Abstract:
An injection device cap including a cap body configured to remove a pen needle installed on the injection device. A method of removing a pen needle from an injection device using the cap includes installing the pen needle onto a proximal end of an injection device and removing the pen needle using the cap. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The instant application is a US non-provisional application based on U.S. provisional application No. 61/174,308, filed Apr. 30, 2009, the disclosure of which is hereby expressly incorporated by reference hereto in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    This invention relates generally to pen injection devices, e.g., pre-loaded syringes, such are utilized for injection of medicament into the body tissues of human and animal patients. More specifically, this invention relates to a pen injection device having a removable pen needle which pen needle can be removed using the pen injection device cap. The cap can also be installed onto the pen injection device while the pen needle is installed on the pen injection device. 
         [0004]    This invention also relates to pen needles for pen injection devices wherein the pen needle is configured to be used with the pen injection device and cap system. 
         [0005]    This invention also relates to caps for pen injection devices which can be used to remove pen needles from the pen injection devices more safely, i.e., preventing the user from being pricked when handling and/or attempting to remove the pen needle from the pen injection device. 
         [0006]    2. Discussion of Background Information 
         [0007]    U.S. Pat. No. 4,973,318, the disclosure of which is hereby expressly incorporated by reference in its entirety, discloses a disposable syringe includes first and second housing elements which are coupled together for rotation without axial movement therebetween. The first housing element receives a cartridge of a solution to be injected, and mounts a liquid outlet needle at its front end. A piston rod is disposed in the second housing element to move axially therein, and this piston rod includes a rod element and a nut element. The rod element is coupled to the first housing element to move axially therein without relative rotation therewith, and the nut element is threaded to the rod element for telescoping movement therewith and is configured to move axially in the second housing element without relative rotation therein. A pressure receiving element is mounted on the nut element. The housing, rod, nut and pressure receiving elements cooperate such that relative rotation between the housing elements in a selected direction causes relative rotation between the nut and rod elements and thereby increases the effective length of the piston rod and causes the pressure receiving element to extend from the second housing element. A protective cap is removably mounted over the first housing element and is configured to abut second housing element while mounted in place on the first housing element. This protective cap is engaged with the first housing element such that rotation of the cap with respect to the second housing element causes rotation of the first housing element with respect to the second housing element. 
         [0008]    This type of syringe is shown in  FIGS. 1-7  wherein the pre-loaded syringe  1  has a proximal threaded end  2  which is configured to accept a needle tip assembly consisting of a needle tip  5 , a needle tip cover  3 , and a needle cover  4 . As is evident from  FIGS. 2 and 3 , a user installs the needle tip assembly  3 / 4 / 5 , after removing the assembly from its individual package, onto the threaded proximal end  2  by simply sliding it onto the end  2  axially. Because internal threads of the needle tip  5  are mounted to radially deflectable members, installation over threads of the end  2  occurs with a ratchet effect. This installation is made safe by the covers  4  and  5  which ensure that the user will not be pricked by the needle N. Once installed, the user can remove the needle tip cover  3  by simply sliding it off axially as is shown in  FIG. 4 . Next, as shown in  FIG. 5 , the user can remove the needle cover  4  to expose the needle N. The pen needle device then assumes the position shown in  FIG. 6  and is made ready for use in providing an injection to the user. After injection, the user will typically remove the needle tip  5  and discard the same. To accomplish the removal, the user will typically reinstall the needle tip cover  3  and rotate it to cause the needle tip to unthread from the threaded end  2  (some users may even install the needle cover  4  prior to installing the cover  3 ). Once removed, however, it is still possible to reinstall the used needle tip  5  by simply repeating the steps noted above.  FIG. 7  illustrates that the needle tip  5  can even be installed without the needle covers  3  and  4 . Unless the user discards the needle tip  5 , it is possible that she or other users will not remember or know that it has already been used. That is, there is nothing to prevent reuse of the needle tip  5  should someone attempt to reinstall the needle tip onto the end  2 . Furthermore, if the user is unable to locate the covers  3  and  4  (i.e., if they have become lost), she must then attempt to grip the needle tip  5  in order to unthread it from the end  2 . As is apparent, this action can be risky because the user can possibly inadvertently be pricked by the needle N either in attempting to properly grip the needle tip  5 , in the action of rotating it to the point it is removed, or even in the handling of the needle tip  5  after it has been removed and prior to being properly discarded. Still further, if the needle tip  5  is not properly discarded (such as being correctly placed in a sharps container), others may come in contact with the needle tip  5  and possibly become injured thereby. 
         [0009]      FIG. 8  shows a proximal end of a pen needle device with a removable protective cap according to the prior art.  FIG. 9  shows a proximal end of a pen needle device with the removable protective cap removed according to the prior art. 
         [0010]    It is desirable to provide a pen needle system which is safer to use compared to the conventional devices discussed above and/or which does not have one or more of the above-noted disadvantageous. 
         [0011]    US 2008/0108951 to JERDE et al. discloses a pen injection device having a cap that can store an unused needle. The disclosure of this document is hereby expressly incorporated by reference in its entirety, whereby one or more of the disclosed features can be used in combination with the instant invention. 
         [0012]    US 2007/0203458 to TSUBOTA discloses a pen injection device having a cap that can be used to remove the small pen needle safety cap. The disclosure of this document is hereby expressly incorporated by reference in its entirety, whereby one or more of the disclosed features can be used in combination with the instant invention. 
         [0013]    US 2005/0283115 to GIAMBATTISTA et al., US 2005/0277895 to GIAMBATTISTA et al., US 2003/0014018 to GIAMBATTISTA et al., and US 2002/0133122 to GIAMBATTISTA et al. each discloses a pen injection device having a cap that includes an integral a safety needle guard. The disclosure of each of these documents is hereby expressly incorporated by reference in their entireties, whereby one or more of the disclosed features can be used in combination with the instant invention. 
         [0014]    US 2004/0236284 to HOSTE et al. discloses a pen injection device having an integral a safety needle guard. The disclosure of this document is hereby expressly incorporated by reference in its entirety, whereby one or more of the disclosed features can be used in combination with the instant invention. 
