Patent Publication Number: US-2023149625-A1

Title: Application device for a fluid delivery apparatus and method of use

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This nonprovisional application is a continuation, under 35 U.S.C. § 120, of U.S Pat. Application 16/469,377 filed on Jun. 13, 2019, which is a U.S. National Phase Application of PCT/US2017/064642, filed Dec. 5, 2017, which claims the benefit of priority to U.S. Provisional Pat. Application No. 62/435,108, filed Dec. 16, 2016, the contents of which are hereby expressly incorporated by reference in their entirety. 
    
    
     FIELD OF THE DISCLOSURE 
     The present disclosure relates generally to a fluid delivery apparatus, and more particularly to an applicator for activating the fluid delivery device. 
     BACKGROUND OF THE DISCLOSURE 
     Numerous apparatus have been developed for transdermal delivery of medicines using microneedle assemblies. Microneedle assemblies facilitate reducing an amount of pain felt by a patient as compared to larger conventional needles. Moreover, conventional subcutaneous (and often intra-muscular) delivery of medicines using a needle operates to deliver a large quantity of the medicine at one time, thereby creating a spike in the bioavailability of the medicine. While this is not a significant problem for some medicines, many medicines benefit from having a steady state concentration in the patient’s blood stream. Transdermal delivery apparatus are capable of administering drugs at a substantially constant rate over an extended period of time. 
     However, delivery of medicine using transdermal delivery apparatuses poses several challenges. For example, with at least some known transdermal delivery apparatuses, the placement of the device with respectto auser’s skin and the amount of force used to attach the device to the skin can vary, thereby affecting the ability of the microneedles to properly penetrate the user’s skin. In addition, the medicine may have air bubbles dispersed therethrough, which can also affect the delivery of the medicine through each microneedle of the microneedle assembly. Moreover, the quantity of the medicine delivered through each microneedle of the microneedle assembly may not be constant or equal due to variances in the pressure supplied to the medicine. 
     BRIEF DESCRIPTION 
     In one aspect, an application device for a fluid delivery apparatus is provided. The application device includes ahousing having a bore extending from abottom ofthe housing. The bore is sized and shaped for receiving at least a portion of the fluid delivery apparatus therein. The application device also includes an impact component for impacting the fluid delivery apparatus and moving at least a portion of the fluid delivery apparatus towards a user’s skin. Moreover, the application device includes a safety arm positionable relative to the impact component between a locked configuration in which the impact component is secured in a safety position, and a released configuration in which the impact component is free to move within the housing for impacting the fluid delivery apparatus. 
     In another aspect, a system is provided. The system includes an application device and a fluid delivery apparatus. The application device includes a housing having a bore extending upward from a bottom of the housing. The bore is sized and shaped for receiving at least a portion of the fluid delivery apparatus therein. The application device has aretention member and an impact component positioned within the bore. The impact component is adapted for impacting the fluid delivery apparatus and moving at least a portion of the fluid delivery apparatus toward a user’s skin. The impact component is positionable relative to the housing between a safety position in which the impact component is secured to the retention member, and a released configuration in which the impact component is free to move within the housing for impacting the fluid delivery apparatus. The application device has a release component configured to transition the impact component from the safety position to the released configuration. 
     In yet another aspect, a method of activating a fluid delivery apparatus is provided. The fluid delivery apparatus includes a fluid therein and a plurality of microneedles for delivering the fluid to a user via the plurality ofmicroneedles. The method includes positioning the fluid delivery apparatus relative a portions of the user’s body such that the plurality of microneedles are adjacent the user’s skin. The method also includes positioning an application device into direct contact with the fluid delivery apparatus. Furthermore, the method includes activating the application device to cause a piston of the application device to contact the fluid delivery apparatus at a predetermined velocity and drive the plurality of microneedles into the user’s skin at a velocity in the range between 4.5 meters/second (m/s) to 6 m/s. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other features, aspects, and advantages of the present disclosure will become better understood when the following detailed description is read with reference to the accompanying drawings in which like characters represent like parts throughout the drawings, wherein: 
         FIG.  1 A  is a sectional view of an exemplary fluid delivery apparatus in apre-use configuration; 
         FIG.  1 B  is a sectional view of the fluid delivery apparatus in a pre-activated configuration; 
         FIG.  2    is an exploded, sectional view of fluid delivery apparatus; 
         FIG.  3    is a sectional view of a collet assembly of the fluid delivery apparatus; 
         FIG.  4    is an exploded, perspective view of the collet assembly shown in  FIG.  3     
         FIG.  5    is a sectional view of a plenum assembly of the fluid delivery apparatus; 
         FIG.  6    is an exploded, perspective view of the plenum assembly; 
         FIG.  7    is a top view of a sleeve component of the plenum assembly; 
         FIG.  8    is a bottom view of the sleeve component; 
         FIG.  9    is a section view of the sleeve component taken about line 9-9 shown in  FIG.  7   ; 
         FIG.  10    is a section view of the sleeve component taken about line 10-10 shown in  FIG.  8   ; 
         FIG.  11    is a top view of a plenum component of the plenum assembly; 
         FIG.  12    is a bottom view of the plenum component; 
         FIG.  13    is a section view of the plenum component taken about line 13-13 shown in  FIG.  11   ; 
         FIG.  14    is an exploded, schematic of a plenum cap assembly of the fluid delivery apparatus; 
         FIG.  15    is a top view of the plenum cap assembly, showing a first adhesive layer; 
         FIG.  16    is a top view of a second adhesive layer of the plenum cap assembly; 
         FIG.  17    is atop view of a third adhesive layer of the plenum cap assembly; 
         FIG.  18    is an exploded, schematic of a microneedle array assembly of the fluid delivery apparatus; 
         FIG.  19 A  is a schematic cross-sectional view of the microneedle array assembly; 
         FIG.  19 B  is a schematic cross-sectional view of the microneedle array assembly of  FIG.  19 A  but showing a protective cover covering the microneedle array assembly; 
         FIG.  20    is a sectional view of a cartridge assembly of the fluid delivery apparatus; 
         FIG.  21    is an exploded, schematic of the cartridge assembly; 
         FIG.  22    is asectional view of a cap assembly of the fluid delivery apparatus; 
         FIG.  23    is an exploded, perspective view of a mechanical controller assembly of the fluid delivery apparatus; 
         FIG.  24    is a perspective view of a body component of the mechanical controller assembly; 
         FIG.  25    is a top view of the body component; 
         FIG.  26    is a sectional view of the body component taken about line 26-26 of  FIG.  25   ; 
         FIG.  27    is a sectional view of the body component taken about line 27-27 of  FIG.  25   ; 
         FIG.  28    is a perspective view of a pivoting latch of the mechanical controller assembly; 
         FIG.  29    is a front perspective view of a retention plate of the mechanical controller assembly; 
         FIG.  30    is a rear perspective view of the retention plate; 
         FIG.  31    is a perspective section view of the assembled mechanical controller assembly; 
         FIG.  32    is a top view of the mechanical controller assembly; 
         FIG.  33    is a sectional view of the mechanical controller assembly taken about line 33-33 of  FIG.  32   ; 
         FIG.  34    is a sectional view of the mechanical controller assembly taken about line 34-34 of  FIG.  32   ; 
         FIG.  35    is a perspective section view of an insert component of the mechanical controller assembly; 
         FIG.  36    is a perspective view of a band of the fluid delivery apparatus; 
         FIG.  37    is an enlarged sectional view of aportion of the band capturing the collet assembly shown in  FIG.  4   ; 
         FIG.  38    is an enlarged perspective view of the band and collet assembly shown in  FIG.  37   , illustrating a first orientation of an indicator in a pre-use configuration; 
         FIG.  39    is an enlarged perspective view similar to  FIG.  8   , but illustrating a second orientation of the indicator in a use configuration; 
         FIG.  40   is aperspective view of an applicator of the fluid delivery apparatus; 
         FIG.  41    is a front sectional view of the applicator shown in  FIG.  40   ; 
         FIG.  42    is a side sectional view of the applicator shown in  FIG.  40   ; 
         FIG.  43    is a top sectional view of the applicator taken about line 43-43 shown in  FIG.  40   ; 
         FIG.  44    is a perspective view of a safety arm of the applicator; 
         FIG.  45    is a front perspective view of a piston of the applicator; 
         FIG.  46    is a rear perspective view of the piston; 
         FIG.  47    is a side view of the piston; and 
         FIG.  48    is a sectional view of the applicator attached to the fluid delivery apparatus. 
     
    
    
