Patent Publication Number: US-2010130942-A1

Title: Device for securing intravenous needles to treatment sites

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
     (none) 
     STATEMENT REGARDING FED SPONSORED R &amp; D 
     (none) 
     FIELD OF THE INVENTION 
     The present invention relates generally to medical devices and particularly to a device for securing intravenous needles, cannulas and tubing to treatment sites including arterial-venous fistula sites as used in dialysis treatment. 
     BACKGROUND OF THE INVENTION 
     Intravenous needles and cannulas, also referred to as venous access devices, must he secured to patients to prevent dislodgment during medical treatment. The term needle will be used herein to refer to both needles and cannulas. The location of the needle insertion point or points on a patient vary with the type of medical treatment and the location of a suitable vein. Such locations include for example an upper arm, a surface on the outside surface of a hand, a wrist of a hand, a lower arm or an inside of an elbow of an arm. In dialysis treatment, a special site is typically created to provide for a strengthened vein, most commonly in the forearm and less frequently in the leg, to repeatedly accept two large needles and provide for sufficient flow of blood. The special site is created by joining a vein and an artery and is called a fistula and receives two arterial-venous (AV) fistula needles. In any of the above mentioned locations, it is very difficult to keep the needle secured to operate satisfactorily. In dialysis treatment, where the treatment is prolonged, repeated frequently, and two large needles are used, the problem of securing the needles is exasperated. 
     It is of the utmost importance that the needle or needles be kept under surveillance to check for proper operation and potential dislodgment or leaks of fluid. The most prevalent method to secure needles is to apply adhesive bandages and or tape to keep the needles in place. Unfortunately, bandages and tape can frequently obscure the view of the needle insertion point and needle assembly. Furthermore, many patients cannot tolerate prolonged or repeated applications of adhesive bandages and tape to their skin and have or develop an allergic reaction to adhesive bandages and tape. It has been known that patients who undergo dialysis treatments several times a week for a prolonged period of time can exhibit blue and black spots on their skin because of such an allergy to the adhesive and the continuous application thereof. Other solutions such as arm boards with straps around the location of the needle to keep it in place are not satisfactory because they severely restrict the movement of the patient. What is needed is a device that secures one or more intravenous needles, such as two arterial-venous fistula needles, securely in place, provides for observance of the treatment location, allows for some movement of the patient and does not require adhesive bandages. 
     SUMMARY OF THE INVENTION 
     The invention at hand solves the above noted problems. In the securement of the needles or a needle in either a dialysis or other intravenous (IV) procedure, no adhesives arc used. Once a needle is placed within a vein, the needle is kept in place by straps that cross each other in that particular location. The straps are derived from and are fixed to a pad that is placed on an opposite side of the limb, hand or other part of the patient&#39;s body to which the needle is located. As the straps are moved around the location of the needle, they will cross that location and will return to their origin of the other side of the pad and will be fastened thereto. More than one strap will cross each other at the needle to thereby securely hold the needle in place at that location. A first strap can be used to apply a first pressure to secure the needle. A second strap can be used to apply a second pressure to further secure the needle. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a double needle, such as two arterial-venous fistula needles, secured on an inside of an arm; 
         FIG. 2  shows the location of a pad on the outside of an arm from which straps will come forward to cross a needle; 
         FIG. 3  illustrates a typical pad, such as that depicted in  FIG. 2 , having straps thereon and how they are fastened thereto; 
         FIG. 4  shows a pad having straps thereon to be used on the inside of a hand; 
         FIG. 5  shows a needle secured on the outside surface of a hand; 
         FIG. 6  shows the pad of  FIG. 4  as it is applied to the inside of a hand including the straps as they are fastened; 
         FIG. 7  illustrates a pad having straps thereon that is to be used on top of the wrist of a hand; 
         FIG. 8  illustrates the pad of  FIG. 7  to show how the straps will wrap around the hand; 
         FIG. 9  illustrates a needle secured to the inside wrist of a hand; 
         FIG. 9   a  illustrates a needle secured to the inside wrist of a hand in an alternate location to that depicted in  FIG. 9 ; 
         FIG. 10  shows a pad having straps thereon to be used on an elbow of an arm; 
         FIG. 11  shows a needle secured in the inside of an elbow; 
