Patent Abstract:
A drug delivery assembly for use in association with an outlet port of an injection device, the assembly including a connector for association with the outlet port of the injection device, a skin interface element including a fluid flow channel in fluid connection with at least one hollow penetrating element deployed for penetrating into a biological barrier and a shield deployed to prevent inadvertent contact with said hollow penetrating element prior to use. The shield being retained in engagement with at least one of the connector and the skin interface element. The skin interface element is mechanically engaged with the connector so as to be displaceable relative to the connector between an inactive position and an active position. The motion of the skin interface element relative to the connector from the inactive position to the active position is effective to disengage retention of the shield.

Full Description:
REFERENCE TO RELATED APPLICATIONS 
       [0001]    Reference is made to PCT Patent Application WO2010067319A3, filed Dec. 9, 2009 and entitled “DEVICE FOR INJECTING FLUID ISOLATED FROM MICRONEEDLE HUB WITH DEAD-SPACE-REDUCING INSERT”, the disclosures of which is hereby incorporated by reference. 
         [0002]    Reference is further made to U.S. Provisional Patent Application Ser. No. 61/433,538, filed Jan. 18, 2011 and entitled “Needle Safety Device”, the disclosure of which is hereby incorporated by reference and priority of which is hereby claimed pursuant to 37 CFR 1.78(a) (4) and (5)(i). 
     
    
     FIELD OF THE INVENTION 
       [0003]    The present invention relates to medication delivery assemblies and more particularly to medication delivery assemblies for injection devices. 
       BACKGROUND OF THE INVENTION 
       [0004]    The following publications are believed to represent the current state of the art: U.S. Pat. Nos. 5,232,454; 5,447,501; 5,665,075; 6,406,459; 6,632,199; 6,719,732; 7,241,277; 7,300,421; 7,387,617; 7,530,965; 7,537,581; 7,798,994; 
         [0005]    U.S. Patent Publication Nos. 20070016141; 20090012478; 20090105661; 20090062744; 20100137810; 20100222749; 4202334; 20020045864; 5785691; 20100274185A1. 
       SUMMARY OF THE INVENTION 
       [0006]    The present invention seeks to provide an improved medication delivery assembly. There is thus provided in accordance with a preferred embodiment of the present invention a drug delivery assembly for use in association with an outlet port of an injection device, the assembly including a connector for association with the outlet port of the injection device, a skin interface element including a fluid flow channel in fluid connection with at least one hollow penetrating element deployed for penetrating into a biological barrier, and a shield deployed to prevent inadvertent contact with the hollow penetrating element prior to use, the shield being retained in engagement with at least one of the connector and the skin interface element. 
         [0007]    The skin interface element is mechanically engaged with the connector so as to be displaceable relative to the connector between an inactive position in which the fluid flow channel is isolated from the outlet port of the injection device and an active position in which the fluid flow channel is in fluid connection with the outlet port of the injection device. The motion of the skin interface element relative to the connector from the inactive position to the active position is effective to disengage retention of the shield. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]    The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which: 
           [0009]      FIG. 1  is a simplified pictorial illustration of a medication delivery assembly constructed and operative in accordance with a preferred embodiment of the invention; 
           [0010]      FIGS. 2A and 2B  are simplified respective detailed front and rear sub assembly exploded view illustrations of the medication delivery assembly of  FIG. 1 ; 
           [0011]      FIG. 3  is a simplified pictorial view of a connector element forming part of the medication delivery assembly of  FIG. 1 ; 
           [0012]      FIGS. 3A and 3B  are simplified respective side view and sectional illustrations of the connector element of the medication delivery assembly of  FIG. 1 ,  FIG. 3B  being taken along lines D-D in  FIG. 3A ; 
           [0013]      FIGS. 3C and 3D  are simplified respective side view and sectional illustrations of the connector element of the medication delivery assembly of  FIG. 1 , 
           [0014]      FIG. 3D  being taken along lines B-B in  FIG. 3C , perpendicular to lines D-D in  FIG. 3A ; 
           [0015]      FIG. 3E  is a simplified bottom view of the connector element of the medication delivery assembly of  FIG. 1 ; 
           [0016]      FIG. 4  is a simplified pictorial view of a septum element forming part of the medication delivery assembly of  FIG. 1 ; 
           [0017]      FIGS. 4A and 4B  are simplified respective side view and sectional illustrations of the septum element of the medication delivery assembly of  FIG. 1 ,  FIG. 4B  being taken along lines A-A in  FIG. 4A ; 
           [0018]      FIG. 5  is a simplified pictorial view of a skin interface element forming part of the medication delivery assembly of  FIG. 1 ; 
           [0019]      FIGS. 5A and 5B  are simplified respective side view and sectional illustrations of the skin interface element of the medication delivery assembly of  FIG. 1 ,  FIG. 5B  being taken along lines C-C in  FIG. 5A ; 
           [0020]      FIGS. 5C and 5D  are simplified respective side view and sectional illustrations of the skin interface element of the medication delivery assembly of  FIG. 1 ,  FIG. 5D  being taken along lines E-E in  FIG. 5C , perpendicular to lines C-C in  FIG. 5A ; 
           [0021]      FIG. 5E  is a simplified bottom view of the skin interface element forming part of the medication delivery assembly of  FIG. 1 ; 
           [0022]      FIG. 6  is a simplified pictorial view of a shield element forming part of the medication delivery assembly of  FIG. 1 ; 
           [0023]      FIGS. 6A and 6B  are simplified respective side view and sectional illustrations of the shield element of the medication delivery assembly of  FIG. 1 ,  FIG. 6B  being taken along lines F-F in  FIG. 6A ; 
           [0024]      FIGS. 6C and 6D  are simplified respective side view and sectional illustrations of the shield element of the medication delivery assembly of  FIG. 1 , 
           [0025]      FIG. 6D  being taken along lines B-B in  FIG. 6C , perpendicular to lines F-F in  FIG. 6A ; 
           [0026]      FIGS. 7A and 7B  are simplified respective side view and sectional illustrations of the medication delivery assembly of  FIG. 1  in an inactive operative position.  FIG. 7B  being taken along lines I-I in  FIG. 7A ; 
           [0027]      FIG. 7C  is a simplified partial enlargement of  FIG. 7B ; 
           [0028]      FIGS. 7D and 7E  are simplified respective side view and sectional illustrations of the medication delivery assembly of  FIG. 1  in an inactive operative position.  FIG. 7E  being taken along lines K-K in  FIG. 7D , perpendicular to lines I-I in  FIG. 7A ; 
           [0029]      FIG. 7F  is a simplified partial enlargement of  FIG. 7E ; 
           [0030]      FIG. 8A  is a simplified partial enlargement of sectional illustration of the medication delivery assembly of  FIG. 1  in an active operative position, taken along lines I-I in  FIG. 7A ; 
           [0031]      FIG. 8B  is a simplified partial enlargement of sectional illustration of the medication delivery assembly of  FIG. 1  in an active operative position, taken along lines K-K in  FIG. 7D , perpendicular to lines I-I in  FIG. 7A ; 
           [0032]      FIG. 9A  is a simplified partial enlargement of sectional illustration of the medication delivery assembly of  FIG. 1  in an open operative position, taken along lines I- 1  in  FIG. 7A ; 
           [0033]      FIG. 9B  is a simplified partial enlargement of sectional illustration of the medication delivery assembly of  FIG. 1  in an open operative position, taken along lines K-K in  FIG. 7D , perpendicular to lines I-I in  FIG. 7A ; 
           [0034]      FIG. 10A  is a simplified partial enlargement of sectional illustration of the medication delivery assembly of  FIG. 1  in an injection operative position, taken along lines I-I in  FIG. 7A ; 
           [0035]      FIG. 10B  is a simplified partial enlargement of sectional illustration of the medication delivery assembly of  FIG. 1  in an injection operative position, taken along lines K-K in  FIG. 7D , perpendicular to lines I-I in  FIG. 7A ; 
           [0036]      FIG. 11  is a simplified pictorial illustration of a medication delivery assembly constructed and operative in accordance with another preferred embodiment of the invention; 
           [0037]      FIGS. 12A and 12B  are simplified respective detailed front and rear sub assembly exploded view illustrations of the medication delivery assembly of  FIG. 11 ; 
           [0038]      FIG. 13  is a simplified pictorial view of a connector element forming part of the medication delivery assembly of  FIG. 11 ; 
           [0039]      FIGS. 13A and 13B  are simplified respective side view and sectional illustrations of the connector element of the medication delivery assembly of  FIG. 11 ,  FIG. 13B  being taken along lines A-A in  FIG. 13A ; 
           [0040]      FIGS. 13C and 13D  are simplified respective side view and sectional illustrations of the connector element of the medication delivery assembly of  FIG. 11 , 
           [0041]      FIG. 13D  being taken along lines C-C in  FIG. 13C , perpendicular to lines A-A in  FIG. 13A ; 
           [0042]      FIG. 13E  is a simplified bottom view of the connector element of the medication delivery assembly of  FIG. 11 ; 
           [0043]      FIG. 14  is a simplified pictorial view of a septum element forming part of the medication delivery assembly of  FIG. 11 ; 
           [0044]      FIGS. 14A and 14B  are simplified respective side view and sectional illustrations of the septum element of the medication delivery assembly of  FIG. 11 ,  FIG. 14B  being taken along lines D -Din  FIG. 14A ; 
           [0045]      FIG. 15  is a simplified pictorial view of a skin interface element forming part of the medication delivery assembly of  FIG. 11 ; 
           [0046]      FIGS. 15A and 15B  are simplified respective side view and sectional illustrations of the skin interface element of the medication delivery assembly of  FIG. 11 ,  FIG. 15B  being taken along lines B-B in  FIG. 15A ; 
           [0047]      FIGS. 15C and 15D  are simplified respective side view and sectional illustrations of the skin interface element of the medication delivery assembly of  FIG. 11 ,  FIG. 15D  being taken along lines C-C in  FIG. 15C , perpendicular to lines B-B in  FIG. 15A ; 
           [0048]      FIG. 15E  is a simplified bottom view of the skin interface element forming part of the medication delivery assembly of  FIG. 11 ; 
           [0049]      FIG. 16  is a simplified pictorial view of a shield element forming part of the medication delivery assembly of  FIG. 11 ; 
           [0050]      FIGS. 16A and 16B  are simplified respective side view and sectional illustrations of the shield element of the medication delivery assembly of  FIG. 11 ,  FIG. 16B  being taken along lines B-B in  FIG. 16A ; 
           [0051]      FIGS. 16C and 16D  are simplified respective side view and sectional illustrations of the shield element of the medication delivery assembly of  FIG. 11 , 
           [0052]      FIG. 16D  being taken along lines D-D in  FIG. 16C , perpendicular to lines B-B in  FIG. 16A ; 
           [0053]      FIGS. 17A and 17B  are simplified respective side view and sectional illustrations of the medication delivery assembly of  FIG. 11  in an inactive position.  FIG. 17B  being taken along lines A-A in  FIG. 17A ; 
           [0054]      FIG. 17C  is a simplified partial enlargement of  FIG. 17B ; 
           [0055]      FIGS. 17D and 17E  are simplified respective side view and sectional illustrations of the medication delivery assembly of  FIG. 11  in an inactive operative position.  FIG. 17E  being taken along lines E-E in  FIG. 17D , perpendicular to lines A-A in  FIG. 17A ; 
           [0056]      FIG. 17F  is a simplified partial enlargement of  FIG. 17E ; 
           [0057]      FIG. 18A  is a simplified partial enlargement of sectional illustration of the medication delivery assembly of  FIG. 11  in a first active operative position, taken along lines A-A in  FIG. 17A ; 
           [0058]      FIG. 18B  is a simplified partial enlargement of sectional illustration of the medication delivery assembly of  FIG. 1  in a first active operative position, taken along lines E-E in  FIG. 17D , perpendicular to lines A-A in  FIG. 17A ; 
           [0059]      FIG. 19A  is a simplified partial enlargement of sectional illustration of the medication delivery assembly of  FIG. 1  in a second active operative position, taken along lines A-A in  FIG. 17A ; 
           [0060]      FIG. 19B  is a simplified partial enlargement of sectional illustration of the medication delivery assembly of  FIG. 1  in a second active operative position, taken along lines E-E in  FIG. 17D , perpendicular to lines A-A in  FIG. 17A ; 
           [0061]      FIG. 20A  is a simplified partial enlargement of sectional illustration of the medication delivery assembly of  FIG. 11  in an open operative position, taken along lines A-A in  FIG. 17A ; 
           [0062]      FIG. 20B  is a simplified partial enlargement of sectional illustration of the medication delivery assembly of  FIG. 11  in an open operative position, taken along lines E-E in  FIG. 17D , perpendicular to lines A-A in  FIG. 17A ; 
           [0063]      FIG. 21A  is a simplified partial enlargement of sectional illustration of the medication delivery assembly of  FIG. 11  in an injection operative position, taken along lines A-A in  FIG. 17A ; 
           [0064]      FIG. 21B  is a simplified partial enlargement of sectional illustration of the medication delivery assembly of  FIG. 11  in an injection operative position, taken along lines E-E in  FIG. 17D , perpendicular to lines A-A in  FIG. 17A ; 
           [0065]      FIG. 22A and 22B  are simplified enlargement orthogonal cross sectional view illustrations of a medication delivery assembly in an inactive operative position constructed and operative in accordance with another preferred embodiment of the invention; 
           [0066]      FIG. 23A and 23B  are simplified enlargement orthogonal cross sectional view illustrations of a medication delivery assembly of  FIGS. 22A and 22B . 