     Unless otherwise indicated, the drawings provided herein are meant to illustrate features of embodiments of the disclosure. These features are believed to be applicable in a wide variety of systems comprising one or more embodiments of the disclosure. As such, the drawings are not meant to include all additional features known by those of ordinary skill in the art to be required for the practice of the embodiments disclosed herein. 
     DETAILED DESCRIPTION 
     In the following specification and the claims, reference will be made to a number ofterms, which shall be defined to have the following meanings. The singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. “Optional” or “optionally” means that the subsequently described event or circumstance may or may not occur, and that the description includes instances where the event occurs and instances where it does not. 
     Approximating language, as used herein throughout the specification and claims, may be applied to modify any quantitative representation that could permissibly vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term or terms, such as “about,” “approximately,” and “substantially,” are not to be limited to the precise value specified. In at least some instances, the approximating language may correspond to the precision of an instrument for measuring the value. Here and throughout the specification and claims, range limitations may be combined and/or interchanged; such ranges are identified and include all the sub-ranges contained therein unless context or language indicates otherwise. 
     As used herein, positional terms such as upward, downward, upper, lower, top, bottom, and the like are used only for convenience to indicate relative positional relationships. 
     As used herein, for the purposes of description and claims, the term “fluid” applies only to liquids, and should not be taken to include gaseous products. 
       FIG.  1 A  is a sectional view of an exemplary fluid delivery apparatus (e.g., a drug delivery apparatus), indicated generally by  10 , in a pre-use configuration.  FIG.  1 B  is a sectional view of the fluid delivery apparatus  10  in a pre-activated configuration.  FIG.  2    is an exploded, sectional view of fluid delivery apparatus  10 . In the exemplary embodiment, the fluid delivery apparatus  10  includes a plurality of subassembly components coupled together to form the fluid delivery apparatus  10 , including a collet assembly  12  and a fluid distribution assembly  14 . The collet assembly  12  and the fluid distribution assembly  14  are indicated generally by their respective reference numbers. As shown in  FIG.  2   , the fluid distribution assembly  14  includes a plurality of additional subassembly components, including a plenum assembly  16 , a cartridge assembly  18 , a cap assembly  320 , and a mechanical controller assembly  20 . Each of the collet assembly  12 , the fluid distribution assembly  14 , the plenum assembly  16 , the cartridge assembly  18 , the cap assembly  320 , and the mechanical controller assembly  20  is indicated generally in the accompanying drawings by their reference numbers. The collet assembly  12  forms the body or housing of the fluid delivery apparatus  10  and is slidably coupled to the fluid distribution assembly  14 . To form the fluid distribution assembly  14 , the cap assembly  320  is coupled to the cartridge assembly  18 , and the cartridge assembly  18  is slidably coupled to the plenum assembly  16 . In addition, the mechanical controller assembly  20 , as explained in more detail below, is coupled to the cartridge assembly  18 . 
       FIG.  3    is a sectional view and  FIG.  4    is an exploded, perspective of the collet assembly  12  of the fluid delivery apparatus  10 . Referring to  FIGS.  2 - 4   , in the exemplary embodiment, the collet assembly  12  includes acollet  22  coupled to a collet lock  50 . In the exemplary embodiment, the collet  22  is formed in a generally frustoconical shape, having a hollow interior space  24  defined therein. The collet  22  is formed generally symmetrically about acentral axis “A.” An upper rim  26  ofthe collet  22  defines an opening  28  to the interior space  24 . A cylindrical upper wall  30  extends generally vertically downward from the upper rim  26  towards a central portion  32  ofthe collet  22 . A lower wall  34  extends downward at an outward angle from the central portion  32  toward a base  36  (or lower edge) of the collet  22 . The upper wall  30 , central portion  32 , and the lower wall  34  collectively define the interior space  24 . A step  38  extends around the upper wall  30 , defining an outer horizontal surface  40  (or ledge) configured to engage an attachment band  430  (shown in  FIG.  36   ), as is described further herein. The step  38  also defines an inner horizontal surface  42  (or step) configured to engage with the plenum assembly  16  to facilitate properly positioning the plenum assembly  16  above a user’s skin surface prior to use of the fluid delivery apparatus  10 . 
     As illustrated in  FIG.  4   , the collet  22  includes a pair of notches, indicated generally at  44 , opposite each other and formed through the lower wall  34 . In the exemplary embodiment, the notches  44  are generally rectangular in shape and configured to receive a portion of the collet lock  50 . In addition, the collet  22  includes one or more stops  46  configured to facilitate positioning ofthe collet lock  50  when coupled to the collet  22 . For example, and without limitation, the one or more stops  46  are formed as inward extending projections formed on lower wall  34 . The stops  46  can have form or shape that enables the stops  46  to function as described herein. 
     As illustrated in  FIGS.  3  and  4   , the collet  22  includes a plurality of flexible tabs  48  formed integrally with the upper wall  30 . In addition, the plurality of flexible tabs  48  are positioned about and equidistant from the central axis “A.” In particular, the plurality of flexible tabs  48  extend from a first end  76  to an opposite free second end  78 . In the exemplary embodiment, the free second end  78  angles radially inward and is configured to engage with the plenum assembly  16  to facilitate properly positioning the plenum assembly  16  at the user’s skin surface during use of the fluid delivery apparatus  10 . 
     As illustrated in  FIGS.  3  and  4   , in the exemplary embodiment, the collet lock  50  is generally ring-shaped, having a convex inner surface  52  extending from alower outer edge  54  of the collet lock  50  to a generally cylindrical inner wall  56 . The inner wall  56  extends upward to an upper surface  58 . The collet lock  50  includes a generally cylindrical outer wall  60  that is concentric with inner wall  56  and extends upward from the lower outer edge  54 . In addition, the collet lock  50  includes latching members  62 ,  64 , opposite each other and extending upward from the upper surface  58 . The latching members  62 ,  64  are configured to couple to the notches  44  of the collet  22 . The latch member  62  includes a first coupling member  66  that extends outward from latch member  62 . In particular, the first coupling member  66  includes a neck portion  63  that extends at an upward angle substantially perpendicular to the lower wall  34  of the collet  22 . In addition, the first coupling member  66  includes a head portion  65  that extends generally parallel to the lower wall  34  beyond a periphery of the neck portion  63 . Furthermore, the first coupling member  66  includes a window or aperture  61  extending through the head portion  65 . The window  61  is configured to present an indication to the user of the fluid delivery apparatus  10  of a tightness of the attachment band  430 , as is further described herein. 
     Similarly, the latching member  64  includes an adjacent pair of second coupling members  68  that extend outward from latching member  64 . In the exemplary embodiment, the coupling members  68  each include a neck portion  67  that extends at an upward angle substantially perpendicular to the lower wall  34  of the collet  22 . In addition, the second coupling members  68  include ahead portion  69  that extends generally parallel to the lower wall  34  beyond a periphery ofthe neck portion  67 . The first coupling member  66  and the pair of second coupling members  68  are configured to engage the attachment band  430 , as is described further herein. 
     In the exemplary embodiment, the outer wall  60  of the collet lock  50  includes an upper outer surface  70  that inclines inward at an angle substantially parallel to the lower wall  34  to facilitate face-to-face engagement therewith. In addition, the upper surface  58  includes a plurality of stop members  72  that extend upward and are configured to engage the one or more stops  46  of the collet  22  to facilitate properly positioning of the collet lock  50  when coupled to the collet  22 . Extending radially inward from the convex inner surface  52  is aplurality of tabs  74  configured to engage with the plenum assembly  16  to facilitate properly positioning the plenum assembly  16  at the user’s skin surface during use of the fluid delivery apparatus  10 . 
     In the exemplary embodiment, the collet  22  is coupled to the collet lock  50  to form a unitary assembly (shown in  FIG.  3   ). In particular, the upper surface  70  and the latching members  62 ,  64  ofthe collet lock  50  engage the lower wall  34  and the notches  44  ofthe collet  22  via a permanent coupling method, for example, and without limitation, via an adhesive bond, a weld joint (e.g., spin welding, ultrasonic welding, laser welding, or heat staking), and the like. Alternatively, the collet  22  andthe colletlock  50  may be coupled together using any connection technique that enables the formation of the collet assembly  12 . 
       FIG.  5    is a sectional view of the plenum assembly  16  of the fluid delivery apparatus  10 .  FIG.  6    is an exploded, perspective view of the plenum assembly  16 . In the exemplary embodiment, the plenum assembly  16  includes a sleeve component  100 , a plenum component  102 , a cannula  104 , a plenum cap assembly  106  (broadly, “agas extraction device”), and a microneedle array assembly  108  coupled together to form the unitary plenum assembly  16 . In particular, the sleeve component  100  is coupled to the plenum component  102  to define a cavity  110  therein. In the exemplary embodiment, the sleeve component  100  is coupled to the plenum component  102  for example, and without limitation, via an adhesive bond, a weld j oint (e.g., spin welding, ultrasonic welding, laser welding, or heat staking), and the like. Alternatively, the sleeve component  100  and the plenum component  102  may be coupled together using any connection technique that enables the formation of the plenum assembly  16 . 
       FIG.  7    is a top view ofthe sleeve component  100 ,  FIG.  8    is abottom view of the sleeve component  100 ,  FIG.  9    is asection view of the sleeve component  100  taken about line 9-9 shown in  FIG.  7   , and  FIG.  10    is a section view of the sleeve component  100  taken about line 10-10 shown in  FIG.  8   . As illustrated in  FIGS.  5 - 10   , in the exemplary embodiment, the sleeve component  100  includes a lower annular wall portion  112  and an upper annular wall portion  114 . The upper annular wall portion  114  includes a plurality of flexible tabs  116  that extend substantially axially about the central axis “A” of the sleeve component  100  and are formed integrally with the upper wall portion  114 . The plurality of flexible tabs  116  are positioned equidistant about the central axis “A” with respect to each other. While four flexible tabs  116  are shown in the figures, it is noted that in other embodiments the sleeve component  100  has any number of the flexible tabs  116  that enable the sleeve component  100  to function as described herein. In the exemplary embodiment, each flexible tab  116  extends from a first end  118  to an opposite free second end  120 . The free second end  120  includes a radially inward extending protrusion  122  that is positioned to engage the cartridge assembly  18  to facilitate properly positioning the cartridge assembly  18  in the pre-use and pre-activated configurations. 
     As illustrated in  FIG.  7   , the lower wall portion  112  has an outer diameter  124  and an inner diameter  126 , between which a plurality of recesses  128 , 130 , 132  are defined. While four sets of recesses  128 ,  130 ,  132 , positioned equidistant about the central axis “A,” are shown in the figures, it is noted that in other embodiments the sleeve component  100  has any number of sets of recesses  128 ,  130 ,  132  that enables the sleeve component  100  to function as described herein. The lower wall portion  112  also includes a plurality of inwardly extending flange members  134  positioned equidistant about central axis “A.” Four flange members  134  are shown in the figures, however, it is noted that in other embodiments, the sleeve component  100  has any number of flange members  134  that enables the sleeve component  100  to function as described herein. In the exemplary embodiment, the flange members  134  are configured to engage and couple to corresponding recesses  190  formed in the plenum component  102 . 
     In the exemplary embodiment, arespective recess  128  (or pocket) is formed as a generally rectangular-shaped recess in the lower wall portion  112 , extending from the outer diameter  124  apredefined radial distance  138  into the lower wall portion  112 . As illustrated in  FIG.  8   , the recess  128  is offset circumferentially from the center of a respective flange member  134  at an angle a. As best illustrated in  FIG.  10   , the recess  128  extends upwardly from a bottom surface  136  of the sleeve component  100  a predetermined distance  140 , and is configured to receive a respective tab  74  of the collet lock  50  therein. Furthermore, in the exemplary embodiment, a respective recess  130  is formed as a flat surface formed in the lower wall portion  112 , wherein the recess  130  extends from the bottom surface  136  to atop surface  142  (or ledge) of the lower wall portion  112  and is substantially perpendicular to a radial line extending from the central axis “A” As illustrated in  FIG.  8   , the recess  130  is formed substantially perpendicular to a radial line defined at an angle from the center of a respective flange member  134 . In the exemplary embodiment, the recess  130  is configured to enable a respective tab  74  of the collet lock  50  to pass in an axial direction without interference with the sleeve component  100  during assembly of the plenum assembly  16  with the collet assembly  12 . 
     Moreover, in the exemplary embodiment, a respective recess  132  is formed as an arcuate recess that extends tangentially from the recess  130  in a circumferential direction and with a continuous radius with respect to the central axis “A.” In particular, the recess  132  extends circumferentially an arcuate distance that allows a respective tab  74  of the collet lock  50  tobereceived therein, while simultaneously allowing a respective flexible tab  48  ofthe collet  22  to align with, and be received by, the recess  130  during assembly of the plenum assembly  16  with the collet assembly  12 . As illustrated in  FIG.  6   , the recess  132  extends upwardly from the bottom surface  136  a predetermined height  144 . 
     The lower wall portion  112  also includes a plurality of protrusions or stops  146  defined in part by recesses  128 ,  130 ,  132 . In the exemplary embodiment, each of the stops  146  extends between a circumferential end portion  148  of the recess  132  and an adjacent recess  128  (shown in  FIG.  8   ). The stops  146  are configured to prevent rotation of the plenum assembly  16  when the tabs  74  of the collet lock  50  are located in the recesses  128  or at the circumferential end portions  148  of the recesses  132 . Each of the stops  146  includes an outer surface  150  that extends generally axially and is substantially perpendicularto a radial line extending from the central axis “A” In addition, each of the stops  146  includes an inclined surface  152  that extends upwardly from the outer surface  150  to the top surface  142  of the lower wall portion  112 . The stops  146  are configured to engage the flexible tabs  48  of the collet  22  to facilitate preventing rotation of the plenum assembly  16  with respect to the collet assembly  12  after assembly of the fluid delivery apparatus  10 . As illustrated in  FIG.  6   , a portion ofthe surface ofthe recess  130  extends circumferentially over the recess  132  and couples to the inclined surface  152 , thereby functioning as a ramp configured to engage the flexible tabs  48  of the collet  22  during assembly of the plenum assembly  16  to the collet assembly  12 . 
