Abstract:
The present invention is a needle holder assembly for using during a blood collection procedure and more particularly to a blood collection tube holder with means for easily engaging and disengaging a blood collection needle from the holder and for not prematurely disengaging a blood collection needle. The needle holder includes an engaging trigger to engage the holder with a needle and a disengaging trigger to disengage the holder with a needle and a preventative needle release indicator that prevents premature movement of the disengaging trigger and disengagement of the needle from the holder.

Description:
This application claims the benefit of U.S. Provisional Application No.: 60/077,996 Mar. 13, 1998. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to needle holder assemblies for use during a blood collection procedure and more particularly to a blood collection tube holder with means for easily engaging and disengaging a blood collecting needle from the holder. 
     2. Description of Related Art 
     Conventional blood collection systems typically employ some form of a reusable holder on which detachable and disposable needles and fluid collection tubes may be mounted. A blood collection system of this nature can be assembled prior to use and then disassembled after use. Thus, these blood collection systems allow repeated use of the holder upon replacement of the disposable needle and/or fluid collection tube. 
     Conventional blood collection procedures involve venipuncture to draw blood into a blood collection tube using a doubled ended needle assembly and a holder for maintaining the needle assembly and the collection tube in a fixed relation. The conventional double ended needle assembly includes a hub having an intravenous needle extending in one direction and a non-patient needle extending in the other direction. The hub is threadedly engaged with the holder wherein the non-patient needle is located within the housing of the holder and the intravenous end of the needle extends forwardly from the holder for puncturing the vein of a patient. The housing of the holder is open to receive an evacuated blood collection tube having a stopper to penetrably receive the non-patient needle. To draw a blood sample from a patient using this assembly, the blood collection tube is fully inserted into the housing of the holder such that blood will be drawn through the needle and into the collection tube. 
     On completion of the procedure, the intravenous needle is withdrawn from the patient and the needle assembly is detached from the holder. The manner of the disposal of the needle assembly varies, depending upon the phlibotomist, the procedures to be followed and other considerations. 
     Many incurable or fatal diseases are transmissible through contact with the blood of an infected person. A needle used during a blood collection procedure obviously contains a quantity of blood. In the event of needle stick, infection from infected blood is possible. Considering that inadvertent needle stick occurs frequently, the degree of exposure of medical personnel to incurable or fatal diseases is possible. 
     Particularly in recent years, various devices have been developed to assist with safely engaging and disengaging the needle from a needle holder to minimize instances of needle stick and exposure to blood. 
     However, these holders are concerned with custom designed blood collecting needles that have a depression or raised part on the hub, unlike a conventional blood collecting needle. Therefore these holders are not compatible with conventional blood collecting needles. In addition the needle is not fixed in the holder by screw-meshing as a conventional blood collecting needle is, so they have the drawback that the fixing of the blood collecting needle in the holder becomes loose. 
     Other holders have been developed that have a needle fixed in the holder with a one touch type for engaging and disengaging the needle. However, these devices have the drawback whereby needles may be prematurely released from the holder while the needle is in the patient. 
     Therefore, there exists a need to provide a blood collecting needle holder: (i) that is compatible with conventional blood collecting needles; (ii) whereby the user can disengage the blood collecting needle from the holder without touching the needle; (iii) whereby the blood collecting needle maybe securely engaged with the needle holder without the possibility of premature release from the holder; (iv) that has tactile features whereby the user may be deterred from touching the needle, assist the user in orienting the needle with the patient and triggering the appropriate disengaging mechanisms; (v) that has visual features whereby the user may be deterred from touching the needle, assist the user in orienting the needle with the patient and triggering the appropriate disengaging mechanisms; and (vi) that holder is capable of operating effectively without the need for any additional components. 
     SUMMARY OF THE INVENTION 
     The present invention is a needle holder assembly comprising a holder, means for disengaging a conventional blood collecting needle from the holder, means for engaging a conventional blood collecting needle to the holder, and means for deterring the user from touching the needle, assisting the user in orienting the needle with the patient and preventing premature release of the needle from the holder. 
     Preferably, the holder comprises a tubular body comprising a top end, an open bottom end and a sidewall extending between the top end and the bottom end. 
     Preferably, the means for disengaging a conventional blood collection needle from the holder is a needle actuation mechanism located at the top end of the holder. 
     Preferably, the means for engaging a conventional blood collection needle to the holder is a threaded passageway in the needle actuation mechanism. 
