Patent Publication Number: US-2019167910-A1

Title: Portable drug mixing and delivery system and method

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. patent application Ser. No. 14/255,909 filed on Mar. 17, 2014, which claims priority to U.S. Provisional Patent application 61/917,943 filed on Dec. 19, 2013 and U.S. patent application Ser. No. 14/218,355 filed on Mar. 18, 2014, now patented as U.S. Pat. No. 9,199,037 issued on Dec. 1, 2015 which claims the benefit of U.S. Provisional Application 61/800,014 filed on Mar. 15, 2013, which are incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to auto-injectors and prefilled syringes and more particularly to auto-injectors that store in a compact state and allow for formation or reconstitution of the drug. 
     BACKGROUND OF THE INVENTION 
     Individuals who suffer from certain medical conditions are often required to keep an auto-injector or prefilled syringe nearby in order to address a medical need. A few examples of this are insulin pens for people with diabetes, EPIPENS for those with food and insect stings allergies, and antidotes for soldiers at risk of exposure to chemical and/or biological toxins in the field. For example, an allergic reaction may occur in a location physically distant from the nearest hospital or medical facility. For example, bee stings, are more likely to occur outside than indoors. Food containing peanuts are more likely to be supplied to the individual away from a controlled home environment like at a baseball park. Having a portable epinephrine auto-injector nearby enables emergency intervention after an exposure to an allergen. 
     Size is an issue when it comes to auto-injectors. Many owners of the devices do not carry it with them and a compact device may make it more likely that they will. Common epinephrine auto injector case sizes are about 6 inches by 1½ inches by 1 inch, making them difficult to carry without a secondary carrying device like a purse and/or backpack and/or other container. 
     SUMMARY OF THE INVENTION 
     It has been recognized that if a drug can be kept out of the liquid phase and stored as a dry medication, the shelf-life, temperature susceptibility may increase allowing the efficacy and potency of the drug to endure longer and through harsher environments. 
     It has been recognized that a smaller drug delivery device than a conventional epinephrine auto-injector, which could be attached to a key chain and/or easily fit in a person&#39;s pocket, would make the device easier to carry and more likely that the user will have it on their person when needed. An example of such a device package, purely for the purpose of comparison, could be sized similarly to that of a USB “thumb drive” which is designed to be with users on a fairly constant basis. For example, an auto-injector device embodiment has dimensions of 3 inches by 1 inch by ½ inch. However, dimensions of an auto-injector device may vary. 
     A portable auto-injector is capable of moving from a compact state where the auto-injector is in a shape easier to transport than in an activation state wherein the auto-injector has been extended and/or made larger and/or longer and/or easier to handle in some way. In some embodiments a safety limits movement of the needle assembly and prevents premature needle sticks. The drug is stored in one or more dry and/or wet medicament states until needed. 
     In an embodiment of a drug mixing system, the system has a movable body in fluid communication with a first and second chamber. The first chamber is configured to store a wet component. The system has a first actuation device or assembly which can be configured to cause the movable body to enter a portion of the first chamber during a first actuation process and a second chamber during a second actuation process. The movable body as it enters the first chamber forces a wet component through a fluidic channel and into the second chamber. Fluidic communication may be enabled with the first chamber and the fluidic channel through a one-way valve, burst membrane, orifice or other mechanism and opening. 
     For example, the force of the movable body entering into a portion of the first chamber is sufficient to cause fluid communication (such as opening a one-way valve) and allow the wet component stored in the first chamber to flow into the fluidic channel where a dry medicament is stored and cause the dry medicament to combine with the wet component and flows into the second chamber. In a second motion, the movable body moves into the second chamber and forces the combined wet component and dry medicament (now a wet medicament) into a delivery assembly, such as through a needle or jet (needle-less system) and into a subject. One-way fluid communication (as a result of another one-way valve) between the fluidic channel and the second chamber may prevent the wet medicament from flowing back through the fluidic channel when the movable body moves into the second chamber. 
     In an embodiment of the system, the needle assembly and the second chamber are movable as one unit relative to the housing. In an embodiment, a second actuation device causes a portion of the needle assembly to be expelled outwardly from the housing and into a subject wherein the wet medicament may be delivered through the needle assembly into the tissue, vessel, and/or muscle of the subject. 
     In an embodiment of the drug mixing system, the movable body has a mixing volume for retaining a dry medicament component. In an embodiment, the movable body has a valve for allowing fluid in one direction from the first chamber into the mixing volume. In an embodiment, the movable body has a valve for allowing fluid in one direction from the mixing volume into the second chamber. 
     In an embodiment, the movable body has burst valves that allow fluid communication between the mixing volume and the first chamber and the second chamber when required. 
     In an embodiment of the drug mixing system, the volume of the movable body includes a fluidic channel. In an embodiment the fluidic channel is designed to promote mixing. In an embodiment, the fluidic channel is a micro-fluidic channel. 
     In an embodiment, the fluidic channel is a tortious path for carrying and/or storing the dry medicament component. In one embodiment, the fluidic channel defines the volume for mixing the wet component with the dry medicament. In an embodiment, the tortious path creates chaotic flow for mixing the wet component with the dry medicament. In an embodiment, the series of structures, walls, or grooves in the walls of the mixer body and or channel help promote mixing of the dry medicament and defining the volume for mixing the wet component with the dry medicament. 
     In an embodiment, at least one of the dimensions in the channel is less than 2 millimeters. In an embodiment, the Reynolds number in the fluidic channel is less than 2300 causing laminar flow. In an embodiment, the Reynolds number of the laminar flow in the fluidic channel is less than 100. In an embodiment, the Reynolds number in the fluidic channel is less than 10 and, in some cases, may cause turbulent or chaotic flow. In an embodiment the Reynolds number in the fluidic channel is greater than 2300. In an embodiment, the mixing assembly further includes a plurality of grooves formed therein, wherein the grooves promote mixing when a wet component flows by and/or near the grooves. In an embodiment the mixing assembly further includes bends in the channel wherein the bends promote mixing when a wet component flows by the bends. In an embodiment, the mixing assembly includes obstructions in the flow path wherein said obstructions promote mixing when the wet component flows by the obstructions. 
     In an embodiment, the movable body has a mixing volume for retaining a dry medicament component prior to mixing with a wet component to form a wet medicament. In an embodiment, the movable body is sized to define a hollow volume sized to the dry medicament component received. 