       FIG.  11    is atop view of the plenum component  102 ,  FIG.  12    is a bottom view of the plenum component  102 , and  FIG.  13    is a section view of the plenum component  102  taken about line 13-13 shown in  FIG.  11   . Referring to  FIGS.  5 ,  6 , and  11 - 13   , in the exemplary embodiment, the plenum component  102  includes a generally planar annular disk body portion  160  that extends horizontally across the lower wall portion  112  of the sleeve component  100  adjacent the bottom surface  136  to define the cavity  110 . The body includes an upper surface  162  ( FIG.  11   ) and an opposite lower surface  164  ( FIG.  12   ). The upper surface  162  of the plenum component  102  has an upwardly extending annular central wall  166  positioned proximate a central portion of the body portion  160  and defining a chamber  167 . The annular central wall  166  includes an upper rim  168  that is configured to couple to the cartridge assembly  18 . The lower surface  164  of the plenum component  102  includes a rectangular frame portion  170  that extends downwardly from the body portion  160 . The frame portion  170  defines amounting space  172  for coupling the plenum cap assembly  106  and the microneedle array assembly  108  to amounting surface  174  located within the mounting space  172 . 
     The plenum component  102  includes an arcuate channel  176  having a plurality of axially extending apertures  178  defined therein. In particular, as best illustrated in  FIG.  12   , the arcuate channel  176  is defined in the mounting surface  174  within the mounting space  172 . The arcuate channel  176  has a predetermined width that is centered about a center radius  180 . The center radius  180  is concentric with the central axis “A” of the plenum component  102 . In the exemplary embodiment, the arcuate channel  176  extends circumferentially about 270°. In other embodiments, the arcuate channel  176  can extend any circumferential angle that enables the plenum component  102  to function as described herein. In the exemplary embodiment, the axially extending apertures  178  are uniformly disposed in the arcuate channel  176 . Each aperture  178  is centered on the center radius  180  and extends through the body portion  160  from the lower surface  164  to the upper surface  162 . In the exemplary embodiment, the plenum component  102  includes ten axially extending apertures  178 . Alternatively, in other suitable embodiments, the plenum component  102  can include any number of axially extending apertures  178  that enables the plenum component  102  to function as described herein. 
     In the exemplary embodiment, as best shown in  FIG.  5   , the cannula  104  is coupled to amount  184  that extends upwardly from the upper surface  162  of the plenum component  102 . In particular, the cannula  104  is coupled in fluid communication to a fluid passage  186  that extends through the plenum component  102 , coaxial with the central axis “A.” The cannula  104  is coupled to the plenum component  102  via an interference fit with the mount  184  and an adhesive disposed in a cavity  188  defined in the mount  184 . As used herein, the phrase “interference fit” means a value of tightness between the cannula  104  and the mount  184 , i.e., an amount of radial clearance between the components. A negative amount of clearance is commonly referred to as a press fit, where the magnitude of interference determines whether the fit is a light interference fit or interference fit. A small amount of positive clearance is referred to as a loose or sliding fit. Alternatively, the cannula  104  may be coupled to the mount  184  using any suitable fastening technique that enables the plenum component  102  to function as described herein. In the exemplary embodiment, an upper portion the cannula  104  is sharply pointed and extends upwardly away from the plenum component  102 , such that the cannula  104  can pierce a portion ofthe cartridge assembly  18 , as is described herein. 
     Referring to  FIG.  11   , the plenum component  102  includes a plurality of recesses  190  defined in the upper surface  162  and positioned equidistant about the central axis “A.” The recesses  190  are sized and shaped to correspond to the flange members  134  of the sleeve component  100 , as described above. Specifically, in the exemplary embodiment, the plenum component  102  includes four recesses  190  shown in the figures, however, it is noted that in other embodiments, the plenum component  102  has any number of recesses  190  that enables the plenum component  102  to function as described herein. As described herein, the sleeve component  100  is coupled to the plenum component  102  for example, and without limitation, via an adhesive bond, a weld joint (e.g., spin welding, ultrasonic welding, laser welding, or heat staking), and the like. In particular, the flange members  134  of the sleeve component  100  are coupled to the recesses  190  of the plenum component  102  to form a unitary assembly. 
       FIG.  14    is an exploded, schematic of the plenum cap assembly  106  of the fluid delivery apparatus  10  shown in  FIG.  1 A   FIG.  15    is atop view of the plenum cap assembly  106 . In the exemplary embodiment, the plenum cap assembly  106  is a unitary assembly comprising a plurality of layers bonded together. The plenum cap assembly  106  is bonded to the mounting surface  174  of the plenum component  102  viaafirst adhesive layer  192 , which is fabricated from pressure-sensitive adhesive film. The first adhesive layer  192  includes an arcuate slot  202  defined therethrough. The arcuate slot  202  is positioned substantially concentric with an aperture  204  formed coaxial with the central axis “A.” The arcuate slot  202  has a predetermined width that is centered about a center radius  206 . The center radius  206  is concentric with the central axis “A.” In the exemplary embodiment, the arcuate slot  202  extends circumferentially at an angle 8. In other embodiments, the arcuate slot  202  can extend any circumferential angle 8 that enables the plenum cap assembly  106  to function as described herein. In the exemplary embodiment, the arcuate slot  202  is configured to at least partially correspond to the arcuate channel  176  of the plenum component  102  and the aperture  204  is positioned to correspond to the fluid passage  186 . 
     The plenum cap assembly  106  includes a vent membrane  194  coupled to the first adhesive layer  192  opposite the plenum component  102 . In the exemplary embodiment, the vent membrane  194  includes a fluid inlet aperture  208  formed coaxial with the central axis “A” In the exemplary embodiment, the aperture  208  is substantially the same size as the aperture  204  of the first adhesive layer  192 . In one suitable embodiment, the vent membrane  194  is fabricated from a gas permeable oleophobic/hydrophobic material. It is understood that other types of suitable materials can be used in other embodiments. For example, and without limitation, in one embodiment, the vent membrane  194  is fabricated from an acrylic copolymer membrane formed on a nylon support material, such as Versapor® R Membrane available from Pall Corporation in Port Washington, NY. In the exemplary embodiment, the pore size of vent membrane  194  is about 0.2 microns. The vent membrane  194  has a flow rate for air in the range between about 200 milliliters/minute/centimeter 2  (ml/ min/cm 2 ) and about 2000 ml/ min/cm 2 ), as measured at about 150 kilopascal (kPa). In addition, the vent membrane  194  has a minimum fluid bubble pressure in the range between about 35 kilopascal (kPa) and about 300 kPa. In one suitable embodiment, the vent membrane  194  has a flow rate for air of at least 250 ml/ min/cm 2 , as measured at about 150 kPa, and a minimum fluid bubble pressure of at least 150 kPa. Alternatively, the vent membrane  194  can be fabricated from any gas permeable material that enables the plenum cap assembly  106  to function as described herein. 
       FIG.  16    is a top view of a second adhesive layer  196  of the plenum cap assembly  106 . In the exemplary embodiment, the second adhesive layer  196  is formed from a pressure-sensitive adhesive film and is coupled to the vent membrane  194  opposite the first adhesive layer  192 . The second adhesive layer  196  is formed similarly to the first adhesive layer  192  and includes an arcuate slot  210  defined therethrough. The arcuate slot  210  is configured to form a tortuous flow path that extends generally perpendicular to the central axis “A” to facilitate removing gas from the fluid. The arcuate slot  210  is sized and positioned to substantially correspond to the slot  202  of the first adhesive layer  192 . The slot  210  is positioned concentric with a central aperture portion  212 , which is formed coaxial with the central axis “A.” A first end  214  of the arcuate slot  210  is connected to the central aperture portion  212  with a linear slot portion  216 . The arcuate slot  210  has a predetermined width that is centered about a center radius  218 , which corresponds to the center radius  206  of the first adhesive layer  192 . In the exemplary embodiment, the arcuate slot  210  extends circumferentially at the same angle 8 as the arcuate slot  202 . In other embodiments, the arcuate slot  210  can extend any circumferential angle that enables the plenum cap assembly  106  to function as described herein. 
     The plenum cap assembly  106  includes an impermeable membrane  198  coupled to the second adhesive layer  196  opposite the vent membrane  194 . In the exemplary embodiment, the impermeable membrane  198  includes a fluid aperture  222  formed coaxial with a second end  220  of the arcuate slot  210 . In the exemplary embodiment, the aperture  222  is substantially the same size as the apertures  204 ,  208  of the first adhesive layer  192  and the vent membrane  194 , respectively. The impermeable membrane  198  is fabricated from a gas and liquid impermeable material. For example, and without limitation, in one embodiment, the impermeable membrane  198  is fabricated from a polyethylene terephthalate (PET) film. Alternatively, the impermeable membrane  198  can be fabricated from any gas and liquid impermeable material that enables the plenum cap assembly  106  to function as described herein. 
       FIG.  17    is a top view of a third adhesive layer  200  of the plenum cap assembly  106 . In the exemplary embodiment, the third adhesive layer  200  is formed from a pressure- sensitive adhesive film and is coupled to the impermeable membrane  198  opposite the second adhesive layer  196 . The third adhesive layer  200  includes a slot  224  defined therethrough. The slot  224  includes a first end  226  that is sized and positioned to substantially correspond to the aperture  222  of the impermeable membrane  198 . In addition the slot extends from the first end  226  to a second end  228 , which includes a full radius end sized substantially similar to the apertures  204 ,  208  of the first adhesive layer  192  and the vent membrane  194 , respectively. Moreover, the second end  228  is positioned substantially coaxial with the central axis “A”. 
     As described herein with respect to  FIGS.  5  and  6   , the plenum assembly  16  includes the microneedle array assembly  108  coupled to the plenum cap assembly  106 , which is mounted to the mounting surface  174  of the plenum component  102 .  FIG.  18    is an exploded, schematic of the microneedle array assembly  108  of the fluid delivery apparatus  10  shown in  FIG.  1 A .  FIG.  19 A  is a schematic cross-sectional view of the microneedle array assembly  108 . In the exemplary embodiment, the microneedle array assembly  108  is bonded to the plenum cap assembly 106viathe third adhesive layer  200  of the plenum cap assembly  106 . The microneedle array assembly  108  includes a microneedle array  230  and a membrane  232  draped at least partially across a plurality of microneedles  234  and a base surface  236  of the microneedle array  230 . The microneedle array assembly  108  also includes a distribution manifold  238  that extends across a back surface  240  of the microneedle array  230  and is bonded thereto by an adhesivelayer242. The distribution manifold  238  includes a fluid distribution network  244  for providing a fluid to the microneedle array  230 . The fluid supplied from the distribution manifold  238  may be in the form of a liquid drug formulation. The membrane-draped microneedles  234  are configured to penetrate a user’s skin, such as for providing the liquid drug formulation into the user’s skin by way of one or more passageways or apertures  246  formed in each microneedle  234 . 
     In the exemplary embodiment, the draped membrane  232  may be fabricated from a polymeric (e.g., plastic) film, or the like, and coupled to the microneedle array  230  using an additional adhesive layer  242 . In other embodiments, the draped membrane  232  may include an embossed or nano-imprinted, polymeric (e.g., plastic) film, or be fabricated from a polyether ether ketone (PEEK) film, or the draped membrane  232  may be any other suitable material, such as a polypropylene film. It is contemplated that the microneedle array assembly  108  may not include the draped membrane  232  in some embodiments. 
     In the exemplary embodiment, the microneedle array  230  may be fabricated from a rigid, semi-rigid, or flexible sheet ofmaterial, for example, without limitation, a metal material, a ceramic material, a polymer (e.g., plastic) material, or any other suitable material that enables the microneedle array  230  to function as described herein. For example, in one suitable embodiment, the microneedle array  230  may be formed from silicon by way of reactive-ion etching, or in any other suitable fabrication technique. 
     As illustrated in  FIG.  19 A , the microneedle array  230  includes the plurality of microneedles  234  that extend outwardly from the back surface  240  of the microneedle array  230 . The microneedle array  230  includes a plurality of passageways  246  extending between the back surface  240  for permitting the fluid to flow therethrough. For example, in the exemplary embodiment, each passageway  246  extends through the microneedle array  230  as well as through the microneedle  234 . 
     Each microneedle  234  includes a base that extends downwardly from the back surface  240  and transitions to a piercing or needle-like shape (e.g., a conical or pyramidal shape or a cylindrical shape transitioning to a conical or pyramidal shape) having a tip  248  that is distal from the back surface  240 . The tip  248  of each microneedle  234  is disposed furthest away from the microneedle array  230  and defines the smallest dimension (e.g., diameter or cross-sectional width) of each microneedle  234 . Additionally, each microneedle  234  may generally define any suitable length “L” between the base surface  236  of the microneedle array  230  to its tip  248  that is sufficient to allow the microneedles  234  to penetrate the user’s skin, i.e., penetrate the stratum corneum and pass into the epidermis of a user. Itmay be desirable to limit the length L of the microneedles  234  such that the microneedles  234  do not penetrate through the inner surface of the epidermis and into the dermis, which may advantageously facilitate minimizing pain for the user. In the exemplary embodiment, each microneedle  234  has a length L of less than about 1000 micrometers (um), such as less than about 800 um, or less than about 750 um, or less than about 500 um (e.g., an overall length L ranging from about 200 um to about 400 um), or any other subranges therebetween. The overall length L of the microneedles  234  may vary depending on the location at which the fluid delivery apparatus  10  is being used on the user. For example, and without limitation, the overall length L of the microneedles  234  for a fluid delivery apparatus to be used on a user’s leg may differ substantially from the overall length L of the microneedles  234  for a fluid delivery apparatus to be used on a user’s arm. Each microneedle  234  may generally have any suitable aspect ratio (i.e., the length Lover a cross-sectional width dimension D of each microneedle  234 ). The aspect ratio may be greater than 2, such as greater than 3 or greater than 4. In instances in which the cross-sectional width dimension (e.g., diameter) varies over the length of each microneedle  234 , the aspect ratio may be determined based on the average cross- sectional width dimension. 
     The channels or passageways  246  of each microneedle  234  may be defined through the interior of the microneedles  234  such that each microneedle forms a hollow shaft, or may extend along an outer surface of the microneedles to form a downstream pathway that enables the fluid to flow from the back surface  240  of the microneedle array  230  and through the passageways  246 , at which point the fluid may be delivered onto, into, and/or through the user’s skin. The passageways  246  may be configured to define any suitable cross-sectional shape, for example, without limitation, a semi-circular or circular shape. Alternatively, each passageway  246  may define a non-circular shape, such as a “v” shape or any other suitable cross-sectional shape that enables the microneedles  234  to function as described herein. 
