Abstract:
A needle safety guard for use with a Huber needle assembly having a body portion and a needle including an elongated body having an elongated interior cavity, the interior cavity being defined by opposed front and rear interior surfaces of the elongated body, the elongated body having a slot opening into the interior cavity and extending substantially between end portions of the elongated body; wherein the slot of the elongated body is sized and shaped to closely and slidingly engage the Huber needle body portion and the cavity is sufficiently long to fully receive the needle therein upon sliding action of the body portion along the elongated body slot from one end portion toward another; and a stop mechanism which engages the body portion to retain the needle within the cavity.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]    This application claims the benefit of priority to U.S. provisional patent application serial No. 60/290,331 filed on May 11, 2001. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    This invention relates to a needle safety guard, particularly to an needle safety guard applicable to and intended for use in conjunction with a Huber needle with a 90° bend.  
         BACKGROUND  
         [0003]    Huber needles are widely used in the medical field, typically in oncology applications in conjunction with vascular access devices, particularly those located subcutaneously.  
           [0004]    As with other applications of needles utilized in conjunction with vascular applications, it is specially important to cover or shield used needles from the patient, other patients or healthcare providers. In that regard, it is important to provide protective measures that are not only effective, but easy to use and relatively low in cost.  
         SUMMARY OF THE INVENTION  
         [0005]    A primary aspect of the invention is a needle safety guard adapted to work in conjunction with a Huber needle, the safety guard comprising a slide which covers the needle as it is extracted from the patient. The slide may be part of a clamp, a Luer connector, “y” injection site or added as an additional component clipped onto tubing, allows the needle hub to enter and slide up a track and lock into place, the lock component preventing the needle from sliding out of the track once engaged to assist in forcing the needle to stay captured in the track and not “stick” the patient or a healthcare provider.  
           [0006]    In another aspect the invention encompasses a needle safety guard for use with a Huber needle assembly having a body portion and a needle including an elongated body having an elongated interior cavity, the interior cavity being defined by opposed front and rear interior surfaces of the elongated body, the elongated body having a slot opening into the interior cavity and extending substantially between end portions of the elongated body. The slot of the elongated body is sized and shaped to closely and slidingly engage the Huber needle body portion and the cavity is sufficiently long to fully receive the needle therein upon sliding action of the body portion along the elongated body slot from one end portion toward another. A stop mechanism engages the body portion to retain the needle within the cavity. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0007]    [0007]FIG. 1 is a schematic perspective view of a Huber needle prior to insertion into a portion of a patient.  
         [0008]    [0008]FIG. 2 is a schematic perspective view of the Huber needle of FIG. 1 in place in a patient and a needle safety guard in accordance with aspects of the invention prior to its application to the Huber needle.  
         [0009]    [0009]FIG. 3 is a schematic perspective view of the Huber needle located within a patient substantially as shown in FIG. 2, with the needle safety device engaging the Huber needle prior to removal from the patient.  
         [0010]    [0010]FIG. 4 is a schematic perspective view of the Huber needle assembly fully engaging the needle safety device after having been removed from the patient.  
         [0011]    [0011]FIG. 5 is a top plan view of a needle safety guard fully housing a Huber needle assembly in accordance with aspects of the invention.  
         [0012]    [0012]FIG. 6 is a rear perspective view of the needle safety guard shown in FIG. 4.  
         [0013]    [0013]FIG. 7 is a front perspective view of the needle safety guard shown in FIG. 4.  
         [0014]    [0014]FIG. 8 is a side elevational view of the needle safety guard shown in FIG. 4.  
         [0015]    [0015]FIG. 9 is a rear elevational view of the needle safety guard shown in FIG. 4.  
         [0016]    [0016]FIG. 10 is a cross-sectional view taken along the lines A-A of FIG. 8.  
         [0017]    [0017]FIG. 11 is a side elevational view of a Huber needle assembly engaged with a needle safety guard in accordance with the invention, the Huber needle assembly being at a position half way retracted into the needle safety guard.  