       
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0067]    Reference is now made to  FIG. 1 , which is a simplified pictorial illustration of a medication delivery assembly constructed and operative in accordance with a preferred embodiment of the invention and to  FIGS. 2A and 2B , which are simplified respective detailed front and rear sub assembly exploded view illustrations of the medication delivery assembly of  FIG. 1 . 
         [0068]    As seen in  FIG. 1 , there is provided a medication delivery assembly  100  adapted to fit a standard injection device  102 , which may be pre-filled with medication. The medication delivery assembly  100  may be alternatively adapted to fit a pen injector. 
         [0069]      FIGS. 2A and 2B  are exploded view illustrations of the medication delivery assembly  100  including the pre-filled injection device  102 , which may contain a medication. The pre-filled injection device  102  having two opposing ends, rearward end  114  and forward end  116  that defines the outlet port of the injection device, while a hollow penetrating element, such as a needle  103  may be attached to the outlet port  116  of the pre-filled injection device  102 . The pre-filled injection device  102  and the needle  103  are arranged along a mutual longitudinal axis  124 . 
         [0070]    The pre-filled injection device having a luer portion  115  at its outlet port  116  and a rearwardly facing stopping rim  117 . 
         [0071]    The prefilled injection device  102  with the needle  103  are designed to be attached to the medication delivery assembly  100 . It can be seen in  FIG. 2  that the medication delivery assembly  100  is a sub assembly comprising a connector  104 , septum  106 , skin interface element  108 , microneedle chip  110  and a shield  112 . Alternatively, the injection device  102  may be integrally formed with the connector  104 , such as by injection molding. 
         [0072]    The connector  104  is defined by a generally cylindrical partially open outer circumference  118  and having two opposite ends, rearward end  120  and forward end  122 . The connector  104  is arranged along a longitudinal axis  124  and having an inner circumference  126 . 
         [0073]    The skin interface element  108  is arranged along a longitudinal axis  124  and having a connector engaging portion  132  and a needle engaging portion  134 , a rearward end  128  adjacent the connector engaging portion  132  and a forward end  130  adjacent the needle engaging portion  134 . The connector engaging portion  132  of the skin interface element  108  is adapted to be inserted into the connector  104 . The microneedle chip  110  is adapted to be coupled to the needle engaging portion end  130  of the skin interface element  108 . One side of the skin interface element  108  has a straight surface, which is operative to fit skin surface while injection is performed. 
         [0074]    The septum  106  is arranged along a longitudinal axis  124  and is defined by a generally cylindrical outer circumference  136 . The septum  106  is adapted to be inserted into the skin interface element  108 . 
         [0075]    The shield  112  is arranged along a longitudinal axis  124  and having a forwardly facing edge  138  and a rearwardly facing edge  140 , which are connected by an outer surface  142 . The shield  112  further has locking arms  144  extending partially rearwardly of the rearward edge  140 . The shield  112  is adapted to cover the skin interface element  108 . 
         [0076]    Reference is now made to  FIGS. 3 ,  3 A- 3 D, which illustrate the connector  104  forming part of the medication delivery assembly  100  of  FIGS. 1-2B . The connector  104  may be an integrally formed element, preferably formed of plastic, which is symmetric about a longitudinal axis, such as axis  124  ( FIGS. 1-2B ). 
         [0077]    As noted hereinabove with reference to  FIGS. 1-2B , the connector  104  is defined by a generally cylindrical partially open outer circumference  118  and having two opposite ends, rearward end  120  and forward end  122 . The connector  104  has an inner circumference  126 . The connector&#39;s  104  outer circumference  118  includes two opposed generally cylindrical engaging arms  146  extending from an annular connecting wall  148  and forming an imaginary cylinder arranged about longitudinal axis  124 . 
         [0078]    It can be seen on  FIGS. 3B and 3D  that there is an aperture  150  formed in the connecting wall  148  of the connector  104 , acting as a resilient lock for enabling insertion of the pre-filled injection device  102 . The aperture is preferably surrounded by a segmented rim. 
         [0079]    Each engaging arm  146  has two lateral portions  152  and a medial portion  154  separating between them. There are a forward skin interface element holding recess  155  and a rearward skin interface element holding recess  156  extending through the medial portion  154  of arm  146 . There are grooves  158  separating between medial portion  154  and lateral portions  152  of the engaging arms  146 , the grooves extend from the outer circumference  118  to the inner circumference  126 . 
         [0080]    The lateral portions of engaging arm  146  have a forward wide portion  168  defining edge  170  and more narrow portion  172  defining edge  174 . 
         [0081]    Each lateral portion of engaging arm  146  having a longitudinal rim  176  located adjacent to groove  158 , and extending from forward end  122  and the connecting wall  148 . 
         [0082]    The medial portion  154  of the engaging arm  146  has a stepped recess  178  on its inner circumference  126  and extends rearwardly from forward end  122  partially along the medial portion  154  of the engaging arm  146 . 
         [0083]    The connector has a raised wall portion  160  connecting between the lateral portions  152  of the engaging arms  146 , which has a forwardly facing end  162 . There is a raised releasing protrusion  164  located on the forwardly facing wall  162 . 
         [0084]    Said raised protrusion  164  having an outwardly facing sloped end  166 . 
         [0085]    Reference is now made to  FIGS. 4 ,  4 A- 4 C, which illustrate the septum  106  forming part of the medication delivery assembly  100  of  FIGS. 1-2B . 
         [0086]    The septum  106  may be an integrally formed element, preferably formed of silicon rubber or thermoplastic material with similar characteristics. The septum  106  is symmetric about a longitudinal axis, such as axis  124  ( FIGS. 1-2B ). 
         [0087]    As noted hereinabove with reference to  FIGS. 1-2B , the septum  106  is defined by a generally cylindrical outer circumference  136 . There are several integrally formed annular rings  182  of a greater diameter than the outer circumference  136 . The rings  182  are formed on the outer circumference  136  in a longitudinally spaced manner. 
         [0088]    The septum  106  further has two opposite ends, a rearward end  184  and a forward end  186 . A longitudinal recess  188  is extending from rearward end  184  partially through the septum  106 . The forward end  186  is concave in order to fit tightly within skin interface element  108  and thus prevent or minimize dead space. 
         [0089]    Reference is now made to  FIGS. 5 ,  5 A- 5 E, which illustrate the skin interface element  108  forming part of the medication delivery assembly  100  of  FIGS. 1-2B . The skin interface element  108  is an integrally formed element, preferably formed of plastic, which is symmetric about a longitudinal axis, such as axis  124  ( FIGS. 1-2B ), in all respects other than with respect to the needle engaging portion  134 . 
         [0090]    As noted hereinabove with reference to  FIGS. 1-2B , the skin interface element  108  is arranged along a longitudinal axis  124  and having a connector engaging portion  132  and a needle engaging portion  134 , a rearward end  128  adjacent the connector engaging portion  132  and a forward end  130  adjacent the needle engaging portion  134 . The connector engaging portion  132  of the skin interface element  108  is adapted to be inserted into the connector  104 . The microneedle chip  110  is adapted to be coupled to the needle engaging portion end  130  of the skin interface element  108 . 
         [0091]    The skin interface element  108  having a flow path  190  therein, comprised of a small diameter forward portion  192  and greater diameter rearward portion  194 , forming a shoulder  193  therebetween. The forward portion  192  terminates at flow path forward end  196 . There is a recessed area  198  provided between flow path forward end  196  and forward end  130 . The rearward portion  194  terminates at flow path rearward end  200 . The rearward portion  194  has a generally cylindrical inner surface  202 . This specific construction of the flow path  190  is designed to prevent or minimize dead space. 