     In an embodiment, the second chamber carries a second wet component. The first chamber carries the first wet component to mix with the dry medicament in the fluidic channel disposed in the movable body prior to mixing with the second wet component in the second chamber. 
     In an embodiment, the second actuation device is a pre-loaded force. In an embodiment, the pre-loaded force is a compression spring. In an embodiment, the second actuation device is activated by the user. In an embodiment, the second actuation device is a torsion spring. In an embodiment, the second actuation device is a torsion spring. In another embodiment an elastic device is used as an actuation device. In another embodiment CO2 cartridges are used. In another embodiment an electronically controlled valves, and chemical driven actuators, compressed gas cylinders, solenoids, electromagnetics, linear motors. 
     In an embodiment of a drug delivery system, the system has a housing having an extension component that is movable relative to the housing and causing the effective length of the housing to have a larger dimension. The extension component may be a telescoping component, an unfolding component or reattachable component. In one embodiment, the extension component, when activated and/or lengthened, can cause or allow the first actuation device to cause the movable body to move into the first chamber. 
     In an embodiment, the telescoping component moves laterally relative to the first housing to form the housing having a larger dimension. In an embodiment, the unfolding component rotates about a pivot relative to the housing to form the housing having a larger dimension. In an embodiment, the telescoping component rotates about a longitudinal axis extending through the needle assembly relative to a first and second end of the housing causing the housing to have a larger dimension. In an embodiment, reattachable portion is detached and then reattached to the housing at a different position, thus causing the housing to have a large dimension. 
     In an embodiment, the system includes a needle assembly in fluid communication with the second chamber and a safety. The needle assembly and the second chamber are movable as one unit relative to the housing. The system has a second actuation device that causes the needle assembly to be exposed or protrude from the housing and capable of injecting a wet medicament formed in the fluidic channel. The safety is movable from a first safety position to a second position prior to the activation of the actuation device. 
     In an embodiment of the drug delivery system, the system has a needle assembly. The needle assembly and the second chamber are movable as one unit relative to the housing. A second actuation device causes the needle assembly to be exposed or protrude from the housing and capable of injecting a drug formed in fluidic channel that is disposed in the movable body. The movement of the second housing relative to the first housing arms/allows the second actuation device. In an embodiment, the system has a stop for limiting the movement of the second actuation device until triggered. 
     In an embodiment, the first chamber is collapsible. In an embodiment, the movement of the movable body reduces the volume of the first chamber. 
     These aspects of the invention are not meant to be exclusive and other features, aspects, and advantages of the present invention will be readily apparent to those of ordinary skill in the art when read in conjunction with the following description, appended claims, and accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing and other objects, features, and advantages of the invention will be apparent from the following description of particular embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. 
         FIG. 1A  is a schematic of a method of using a portable auto-injector according to the invention; 
         FIG. 1B  is a schematic of an alternative embodiment and method of using a portable auto-injector according to the invention; 
         FIG. 2A  is a front sectional view of a portable auto-injector  30  in a compact/storage position  22 ; 
         FIG. 2B  is a side sectional view of the portable auto-injector  30  in the compact/storage position  22  of  FIG. 2A ; 
         FIG. 2C  is a top view of the portable auto-injector  30  in the compact/storage position; 
         FIG. 2D  is a perspective view of the portable auto-injector in the compact/storage position with portions broken away; 
         FIG. 3A  is a front sectional view of the portable auto-injector  30  in the extension position; 
         FIG. 3B  is a side sectional view of the portable auto-injector  30  in the extension position; 
         FIG. 4A  is a front sectional view of the portable auto-injector  30  with the safety extracted; 
         FIG. 4B  is a side sectional view of the portable auto-injector  30  with the safety extracted; 
         FIG. 5A  is a front sectional view of the portable auto-injector  30  in an injection position with the trigger pushed down; 
         FIG. 5B  is a side sectional view of the portable auto-injector  30  in the injection position with the trigger pushed down; 
         FIG. 6A  is a front sectional view of the portable auto-injector  30  in injecting position; 
         FIG. 6B  is a side sectional view of the portable auto-injector  30  in injecting position; 
         FIG. 7A  is a front sectional view of the portable auto-injector  30  in a drug delivery position; 
         FIG. 7B  is a side sectional view of the portable auto-injector  30  in the drug delivery position of  FIG. 7A ; 
         FIG. 8A  is an enlarged view of the drug delivery portion of the portable auto-injector; 
         FIG. 8B  is an enlarged view of the plunger membrane interface; 
         FIGS. 9A-9F  are illustrations of an alternative portable auto-injector in various positions; 
         FIG. 10A  is a front sectional view of an alternative pivotable portable auto-injector in the compact position; 
         FIG. 10B  is a front sectional view of the alternative pivotable portable auto-injector of  FIG. 10A  in the extended position; 
         FIG. 10C  is a front sectional view of another alternative pivotable portable auto-injector in the compact position; 
         FIG. 10D  is a front sectional view of the alternative pivotable portable auto-injector of  FIG. 10C  in the extended position; 
         FIG. 11A  is a front sectional view of an alternative twist portable auto-injector in the compact position; 
         FIG. 11B  is a front sectional view of the alternative twist portable auto-injector in the extended position; and 
         FIGS. 12 and 13  are sectional views of two alternative micro-channels. 
         FIGS. 14A-D  illustrate an unfolding injector device. 
         FIGS. 15  A-B illustrate a dual wet chamber injection configured to hold two wet components that combine to aide in dissolving dry medicament in a fluidic channel. 
         FIGS. 16  A-D illustrate a fluidic channel adjacent a movable body disposed between two chambers. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     A system and method for storing and mixing a dry medicament component with a wet component for delivery to a user. The auto-injector is stored in a compact state where the components of the drug are stored in two or more states that allows for more latitude in storage. 
     Ease-of-use of an auto-injector becomes critical since it can be sometimes difficult to hold and/or operate a small device. For example, toothbrushes designed for kids are often larger than adult versions in order to make it easier for small hands to grasp. When proposing a small auto-injector this must be taken into consideration since children are likely users of a device that may be needed to save their lives. One way of addressing this would be to produce a device that is small and ultraportable when not in use, but larger when in use. 
