Abstract:
A disposable patch pump may be provided with a filling adapter, to ensure filling by an authorized user. The adapter mates with the pump and a source of medicament, such as an insulin vial, to prevent filling the pump directly with a conventional syringe. The adapter and/or pump filling port may be configured with a frangible element, to limit the system to single use.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62/000,771 filed on May 20, 2014, which is incorporated herein in its entirety by reference. 
     
    
     TECHNICAL FIELD OF THE INVENTION 
       [0002]    The invention relates generally to wearable infusion pump devices (e.g., patch pumps) and other medical delivery devices having a filling port for filling the device with medicament and, more particularly, to systems and methods for preventing unauthorized filling of the device. 
       BACKGROUND 
       [0003]    Infusion devices (e.g., the infusion device described in U.S. Pat. No. 8,547,239, the contents of which are incorporated by reference as if set forth herein in their entirety) are often used to deliver medicament (e.g., insulin) to a user. With many insulin infusion devices, there is no physical restriction on the types of substances that can be used to fill the devices. Typically, an exposed septum on the device can be pierced by a hollow needle, allowing for the transfer of any substance that can move through the hollow needle into the device. This can lead to unintended uses and pose a risk to the user. 
       SUMMARY OF THE INVENTION 
       [0004]    It is therefore desirable to provide systems and methods to restrict access to a filling port of an infusion device, for safety and other reasons. An objective of the invention is to provide a lock and key type filling interface, in which the pump body includes one or more components forming a portion of the lock and an adapter forms corresponding mating key components. In this manner, access to fill the pump is limited to individuals possessing the adapter key, the manufacture and distribution of which may be suitably controlled. In one embodiment, a shutter and/or a valve may only be opened with the key, which key may have a specific mechanical shape, a specific distance between a needle and a coupling feature, and/or a specific length of the coupling feature. One or more components of the lock and key may be made sterile, as necessary, and single use features may be incorporated in the pump and/or adapter components to preclude unauthorized reuse of single-use components. 
         [0005]    Another objective of the invention to prevent user error. One type of user error occurs when an incorrect type of medicament is used. By limiting delivery of the adapter with a specific type(s) of insulin, it is unlikely the adapter would be used with another, unauthorized medicament container. Another form of user error can occur through needle injury, such as “sticking” Certain features (e.g., the key) can be designed to protect against needle injury, such as by recessing the needle relative to another surface or covering the needle. User error may also occur when a user injects medicament into any other soft element (e.g., soft control buttons) on the patch pump device and not the filling port septum. Protecting the septum may make it difficult, if not impossible, to fill the device through any access other than the filling port, which filling port may only be accessed with the key. This configuration is especially useful in patch pumps and other medical delivery devices with a single port, although this configuration can also be used with multiple port pumps. 
         [0006]    Embodiments of insulin and other medicament infusion devices, such as disposable patch pumps that adhere to a patient&#39;s skin, include a restricted insulin filling port. In one embodiment, the filling port includes a movable cover mechanism (e.g., a shutter) that obstructs access to the filling port or a portion of the port, such as a needle piercing septum. The shutter can be automatically retracted to expose the septum when a unique adapter is mated with the filling port. 
         [0007]    Some embodiments have a sliding, rotating, or cantilevered shutter that is retracted, moved, or displaced with an adapter to provide access to the septum for filling the device with insulin. The adapter may uniquely interface with a housing of the device, so that the shutter may only be opened with a specific matching adapter, e.g., through a unique mating configuration or design. In some embodiments, the adapter is inserted into the patch pump base and rotated to shift or retract the shutter. A medicament container (e.g., a syringe, a pen, a cartridge, or a vial containing insulin or other medicament) may be coupled to the adapter and used to fill the patch pump. Embodiments of the system advantageously prevent filling of the patch pump directly with a conventional syringe. 
         [0008]    In one embodiment, the adapter is disposed at the end of an insulin delivery apparatus (or a medicament container) and provided with a standard 3 mL cartridge of insulin. To couple the medicament container to the device, the adapter is pushed into the pump base and rotated to open the shutter and expose the septum. The delivery apparatus is pushed further and then the cartridge is emptied into the pump reservoir. In another embodiment, the vehicle is preloaded with insulin instead of using a removable cartridge. In still another embodiment, the adapter may be used to secure a vial for withdrawing fluid into the delivery apparatus syringe, and the same adapter may be used to couple the device to the pump and fill the pump with insulin. In yet another embodiment, a vial may be coupled directly to the adapter which couples directly to the device. Various combinations of elements and kits can be delivered together, including pump(s), adapters, syringes, and medicament containers (e.g., vials, cartridges, pens, etc.). 
         [0009]    In one aspect, the invention relates to a patch pump system. The patch pump system has a patch pump device with a filling port and a shutter proximate the filling port movable between a closed position and an open position and adapted to prevent access to the filling port in the closed position. The patch pump system also has a filling adapter adapted to be coupled to the filling port and move the shutter from the closed position to the open position. 
         [0010]    In one embodiment of the above aspect, the filling port has a septum. The filling port may be accessible from a user contact side of the patch pump device. In some embodiments, the shutter is accessible from a user contact side of the patch pump device. The shutter may be disposed within the patch pump device, and the shutter may be disposed within the filling port. The shutter can define a shutter opening, such that the shutter is in the open position when the shutter opening is aligned with a septum of the filling port. In some embodiments, the shutter is a valve or further includes a valve. 
         [0011]    In some embodiments of the above aspect, the patch pump device defines a device opening for coupling the filling adapter to the filling port and enabling controlled movement of the shutter. The filling adapter may have a mating surface adapted to fit in the device opening. The mating surface may have a protrusion and/or the mating surface may be adapted to contact the shutter. In certain embodiments, the filling adapter has a hollow needle. The needle may be exposed on two sides and be adapted to pierce two septa simultaneously. A first end of the filling adapter may be adapted to mate with a medicament container, which may be medicament container may be a syringe, a pen, a cartridge, and/or a vial. In some embodiments the patch pump system also has a socket adapted to receive the filling adapter, which socket may be adapted to support rotation of the filling adapter. 
         [0012]    In another aspect, the invention relates to a filling adapter for use with a patch pump device. The filling adapter has a first end adapted to mate with a medicament container and a second end adapted to couple to a filling port of a patch pump device and to move a shutter of the patch pump device from a closed position to an open position. 
         [0013]    In some embodiments of the above aspect, the first end defines a recess for receiving the medicament container. The first end may have a needle for piercing the medicament container. The medicament container may be a syringe, a pen, a cartridge, and/or a vial. The second end may have a needle. In certain embodiments, the second end has a protrusion adapted to extend into the patch pump device, such as a resilient tab. At least one of the first end and the second end may have a frangible component adapted to break after a single use. 
         [0014]    In another aspect, the invention relates to a method of filling a patch pump device. The method includes coupling a first end of a filling adapter to a medicament container, coupling a second end of the filling adapter to a filling port on a patch pump device to move a shutter proximate the filling port from a closed position preventing access to the filing port to an open position allowing access to the filling port, and filling a reservoir of the patch pump device with medicament from the medicament container via the filling port. 