         [0092]    The connector engaging portion  132  having first two opposite faces  204 . Each face  204  if formed of a skin interface element medial portion  206  and two laterally spaced portions  208 , defining grooves  210  from each side of the medial portion  206 , which extend through the entire length of the skin interface element medial portion  132  and the two laterally spaced portions  208 . A connector locking protrusion  212  is positioned generally at the rearward portion of the skin interface element medial portion  206 . The medial portion  206  defines a forwardly facing edge  205 . 
         [0093]    The second two opposite faces  214  forming are each forming a shield locking portion  216 . The shield locking portion  216  is formed between a forwardly disposed connecting flange  218 , which is connecting between laterally spaced portions  208  and between a rearwardly disposed connecting shoulder  220 , which is connecting between laterally spaced portions  208  and terminates at rearward end  128 . 
         [0094]    Reference is now made to  FIGS. 6 ,  6 A- 6 D, which illustrate the shield element  112  forming part of the medication delivery assembly  100  of  FIGS. 1-2B . The shield element  112  is an integrally formed element, preferably formed of plastic, which is symmetric about a longitudinal axis, such as axis  124  ( FIGS. 1-2B ). 
         [0095]    As noted hereinabove with reference to  FIGS. 1-2B , the shield  112  is arranged along a longitudinal axis  124  and having a forwardly facing edge  138  and a rearwardly facing edge  140 , which are connected by an outer surface  142 . The shield  112  further has locking arms  144  extending partially rearwardly of the rearward edge  140 . The shield  112  is adapted to cover the skin interface element  108 . 
         [0096]    The shield  112  further defines an inner surface  222 . The locking arms  144  having an integrally formed, generally rearwardly disposed skin interface element locking protrusions  224 , which are generally wider than the locking arms  144 . The locking protrusions  224  are extending internally from the outer surface of the locking arms  144 . 
         [0097]    Reference is now made to  FIGS. 7A-7F , which are simplified sectional illustrations of the medication delivery assembly  100  of  FIG. 1  in an inactive operative position, while in engagement with the prefilled injection device  102 . 
         [0098]    It can be seen from the above mentioned drawings showing the medication delivery assembly  100  in an inactive position that the medication delivery assembly  100  may be attached to a pre-filled injection device  102 . The prefilled injection device  102  may be attached to the connector  104  of medication delivery assembly  100  by means of a stopping rim  117 , positioned on the luer portion  115  of the prefilled injection device  102 . The luer portion  115  of the injection device  102  is inserted through the aperture  150  of the connector  104 . The rim of the aperture  150  is preferably segmented and slightly undersized for the lip of the stopping rim  117 , so that the rim of the aperture  150  momentarily flexes outwards as the luer portion  115  is inserted through the aperture  150  of the connector  104  and snaps into place behind the stopping rim  117 . 
         [0099]    The connector  104  and the injection device  102  then become permanently attached such that they cannot be readily released from each other in a non-destructive manner. It is appreciated that the injection device  102  may be integrally formed with the connector  104 , for example by means of injection molding. 
         [0100]    It can also be seen from the above mentioned drawings that the skin interface element  108  at the inactive position may be engaged with the connector  104  in a first lockable manner. A connector locking protrusion  212  on the skin interface element  108  is engaged in a lockable manner within the forward skin interface element holding recess  155 . 
         [0101]    The septum  106  may be located within the skin interface element  108  flow path  190  and may be securely held within by means of annular rings  182  that are frictionally held against the cylindrical inner surface  202 . The annular rings  182  may also provide a seal by preventing the fluid from the prefilled injection device  102  that is flowing through the flow path  190  from flowing around the septum  106 . The septum is spaced from the luer portion  115  of the prefilled injection device  102 . 
         [0102]    The sharp end of the needle  103  of the pre-filled injection device  102  is extending into the septum  106  without piercing the septum therethrough at the inactive position. The sharp end of the needle  103  is not exposed in this position, thus fluid flow is not permitted. 
         [0103]    The microneedle chip  110  is preferably permanently attached to the forward end  130  of the skin interface element  108 . 
         [0104]    The shield  112  may be attached to the skin interface element  108  at the inactive position. The rearwardly facing edge  140  of the shield  112  is disposed adjacent to the forwardly facing edge  205  of the skin interface element  108 . 
         [0105]    It can further be seen that the skin interface element locking protrusions  224  of the shield  112  are fixedly engaged within the shield locking portion  216 , due to the fact that the locking arms  144  are held between the faces  214  of the skin interface element  108  and the inner circumference  126  of the connector  104 . 
         [0106]    It is appreciated that the medication delivery assembly  100  in the state shown in  FIGS. 7A-7F  is capable of preventing inadvertent microneedle puncturing and disposal of medication by means of shielding the microneedle chip  110  and plugging the needle  103  of the prefilled injection device  102 . 
         [0107]    Reference is now made to  FIGS. 8A and 8B , which are simplified partial enlargement of sectional illustration of the medication delivery assembly  100  of  FIG. 1  in an active operative position, while in engagement with the prefilled injection device  102 . 
         [0108]    It can be seen from the above mentioned drawings showing the medication delivery assembly  100  in an active position that the medication delivery assembly  100  may be attached to a pre-filled injection device  102 . The prefilled injection device  102  may be attached to the connector  104  of medication delivery assembly  100  by means of a stopping rim  117 , positioned on the luer portion  115  of the prefilled injection device  102 . The luer portion  115  of the injection device  102  is inserted through the aperture  150  of the connector  104 . The rim of the aperture  150  is preferably segmented and slightly undersized for the lip of the stopping rim  117 , so that the rim of the aperture  150  momentarily flexes outwards as the luer portion  115  is inserted through the aperture  150  of the connector  104  and snaps into place behind the stopping rim  117 . 
         [0109]    The connector  104  and the injection device  102  then become permanently attached such that they cannot be readily released from each other in a non-destructive manner. It is appreciated that the injection device  102  may be integrally formed with the connector  104 , for example by means of injection molding. 
         [0110]    It can also be seen from the above mentioned drawings that the skin interface element  108  at the active position is engaged with the connector  104  in a second lockable manner. Following rearward displacement of the shield  112 , in order to activate the medication delivery assembly  100 , a connector locking protrusion  212  on the skin interface element  108  may be displaced and become engaged in a lockable manner within the rearward skin interface element holding recess  156 . 
         [0111]    The septum  106  may be located within the skin interface element  108  flow path  190  and may be securely held within by means of annular rings  182  that are frictionally held against the cylindrical inner surface  202 . The annular rings  182  are also providing a seal by preventing the fluid from the prefilled injection device  102  that is flowing through the flow path  190  from flowing around the septum  106 . 
         [0112]    The sharp end of the needle  103  of the prefilled injection device  102  may extend throughout the septum  106  at the active position. The septum rearward end  184  is disposed adjacent the forward end  116  of the prefilled injection device  102 . The forward end  116  of the pre-filled injection device  102  may supports the septum  106  and thus prevent rearward movement of the septum  106  due to back pressure of the medication. The sharp end of the needle  103  may be exposed into the forward portion  192  of the flow path  190  of the skin interface element  108  in the active position, thus fluid flow may be permitted from the prefilled injection device  102  via the needle  103 , further via the forward portion  192  of the flow path  190  of the skin interface element  108  and through the microneedle array arranged on the microneedle chip  110 . 
         [0113]    In accordance to a preferred embodiment of the invention, the microneedle chip  110  may be formed of at least one hollow penetrating element, which is implemented as at least one hollow microneedle integrally formed with an underlying substrate. 
         [0114]    The microneedle chip  110  may be preferably formed of two hollow microneedles integrally formed with an underlying substrate or may be alternatively formed of a linear array of at least three hollow microneedles integrally formed with an underlying substrate. 
         [0115]    Each microneedle within the microneedle chip  110  may be preferably formed primarily from silicon. 
         [0116]    It may be appreciated that in a particular embodiment of the invention, each hollow microneedle is formed with at least one upright surface standing upright relative to a surface of said underlying substrate, an inclined surface intersecting said at least one upright surface and a fluid flow bore intersecting said inclined surface. 
         [0117]    In accordance to an embodiment of the invention, each hollow microneedle is preferably less than 1 mm of height. 
         [0118]    Each hollow microneedle is located adjacent to an edge of said underlying substrate in such a manner that the microneedle having a height, and being less than twice its own height away from the edge. 
         [0119]    It is further appreciated that the microneedle chip  110  may be constructed as it is previously disclosed in U.S. Pat. Nos. 7,648,484 and 6,533,949, assigned to Nanopass Technologies. 
         [0120]    The microneedle chip  110  may be permanently attached to the forward end  130  of the skin interface element  108 . 
         [0121]    In active position, the shield  112  may be disposed over the skin interface element  108 , however it is no longer attached to the skin interface element  108 . The rearwardly facing edge  140  of the shield  112  is still disposed adjacent to the forwardly facing edge  205  of the skin interface element  108  in the active position. 
         [0122]    It can further be seen that the skin interface element locking protrusions  224  of the shield  112  are no longer engaged within the shield locking portion  216 . Due to manual rearward displacement of the shield  112 , the skin interface element  108  is adapted to be displaced rearwardly as well, the connector locking protrusion  212  of the skin interface element  108  is enabled to move out of engagement with the forward skin interface element holding recess  155  of the connector  104  and becomes instead locked within the rearward holding recess  156  of the connector  104 . The locking of the connector locking protrusion  212  with the holding recess  156  is made permanent due to the structure of the locking protrusions  212 , which have one straight end and one sloped end, such that the connector  104  and the skin interface element  108  cannot be unlocked unless sufficient force is exerted to overcome this locking relation that is not readily achieved manually. 
         [0123]    Simultaneously, due to the rearward movement of the skin interface element  108 , the locking arms  144  of the shield  112  are deflected outwardly and sliding generally rearwardly over the sloped end  166  of the raised protrusion  164  of the connector  104 . 
         [0124]    The rearward end  128  of the skin interface element  108  is positioned adjacent the connecting wall  148  of the connector  104  at the active position. 
         [0125]    It is appreciated that the medication delivery assembly  100  in the state shown in  FIGS. 8A and 8B  is a transitional stage of activation, which still doesn&#39;t allow inadvertent microneedle puncturing, however the shield  112  is released from lockable engagement at this stage and is ready to be removed from the medication delivery assembly  100  and the hollow needle  103  penetrates entirely through the septum  106 . 
         [0126]    Reference is now made to  FIGS. 9A and 9B , which are simplified partial enlargement of sectional illustration of the medication delivery assembly  100  of  FIG. 1  in an open operative position, while in engagement with the prefilled injection device  102 . 