     Preferably, the actuation mechanism comprises a disengaging trigger, an engaging trigger, a threaded passageway and a finger recess indicator. Most preferably, the triggers and indicator have distinct features that provide the user with visual and tactile means for distinguishing between them. 
     Most preferably, the needle actuation mechanism comprises first and second half female members or jaws with surfaces that cooperate to define the threaded passageway therebetween, an engaging trigger for cooperating the female members and a disengaging trigger for separating the female members and a finger recess indicator. 
     When the engaging trigger is activated, the jaws cooperate to a closed position to define a threaded passageway. A conventional needle assembly comprising a non-patient end, an intravenous end and a hub, is then screwed into the threaded passageway by the user whereby the non-patient end of the needle extends into the body of the holder and the intravenous end of the needle extends outwardly from the top end of the holder. To release and dispose of the needle from the holder, the holder is held over a sharps disposal container such that the intravenous end of the needle extends vertically from the holder, then the disengaging trigger is activated, whereby the female members are separated to an open or retracted position and so that the threaded passageway is interrupted and there is a gap which is greater than the cross section of the hub of the conventional needle assembly so that the needle assembly is released from the holder and into the sharps disposal container. 
     In use, a user will use one finger of one hand to close the actuation mechanism whereby the threaded passageway is available for engaging a conventional needle assembly. The user then screws into the threaded passageway a conventional needle assembly whereby the hub of the needle assembly is screwed into the threaded passageway and the intravenous end of the needle extends from the top end of holder and the non-patient end of the needle extends into the housing of the holder. 
     The intravenous end of the needle is then inserted into the patient&#39;s skin as guided by the finger recess indicator to the user. A fluid collection tube is then inserted into the holder in communication with the non-patient end of the needle. 
     In addition to guiding the user for proper orientation of the holder assembly relative to the user, the needle is prevented from being prematurely released from the actuation mechanism due to the finger recess indicator. The finger recess indicator prevents the patient&#39;s skin from activating the disengaging trigger or the actuation mechanism. 
     After use, the fluid collection tube is removed from the holder, the holder is positioned over a sharps disposal container and the disengaging trigger is depressed with one finger of the user whereby the threaded passageway is interrupted and there is a gap and the needle falls into the sharps disposal container under the force of gravity. During the disengaging procedure, the user is deterred from touching the needle by the finger recess indicator. 
     A significant advantage of the present invention as compared to previously available needle holder assemblies with an ejection capability is reduced cost. Since the present invention is compatible with conventional needle assemblies and conventional fluid collection tubes, holders in accordance with the present invention do not require the use of special or custom made needle assemblies and/or additional custom made components. 
     A further advantage of the present invention as compared to previously available needle holder assemblies is improved reliability and ease of operation. 
     Another notable advantage of the present invention is that because of the finger recess indicator, the user is physically deterred from touching the needle that is removably secured in the holder of the present invention. As such, the finger recess indicator substantially reduces the touch contamination potential that may be faced by the user that is associated with blood collecting needle holder assemblies. 
     Also notable is that the finger recess indicator of the present invention provides a tactile response and feedback to the user whereby when the user touches the finger recess indicator the user is alerted not to proceed past the finger recess indicator as compared with visual response and feedback. 
     In addition, the finger recess indicator provides the user with tackle identification of where the activation and reset positions of the assembly are located. For example, when the user touches the finger recess indicator, the user is alerted to the position of the holder and the needle with respect to the engaging or disengaging triggers. Therefore if the user is unable to visually look at the holder, the tactile response and feedback from the finger recess indicator will assist the user in properly identifying the engaging or disengaging triggers of the holder. 
     In addition, the engaging and disengaging triggers also provide a tactile response and feedback to the user. The finger guides associated with the triggers are distinct from one another so that the user is able to distinguish the engaging trigger from the disengaging trigger. Furthermore, the triggers provide the user with visual identification to distinguish the engaging trigger from the disengaging trigger. 
     Another notable attribute of the present invention is that the finger recess indicator prevents the disengaging trigger from prematurely being pushed by the user or the patient&#39;s skin. When the holder is in use in the patient&#39;s skin, the finger recess indicator provides a shield between the patient&#39;s skin and the disengaging trigger so that the needle is not prematurely released from the holder. 
    
    
     DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of the unassembled holder and actuation mechanism of the present invention. 
