more accurately and an occlusion support member for suppressing upstream influences are shown in FIG. It can be mounted without departing from the scope of FIGS. 11, 12 and 13.

[Fifth Embodiment]
Next, a sphygmomanometer cuff 250 of the fifth embodiment will be described with reference to FIG. FIG. 16 is a cross-sectional view of the sphygmomanometer cuff of the fifth embodiment along the axis around which the cuff is wound.

  In the fifth embodiment of the sphygmomanometer cuff, as shown in FIG. 16, the closing member 201 is disposed on the measurement object side, and the compliance fluid bag 202 is disposed on the closing member 201. Note the width of the occlusion member 201 and the compliance fluid bag 202 in the direction parallel to the artery 205, ie, the length in the direction of the axis around which the cuff is wound. The width of the compliance fluid bag 202 is larger than the width w2 of the closing member 201 by (x2 + y2).

  In the configuration shown in FIG. 16, the stacking order of the closing member and the compliance fluid bag is reversed from that shown in FIG. 3, but as shown in FIGS. 3 and 16, the closing member and the compliance fluid bag are in contact with each other. Just do it.

  Also in the present embodiment, the effect of reducing the cuff edge effect can be obtained as in the first embodiment. Since the compliance fluid bag does not exist between the measurement object and the closing member, the pressure inside the closing member is almost directly applied to the measurement site. Therefore, the pressure applied to the measurement site can be accurately controlled by adjusting the pressure in the blocking member, and the measurement accuracy of blood pressure is improved.

[Sixth Embodiment]
Next, a sphygmomanometer cuff according to a sixth embodiment will be described with reference to FIG. FIG. 17 is a cross-sectional view of a sixth embodiment of a sphygmomanometer cuff along the axis around which the cuff is wound. In FIG. 17, illustration of the artery 205 shown in FIG. 16 is omitted, but “upstream side” and “downstream side” indicate the upstream side and the downstream side of the artery 205. The same applies to the drawings after FIG.

  As shown in FIG. 17, the sphygmomanometer cuff according to the sixth embodiment has a flexible hard support 211 having flexibility. The sphygmomanometer cuff shown in FIG. 17 has a configuration in which a flexible hard support 211 is arranged on the surface of the compliance fluid bag 202 opposite to the surface in contact with the closing member 201 in the sphygmomanometer cuff shown in FIG.

  Also in this embodiment, the same effect as the fifth embodiment can be obtained. Further, the effect of the flexible hard support (hereinafter referred to as “hard support”) coming into contact with the compliance fluid bag will be described below.

  In the sphygmomanometer cuff structure, when the sphygmomanometer cuff is used as a reference, the surface where the sphygmomanometer cuff contacts the measurement object is the inside, and the opposite side is the outside. For example, in a cuff formed in a cylindrical shape in advance, the side close to the center of the cylinder is the inside, and the surface away from the center of the cylinder is the outside. Moreover, in the cuff provided with a certain curvature, the center direction of the curvature is the inside.

  As described in the second embodiment, the hard support has a property that it is difficult to be deformed by pressure. Therefore, when the closing member is pressurized via the hard support, the closing member is deformed inward without being deformed to the outside. Therefore, the site to be measured can be efficiently blocked.

  Furthermore, when the compliance fluid bag is disposed between the hard support and the closing member, the fluid moves to a site where the close contact between the hard support and the closing member is poor, so that the hard support and the closing member are in close contact with each other. It becomes uniform. As a result, the expansion of the closing member to the outside is more effectively controlled, and therefore the measurement site can be blocked more efficiently.

  As described with reference to FIG. 5 in the second embodiment, even if the closing member is disposed on the fluid bag, the flexible hard support provides the same effect as the present embodiment. be able to.

  Note that the contact between the hard support and the compliance fluid bag is not limited to the case where the hard support and the compliance fluid bag are directly fixed. Even when the hard support and the compliance fluid bag are not directly fixed, the hard support and the compliance fluid bag may be in contact with each other by being supported by a member such as cloth or plastic from the outside. As a method of directly fixing, a case where the hard support and the compliance fluid bag are bonded or a case where these are mechanically fixed can be considered. Examples of bonding include a method of fusing with heat or ultrasonic waves, and a method of using an adhesive or a double-sided tape. Examples of mechanical fixing include a method of fixing by sewing and a method of fixing by a metal or plastic member.

