Abstract:
The present invention relates to a needle-stick protector for an intravenous catheter having a body, a needle hub, a needle, and means for ensuring that the needle-stick protector is not removed from a catheter hub before the needle is fully retracted and locked in the body of the needle-stick protector.

Description:
FIELD OF THE INVENTION  
       [0001]     This invention pertains to a needle-stick protector for an intravenous catheter. More specifically, the invention is directed to a needle-stick protector having a body, a needle hub, a needle, and means for ensuring that the needle is retracted and locked in the body before the needle-stick protector is disengaged from the catheter.  
       BACKGROUND OF THE INVENTION  
       [0002]     Intravenous catheters are medical devices for administering intravenous fluids, medications, and blood products. An intravenous catheter generally consists of a hollow-bore needle and a close-fitting, over the needle plastic catheter tubing used to access the lumen of a blood vessel in a patient. After the needle and catheter are inserted into the blood vessel, the needle is retracted from the patient and discarded, leaving only the catheter in the blood vessel. The distal end of the catheter contains a catheter hub through which fluids, medications, and blood may be injected or through which blood samples may be taken from the patient. When the needle is removed from the catheter, the pointed end of the needle can be accidentally poked into the person handling the needle or someone in the vicinity of the needle. Any residual blood on the needle can be inserted in the person poked by the needle thereby transmitting microorganisms, e.g., bacteria and viruses, usually referred to collectively as blood-borne pathogens.  
         [0003]     In order to prevent accidental pokes, needle-stick protectors have been designed to capture the needle as it is being withdrawn from the catheter. One such needle-stick protector is illustrated in U.S. Pat. No. 6,080,137, incorporated herein by reference. However, present needle-stick protectors rely on the user operating the device correctly. If a needle is not properly locked in the needle-stick protector, the needle may exit the protector and accidentally poke the user. Therefore, a need exists for a needle-stick protector having a means that ensures that the pointed, contaminated end of the needle can never be exposed to the user during the extraction and disposal of the needle.  
       SUMMARY OF THE INVENTION  
       [0004]     The present invention relates to a needle-stick protector for an intravenous catheter wherein the needle-stick protector is attached to a catheter hub by a luer lock engagement. The needle-stick protector of the present invention includes a body, a needle hub, a needle, and means for ensuring that the needle-stick protector is not removed from a catheter hub before the needle is fully retracted and locked in the body of the needle-stick protector. The body has a first end and a second end and includes a plurality of side walls extending between the first and second ends in a geometric configuration. The side walls define an interior space and at least two slots. The needle hub having a front end, a back end, a first side, and a second side is positioned in the interior space of the body. The front end of the needle hub is adapted to receive a needle. The first and second sides of the needle hub each includes a handle. The handles extend through the slots of the body to positions outside of the body. Movement of the handles of the needle hub causes corresponding movement of the needle. Therefore, when the handles are moved from the first end of the body to the second end of the body along the slots of the body, the needle moves from the exterior of the body into the interior space defined by the body. Accordingly, the needle is fully contained in the body before the needle-stick protector is removed from the catheter hub, thereby preventing accidental needle sticks. The needle-stick protector of the present invention further includes means for preventing movement of the luer lock engagement that connects the needle-stick protector to the catheter hub until the needle is securely locked in the body of the needle-stick protector. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0005]      FIG. 1A  shows a safety feature component of the present invention.  
         [0006]      FIG. 1B  is a perspective view of a needle-stick protector according to an embodiment of the present invention attached to a catheter hub.  
         [0007]      FIG. 1C  is a perspective view of a needle-stick protector according to another embodiment of the present invention attached to a catheter hub.  
         [0008]      FIG. 2  is a perspective view of a needle-stick protector according to the present invention illustrating a needle fully retracted in the body of the needle-stick protector.  
         [0009]      FIG. 3  is a perspective view of a needle-stick protector according to the present invention showing the needle-stick protector disengaged from a catheter hub.  
         [0010]      FIG. 4  is a top view of the body of the present needle-stick protector according to an embodiment of the present invention.  
         [0011]      FIG. 5  is a cross-sectional view taken along line  5 - 5  of  FIG. 4 .  
         [0012]      FIG. 6  is an elevational view of the second end of the body of the present needle-stick protector.  
         [0013]      FIG. 7  is an elevational view of the first end of the body of the present needle-stick protector.  