         [0127]    It can be seen from the above mentioned drawings showing the medication delivery assembly  100  in an open position that the medication delivery assembly  100  is attached to a pre-filled injection device  102 . The prefilled injection device  102  may be attached to the connector  104  of medication delivery assembly  100  by means of a stopping rim  117 , positioned on the luer portion  115  of the prefilled injection device  102 . The luer portion  115  of the injection device  102  is inserted through the aperture  150  of the connector  104 . The rim of the aperture  150  is preferably segmented and slightly undersized for the lip of the stopping rim  117 , so that the rim of the aperture  150  momentarily flexes outwards as the luer portion  115  is inserted through the aperture  150  of the connector  104  and snaps into place behind the stopping rim  117 . 
         [0128]    The connector  104  and the injection device  102  then become permanently attached such that they cannot be readily released from each other in a non-destructive manner. It is appreciated that the injection device  102  may be integrally formed with the connector  104 , for example by means of injection molding. 
         [0129]    It can also be seen from the above mentioned drawings that the skin interface element  108  at the open stage is engaged with the connector  104  in a second lockable manner. 
         [0130]    As previously shown in  FIGS. 8A and 8B , following rearward displacement of the shield  112 , in order to activate the medication delivery assembly  100 , a connector locking protrusion  212  on the skin interface element  108  is displaced and engaged in a lockable manner within the rearward skin interface element holding recess  156 . 
         [0131]    In an open operative position shown in  FIGS. 9A and 9B , the shield  112  is still disposed over the skin interface element  108 . 
         [0132]    The shield  112  may be released from rearward displacement and consequentially the locking arms  144  of the shield  112  are not deflected anymore, thus the locking arms  144  return to their normal position while sliding generally forwardly along the sloped end  166  of the raised protrusion  164  of the connector  104 . The locking arms  144  in the open operative position are disposed between the faces  214  of the skin interface element  108  and between the inner circumferences  126  of the connector  104 , however the locking arms  144  are not held at this position, as it was shown on  FIGS. 7A-7F  in the inactive position, since the skin interface element locking protrusions  224  of the shield  112  are out of engagement with the shield locking portion  216  following the activation stage, as described with reference to  FIGS. 8A and 8B . 
         [0133]    While referring specifically to  FIGS. 9A and 9B , the rearwardly facing edge  140  of the shield  112  is spaced from the forwardly facing edge  205  of the skin interface element  108  as the shield  112  is moving forwardly. 
         [0134]    The skin interface element  108  at the open operative stage is displaced rearwardly, the connector locking protrusions  212  of the skin interface element  108  are engaged with the rearward skin interface element holding recess  156  of the connector  104 . 
         [0135]    The septum  106  is located within the skin interface element  108  flow path  190  and is securely held within by means of annular rings  182  that are frictionally held against the cylindrical inner surface  202 . The annular rings  182  are also providing a seal by preventing the fluid from the prefilled injection device  102  that is flowing through the flow path  190  from flowing around the septum  106 . 
         [0136]    The sharp end of the needle  103  of the prefilled injection device  102  extends throughout the septum  106  at the open operative position. The septum rearward end  184  is disposed adjacent the forward end  116  of the prefilled injection device  102 . The sharp end of the needle  103  is exposed into the forward portion  192  of the flow path  190  of the skin interface element  108  in the open operative position, thus fluid flow is permitted from the prefilled injection device  102  via the needle  103 , further via the forward portion  192  of the flow path  190  of the skin interface element  108  and through the microneedle array arranged on the microneedle chip  110 . 
         [0137]    In accordance to a preferred embodiment of the invention, the microneedle chip  110  may be formed of at least one hollow penetrating element, which is implemented as at least one hollow microneedle integrally formed with an underlying substrate. 
         [0138]    The microneedle chip  110  may be preferably formed of two hollow microneedles integrally fowled with an underlying substrate or may be alternatively formed of a linear array of at least three hollow microneedles integrally formed with an underlying substrate. 
         [0139]    Each microneedle within the microneedle chip  110  may be preferably formed primarily from silicon. 
         [0140]    It may be appreciated that in a particular embodiment of the invention, each hollow microneedle is formed with at least one upright surface standing upright relative to a surface of said underlying substrate, an inclined surface intersecting said at least one upright surface and a fluid flow bore intersecting said inclined surface. 
         [0141]    In accordance to an embodiment of the invention, each hollow microneedle is preferably less than 1 mm of height. 
         [0142]    Each hollow microneedle is located adjacent to an edge of said underlying substrate in such a manner that the microneedle having a height, and being less than twice its own height away from the edge. 
         [0143]    It is further appreciated that the microneedle chip  110  may be constructed as it is previously disclosed in U.S. Pat. Nos. 7,648,484 and 6,533,949, assigned to Nanopass Technologies. 
         [0144]    The microneedle chip  110  is permanently attached to the forward end  130  of the skin interface element  108 . 
         [0145]    The rearward end  128  of the skin interface element  108  is fixedly positioned adjacent the connecting wall  148  of the connector  104  at the open operative position. 
         [0146]    It is appreciated that the medication delivery assembly  100  in the state shown in  FIGS. 9A and 9B  is a transitional stage of releasing the shield  112 , which still doesn&#39;t allow inadvertent microneedle puncturing. 
         [0147]    Reference is now made to  FIGS. 8A and 8B , which are simplified partial enlargement of sectional illustration of the medication delivery assembly  100  of  FIG. 1  in an injection position, while in engagement with the prefilled injection device  102 . 
         [0148]    It can be seen from the above mentioned drawings showing the medication delivery assembly  100  in an injection position that the medication delivery assembly  100  may be attached to a pre-filled injection device  102 . The prefilled injection device  102  may be attached to the connector  104  of medication delivery assembly  100  by means of a stopping rim  117 , positioned on the luer portion  115  of the prefilled injection device  102 . The luer portion  115  of the injection device  102  is inserted through the aperture  150  of the connector  104 . The rim of the aperture  150  is preferably segmented and slightly undersized for the lip of the stopping rim  117 , so that the rim of the aperture  150  momentarily flexes outwards as the luer portion  115  is inserted through the aperture  150  of the connector  104  and snaps into place behind the stopping rim  117 . 
         [0149]    The connector  104  and the injection device  102  then become permanently attached such that they cannot be readily released from each other in a non-destructive manner. It is appreciated that the injection device  102  may be integrally formed with the connector  104 , for example by means of injection molding. 
         [0150]    It can also be seen from the above mentioned drawings that the skin interface element  108  at the injection stage is fixedly engaged with the connector  104  in a second lockable manner. As previously shown in  FIGS. 8A and 8B , following rearward displacement of the shield  112 , in order to activate the medication delivery assembly  100 , a connector locking protrusion  212  on the skin interface element  108  is displaced and engaged in a lockable manner within the rearward skin interface element holding recess  156 . 
         [0151]    In the injection position shown in  FIGS. 10A and 10B , the shield  112  is removed completely from the skin interface element  108 . 
         [0152]    The skin interface element  108  at the injection position is disposed rearwardly, the connector locking protrusion  212  of the skin interface element  108  are engaged with the rearward skin interface element holding recess  156  of the connector  104 . 
         [0153]    The septum  106  may be located within the skin interface element  108  flow path  190  and may be securely held within by means of annular rings  182  that are frictionally held against the cylindrical inner surface  202 . The annular rings  182  are also providing a seal by preventing the fluid from the prefilled injection device  102  that is flowing through the flow path  190  from flowing around the septum  106 . 
         [0154]    The sharp end of the needle  103  of the prefilled injection device  102  extends throughout the septum  106  at the injection position. The septum rearward end  184  is disposed adjacent the forward end  116  of the prefilled injection device  102 . The sharp end of the needle  103  is exposed into the forward portion  192  of the flow path  190  of the skin interface element  108  in the injection operative position, thus fluid flow is permitted from the prefilled injection device  102  via the needle  103 , further via the forward portion  192  of the flow path  190  of the skin interface element  108  and through the microneedle array arranged on the microneedle chip  110 . 
         [0155]    In accordance to a preferred embodiment of the invention, the microneedle chip  110  may be formed of at least one hollow penetrating element, which is implemented as at least one hollow microneedle integrally formed with an underlying substrate. 
         [0156]    The microneedle chip  110  may be preferably formed of two hollow microneedles integrally formed with an underlying substrate or may be alternatively formed of a linear array of at least three hollow microneedles integrally formed with an underlying substrate. 
         [0157]    Each microneedle within the microneedle chip  110  may be preferably formed primarily from silicon. 
         [0158]    It may be appreciated that in a particular embodiment of the invention, each hollow microneedle is fanned with at least one upright surface standing upright relative to a surface of said underlying substrate, an inclined surface intersecting said at least one upright surface and a fluid flow bore intersecting said inclined surface. 
         [0159]    In accordance to an embodiment of the invention, each hollow microneedle is preferably less than 1 mm of height. 
         [0160]    Each hollow microneedle is located adjacent to an edge of said underlying substrate in such a manner that the microneedle having a height, and being less than twice its own height away from the edge. 
         [0161]    It is further appreciated that the microneedle chip  110  may be constructed as it is previously disclosed in U.S. Pat. Nos. 7,648,484 and 6,533,949, assigned to Nanopass Technologies. 
         [0162]    The microneedle chip  110  may be permanently attached to the forward end  130  of the skin interface element  108 . 
         [0163]    The rearward end  128  of the skin interface element  108  may be fixedly positioned adjacent the connecting wall  148  of the connector  104  at the injection position. 
         [0164]    It is appreciated that the medication delivery assembly  100  in the state shown in  FIGS. 10A and 10B  is an injection stage while the shield  112  is completely removed and injection of fluid from the prefilled injection device  102  throughout the medication delivery assembly  100  and through the microneedles  110  is permitted. 
         [0165]    It is further appreciated that following the injection, the shield  112  may be placed back onto the skin interface element  108  as it is shown on  FIGS. 9A and 9B . At this position, the shield  112  covers the microneedle chip  110 , which provides for safety functionality by preventing inadvertent needle puncturing at the discarding stage. 
         [0166]    Reference is now made to  FIG. 11 , which is a simplified pictorial illustration of a medication delivery assembly constructed and operative in accordance with another preferred embodiment of the invention and to  FIGS. 12A and 12B , which are simplified respective detailed front and rear sub assembly exploded views illustrations of the medication delivery assembly of  FIG. 11 . 
         [0167]    As seen in  FIG. 11 , there is provided a medication delivery assembly  300  adapted to fit a standard pre-filled injection device  302 . 
