Abstract:
An intravenous catheter securement device comprises of an intravenous catheter board stabilizer that conforms to patients&#39; bodies and an adjustable elastic sleeve with a hole for catheter insertion, with two overlying flaps for catheter securement. The intravenous catheter hoard base has holes on either side, one side for connection of the elastic sleeve, and the other side provides a fastening location for elastic bands attached to the sleeve for tightness adjustment. An embodiment of the invention involving the intravenous board is displayed separately as an alternative innovation. This device is comprised of a simple form fitting elastic sleeve having a catheter opening with the intent of applying a removable adhesive to the sleeve itself over the catheter for securement purposes. These embodiments establish a simple, standardized, and safe method of securing intravenous catheters sans adhesive material in contact with the epidermis.

Description:
FEDERALLY SPONSORED RESEARCH 
       [0001]    Not Applicable 
       SEQUENCE LISTING OR PROGRAM 
       [0002]    Not Applicable 
       BACKGROUND  
       [0003]    1. Field of Invention 
         [0004]    This invention relates to catheter securement devices, specifically in their use to stabilize intravenous catheters in clinical settings. 
         [0005]    2. Description of Prior Art 
         [0006]    More than 400,000 newborns are admitted to Neonatal Intensive Care Units (NICO) each year in the United States. Of these, a majority require long-term intravenous catheters to deliver necessary fluids and medicines. Many patients in NICUs are born considerably premature and have underdeveloped skin. A problem arises when traditional catheter securement devices damage underdeveloped skin and thus present a risk to neonates&#39; health. 
         [0007]    Traditional methods to secure catheters to patients require adhesives. It is common practice to lay multiple adhesive strips across the hub of the catheter and directly onto patients&#39; skin adjacent to the site of entry. During a patient&#39;s stay, catheters are removed, cleaned, and re-attached periodically in patients requiring long-term intravenous tubes. This usually occurs once every two days, although specific routines vary by hospital. 
         [0008]    Conventional catheter-anchoring methods have been used for nearly a century. While specific adhesive compounds have been changed to alter binding properties to the skin or to catheters, there have been no fundamental modifications to the solution. This method is generally effective in securement, but it fails to accommodate all the needs of the wide variety of patients admitted to hospitals. Its implementation on neonates is especially problematic. 
         [0009]    Premature infants are underdeveloped in almost every way. Consequently, their skin is incredibly fragile and thin. The same tape-based securement methods used on adults are commonly used on NICU patients. Whereas the extent of adhesive-related damage in adults is generally moderate irritation, NICU patients face much more severe health issues. Their skin is so delicate that when tape is peeled away to change at catheter, the layer of skin in contact with the adhesive is often also peeled away. The resulting wounds are prone to infection, an obstacle that many premature infants&#39; underdeveloped immune systems may not have the ability to overcome. There is clearly a pressing need for alternative catheter-securement methods or devices for NICU patients. 
       SUMMARY 
       [0010]    The present invention has been developed in response to problems and needs in the art that have not yet been fully resolved by currently available universal catheter securement devices and methods. Thus, the following device, and method of application herein, establish a more effective alternative for securing an intravenous catheter to the skin without damage or otherwise harmful effects while ensuring effective catheter function for the duration of insertion. 
         [0011]    An embodiment of the present invention provides an universal catheter securement device and related method for applying the device properly to the patient to prevent the use of adhesive materials or the movement, shearing, or displacement of the catheter once inserted in the patient. The present device promotes standardised, quick, and simple application of catheter securement free from any adhesive components in direct contact with the patient&#39;s skin. This innovation will improve skin care, the incidence of infection, nursing convenience, and intravenous catheter stability and therefore functions associated with intravenous&#39; catheter application. 
         [0012]    The ability to stabilize intravenous catheters sans adhesive contact with the skin is imperative in maintaining the integrity of skin upon application and removal of intravenous catheters, which leads to a lower incidence of skin deformation, tearing, or damage and therefore a lower rate of infection due to an intact epidermis barrier. The device herein established will provide a standardized and simple means of securing intravenous catheters without any damaging effects to the epidermis. This will improve patient comfort, care, and overall outcome. 
     
    
     
       DRAWING FIGURES 
         [0013]    In the drawings, closely related figures have the same number but different alphabetic suffixes. These drawings only depict typical embodiments of the invention and are not intended to be considered the only possible embodiments or to limit the scope of the invention. 
           [0014]      FIG. 1A-B  shows the placement of an intravenous catheter board device on the arm of a patient according to a representative embodiment. 
           [0015]      FIG. 2A-B  shows a perspective view of an intravenous catheter board device according to a representative embodiment. 
           [0016]      FIG. 3A-B  shows a perspective view of the upper fabric open and. closed flap assemblies according to a representative embodiment. 
           [0017]      FIG. 4  shows a perspective view of an intravenous catheter board, base according to a representative embodiment. 
           [0018]      FIG. 5  shows the placement of an elastic fabric sleeve device on the arm of a patient according to a representative embodiment. 
           [0019]      FIG. 6  shows a perspective view of the operation of an elastic fabric sleeve device according to a representative embodiment. 
           [0020]      FIG. 7  shows a perspective view of an elastic fabric sleeve device according to a representative embodiment. 
           [0021]      FIG. 8  shows a perspective view of an elastic fabric sleeve device and its operation with Tegaderm according to a representative embodiment. 
           [0022]      FIG. 9  shows a perspective view of an elastic band at the end of an elastic fabric sleeve device. 
           [0023]      FIG. 10A-D  shows a top view of the possible embodiments of the fabric cutout shapes. 
           [0024]      FIG. 11  shows a top view of the sewing pattern used for discussed designs. 
       
