JP6426412B2 - Blood pressure cuff with air chamber with taper (Blood Pressure Cuff) - Google Patents

Description

  The present invention relates to blood pressure measurement, and more particularly to a blood pressure cuff (sphygmomanometer) that provides accurate measurements on the patient's arm circumference.

  Patient blood pressure is most often measured using a sphygmomanometer, or blood pressure cuff. This term is used to refer to a device comprised of an air chamber housed within a sleeve (cuff) and connected to a pressure gauge. The cuff is wrapped around the patient's upper arm and an air chamber is insufflated to limit blood flow through the patient's brachial artery. The sphygmomanometer measures the pressure at which blood flow first resumes (known as systolic blood pressure or SBP), and the pressure at which blood flow resistance ceases (diastolic blood pressure or DBP) Used to measure). These events are manually confirmed by using a stethoscope (listening to the appearance and disappearance of Korotkoff sounds).

  Presently, a typical blood pressure cuff is one that includes an air chamber of adjusted width along the circumference of the upper arm, and also of a fixed width. This is in spite of the fact that the SBP and the DBP measured by the sphygmomanometer change as the ratio of the width of the air chamber to the arm circumference changes. As a result, patients whose arm perimeter does not fit within the predefined cuff size will obtain inaccurate blood pressure measurements. To alleviate this problem, the American Heart Association (AHA) uses seven different sized cuffs (corresponding to seven different lengths across the arm) for patients from children to large adults on the body Has been recommended. However, because each cuff size has an air chamber of a certain width, even an appropriately sized cuff can result in an error of up to plus or minus 5% in blood pressure measurements. In addition, many practitioners (e.g., in a hospital, in a ward, and / or in a doctor's office) have said the recommendation because the AHA recommendation requires that the patient's arm be measured prior to choosing an appropriate cuff size. Ignore and use a standard cuff with a 12 cm wide air chamber for most blood pressure measurements. This can result in larger errors for the SBP and the DBP, at about 5-10 millimeters mercury in some tests. Such errors are likely to lead to serious misdiagnosis that should be avoided, especially for patients whose blood pressure is close to the cutoff level prescribed for treatment of hypertension. Furthermore, at the cut-off level used to prescribe medication for high blood pressure, errors in blood pressure measurement that occur on the high blood pressure side when diagnosing high blood pressure may result in the patient receiving medication that is not needed . This results in added costs and the patient being dosed unnecessarily. Errors in blood pressure measurements that are measured lower than the actual blood pressure may result in patients who should receive blood pressure medications not being able to receive such medications, thereby harming health due to untreated hypertension. Become.

It has been proposed that the width of the air chamber covering the artery relative to the patient's arm circumference should be in the range of about 40% in order to properly occlude the artery. In addition, in order to provide an accurate measurement, the air chambers (the air chambers do not overlap themselves) should surround at least about 80% of the arms and not more than 100% of the arms. It has been proposed. Based on the general clinical discussion above, there is a need to meet both the accuracy of the blood pressure cuff and the requirement to match the length across the patient's arm.
As prior art document information related to the invention of this application, there are the following.
(Prior art reference)
(Patent document)
(Patent Document 1) US Patent No. 369,945
(Patent Document 2) US Patent No. 1,063,287
(Patent Document 3) U.S. Pat. No. 2,841,149
(Patent Document 4) U.S. Patent No. 3,513,831
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(Patent Document 8) U.S. Patent No. 4,542,743
(Patent Document 9) U.S. Patent No. 4,716,906
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(Patent Document 19) US Patent Application Publication No. 2004/0034308
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(Patent Document 21) US Patent Application Publication No. 2007/0135720
(Patent Document 22) US Patent Application Publication No. 2009/0043215
(Patent Document 23) US Patent Application Publication No. 2012/0130419
(Patent Document 24) US Patent Application Publication No. 2013/0109981
(Patent Document 25) WO 2016/044459
(Non-patent literature)
(Non-Patent Document 1) FEDER et al. , Tapered Blood Pressure Cuff for Varying Arm Circumferences, The Fischell Department of Bioengineering (May. 18, 2012, Page 1. James Clark School of Engineering and University of Maryland).
(Non-Patent Document 2) International Search Report and Written Opinion dated December 28, 2015 for PCT / US2015 / 50489.
(Non-Patent Document 3) European Search Report and Written Opinion dated March 17, 2015 for EP 14184913.3
(Non-Patent Document 4) MAXWELL, GEORGE et al. , "Comparison of the Conical Cuff and the Standard Rectangular Cuff", International Journal of Epidemiology, Volume 14, number 3, (1985), 468-472.
(Non-Patent Document 5) GOTKIN, JOEL et al. , "Dynasleeve-Blood Pressure Cuff Suitable for Obese Patients", Duke Diet and Fitness Center, (February 13, 2007)