         [0168]      FIGS. 12A and 12B  are exploded view illustrations of the medication delivery assembly  300  including the pre-filled injection device  302 , which may contain a medication. The pre-filled injection device  302  having two opposing ends, rearward end  314  and forward end  316  that defines the outlet port of the injection device, while a hollow penetrating element, such as a needle  303  may be attached to the outlet port  316  of the pre-filled injection device  302 . The pre-filled injection device  302  and the needle  303  are arranged along a mutual longitudinal axis  324 . 
         [0169]    The pre-filled injection device having a luer portion  315  at its outlet port  316  and a rearwardly facing stopping rim  317 . 
         [0170]    The prefilled injection device  302  with the needle  303  are designed to be attached to the medication delivery assembly  300 . It can be seen on  FIG. 11  that the medication delivery assembly  300  is a sub assembly comprising a connector  304 , septum  306 , skin interface element  308 , microneedle chip  310  and a shield  312 . 
         [0171]    The connector  304  is defined by a generally cylindrical partially open outer circumference  318  and having two opposite ends, rearward end  320  and forward end  322 . The connector  304  is arranged along a longitudinal axis  324  and having an inner circumference  326 . 
         [0172]    The skin interface element  308  is arranged along a longitudinal axis  324  and having a connector engaging portion  332  and a needle engaging portion  334 , a rearward end  328  adjacent the connector engaging portion  332  and a forward end  330  adjacent the needle engaging portion  334 . The connector engaging portion  332  of the skin interface element  308  is adapted to be inserted into the connector  304 . The microneedle chip  310  is adapted to be coupled to the needle engaging portion end  330  of the skin interface element  308 . 
         [0173]    The septum  306  is arranged along a longitudinal axis  324  and is defined by a generally cylindrical outer circumference  336 . The septum  306  is adapted to be inserted into the skin interface element  308 . 
         [0174]    The shield  312  is arranged along a longitudinal axis  324  and having a forwardly facing edge  338  and a rearwardly facing edge  340 , which are connected by an outer surface  342 . The shield  312  further has locking arms  344  extending partially rearwardly of the rearward edge  340 . The shield  312  is adapted to cover the skin interface element  308 . 
         [0175]    Reference is now made to  FIGS. 13 ,  13 A- 13 E, which illustrate the connector  304  forming part of the medication delivery assembly  300  of  FIGS. 11-12B . The connector  304  is an integrally formed element, preferably formed of plastic, which is generally symmetric about a longitudinal axis, such as axis  324  ( FIGS. 11-12B ), however having an asymmetric feature in order to define assembling direction. 
         [0176]    As noted hereinabove with reference to  FIGS. 11-12B , the connector  304  may be defined by a generally cylindrical partially open outer circumference  318  and having two opposite ends, rearward end  320  and forward end  322 . The connector  304  has an inner circumference  326 . The connector&#39;s  304  outer circumference  318  includes two opposed generally cylindrical engaging arms  346  extending from an annular connecting wall  348  and forming an imaginary cylinder arranged about longitudinal axis  324 . 
         [0177]    It can be seen in  FIGS. 13B and 13D  that there is an aperture  350  formed in the connecting wall  348  of the connector  304 , acting as a resilient lock for enabling insertion of the pre-filled injection device  302 . The aperture  35  is preferably surrounded by a segmented rim. 
         [0178]    Each engaging arm  346  has two lateral portions  352  and a medial portion  354  separating between them. There are a forward skin interface element holding recess  355  and a rearward skin interface element holding recess  356  extending through the medial portion  354  of arm  346 . There are grooves  358  separating between medial portion  354  and lateral portions  352  of the engaging arms  346 , the grooves extend from the outer circumference  318  to the inner circumference  326 . 
         [0179]    One of each couple of lateral portions  352  of the engaging arms  346  having a radial skin interface element engaging recess  375  which is extending partially through the circumference of the lateral portion  352 . A forwardly facing skin interface element engaging protrusion  376  may be disposed rearwardly of the skin interface element engaging recess  375 , extending through the same circumference extent as the skin interface element engaging recess  375 . 
         [0180]    The medial portion  354  of the engaging arm  346  has a stepped recess  378  on its inner circumference  326  and extends rearwardly from forward end  322  partially along the medial portion  354  of the engaging arm  346 . 
         [0181]    The connector has a raised wall portion  360  connecting between the lateral portions  352  of the engaging arms  346 , which has an outwardly facing sloped end  366 . 
         [0182]    Reference is now made to  FIGS. 14 ,  14 A- 14 C, which illustrate the septum  306  forming part of the medication delivery assembly  300  of  FIGS. 11-12B . 
         [0183]    The septum  306  may be an integrally formed element, preferably formed of silicon rubber or thermoplastic material with similar characteristics. The septum  106  is preferably symmetric about a longitudinal axis, such as axis  324  ( FIGS. 11-12B ). 
         [0184]    As noted hereinabove with reference to  FIGS. 11-12B , the septum  306  may be defined by a generally cylindrical outer circumference  336 . There are several integrally formed annular rings  382  of a greater diameter than the outer circumference  336 . The rings  382  are formed on the outer circumference  336  in a longitudinally spaced manner. The septum further has two opposite ends, a rearward end  384  and a forward end  386 . 
         [0185]    Reference is now made to  FIGS. 15 ,  15 A- 15 E, which illustrate the skin interface element  308  forming part of the medication delivery assembly  300  of  FIGS. 11-12B . The skin interface element  308  is preferably an integrally formed element, preferably fowled of plastic, which is generally symmetric about a longitudinal axis, such as axis  324  ( FIGS. 11-12B ), however having an asymmetric feature in order to define assembling direction. 
         [0186]    As noted hereinabove with reference to  FIGS. 11-12B , the skin interface element  308  may be arranged along a longitudinal axis  324  and having a connector engaging portion  332  and a needle engaging portion  334 , a rearward end  328  adjacent the connector engaging portion  332  and a forward end  330  adjacent the needle engaging portion  334 . The connector engaging portion  332  of the skin interface element  308  is adapted to be inserted into the connector  304 . The microneedle chip  310  is adapted to be coupled to the needle engaging portion end  330  of the skin interface element  308 . 
         [0187]    The skin interface element  308  having a flow path  390  therein, comprised of a small diameter forward portion  392  and greater diameter rearward portion  394 , forming a shoulder  393  therebetween. The forward portion  392  terminates at flow path forward end  396 . There is a recessed area  398  provided between flow path forward end  396  and forward end  330 . The rearward portion  394  terminates at flow path rearward end  400 . The rearward portion  394  has a generally cylindrical inner surface  402 . 
         [0188]    The connector engaging portion  332  having first two opposite faces  404 . A connector locking protrusion  412  is positioned on the face  404 . The face  404  defines a forwardly facing edge  405 . 
         [0189]    The second two opposite faces  414  are each forming a rotational recess  416 . The rotational recess  416  may be formed between a forwardly disposed connecting flange  418 , which is connecting between opposed faces  404  and between a rearwardly disposed connecting wall  420 , which is connecting between opposed faces  404  and terminates at rearward end  328 . 
         [0190]    Reference is now made to  FIGS. 16 ,  16 A- 16 D, which illustrate the shield element  312  forming part of the medication delivery assembly  300  of  FIGS. 11-12B . The shield element  312  may be an integrally formed element, preferably formed of plastic, which is symmetric about a longitudinal axis, such as axis  324  ( FIGS. 11-12B ). 
         [0191]    As noted hereinabove with reference to  FIGS. 11-12B , the shield  312  may be arranged along a longitudinal axis  324  and have a forwardly facing edge  338  and a rearwardly facing edge  340 , which are connected by an outer surface  342 . The shield  312  further has locking arms  344  extending partially rearwardly of the rearward edge  340 . The shield  312  is adapted to cover the skin interface element  308 . 
         [0192]    The shield  312  further defines an inner surface  422 . The locking arms  344  having an integrally formed, generally rearwardly disposed skin interface element locking protrusions  424 . The locking protrusions  424  are extending internally from the outer surface of the locking arms  344 . 
         [0193]    Reference is now made to  FIGS. 17A-17F , which are sectional illustrations of the medication delivery assembly  300  of  FIG. 11  in an inactive operative position, while in engagement with the prefilled injection device  302 . 
         [0194]    It can be seen from the above mentioned drawings showing the medication delivery assembly  300  in an inactive position that the medication delivery assembly  300  is attached to a pre-filled injection device  302 . The prefilled injection device  302  may be attached to the connector  304  of medication delivery assembly  300  by means of a stopping rim  317 , positioned on the luer portion  315  of the prefilled injection device  302 . The luer portion  315  of the injection device  302  is inserted through the aperture  350  of the connector  304 . The rim of the aperture  350  is preferably segmented and slightly undersized for the lip of the stopping rim  317 , so that the rim of the aperture  350  momentarily flexes outwards as the luer portion  315  is inserted through the aperture  350  of the connector  304  and snaps into place behind the stopping rim  317 . 
         [0195]    The connector  304  and the injection device  302  then become permanently attached such that they cannot be readily released from each other in a non-destructive manner. It is appreciated that the injection device  302  may be integrally formed with the connector  304 , for example by means of injection molding. 
         [0196]    It can also be seen from the above mentioned drawings that the skin interface element  308  at the inactive position may be engaged with the connector  304  in a first lockable manner. A connector locking protrusion  412  on the skin interface element  308  is engaged in a lockable manner within the forward skin interface element holding recess  355 . 
         [0197]    The septum  306  may be located within the skin interface element  308  flow path  390  and securely held within by means of annular rings  382  that are frictionally held against the cylindrical inner surface  402 . The annular rings  382  are also providing a seal by preventing the fluid from the prefilled injection device  302  that is flowing through the flow path  390  from flowing around the septum  306 . The septum is spaced from the luer portion  315  of the prefilled injection device  302 . 
         [0198]    The sharp end of the needle  303  of the prefilled injection device  302  extends into the septum  306  at the inactive position and does not penetrate the septum therethrough. The sharp end of the needle  303  is not exposed in this position, thus fluid flow is not permitted. 
         [0199]    The microneedle chip  310  may be permanently attached to the forward end  330  of the skin interface element  308 . 
         [0200]    The shield  312  may be attached to the skin interface element  308  at the inactive position. The rearwardly facing edge  340  of the shield  112  may be disposed adjacent to the forwardly facing edge  405  of the skin interface element  308 . 
