Abstract:
The present invention is a safety shield assembly having a shield and a collar for connecting the shield to a fluid handling device whereby the shield may be pivoted with respect to the collar. Preferably, the safety shield assembly may be used with a needle assembly, an intravenous infusion set a syringe, a catheter or other fluid handling devices or assemblies that contain piercing elements. The shield includes a cannula channel with a finger lock for preventing re-exposure of the used needle.

Description:
RELATED APPLICATION  
       [0001]    This application is a continuation-in-part of U.S. patent application Ser. No. 09/378,976, filed Aug. 23, 1999. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The present invention relates to a shield for a needle and more particularly to a safety shield assembly that may be used in conjunction with a syringe assembly, a hypodermic needle, a needle assembly, a needle assembly with a needle holder, a blood collection needle, a blood collection set, an intravenous infusion set or other fluid handing devices or assemblies that contain piercing elements.  
         BACKGROUND OF THE INVENTION  
         [0003]    Disposable medical devices having piercing elements for administering a medication or withdrawing a fluid, such as hypodermic needles, blood collecting needles, fluid handling needles and assemblies thereof, require safe and convenient handling. The piercing elements include, for example, pointed needle cannula or blunt ended cannula.  
           [0004]    Safe and convenient handling of disposable medical devices is recognized by those in the medical arts so as to minimize exposure to blood borne pathogens. Safe and convenient handling of disposable medical devices results in the disposal of the medical devices intact.  
           [0005]    As a result of this recognition, numerous devices have been developed for shielding needles after use. Many of these devices are somewhat complex and costly. In addition, many of these devices are cumbersome to use in performing procedures. Furthermore, some of the devices are so specific that they preclude use of the device in certain procedures or with certain devices and/or assemblies. For example, some devices employ very short thin needle cannulas. A shield designed to lock near the distal end of one needle cannula might not engage a much shorter needle cannula. Additionally, a shield designed to lock with a wider gauge needle cannula might be more likely to generate a spray upon engaging a much narrower needle cannula. Furthermore, it may be desirable to reduce the force required to effect shielding without reducing the audible and tactile indications of complete shielding.  
           [0006]    Therefore, there exists a need for a safety shield assembly: (i) that is manufactured easily; (ii) that is applicable to many devices; (iii) that is simple to use with one hand; (iv) that can be disposed of safely; (v) that does not interfere with normal practices of needle use; (vi) that has tactile features whereby the user may be deterred from contacting the needle, the user may easily orient the needle with the patient and easily actuate and engage the shield assembly; (vii) that has visual features whereby the user may be deterred from contacting the needle, the user may easily orient the needle with the patient and easily actuate and engage the shield assembly; (viii) that is not bulky; (ix) that includes means for minimizing exposure to the user of residual fluid leaking from the needle; and (x) provides minimal exposure to the user because the needle shield is immediately initiated by the user after the needle is withdrawn from the patient&#39;s vein.  
         SUMMARY OF THE INVENTION  
         [0007]    The present invention is a safety shield assembly that comprises: a shield; means for connecting the shield to a fluid handling device that contains a piercing element, such as needle; means for pivoting the shield away from the needle; and means for securely covering and/or containing the needle within the shield.  
           [0008]    Preferably, the shield comprises a rearward end, a forward end, a slot or longitudinal opening for housing the used needle in the forward end, means for securing the needle in the slot, means for guiding the needle into the slot, means for connecting the shield and the fluid handling device, means for guiding the user&#39;s fingers to move the shield into various positions, and means for retaining the shield securely over the used needle.  
           [0009]    Desirably, the means for connecting the shield to the fluid handling device is a collar. Preferably, the shield is connected movably to a collar which is connected to a fluid handling device.  
           [0010]    Preferably, the shield is connected to the collar by a hanger bar that engages with a hook arm on the collar so that the shield may be pivoted with respect to the collar into several positions. It is within the purview of the present invention to include any structure for connecting the shield to the collar so that the shield may be pivoted with respect to the collar. These structures include known mechanical hinges and various linkages, living hinges, or combinations of hinges and linkages.  
