Abstract:
An apparatus having a syringe body, a plunger, a guard, a biasing member, a needle, and a release mechanism is described. In some versions, the release mechanism may include a flexible hinge mechanism. In some versions, the guard may have a retracted position and an extended position in communication with the flexible hinge mechanism. In some versions, the guard may have a first position and a second position in communication with a release mechanism.

Description:
PRIORITY 
       [0001]    This application claims priority to U.S. Nonprovisional patent application Ser. No. 12/256,139, filed Oct. 22, 2008, entitled “Syringe Guard for Pre-Filled Medicament Vial” and U.S. Nonprovisional patent application Ser. No. 11/211,336, filed Aug. 25, 2005, entitled “Syringe Guard for Pre-Filled Medicament Vial,” the disclosures of which are herein incorporated by reference in their entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention pertains generally to fluid infusion devices. More particularly, the present invention pertains to fluid infusion devices that include an automatically activated guard for covering and protecting the needle of the device after its use. The present invention is particularly, but not exclusively, useful as a syringe, with a needle guard, where the syringe is engageable with a pre-filled fluid vial to establish a fluid infusion device. 
       BACKGROUND OF THE INVENTION 
       [0003]    Fluid medicaments, as well as other commercially available fluids, can be purchased in a variety of different type containers. The container of particular interest here, however, is the pre-filled vial. Typically, such a container/vial is made of glass, and is formed as a hollow cylindrical tube that has two open ends. One end can then be closed with a plug, and a stopper can be inserted through the opposite end to create a fluid chamber in the vial between the plug and the stopper. Thus, the chamber of the container/vial can then be filled with a predetermined amount of a desired fluid (e.g. a fluid medicament). 
         [0004]    For the context wherein a container, such as the pre-filled fluid vial described above, is to be used for an infusion of fluid, the fluid must somehow be brought into fluid communication with a needle. Heretofore, a typical procedure for accomplishing this purpose has been to penetrate the stopper of the container/vial with a hypodermic needle. Fluid in the vial is then evacuated from the fluid chamber of the vial. In this example, the fluid is caused to flow through the needle and into the fluid chamber of a syringe. The now-filled syringe can then be disengaged from the vial and used for an infusion. The procedure just described, however, is somewhat cumbersome. In particular, this is so because the filling of the syringe, and the infusion of the fluid are performed as two separate and distinct operations. And, as such, each has its own attendant hazards. Further, with the increased awareness of communicable diseases (e.g. AIDS), the protection of the user from unwanted needle sticks has become of paramount importance. The consequence here is that the commercial potential for using pre-filled fluid vials may be enhanced by reducing the number of required manipulations in a procedure, and by directly incorporating pre-filled fluid vials into systems/devices that automatically protect the user from unwanted or inadvertent needle sticks. 
         [0005]    In light of the above, it is an object of the present invention to provide a device which can be engaged with a pre-filled fluid vial for infusing fluid directly from the vial. Another object of the present invention is to provide a device for infusing a fluid medicament that automatically protects the user from unwanted or inadvertent needle sticks after the fluid from a pre-filled fluid vial has been infused. Yet another object of the present invention is to provide a device for infusing fluid from a pre-filled vial that is easy to use, is relatively simple to manufacture, and is comparatively cost effective. 
       SUMMARY OF THE INVENTION 
       [0006]    In accordance with the present invention, a device is provided for expelling fluid from a pre-filled vial, through a needle. As envisioned for the present invention, the pre-filled fluid vial will have a hollow, cylindrical-shaped, glass wall, with a plug covering one of its open ends. A stopper will be inserted into the other open end of the cylindrical wall to thereby create a fluid chamber in the vial for holding fluid therein between the plug and the stopper. 
         [0007]    Structurally, the device of the present invention includes a hollow, cylindrical-shaped syringe body that is formed with a lumen and has an open proximal end, and an open distal end. Thus, the syringe body defines a longitudinal axis that extends between the two ends. Further, an elongated adapter is axially aligned within the syringe body, and it is fixedly mounted in the lumen of the syringe body. As so mounted, a space is created between the adapter and the syringe body. 
         [0008]    For the device of the present invention, the adapter is substantially cylindrical in shape, and it is formed with a lumen. Additionally, a hollow needle is mounted in the lumen of the adapter such that the needle extends along the longitudinal axis of the syringe body. Importantly, the adapter is formed with both a proximal hinge, and a distal hinge. Both of these hinges are so-called “living” hinges, and they are longitudinally aligned with each other. The adapter is also formed with at least one slot that extends along its length. 
