Abstract:
A device contemplated to be used in lieu of tape to secure and protect an IV catheter while maintaining the patient&#39;s comfort and an acceptable range of movement is formed with a thin, flexible body configured to be wrapped around a portion of a patient&#39;s anatomy, and particularly a patient&#39;s hand. The body of the device includes a slot extending into the body from one end, with an aperture at the base of the slot into which a patient&#39;s thumb is to be received, and the ends of the device are wrapped around to the palm of the hand and secured to each other without any of the securing adhesive to contact the skin of the patient. In preferred embodiments a releasable and re-connectable cover is provided over the catheter site to allow inspection and adjustment with minimal disturbance of the device or the patient.

Description:
RELATED APPLICATION DATA 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/271,936, filed Jul. 29, 2009, by the same inventor/applicant. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention generally relates to medical devices, and in its preferred embodiments more specifically relates to devices for covering and securing a catheter, with associated tubing, inserted into a vein or artery in a human patient&#39;s arm, and especially the patient&#39;s hand, while maximizing freedom of movement and patient comfort. The invention includes devices for covering and protecting a catheter located on the patient&#39;s hand, and a catheter located on the patient&#39;s arm. 
       BACKGROUND 
       [0003]    It is a relatively common practice in the medical field to insert a catheter into a patient&#39;s vein or artery for the injection of fluids during a period of hospitalization, day surgery, etc. Since that practice began, one of the problems associated with it has been securing and stabilizing the catheter at the insertion site. Most commonly, a catheter is inserted into a vein. In the following description, the term “IV catheter” is used for convenience and is to be taken as encompassing both venous catheters and arterial catheters. The term catheter is used to refer to a tube, rigid or flexible, that is inserted through the patient&#39;s skin and into a vein, and a hub or connector that remains on the exterior of the skin, for connection of tubing to carry fluids through the catheter and into the patient. The most common and preferred insertion sites are the inside of the patient&#39;s arm, and the back of the patient&#39;s hand. Unless the exterior portion of the catheter is well secured, it can be easily pushed or pulled out of position, which can result in full or partial removal of the catheter, usually accompanied by both physical and mental distress for the patient. Inadvertent removal of the catheter from the vein or from the patient completely may cause injury to the patient, and, at the least, will interfere with the administration of fluid through the catheter, potentially creating a life-threatening situation. 
         [0004]    In normal current practice the catheter is inserted into a vein and then secured by applying a sufficient amount of adhesive tape over the catheter on the patient&#39;s arm to assure that the catheter remains in place and is not disturbed by normal movements. Typically, a medical practitioner will apply a substantial amount of tape over the catheter and over tubing running from the catheter. That practice is time consuming, wasteful of tape, and, perhaps most significantly, uncomfortable for the patient. After a catheter is inserted it must be periodically inspected, and the insertion site may be changed, both of which require removal of some or all of the tape. Removal of the tape can be considerably more uncomfortable than placement. Some patients are allergic or otherwise sensitive to the adhesive, and those patients may suffer skin burns and other adverse reactions. 
         [0005]    Various efforts have been made to alleviate the problems associated with stabilizing and protecting an IV catheter, and a number of devices are known in the prior art. Some of these devices provide very secure confinement of an IV catheter and associated tubing, but also restrict patient movement and compromise comfort. Others are more comfortable to the patient, but provide less effective stability for the catheter apparatus. None of the known devices from the prior art have been fully successful in addressing the need for a device that provides both acceptable catheter security and patient comfort, and the use of adhesive tape remains the most prevalent manner of securing a catheter, despite the well known problems associated with that approach. 
       SUMMARY OF THE INVENTION 
       [0006]    The present invention provides a device to be used in lieu of tape to secure and protect a catheter while maintaining the patient&#39;s comfort and an acceptable range of movement. The device is preferably formed of a flexible, non-woven, tear-resistant fabric material in a generally rectangular configuration. An opening is formed in the piece of material and covered with a flexible transparent panel or window that is adhered to the material around the opening. In a particularly preferred embodiment, the panel may be lifted to allow care giver access to the catheter, and then re-affixed to again establish the protective cover over the catheter without replacing the complete device each time access is required. The device of the invention will be provided in at least two configurations, one to secure a catheter placed on the back of the patient&#39;s hand, and another to secure a catheter placed on the arm adjacent to the elbow. The structure and features of preferred embodiments of the device will be described in detail below, with reference to the accompanying drawing figures. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]      FIG. 1  is a top plan view of a preferred embodiment of a hand wrap configuration of the device of the invention, for use on a patient&#39;s left hand. 
