Patent Publication Number: US-10765813-B2

Title: Self injection device with multi-position cap

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a continuation of U.S. patent application Ser. No. 13/513,073, filed on Jul. 20, 2012, which is the U.S. national stage of International Application No. PCT/US10/03085, filed on Dec. 3, 2010, which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/266,697, filed Dec. 4, 2009 at the U.S. Patent and Trademark Office, the disclosures of which are incorporated herein by reference in their entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to a self-injection device, and more particularly to self-injection device with a multi-position cap. 
     BACKGROUND OF THE INVENTION 
     Medication delivery pens are hypodermic syringes used for self-injection of precisely measured doses of medication. Pens are widely used, for example, by diabetics to self-inject insulin. A typical prior art medication delivery pen includes a cartridge which contains a volume of liquid medication sufficient for several doses. The dose is injected into a tissue area, such as the intramuscular tissue layer, the subcutaneous tissue layer, or the intradermal tissue layer. 
     The assembly and operation of a typical pen injection device is described in commonly-assigned U.S. Pat. No. 7,645,264, issued on Jan. 12, 2010, which is incorporated herein by reference in its entirety. 
     Pen injection devices, such as the exemplary pen injector  50 , as shown in  FIGS. 1 and 2 , typically comprise a dose knob/button  24 , an outer sleeve  13 , and a cap  21 . The dose knob/button  24  allows a user to set the dosage of medication to be injected. The outer sleeve  13  is gripped by the user when injecting medication. The cap  21  is employed by the user to securely hold the pen injector  50  in a shirt pocket, purse, or other suitable location. 
       FIG. 2  is an exploded view of the exemplary drug delivery pen  50  shown in  FIG. 1 . The dose knob/button  24  has a dual purpose and is used to both set the dosage of the medication to be injected and to inject the dosed medicament via a lead screw  7  and stopper  15  from a medicament cartridge  12 , which is attached to the drug delivery pen through a lower housing  17 . The lower housing  17  typically has dosage indicia on the exterior thereof. The medicament cartridge  12  is typically a glass tube sealed at one end with a septum  16  and at the other end with the stopper  15 . In standard drug delivery pens, the dosing and delivery mechanisms are all found within the outer sleeve  13 . Those mechanisms are not described in greater detail here as they are understood by those knowledgeable of the art. 
     A pen needle assembly  10  (hereinafter referred to as pen needle  10  for brevity) includes a hub  20 , a patient needle  11  extending from a patient end of the pen needle, and a septum-penetrating needle cannula  18  disposed within the hub  20  on a non-patient side thereof. The septum-penetrating needle cannula  18  is in fluid communication with the patient needle  11 . The hub  20  is preferably screwed onto the lower housing  17 . In attaching the hub  20  to the lower housing  17 , the septum-penetrating cannula  18  pierces the septum  16 , but the septum  16  does not move with respect to the medicament cartridge  12 . The stopper  15 , however, is axially displaceable within the medicament cartridge  12  while maintaining a fluid tight seal. The distal movement of the plunger or stopper  15  within the medicament cartridge  12  (due to advancement of the lead screw  7 ) causes medication to be forced into the patient needle  11  of the hub  20 . 
     To protect a user, or anyone who handles the pen needle assembly  10 , an outer shield  29 , which attaches to the hub  20 , covers the hub  20 . The outer shield  29  can also be used as a handle or grip to screw hub  20  onto or off pen injector  50 . An inner shield  28  covers the patient needle  11  within the outer shield  29 . The inner shield  28  can be secured to the hub  20  to cover the patient needle  11  by any suitable means, such as an interference fit or a snap fit. The outer shield  29  and inner shield  28  are removed prior to use. The cap  21  fits snugly against outer sleeve  13  to allow a user to securely carry the pen injection device  50 . 