     FIG. 2 is a perspective view of the holder and assembled actuation mechanism of the present invention. 
     FIG. 3 is a perspective view of the holder and assembled actuated mechanism of the present invention with the needle assembly engaged with the actuation mechanism. 
     FIG. 4 is a perspective of the assembled holder and the actuator mechanism of the present invention with the needle assembly engaged with the actuation mechanism. 
     FIG. 5 is a cross sectional side view of the assembly of FIG. 4 taken along lines  5 — 5 . 
     FIG. 6 is an exploded cross sectional side view of the assembly of FIG.  5 . 
     FIG. 7 is a cross sectional side view of the assembly of FIG. 4 taken along lines  7 — 7  without the needle assembly and with the actuation mechanism in the open position. 
     FIG. 8 is an exploded cross sectional side view of the assembly of FIG.  7 . 
     FIG. 9 is a perspective view of the components of the actuation mechanism. 
     FIG. 10 is an exploded perspective view of the frame of actuation mechanism. 
     FIG. 11 is an exploded perspective view of the bottom view of the frame of actuation mechanism. 
     FIG. 12 is a top view of the holder of FIG.  1 . 
     FIG. 13 is a top view of the holder assembly in the closed position without a needle assembly of FIG.  4 . 
     FIG. 14 is a top view of the holder assembly in the open position without a needle assembly of FIG.  6 . 
     FIG. 15 is a perspective view of the components of the holder. 
     FIG. 16 illustrates the user pushing the first slider to move the actuation mechanism into a closed position. 
     FIGS. 17 and 18 illustrates the benefits of the recess indicators and indicator guides. 
    
    
     DETAILED DESCRIPTION 
     Referring to the drawings in which like reference characters refer to like parts throughout the several views thereof, in particular FIG. 2 illustrates a holder  10  for a blood collection needle comprising a housing  20  and an actuation mechanism  100 . 
     As shown in FIGS. 1 and 5, housing  20  has a top end  22 , an upper section  24 , and a bottom end  26 . A first sidewall  28  extends from top end  22  to a shoulder  23  and a second sidewall  30  extends from shoulder  23  to bottom end  26 . First sidewall comprises an inner surface  34  and an outer surface  36  and second sidewall comprises an inner surface  38  and an outer surface  40 . The inner diameter  44  of second sidewall  30  is larger than the inner diameter  42  of first sidewall  28 . As shown in FIGS. 5 and 6, a projection  43  is integrally formed on outer surface  34  of the first sidewall. 
     As shown in FIG. 15, the holder further includes a sleeve  50  removably inserted in the bottom end of the housing. Sleeve  50  comprises a body  52  and flange  54 . Flange  54  extends outwardly from the rearward end  56  of the sleeve to support the holder on a flat surface and also to provide the user with a means for gripping the holder. 
     As shown in FIG. 12, at top end  22  of the housing there is a top surface  60 . At top surface  60  there is an aperture  62 , a pair of side openings  64 , a pair of projecting guide arms  66  that extend upwardly from the top surface and a recessed surface  68  surrounding the aperture. 
     As shown in FIGS. 1 and 9, actuation mechanism  100 , includes a retainer  200 , a first slider  300 , a second slider  400  and a frame  500 . 
     As shown in FIGS. 1 and 9, retainer  200  includes a bottom platform  210 , an upper platform  212  and a half female member  214  extending between the bottom and upper platforms. Bottom platform  210  has a larger surface area than upper platform  212 . Half female member  214  includes an opening  216  and threads  218 . 
     As shown in FIGS. 1,  6  and  9  first slider or engaging trigger  300  includes a body  320  comprising a top surface  322 , a bottom surface  324 , a rearward end  326  and a forward end  328 . A pair of arms  340  extend from the forward end of the body. Arms  340  each include a forward end  342 , a rearward end  343 , an inner surface  346  and an outer surface  348 . At the rearward end  342  of each arm is a hook  344  and on the outer surface of each arm is an indentation or groove  350 . A half female member  352  extends from the rearward end of the body and includes threads  354 . Rearward end  326  includes a finger guide  356  and on bottom surface  324  of the body at rearward end  326  is a downwardly extending flange  360 . 
