Abstract:
A needle dispensing system including a pen-type hypodermic syringe having a threaded end that is suitable for mating with a needle assembly having a threaded portion that is complementary to the threaded end of the syringe and located within a closed pod. A hand tool is provided for controlling the pod that includes a collet sized so as to releasably grip a portion of the closed pod for opening. The hand tool also includes a radiused guard that helps to prevent inadvertent needle sticks during use, and a biased release button the actuation of which causes the opened pod to be released from the collet. A hand tool is also provided for controlling a container holding a disposable needle assembly that includes a housing that supports a collet that is sized so as to releasably grip a portion of the container for opening, and a biased release button the actuation of which causes the opened pod to be released from the collet.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention generally relates to patient controlled injection systems and, more particularly to patient operated hypodermic syringes that often have the general appearance of a pen and that require periodic removal and replacement of a needle portion of the hypodermic syringe. 
       BACKGROUND OF THE INVENTION 
       [0002]    Home treatment methods for the control and management of various diseases are becoming more popular, with high success rates being achieved for treatment of diabetes when a patient controls the disease by self-testing blood glucose levels and administering a correct dose of insulin. Between doctor&#39;s office visits, the patient is responsible for carrying out the prescribed regimen, which often includes frequent insulin injections using a syringe. Traditionally, patients were required to insert the needle of the syringe into a separate medication vial to withdraw medication, and once the medication is withdrawn from the vial, remove any air bubbles or extra medication, and then inject the medication. 
         [0003]    Typical syringes were not be preloaded with medication; thus, requiring the patient to carry a separate medication vial. Also, people with dexterity disorders often had difficulty lining up the needle portion of the syringe with the rubber septum on the medication vial. This lead to unintentional needle pricks or excessive time being required to complete an injection. Pen-type injectors that often incorporate prepackaged insulin have been developed for the foregoing patients. A disadvantage to pen-type injectors is that the disposable needles must be removed from the pen injector assembly after use. Individuals with limited dexterity or eyesight have often found this procedure to be difficult, and sometimes dangerous, due to unintentional needle jabs. 
       SUMMARY OF THE INVENTION 
       [0004]    In one embodiment, the present invention provides a needle dispensing system including a pen-type hypodermic syringe having a threaded end that is suitable for mating with a needle assembly having a threaded portion that is complementary to the threaded end of the syringe and located within a closed pod. A hand tool is provided for controlling the pod that includes a collet sized so as to releasable grip a portion of the closed pod for opening. The hand tool also includes a biased release button the actuation of which causes the opened pod to be released from the collet. 
         [0005]    In another embodiment of the invention, a hand tool is provided for controlling a container holding a disposable needle assembly that includes a housing that supports a collet that is sized so as to releasably grip a portion of the container for opening, and a biased release button the actuation of which causes the opened pod to be released from the collet. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0006]    These and other features and advantages of the present invention will be more fully disclosed in, or rendered obvious by, the following detailed description of the preferred embodiment of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts and further wherein: 
           [0007]      FIG. 1  is a perspective view of a needle dispenser system formed in accordance with one embodiment of the invention, with a pen-type personal syringe having a needle assembly threaded onto a distal end, and positioned above a needle-pod receptacle having a now empty needle-pod received within a receptacle opening; 
           [0008]      FIG. 2  is a broken-away, perspective view of a needle assembly threaded onto a distal end of the pen-type personal syringe system shown in  FIG. 1 ; 
           [0009]      FIG. 3  is a broken-away, perspective view of the pen-type personal syringe system shown in  FIG. 2 , with a needle guard removed from a distal portion of a hypodermic needle; 
           [0010]      FIG. 4  is a perspective view of a pen-type personal syringe system of the type used in connection with the present invention; 
           [0011]      FIG. 5  is a perspective view of a pen-type personal syringe system of the type used in connection with the present invention with its cap removed; 
           [0012]      FIG. 6  is a perspective view of a needle-pod receptacle formed in accordance with the present invention having a needle-pod positioned above it ready for insertion; 
           [0013]      FIG. 7  is a cross-sectional view of a needle-pod and needle-pod receptacle shown in  FIG. 6 ; 
           [0014]      FIG. 8  is a perspective view of a needle-pod receptacle having a needle-pod received within a receptacle opening; 