     A pen injector, such as pen injector  50 , can be designed to have the shortest length possible, or it can be designed to protect a pen needle  10  that has already been assembled to the pen injector  50 . While it is highly desirable to produce the shortest, smallest pen possible, there are times when a user might want to pre-assemble a pen needle  10  to a pen injector. For example, a user may be going to a restaurant to eat and may need to provide an injection of very fast acting insulin just prior to eating. When timed properly, such an injection provides a more consistent glucose level. But the injection cannot be given too far in advance because the user&#39;s glucose level will drop too much. This situation effectively requires that the injection be given at the restaurant. For convenience, the user may wish to pre-assemble the pen needle  10  with the pen injector so that it is ready to use. If the pen injector  50  is designed to protect an assembled pen needle  10  within the cap  21  when the pen needle  10  is not assembled with the pen injector  50 , the pen injector  50  is longer than it needs to be, and thus takes up more space. What is needed is a pen injector that can accomplish both modalities, one in which the pen injector is as small as possible, and one in which a pen needle can be accommodated while assembled to the pen injector. 
     SUMMARY OF THE INVENTION 
     An aspect of the present invention is to provide a self-injection device with a body and a cap that can accommodate and protect a pen needle assembled to the body in a first mode, and that can minimize the size of the self-injection device in a second mode. 
     The foregoing and/or other aspects of the present invention are achieved by providing a self-injection device, including a pen body connectable with a pen needle, and a cap selectively connectable to the pen body in a first orientation with respect to the pen body to minimize the length or volume of the self injection device, and in a second orientation to provide sufficient length or volume in an interior of the cap to house a pen needle connected with the pen body. 
     The foregoing and/or other aspects of the present invention are also achieved by providing a self-injection device, including a body selectively connectable with a pen needle at a first end of the body, and a cap having an interior cavity, the cap being connectable to the body in a first orientation with respect to the body, and in a second orientation with respect to the body that is axially further from a second end of the body than the first orientation, to accommodate the pen needle connected to the body within the interior cavity, the second end of the body being opposite to the first end. 
     The foregoing and/or other aspects of the present invention are also achieved by providing a method using a self-injection device comprising a body and a cap, the method including the operations of: at a first time, connecting the cap with the body in a first orientation in which the length or volume of the of the self-injection device is minimized; and at a second time, connecting the cap with the body in a second orientation in which, with respect to the first orientation, a length or volume in an interior of the cap is increased to house a pen needle connected with the pen body. 
     Additional and/or other aspects and advantages of the present invention will be set forth in part in the description that follows and, in part, will be apparent from the description, or may be learned by practice of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The above and/or other aspects and advantages of embodiments of the invention will be more readily appreciated from the following detailed description, taken in conjunction with the accompanying drawings, in which: 
         FIG. 1  is a perspective view of an exemplary drug delivery pen; 
         FIG. 2  is an exploded view of the exemplary drug delivery pen of  FIG. 1 ; 
         FIG. 3  is a perspective view of a self-injection device in a first orientation in accordance with an embodiment of the present invention; 
         FIG. 4  is a perspective view of a the self-injection device of  FIG. 3  in a second orientation; 
         FIGS. 5 and 6  are partial perspective views respectively illustrating the first and second orientations of the self-injection device of  FIG. 3 ; 
         FIG. 7  is a perspective view of a body of the self-injection device of  FIG. 3 ; 
         FIG. 8  is a perspective view of the cap of the self-injection device of  FIG. 3 ; 
         FIG. 9  is another perspective view of a body of the self-injection device of  FIG. 3 ; 
         FIG. 10  is a perspective view illustrating a connection mechanism of the self-injection device of  FIG. 3   
         FIG. 11  is a perspective view of a self-injection device in accordance with another embodiment of the present invention; 
         FIG. 12  is a perspective view of a cap of the self-injection device of  FIG. 11 ; 
         FIG. 13  is a perspective view of a body of the self-injection device of  FIG. 11 ; 
         FIG. 14  is another perspective view of the body of the self-injection device of  FIG. 11 ; 
         FIG. 15  is a perspective view of the self-injection device of  FIG. 11  in the second orientation; 
         FIGS. 16 and 17  are perspective views illustrating an anti-rotation feature in accordance with an embodiment of the present invention; and 
         FIG. 18  is a perspective view of the body of the self-injection device of  FIG. 11  illustrating a connection mechanism thereof. 
     
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
     Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to the like elements throughout. The descriptions of these embodiments exemplify the present invention by referring to the drawings. 