           [0011]    Most preferably, the shield is connected to the collar by an interference fit between the hanger bar and the hook bar. Therefore, the shield always is oriented in a stable position and will not move forward or backwards unless movement of the shield relative to the hanger bar and the hook bar is initiated by the user.  
           [0012]    Alternatively, the collar and at least a portion of the shield may be a unitary one-piece structure. The one-piece structure may be obtained by many methods, including molding the shield and the collar as a one-piece unit, thereby eliminating the separate shield and collar during the manufacturing or assembly process.  
           [0013]    The assembly of the present invention may further comprise tactile and visual means for deterring the user from contacting the needle, providing easy orientation of the needle with the patient and providing the user with a guide for actuation and engagement with the shield.  
           [0014]    The assembly of the present invention may further comprise means for minimizing exposure by the user to residual fluid leaking from a used needle. For example, a polymer material, such as a gel, may be located in the shield.  
           [0015]    Most desirably, the assembly of the present invention is such that the cooperating parts of the assembly provide the means for the shield to move into a forward position over the needle. Thus, by simple movement of the shield into a forward position over the used needle, the assembly is ready for subsequent disposal. Therefore, the safety shield assembly of the present invention provides minimal exposure of the user to a needle because the shielding is initiated by the user immediately after the needle is withdrawn from the patient&#39;s vein.  
           [0016]    Desirably, the assembly of the present invention may be used with a syringe assembly, a hypodermic needle, a needle assembly, a needle assembly with a needle holder, a blood collection set, an intravenous infusion set or other fluid handling devices. Preferably, the assembly of the present invention is used with a needle assembly comprising a needle and a hub. Preferably the needle is a conventional double ended needle.  
           [0017]    Most preferably, the present invention is used with a needle assembly comprising a hub and a needle connected to the hub whereby the needle comprises a non-patient end and an intravenous end. The collar of the present invention may comprise a hook arm and the shield may be connected movably to the hook arm. Thus the shield may be pivoted with respect to the collar and moved easily into several positions.  
           [0018]    Preferably, the collar is fitted non-rotatably with the hub of the needle assembly. Additionally, the collar includes cooperating means that mate with reciprocal means on the shield to provide a clear audible and tactile indication of shielding. The cooperating means on the collar may include generally chevron-shaped projection formed on a side of the collar substantially diametrically opposite the hook arm or other such structure that provides the hinge connection to the shield. The chevron-shaped structure includes a forward or distal point. Slanting surfaces diverge and extend proximally from the distal point. The slanting surfaces cooperate with the reciprocal means on the shield to generate a deflection of the sidewalls of the shield away from one another. The chevron-shaped structure further includes proximal ends that are convexly arcuate. The convexly arcuate ends of the chevron-shaped structure on the collar cooperate with the reciprocal means on the shield and with the resiliently deflectable sidewalls of the shield to generate the tactile and audible indication of shielding.  
           [0019]    The shield preferably includes a proximal or rearward portion that is hingedly connected to the collar and a distal or forward portion that comprises a support extending unitarily from the rearward portion of the shield. The shield may further comprise a cannula channel securely mounted to at least the support of the forward portion. The channel may comprise a top wall securely connected to the support of the shield and a pair of opposed spaced apart sidewalls extending downwardly from the top wall. The spacing between the sidewalls is selected to accommodate the needle cannula in the channel. At least one of the sidewalls of the cannula channel is formed with at least one cannula finger lock that projects angularly toward the top wall of the cannula channel. The cannula finger lock is dimensioned, disposed and aligned to contact the needle cannula when the shield approaches the second position. Contact between the needle cannula and the cannula finger lock will cause the cannula finger lock to resiliently deflect toward the sidewall from which the cannula finger lock extends. Sufficient rotation of the shield will cause the needle cannula to pass the cannula finger lock. As a result, the cannula finger lock will resiliently return to or toward its undeflected condition for securely trapping the needle cannula in the shield.  
