Abstract:
A needle protective housing used to cover a contaminated needle after use is configured to have at least one cam positioned below the lip of the sheath attached to the base of the needle device for covering the needle prior to use. When the sheath is attached to the base of the needle device, the needle protective housing is positioned in proximity to the sheath. To remove the sheath, a user would pivotally move the needle protective housing in a direction away from the sheath so that the cam coacts against the lip of the sheath in an upward direction as the needle protective housing is pivoted downwards relative to the needle device. Consequently, the sheath that covers the needle prior to use is forced upwards until it is disengaged from the needle base. The cam may be an integral extension of the needle protective housing, or it may be a clip retrofittable to the needle protective housing.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to needle devices such as syringes that have a needle assembly attached thereto or fixed needle syringes, and more particularly to a sheath removal mechanism that enables a user to remove the sheath that covers the needle of such a needle device prior to its use without using both hands. 
       BACKGROUND OF THE INVENTION 
       [0002]    Sheathed needle devices are not new. Some sheathed needle devices include a needle protective housing pivotally hinged to the base of the needle. Once the sheath that covers the needle prior to its use has been removed and the needle presumably having been used, the needle protective housing is moved to cover the needle to prevent the contaminated needle from being further exposed. Among patents disclosing needle devices that have a needle protective housing hingedly connected to the base of the needle, the following are assigned to the same assignee of the instant application: U.S. Pat. No. 5,139,489, U.S. Pat. No. 5,277,311, U.S. Pat. No. 5,154,285, U.S. Pat. No. 5,232,455, U.S. Pat. No. 5,277,311, U.S. RE37,110 and U.S. RE37,252. For these devices, as shown for example in U.S. RE37,252, prior to use, the needle is covered by a sheath. To use, the needle device is held with one hand, while the sheath is removed by the other hand. After use, the needle protective housing is pivoted in a direction toward the needle to cover the contaminated needle. 
         [0003]    That a sheathed needle device requires a two-handed operation means that the clinician has to have both hands free, one hand holding the needle device while the other hand being used to remove the sheath. But oftentimes while the clinician is holding the sheathed needle device with one hand, her other hand is holding something else that requires that she continues to hold. There is therefore a need for a sheathed needle device that is designed to have its sheath removed by a one handed operation, in that the hand of the clinician that is holding the sheathed needle device is also adaptable to remove the sheath from the needle device. 
       BRIEF DESCRIPTION OF THE PRESENT INVENTION 
       [0004]    The needle device of the instant invention is configured to have at the proximal end of the needle protective housing at least one cam that is positioned below the lip at the open end of the sheath that covers the needle that extends from the base prior to use. The sheath is frictionally mated to and in contact with the base of the needle device such that it is not removable from the base without a user having to apply a predetermined force longitudinally along the axis of the base to pull the sheath off the base. Utilizing the pivotal movement of the needle protective housing, the cam is configured such that it extends from the proximal end of the needle protective housing to be positioned below the open end of the sheath when the needle protective housing is located at a first position at a small angle proximate to the longitudinal axis of the base of the needle device, with the sheath covering the needle and its open end mated to the base of the needle device. 
         [0005]    To remove the sheath from the base of the needle device, a user would use one of her digits, possibly her thumb, to move the needle protective housing in a direction away from the longitudinal axis of the base, while holding the needle device—be it a needle assembly mated to a syringe, a fixed needle syringe or another type of needle device for example a Vacutainer holder. Such pivotal movement of the needle protective housing applies the required predetermined force longitudinally along the axis of the base upwardly against the sheath. As a result, as the needle protective housing is moving away from the longitudinal axis of the needle device, the sheath that covers the needle is automatically removed. The user can thereafter readily use the needle since the needle protective housing is now at a second position at a greater angle away from the needle and the longitudinal axis of the base and therefore does not interfere with the use of the needle. 
         [0006]    The cam that extends from the proximal end of the needle protective housing proximate to the base of the needle device may extend from the back wall of the housing. Alternatively, two cams may be provided at the proximal end of the housing, with each cam extending from a corresponding sidewall of the housing so that the respective tips or fingers of the cams are at opposite sides of the base to apply even pressure to the sheath to remove it from the base, when the needle protective housing is pivotally moved away from the base. 