           [0008]      FIG. 2  is a side elevation view of the hand wrap embodiment of the device of  FIG. 1 , looking toward the first edge of the device, in which the thickness of the components of the device is exaggerated for clarity. 
           [0009]      FIG. 3  is a top plan view of a particularly preferred embodiment of the hand wrap device configuration of  FIG. 1 . 
           [0010]      FIG. 4  is a top plan view of the embodiment of the device as in  FIG. 3 , with a removable and adjustable catheter cover. 
           [0011]      FIG. 5  is a side elevation view of the hand wrap embodiment shown in  FIG. 4  looking toward the first edge of the device, in which the thickness of the components is exaggerated for clarity. 
           [0012]      FIG. 6  is a top plan view of the hand wrap configuration embodiment of  FIG. 1 , in place upon the back of a patient&#39;s hand, with a catheter in place, and ready for connection. 
           [0013]      FIG. 7  is a top plan view Of the hand wrap embodiment of the device of  FIG. 1 , with the first end of the device wrapped around to the palm of the hand in one of the steps for connection of the device around the hand. 
           [0014]      FIG. 8  is a top plan view of a particularly preferred embodiment of hand wrap configuration of the device, in progress of attachment in the position and manner shown in  FIG. 7  for that embodiment. 
           [0015]      FIG. 9  is a top plan view of the hand wrap embodiment of the device configuration of  FIG. 1 , with both ends of the device wrapped around to the palm of the hand and connected to each other to secure the device around the hand and over a catheter. 
           [0016]      FIG. 10  is a top plan view of the particularly preferred embodiment of the hand wrap configuration of, with both ends of the device wrapped around the hand as in  FIG. 9 . 
           [0017]      FIG. 11  is a top plan view of an embodiment of the hand wrap configuration of the device and the palm of a patient&#39;s hand, showing the configuration of the connected device on the palm side of the hand, the palm side view being the same for all embodiments. 
           [0018]      FIG. 12  is a is a top plan view of the an embodiment of the hand wrap configuration of the device of the invention, for use on a patient&#39;s right hand. 
           [0019]      FIG. 13  is a top plan view of an embodiment of the arm wrap configuration of the device of the invention. 
           [0020]      FIG. 14  is a side elevation view of the embodiment of the arm wrap configuration shown in  FIG. 13 , looking toward the first edge of the device, in which the thickness of the components is exaggerated for clarity. 
           [0021]      FIG. 15  is a top plan view of a particularly preferred embodiment of the arm wrap configuration of the device. 
           [0022]      FIG. 16  is a top plan view of a variation of the particularly preferred embodiment of the arm wrap configuration of the device. 
           [0023]      FIG. 17  is a top plan view of an embodiment of the arm wrap configuration of the device, laid across the inside of a patient&#39;s arm in preparation for connection of the device around the arm. 
           [0024]      FIG. 18  is a is a top plan view of the embodiment of the arm wrap configuration of the device, as in  FIG. 17 , positioned over the arm, with the first end of the device wrapped around the arm. 
           [0025]      FIG. 19  is a top plan view of the embodiment of the arm wrap configuration of the device of  FIG. 17 , positioned over the arm, with both ends wrapped around the arm for connection to each other. 
           [0026]      FIG. 20  is a top plan view of a particularly preferred embodiment of the arm wrap configuration, with both ends wrapped around the arm, allowing access directly to the catheter insertion site without fully removing the device. 
           [0027]      FIG. 21  is a top plan view of an elongate strip for wrapping around a patient&#39;s arm to retain tubing extending from a catheter insertion site to a source of IV fluid or the like. 
           [0028]      FIG. 22  is an edge elevation view of a first embodiment of an elongate retaining strip with an adhesive strip at both ends, connected to a section of tubing (shown in cross-sectional view). 