         [0009]    In addition to the needle, a guard is also mounted in the lumen of the adapter. Specifically, the guard is cylindrical shaped and it is positioned within the lumen of the adapter for axial movement over the needle between a first position and a second position. In its first position, the guard is held within the syringe body to expose a distal portion of the needle as it extends beyond the distal end of the syringe body. Structurally, the guard is held in the first position by a flexible hinge lock on the guard that engages with the adapter. Upon release of the hinge lock, however, the guard moves distally into its second position. In its second position, the guard extends beyond the distal end of the syringe body, to cover the distal portion of the needle. For the device of the present invention, this distal movement of the guard in the axial direction is caused by a spring that is located between the adapter and the guard to push distally against the guard. This movement, however, is limited by a tab on the guard that extends into the slot of the adapter. 
         [0010]    In operation, the fluid vial is first engaged with the proximal end of the syringe body. With this engagement, the proximal end of the needle pierces the stopper in the vial. This then establishes fluid communication between the fluid chamber of the vial and the needle. Also, during this engagement, the wall of the vial is introduced into the space between the syringe body and the adapter. Subsequently, as the wall of the vial is advanced distally into the space between the syringe body and the adapter, it activates the proximal hinge of the adapter. When activated, the proximal hinge of the adapter releases the hinge lock of the guard for movement of the guard in the distal direction. As indicated above, this causes the guard to extend beyond the distal end of the syringe body to cover and protect the distal end of the needle. It is to be noted here, however, that if the needle is being used for an infusion, the body into which the infusion is being made may prevent the guard from making its full distal movement. Next, as further distal movement of the wall of the vial is made during the infusion, the wall repositions the distal hinge of the adapter to prevent a subsequent proximal movement of the guard. Thus, subsequent to an infusion, and after the needle has been withdrawn from the body being infused, the guard remains extended beyond the distal end of the syringe body. This causes the guard to cover the needle and to thereby protect against accidental of inadvertent sticks by the needle. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which: 
           [0012]      FIG. 1  is a view of an assembled device for infusing fluids from a pre-filled vial, in accordance with the present invention; 
           [0013]      FIG. 2  is an exploded perspective view of the component elements of the device; 
           [0014]      FIG. 3  is a cross section view of a pre-filled vial for use with the device of the present invention as seen along the line  3 - 3  in  FIG. 1 ; 
           [0015]      FIG. 4  is an elevation view of the device of the present invention ready for use with a pre-filled vial, and with portions broken away for clarity; 
           [0016]      FIG. 5A  is an elevation view of a device in accordance with the present invention when it is engaged with a pre-filled vial and ready for use in an infusion procedure, again, with portions of the device broken away for clarity; 
           [0017]      FIG. 5B  is a view of the device shown in  FIG. 5A  during an infusion procedure, when configured with the vial engaging the adapter of the device to release the guard of the device for its distal movement; and 
           [0018]      FIG. 5C  is a view of the device shown in  FIGS. 5A and 5B , after an infusion procedure. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0019]    Referring initially to  FIG. 1 , a device for expelling fluid from a pre-filled vial is shown and is generally designated  10 . As shown, the device  10  includes a syringe body  12  that is engaged with a pre-filled vial/container  14 . In accordance with the discussion below, it will be appreciated that the device  10  is useful for expelling fluid from the vial  14 , and through a hollow needle  16 , during an infusion procedure. Further, it will also be appreciated that the device  10  provides structure for covering the needle  16  after the infusion procedure has been completed. The purpose here is to prevent accidental or inadvertent sticks with the needle  16  that might otherwise occur after using the device  10 . Preferably, the needle  16  is made of a stainless steel type material. 
         [0020]    The various structural components of the device  10  will, perhaps, be best appreciated with reference to  FIG. 2 . There it can be seen that the pre-filled vial  14  includes a hollow cylindrical wall  18  that has both an open proximal end  20  and an open distal end  22 . Further, the vial  14  includes a plug  24  and a stopper  26 . When the vial  14  is assembled, as shown in  FIG. 3 , the plug  24  is positioned to cover the proximal end  20 , and the stopper  26  is inserted through the distal end  22 . Thus, a fluid chamber  28  is created for the vial  14 . A fluid (e.g. a fluid medicament) can then be held inside the fluid chamber  28  that is surrounded by the wall  18  and enclosed by the plug  24  and the stopper  26 . As intended for the device  10 , the stopper  26  is moveable within the vial  14 , and the wall  18  is preferably made of a rigid transparent material, such as glass. 
         [0021]    Still referring to  FIG. 2 , it will be seen that the device  10  includes an adapter  30 . As shown, the adapter  30  is elongated and is substantially cylindrical in shape. It is also shown in  FIG. 2  that the adapter  30  is formed with a proximal hinge  32  and a distal hinge  34 . For purposes of the present invention, both of the hinges  32  and  34  are so-called “living” hinges, in that they are integral with the adapter  30 . It is also seen in  FIG. 2  that the adapter  30  is formed with a slot  36  that extends longitudinally along the adapter  30 . Actually, the adapter  30  can have two such slots that are diametrically opposite each other (one such slot, however, is not shown in  FIG. 2 ). Further, the adapter  30  is formed with a series of circumferentially oriented structural detents  38 . Also, in conjunction with the proximal hinge  32 , the adapter  30  is formed with a slit  40  into which the hinge  32  can be deflected. As shown, the slit  40  creates an abutment  42  at its distal end. 