         [0015]    In some embodiments of the above aspect, coupling the first end of the filling adapter to the medicament container includes receiving at least a portion of the medicament container in a recess of the filling adapter. Coupling the first end of the filling adapter to the medicament container may include piercing the medicament container with a needle. Coupling the second end of the filling adapter to the filling port on the patch pump device may include inserting a mating surface of the second end into the patch pump device, and may include rotating the filling adapter to move the shutter. In certain embodiments, the inserting step moves the shutter to the open position. The medicament container may be a syringe, a pen, a cartridge, and/or a vial. Filling the reservoir can include transferring medicament from the medicament container under pressure. The method may also include, after coupling the first end of the filling adapter to the medicament container, drawing medicament into the medicament container. The medicament may be drawn from a vial coupled to the second end. 
         [0016]    In another aspect, the invention relates to a patch pump device. The patch pump device has a filling port and a shutter proximate the filling port movable between a closed position and an open position and adapted to prevent access to the filling port when in the closed position, wherein the shutter comprises at least one mating surface adapted to couple to a filling adapter to move the shutter to the open position. 
         [0017]    In another aspect, the invention relates to a filling system adapted for use with a patch pump device. The filling system includes a filling adapter having a first end adapted to receive a medicament container and a second end adapted to mate with a filling port of a patch pump device and move a shutter of the patch pump device from a closed position to an open position. The filling system also includes a medicament container. 
         [0018]    In another aspect, the invention relates to a patch pump kit. The patch pump kit includes a patch pump device with a filling port and a shutter proximate the filling port movable between a closed position and an open position and adapted to prevent access to the filling port when in the closed position. The patch pump kit also includes a filling adapter with a first end adapted to receive a medicament container and a second end adapted to mate with the filling port and move from the closed position to the open position. The patch pump kit also includes a medicament container. 
         [0019]    In another aspect, the invention relates to a filling adapter kit. The filling adapter kit includes a medicament container adapter, a syringe adapter, and a pump device filling port adapter. 
         [0020]    In some embodiments of the above aspect, at least a portion of the syringe adapter is adapted to actuate a shutter disposed in a pump device to move the shutter from a closed position to an open position. 
         [0021]    In another aspect, the invention relates to a patch pump kit. The patch pump kit includes a patch pump device with a filling port and a shutter movable between a closed position and an open position and adapted to prevent access to the filling port in the closed position. The patch pump kit also includes a filling pump device adapted to mate with the filling port and move the shutter to the open position. The filling pump device includes an inlet for receiving a medicament container, an outlet for mating with the filling port, and a pump for transferring medicament from the inlet to the outlet. The patch pump kit also includes an adapter for mating the medicament container to the inlet. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]    In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings, in which: 
           [0023]      FIG. 1A  shows a perspective view of an illustrative embodiment of an adapter key in accordance with the present invention; 
           [0024]      FIG. 1B  shows a cross-sectional view of the adapter key of  FIG. 1A  in accordance with some embodiments of the present invention; 
           [0025]      FIG. 1C  shows a perspective view of an illustrative embodiment of a socket in accordance with the present invention; 
           [0026]      FIG. 1D  shows a top view of an illustrative embodiment of a shutter in accordance with the present invention; 
           [0027]      FIG. 2A  shows a cross-sectional view of the adapter key of  FIG. 1A  coupled to a medicament container in accordance with some embodiments of the present invention; 
           [0028]      FIGS. 2B and 2C  show perspective views of a medicament delivery system with the adapter key of  FIG. 1A  in accordance with some embodiments of the present invention; 
           [0029]      FIG. 3A  shows a perspective view of a medicament delivery system coupled to a patch pump system in accordance with some embodiments of the present invention; 
           [0030]      FIG. 3B  shows a bottom view of the coupled medicament delivery system of  FIG. 3A  in which the shutter is in a first closed position in accordance with some embodiments of the present invention; 
           [0031]      FIG. 3C  shows a cross-sectional detail of the coupled medicament delivery system of  FIG. 3A  in which the shutter is in an open position in accordance with some embodiments of the present invention; 
           [0032]      FIG. 3D  shows a bottom view of the coupled medicament delivery system of  FIG. 3A  in which the shutter is in the open position in accordance with some embodiments of the present invention; 
           [0033]      FIG. 3E  shows cross-sectional detail of the coupled medicament delivery system of  FIG. 3A  in which the shutter is in the open position in accordance with some embodiments of the present invention and the needle has pierced a septum fluidically coupled to a reservoir in the patch pump system in accordance with some embodiments of the present invention; 
           [0034]      FIG. 3F  shows a cross-sectional detail of the coupled medicament delivery system of  FIG. 3A  in which the needle has been retracted and the shutter has been re-closed to a second position in accordance with some embodiments of the present invention; 
           [0035]      FIG. 3G  shows a bottom view of the medicament delivery system and patch pump system of  FIG. 3A  with the shutter re-closed to the second position in accordance with some embodiments of the present invention; 
           [0036]      FIGS. 4A and 4B  show perspective views of a second adapter key in accordance with some embodiments of the present invention; 
           [0037]      FIG. 5A  shows a perspective views of an illustrative embodiment of a valve-type shutter for use with the adapter key of  FIGS. 4A and 4B  in accordance with the present invention; 
           [0038]      FIG. 5B  shows a cross-sectional view of the valve-type shutter of  FIG. 5A  in accordance with the present invention; 
           [0039]      FIG. 5C  shows a cross-sectional view of an embodiment of a valve-type shutter having two fluid outlet paths in an open state for use with the adapter key of  FIGS. 4A and 4B  in accordance with the present invention; 
           [0040]      FIG. 6A  shows a bottom perspective view of the valve-type shutter disposed at a first location within a ratchet-type system within the patch pump system for use with the adapter key of  FIGS. 4A and 4B  in accordance with some embodiments of the present invention; 
           [0041]      FIG. 6B  shows a bottom perspective view of the valve-type shutter disposed at a second location within the ratchet-type system within the patch pump system for use with the adapter key of  FIGS. 4A and 4B  in accordance with some embodiments of the present invention; 
           [0042]      FIG. 7A  shows a cross-sectional view of the second adapter key of  FIGS. 4A and 4B  mounted in the valve-type shutter of  FIGS. 5A and 5B  in a closed position in accordance with some embodiments of the present invention; 
           [0043]      FIG. 7B  shows a bottom view of the coupled valve-type shutter and adapter key of  FIG. 7A  with a resilient tab disposed at a first location within a ratchet-type system of the patch pump system in accordance with some embodiments of the present invention; 
           [0044]      FIG. 7C  shows a cross-sectional view of the second adapter key of  FIGS. 4A and 4B  mounted in the valve-type shutter of  FIGS. 5A and 5B  in an open position accordance with some embodiments of the present invention; 
           [0045]      FIG. 7D  shows a bottom view of the coupled valve-type shutter and adapter key of  FIG. 7C  with a resilient tab disposed at a second location within a ratchet-type system of the patch pump system in accordance with some embodiments of the present invention; 
           [0046]      FIG. 7E  shows a bottom view of the coupled valve-type shutter and adapter key of  FIG. 7A  with a resilient tab disposed at a third location within a ratchet-type system of the patch pump system in accordance with some embodiments of the present invention; 