     Referring to  FIG. 1 , a schematic of a method of using a portable auto-injector  30  is shown. The portable auto-injector  30  is carried by a user in a compact state as represented by block  32 . In the compact state  32 , a dry medicament, which is going to be delivered to a user  36  (as a wet medicament) is stored separately from wet components, such as a dry medicament  38  and a wet component  40  as shown in  FIG. 8A . In addition, in the compact state  32 , the portable auto-injector  30  is in a safe position where the auto-injector  30  cannot inadvertently stab a user  36  with a needle  46  until desired, as seen in  FIGS. 6A-7B and 9F . 
     The auto-injector  30  is moved from the compact state  32  by an extension process as represented by a parallelogram  48 . The extension process  48  can take several forms as explained in further detail below, such as by pulling components relative to each other, rotating components relative to each other, or twisting components relative to each other. With the extension process  48  completed, the auto-injector  30  is of a size that it is comfortable for the user to operate, an operation size state  50 . 
     The housing has a larger dimension in the operation size 50. In one embodiment, the portable auto-injector  30  is 3 inches by 1 inch by 0.5 inches in the compact state  32  and 4½ inches by 1 inch by 0.5 inches in the operation size state  50 . 
     The mixing of the dry medicament and wet components in some embodiments may occur as part of the extension process  48  or another mixing step as represented by a parallelogram  52 . The mixing step  52  causes the wet component  40  to pass through and combine with the dry medicament  38  therein forming the wet medicament  34  which is to be delivered to a user  36 . The wet medicament ready state is represented by a block  54 . 
     In certain embodiments, the extension process  48  places the auto-injector  30  in condition for use. In the alternative and as represented in  FIG. 1A , the portable auto-injector requires a separate and distinct step of removal of a safety step/pre-activation step as represented by a parallelogram  58  to place the auto-injector  30  in the ready for activation state as represented by a block  60 . 
     Still referring to  FIG. 1A , with the auto-injector  30  in the ready for activation state  60 , the auto-injector  30  can be placed in proximity to the user  36 . The injection process step as represented by a parallelogram  62  can be triggered to deliver the drug to the user  36 . 
     It is recognized that the operator of the portable auto-injector  30  and the person receiving the drug  34  can be two distinct persons. For example, the person receiving the wet medicament  34  could be a child or someone in a state in which at they could not operate the auto-injector  30 . 
     Referring to  FIG. 1B , a schematic of an alternative embodiment and method of using a portable auto-injector  30  is shown. In contrast to the embodiment shown in  FIG. 1A , where the extension process  48 , the mixing step  52 , and the removal of the safety  58  occur at separate and distinct steps, the process of extending the components to the operation size state  50  accomplish other steps. For example, the extension process  48  also causes the mixing step  52 . The mixing step  52  causes the wet component  40  to pass through and combine with the dry medicament  38  therein forming the wet medicament  34  which is going to be delivered to a user  36 . 
     In addition, the extension process  48  also results in the removal of the safety  58  therein placing the auto-injector  30  in the ready for activation state as represented by a block  60 . 
     In  FIG. 1B , the operation size state block  50  and the drug ready state block  54  are shown adjacent to the ready for activation state  60 , the desired state. In certain embodiments, the drugs may be in a ready state in the compact state  32  (i.e., there is no mixing of a wet component  40  with a dry medicament  38  to form the wet medicament  34  after the portable auto-injector  30  is shipped to the user in that the wet medicament  34  is already mixed.) In certain embodiments, the auto-injector  30  does not have separate components associated with the safety. 
     Still referring to  FIG. 1B , with the auto-injector  30  in the ready for activation state  60 , the auto-injector  30  can be placed in proximity to the user  36 . The injection process step as represented by the parallelogram  62  can be triggered to deliver the drug to the user  36 . 
     Referring to  FIG. 2A , a front sectional view of a portable auto-injector  30  in a compact/storage position  32  is shown. The auto-injector  30  has a series of components including a housing  70  having a top shell  72  and a bottom shell  74  as best seen in  FIG. 2C  which shows the top view of the portable auto-injector  30  in the compact/storage position  32  and  FIG. 2B  which shows a side sectional view of the portable auto-injector  30  in the compact/storage position  32 . 
     Illustrated herein is a first actuation device or assembly  150 , the actuation device or assembly  150  can include an extension component, illustrated herein as an extender slide  90 , which is movable relative to the housing  70  and configured to cause the effective length of the housing to increase in an axial dimension. The extension component  90  may be a telescoping component, an unfolding component or reattachable component. In one embodiment, the extension component, when activated and/or lengthened, allows the first actuation device to cause the movable body to move into the first chamber as illustrated by the load path  152 , shown here as a dotted line extending through various components until acting on the movable body  118 . The housing  70  has a pair of side walls (not labeled) each having a plurality of grooves that engage components of an extender slide/extension component  90  for retaining the extender slide  90  in the compact state  32  as seen in  FIGS. 2A and 2C  and the operation state  50 , as seen in  FIGS. 3A and 3B . In addition, the housing  70  has a plurality of detents and stops that interact with components of an injector  100  for retaining it in the compact state and the operation state. The extender slider/extension component  90  is held into place by split fingers after an actuation latch member is pulled through the split fingers and the split fingers retain their position while the latch member is supported on the split fingers. In other words, the actuation device  150  as illustrated translates a manual input from the user into an axial translation of the movable body  118  into the first chamber  232  formed by the first vial  112 . This is achieved by transferring a force describing the manual input into the movable body through various mechanical components as described above, but could be achieved through various alternative means as will be recognized by those having skill in the art. 
     The portable auto-injector  30  has a wet/dry component combining system  110 . The wet/dry component combining system  110  has a pair of vials  112  and  114 . The first vial  112  has a first sidewall  113  which defines a chamber configured to hold the wet component  40  when the auto-injector  30  is in the compact state  32 . The second vial  114  has a second sidewall  115  which defines a chamber being fluidly connected to a needle assembly  116  that includes the injection needle  46  and stores the wet medicament  34  prior to delivery as further described below. The wet/dry component combining system  110  has a movable body  118  with a fluidic channel disposed therein and a pair of plungers  120  and  122 . The first plunger  120  interacts with the first vial or chamber  112  and the second plunger  122  interacts with the second vial or chamber  114 . In another embodiment, first plunger  120  and second plunger  122  and movable body  118  with fluidic channel are all made of one piece of material. In another embodiment, these are separate assemblies. In another embodiment  118  simply creates a fluid path from vial  112  to vial  114 . 