         [0022]    To best appreciate how the needle  16  and the adapter  30  are mounted on the syringe body  12 , it is necessary to cross reference  FIG. 2  with  FIG. 4 . With this cross-reference, it can be seen that the needle  16  is fixedly held at the proximal end  44  of the adapter  30  (see  FIG. 4 ). Also, it can be seen that the detents  38  at the distal end  46  of the adapter  30  are fixedly engaged with the syringe body  12  (see  FIG. 2 ). A consequence of this arrangement is that a space  48  is created between the adapter  30  and the syringe body  12 . 
         [0023]      FIG. 2  also shows that the device  10  includes a guard  50 . Specifically, the guard  50  is a hollow, substantially cylindrical-shaped structure that defines a lumen  52 , and that has diametrically opposed tabs  54  (one such tab  54  is not shown). Additionally, and importantly, the guard  50  is formed with a hinge lock  56 . In its cooperation with the adapter  30 , the guard  50  is inserted into the lumen  58  of the adapter  30 , over the needle  16 . More specifically, the guard  50  inserted into the lumen  58  until the hinge lock  56  of guard  50  extends through the slit  40  of adapter  30 , for engagement of the hinge lock  56  with the abutment  42 . In this combination, a spring  60  (see  FIG. 4 ) is positioned between the guard  50  and the proximal end  44  of the adapter  30  to urge the guard  50  in a distal direction. This, of course, also urges the hinge lock  56  against the abutment  42  to hold the guard  50  in the position shown in  FIG. 4 . 
         [0024]    With the guard  50  engaged to the adapter  30  as described above, and with the adapter  30  mounted on the syringe body  12  as also described above, the needle  16  will be longitudinally aligned along the axis  61  that is defined by the syringe body  12  (see  FIG. 2 ). A proximal shield  62  can then be engaged with the syringe body  12  to cover and protect the proximal end  64  of the needle  16 . Similarly, a distal shield  66  can be engaged with the syringe body  12  to cover and protect the distal end  68  of the needle  16 . The result is a combination of components as shown in  FIG. 4 . 
         [0025]    In the operation of the device  10  of the present invention, the proximal shield  62  is removed from the syringe body  12  to expose the proximal end  64  of the needle  16 . The pre-filled vial  14  is then engaged with the syringe body  12 . Specifically, with this engagement, the proximal end  64  of the needle  16  penetrates through the stopper  26  to establish fluid communication between the needle  16  and fluid in the chamber  28  of vial  14 . Also, with this engagement, the end  22  of wall  18  of the vial  14  is positioned in the space  48  between the syringe body  12  and the adapter  30 . The distal shield  66  can then be removed from the syringe body  12  to expose a distal portion of the needle  16 , as shown in  FIG. 5A . The device  10  is now ready for an infusion procedure. 
         [0026]    To perform an infusion procedure, with the device  10  in the configuration shown in  FIG. 5A , the distal end  68  of the needle  16  is penetrated into the body that is to be infused (not shown). The pre-filled fluid vial  14  is then advanced distally along the axis  61 , and into the syringe body  12 . With this advancement, the end  22  of wall  18  comes into contact with the proximal hinge  32  of adapter  30  (see  FIG. 5B ). This contact then causes the proximal hinge  32  to deflect into the slit  40  of the adapter  30 , and against the hinge lock  56  of the guard  50 . In turn, this deflection moves the hinge lock  56  from its position against the abutment  42  of adapter  30 . This frees the guard  50  for distal movement along the axis  61  under the influence of spring  60 . As stated above, a full distal movement of the guard  50  may not occur at this time due to contact between the guard  50  and the body (not shown) into which the needle  16  may be penetrated. 
         [0027]    As the pre-filled vial  14  is further advanced from its position in  FIG. 5B  to the position shown in  FIG. 5C , the end  22  of wall  18  comes into contact with the distal hinge  34  of the adapter  30 . This contact then causes the distal hinge  34  to be deflected and held in a position wherein it, the hinge  34 , will block any return movement of the guard  50  in a proximal direction. Consequently, when the device  10  is configured as shown in  FIG. 5C , and the guard  50  is no longer constrained to move distally, the hinge  34  and syringe body  12  cooperate to block a proximal movement of the guard  50 . This causes the guard  50  to remain in place over the distal end  68  of the needle  16 , to thereby prevent accidental or inadvertent “sticks”. 
         [0028]    While the particular Syringe Guard for Pre-Filled Medicament Vial as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.