           [0020]    The top wall of the cannula channel may comprise means for engaging reciprocal means on the support of the forward portion of the shield. The mounting means on the cannula channel may be disposed in a non-central position relative to the longitudinal direction of the channel. Thus, the cannula channel can be mounted to the shield support in either of two alternate orientations that are rotated 180° from one another. In a first rotational orientation, the cannula channel projects distally or forwardly beyond the support of the shield. In a second rotational orientation, the cannula channel projects rearwadly or proximally from the support of the shield to overlie the rearward portion of the shield. Thus, the first rotational orientation of the cannula channel ensures that the pointed distal end of a long needle cannula is surrounded by the cannula channel and engaged by the cannula finger locks. The second rotational orientation of the cannula channel ensures that a shorter needle cannula is surrounded by the cannula channel and engaged by the cannula finger locks.  
           [0021]    The cannula channel may have a proximal or rear end configured for engaging the collar or hub when the shield is in its second position. Engagement of the channel with the collar or hub may contribute to locked retention of the shield in the second position. Additionally, engagement of the proximal end of the cannula channel with the collar or hub may further support the channel and prevent excessive deformation of the channel.  
           [0022]    Preferably, the collar is fitted with the hub of the needle assembly so that the collar cannot rotate around the hub. Alternatively, the collar and hub may be a unitary one-piece structure. The one piece structure may be accomplished by many methods including molding the collar and the hub as a one-piece unit thereby eliminating the need to separately assemble the collar to the hub during the manufacturing process.  
           [0023]    Most preferably, the collar is fitted with the hub of the needle assembly so that the bevel surface or bevel up surface of the intravenous or distal end of the needle faces the same side of the collar when the shield is in the first position. Alignment of the collar, hub, shield and needle with the bevel surface up makes it easier to insert the needle into the patient without manipulating the assembly. The orientation of the intravenous end of the needle with the bevel up assures the user that the needle is properly oriented for use and does not require any manipulation before use. Most notably, the orientation of the shield provides a visual indication to the user of the orientation of the bevel surface of the needle.  
           [0024]    Preferably, the shield is capable of pivoting from a first position where the intravenous end of the needle is exposed and bevel up, to an intermediate position where the needle is partially covered, to a second position where the needle is covered completely.  
           [0025]    Alternatively, it is within the purview of the present invention that the collar, hub and at least a portion of the shield may be a unitary one-piece structure. The one-piece structure may be accomplished by many methods including molding the shield, collar and hub as a one-piece unit thereby eliminating the need to separately assemble the shield, collar and hub during the manufacturing process.  
           [0026]    It is an advantage of the present invention that the shield covering the used intravenous end of the needle provides easy containment of the used needle. A further advantage of the shield is that it will only move upon initiation by the user.  
           [0027]    The assembly of the present invention when used with a fluid handling device is also easily disposable when removed from a conventional needle holder, or other such device.  
           [0028]    A notable attribute of the present invention is that it is easily adaptable with many devices. For example, the invention is usable with syringe assemblies, hypodermic needles, needle holders, blood collection needles, blood collection sets, intravenous infusion sets such as catheters or other fluid handling devices or assemblies that contain piercing elements.  
           [0029]    Another notable attribute of the present invention is that the tactile and visual features deter the user from touching the needle, allow the user to easily orient the needle with the patient and guide the user to actuate and engage the shield of the assembly. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0030]    [0030]FIG. 1 is a perspective view of the safety shield assembly of the present invention as connected to a needle assembly and related packaging features.  
         [0031]    [0031]FIG. 2 is a perspective view of the unassembled pieces of FIG. 1.  
         [0032]    [0032]FIG. 3A is a bottom view of the shield as shown in FIG. 2.  
         [0033]    [0033]FIG. 3B is an enlarged bottom view of an ear of the shield.  
         [0034]    [0034]FIG. 4 is a cross sectional view of the collar as shown in of FIG. 2 taken along lines  4 - 4  thereof.  
         [0035]    [0035]FIG. 5 is a cross sectional view of the needle hub as shown in FIG. 2 taken along lines  5 - 5  thereof.  