           [0029]      FIG. 23  is an edge elevation view of a second embodiment of an elongate retaining strip with an adhesive strip at one end, connected to a section of tubing (shown in cross-sectional view). 
       
    
    
     DESCRIPTION OF THE INVENTION 
       [0030]    The device of the invention is contemplated to be provided in at least two configurations, each having at least two embodiment; a first, or hand wrap, configuration to be used to secure an IV catheter placed in a vein on the back of the patient&#39;s hand adjacent to the wrist, illustrated in  FIGS. 1-12 , and a second, or arm wrap, configuration to secure a catheter placed in a vein on the inside of a patient&#39;s arm, illustrated in  FIGS. 13-20 . 
         [0031]    Referring first to  FIGS. 1 and 2 , a first, or basic embodiment of the hand wrap configuration of the invention is formed as a thin, flexible body  10 , with a first face  11 , a second face  12 , a first edge  13 , a second edge  14 , a first end  15 , and a second end  16 . In the embodiment shown, first edge  13  is generally straight, and second edge  14  is formed at an angle to the first edge, so that the width of body  10  between the first and second edges increases between first end  15  and second end  16 . Second edge  14  is preferably curved along its length to follow the shape of a patient&#39;s hand during placement and use of the device, but it is to be understood that the scope of the invention is not limited to the proportional relationships specifically shown and described, but encompasses a variety of proportional relationships, so long as the selected proportional relationship provides acceptable fit and function. 
         [0032]    In this embodiment body  10  includes a generally keyhole-shaped cut-out  17  formed in body  10 , the keyhole including a generally circular aperture  18  disposed between the first and second edges and the first and second ends, and a relatively wide slot  19  extending from the second end of the body to aperture  18 . Removing a portion of body  10  to form cut-out  17  and slot  19  creates a first strip  20  and a second strip  21 , separated by slot  19 . Strip  20  includes the portion of the body along first edge  13  between that edge and the adjacent edge of cut-out  17 , and a portion of second end  16  of the body. Strip  21  includes the portion of the body along second edge  14  and the adjacent edge of cut-out  17  and a portion of second end  16 . Cut-out  17  is preferably formed with smooth transitions at the intersection of slot  19  with aperture  18 , but the exact nature of the transitions is not critical. 
         [0033]    So that the device may be easily and releasably applied to a patient, the described and illustrated embodiments include a first adhesive band  22  on face  12  of body  10  along first end  15 , and extending from the end of the device a short distance into the interior toward the second end. A second adhesive band  23  is formed on face  11  of body  10  along the second end portion of strip  20 , and a third adhesive band  24  is formed on face  11  of the body along the second end portion of strip  21 . The width of the adhesive bands from the end of the body inward is preferably approximately one inch, but any width that will assure secure adhesion to the material from which the body of the device is formed may be satisfactorily used. It is preferred that the adhesive material forming the adhesive bands be covered with a release sheet  25  for protection. The same adhesive material  26  is preferably used to form bands  22 ,  23 , and  24  so that the adhesive strength between each band and the body of the device is the same. 
         [0034]    The device of the invention further includes a transparent window  27  disposed in body  10  between aperture  18  of cut-out  17  and the first end  15  of the body, covering a window aperture  28  formed in body  10 . Window  27  is formed of a flexible transparent material, and will cover the insertion site of a catheter through the patient&#39;s skin to provide stability and protection for the catheter while allowing the insertion site and catheter to be visually inspected. It is preferred that the face of window  27  to be received against the skin of a patient over the catheter insertion site be covered with a transparent adhesive  29  that is gently adhesive to human skin, to facilitate placement and retention of the device with window  27  over the catheter insertion site for visibility. Alternatively, adhesive compound  29  may be provided around the perimeter of the window to provide such adhesion without adhering the window itself to the catheter. A preferred type of adhesive material for window  27  is non-irritating to human skin and forms a bond to skin that is easily removed without damaging the skin, but it is to be understood that adhesive  29  could be omitted from the window or window perimeter if desired. 