         FIG. 12  illustrates the pad of  FIG. 10  as it holds the needle of  FIG. 11  in place. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIGS. 1 and 2  illustrate how the present invention is applied to an inner surface of an upper arm of a patient to secure two intravenous (IV) needles  5  and  6 , such as two arterial-venous (AV) fistula needles. Needles  5  and  6  respectively have tubes  9  and  10  and tabs, also called wings,  7  and  8  attached thereto to form needle assemblies also referred to herein as needle assemblies  9  and  10 , respectively. The embodiment depicted in  FIGS. 1 and 2  employs four straps  1 ,  2 ,  3  and  4  to hold the two needles in place. In the orientation shown in  FIGS. 1 and 2 , straps  1  and  2  are upper straps and straps  3  and  4  are lower straps. Strap  1  is fastened to an oval pad  11  by way of a grommet  1   a.  Grommet  1   a  should be fastened in such a way so that the strap  1  can rotate relative to the pad  11  and can follow the angle of direction to which the strap  1  is forced when it is applied thereby preventing kinks. This is also true for grommets  2   a,    3   a  and  4   a  which fasten straps  2 ,  3  and  4  to the pad  11  respectively. The pad  11  is applied to the outer arm if the locations if the needles  5  and  6  are applied to the inner arm. In this application, the upper straps  1  and  2  cross each other over the upper needle  5  and return to the pad  11  where both of the straps are fastened to the pad  11  by way of the well known hook and loop fastening system, VELCRO™. This is equally true for the lower straps  3  and  4  which cross each other over the lower needle  6 . This way the upper straps  1  and  2  and the lower straps  3  and  4  can each be individually adjusted to properly fit over the tab  7  of upper needle assembly  9  and tab  8  of lower needle assembly  10 , respectively. The needles  5  and  6  are held in place by crossing straps  1  and  2 , and  3  and  4 , over tabs  7  and  8 , respectively. The needles are thereby securely fastened without adhesive bandages, the injection points and treatment sites are easily observed, and the patient has some ability for movement. 
       FIG. 3  shows the pad  11  of  FIGS. 1 and 2  when it is not applied to a patient. The pad  11  has hooks  11   a  of the VELCRO™ system on an outer surface as indicated in  FIG. 3 . The four straps  1 ,  2 ,  3  and  4  are fastened to the pad  11  at  1   a,    2   a,    3   a,  and  4   a  by grommets that are applied in such a manner so that the straps are able to rotate into the direction by which they are forced by the application of the pad and the location of the needles themselves. Straps  1 ,  2 ,  3  and  4  have loops of the VELCRO™ system applied to the surface facing pad  11  (not shown), which also faces the patient when the device is applied. The loops of the VELCRO™ system tend to be softer and more compliant than the hooks. Thus patient comfort can be improved with this arrangement of the hooks and loops. Furthermore, the more compliant loops will better conform to the tabs  7  and  8  thereby providing for good retention thereof. Alternatively, the outer surface of the pad  11  could have the loops thereon so that the VELCRO™ system cannot snag on any outer garment. However, this arrangement would require the hooks to be applied to straps  1 ,  2 ,  3  and  4  and the previously mentioned patient comfort and tab retention may be lessened as, a result. 
       FIG. 4  illustrates a pad  12  having three corners in a triangular shape where straps  13 ,  14  and  15  are applied. Again, the straps  13 ,  14  and  15  are fastened by way of grommets  13   a,    14   a  and  15   a,  respectively, in a rotational manner as was explained with regard to  FIG. 3 , and have VELCRO™ loops on the surface facing pad  12  as exemplified by section  16  of strap  15 . Again, the outer surface of the pad comprises hooks  12   a  of VELCRO™ as explained above. The pad  12  of  FIG. 4  is used in the event when a needle is applied to the back of a hand as shown in  FIGS. 5 and 6 . The three straps  13 ,  14  and  15  are applied as shown in  FIG. 5  where the straps  13  and  14  cross each other over a tab  17  and the strap  15  secures the implement around the wrist of the patient.  FIG. 6  shows the implement of  FIG. 5  as it is applied to the inside of the hand. The triangular shape of the pad  12  can clearly be seen in  FIGS. 4 and 6 . 
       FIG. 7  shows a different pad  20  of a substantially rectangular configuration having straps  25 ,  26 ,  27  and  28  fastened by way of grommets  25   a,    26   a,    27   a  and  28   a,  respectively, in a rotational manner as discussed in pads  11  and  12 , and have VELCRO™ loops on the surface facing pad  20  as exemplified by section  29  of strap  27 . The outer surface of the pad  20  comprises hooks  20   a  of VELCRO™ as explained above. One end of pad  20  is somewhat enlarged where the grommets  25   a  and  26   a  are located. This pad can be used when a needle is inserted on the inside wrist of a hand as can be seen in  FIGS. 8 ,  9  and  9   a.  Referring first to  FIGS. 8 and 9 , the pad  20  is placed on the outside of the hand and the straps  27  and  28  cross each other over a tab  21  of a needle assembly  22 . Straps  25  and  26  serve to additionally secure the pad  20  and the tube of needle assembly  22  to the hand. Referring now to  FIG. 9   a,  this system will work perfectly well even if the IV is somewhat offset from the middle of the wrist. The straps  26  and  28  cross over a tab  33  on an IV assembly  31 . This is a somewhat complicated installation, but the cooperation between the pad  20  and the straps  25 ,  26 ,  27  and  28  makes for a versatile installation. 