       SUMMARY OF THE INVENTION 
       [0015]    According to one non-limiting embodiment of the invention, there is provided an injection device cap comprising a cap body configured to remove a pen needle installed on the injection device. 
         [0016]    The cap body may comprise a plurality of mechanisms for engaging portions of the pen needle. The plurality of mechanisms may ensure that when a user rotates the cap body, the pen needle is caused to rotate or un-thread from an injection device. The plurality of mechanisms may comprise radial projections which engage with radial recesses of the pen needle. The plurality of mechanisms may comprise inwardly oriented radial projections which engage with external recesses of the pen needle. 
         [0017]    The cap body may comprise a device for removing the pen needle from the cap body. The cap body may comprise a device for ejecting the pen needle from the cap body. The cap body may comprise a device for ejecting the pen needle from within the cap body. The cap body may comprise a user activated device for ejecting the pen needle from within the cap body. The cap body may comprise a clip for removably securing an injection device to a user&#39;s garment. 
         [0018]    The cap body may be installable onto an injection device when with the pen needle is installed on the injection device. The cap body may not rotatably engage with the pen needle when a needle cap of the pen needle is installed thereon and may rotatably engage with the pen needle when the needle cap of the pen needle is removed. The cap body may comprise a user activated device for ejecting the pen needle from within the cap body. 
         [0019]    The cap body may rotatably engage with the pen needle when a needle cap of the pen needle is removed and may not rotatably engage with the pen needle when the needle cap of the pen needle is not removed. 
         [0020]    The cap body may comprise a device for indicating to a user that the cap body is and/or is not rotatably engaged with the pen needle. The cap body may comprise a visual indicator which indicates to a user that the cap body is and/or is not rotatably engaged with the pen needle. 
         [0021]    The cap body may comprise a system for preventing rotatable engagement with the pen needle when a needle cap of the pen needle is installed thereon and for automatically causing rotatable engagement with the pen needle when the needle cap of the pen needle is removed. The cap body may comprise a user activated device for ejecting the pen needle from within the cap body. The cap body may comprise a system for preventing rotatable engagement with the pen needle when a needle cap of the pen needle is installed thereon and a system for automatically causing rotatable engagement with the pen needle when the needle cap of the pen needle is removed. 
         [0022]    The cap body may comprise a two-part cap body. The cap body may comprise a user activatable system for preventing engagement with the pen needle and for causing engagement with the pen needle. The cap body may comprise a user activatable system for preventing locking engagement with the pen needle and for causing locking engagement with the pen needle. The cap body may comprise a user activatable system for causing locking engagement between the cap body and the pen needle. 
         [0023]    The cap body may comprise a three-part cap body. At least two parts of the three-part cap body may slide with respect to one another. At least two parts of the three-part cap body may be arranged to telescopically slide with respect to one another. At least two parts of the three-part cap body may be arranged to rotate freely with respect to one another in one position and to prevent relative rotation in another position. At least two parts of the three-part cap body may be arranged to rotate freely with respect to one another in one position and to releasably lock together in another position. At least two of parts of the three-part cap body may be connected to each other via a threaded connection. 
         [0024]    The injection device may be one of a pre-filed injection device, a pen injection device, and an insulin injection device. 
         [0025]    The invention also provides for a method of removing a pen needle from an injection device using the cap described above, wherein the method comprises installing the pen needle onto a proximal end of an injection device and removing the pen needle using the cap. 
         [0026]    The invention also provides for a pre-filled injection device comprising at least one feature shown in at least one drawing of the instant application. 
         [0027]    The invention also provides for a pre-filled injection device comprising at least one feature described in the instant application. 
         [0028]    The invention also provides for a pre-filled injection device comprising a pre-filled injection device body and a removable cap configured to remove a pen needle installed on the pre-filled injection device body. 
         [0029]    Other exemplary embodiments and advantages of the present invention may be ascertained by reviewing the present disclosure and the accompanying drawing. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0030]    The present invention is further described in the detailed description which follows, in reference to the noted plurality of drawings by way of non-limiting examples of exemplary embodiments of the present invention, in which like reference numerals represent similar parts throughout the several views of the drawings, and wherein: 
           [0031]      FIG. 1  shows an enlarged partial side view of a proximal end of a prior art pen needle device or pre-loaded syringe/injection device. The proximal end is shown with the cap removed and in a prior-use state, i.e., it is ready to receive thereon a needle tip or pen needle; 
           [0032]      FIG. 2  shows the proximal end of  FIG. 1  along with a prior art needle tip assembly in a position prior to installation onto the proximal end. The needle tip cap and the needle cap are both shown in cross-section; 
           [0033]      FIG. 3  shows the proximal end and prior art needle tip assembly of  FIG. 2  after installation of the needle tip assembly onto the proximal end; 
           [0034]      FIG. 4  shows how the needle tip cap can be removed from the prior art needle tip assembly of  FIG. 3 ; 
           [0035]      FIG. 5  shows how the needle cap can be removed from the prior art needle tip of  FIG. 4 ; 
           [0036]      FIG. 6  shows the needle tip mounted onto the pen needle device in a position ready for injection according to the prior art; 
           [0037]      FIG. 7  shows the needle tip being removed from the pen needle device according to the prior art. This would occur after use and can occur by unthreading the needle tip from the threaded proximal end of the pen needle device. The arrow illustrates that it is possible to re-install the needle tip onto the threaded proximal end of the pen needle device; 
           [0038]      FIG. 8  shows a proximal end of a pen needle device with a removable protective cap according to the prior art; 
           [0039]      FIG. 9  shows a proximal end of a pen needle device with the removable protective cap removed according to the prior art; 
           [0040]      FIG. 10  shows a side view of a removable cap for a pen needle device according to a first non-limiting embodiment of the invention; 