     The movable body  118  with a fluidic channel  140  is interposed between the two vials  112  and  114  and the two plungers  120  and  122 . The movable body  118  with a fluidic channel has a cylindrical body  126  and a pair of parallel ends  128 . The movable body  118  with a fluidic channel  140  has a pair of posts  130  and  132 . A post  130  and  132  extends from each of the parallel ends  128 . Each post  130  and  132  has an enlarged tip  134  for engaging the walls  136  of a void  138  in one of the plungers  120  and  122  as best seen in  FIG. 8B . The movable body  118  with a fluidic channel may include a single fluidic channel  140  that extends from the first post  130  to the second post  132 . The movable body  118  has an annular ring  146  with a lip  148 . The lip  148  interacts with a first end  162  of a compression spring  160 . 
     The compression spring  160  has a second end  164  that interacts with an intra-housing  170  that has a base  172  and an annular ring  174  that encircles the compression spring  160 . The base  172  of the intra-housing  170  has an annular lip  178  that engages the second end  164  of the compression spring  160 . The base  172  has a hole  180 . The intra-housing  170  has a pair of tabs  182 . Each tab  182  is interposed between a split finger  186  of the injector  100  as best seen in  FIG. 2D . 
     The intra-housing  170  is connected to the extender slide  90 . The two components move together in lateral movement from the compact state  32  to the operation size state  50 . The extender slides  90  is the component that a user can grab to move the auto-injector  30  to the operation size state  50 . 
     Still referring to  FIGS. 2A and 2B , the portable auto-injector  30  has a drug delivery movement ring  190 . The drug delivery movement ring  190  has a base  192  with a stub  194  that projects through the hole  180  in the intra-housing  170 . The stub  194  has a slot  196  that extends across the stub  194  which creates a pair of legs that can flex as explained below. The stub has a hole  198  that extends through the slot  196 . The stub  194  has a lip  200  that engages the outer surface of the base of the intra-housing  170  so the drug delivery movement ring  190  moves with the intra-housing  170 . 
     The portable auto-injector has a safety  210 . The safety  210  has a U-shape with a pair of legs  212 . Each leg  212  has a series of knurls  214  to facilitate the user moving the safety  210  from a safe position as seen in  FIGS. 2A-3B , to an activation position as seen in  FIGS. 4A-6D  and explained below. In addition, each leg  212  has a detent  216  that extends through an opening  218  in the extender slide  90  to hold the safety  210  in the safe position. The base  220  of the U-shaped safety  210  has a pin  222 . The pin  222  of the safety  210  extends into the hole  198  of the stub  194  of the drug delivery movement ring  190 . 
     Referring to  FIG. 2D , a perspective view of the portable auto-injector  30  in the compact/storage position  32  with portions broken away is shown. The safety  210  is received in a groove within the extender slide  90 . The detent  216  of the safety  210  can be seen extending through the opening  218  in the extender slide  90  to hold the safety  210  in the safe position. The series of knurls  214  project beyond the surface of the adjacent extender slide  90  to facilitate the user moving the safety  210  from the safe position as seen in  FIG. 2D  to the activation position as seen in  FIGS. 4A-4B . The pin  222  of the safety  210  is shown extending through the hole  198  of the stub  194  of the drug delivery movement ring  190 . 
     The compression spring  160  is seen extending from the first end  162  where it engages the lip  148  of the annular ring  146  of the movable body  118  to the second end  164  where it engages the annular lip  174  of the base  172  of the intra-housing  170 . One of the tabs  182  of the intra-housing  170  is shown between one of the pair of split fingers  186  of the injector  100 . In addition, a drive block  226  is shown on the split finger  186  of the injector  100 . 
     The base of the extender slide  90  can then be provided with a slot to receive a rib on the housing  70  to maintain alignment. 
     Referring to  FIG. 3A , a front sectional view of the portable auto-injector  30  in the operation size state  50  is shown. A side sectional view of the portable auto-injector  30  in the operation size state  50  is shown in  FIG. 3B . As the extender slide  90  moves in the extension process  48  to the operation size state  50 , the intra-housing  170 , the safety  210 , and the drug delivery movement ring  190  also moves. The movement of the drug delivery movement ring  190  causes the mixer/movable body  118  of the drug mixing system  110  to move upward in response to an extension force applied to the extender slide/extension component  90 , as part of the first actuation device/assembly  150  as illustrated by load path  152 . This upward movement forces the first plunger  120  to move upward in the first vial  112  therein reducing the volume in the first vial  112 ; the volume is referred to as a first chamber  232 . This decrease in volume in the first vial  112  causes the wet component  40  to be forced through a hollow volume, the micro channel or fluidic channel  140  in the movable body  118  that may contain a dry medicament. As the first plunger  120  moves into the first vial  112 , the second plunger  122  is moving out of the second vial  114  therein creating a volume, a second chamber  234 , to receive the wet medicament  34  created by the mixing of the wet component  40  with the dry medicament  38  in the fluidic channel  140 . 
     In this embodiment, the extension process  48  and the mixing step  52  occurs concurrently; this is in contrast to the two distinct steps as described with respect to  FIG. 1A . The mixing of the wet component  40  with the dry medicament  38  is described with respect to  FIGS. 8A and 8B . 
     Referring to  FIG. 4A , a front sectional view of the portable auto-injector  30  with the safety  210  extracted is shown. A side sectional view of the portable auto-injector  30  with the safety  210  extracted is shown in  FIG. 4B . As indicated above, the intra-housing  170  and the drug delivery movement ring  190  move with the extender slide  90 . The user engages the knurls  214  on the safety  210  moving the safety  210  to the ready for activation state  60 . The pair of detents  216  that were held in the openings  218  of the extender slide  90  are forced out of the openings  218  and flex inward by the movement of the safety  210  upward. 
     Depression of a bump trigger  188  forces together stub  194  into a bump groove, and allows movement of the safety  210 , which then results in the injector  100  moving downward, which is possible after the safety  210  (and a pin portion of the safety) is removed. This forcing together of the stub  194  allows it to fall back through the aperture and releases the stored energy in the compression spring, thus driving the injector out of the housing and into a user or subject. The bump groove may be shaped in a conical or similar shape having an angle(s) that put pressure on the outside of objects and push them inward as the object is forced into the groove. Usually the objects are stubs that won&#39;t pass through apertures or holes without pressing the nubs or sides of the stubs allowing them to fit through the aperture or opening. 