         [0007]    The cam(s) may be formed as an integral extension from the needle protective housing. The needle protective housing likewise is formed as an integral extension of the needle base. Thus, the cam, the needle protective housing and the base are all molded as a one-piece unit or component. Alternatively, the cam may be a separate molded clip piece retrofitted to the needle protective housing, for example at a lower portion at the back wall of the housing. For such retrofitting, respective retainer mechanisms are provided or integrated to the housing and the cam. The respective retainer mechanisms at the housing and the cam clip may be corresponding aperture/anchor formed at those components. 
         [0008]    The instant invention is therefore directed to an apparatus that comprises a base with a needle end to which a needle extends, a needle protective housing pivotably connected to the base, a sheath non-fixedly mated to the base to cover the needle extending therefrom prior to the use thereof, the sheath having an open end that frictionally contacts the base so as not to be removable from the base without a predetermined force applied thereto longitudinally along the axis of the base or the needle in order to remove it from the base, the sheath having a circumferential lip at its open end, wherein the housing comprises finger means that are positioned below the lip of the sheath with the housing being in a first position in relative proximity to the sheath when the sheath is mated to the base and covers the needle, the finger means applying at least the predetermined force against the lip of the sheath to remove the sheath from the base when the housing is pivotally moved from the first position in a direction away from the longitudinal axis of the base or the needle toward a second position. 
         [0009]    Another aspect of the instant invention is directed to a needle assembly that comprises a base with a needle end to which a needle extends and a receptacle end adapted to connect the needle assembly to a luer of a syringe, a needle protective housing pivotably connected to the base, a sheath non-fixedly mated to the base to cover the needle extending therefrom prior to the use thereof, the sheath having an open end that frictionally contacts the base so as not to be removable from the base without a predetermined force applied thereto longitudinally along the axis of the base toward the needle to remove it from the base, wherein the housing comprises at least one cam positioned adjacent to the opening of the sheath with the housing being in a first position in relative proximity to the sheath when the sheath is mated to the base and covers the needle, the cam applying at least the predetermined force against the sheath to remove the sheath from the base when the housing is pivotally moved from the first position toward a second position away from the longitudinal axis of the base. 
         [0010]    Yet another aspect of the instant invention is directed to a device for removing a sheath from the needle assembly having a base to which the sheath is removably mated, the sheath covering a needle extending from the base, the sheath having an open end that frictionally contacts the base so as not to be removable from the base without a predetermined force applied thereto longitudinally along the axis of the base toward the needle, the sheath having a circumferential lip at its open end, the device comprising a needle protective housing pivotably connected to the base having at least one cam positioned below the lip of the sheath with the housing being at a first position in relative proximity to the sheath when the sheath is mated to the base and covers the needle, the cam applying at least the predetermined force against the sheath to remove the sheath from the base when the housing is pivotally moved from the first position toward a second position away from the longitudinal axis of the base. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0011]    The present invention will become more apparent and the invention itself will be best understood by reference to the following description of an embodiment of the invention taken in conjunction with the following drawings, wherein: 
           [0012]      FIG. 1   a  is a side view of a syringe fitted with a needle assembly of the instant invention; 
           [0013]      FIG. 1   b  is an enlarged perspective view of the needle assembly of the instant invention, as attached to the luer end of a syringe; 
           [0014]      FIG. 2   a  is a side view of a needle assembly of the instant invention; 
           [0015]      FIG. 2   b  is an enlarged view of the circled portion of the  FIG. 2   a  needle assembly; 
           [0016]      FIG. 2   c  is a plan view showing the interior of the housing of the  FIG. 2   a  needle assembly and the connection of the housing with the cam mechanism to the needle base; 
           [0017]      FIG. 2   d  is an enlarged view of the circled portion of the needle assembly shown in  FIG. 2   c;    
           [0018]      FIGS. 3   a - 3   c  show a syringe fitted with the sheath removal apparatus of the instant invention and in particular show the movement of the needle protective housing traveling from a position proximate to the sheath to a position away from the sheath, and the corresponding movements of the sheath during its removal; 