         [0014]      FIG. 8  is a cross-sectional view taken along  7 - 7  of  FIG. 4 .  
         [0015]      FIG. 9  is a perspective view of the end cap according to the present invention.  
         [0016]      FIG. 10  is a perspective view of the needle hub and needle according to the present invention.  
         [0017]      FIG. 11  is a top view of the needle hub according to the present invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0018]     The needle-stick protector of the present invention includes a safety feature that provides “passive protection” to the user. “Passive protection” means that the user cannot misuse the safety feature, i.e., the user cannot forget to make sure the needle is locked into the needle-stick protector after withdrawing the needle from the catheter. The safety feature of the present invention is “passive” because the user does not have to deviate from the standard procedure in order to achieve needle-stick safety. The safety feature of the present invention includes any means that prevents movement of the luer lock engagement of a needle-stick protector and a catheter hub until the needle is fully retracted and locked in the body of the needle-stick protector.  
         [0019]     Needle-stick protectors of the present invention are attached to a catheter hub using a luer lock engagement. The luer lock engagement comprises threads on the outside wall of the catheter hub engaged by threads located inside the opening of the needle-stick protector that attaches to the catheter hub. Needle-stick protectors not having the safety feature of the present invention are disengaged from the catheter hub by simply rotating the luer lock engagement counter-clockwise until the needle-stick protector is released from the catheter hub. The safety feature of the present invention prevents the disengagement of a needle-stick protector from a catheter hub until the needle is safety locked back into the body of the needle-stick protector by preventing the luer lock engagement from rotating until the needle is securely locked in the body of the needle-stick protector. By providing a means for connecting the locking mechanism for the needle in the body of a needle-stick protector with the luer lock engagement, the needle-stick protector cannot be released from the catheter hub until the needle is locked into the locking mechanism.  
         [0020]     The safety feature of the present invention includes a wire that extends along the length of the interior space of the body of a needle-stick protector. The wire has a first end and a second end, with the first end acting as a locking pin that engages a hole on both sides of the luer lock engagement. In one embodiment of the present invention, the first end of the wire just penetrates the leur lock engagement. In another embodiment of the present invention, the first end of the wire engages the entire luer lock engagement and just penetrates the catheter hub, but does not enter the internal chamber of the cathether hub. The second end of the wire forms an L-shaped pin and is located near the locking mechanism for the needle hub at the second end of the needle-stick protector. The wire may be made of any suitable material, preferably metal or plastic. As the needle hub is locked into the needle-stick protector, the wire is activated by the L-shaped pin near the locking mechanism and the wire disengages the locking pin from the luer lock engagement. When the locking pin is released from the luer lock engagement, the needle-stick protector can now be disengaged from the catheter hub by simply rotating the luer lock engagement counter-clockwise while separating the needle-protector from the catheter hub.  
         [0021]     The preferred embodiments and best mode of the present invention will now be described in detail with reference being made to the drawings. The needle-stick protector of the present invention is indicated generally in the drawings by the reference number “ 10 .” 
         [0022]     Referring to  FIGS. 1-5 , the needle-stick protector  10  includes a body  12  having a first end  14  and a second end  16 . As shown in  FIGS. 1, 2 ,  3  and  5 , the first end  14  is adapted to receive a catheter hub  18 . The first end  14  includes a plurality of threads  20 , as shown in  FIGS. 5 and 7 , for receiving mating threads (not shown) positioned on the connection end  22  of the catheter hub  18 . The mating of the threads  20  on the first end  14  of the body  12  with the threads (not shown) on the connection end  22  of the catheter hub  18  form a leur lock engagement  180  between the body  12  and the catheter hub  18 . It should be understood that the first end  14  of the needle-stick protector  10  can be adapted to receive a variety of devices depending on the application. For the purpose of explanation, the catheter hub  18  shown in the present drawings will be used in conjunction with the needle-stick protector  10 .  
         [0023]     As shown in  FIGS. 1B, 1C ,  2  and  3 , the second end  16  of the body  12  can be adapted to receive an end cap  24  shown in  FIG. 9 , having an exterior surface  28  and an interior surface  30 . A first leg  32  and a second leg  34  extend outwardly from the interior surface  30  of a head  26 . Each of the first and second legs  32  and  34  includes a locking recess  36  having a locking surface  38 . The first and second legs  32  and  34  are inserted in the second end  16  of the body  12  to attach the cap  24  to the body.  