     While the process is referred to as the removal of the safety  58 , the safety  210  is still connected to the rest of the auto-injector. The movement of the safety  210  results in the pin  222  being extracted from the hole  196  in the stub  194 . With the pin  222  removed from the stub  194 , the stub  194  can flex inward into the space occupied by the slot  198 . The lip  200  of the stub  194  is no longer engaging the base  192  of the drug delivery movement ring  190  so the entire stub  194  can push through the hole  180  in the base of the intra-housing  170  as seen in  FIGS. 6A and 6B . However, prior to the movement of the drug delivery movement ring  190  relative to the intra-housing, the injector  100 , which has been driven downward as described above, needs to be move back up relative to the housing  70  as described below with respect to  FIGS. 5A and 5B . 
     Referring to  FIG. 5A , a front sectional view of the portable auto-injector  30  in an injection position with the trigger pushed down is shown. A side sectional view of the portable auto-injector  30  in the injection position with the trigger pushed down is shown in  FIG. 5B . 
     Referring to  FIG. 6A , a front sectional view of the portable auto-injector  30  in the injecting position is shown. A side sectional view of the portable auto-injector  30  in the injecting position is shown in  FIG. 6B . The movement of the injector  100  upward back into the housing  70  results in the intra-housing  170  moving upward relative to the drug delivery movement ring  190 . 
     In that the pin  222  of the safety  240  is no longer in the hole  198  of the stub  194 , the stub  194  can flex. The stub  194  flexes, filling the space of the slot  196  therein allowing the lip  200  to pass through the hole  180  in the base  172  of the intra-housing  170 . The lip  148  of the annular ring  146  of the movable body  118 , which is engaged by the second end  164  of the compression spring  160 , is forced downward. This force moves the movable body  118  and the drug delivery movement ring  190  downward. 
     The compression spring  160  continues to push the lip  148  of the annular ring  146  of the movable body  118  with fluidic channel  140  downward. The needle  46  is driven downward through an opening in the injector  100 . The needle  46  is driven until the second vial  114  engages the injector  100 . 
     Referring to  FIG. 7A , a front sectional view of the portable auto-injector  30  in a drug delivery position is shown. A side sectional view of the portable auto-injector  30  in the drug delivery position is shown in  FIG. 7B . The compression spring  160  continues to push the lip  148  of the annular ring  146  of the movable body  118  with fluidic channel  140  downward causing the mixer  118  and the plungers  120  and  122  to move relative to the vials  112  and  114  and in particular the second vial  114  forcing the drug  34  out of the second chamber  234  within the second vial  114  through the needle  46  into the user  36 . 
     Referring to  FIG. 8A , an enlarged view of the drug mixing system  110  of the portable auto-injector  30  is shown. As indicated above, the movement of the movable body  118  with fluidic channel and the two plungers  120  and  122  relative to the vials  112  and  114  occurs at different times in the operation. In the embodiment described with respect to  FIG. 1A , the mixer  118  and the two plungers  120  and  122  move at a time distinct from the extension process  48  of the portable auto-injector  30 . In the embodiment described with respect to  FIGS. 2A-7B , the movement of the movable body  118  and the two plungers  120  and  122  to combine the wet medicament  34  occurs with the extension process  48  into the operation size state  50 . In both cases, the movable body  118  and the two plungers  120  and  122  move again relative to the vials  112  and  114  to move the wet medicament  34  out of the second vial  114  by reducing the second chamber  234 . The wet medicament  34  is forced through the needle  46  which is driven by the compression spring  160  just prior to the movable  118  with fluidic channel  140  and the two plungers  120  and  122  move again relative to the vials  112  and  114 . 
     Still referring to  FIG. 8A , the wet/dry combining system  110  in one embodiment has first vial  112  and the second vial  114  made of glass and/or biocompatible plastic and/or metal and/or any other acceptable material and or other materials acceptable by a regulatory body (such as the FDA) or other approved bodies. The first chamber  232  of the first vial  112  is where the liquid solution, the wet component  40 , for dissolving (reconstituting, holding in solution) the dry medicament is stored. In one embodiment the solution may contain water for injection. In one embodiment the solution can be pH optimized with a buffer to enable dissolution. In one embodiment the buffer can be an acid or a base. In one embodiment the buffer can be HCl. In one embodiment, the solution can contain other additives and preservatives, like NaCl, metabisulfite, or others. The first plunger  120  is inserted into the first vial  112 ; the movement of the first plunger  120  defines the size, the volume, of the first chamber  232 . 
     The second vial  114  starts out empty in the embodiments discussed above; the second chamber  234  essentially has no volume when the auto-injector is in the compact state  32  as seen in  FIGS. 2A-2D . It is recognized that the second vial  114  may be designed and sized such that the second chamber  234  has a volume sufficient to contain a liquid such as a pH adjusting solution, which in one embodiment can be water for injection. In another embodiment the pH adjusting solution can contain a buffer. In another embodiment the neutralizing agent may be an acid. In another embodiment the neutralizing agent can be a base. In another embodiment a neutralizing agent could be sodium hydroxide. The second plunger  122  is inserted in the second vial  114 . Thus, a method of quickly dissolving a dry medicament in a buffer solution, which is later pH adjusted in a second solution in the second chamber and suitable for injecting into a person allows for a quick and compact drug mixing and delivery solution that can have a greater shelf-life and be less susceptible to environmental factors. A neutralizing agent may be used. A buffer may be comprised of an acid and a base. 
     In the embodiments shown above, the movable body  118  with fluidic channel  140  stores the dry medicament  38 . A dry medicament storage assembly (also called the microfluidic assembly) in one embodiment has no microfluidic channels but contains the dry medicament  38 . In another embodiment, it has at least fluidic and/or one microfluidic channel. In another embodiment it has more than one fluidic or microfluidic channel. In another embodiment a dry medicament  38  is stored inside at least one fluidic and/or microfluidic channel. In another embodiment a dry powder medicament is stored outside the fluidic and/or microfluidic channel while still being contained within the dry medicament storage assembly. In another embodiment a liquid is stored inside the microfluidic or fluidic channel and is forced out by another liquid. In another embodiment different liquid medicaments and/or dry medicaments are stored in a plurality of microfluidic channels inside the microfluidic assembly. In another embodiment, some of the microfluidic channels are in fluid communication with each other. In another embodiment, at least two microfluidic channels are in fluid communication with each other. In another embodiment, none of the microfluidic channels are in fluid communication each other, except for they may all empty into a shared vial or chamber. 
