United States Patent 91 Goldblat et al.
[ 1 Sept. 11, 1973 DISPOSABLE COMBINED SPHYGMOMANOMETER CUFF AND SOUND CHAMBER [76] Inventors: Alexander Goldblat, 210 Central Park South, New York, N.Y. 10019; Raymond Miller, 315 E. 86th St., New York, N.Y. 10028 [22] Filed: Aug. 27, 1971 [21] Appl. No.: 175,488
[52] US. Cl.... 128/2.05 G, 128/205 C, 128/205 S,
[51] Int. Cl A61b 5/02 [58] Field of Search 128/2.05 C, 2.05 G, 128/2.05 S, 2.05 P, 2.05 R; 181/24 [56] References Cited UNITED STATES PATENTS 3,621,845 11/1971 Oates 128/205 S 3,473,525 10/1969 Hanafin..... 128/2.05 C 3,621,831 11/1971 Pisacano... 128/205 C 2,981,251 4/1961 Berman 128/205 C 3,416,516 12/1968 Cohen et al. 128/205 S 3,603,304 9/1971 Maier 128/205 C 3,315,662 4/1967 Buffington.... 128/2.05 G 3,258,009 6/1966 London 128/205 C 2,753,863 7/1956 Bailey 128/205 G FOREIGN PATENTS OR APPLICATIONS 1,068,749 5/1967 Great Britain 128/205 C Primary Examinerl(yle L. Howell AttorneySydney B. Schlessel [57] ABSTRACT A sphygmomanometer cuff and sound chamber combined as a unit. The cuff embraces a pliant plastic bladder integral with a wrap-around plastic sleeve. Two air tubes extend from the bladder interior for engagement, respectively, with an air bulb and a manometer. The sound chamber comprises an arcuate shell of rigid plastic greater in length in the direction of curvature, with extending walls to define an open cavity, with a peripheral lip extending outwardly from the wall edges. A tube extends from a side wall of the chamber affording sound communication between the chamber interior and a stethoscope secured to the free end of the tube. A sling is bonded to the shorter sides of the bladder undersurface to which the chamber is bonded centrally around its lip, with the cavity exposed. In another embodiment the chamber is recessed within a window in the bladder undersurface, with its cavity exposed. The cuff is secured adhesively.
1 Claim, 7 Drawing Figures DISPOSABLE COMBINED SPHYGMOMANOMETER CUFF AND SOUND CHAMBER BACKGROUND OF THEINVENTION 1. Field of the Invention This invention relates generally to the field of medicine and more particularly to the blood pressure measurement of patients by means of a sphygmomanometer employed in combination with a stethoscope. The standard sphygmomanometer comprises a cuff containing an inflatable bladder, which is secured around a main artery, usually the brachial artery, of a patient with the bladder disposed directly over the artery, an air tube leading into the bladder from an air bulb or similar air pumping device by means of which the bladder is inflated, and an air tube communicating the interior of the bladder with an air pressure gauge, or manometer, for the measurement of the pressure in the bladder as air is pumped into the bladder and released therefrom. The customary procedure for the physician or other qualified operative using the device is to secure the cuff around the patients arm with the bladder disposed over the brachial artery, inflate the bladder by successive compressions of the air bulb until the flow of blood through the artery is completely stopped and the needle of the manometer registers a designated air pressure within the bladder, and then slowly to release, or bleed, the air from the bladder by means of an air leak or bleeder valve mounted on the bulb, meanwhile applying the audio pickup of the stethoscope over the constricted area of the artery, listening to the changing sounds, known as Korotkoffs sounds, as the blood again begins to flow through the artery with the reduction of air pressure in the bladder, and noting the changes of pressure as indicated on the manometer, to determine the systolic and diastolic blood pressures of the patient.
The novelty of the'present invention lies in the provision of a disposable combination of sphygmomanometer cuff and integral sound chamber as a single unit. The sound transmitting tube of a standard stethoscope is attachable to a tube extending from the sound chamber prior to commencement of the procedure.
2. Prior Art.
In the present state of the art sphygommanometer cuffs are generally made of a fabric material with an insertable inflatable bladder of rubber, a combination too expensive to discard after a single use, and consequently used over and over again with a vast succession of patients, with the inherent and obvious danger of contamination and communication of infection between patients. Regular and frequent cleaning and sterilization has been found to be impractical, expensive and time consuming. A further disadvantage with such devices is that the audio pickup button of the standard stethoscope is not always placed over the identical area of the constricted artery, which may lead to inconsistent and possibly inaccurate readings, particularly where the blood pressure of the same patient must be taken with frequent regularity, as during an extended surgical procedure. In such latter instances the customary taping or strapping of the stethoscope audio pickup to the patients arm tends to cause irritation and soreness to the area, as well as discomfort to the patient. A further disadvantage is to be found with present types of cuffs in that the fabric tends to deteriorate, and the rubber bladder and tubing to dry out and become brittle with long periods of disuse, as when stored in emergency medical boxes or in military field equipment, and the like.