         [0018]    [0018]FIG. 12 is a rear elevational view of the Huber needle assembly and needle safety guard shown in FIG. 11.  
         [0019]    [0019]FIG. 13 is a cross section taken along the lines B-B of FIG. 11.  
         [0020]    [0020]FIG. 14 is a schematic perspective view of a Huber needle in place in a patient.  
         [0021]    [0021]FIG. 15 is a schematic perspective view of the Huber needle of FIG. 14 with another embodiment of a needle safety guard positioned above the Huber needle prior to removal of the Huber needle from the patient.  
         [0022]    [0022]FIG. 16 is a schematic perspective view of the needle safety guard of FIG. 15 engaging the Huber needle prior to removal from the patient.  
         [0023]    [0023]FIG. 17 is a schematic perspective view of the Huber needle and safety guard of FIG. 15 with the Huber needle substantially removed from the patient.  
         [0024]    [0024]FIG. 18 is a schematic perspective view of the Huber needle and safety guard of FIG. 17 with the Huber needle removed completely removed from the patient and in a locked position in the safety guard.  
         [0025]    [0025]FIG. 19 is a side elevational view of the Huber needle and safety guard of FIG. 17.  
         [0026]    [0026]FIG. 20 is a front elevational view of the Huber needle and safety guard of FIG. 17.  
         [0027]    [0027]FIG. 21 is a top plan view of the Huber safety needle and safety guard of FIG. 17.  
         [0028]    [0028]FIG. 22 is a sectional view taken along the lines A-A of FIG. 19.  
         [0029]    [0029]FIG. 23 is a side elevational view of the Huber needle and safety guard of FIG. 18.  
         [0030]    [0030]FIG. 24 is a front elevational view of the Huber needle and safety guard of FIG. 23.  
         [0031]    [0031]FIG. 25 is a sectional view taken along the lines B-B of FIG. 23. 
     
    
     DETAILED DESCRIPTION  
       [0032]    While the invention will be described in connection with one or more preferred embodiments, it will be understood that the description is not intended to limit the invention to the described embodiments. On the contrary, the description is intended to cover all alternatives, modifications and equivalents as may be included within the spirit and scope of the invention as defined by the appended claims.  
         [0033]    Turning now to the drawings in general and FIG. 1 in particular, there is shown a Huber needle assembly  10  which includes a main body  12 , a pair of butterfly wings  14 , and a needle  16 . The Huber needle assembly  10  is in a position to be inserted into an appropriate location on patient skin surface  18 . Typically, but not always, the needle  16  is inserted into a subcutaneously located port  20 .  
         [0034]    In FIG. 2, Huber needle assembly  10  has been inserted into port  20  (not shown in FIG. 2) and the butterfly wings  14  are essentially parallel to and in contact with the patients skin surface  18 . FIG. 2 also shows a needle safety device  22  which includes a main body  24  and a substantially perpendicularly orientated foot  26  attached to one end portion  28  thereof. The foot  26  has a slot  30  sized and shaped to receive needle  16 . Main body  24  also has a slot  32  which is sized and shaped to receive a neck portion  34 . Body end portion  36  of body  12  is sized and shaped to slide within an interior cavity of main body  24  a clamp  38  is affixed to the rear side of main body  24 .  
         [0035]    In FIG. 2, needle safety device  22  is positioned above and slightly away from Huber needle assembly  10  and patient skin surface  18 . Upon completion of the task to be performed by Huber needle assembly  10  and just prior to complete removal of needle  16  from port  20 , Huber needle assembly  10  is separated slightly from surface  18  in an amount sufficient to permit foot  26  to slide between butterfly wings  14  and surface  18 . This is shown in FIG. 3. In so doing, it is necessary to align needle  16  with slot  30 . Needle slot  30  extends from a front opening  27  on the left side to a rear opening  28  of slot  30  on the right side (as shown in FIG. 2). As needle safety device  22  is moved in the direction shown by arrow A in FIG. 2, as applied to FIG. 3, needle  16  moves through the slot  30  and end portion  36  of body  12  enters through an opening  40  in slot  32  that is sized and shaped to permit passage of end portion  36  into the interior cavity of main body  24 .  