         [0035]    In a particularly preferred embodiment, shown in  FIGS. 3-5 , window aperture  28  is replaced by a slot  30  formed in body  10  to extend inwardly from second edge  14  of the body a distance generally equal to the distance between edge  14  and the farthest edge of aperture  28  from edge  14  in the previously described embodiment. Slot  30  has first and second parallel opposed edges  31  and  32 . Instead of a discrete window panel  27  adhered at its edges to body  10  around aperture  28 , a catheter cover panel  33  is disposed over slot  30  and releasably adhered along three of its edges to body  10 . Cover panel  33  includes opposed side edges  34  and  35  and opposed inner and outer edges  36  and  37 , and is larger in dimension than slot  30  so that the side edges and the inner edge  36  overlie a portion of body  10  around slot  30  and are received against the second face  12  of body  10  around the edges of the slot. In one variation, cover panel  33  may be formed of the same transparent material as window panel  27 , to permit visual inspection of the entirety of the catheter and tubing that underlies the device when in place on a patient&#39;s hand. When access to the catheter and/or tubing is required, panel  33  can be detached and lifted at least partially away from the catheter and tubing to provide access, and then re-adhered, allowing the same device to remain in place rather than being replaced each time catheter access is needed. 
         [0036]    In a variation, a window  27 , essentially as described above, may be structured within a portion of cover  33 , with the remainder of cover  33  formed of the same material as body  10 . As noted above, the skin-contact side of the transparent window material, or of the entire cover panel  33  if desired, may be provided with an adhesive layer to gently adhere it to the patent&#39;s skin over the catheter and connected tubing, or may be left adhesive free. 
         [0037]    A variety of materials could be used to form body  10  of the device within the scope of the invention, but it is preferred that the material of construction have certain properties or characteristics that are deemed to be desirable. It is preferred that the material be of a woven fabric construction, breathable, and hypo-allergenic. Other desirable but non-essential characteristics include slight deformability without tearing, and some degree of elasticity. It is to be understood that any suitable material that will provide appropriate performance may be used within the scope of the invention. 
         [0038]    To use the device of the invention to secure and protect a catheter inserted through a patient&#39;s skin on the back of the patient&#39;s left hand adjacent to the wrist, the device of the invention is, as illustrated in  FIG. 3 , placed on the back of the patient&#39;s hand with face  11  in contact with the skin and with window  27  directly overlying the catheter insertion site, after first removing the release sheet  25 , if adhesive is used on or around the window, and the window is lightly pressed against the patient&#39;s skin around the catheter. The first end of the device extends outwardly beyond the edge of the hand opposite the thumb, and strips  20  and  21  extend outwardly beyond the opposite edge of the hand, with the thumb between the strips. The first end of the device is wrapped over the edge of the hand opposite the thumb and over a portion of the palm of the hand, as shown in  FIG. 4 , with first adhesive band  22  facing upward, away from the hand. Release sheet  25  is removed from first adhesive band  22 , and the release sheets are also removed from the second and third adhesive bands  23  and  24 . First band  20  is wrapped around the heel of the patient&#39;s hand and across the palm, over adhesive band  22  at the first end of the device, and onto the body of the device. Adhesive band  22  engages the facing surface of strip  20 , and adhesive band  23 , at the end of strip  20 , engages the body of the device it overlies. Strip  21  is then wrapped around the opposite side of the thumb between the thumb and forefinger and onto the body of the device overlying the palm. In the same manner as with strip  20 , strip  21  adheres to adhesive band  22 , and the third adhesive band  24  adheres to the body of the device, securing the device in place around the patient&#39;s hand and over the catheter insertion site, as can be seen in  FIG. 5 .  FIG. 6  shows the device connected to the hand as in  FIG. 5 , from the palm side of the hand. Strip  21  will typically overlie strip  20 , as shown, to achieve a close fit of the device on the patient&#39;s hand, but it is to be understood that the specific placement and/or order of placement of strips  20  and  21  is not critical and can be varied, so long as a secure fit is achieved. 