         [0201]    It can further be seen that the skin interface element locking protrusions  424  of the shield  312  are out of engagement with the rotational recess  416  of the skin interface element  308  and the rotational recess  416  are in turn out of engagement with the skin interface element engaging recess  375  of the connector  304 . The locking arms  344  of the shield  312  are held between the faces  414  of the skin interface element  308  and between the inner circumferences  326  of the connector  304 . 
         [0202]    It is appreciated that the medication delivery assembly  300  in the state shown in  FIGS. 17A-17F  prevents inadvertent microneedle puncturing and disposal of medication by means of shielding the microneedle chip  310  and plugging the needle  303  of the prefilled injection device  302 . 
         [0203]    It is further seen from the abovementioned drawings that the shield  312  cannot be axially displaced from the inactive position shown in  FIGS. 17A-17F , since the skin interface element locking protrusions  424  of the shield  312  are out of engagement with the rotational recess  416  of the skin interface element  308  and the rotational recesses  416  are in turn out of engagement with the skin interface element engaging recess  375  of the connector  304 . The shield  312  can be only rotationally displaced from the inactive position. 
         [0204]    Reference is now made to  FIGS. 18A and 18B , which are simplified partial enlargement of sectional illustration of the medication delivery assembly  300  of  FIG. 11  in a first active operative position, while in engagement with the prefilled injection device  302 . 
         [0205]    It can be seen from the above mentioned drawings showing the medication delivery assembly  300  in a first active position that the medication delivery assembly  300  may be attached to a pre-filled injection device  302 . The prefilled injection device  302  may be attached to the connector  304  of medication delivery assembly  300  by means of a stopping rim  317 , positioned on the luer portion  315  of the prefilled injection device  302 . The luer portion  315  of the injection device  302  is inserted through the aperture  350  of the connector  304 . The rim of the aperture  350  is preferably segmented and slightly undersized for the lip of the stopping rim  317 , so that the rim of the aperture  350  momentarily flexes outwards as the luer portion  315  is inserted through the aperture  350  of the connector  304  and snaps into place behind the stopping rim  317 . 
         [0206]    The connector  304  and the injection device  302  then become permanently attached such that they cannot be readily released from each other in a non-destructive manner. It is appreciated that the injection device  302  may be integrally formed with the connector  304 , for example by means of injection molding. 
         [0207]    It can also be seen from the above mentioned drawings that the skin interface element  308  at the first active position is engaged with the connector  304  in a first lockable manner. The shield  312  is rotationally displaced from the deactivated position shown in  FIGS. 17A-17F . This displacement urges the skin interface element locking protrusions  424  into engagement with the rotational recess  416  of the skin interface element  308 . Simultaneously, the rotational recess  416  of the skin interface element  308  are urged into engagement with the skin interface element engaging recess  375  of the connector  304 , causing the skin interface element locking protrusions  424  to lockably engage the rotational recess  416  of the skin interface element  308  and further causing the rotational recess  416  of the skin interface element  308  to lockably engage the skin interface element engaging recess  375  of the connector  304 . 
         [0208]    Following the abovementioned engagement, the connector locking protrusions  412  on the skin interface element  308  are engaged in a lockable manner within the forward skin interface element holding recess  355 . 
         [0209]    The septum  306  may be located within the skin interface element  308  flow path  390  and securely held within by means of annular rings  382  that are frictionally held against the cylindrical inner surface  402 . The annular rings  382  are also providing a seal by preventing the fluid from the prefilled injection device  302  that is flowing through the flow path  390  from flowing around the septum  306 . The septum is spaced from the luer portion  315  of the prefilled injection device  302 . 
         [0210]    The sharp end of the needle  303  of the prefilled injection device  302  extends into the septum  306  at the first activated position and does not pierce the septum  306  therethrough. The sharp end of the needle  303  is not exposed in this position, thus fluid flow is not permitted. 
         [0211]    The microneedle chip  310  may be permanently attached to the forward end  330  of the skin interface element  308 . 
         [0212]    The shield  312  may be attached to the skin interface element  308  at the first active position, as it is described above. The rearwardly facing edge  340  of the shield  312  is disposed adjacent to the forwardly facing edge  405  of the skin interface element  308 . 
         [0213]    It is appreciated that the medication delivery assembly  300  in the state shown in  FIGS. 18A and 18B  prevents inadvertent microneedle puncturing and disposal of medication by means of shielding the microneedle chip  310  and plugging the needle  303  of the prefilled injection device  302 . 
         [0214]    Reference is now made to  FIGS. 19A and 19B , which are simplified partial enlargement of sectional illustration of the medication delivery assembly  300  of  FIG. 11  in a second active operative position, while in engagement with the prefilled injection device  302 . 
         [0215]    It can be seen from the above mentioned drawings showing the medication delivery assembly  300  in the second active position that the medication delivery assembly  300  may be attached to a pre-filled injection device  302 . The prefilled injection device  302  may be attached to the connector  304  of medication delivery assembly  300  by means of a stopping rim  317 , positioned on the luer portion  315  of the prefilled injection device  302 . The luer portion  315  of the injection device  302  is inserted through the aperture  350  of the connector  304 . The rim of the aperture  350  is preferably segmented and slightly undersized for the lip of the stopping rim  317 , so that the rim of the aperture  350  momentarily flexes outwards as the luer portion  315  is inserted through the aperture  350  of the connector  304  and snaps into place behind the stopping rim  317 . 
         [0216]    The connector  304  and the injection device  302  then become permanently attached such that they cannot be readily released from each other in a non-destructive manner. It is appreciated that the injection device  302  may be integrally formed with the connector  304 , for example by means of injection molding. 
         [0217]    It can also be seen from the above mentioned drawings that the skin interface element  308  at the second active position is engaged with the connector  304  in a second lockable manner. Following rearward displacement of the shield  312 , in order to activate the medication delivery assembly  300 , a connector locking protrusion  412  on the skin interface element  308  is displaced and is now engaged in a lockable manner within the rearward skin interface element holding recess  356 . 
         [0218]    The septum  306  may be located within the skin interface element  308  flow path  390  and securely held within by means of annular rings  382  that are frictionally held against the cylindrical inner surface  402 . The annular rings  382  are also providing a seal by preventing the fluid from the prefilled injection device  302  that is flowing through the flow path  390  from flowing around the septum  306 . 
         [0219]    The sharp end of the needle  303  of the prefilled injection device  302  extends throughout the septum  306  at the second active position the septum rearward end  384  is disposed adjacent the forward end  316  of the prefilled injection device  302 . The sharp end of the needle  303  is exposed into the forward portion  392  of the flow path  390  of the skin interface element  308  in the second active position, thus fluid flow is permitted from the prefilled injection device  302  via the needle  303 , further via the forward portion  392  of the flow path  390  of the skin interface element  308  and through the microneedle array arranged on the microneedle chip  310 . 
         [0220]    In accordance to a preferred embodiment of the invention, the microneedle chip  310  may be formed of at least one hollow penetrating element, which is implemented as at least one hollow microneedle integrally formed with an underlying substrate. 
         [0221]    The microneedle chip  310  may be preferably formed of two hollow microneedles integrally formed with an underlying substrate or may be alternatively formed of a linear array of at least three hollow microneedles integrally formed with an underlying substrate. Each microneedle within the microneedle chip  310  may be preferably formed primarily from silicon. 
         [0222]    It may be appreciated that in a particular embodiment of the invention, each hollow microneedle is formed with at least one upright surface standing upright relative to a surface of said underlying substrate, an inclined surface intersecting said at least one upright surface and a fluid flow bore intersecting said inclined surface. 
         [0223]    In accordance to an embodiment of the invention, each hollow microneedle is preferably less than 1 mm of height. 
         [0224]    Each hollow microneedle is located adjacent to an edge of said underlying substrate in such a manner that the microneedle having a height, and being less than twice its own height away from the edge. 
         [0225]    It is further appreciated that the microneedle chip  310  may be constructed as it is previously disclosed in U.S. Pat. Nos. 7,648,484 and 6,533,949, assigned to Nanopass Technologies. 
         [0226]    The microneedle chip  310  may be permanently attached to the forward end  330  of the skin interface element  308 . 
         [0227]    The shield  312  is disposed over the skin interface element  308  at the second active position; however it is no longer attached to the skin interface element  308 . The rearwardly facing edge  340  of the shield  312  is still disposed adjacent to the forwardly facing edge  405  of the skin interface element  308 . 
         [0228]    It can further be seen that the skin interface element locking protrusions  424  of the shield  312  are no longer engaged within the rotational recess  416 . Due to manual rearward displacement of the shield  312 , the skin interface element  308  is displaced rearwardly as well, the connector locking protrusion  412  of the skin interface element  308  is moving out of engagement with the forward skin interface element holding recess  355  of the connector  304  and becomes instead locked within the rearward holding recess  356  of the connector  304 . The locking of the connector locking protrusion  412  with the holding recess  356  is made permanent due to the structure of the locking protrusions  412 , which have one straight end and one sloped end, such that the connector  304  and the skin interface element  308  cannot be unlocked unless sufficient force is exerted to overcome this locking relation that is not readily achieved manually. 
         [0229]    Simultaneously, due to the rearward movement of the skin interface element  308 , the locking arms  344  of the shield  312  are deflected outwardly and are sliding generally rearwardly over the sloped end  366  of the raised wail  360  of the connector  304 . 
         [0230]    The rearward end  328  of the skin interface element  308  may be positioned adjacent the connecting wall  348  of the connector  304  at the second active position. 
         [0231]    It is appreciated that the medication delivery assembly  300  in the state shown in  FIGS. 19A and 19B  is a transitional stage of activation, which still doesn&#39;t allow inadvertent microneedle puncturing, however the shield  312  is released from lockable engagement at this stage and is ready to be removed from the medication delivery assembly  300 . 
         [0232]    Reference is now made to  FIGS. 20A and 20B , which are simplified partial enlargement of sectional illustration of the medication delivery assembly  300  of  FIG. 11  in an open operative position, while in engagement with the prefilled injection device  302 . 
         [0233]    It can be seen from the above mentioned drawings showing the medication delivery assembly  300  in an open position that the medication delivery assembly  300  may be attached to a pre-filled injection device  302 . The prefilled injection device  302  may be attached to the connector  304  of medication delivery assembly  300  by means of a stopping rim  317 , positioned on the luer portion  315  of the prefilled injection device  302 . The luer portion  315  of the injection device  302  is inserted through the aperture  350  of the connector  304 . The rim of the aperture  350  is preferably segmented and slightly undersized for the lip of the stopping rim  317 , so that the rim of the aperture  350  momentarily flexes outwards as the luer portion  315  is inserted through the aperture  350  of the connector  304  and snaps into place behind the stopping rim  317 . 