           [0047]      FIG. 8A  shows a perspective view of an adapter key for use with a syringe in accordance with some embodiments of the present invention; 
           [0048]      FIG. 8B  shows a cross-sectional view of the adapter key of  FIG. 8A  in accordance with some embodiments of the present invention; 
           [0049]      FIGS. 9A and 9B  show perspective views of an illustrative embodiment of a syringe-type medicament delivery system having the adapter key of  FIG. 8A  in accordance with the present invention; 
           [0050]      FIGS. 9C and 9D  show perspective views of the syringe-type medicament delivery system of  FIGS. 9A and 9B  and a medicament vial in accordance with the present invention; 
           [0051]      FIG. 9E  shows a cross-sectional view of the adapter key of  FIG. 8A  coupled to a medicament vial of  FIG. 9D  in accordance with some embodiments of the present invention; 
           [0052]      FIG. 10A  shows a cross-sectional detail of the medicament delivery system of  FIG. 9B  and patch pump system with a closed shutter in accordance with some embodiments of the present invention; 
           [0053]      FIG. 10B  shows a cross-sectional detail of the medicament delivery system of  FIG. 9B  and patch pump system with an open shutter in accordance with some embodiments of the present invention; 
           [0054]      FIG. 10C  shows a cross-sectional detail of the medicament delivery system of  FIG. 9B  in which the needle has pierced the septum of the patch pump system in accordance with some embodiments of the present invention; 
           [0055]      FIG. 10D  shows a cross-sectional detail of the medicament delivery system of  FIG. 9B  and patch pump system in which the shutter is re-closed in accordance with some embodiments of the present invention; 
           [0056]      FIG. 11A  shows a perspective view of an adapter key with a safety tab for use with a syringe in accordance with some embodiments of the present invention; 
           [0057]      FIG. 11B  shows a cross-sectional view of the adapter key of  FIG. 11A  in accordance with some embodiments of the present invention; 
           [0058]      FIGS. 12A and 12B  show perspective views of an illustrative embodiment of a syringe-type medicament delivery system having the adapter key of  FIG. 11A  in accordance with the present invention; 
           [0059]      FIG. 12C  shows a perspective view of the safety-tabbed syringe-type medicament delivery system of  FIGS. 11A and 11B  and a medicament vial in accordance with the present invention; 
           [0060]      FIG. 12D  shows a cross-sectional view of the safety-tabbed adapter key of  FIG. 11A  coupled to a medicament vial in accordance with some embodiments of the present invention; 
           [0061]      FIG. 13A  shows a perspective view of an arcuate shutter for use with another medicament delivery system in accordance with some embodiments of the present invention; 
           [0062]      FIG. 13B  shows a perspective view of a socket in accordance with some embodiments of the present invention; 
           [0063]      FIG. 13C  shows a perspective view of an adapter key for use with another medicament delivery system in accordance with some embodiments of the present invention; 
           [0064]      FIG. 13D  shows a perspective view of a cap for a medicament vial for use with another medicament delivery system in accordance with some embodiments of the present invention; 
           [0065]      FIG. 14A  shows a perspective view of a medicament delivery system with the adapter key of  FIG. 13C  in accordance with some embodiments of the present invention; 
           [0066]      FIG. 14B  shows a perspective view of the medicament delivery system of  FIG. 14A  coupled to a medicament vial in accordance with some embodiments of the present invention; 
           [0067]      FIG. 14C  shows a cross-sectional view of the adapter key of  FIG. 13C  coupled to a medicament vial in accordance with some embodiments of the present invention; 
           [0068]      FIG. 15A  shows a perspective view of the medicament delivery system of  FIG. 14A  aligned over the socket of a patch pump system in accordance with some embodiments of the present invention; 
           [0069]      FIG. 15B  shows a perspective view of the medicament delivery system of  FIG. 14A  coupled with the socket of a patch pump system in accordance with some embodiments of the present invention; 
           [0070]      FIG. 16A  shows a cross-sectional detail of the coupled medicament delivery system of  FIG. 15B  with the arcuate shutter in a closed position in accordance with some embodiments of the present invention; 
           [0071]      FIG. 16B  shows a bottom view of the coupled shutter and adapter key of  FIG. 16A  in accordance with some embodiments of the present invention; 
           [0072]      FIG. 16C  shows cross-sectional detail of the coupled medicament delivery system of  FIG. 15B  with the arcuate shutter in an open position in accordance with some embodiments of the present invention; 
           [0073]      FIG. 16D  shows a bottom view of the coupled shutter and adapter key of  FIG. 16C  in accordance with some embodiments of the present invention; 
           [0074]      FIG. 16E  shows cross-sectional detail of the coupled medicament delivery system of  FIG. 15B  with the hollow needle piercing the septum of the patch pump system in accordance with some embodiments of the present invention; 
           [0075]      FIG. 16F  shows a bottom view of the coupled shutter and adapter key of  FIG. 16E  in accordance with some embodiments of the present invention; 
           [0076]      FIG. 17  shows a perspective view of a contained medicament delivery system coupled with a patch pump system in accordance with some embodiments of the present invention; 
           [0077]      FIG. 18  shows a cross-sectional view of the coupled medicament delivery system of  FIG. 17  in a closed position and having a medicament vial attached in accordance with some embodiments of the present invention; and 
           [0078]      FIG. 19  shows a cross-sectional detail of an activating pin of the contained medicament delivery system of  FIG. 17  in accordance with some embodiments of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0079]    A patch pump system  30  and uniquely-keyed medicament delivery system  40  in accordance with one embodiment of the present invention are depicted in  FIGS. 1A-3G . Advantageously, the patch pump system  30  and keyed medicament delivery system  40  are structured and arranged to mate or couple with a guiding socket  13  to provide a lock-and-key-type filling interface. In this manner, access for filling a medicament reservoir or pump  17  of the patch pump system  30  is limited to individuals possessing the filling adapter or adapter key  20   a , the manufacture and distribution of which may be suitably controlled to prevent coupling with and/or filling the patch pump system  30  using unauthorized or improper medicaments, or by unauthorized individuals. 
         [0080]    In some implementations of the embodiment, the patch pump system  30  includes a guiding socket  13 , a key-lock filling port  32 , and a movable, e.g., rotatable, shutter  14   a  that are integrated on or into the user contact side  31  of the patch pump system  30 . The socket  13 , which may be disposed on the surface of the user contact side  31 , is provided as an initial guide for the adapter key  20   a . For example, the socket  13  may define an opening  15  and may be shaped and dimensioned to accommodate the outer peripheral surface and/or a rim  25  of the adapter key  20   a . In some variations, the socket  13  may also include one or more elastic expansion elements  12  that are structured and arranged to displace radially when the adapter key  20   a  is inserted into and rotated within the socket opening  15  and oriented to position the shutter  14   a  in an open (uncovered) state. 
         [0081]    The shutter  14   a  may be configured to cover and uncover a septum  16  that seals the reservoir or pump  17 . As shown in  FIG. 1D , the shutter  14   a  may have a rounded T-shape having a central portion  19  and two wing portions  18 . A central, elongate opening  11  adapted to receive a protrusion  26  of the adapter key  20   a  and a pin  29  about which the shutter  14   a  may rotate, may be provided in the central portion  19  of the shutter  14   a . In some implementations, the shutter  14   a  is disposed beneath the user contact side  31  of the patch pump system  30  ( FIG. 3B ), such that the pin  29  is disposed within a distal end of the elongate opening  11 . In operation, the shutter  14   a  is configured to rotate about the pin  29  upon application of a rotating force or torque to the protrusion  26  of the adapter key  20   a . Although the shutter  14   a  has been described as having a rounded T-shape, those of ordinary skill in the art can appreciate that a myriad of, for example, rounded and polygonal shapes may be used to effect the purpose and function of the shutter  14   a . For example, the shutter may be L-shaped, I-shaped, rectangular, triangular, and so forth. 
