Abstract:
An improved, user-friendly medical device is provided for inducing blood vessel distension and for reducing post-venipuncture bruising. The device comprises an elastomeric band adapted to be stretched to encircle a limb with overlap lengths, a pressure applicator secured to the band and a pair of complementary releasably engageable coupling pads spaced apart and secured to the elastomeric band. At least one of the pair of coupling pads is elastic such that the device is elastic over at least about 80 percent of the length of the band.

Description:
FIELD OF THE INVENTION  
         [0001]    This invention relates to a device to promote distention for vein spotting and to reduce post-withdrawal bruising in phlebotomy and other venipuncture procedures.  
         BACKGROUND OF THE INVENTION  
         [0002]    Medical procedures involving needle venipuncture typically begin with the use of a tourniquet device near the desired puncture site to distend one or more veins for easy visual identification by the attendant. The same procedures typically end when the attendant removes the puncture needle and applies finger, i.e. digital, pressure on the puncture site over a bandage.  
           [0003]    For younger and more robust patients, a typical phlebotomy wound is stable for finger release after just a couple moments and the resulting puncture site is almost undetectable. For older more fragile patients, however, an extensive period of finger pressure is required to prevent bruising about the puncture site. While minor bruising is not a health concern, patients are known to complain about the appearance. Medical personnel are often forced to use otherwise productive time waiting for sufficient clotting at the venipuncture site.  
           [0004]    Devices for unattended pressure application at a venipuncture site have been proposed. For example, U.S. Pat. No. 4,182,338 to Stanulis is directed to a device for providing localized pressure to a puncture wound. The device includes an elastomeric pyramid-shaped body attached to securing straps. U.S. Pat. No. 5,269,803 to Geary et al. is directed to housing attached to an adjustable band for tightening the housing against a puncture site before needle puncture. The Geary patent further describes leaving the pad in place after the needle is withdrawn to stop bleeding.  
           [0005]    Such prior designs have thus far not been commercially successful. Venipuncture, especially for blood drawings, is a very routine procedure for medical attendants. Experienced phlebotomists favor neither new additional steps nor new additional equipment unless such extras are user friendly and immediately beneficial. The prior approaches to the hemostasis problem are neither user friendly nor compatible with existing venipuncture procedures.  
           [0006]    For example, both of the prior art approaches to the hemostasis problem discussed above call for the medical attendant to have available a tourniquet and an extra device, the pressure applicator. Furthermore, the prior art devices include new materials or mechanisms not immediately familiar to medical personnel.  
           [0007]    Accordingly, it would be desirable to provide a device that reduces post-venipuncture bruising without continuous user attention. Specifically, it would be desirable to provide a hemostasis aid that is user friendly and compatible with existing venipuncture procedures.  
         SUMMARY OF THE INVENTION  
         [0008]    Devices according to the present invention are suitable for both inducing blood vessel distension and for reducing post-venipuncture bruising. The devices comprise an open elastomeric band adapted to be stretched to encircle a limb with overlapping lengths, a pressure applicator secured to the band and a pair of complementary releasably engageable coupling pads spaced apart and secured to the elastomeric band. At least one of the pair of coupling pads is elastic such that the device is elastic over at least about 80 percent of the length of the band. The pair of complementary releasably engageable coupling pads preferably employ a multiminihook-to-pile adhesion system.  