     Referring to  FIG. 8B , in an embodiment one or both of the plungers  120  and  122  contain an orifice and/or burst membrane  244  or sealed structure and/or valve that may break and/or move and/or open and/or create fluid communication between the first vial  112  and the movable body  118 , the microfluidic assembly, and/or fluid communication between the second vial  114  and the microfluidic assembly upon the action of extending the device. The placement of the orifice and/or burst membrane  244  is dependent on the embodiment and the particular medicament and drug. 
     In the portable auto-injector  30 , the needle assembly  116  extends from the second vial  114 . In the embodiment shown, the injector  100  prevents the needle  46  from premature needle sticks. However, the end of the injector  100  can be covered to maintain the sterility of the needle  46 . It is recognized that in certain embodiments, the needle assembly  116  contains a needleless drug delivery mechanism. In one embodiment the needle is covered with a rubber protective barrier which may be used to prevent contamination from entering the needle when the injector is stowed and not in use. 
     Referring to  FIGS. 9A-9F , illustrations of an alternative portable auto-injector in various positions is shown. In this embodiment the auto-injector  30 , the first vial  112  is narrower and longer than the second vial  114  therein making the portable auto-injector slightly longer in the stowed compact state and also adding hydraulic assistance to fluid flow from the first vial  112  into the second vial  114  which makes the action of extending the injector easier to accomplish. Hydraulic assistance is created by narrowing the vial and making it longer, thus giving extra throw in order to exchange fluid volumes between vials. 
     The portable auto-injector  30  is shown in the compact/storage position in  FIG. 9A . It is unable to make an injection in this condition. This is the condition where it may be carried and stored until ready for use. 
     Referring to  FIG. 9B , the portable auto-injector in the extended/drug ready position is shown. The moving of the extender, and the extender slide  90 , in an upward direction can then result in the outer pin and the inner pin being extended together; the outer pin is similar to the intra-housing  170  and the inner pin is similar to the drug delivery movement ring  190  in the embodiment described with relation to  FIGS. 2A-7B . This action causes the first plunger  120  to move upward into the first vial  112  in a way that creates a build-up of pressure in the first vial forcing the sealing device  244 , such as an orifice and/or seal and/or or membrane and/or valve, as best seen in  FIG. 8B , to move and/or change in some way in order to create fluid communication between the first vial  112  and the movable body  118 , comprising a dry medicament storage assembly. As the movable body  118  and the plungers  120  and  122  move relative to the vials  112  and  114 , the volume of the second vial  114 , the second chamber  234 , increases in size. The movable body  118 , the dry medicament storage assembly, is in fluid communication with the second vial  114 . The solution, the wet component  40 , in the first vial  112  begins to flow into the dry medicament storage assembly, the movable body  118 , dissolving the dry powder into a liquid or wet medicament, the dry medicament  38 , and then flowing into the second vial  114 . 
     In this state, the extended auto-injector becomes longer making the auto-injector easier to grip. The dissolved liquid medicament and/or partially dissolved medicament is transferred into the second vial  114  and stored until the next step is initiated. 
     Referring to  FIG. 9C , the portable auto-injector  30  in the ready for activation state with the safety removed is shown. After the inner pin has stopped moving as seen in  FIG. 9B , the needle assembly housing is resting on the split fingers and needle assembly housing stops. The safety  210  can extend further outward and/or be completely removed as shown in  FIG. 9C . The outward movement of the safety  210  results in the safety pin being removed from the stub, which was previously prevent the firing or unloading of the compression spring. A bump switch allows the user or administrator to push on the needle injection side of the injector, which pushes the stub into the bump groove and allows the stub to slide through the hole releasing the stored energy in the compression spring. The released energy forces the needle assembly into the person as well as movable body into the second vial, thus forcing the wet medicament through the needle assembly into the person. While the safety  210  is shown as slid upward, it is recognized that in some embodiments the safety  210  can removed entirely from the portable auto-injector  30 . In the same step the trigger extends out from the device on the injection side making the injector ready for injection. 
     Referring to  FIG. 9D , the portable auto-injector  30  in a pre-trigger position is shown. In this position, the bump trigger  100  can be pressed causing the needle assembly to rise forcing the bump switch to pinch together. The bump switch becomes smaller allowing it to clear a hole. The needle assembly then ejects, as seen in  FIG. 9E  under the force of a spring pushing the needle into a human and/or non-human. The spring continues to apply force, which then forces the liquid into the body as seen in  FIG. 9F . 
     Referring to  FIG. 10A , a front sectional view of an alternative pivotable portable auto-injector  1000  in the compact position is shown. Similar to the previous embodiments, the portable auto-injector  100  has a wet/dry combining system  110  and an injector  100 . In contrast to the previous embodiments, the auto-injector  1000  does not go from a compact state to the extended state by pulling an extender in a longitudinal direction. In this embodiment, the auto-injector  1000  has a flip design that has an upper housing  1010  that rotates relative to a lower housing  1020  about a hinge point  1030 . In this embodiment, the upper housing  1010  contains a drive mechanism that moves the components of the wet/dry combining system  110  located in the lower hosing.  FIG. 10D  shows the auto-injector  1000  in the extended state. 
     Referring to  FIG. 10C , a front sectional view of an alternative pivotable portable auto-injector  1005  in the compact position is shown. Similar to the previous embodiments, the portable auto-injector  100  has a wet/dry combining system  110  and an injector  100 . In this embodiment, the auto-injector  1005  has an outer housing  1040  that rotates relative to an inner housing  1050  about a pivot point  1060 .  FIG. 10D  shows the auto-injector  1005  in the extended state. 
