Abstract:
Described is a medicament delivery device comprising a case, a container slidably disposed in the case between a first position and a second position, a needle coupled to the container, and a needle alignment detection mechanism disposed on the case and adapted to receive the needle. The needle alignment detection mechanism determines whether the needle is aligned with a longitudinal axis (L) when the needle is in the first position, the second position or translating between the first position and the second position.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is a U.S. National Phase Application pursuant to 35 U.S.C. §371 of International Application No. PCT/EP2013/068714 filed Sep. 10, 2013, which claims priority to European Patent Application No. 12183929.4 filed Sep. 11, 2012. The entire disclosure contents of these applications are herewith incorporated by reference into the present application. 
     TECHNICAL FIELD 
     The invention relates to a medicament delivery device with a needle alignment detection mechanism. 
     BACKGROUND 
     Conventional medicament delivery devices, e.g., pen injectors, autoinjectors, syringes, etc., typically utilize a syringe or cartridge containing a medicament, and the syringe or cartridge has an integral needle or removable needle assembly. The conventional medicament delivery devices typically do not check needle alignment prior to an injection. The needle can be bent prior to the injection when, for example, there is a manufacturing defect, there is bending during shipping, when a cap or needle boot is placed on the device during manufacture, when the cap or the needle boot is being removed prior to use, or during handling of the device prior to or during use. 
     A bent needle can be problematic for several reasons. For example, a bent needle may affect dosing (e.g., if a flow path for the medicament is disrupted). The bent needle may alter an intended injection depth. The bent needle may lead to a more painful injection due to a non-perpendicular insertion of the needle. 
     Thus, there remains a need for an improved medicament delivery device with a needle alignment detection mechanism. 
     SUMMARY 
     It is an object of the present invention to provide an improved medicament delivery device with a needle alignment detection mechanism. 
     In an exemplary embodiment, a medicament delivery device according to the present invention comprises a case, a container slidably disposed in the case between a first position and a second position, a needle coupled to the container, and a needle alignment detection mechanism disposed on the case and adapted to receive the needle. The needle alignment detection mechanism determines whether the needle is aligned with a longitudinal axis when the needle is in the first position, the second position or translating between the first position and the second position. 
     In an exemplary embodiment, the container is a syringe or a cartridge. 
     In an exemplary embodiment, the needle is integrally formed with the container or removably coupled to the container. 
     In an exemplary embodiment, the needle alignment detection mechanism includes at least one hinged door disposed along a transverse axis. The door has a non-deflected position aligned with the transverse axis and a deflected position at an angle to the transverse axis. The at least one door is biased in the non-deflected position. The at least one door includes a first door and a second door, and the first door includes a first cut-out and the second door includes a second cut-out. When the doors are in the non-deflected positions, the cut-outs form a hole. The hole has a cross-section at least as large as a diameter of the needle. The cross-section includes a buffer space. 
     In an exemplary embodiment, the medicament delivery device further includes an interlock mechanism adapted to control a component in the delivery device. Transition of at least one of the doors to the deflected position causes activation of the interlock mechanism. The needle alignment detection mechanism includes at least one sensor adapted to detect a transition of at least one of the doors from the non-deflected position to the deflected position. 
     In an exemplary embodiment, the needle alignment detection mechanism includes an electrode coupled to the needle and a conductive transverse element having a hole adapted to receive the needle. Impingement of the needle on the transverse element creates a circuit. 
     In an exemplary embodiment, the needle alignment detection mechanism includes an electrode adjacent to the needle and a conductive transverse element having a hole adapted to receive the needle. Impingement of the needle on the transverse element results in a measured impedance change. 
     In an exemplary embodiment, the needle alignment detection mechanism includes two light sources disposed perpendicularly on a transverse element and two optical sensors each adapted to receive a respective optical signal from a given one of the light sources. Impingement of the needle on a center point of an intersection of light beams from the light sources generates a changed optical signal. Impingement of the needle on an intersection of light beams from the light sources other than a center point of the intersection generates a changed optical signal. 
     The term “drug” or “medicament”, as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound,
         wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody or a fragment thereof, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound,   wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis,   wherein in a further embodiment the pharmaceutically active compound comprises at least one peptide for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy,   wherein in a further embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-1) or an analogue or derivative thereof, or exendin-3 or exendin-4 or an analogue or derivative of exendin-3 or exendin-4.       

     Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin. 
     Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N—(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N—(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin. 
     Exendin-4 for example means Exendin-4(1-39), a peptide of the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2. 