     Themicroneedle array  230  may generally include any suitable number of microneedles  234  extending from back surface  240 . For example, in some suitable embodiments, the quantity of microneedles  234  included within the microneedle array  230  is in the range between about 10 microneedles per square centimeter (cm 2 ) to about 1,500 microneedles per cm 2 , such as from about 50 microneedles per cm 2  to about 1250 microneedles per cm 2 , or from about 100 microneedles per cm 2  to about 500 microneedles per cm 2 , or any other subranges therebetween. 
     The microneedles  234  may generally be arranged in a variety of different patterns. For example, in some suitable embodiments, the microneedles  234  are spaced apart in a uniform manner, such as in a rectangular or square grid or in concentric circles. In such embodiments, the spacing of the microneedles  234  may generally depend on numerous factors, including, but not limited to, the length and width of the microneedles  234 , as well as the amount and type of liquid formulation that is intended to be delivered through or along the microneedles  234 . 
     Furthermore, in the exemplary embodiment, the fluid distribution network  244  includes, for example, a plurality of channels and/or apertures extending between atop surface  250  and a bottom surface  252  of the distribution manifold  238 . The channels and/or apertures include a centrally-located inlet channel  254  coupled in flow communication with aplurality of supply channels  256  and the slot224 formed in the thirdadhesivelayer200oftheplenumcap assembly 106(shownin  FIG.  14   ). In the exemplary embodiment, the supply channels  256  facilitate distributing a fluid supplied by the inlet channel  254  across an area of the distribution manifold  238 . Each ofthe supply channels  256  is coupled in flow communication to a plurality of resistance channels (not shown). The resistance channels extend away from the supply channels  256  and are formed to facilitate an increase in the resistance of the fluid distribution network  244  to the flow of the fluid. Each resistance channel is coupled in flow communication to an outlet channel  258 . As illustrated in  FIG.  19 A , each outlet channel  258  is aligned with a respective microneedle  234  for distributing the fluid through the microneedle passageways  246 . In other embodiments, the resistance channel and channels  254 ,  256 , and  258  may be formed in any configuration that enables the distribution manifold  238  to function as described herein. 
     In the exemplary embodiment, the distribution manifold  238  is formed by bonding abase substrate  260  including the inlet channel  254  formed through the substrate, and the supply channels  256  and the resistance channels formed in a bottom surface  264 , to a cover substrate  262  including the outlet channels  258  formed therethrough. The inlet channel  254  may be formed in the substrate  260  by drilling, cutting, etching, and or any other manufacturing technique for forming a channel or aperture through substrate  260 . In the exemplary embodiment, the supply channels  256  and the resistance channels are formed in the bottom surface  264  of the substrate  260  using an etching technique. For example, in one suitable embodiment, wet etching, or hydrofluoric acid etching, is used to form the supply channels  256  and the resistance channels. In another suitable embodiment, Deep Reactive Ion Etching (ORIE or plasma etching) may be used to create deep, high density, and high aspect ratio structures in substrate  260 . Alternatively, the supply channels  256  and resistance channels can be formed in bottom surface  264  using any fabrication process that enables the distribution manifold  238  to function as described herein. In the exemplary embodiment, the outlet channels  258  are formed through the cover substrate  262  by drilling, cutting, etching, and or any other manufacturing technique for forming a channel or aperture through substrate  262 . 
     In the exemplary embodiment, the base substrate  260  and the cover substrate  262  are bonded together in face-to-face contact to seal the edges of the supply channels  256  and the resistance channels of the distribution manifold  238 . In one suitable embodiment, direct bonding, or direct aligned bonding, is used by creating a prebond between the two substrates  260 ,  262 . The prebond can include applying a bonding agent to the bottom surface  264  of the substrate  260  and atop surface  266  of the cover substrate  262  before bringing the two substrates into direct contact. The two substrates  260 ,  262  are aligned and brought into face-to-face contact and annealed at an elevated temperature. In another suitable embodiment, anodic bonding is used to form the distribution manifold  238 . For example, an electrical field is applied across the bond interface at surfaces  264  and  266 , while the substrates  260 ,  262  are heated. In an alternative embodiment, the two substrates  260 ,  262  may be bonded together by using a laser-assisted bonding process, including applying localized heating to the substrates  260 ,  262  to bond them together. 
     In the exemplary embodiment, the base substrate  260  and the cover substrate  262  are fabricated from a glass material. Alternatively, the base substrate  260  and the cover substrate  262  may be fabricated from silicon. It is contemplated that the base substrate  260  and the cover substrate  262  may be fabricated from different materials, for example, substrate  260  may be fabricated from aglass and the substrate  262  may fabricated from silicon. In other embodiments, the base substrate  260  and the cover substrate  262  may be fabricated from any material and material combination that enables the distribution manifold  238  to function as described herein. 
       FIG.  19 B  is a schematic cross-sectional view of an alternative embodiment of the microneedle array assembly  108 . In the exemplary embodiment, the microneedle array assembly  108  includes a protective cover  268  coupled to the microneedle array assembly  108  via an adhesive  267 . The adhesive  267  may be attached to a periphery of the protective cover  268  to facilitate securing the protective cover  268  to the microneedle array assembly  108 , and in particular, to the microneedle array  230 . Alternatively, the adhesive layer  242  used to couple the draped membrane  232  to the microneedle array  230  may extend outward toward a periphery of the microneedle array  230  and may be used to attach the protective cover  268  to the microneedle array assembly  108 . In the exemplary embodiment, the protective cover  268  may be fabricated from a material that is substantially impermeable to fluids, such as, for example, polymers, metal foils, and the like. The adhesive  267  may be a pressure-sensitive adhesive that includes, for example, solvent-based acrylic adhesives, solvent- based rubber adhesives, silicone adhesives, and the like as is known in the art. While the protective cover  268  is illustrated as a planar cover having a flanged peripheral sidewall, it is understood that it the protective cover  268  may be a flexible sheet material, such as a laminate. The protective cover  268  also includes at least one tab  269  that extends from an edge of the protective cover  268  beyond the adhesive  267  to facilitate removing (e.g., peeling) the protective cover away from the microneedle array assembly  108 . 
       FIG.  20    is a sectional view of the cartridge assembly  18  of the fluid delivery apparatus  10  shown in  FIG.  1 A   FIG.  21    is an exploded, schematic of the cartridge assembly  18 . In the exemplary embodiment, the cartridge assembly  18  includes a reservoir component  270  formed generally concentric about the central axis “A.” The reservoir component  270  includes an upper cavity  272  and an opposing lower cavity  274  coupled together in flow communication via a fluid passage  276 . In the exemplary embodiment, the upper cavity  272  has agenerally concave cross-sectional shape, defined by a generally concave body portion  278   of the reservoir component  270 . The lower cavity  274  has a generally rectangular cross-sectional shape, defined by a lower wall  275  that extends generally vertically downward from a central portion of the concave body portion  278 . An upper portion of the end of the fluid passage  276  is open at the lowest point of the upper cavity  272 , and an opposite lower portion of the fluid passage  276  is open at a central portion of the lower cavity  274 . The lower portion of the fluid passage  276  expands outward at the lower cavity  274 , forming a generally inverse funnel cross-sectional shape. In other embodiments, the cross-sectional shapes of the upper cavity  272 , the lower cavity  274 , and the fluid passage  276  may be formed in any configuration that enables the reservoir component  270  to function as describe herein. 
     The cartridge assembly  18  also includes an upper sealing member  280  (or membrane) configured to couple to the reservoir component  270  and close the upper cavity  272 . The upper sealing member  280  is formed as an annular sealing membrane and includes a peripheral ridge member  282  to facilitate sealingly securing the upper sealing member  280  to the cartridge assembly  18 . A cartridge housing  284  extends over the upper sealing member  280  and is configured to fixedly engage the reservoir component  270 . This facilitates securing the upper sealing member  280  in sealing contact with the reservoir component  270 , thereby closing the upper cavity  272 . 
     In the exemplary embodiment, the cartridge housing  284  includes a annular, vertically-extending wall  286  that has an inward extending flange member  288  configured to couple to the peripheral ridge member  282  of the upper sealing member  280 . In particular, the flange member  288  cooperates with the concave body portion  278  of the reservoir component  270  to compress and sealingly secure the upper sealing member  280  therebetween. In the exemplary embodiment, a lower end  300  ofthe vertically-extending wall  286  is coupled to a flange  302  of the reservoir component  270  via welding, for example, and without limitation, ultrasonic welding, spin welding, laser welding, and/or heat staking. In other embodiments, the vertically-extending wall  286  may be coupled to a flange  302  using any connection technique that enables the cartridge housing  284  to fixedly engage the reservoir component  270 , for example, and without limitation, via an adhesive bond and the like. 
     The cartridge housing  284  also includes an upper groove  304  and a lower groove  306  formed circumferentially in an outer surface  308  of the vertically-extending wall  286 . The upper and lower grooves  304 ,  306  are sized and shaped to engage the plurality of flexible tabs  116  of the sleeve component  100 , and, in particular, the radially inward extending protrusions  122  formed at the free second end  120  of the plurality of flexible tabs  116 , as is described herein. In addition, the cartridge housing  284  also includes a plurality of latch receiving openings  310  formed on an upper edge portion  312  of the vertically-extending wall  286 . The latch receiving openings  310  are configured to couple to the mechanical controller assembly  20  to secure it to the cartridge assembly  18 , as described herein. 
       FIG.  22    is a sectional view of the cap assembly  320  of the fluid delivery apparatus  10  shown in  FIG.  1 A . In the exemplary embodiment, the cap assembly  320  includes a septum component  322  and a snap cap component  324  coupled together. The septum component  322  is configured to couple to the reservoir component  270  and close the lower cavity  274 . The septum component  322  has a lower wall  326  that extends substantially perpendicular to the central axis “A.” The lower wall  326  includes a peripheral channel  328  that is configured to sealingly engage a rim  330  of the lower wall  275  of the reservoir component  270 . The septum component  322  also includes an annular upper seal wall  332 , transverse to the lower wall  326 , and that extends axially into the lower cavity  274  when coupled to the reservoir component  270 . The snap cap component  324  extends over the septum component  322  and is configured to fixedly engage the lower wall  275  of the reservoir component  270 . This facilitates securing the septum component  322  in sealing contact with the reservoir component  270 , thereby sealingly closing the lower cavity  274 . 
     The snap cap component  324  includes alower wall  334  that has a central opening  336  to facilitate access to the lower wall  326  of the septum component  322  during use of the fluid delivery apparatus  10 . The snap cap component  324  includes an annular vertically-extending wall  338  that extends upwardly and downwardly from a periphery of the lower wall  334 . In the exemplary embodiment, an upper portion  340  of the vertically-extending wall  338  engages the lower wall  275  of the reservoir component  270  via a latching component  342 . The latching component  342  includes an inwardly projecting flange for connecting with an opposing groove  344  formed in the lower wall  275  of the reservoir component  270 . It is contemplated that the latching component  342  can be a continuous annular flange or may include a plurality of inwardly projecting flange components. In other embodiments, the vertically-extending wall  338  may engage the lower wall  275  of the reservoir component  270  using any connection technique that enables the snap cap component  324  to fixedly engage the lower wall  275 , for example, and without limitation, via an interference fit, an adhesive bond, a weld joint (e.g., spin welding, ultrasonic welding, laser welding, or heat staking), and the like. In the exemplary embodiment, alower portion  346  of the vertically-extending wall  275  includes an outwardly extending flange portion  348  that defines a peripheral sealing surface  350  configured to engage an additional seal member (not shown) that extends between the snap cap component  324  and the upper rim  168  of the annular central wall  166  of the plenum component  102 . 
       FIG.  23    is an exploded, perspective view of the mechanical controller assembly  20  ofthe fluid delivery apparatus  10  shown in  FIG.  1 A . In the exemplary embodiment, the mechanical controller assembly  20  includes at least a body component  360 , a plunger component  362 , and a biasing assembly  364  positioned between the body component  360  and the plunger component  362  for biasing the plunger component  362  in an axial direction away from the body component  360 . The body component  360  includes a pair of retention plates  366  configured to couple a pair of pivoting latches  368  to the body component  360 , and a threaded adjustment member  370  configured to adjust an amount of force applied by the biasing assembly  364  to the plunger component  362 . 
       FIG.  24    is a perspective view of the body component  360 .  FIG.  25    is a top view of the body component  360 .  FIG.  26    is a sectional view of the body component  360  taken about line 26-26 of  FIG.  25   .  FIG.  27    is a sectional view of the body component  360  taken about line 27-27 of  FIG.  25   . In the exemplary embodiment, the body component  360  includes a generally disk-shaped outer body portion  390  and a generally cylindrical-shaped inner portion  392  extending upward from the outer body portion  390 . The body component  360  is formed generally symmetrically about lines 26-26 and 27-27 as illustrated in the figures. The outer body portion  390  includes atransversely extending top wall  394  and an annular sidewall  396  depending from the top wall  394 . The top wall  394  has a cavity  398  defined therein with a smaller central aperture  400  extending therethrough. In the exemplary embodiment, the cavity  398  and the aperture  400  are generally rectangular in shape. Alternatively, the cavity  398  and the aperture  400  can be any shape that enables the body component  360  to function as described herein. In the exemplary embodiment, the cavity  398  has a plurality of notches  402  defined therein for receiving the pivoting latches  368 . In particular, the plurality of notches  402  includes two pairs and notches  402  generally aligned across the central aperture  400  and positioned generally symmetrically about line 26-26. As illustrated in  FIGS.  24  and  27   , the notches  402  extend downwardly into a bottom wall  404  of the cavity  398 . 
     The top wall  394  includes a plurality of openings  406  defined therethrough and configured to receive a latch component of a respective retention plate  366 . Positioned on either side of a respective opening  406  are threaded holes  408 . The threaded holes  408  receive mechanical hardware  410  used to couple the retention plates  366  to the body component  360 . As illustrated in  FIGS.  24  and  26   , the annular sidewall  396  includes cutouts  412  proximate each opening  406  to enable the latch components of the retention plates  366  to extend thereby, as described further herein. 