[Seventh Embodiment]
Next, a sphygmomanometer cuff according to a seventh embodiment will be described with reference to FIG. FIG. 18 is a cross-sectional view of a seventh embodiment of a sphygmomanometer cuff along the axis around which the cuff is wound.

  As shown in FIG. 18, the sphygmomanometer cuff of the seventh embodiment has a configuration in which the width of the compliance fluid bag 202 is smaller than the width of the closing member 201 compared to the sphygmomanometer cuff shown in FIG. 16. The width w3 of the compliance fluid bag 202 is smaller than the width of the closing member 201 by (x3 + y3). The reason why the width of the compliance fluid bag 202 may be smaller than the width of the closing member 201 will be described.

  The position of the width of the closing member 201 is defined similarly to the second embodiment. That is, in the width of the occluding member 201, the center is defined as 0%, and the positions of the end portions of the occluding member 201 on the upstream side and the downstream side of the artery 205 are defined as 50%. As can be seen from FIG. 18, the compliance fluid bag 202 overlaps the occlusion member 201 in the range of 0% to about 40% on the upstream side of the artery 205. This range corresponds to the range of 15% to 50% described with reference to the graph shown in FIG. 4 in the second embodiment, and 25% (> 10%) of the entire width of the closing member 201. If the overlap is too narrow, the area where the compression pressure is improved becomes narrow, and the practical effect is small. Therefore, the lower limit of overlap is 10%.

  Furthermore, it is preferable that there is a portion where the compliance fluid bag 202 and the closing member 201 overlap each other in a range of at least 20% to 50%. In particular, since the cuff edge effect becomes remarkable, it is important that the compliance fluid bag 202 and the closing member 201 overlap in a range of 30% to 50%. When the overlap width is wide, the effect of improving the compression pressure is enhanced, but the compliance fluid bag and the closing member do not need to overlap with the entire width of the closing member. If the width of the overlapping portion is narrow, the sphygmomanometer cuff becomes lighter. However, if the overlapping portion is too narrow, the effect of improving the compression force cannot be obtained. Therefore, for example, the width of the overlapping portion is preferably 10% or more of the entire width of the closing member.

  Since the effect of improving the compliance of the closing member cannot be obtained in the portion where the fluid bag is not present, a cuff edge effect occurs. However, in the portion where the fluid bag is present, the compliance is improved, and the cuff edge effect is reduced. Therefore, the length of w1 shown in FIG. 18 is longer than when no fluid bag is present. In other words, even if the width of the occlusion member is shortened, good occlusion characteristics can be obtained and good blood pressure measurement accuracy can be obtained.

  Thus, this embodiment is not limited to the case where the fluid bag is equal to or larger than the closing member, and includes the case where the fluid bag is shorter than the closing member. When the fluid bag is short, it becomes light, thereby improving comfort.

[Eighth Embodiment]
Next, with reference to FIG. 19, a blood pressure cuff according to an eighth embodiment will be described. FIG. 19 is a cross-sectional view of an eighth embodiment of a sphygmomanometer cuff along the axis around which the cuff is wound.

  As shown in FIG. 19, the sphygmomanometer cuff of the eighth embodiment has a configuration in which the compliance fluid bag 202 of the sphygmomanometer cuff shown in FIG. 3 is divided into a plurality of parts. Among the plurality of compliance fluid bags 202, the compliance fluid bag 202a disposed on the most upstream side is within the range of 15% to 50% upstream of the closing member 201 width center (0%). It overlaps with the closing member 201 at 10% or more of the entire width. Therefore, the cuff edge effect is reduced and good compression characteristics can be obtained. FIG. 19 shows a case where the compliance fluid bag 202 is divided into four, but the number of compliance fluid bags is not limited to four.