         [0039]    It will be understood from the foregoing that none of the adhesive forming adhesive bands  22 ,  23 , and  24  is brought into contact with the patient&#39;s skin, eliminating the possibility of skin irritation or a more severe allergic reaction to the adhesive. The only adhesive in direct contact with the patient&#39;s skin is the adhesive associated with window  27  and/or panel  33 . Because the adhesive bond between the window and the skin plays a limited role on retaining the device on the hand, a mild adhesive, much less likely to cause an adverse reaction, may be used, or, as noted above, adhesive may be omitted from the window altogether. The configuration of the device and its placement on the hand, with strips  20  and  21  on opposite sides of the thumb, prevents the device from sliding forward toward the fingers, backward toward the wrist, and/or around the hand, and thus provides a secure protective covering for a catheter and its insertion site while avoiding the disadvantages and discomfort associated with taping the catheter in place. 
         [0040]    The body of the device, absent the adhesive bands at the first and second ends of the body and absent the adhesive associated with window  25 , can be used for either the left hand or the right hand. The only difference between a left-hand version and a right-hand version is the face of the body on which the adhesive bands, and window adhesive, are placed. For a right-handed version, shown in  FIG. 7 , adhesive band  22  is formed on first face  11  of the body rather than on second face  12 , and adhesive bands  23  and  24  are formed on second face  12 . Adhesive for window  27  is placed on or around the face of the window that will be in contact with the skin. 
         [0041]    The hand wrap configuration of the device may also be made universal, or reversible, in a variation that may be used on either hand interchangeably. Looking to  FIG. 7 , in a universal variation of the device, an adhesive band  22  is formed on both first and second faces of body  10  at first end  15 , each covered by a release strip  25 . The adhesive material for window  25  may be placed on both sides of the window, each covered by a release sheet, or window adhesive may be omitted altogether. In one embodiment of this variation, adhesive material is omitted entirely from the ends of strips  20  and  21 , and the device in connected to a patient by first wrapping strips  20  and  21  around to the palm of the hand and then wrapping the first end  15  around to overlie and connect to the strips. In another embodiment, adhesive material may be placed on both faces of the ends of strips  20  and  21 , like the doubled adhesive band described above, with each layer of adhesive material covered by a release sheet. When the device is connected to a patient, the care giver selects which sets of release strips to remove so as to accommodate the selected one of the patient&#39;s hands, and the device is connected as described above for the non-reversible embodiments. 
         [0042]    An arm wrap configuration of the device of the invention, shown in  FIGS. 13-20 , includes a body  110 , a first face  111 , a second face  112 , a first edge  113 , a second edge  114 , a first end  115 , and a second end  116 . It is preferred that second edge  114  be generally straight, and that first edge  113  be slightly curved between the first and second ends of the body, and be of greater length than second edge  114 . First and second ends  115  and  116 , extend between the first and second edges of the body at a non-perpendicular angle relative to either edge. 
         [0043]    To provide for connection of the arm wrap configuration around the arm of a patient, a first, or basic, embodiment includes a first adhesive band  122  on face  112  of body  110  along first end  115 , and extending from the end of the device a short distance into the interior toward the second end. A second adhesive band  123  is formed on face  111  of body  110  along second end  116 . As in the hand wrap embodiments, the width of the adhesive bands from the end of the body inward is preferably approximately one inch. It is also preferred that the adhesive material forming all adhesive bands be covered with a release sheet  125 . The same adhesive material used for the bands  22 ,  23 , and  24  of the hand wrap embodiment is also preferably used for bands  122  and  123  in the arm wrap embodiments, and is identified by reference number  126  in the context of the arm wrap embodiment. 
         [0044]    The first arm wrap embodiment also includes a transparent window  127  disposed in body  110  over a window aperture  128 . The description of window  27 , above, is equally applicable to window  127  of the arm wrap configuration, and need not be repeated here. As in the hand wrap embodiment, it is preferred that window  127  be directly adhesive to the patient&#39;s skin or be surrounded by adhesive material  129 . The adhesive material, preferably the same as adhesive  29 , the nature of which is as described above, may be omitted from the window or the surrounding area of the body if desired, also as discussed above, within the scope of the invention. If used, window adhesive  129  is disposed on the face of window  127  that is associated with the first face  111  of the body and is to be received against the patient&#39;s skin. Window  127  is preferably not disposed in the geometric center of body  110 , but is offset toward edge  114  and toward end  115  from the center. The off center placement of window  127  is preferred in order to facilitate placement and connection of the device of the invention around a patient&#39;s arm, but is not an essential feature, and other proportional relationships may be used. 