         [0234]    The connector  304  and the injection device  302  then become permanently attached such that they cannot be readily released from each other in a non-destructive manner. It is appreciated that the injection device  302  may be integrally formed with the connector  304 , for example by means of injection molding. 
         [0235]    It can also be seen from the above mentioned drawings that the skin interface element  308  at the open stage is engaged with the connector  304  in a second lockable manner. 
         [0236]    As previously shown in  FIGS. 19A and 19B , following rearward displacement of the shield  312 , in order to activate the medication delivery assembly  300 , a connector locking protrusion  412  on the skin interface element  308  is displaced and engaged in a lockable manner within the rearward skin interface element holding recess  356 . 
         [0237]    In an open operative position shown in  FIGS. 20A and 20B , the shield  312  is still disposed over the skin interface element  308 . 
         [0238]    The shield  312  is released from rearward displacement and consequentially the locking arms  344  of the shield  312  are not deflected anymore, thus the locking arms  344  return to their normal position while sliding generally forwardly along the sloped end  366  of the raised wall  360  of the connector  304 . The locking arms  344  of the shield  312  in the open operative position are disposed between the two lateral portions  352  of the connector  304 , however the arms  344  are not held at this position, as it was shown in  FIGS. 18A and 18B  in the first active position, since the skin interface element locking protrusions  424  of the shield  312  are out of engagement with the shield locking portion  416  of the skin interface element  308  following the second activation stage, as described with reference to  FIGS. 19A and 19B . 
         [0239]    While referring specifically to  FIGS. 20A and 20B , the rearwardly facing edge  340  of the shield  312  is spaced from the forwardly facing edge  405  of the skin interface element  308  as the shield  312  is moving forwardly. 
         [0240]    The skin interface element  308  at the open operative stage is displaced rearwardly, the connector locking protrusion  412  of the skin interface element  308  are engaged with the rearward skin interface element holding recess  356  of the connector  304 . 
         [0241]    The septum  306  may be located within the skin interface element  308  flow path  390  and securely held within by means of annular rings  382  that are frictionally held against the cylindrical inner surface  402 . The annular rings  382  are also providing a seal by preventing the fluid from the prefilled injection device  302  that is flowing through the flow path  390  from flowing around the septum  306 . 
         [0242]    The sharp end of the needle  303  of the prefilled injection device  302  extends throughout the septum  306  at the open operative position. The septum rearward end  384  may be disposed adjacent the forward end  316  of the prefilled injection device  302 . The sharp end of the needle  303  is exposed into the forward portion  392  of the flow path  390  of the skin interface element  308  in the open operative position, thus fluid flow is permitted from the prefilled injection device  302  via the needle  303 , further via the forward portion  392  of the flow path  390  of the skin interface element  308  and through the microneedle array arranged on the microneedle chip  310 . In accordance to a preferred embodiment of the invention, the microneedle chip  310  may be formed of at least one hollow penetrating element, which is implemented as at least one hollow microneedle integrally formed with an underlying substrate. 
         [0243]    The microneedle chip  310  may be preferably formed of two hollow microneedles integrally formed with an underlying substrate or may be alternatively formed of a linear array of at least three hollow microneedles integrally formed with an underlying substrate. 
         [0244]    Each microneedle within the microneedle chip  310  may be preferably formed primarily from silicon. 
         [0245]    It may be appreciated that in a particular embodiment of the invention, each hollow microneedle is formed with at least one upright surface standing upright relative to a surface of said underlying substrate, an inclined surface intersecting said at least one upright surface and a fluid flow bore intersecting said inclined surface. 
         [0246]    In accordance to an embodiment of the invention, each hollow microneedle is preferably less than 1 mm of height. 
         [0247]    Each hollow microneedle is located adjacent to an edge of said underlying substrate in such a manner that the microneedle having a height, and being less than twice its own height away from the edge. 
         [0248]    It is further appreciated that the microneedle chip  310  may be constructed as it is previously disclosed in U.S. Pat. Nos. 7,648,484 and 6,533,949, assigned to Nanopass Technologies. 
         [0249]    The microneedle chip  310  may be permanently attached to the forward end  330  of the skin interface element  308 . 
         [0250]    The rearward end  328  of the skin interface element  308  is fixedly positioned adjacent the connecting wall  348  of the connector  304  at the open operative position. 
         [0251]    It is appreciated that the medication delivery assembly  300  in the state shown in  FIGS. 20A and 20B  is a transitional stage of releasing the shield  312 , which still doesn&#39;t allow inadvertent microneedle puncturing. 
         [0252]    Reference is now made to  FIGS. 21A and 21B , which are simplified partial enlargement of sectional illustration of the medication delivery assembly  300  of  FIG. 11  in an injection position, while in engagement with the prefilled injection device  302 . 
         [0253]    It can be seen from the above mentioned drawings showing the medication delivery assembly  300  in an injection position that the medication delivery assembly  300  may be attached to a pre-filled injection device  302 . The prefilled injection device  302  may be attached to the connector  304  of medication delivery assembly  300  by means of a stopping rim  317 , positioned on the luer portion  315  of the prefilled injection device  302 . The luer portion  315  of the injection device  302  is inserted through the aperture  350  of the connector  304 . The rim of the aperture  350  is preferably segmented and slightly undersized for the lip of the stopping rim  317 , so that the rim of the aperture  350  momentarily flexes outwards as the luer portion  315  is inserted through the aperture  350  of the connector  304  and snaps into place behind the stopping rim  317 . 
         [0254]    The connector  304  and the injection device  302  then become permanently attached such that they cannot be readily released from each other in a non-destructive manner. It is appreciated that the injection device  302  may be integrally formed with the connector  304 , for example by means of injection molding. 
         [0255]    It can also be seen from the above mentioned drawings that the skin interface element  308  at the injection stage may be fixedly engaged with the connector  304  in a second lockable manner. 
         [0256]    As previously shown in  FIGS. 19A and 19B , following rearward displacement of the shield  312  in order to activate the medication delivery assembly  300 , a connector locking protrusion  412  on the skin interface element  308  is displaced and engaged in a lockable manner within the rearward skin interface element holding recess  356 . 
         [0257]    In the injection position shown in  FIGS. 21A and 21B , the shield  312  is removed completely from the skin interface element  308 . 
         [0258]    The skin interface element  308  at the injection position is disposed rearwardly, the connector locking protrusion  412  of the skin interface element  308  are engaged with the rearward skin interface element holding recess  356  of the connector  304 . 
         [0259]    The septum  306  may be located within the skin interface element  308  flow path  390  and securely held within by means of annular rings  382  that are frictionally held against the cylindrical inner surface  402 . The annular rings  382  are also providing a seal by preventing the fluid from the prefilled injection device  302  that is flowing through the flow path  390  from flowing around the septum  306 . 
         [0260]    The sharp end of the needle  303  of the prefilled injection device  302  extends throughout the septum  306  at the injection position. The septum rearward end  384  is disposed adjacent the forward end  316  of the prefilled injection device  302 . The sharp end of the needle  303  is exposed into the forward portion  392  of the flow path  390  of the skin interface element  308  in the open operative position, thus fluid flow is permitted from the prefilled injection device  302  via the needle  303 , further via the forward portion  392  of the flow path  390  of the skin interface element  308  and through the micro needle array arranged on the micro needle chip  310 . 
         [0261]    In accordance to a preferred embodiment of the invention, the microneedle chip  310  may be formed of at least one hollow penetrating element, which is implemented as at least one hollow microneedle integrally formed with an underlying substrate. 
         [0262]    The microneedle chip  310  may be preferably formed of two hollow microneedles integrally formed with an underlying substrate or may be alternatively formed of a linear array of at least three hollow microneedles integrally formed with an underlying substrate. 
         [0263]    Each microneedle within the microneedle chip  310  may be preferably formed primarily from silicon. 
         [0264]    It may be appreciated that in a particular embodiment of the invention, each hollow microneedle is formed with at least one upright surface standing upright relative to a surface of said underlying substrate, an inclined surface intersecting said at least one upright surface and a fluid flow bore intersecting said inclined surface. 
         [0265]    In accordance to an embodiment of the invention, each hollow microneedle is preferably less than 1 mm of height. 
         [0266]    Each hollow microneedle is located adjacent to an edge of said underlying substrate in such a manner that the microneedle having a height, and being less than twice its own height away from the edge. 
         [0267]    It is further appreciated that the microneedle chip  310  may be constructed as it is previously disclosed in U.S. Pat. Nos. 7,648,484 and 6,533,949, assigned to Nanopass Technologies. 
         [0268]    The microneedle chip  310  may be permanently attached to the forward end  330  of the skin interface element  308 . 
         [0269]    The rearward end  328  of the skin interface element  308  is fixedly positioned adjacent the connecting wall  348  of the connector  304  at the injection position. 
         [0270]    It is appreciated that the medication delivery assembly  300  in the state shown in  FIGS. 21A and 21B  is an injection stage while the shield  312  is completely removed and injection of fluid from the prefilled injection device  302  throughout the medication delivery assembly  300  and through the microneedles  310  is permitted. 
         [0271]    It is appreciated that the medication delivery assembly  300  as shown in  FIG. 11  requires two stages of activation in order to allow injection of fluid from the prefilled injection device  302 . First activation stage is performed by means of rotational displacement of the shield  312  relative the connector  304  as shown in  FIGS. 18A and 18B  and second activation stage is performed by means of axial displacement of the shield  312  relative the connector  304  as shown in  FIGS. 19A and 19B . 
         [0272]    It is further appreciated that following the injection, the shield  312  may be placed back onto the skin interface element  308  as it is shown on  FIGS. 20A and 2013 . At this position, the shield  312  covers the microneedle chip  310 , which provides for another safety functionality by preventing inadvertent needle puncturing at the discarding stage. 
         [0273]    Reference is now made to  FIGS. 22A and 22B , which are simplified enlargement orthogonal cross sectional view illustrations of a medication delivery assembly in an inactive operative position constructed and operative in accordance with another preferred embodiment of the invention. 
         [0274]      FIGS. 22A and 22B  are respective illustrations to  FIGS. 7C and 7F , showing another preferred embodiment of the invention. 
         [0275]      FIGS. 22A and 22B  show a medication delivery assembly  500  in an inactive position that may be attached to a pre-filled injection device  502 . The prefilled injection device  502  may be attached to a connector  504  of medication delivery assembly  500  by means of a stopping rim  517 , positioned on a luer portion  515  of the prefilled injection device  502 . 