  Furthermore, in this embodiment, since the compliance fluid bag 202 is divided into a plurality of parts, it is possible to alleviate the imbalance of the compression pressure due to gravity. For example, when the contents of the fluid bag are liquid and the measurement subject takes a posture in which gravity acts on the liquid from the upstream side to the downstream side, the downstream pressure is It tends to be higher than the upstream side due to the influence of hydrostatic pressure. On the other hand, in FIG. 19, since the compliance fluid bag is divided into a plurality in the direction parallel to the artery, the influence of the hydrostatic pressure on the upstream side and the downstream side is reduced. Therefore, the uniformity of the compression pressure can be further improved, and the blood pressure measurement error can be reduced. Therefore, at least one of the influence of the hydraulic pressure difference and the influence of gravity on the upstream side and the downstream side in the sphygmomanometer cuff due to the liquid contents in the compliance fluid bag can be reduced to some extent, and the blood pressure measurement error can be reduced. Can be reduced.

[Ninth Embodiment]
Next, a sphygmomanometer cuff according to a ninth embodiment will be described with reference to FIG. FIG. 20 is a cross-sectional view of a ninth embodiment of a sphygmomanometer cuff along the axis around which the cuff is wound.

  As shown in FIG. 20, in the sphygmomanometer cuff of the ninth embodiment, the fluid bag is divided into two compliance fluid bags 202 a and 202 b arranged on the closing member 201. The compliance fluid bag 202a is disposed near the end of the occlusion member 201 on the upstream side of the artery, and the compliance fluid bag 202b is disposed near the end of the occlusion member 201 on the downstream side of the artery. A fluid bag is not disposed between the two compliance fluid bags 202a and 202b.

  The compliance fluid bags 202a and 202b shown in FIG. 20 are similar in arrangement to the compliance fluid bags shown in FIGS. 15A and 15B, but the cross-sectional shape of the compliance fluid bag is different. Referring to FIGS. 14A and 14B, the shape of the compliance fluid bag shown in FIGS. 15A and 15B is previously matched with the crushed elliptical curved surface (the bottom surface of the closing member 501 shown in FIGS. 14A and 14B). It is a shaped shape. However, the cross-sectional shape of the compliance fluid bag is not limited to the shape shown in FIGS. 14A and 14B. This is because the compliance fluid bag can be deformed so as to fill a gap with the opposing object.

  Here, the arrangement of the compliance fluid bag 202a will be described.

  The definition explained in the second and seventh embodiments is used for the position of the width of the closing member 201. Referring to FIG. 20, the compliance fluid bag 202 a overlaps the closing member 201 at 10% or more of the entire width of the closing member 201 in the range of 15% to 50% on the upstream side. Specifically, the compliance fluid bag 202a overlaps the closing member 201 in the range of 30% to 50% where the cuff edge effect becomes significant. This overlapping portion corresponds to 20% of the entire width of the closing member 201.

  Since the cuff edge effect is small near the center of the closing member, there is no need to dispose a fluid bag near the center of the closing member as in this embodiment, and thus the sphygmomanometer cuff can be reduced in weight.

[Tenth embodiment]
Next, a sphygmomanometer cuff according to a tenth embodiment will be described with reference to FIG. FIG. 21 is a cross-sectional view of a tenth embodiment of a sphygmomanometer cuff along the axis around which the cuff is wound.

  Referring to FIG. 21, in the sphygmomanometer cuff of the tenth embodiment, the compliance fluid bags 202a and 202b are arranged on the closing member 201 as in the sphygmomanometer cuff shown in FIG. 202b is smaller than that shown in FIG. Specifically, the width of the compliance fluid bag 202b shown in FIG. 20 reaches the downstream end of the closing member 201, but in this embodiment, the width of the compliance fluid bag 202b shown in FIG. The end of the closing member 201 has not been reached.

  Also in this embodiment, the position of the compliance fluid bag 202a and the overlapping portion between the compliance fluid bag 202a and the closing member 201 are the same as those of the compliance fluid bag 202a of the ninth embodiment. Therefore, detailed description thereof is omitted here.

  As in this embodiment, the shape and position of the fluid bag may be different between the upstream side and the downstream side of the blood flow of the artery. For example, on the upstream side where the cuff edge effect is large, the fluid bag can be enlarged to greatly reduce the cuff edge effect, and on the downstream side where the cuff edge effect is relatively small, the fluid bag can be made small. As long as the cuff edge effect can be reduced, the position and size of the fluid bag can be freely determined as necessary.

[Eleventh embodiment]
Next, a sphygmomanometer cuff according to an eleventh embodiment will be described with reference to FIG. FIG. 22 is a cross-sectional view of an eleventh embodiment of a sphygmomanometer cuff along the axis around which the cuff is wound.