           [0041]      FIG. 11  shows a side cross-section view of the removable cap shown in  FIG. 10 ; 
           [0042]      FIG. 12  shows a distal end view of the removable cap shown in  FIG. 10 ; 
           [0043]      FIG. 13  shows a side view of the removable cap of  FIG. 10  installed onto the proximal end of a prior art pen needle device or pre-filled syringe; 
           [0044]      FIG. 14  shows a side view of the proximal end of a pen needle device with the pen needle installed thereon according to the prior art. The small needle cap is installed on the pen needle thereby indicating that the pen needle has not yet been used; 
           [0045]      FIG. 15  shows a side view of the cap of  FIG. 10  installed onto the proximal end of a prior art pen needle device or pre-filled syringe shown in  FIG. 14 ; 
           [0046]      FIG. 16  shows a side view of a proximal end of a pen needle device with the pen needle installed thereon according to the prior art. The small needle cap is removed from the pen needle thereby indicating that the pen needle has been used; 
           [0047]      FIG. 17  shows a side view of the cap of  FIG. 10  installed onto the proximal end of a prior art pen needle device or pre-filled syringe shown in  FIG. 16 ; 
           [0048]      FIG. 18  shows a side view of the cap of  FIG. 10  being rotated and removed from the proximal end of a prior art pen needle device or pre-filled syringe shown in  FIG. 16 ; 
           [0049]      FIG. 19  shows a side cross-section view of the cap of  FIG. 10  after being removed from the proximal end of a prior art pen needle device or pre-filled syringe shown in  FIG. 16  and shows the pen needle being retained within the cap; 
           [0050]      FIG. 20  shows the cap of  FIG. 19  after a user activates a mechanism for ejecting the pen needle from engagement within the cap; 
           [0051]      FIG. 21  shows a side cross-section view of a removable cap for a pen needle device according to another non-limiting embodiment of the invention. This embodiment is similar to that of  FIG. 10  except that it additionally includes a spring for biasing the ejecting mechanism; 
           [0052]      FIG. 22  shows a side cross-section view of a removable cap for a pen needle device according to another non-limiting embodiment of the invention. The ejecting mechanism is shown in an initial or retracted position; 
           [0053]      FIG. 23  shows another side cross-section view of the removable cap shown in  FIG. 22 . The ejecting mechanism is shown in an ejection or extended position; 
           [0054]      FIG. 24  shows a side cross-section view of a removable cap for a pen needle device according to another non-limiting embodiment of the invention. This embodiment is similar to that of  FIG. 10  except that it additionally includes a spring for biasing the ejecting mechanism. In  FIG. 24 , the position of the ejection mechanism provides an indication to the user that the pen needle has not yet been used; 
           [0055]      FIG. 25  shows another side cross-section view of the removable cap of  FIG. 24 . In  FIG. 25 , the position of the ejection mechanism provides an indication to the user that the pen needle has been used; 
           [0056]      FIG. 26  shows a side view of a removable cap for a pen needle device according to another non-limiting embodiment of the invention. In  FIG. 26 , a system is shown automatically engaging with the pen needle after the pen needle has been used; 
           [0057]      FIG. 27  shows another side view of the removable cap of  FIG. 26 . In  FIG. 27 , the system is shown not yet engaging with the pen needle as a result of the pen needle not yet being used; 
           [0058]      FIG. 28  shows a side cross-section view of the removable cap shown in  FIG. 26  after it is removed from the pen needle device and after the pen needle is removed from within the removable cap; 
           [0059]      FIG. 29  shows a side cross-section view of a main body portion of the removable cap shown in  FIG. 28 ; 
           [0060]      FIG. 30  shows a cross-section view through arrows in  FIG. 29 ; 
           [0061]      FIG. 31  shows a side cross-section view of an engaging member used in the removable cap shown in  FIG. 28 ; 
           [0062]      FIG. 32  shows a distal end view of the member shown in  FIG. 31 ; 
           [0063]      FIG. 33  shows a proximal end view of the member shown in  FIG. 31 ; 
           [0064]      FIG. 34  shows a side cross-section view of a spring used in the removable cap shown in  FIG. 28 ; 
           [0065]      FIG. 35  shows a side cross-section view of an optional engaging member that can be used in the removable cap shown in  FIG. 28 ; 
           [0066]      FIG. 36  shows a distal end view of the member shown in  FIG. 35 ; 
           [0067]      FIG. 37  shows a proximal end view of the member shown in  FIG. 35 ; 
           [0068]      FIG. 38  shows a side cross-section view of a removable cap for a pen needle device according to another non-limiting embodiment of the invention. In  FIG. 38 , a system is shown automatically engaging with the pen needle after the pen needle has been used and after the removable cap is removed from the pen needle device; 
           [0069]      FIG. 39  shows another side cross-section view of the removable cap of  FIG. 38 . In  FIG. 39 , the system is shown disengaging with the pen needle as a result of the movement of the ejecting mechanism; 
           [0070]      FIG. 40  shows a side view of the removable cap shown in  FIG. 38  with the pen needle removed; 
           [0071]      FIG. 41  shows a side cross-section view of an engaging member used in the removable cap shown in  FIG. 40 ; 
           [0072]      FIG. 42  shows a distal end view of the member shown in  FIG. 41 ; 
           [0073]      FIG. 43  shows a proximal end view of the member shown in  FIG. 41 ; 
           [0074]      FIG. 44  shows a side cross-section view of another non-limiting embodiment of a removable cap according to the invention. The device is similar to that of  FIG. 28  and utilizes a two-part main body; 
           [0075]      FIG. 45  shows a side cross-section view of the removable cap of  FIG. 44  with a pen needle arranged therein; 
           [0076]      FIG. 46  shows a side cross-section view of the removable cap of  FIG. 45  with a proximal part of the two-part main body being separated from the distal part thereof; 
           [0077]      FIG. 47  shows a side view of a removable cap installed on a pen needle injection device according to another non-limiting embodiment of the invention. In  FIG. 47 , a system is shown automatically engaging with the pen needle after the pen needle has been used and after the removable cap is installed on the pen needle device; 
           [0078]      FIG. 48  shows another side view of  FIG. 47 . In  FIG. 48 , the system is shown non-engaged with the pen needle as a result of the injection not yet being used; 
           [0079]      FIG. 49  shows another side view of the removable cap of  FIG. 47 , but removed from the injection device. In  FIG. 49 , the system is shown engaged with the pen needle indicating that the removable cap has been under to remove the pen needle from the injection device; 
           [0080]      FIG. 50  shows another side view of  FIG. 49 . In  FIG. 50 , the system is shown disengaged with the pen needle as a result of the user moving a push-button along the direction of the arrow and showing how to disengage and eject the pen needle from within the removable cap; 