         [0036]    [0036]FIG. 6A is a cross sectional view of the shield of FIG. 2 taken along lines  6 A- 6 A thereof.  
         [0037]    [0037]FIGS. 6B is a cross-sectional view similar to FIG. 6A, but showing the cannula channel in an end-to-end reversed orientation.  
         [0038]    FIGS.  7 - 12  illustrate the use of the safety shield assembly with the needle assembly of FIG. 1 with a conventional needle holder.  
         [0039]    [0039]FIG. 13 is a cross sectional view of the assemblies in use with a conventional needle holder as shown in FIG. 12 taken along lines  13 - 13  thereof.  
         [0040]    [0040]FIG. 14 is a cross-sectional view of the assemblies of FIG. 13 taken along lines  14 - 14  thereof.  
         [0041]    [0041]FIG. 15A is a bottom view of the assemblies as shown in FIG. 11.  
         [0042]    [0042]FIG. 15B is an enlarged bottom view showing the engagement of the ear and the chevron-shaped projection.  
         [0043]    [0043]FIG. 16 illustrates an additional embodiment of the present invention, whereby a gel material is located in the shield as shown in a bottom view of the assemblies of FIG. 11.  
         [0044]    [0044]FIG. 17 is a perspective view of an additional embodiment of the present invention in use with a blood collection set.  
         [0045]    [0045]FIG. 18 is a perspective view of an additional embodiment of the present invention in use with a syringe.  
         [0046]    [0046]FIG. 19 is a perspective view of an additional embodiment of the present invention in use with a catheter.  
         [0047]    [0047]FIG. 20 is an exploded side elevational view of an additional embodiment of the present invention.  
         [0048]    [0048]FIG. 21 is a bottom view of the clip of FIG. 20.  
         [0049]    [0049]FIG. 22 is a bottom view of the assembly similar to FIG. 15A, but showing an additional embodiment of the present invention without a chevron-shaped structure on the collar and without locking ears on the shield.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0050]    While this invention is satisfied by embodiments in many different forms, there is shown in the drawings and will herein be described in detail, the preferred embodiments of the invention, with the understanding that the present disclosure is to be considered as exemplary of the principles of the invention and is not intended to limit the invention to the embodiments illustrated. Various other modifications will be apparent to and readily made by those skilled in the art without departing from the scope and spirit of the invention. The scope of the invention will be measured by the appended claims and their equivalents.  
         [0051]    Referring to the drawings in which like reference characters refer to like parts throughout the several views thereof, FIGS. 1 and 2 illustrate a needle assembly with the safety shield assembly of the present invention and the related packaging features. The needle assembly includes a needle  40 , a hub  60 , packaging features to cover the needle and a label. The safety shield assembly includes a collar  90  and a shield  140 .  
         [0052]    As shown in FIG. 2 and  5 , needle  40  includes a non-patient end  42 , an intravenous end  44  and a passageway  46  extending between the non-patient end and the intravenous end. An elastomeric sleeve  48  covers the non-patient end. A first rigid sleeve  50  covers the intravenous end and a second rigid sleeve  52  covers the non-patient end and the elastomeric sleeve. As shown in FIG. 1, a label  196  may also be applied to the finally assembled parts.  
         [0053]    As shown in FIGS. 2 and 5, hub  60  includes a threaded end  64 , a ribbed end  66  and passageway  62  extending between the threaded end and the ribbed end. Threaded end  64  and ribbed end  66  are separated by flange  68 . Non-patient end  42  of needle  40  extends from threaded end  64  and intravenous end  44  of needle  40  extends from ribbed end  66 . Preferably, threaded end  64  comprises male threads  80  for mounting the hub on a conventional needle holder and ribbed end  66  comprises male ribs  82  for connecting the hub and collar  90 .  
