Abstract:
A safety device to be used with a winged intravenous infusion assembly has a base that is adaptable to fit over the body of the infusion assembly. Attached to the base is a housing that is pivotable to a position in substantial alignment along the longitudinal axis of the base for enveloping a needle extending from the infusion assembly when the housing is pivoted to the alignment position. Locking mechanisms may be provided in the housing for preventing movement of the housing relative to the needle once the needle is enveloped by the housing. The base can be configured to include a tubular portion that slidably fits over the front end of the infusion assembly or a pair of arms that intimately embrace the body of the infusion assembly. Alternatively, the safety device could be cast from the same mold as the IV infusion assembly so that the molded IV infusion assembly could have directly extending therefrom the safety device.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates to needle protection devices and more particularly to a safety device adaptable to be used with an intravenous infusion needle.  
         BACKGROUND OF THE INVENTION  
         [0002]    For intravenous (IV) infusions and/or withdrawing of venous blood, a device commonly known as a “butterfly” or winged intravenous infusion assembly is often used. This device may also be known as a hemodialysis needle.  
           [0003]    Given the increasing risks of blood borne disease that a care giver, or for that matter a bystander, is exposed to when needle devices are used, some states have now mandate the use of protection devices that would preclude a contaminated needle from being exposed to the environment. Some of the currently available needle protection devices for IV infusion needles include the SAFETY-LOK blood collection sets manufactured by the Becton Dickinson Company and the ANGLWING safety needle protection system manufactured by the Sherwood Medical Company. These systems are sold as sets in that the needle protection device is already built onto the winged infusion assembly.  
           [0004]    Yet there are standalone winged infusion assemblies. For those types of assemblies, there is therefore a need to provide or fit them with a safety device that would preclude the needle, after it has been contaminated with a patient&#39;s blood, from being exposed to the environment. Moreover, for ease of manufacture, it may be advantageous to mold the safety device and the IV infusion assembly as a single unit.  
         SUMMARY OF THE PRESENT INVENTION  
         [0005]    The present invention is a safety device that is adaptable to be used with various types of winged intravenous infusion assemblies. In addition, the present invention safety device also can lend itself to being integral with the molding of the IV butterfly wings. Specifically, the safety device of the instant invention can be used as an add-on device that has a base which is adaptable to be fitted to the body of a winged IV infusion assembly. The base is configured to have an interior surface that comes into intimate contact with the outside surface of the body of the winged IV infusion assembly so that, once the base of the safety device is fitted over the body of the infusion assembly, it is securely mounted thereto. Alternatively, the base can be an integral part of the body of the winged IV infusion assembly.  
           [0006]    Attached to the side of the base that faces the needle that extends from the infusion assembly is a housing or sheath. The housing is hingedly attached to the base by, for example, a living hinge. The housing further has a groove or a passage extending substantially along the length thereof so that after the needle of the infusion device is removed from the patient, the housing can be pivoted to a position in substantial alignment along the longitudinal axis of the base to envelop the contaminated needle.  
           [0007]    Locking mechanisms may be integrated to the housing for fixedly retaining the contaminated needle within the housing once the housing has been pivoted to the alignment position. Such locking mechanisms may include for example a hook or opposing fingers within the housing that act as a barrier for the removal of the housing from the needle. Locking mechanisms may also be used external of the housing for keeping the needle relatively fixed in relation to the housing. Such external locking mechanisms may include for example a side snap mechanism in which at least one locking means at the base would cooperate with a corresponding locking means external of the housing so that once the housing is pivoted to the alignment position, it is prevented from further movement from the alignment position.  
           [0008]    The base of the safety device of the instant invention may be configured in two ways. First, it may be configured to have two pairs of extending arms each of which would snappingly secure to a corresponding portion of the body of the infusion assembly. Another embodiment of the instant invention provides a base that has a tubular section slidable over an end portion of the body of the infusion assembly for securing the base thereto. A pair of arms extending from the base may also be added to the tubular section embodiment for snappingly embracing yet another portion of the body of the infusion assembly to thereby even more securely mate the base of the safety device to the body of the infusion assembly. To further ensure that the base be securely coupled to the body of the infusion assembly, a coating of conventional adhesive may be sprayed or added to the interior surface of the base of the safety device so that, once the base is mounted to the body of the infusion assembly, it becomes bonded thereto.  
           [0009]    It is therefore an objective of the present invention to provide a safety device that can easily be adapted to be used with a conventional intravenous infusion needle assembly.  
           [0010]    It is yet another objective of the present invention to provide a safety device that can particularly be used to prevent a needle from a winged intravenous infusion needle assembly, once contaminated, from being exposed to the environment.  
           [0011]    It is still another objective of the present invention to provide a one piece molded IV assembly with a built in safety device.  