           [0081]      FIG. 51  shows a side view of the removable cap of  FIG. 50  with the pen needle removed; 
           [0082]      FIG. 52  shows an enlarged partial side cross-section view of a main body portion of the removable cap shown in  FIG. 51 ; 
           [0083]      FIG. 53  shows a cross-section view through arrows in  FIG. 52 ; 
           [0084]      FIG. 54  shows a side view of a push-button actuator used in the removable cap shown in  FIG. 51 ; 
           [0085]      FIG. 55  shows a side cross-section view of  FIG. 54 ; 
           [0086]      FIG. 56  shows a side cross-section view of an engaging member used in the removable cap shown in  FIG. 51 ; 
           [0087]      FIG. 57  shows a distal end view of the member shown in  FIG. 56 ; 
           [0088]      FIG. 58  shows a proximal end view of the member shown in  FIG. 56 ; 
           [0089]      FIG. 59  shows a side cross-section view of a removable cap for a pen needle device according to another non-limiting embodiment of the invention. In  FIG. 59 , a system is shown automatically engaging with the pen needle after the pen needle has been used and after the removable cap is removed from the pen needle device; 
           [0090]      FIG. 60  shows another side cross-section view of the removable cap of  FIG. 59 . In  FIG. 60 , the system is shown disengaging with the pen needle as a result of the movement of the ejecting mechanism along the direction of the arrow; 
           [0091]      FIG. 61  shows an enlarged partial side cross-section view of  59 ; 
           [0092]      FIG. 62  shows a side cross-section view of another non-limiting embodiment of a removable cap according to the invention. The device utilizes a three-part main body. In  FIG. 62 , the system for engaging with the pen needle is shown non-engaged therewith; 
           [0093]      FIG. 63  shows another side cross-section view of the removable cap of  FIG. 62 . In  FIG. 63 , the system for engaging with the pen needle is shown in an engaged position; 
           [0094]      FIG. 64  shows an enlarged partial side cross-section view of a modified version of the embodiment of  FIG. 62 ; and 
           [0095]      FIG. 65  show one non-limiting way in which the removable cap of the types described herein can be releasably connected to a pen needle device. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0096]    Referring now to the drawings and first to  FIGS. 10-20  which shows a first embodiment of a removable cap or removable cap assembly according to the invention. The removable cap  60  includes a generally cylindrical main body  69 . In embodiments, the main body  69  is a one-piece integrally formed member. A clip C is coupled to the main body  69  so as to allow for clipping onto a user. The main body  69  also includes a generally cylindrical section  61  sized and configured to slide onto a proximal end of a pen injection device  1 ′ (see  FIG. 13 ). The main body  69  also includes a plurality of generally radially oriented ribs  62  sized and configured to engage with a plurality of recesses and/or spaces between plural projections of the pen needle  5  (see  FIG. 15 ). The main body  69  further also includes another generally cylindrical section  63  sized and configured to movingly receive therein a distal portion  72  of an ejection member  70  (see  FIG. 11 ). The ejection member  70  has a portion  73  that slidably moves within a through opening formed in a proximal end of the removable cap  60 . A push-button  71  extends outside the removable cap  60  and is sized and configured to be depressed by a user when the user wishes to cause ejection (see  FIG. 20 ) of the pen needle  5  from within the cap  60 . 
         [0097]    The engagement between the ribs  62  and the exterior surface of the pen needle  5  is such that the removable cap  60  can be slid off and onto the injection device  1 ′ axially under various conditions.  FIG. 13  illustrates how the removable cap  60  can be slid onto the injection device  1 ′ without the ribs  62  contacting and/or interfering with the threaded proximal end  2 ′ in a manner similar to that of the prior art (see  FIG. 8 ). The position/configuration of  FIG. 13 , wherein the injection device  1 ′ has installed thereon the removable cap  60 , is characteristic of a storage configuration, an initial use configuration, and/or a shipping or packaged configuration. Once the user removes the removable cap  60 , the user can installed a pen needle  5  (in a manner similar to that shown in  FIGS. 2-4 ) in order to place the injection device in a pre-ready-to-use configuration as shown in  FIG. 14 . To then use the device shown in  FIG. 14  for injection, the user simply removes the safety cap  4  and then injects the needle of the pen needle  5  while the device has the configuration shown in  FIG. 16 . However, it is also possible to re-install the removable cap  60  while the device is in the pre-ready-to-use configuration as shown in  FIG. 14 , as shown in  FIG. 15 . To then use the device shown in  FIG. 15  for injection, the user simply removes the removable cap  60 , followed by the safety cap  4 . Once the device assumes the configuration shown in  FIG. 16 , the needle of the pen needle  5  can then be injected. Once the device is used for injection, the user can re-install the removable cap  60  while the user pen needle  5  is still installed on the device  1 ′ (see  FIG. 17 ). This renders the device safe or safer to handle as the removable cover  60  serves to cover the needle of the pen needle  5 . The user can then use removable cap  60  to remove the used pen needle  5  from the device  1 ′. As is apparent from a comparison of  FIG. 17  and  FIG. 18 , since the ribs  62  engage with the pen needle  5 , all the user need do to remove the pen needle  5  from the device  1 ′ is to rotate the removable cap  60  along a direction that causes the threads of the pen needle  5  to unthread from section  2 ′ of the device  1 ′. Once fully unthreaded (see  FIG. 18 ), the removable cap  60  with the used pen needle  5  safely arranged within can be removed from the device  1 ′ and thereby assume the configuration shown in  FIG. 19 . At this point, the user can cause the pen needle  5  to be ejected from within the removable cap  60  simply by depressing or moving the member  70  generally along the direction of arrow in  FIG. 20 . Ejection occurs when the distal end of the member  70  contacts a proximal surface of the body of the pen needle  5  as pushes against the same. Since the only mechanism retaining the pen needle  5  within the removable cap  60  are the ribs  62  (which frictionally engage with the external surface of the pen needle  5 ), movement of the member  70  along the distal axial direction indicated by arrow in  FIG. 20  eventually results in the pen needle  5  disengaging from the ribs  62 . At this point, the pen needle  5  can simply fall out of the removable cap  60  (by the user tipping the cap  60  to the point where the open end is lower than the closed end), and is preferably dropped into a sharps container for safe disposal. Once the used pen needle  5  is removed from the removable cap  60 , the user can place the cap  60  back onto the injection device  1 ′ so that the device once again assumes the configuration shown in  FIG. 13 . 