       FIGS. 3 and 4  are perspective views illustrating first and second connection orientations of a self-injection device  100  in accordance with an embodiment of the present invention. As shown in  FIGS. 3 and 4 , the self-injection device (or pen injector)  100  includes a cap  104  and a body or pen body  108 . The cap  104  and the body  108  are connectable to each other in first (for example,  FIG. 3 ) and second (for example,  FIG. 4 ) radial orientations. In  FIG. 3 , the cap  104  is connected with the body  108  in the first orientation to be as compact as possible. In other words, the overall volume and/or length of the pen injector  100  are minimized in the first orientation. In  FIG. 4 , the cap  104  is radially rotated with respect to the first orientation, and is connected to the body  108  in the second orientation to allow a pen needle  10  to be protected inside the cap  104 . In other words, in the second radial orientation, there is sufficient volume and/or length in an interior of the cap  104  to house the pen needle  10  connected with the body  108 . 
     The body  108  includes an axial protrusion  112  and an axial recess  116 . Similarly, the cap  104  includes an axial protrusion  120  and an axial recess  124 . In the first orientation, the respective axial protrusions  112  and  120  abut the respective axial recesses  116  and  124 . In other words, as shown in  FIG. 3 , the body axial protrusion  112  abuts the cap axial recess  124  and the cap axial protrusion  120  abuts the body axial recess  116 . In the second orientation, as shown in  FIG. 4 , body axial protrusion  112  abuts cap axial protrusion  120 . In the first and second orientations, the cap  104  encloses the distal end of the body  108 , as shown, for example, in  FIGS. 3-6 . 
       FIGS. 5 and 6  respectively illustrate further details of the first and second orientations. In  FIGS. 5 and 6 , the cap  104  is shown in dotted lines for clarity. As shown in  FIG. 5 , an outer sleeve or cartridge container  128  of the body  108  includes a screw thread  132  at a first end of the body  108  for connecting a pen needle  10  thereto. The cartridge container  128  holds a medicament cartridge in the body  108 . In the first orientation, there is insufficient space in an interior cavity  136  of the cap  104  to accommodate a pen needle  10 . In contrast, as shown in  FIG. 6 , in the second orientation, cap  104  protectively houses the pen needle  10 . 
       FIG. 7  is a perspective view of the body  108  and  FIG. 8  is a perspective view of the cap  104 . As shown in  FIG. 7 , the body  108  includes a first body connector  140  disposed within the body axial recess  116 . Correspondingly, as shown in  FIG. 8 , the cap  104  has a cap connector  144  disposed on an interior of the cap axial protrusion  120 . As shown, the first body connector  140  is embodied as a radial protrusion and the cap connector  144  is embodied as a radial recess, but one skilled in the art will appreciate that the body connector  140  may be embodied as a radial recess and the cap connector  144  may be embodied as a radial protrusion without departing from the scope of the present invention. In addition, one skilled in the art will appreciate that the first body connector  140  and the cap connector  144  may be embodied as other types of connectors without departing from the scope of the present invention. 
     Showing another perspective view of the body  108 ,  FIG. 9  illustrates an axial slot  148  of the cartridge container  128 . Through the axial slot  148 , the user can view the progress of the stopper (such as stopper  15 ) in the medicament cartridge (such as cartridge  12 ).  FIG. 10  is a perspective view of the cap  104  in which an interior surface of the cap  104  is shown in dotted lines. A radial connecting protrusion  152  projects inwardly from the interior surface of the cap  104 . According to one embodiment, to secure the cap  104  and the body  108  in the second orientation, the radial connecting protrusion  152  engages the axial slot  148 . 
       FIG. 11  is a perspective view of another pen injector  200  in accordance with an embodiment of the present invention. Like the embodiment of  FIGS. 3-10 , the pen injector  200  has a cap  204  and a body  208  with respective axial protrusions  212  and  220  and axial recesses  216  and  224 . In addition, the pen injector  200  has an anti-rotation feature for preventing radial rotation of the cap  204  relative to the body  208 , and therefore, preventing inadvertent collapse of the cap  204  onto a pen needle  10  assembled to the body  208 . 