Improvements have heretofore been developed in this field to overcome the foregoing disadvantages, but these improvements have been limited in scope and benefit. For example, cuffs of disposable material have been devised, but these are not provided with disposable sound chambers, and must be used with standard stethoscopes using button-type audio pickups. Again, a separate blood pressure sound chamber, or transducer has heretofore been devised for use with a conventional type of cuff, but this transducer is a separate unit of expensive construction, intended for multiple re-use, with the consequent attendant hazards of communication of infection and contamination between patients.
BRIEF SUMMARY OF THE INVENTION The novelty of our invention resides in the unique provision of a combined, or unitary, sphygmomanometer cuff integral with an improved sound chamber, all constructed of an inexpensive material, such as plastic and the like, and hence disposable after use on a single patient because of the nominal cost. THe cuff comprises an inflatable bladder extending into a noninflatable, or flat, segment adapted to be secured around the patients arm by adhesive means, with air tubes in communication with the interior or the bladder and extending therefrom, one for communication with and connection to an air bulb, and the other for communication with and connection to an air pressure gauge, or manometer. The sound chamber is integral with the bottom surface of the bladder, and is arcuate to define a hollow cup or cavity, with a tube extending from the side wall of the chamber for connection to the sound transmitting, or audio, tube of a standard stethoscope, to provide communication of sounds within the chamber to the stethoscope ear piece.
This novel construction provides numerous advantages over the previously discussed art, and the elimination of the disadvantages heretofore mentioned. Some of the major advantages are worth noting herein.
The principal object of our invention, therefore, lies in the provision of a combined sphygmomanometer cuff and sound chamber, which is disposable after use on a single patient, thereby eliminating the possiblity of cross-infection between patients.
A second important object of our invention lies in the provision of a combined cuff and sound chamber as above described in which the sound chamber is adapted to cover a greater segment of tissue over the artery than is possible with the button-type of audio pickup of standard stethoscope, thereby insuring a better quality of sound and thereby greater accuracy of blood pressure measurement.
A third important object of our invention lies in the provision of a unitary sphygmomanometer cuff and sound chamber combination which is lightweight and comfortable, and which can therefore be left in deflated state on the patients arm for long periods of time, as during surgery, without discomfort or soreness to the patients arm, to be successively inflated whenever blood pressure measurement is required.
A fourth important object of our invention lies in the provision of a combined cuff and sound chamber as above described which, in cases of repeated use on the same patient, as during surgery, maintains the sound chamber in the same position on the patients arm for successive readings, thereby insuring the proper correlative accuracy of the readings.
, Still another important object of our invention lies in the provision of a combined cuff and sound chamber which can be stored for long periods of time without disintegration or diminution of efficiency.
These and other salient objects, advantages and functional features of our invention, together with the novel features of construction, composition and arrangement of parts, will become more readily apparent from an examination of the following specification, taken with the accompanying drawings, wherein:
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a preferred embodiment of our invention, shown secured around a patients arm and in engagement with an air bulb, manometer and stethoscope, preparatory to taking a blood pressure reading;
FIG. 2 is an enlarged bottom view of the embodiment of FIG. 1;
FIG. 3 is an enlarged cross-sectional view, partly fragmented, showing the construction of the tube members leading into the inflatable bladder;
FIG. 4 is a cross-sectional view, taken on lines 4-4 of FIG. 2;
FIG. 5 is an enlarged cross-sectional view of the combined cuff and sound chamber engaged around a patients arm, as shown in FIG. 1;
FIG. 6 is a bottom, perspective view, similar to FIG. 2, of a modified embodiment of our invention; and
FIG. 7 is a cross-sectional view, taken on lines 77 of FIG. 6.
Similar reference characters designate similar parts throughout the different views.