         [0098]      FIG. 21  shows a side cross-section view of a removable cap  60 ′ installable on a pen needle device  1 ′ according to another non-limiting embodiment of the invention. This embodiment is similar to that of  FIG. 10  except that it additionally includes a spring S 1  for biasing the ejecting mechanism  70 ′ towards an initial position. The spring S 1  ensures that when the user moves the member  70 ′ along the direction of arrow shown in  FIG. 20  and then stops depressing the member  70 ′, the member  70 ′ automatically moves back to the initial position shown in  FIG. 21 . 
         [0099]      FIGS. 22 and 23  show another embodiment of a removable cap or removable cap assembly according to the invention. The removable cap  60 ″ includes a generally cylindrical main body  69 ″. In embodiments, the main body  69 ″ is a one-piece integrally formed member. A clip C (not shown but similar to of  FIG. 10 ) that is coupled to the main body  69 ″ so as to allow for clipping onto a user. The main body  69 ″ also includes a generally cylindrical section  61 ″ sized and configured to slide onto a proximal end of a pen injection device  1 ′ (see e.g.,  FIG. 13 ). The main body  69 ″ also includes a plurality of generally radially oriented ribs  62 ″ sized and configured to engage with a plurality of recesses and/or spaces between plural projections of the pen needle  5  (see e.g.,  FIG. 15 ). The main body  69 ″ further also includes another generally cylindrical section  63 ″ sized and configured to movingly receive therein a main portion  72 ″ of an ejection member  70 ″. The ejection member  70 ″ has a portion  73 ″ that slidably moves within a through slot  65 ″ formed in a side of the removable cap  60 ″. A push-button  71 ″ extends outside the removable cap  60 ″ and is sized and configured to be slid forwards and back by a user when the user wishes to cause ejection (by moving member  70 ″ to the position shown in  FIG. 23 ) of the pen needle  5  from within the cap  60 ″. In  FIG. 22 , the ejection member  70 ″ is in an initial position. 
         [0100]      FIGS. 24 and 25  show a removable cap  60 ′″ installable on a pen needle device  1 ′ according to another non-limiting embodiment of the invention. This embodiment is similar to that of  FIG. 10  except that it additionally includes a spring S 2  for biasing the ejecting mechanism  70 ′″ towards an ejection position. In  FIG. 24 , the position of the ejection mechanism  70 ′″ provides an indication to the user that the pen needle  5  has not yet been used. When the user installs the pen needle  5  onto the injection device  1 ′, it typically occurs with the safety cap  4  installed thereon. With the safety cap  4  installed, the member  70 ′″ will protrude out past the proximal end of the cap  60 ′″ in  FIG. 24 . This provides a visual indicator to the user. In  FIG. 25 , the position of the ejection mechanism  70 ′″ provides an indication to the user that the pen needle  5  has been used. When the user uses the pen needle  5  on the injection device  1 ′, it occurs with the safety cap  4  removed. Re-installing the cap  60 ′″ on the device  1 ′ with the safety cap  4  removed from the pen needle  5  allows the member  70 ′″ to assume the position shown in  FIG. 25 . According to this embodiment, the user can remove the pen needle  5  from the injection device  1 ′ can take place in the conventional manner after or before the user re-installs the cap  60 ′″. Alternatively, the user can rotate the cap  60 ′″ to cause unthreading of the pen needle  5  from the device  1 ′ and then subject the cap  60 ′″ to a shaking movement until the pen needle  5  disengages from the ribs and falls out of the cap  60 ′″ so that it can be safely discarded. 
         [0101]      FIGS. 26-34  show another embodiment of a removable cap or removable cap assembly according to the invention. The removable cap  60   IV  includes a generally cylindrical main body  69   IV . In embodiments, the main body  69   IV  is a one-piece integrally formed member. A clip C (not shown) is coupled to the main body  69   IV  so as to allow for clipping onto a user. The main body  69   IV  also includes a generally cylindrical section  61   IV  sized and configured to slide onto a proximal end of a pen injection device  1 ′ (see  FIGS. 26 and 27 ). The main body  69   IV  also includes an inner support  66   IV  having a plurality of generally radially oriented slots  67   IV  sized and configured to slidably receive therein a plurality of projections  82  arranged on an engaging member  80 . A spring S 3  biases the engaging member  80  towards the engaging position (see  FIG. 26 ) wherein engaging members  85  engage with recesses formed on the pen needle  5 . As shown in  FIGS. 31-33 , the engaging member  80  includes a proximal end  81 , a support ring  83 , a main generally cylindrical open area  84 , a distal end  87 , plural engaging members  85 , i.e., two engaging members, having tapered ends  86 , and can slide within the cap  60   IV . 