     Exendin-4 derivatives are for example selected from the following list of compounds:
     H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2,   H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2,   des Pro36 Exendin-4(1-39),   des Pro36 [Asp28] Exendin-4(1-39),   des Pro36 [IsoAsp28] Exendin-4(1-39),   des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),   des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),   des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),   des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),   des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),   des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); or   des Pro36 [Asp28] Exendin-4(1-39),   des Pro36 [IsoAsp28] Exendin-4(1-39),   des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),   des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),   des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),   des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),   des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),   des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39),   wherein the group -Lys6-NH2 may be bound to the C-terminus of the Exendin-4 derivative;   or an Exendin-4 derivative of the sequence   des Pro36 Exendin-4(1-39)-Lys6-NH2 (AVE0010),   H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2,   des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2,   H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2,   H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-NH2,   des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,   H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,   H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,   H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25] Exendin-4(1-39)-NH2,   H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2,   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2,   des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,   H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,   H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2,   des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2,   H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2,   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2,   des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2,   H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2,   H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2,   H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,   H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25] Exendin-4(1-39)-NH2,   H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2,   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-NH2,   des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,   H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(S1-39)-(Lys)6-NH2,   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2;   or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned Exendin-4 derivative.   

     Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin. 
     A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. 
     Antibodies are globular plasma proteins (˜150 kDa) that are also known as immunoglobulins which share a basic structure. As they have sugar chains added to amino acid residues, they are glycoproteins. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimeric with two Ig units as with IgA, tetrameric with four Ig units like teleost fish IgM, or pentameric with five Ig units, like mammalian IgM. 
     The Ig monomer is a “Y”-shaped molecule that consists of four polypeptide chains; two identical heavy chains and two identical light chains connected by disulfide bonds between cysteine residues. Each heavy chain is about 440 amino acids long; each light chain is about 220 amino acids long. Heavy and light chains each contain intrachain disulfide bonds which stabilize their folding. Each chain is composed of structural domains called Ig domains. These domains contain about 70-110 amino acids and are classified into different categories (for example, variable or V, and constant or C) according to their size and function. They have a characteristic immunoglobulin fold in which two β sheets create a “sandwich” shape, held together by interactions between conserved cysteines and other charged amino acids. 
     There are five types of mammalian Ig heavy chain denoted by α, δ, ε, γ, and μ. The type of heavy chain present defines the isotype of antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively. 
     Distinct heavy chains differ in size and composition; α and γ contain approximately 450 amino acids and δ approximately 500 amino acids, while μ and ε have approximately 550 amino acids. Each heavy chain has two regions, the constant region (C H ) and the variable region (V H ). In one species, the constant region is essentially identical in all antibodies of the same isotype, but differs in antibodies of different isotypes. Heavy chains γ, α and δ have a constant region composed of three tandem Ig domains, and a hinge region for added flexibility; heavy chains μ and ε have a constant region composed of four immunoglobulin domains. The variable region of the heavy chain differs in antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone. The variable region of each heavy chain is approximately 110 amino acids long and is composed of a single Ig domain. 
     In mammals, there are two types of immunoglobulin light chain denoted by λ and κ. A light chain has two successive domains: one constant domain (CL) and one variable domain (VL). The approximate length of a light chain is 211 to 217 amino acids. Each antibody contains two light chains that are always identical; only one type of light chain, κ or λ, is present per antibody in mammals. 
     Although the general structure of all antibodies is very similar, the unique property of a given antibody is determined by the variable (V) regions, as detailed above. More specifically, variable loops, three each the light (VL) and three on the heavy (VH) chain, are responsible for binding to the antigen, i.e. for its antigen specificity. These loops are referred to as the Complementarity Determining Regions (CDRs). Because CDRs from both VH and VL domains contribute to the antigen-binding site, it is the combination of the heavy and the light chains, and not either alone, that determines the final antigen specificity. 
     An “antibody fragment” contains at least one antigen binding fragment as defined above, and exhibits essentially the same function and specificity as the complete antibody of which the fragment is derived from. Limited proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical amino terminal fragments, each containing one entire L chain and about half an H chain, are the antigen binding fragments (Fab). The third fragment, similar in size but containing the carboxyl terminal half of both heavy chains with their interchain disulfide bond, is the crystalizable fragment (Fc). The Fc contains carbohydrates, complement-binding, and FcR-binding sites. Limited pepsin digestion yields a single F(ab′)2 fragment containing both Fab pieces and the hinge region, including the H—H interchain disulfide bond. F(ab′)2 is divalent for antigen binding. The disulfide bond of F(ab′)2 may be cleaved in order to obtain Fab′. Moreover, the variable regions of the heavy and light chains can be fused together to form a single chain variable fragment (scFv). 
     Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Acid addition salts are e.g. HCl or HBr salts. Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10-heteroaryl group. Further examples of pharmaceutically acceptable salts are described in “Remington&#39;s Pharmaceutical Sciences” 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of Pharmaceutical Technology. 