DETAILED DESCRIPTION OF THE INVENTION Illustrative of the embodiment shown by FIGS. l-S, our invention comprises asphygmomanometer cuff 10 integral with asound chamber 12. Thecuff 10 consists of a sheet of pliable plastic material folded over along one side to form top andbottom surfaces 14 and 16, having a length of approximately 28 cm and a width of approximately 16 cm. The fold edge has anextension 18 provided centrally with two spacedopenings 20 and 22, and is provided for by a cut-out pattern of plastic sheeting. A pair of flexibleplastic tubes 24 and 26, sealed in parallel, spaced relationship to each other within aflap 28, are disposed through therespective openings 20 and 22, with theflap 28 within the fold of theextension 18 and thetubes 24 and 26 extending out therefrom, as shown. A sleeve of plastic sheeting is disposed with its edge between the shorter edges of thesurfaces 14 and 16, and thesurfaces 14 and 16 are then bonded around their perimeters, the edges of the extension and on either side of the edge of thesleeve 30, by heat sealing or other suitable means, to define a closed pocket orbladder 32, whose internal measurements are at least 12 cm in width and 23 cm in length, with thetubes 24 and 26 extending therefrom and providing air communication with the interior, while thesleeve 30 extends from the side of thebladder 32 and measures at least cm in length. Thetop surface 14 of thebladder 32, and theinner surface 34 of thesleeve 30 are provided with means to secure thecuff 10 around thepatients arm 36 in encircling relationship, as shown in FIG. 1, and in the embodiment shown comprises strips ofpile material 38 bonded to thetop surface 14 of thebladder 32, and cooperating strips ofbarb material 40 bonded to theinner surface 34 of thesleeve 30, the combinedstrips 38 and 40 releasably engageable to secure thecuff 10 to thepatients arm 36, and comprising a fastening material known by the trademark Velcro.
The open ends of thetubes 24 and 26 are each provided with acoupling 42, one of which is adapted to be secured to the flexible tube 44 of anair bulb 46 provided with anexhaust valve 48, and the other to the flexible tube 50 of amanometer 52, both of which are too well known in the art to require further elaboration and description.
Referring now more particularly to FIGS. 2 and 4, thesound chamber 12 is composed of a single piece of rigid plastic material and is formed, either by compression, injection or vacuum molding, as an arcuate shell extending greater in length in the direction of its curvature, having an arcuate base 54 extending intoupright end walls 56, andside walls 58, thereby to define an open pocket orcavity 62, with aperipheral lip 60 extending outwardly from the edges of thewalls 56 and 58, thelip 60 forming a smooth, flat and arcuate surface adapted to simulate the contour of a human limb. An opening 64 is provided in one of theside walls 58, through which there is secured a flexibleplastic tube 66 which extends therefrom at right angles to thewall 58, to provide communication between the interior and ex terior of thecavity 62, and whose free end is provided with acoupling 42 by which it may be connected to thehearing tube 68 of astandard stethoscope 70. As shown more graphically by FIG. 4, thesound chamber 12 is centrally nested in a flexibleplastic sling 72, the ends of which are bonded to the sides ofbottom surface 16 of thebladder 32, so that thesound chamber 12 rides freely between these sides, with itscavity 62 opening in a direction away from thebottom surface 16, thechamber 12 being disposed closer to the side of thebladder 32 from which thetubes 24 and 26 extend, and the length of thesling 72 being slightly shorter than the distancebetween the sides of thesurface 16 to which it is attached, whereby, in the curvature of thecuff 10 in placement around the patients arm 36 see FIG. 5), thesling 72 will fit smoothly and without slack. Prior to bonding of thesling 72. to thesurface 16 thesound chamber 12 is secured to thesling 72 by the underlap and overlap of thesling 72 along the shorter sides of thesound chamber 12 and heat sealing as at 74 and 76, to imprison some air within the overlaps to defineair cushions 78 adapted to cushion thesound chamber lip 60 from contact with thepatients arm 36. As shown by FIG. 2, thetube 66 is secured to thebottom surface 16 of thebladder 32 by anadhesive strip 80, to lie parallel with, and on the same plane, as thetubes 24 and 26.
Coming now to FIGS. 6 and 7, there is shown a modified embodiment of our invention, wherein theVelcro fastener 38, 40 is replaced by acoating 82 of hot-melt adhesive disposed on theinner surface 84 of the sleeve 30', and which is provided with aprotective strip 86 adapted to be peeled off when the cuff 10' is ready to be used. In this embodiment thesound chamber 12 is bonded to thebottom surface 16 of the bladder 32' by securing it through awindow 88 cut in saidbottom surface 16, the edges of thewindoew 88 being heat sealed upon and around thelip 60 of the sound chamber 12' to provide an air-tight bladder 32. In this embodiment, therefore, thesling 72 has been eliminated.