           [0019]      FIGS. 4   a - 4   c  illustrate the removal of a sheath from the needle hub by a cam mechanism extending from the back wall of the needle protective housing; 
           [0020]      FIG. 5   a  is a plan view of a needle protective housing; 
           [0021]      FIG. 5   b  is a side view of the needle protective housing of  FIG. 5   a;    
           [0022]      FIG. 5   c  is an end view from the proximal end of the  FIG. 5   a  housing; 
           [0023]      FIG. 5   d  is a perspective view of the  FIG. 5   a  housing; 
           [0024]      FIG. 6   a  is a perspective view of a cam mechanism in the form of a clip combinable with the needle protective housing of  FIGS. 5   a - 5   d;    
           [0025]      FIG. 6   b  is a plan view looking into the interior of the  FIG. 6   a  cam mechanism; 
           [0026]      FIG. 6   c  is a side view of the  FIG. 6   a  cam mechanism; 
           [0027]      FIG. 6   d  is an end view of the  FIG. 6   a  cam mechanism showing the fingers of the cam mechanism; 
           [0028]      FIG. 6   e  is another end view of the  FIG. 6   a  cam mechanism; 
           [0029]      FIG. 7  is a side view illustration of an exemplar needle assembly of the instant invention in which the needle protective housing of  FIGS. 5   a - 5   d  is fitted with the cam mechanism of  FIGS. 6   a - 6   e,  with the needle protection housing shown at a position where the sheath is being removed from the needle hub; and 
           [0030]      FIG. 8  is a perspective view of the device of  FIG. 7  sans the sheath shown in  FIG. 7 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0031]    With reference to  FIGS. 1   a - 1   b  and  FIGS. 2   a - 2   b,  a first embodiment of a needle device that has the one-handed sheath removal apparatus is shown. In particular, a needle mechanism in the form of a needle assembly  2  coupled to a syringe  4  is shown to have a needle base  6  to which a needle or cannula  8  extends from a needle hub  6   a  that is at a distal or patient end of base  6 . Base  6  further includes a proximal end  6   b  that has a luer that allows needle assembly  2  to be matingly coupled to a counterpart luer end of a syringe, such as  4  shown in  FIGS. 1   a  and  1   b.    
         [0032]    Needle assembly  2  for the instant invention is further shown to include a needle protective housing  10  that has a main portion  10   a  that, as best shown in  FIG. 3   b,  has a slot  12  that allows needle  8  to pass into housing  10 , when housing  10  is pivoted in the direction as indicated by directional arrow  14 . Housing  10  also has a lower portion  10   b  that is pivotally connected to base  6 , by way of a living hinge  16 . As best shown in the enlarged illustration of the circled portion  18  of  FIG. 2   b,  there is a finger means in the shape of a cam  20  having a finger portion  22   a  that extends from the lower edge of the lower portion  10   b  of housing  10 . In  FIG. 2   b,  finger  20   a  is shown to be pointed upwards toward the tip of needle  8 . For the needle assembly  2  shown in  FIGS. 2   a - 2   d,  a needle sheath that is mated to base  6  for covering needle  8  prior to needle  8  being used is not shown. Such sheath is shown in  FIGS. 1   a  and  1   b  with designation  22 . 
         [0033]    With reference to  FIG. 2   c,  housing  10  is shown to have a back wall  10   c  and two sidewalls  10   d  and  10   d ′ that together form an enclosed portion  10   c,  with a slot  12  formed thereat to allow needle  8  to pass into housing  10 , when housing  10  is pivoted in the direction as indicated by directional arrow  14 . As further shown, cam  10  extends from the lower edge of the lower portion  10   b  of housing  10  so as to be substantially in the middle of housing  10 . The lower edge of housing  10  is designated  10   e  in the enlarged circled illustration  24 , per shown in  FIG. 2   d.  The illustration in  FIG. 2   d  further shows two hooks  26   a  and  26   b  that extend from a rib  28  that extends from the patient end  6   a  of base  6 . As best shown in  FIG. 2   c,  there are four ribs  28  extending from the patient end  6   a  of the needle hub. As shown in  FIG. 2   d,  one of the ribs  28 ′ faces housing  10 . In practice and for the discussion of this invention, ribs  28  may be referred to as a part of the needle hub, or the patient end or the needle end of base  6 . 
         [0034]    Two loops  30   a  and  30   b  that extend from back wall  10   c  of housing  10  are shown in  FIG. 2   c.  Housing  30   a  and  30   b  come into contact with and lockingly mate to hooks  26   a  and  26   b,  respectively, when housing  10  is pivotally moved along the direction indicated by directional arrow  14 , after needle  8  has passed into the interior of housing  10  and housing  10  substantially is in alignment along the longitudinal axis  32  that runs through needle  8  and base  6 . 
         [0035]      FIGS. 1   a  and  1   b  show the attachment of needle assembly  2  to a syringe  4 . The needle assembly  2  shown in  FIGS. 1   a  and  1   b  is an alternative embodiment of the needle assembly  2  shown in  FIGS. 2   a - 2   d.  For the further discussion of the instant invention, elements that are the same or have the same functionality for the different disclosed embodiments are labeled the same. 