  Embodiments described herein relate to blood pressure cuffs for accurately measuring blood pressure. In an embodiment, the blood pressure cuff includes an alignment tab having an edge, a sleeve, and an air chamber disposed within the sleeve. The air chamber is in a direction away from the alignment tab from a first rectangular portion having a first width, a first end and a second end, and a second end of the first rectangular portion. It includes a tapered portion whose width gradually increases. The length from the edge of the alignment tab to the second end of the first rectangular portion is approximately equal to the minimum arm circumference of the blood pressure cuff.

  Embodiments described herein relate to a blood pressure cuff including a sleeve and an air chamber disposed within the sleeve. The air chamber is a first rectangular portion having a first width, a second rectangular portion having a second width, and the second width is greater than the first width, and the first rectangular portion And a tapered portion extending between the second rectangular portions. The tapered portion may be a linear taper or a curved taper.

FIG. 1 shows a schematic view of a blood pressure cuff with a linearly tapered air chamber. FIG. 2 shows a schematic view of a method of adjusting the blood pressure cuff on the patient's arm such that the air chamber contacts the patient at the appropriate location of the brachial artery for accurate measurement. It is. FIG. 3 shows a schematic view of a blood pressure cuff with a curved tapered air chamber and an alignment tab. FIG. 4 is a graph showing the width of an air chamber corresponding to the longitudinal (longitudinal) distance from the edge of the air chamber using the linear tapers of the small, medium and large cuffs. FIG. 5 is a graph showing the width of an air chamber corresponding to the longitudinal (longitudinal) distance from the edge of the air chamber using linear tapers of small, medium and large cuffs. FIG. 6 is a graph showing the width of an air chamber corresponding to the longitudinal (longitudinal) distance from the edge of the air chamber using linear tapers of small, medium and large cuffs. FIG. 7 is a graph showing the width of an air chamber corresponding to the longitudinal (longitudinal) distance from the edge of the air chamber using curvilinear tapers of small, medium and large cuffs. FIG. 8 is a graph showing the width of an air chamber corresponding to the longitudinal (longitudinal) distance from the edge of the air chamber using curvilinear tapers of small, medium and large cuffs. FIG. 9 is a graph showing the width of an air chamber corresponding to the longitudinal (longitudinal) distance from the edge of the air chamber using curvilinear tapers of small, medium and large cuffs.

  Specific embodiments of the present invention are described below with reference to the above drawings, and reference numerals indicate identical or functionally similar components.

  The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Furthermore, there is no intention to be bound by any clear or implicit theory presented in the aforementioned technical field, background, brief summary or the following detailed description. "Sphygmomanometer" and "blood pressure cuff" are used interchangeably in this specification and are understood by those skilled in the art as interchangeable terms.