     Referring to  FIG. 11A , a front sectional view of an alternative twist portable auto-injector  1100  in the compact position is shown. In this embodiment, the auto-injector  1100  has an upper housing  1110  and a lower housing  1120 . The two housings  1110  and  1120  are rotated relative to each other to allow the housings  1110  and  1120  to move apart through a central telescoping shaft  1140 .  FIG. 11B  shows the twist portable auto-injector  1100  in the extended position. The movable body  118  in the wet/dry component combining system  110  is shown with one micro channel  140  in the embodiment discussed with respect to  FIGS. 2A-7B . It is recognized that the wet/dry component combining system  110  can having multiple conduits or channels and seals. The mixing assembly allows for two different types of medicaments (or two doses of the same) to be mixed and inserted into a person using a single needle or other delivery system. A seal can span the orifices of each storage cavity which are each in fluid communication with a different channel contained within the mixing device. 
     These channels may vary in length and size enabling a time mixing/release of each medicament. For example, a first wet component is stored in a unique channel(s) that has a pathway shorter than the unique channel(s) in which the second wet component are stored in and are in fluid communication with. The first wet component mixes with the first dry component, homogenizes (in this embodiment, but not all embodiments), enters the needle assembly and is injected into a person, where the second wet component takes longer to mix with the second dry component and follows after the first mixed medicament has entered the needle assembly to be injected into the person. This is useful for two medicaments that are not compatible to be stored in the same portions of the mixing assembly and/or reconstituted or mixed together in the same channel. 
     Microfluidic devices or systems enable control and manipulation of fluids at very small scales. At sub-centimeter and/or sub-millimeter dimensions, the role of interfaces starts to become dominate and surface tension, fluidic resistance and such begin to control behavior, which may respond differently than macroscopic properties of fluid flow. For example, a main flow channel is machined in glass or polymer with a series of “herringbone” or other type of grooves, which create an environment causing the flow of material through the channel to induce mixing. These structures and features create a series of eddies, vortices, or folds inside the channel, which function to stir or mix and dissolve dry medicaments into a wet component thus forming a solution. 
     Embodiment may be made of two parts, such as a machined portion where the main channel and grooves have an alternating pattern (these grooves may also be randomized) are all formed therein. A base that is a flat glass or polymer is then attached to machined portion enclosing the main channel. 
     Alternatively, the flow channel may be constructed to widen and narrow or bulb/bulge along one side, two sides, or around the entire cross-section of the channel. A microchannel that gets wider and smaller may be useful in inducing mixing within the flow channel. For example, the main channel is initially smaller in width and then expands in width to a swell. The swell in other configurations may act as a reservoir or well and have larger amounts of dry component stored therein. Again, the swell may be a larger pocket or open area in which smaller structures may be placed within, the swell and any contained structures therein help cause disruption of flow. Swells or wells may be placed strategically through a micro-channel system to facilitate mixing. 
     Another way of promoting mixing is to introduce bends or turns into the channels and/or microchannel(s) of the mixing device such as using a serpentine channel shown in  FIGS. 12 and 13  rather than a straight channel, varying width, or herringbone design. These serpentines have two functions. First, they enable miniaturization of the plumbing by bending the fluid flow direction so that the channel can double back, thus a longer channel more efficiently utilizes a smaller area. Second, natural flow becomes disrupted every time there is a bend or elbow in the channel, which results in mixing. These serpentine meanders can be designed so there are soft turns  1220  that snake back and forth (shown in embodiment  1200   e ), or they can be designed with sharp 90-degree bends  1300 , which is shown in  1300   f . They can even be designed so that the bend exceeds 90 degrees (not shown) that forms a more saw-like tooth pattern. Each embodiment will result in different mixing properties that can enable control over the quantity and quality of mixing. This may be important given that certain drug compounds can be damaged if mixing is too aggressive whereas other compounds may require a more aggressive mixing device. This variability in tuning the mixing conditions allows for a variety of wet/dry components to be used in a compact auto-mixing injector device as control is one key performance attribute of the present application. In each of these microfluidic embodiments  1200   e  and  1300   f  each is comprised of a single channel having an opening  1224 ,  1334  to receive a wet component after the seal has been activated to an open or mixing state and an exit  1226 ,  1336  configured to be in fluid communication with a needle assembly or an in-between homogenization region. 
     In another configuration, a straight microfluidic channel configured with parallel walls may be sufficient to mix wet and dry components. Dry components stored inside a portion of the microfluidic channel may act to promote mixing within the channel. When the liquid moves through the channel and begins to push into the dry component contained in a portion therein, the flow front will cause natural turbulence or chaotic flow that focuses the flow towards the center of the channel and then causes the liquid to double back in the reverse direction near the channel wall. In order to make this happen, the channel dimension, which, in one embodiment can be defined by a square cross-section, should be below a certain size. For this embodiment and many of the embodiments described herein, one or both sides of the channel cross-section may have a dimension less than 2 mm, or between 1 mm and 2 mm, or less than 1 mm, or between 500 um and 1 mm, or less than 500 um, or between 250 um and 500 um, or less than 250 um, or between 100 um and 250 um, or less than 100 um, or between 50 um and 100 um, or less than 50 um, or between 10 um and 50 um, or less than 10 um, or between 1 um and 10 um, or less than 1 um. For purposes of this application, channels having a channel with a cross-sectional dimension less than 1 um are considered to be nanofluidic and have their respective set of properties for mixing medicaments. 
     U.S. patent application Ser. No. 13/529,757 filed on Jun. 21, 2012 and published a published patent application US 2013/0178823 on Jul. 11, 2013 describes additional designs of micro channels and is incorporated herein by reference. 
     In an embodiment, at least one dimension in the channel is less than 2 millimeters which mixes the dry component  24  into the wet component  26  where the Reynolds number in the diluent is less than 100, relying on chaotic mixing. An example of this could be a series of structures where at least one dimension in the channel is less than 2 millimeters which mixes the dry drug into the diluent where the Reynolds number in the diluent is less than 10, enabling mixing. In some embodiments the dry medicament fully dissolves into the wet component. However, in other embodiments the dry medicament is suspended in the wet component. 
     It is recognized that the syringe  40  can be replaced by an alternative source of fluid and motive force such as a fluid pump. 
     In embodiments described above, the actuation force of the auto-injector is supplied by a stored energy source such as the compression spring  160 . It is recognized that the energy may also come from user input. For example, when the user telescopes and/or hinges the device, this mechanical action can simultaneously load the auto-injector with the source of energy and put the device in ready mode. A trigger can then be used to discharge the energy source, pushing the needle into the body and delivering a liquid dose of medicament and/or hydrate a powdered medicament into a liquid dose and deliver this medicament into the body of a patient. 