  Referring to FIG. 22, in the sphygmomanometer cuff of the eleventh embodiment, the compliance fluid bag 202a is disposed on the closing member 201 as in the sphygmomanometer cuff shown in FIG. 20, but the compliance shown in FIG. The fluid bag 202b is not provided. Like this embodiment, you may abbreviate | omit the fluid bag of the downstream of the blood flow of an artery as needed.

  Also in this embodiment, the position of the compliance fluid bag 202 and the overlapping portion between the compliance fluid bag 202 and the closing member 201 are the same as those of the compliance fluid bag 202a of the ninth embodiment. Therefore, detailed description thereof is omitted here.

  In the present embodiment, the sphygmomanometer cuff can be further reduced as compared with those described in the tenth and eleventh embodiments.

[Twelfth embodiment]
Next, an example of the sphygmomanometer cuff according to the twelfth embodiment will be described with reference to FIGS. 23A to 23D. 23A-23D are cross-sectional views of Examples 1-4 of the twelfth embodiment of the sphygmomanometer cuff along the axis around which the cuff is wound.

  As shown in FIG. 23A, in the sphygmomanometer cuff of the first embodiment, the fluid bag is divided into two compliance fluid bags 202a and 202b. One compliance fluid bag 202 a is disposed on the closing member 201 so as to cover the upstream outer end portion of the closing member 201, and the other compliance fluid bag 202 b has an inner end portion on the downstream side of the closing member 201. It arrange | positions under the closure member 201 so that it may cover. Thus, a plurality of fluid bags may be provided at different positions in the width direction of the occluding member between the upstream side and the downstream side of the artery.

  As shown in FIG. 23B, in the sphygmomanometer cuff of the second embodiment, the fluid bag is divided into three compliance fluid bags 202a, 202b, and 202c. One compliance fluid bag 202a is arranged on the closing member 201 so as to cover the upstream outer end portion of the closing member 201, and the other compliance fluid bag 202c is an inner end portion on the upstream side of the closing member 201. It is arrange | positioned under the closure member 201 so that it may cover. The last compliance fluid bag 202 b is arranged on the closing member 201 so as to cover the outer end portion on the downstream side of the closing member 201. In this way, fluid bags may be provided on both the outer side and the inner side of the upstream side of the artery in the width direction of the occluding member.

  As shown in FIG. 23C, in the sphygmomanometer cuff of the third embodiment, the fluid bag is divided into three compliance fluid bags 202a, 202b, and 202c. One compliance fluid bag 202b is disposed on the closing member 201 so as to cover the outer end portion on the downstream side of the closing member 201, as in the second embodiment. Another compliance fluid bag 202c is disposed on the closure member 201 so as to cover the upstream outer end of the closure member 201, and the last compliance fluid bag 202a is stacked outside the compliance fluid bag 202c. Yes. Thus, a plurality of fluid bags may be stacked on the upstream side of the artery with respect to the width direction of the occluding member.

  As shown in FIG. 23D, in the sphygmomanometer cuff of the fourth embodiment, the fluid bag is divided into three compliance fluid bags 202a, 202b, and 202c. Similar to the second embodiment, the two compliance fluid bags 202a and 202b are arranged on the closing member 201 so as to cover the outer end portions on the upstream side and the downstream side of the closing member 201, respectively. The last compliance fluid bag 202 c is disposed near the center of the width of the closing member 201 and below the closing member 201.

  According to this embodiment, by disposing a fluid bag on each of the outside and inside of the occlusion member on the upstream side of the artery, or arranging a plurality of fluid bags on the outside of the occlusion member on the upstream side of the artery, The compliance of those overlapping portions can be particularly improved.

[Thirteenth embodiment]
Next, a sphygmomanometer cuff according to a thirteenth embodiment will be described with reference to FIG. FIG. 24 is a cross-sectional view of a thirteenth embodiment of a sphygmomanometer cuff along the axis around which the cuff is wound. The sphygmomanometer cuff of the present embodiment has a configuration in which the occlusion support member in the fourth embodiment is added to the sphygmomanometer cuff of the fifth embodiment.