           [0015]      FIG. 9  is a perspective view similar to that shown in  FIG. 8 , with a foil seal being removed so as to provide access to the needle assembly within the needle-pod; 
           [0016]      FIG. 10  is a perspective view of a needle-pod receptacle formed in accordance with the present invention; 
           [0017]      FIG. 11  is a side view of the needle-pod receptacle shown in  FIG. 10 ; 
           [0018]      FIG. 12  is a further side view of the needle-pod receptacle shown in  FIG. 10 , rotated by about ninety degrees from the side view shown in  FIG. 11 ; 
           [0019]      FIG. 13  is a top view of the needle-pod receptacle shown in  FIG. 10 ; 
           [0020]      FIG. 14  is a bottom view of the needle-pod receptacle shown in  FIG. 10 ; 
           [0021]      FIG. 15  is a cross-sectional view of a needle-pod receptacle having a needle-pod received within a receptacle opening as shown in  FIG. 8 ; 
           [0022]      FIG. 16  is a perspective view of a pen-type personal syringe system of the type used in connection with the present invention, with its cap removed, and positioned above a needle-pod receptacle having a needle-pod received within a receptacle opening; 
           [0023]      FIG. 17  is a perspective view of a pen-type personal syringe system of the type used in connection with the present invention being rotated into threaded engagement with a portion of a needle-pod received within a receptacle opening of a needle-pod receptacle; 
           [0024]      FIG. 18  is a broken-away, cross-sectional view of the pen-type personal syringe system arranged in threaded engagement with a portion of a needle-pod received within a receptacle opening of a needle-pod receptacle, as shown in  FIG. 17 ; 
           [0025]      FIG. 19  is a perspective view of the pen-type personal syringe system, with a distal portion of a hypodermic needle exposed for use; 
           [0026]      FIG. 20  is a perspective view of a pen-type personal syringe system, with a distal portion of a hypodermic needle exposed after use, and positioned above a needle-pod receptacle having a needle-pod received within a receptacle opening; 
           [0027]      FIG. 21  is a broken-away, cross-sectional view of the pen-type personal syringe system arranged in threaded engagement with a portion of a needle-pod received within a receptacle opening of a needle-pod receptacle; 
           [0028]      FIG. 22  is a perspective view of a needle-pod receptacle having a needle-pod received within a receptacle opening; 
           [0029]      FIG. 23  is a bottom view of the needle-pod receptacle shown in  FIGS. 21 and 22 ; 
           [0030]      FIG. 24  a cross-sectional view of a needle-pod receptacle having a refilled needle-pod received within a receptacle opening with a finger about to actuate the pod-release assembly; and 
           [0031]      FIG. 25  a cross-sectional view of a needle-pod receptacle similar to that shown in  FIG. 24 , having showing the pod-release assembly fully actuated so as to release the refilled needle-pod from within the receptacle opening of the needle-pod receptacle. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0032]    This description of preferred embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description of this invention. The drawing figures are not necessarily to scale and certain features of the invention may be shown exaggerated in scale or in somewhat schematic form in the interest of clarity and conciseness. In the description, relative terms such as “horizontal,” “vertical,” “up,” “down,” “top” and “bottom” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing figure under discussion. These relative terms are for convenience of description and normally are not intended to require a particular orientation. Terms including “inwardly” versus “outwardly,” “longitudinal” versus “lateral” and the like are to be interpreted relative to one another or relative to an axis of elongation, or an axis or center of rotation, as appropriate. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. The term “operatively connected” is such an attachment, coupling or connection that allows the pertinent structures to operate as intended by virtue of that relationship. In the claims, means-plus-function clauses, if used, are intended to cover the structures described, suggested, or rendered obvious by the written description or drawings for performing the recited function, including not only structural equivalents but also equivalent structures. 
         [0033]    Referring to  FIGS. 1-6 , needle dispenser system  3  is provided that includes a patient operated hypodermic syringe  5 , that often has the general appearance of a pen, and requires periodic replacement of a needle assembly  7  that is provided to the patient safely housed within a needle-pod  9 , i.e., in a protective case or closed receptacle that is suitable for transporting a disposable hypodermic needle in a sterile and untampered-with condition. The periodic removal, replacement, and disposal of needle assembly  7  is facilitated through use of needle-pod-tool  10 . In some embodiments of the invention, a patient operated hypodermic syringe  5  generally includes a multi-piece housing  12  that is often adapted to receive liquid  13  such as a dose of medication, e.g., insulin, antidote, etc. A distal end  14  of housing  12  includes a threaded portion  16 . Exemplary patient operated hypodermic syringes of the type contemplated for use in the present invention may be found in U.S. Pat. Nos. 6,562,011; 6,221,046; 5,820,602; 5,584,815; 5,454,786; 5,334,162; 5,308,340; 5,295,976; 5,228,883; 5,226,895; 5,226,896, which patents are hereby incorporated herein by reference. 
