Patent Publication Number: US-2020281486-A1

Title: Blood pressure cuff having improved comfort and safety and methods of manufacturing same

Description:
RELATED APPLICATIONS 
     The present application claims priority to U.S. Provisional Patent Application Ser. No. 62/815,757, filed Mar. 8, 2019, the contents of which is hereby incorporated by reference in its entirety as if fully set forth herein. 
    
    
     FIELD OF THE DISCLOSURE 
     The present disclosure relates to blood pressure cuffs for use in medical settings. More particularly the present disclosure relates to blood pressure cuffs having novel profiles for improved fit, comfort, and safety. 
     BACKGROUND OF THE DISCLOSURE 
     Cuffs for measuring blood pressure generally include a tubular constrictable sleeve for a limb of a person, a source for fluid pressure, means for measuring static pressure, and means arranged in proximity to an artery for listening to flow in the artery. 
     Modern blood pressure measurements have long traditions and fall into two distinct types. Both the auscultatory and the oscillometric method use the constriction of an artery to such a degree that blood flow is stopped and then allowed to flow while a signal derived from the blood pressure is monitored. The constriction occurs by means of a cuff surrounding a limb (in most cases an upper arm or a wrist). The cuff has a non-stretchable fabric on the outside enclosing an elongate bladder surrounding a large part of the limb periphery. The bladder is pressurized by means of air, and the air pressure is monitored. The Korotkoff method depends on listening to sounds in the artery downstream of the constriction as blood begins to flow, and to read the pressure when certain sounds related to the heartbeat are heard and again when sounds begin to disappear. Traditionally, the listening has occurred by means of a stethoscope, the chestpiece of which is held against the skin in proximity to the artery downstream from the occlusion, frequently supported against the edge of the cuff. 
     Traditional cuffs are generally rectangular in shape and tend to fit poorly. These cuffs may be prone to error. For example, if the cuff is too small the blood pressure readings may be artefactually high. Alternatively, if the cuff is too big the blood pressure readings will be too low. The cuff often slips down past the patient&#39;s antecubital fossa causing skin tears, blisters, ecchymosis and unnecessary pain. Additionally, rectangular cuffs require a nurse or practitioner to reapply the cuff frequently for patient comfort and safety. In an ICU setting, for example, vital signs are taken frequently depending on the condition of the patient. Patients may require blood pressure readings at five, ten, fifteen or thirty-minute intervals. While most cuffs are disposable, they are often kept for longer durations, and they may become discolored, soiled or emit a foul odor, harboring bacteria. 
     The present disclosure seeks to address many of these problems in order to improve patient safety and comfort. 
     SUMMARY OF THE DISCLOSURE 
     In some embodiments, a blood pressure cuff extending between a proximal end and a distal end includes a body having a fillable chamber and a hose connector, the body having a pair of opposing sides having at least one first pair of concave curvatures formed approximately ⅓ along a length of the body from the proximal end to the distal end. 
    
    
     
       BRIEF DESCRIPTION OF THE DISCLOSURE 
       Various embodiments of the presently disclosed blood pressure cuffs are disclosed herein with reference to the drawings, wherein: 
         FIGS. 1A-G  are schematic bottom, top, perspective, front, back, and side views of a blood pressure cuff according to a first embodiment of the present disclosure; 
         FIG. 1H  is a schematic illustration of the blood pressure cuff of  FIGS. 1A-G  being disposed about a patient&#39;s arm; 
         FIGS. 2A-G  are schematic bottom, top, perspective, front, back, and side views of a blood pressure cuff according to a second embodiment of the present disclosure; 
         FIGS. 3A-G  are schematic bottom, top, perspective, front, back, and side views of a blood pressure cuff according to a third embodiment of the present disclosure; 
         FIGS. 4A-G  are schematic bottom, top, perspective, front, back, and side views of a blood pressure cuff according to a fourth embodiment of the present disclosure; and 
         FIGS. 5A-B  are schematic view of other profiles of the blood pressure cuff. 
     
    
    