         [0054]    As shown in FIGS. 2 and 4, collar  90  includes a forward skirt  92  and a rearward skirt  94 . Forward skirt  92  is cylindrical and comprises an inner circumferential surface  96  and an outer circumferential surface  98 . Forward skirt  92  mates with rearward skirt  94  at a shoulder  100 . Rearward skirt  94  is cylindrical and comprises an inner circumferential surface  102  and an outer circumferential surface  104  and extends from shoulder  100  opposite of forward skirt  92 . The inner diameter of forward skirt  92  is larger than the inner diameter of rearward skirt  94 . Alternatively, the inner diameters for collar  90  can be equal. A hook  114  extends from outer circumferential surface  98  of forward skirt  92 . Additionally a chevron-shaped protrusion  118  projects outwardly from outer circumferential surface  98  of forward skirt  92  at a side opposite hook  114 . The chevron-shape protrusion  118  is substantially symmetrical and has a peak  120  pointed toward forward skirt  92  and ramp surfaces  122  that diverge symmetrically from peak  120  toward rearward skirt  94 . Ramp surfaces  122  terminate at rounded ends  124  at the outer side and proximal extremes of chevron-shaped protrusion  118 . Rounded ends  124  extend continuously into the proximal side of chevron-shaped protrusion  118  facing toward rearward skirt  94 .  
         [0055]    As shown in FIGS. 2 and 6, shield  140  comprises a rearward end  144  and a forward end  146 . Forward end  146  of shield  140  defines an elongate support wall  150  with a distal end  152  and top and bottom surfaces  154  and  156  extending proximally from distal end  152 . In the illustrated embodiment, top and bottom surfaces  154  and  156  are slightly arcuate from side-to-side. However, in other embodiments, top surface  154  and/or bottom surface  156  may be substantially planar. Support wall  152  is characterized by axially spaced apertures  158  extending entirely therethrough from top surface  154  to bottom surface  156 .  
         [0056]    Rearward end  144  of shield  140  defines a collar engaging area  166 . Collar engaging area  166  includes a rearward end  168 , a forward end  170 , a top finger guide area  172 , sidewalls  174  that extend downwardly from top finger guide area  172 , an underside area  176  dimensioned for surrounding collar  90 , and extending arms  180  to support hanger bar  182 . Sidewalls  174  are spaced apart by a major width adjacent rearward end  168 . The major width is selected to enable sidewalls  174  to slide across diametrically opposite side surfaces of forward skirt  92  of collar  90 . Sidewalls  174  converge, however, toward forward end  170  to define a minor distance therebetween. Sidewalls  174  include bottom edges  177  that face away from top finger guide area  172 . As shown most clearly in FIG. 6, bottom edges  177  curve toward top finger guide area  172  at locations between rearward end  168  and forward end  170  of collar engaging area  166 .  
         [0057]    Shield  140  further includes a cannula channel  220 . Cannula channel  220  includes opposed longitudinal ends  222  and  224 , an elongate convex outer surface  226  extending between ends  222  and  224  and an inner concave surface  228  extending between ends  222  and  224 . An entry to concave inner surface  228  is defined by opposed parallel edges  230  that extend substantially between ends  222  and  224  of channel  220 . Mounting projections  232  project from convex outer surface  226  at a location substantially equally spaced from edges  230 . Thus, mounting projections  232  are substantially opposite from the entry into concave inner surface  228  of channel  220 . Mounting projections  232  are spaced from one another by a distance substantially equal to the spacing between mounting apertures  158  in support wall  150 . Additionally, mounting projections  232  are dimensioned to be snapped or force fit into apertures  158 . Mounting projections  232  are not symmetrically disposed along the length of cannula channel  220 . Rather, mounting projections  232  are closer to end  222  than to end  224 . Channel  220  is defined further by cannula finger locks  234  that project obliquely inwardly from one of side edges  230 . Cannula finger locks  234  are resiliently deflectable in response to forces exerted by needle  40  as explained further below.  