  FIG. 1 shows a schematic view of a blood pressure cuff 100 having an air chamber 102 and an alignment tab 104. Air chamber 102 is inflatable and includes a narrow rectangular portion 106, a straight tapered portion 108, and a wide rectangular portion 110. The air chamber 102 is composed of PVC synthetic rubber, plastic, or other similar material that is generally impervious to air. The air chamber 102 consists of two layers and forms a pocket for holding air. Since the air chamber 102 is housed in the sleeve 112, it is shown by a dotted line in FIG. The tube 114 is connected at a first end to the inner pocket of the air chamber 102 and to a hand-held balloon 116 at the second end. Air in the atmosphere is designed to enter the air balloon 116 from the opening 118 in the air balloon 116. As the balloon 116 is grasped, air is transferred through the tube 114 into the air chamber 102, which expands. The second tube 120 has a first end connected to the inner pocket of the air chamber 102 and a second end (not shown) connected to a pressure gauge (not shown).

  In the embodiment of FIG. 1, the hook and loop portions 122 and 124 on the opposite side of the cuff 100 are used to secure the cuff 100 around the patient's arm. However, other means may be used as long as the cuff is fixed as it is so as to stay in a fixed position when wound around the patient's arm. In addition, although FIG. 1 shows the shape of the sleeve 112 corresponding to the shape of the air chamber 102, any shape may be used as long as the sleeve 112 is larger than the air chamber 102, and the air chamber 102 moves violently in the sleeve 112. It is also possible to combine or use other means. The sleeve 112 is made of nylon or fabric or another sufficiently flexible material. Alignment tab portion 104 may be comprised of the same material as sleeve 112, or another sufficiently flexible material. The tab portion 104 is shown as rectangular in FIG. 1 but may be of any shape and may be wider or narrower than the sleeve 112 to be joined.

  FIG. 2 schematically illustrates a method of positioning the cuff 100 on the arm 150 of a patient. As shown in FIG. 2, the edge 126 of the tab portion 104 is disposed along the tangential direction of the brachial artery 152 of the patient. The cuff 100 is wrapped around the arm 150 so that the air chamber 102 intersects the patient's brachial artery, and the cuff 100 is then secured by joining the hook and loop sections 122 and 124 together. It is important that the user be able to easily position the cuff properly and position the cuff 100 along the brachial artery with the appropriate width of the air chamber 102.

  The alignment tab portion 104 is adjusted by the length of the cuff 100 extending around the patient's arm. If the length of the alignment tab portion 104 wrapped around the patient's arm 150 is equal to the minimum value that the patient's arm circumference corresponds with the specific size of the cuff 100, the narrow rectangular portion 106 of the air chamber 102 It crosses the brachial artery 152. Similarly, the tab portion 104 is such that the broad rectangular portion 110 intersects the brachial artery 152 and the patient's arm perimeter is cuff 100 when the patient's perimeter is equal to the maximum value supported by the particular size cuff 100. A portion of the appropriate proportion of the linear taper 108 is such that it crosses the brachial artery 152 if it falls within the limits dictated by the size of the. This design guarantees that if the width of the air chamber (where the air chamber intersects the brachial artery 152) and the ratio to the arm circumference, the circumference of the arm falls within the range supported by the size of the cuff 100. , The desired air chamber width ratio with respect to the arm circumference is maintained. In addition, the lengths of the tab portion 104 and the air chamber 102 allow the air chambers 102 to surround the patient's arm 150 without overlapping one another when the arm circumference falls within the bounds specified by the size of the cuff 100. It has become.