     As shown in FIGS. 1,  6  and  9 , second slider or disengaging trigger  400  includes a frame  410  that surrounds a cavity  412 . Frame  410  includes a forward end  414 , a rearward end  416 , a bottom surface  418  and an upper surface  420 . Sidewalls  422  extend between the forward end and the rearward end of the frame. Sidewalls  422  include an outer surface  424  and an inner surface  426  and an indentation or cutout  436  on the outer surface of each sidewall. Cavity  412  includes a stopping end  428  at forward end  414 . At rearward end  416  on upper surface  420  is a raised ledge  430 . Raised ledge  430  includes a rearward end  432  and a forward end  434 . At forward end  434  are two opposing projections  437  and a lug  438  located between the projections. At rearward end  432  there is a finger guide  440  for providing the user with finger identification for locating and using the disengaging trigger. Finger guide  440  is distinct from finger guide  356  of the first slider so that the user may easily distinguish the disengaging trigger from the engaging trigger. The finger guides may be structurally distinct as well as color coded. For example, the finger guide for the disengaging trigger may be green and the finger guide for the engaging trigger may be blue. Sidewalls  422  further include cutouts  436  on the outer surface of each sidewall. 
     As shown in FIGS. 1,  6 ,  9 ,  10 ,  11  and  12  frame  500  includes a top wall  510  comprising a top surface  512 , a bottom surface  514 , a forward end  516 , a rearward end  518  and a bore  520  surrounded by top surface  512 . At bottom surface  514  at forward end  516  is a recess  522  and at rearward end  518  is another recess  524 . Extending downwardly from top wall  510  are a pair of guidewalls  526 . Extending downwardly from guidewalls  526  are feet  528  with hooks  530 . Guidewalls  526  include an inner surface  532  and an outer surface  534 . On inner surface  532  are protrusions  536 . At forward end  516  is a recess indicator  540  that extends into indicator guides  542 . Indicator guides  542  extend radially forward and at an incline upwardly from forward end  516  and recess indicator  540 . 
     The four parts of the actuation mechanism  100 , retainer  200 , first slider or engaging trigger  300 , second slider or disengaging trigger  400  and frame  500 , are arranged relative to each other in the manner shown in FIGS. 1,  6 ,  7 ,  8  and  9 . 
     As shown in FIGS. 6,  7  and  8 , retainer  200  fits with forward end  516  of frame  500  in recess  522 . First slider  300  is associated with the rearward end of frame  500  whereby the top surface  322  of the first slider faces bottom surface  514  of the frame and indentations  350  of the first slider engage with protrusions  536  of guidewalls  526 . Half female member  352  of the first slider faces half female member  214  of retainer  200  to from a threaded passageway where the hub of a needle assembly is engaged. 
     Cavity  412  of second slider  400  surrounds half female members  352  and  214  of the first slider and retainer respectively. Lug  438  fits within opening  216  of half female member  214  of retainer  200 . 
     The actuation mechanism is then secured to top surface  60  of holder  10 , whereby hooks  530  of feet  528  of the frame engage with pair openings  64  in the top surface of the holder. The projecting guide arms  66  in the top surface of the holder are to assist in guiding the attachment of the actuation mechanism to the holder. 
     The actuation mechanism is moved into a closed position when rearward end  326  of the first slider is pushed forward with the user&#39;s finger using finger guide  356  as shown in FIG.  16 . When there rearward end is pushed forward, indentations  350  engage with protrusions  536  of guidewalls  526  and female half member  352  moves to meet with female half member  214  of retainer  200  to form a threaded passageway so that the hub of a conventional needle can be secured in the passageway. 
     The actuation mechanism is moved into the open position when rearward end  432  of the second slider is pushed forward towards the first slider whereby the user pushes the slider at the finger guide  440 . When the rearward end is pushed forward, cutout  436  pushes arms  340  of the first slider so that indentations  350  disengage from protrusions  536  of the guidewalls, and the first slider moves backwards but not beyond the point when stopping end  428  of cavity  412  holds half female member  352  of the first slider. 
     As shown in FIGS. 17 and 18, the recess indicators  542  and indicator guides  542  deter the user from touching the needle and the prevention of premature release of the needle whereby the guides act as a shield between the patient&#39;s skin and the disengaging trigger. As shown in FIG. 17, indicator guides  542  rest upon the patient&#39;s skin so that the patient&#39;s skin does not prematurely trigger disengaging trigger  400  at finger guide  440 . In addition as shown in FIG. 18, recess indicator  540  provides the user with notification that the disengaging trigger is near and therefore prevents the user from prematurely activating the disengaging trigger.