         [0082]    The key-lock filling port  32  includes an opening in the user contact side  31  of the patch pump system  30  and the septum  16 , which may be pierced, e.g., by a hollow needle  22 , before the reservoir or pump  17  can be filled with a measured amount of medicament. The shutter  14   a  covers and uncovers the filling port  32 , respectively, to protect the septum  16  from and to expose the septum  16  to the needle  22  of the adapter key  20   a . In addition to the shutter  14   a , the patch pump system  30  may also include a receptacle  33  to provide another degree of security from improper medicament containers  35 . For example, the receptacle  33  may be adapted to position the medicament delivery system  35  in a desired location before enabling delivery of a measured amount of medicament and, moreover, may be dimensioned to receive a safety protrusion  24  that may be formed in the adapter key  20   a . Advantageously, the safety protrusion  24  and receptacle  33  are structured and arranged to mate or couple, so that, only when a proper medicament container  35  is being used can the safety protrusion  24  advance into the receptacle  33 , enabling the hollow needle  22  to penetrate the septum  16 . 
         [0083]    As shown in  FIGS. 2A-2C , the keyed medicament delivery system  40  includes a medicament container  35 , e.g., a pen and/or a cartridge pre-filled with a measured amount of insulin, and an adapter key  20   a  that provides a fluidic connection between the medicament container  35  and a reservoir  17  in the patch pump device  30 , e.g., for the purpose of filling the reservoir  17  with a measured amount of a medicament. As shown in  FIGS. 1A and 1B , in some implementations, the adapter key  20   a  includes a first end  21  and a second end  23 , each of which includes a hollow, cylindrical or substantially cylindrical portion. The hollow portions of the first end  21  and second end  23  are separated by a wall  28  through which a hollow needle  22  passes. To protect a user against inadvertently sticking the user or another, the hollow needle  22  may be contained or recessed within the adapter key  20   a  or, more particularly, within the hollow portions at the first  21  and second ends  23  of the adapter key  20   a.    
         [0084]    The first end  21  and the second end  23  of the adapter key  20   a  may be movable with respect to each other, such that the medicament container  35  can be urged to force the hollow needle  22  through the septum  16  of the filling port  32 , e.g., by sliding, e.g., in an axial direction, the first end  21  of the adapter key  20   a  relative to the second end  23  of the adapter key  20   a . The first end  21  may include a raised, alignment device  111  formed on the outer, peripheral surface of the first end  21 . The alignment device  111  can be structured and arranged to mate or couple with a receiving groove or track defined by the inner surface of the second end  23 . The groove or track may be dimensioned to receive the alignment device  111 . The alignment device  111  and groove combination position and guide the first end  21  with respect to the second end  23  while the first end  21  slidingly translates into and within the second end  23  during the septum piercing process and medicament delivery. The first end  21  of the adapter key  20   a  is further configured to receive and to pierce a septum or seal  37  of the medicament container, e.g., by axial pressing and/or twisting, while the second end  23  of the adapter key  20   a  may be coupled to the socket  13  of the patch pump device  30 . 
         [0085]    As shown in  FIGS. 2A-2C , the first end  21  is adapted to mate with a medicament container  35  at a first end  39  thereof. In some variations, the first end  39  of the medicament container  35  includes a fitting  38  for releasably connecting, e.g., by close sliding fit, with threadings, or the like, the medicament container  35  to the first end of  21  the adapter key  20   a . When the adapter key  20   a  is properly attached to the medicament container  35 , the hollow needle  22  of the adapter key  20   a  is located to pierce the septum  37  of the medicament container  35 , during attachment. Referring also to  FIG. 1B , the first end  21  of the adapter key  20   a  may also include an additional safety feature, e.g., a safety protrusion  24 , that is cantilevered axially from the wall  28 . The safety protrusion  24  is configured to prevent the premature deployment of the needle  22 , e.g., until the filling port shutter  14   a  is opened and the needle  22  and the septum  16  are properly aligned. Once mated in a receptacle  33  in the patch pump system  30 , the safety protrusion  24  aligns with the receptacle  33  ( FIG. 3C ) to enable advancement of the needle  22  into and through the septum  16 . 
         [0086]    Referring to  FIG. 1A , in some variations, the second end  23  of the adapter key  20   a  may include a rim  25  having a desired shaped and dimensions and on which a protrusion  26  is formed. Advantageously, the shape and dimension of the rim  25  can be selected to mate with the opening  15  of the socket  13  on the user contact side  31  of the patch pump system  30 . 
         [0087]      FIGS. 3A-3G  illustrate an embodiment of a method of filling the reservoir  17  of a patch pump system  30  using the medicament delivery system  40  described above. In a first step ( FIGS. 3A and 3B ), the adapter key  20   a  is inserted into the socket  13  of the patch pump system  30 . As shown in  FIG. 3B , when the adapter key  20   a  is first inserted, the shutter  14   a  is in a closed position, hence, the septum  16  of the reservoir  17  is covered by one of the wings  18  of the T-shaped shutter  14   a . In a second step ( FIGS. 3C and 3D ), the medicament container  35  and the patch pump system  30  and, more specifically, the needle  22  is aligned with the septum  16 , in preparation for piercing the septum  16  and for delivery of the medicament. Such alignment can be achieved, for example, by rotation of the medicament container  35  and the adapter key  20   a  within the socket  13 . During rotation, the protrusion  26  on the rim  25  of the adapter key  20   a  slides along the peripheral wall of the elongate opening  11  of the shutter  14   a , urging the shutter  14   a  such that the proximal end of the elongate opening  11  is aligned with the filling port  32  and the septum  16 . Neither wing  18  of the shutter  14   a  covers the port  32  or septum  16 . In one variation, the socket  13  guides and controls rotation and, advantageously, locks the adapter  20   a  in place, e.g., using the elastic expansion elements  12  and/or a resilient detent, when in the proper position for piercing the septum  16  and for filling the reservoir  17 . 
         [0088]    With the shutter  14   a  in an open state ( FIG. 3E ), in a next step, with the safety protrusion  24  on the first end  21  also aligned with the receptacle  33 , the first end  21 , slides in an axial direction within the second end  23 . The needle  22  is advanced to the delivery position, piercing the septum  16  and allowing for the delivery of medicament to the reservoir  17  in the patch pump device  30 . Once the reservoir  17  has been filled with a measured amount of the medicament, the medicament delivery system  40  can be retracted, e.g., by twisting and lifting the medicament container  35  ( FIGS. 3F and 3G ), to remove and disengage the adapter  20   a  and medicament container  35  from the patch pump device  30  and to re-close the shutter  14   a . As depicted, the container  35  and adapter  20   a  are twisted past the shutter open position, to cover the port  32  and septum  16  with the second lobe or wing  18  of the shutter  14   a . Alternatively, the system  10  could be rotated in the opposite direction to cover the port  32  and septum  16  with the first lobe or wing  18  of the shutter  14   a . Advantageously, to prevent additional uses of the adapter  20   a , in some variations, certain features, such as the safety protrusion  24 , may be frangible so as to break off after filling has been completed, e.g., through twisting while the safety protrusion  24  is contained within the receptacle  33  to the second, re-closed position. 