Thus, as shown in the table provided below, the sum of the length of the tab portion 104 and the length of the narrow rectangular portion 106 of the air chamber 102 is the minimum arm perimeter of the cuff 100. The sum is not the same as the patient's minimum arm circumference because there is a distance or gap 111 of about 1 centimeter from the second end 127 of the tab portion 104 to the edge 107 of the narrow rectangular portion 106 of the air chamber 102 . Thus, the length from the edge 126 of the tab portion 104 to the transition portion 109, the length from the narrow rectangular portion 106 of the air chamber 102 to the taper portion 108 of the air chamber 108 is approximately equal to the minimum arm circumference of the cuff. Become. The degree of change in length of the tab portion 104, the narrow rectangular portion 106, and the gap 111 is such that the total length from the edge 126 of the tab portion 104 to the transition portion 109 is approximately the minimum arm perimeter of the cuff. Those skilled in the art will recognize what is defined. The terms "approximately" or "substantially" are used herein in the sense of "about" or "approximately" and are used to adjust for manufacturing tolerances and variations. Thus, as used herein, the term "approximately" or "substantially" means within 5%. The table below provides an example of the partial size of the cuff 100 for a specific length across the arm circumference. The reference numbers used in the table refer to FIG. 1, which table applies equally to the embodiment of FIG. 3 described below. All numbers provided in the table are in centimeters.

In the above table, the taper is a linear taper. As such, the width of the air chamber along the length of the taper is the generally known linear formula: Y = m ^* X + b, m is equal to the slope and b is equal to the intercept of the Y axis. The air chamber settings are arranged on the graph to calculate the taper line formula. The two straight lines on the formula are half the width of the narrow portion of the air chamber at a point 2 cm on the X axis as the first point on the Y axis, and 6 on the X axis as the second point on the Y axis It is determined by the half width of the wide part of the air chamber at the centimeter point. One half of the width is used such that half of the air chamber is on the upper side of the X axis and half of the air chamber is on the lower side of the X axis. Solving that equation we can see the line of tapers in the air chamber of the small cuff defined as Y = 0.245 ^* X + 4.675 and identified above. 4-6 show graphs of the air chamber portion of the small, medium and large cuffs as indicated above. In addition, the width of the narrow rectangular portion 106 and the width of the wide rectangular portion 110 are respectively given by the formula: W = (C-LOG (C) / 2; Calculated by the width.

  FIG. 3 shows a schematic of another embodiment of a blood pressure cuff 200 that also includes an air chamber 202 and an alignment tab 204. The cuff 200 in this embodiment is similar to the cuff 100 except that the air chamber 202 includes a curved taper 208 between the narrow rectangular portion 206 and the wide rectangular portion 210. The appropriate curvature is defined as C = patient's arm circumference, and W = width of taper to a specific circumference in the following formula: W = (C-LOG (C)) / 2; Thus, while the above formula is used for the width of the air chambers in the narrow and wide rectangular sections in the straight taper table above, the following table uses the respective width formulas. 7-9 are tables showing air chambers according to the above formula. Otherwise, the cuff 200 is similar to the cuff 100. An air chamber 202 is housed within the sleeve 212 and is inflatable through the tube 214 to squeeze the ball 216. The second tube 220 has a first end connected to the inner pocket of the air chamber 202 and a second end (not shown) connected to a pressure gauge (not shown). The shape and material of the air chamber 202, the tab portion 204 and the sleeve 212 are as outlined in the first embodiment above. In addition, although FIG. 3 shows the inclusion of opposing hook and loop portions 222 and 224 on the cuff 200, any other means can be used as long as the cuff 200 can be fixed itself around the patient's arm. It is usable. The cuff 200 is adapted to be attached to the patient's arm, as shown in FIG. 2 and in the same manner as discussed above.

While specific embodiments of linear tapers and curved tapers are shown as described above, one skilled in the art will recognize that other linear tapers or curved tapers may be used. For example, in the straight taper embodiment described above, the ratio of the air chamber covering the artery to the patient's arm circumference is approximately 47%. The design of the air chamber taper can be adjusted to fit any desired ratio. By way of example and not limitation, the air chamber of the blood pressure cuff is configured to meet a 40% percentage by using the following cuff and air chamber dimensions: Yes (all centimeters).