       
    
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0012]    The above-mentioned objectives and advantages of the present invention will become apparent and the invention itself will be best understood by reference to the following description of embodiments of the present invention taken in conjunction with the accompanying drawings, wherein:  
         [0013]    [0013]FIG. 1 is a perspective view of a first embodiment of the safety device of the present invention;  
         [0014]    [0014]FIG. 2 is a perspective view of another embodiment of the safety device of the present invention;  
         [0015]    [0015]FIG. 3 is a side view of the safety device of the present invention;  
         [0016]    [0016]FIG. 4 a  is a bottom view of the safety device of the present invention;  
         [0017]    [0017]FIG. 4 b  is a cross-sectional view of the housing of the FIG. 4 a  embodiment of the instant invention;  
         [0018]    [0018]FIG. 5 a  is a bottom view of another embodiment of the safety device of the instant invention;  
         [0019]    [0019]FIG. 5 b  is a cross-sectional view of the housing of the FIG. 5 a  embodiment;  
         [0020]    [0020]FIG. 6 is a perspective view of another embodiment of the instant invention safety device showing an external locking mechanism comprising coacting locking means at the housing and the base of the device;  
         [0021]    [0021]FIG. 7 is a perspective illustration of the FIG. 6 device which housing has been pivoted to a position in alignment along the longitudinal axis of the base; and  
         [0022]    [0022]FIG. 8 shows an embodiment of the instant invention in which an IV infusion assembly has molded thereto the safety device as illustrated in the previous figures.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]    With reference to FIG. 1, a conventional winged intravenous infusion assembly  2  is shown to include a body  4  that has extending from one end thereof an intravenous needle  6 . At the other end of body  4 , which for the instant discussion is referred to as a hub  8 , there is attached a flexible tubing  10 . Extending in a direction perpendicular to the longitudinal axis of base  4  is a pair of wings  12   a  and  12   b . For the sake of clarity, wing  12   b  is not fully shown. Insofar as winged intravenous infusion assembly  2  is well known, no further discussion thereof is deemed to be necessary.  
         [0024]    The safety apparatus of the instant invention, which is to be added to winged intravenous infusion assembly  2 , is shown in FIG. 1 as safety device  14 . Safety device  14 , as shown being superposed over infusion assembly  2 , comprises a base  16  that is made up of a front portion  18  and an aft portion  20 . For the embodiment shown in FIG. 1, the forward portion  18  of base  16  is a tubular section with an opening  22  that can be slideably fitted over needle  6  onto front end portion  4   a  of infusion assembly  2 . Aft portion  20  of base  16  of safety device  14  of the FIG. 1 embodiment is comprised of a pair of arms  24   a  and  24   b  which, due to the characteristics of the plastic material used for molding safety device  14 , are somewhat elastic. Thus, once tubular portion  18  is slidably fitted over section  4   a  of body  4 , arms  24   a  and  24   b  will snappingly engage with hub  8  of body  4 . And due to their elastic characteristics, once arms  24   a  and  24   b  are forcibly snapped over hub  8 , they will intimately embrace hub  8  to thereby preclude their removal from hub  8 .  
         [0025]    The inner circumferential surface of body  6 , designated  26 , is configured to make intimate contact with the outer circumferential surface of body  4  so that, once fitted onto body  4 , the inside surface of base  16  will intimately contact a substantial portion of body  4  of infusion assembly  2 . To further ensure that base  16  would not separate from body  4  once the former is fitted onto the latter, a coating of conventional adhesive such as for example epoxy may be added to the interior surface of base  16  so that base  16  will bond to body  4  after it is appropriately fitted onto body  4 . Note that to provide adequate bonding, only a given portion of the interior surface of base  6  may need to be coated with the appropriate adhesive, as it may not be necessary that all of the internal surfaces of base  16  be coated with the adhesive.  
         [0026]    As further shown in the FIG. 1 embodiment, safety device  14  has hingedly connected to base  16  a housing  28 . Housing  28  may be connected to base  16  by means of a living hinge  31 . As shown, housing  28  has a groove  32  that extends along its length. Thus, once base  16  is fitted onto body  4  of infusion assembly  2 , to prevent needle  16  from being exposed to the environment, the care giver only needs to pivot housing  28  in the direction as shown by directional arrow  30  to thereby envelop needle  6 . Locking mechanisms, not shown in FIG. 1, would secure needle  6  within housing  28 .  
         [0027]    [0027]FIG. 2 shows a second embodiment of the safety device of the instant invention. The same components shown in FIG. 2, as well as shown in the remaining drawings, that are the same as those shown in FIG. 1 are labeled with the same numerals. For the FIG. 2 embodiment, forward portion  18  of base  16 , instead of being a tubular section, is seen to be made up of a pair of arms  32   a  and  32   b . Arms  32   a  and  32   b , similar to arms  24   a  and  24   b , have elastic characteristics that enable them to expand somewhat when they are being snappingly fitted over portion  4   a  of body  4  of infusion assembly  2 , and return to their original position after they have been firmly fitted onto portion  4   a  to thereby securely embrace portion  4   a.    