         [0036]    The needle assembly  2  shown in  FIGS. 1   a  and  1   b,  and illustrated in  FIGS. 3   a - 3   c,  is different from the needle assembly  2  shown in  FIGS. 2   a - 2   d  in that the cam mechanism for the  FIGS. 1   a - 1   b  embodiment comprises two finger means each extending from a corresponding one of the sidewalls of needle protective housing  10 . As particularly shown in  FIGS. 1   a  and  1   b,  at sidewall  10   d ′ of housing  10  there is extended a cam  34  that has a tip or finger  34   a  that is positioned below the lip  22   a  at the opening or open end of sheath  22 . As shown, lip  22   a  has a surface  22   b  that is above or adjacent to finger  34   a  of cam  34 . In other words, finger  34   a  of cam  34  is below lip  22   a  of sheath  22 . In practice, finger  34   a  may be adjacent to or be in contact with surface  22   b  of lip  22   a  of the sheath  22 . In the position shown in  FIGS. 1   a  and  1   b,  housing  10  is at an angle in relative proximity to the sheath  22 , which is covering needle  8  and is frictionally coupled to base  6  of the needle assembly  2 . 
         [0037]      FIGS. 3   a - 3   c  illustrate the removal of sheath  22  from needle assembly  2 . Such removal is done in a one-handed fashion by a user, with the user holding the body of syringe  4  with the palm of her hand and a number of her fingers, and moving needle protective housing  10  with one of her digits, for example her thumb per the direction indicated by directional arrow  36 . As housing  10  is moved from where it is in close proximity to sheath  22  towards another position substantially at right angle from longitudinal axis  32 , cam fingers  34   a  that extend from each of the sidewalls  10   d  and  10   d ′ at the lower portion of housing  10  would first come into contact with surface  22   d  of lip  22   a  (if they are not already in contact with surface  22   d ), and then push against lip  22   a  and therefore sheath  22  with an upwards force. As long as the movement of housing  10  in the direction of directional arrow  36  produces a force via the cams against sheath  22  that exceeds the predetermined force that holds sheath  22  in frictional contact connection to base  6  of the needle assembly, sheath  22  is disengaged from base  6 . With housing  10  at the position shown in  FIG. 3   b,  the open end of sheath  22  is no longer in frictional engagement with base  6 . Sheath  22  can then readily be removed, as for example by the user turning syringe  4  upside down or sideways so that the sheath can slide off or fall off from the needle assembly. The ejection removal of sheath  22  from needle assembly  2  is shown in  FIG. 3   c,  whereby the removal force by the cams is such that housing  10  may actually be popped off from base  6 . 
         [0038]    As illustrated in  FIGS. 3   b  and  3   c,  sheath  22  is disengaged from base  6 , and housing  10  has been moved to a second position that is substantially orthogonal to the longitudinal axis  32 . But it should be appreciated that the location of the position of housing  10  when sheath  22  is disengaged from base  6  is dependent to a large extent on the design of cam  34 , as finger  34   a  of cam  34  may well be designed to angle in such a way relative to the lip of sheath  22  that housing  10  may only need to be moved to a second position that is 45°, or some other degree less than 90°, from the longitudinal axis  32  in order to force sheath  22  to be disengaged from base  6 . 
         [0039]      FIGS. 4   a - 4   c  are illustrations of the removal of sheath  22  from base  6  of the needle assembly  2  by the use of the cam mechanism shown in  FIGS. 2   a - 2   d.  In particular, the single cam  20  that extends from the bottom edge of housing  10  is positioned below lip  22   a  of sheath  22 , when housing  10  is in a close proximity position relative to sheath  22 , per shown in  FIG. 4   a.  With the user holding syringe  4  and probably plunger  4   a  with possibly her index, middle and ring fingers, the user can use her thumb to move housing  10  to the second position shown in  FIGS. 3   b  and  3   c  to forcedly disengage sheath  22  from base  6  of the needle assembly. 