         [0034]    Referring initially to  FIGS. 2-3  and  15 , needle assembly  7  includes cylindrical header  22  and a hypodermic needle  23 . Cylindrical header  22  has a blind recess  24  defined by an annular wall  26  that projects outwardly from the peripheral edge of a substantially circular base wall  28  ( FIG. 15 ). The inner surface of annular wall  26  includes a raised thread  30 , while the outer surface of annular wall  26  comprises one or more raised structures, e.g., a plurality of ribs  32 . Hypodermic needle  23  comprises an elongate, substantially cylindrical steel tube, having a proximal end and a sharpened distal end  36  that permits subcutaneous or intramuscular injection. Hypodermic needle  23  is lodged within a central portion of base wall  28  so that the proximal end projects outwardly from base wall  28  within blind recess  24 , and sharpened distal end  36  projects outwardly from the outer surface of base wall  28 . A separable needle safety cap  39  is often positioned over sharpened distal end  36  of hypodermic needle  23 . 
         [0035]    Referring to  FIGS. 6-9 ,  15 - 16 ,  18 ,  21 - 22 , and  24 - 25 , needle assembly  7  is protectively housed within needle-pod  9  which generally comprises a blind receptacle formed by a first cylindrical wall  40 , an intermediate tapered wall  42 , and a second cylindrical wall  44 . First cylindrical wall  40  defines an open end  45  that may be covered with a peel-away foil shield  47  that includes a tab  48  for easy removal from needle-pod  9 . First cylindrical wall  40  defines an inner diameter that is somewhat larger than the diameter of annular wall  26  of needle assembly  7 , but somewhat smaller than the diameter of annular wall  26  plus the one or more raised structures, such as plurality of ribs  32 . In this way, annular wall  26  may be snugly press-fit within open end  45  of needle-pod  9 . Intermediate wall  42  projects radially inwardly from the bottom end of first cylindrical wall  40 , and defines an annular shoulder  50 . Second cylindrical wall  44  projects outwardly from the center of shoulder  50 , has an end wall  52 , and is often somewhat longer and substantially larger in diameter that sharpened distal end  36  of hypodermic needle  23 . 
         [0036]    Referring to  FIGS. 1 ,  6 - 9 ,  15 ,  22 ,  24 , and  25 , needle-pod-tool  10  comprises a handle  60 , a face plate  62 , and a pod handling assembly  64 . More particularly, handle  60  includes a wall  65  having a proximal end  67 , a distal end  68 , and which defines an interior chamber  69 . In preferred embodiments, proximal portions of wall  65  have a substantially cylindrical, ergonomic shape that is suitably sized for gripping comfortably within a patient&#39;s hand. Wall  65  has a rounded proximal end edge  70  that has a first inner diameter and defines an opening  72  that is in communication with interior chamber  69 . The first inner diameter of proximal end edge  70  is somewhat smaller than the inner diameter of the next adjacent section  73  of wall  65  so as to define a first annular shoulder  74  ( FIG. 25 ). Wall  65  has a third inner diameter at distal end  68  that is somewhat larger than the inner diameter of section  73  so as to define a second inner annular shoulder  76 . 
         [0037]    The distal-most portions of wall  65  flair radially outwardly so as to form a hand guard  80 . A peripheral shoulder  82  is circumferentially defined on the peripheral edge of hand guard  80  by an annular wall  84  that projects substantially upwardly from the distal-most, flared portions of wall  65 . Hand guard  80  often includes a chordal or inwardly curved edge  81  ( FIGS. 12-14 ) and is sized so as to provide adequate protection for the user&#39;s hand during operation so as to avoid needle sticks. Face plate  62  comprises a convex disk having an outer diameter that is substantially equal to the diameter of hand guard  80 . A central opening is defined through face plate  62  by an annular wall  88  that projects outwardly from the rear, concave surface of face plate  62 . A peripheral recessed groove  86  is circumferentially defined in the inner peripheral edge of face plate  62  that is complementary to annular wall  84  of hand guard  80 . Face plate  62  also often includes a chordal or inwardly curved edge  85 . 