     In the exemplary embodiment, the cylindrical-shaped inner portion  392  includes an annular wall  414  that extends upwardly from the bottom wall  404  of the cavity  398 , as best illustrated in  FIGS.  24  and  26   . In addition, as illustrated in  FIGS.  24  and  27   , the annular wall  414  has a bottom edge  416  over the central aperture  400  that is located a predetermined distance  418  above the top wall  394 . Accordingly, a space is defined between the bottom wall  404  of the cavity  398  and the bottom edge  416  of the annular wall  414  to enable the pivoting latches  368  to engage the plunger component  362  as is described further herein. The cylindrical-shaped inner portion  392  further includes a plurality of gusset portions  418  that extend from top wall  394  to atop edge420 of annular wall  414 . In particular, the body component  360  includes two symmetrically oriented gusset portions  418  that extend radially outward from annular wall  414  through the cavity  398  and into the top wall  394 . In addition, the gusset portions  418  extend upwardly and taper radially inwardly from the top wall  394  to the top edge  420  of the annular wall  414 . The gusset portions  418  are configured to provide additional structural support to the cylindrical-shaped inner portion  392  of the body component  360 . Furthermore, as illustrated in  FIG.  27   , the annular wall414 has apredetermined length422 from the top edge  420  to the predetermined distance  418  above the top wall  394 . The annular wall  414  includes a threaded portion  424  defined therein that extends downwardly from the top edge  420  a distance  426 , where the distance  426  is less than the length  422  of the annular wall  414 . This enables the threaded adjustment member  370  to be coupled to the body component  360 , without being able to be threaded entirely through the cylindrical- shaped inner portion  392 . 
       FIG.  28    is a perspective view of a pivoting latch  368  of the mechanical controller assembly  20 . In the exemplary embodiment, the pivoting latch  368  is formed generally symmetrically about an X-Y plane defined by the axes  460 . The pivoting latch  368  includes an elongated lever portion  450  that has a pair of cylindrical pins  452  coupled to an end portion  454  of the lever portion  450 . A respective cylindrical pin  452  extends from each side of the lever portion  450  such that the cylindrical pins  452  are coaxial about a centerline “B.” A latch portion  456  extends away from the lever portion  450  at the end portion  454 . In particular, the latch portion  456  extends from the end portion  454  of the lever portion  450  at an angle a with respect to the lever portion  450 . The latch portion  456  includes a concave cutout  458  that extends through the latch portion  456 . More specifically, the concave cutout458is defined by a radius “R” about a centerline “C.” Centerline “C” is in the X-Y plane of the axes  460  and is inclined at the same angle a as the latch portion  456  is with respect to the lever portion  450 . As such, the concave cutout  458  extends through the latch portion  456  at angle a, where the centerline “C” of the concave cutout  458  is substantially perpendiculartothe lever portion  450 . 
       FIG.  29    is a front perspective view of a retention plate  366  of the mechanical controller assembly  20 .  FIG.  30   is arearperspective view of the retention plate  366 . In the exemplary embodiment, the retention plate  366  is generally symmetrical about a centerline “D,” and includes a generally rectangular-shaped body portion  462 . A front or outer edge  464  of the body portion  462  has a radius that is substantially similar to a periphery of the body component  360 . A pair of countersink holes  466  are formed through the body portion  462  and are configured to receive the mechanical hardware  410 , as is described herein. Each countersink hole  466  includes an elongated slot  468  formed therethrough and generally parallel to the centerline “D.” The slots  468  enable the retention plate  366  to slide radially with respect to the central axis “A” of the body component  360  when coupled thereto. The body portion  462  also includes an elongated open-ended slot  470  extending therethrough and generally centered on the centerline “D.” The open-ended slot  470  is configured to receive at least a portion of a respective gusset portion  418  of the body component  360  when coupled thereto. 
     Extending downwardly from the bottom of the body portion  462  is a pair of bosses  472 ; one positioned on each side of the open-ended slot  470  and adjacent a rear edge  474  of the retention plate  366 . The bosses  472  are configured to facilitate coupling the pivoting latches  368  to the body component  360 . In particular, the bosses  472  are sized and shaped to extend into the cavity  398  in generally face-to-face contact with the bottom wall  404 , and to extend across a width of the notches  402  formed in the cavity  398  of the body component  360 , i.e., a respective boss  472  extends across a top opening of a respective notch  402 . As described further herein, the cylindrical pins  452  of the pivoting latches  368  are positioned into the notches  402  when the fluid delivery apparatus  10  is assembled, and as described, are retained within the notches  402  by the bosses  472  ofthe retention plates  366 . 
     Each retention plate  366  also includes a latch component  476  that extends downwardly from the bottom of the body portion  462  adjacent the outer edge  464 . The latch component  476  is positioned such that it is generally centered about the centerline “D.” The latch component  476  has an elongate body portion  478  formed integrally with the body portion  462  of the retention plate  366 . The free end of the latch component  476  includes an outward extending protrusion  480  configured to provide a releasable latching connection with the latch receiving openings  310  of the cartridge housing  284  of the cartridge assembly  18 . 
       FIG.  31    is a perspective section view of the assembled mechanical controller assembly  20 ,  FIG.  32    is a top view of the mechanical controller assembly  20 ,  FIG.  33    is a sectional view of the mechanical controller assembly  20  taken about line 33-33 of  FIG.  32   , and  FIG.  34    is a sectional view of the mechanical controller assembly  20  taken about line 34-34 of  FIG.  32   . Withreference to the  FIGS.  23  and  31 - 34   , the biasing assembly  364  includes a first biasing member  372  and a second biasing member  378 . In one embodiment, first biasing member  372  and a second biasing member  378  are springs. Alternatively, first biasing member  372  and a second biasing member  378  include any biasing component that enables biasing assembly  364  to function as described herein, including, for example, elastic, resilient materials; foams; fluid (i.e., gas or liquid) compression members, and the like. In the exemplary embodiment, the first biasing member  372  and the second biasing member  378  each have a different length and a different force constant (or force profile). The biasing assembly  364  also includes a threaded fastener  374 , a tube  376 , an insert component  380 , and a nut  382  configured to couple to the threaded fastener  374 . 
     The insert component  380 , as best illustrated in  FIGS.  23  and  35   , is generally cylindrically shaped and is symmetrical about the central axis “A.” The insert component  380  includes a body  482  that has a cylindrical protrusion  484  extending from a first end  486  of the body  482 . A second end  488  of the body  482  includes a first bore  490  that is sized to receive an end ofthe first biasing member  372  therein. The body  482  also includes a second bore  492  that is smaller than the first bore  490  and is sized to receive an end of the second biasing member  378  therein. An aperture  494  extends through the insert component  380  and is sized to receive the tube  376  therethrough. 
     As illustrated in the  FIGS.  23  and  31 - 34   , the threaded fastener  374  is inserted through the tube  376 . The second biasing member  378  is positioned about the tube  376  such that an end ofthe second biasing member  378  rests on a head  384  of the threaded fastener  374 . As such, the second biasing member  378  has as inner diameter that is larger than the periphery of the tube  376  and smaller than the periphery ofthe head 3  84  of the threaded fastener  374 . The threaded fastener  374  and the tube  376  are inserted through the aperture  494  of the insert component  380  from the second end  488  such that the second biasing member  378  is seated in the second bore  492  of the insert component  380 . The nut  382  is coupled to the threaded fastener  374  to facilitate retaining the insert component  380  on the threaded fastener  374  and the tube  376 . 
     In the exemplary embodiment, the threaded adjustment member  370  is coupled to the threaded portion  424  of the cylindrical-shaped inner portion  392  of body component  360  to facilitate positioning the insert component  380  axially within the cylindrical-shaped inner portion  392 . As described herein, this enables an amount of force applied by the biasing assembly  364  to the plunger component  362  to be adjusted. In the exemplary embodiment, the insert component  380 , with the threaded fastener  374 , the tube  376 , the second biasing member  378 , and the nut  382  coupled thereto, is inserted into the cylindrical-shaped inner portion  392  such that it is in contact with the threaded adjustment member  370 . 
     The pivoting latches  368  are positioned in the body component  360  such that the cylindrical pins  452  are located in the notches  402  and the latch portions  456  extend radially inward. The retention plates  366  are positioned on the body component  360  with each respective latch component  476  extending downwardly through a respective opening  406 . The bosses  472  of each respective retention plate extend over the notches  402 , thereby retaining the cylindrical pins  452  of the pivoting latches  368  therein. This enables the pivoting latches  368  to rotate about the cylindrical pins  452 , but to remain coupled to the body component  360 . The retention plates are coupled to the body component  360  via the mechanical hardware  410  threadably coupled to the threaded holes  408  of the body component  360 . 
     As illustrated in the  FIGS.  31 ,  33 , and  34   , the first biasing member  372  positioned in the first bore  490  of the insert component  380 . In the exemplary embodiment, the first biasing member  372  has an inner diameter that is larger than the periphery of the second biasing member  378  and the head  384  of the threaded fastener  374 . The first biasing member  372  extends from the first bore  490  of the insert component  380  to the plunger component  362 . The plunger component  362  includes a disk-shaped domed head  386  with an annular guide wall  387  coaxially extending vertically-upward from the domed head  386 . As illustrated, the guide wall  387  is configured to receive the first biasing member  372  and the second biasing member  378  therein. The guide wall  387  includes an outwardly extending flange  388  adjacent the free end of the guide wall  387 . The flange 3  88  is configured to engage the pivoting latches  368 , and in particular, the latch portions  456 , to facilitate retaining the plunger component  362  in a pre-use configuration, as shown in the  FIGS.  33  and  34   . In the exemplary embodiment, the domed head  386  is configured to engage the upper sealing member  280  of the cartridge assembly  18  via force applied by the biasing assembly  364  during use of the fluid delivery apparatus  10 . 
     In the exemplary embodiment, with reference to the figures, in one suitable embodiment, the fluid distribution assembly  14  of the fluid delivery apparatus  10  is assembled by coupling the cap assembly  320  to the cartridge assembly  18 . In particular, the upper seal wall  332  of the septum component  322  is inserted into the lower cavity  274  of the reservoir component  270  and the latching component  342  of the snap cap component  324  is snapped into the groove  344  of the reservoir component  270 . As such, the snap cap assembly  320 , and in particular, the septum component  322  seals the fluid passage  276  of the upper cavity  272  of the cartridge assembly  18 . A fluid may be disposed into the upper cavity  272  for delivery to a user during use of the fluid delivery apparatus  10 . The upper cavity  272  is closed by the upper sealing member  280 , which is secured by the cartridge housing  284 . 
     The mechanical controller assembly  20  is assembled in the pre-use configuration, as shown in the  FIGS.  33  and  34   , and is coupled to the upper portion of the cartridge assembly  18  via the retention plates  366 . In particular, the annular sidewall  396  of the body component  360  is positioned on the upper edge portion  312  of the cartridge housing  284  such that the cutouts  412  in the annular sidewall  396  are aligned with the latch receiving openings  310  of the cartridge housing  284 . The mechanical hardware  410  is loosened to enable the retention plates  366  to be displaced radially about the centerline “E,” and enable the latch components  476  to engage the latch receiving openings  310 . The mechanical hardware  410  is then tightened to secure the mechanical controller assembly  20  to the cartridge assembly  18 . 
     In the exemplary embodiment, the cartridge assembly  18 , along with the attached cap assembly  320  and the mechanical controller assembly  20 , is coupled to the plenum assembly  16 . As described herein, the plenum assembly  16  includes the plenum cap assembly  106  and the microneedle array assembly  108  coupled thereto. The cartridge assembly  18  is inserted into the cavity  110  of the plenum assembly  16 . The flexible tabs  116  flex radially outwardly to receive the cartridge assembly  18  therebetween. The annular lower groove  306  of the cartridge housing  284  is aligned with the radially inward extending protrusions  122  of the flexible tabs  116 , which enables the flexible tabs  116  to flex radially inward to secure the cartridge assembly  18  in the pre-use configuration. 
     In the exemplary embodiment, the fluid distribution assembly  14  ofthe fluid delivery apparatus  10  is coupled to the collet assembly  12  with by inserting the fluid distribution assembly  14  axially into the hollow interior space  24  of the collet assembly  12  from below. In particular, the recesses  130  of the sleeve component  100  of the plenum assembly  16  are axially aligned to the tabs  74  of the collet lock  50 . The fluid distribution assembly  14  is displaced axially upwardly until top surface  142  of the lower wall portion  112  of the sleeve component  100  contacts the flexible tabs  48  ofthe collet assembly  12 . The fluid distribution assembly  14  is rotated about the central axis “A” to axially align the flexible tabs  48  to the recesses  130 . This facilitates displacing the tabs  74  of the collet lock  50  circumferentially into the recesses  132  of the sleeve component  100 . The fluid distribution assembly  14  is again displaced axially upwardly, the displacement being stopped in response to the top surface  142  ofthe lower wall portion  112  ofthe sleeve component  100  contacting the inner horizontal surface  42  of the step  38  of the collet  22 . As such, the fluid distribution assembly  14  is axially positioned above the tabs  74  of the collet lock  50 . The fluid distribution assembly  14  is thenrotated about the central axis “A” to axially align the recesses  128  of the sleeve component  100  with the tabs  74 . As the fluid distribution assembly  14  is rotated, the flexible tabs  48  slide along the planar portion of the recesses  130  that overhangs the recesses  132 . This causes the flexible tabs  48  to flex radially outwardly. As the fluid distribution assembly  14  is rotated, the flexible tabs  48  rotationally engage the outer surface  150  of the stops  146  and flex radially inwardly against the outer surface  150  to provide a snap-fit connection between the fluid distribution assembly  14  and the collet assembly  12 . This facilitates preventing additional rotation of fluid distribution assembly  14  with respect to the collet assembly  12  and positions the recesses  128  into axial alignment with the tabs  74 . The fluid delivery apparatus  10  is thereby assembled in the pre-use configuration shown in  FIG.  1 A . 
     In one suitable embodiment, the fluid delivery apparatus  10  includes the attachment band  430 , such as, for example, and without limitation, an armband, a leg band, a waist band, wrist band, and the like. The attachment band  430  is configured to couple to the collet assembly  12  to facilitate attaching the fluid delivery apparatus  10  to a user during use.  FIG.  36   is a perspective view of the attachment band  430  of the fluid delivery apparatus  10  of  FIG.  1 A , and  FIG.  37    is an enlarged side sectional view of the attachment band  430  assembled to the collet assembly  12 . In the exemplary embodiment, the attachment band  430  includes an annular body  432  having a wall  434  that is formed in a generally frustoconical shape, having a hollow inner space  435  defined therein. The annular body  432  is sized and shaped to correspond to the upper wall  30  and the lower wall  34  the collet  22 . The inner space  435  is configured for receiving the fluid delivery apparatus  10 . The attachment band  430  includes an inner step  436  that extends circumferentially around an inner surface  438  of the wall  434  of the annular body  432 . In the exemplary embodiment, the inner step  436  corresponds to the step  38  and the horizontal surface  40  that extends around the upper wall  30  ofthe collet  22 . 