         [0089]    In another embodiment, depicted in  FIGS. 4A-7E , a medicament container  35 , e.g., a pen, a cartridge, and/or a vial, can be coupled to a first end  21  of a second embodiment of an unique adapter key  20   b , which is adapted to receive the medicament container  35 , while a second end  23  of the unique adapter key  20   b  is adapted to mate or couple to a patch pump device  30  via a valve-type shutter  14   b . In this embodiment, the shutter  14   b  may be a valve that is axially rotatable to open or close a fluid path between the needle  22  and the reservoir  17  of the patch pump device  30  when the adapter key  20   b  and shutter  14   b  properly aligned. In some implementations, the shutter  14   b  may have one or more resilient tabs  57 ,  58  that are designed to deflect more easily in one direction of rotation than another, e.g., for use within a patch pump device  30  having a surrounding ratchet-type configuration  72  ( FIGS. 5A ,  6 A, and  6 B). As a result, rotation of the shutter  14   b  may occur in only one direction, e.g. clockwise, and such rotation, in combination with a ratchet-type configuration, locks or secures the shutter  14   b  in a desired orientation. 
         [0090]    The adapter key  20   b  ( FIGS. 4A and 4B ) for the valve-type shutter  14   b  includes a hollow needle  22  and first end  21  that serve similar purposes as those described in connection with the first embodiment of an adapter key  20   a . In contrast to the first embodiment, the second end  23  of the adapter key  20   b  is more convex than concave and includes any number of unique interface elements, such as mating male  51 ,  52  and female portions  54  and openings  56 . The interface elements enable the adapter key  20   b  to mate or couple discretely with a valve-type shutter  14   b  and/or with a patch pump device  30  that has an integrated valve-type shutter  14   b  feature, so as to allow the valve-type shutter  14   b  to be rotated within the patch pump device  30 , e.g., to align the fluid outlet path  59  with fluid channels leading to the reservoir  17 , only when the unique adapter key  20   b  is used. The adapter key  20   b  may also have locking tabs  55  for securing a connection with the patch pump device  30 . For example, locking tabs  55  may be used in combination with a bayonet connection  53  ( FIG. 7A ) formed in the patch pump device  30 . Advantageously, these locking tabs  55  may be frangible, so as to break away, e.g., within and while in contact with the bayonet connection  53 , after a first use to prevent reuse of the adapter key  20   b , e.g., by preventing, upon an attempted reuse, a seal for sufficiently pressurizing the medicament for filling the patch pump device  30 . 
         [0091]    An illustrative embodiment of a valve-type shutter  14   b , which may be manufactured from a metal, alloy, plastic, and the like, is shown in  FIGS. 5A and 5B . The shutter  14   b  includes a distal portion  60 , a proximal portion  62 , and a central portion  61 . The distal portion  60  includes, e.g., a cylindrical or substantially cylindrical nose  67  that is configured to fit snugly into a first recessed portion  10  in the patch pump device  30  to align the shutter  14   b  and needle  22  properly and to provide an axis about which to rotate the medicament delivery system  40 . The proximal portion  62  includes a first opening  36  that is dimensioned for receiving, inter alia, a male portion  52  of the adapter key  20   b , e.g., in a tight, sliding fit, to provide an air- and fluid-tight seal. A plurality of tabs  57 ,  58  may be formed on the outer surface of the proximal portion  62 . The longer tab  57  is configured to fit into a plurality of locations  71 ,  73 , and  74  for the purposes described in detail below. 
         [0092]    The central portion  61  of the shutter  14   b  includes a recessed portion  27 , which is adjacent to and coaxial with the first opening  36  and in fluid communication with a fluid outlet channel  59 , and an outer seal  64 , e.g., an elastomeric material, silicone, thermoplastic elastomer (TPE), and the like, that is disposed or formed about the periphery of the central portion  61 . The recessed portion  27  is dimensioned for receiving, inter alia, the needle  22  and for channeling or communicating medicament from the medicament container  35  into the fluid outlet channel  59 . The outer seal  64 , which includes an opening  65  that surrounds the fluid outlet channel  59 , is adapted to fit snugly against a second recessed portion  34  in the patch pump system  30  to provide an air- and fluid-tight seal around the opening  65  during the filling operation.  FIG. 5C  shows a variation of the valve-type embodiment, in which the recessed portion  27  is adjacent to and coaxial with the first opening  36  and in fluid communication with multiple fluid outlet channels  59   a ,  59   b.    
         [0093]    In use, when the shutter  14   b  is in a closed configuration ( FIG. 7A ), a portion of the outer seal  64  other than the opening  65  is disposed between the fluid outlet channel  59  and a fluid port  63  in the patch pump system  30  to prevent premature delivery of the medicament into the patch pump system  30 . When the shutter  14   b  is in an open configuration ( FIG. 7C ), the opening  65  is disposed about and aligned with the fluid outlet channel  59  and the fluid port  63 , to provide a fluid path and an air- and fluid-tight seal at the fluid port  63  during the filling operation. 
         [0094]      FIGS. 7A-7E  illustrate an embodiment of a method of filling the reservoir  17  of a patch pump system  30  using the medicament delivery system  40  having the adapter key  20   b  and shutter  14   b  described above. Those of ordinary skill in the art can appreciate that the steps of attaching the adapter key  20   b  to the medicament container  35  may be similar to those described above in connection with  FIGS. 2A-2C  and, moreover, that the steps of installing the medicament delivery system  40  on the patch pump system  30  may be similar to those described above in connection with  FIG. 3A . Other attachment systems can alternatively be used, if desired. Once the adapter key  20   b  and medicament container  35  have been joined to create a fluid communication between the needle  22  and the medicament container  35 , in a first step ( FIGS. 7A and 7B ), the adapter key  20   b  may be inserted into an opening  66  in the patch pump system  30  and rotated, so that the locking tabs  55  engage the bayonet connection  53  formed in the patch pump system  30  at the opening  66 .  FIGS. 6A ,  7 A, and  7 B shown the system in a closed position, which is to say, the longer tab  57  may be disposed at a first location  71  of the ratchet-type configuration  72 . At the first location  71 , the longer tab  57  prevents the medicament delivery system  40  from being rotated in a counter direction, e.g., counterclockwise, to the rotation direction, e.g., clockwise, used to lock the locking tabs  55  within the bayonet connection  53 . In this state, the outer seal  64  of the shutter  14   b  may be positioned between the fluid outlet channel  59  and the fluid port  63 . Hence, no fluid path exists for communicating medicament into the reservoir  17  of the patch pump system  30 . 
         [0095]    In a next step ( FIGS. 7C and 7D ), the medicament delivery system  40  may be further rotated until the longer tab  57  reaches the second location  73  of the ratchet-type configuration  72 . When the longer tab  57  reaches the second location  73 , the system is in an open position. At the second location  73 , the longer tab  57  again prevents the medicament delivery system  40  from being rotated in a counter direction. In the open position, the fluid outlet channel  59  and the fluid port  63  are in fluid communication and the outer seal  64  of the shutter  14   b  is positioned, such that opening  65  in the outer seal  64  is disposed about the fluid outlet channel  59  and the fluid port  63 , to provide an air- and fluid-tight connection. Thus, a fluid path is now open for transferring medicament from the medicament delivery system  40  into the reservoir  17  of the patch pump system  30 . 
         [0096]    Finally, in a next step ( FIGS. 6B ,  7 A, and  7 E), the medicament delivery system  40  may be further rotated until the longer tab  57  reaches the third location  74  of the ratchet-type configuration  72 . When the longer tab  57  reaches the third location  74 , the system again is in a closed position. At the third location  74 , the longer tab  57  again prevents the medicament delivery system  40  from being rotated in a counter direction. Moreover, the outer seal  64  of the shutter  14   b  is again positioned, such that outer seal  64  is disposed between the fluid channel  59  and the fluid port  35 . Hence, the fluid paths are closed to transferring medicament into the reservoir  17  of the patch pump system  30 . 