     Pharmaceutically acceptable solvates are for example hydrates. 
     Further scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention will become more fully understood from the detailed description given hereinbelow and the accompanying drawings which are given by way of illustration only, and thus, are not limitive of the present invention, and wherein: 
         FIG. 1A-B  shows an exemplary embodiment of a medicament delivery device with a needle alignment detection mechanism according to the present invention; 
         FIG. 1C  shows an exemplary embodiment of the needle alignment detection mechanism of  FIGS. 1A-B ; 
         FIG. 2  shows another exemplary embodiment of a medicament delivery device with a needle alignment detection mechanism according to the present invention; 
         FIG. 3  shows another exemplary embodiment of a medicament delivery device with a needle alignment detection mechanism according to the present invention; and 
         FIG. 4  shows another exemplary embodiment of a medicament delivery device with a needle alignment detection mechanism according to the present invention. 
     
    
    
     Corresponding parts are marked with the same reference symbols in all figures. 
     DETAILED DESCRIPTION 
       FIGS. 1A and 1B  show an exemplary embodiment of a medicament delivery device  100  with a needle alignment detection mechanism  200  according to the present invention. The delivery device  100  may be any type of injection device which is used to inject a medicament from a syringe or cartridge. Those of skill in the art will understand that such injection devices include, but are not limited to, pen injectors, pre-filled syringes, autoinjectors, perfusion devices, infusion devices, etc. 
     In an exemplary embodiment, the needle alignment detection mechanism  200  is integrally formed with the delivery device  100 . In another exemplary embodiment, the needle alignment detection mechanism  200  may be an attachment to a pre-existing delivery device. For example, the needle alignment detection mechanism  200  may be a cap-type attachment which is removably coupled to the delivery device  100  and can be reused. 
     In the exemplary embodiment, the delivery device  100  may include components common to conventional delivery devices such as, for example, a case  105 , one or more springs, plungers, needle shields, a syringe  110  or a cartridge having an integral or removable needle  115  attached thereto, syringe/cartridge carriers, trigger button, etc. 
     In the exemplary embodiment, a needle alignment detection mechanism  200  is disposed on a distal end of the delivery device  100 . The needle alignment detection mechanism  200  may detect an alignment of the needle  115  when the needle  115  has been deflected away from a longitudinal axis L, e.g., of the syringe  110  and/or the delivery device  100 . 
     In an exemplary embodiment, the needle alignment detection mechanism  200  includes at least one cover element  205 . The cover element  205  may be disposed distal of the needle  115  (assuming the syringe  110  moves distally for insertion of the needle  115  during an injection) such that during the injection, the needle  115  moves relative to the cover element  205 . 
     In the exemplary embodiment shown in  FIG. 1 , the cover element  205  includes a first door  210  and a second door  215  disposed along a transverse axis T which is substantially perpendicular to the longitudinal axis L. The doors  210 ,  215  are hingedly disposed on the delivery device  100 , and the non-deflected position corresponds to disposition along the transverse axis T. In an exemplary embodiment, a resilient element (e.g., a spring) may bias each door  210 ,  215  in the non-deflected position. 
       FIG. 1C  shows an exemplary embodiment of the doors  210 ,  215  in the non-deflected position. Each door  210 ,  215  includes a cut-out  220 ,  225  such that, in the non-deflected position, the cut-outs abut and/or overlap to form a hole  230  through which a straight needle may pass. Thus, a diameter or cross-section of the hole  230  may correspond to a diameter of the needle  115  in addition to a surrounding buffer space for which the needle  115  will not be considered bent though it is not precisely aligned with the longitudinal axis L. The buffer space may provide some tolerance for needle/syringe manufacturing variability. 
     Referring back to  FIGS. 1A and 1B ,  FIG. 1A  shows an exemplary embodiment of the needle alignment detection mechanism  200  when a straight needle  115  passes through the hole  230 .  FIG. 1B  shows an exemplary embodiment of the needle alignment detection mechanism  200  when a bent needle  115  abuts the first door  210 . For example, the syringe  110  may be in a retracted position within the case  105  prior to use, and when the delivery device  100  is actuated, the syringe  110  may translate axially to insert the needle  115  into the injection site. If the needle  115  is bent, it may impact one of the doors  210 ,  215  and cause the impacted door to transition to the deflected position. 
     In an exemplary embodiment, an interlock mechanism may be activated when one of the doors  210 ,  215  transitions to the deflected position. The interlock mechanism may, for example, prevent further translation of the syringe  110  relative to the case  105 , prevent translation of a plunger, activate a syringe refraction mechanism, activate a safety feature (e.g., deploy a needle shield), provide feedback (e.g., audible, visual, tactile to indicate bent needle), etc. In an exemplary embodiment, sensors for the needle alignment detection mechanism  200  may generate a signal when one of the doors  210 ,  215  transitions to the deflected position, and a controller in the delivery device  100  may activate the interlock mechanism. 