    
    
     DETAILED DESCRIPTION 
       [0025]      FIG. 1A  represents the upper fabric assembly  300  attached to the intravenous catheter board base  200  secured on a patient&#39;s arm  30 . The upper fabric assembly  300  shows the intravenous catheter tip securement flap  340  and intravenous catheter line securement flap  330  closed over the intravenous catheter tip  15  and intravenous catheter line  10 . The elastic bands  610  are drawn taught through the cylindrical holes  240  on the intravenous catheter board base  200 . 
         [0026]      FIG. 1B  represents the upper fabric assembly  300  attached to the intravenous catheter board base  200  resting on a patient&#39;s arm  30  not yet secured. The upper fabric assembly  300  shows the rectangle cutout  510  allowing for the insertion of the intravenous catheter tip  15 . The intravenous catheter tip  15  is secured by the intravenous catheter tip securement flap  340  consisting of the loop Velcro  360  that is able to attach to another opposing hook Velcro  350  to cover the rectangle cutout  510 . The flap is lined with non-slip material  320  to prevent movement of the intravenous catheter tip  15 . The intravenous catheter line securement flap  330  is secured over the intravenous catheter line  10  for additional securement. The intravenous catheter line securement flap  330  consists of the loop Velcro  360  that is able to attach to the opposing hook Velcro  350 . The second flap is also lined with non-slip material  320 . For adjustability, elastic bands  610  are attached to the upper fabric assembly  300 . The elastic bands  610 , threaded through the cylindrical holes  240 , are able to attach to the intravenous catheter board base Velcro  230 . 
         [0027]    An embodiment of the design incorporating an intravenous catheter board base  200  is shown in  FIG. 2A  and  FIG. 2B , The upper fabric assembly  300  may manifest itself in any of the variations of the design described earlier, with additional components necessary for the attachment of the upper fabric assembly  300  to the intravenous catheter board base  200  to form the complete intravenous catheter board device  100 . 
         [0028]      FIG. 2A  represents a possible embodiment of the design from the side of the device where the upper fabric assembly  300  is permanently fastened to the intravenous catheter board base  200 . The connection point on the board is comprised of cylindrical holes  240  on the side of the board. Non-elastic bands  380  are threaded through the cylindrical holes  240  and then through eyelet reinforced holes  310  on the upper fabric assembly  300 . The non-elastic bands  380  are tied to form a double band knot  390  that forms a loop that permanently holds the upper fabric assembly  300  to the intravenous catheter board base  200 . The non-elastic bands  380  may be any non-elastic, closed circle structure, either rigid or flexible, that can withhold enough force to facilitate the connection between the two portions of the device.  FIG. 2A  also shows the bottom of the intravenous catheter board base  200 , containing two strips of intravenous catheter board base Velcro  230  where the tightening loop Velcro strips  620  attach to in order to tighten the intravenous catheter board device  100 . In addition, a foam padding  220 , which could be made of foam or any other soft material, may be placed on top of the intravenous catheter board base  200  to add comfort to the patient&#39;s arm. 
         [0029]      FIG. 2B  represents a possible embodiment of the intravenous catheter board device  100  from the opposite side than that of  FIG. 3 . Four elastic bands  610  are made into a single band knot  630  then stitched to the elastic fabric using the sewing pattern shown in  FIG. 15 . The other end of two adjacent elastic bands  610  are connected by a thin loop Velcro strip  620 . The same is done for the other two elastic bands  610 . The elastic bands  610  are threaded through the cylindrical holes  240  on the intravenous catheter board base  200 . 
         [0030]    An embodiment of the upper fabric assembly  300  is represented in  FIG. 3A , a perspective view of the open flap assembly, and  FIG. 3B , a perspective view of the closed flap assembly. The upper fabric assembly  300  rests on a patient&#39;s arm  30  allows an intravenous catheter tip  15  to insert through a rectangle cutout  510  into a skin opening  20 . An intravenous catheter tip securement flap  340  is attached to the upper fabric assembly  300  via elastic fabric stitches  370 . The bottom side of the intravenous catheter tip securement flap  340  has non-slip material  320  attached by elastic fabric stitches  370  to prevent the intravenous catheter tip  15  from moving. The bottom side of the intravenous catheter tip securement flap  340  also has loop Velcro  360  attached by elastic fabric stitches  370  which will link to the hook Velcro  350  in order to close the intravenous catheter tip securement flap  340 . An intravenous catheter line securement flap  330  is attached to the upper fabric assembly  300  via elastic fabric stitches  370 . The bottom side of the intravenous catheter line securement flap  330  has non-slip material  320  attached by elastic fabric stitches  370  to prevent the catheter line from moving. The bottom side of the intravenous catheter line securement flap  330  also has loop Velcro  360  attached by elastic fabric stitches  370  which will link to the hook Velcro  350  in order to close the intravenous catheter line securement flap  330 . There is also non-slip material  320  attached to the upper fabric assembly  300  via elastic fabric stitches  370  beneath the intravenous catheter line  10  to further prevent the movement of the intravenous catheter line  10 . 