         [0038]    Pod handling assembly  64  includes a plunger  90 , a spring  92 , and a pod-collet  96 . Plunger  90  includes an ejector pad  100  having an outer surface  102  ( FIG. 14 ) an inner surface  104 . Outer surface  102  is limited in the radial direction by peripheral edge  106 . A post  108  projects outwardly from inner surface  104 , and is suitably sized to be received within a proximal end of a helical spring  92 . An annular wall  110  projects upwardly from the peripheral edge of inner surface  104  in radially spaced relation to post  108 . An annular ledge  112  projects radially outwardly from the outer surface of annular wall  110 . An annular wall  114  projects upwardly from the peripheral edge of annular ledge  112  in radially spaced relation to post  108 . 
         [0039]    Pod-collet  96  comprises a blind or semi-blind receptacle formed by a cylindrical grip wall  120 , an intermediate tapered wall  122 , and a elongate tapered wall  124 . Cylindrical grip wall  120  comprises a plurality of radially inwardly sloping cantilevered fingers  127  that together define an open end  130  ( FIG. 13 ) that is sized so as to allow for a gripping engagement of a portion of needle-pod  9 . In particular, the end edges  133  of cantilevered fingers  127  define an inner diameter of open end  130  that is somewhat smaller than the outer diameter of first cylindrical wall  40  of needle-pod  9  when fingers  127  are in a first position, but define a somewhat larger diameter than first cylindrical wall  40  of needle-pod  9  when in a second position. Intermediate wall  122  is tapered radially inwardly from the bottom end of cylindrical gripper wall  120 , and defines an annular shoulder  132  ( FIGS. 18 and 21 ). Elongate tapered wall  124  projects outwardly from the center of shoulder  132 , has an open, terminal end  135 , and is often somewhat longer and substantially larger in diameter than at least a portion of second cylindrical wall  44  of needle-pod  9 . The outer diameter of elongate tapered wall  124  is suitably sized to be received within a distal end section of helical spring  92 . 
         [0040]    Needle-pod-tool  10  is assembled for use in connection with the present invention in the following manner. Handle  60  is arranged so that the inner surface of hand guard  80  is directed upwardly. A plunger  90  is then positioned in confronting coaxial relation with interior chamber  69  of handle  60 . Once in this position, plunger  90  is moved toward handle  60  until peripheral edge  106  of outer surface  102  engages first annular shoulder  74  of wall  65 . Once in this position, annular ledge  112  is located in confronting relation to second inner annular shoulder  76  of handle  60 . With plunger  90  positioned within handle  60 , spring  92  is arranged in confronting coaxial relation to inner surface  104  of plunger  90  so that its proximal end slips over post  108 . Spring  92  projects outwardly from around post  108  so that its distal end is substantially coplanar with annular wall  84  of hand guard  80 . Also, chordal or inwardly curved edges  81 ,  85  complementarily line-up so as to form a stabilizer  113  ( FIG. 10 ). 
         [0041]    Pod-collet  96  is then arranged in confronting coaxial relation with the central opening of face plate  62 . Once in this position, pod-collet  96  is moved toward face plate  62  until cylindrical grip wall  120  snugly engages (press-fits) annular wall  88  that projects outwardly from the rear, concave surface of face plate  62 . With pod-collet  96  assembled to face plate  62 , the inner surface of hand guard  80  of handle  60  is brought into coaxial confronting relation with the rear, concave surface of face plate  62 . Once in this position, face plate  62  is moved toward handle  60 , so that elongate tapered wall  124  of pod-collet  96  enters the distal end of spring  92 . As this occurs, annular wall  84  engages peripheral recessed groove  86  of face plate  62 , so as to enclose interior chamber  69 . Face plate  62  is then fixedly attached along the boundary between peripheral recessed groove  86  and annular wall  84  by gluing, ultrasonic welding, or mechanical fastener, as is well-known in the art. 