  As shown in FIG. 24, in the sphygmomanometer cuff of the thirteenth embodiment, a compliance fluid bag 202 is disposed on the closing member 401-a. Similar to the configuration of FIG. 11, the occlusion support member 401-b is connected to the occlusion member 401-a so as to allow inflow and outflow of air, and is provided on the upstream side of the artery in the width direction of the occlusion member 401-a. It has been.

  Compared with the configuration shown in FIG. 11, in the sphygmomanometer cuff of the present embodiment, the closing member 401-a and the closing support member 401-b are upside down. The blocking member 401-a is in contact with the arm of the blood pressure measurement subject, and the blocking support member 401-b is disposed outside the blocking member 401-a. The closing support member 401-b may be disposed inside the closing member 401-a.

  In this embodiment, the unevenness | corrugation of the surface of the part which contacts an arm becomes small because the obstruction | occlusion support member is arrange | positioned so that it may not contact the blood pressure measurement subject's arm. As a result, the uniformity of the pressure applied to the measurement part is improved and the measurement accuracy is improved.

  In any of the fourth and thirteenth embodiments, the desired position can be more strongly compressed by adding the occlusion support member 401-b to the sphygmomanometer cuff.

[Fourteenth embodiment]
Next, a sphygmomanometer cuff according to a fourteenth embodiment will be described. The sphygmomanometer cuff according to the fourteenth embodiment has a configuration in which an incompressible fluid other than liquid and gel is used for the contents of the compliance fluid bag. The thing other than the gel is an aggregate of minute individuals having fluidity such as microbeads. According to the fourteenth embodiment, the air can enter the gap between the minute solids, so that the weight can be reduced compared to a liquid such as a gel.

  When the fluid bag is not pressed in the direction of the blood pressure measurement object, the fluid bag may not be at the desired position described in the above-described embodiment.

  When the internal pressure of the occlusion member is lower than the diastolic blood pressure (for example, when it is lower by 10 mmHg), the fluid bag needs to be in a desired position, but may be in another place when not pressurized. . This is because, for example, when a fluid bag located in a certain place moves to a desired position during pressurization, or when the outer bag of the fluid bag is elastic, the bag expands during pressurization and the desired position It also includes cases that come to exist.

  Whether the bag moves to a desired position during pressurization is determined by, for example, when the bag is attached to the measurement site and a certain pressure is applied to the blocking member, or when the cuff is wound around a substantially cylindrical object. This can be confirmed by examining the relative position between the fluid bag and the closing member when a constant pressure is applied to the member. An example of constant pressurization is, for example, 40 mmHg as a pressure lower than the diastolic blood pressure of a human in a normal health state.

  Next, regarding the blood pressure measurement accuracy of the sphygmomanometer using the sphygmomanometer cuff of one embodiment of the present invention, the experimental results compared with the sphygmomanometer cuff of the related art will be described.

  FIG. 25A is a cross-sectional view of a sphygmomanometer cuff according to an embodiment of the present invention used in an experiment.

  As shown in FIG. 25A, in the sphygmomanometer cuff, as in the thirteenth embodiment, the occlusion support member 401-b is disposed below the occlusion member 401-a, and the flexible hard support 211 is the compliance fluid bag 202. It is the composition arranged on top. Hereinafter, the sphygmomanometer cuff shown in FIG. 25A is referred to as a prototype.

  FIG. 25B is a schematic external view showing a state of blood pressure measurement. A reference sphygmomanometer cuff was wrapped around the subject's right arm, and a prototype was wrapped around the left arm, and blood pressure in the right and left arms was measured almost simultaneously. By using the measured value of the right arm (standard sphygmomanometer cuff) as a reference value, the difference between the measured values of the blood pressure of the right arm and the left arm is defined as “error”. As the reference sphygmomanometer cuff, a commercially available sphygmomanometer approved as a medical device was used. The width Wr of the closing member of the reference sphygmomanometer cuff is 12 cm, and the width Wp of the prototype is 8 cm. A commercially available blood pressure measurement program was used, and the blood pressure measurement algorithm was shared between the reference sphygmomanometer cuff and the prototype.

  The number of subjects is 16. Since three measurements were made for each of the 16 subjects, the total number of data is 48. The circumference of the arms of 16 subjects ranges from 24 cm to 32 cm.