     In an exemplary embodiment, the sensors are electrodes disposed adjacent the doors  210 ,  215  which are made from or covered with a conducting material. If the one or both of the doors  210 ,  215  transition to the deflected position, a distance between the electrodes and the doors  210 ,  215  increase, a capacitance value between the electrodes changes, resulting in a change in measured impedance (or conductance). A change in the measured impedance may be used by a controller to activate the interlock mechanism. 
     In another exemplary embodiment, the sensors are optical sensors that include a reflectance-based proximity switch or photo-interrupter-based sensor actuated by the doors  210 ,  215  blocking a light beam focused on the sensor. 
     In another exemplary embodiment, the sensors measure current supplied to a motor in the delivery device  100  that drives the syringe  110  relative to the case  105 . If the current is increased beyond a predetermined value (e.g., because the needle  115  impacts the doors  210 ,  215  and the motor must apply more force), the controller may activate the interlock mechanism. 
     In a further exemplary embodiment, the sensors may detect contact of the needle  115  with the doors  210 ,  215  which are locked in the non-deflected position. 
       FIG. 2  shows another exemplary embodiment of a needle alignment detection mechanism  300  in which a cover element  305  includes a transverse element  310  including a hole  330  for allowing a straight needle to pass through. Thus, a diameter or cross-section of the hole  230  may correspond to a diameter of the needle  115  in addition to a surrounding buffer space for which the needle  115  will not be considered bent though it is not precisely aligned with the longitudinal axis L. The buffer space may provide some tolerance for needle/syringe manufacturing variability. 
     In this exemplary embodiment, an electrode  340  is coupled to the needle  115 , e.g., at a proximal-most position, and the transverse element  310  is made or covered with a conductive metal. If the needle  115  is bent and impinges upon the transverse element  310 , a circuit is created, and a controller  345  may activate an interlock mechanism. 
       FIG. 3  shows another exemplary embodiment of a needle alignment detection mechanism  400  in which a cover element  405  includes a transverse element  410  including a hole  430  for allowing a straight needle to pass through. Thus, a diameter or cross-section of the hole  430  may correspond to a diameter of the needle  115  in addition to a surrounding buffer space for which the needle  115  will not be considered bent though it is not precisely aligned with the longitudinal axis L. The buffer space may provide some tolerance for needle/syringe manufacturing variability. 
     In this exemplary embodiment, an electrode  440  is disposed adjacent to the needle  115 , e.g., at a proximal-most position, and the transverse element  410  is made or covered with a conductive metal. In this exemplary embodiment, the electrode  440  is a conductive cylinder surrounding, but not making physical contact with, a portion of the needle  115 . While a cylinder is described in the exemplary embodiment, those of skill in the art will understand that the electrode  440  may overlap a surface of the needle  115 . If the needle  115  is bent and impinges upon the transverse element  410 , an impedance measurement will decrease due to change in overall capacitance between the electrode  440  and the transverse element  410 , and a controller  445  may activate an interlock mechanism. 
     In another exemplary embodiment, the controller  445  may measure capacitance around the hole  430  and not utilize the electrode  440 . If the needle  115  is bent and impinges upon the transverse element  410 , the capacitance will change, and the controller  445  may activate an interlock mechanism. 
       FIG. 4  shows another exemplary embodiment of a needle alignment detection mechanism  500  in which a cover element includes a transverse element  510  including a plurality of optical sensors. In the exemplary embodiment, two optical sensors  525 ,  530  are disposed perpendicularly on the transverse element  510  and receive optical signals from respective light sources  535 ,  540 . Light beams from the light sources  535 ,  540  may intersect at a center point, which may have a diameter or cross-section corresponding to a diameter of the needle  115  in addition to a surrounding buffer space for which the needle  115  will not be considered bent though it is not precisely aligned with the longitudinal axis L. The buffer space may provide some tolerance for needle/syringe manufacturing variability. One or more lenses may be utilized to focus/spread the light beams to expand/limit a size of the center point. In an exemplary embodiment, if the needle  115  is not bent, then it will pass through the light beam (s) and reduce intensity of the light incidence on the sensor from its respective source. If the needle  115  is bent and does not pass through the center point, a controller may activate an interlock mechanism. Those of skill in the art will understand that in another exemplary embodiment, the light beams may be arranged to surround the center point such that if the needle is bent and pass through the light beams (and not the center point), the controller may activate the interlock mechanism. 
     Those of skill in the art will understand that modifications (additions and/or removals) of various components of the apparatuses, methods and/or systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.