         [0036]    Then, Huber needle assembly  10  is moved away from surface  18  in the direction of arrow B, while retaining needle safety device  22  in position at surface  18 . Neck portion  34  of body  12  is sized such that the neck portion can move from the lower portion  28  of slot  32  to an upper portion  42  of slot  32  as shown in FIGS. 4 and 5. Sliding movement along the direction of arrow B in FIG. 3 causes needle  16  to progressively move into the interior cavity of body  24  such that the distal end of needle  16  is never exposed to the patient or the healthcare provider. Subsequent to removal of Huber needle  20  from surface  18 , needle  16  is fully contained within housing  24 .  
         [0037]    A ramp may also be provided at an angle to an inner surface of housing  24  which acts to bias the needle against the back surface of housing  24  such that the needle remains captured in the interior portion of body  24  and is not free in any way to come in contact with the patient or the healthcare provider.  
         [0038]    FIGS.  5 - 10  show provide various views of a Huber needle assembly fully engaged with and positioned such that needle  16  of assembly  10  is fully retracted and contained within the interior cavity of main body  24 .  
         [0039]    Referring specifically to FIGS. 9 and 10, a lock mechanism comprising a pair of angled ribs  40  extend from the main body  24  sides into the interior cavity. The angled ribs  40  engage angled surfaces  42  of body end portion  36  during sliding action of assembly  10  relative to needle safety guard  22 . Once the bottom surface  44  of end portion  36  passes ribs  40 , assembly  10  is locked into position within needle safety guard  22  and needle  16  is locked within the interior cavity of main body  24 .  
         [0040]    FIGS.  11 - 13  show assembly  10  at a midpoint in its sliding action with respect to needle safety guard  22 . At that point, angled ribs  40  have yet to contact angled sides  42  and assembly  10  is not yet locked into its final position.  
         [0041]    The needle assembly and needle safety guard can be used according to the following basic guidelines:  
         [0042]    1. Remove the needle assembly from the sealed blister tray, separating the PE tubing guard from the needle. Position the exposed needle perpendicular to the port surface. The guard is appended to the design of the thumb clamp device and does not initially restrict the access of the needle to the port.  
         [0043]    2. Fully insert the needle into the port. Administer treatment as necessary.  
         [0044]    3. Slide the flat end (foot) of the guard device underneath the butterfly wings and position the needle hub in the middle. Position the mating knob extending off the needle hub into the slide of the thump clamp appendage.  
         [0045]    4. Squeeze the butterfly wings and pull out the needle from the port while stabilizing the patient surface by pressing the thumb clamp appendage down. The slide within the thumb clamp appendage guides the needle assembly.  
         [0046]    5. The needle has been pulled completely out of the port and all the way up the slide. At the end of the slide the mating knob now becomes restricted by an internal step, making it extremely difficult to remove.  
         [0047]    FIGS.  14 - 25  show another embodiment of the invention as reflected primarily in needle safety guard  100  which includes a main body  102  having a longitudinally shaped slot  104  extending from the base portion of the safety guard upwardly toward the upper portion of the safety guard. A substantially perpendicularly oriented foot  106  extends outwardly from a base portion of the safety guard in the direction opposite of the side in which the slot  104  is located. The bottom portion of the main body  102  is open, while the upper portion of main body  102  is preferably substantially closed.  
         [0048]    Referring specifically to FIGS.  19 - 25 , a needle assembly lock  108  is located interiorly of main body  102  and extends from the ceiling  110  of main body  102  downwardly into the inner chamber  112  of main body  102 . Lock  108  has a pair of legs  114  connected to ceiling  110  and which at a lower portion of the legs connect to a lock cross member  116 . The legs  114 , cross member  116  and ceiling  110  form the boundaries of a lock slot  118 . The uppermost surface  120  of cross member  116  is oriented at an angle relative to the upper surface of cross member  116 .  
