Device for securing intravenous needles to treatment sites

The invention is directed to a system and device for securing one or more intravenous needles or cannulas to a patient in a treatment site such as on an arm, hand or leg. The device includes a semi-rigid but flexible pad that is placed in a location which is opposite of the treatment site, such as on the opposite side of an arm, hand or leg. The pad has straps emanating from it which extend around the patient and while doing so cross each other to trap a needle or cannula stabilizing feature and then continue around the patient and back to the pad. The pad has a first part of a hook and loop fastening system thereon, while the straps have the second part of the hook and loop fastening system thereon so that when engaged they will securely hold the straps in place. The pads may take on different shapes such as rectangular, oval or triangular shape to be able to be placed at different locations on the patient.

CROSS REFERENCE TO RELATED APPLICATIONS

STATEMENT REGARDING FED SPONSORED R & D

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 be 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 are 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'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.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1 and 2illustrate how the present invention is applied to an inner surface of an upper arm of a patient to secure two intravenous (IV) needles5and6, such as two arterial-venous (AV) fistula needles. Needles5and6respectively have tubes9and10and tabs, also called wings,7and8attached thereto to form needle assemblies also referred to herein as needle assemblies9and10, respectively. The embodiment depicted inFIGS. 1 and 2employs four straps1,2,3and4to hold the two needles in place. In the orientation shown inFIGS. 1 and 2, straps1and2are upper straps and straps3and4are lower straps. Strap1is fastened to an oval pad11by way of a grommet1a. Grommet1ashould be fastened in such a way so that the strap1can rotate relative to the pad11and can follow the angle of direction to which the strap1is forced when it is applied thereby preventing kinks. This is also true for grommets2a,3aand4awhich fasten straps2,3and4to the pad11respectively. The pad11is applied to the outer arm if the locations if the needles5and6are applied to the inner arm. In this application, the upper straps1and2cross each other over the upper needle5and return to the pad11where both of the straps are fastened to the pad11by way of the well known hook and loop fastening system, VELCRO™. This is equally true for the lower straps3and4which cross each other over the lower needle6. This way the upper straps1and2and the lower straps3and4can each be individually adjusted to properly fit over the tab7of upper needle assembly9and tab8of lower needle assembly10, respectively. The needles5and6are held in place by crossing straps1and2, and3and4, over tabs7and8, 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. 3shows the pad11ofFIGS. 1 and 2when it is not applied to a patient. The pad11has hooks11aof the VELCRO™ system on an outer surface as indicated inFIG. 3. The four straps1,2,3and4are fastened to the pad11at1a,2a,3a, and4aby 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. Straps1,2,3and4have loops of the VELCRO™ system applied to the surface facing pad11(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 tabs7and8thereby providing for good retention thereof. Alternatively, the outer surface of the pad11could 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 straps1,2,3and4and the previously mentioned patient comfort and tab retention may be lessened as a result.

FIG. 4illustrates a pad12having three corners in a triangular shape where straps13,14and15are applied. Again, the straps13,14and15are fastened by way of grommets13a,14aand15a, respectively, in a rotational manner as was explained with regard toFIG. 3, and have VELCRO™ loops on the surface facing pad12as exemplified by section16of strap15. Again, the outer surface of the pad comprises hooks12aof VELCRO™ as explained above. The pad12ofFIG. 4is used in the event when a needle is applied to the back of a hand as shown inFIGS. 5 and 6. The three straps13,14and15are applied as shown inFIG. 5where the straps13and14cross each other over a tab17and the strap15secures the implement around the wrist of the patient.FIG. 6shows the implement ofFIG. 5as it is applied to the inside of the hand. The triangular shape of the pad12can clearly be seen inFIGS. 4 and 6.

FIG. 7shows a different pad20of a substantially rectangular configuration having straps25,26,27and28fastened by way of grommets25a,26a,27aand28a, respectively, in a rotational manner as discussed in pads11and12, and have VELCRO™ loops on the surface facing pad20as exemplified by section29of strap27. The outer surface of the pad20comprises hooks20aof VELCRO™ as explained above. One end of pad20is somewhat enlarged where the grommets25aand26aare located. This pad can be used when a needle is inserted on the inside wrist of a hand as can be seen inFIGS. 8,9and9a. Referring first toFIGS. 8 and 9, the pad20is placed on the outside of the hand and the straps27and28cross each other over a tab21of a needle assembly22. Straps25and26serve to additionally secure the pad20and the tube of needle assembly22to the hand. Referring now toFIG. 9a, this system will work perfectly well even if the IV is somewhat offset from the middle of the wrist. The straps26and28cross over a tab33on an IV assembly31. This is a somewhat complicated installation, but the cooperation between the pad20and the straps25,26,27and28makes for a versatile installation.

FIG. 10shows a yet a different pad35which 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. Pad35has straps37,38,39and40fastened by way of grommets37a,38a,39aand40a, respectively, in a rotational manner as discussed in pads11,12and20, and have VELCRO™ loops on the surface facing pad35as exemplified by section45of strap37. The pad35is made up of two parts41and42having outer surfaces comprising hooks41aand42a, respectively, of VELCRO™ as explained above. The parts41and42are connected by way of the grommets43and39a. Grommet39ais therefore fastening together strap39and parts41and42. The two parts41and42have opposing curved inner edges and when connected together leave an open space44which will fit around the elbow. The grommets43and39aenable the parts41and42to rotate around each other so that once the pad is installed on the elbow, the two parts41and42will be able to move with the movement of the elbow.FIG. 11shows the installation of the pad35.FIGS. 11 and 12show how the pad35and an IV assembly47having a tab46are held in place. To this end, the strap40circles the arm below the elbow while holding a loop of tube of assembly47in place. The straps37and38cross each other over the tab46while the strap39circles 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 pad11could 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.