     As illustrated in  FIG.  36   , the attachment band  430  includes an adjacent pair of attachment apertures  440  configured to couple to the second coupling members  68  of the collet lock  50 , respectively. In particular, the apertures are sized and shaped to correspond to the neck portion  67 , such that the head portion  69  retains the attachment band  430  on the collet assembly  12 . In addition, the attachment band  430  includes an indicator aperture  442  opposite the attachment apertures  440 . The indicator aperture  442  is generally kidney-shaped, whereas it is sized and shaped to correspond to the neck portion  63  of the first coupling member  66 , such that the head portion  65  retains the attachment band  430  on the collet assembly  12 . The indicator aperture  442  has an inner extension portion  444 , or an indicator or an indicator portion, that extends inwardly from an edge of the indicator aperture  442 . Inparticular, the indicator  444  is a tab that extends generally upward along wall  434  from a lower edge of indicator aperture  442 . The indicator  444  is configured to extend into the window  61  of the head portion  65  and is configured to present an indication to the user of the fluid delivery apparatus  10  of a tightness of the attachment band  430 . 
     The attachment band  430  includes a first strap  446  that extends generally radially outward from the annular body  432 . In the exemplary embodiment, the first strap  446  is substantially aligned radially with the attachment apertures  440 . The attachment band  430  also includes an opposite second strap  448  that extends generally radially outward from the annular body  432  and is substantially aligned radially with the indicator aperture  442 . In the exemplary embodiment, the straps  446 ,  448  have a width that is less than a diameter of the annular body  432 . Alternatively, the straps  446 ,  448  can have any width that enables the attachment band  430  to function as described herein. Additionally, in the exemplary embodiment, the annular body  432  and the straps  446 ,  448  are fabricated as an integral component. For example and without limitation, in one suitable embodiment, the annular body  432  and the straps  446 ,  448  may be fabricated from a resilient material, such as a thin elastomer. Alternatively, the annular body  432  and the straps  446 ,  448  may be fabricated separately and assembled using any fastening method that enables the attachment band  430  to function as described herein, for example, and without limitation, the straps  446 ,  448  can be coupled to the annular body  432  using spring pins or hinges. 
     As illustrated in  FIG.  36   , the second strap  448  includes at least one retaining aperture  496 . In the exemplary embodiment, the retaining apertures  496  are fabricated from a rigid material, for example, and without limitation, a rigid plastic and/or metal. The retaining aperture  496  can be insert molded into second strap  448  or coupled thereto, for example, and without limitation, via adhesive bonding and/or mechanical coupling. In the exemplary embodiment, the first strap  446  and the second strap  448  are configured to couple to each other to secure the fluid delivery apparatus  10  to the users. For example, the second strap  448  includes two adjacent retaining apertures  496 , and the first strap  446  may be wrapped around a portion of the user (e.g., a wrist, an arm, a leg, etc.) and then fed through one of the retaining apertures  496  and folded back and extended through the second retaining aperture  496 . Alternatively, the attachment band  430  may include one retaining aperture  496 , and the first strap  446  may have a length of hook and loop material (not shown) coupled arranged thereon. The first strap  446  may then be fed through the retaining aperture  496  and folded back upon itself so as to fasten with the loop fastening element to the hook fastening element. In other embodiments, the straps  446 ,  448  can have any coupling mechanism that enables the fluid delivery apparatus  10  to function as described herein. 
       FIG.  38    is an enlarged perspective view of the attachment band  430  coupled to the collet assembly  12 , illustrating a first orientation of the indicator  444  in a pre-use configuration.  FIG.  39    is an enlarged perspective view of the attachment band  430  coupled to the collet assembly  12 , illustrating a second orientation of the indicator  444  in a use configuration. The fluid distribution assembly  14  is not shown in  FIGS.  38  and  39   . In the exemplary embodiment, the straps  446 ,  448  are uncoupled or loose in the pre-use configuration of the fluid delivery apparatus  10 . The indicator  444  is visible through the window  61  formed in the head portion  65  of the first coupling member  66 , however, because the second strap  448  is free of tension, the edge of the indicator  444  is located at the top of the window  61 . The indicator  444  thus provides a visual indication of the lack of tension in the attachment band  430  to the user via the window  61 . During use, the straps  446 ,  448  are coupled together and tension is applied. Thus, as illustrated in  FIG.  39   , the edge of the indicator  444  moves downwardly in the window  61  due to the tension in the resilient material of the second strap  448 . The indicator  444  thus provides a visual indication of an amount of tension in the attachment band  430  to the user via the window  61 . It is contemplated that the head portion  65  of the first coupling member  66  may contain a visual reference to indicate to the user an appropriate amount of tension in the attachment band  430 . For example, and without limitation, the head portion  65  can include amark than aligns with the edge of the indicator  444  when the appropriate amount of tension is achieved in the attachment band  430 . 
     As illustrated in  FIGS.  37 - 39   , the attachment band  430  is coupled to the collet assembly  12  via the apertures  440 ,442. The fluid delivery apparatus  10  is positioned in the inner space  435 . The attachment apertures  440  are expanded to receive a respective coupling member  68 . The resilient material of the attachment band  430  enables each aperture  440  to expand such that the head portion  69  of the coupling member  68  can be displaced therethrough. After displacing the head portion  69  through the aperture  440 , the aperture  440  returns to its original shape and size due to the resiliency of the material used to fabricate the attachment band  430 . As such, the attachment apertures  440  encircle the neck portion  67  of the coupling members  68  such that the head portions  69  cannot be easily displaced back through the attachment apertures  440 . Similarly, the indicator aperture  442  is expanded to receive the first coupling member  66 . The indicator aperture  442  is expanded to enable the head portion  65  to be displaced through the indicator aperture  442 . The indicator aperture  442  returns to its original size and shape to encircle the neck portion  63  such that the head portion  65  cannot be easily displaced back through the indicator aperture  442 . 
     To further secure the fluid delivery apparatus  10  to the attachment band  430  and to enable the attachment band  430  to apply a generally axial force to the fluid delivery apparatus  10 , the inner step  436  of the attachment band  430  to positioned against the step  38  of the collet assembly  12 . In addition, the inner surface  438  of the attachment band  430  in positioned against the upper wall  30  of the collet assembly  12 . The band is secured in place via the apertures  440 ,442, and the coupling members  66 ,  68 . When the attachment band  430  is tightened around the user’s body, such as an arm or wrist of the user, the band provides a substantially axial force to the fluid delivery apparatus  10 , generally along the central axis “A.” The axial force against the user’s body facilitates deforming the user’s skin, for example, by pushing or crowning a portion of the user’s skin encircled by the collet assembly  12 . The indicator  444 , which is visible through the window  61  ofthe first coupling member  66 , presents a visual indication to the user that indicates a proper amount of force is applied to the fluid delivery apparatus  10 . The skin deformation and the crowning of the portion of the user’s skin encircled by the collet assembly  12  facilitate proper penetration of the microneedle array assembly  108  into the user’s skin. 
     An applicator  500  (or broadly an application device) is provided to facilitate the transition of the fluid delivery apparatus  10  from the pre-use configuration shown in  FIG.  1 A  to the pre-activated configuration shown in  FIG.  1 B .  FIG.  40    is a perspective view of one suitable embodiment ofthe applicator  500  of the fluid delivery apparatus  10 .  FIG.  41    is a front sectional view of the applicator  500 .  FIG.  42    is a side sectional view of the applicator  500 .  FIG.  43    is atop sectional view of the applicator  500 , taken about line 43-43 shown in  FIG.  40   . In the exemplary embodiment, the applicator  500  has a housing  502  with a button  504  (or release) for activating the applicator  500 . The housing  502  encloses a piston  506  (or impact component) used to activate the fluid delivery apparatus  10 . The piston is locked into a safety position by one or more safety arms  508 ,  509 . In addition, the housing encloses safety arm springs  510 , piston spring  512 , and button spring  514 . 
     In the exemplary embodiment, the elongate body  520  has a generally cylindrical shape tapering inwardly from abottom  516  to a top  518  of the body  520 . The housing  502  also includes a cap  522  coupled to the top  518  of the body  520 . The cap  522  is configured to retain the button  504 , which is configured to move axially with respect to the body  520 . It is noted that the applicator  500  is formed substantially symmetrical about anX-Y plane and aY-Z plane that includes the centerline “E,” as shown in  FIG.  40   . 
     With reference to the  FIGS.  41 - 43   , the body  520  includes a stepped bore  528  that extends through the body  520 . At the bottom end  516 , the stepped bore  528  includes a first step portion  530  thathas a periphery that is sized and shaped to receive the upper wall  30  of the collet  22  therein. As shown in  FIG.  41   , the first step portion  530  extends upwardly fromthebottom516 ofthe body  520  a predetermined distance  532 . The stepped bore  528  also includes a second step portion  534  that extends upwardly from the first step portion  530  a predetermined distance  536 . In the exemplary embodiment, the second step portion  534  has a periphery that is sized and shaped to receive the fluid distribution assembly  14  while the first step portion  530  is in contact with the upper wall  30  ofthe collet  22 . In addition, the stepped bore  528  includes a third step portion  538  that extends upwardly from the second step portion  534  and continues through the body  520 . Positioned inside the body  520 , and in particular, the third step portion  538  is a retaining ring  525 . The retaining ring  525  is configured facilitate retaining the piston  506  and the safety arms  508 ,  509   axially within the housing  502 . In addition, the third step portion  538  includes a plurality of axially-extending grooves  540  that extend upwardly from the second step portion  534  a predetermined distance  542 . The grooves  540  have a curved cross-sectional shape that is generally centered on a radially extending line from the centerline “E.” That is, the grooves  540  extend axially through the second step portion  534  and are arranged radially about the centerline “E.” Alternatively, the cross-sectional shape of the grooves  540  can be any shape that enables the applicator  500  to function as described herein. In the exemplary embodiment, the third step portion  538  has a periphery that is sized and shaped to receive the piston  506  therein. 
     In the exemplary embodiment, the third step portion  538  ofthe stepped bore  528  includes a piston retention member  546  that is positioned a predetermined distance  544  upwardly from the grooves  540 . The piston retention member  546  is formed from a body that extends radially inwardly from an outer wall  548  of the body  520  and is configured to facilitate locking the piston  506  in place until the safety arms  508 ,  509  are actuated, thereby unlocking the piston  506 . In addition, the piston retention member  546  functions as a spring seat for the piston spring  512  that is positioned between the piston  506  and the piston retention member  546 , and the button spring  514  that is positioned between the button  504  and the piston retention member  546 . 
     The body  520  also includes an opposing pair of longitudinal channels  550  that extend axially through the body  520 . The channels  550  extend through the second and third step portions  534 ,  538 , respectively, of the stepped bore  528 . As best illustrated in  FIG.  41   , the channels  550  are formed in the wall  548  ofthe body  520  and taper outward at the bottom  516  from the third step portion  538  to the second step portion  534 . As such, the safety arms  508 ,  509  can be inserted into the channels  550  such that they do not interfere with the fluid delivery apparatus  10  during activation and/oruseoftheapplicator  500 . Thus, the channels  550  are sized and shaped to receive a respective safety arm  508 ,  509  slidingly therein, i.e., the safety arms  508 ,  509  are free to slide axially within the body  520  during use of the applicator  500 . As best illustrated in  FIG.  43   , the grooves  540  and the channels  550  are generally circumferentially spaced equidistant about the centerline “E.” 
       FIG.  44    is a perspective view of the safety arm  508 . In the exemplary embodiment, the applicator includes two safety arms  508 ,  509 . Alternatively, the applicator may include any number of safety arms that enable the applicator  500  to function as described herein. It is noted that in the exemplary embodiment, the safety arm  509  is formed substantially similar to safety arm  508 , but as a symmetrical opposite. Thus, only the detailed description of safety arm  508  is provided herein. In the exemplary embodiment, the safety arm  508  includes an elongate body portion  552  that includes an upper end  554  and a lower end  556 . The body portion  552  has a cross-sectional shape that is generally rectangular. Alternatively, the body potion can have any cross-sectional shape that enables the safety arm508 to function as described herein. In the exemplary embodiment, at the upper end  554 , the safety arm  508  includes a spring engagement member  562  that extend axially along the elongate body portion  552 . The spring engagement member  562  is configured to engage the safety arm spring  510 , which biases the safety arm  508  into the safety position within the applicator  500 . 
     Furthermore, the safety arm  508  includes a piston locking arm  558  that extends generally perpendicular to the elongate body portion  552 . The piston locking arm  558  includes a protrusion  560  extending therefrom. As illustrated in  FIG.  41   , the locking arm  558  extends radially inward past a portion of the piston retention member  546  to a positioned adjacent the piston  506 . The protrusion  560  extends forward from the locking arm  558  and is configured to facilitate preventing the piston  506  from releasing from the piston retention member  546 , as is described further herein. 
     At the lower end  556 , the safety arm  508  includes a retention member  564  that extends outwardly from an inner surface  566  of the elongate body portion  552 . As illustrated in  FIG.  41   , the retention member  564  extends radially inwardly with respect the applicator  500  and is configured to contact the retaining ring  525  when the safety arm  508  is biased axially in the safety position. Thus, the retention member  564  facilitates retaining the safety arm  508  within the applicator  500 . The lower end  556  of the elongate body portion  552  tapers generally outwardly opposite the retention member  564 , forming a notch  567 . As illustrated in  FIG.  41   , the notch  567  is configured to correspond to the second step portion  534  of the stepped bore  528 . As such, the safety arm  508  may be positioned in the channel  550  of the housing  502  and retained for axial movement therein. 