  26A to 26C are pie charts showing measurement results of the prototype. FIG. 26A shows an average of measurement accuracy of systolic blood pressure (SBP) and measurement accuracy of diastolic blood pressure (DBP), that is, measurement accuracy of the entire blood pressure measurement result. FIG. 26B shows the measurement accuracy of SBP, and FIG. 26C shows the measurement accuracy of DBP.

  Referring to FIG. 26A, the ratio of the blood pressure measurement error to be ± 5 mmHg or less was 84% of the whole. Referring to FIG. 26B and FIG. 26C, the rate at which the SBP measurement error is ± 5 mmHg or less is 77% of the total, and the rate at which the DBP measurement error is ± 5 mmHg or less is 92%.

  The average value and standard deviation of SBP measurement errors measured by the prototype were -0.8 mmHg ± 4.5 mmHg. The average value and standard deviation of DBP measurement errors measured by the prototype were 0.6 mmHg ± 3.0 mmHg.

  Next, regarding the measurement accuracy, a result of comparison between the prototype and the comparative example will be described.

  The width of the reference sphygmomanometer cuff is 12 cm. In the sphygmomanometer cuff of the prototype, each of the closing member and the compliance fluid bag has a width of 8 cm and a length in the direction of wrapping around the arm of 16.5 cm. As a comparative example, a sphygmomanometer cuff of a prototype was prepared with only a closing member. That is, the sphygmomanometer cuff of the comparative example has a configuration in which only a closing member having a width of 8 cm and a length of 16.5 cm in the direction wound around the arm is provided.

  FIG. 27 is a bar graph showing the measurement accuracy of the prototype, the reference sphygmomanometer cuff, and the comparative example. The measurement accuracy (%) on the vertical axis of the bar graph indicates the rate at which the measurement error of SBP and DBP is ± 5 mmHg or less. In FIG. 27, the measurement accuracy of the reference sphygmomanometer cuff is shown in (1), the measurement accuracy of the sphygmomanometer cuff of the comparative example is shown in (2), and the measurement accuracy of the prototype is shown in (3).

  Referring to FIG. 27, the measurement accuracy of the reference sphygmomanometer cuff reaches 80%. Further, the measurement accuracy of the prototype is 84%, and thus it can be seen that the measurement accuracy of the prototype is equivalent to the measurement accuracy of the reference sphygmomanometer cuff that has received medical approval. On the other hand, the blood pressure cuff of the comparative example has a measurement accuracy of only 44%, and therefore the measurement accuracy of the comparative example is extremely low.

  From the results shown in FIG. 27, it was confirmed that when the width of the sphygmomanometer cuff is simply shortened, the measurement accuracy is remarkably lowered. Further, from the result shown in FIG. 27, even when the width of the sphygmomanometer cuff is shortened, a general wide cuff can be obtained by overlapping the closing member and the fluid bag as in the sphygmomanometer cuff of the present embodiment. It can be seen that the same measurement accuracy can be obtained.

  A flexible material is preferable for the bag described above. These materials may be plastic materials or any material or sheet obtained from plastic materials or polymers. The bag is impermeable to fluids such as air or water. Different flexible materials can be used for different bags of cuffs to improve function and compliance.

  While flexible materials are highly appreciated for bag materials, expandable materials would be possible for compliance bags. The compliance bag can extend along the axis around which the cuff is wound. However, during blood pressure measurement, the compliance bag is preferably under the occlusion member to improve compliance to the body part of the subject, and its width is equal to or greater than the width of the occlusion member in the shaft. It can be large.

  Although not shown in detail in the drawing, a substance such as a double-sided adhesive layer that bonds the bags together is used to eliminate malfunctions that can occur when the bags are secured together for more stable blood pressure measurements. be able to. This improves the stability, durability, and reliability of the cuff. Furthermore, other sealing methods and fixing methods are also applicable. Although not shown in the drawings of each embodiment, in order to improve the signal-to-noise ratio, an absorber is disposed between the compliance fluid bag and the pulse wave detection member, and at least the compliance fluid bag and the occlusion member are arranged. Noise and vibration transmitted through one side can be absorbed. The absorbent material may be a plastic sheet, a composite material, a porous material, a foam, or an encapsulating fluid.

  Although not described in detail herein, a cover layer such as plastic or a fabric layer can be placed on the cuff to further protect the cuff. This cover layer may be configured between the cuff and the body part of the subject.