         [0102]    The engagement between the projections  85  and the exterior surface of the pen needle  5  is such that when the cap  60   IV .is installed on the injection device  1 ′ and the safety cap  4  is not installed on the pen needle  5 , the engaging member  80  automatically engages with the pen needle  5  by virtue of the spring S 3  placing the member  80  in the engagement position (see  FIG. 26 ). Engagement, however, does not occur while the safety cap  4  is installed (see  FIG. 27 ).  FIG. 27  illustrates how the removable cap  60   IV  can be slid onto the injection device  1 ′ without the projections  85  engaging with the pen needle  5 . The position/configuration of  FIG. 27 , wherein the injection device  1 ′ has installed thereon the removable cap  60   IV , is characteristic of a storage configuration, an initial use configuration, and/or a shipping or packaged configuration. Once the user removes the removable cap  60   IV , the user can remove the safety cap  4  and use the device  1 ′ for injection. Once the device  1 ′ is used for injection, the user can re-install the removable cap  60   IV  while the user pen needle  5  is still installed on the device  1 ′ (see  FIG. 26 ). This renders the device safe or safer to handle as the removable cover  60   IV  serves to cover the needle of the pen needle  5 . The user can then remove the removable cap  60   IV  to remove the used pen needle  5  from the device  1 ′. As is apparent from  FIG. 26 , since the projections  85  engage with the pen needle  5 , all the user need do to remove the pen needle  5  from the device  1 ′ is to rotate the removable cap  60   IV  along a direction that causes the threads of the pen needle  5  to unthread from section  2 ′ of the device  1 ′. Once fully unthreaded, the removable cap  60   IV  with the used pen needle  5  safely arranged within can be removed from the device  1 ′. At this point, the user can cause the pen needle  5  to be ejected from within the removable cap  60   IV  simply by shaking the removable cap  60   IV  until the pen needle  5  falls out. Since the only mechanism retaining the pen needle  5  within the removable cap  60   IV  are the projections  85  (which frictionally engage with the external surface of the pen needle  5 ) shaking the cap  60   IV  sufficiently causes the pen needle  5  disengaging from the projections  85 . At this point, the pen needle  5  can simply fall out of the removable cap  60   IV  by the user tipping the cap  60   IV  to the point where the open end is lower than the closed end), and is preferably dropped into a sharps container for safe disposal. Once the used pen needle  5  is removed from the removable cap  60   IV , the user can place the cap  60   IV  back onto the injection device  1 ′ while the cap  60   IV  has the configuration shown in  FIG. 28 . 
         [0103]      FIGS. 35-37  show an optional engaging member  80 ′ that can be used in the removable cap  60   IV  shown in  FIG. 28 . As shown in  FIGS. 35-37 , the engaging member  80 ′ includes a proximal end  81 ′, a support ring  83 ′, a main generally cylindrical open area  84 ′, a distal end  87 ′, plural engaging members  85 ′, i.e., four engaging members, having tapered ends  86 ′, and can slide within the cap  60   IV . 
         [0104]      FIGS. 38-42  show another embodiment of a removable cap or removable cap assembly according to the invention. The removable cap  60   V  includes a generally cylindrical main body  69   V . In embodiments, the main body  69   V  is a one-piece integrally formed member. A clip C (not shown) is coupled to the main body  69   V  so as to allow for clipping onto a user. The main body  69   V  also includes a generally cylindrical section  61   V  sized and configured to slide onto a proximal end of a pen injection device  1 ′ (not shown in  FIGS. 38 and 39 ). The main body  69   V  also includes an inner support  66   V  having a plurality of generally radially oriented slots  67   V  sized and configured to slidably receive therein a plurality of projections  82 ″ arranged on an engaging member  80 ″. A spring S 3  biases the engaging member  80 ″ towards the engaging position (see  FIG. 38 ) wherein engaging members  85 ″ engage with recesses formed on the pen needle  5 . As shown in  FIGS. 41-43 , the engaging member  80 ″ includes a proximal end  81 ″, a support ring  83 ″, a main generally cylindrical open area  84 ″, a distal end  87 ″, plural engaging members  85 ″, i.e., two engaging members, having tapered ends  86 ″, plural slots  89 ″, i.e., two slots, that allow the ring  83 ″ to pass by retaining projection  68   V  upon installation. The engaging member  80 ″ also includes a proximal gripping end  88 ″ which allows the user to move the member  80 ″ from outside the cap  60   V . The member  80 ″ can slide axially within the cap  60   V  between an extended and/or initial position and/or engaging position shown in  FIG. 38  and a retracted position shown in  FIG. 39   
         [0105]    The engagement between the projections  85 ″ and the exterior surface of the pen needle  5  is such that when the cap  60   V .is installed on the injection device  1 ′ (not shown in  FIGS. 38 and 39 ) and the safety cap  4  (not shown) is not installed on the pen needle  5 , the engaging member  80 ″ automatically engages with the pen needle  5  by virtue of the spring S 3  placing the member  80 ″ in the engagement position (see  FIG. 38 ). Engagement, however, does not occur while the safety cap  4  is installed (in the same was as shown  FIG. 27 ). Once the user removes the removable cap  60   V , the user can remove the safety cap  4  and use the device  1 ′ for injection. Once the device  1 ′ is used for injection, the user can re-install the removable cap  60   V  while the user pen needle  5  is still installed on the device  1 ′ (as shown in  FIG. 38  but not showing the device  1 ′). This renders the device safe or safer to handle as the removable cover  60   V  serves to cover the needle of the pen needle  5 . The user can then remove the removable cap  60   V  to remove the used pen needle  5  from the device  1 ′. As is apparent from  FIG. 38 , since the projections  85 ″ engage with the pen needle  5 , all the user need do to remove the pen needle  5  from the device  1 ′ is to rotate the removable cap  60   V  along a direction that causes the threads of the pen needle  5  to unthread from section  2 ′ of the device  1 ′. Once fully unthreaded, the removable cap  60   V  with the used pen needle  5  safely arranged within can be removed from the device  1 ′. At this point, the user can cause the pen needle  5  to be ejected from within the removable cap  60   V  simply by shaking the removable cap  60   V  until the pen needle  5  falls out. However, with this embodiment, the user can also pull on the member  88 ″ in the direction of the arrow shown in  FIG. 39  to cause the members  85 ″ to disengage from the pen needle  5 . This disengagement will be facilitated by the projections  68   V  as they stop or prevent axial movement (along the direction of arrow in  FIG. 39 ) of the pen needle  5 . At this point, the pen needle  5  can simply fall out of the removable cap  60   V  by the user tipping the cap  60   V  to the point where the open end is lower than the closed end), and is preferably dropped into a sharps container for safe disposal. Once the used pen needle  5  is removed from the removable cap  60   V , the user can place the cap  60   V  back onto the injection device  1 ′ while the cap  60   V  has the configuration shown in  FIG. 40 . To facilitate installation of the member  80 ″ into the cap  60   V , the member  88 ″ can be made separate from the body of the member  80 ″ so that a distal end of the member  88 ″ is threaded into the end  81 ″ (not shown). Alternatively, the opening in the proximal end of the cap body  69  can be made large enough so that the gripping end of the member  88 ″ passes there through (not shown). 