       FIG.  45    is a front perspective view of the piston  506  of the applicator  500  shown in  FIG.  40   . In the exemplary embodiment, the piston  506  includes apiston head  568  coupled to a piston hanger  570  via mechanical hardware (not shown). The piston head  568  is a generally cylindrical solid body that includes threaded holes (not shown) that correspond to mounting holes  578  formed in the piston hanger  570 . The mounting holes  578  and the threaded holes in the piston head  568  facilitate releasably coupling the piston head  568  to the piston hanger  570 . In the exemplary embodiment, the piston head  568  is fabricated as a generally solid component having a predetermined mass that enables the piston  506  to achieve a desirable velocity and impulse rate during use of the applicator  500  to properly activate the fluid delivery apparatus  10  for use. 
     The piston hanger  570  includes a generally annular bottom wall  572  that includes a plurality of axially extending protrusions  574 . Each of the protrusions  574  generally correspond to a respective groove  540  formed in the body  520  of the housing  502 . The protrusions  574  have a generally curved shape that is generally aligned with a radially extending line from the centerline “E.” That is, the protrusions  574  extend axially along the bottom wall  572  and are arranged radially about the centerline “E.” Alternatively, the shape ofthe protrusions  574  can be any shape that enables the piston hanger  570  to slidably engage the housing  502  as described herein. 
     The piston hanger  570  also includes a pair oftapered arms  576  arranged substantially symmetrically about the centerline “E.” The tapered arms  576  extend upwardly from the bottom wall  572 . As illustrated in the FIGS., the mounting holes  578  are positioned between the tapered arms  576  and extend axially through the bottom wall  572 . As illustrated in the  FIGS.  45 - 47   , the piston hanger  570  includes a bridge portion  580  that extends between upper ends  582  of the tapered arms  576 . As such, a closed longitudinal gap  584  is defined between the tapered arms  576 , the bottom wall  572 , and the bridge portion  580 . The gap is sized to receive the piston retention member  546  of the housing  502  slidingly therein. The bridge portion  580  includes an upper inclined face  586  that is configured to engage the button  504  of the applicator  500  to facilitate release of the piston  506  from the piston retention member  546 , as is further described herein. 
     With reference the  FIGS.  40 - 42   , the button  504  includes a body portion  590  that has a release member  592  extending generally axially downwardly therefrom. The release member  592  includes an inclined face  594  that is configured to slidingly engage the upper inclined face  586  of the piston hanger  570 . The button also includes a cavity  596  that is configured to receive at least a portion of the bridge portion  580  therein when the button  504  is actuated. A pair of opposite retention members  598  extends generally radially outwardly from the bottom of the body portion  590 . As illustrated in  FIG.  42   , each retention member  598  is positioned in a channel defined in the housing  502 . In particular, the body  520  includes a pair of channels  600  that correspond to apair of channels  602  formed in the cap  522  to define a channel that retains the button  504  and facilitates axial displacement of the button  502 . 
     In the exemplary embodiment, the safety arms  508 ,  509  are inserted into the housing  502  and positioned in the channels  550  such that the lower end  556  is positioned at the second step portion  534  ofthe stepped bore  528 . In addition, the piston spring  512  is inserted into the stepped bore  528  and positioned against the bottom of the piston retention member  546 . The piston  506  is positioned in the third step portion  538  of the stepped bore  528 . In particular, the protrusions  574  of the piston  502  are each aligned with a respective groove  540  ofthe housing  502 . Further, the pistonhanger  570  is inserted axially through the piston spring  512  and oriented to engage the piston retention member  546 . The retaining ring  525  is coupled to the housing  502  to axially retain the piston  502  and the safety arms  508 ,  509  within the housing  502 . The safety arm springs  510  and the button spring  514  are inserted into the stepped bore  528  from the top  518  of the body  520 . The button spring  514  rests against the top of the piston retention member  546  and the safety arm springs  510  rest against the top of the safety arms  508 ,  509 . The button  504  is positioned against the top  518  of the body  520  with the retention members  598  aligned with the channels  600  defined in the body  520 . The cap  522  is coupled to the top  518  of the housing  502  with one or more fasteners (not shown) to retain the button  504  and the safety arm springs  510 . 
     In operation, the piston  506  is displaced axially upwardly in the stepped bore  528 . Clearance between the protrusions  574  of the piston  502  and the grooves  540  of the housing  502  enable the bridgeportion  580  of the piston  506  to be displaced an amount off axis to slide axially past the piston retention member  546 . The piston spring  512  functions to bias the piston  506  downwardly with respect to the piston retention member  546 . This also facilitates generally aligning the axis of the piston  506  with the axis of the housing  502  to enable the bridge portion  580  to engage the piston retention member  546 . As such, the piston retention member  546  extends into the gap  584  of the piston  506  to secure the piston  506  in place on the piston retention member  546 . 
     The safety arm springs  510  bias the safety arms  508 ,  509  axially downwardly such that the lower ends  556  of the safety arms  508 ,  509  extend downwardly from the second step portion  534  into the first step portion  530  of the stepped bore  528 . This enables the piston locking arms  558 , and in particular, the protrusions  560  extending therefrom, to be positioned adjacent the upper ends  582  of the tapered arms  576 . In such an orientation, the piston  506  is prevented from being displaced from the piston retention member  546  by the piston locking arms  558 . 
     To use the applicator  500  with the fluid delivery apparatus  10 , as is described herein, the user attaches the attachment band  430  and the fluid delivery apparatus  10  to the user’s body. In particular, the attachment band  430  is stretched and tightened around the user’s body, such as an arm or wrist of the user. The band provides a generally axial force to the fluid delivery apparatus  10 , generally along the central axis “A.” The force of the fluid delivery apparatus  10  against theuser’s body facilitates causes the portion of the user’s skin beneath the fluid delivery apparatus  10  to form a crown within the collet assembly  12 . The collet assembly  12  also facilitates maintaining an appropriate amount of deformation (strain) of the user’s skin during use of the fluid delivery apparatus  10 . The indicator  444 , which is visible through the window  61  of the first coupling member  66 , presents a visual indication to the user that indicates when the attachment band  430  is stretched enough to impart the proper amount of force to the fluid delivery apparatus  10 . The skin deformation and the crowning of the portion of the user’s skin encircled by the collet assembly  12  facilitate proper penetration of the microneedle array assembly  108  into the user’s skin. 
     The applicator  500  is positioned onto the fluid delivery apparatus  10  as shown in  FIG.  48   . The upper wall  30  of the collet assembly  12  is disposed into the first step portion  530  of the stepped bore  528 . The upper wall  30  contacts the lower ends  556  of the safety arms  508 ,  509 . As the user applies downward pressure to the applicator  500 , the safety arms  508 ,  509  are displaced axially upwardly in the channels  550  such that the piston locking arms  558  are displaced away from the upper ends  582  of the tapered arms  576 . The user presses the button  504  to release the piston  506 . In particular, as the button  504  is pressed, the inclined face  594  of the button release member  592  slidingly engages the upper inclined face  586  of the piston hanger  570 . As the button is pressed further down, the upper inclined face  586  of the piston hanger  570  is displaced transversely to the central axis “E” of the applicator  500 . When the bridge portion  580  disengages from the piston retention member  546 , the piston spring  512  forces the piston  506  axially downwardly within the housing  502 . The piston  506  contacts the threaded adjustment member  370  of the mechanical controller assembly  20  to displace the fluid delivery apparatus  10  from the pre-use configuration shown in  FIG.  1 A  to the pre-activated configuration shown in  FIG.  1 B . 
     As described herein, the piston has a predetermined mass that enables the piston  506  to achieve a desirable velocity and impulse rate during use ofthe applicator  500  to properly activate the fluid delivery apparatus  10  for use. In the exemplary embodiment, the mass of the piston  506  and the spring force of the piston spring  512  combine to provide amomentum or impulse ofthe piston  506  greater than about 0.05 newton seconds (Ns), and a kinetic energy of the piston  506  greater than about 0.1 kilogram meters 2 /second 2  (kg · m 2 /s 2 ) or joules (J) at impact with the threaded member  370  of the mechanical controller assembly. The piston contacts the mechanical controller assembly  20  with a predetermined velocity and impulse rate to overcome the mechanical properties of the fluid delivery apparatus  10  such that the plurality of microneedles  234  of the microneedle array assembly  108  are accelerated toward and properly inserted into the user’s skin. In one suitable embodiment, the microneedle array assembly  108  is configured to impact the user’s skin at a velocity of at least about 4 meters/second (m/s). Alternatively, the microneedle array assembly  108  is configured to impact the user’s skin at any velocity that enables the microneedle array assembly  108  to be properly inserted into the user’s skin. 
     After the fluid delivery apparatus  10  is properly attached to the user and configured in the pre-activated configuration shown in  FIG.  1 B , the user can activate the fluid delivery apparatus  10  by pressing the pivoting latches  368  to release the plunger component  362 . In one embodiment, the user may use atool (not shown) configured to simultaneously press the pivoting latches  368 . When the pivoting latches  368  are pressed, the pivot about the cylindrical pins  452  such that the concave cutouts  458  of the latch portions  456  pivot into axial alignment with the central axis “A.” This enables the plunger component  362  to disengage from the pivoting latches  368  and contact the upper sealing member  280  of the cartridge assembly  18 . 
     In the exemplary embodiment, the biasing assembly  364  functions to apply an axial two stage force profile to the plunger component  362  during use of the fluid delivery apparatus  10 . In particular, when the plunger component  362  is released, the second biasing member  378  and the first biasing member  372  apply force to the plunger component  362 , i.e., a first force profile. As illustrated in  FIG.  1 B , the axial location of the upper ends of the second biasing member  378  and the first biasing member  372  are axially displaced with respect to each other. Further, as described herein, the second biasing member  378  and the first biasing member  372  have different lengths and force constants, thus the axial force applied to the plunger component  362  changes with respect to the displacement of the plunger component  362 . 
     Initially, as the plunger component  362  is displaced axially by the biasing assembly  364 , the second biasing member  378  and the first biasing member  372  are applying force to the plunger component  362 . As the plunger component  362  is displaced, the second biasing member  378  and the first biasing member  372  extend such that the force exerted on the plunger component  362  decreases. At a predetermined axial displacement of the plunger component  362 , the second biasing member  378  becomes fully extended or is prevented from being extended further by the threaded fastener  374  and the nut  382 . At this position, the first biasing member  372  continues to apply a force to the plunger component  362 , i.e., a second force profile. 
     In particular, as illustrated in  FIG.  1 B , the second biasing member  378  and the first biasing member  372  are configured to extend axially downwardly when the plunger component  362  is released. The first biasing member  372  and the second biasing member  378  press against the insert component  380 , which is positioned against the threaded adjustment member  370 . As the second biasing member  378  extends downward, the threaded fastener  374 , the tube  376 , and the nut  382  move axially within the insert component  380 . When the nut  382  contacts a top of the insert component  380 , the second biasing member  378  is prevented from expanding, and therefore, from exerting any force on the plunger component  362 . The first biasing member  372 , however, continues to exert force until the plunger component  362  is displaced fully against the reservoir component  270  of the cartridge assembly  18 . 
     The pressure applied to the plunger component  362  by the biasing assembly  364  is transmitted to the cartridge assembly  18 . The pressure facilitates displacing the fluid contained in the upper cavity  272  through the cannula  104  and into the fluid passage  276 . The fluid exits the fluid passage  276  by flowing into the plenum cap assembly  106 . In particular, with reference to  FIG.  14   , the fluid flows downwardly through the aperture  204  of the first adhesive layer  192 , the aperture  208  of the vent membrane  194 , and into the arcuate slot  210  of the second adhesive layer  196 . The impermeable membrane  198  is coupled to the bottom of the second adhesive layer  196 , thereby preventing the fluid from passing directly therethrough. As such, the pressure applied by the biasing assembly  364  forces the fluid to fill the arcuate slot  210 , where it is channeled to the aperture  222  in the impermeable membrane  198 . The fluid passes through the aperture  222  where it enters the slot  224  formed in the third adhesive layer  200 . The fluid is channeled by the slot  224  to the inlet channel  254  of the microneedle array assembly  108 . 
     During use of the fluid delivery apparatus  10 , gas and/or air may be mixed or become mixed with the fluid. As such, the plenum cap assembly  106  is configured to facilitate removing such gas and/or air from the fluid. As the fluid is force through the arcuate slot  210 , the pressure facilitates removing the gas from the fluid. In particular, the fluid fills the arcuate slot  210  such that it contacts the vent membrane  194  positioned above the second adhesive layer  196 . The gas and/or air dispersed through the fluid is forced upward toward the vent membrane  194 , where it passes therethrough. As described herein, the vent membrane  194  is fabricated from a gas permeable oleophobic/hydrophobic material, such that the gas and/or air passes through, but the fluid cannot. The gas and/or air then passes through the slot  202  of the first adhesive layer  192 . The arcuate slot  202  is configured to at least partially correspond to the arcuate channel  176  of the plenum component  102 , such that the gas and/or air may be vented out of the fluid flow and into the internal chamber  167  of the plenum component  102 . As described herein, the plenum component  102  is configured to attach to the cartridge assembly  18 , thereby facilitating creating a sterile internal chamber  167  for receiving the vented gas. 
     The fluid is channeled to the inlet channel  254  of the microneedle array assembly  108 , substantially free of gas and/or air bubbles. The fluid enters the distribution manifold  238 , and then the fluid flows through the supply channels  256 , the resistance channels (not shown), and the outlet channels  258  to the passageways  246  of the microneedles  234  and into the user’s skin. In the exemplary embodiment, the biasing assembly  364  functions in connection with the plunger component  362  to provide substantially complete emptying of the fluid from the cartridge assembly  18  through the cannula  104  and into the fluid passage  276 . The plunger component  362  and the biasing assembly  364  may provide an initial force in a range of about 32 kilopascals (kPa) (4.6 pounds per square inch (psi)) to about 150 kPa (21.8 psi). 
     In the exemplary, embodiment, the mathematical representation of the force provided to the plunger component  362  by the biasing assembly  364  is the sum of the force from the first biasing member  372  and the second biasing member 378: 
     