     Various embodiments of the present invent on will now be described with reference to the appended drawings. It is to be appreciated that these drawings depict only some embodiments of the invention and are therefore not to be considered limiting of its scope. 
     DETAILED DESCRIPTION 
     Despite the various improvements that have been made to blood pressure cuffs, conventional devices suffer from some shortcomings as described above. 
     Therefore, there is a need for further improvements to the devices, systems, and methods of manufacturing blood pressure cuffs. Among other advantages, the present disclosure may address one or more of these needs. To increase patient comfort, several non-rectangular blood pressure cuffs are disclosed, each having improvements on the prior art. 
       FIG. 1A-G  are schematic bottom, top, perspective, front, back, and side views of a blood pressure cuff  100  according to a first embodiment of the present disclosure. Cuff  100  extends between proximal end  102  and distal end  104  and includes a body  105  having an expandable chamber for receiving a fluid (e.g., gas). Body  105  may include two layer of material that define the chamber  106  therein, the two layers defining an anterior surface  110  and a posterior surface  112  ( FIGS. 1A-B ). The chamber  106  is shown in  FIG. 1B , and may generally be between 40% to 60% of the length of the cuff. In at least some examples, body  105  has a rounded piping  107  disposed around its perimeter as shown in the detailed view of  FIG. 1A . This piping  107 , though not shown, is a possible feature on all of the cuffs disclosed herein. In some examples, body  105  may include a fabric or cloth. In some examples, body  105  may be formed of an elastic material, such as spandex, or a non-woven synthetic material and may include a polyurethane material, or a latex-free material or combinations thereof. In at least some examples, X-STATIC Silver® brand of material may be woven into the fabric, the X-STATIC Silver® brand of material providing antimicrobial benefits to possibly prevent or decrease the risk of infection, or inhibit the growth of bacteria. X-STATIC Silver® brand of material may also be used to eliminate odor in the cuff. In at least some examples, the materials described above may be formed on, or form portions of the anterior surface, the posterior surface, or both surfaces. 
     Attachment means are used to couple one end of the cuff to another portion of the cuff to maintain it in a rolled condition. In one example, a VELCRO® brand hook-and-loop fastener system is used, where a hook region  116  is disposed on an anterior surface adjacent the proximal end  102  of the body, while an elongated fabric or cloth having a loop region  118  is disposed on a posterior surface adjacent the distal end  104 . In at least some example, the loop region  118  is formed of a separate material attached to the body. Alternatively, the entire anterior surface of the body may include loops that are coupleable to the hook region  116 . It will be understood that the hook and loop regions are interchangeable with one another. A hose connector  120  is disposed on the anterior surface  110  of the blood pressure cuff  100 , and configured to mate with a hose to receive a gas into the chamber of the body. 
     As shown, the sides of the body are substantially non-linear. Specifically, sides of the body include a first set of concave curvatures C 1 ,C 2  adjacent the proximal end  102  approximately one ⅓ along the length of the body from the proximal end to the distal end, the curvatures C 1 ,C 2  being disposed opposite one another, a second set of concave curvatures C 3 ,C 4  adjacent the distal end  104 , and enlarged convex curvatures C 5 ,C 6  disposed between the two sets of concave curvatures. Pairs of curvature may be symmetric. That is, C 1  and C 2  and may have a same first curvature, C 3  and C 4  may have a same second curvature, and C 5  and C 6  may have a same third curvature. As shown, the cuff may have a series of varying widths from the proximal end  102  to the distal end  104 . In one example, cuff  100  may have a first width 1W1 of 3″, a second width 1W2 of 2 and 7/16″, a third width 1W3 of 3⅜″ and a fourth width 1W4 of 2 and 7/16″. It will be understood that the measurements provided for this embodiment, and in other examples, are presented by way of example to show one possible set of proportions of the widths of the various components of a cuff. Thus, the disclosed cuffs may have different measurements, and may be scaled up or down as desired based on the application. In some examples, cuff  100  may have a concave curvature at C 1 ,C 2  that decreases the width of the cuff by 5% to 20% when comparing 1W1 and 1W2, and the width may increase at 1W3 at C 5 ,C 6  by 5% to 10% as compared to 1W1. The width at 1W4 may be equal to the width at 1W2, or may be slightly smaller than 1W1 by decreasing by 5% to 20% when compared to 1W1. 
     Body may further include a brachial artery indicator  130  disposed on the anterior surface  110  slightly below the hooks region  116  (i.e., closer to the distal end  104  than the hooks region  116 ). Indicator  130  may help position the device on the patient&#39;s limb. 
     In use, the cuff  100  may be wrapped around the patient&#39;s limb (e.g., arm) as shown in  FIG. 1H  and regions  116  and  118  may be coupled together to maintain the cuff in the rolled condition around the patient&#39;s arm. A conduit or hose may be coupled to connector  120  to deliver a fluid or gas into the cuff. The curvatures of the cuff may sit adjacent key landmarks on the arm. For example, curvature C 1  may sit adjacent the upper arm axilla, and curvature C 2  may sit adjacent the antecubital. The curvatures may provide increased comfort to the patient and allow for greater flexion and/or degree of motion of the arm within the cuff. 