         [0058]    The extreme rear ends of sidewalls  174  on collar engaging area  166  include rounded ears  194  that project toward one another from opposed inner surfaces  175  of sidewalls  174 . Rounded ears  194  are disposed to engage chevron-shaped projection  118  on collar  90 . More particularly, each rounded ear  194  includes a distal surface  195 , a proximal surface  197  and a curved surface  198  extending between distal and proximal surfaces  195  and  197 . Distal surface  194  is aligned to sidewall  174  at a rake angle of approximately 60° and proximal surface  197  is aligned to sidewall  174  at an angle of approximately 45°. Curved surface  198  extends smoothly and convexly between distal and proximal surfaces  195  and  197 . Proximal surfaces  197  of rounded ears  194  will engage ramp surfaces  122  of chevron-shaped projection  118  to deflect sidewalls  174  slightly away from one another as shield  140  approaches the second position. The apex of curved surface  198  on each rounded ear  194  passes the respective rounded end surface  124  on chevron-shaped projection  118  on collar  90 . As a result, sidewalls  174  begin to return resiliently toward an undeflected condition. The resilient return of sidewalls  174  and raked distal surface  195  of ears  194  causes sidewalls  174  to snap against chevron-shaped projection  118 . This snapping action provides a clear audible and tactile indication of complete shielding and occurs substantially when the used needle is trapped by cannula finger locks  234 . The angles of distal and proximal surfaces  195  and  197  of rounded ears  194  affects the performance of shield  140 . In particular, a smaller acute angle alignment of proximal face  197  reduces the force required to move shield  140  passed rounded ears  194 . A larger acute angle proximal surface  197  of rounded ears  194  requires a greater force to move shield  140  toward the second position. Similarly, the angle between distal surface  195  and sidewall  174  affects the acceleration characteristics as shield  140  is propelled toward the second position in response to the resilient return of sidewalls  174 . This change in acceleration characteristics affects the audible indication of shielding. Different audible and acceleration characteristics can be achieved by employing more sharply pointed corners on the end surface of chevron-shaped projection  118  for engagement by rounded ears  194  of shield  140 .  
         [0059]    Top finger guide area  172  comprises a first ramp  184  that extends slightly on an upwardly slope from the rearward end of the collar engaging area to a shoulder  186 . From shoulder  186  extends a second ramp  188  which slopes downwardly towards support wall  150 . Most preferably, first ramp  184  comprises touch bumps  190 . The touch bumps provide a tactile and visual guide to alert the user that the user&#39;s finger has contacted the shield and that the shield is in a defined or controlled position. The touch bumps may be any configuration so long as they extend and are distinct from the top finger guide area. The touch bumps may also be of a distinguishing color as compared to the top finger guide area or the shield.  
         [0060]    Second ramp  188  has interior surface  192  for urging the needle toward the center as the shield is being rotated into the closed position. The exterior surfaces are slightly inclined and extending radially from the second ramp. The interior surfaces are especially helpful if the longitudinal axis of the needle is misaligned with respect to the longitudinal axis of the hub.  
         [0061]    Extending arms  180  are located at rearward end  168  and at the beginning of top finger area  172  and hold hanger bar  182 .  
         [0062]    The safety shield assembly and the needle assembly are assembled together whereby needle  40  is connected to hub  60  and sealed with adhesive at the ends of the hub. Hub  60  is then joined with collar  90  by ultra-sonic welding techniques or any other bonding techniques, or mechanical fit, whereby rearward annular skirt  94  of collar  90  mates with ribbed end  66  of the hub. Male ribs  82  of the hub are contained or forced fitted within inner sidewall  102  of rearward annular skirt  94  of collar  90 . The collar is aligned with the intravenous end of the needle whereby the hook arm is aligned with the bevel up of the needle. Then rigid sleeve  50  is force fitted into inner side wall  96  of forward skirt  92  of collar  90  to cover the needle. Channel  220  then is mounted to support wall  150 . More particularly, as shown in FIGS. 2, 3 and  6 A, channel  220  is oriented such that end  224  of channel  220  projects distally or forwardly beyond support wall  150 . This orientation is appropriate in situations where it is known that a relatively long needle cannula will be employed with the needle assembly. Alternatively, however, channel  220  can be oriented as shown in FIG. 6B so that end  222  of channel  220  is aligned substantially with the distal end  152  of support wall  152  while end  224  of channel  222  projects rearwardly or proximally into rearward end  144  of shield  140 . Thereafter, shield  140  is connected to collar  90  whereby hanger bar  182  is force fitted into hook member  114  whereby slot  160  faces rigid sleeve  50 . Most preferably, the shield is connected to the collar by a force fit or interference fit between the hanger bar and the hook bar. Therefore, the shield is always oriented in a stable position and will not move unless movement of the shield is positively initiated by the user. To assemble the last piece, shield  140  is moved towards rigid sleeve  50  and second rigid sleeve  52  is force fitted onto outer sidewall  104  of rearward skirt  94  of collar  90 .  