         [0028]    For the FIG. 2 embodiment, therefore instead of having to slidably fit forward portion  18  over needle  6  and then onto portion  4   a  of body  4 , a user only needs to snap safety device onto body  4  of infusion assembly  2  by snappingly fitting arms  32   a  and  32   b  over portion  4   a  and arms  24   a  and  24   b  over hub  8  of body  4 . As was the case with respect to the embodiment shown in FIG. 1, a portion, or all, of the interior surface of base  16  may be coated with an adhesive such as the exemplar epoxy, so that once fitted onto body  4 , base  16  will be bonded thereto.  
         [0029]    Also similar to the FIG. 1 embodiment, housing  28  is hingedly attached to forward portion  18  of base  16 . For the FIG. 2 embodiment, however, there is shown within housing  28  a pair of fingers, or extensions  34   a  and  34   b  that may be configured to allow needle  6  to pass therethrough when housing  28  is pivoted to envelop needle  6 , and yet would prevent housing  28  from being removed from needle  6  via a movement in reverse of the direction as indicated by directional arrow  30 .  
         [0030]    [0030]FIG. 3 shows a side view of safety device  14  as shown in FIG. 1. Housing  28  of safety device  14  is shown to include a hook  36  integrated within housing  28 .  
         [0031]    [0031]FIG. 4 a  is a bottom view of safety device  14  of the instant invention, as represented by the embodiment shown in FIG. 1. As illustrated, base  16  includes a tubular portion  18  and a pair of arms  24   a  and  24   b . Attached to base  16  is housing  28  having formed within groove  32  a hook  36  and a pair of fingers  34   a  and  34   b  for retaining a contaminated needle of a winged intravenous infusion assembly. Note that even though both hook  36  and fingers  34  are shown, in practice, only one of those locking mechanisms need to be utilized for the instant invention.  
         [0032]    [0032]FIG. 5 a  is a bottom view of the embodiment of the instant invention as shown in FIG. 2. In particular, base  16  is shown in FIG. 5 a  to include a pair of arms  32   a ,  32   b  and  24   a ,  24   b . So instead of having to slide base  16  over needle  6  and then onto front portion  4   a  of body  4  of the infusion assembly, a user only needs to snap base  16  onto body  4  of the infusion assembly. The pairs of arms  32   a ,  32   b  and  24   a ,  24   b  would secure base  16  to body  4  of the infusion device. Housing  28 , as shown in the FIG. 5 a  embodiment, does not have any locking mechanism integrated thereto. This is because, for the FIG. 5 a  embodiment, groove  32  is configured to have a cross-section that is somewhat smaller than the cross-section of needle  6 . Given the elastic characteristics of housing  28 , by configuring groove  32  to have a somewhat smaller cross-sectional dimension than that of needle  6 , once housing  28  is pivoted to envelop needle  6 , needle  6  will be held within groove  32 . This is better illustrated in the cross-section view of the housing  28  in FIG. 5 b  which shows groove  32  to have an exaggerated diameter at the center of housing  28  as compared to passage  38  through which needle  6  passes.  
         [0033]    [0033]FIGS. 6 and 7 are perspective views of yet another embodiment of the safety device of the instant invention. As shown in FIG. 6, safety device  14  has a first locking means, configured as a pair of hooks  40   a  and  40   b , formed externally of housing  28 . A corresponding pair of second locking means, represented by only one flange  42 , is formed at portion  18  of base  16 . Thus, once housing  28  is pivoted into the position in substantial alignment along the longitudinal axis of base  16 , hooks  40   a  and  40   b  will coact with flanges  42  to thereby fixedly retain housing  28  to base  16 , as shown in FIG. 7.  
         [0034]    [0034]FIG. 8 shows another embodiment of the instant invention in which housing  28  is integrated to body  4  via living hinge  31 . This can be accomplished by casting housing  28  and intravenous infusion assembly  2  from the same mold. Although not shown for the sake of simplicity in FIG. 8, the locking mechanisms with respect to housing  28  and its base as shown in FIGS.  2 - 7  are equally applicable for the embodiment shown in FIG. 8. The one difference is that the coacting locking portion shown in those figures as integrated to portion  18  of the safety device is now integrated to front end portion  4   a  of body  4 .  
         [0035]    It should be appreciated that the present invention is subject to many variations, modifications, and changes in detail. For example, in place of the hooks and flanges shown in FIGS. 6 and 7, coacting tabs/openings may be formed at the base and housing of the safety device for providing cooperative means to fixedly retain the base to the housing. Moreover, instead of using hooks and coacting fingers integrated to the housing for retaining the needle once the housing is pivoted to envelop the needle, other types of locking mechanisms may also be used. These include for example the use of a single finger, the use of flaps within the housing or one way valves that would allow the needle to pass into the groove of the housing but yet prevent the housing from further movement relative to the needle once the needle is enveloped by the housing. Thus, it is the intention of the inventor that all matter described throughout this specification and shown in the accompanying drawings be interpreted as illustrative only and not in a limiting sense. Accordingly, it is intended that this invention be limited only by the spirit and scope of the hereto appended claims.