         [0042]    Referring first to  FIGS. 5-9 , needle dispenser system  3  may be employed to attach a needle assembly  7  to hypodermic syringe  5  in the following manner. A needle-pod  9  is first arranged in confronting coaxial relation with opening  130  of pod-collet  96 . Once in this position, needle-pod  9  is moved toward pod-collet  96  so that second cylindrical wall  44  enters opening  130  until cantilevered fingers  127  engage the outer surface of first cylindrical wall  40  of needle-pod  9 . It will be understood that due to the difference in respective diameters of opening  130  and first cylindrical wall  40 , plurality of cantilevered fingers  127  will be biased radially outwardly by the introduction of needle pod  9  into pod-collet  96  ( FIG. 6 ). Once in this position, needle-pod  9  is firmly gripped within pod-collet  96  by plurality cantilevered fingers  127 , with a portion of second cylindrical wall  44  of needle-pod  9  snugly positioned within elongate tapered wall  124  of pod-collet  96  and another portion projecting outwardly from open end  135  ( FIGS. 15 ,  18 ,  21 ,  22  and  24 ). Tab  48  of peelable foil  47  may now be pulled back, thus exposing the top of cylindrical header  22  of needle assembly  7  ( FIGS. 8 and 9 ). 
         [0043]    With needle-pod  9  firmly positioned within pod-collet  96 , hypodermic syringe  5  may retrieve the needle assembly  7  located within needle-pod  9 . More particularly, hypodermic syringe  5  is positioned in confronting coaxial relation with needle-pod  9  ( FIG. 16 ). Hypodermic syringe  5  is then moved toward needle-pod  9 , so that threads  16  on distal end  14  engage threads  30  located on the interior surface of first cylindrical wall  40  of needle assembly  7  ( FIGS. 16-17 ). Once in this position, hypodermic syringe  5  is rotated about its longitudinal axis so that threads  16  and  30  engage one another. In this way once threads  16  and  30  are engaged with one another, movement of hypodermic syringe  5  away from face plate  62  of needle-pod-tool  10  provides sufficient force to overcome the press-fit engagement (i.e., a substantially frictional engagement) between plurality of ribs  32  on the outer surface of annular wall  26  and the inner surface of first cylindrical wall  40  of needle-pod  9  ( FIGS. 16-20 ). 
         [0044]    Hypodermic syringe  5  may then be moved to the appropriate location on the patient&#39;s body for injection of fluid  13  located within the syringe. Once the injection has been completed, needle assembly  7  may be repositioned within needle-pod  9  and thereby be removed from distal end  14  of hypodermic syringe  5 . More particularly, needle  23  along with needle assembly  7  at distal end  14  of hypodermic syringe  5  is first positioned in confronting coaxial relation with needle-pod  9 . Once in this position, hypodermic syringe  5  is moved toward needle-pod  9  so that needle assembly  7  reenters needle-pod  9  until plurality of ribs  32  re-engage the interior surface of first cylindrical wall  40 . Once in this position, hypodermic syringe  5  is rotated so as to disengage threads  16  from threads  30  ( FIGS. 20-22 ). Once threads  16  are fully disengaged from threads  30 , hypodermic syringe  5  may be withdrawn from the vicinity of needle-pod-tool  10 , recapped, and repositioned in a pocket or cabinet as desired. 
         [0045]    With now-used needle assembly  7  repositioned within needle-pod  9 , needle-pod  9  may be removed from needle-pod-tool  10  and discarded. More particularly, needle-pod-tool  10  is first positioned over an appropriate waste receptacle, such that face plate  62  is positioned in spaced confronting relation to the opening of the receptacle. In this position, ejector pad  100  of plunger  90  is visible within the center of opening  72  in handle  60 . Once in this position, the patient may press ejector pad  100  with a finger  150  so as to move plunger  90  within interior chamber  69  and move peripheral edge  106  away from first shoulder  74 . This, in turn, compressibly biases spring  92  against a portion of pod-collet  96 . As plunger  90  moves toward pod-collet  96 , post  108  engages the terminal end of elongate tapered wall  124  of needle-pod  9  that defines opening  135 . The movement of post  108  against the terminal end of elongate tapered wall  124  is sufficient to overcome the gripping force exerted by plurality of finger cantilevers  127  so as to free and dislodge needle-pod  9  from pod-collet  96  and allow it to fall safely into the receptacle. 
         [0046]    It is to be understood that the present invention is by no means limited only to the particular constructions herein disclosed and shown in the drawings, but also comprises any modifications or equivalents within the scope of the claims.