         [0063]    In addition, a label  196  may be applied to the finally assembled parts. The label may be used to prevent tamper resistance of the parts, so that they are not reused.  
         [0064]    In use, as shown in FIGS.  7 - 15 , the non-patient needle shield is removed and then a needle holder is screwed onto the hub of the needle. As specifically shown in FIGS. 8 and 12 the shield is then rotated back by the user towards the needle holder. Then as shown in FIG. 9, the intravenous needle shield is removed from covering the intravenous needle. Then as shown in FIG. 10, a venipuncture is conducted whereby the intravenous end of the needle is inserted into a vein of a patient and an evacuated tube having a closure is inserted into the needle holder. Then as shown in FIGS. 11 and 13, when the venipuncture is complete the user easily rotates the shield from the first position towards the intravenous needle to an intermediate position and then the user pushes on the shield at the top finger guide area to move the shield into a second position whereby the needle is trapped in the longitudinal opening. More particularly, needle  40  contacts cannula finger locks  234 . Accordingly, cannula finger locks  234  deflect toward support wall  150  and away from edges  230 . Sufficient rotation of shield  140  will cause needle  40  to pass cannula finger locks  234 . As a result, cannula finger locks  234  will return resiliently to an undeflected condition. Thus, needle  40  will be trapped above cannula finger locks  234 .  
         [0065]    Needle  40  is contained within shield  140  as the shield is pivoted into the closed position. More particularly, proximal surfaces  197  of rounded ears  194  move over ramp surfaces  122  of chevron-shaped projection  118  and cause sidewalls  174  to deflect away from one another. The angularly aligned proximal faces  197  of rounded ears  194  ensure easy movement of shield  140 . Additionally, the resiliency of sidewalls  174  and the angular alignment of distal surface  195  of ears  194  causes a cooperation with rounded proximal ends  124  of chevron-shaped projection  118  to accelerate shield  140 . This accelerated movement of shield  140  helps to generate a clear audible and tactile indication of complete shielding.  
         [0066]    [0066]FIGS. 17, 18, and  19  are further embodiments of the invention that include may components which are substantially identical to the components of FIGS.  1 - 3 . Accordingly, similar components performing similar functions will be numbered identically to those components of FIGS.  1 - 3 , except that a suffix “a” will be used to identify those similar components in FIG. 17, a suffix “b” will be used to identify those similar components in FIG. 18 and a suffix “c” will be used to identify those similar components in FIG. 19.  
         [0067]    Alternatively, the safety shield assembly of the present invention may be used in conjunction with a conventional intravenous (IV) infusion set, as illustrated in FIG. 17.  
         [0068]    For purposes of illustration, shield  140   a  and collar  90   a  are connected to a conventional IV infusion set,  200 , or butterfly structure comprising a needle body with a needle hub  204  extending from the forward end of the needle body and a needle  206  embedded in hub  204 . Extending from the rearward end of the needle body is flexible tubing  208  which is conventional and utilized to allow the user to manipulate the structure and to connect it subsequently to supplies of infusion liquids or for the return of collected blood if the arrangement is being used to collect blood.  
         [0069]    Infusion set  200  further comprises flexible wings  210  attached to and projecting outwardly from needle hub  204 .  
         [0070]    Alternatively, the safety shield assembly of the present invention may be used in conjunction with a syringe, as illustrated in FIG. 18.  
         [0071]    For purposes of illustration, shield  140   b  and collar  90   b  are connected to a conventional hypodermic syringe  300  comprising a syringe barrel  302  having a distal end  304  a proximal end  306  and a plunger  312 .  