         [0024]     Referring to  FIG. 3 , the body  12  includes a plurality of side walls extending between the first end  14  and the second end  16  in a geometric configuration. It should be understood that the number of side walls of the body  12  can be changed to form various geometric configurations, such as square, circular, rectangular, polygonal, with a hexagonal configuration being preferred. As shown in  FIGS. 1-5 , a plurality of spaced upwardly extending projections  52  are positioned on a first side wall  40 . A first projection or tab  145  on the first wall  40  is engaged by a finger of a user to accurately position the body  12  with respect to a blood vessel. The projections  52  may be engaged by the thumb to more accurately and easily handle the needle protector  10 .  
         [0025]     Referring to  FIG. 4 , the side walls of the body  12  define at least two slots. The first and second slots  54  and  56 , respectively extend longitudinally between the first end  14  and the second end  16  of the body  12  in an opposed relationship to one another. As shown in  FIGS. 3 and 4 , the first and second slots  54  and  56  define first and second locking portions  58  and  60 , respectively, adjacent the second end  16  of the body  12  in opposed relationship to one another. The first and second locking portions  58  and  60  are positioned adjacent to the locking recesses  36  of the first and second legs  32  and  34  of the end cap  24  depicted in  FIG. 9 .  
         [0026]     Referring to  FIGS. 10 and 11  the needle-stick protector  10  includes a needle hub  66  having a front end  68 , a back end  70 , a first side  72  and a second side  74 . The needle hub  66  is movably positioned in an interior space  62  of the body  12 . The front end  68  of the needle hub  66  is adapted to receive a needle  76 . The front end  68  includes a front end opening  80  for receiving the needle  76 . The first side  72  and the second side  74  of the needle hub  66  are adapted to receive first and second handles  86  and  88 , respectively. The first and second handles  86  and  88  include first and second wings  90  and  92 , respectively. The first and second wings  90  and  92  extend from the needle hub  66  through the first and second slots  54  and  56 , respectively, to the exterior of the body  12 .  
         [0027]     Still referring to  FIGS. 10 and 11 , the first and second handles  86  and  88  include first and second handle members  94  and  96 , respectively, attached to the first and second wings  90  and  92 , respectively. Each of the first and second handle members  94  and  96  includes an interior surface  98  and an exterior surface  100 . As shown in  FIG. 10 , each exterior surface  100  includes a plurality of spaced grips  102  as shown in  FIG. 2 . The grips  102  allow the first and second handles  86  and  88  to be firmly gripped during actuation of the needle hub  66 . The first and second handle members  94  and  96  each includes a locking projection  104  extending inwardly from the interior surface  98 . The locking projections  104  are received by the locking recesses  36  of the first and second legs  32  and  34  of the end cap  24 .  
         [0028]     Referring to  FIGS. 6, 7 , and  8 , the side walls  40 - 50  define the interior space  62  extending between the first and second ends  14  and  16  of the body  12 . As shown in  FIG. 7 , an opening  64  for the needle  76  and an opening  70  for a wire  120  are defined by the body  12  at the first end  14 . The opening  70  for a wire  120  is shown in  FIG. 7  as circular, but the opening  70  may be of any geometric configuration, such as square, rectangular, or polygonal. The opening may also be a V-shaped opening. The threads  20  on the interior walls of the first end  14  of the body  12  mate with threads (not shown) on the connection end  22  of the catheter hub  18  to form a leur lock engagement  180  between the needle-stick protector  10  and the catheter hub  18 .  
         [0029]     As shown in  FIG. 1A , the safety feature component of the present invention includes a wire  120  having a first end  150  and a second end  160 . The second end  160  of the wire  120  forms an L-shaped pin  130  and the first end  150  of the wire  120  forms a locking pin  200 .  FIGS. 1B and 1C  illustrate embodiments of the safety feature component of the present invention in a needle-stick protector.  