         [0097]    Advantageously, to prevent multiple uses of the adapter  20   b , in some variations, certain features, e.g., the locking tabs  55 , may be frangible so as to break off after filling has been completed, e.g., through further twisting. The valve-type shutter  14   b , however, may be reused and can be properly sanitized to remove any trace of the transferred medicament or contamination. 
         [0098]    In yet another embodiment, the medicament delivery system  45  may include a syringe  95  as a medicament container instead of a pen, a vial, and/or a cartridge. Referring to  FIGS. 8A and 8B , in some implementations, for use with a syringe  95 , the adapter key  20   c  includes a first portion  80  and a second portion  85  that are coaxially arranged with respect to each other, such that first portion  80  may displace co-axially and slidingly within the plenum  96  of the second portion  85 . Hence, the outer diameter of the first portion  80  may be slightly smaller than the inner diameter of the second portion  85  to facilitate the axial displacement. The first portion  80  of the adapter key  20   c  may be configured receive and retain a syringe  95 , e.g., by axial pressing and/or twisting, while the second portion  85  of the adapter key  20   c  may be adapted, first, to receive and retain a medicament vial  99  while filing the reservoir of the syringe  95  with a measured amount of a medicament and, subsequently, may be coupled to the patch pump device  30 , e.g., by axial pressing and/or twisting, for filling the reservoir  17  of the patch pump system  30 . The first portion  80  and a second portion  85  may be manufactured of metal, an elastomeric material, plastic, rubber, and the like. 
         [0099]    The first portion  80  may be cylindrical or substantially cylindrical in shape and may include an open first end  21  and a second end that is closed by a wall  84 , defining a plenum  82  within the wall  84  and the circumferential walls of the first portion  80 . The wall  84  includes an aperture through which a hollow needle  22 , extending into both the plenum  82  of the first portion  80  and the plenum  96  of the second portion  85 , is disposed. In some variations, a reinforced area  83  is provided in the vicinity of a needle aperture to provide greater support to the cantilevered needle  22  and to ensure that the needle  22  remains centered and normal or substantially normal to the surface of the wall  84 . The wall  84  may disk-shaped and dimensioned to have a diameter that is slightly larger than the outer diameter of the first portion  80  to provide a shoulder  94 . The shoulder  94  of the first portion  80  is configured to abut an annular ring  97  of the second portion  85  and to support a cantilevered safety protrusion  88 , the purpose of which will be described in detail below. An alignment device  81 , which is dimensioned to fit into a groove to track in the second portion  85  and structured and arranged to control the axial sliding of the first portion  80  with respect to the second portion  85 , may also be formed on the outer peripheral surface of the first portion  80 . 
         [0100]    The second portion  85  may be hollow and cylindrical or substantially cylindrical in shape, including an open first and second ends  23 , such that, once the first portion  80  of the adapter key  20   c  has been properly inserted into the hollow second portion  85 , the wall  84  of the first portion  80  and the circumferential walls of the second portion  85  produce a plenum  96  within in the second portion  85 . A continuous, uninterrupted annular ring  97  may be formed about the entire circumference of the second portion  85  at the open first end. The outer diameter of the annular ring may be dimensioned to be flush with the outer peripheral surface of the circumferential wall of the second portion  85 . The thickness and inner diameter of the annular ring  97  are dimensioned to abut the shoulder  94  of the wall  84  of the first portion  80 , while allowing the circumferential wall of the first portion  80  to slidingly and axially translate within the plenum  96  of the second portion  85 . A groove or track that is dimensioned to receive the alignment device  81  formed on the outer, peripheral surface of the first portion  80  may be included in the annular ring  97  and/or the inner surficial wall of the second portion  85 . The groove or track and the alignment device  81  retain the concentric and coaxial first  80  and second portion  85  at a desired orientation with respect to each other during translation of the first portion  80  within the second portion  85 . 
         [0101]    The circumferential wall  106  of the second portion  85  includes a plurality of, e.g., two, locking tabs  86  and a first opening  104 , which is dimensioned to receive the safety protrusion  88  of the first portion  80 . The locking tabs  86  are cantilevered sections in the circumferential wall  106  of the second portion  85  and include keyed ends  90 . The cantilevered nature of the locking tabs  86 , which allows the locking tabs  86  to displace, e.g., elastically, in a radial direction, is provided by forming axially-oriented slits  87  on either side of the locking tab  86 . The keyed ends  90  include a projection that protrudes radially inward of the locking tab  86 . The safety protrusion  88  is supported by the wall  84  of the first portion  80  and cantilevered to allow the protrusion  88  to displace, e.g., elastically, in a radial direction. The safety protrusion  88  includes a keyed end  89  that includes a projection that protrudes radially inward of the protrusion  88 . In some variations, the second end  23  of the adapter key  20   c  may include a rim  25  having a desired shaped and dimensions and on which a protrusion  26  is formed. Advantageously, the shape and dimension of the rim  25  can be selected to mate or couple with the opening  15  of the socket  13  on the user contact side  31  of the patch pump system  30 . 
         [0102]    The first end  21  and the first portion  80  of an adapter key  20   c  may be structured and arranged to receive a syringe  95 , while a second end  23  and the second portion  85  of the adapter key  20   c  may be structured and arranged to receive a medicament vial  99  to fill the reservoir of the syringe  95  with a measured amount of a medicament, as well as to mate with the socket  13  of the patch pump system  30  to provide a lock and key type filling interface. In this manner, access for filling the medicament reservoir or pump  17  of the patch pump system  30  is limited to individuals possessing the adapter key  20   c , the manufacture and distribution of which may be suitably controlled to prevent filling the patch pump system  30  with unauthorized or improper medicaments or by unauthorized individuals. 
         [0103]    As shown in  FIGS. 9A-9D , the embodied keyed medicament delivery system  45  includes a syringe  95  that may be filled with a measured amount of insulin and the unique adapter key  20   c  previously described. The unique adapter key  20   c  initially provides a fluidic connection between the syringe  95  and a medicament vial  99  for the purpose of filling the syringe  95  with a measured amount of medicament and, subsequently, provides a fluidic connection between the syringe  95  and the socket  13  of the patch pump device  30  for the purpose of filling the reservoir  17  with the measured amount of a medicament. 
         [0104]    As shown in  FIGS. 8A and 8B , the hollow needle  22 , extending axially in opposing directions about the wall  84 , may be contained within the adapter key  20   c  and may be disposed within the plenums  82 ,  96  of the first portion  80  and the second portion  85  to protect a user against inadvertent sticking. The first portion  80  and the second portion  85  of the adapter key  20   c  may be movable with respect to each other, so that the first portion  80 , including the needle  22  and the safety protrusion  88  may translate axially within the plenum  96  of the second portion  85 . Such relative translation forces the hollow needle  22  through the septum  16  of the filling port  32 . 
         [0105]    As shown in  FIGS. 9A and 9B , the first portion  80  of the adapter key  20   c  is adapted to mate or couple with a syringe  95  at a first end  92  thereof. In some variations, the first end  92  of the syringe  95  includes a fitting  91  for releasably connecting, e.g., by tight sliding fit, with threadings, and the like, the syringe  95  within the plenum  82  of the first portion  80  at the first end of  21  the adapter key  20   c . In some variations, the coupling between the first portion  80  and the first end  92  of the syringe  95  provides an air- and fluid-tight seal, such that, when a syringe piston  93  is retracted from the reservoir of the syringe  95 , suction or a negative pressure is produced to draw a measured amount of medicament from a vial  99  through the needle  22  into the reservoir of the syringe  95 . 