         [0276]    The luer portion  515  of the injection device  502  is inserted through an aperture  550  of the connector  504 . The rim of the aperture  550  is preferably segmented and slightly undersized for the lip of the stopping rim  517 , so that the rim of the aperture  550  momentarily flexes outwards as the luer portion  515  is inserted through the aperture  550  of the connector  504  and snaps into place behind the stopping rim  517 . 
         [0277]    The connector  504  and the injection device  502  then become permanently attached such that they cannot be readily released from each other in a non-destructive manner. It is appreciated that the injection device  502  may be integrally formed with the connector  504 , for example by means of injection molding. 
         [0278]    It can also be seen from the above mentioned drawings that a skin interface element  508  at the inactive position may be movably disposed at least partially within the connector  504 . Connector locking protrusions  513  on the skin interface element  508 , having one straight face  516  and one sloped end  519 , are not engaged with the connector  504  at the inactive position. 
         [0279]    A septum  506  may be located within the skin interface element  508  flow path  590  and may be securely held within by means of annular rings  582  that are frictionally held against the cylindrical inner surface  602 . The annular rings  582  may also provide a seal by preventing the fluid from the prefilled injection device  502  that is flowing through the flow path  590  from flowing around the septum  506 . The septum is spaced from the lure portion  515  of the prefilled injection device  502 . 
         [0280]    The sharp end of a needle  503  of the pre-filled injection device  502  is extending into the septum  506  without piercing the septum therethrough at the inactive position. The sharp end of the needle  503  is not exposed in this position, thus fluid flow is not permitted. 
         [0281]    A microneedle chip  510  is preferably permanently attached to a forward end  530  of the skin interface element  508 . 
         [0282]    The embodiment of  FIGS. 22A and 22B  differs from the previously described embodiments primarily in that the transition from the inactive to the active states occurs through motion of skin interface element  508  alone, without motion of its shield  512 . In the non-limiting example illustrated here, shield  512  is initially fixedly attached to the connector  504  while the skin interface element is in the inactive position. Connector locking arms  524  of the shield  512  are fixedly engaged within skin interface element locking recesses  525  of the connector  504  in a lockable manner, such that the connector locking arms  524  cannot be removed from the skin interface element locking recesses  525  without outward deflection of the locking arms  524 . The skin interface element locking recesses  525  are defined by two opposed ends, a forward end  527  having a slightly sloped angle and a straight rearward end  529 . The locking arms  524  of the shield  512  are supported by the rearward end  529  of the skin interface element locking protrusions  525 , thus axial rearward displacement of the shield  512  is not permitted. 
         [0283]    It can be further seen specifically in  FIG. 2213  that he skin interface element  508  further has outwardly extending gripping wings  532 , which are configured to protrude through recesses  534  in the shield  512  and thus provide gripping surface to allow axial displacement of the skin interface element  508  relative to the shield  512 . 
         [0284]    It is appreciated that the medication delivery assembly  500  in the state shown in  FIGS. 22A and 22B  is capable of preventing inadvertent microneedle puncturing and disposal of medication by means of shielding the microneedle chip  510  and plugging the needle  503  of the prefilled injection device  502 . 
         [0285]    Reference is now made to  FIGS. 23A and 23B , which are simplified enlargement orthogonal cross sectional view illustrations of a medication delivery assembly of  FIGS. 22A and 22B . 
         [0286]    It can be seen from the above mentioned drawings showing the medication delivery assembly  500  in an active position that the medication delivery assembly  500  may be attached to a pre-filled injection device  502 . The prefilled injection device  502  may be attached to the connector  504  of medication delivery assembly  500  by means of a stopping rim  517 , positioned on the luer portion  515  of the prefilled injection device  502 . The luer portion  515  of the injection device  502  is inserted through the aperture  550  of the connector  504 . The rim of the aperture  550  is preferably segmented and slightly undersized for the lip of the stopping rim  517 , so that the rim of the aperture  550  momentarily flexes outwards as the luer portion  515  is inserted through the aperture  550  of the connector  504  and snaps into place behind the stopping rim  517 . 
         [0287]    The connector  504  and the injection device  502  then become permanently attached such that they cannot be readily released from each other in a non-destructive manner. It is appreciated that the injection device  502  may be integrally formed with the connector  504 , for example by means of injection molding. 
         [0288]    It can also be seen from the above mentioned drawings that the skin interface element  508  at the active position is engaged with the connector  504  in a lockable manner. The skin interface element  508  is axially rearwardly disposed due the manual force exerted on the gripping wings  532 , which are slidable along the recesses  534  of the shield  512  in order to activate the medication delivery assembly  500 , i.e., to make it ready for use. The sloped face  519  of the connector locking protrusion  513  of the skin interface element  508  slides along the inner surface of the connector  504  and the straight face  516  of the connector locking protrusions  513  on the skin interface element  508  may then snap over the forward end  527  of the skin interface element locking recesses  525  of the connector  504  and become engaged in a lockable manner within the skin interface element locking recesses  525  of the connector  504 , between the forward end  527  and the rearward end  529  of the skin interface element locking recesses  525 . 
         [0289]    The rearward displacement of the skin interface element  508  and snapping behind the forward end  527  of the skin interface element locking recesses  525  is permitted due to a substantial resiliency of the material that the skin interface element  508  and/or connector  504  are made from, optionally in combination with various cut-outs or other geometrical features designed to accommodate the required momentary deflection and then return resiliently towards their original shapes. 
         [0290]    The rearward displacement of the skin interface element  508  causes the connector locking protrusions  513  of the skin interface element  508  to be inserted into the skin interface element locking recesses  525  and thereby urges the connector locking arms  524  of the shield  512  to deflect outwardly and thus disengage from the skin interface locking recesses  525  of the connector  504  sufficiently to allow manual removal of the shield. 
         [0291]    While in the activation position, the connector locking arms  524  of the shield  512  cannot be axially displaced since they are locked between the forward end  527  and the rearward end  529  of the skin interface element locking recesses  525 . 
         [0292]    Following the engagement of the connector locking protrusions  513  of the skin interface element  508  with the skin interface element locking recesses  525 , the connector locking arms  524  of the shield  512  are thus released and can be displaced forwardly and slide along the sloped angle of the forward end  527  of the skin interface element locking recesses  525  and thus the shield  512  can be removed to uncover the microneedle chip  510  for injection of medication. Parenthetically, it should be noted that the term “release” as used herein throughout the description and claims refers to a transition from a state that cannot readily be removed or separated manually to a state that can readily be removed or separated manually, but does not preclude there being a remnant retention force which must be manually overcome in order to actually remove the shield. For example, in the present embodiment, removal of shield  512  requires application of forward force in order to slightly flex locking arms  524  further outwards as the connector locking protrusions  513  ride over the outwardly sloped external bevel angle of the forward end  527  of the skin interface element locking recesses  525 . 
         [0293]    It may be appreciated that a single rearward axial movement of the skin interface element  508  causes both activation of the medication delivery device  500  by engaging the connector locking protrusions  513  of the skin interface element  508  with the skin interface element locking protrusions  525  of the connector  504  and release of the connector locking arms  524  of the shield  512  from the connector  504 . 
         [0294]    The septum  506  may be located within the skin interface element  508  flow path  590  and may be securely held within by means of annular rings  582  that are frictionally held against the cylindrical inner surface  602 . The annular rings  582  are also providing a seal by preventing the fluid from the prefilled injection device  502  that is flowing through the flow path  590  from flowing around the septum  506 . 
         [0295]    The sharp end of the needle  503  of the prefilled injection device  502  may extend throughout the septum  506  at the active position. The septum rearward end  584  is disposed adjacent the forward end  516  of the prefilled injection device  502 . The forward end  516  of the pre-filled injection device  502  may supports the septum  506  and thus prevent rearward movement of the septum  506  due to back pressure of the medication. The sharp end of the needle  503  may be exposed into the forward portion  592  of the flow path  590  of the skin interface element  508  in the active position, thus fluid flow may be permitted from the prefilled injection device  502  via the needle  503 , further via the forward portion  592  of the flow path  590  of the skin interface element  508  and through the microneedle array arranged on the microneedle chip  510 . 
         [0296]    In accordance to a preferred embodiment of the invention, the microneedle chip  510  may be formed of at least one hollow penetrating element, which is implemented as at least one hollow microneedle integrally formed with an underlying substrate. 
         [0297]    The microneedle chip  510  may be preferably formed of two hollow microneedles integrally formed with an underlying substrate or may be alternatively formed of a linear array of at least three hollow microneedles integrally formed with an underlying substrate. 
         [0298]    Each microneedle within the microneedle chip  510  may be preferably formed primarily from silicon. 
         [0299]    It may be appreciated that in a particular embodiment of the invention, each hollow microneedle is formed with at least one upright surface standing upright relative to a surface of said underlying substrate, an inclined surface intersecting said at least one upright surface and a fluid flow bore intersecting said inclined surface. 
         [0300]    In accordance to an embodiment of the invention, each hollow microneedle is preferably less than 1 mm of height. 
         [0301]    Each hollow microneedle is located adjacent to an edge of said underlying substrate in such a manner that the microneedle having a height, and being less than twice its own height away from the edge. 
         [0302]    It is further appreciated that the microneedle chip  110  may be constructed as it is previously disclosed in U.S. Pat. Nos. 7,648,484 and 6,533,949, assigned to Nanopass Technologies. 
         [0303]    The microneedle chip  510  may be permanently attached to the forward end  530  of the skin interface element  508 . 
         [0304]    In active position, the shield  512  may be disposed over the skin interface element  508 , however it is no longer attached to the skin interface element  508  rather it can be readily removed by sliding the shield  512  forwardly along the sloped angle of the forward end  527  of the skin interface element locking recesses  525 . 
         [0305]    Due to the manual rearward displacement of the skin interface element  508 , as described in detail hereinabove, the connector locking protrusions  513  of the skin interface element  508  are enabled to move into engagement with the skin interface element locking recesses  525  of the connector  504 . The locking of the connector locking protrusions  513  with the skin interface element locking recesses  525  is made permanent, such that the connector  504  and the skin interface element  508  cannot be unlocked unless sufficient force is exerted to overcome this locking relation that is not readily achieved manually. 
         [0306]    It is appreciated that the medication delivery assembly  500  in the state shown in  FIGS. 23A and 23B  is a transitional stage of activation, which still doesn&#39;t allow inadvertent microneedle puncturing, however the shield  512  is released from lockable engagement at this stage and is ready to be removed from the medication delivery assembly  500  and the hollow needle  503  penetrates entirely through the septum  506 . 
         [0307]    It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and sub combinations of various features described hereinabove as well as variations and modifications thereof which are not in the prior art.

Technology Classification (CPC): 0