  The present invention is not limited to the descriptions and figures described above. Additions, omissions, substitutions, and other modifications can be made without departing from the scope of the invention. Accordingly, the invention is not to be construed as limited by the foregoing description, but is only limited by the scope of the appended claims.

[Industrial applicability]
The present invention is applicable to a sphygmomanometer and ABMP.

10, 100, 200 Sphygmomanometer cuff 11, 101, 201, 401-a, 501 Occlusion member 12, 103, 203, 151 Subject (body part of arm or leg)
13, 104, 204 Heart 14, 19, 105, 110, 205, 210 Artery 15, 106, 206 Blood flow 16, 107, 207 Upstream flow 17 Cuff edge effect 18 Non-uniform pressure distribution 102, 202, 202-a 202-b, 202-c, 222, 232, 502, 521, 522 Compliance fluid bag 108, 208 Reduced cuff edge effect 109, 209 Uniform pressure distribution 112, 113, 212, 213, 214, 217, 218, 224, 225, 226, 227 Interface 150 Sphygmomanometer 152 Sphygmomanometer cuff 153, 154, 160 Fluid connection part 155 Measurement unit 156 Pressurization / reduction unit 157 Blood pressure measurement unit 158 Control operation unit 159 Display unit 211 Flexible hard support 215 Bone 216 Fastening 223 pulse wave detection member 401-b, 411 and 421 closed support member 401-c fluid connection 503,503-a, 503-b flexible sheet

Claims (14)

A blood pressure cuff,
An occlusion member configured to occlude the artery;
A compliance fluid bag containing an incompressible fluid and overlaid with the closure member;
The compliance fluid bag is at least upstream from the center of the width of the occlusion member, which is the length of the occlusion member along the axis around which the sphygmomanometer cuff is wound, with respect to the width direction of the occlusion member A sphygmomanometer cuff that overlaps the closure member.   When the central position of the width is defined as 0% and the respective positions at both ends of the width are defined as 50% with respect to the width of the closing member, the entire overlapping portion of the closing member and the compliance fluid bag, or The sphygmomanometer cuff according to claim 1, wherein the entire overlap is in a range of 15% to 50% upstream of the artery in the width direction of the occlusion member.   The sphygmomanometer cuff according to claim 2, wherein an overlapping portion between the closing member and the compliance fluid bag is 10% or more of the entire width of the closing member.   When the surface on which the sphygmomanometer cuff contacts the subject is defined as the inner side and the opposite side of the surface is defined as the outer side with respect to the sphygmomanometer cuff, the compliance fluid bag is disposed outside the blocking member. The sphygmomanometer cuff according to any one of claims 1 to 3.   When the surface on which the sphygmomanometer cuff contacts the subject is defined as the inner side and the opposite side of the surface is defined as the outer side with respect to the sphygmomanometer cuff, the blocking member is disposed outside the compliance fluid bag. The sphygmomanometer cuff according to any one of claims 1 to 3.   The sphygmomanometer cuff according to any one of claims 1 to 5, further comprising a pulse wave detection member provided between the compliance fluid bag and the subject for measuring an arterial pulse wave. A plurality of compliance fluid bags,
The sphygmomanometer cuff according to any one of claims 1 to 6, wherein at least one compliance fluid bag of the plurality of compliance fluid bags overlaps the closing member on the upstream side.   The sphygmomanometer cuff of claim 4, further comprising a flexible hard support disposed outside the compliance fluid bag.   The sphygmomanometer cuff according to claim 5, further comprising a flexible hard support disposed outside the occluding member. An occlusion support member provided upstream of the artery in the width direction of the occlusion member and provided inside or outside the occlusion member;
The sphygmomanometer cuff according to claim 4 or 5, wherein the occlusion support member is connected to allow air to flow into or out of the occlusion member. A plurality of compliance fluid bags;
The sphygmomanometer cuff according to claim 7, wherein the plurality of compliance fluid bags are separately arranged on the upstream side and the downstream side with respect to the width direction of the closing member.   The sphygmomanometer cuff according to claim 11, wherein the plurality of compliance fluid bags are connected via a flexible sheet or configured on the flexible sheet.   The sphygmomanometer cuff according to claim 1, wherein the closing member is an air bag that can be inflated / deflated by air. A sphygmomanometer including the sphygmomanometer cuff according to claim 1.

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