         [0045]    In a particularly preferred embodiment of the arm wrap configuration, window aperture  128  is replaced by a slot  130 , with edges  131  and  132 , that extends into body  110  from edge  114 , and is covered by a cover panel  133 . As described above, the entire cover panel  133  may be formed of a transparent window material, or may be formed of the material of body  110  with a window panel  127  disposed within it. 
         [0046]    As illustrated in  FIG. 17 , the arm wrap embodiment of the device of the invention is used to cover and secure a catheter inserted into a patient&#39;s arm adjacent to the elbow by first removing the release sheet  125  covering the window adhesive  129 , if used, and placing the device over with catheter with window  127  overlying the catheter, so that the catheter is visible through the window material. The device is oriented on the patient&#39;s arm with edge  114  facing the wrist, and with edge  113  facing or slightly overlapping the inside of the elbow. The release sheets  125  are removed from adhesive bands  122  and  123 . The first end  115  of the body of the device is wrapped around the patient&#39;s arm and received against the patient&#39;s skin, with adhesive of band  122  on the surface of the device facing away from the patient&#39;s skin, as in  FIG. 18 . The first end of the device is held in place while the second end  116  is wrapped in the opposite direction until the portion of the body at the second end overlaps the first end of the body, bringing the portion of the body adjacent to the second end into contact with adhesive band  122 , and bringing adhesive band  123  into contact with the portion of the body adjacent to the first end.  FIGS. 19 and 20  show different embodiments of the device fully wrapped around the arm. The adhesive bonds formed between the adhesive material and the material of the body retains the device around the patient&#39;s arm without contact between the material of adhesive bands  122  and  123  and the patient&#39;s skin. 
         [0047]    Elongate strips  134  of the same material as body  10  or  110 , with one or more adhesive bands, may be provided with the primary device of the invention in a kit, and used to secure IV tubing routed along a patient&#39;s arm. Connection of these strips around the arm is preferably accomplished in generally the same manner as body  110  is connected, so as to avoid direct contact between the adhesive and the patient&#39;s skin. An embodiment with adhesive bands  135  and  136  at opposite ends of strip  134  is illustrated in  FIGS. 21 and 22 . When such strips are used, adhesive band  135  at one end of the strip may be wrapped around and adhesively secured to the tubing, the strip is then wrapped around the patient&#39;s arm, and adhesive band  136  at the opposite end is connected to the strip itself, as illustrated in  FIG. 14 . Alternatively, as shown in  FIG. 23 , adhesive band  136  may be omitted and band  135  made with sufficient length to wrap around the tubing with a length of adhesive exposed to receive and adhere to the opposite end of the strip. In both embodiments of strip  134 , the same adhesive material used to form adhesive bands  122  and  123  is preferably used for bands  136  and/or  135 , although other adhesive materials could be used if desired. 
         [0048]    With either embodiment of the device in place and secured on a patient&#39;s hand or arm, the catheter and insertion site are covered and protected by the transparent window, which allows the catheter to be seen, and/or to be seen and adjusted, depending on the embodiment chosen, without removing or rearranging the device. The catheter is retained in place between the device and the patient, the IV tubing adjacent to the catheter can also be held in place by the device, and can be, if desired, secured to the outer surface of the device, rather than to the patient&#39;s skin, with tape. 
         [0049]    With the device of the invention, nothing more irritating than the mild window adhesive, if that, is in direct contact with the patient&#39;s skin, and most of the discomfort associated with IV catheters is avoided. While the device is in place, air can reach the patient&#39;s skin where tape would otherwise cover it, and the device can move slightly to accommodate patient movements without pulling on the skin. When the device is removed, the patient&#39;s skin and/or hair is not pulled, no adhesive residue is left, and no adhesive induced skin irritation is created. Therefore, the device can be removed and replaced easily and quickly whenever replacement is warranted, without creating concern for the patient&#39;s skin condition and comfort. 
         [0050]    The foregoing description of preferred embodiments, alternatives, and variations of the device of the invention is intended to be illustrative and not limiting. It is contemplated that further embodiments and variations may be devised from and on the basis of the present invention, the scope of which is to be understood in accordance with the following claims.