         [0040]    Although the needle assembly  2  and syringe  4  shown in  FIGS. 1   a - 1   b,    3   a - 3   c  and  4   a - 4   d  are separate components, it should be appreciated that the cam mechanism provided at housing  10  may be incorporated into a fixed needle syringe where needle  8  extends from the needle hub that is part of a syringe. In other words, the fixed needle syringe is a one-piece syringe that includes the needle hub and the syringe body into which the plunger is inserted, with the needle of the syringe mounted to the needle hub to be in fluid communication with the interior of the barrel of the syringe. For the fixed needle syringe embodiment, there is no luer end  4   b  that is present in a conventional syringe, per shown by the illustrated syringe  4  in  FIGS. 3   a - 3   c.  However, the needle of a fixed needle syringe continues to be covered by a sheath, and the needle protective housing with the cam mechanism of the instant invention may be either mounted about the needle hub or the distal end of the syringe, or be molded together with the syringe to effect a one piece unitary fixed needle syringe with the cam fingered needle protective housing of the instant invention. 
         [0041]    The cam mechanism is an integral extension of housing  10  in that housing  10  and base  6  are molded as a one piece unit from a single mold. Color pigments may be added to the plastics molding material so that the one piece needle assembly may be molded to have a color that corresponds to the gauge of the needle extending from the needle end of the needle assembly. Thus, be the cam mechanism the unitary finger that extends from the back wall of the housing per shown in  FIGS. 2   a - 2   d  or the opposing cams that extend from each sidewall of the housing per shown in  FIGS. 1   a - 1   b  and  3   a - 3   c,  the cam mechanism disclosed thus far is an integral extension of the needle protective housing  10 . 
         [0042]    Instead of being an integral extension of housing  10 , the cam mechanism may be a separate component that is retrofitted to housing  10  of a needle device to allow one handed removal of the sheath that covers the needle at the needle device prior to its use. 
         [0043]    For ease of illustration, housing  10  is shown by itself in  FIGS. 5   a - 5   d.  As shown, needle protective housing  10  has an upper closed end portion  10   a  and a lower portion  10   b  that has sidewalls  10   d  and  10   d ′. As best shown in  FIG. 5   a,  a slot  12  allows the needle to pass through is provided at upper portion  10   a  and two loops  30   a  and  30   b  that engage the anchors  26   a  and  26   b  ( FIG. 2   d ) to fixedly hold housing  10  to base  6  are provided at lower portion  10   d.  For a more securement of needle  8 , a hook  36  may also be formed inside housing  10  for grasping needle  8 , when the housing is pivotally moved to cover needle  8 . There is an aperture  38  ( FIG. 5   a ) at the lower portion of back wall  10   c  of housing  10 . 
         [0044]      FIGS. 6   a - 6   e  show an add-on cam, in the form of a clip attachable to housing  10 , for effecting the cam mechanism of the instant invention. In particular, clip  40  has a back wall  40   a  and two sidewalls  40   b  and  40   b ′. The sidewalls  40   b  and  40   b ′, as well as back wall  40   a,  are configured to enable clip to conform to the back and sidewalls at the lower portion  10   b  of housing  10 . At each of sidewalls  40   b  and  40   b ′ there is a cam portion  42  and  42   a,  respectively. Cams  42  and  42   a  have respective fingers  42 ′ and  42   a ′. There is moreover extending from back wall  40   a  an anchor  44  that may be made of two pieces  44   a  and  44   b  ( FIG. 6   b ) that have an enlarged upper portion with a reduced portion  44   c  ( FIGS. 6   d  and  6   e ) configured to fit into aperture  38  ( FIG. 5   a ) of housing  10  so as to securely couple clip  40  to the lower portion of housing  10  when clip  40  is press-fitted to housing  10 . 
         [0045]      FIGS. 7 and 8  each illustrate housing  10  having fixedly coupled thereto clip  40 . As shown in  FIG. 7 , sheath  22  has been substantially disengaged from base  6  by finger  42 ′ of cam  42  (and the not shown opposed finger  42   a ′ of cam  42   a ) so that sheath  22  is freely resting on base  6  and also cams  42  and  42   a.    FIG. 8  shows a perspective view of the needle assembly of  FIG. 7  with the sheath having been removed. 
         [0046]    Even though different embodiments of the inventive needle assembly have been shown in  FIGS. 2   a  and  2   d  and  FIGS. 7 and 8 , it should be appreciated that the one handed automatic sheath removal mechanism of the instant invention may also be adapted to be used in other needle devices such as a vacuum tube holder that is disclosed in the above-mentioned U.S. Pat. Nos. 5,139,489 and 5,277,311. The disclosures of the &#39;489 and &#39;311 patents are incorporated by reference herein.