         [0106]    As shown in  FIGS. 9C and 9D , the second portion  85  of the adapter key  20   c  is adapted to mate or couple with a medicament vial  99 . In some variations, the medicament vial  99  includes a fitting  98  for releasably connecting with the second portion  85  of the adapter key  20   c . More specifically, as shown in  FIGS. 9D and 9E , as the second portion  85  of the adapter key  20   c  is urged over the fitting  98 , the protrusions  90  of the locking tabs  86  and the protrusion  89  of the safety protrusion  88  are displaced radially outward away from the needle  22  until the protrusions  89 ,  90  reach the end of the fitting  98 . Once the protrusions  89 ,  90  have slid or passed over the end of the fitting  98 , the hollow needle  22  has established fluidic communication between the medicament vial  99  and the syringe  95 . Moreover, the protrusions  89 ,  90  have been allowed to return, e.g., elastically, at least partially toward their normal or original position. Advantageously, in their normal or original position, the protrusions  89 ,  90  are able to engage and retain the rim of the fitting  98  during the syringe-filling operation. The syringe piston  93  may then be retracted from the reservoir of the syringe  95 , drawing a measured amount of medicament from the medicament vial  99  into the syringe reservoir. Once a desired volume of medicament has been drawn into the reservoir of the syringe  95 , the medicament delivery system  45  is ready to fill the reservoir  17  of the patch pump system  30  and may be removed from the medicament vial  99 . 
         [0107]    Due to the many similarities of the first unique adapter key  20   a  and the adapter key  20   c  of  FIGS. 9A-9E  and  FIGS. 10A-10D , the arrangement of the patch pump system  30  and the steps for filling the reservoir  17  of the same may be similar. For example, in some implementations of this embodiment, the patch pump system  30  includes a guiding socket  13 , a key-lock filling port  32 , and a rotatable shutter  14   c  that are integrated on or into the user contact side  31  of the patch pump system  30 . The socket  13 , which may be disposed on the surface of the user contact side  31 , is provided as an initial guide for the adapter key  20   c . For example, an opening  15  may be formed in the socket  13  and may be shaped and dimensioned to accommodate the outer peripheral surface and/or a rim  25  of the adapter key  20   c . In some variations, the socket  13  may also include one or more elastic expansion elements  12  that are structured and arranged to displace radially when the adapter key  20   c  is inserted into and rotated within the socket opening  15  and oriented to position the shutter  14   c  in an open or uncovered state. 
         [0108]    As previously described, the shutter  14   c  is provided to cover and uncover a septum  16  that seals the reservoir or pump  17 . The shutter  14   c  may be configured to include a rounded T-shape having a central portion  19  and two wing portions  18 . A central, elongate opening  11  adapted to receive a protrusion  26  of the adapter key  20   c  and a pin  29  about which the shutter  14   c  may rotate, may be provided in the central portion  19  of the shutter  14   c . In some implementations, the shutter  14   c  is disposed beneath the user contact side  31  of the patch pump system  30  ( FIGS. 10A-10D ), such that the pin  29  is disposed within a distal end of the elongate opening  11 . In operation, the shutter  14   c  is configured to rotate about the pin  29  upon application of a rotating force or torque to the protrusion  26  of the adapter key  20   c . Although the shutter  14   c  has been described as having a rounded T-shape, those of ordinary skill in the art can appreciate that a myriad of, for example, rounded and polygonal shapes may be used to effect the purpose and function of the shutter  14   c . For example, the shutter may be L-shaped, I-shaped, rectangular, triangular, and so forth. 
         [0109]    The key-lock filling port  32  includes an opening in the user contact side  31  of the patch pump system  30  and the septum  16 , which may be pierced, e.g., by a hollow needle  22 , before the reservoir or pump  17  can be filled with a measured amount of medicament. The shutter  14   c  covers and uncovers the filling port  32 , respectively, to protect the septum  16  from and to expose the septum  16  to the needle  22  of the adapter key  20   c . In addition to the shutter  14   c , the patch pump system  30  may also include a receptacle  33  to provide another degree of security from improper medicament containers  45 . For example, the receptacle  33  may be adapted to position the medicament delivery system  45  in a desired location before enabling delivery of a measured amount of medicament and, moreover, is dimensioned to receive a safety protrusion  88  that may be formed in the adapter key  20   c . Advantageously, the safety protrusion  88  and receptacle  33  are structured and arranged to mate or couple, so that, only when a proper medicament container  45  is being used can the safety protrusion  88  advance into the receptacle  33 , enabling the hollow needle  22  to penetrate the septum  16 . 
         [0110]      FIGS. 10A-10D  illustrate an embodiment of a method of filling the reservoir  17  of a patch pump system  30  using the medicament delivery system  45  described above. In a first step, the adapter key  20   c  is inserted into the socket  13  of the patch pump system  30 . As shown in  FIG. 10A , when the adapter key  20   c  is first inserted, the shutter  14   c  is in a closed position, hence, the septum  16  of the reservoir  17  is covered by one of the wings  18  of the T-shaped shutter  14   c . In a second step ( FIG. 10B ), the syringe  95  and the patch pump system  30  are aligned for piercing the septum  16  and delivery of the medicament. Such alignment can be achieved, for example, by rotation of the syringe  95  and the adapter key  20   c  within the socket  13 . During rotation, the protrusion  26  on the rim  25  of the adapter key  20   c  slides along the peripheral wall of the elongate opening  11  of the shutter  14   c , urging the T-shaped shutter  14   c , such that the proximal end of the elongate opening  11  is aligned with the filling port  32  and/or the septum  16 . Neither wing  18  of the shutter  14   c  covers the port  32  or septum  16 . In one variation, the socket  13  guides and controls the rotation and, advantageously, locks the adapter  20   c  in place, e.g., using the elastic expansion elements  12  and/or a resilient detent, when in the proper position for filling the reservoir  17 . Advantageously, when the syringe  95  and the patch pump system  30  the needle  22  and the septum  16  as well as the safety protrusion  88  and the receptacle  33  are properly aligned. 
         [0111]    With the shutter  14   c  in an open state, in a next step ( FIG. 10C ), once the safety protrusion  88  is aligned with the receptacle  33 , the needle  22  can be advanced, e.g., axially, to the delivery position, piercing the septum  16  and allowing for the delivery of medicament to the reservoir  17  in the patch pump device  30 . Once the reservoir  17  has been filled, the medicament delivery system  45  can be retracted, e.g., by twisting and lifting the syringe  95 , to remove and disengage the adapter  20   c  and syringe  95  from the patch pump device  30  and to re-close the shutter  14   c . As depicted, the syringe  95  and adapter  20   c  are twisted past the shutter open position, to cover the port  32  and septum  16  with the second wing  18  of the shutter  14   c . Alternatively, the system could be rotated in the opposite direction to cover the port  32  and septum  16  with the first wing  18 . Advantageously, to prevent additional uses of the adapter  20   c , in some variations, certain features, such as the safety protrusion  88 , may be frangible so as to break off after filling has been completed, e.g., through twisting while the safety protrusion  88  is contained within the receptacle  33  to the second, re-closed position. 