           [0009]    In a preferred embodiment at least 80 percent of the length of the band has a length-wise elasticity substantially the same as a conventional, disposable rubber tourniquet. And surprisingly, it has been found that, in addition to compatible tactile response, the location of the pressure applicator at one end of the elastomeric band is an important feature for gaining acceptance by phlebotomists. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]    In the accompanying drawings that form part of the specification, and in which like numerals are employed to designate like parts throughout the same,  
         [0011]    [0011]FIG. 1 is a perspective view of a bruising control device according to the present invention;  
         [0012]    [0012]FIG. 2 is a fragmentary cross-section of the pressure applicator taken along the plane  2 - 2  in FIG. 1;  
         [0013]    [0013]FIG. 3 is a perspective view of a bruising control device according to an alternate embodiment of the present invention;  
         [0014]    [0014]FIG. 4 is a fragmentary cross-section of the pressure applicator taken along the plane  4 - 4  in FIG. 3;  
         [0015]    [0015]FIG. 5 is perspective view showing the use of the device of FIG. 1 for distending blood vessels;  
         [0016]    [0016]FIG. 6 is a perspective view showing the use of the device of FIG. 1 for bruising control after a venipuncture procedure; and  
         [0017]    [0017]FIG. 7 is a perspective view of a bruising control device according to an alternate embodiment of the present invention. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0018]    While this invention is susceptible to embodiment in many different forms, this specification and the accompanying drawings disclose only preferred forms as examples of the invention. The invention is not intended to be limited to the embodiments so described, however. The scope of the invention is identified in the appended claims.  
         [0019]    Referring to FIGS. 1 and 2, a hemostasis aid  10  includes an open band (or strip) of elastomeric material  12 , a pressure applicator  14  and complementary coupling pads  16 ,  18  and  20 . Band  12  has opposing wide surfaces  22  and  24 , and opposing end portions  26 ,  28  each with opposing absolute edges  30  and  32 , respectively.  
         [0020]    Band  12  is made of a flexible, elastomeric material such as latex and latex-free synthetic rubber. The material is preferably selected to have the same tactile feel as conventional disposable tourniquet bands (or straps). For example, Becton, Dickinson and Co. offers a latex-free disposable tournique under the trade designation “UNIQUET.” 
         [0021]    Hemostasis aid  10  preferably has a length and width comparable to that of disposable phlebotomy tourniquets, although other lengths and thicknesses are also suitable. Accordingly, hemostasis aid  10  has a length in the range of about 12 to about 18 inches and a thickness in the range of about ¾ of an inch to about one inch.  
         [0022]    As illustrated in FIG. 2, the pressure applicator  14  is preferably a semisphere presenting a flat connecting surface  34  and a rounded contact surface  36 . Pressure applicator  14  is generally made of a more rigid material. Pressure applicator  14  may also be constructed of a relatively soft material or include a padding layer for the contact surface provided pressure applicator  14  is relatively more rigid than the surface of the human body targeted for contact, e.g. the arm.  
         [0023]    The adhesive  38  for securing pressure applicator  14  to band  12  necessarily varies according to the respective materials of construction. For a latex rubber band and a wooden pressure applicator a polyvinyl adhesive is suitable.  
         [0024]    In a preferred embodiment as shown in FIGS.  1 - 2  and  3 - 4 , pressure applicator  14  is fixed at an end portion  26  of band  12 . Surprisingly, it has been found that this special location of the pressure applicator at one end of the elastomeric band is an important feature for gaining acceptance by phlebotomists. The end-point placement of the applicator allows the phlebotomist to apply aid  10  around a patient&#39;s limb by first using one hand to press applicator  14  at the puncture site and then with the other hand wrap band  12  over applicator  14  and around the limb.  
         [0025]    The requirement for this beneficial effect is that pressure applicator  14 ,be secured towards the end portion  26 . As illustrated in alternate embodiment FIGS. 3 and 4, a short distance of offset from edge  30  is permissible, however.  
         [0026]    Hemostasis aid  10  is equipped with a pair of complementary releasably engageable coupling pads  16  and  18  spaced apart and secured to elastomeric band  12 . Suitable complementary releasable coupling pads are commercially available from Velcro Industries B.V. (Manchester, NH) and other resellers under the trade designation “VELCRO.” These couplings include one area having a plurality of fibers in a miniloop configuration (i.e. pile) and one area having a plurality of relatively stiffer fibers in a minihook configuration, also referred to herein as a “multiminihook” pad. The minihook area may also be labeled a “burr.” 
         [0027]    Hemostasis aid  10  includes a pair of complementary releasably engageable coupling pads in the form of a pile pad  16  and a multiminihook pad  18 . As illustrated, hemostasis aid  10  may include a second multiminihook pad  20  for increased adhesion strength. Pile pad  16  and multiminihook pads  18 ,  20  are preferably secured to band  12  by adhesive, although stitching  21  is also suitable. Furthermore, a combination of stitching and adhesive is also effective.  
         [0028]    As shown in FIGS. 1 and 3, pile pad  16  and pressure applicator  14  extend outwardly from the same wide surface side  22  of band  12 , while multihook pads  18  and  20  extend outwardly from opposite wide surface side  24 .  
         [0029]    Pile pad  16  is relatively longer than either multihook pad  18  or  20  (alone or combined) and is made of an elastic material. Suitable elastic pile pads are commercially available from Velcro Industries B.V. under the designation “VELSTRETCH.” 
         [0030]    The material for band  12  and pad  16  is selected to provide a hemostasis aid  10  that is elastic in the length direction (i.e. lengthwise) over at least about  80  percent of the length of band  12 . More preferably, hemostasis aid  10  is elastic over at least about  90  percent of its length.  
         [0031]    Applicant contemplates including advertisement markings on band  12 .  
         [0032]    [0032]FIGS. 5 and 6 illustrate the use of hemostasis aids according to the present invention. As shown in FIG. 5, hemostasis aid  10  is suitable for use as a phlebotomy tourniquet proximal to the targeted puncture site  40 . In the standard tourniquet configuration, ends  26  and  32  of band  12  are overlapped and crossed. Device  10  is elastic and can be stretched to compress the arm tissue and restrict blood flow.  
         [0033]    After a blood drawing needle (or other puncture conduit) is withdrawn, the same device ( 10 ) can be used to apply pressure to promote hemostasis at the puncture site as shown in FIG. 6. In this hemostasis-aid configuration, side  22  of band  12  and pressure applicator  14  face towards arm. In FIG. 6, gauze  42  or a similar absorbent is positioned between the arm puncture site  40  and applicator  14 . Device  10  is elastic and can be stretched around the arm to put compressive force on applicator  14  towards the arm.  
         [0034]    [0034]FIG. 7 is a perspective view of a hemostasis aid employing a single, relatively longer multiminihook pad  44 . Applicator  14  is attached near end  30 . Pile pad  16  extends from opposite end  32 .  
         [0035]    An example embodiment was constructed according to FIGS. 1 and 2 with an open band length (unstretched) of 45.5 centimeters (cm) an open band width of 2.4 centimeters (cm), a pile pad length of 32.5 centimeters (or about 70 percent of the band length) and two multihook pads each 2.0 centimeters (cm) (or about 4 percent each of the band length). An elastic pile pad  16  was attached to band  12  with adhesive and positioned to extend from one of the two opposing ends  28 . A semisphere shaped applicator  14  was attached with adhesive to end portion  26  of the band  12  opposite pad  18  such that a multihook pad  18  directly opposes applicator  14  on the opposite surface  24  of band  12 . Two multiminihooks pads  18  and  20  were attached by stitching and adhesive.  
         [0036]    Users of the example embodiment  10  reported a tactile feedback comparable to a conventional disposable strip tourniquet. Indeed, the medical devices of the present invention have several key features. One key feature of the present invention is substantially uniform elasticity. Another key feature of the present invention is tactile compatibility with conventional disposable tourniquets. The present invention provides a combination tourniquet and hemostasis aid having a lengthwise elasticity substantially similar to universally accepted latex and latex-free disposable tourniquet bands. Through experience, medical personnel are already aware of the necessary or optimal tension with which to wrap limbs at this elasticity.  
         [0037]    The foregoing specification and drawings are to be taken as illustrative but not limiting of the present invention. Still other configurations and embodiments utilizing the spirit and scope of the present invention are possible, and will readily present themselves to those skilled in the art.