         [0106]      FIGS. 44-46  shows another embodiment of a removable cap or removable cap assembly according to the invention. The removable cap  60   VI  includes a generally cylindrical main body  69   VI . In embodiments, the cap  60   VI  is a two-piece member including a distal part  60   VI A and threadably and removable connected proximal part  60   VI B. A clip C (not shown) is coupled to the main body so as to allow for clipping onto a user. The distal part  60   VI A includes a generally cylindrical section  61   VI  sized and configured to slide onto a proximal end of a pen injection device  1 ′. The proximal part  69   VI B includes an inner support  66   VI  having a plurality of generally radially oriented slots  67   VI  sized and configured to slidably receive therein a plurality of projections  82  arranged on an engaging member  80 . A spring S 3  biases the engaging member  80  towards the engaging position (see  FIG. 44 ) wherein engaging members  85  engage with recesses formed on the pen needle  5 . The cap assembly shown in  FIGS. 44-46  functions similar to that shown in  FIGS. 26-28  except that it can be separated to allow the user to grip the pen needle  5  and remove it from the proximal part  60   VI B. That is, once the user removes the cap assembly from the injection device (by using it to unthread the pen needle  5 ) so that it assumes the configuration shown in  FIG. 45 , the user can unthread the proximal part  60   VI B from the distal part  60   VI A as shown in  FIG. 46  and then manually remove the pen needle  5  from the proximal part  60   VI B for proper disposal of the pen needle  5 . The user can then reconnect the proximal part  60   VI B to the distal part  60   VI A so that the cap assembly can again assume the ready-to-use configuration shown in  FIG. 44 . 
         [0107]      FIGS. 47-58  show another embodiment of a removable cap or removable cap assembly according to the invention. The removable cap  60   VII  includes a generally cylindrical main body  69   VII . In embodiments, the main body  69   VII  is a one-piece integrally formed member. A clip C (not shown) is coupled to the main body  69   VII  so as to allow for clipping onto a user. The main body  69   VII  also includes a generally cylindrical section  61   VII  sized and configured to slide onto a proximal end of a pen injection device  1 ′ (see  FIGS. 47 and 48 ). The main body  69   VII  also includes an inner support  66   VII  having a plurality of generally radially oriented slots  67   VII  sized and configured to slidably receive therein a plurality of projections  82 ′″ arranged on an engaging member  80 ′″. The main body  69   VII  further also includes a smaller inner support  69   VII  having a plurality of generally radially oriented slots  69   VII  sized and configured to slidably receive therein a main rib  81 ′″ c  arranged on the engaging member  80 ′″. A spring S 3  biases the engaging member  80 ′″ towards the engaging position (see  FIG. 47 ) wherein engaging members  85 ′″ engage with recesses formed on the pen needle  5 . A finger actuated slide  90  is movably arranged on the cap assembly and allows a user to move the member  80 ′″ between the extended position shown in  FIG. 47  and the retracted position shown in  FIG. 48 . As can be seen in  FIGS. 54 and 55 , the slide member  90  has a button portion and a portion which extends into the guide slot GS and engages with the member  80 ′″. As shown in  FIGS. 56-58 , the engaging member  80 ′″ includes a proximal end  81 ′″, a support ring  83 ′″, a main generally cylindrical open area  84 ′″, a distal end  87 ′″, plural engaging members  85 ′″, i.e., two engaging members, having tapered ends  86 ′″, plural openings  81 ′″ a  and  81 ′″ b , a connecting rib  81 ′″ c , and can slide within the cap  60   VII . 
         [0108]    The engagement between the projections  85 ′″ and the exterior surface of the pen needle  5  is such that when the cap  60   VII .is installed on the injection device  1 ′ and the safety cap  4  is not installed on the pen needle  5 , the engaging member  80 ′″ automatically engages with the pen needle  5  by virtue of the spring S 3  placing the member  80 ′″ in the engagement position (see  FIG. 47 ). Engagement, however, does not occur while the safety cap  4  is installed (see  FIG. 48 ).  FIG. 48  illustrates how the removable cap  60   VII  can be slid onto the injection device  1 ′ without the projections  85 ′″ engaging with the pen needle  5 . The position/configuration of  FIG. 48 , wherein the injection device  1 ′ has installed thereon the removable cap  60   VII , is characteristic of a storage configuration, an initial use configuration, and/or a shipping or packaged configuration. Once the user removes the removable cap  60   VII , the user can remove the safety cap  4  and use the device  1 ′ for injection. Once the device  1 ′ is used for injection, the user can re-install the removable cap  60   VII  while the user pen needle  5  is still installed on the device  1 ′ (see  FIG. 47 ). This renders the device safe or safer to handle as the removable cover  60   VII  serves to cover the needle of the pen needle  5 . The user can then remove the removable cap  60   VII  to remove the used pen needle  5  from the device  1 ′. As is apparent from  FIG. 47 , since the projections  85 ′″ engage with the pen needle  5 , all the user need do to remove the pen needle  5  from the device  1 ′ is to rotate the removable cap  60   VII  along a direction that causes the threads of the pen needle  5  to unthread from section  2 ′ of the device  1 ′. Once fully unthreaded, the removable cap  60   VII  with the used pen needle  5  safely arranged within can be removed from the device  1 ′ so that it assumes the configuration shown in  FIG. 49 . At this point, the user can cause the pen needle  5  to be ejected from within the removable cap  60   VII  simply by shaking the removable cap  60   VII  until the pen needle  5  falls out. Preferably, however, the user can slide the member  90  along the direction of arrow as shown in  FIG. 50 . While this movement will move the member  80 ′″ along the same direction which in turn moves the pen needle  5  also, once the pen needle  5  contacts the ends  69   VII   a  of the members  69   VII   b , further movement of the member  80 ′″ causes the members  85 ′″ to disengage from the pen needle  5  as shown in  FIG. 50 . A shoulder  69   VII   d  limits movement of the member  80 ′″ along this ejection/disengagement movement. Since the only mechanism retaining the pen needle  5  within the removable cap  60   VII  are the projections  85 ′″ (which frictionally engage with the external surface of the pen needle  5 ), this movement causes the pen needle  5  disengaging from the projections  85 ′″. At this point, the pen needle  5  can simply fall out of the removable cap  60   VII  by the user tipping the cap  60   VII  to the point where the open end is lower than the closed end), and is preferably dropped into a sharps container for safe disposal. Once the used pen needle  5  is removed from the removable cap  60   VII , the user can place the cap  60   VII  back onto the injection device  1 ′ while the cap  60   VII  has the configuration shown in  FIG. 51 . 