         [0030]     Referring to  FIGS. 1B, 5 , and  7 , the wire  120  extends along the interior space  62  of the body  12  of the needle-stick protector  10 . The interior space  62  of the body  12  contains a bracket  190  for holding the wire  120  parallel to the sidewall  40  of the body  12 . The wire  120  is restrained in this way so to disallow intentional or inadvertent disengagement of the wire  120  until the needle hub  66  is locked back in position  82 . The L-shaped pin  130  at the second end  16  of the body  12  is positioned adjacent to first and second locking positions  58  and  60 , respectively. When the needle  76  is located in the catheter, the L-shaped pin  130  is in a first position  80 . When the needle  76  is fully retracted and locked in the body of the needle-stick protector, the L-shaped pin  130  is in a second position  82 . According to an embodiment of the present invention, illustrated in  FIGS. 1B and 7 , the first end  150  of the wire  120  exits through an opening  70  in the first end  14  of the body  12  and slightly penetrates the leur lock engagement  180 , terminating at about 0.025 to about 0.100 inch, preferably about 0.050 inch into the leur lock engagement  180 . At this position, the first end  150  of the wire  120  forms a locking pin  200  which prevents any movement in the leur lock engagement  180 .  
         [0031]     According to a further embodiment of the present invention, illustrated in  FIGS. 1C and 7 , the first end  150  of the wire  140  exits through an opening  70  in the first end  14  of the body  12  and extends through the leur lock engagement  180 , terminating at about 0.010 to about 0.050 inch, preferably about 0.025 inch into the catheter hub  18 , but not penetrating the interior chamber of the catheter hub (not shown). As in  FIG. 1   b , in this position, the first end  150  of the wire  120  also forms a locking pin  200  which prevents any movement in the leur lock engagement  180 .  
         [0032]     Referring to  FIGS. 1B, 1C , and  2 , the operation and intended use of the needle protector  10  will now be described. As shown in  FIGS. 1B and 1C , the catheter hub  18  includes a catheter  110 . The needle hub  66  is positioned adjacent the first end  14  of the body  12 . When the needle hub  66  is so positioned, the needle  76 , which includes a pointed end  112 , extends through the catheter hub  18  and the catheter  110 . When the catheter  110  is to be inserted into the blood vessel of a patient (not shown), the needle protector  10  is moved to the side of the blood vessel. The user of the needle protector  10  grips the body  12  and places his or her middle finger on the first wall  40  and thumb on the second handle  88 . The index finger engages the first projection or tab  145  so that the body  12  can be accurately positioned with respect to the blood vessel. When the pointed end  112  of the needle  76  is properly positioned, the user of the needle protector  10  pushes the pointed end of the needle  112  into the blood vessel. Insertion of the needle  76  into the blood vessel results in the insertion of the catheter  110  into the blood vessel.  
         [0033]     After the catheter  110  has been inserted into a blood vessel, the user of the needle protector  10  uses his or her thumb and middle finger to engage the first and second handles  86  and  88  of the needle hub  66 . The grips  102  prevent slippage by the user. The user pulls back on the first and second handles  86  and  88  thereby causing the needle hub  66  to move from proximal the first end  14  to proximal the second end  16  of the body  12 . The first and second handles  86  and  88  move along the first and second slots  54  and  56 , respectively, to guide the needle hub  66  along its predetermined path. Movement of the needle hub  66  causes corresponding movement of the needle  76 , thereby withdrawing it from the patient&#39;s blood vessel. As the needle hub  66  moves toward the second end  16  the needle  76  passes through the needle opening  64  into the interior space  62  of the body  12  as shown in  FIG. 7 .  
         [0034]     As the needle hub  66  moves along the interior space  62  of the body  12 , it encounters the L-shaped pin  130  at the second end  16  of the body  12 . The engagement of the needle hub  66  with the L-shaped pin  130  causes the L-shaped pin  130  to move from a first position  80  to a second position  82  as the needle hub  66  moves into the locking positions  58  and  60 . Movement of the L-shaped pin  130  from the first position  80  to a second position  82  causes the wire  120  to move towards the second end  16  of the body and causes the first end  150  of the wire  120  to disengage from the luer lock engagement  180 . Disengagement of the locking pin  200  from the luer lock engagement  180  unlocks the luer lock engagement  180 , allowing the user to freely move the luer lock engagement  180  and disengage the needle-stick protector  10  from the catheter hub  18  but only after the needle  76  is securely locked into the body  12  of the needle-stick protector  10 . The catheter hub  18  can then be used as intended.  
         [0035]     The above detailed description of the present invention is given for explanatory purposes. It will be apparent to those skilled in the art that numerous changes and modifications can be made without departing from the scope of the invention. Accordingly, the whole of the foregoing description is to be construed in an illustrative and not a limitative sense, the scope of the invention being defined solely by the appended claims.