  The width of the air chamber relative to the arm circumference, the length of the narrow rectangular portion of the air chamber, and the desired proportions of the length of the tabs are varied and correspond to each arm circumference using the arrangement described above Those skilled in the art will recognize that the desired width of the air chamber can be made as such.

  While various embodiments in accordance with the present invention have been described above, it should be understood that they have been presented for the purpose of illustration and example only. It will be apparent to those skilled in the relevant art that various changes in form and detail may be made herein without departing from the spirit and scope of the invention. Each property of each embodiment discussed in the present specification and in the respective literature cited in the specification may be used in combination with the property of any other embodiment. . All patents and publications discussed herein are hereby incorporated by reference in their entirety.

Claims (10)

A blood pressure cuff,
An alignment tab having an edge;
With the sleeve,
An air chamber disposed within the sleeve;
Have
The air chamber has a first rectangular portion having a first width, a first end, and a second end, and the alignment from the second end of the first rectangular portion. And a tapered portion formed so as to gradually increase in width in a direction away from the tab portion,
The length from the edge of the alignment tab to the second end of the first rectangular section is approximately equal to the minimum arm circumference of the blood pressure cuff,
The blood pressures off includes a first perimeter, is set to be sized to the arm circumferential length of the predetermined range and a second perimeter, the second perimeter is the first perimeter Greater than
The first width is approximately equal to 1/2 (W ₁ = (C ₁ −LOG (C ₁ )) / 2) of the difference between Log of the first perimeter and Log of the first perimeter. is there,
Blood pressure cuff. The blood pressure cuff according to claim 1, wherein the air chamber further comprises:
And a second rectangular portion having a second width greater than the first width, wherein the tapered portion extends between the first rectangular portion and the second rectangular portion. The second width is approximately equal to 1⁄2 (W ₂ = (C ₂ −LOG (C ₂ )) / 2) of the difference between Log of the second perimeter and of the second perimeter Is the blood pressure cuff.   The blood pressure cuff according to claim 1, wherein the tapered portion is a linear taper.   The blood pressure cuff according to claim 1, wherein the tapered portion is a curved taper. The blood pressure cuff according to claim 1, wherein the blood pressure cuff is
Adapted to fit to an arm circumference of about 22 centimeters to 26 centimeters, wherein the length from the edge of the alignment tab portion to the second end of the first rectangular portion The blood pressure cuff is about 22 centimeters in length. The blood pressure cuff according to claim 1, wherein the blood pressure cuff is
Adapted to fit an arm perimeter of about 27 centimeters to 34 centimeters, wherein the length from the edge of the alignment tab portion to the second end of the first rectangular portion The blood pressure cuff is about 27 centimeters in length. The blood pressure cuff according to claim 1, wherein the blood pressure cuff is
Adapted to fit to an arm circumference of about 35 cm to 44 cm, wherein the length from the edge of the alignment tab to the second end of the first rectangular portion The blood pressure cuff is about 35 centimeters in length. A blood pressure cuff,
With the sleeve,
An air chamber disposed within the sleeve;
Have
The air chamber includes a first rectangular portion having a first width, a second rectangular portion having a second width greater than the first width, the first rectangular portion, and the second rectangular portion. And a tapered portion extending between the rectangular portion and
The blood pressures off includes a first perimeter, is set to be sized to the arm circumferential length of the predetermined range and a second perimeter, the second perimeter is the first perimeter Greater than
The first width is approximately equal to 1/2 (W ₁ = (C ₁ −LOG (C ₁ )) / 2) of the difference between Log of the first perimeter and Log of the first perimeter. Yes,
The second width is approximately equal to 1⁄2 (W ₂ = (C ₂ −LOG (C ₂ )) / 2) of the difference between Log of the second perimeter and the second perimeter. is there,
Blood pressure cuff.   The blood pressure cuff according to claim 8, wherein the tapered portion is a linear taper.   The blood pressure cuff according to claim 8, wherein the tapered portion is a curved taper.

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