       FIG. 10  shows a yet a different pad  35  which can be installed at the elbow of a patient. This pad comes is particularly useful when a needle is to be inserted at the inside of the inner arm opposite an elbow. Pad  35  has straps  37 ,  38 ,  39  and  40  fastened by way of grommets  37   a,    38   a,    39   a  and  40   a,  respectively, in a rotational manner as discussed in pads  11 ,  12  and  20 , and have VELCRO™ loops on the surface facing pad  35  as exemplified by section  45  of strap  37 . The pad  35  is made up of two parts  41  and  42  having outer surfaces comprising hooks  41   a  and  42   a,  respectively, of VELCRO™ as explained above. The parts  41  and  42  are connected by way of the grommets  43  and  39   a.  Grommet  39   a  is therefore fastening together strap  39  and parts  41  and  42 . The two parts  41  and  42  have opposing curved inner edges and when connected together leave an open space  44  which will fit around the elbow. The grommets  43  and  39   a  enable the parts  41  and  42  to rotate around each other so that once the pad is installed on the elbow, the two parts  41  and  42  will be able to move with the movement of the elbow.  FIG. 11  shows the installation of the pad  35 .  FIGS. 11 and 12  show how the pad  35  and an IV assembly  47  having a tab  46  are held in place. To this end, the strap  40  circles the arm below the elbow while holding a loop of tube of assembly  47  in place. The straps  37  and  38  cross each other over the tab  46  while the strap  39  circles around the arm just above the elbow. This arrangement assures for a secure holding of the IV needle in place while at the same time affording visibility of the performance of the needle itself while the arm may rotate around the elbow. 
     The pad itself, in all of the above described installations, should be made of a semi-rigid material. That is, it should not give in any planar direction; yet, it should be bondable so that it can conform to any contours of an arm, hand, leg or other part of the body. The pad should not turn or flex with the different directions the straps may take. The grommets should allow the straps to turn relative to the pad. The application of two straps crossing over the needle assembly and tab thereof as described in the above installations, enables a first strap to apply a first pressure to initially secure and position said assembly, and a second strap to apply a second pressure further securing said assembly. As noted above, the pad can comprise hooks of the VELCRO™ fastening system, thereby allow the softer loops thereof to be used on the straps which face the patient. Patient comfort can be improved with this arrangement of the hooks and loops. Furthermore, the more compliant loops will better conform to the tabs of needle assemblies thereby providing for good retention thereof. Alternatively, the outer surface of the pad  11  could have the loops thereon so that the VELCRO™ system cannot snag on any outer garment. However, this arrangement would require the hooks to be applied to the straps and the previously mentioned patient comfort and tab retention may be lessened as a result. In an alternative embodiment, adhesives could be used to attach the straps to the pads after wrapping said straps around the patient. In this embodiment, the adhesive could be applied such that it would not come into contact with the patient. This embodiment may be preferable when the device is to be disposed of after a single use. However, the VELCRO™ system may provide a more secure attachment of the straps to the pad than an adhesive. Furthermore, as noted above, the soft and compliant loops of the VELCRO™ system may provide for improved patient comfort and improved retention of the tabs of the needle assemblies. 
     As mentioned earlier, needles and cannulas are also referred to as venous access devices. The present invention can also be used with venous access device assemblies which do not have tabs, or as they are also called, wings or butterflies. Generally there will be a firm portion between the base of the needle or cannula and the tubing which is suitable for gripping or holding the venous access device assembly near the insertion point. A wing, butterfly, tab or said firm portion can be referred to as a stabilizing feature of the needle. 
     Given the benefit of the above disclosure of the present invention, those skilled in the art may envision how the present invention could be practiced using variations to the disclosed embodiments. For example, the present invention can be practiced and used to secure venous access devices to other locations of the body such as locations on the legs, and alternative pad shapes and strap arrangements can be envisioned, all without departing from the spirit and scope of the invention. Furthermore, the present invention can also be used to secure tubing and assemblies related to implanted venous catheters, which is yet another form of a venous access device. The foregoing detailed description should be regarded as illustrative rather than limiting and the appended claims, including all equivalents, are intended to define the scope of the invention.