     Other configurations are also possible. For example,  FIG. 2A-G  are schematic bottom, top, perspective, front, back, and side views of a blood pressure cuff  200  according to a second embodiment of the present disclosure. Cuff  200  extends between proximal end  202  and distal end  204  and includes a body  205  having an expandable chamber  206  for receiving a fluid. Body  205  has an anterior surface  210  and a posterior surface  212  ( FIGS. 2A-B ), and may include any of the materials described above. Attachment means  216 , 218  may also be provided as described above with reference to hook and loop regions  116 , 118 , and a hose connector  220  may be disposed on the anterior surface  210  of the blood pressure cuff  200 . 
     As shown, the sides of the body are substantially non-linear. Specifically, sides of the body include a first set of concave curvatures D 1 ,D 2  adjacent the proximal end  202  disposed opposite one another, a second set of indentations or tapers D 3 ,D 4  adjacent the distal end  204 , and a linear portion disposed therebetween. Pairs of curvature may be symmetric as previously described. 
     As shown, cuff  200  may have a series of varying widths from the proximal end  202  to the distal end  204 . In one example, cuff  200  may have a first width 2W1 of 1 3/16″, a second width 2W2 of ¾″, a third width 2W3 of 1 3/16″ and a fourth width 2W4 of ¾″. In some examples, cuff  200  may have a concave curvature at D 1 ,D 2  that decreases the width of the cuff by 15% to 35% when comparing 2W1 and 2W2, and the width may increase at 2W3 to a width approximately equal to 2W1. The width at 2W4 at the end of the tapers D 3 ,D 4  may be approximately equal to the width at 2W2. 
     Body may further include a brachial artery indicator  230  disposed on the anterior surface  210  slightly below the hooks region  216  (i.e., closer to the distal end  204  than the hooks region  216 ). Indicator  230  may help position the device on the patient&#39;s limb. In use, the cuff  200  may be wrapped around the patient&#39;s limb and curvatures D 1 ,D 2  of the cuff  200  may sit adjacent key landmarks on the arm. For example, curvature D 1  may sit adjacent the upper arm axilla, and curvature D 2  may sit adjacent the antecubital. Additionally, tapers D 3 ,D 4  may allow for increased comfort when the cuff is wrapped over an arm. 
     A third embodiment is shown in  FIGS. 3A-G . Cuff  300  extends between proximal end  302  and distal end  304  and includes a body having an expandable chamber  306  for receiving a fluid. The body has an anterior surface  310  and a posterior surface  312  ( FIGS. 3A-B ), and may include any of the materials described above. The main difference in this third embodiment is the curvatures E 1 -E 6 . Most notably, cuff  300  includes a pair of convex curvatures on each side (i.e. E 1  and E 5  on one side, and E 2  and E 6  on a second side), and a concave curvature (E 3  on one side, and E 4  on a second, opposing side) approximately halfway along the length of the cuff, the concave curvature being sandwiched between the convex curvatures. 
     As shown, the cuff may have a series of varying widths from the proximal end  302  to the distal end  304 . In one example, cuff  300  may have a first width 3W1 of ⅜″, a second width 3W2 of 1⅜″, a third width 3W3 of 1¼″, a fourth width 3W4 of 1 7/16″, and a fourth width 3W5 of ¾″. In some examples, cuff  300  may have a convex curvature at E 1 ,E 2  that increases the width of the cuff by 50% to 400% when comparing 3W1 and 3W2, and the width may decrease at 3W3 at E 3 ,E 4  by 5% to 20% as compared to 3W2. The width at 3W4 may be equal to the width at 3W2, or may be slightly larger than 3W2 by increasing the width by 5% to 10% when compared to 3W2. The width at 3W5 may be equal to 3W1 or larger by 30% to 50%. 
     A fourth embodiment is shown in  FIGS. 4A-G . Cuff  400  extends between proximal end  402  and distal end  404  and includes a body having an expandable chamber  406  for receiving a fluid. The body has an anterior surface  410  and a posterior surface  412  ( FIGS. 4A-B ), and may include any of the materials described above. The main difference in this fourth embodiment is the curvatures F 1 -F 6 . Most notably, cuff  400  includes a pair of convex curvatures on each side (i.e. F 1  and F 5  on one side, and F 2  and F 6  on a second side), and a concave curvature (F 3  on one side, and F 4  on a second, opposing side) approximately halfway along the length of the cuff, the concave curvature being sandwiched between the convex curvatures. 
     As shown, the cuff may have a series of varying widths from the proximal end  402  to the distal end  404 . In one example, cuff  400  may have a first width 4W1 of 3″, a second width 4W2 of 5.5″, a third width 4W3 of 4.5″, a fourth width 4W4 of 5.5″, and a fifth width 4W5 of 3″. In at least some examples, cuff  400  is symmetric about both a vertical and a horizontal axis. Other profiles are also possible as shown in  FIGS. 5A and 5B  with cuffs  500 A, 500 B. 
     Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims. 
     It will be appreciated that the various dependent claims and the features set forth therein can be combined in different ways than presented in the initial claims. It will also be appreciated that the features described in connection with individual embodiments may be shared with others of the described embodiments.