     According to one embodiment, the anti-rotation feature includes an axial horn protrusion  228  disposed on a top, radial side of the body axial protrusion  212 , and a corresponding axial horn recess  232  disposed on a radial side of the cap axial recess  224 . As shown in  FIGS. 11-14 , according to one embodiment, the anti-rotation feature includes a pair of axial horn protrusions (or horns)  228  and a pair of corresponding axial horn recesses  232 . When the cap  204  is secured with the body  208  in the first orientation, as shown in  FIG. 11 , the horns  228  interact with the horn recesses  232  to prevent rotation of the cap  204  relative to the body  208 . In contrast, when the cap  204  is secured with the body  208  in the second orientation, as shown in  FIG. 15 , the horns  228  interact with radial sides of the cap axial protrusion  220  to prevent rotation of the cap  204  relative to the body  208 . 
     According to another embodiment, as shown in  FIGS. 16 and 17 , the anti-rotation feature includes a key  234  axially disposed on the body  208  and a corresponding slot  236  formed between a pair of radial slot protrusions  238  disposed on the interior of the cap  204 . When the key  234  is disposed in the slot  236 , the cap  204  is prevented from radially rotating with respect to the body  208 . Although the key  234  and slot  236  are illustrated as preventing rotation in the first orientation, the key  234  and slot  236  may be positioned axially further away from a second end of the body  208  opposite to the first end, and thereby prevent rotation in the second orientation. Alternatively, keys  234  and slots  236  may be disposed at both locations to prevent relative rotation in both the first and the second orientations. 
     Although the horns  228  are illustrated as being disposed on the body  208  and the horn recesses  232  are illustrated as being disposed on the cap  204 , one skilled in the art will appreciate that the horns  228  may be disposed on the cap  204  and the corresponding horn recesses  232  may be disposed on the body  208  without departing from the scope of the present invention. Similarly, although the key  234  is illustrated as being disposed on the body  208  and the slot  236  is illustrated as being disposed on the cap  204 , one skilled in the art will appreciate that the key  234  may be disposed on the cap  204  and the corresponding slot  236  may be disposed on the body  208  without departing from the scope of the present invention. 
     Additionally, although the embodiment shown in  FIGS. 11-15  illustrates horns  228  and horn recesses  232 , and  FIGS. 16 and 17  illustrate a slot  236  and a key  234 , one skilled in the art will appreciate that, without departing from the scope of the present invention, other shapes may be used to prevent inadvertent rotation of the cap  204  relative to the body  208  and thereby prevent the cap  204  from moving out of the second orientation and moving axially toward the second end of the body  208 . 
     To secure the cap  204  to the body  208  in the first orientation, similar to the embodiment of  FIGS. 3-10 , the body  208  includes a first body connector  240  and the cap  204  includes a cap connector  244  (see  FIG. 12 ). According to one embodiment, the first body connector is a radial protrusion and the cap connector  244  is a corresponding radial recess. One skilled in the art will appreciate that the cap connector may be a radial protrusion and the first body connector  240  may be a corresponding radial recess without departing from the scope of the present invention. As shown in  FIG. 16 , however, to secure the cap  204  to the body  208  in the second orientation, the body includes a second body connector  248 . In the second orientation, the radially protruding second body connector interacts with the correspondingly radially recessed cap connector  244  to provide a snap-fit connection to secure the cap  204  to the body  208 . 
     Although the radial connecting protrusion  152  is illustrated as the connection mechanism for securing the cap to the body in the second orientation in the embodiment shown in the first embodiment shown in  FIGS. 3-10 , and the second body connector  248  is illustrated as the connection mechanism for securing the cap to the body in the second orientation in the second embodiment shown in  FIGS. 11-16 , one skilled in the art will appreciate that the connecting protrusion  152  may be employed with the second embodiment and the second body connector  248  may be employed with first embodiment, without departing from the scope of the present invention. 
     Embodiments of the present invention provide a cap that is connectable to the body in a first orientation in which the cap is as compact as possible to allow the smallest pen injector. Additionally, the cap is connectable to the body in another orientation to provide space for protection for a pen needle that has been assembled to the pen injector. 
     Although only a few exemplary embodiments of the present invention have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of the appended claims and equivalents thereof.