         [0109]      FIGS. 59-61  show another embodiment of a removable cap or removable cap assembly according to the invention. The removable cap  60   VIII  includes a generally cylindrical main body  69   VIII . In embodiments, the main body  69   VIII  is a one-piece integrally formed member. A clip C (not shown) is coupled to the main body  69   VIII  so as to allow for clipping onto a user. The main body  69   VIII  also includes a generally cylindrical section  61   VIII  sized and configured to slide onto a proximal end of a pen injection device  1 ′ (not shown in  FIGS. 59 and 60 ). The main body  69   VIII  also includes an inner support  66   VIII  having a plurality of generally radially oriented slots  67   VIII  sized and configured to slidably receive therein a plurality of projections  82 ″ arranged on an engaging member  80   IV . A spring S 3  biases the engaging member  80   IV  towards the engaging position (see  FIG. 59 ) wherein engaging members  85   IV  engage with deflectable members DA arranged on the pen needle  5 ′. The engaging member  80   IV  includes a proximal gripping end  88   IV  which allows the user to move the member  80   IV  from outside the cap  60   VIII . The member  80   IV  can slide axially within the cap  60   VIII  between an extended and/or initial position and/or engaging position shown in  FIG. 59  and a retracted position shown in  FIG. 60 . In order to allow the members  85   IV  to disengage from the members DA of the pen needle  5 ′, when the user moves member  88   IV  along the direction of arrow shown in  FIG. 60 , plural projections (not shown but similar to projections  68   V  shown in  FIG. 40 ) stop axial movement of the pen needle  5 ′ so that the members  85   IV  can disengage from the members DA as shown in  FIG. 60 . As can be seen in  FIG. 61 , when the members  85   IV  are engaged with the members DA of the pen needle  5 ′, the threaded portions TET (which are the only portions of the pen needle  5 ′ in threaded engagement with the threaded section  2 ′) are deflected out of engagement with the threaded section  2 ′ of the device  1 ′ allowing the pen needle  5 ′ to be slid off of the device  1 ′. 
         [0110]      FIGS. 62-64  shows other embodiments of a removable cap or removable cap assembly according to the invention. The removable cap  60   IX  includes a generally cylindrical main body  69   IX . In embodiments, the cap  60   IX  is a three-piece member including a distal part  60   IX A, an intermediate part  60   IX B, and threadably and removable connected proximal part  60   IX C. A clip C (not shown) is coupled to the main body so as to allow for clipping onto a user. The distal part  60   IX A includes a generally cylindrical section sized and configured to slide onto a proximal end of a pen injection device  1 ′. The proximal part  69   IX C includes an inner support  66   IX  having a plurality of engaging members  67   IX  which function to engage with the pen needle  5 . The intermediate part  69   IX B is an intermediate member IM which can move axially and optionally lock (via locking projection LP and locking recess LR in  FIG. 64 ) to the distal part  60   IX A and can unthread from the proximal part  69   IX C. The cap assembly shown in  FIGS. 62-64  functions similar to that shown in  FIG. 44  except that it can be expanded, via intermediate member IM, and separated to allow the user to grip the pen needle  5  and remove it from the proximal part  60   IX C. That is, once the user removes the cap assembly from the injection device (by using it to unthread the pen needle  5 ) so that it assumes the configuration shown in  FIG. 63 , the user can then move the proximal part  60   IX C away from the distal part  60   IX A as shown in  FIG. 62  and then either allow the pen needle  5  to fall out or manually unthread the proximal part  60   IX C from the intermediate part  60   IX B, and then remove the pen needle  5  from the proximal part  60   IX C for proper disposal of the pen needle  5 . The user can then reconnect the proximal part  60   IX C to the intermediate part  60   IX B and place the cap assembly in the position shown in  FIG. 63  so that the cap assembly can again assume a ready-to-use configuration. In order to allow the members  67   IX  to disengage from the pen needle  5 ′, when the user moves member  60   IX C from that shown in  FIG. 63  to that shown in  FIG. 62 , plural projections (not shown but similar to projections  68   V  shown in  FIG. 40 ) are arranged on member IM and stop axial movement of the pen needle  5  so that the members  67   IX  can disengage from the pen needle  5  as shown in  FIG. 62 . 
         [0111]      FIG. 65  show one non-limiting way in which the removable cap of the types described herein can be releasably connected to a pen needle device. In this embodiment, the main body  69  has a recess R which can receivingly retain therein a projection P arranged on the device  1 ″. Other snap-type connections can also be utilized to releasably retain the cap assembly on the device  1 ″. 
         [0112]    The devices described herein can also utilize one or more features disclosed in prior art documents expressly incorporated by reference in pending U.S. patent application Ser. No. 11/616,195 (Publication No. 2008/0154192). This application and the documents expressly incorporated therein is hereby expressly incorporated by reference in the instant application. Furthermore, one or more of the various parts of the device can preferably be made as one-piece structures by e.g., injection molding, when doing so reduces costs of manufacture. Non-limiting materials for most of the parts include synthetic resins such as those approved for syringes, blood collection devices, or other medical devices. Furthermore, the invention also contemplates that any or all disclosed features of one embodiment may be used on other disclosed embodiments, to the extent such modifications function for their intended purpose. 
         [0000]    purpose. 
         [0113]    It is noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention. While the present invention has been described with reference to an exemplary embodiment, it is understood that the words which have been used herein are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present invention in its aspects. Although the present invention has been described herein with reference to particular means, materials and embodiments, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims.