Patent Publication Number: US-2021170092-A1

Title: Pen needle assembly apparatus

Description:
FIELD OF THE INVENTION 
     This application claims priority to Chinese Application No. 201810345779.9 filed Apr. 18, 2018 and Chinese Utility Model Application No. 201820549944.8 filed Apr. 18, 2018, which are incorporated by reference in their entireties. 
     The present invention relates generally to an apparatus for use in mounting and attaching a pen needle assembly to a delivery device, such as a pen delivery device. The apparatus has a first well or opening with a movable clamping member for retaining a needle hub having an inner shield covering a cannula on the needle hub for attaching the needle hub to the delivery device. The apparatus has a second well to receive the inner shield for separating the inner shield from the needle hub without the need to handle the inner shield. The apparatus is constructed to retain and store the needle hub after use to reduce the risk of inadvertent needle stick. 
     BACKGROUND 
     Insulin and other injectable medications are commonly delivered with drug delivery pens. The drug delivery pen has a disposable pen needle hub attached to the pen to facilitate drug container access and allow fluid egress from the container through the needle into the patient. 
     Various pen needle delivery devices are known in the art for dispensing the substance to the patient. The delivery devices often use a disposable needle hub having a cannula or needle extending from a patient end of the hub for inserting into the patient. A non-patient end of the hub is coupled to the pen delivery device for delivering the substance to the patient. 
     The needle hub is often packaged in a container containing several pen needle hubs. A needle hub is selected from the package and attached to the pen needle delivery device for injecting the patient and then removed to be discarded. The needle hub package includes an outer cover that encloses the needle hub and a removable seal that is peeled from the outer cover to open the cavity of the cover so that the needle hub can be removed. The needle hub can have threaded non-patient end that is threaded onto the delivery device. The delivery device with the attached needle hub is then removed from the outer cover. An inner needle shield is attached to the needle hub to cover the cannula until the device is ready for use. The inner shield is removed to expose the cannula for use to deliver the substance to the patient. After use, the needle hub can be inserted back into the outer cover to enclose the exposed cannula. The pen delivery device is separated from the needle hub leaving the needle hub within the outer cover. 
     The prior devices require the use of both hands to connect to and remove the needle hub from the delivery device. During the placement back into the outer cover, the cannula is exposed and provides an increased risk of accidental needle stick. The manual operation of holding the outer cover while positioning the spent needle hub and cannula into the cavity of the outer cover can be difficult without accidental needle stick. 
     Existing pen needle assemblies are disclosed in U.S. Patent Application Publication Nos. 2006/0229562 to Marsh et al. and 2007/0149924 to R. Marsh, the entire contents of both of which are hereby incorporated by reference for this purpose. 
     Although the prior devices have been suitable for the intended use, there is a continuing need in the industry for improved packaging for a pen needle hub assembly. 
     SUMMARY 
     The present invention is an apparatus and device for receiving and supporting at least one pen needle assembly for attaching the pen needle assembly to a delivery device, such as a delivery pen. In particular, the apparatus is for use with a pen needle assembly that can be used in a manner to reduce the risk of inadvertent needle stick while attaching and removing the pen needle assembly from the delivery pen. The apparatus is also able to store used pen needles for disposal. 
     The apparatus includes a movable clamping assembly and an actuator mechanism to operate the clamping assembly. In one embodiment, the apparatus is provided with an opening or well for a pen needle assembly. The pen needle assembly includes an outer cover, a needle hub supporting a cannula or needle, and an inner shield covering the cannula. A removable seal closes the open end of the outer cover that is removed before attaching the needle hub to the delivery pen. The apparatus retains and supports the pen needle assembly and the needle hub and cannula while attaching to a delivery pen or other delivery device. The apparatus is able to store a used needle hub and the outer cover for disposal. 
     The apparatus has a recess or well for receiving and retaining the inner shield that covers the cannula so that the inner shield can be removed from the needle hub without the operator handling the inner shield. The used needle hub can be inserted back into the outer cover and transferred to a storage area, tray, or internal sharps container for disposal. The inner shield optionally can be re-attached to the needle hub or can be discarded in the storage area. An actuator mechanism is provided to operate the clamping assembly and release the needle hub, outer cover, and inner shield to a suitable disposal area, bin, or container, such as a sharps container in the apparatus. 
     One aspect is to provide an apparatus or device for receiving and supporting a pen needle assembly to attach a needle hub to a delivery device without the need for the user to handle the needle hub with an exposed cannula on the needle hub. The needle hub assembly is positioned in the apparatus so that the delivery device can be attached to the non-patient end of the needle hub. An inner needle shield on the needle hub can then be inserted into an opening in the apparatus to grip the inner shield by an extraction mechanism so that the inner shield can be separated from the needle hub without the user handling the inner shield. After use, the needle hub is positioned in the outer cover that is retained in an opening of the apparatus and disconnected from the delivery device where the apparatus retains the used needle hub and outer cover. 
     The apparatus includes a housing having an internal cavity for receiving pen needles for attaching to a delivery pen and storing used pen needle assemblies and the associated components after use. The housing has a clamping assembly mechanism with at least one clamping member, such as a movable clamping member, that is able to grip the outer cover of a pen needle assembly so that the needle hub can be attached to the delivery pen. The used needle hub can be inserted back into the outer cover that is retained in the apparatus and separated from the delivery pen. An actuator can be deployed to release the outer cover so that the outer cover and used needle hub can be removed from the apparatus or deposited directly into a storage area or compartment in the apparatus for storing used pen needle assemblies until ready for disposal. 
     A pen needle apparatus in one aspect comprises a clamping assembly including a movable clamping member and an actuator. A tray forming a housing has an inner cavity, a top end, and a bottom end. The movable clamping member is configured for gripping an outer cover of a pen needle assembly when the movable clamping member is in a first closed position and for releasing the outer cover when the clamping member is in a second open position. The actuator is connected to the apparatus and the movable clamping member to enable the clamping member to move between the first position and the second open position to release the outer cover. 
     In one embodiment, the movable clamping member is spring biased to the first open position. A suitable latching mechanism engages the movable clamping member to latch the movable clamping member in the closed position. The latching mechanism is associated with the actuator to engage the movable clamping member to retain the clamping member in the closed position. The actuator is deployed to release the clamping member to enable the clamping member to move to the open position by the biasing force of the spring. 
     The clamping assembly in one embodiment includes at least one movable clamping member and fixed clamping member that can grip and retain the outer cover. The movable clamping member can move in a direction relative to the fixed clamping member to capture and release the outer cover. In one embodiment, the movable clamping member can slide in a substantially linear direction away from the fixed clamping member. The sliding movement can be in a direction substantially perpendicular to a center axis of an opening formed between the movable clamping member and the fixed clamping member. 
     The assembly includes the actuator, such as a button, that can include a mechanism to release the movable clamping member to release the outer cover. The actuator can have a connecting body with a detent that cooperates with a detent on the movable clamping member to latch or lock the movable clamping member in a closed position and release the movable clamping member to enable the movable clamping member to move to an open position. The movable clamping member and the actuator can be spring biased to a starting position. In one embodiment, the movable clamping member can be manually moved to the closed position where the movable clamping member is latched or locked in the closed position until the actuator is deployed. 
     The features are further provided by a pen needle assembly apparatus for receiving a pen needle assembly, where the pen needle assembly apparatus includes a base having a plurality of openings, each of the openings having a clamping assembly including a fixed clamping member oriented with a first side of each of said openings. A movable clamping member is coupled to the base on a second side of the opening, and complementing the respective fixed clamping member, where the movable clamping member is movable between an open position and a closed position to grip a pen needle assembly. IN one embodiment, the movable clamping member slides in a slot in the base in a linear direction toward and away from the fixed clamping member. An actuator is included to move the movable clamping member to the open position to release the pen needle assembly. 
     After use of the needle hub and cannula, the needle hub attached to the delivery pen is inserted into the outer cover that is retained in the apparatus. The needle hub can be gripped by a friction fit or interference fit to the outer cover so that the pen needle delivery device can be separated from the needle hub without the operator handling the needle hub thereby reducing the risk of inadvertent needle stick. 
     The features are further provided by a pen needle assembly apparatus comprising a base having a plurality of openings, where each of the openings having a clamping assembly. The clamping assembly has a fixed clamping member associated with a first side of each of the openings. The fixed clamping member has a gripping surface configured for gripping a pen needle assembly. The clamping assembly has a movable clamping member coupled to the base on a second side of each of the openings and is movable between an open position and a closed position for gripping the pen needle assembly between the fixed clamping member and the movable clamping member. The movable clamping member is biased to the open position. An actuator is movable between a first position where the movable clamping member is locked in the closed position and a second position to release said movable clamping member so that the movable clamping member moves to the open position by a spring member and releases the pen needle assembly from between the clamping members. 
     The features of the apparatus are further attained by a method of coupling the needle hub of a pen needle assembly to a delivery device using a pen needle assembly apparatus. The method comprises the steps of inserting a pen needle assembly into an apparatus having an opening with a dimension for receiving the pen needle assembly, where the apparatus has a fixed clamping member oriented on a first side of the opening and a movable clamping member on a second side of the opening, where the movable clamping member is movable between an open position and a closed position for gripping an outer cover of the pen needle assembly inserted into the opening; coupling the pen needle delivery device to a needle hub of the pen needle assembly; removing the pen needle delivery device and pen needle hub for delivery of a substance to a patient; returning the pen needle delivery device and pen needle hub into the outer cover and separating the pen needle delivery device from needle hub; and actuating an actuator to release the pen needle assembly from the opening in the assembly. 
     The objects, advantages, and salient features of the invention will become apparent from the following detailed description, which, taken in conjunction with the annexed drawings, discloses exemplary embodiments of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The above benefits and other advantages of the various embodiments of the present invention will be more apparent from the following detailed description of exemplary embodiments of the present invention and from the accompanying figures, in which: 
         FIG. 1  is an exploded perspective view of a pen needle delivery device in one embodiment showing the pen needle assembly that includes a needle hub supporting a cannula, inner shield, and outer cover; 
         FIG. 2  is a cross-sectional view of the pen needle assembly; 
         FIG. 3  is a perspective view of the apparatus and storage device in one embodiment of the invention; 
         FIG. 4  is a side view of the apparatus in one embodiment; 
         FIG. 5  is a front view of the apparatus of  FIG. 3 ; 
         FIG. 6  is a top view of the apparatus; 
         FIG. 7  is an exploded perspective view of the apparatus; 
         FIG. 8  is a top view of the base of the apparatus without the clamping members and actuators; 
         FIG. 9  is a bottom view of the base of the apparatus of  FIG. 8 ; 
         FIG. 10  is bottom view of the base of the apparatus showing the ends of the actuator buttons and the clamping members for removing the inner cover of the pen needle assembly; 
         FIG. 11  is a top perspective view of the fixed gripping member separated from the base; 
         FIG. 12  is a bottom view of the fixed gripping member of  FIG. 11 ; 
         FIG. 13  is a perspective view of the apparatus showing the actuator mechanism and the collection tray removed; 
         FIG. 14  is a bottom perspective view of the movable clamping member of the gripping mechanism; 
         FIG. 15  is a top perspective side view of the movable clamping member of  FIG. 14 ; 
         FIG. 16  is a top perspective view of the body of the ratchet member of the movable clamping member; 
         FIG. 17  is a top perspective view showing a actuator button connected to the body of the ratchet member; 
         FIG. 18  is a top perspective view of the actuator button; 
         FIG. 19  is a bottom perspective view of the actuator button of  FIG. 18 ; 
         FIG. 20  is a top perspective view of the connecting arm and detent of the actuating mechanism; 
         FIG. 21  is a perspective view of the gripping spring member; 
         FIG. 22  is a perspective view of the movable clamping member showing the spring member for gripping the pen needle hub; 
         FIG. 23  is a partial cross-sectional view showing the actuating mechanism; 
         FIG. 24  is a top perspective view of the apparatus showing the movable clamping member in the closed position; 
         FIG. 25  is a partial top view of the apparatus showing the movable clamping member in the closed position; 
         FIG. 26  is a partial cross-sectional view of the actuator mechanism showing the movable clamping member in the open position; 
         FIG. 27  is a cross-sectional view showing the movable clamping member in the open position; 
         FIG. 28  is a perspective view showing the actuator mechanism retaining the movable clamping member in the open position; 
         FIG. 29  is a cross sectional view of the actuator mechanism; 
         FIG. 30  is a top view of the apparatus showing the movable clamping member in the closed position; 
         FIG. 31  is a bottom perspective view of the apparatus showing the movable clamping member in the closed position; and 
         FIG. 32  is a partial cross-sectional view showing the movable clamping members in the closed position. 
     
    
    
     Throughout the drawings, like reference numbers will be understood to refer to like parts, components, and structures. 
     DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS 
     The present invention is directed to a pen needle apparatus for storing and supporting at least one and preferably a plurality of pen needle assemblies for use with a pen needle delivery device. The apparatus can function as a storage device for a used needle hub where the used needle hub can be replaced in the apparatus after use and later discarded without handling the needle hub to reduce the risk of accidental needle stick. 
     Reference are made in detail to embodiments of the present invention, which are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. The embodiments described herein exemplify, but do not limit, the present invention by referring to the drawings. The exemplary embodiments are presented in separate descriptions, although the individual features and construction of these embodiments can be combined in any number of ways to meet the therapeutic needs of the user. 
     This disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The embodiments herein are capable of being modified, practiced or carried out in various ways. The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms “connected,” “coupled,” and “mounted,” and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms “connected” and “coupled” and variations thereof are not limited to physical or mechanical connections or couplings. Further, terms such as up, down, bottom, and top are relative, and are employed to aid illustration, but are not limiting. The features of the assembly can be combined with other embodiments so long as they do not contradict each other. The term “substantially” mean mostly or entirely and can include a range or value. The term can include a given value or a reasonable range encompassing the value. Terms of degree, such as “substantially” or “approximately” are understood by those skilled in the art to refer to reasonable ranges around and including a given value. 
     The apparatus for the needle hub assemblies can enable the convenient and easy assembly and removal of the needle hub on the pen delivery device with reduced handling of the exposed needle cannula. The device for the needle hub assemblies can be placed on a flat surface, such as a table, so that the pen needle delivery device can be attached to the needle hub assembly with one hand thereby reducing the risk of the needle stick by handling the needle hub with the exposed needle cannula. 
     Pen needle delivery device  10 , as shown in  FIG. 1  typically comprises a dose knob/button, an outer sleeve  12 , and a cap. A dose knob/button allows a user to set the dosage of medication to be injected. The outer sleeve  12  is gripped by the user when injecting medication. The cap is used by the user to securely hold the pen needle device  10  in a shirt pocket or other suitable location and provide cover/protection from accidental needle injury. 
     In standard pen needle devices the dosing and delivery mechanisms are all found within the outer sleeve  12  and is not described in greater detail here as they are understood by those knowledgeable of the delivery device. A medicament cartridge is typically attached to a standard pen injector housing by known attachment mechanism. The distal movement of a plunger or stopper within the medicament cartridge causes medication to be forced into the reservoir housing. The medicament cartridge is sealed by a septum and punctured by a septum penetrating needle cannula located within a reservoir or housing. Reservoir housing preferably is screwed onto the medicament cartridge although other attachment means can be used. The pen needle delivery device can be a standard pen delivery device known in the industry so that the pen needle delivery device is not shown in detail. The pen needle assembly  18  as shown in  FIG. 2  includes a needle hub  16  supporting a cannula  20 , an outer cover  22 , and an inner shield  24 . A protective seal  26  is attached to the open end of the outer cover as shown in  FIG. 2  to enclose the needle hub and cannula to maintain a clean and sterile condition. The seal  26  can be a label or other closure member that can be peeled easily from the outer cover to access the needle hub during use. 
     The pen needle delivery device  10  is connected to needle hub  16  shown in  FIG. 1  that has a connecting non-patient end with internal threads that screw onto a threaded end  18  of the delivery device  10 . The needle cannula  20  extends from the patient end of the needle hub  16  for delivering the substance to the patient. The outer cover  22  can be provided to cover the needle cannula to protect the patient from accidental needle stick before and after use. The outer cover  22  includes ribs  23  to assist in gripping the outer cover during use. The inner shield  24  is provided over a post extending from the end of the needle hub  16  to enclose the cannula. During use, the needle hub  16  is connected to the pen delivery device and the inner shield is removed. After use, the outer cover is generally placed back on needle hub to cover the needle cannula. The needle hub with the cover is then removed from the pen needle delivery device and discarded. 
     The apparatus  30  is configured for receiving and supporting at least one pen needle assembly  18  in a position where the delivery device  10  can be coupled to the needle hub  16  for use for injecting the substance to the patient without the need for the user to handle the needle hub  16  with the exposed cannula. The used needle hub  16  and cannula  20  can then be positioned back into the outer cover  22  that is retained in the apparatus and separated from the delivery device. The used outer cover and needle hub and the inner shield are retained in the assembly. In the embodiment shown, the apparatus is configured for receiving a plurality of needle assemblies. 
     An apparatus  30  is provided for receiving a pen needle assembly  18  for coupling the pen needle hub  16  to the pen needle delivery device and for separating the pen needle hub from the pen needle delivery after use. In one embodiment, the apparatus  30  includes a base  32  coupled to a housing  34  forming a tray, a retaining and clamping assembly  36 , and an actuator assembly  38 . The housing  34  as shown in  FIG. 3  has a top end  40  and a bottom end  42 . Bottom end  42  can have a bottom face with a non-slip surface. The nonslip surface can be molded directly onto the bottom face or can be a nonslip material, such as an elastomeric material or resilient polymer, applied to the bottom surface to retain the housing in a stable position during use on a table or other flat surface. 
     As shown in the drawings the apparatus  30  is configured for receiving a plurality of pen needle assemblies at the same time. The apparatus  30  includes a plurality of clamping assemblies  36  with a respective actuator assembly  38  positioned adjacent each other where each clamping assembly  36  and actuator assembly  38  are independently operable. Each clamping assembly  36  of the apparatus  30  is able to support a pen needle assembly until ready for use and discard the pen needle assembly individually after use. A pen needle delivery device can be connected to the respective pen needle assembly and stored in the apparatus  30  until ready for use as shown in  FIG. 5 . At that time, the pen needle delivery device and a single needle hub are removed for use. 
     The tray  34  has an inner cavity with a dimension sufficient to retain and store a plurality of used pen needle assemblies. In the embodiment shown, a housing  34  is formed to couple with the base  32  by hooks  44  extending from the base  32  for mating with a complementing tab or hook within the tray  34 . As shown in the drawings, the base  32  defines a removable cover for the tray  34 . 
     Referring to  FIGS. 3-6 , the clamping assembly  36  is provided for supporting and gripping a pen needle assembly for connecting the needle hub  16  to the delivery pen and disconnecting the needle hub from the delivery pen after the use. The clamping assembly  36  is a movable assembly that can move between an open position for receiving the outer cover of the pen needle assembly and a closed position for engaging and gripping the outer cover the pen needle assembly. 
     In the embodiment shown, the clamping assembly  36  includes two opposing clamping members or jaws where at least one is movable relative to the other. In one embodiment the clamping assembly  36  includes a fixed clamping member  46  coupled to the base  32  and a movable clamping member  48  that is movable relative to the base  32  and the fixed clamping member  46 . The base  32  has an opening  76  with a dimension complementing the outer dimension of the pen needle assembly so that the pen needle assembly can slide through into the housing when released by the clamping assembly  36 . As shown, an opening  76  is provided for each clamping assembly  36 . 
     The fixed clamping member  46  in the embodiment shown is formed as a separate member that is attached to the base  32  by a suitable fastening mechanism such as adhesives or mechanical fasteners. As shown in  FIGS. 7, 11 and 12 , the fixed clamping member  46  has a front face  50  with a plurality of recessed areas  52  extending between a top face  54  and a bottom face  56 . In the embodiment shown, the front face  50  is substantially flat for mating with the movable clamping member  48 . As shown in  FIG. 11 , the recessed areas  52  are spaced apart from each other and have a substantially U-shape inner surface  58  with a dimension and configuration to accommodate the pen needle assembly  18 . The inner surface  58  in the embodiment shown is provided has an arcuate shaped flange  60  that is able to grip the outer surface of the pen needle assembly. A slot  62  is formed in the inner surface  58  to receive a spring metal slip gripping member  64  as shown in  FIG. 21 . 
     An extractor mechanism can be provided in the base or the fixed clamping member for separating the inner shield from the needle hub without the need for the technician to manually remove the inner shield. Referring to  FIGS. 11 and 12 , an aperture  66  is formed at one end of the fixed clamping member  46  and has a dimension to receive the inner shield  24  of the pen needle assembly. Alternatively, the aperture  66  is formed in eh top face of the base  32 . A collar  67  extends from the top face  54  and surrounds the aperture  66 . A gripping member shown as the spring metal clip  68  is attached to the bottom surface of the fixed clamping member  46  next to the aperture  66 . The spring metal clip  68  has a first end  70  attached to a boss  72  extending from the bottom face  56  of the fixed clamping member  46  and a second free end  74  extending a slight distance into the opening defined by the aperture  66  a distance sufficient to engage the inner shield. 
     In the embodiment shown, the two spring metal clips  68  are oriented on opposite sides of the aperture  66  where the free ends  74  extend into the opening of the aperture a distance sufficient to grip the outer surface of the inner shield  24 . During use, the inner shield  24  is manually pushed through the aperture  66  where the spring clips  68  grips the outer edge of the inner shield with a sufficient force to enable needle hub to separate from the inner shield by pulling needle hub  16  upward while retaining the inner shield within the aperture. During subsequent use, a new inner shield is pushed downwardly against the inner shield captured by the spring clips  68  to push the original inner shield through the aperture to be deposited into the tray  34  below the aperture  66 . 
     Base  32  has a dimension for mating with the open top end of the housing  4  to define a tray or enclosure for receiving the used pen needle assemblies. Referring to  FIGS. 7-9 , base  32  has a substantially rectangular configuration with a plurality of openings  76  associated with each of the fixed clamping members  46  and movable clamping members  48 .  FIG. 8  is a top view of the base  32  showing the opening  76  aligned next to each other and an opening  78  at one end cooperating with the aperture  66  of the fixed clamping member  46  to enable the used inner shield to fall into the tray  34 . A plurality of apertures  80  are provided on the base  32  to receive the corresponding boss  82  on the bottom side of the fixed clamping member  46  for coupling the fixed clamping member  46  to the base  32  as shown in  FIG. 12 . 
       FIG. 9  is a bottom view of the base  32  showing the openings  76  surrounded by a collar  84 . Each opening  76  includes a pair of guide slots  86  for cooperating with the movable clamping member  48  and allowing the moving clamping member  48  to slide in a linear direction perpendicular to a center axis of the opening  76 . An elongated slot  88  extends away from the respective openings  76  for cooperating with the movable clamping member  48 . 
     Referring to  FIGS. 14 and 15  the movable clamping member  48  has a front face  90  for mating with the front face  50  of the fixed clamping member  46 . A recessed area  92  has a substantially U-shape to complement the U-shaped recess  52  of the fixed clamping member  46  to form a well  94  or opening for receiving and clamping the pen needle assembly as shown in  FIG. 6  and  FIG. 13 . As shown  FIG. 15 , the U-shaped recess  92  includes an angled flange  96  for gripping the pen needle assembly. A slot  98  in the recess  92  receives a metal spring clip  64  shown in  FIG. 21  forming a gripping member. 
     As shown in  FIG. 14  the bottom face of the clamping member  48  includes spaced apart posts  100 . The posts  100  are positioned for attaching the spring metal clip gripping member  64  to the movable clamping member  48 . As shown in  FIG. 21 , the spring metal clip  64  includes a pair of legs  102  having an aperture  104  for mating with posts  100  of the clamping member  48  and corresponding posts  106  on the bottom side of the fixed clamping member  46  as shown in  FIG. 12 . The spring metal clip  64  has an inclined end portion  108  forming a gripping edge  110  that extends through the slot  98  to engage the pen needle assembly. As shown in  FIG. 21  the gripping edge  110  as a concave recessed area  112  for mating with the outer surface of the pen needle assembly. The inclined end portion  108  is angled downwardly with respect to the well  94  or opening to enable the outer cover to slide past the gripping edge  110  while resisting removal of the outer cover in an upward direction. 
     Referring to  FIG. 14  the movable clamping member  48  includes two spaced apart posts  114  having a length to extend through the guide slots  86  of the base  32 . The distal ends of the post  114  include a notch  116  for mating with the actuator assembly  38 . A leg  118  extends from the movable clamping member  48  in a direction opposite the recessed area  92 . The distal end of the leg  118  includes a downwardly extending tab  120  extending through the slot  86  for mating with the actuator assembly  38 . 
     The actuator assembly  38  in the embodiment shown includes an actuator button  122  and a ratchet assembly  124  shown in  FIG. 17 . As shown in  FIG. 18 , actuator button  122  includes a top portion and legs  128  that pass through the openings  130  in the base  32  to enable the actuator button  122  to reciprocate in an up-and-down direction relative to the base. In the embodiment shown, two legs  128  are provided although a single leg can be used. In one embodiment a spring  132  is positioned between the base  132  and the actuator button  122  for biasing the actuator button  122  in an upward direction away from the base as shown in  FIG. 23 . As shown in  FIG. 19  a post  134  is provided in the bottom face of the actuator button  122  for mating with and positioning the spring  132  on the actuator button  122  between the legs  128 . 
     Ratchet assembly  124  as shown in  FIG. 20  includes a ratchet connecting member having a body  136  with legs  138  extending from one end. In the embodiment shown, two parallel legs  138  are provided although a single or multiple legs can be used. The distal end of each leg  138  includes an aperture  140  for receiving a pivot pin  142  for connecting the legs  138  to the legs  128  of the respective actuator button  122  as shown in  FIG. 17 . The opposite end of the body  136  includes a leg  144  having an aperture  146  for receiving a pivot pin  148  for pivotally connecting the body  136  to the base  32 . As shown in  FIG. 20 , body  136  includes at least one detent  150 . In the embodiment shown, two spaced apart detents are provided for mating with the movable clamping member  48 . In the embodiment shown, detents  150  have an inclined face  152  forming a cam surface and an opposite flat face  154  oriented substantially perpendicular to the longitudinal dimension of the body  136 . Referring to  FIG. 9  the bottom face of the base  32  includes two raised posts  156  at one end of the respective guide slots  86 . Each post  156  includes an aperture  158  for receiving a pivot pin  142  for pivotally connecting the leg  144  of the body  136  to the base  32  as shown in  FIGS. 7 and 23 . 
     A complementing ratchet member  160  as shown  FIG. 16  and  FIG. 21  is attached to the bottom side of the movable clamping member  148 . In the embodiment shown, the ratchet member  160  is fixed to the movable clamping member  160 . Referring to  FIG. 16 , ratchet member  160  includes a body  162  having legs  166  extending from one end. In the embodiment shown, two spaced apart and parallel legs  166  are provided. Each leg  166  has an outwardly extending tab  168  for coupling with the respective movable clamping member  48 . The opposite end of the body  162  includes an aperture  170  for mating with the aperture  170  on the movable clamping member  48 . 
     Detents  172  are provided on opposite sides of the aperture as shown in  FIG. 16 . The detents  172  have an inclined face  174  forming a cam surface and a flat face  176  extending substantially perpendicular to a longitudinal dimension of the body  62 . As shown in  FIG. 26  ratchet member  160  is coupled to the movable clamping member  48  by the tabs  168  mating with the notch  116  formed in the posts  114  of the movable clamping member  48 . The movable clamping member is positioned on the outer top face of the base  32  with the legs  114  extending through the apertures in the base. The ratchet member  160  is positioned below the apertures in the base. The ratchet member  160  is positioned below the base  32  opposite the movable clamping member and attached to the movable clamping member so that the movable clamping member and ratchet member move a single unit in a linear direction. A fastener, such as a screw, can extend through the aperture  170  formed in the body  162  for mating with an aperture  178  formed in the bottom face of the tab  120 . 
     In the embodiment shown, two spaced apart detents  172  are provided for mating with a respective detent  150  on the body  136  of the ratchet assembly  124 . It will be understood that the number of detents can vary although the number of detents  150  of the body  136  generally correspond to the number of detents  172  of the ratchet member  160 . As shown in  FIGS. 22, 23, 26, and 27  the inclined face  174  of the detents  172  of the ratchet member  160  mate with the inclined face  152  of the detent  150  of the body  136  to be able to slide over each other. The movable lamping member slide manually where the inclined faces  174  of the ratchet member slide over the inclined faces  152  where the body  136  pivots about the axis of the pivot pin  148  away from the base. Once the inclined faces slide over one another, the body  136  springs back to the original position. The flat face  176  of the ratchet member  160  engages the flat face  154  of the body  136  to hold the movable clamping member  48  in the closed position as shown in  FIGS. 31 and 32  until released by the actuator mechanism. 
     As shown in  FIG. 26  and  FIG. 27 , the posts  114  and the leg  118  of the movable clamping member  48  extend through the respective guide slots  86  and elongated slot  88  in the base  32 . The body  136  of the ratchet assembly  124  is coupled to the respective posts  114  and leg  118  to capture base  32  between the movable clamping member  148  and the body  136  and couple the movable clamping member  48  to the base  32  while allowing the movable clamping member  48  to slide in a linear direction relative to the guide slots  86  and the elongated slot  88  and relative to the fixed clamping member  46 . 
     The legs  128  of the button  122  extend through the respective openings  130  formed in the base  32  as shown in  FIG. 26  and  FIG. 27 . The legs  138  of the body  136  of the ratchet assembly  124  are pivotally connected to the legs  128  of the actuator button  122  by the pivot pin  142  to capture the actuator button  122  to the base  32 . The leg  144  of the body  136  is connected to the respective post  156  on the bottom face of the base  32  by the pivot pin  148 . As shown, the actuator button  122  slides in an up-and-down direction and is biased upward by the spring  132 . The downward movement of the actuator button  122  pivots the body  136  in a downward direction relative to the base  32 . 
     As shown in  FIG. 27  a spring  182  is positioned in the longitudinal slot  88  and extends between the post  120  and the inner edge of the slot  88  to bias the movable clamping member  48  to the position shown in  FIG. 27  and the open position relative to the fixed clamping member  46 . During use, the movable clamping member  48  is pushed manually toward the fixed clamping member  46  against the biasing force of the spring  182  to the position shown in  FIGS. 30 and 32 . As shown in  FIG. 27  inclined surface  174  of the ratchet member  160  attached to the movable clamping member  48  opposes the inclined face  152  of the detent  150  on the body  136 . The movable clamping member  48  can slide towards the fixed clamping member  46  so that the inclined surfaces  152  and  174  are able to slide over each other by pivoting the body  136  downward relative to the pivot pin  142  to separate the detents allowing the movable clamping member  48  to slide toward the fixed clamping member  46 . Once the inclined surface  174  slide past the inclined surface  152 , the biasing force of the spring  132  returns the body  136  to the original position to latch or lock the movable clamping member  48  in the closed position as shown in  FIGS. 31 and 32  by the face  176  of the ratchet member  160  of  FIG. 16  engaging the flat face  154  of the ratchet assembly  124  of  FIG. 20 . Manually sliding the movable clamping member  48  to the closed position relative to the fixed clamping member  46  as shown in  FIG. 32  enables the flat face  176  of the detent  172  to engage the flat face  154  of the detent  150  to capture and latch the movable clamping member in the closed position and resist separation of the movable clamping member  48  relative to the fixed clamping member  46 . 
     Once the movable clamping member  48  is latched in the closed position with respect to the fixed clamping member  46  shown in  FIG. 23 , the apparatus can be used for coupling a pen needle assembly  18  to a delivery device such as a pen needle  10 . A pen needle assembly  18  can be positioned in one or more of the wells  94  formed by the closed clamping members  46  and  48 . The pen needle assembly  18  can be manually placed in the respective well  94  or opening and pushed downwardly until the flanges  60  and  96  and spring clip  64  engage the outer cover  22 . Typically the outer cover  22  is secured when an audible sound or tactile click provides an indication of a proper connection of the pen needle assembly to the well  94 . 
     The flanges  60  and spring metal clip  64  are able to grip the outer surface of the outer cover  22  to resist rotation of the outer cover relative to the clamping members and resist removal of the outer cover from the well  94 . The label  26  can then be peeled from the outer cover  22  to expose the needle hub  16  for use. The delivery device such as the pen needle  10  is then inserted into the needle hub  16  and threaded onto the needle hub in the usual manner. The delivery device with the needle hub  16  attached is removed from the outer cover  22  to expose the inner shield  24 . The inner shield  24  is then inserted through the aperture  66  to engage the spring clip  68 . The delivery device is pulled away to separate the inner shield  24  from the needle hub  16 . The inner shield  24  can be pushed manually through the opening in the base  32  into the housing  34  for disposal. Alternatively, a subsequent inner shield can be pushed into the aperture  66  pushing the previous inner shield through the opening into the housing  34 . 
     The delivery device with the needle hub attached can be prepared for use by the technician such as by adjusting the dose and expelling air from the delivery device and cannula  20 . At this stage, the needle hub  16  and the delivery device can be inserted back into the respective outer cover  22  until ready for use. A delivery device can be prepared for each pen needle assembly positioned in a respective well  94 . The respective actuator button  122  can include indicia such as a number or letter to designate a selected patient, dosage or medication contained in the delivery device. Each of the wells formed by the clamping members  46  and  48  receive a pen needle assembly for preparing a delivery device for use. In this manner, a plurality of delivery devices can be prepared simultaneously for use where each delivery device is positioned in a respective well identified by the indicia on the actuator button. 
     Each of the delivery devices can be used to deliver the medication to the patient. After use, the needle hub  16  while still attached to the delivery device is inserted back into the respective outer cover  22  where the delivery device can be separated from the respective needle hub and leaving the used needle hub in the cover retained in the well formed by the clamping members  46  and  48 . The respective actuator button  122  for the respective well  94  can then be depressed causing the body  136  of the ratchet mechanism  124  to pivot away to separate the detent  150  on the body  136  from the detent  172  on the body  166  of the ratchet member attached to the movable clamping member  48 . The spring  182  then biases the movable clamping member  48  to the open position allowing the used pen needle assembly to separate from the clamping member  46  and  48  and drop into an area in the tray  34  for safe disposal. The movable clamping member  48  can then be manually pushed to the closed position for receiving a new pen needle assembly. In this manner, the used pen needle assemblies can be discarded into the tray after use without the need for the technician to handle the needle hub thereby reducing the risk of needle stick during use and disposal of the delivery device and the needle hub. 
     In another embodiment, the extractor can be formed from a sheet metal clip attached to the base where the clip includes sharp edges to engage the inner shield. The extractor can have a substantially keyhole shaped slot with an enlarged, substantially circular opening and a longitudinally extending opening having a width less than the diameter of the circular opening. The circular opening can have a dimension slightly larger than the outermost dimension of the inner shield  24  so that the inner shield can pass through without interference. The distal end of the longitudinal opening can include at least one tooth projecting inwardly with respect to the circular opening. The tooth can have an inclined surface forming a sharp tip and inclined in a generally downward direction to allow the inner shield  24  to slide over the tip and resist removal of the inner shield in an upward direction. The tooth can be sufficiently flexible so that the inner shield can be pushed through the opening to pass into the tray or other receptacle in the housing. 
     The steps can be repeated by placing a new pen needle assembly in the housing and the delivery pen can be attached to the needle hub. The new needle hub with the inner shield  24  can be inserted into the opening for the extractor where the tip of the inner shield engages the top end of the previous shield so that a downward force pushes the previous shield past the flexible edges of the spring clip. The inner shield  24  is then able to drop downward into the tray. 
     In a further embodiment shown in  FIG. 21  and  FIG. 22  the outer cover  22  can be re-attached to the hub  16  without separating the needle hub from the delivery pen. The delivery pen with the attached needle hub  16  can be inserted through the collar and the housing so that the needle hub  16  is received in the outer cover  22 . The actuator  108  can then be depressed to separate the clamping members to release the outer cover  22 . The delivery pen can then be withdrawn with the outer cover protecting the cannula to avoid inadvertent needle stick. 
     The foregoing embodiments and advantages are exemplary and are not to be construed as limiting the scope of the present invention. The description of an exemplary embodiment of the present invention is intended to be illustrative, and not to limit the scope of the present invention. Various modifications, alternatives, and variations will be apparent to those of ordinary skill in the art, and are intended to fall within the scope of the invention. It is particularly noted that the features of different embodiments and claims may be combined with each other as long as they do not contradict each other. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the appended claims and their equivalents.