     It is recognized that this might be enabled with a tension spring that remains in a coiled state before activation. The action of telescoping the injection device may compress the spring in such a way as to create sufficient potential energy needed to trigger the device during a second actuation step, which can be initiated by pressing the device against an injection step and activate a bump trigger, thus allowing the device to release energy from the spring and inject the medicament into the patient, and thus deliver the medicament. In such an embodiment, the bump trigger can be provided about the injection end of the device and function together with the plungers and spring so as to form a second actuation device or assembly which is actuated so as to enable injection of the mixed medicament components now present in the second vial. 
     Another embodiment would be to use a compression spring that is in the extended state before activation. The action of telescoping the injection device may compress the spring in such a way to create sufficient potential energy needed to trigger the device, inject the patient, and deliver the medicament. 
     Most auto-injectors have a pre-stored energy source, for example, a spring or cartridge of compressed gas. If the safety mechanism fails the injector can accidentally fire in an unintended way. Since this device&#39;s actuation force is not pre-stored, there is less risk of an accidental discharge and additional degree of safety. 
     In the embodiments discussed, a blister or burst membrane are described as one method of separating the wet and dry components. It is recognized that for this device another method of sealing is have the seal moved out of the way when the device becomes activated and/or telescoped. For example, like removing a cork from a wine bottle, the sealing structure can be moved out of the way creating fluid communication between the wet and dry components upon telescoping or flipping open the injector. 
     It is also recognized that while telescoping or flipping the device, after the seal has been removed or moved out of the way, there can be a force that simultaneously draws or pulls fluid into the dry powdered medicament that results in the reconstitution or hydration of the medicament into a liquid dose. This is slightly different from the pushing of liquid into/through the dry powdered medicament. 
     In one embodiment the dry medicament is epinephrine. In one embodiment the dry medicament is glucagon. In one embodiment the dry medicament is a clotting factor. In one embodiment the dry medicament is diazepam. In one embodiment the dry medicament is Embrel. In one embodiment the dry medicament is Xolair. In one embodiment the dry medicament is a nerve agent antidote, such as butyrylcholinesterase. In one embodiment the dry medicament is sumatriptan. In one embodiment the dry medicament is a pharmaceutical agent. In one embodiment the dry medicament is a biologic. It may also be a small molecule pharmaceutical agent. 
     Referring to  FIGS. 14A-D  illustrate an unfolding injector device. A cross-sectional view of an unfolding mixing and delivery device  1400  is shown. A safety  1402  is positioned one end of  1400  and prevents it from being able to unfold. Upon removal of safety  1402  the housing  1404 , which has a preloaded spring  1406  disposed therein, is configured to pivot and elongate the device  1400  as shown in  FIG. 14D . Spring  1406  may then engage with a mixing body  1408  that has at least one wet component stored therein and cause it to mix with a dry medicament. For example, as the housing rotates about a hinge the downward pressure on the vial causes the vial to mix with the dry medicament. The mixing assembly is steadied about a ledge prior to downward force of the portion of the housing containing the compressions spring engages the needle and mixing assembly side. The mixing assembly is then actuated as stated as it moves off the ledge and begins combining the wet component from the vial with the dry medicament in the mixing assembly. Similar to the telescoping embodiment above, a bump trigger can be provided at the injection end, which can then act as a second actuation device or assembly, may then cause the preloaded compression spring to engage and cause the needle assembly to protrude from the injection end of the housing. The combined wet medicament may then traverse the needle assembly  1410 , which upon a second actuation step causes a needle to protrude through opening  1412  and deliver the wet medicament upon depression against an injection site. As discussed elsewhere, the unfolding device may be comprised of various safety&#39;s and release mechanisms that allow for a single or multi-step process of mixing the wet and dry components and delivering such into a subject. 
     Referring to  FIGS. 15A-B , a schematic of alternative embodiment system  1500  having a pair wet component containers  1516   a  and  1516   b  that contains a first wet component  1508   a  and a second wet component  1508   b  which are mixed together prior to mixing with a dry medicament component. The syringe of the system  1500  has a plunger  1502  with a pair of shafts  1504  that each drive a plunger  1506  in a respective wet component volume. As the respect wet components  1508   a  and  1508   b  are pushed through their respective valve  1510   a  and  1510   b , the wet components mix in a wet mixing volume  1512  where a combined wet component is formed. 
     As the plunger  1502  is continue to push the combined wet component flows through a fluidic channel  1530  of a mixer  1520  that contains the dry medicament component. The combined medicament, which contains the dry medicament within the combined wet component, flows through the needle  1540 . 
     While the two wet component containers  1516   a  and  1516   b  are shown the same size, it is recognized that the cross-sectional area can be adjust to tailor the mixing of the two wet components. In certain embodiments that mixer  1520  and needle  1540  component can be separable from the syringe at the syringe output  1514 . 
     Referring to  FIGS. 16A-D  illustrate a fluidic channel  1610  adjacent to a movable body  1608  disposed between two chambers  1604  and  1606  inside a mixing device  1600 . As illustrated a wet component stored initially in chamber  1604  remains until a force moves movable body  1608  into the cavity portion of chamber  1604 , which begins forcing the wet component through fluidic channel  1610 , which is in a fixed position between chambers  1604  and  1606  and adjacent to movable body  1608 . As previously described, the force or pressure created from movable body  1608  entering chamber  1604  is what causes a one-way opening to be forced upon and the wet component to flow through the fluidic channel. A dry medicament may be deposited near the entry, throughout or in pockets of the fluidic channel  1610  and combine with the wet component to form a wet medicament. 
       FIG. 16B  illustrates the flow from  1604  through  1610  into  1606 . Once a majority of the wet component has been forced out of  1604  and combined into chamber  1606 , movable body  1608  may again be actuated to force the wet medicament through a needle assembly  1612  into a user or patient. Again, a one way opening between the fluidic channel and  1604  and possibly a second one-way channel between  1606  and  1610  prevents the wet medicament from reentering  1604  and thus forces it through needle assembly  1612  as shown in  FIG. 16D . 
     While the principles of the invention have been described herein, it is to be understood by those skilled in the art that this description is made only by way of example and not as a limitation as to the scope of the invention. Other embodiments are contemplated within the scope of the present invention in addition to the exemplary embodiments shown and described herein. Modifications and substitutions by one of ordinary skill in the art are considered to be within the scope of the present invention.