         [0031]      FIG. 4  is a representation of the intravenous catheter board base  200 . The plastic board  210  has a cylindrical indentation which is covered with foam padding  220 . The indentation is to allow the neonate&#39;s arm to rest on the intravenous board securely. The foam padding  220  is to allow for comfort of the neonate&#39;s arm and prevent any harsh surface from being in contact with the neonate&#39;s skin. The cylindrical holes  240  within the plastic board  210  are to allow for the attachment of the elastic bands  610 . 
         [0032]      FIGS. 5 ,  6 ,  7  are representations of the elastic fabric  400  sleeve.  FIG. 5  is an aerial representation of the elastic fabric  400  sleeve on a patient&#39;s arm  30  when, observed from above. The ends are sewn with elastic fabric stitches  370  and the elastic fabric  400  allows the sleeve to be stretched over the patient&#39;s arm  30  and then retreat back to a snug secure position on the arm. An intravenous catheter line  10  and an intravenous catheter tip  15  are shown to demonstrate the placement of the intravenous catheter in relation to the sleeve and the placement of the catheter within the skin opening  20  of the elastic fabric  400 . The skin opening  20  is created by a rectangle cutout  510  of the elastic fabric  400  with elastic fabric stitches  370  around the ends.  FIG. 7  is a representation of the elastic fabric  400  sleeve by itself. Elastic fabric stitches  370  are sewn are the ends and around the rectangle cutout  510 .  FIG. 5  is a representation of the elastic fabric  400  sleeve on a patient&#39;s arm  30  from the perspective of observing a neonate&#39;s bent elbow. The elastic fabric stitches  370  are at the ends of the sleeve and the top of the arm stretches the elastic fabric stitches  370  to a greater extent because that part of the arm is larger. The rectangle cutout  510  allows for the intravenous catheter tip  15  to enter the arm by creating a skin opening  20 . 
         [0033]    Referring now to  FIG. 8 , a perspective view of the elastic fabric sleeve device and its operation with Tegaderm  40  according to a representative embodiment, the intravenous catheter tip  15  placed in the circle cutout  520  of the upper fabric assembly  300  is secured by Tegaderm  40 . 
         [0034]      FIG. 9  shows a perspective view of an elastic band at one end of the upper fabric assembly  300 . In this variation of the design, the upper fabric assembly  300  forms a tube so that in use the patient&#39;s arm is inside. The elastic fabric  400  is double hemmed with the stitch pattern described in  FIG. 15  using elastic fabric stitches  370 . 
         [0035]      FIG. 10A-D  shows the four possible fabric cutout shapes  500  in the elastic fabric  400 . The rectangle cutout  510  is represented, in  FIG. 7 , a perspective view of the full sleeve, and  FIG. 6 , a perspective view of the full fabric assembly rested on a patient&#39;s arm. Alternate fabric cutout shapes  500  include a circle cutout  520 , oval cutout  530 , and a diamond cutout  540 . 
         [0036]      FIG. 11  represents a three-step zig-zag stitch pattern using elastic fabric stitches  370 . 
         [0037]    It should be appreciated that various sizes, dimensions, contours, rigidity, shapes, flexibility and materials of any of the components or portions of components in the various embodiments discussed throughout may be varied and utilized as desired or required. Similarly, locations and alignments of the various components may vary as desired or required. 
         [0038]    It should be appreciated that any of the components or modules referred to with regards to any of the present invention embodiments discussed herein, may be integrally or separately formed with one another. Further, redundant functions or structures of the components or modules may be implemented. 
         [0039]    It should be appreciated that the device and related components discussed herein may take on all shapes along the entire continual geometric spectrum of manipulation of x, y and z planes to provide and meet the anatomical and structural demands and operational requirements. Moreover, locations and alignments of the various components may vary as desired or required. 
       CONCLUSION 
       [0040]    An embodiment provides a universal catheter securement device with the ability to stabilize intravenous catheters sans adhesive contact with the skin. Unlike other catheter securement devices, certain embodiments of this device minimize skin deformation, tearing, or damage to the epidermis barrier, and can provide a simple means of securing intravenous catheters.