       
         
           
             F 
             
               x 
             
             = 
             F 
             M 
             
               x 
             
             + 
             F 
             T 
             
               x 
             
           
         
       
     
      Where FM(x) equals the force from the first biasing member  372  in newtons as a function of position in millimeters, and where FT(x) equals the force from second biasing member  378  in newtons as a function of position in millimeters. 
     The force from the first biasing member  372  can be represented by two expressions, depending on where the plunger component362 is located with respect to the length of the first biasing member 372: 
     
       
         
           
             F 
             M 
             
               x 
             
             = 
             
               
                 
                   
                     
                       K 
                       m 
                     
                     
                       
                         
                           L 
                           m 
                         
                         − 
                         
                           
                             
                               B 
                               m 
                             
                             − 
                             x 
                           
                         
                       
                     
                   
                 
               
               
                 
                   0 
                 
               
             
               
               
               
               
             
               
                 
                   
                     x 
                     &lt; 
                     
                       L 
                       M 
                     
                     − 
                     
                       B 
                       M 
                     
                   
                 
               
               
                 
                   
                     x 
                     ≥ 
                     
                       L 
                       M 
                     
                     − 
                     
                       B 
                       M 
                     
                   
                 
               
             
           
         
       
     
      Where Km equals the force constant of the first biasing member  372 , L M  equals the length of the first biasing member  372 , B M  equals the base length of the first biasing member  372 , and x equals the displacement of the plunger component  362  with respect to the length of the first biasing member  372 . 
     Similarly the force from second biasing member  378  is: 
     
       
         
           
             F 
             T 
             
               x 
             
             = 
               
               
             
               
                 
                   
                     
                       K 
                       T 
                     
                     
                       
                         
                           L 
                           T 
                         
                         − 
                         
                           
                             
                               B 
                               T 
                             
                             − 
                             x 
                           
                         
                       
                     
                   
                 
               
               
                 
                   0 
                 
               
             
               
               
               
               
               
             
               
                 
                   
                     x 
                     &lt; 
                     
                       L 
                       T 
                     
                     − 
                     
                       B 
                       T 
                     
                   
                 
               
               
                 
                   
                     x 
                     ≥ 
                     
                       L 
                       T 
                     
                     − 
                     
                       B 
                       T 
                     
                   
                 
               
             
           
         
       
     
      Where K T  equals the force constant of the second biasing member  378 , L T  equals the length of the second biasing member  378 , B T  equals the base length of the second biasing member  378 , and x equals the displacement of the plunger component  362  with respect to the length of the second biasing member  378 . 
     In the exemplary embodiment, the first biasing member  372  length extends beyond the maximum travel of the plunger component  362  such that the condition described in Equation 2 cannot be met. As such, the first biasing member  372  always applies a force to plunger component  362 . In addition, a length of the second biasing member  378  is predetermined such that the second biasing member  378  discontinues providing force to the plunger component  362  before the plunger component  362  has reached its maximum travel. In the exemplary embodiment, the conditions described in Equation 3 are valid for at least some portion of the travel of the plunger component  362 . 
     The apparatus, system, and methods described in detail herein enable a fluid delivery apparatus to remove gas and/or air from a medicine and to distribute a substantially equal quantity of the medicine through each microneedle of the microneedle assembly. A plenum cap assembly of the fluid delivery apparatus includes a fluid supply channel disposed between an impermeable material and a gas permeable oleophobic/hydrophobic material. This facilitates removing the gas and/or air from the medicine while delivering substantially all of the medicine to the user of the fluid delivery apparatus  10 . In addition, a biasing assembly enables a pressure profile to be determined to facilitate optimizing the flow rate and distribution of the medicine through a microneedle array assembly over an extended period of time, thereby facilitating a steady state concentration of the fluid that is delivered to the user. Moreover, the fluid delivery apparatus includes a band or strap that enables the fluid delivery apparatus to be appropriately attached to the user’s skin to facilitate optimal insertion of the microneedles into the user’s skin. 
     Exemplary embodiments of an apparatus, system, and methods for a fluid delivery apparatus are described above in detail. The apparatus, system, and methods described herein are not limited to the specific embodiments described, but rather, components of apparatus, systems, and/or steps of the methods may be utilized independently and separately from other components and/or steps described herein. For example, the methods may also be used in combination with other fluid delivery apparatus, systems, and methods, and are not limited to practice with only the apparatuses, systems, and methods described herein. Rather, the exemplary embodiments can be implemented and utilized in connection with many fluid delivery applications. 
     Although specific features of various embodiments ofthe disclosure may be shown in some drawings and not in others, this is for convenience only. In accordance with the principles of the disclosure, any feature of a drawing may be referenced and/or claimed in combination with any feature of any other drawing. This written description uses examples to disclose the embodiments, including the best mode, and also to enable any person skilled in the art to practice the embodiments, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the disclosure is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims. 
     As various changes could be made in the above embodiments without departing from the scope of the disclosure, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.