OPERATION OF THE INVENTION In the operation of the embodiment shown by FIGS. 15, thebladder 32 is placed over thepatients arm 36, as shown in FIG. 5, so that thesound chamber 12 is centrally disposed across the brachial artery 90, thesleeve 30 being them wound snugly around thearm 36 and thebladder 32, and secured in place by the engagement of thefasteners 38 and 40. Theair bulb 46 is secured totube 24, themanomter 52 totube 26, and thehearing tube 68 of the stethoscope to thetube 66, as shown in FIG. 1. The physician then compresses theair bulb 46 with successive compressions to inflate thebladder 32 until the flow of blood through the artery 90 is completely occluded by the air pressure within thebladder 32, this pressure being noted on themanomter 52 by the physician, who then slowly exhausts air from thebladder 32 by means of thevalve 48, meanwhile listening through the stethoscope to the sounds made as the blood begins to flow again through the artery 90, and noting the pressure readings onthemanometer 52 with the sound changes, to determine the systolic and diastolic blood pressures of the patient. The identical procedure is followed with the use of the embodiment shown by FIGS. 6 and 7.
It is to be particularly noted here that in the employment of our invention during surgery, where frequent and repeated measurements of the patients blood pressure are required, thecuff 10 remains on the patients arm 36 in deflated state at all times, between readings, so that thesound chamber 12 remains in the identical position at all times, thereby assuring complete accuracy of successive readings. Where the standard stethoscope audio pickup button is used it cannot always be placed on the identical area of thepatients arm 36, thereby leading to possible errors and inaccuracies in successive readings, unless the button is taped or strapped to thearm 36, in which event soreness and discomfort may result, both from the button pressure and the tapes or straps.
COMPOSITION OF THE INVENTION In the construction and composition of our invention thesleeve 30,bladder 32,flap 28 andsling 72 are preferably made of polyvinyl chloride homopolymer or copolymer resins or films having a thickness of approximately 0.005 inch to 0.008 inch. Polyethylene and polyolefin polymers, including polypropylene and polibutenes may be used, as well, or any of the other and numerous plastic resins presently available. These will provide satifactory strength and tear resistance, and can easily be heat sealed. They can also be produced in a glossy, matte or embossed state, either transparent or opaque, and in colors.
Thesound chamber 12 can be made from rigid polyolefin, but can as well be made from similar resins. Polyolefin is preferred for compression, injection or vacuum molding operations to produce such units, which can then be heat sealed, either to thesling 72 in the embodiment of FIGS. 1-5, or to the bottom surface 16' of thebladder 32, in the embodiment of FIGS. 6 and 7.
As is apparent from the foregoing, our combined sphygmomanometer cuff and sound chamber can be produced at a nominal cost per unit, including sterilization and packaging in a sealed container, so that they are economically disposable following use on a single patient, thereby avoiding the possibility of crosscontamination or infection between patients, and encompassing the further advantages previously noted.
It is also clearly obvious from the foregoing that the preferred embodiments shown and described are by way of illustration and not of limitation, and that various changes may be made in the construction, composition and arrangement of parts without limitation upon or departure from the spirit and scope of the invention or sacrificing any of the advantages thereof inherent therein.
Having described our invention we claim:
1. In combination with a stethoscope tube, an air introducing and exhausting means and a pressure indicating means, for the measurement of blood pressure, a disposable combined sphygmomanometer cuff and sound chamber composed of plastic material, the cuff comprising a pair of substantially rectangular pliant sheets overlying one another and secured together along their abutting edges to define an air-tight inflatable bladder, together with an elongated pliable sheet secured to one end of the bladder and adapted to encircle a human limb in overlying relationship to the bladder, means to releaseably secure the cuff around the limb, tubular means secured through one side of the bladder and extending therefrom and adapted to provide communication between the bladder interior and the air introducing and exhausting means and between the bladder and the pressure indicating means, the sound chamber comprising an arcuately shaped member of rigid plastic greater in length in the direction of its curvature, having an arcuate base and end walls, and side walls extending therefrom to define an open cavity, a peripheral lip extending outwardly from the wall edges on a plane parallel with the base, tubular means secured through a side wall of the chamber and extending outwardly therefrom in the direction of the tubular means of the bladder and adapted for engagement with the stethoscope tube to provide some communication with the interior of the chamber, and means to secure the sound chamber centrally of the bottom surface of the bladder with its cavity facing outwardly therefrom, comprising a pliant plastic sling secured along its edges to the ends of the bladder undersurface, the intermediate portions of the sling being lapped under and over the ends of the peripheral lip of the chamber and secured thereto, with air imprisoned within the overlaps to define cushions for the sound chamber.
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