         [0049]    Huber needle assembly  122  is substantially the same as Huber needle assembly  10  referred to with respect to FIGS.  1 - 13  inasmuch as the main body neck portion  34  and body end portion  36  are still present as best shown in FIG. 15. However, there is an angled locking wedge  124  extending from body end portion  36  which is particularly shown in FIG. 19. The remaining portions including the main body  12 , butterfly wings  14  and needle  16  are, as mentioned above, substantially similar to those described with respect to the embodiment shown in FIG. 13.  
         [0050]    The size and shape of locking wedge  124  and needle assembly lock  108  are sized, shaped and positioned with respect to one another such that a locking surface  126  of locking wedge  124  engages upper surface  120  of cross member  116  when needle assembly  122  is fully retracted into needle guard  100  and in a “locked” and safe position. This action is described in more detail below with respect to operation of the device.  
         [0051]    Referring specifically to the process of removing Huber needle assembly  122  from a patient, reference is made to FIGS.  14 - 18  in particular. FIG. 14 shows Huber needle assembly  122  in its use position in a patient. Prior to removal of Huber needle assembly  122 , safety guard  100  is placed in a position above Huber needle assembly  122  as shown in FIG. 15 and moved toward Huber needle assembly  122  in the direction shown by arrow A. As shown in FIG. 16, the foot  106  is placed against the surface  124  of the patient and the body  12  of Huber needle assembly  122  is positioned in the opening in the base of main body  102  such that body end portion  36  of main body  12  is positioned in the opening and neck portion  34  is located within slot  104  such that main body portion  36  is located interiorly of main body  102  and main body  12  of Huber needle assembly  122  is located exteriorly of main body  102 . Also, butterfly wings  14  are folded upwardly and away from the patient surface  124 .  
         [0052]    Referring to FIG. 17, Huber needle assembly  122  is moved away from the patient surface  124  along slot  104  in the direction of arrow B, while maintaining foot  106  in contact with the patient. As shown in FIG. 18, when Huber needle assembly  122  is moved to an upper portion of slot  104 , the Huber needle assembly  122  is then in a “locked” position within main body  102  and safety guard  100  can be removed from the patient surface  124 .  
         [0053]    Referring now to FIGS.  19 - 25 , interior portions of the removal process are shown. FIGS.  19 - 22  correspond to the part of the removal process shown in FIG. 17 wherein Huber needle assembly  122  has been moved partially upwardly through slot  104  with locking wedge  124  still away from lock  108  and outside of lock slot  118 .  
         [0054]    FIGS.  23 - 25  correspond to the position of the safety guard  100  and Huber needle assembly  122  as shown in FIG. 18. As particularly shown in FIG. 25, locking wedge  124  has fully engaged lock  108  and is positioned within lock slot  118  such that locking surface  126  of locking wedge  124  has engaged upper surface  120  of lock  108 , thereby locking Huber needle assembly  122  safely within safety guard  100 . This is achieved bypositioning of lock  108  sufficiently toward the wall  126  of main body  102  such that the surface  128  of locking wedge  124  engages the lower surface  117  of cross member  116  and, as locking wedge  124  is moved upwardly toward ceiling  110 , deflects the lower portion of lock  108  towards sidewall  130  of main body  102  and, upon locking surface  126  clearing upper surface  120  of crossbar  116  by virtue of upper movement, “snaps” back into its original at-rest position, thereby locking Huber needle assembly  122  in its final position. Also by virtue of the angular orientation of upper surface  120 , this causes a rotational movement of Huber needle assembly  122  in the direction shown by the arrow C of FIG. 25. The angular positioning of upper surface  120  of crossbar  116  is substantially calculated such that the lowermost tip portion  132  of needle  16  will forcibly engage the sidewall of main body  102  as shown in FIGS. 24 and 25. This provides a further level of safety against an accidental “stick” and further provides a means to prevent Huber needle assembly  122  from being accidentally removed from guard  100 .  
         [0055]    This invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof and, accordingly, reference should be made to the appended claims, in addition to the foregoing specification, as indicating the scope of the invention.