         [0072]    Alternatively, the present invention may be used in conjunction with a catheter as illustrated in FIG. 19.  
         [0073]    [0073]FIGS. 20 and 21 show a further alternate to the needle assemblies described and illustrated above. In particular, the embodiment of FIGS. 20 and 21 includes a shield  140   d  that is similar to the shield  140  described and illustrated above. Shield  140   d  includes a collar engaging area  166   d  with a top finger guide area  172   d  and sidewalls  174   d  that extend downwardly from top finger guide area  172   d . Sidewalls  174   d  differ from the embodiments described and illustrated above in that they extend a shorter distance from top finger guide area  172   d  and have no means for engaging the chevron-shaped projection on the collar.  
         [0074]    Shield  140   d  includes a forward end  146   d  with a top wall  163   d  and sidewalls  162   d  extending down from top wall  163   d . Top wall  163   d  is characterized by spaced apart mounting apertures  164   d.    
         [0075]    Shield  140   d  further includes a channel-shaped clip  220   d  having a proximal end  222   d , a distal end  224   d  and a top wall  226   d  extending from distal end  224   d  toward proximal end  222   d . The top wall includes a pair of spaced apart mounting projections  228   d  that are dimensioned to be mounted in mounting apertures  158   d  on forward end  146   d  of shield  140   d . Cannula finger locks  230   d  extend from the channel-shaped clip in a direction away from mounting projections  228   d . Each cannula finger lock  230   d  includes a support leg and a cannula engaging leg  234   d . Cannula finger locks  230   d  are dimensioned and configured to trap the needle cannula when shield  140   d  is rotated into the closed position.  
         [0076]    Proximal end  222   d  of clip  220   d  includes a pair of collar engaging legs  236   d  extending generally proximally from top wall  226   d . Cannula engaging legs  236   d  are configured to pass around opposite respective sides of the collar. Ends of collar engaging legs  236   d  furthest from top wall  226   d  are formed with rounded ears  238   d . Ears  238   d  are configured to snap into engagement with the chevron-shaped projection, as described above.  
         [0077]    Shield  140   d  is used substantially exactly as shield  140  described above. In particular, shield  140   d  can be rotated from the open position to the closed position. As shield  140   d  approaches the closed position, cannula engaging legs  234   d  of cannula locking fingers locks  230   d  engage the needle cannula. Simultaneously, rounded ears  238   d  engage the chevron-shaped projection. The rounded configuration of ears  238   d  helps to propel shield  140   d  toward the closed position. In the closed position, cannula finger locks  230   d  will snap past the needle cannula for permanently trapping the needle cannula within shield  140   d.    
         [0078]    The shield and collar of the safety shield assembly of the present invention are comprised of moldable parts which can be mass produced from a variety of materials including, for example, polyethylene, polyvinyl chloride, polystyrene or polyethylene and the like. Materials will be selected which will provide the proper covering and support for the structure of the invention in its use, but which will provide also a degree of resiliency for the purpose of providing the cooperative movement relative to the shield and the collar of the assembly.  
         [0079]    A further alternate embodiment is illustrated in FIG. 22, and is virtually identical to the embodiment of the invention depicted in FIG. 15A. As a result, comparable numerals have been employed to identify identical or very similar components. FIG. 22, however, differs from FIG. 15A in that collar  90  does not have the chevron-shaped protrusion  118  illustrated in FIG. 15A. Additionally, shield  140  does not have ears comparable to rounded ears  194  of FIG. 15A. Thus, the embodiment illustrated in FIG. 22 relies entirely upon the engagement of cannula finger locks  234  with needle  40 . There are fewer structures on the embodiment of FIG. 22 to achieve the clear audible and tactile indication of complete shielding as in the previous embodiment and no structure for accelerating shield  140  in to the second position around needle  40 . However, upon complete shielding, the retention between shield  140  and needle  40  in the embodiment of FIG. 22 is comparable to the retention achieved by the previous embodiments.