         [0112]    A further variation to the adapter key  20   c  and medicament delivery system  45  shown in  FIGS. 8A through 9B  is depicted in  FIGS. 11A through 12D . Several of the components and their functional relationships are common to the embodiments of  FIGS. 8A through 9B  and  FIGS. 11A through 12  E, and may be used in a similar manner. One difference to the second portion  85  of the adapter key  20   d  is the inclusion of a removable safety tab  110  that is structured and arranged to prevent premature deployment of the needle  22  and, thus, exposing the sharp end of the needle  22  while filling the syringe  95  from a medicament vial  99 . In some implementations, the removable safety tab  110  is formed on the outer, circumferential wall  106  of the second portion  85  of the adapter key  20   d , e.g., diametrically opposed to the aperture  104 . In some implementations, the safety tab  110  ( FIGS. 11A and 11B ) includes a paddle or grip portion  101  and plurality of, e.g., two, elongate legs  100 . In some implementations, the paddle portion  101  is perpendicularly or substantially perpendicularly attached to each of the elongate legs  100  at a juncture  102  to form an L shape. The elongate legs  100  are removably attached to the circumferential wall  106  of the second portion  85  of the adapter key  20   d  and pivotable about corresponding weakened areas  103  in the second portion  85 . The elongate legs  100 , which extend from the circumferential wall  106  of the second portion  85 , are configured to run axially along the peripheral surface of the first portion  80  of the adapter key  20   d . More particularly, the elongate legs  100  are axially (longitudinally) dimensioned such that when the first portion  80  of the adapter key  20   d  is attached to the syringe  95  ( FIGS. 12A-12D ), the juncture  102  abuts the lip  105  of the syringe  95 . Advantageously, such an abutment, retains the sharp end of the needle  22  within the plenum  96  of the second portion  85 , preventing exposing the needle  22  prematurely. 
         [0113]    Advantageously, while the second portion  85  of the adapter key  20   d  is attached to the medicament vial  99  ( FIG. 12C ), as previously described in connection with  FIGS. 9C through 9E , the safety tab  110  prevents exposing the needle  22 , the abutment afforded by the safety tab  110  does not prevent or hinder the needle  22  from piercing the vial  99  septum or interfere with filling the syringe  95  with a measured amount of medicament. Thereafter, once the medicament vial  99  is removed from the second portion  85  of the adapter key  20   d , and before the medicament delivery system  45  is coupled to the patch pump system  30 , the tab  110  may be removed from the adapter key  20   d , e.g., by rotating the paddle portion  101  about the juncture  102  and/or by pulling the paddle portion  102  towards the weakened sections  103 . With some manual twisting and wiggling, the tab  110  should break away from the circumferential wall  106  of the second portion  85  of the adapter key  20   d . With the tab  110  removed, as previously describe in connection with  FIGS. 10A through 10C , the adapter key  20   d , which is now substantially the same as the adapter key  20   c , may be mated with or coupled to the socket  13  of the patch pump device  30  and longitudinal advancement of the needle  22  to pierce the septum  16  at the filling port  32  to the medicament delivery position is possible. 
         [0114]    Yet another illustrative embodiment of the present invention is depicted in  FIGS. 13A through 16F . The patch pump system  30  ( FIGS. 15A and 15B ) includes a guiding cap  130  ( FIG. 13B ) that is integrated on or into the user contact side  31  of the patch pump system  30  and an arcuate shutter  14   e  ( FIG. 13A ) that also is integrated on or into the patch pump system  30 . The arcuate shutter  14   e  may be disposed beneath the user contact side  31  of the patch pump system  30 , so as to open and close the key-lock filling port  32 , respectively, to expose and cover the septum  16  to the reservoir  17 . Although the invention will be described as having a single arcuate shutter  14   e , those of ordinary skill in the art can appreciate that there may be multiple arcuate shutters  14   e , e.g., a number less than or equal to the number of resilient tabs  48  on the adapter key  20   e . In some implementations, a biasing system, e.g., comprising one or more springs, may bias the arcuate shutter(s)  14   e  toward the closed position ( FIG. 16A ). Accordingly, the shutter(s)  14   e  would require a constant, greater opposing force to remain in the open position ( FIG. 16C ), which can be provided by the adapter key  20   e.    
         [0115]    The cap  130  ( FIG. 13B ), which may be disposed on or integrated into the surface of the user contact side  31 , is provided as an initial guide for the adapter key  20   e  ( FIG. 13C ). For example, the cap  130 , e.g., made of a hard plastic and the like, may be shaped and dimensioned to accommodate a plurality of resilient tabs  48  that are formed on a second portion  150  of the adapter key  20   e . In some variations, the cap  130  is hollow with a conical or frusto-conical shape that includes a plurality of raised portions  138  that project, e.g., in an axial direction, from a base portion  138  and a plurality of cut-out portions  137  that cut into the base portion  138 . In some variations, the cut-out portion  137  and the raised portion  138  alternate about the periphery of the cap  130 . Although the cap  130  is being described as having a conical or frusto-conical shape, that is done for illustrative purposes only, as the cap  130  could assume any practical shape. Advantageously, the cap  130  includes a centrally located opening  139  that passes through the entire cap  130  and that enables the needle  22  to access the septum  16 , as will be described in greater detail below. Each of the cut-out portions  137  is dimensioned to receive and to accommodate a corresponding resilient tab  48  formed in the adapter key  20   e . More particularly, each of the cut-out portions  137  is configured to align with a corresponding opening  119  ( FIGS. 16C and 16E ) formed in the user contact side  31  of the patch pump system  30 . The openings  119  are adapted to position the medicament delivery system  45  in a desired location before delivering the measured amount of medicament. 
         [0116]    As shown in  FIGS. 14A and 14B , the medicament delivery system  45  includes a medicament container, e.g., a syringe  95  that can be filled with a measured amount of insulin, and an adapter key  20   e  that is structured and arranged to mate or couple with the guide cap  130  and to provide a fluidic connection between the syringe  95  and a reservoir  17  in the patch pump device  30 , for the purpose of filling the reservoir  17  with a measured amount of a medicament. As shown in  FIG. 13C , in some implementations, the adapter key  20   e  includes a first portion  143  and a second portion  150 , which are separated by a wall  128  through which an aperture for a needle  22  is formed. To provide greater stiffness to the cantilevered needle  22 , a built-up portion  121  may be provided on at least one side of the aperture, e.g., on the first portion  143  side or the second portion  150  side of the wall  128 . The hollow needle  22 , which is disposed in the aperture in the wall  128  and extends axially in opposing directions, may be surrounded by a plurality of resilient tabs  48  in the second portion  150  and by a circumferential wall  140  in the first portion  143  of the adapter key  20   e  to protect a user against inadvertent sticking. 
         [0117]    The first portion  143  of the adapter key  20   e  is structured and arranged to mate or couple with a medicament container, e.g., a syringe  95 , while filling the syringe  95  from a vial  99  and while delivering a measured amount of medicament to the reservoir  17  in the patch pump system  30 . In some variations, the first portion  143  includes a circumferential wall  140  that, with the wall  128 , defines a plenum space in the first portion  143 . The plenum space and the circumferential wall  140  enable releasably connecting, e.g., by sliding fit, with threadings and the like, the adapter key  20   e  to the syringe  95 . The second portion  150  of the adapter key  20   e  is structured and arranged to mate or couple with a medicament container  99 , e.g., a medicament vial, for the purpose of filling the syringe  95  with a measured volume of medicament; to mate or couple with the guide cap  130  of the patch pump system  30 ; and to move the arcuate shutter(s)  14   e , so as to expose the septum  16  to the reservoir  17  to the needle  22 . Unlike previous embodiments, rotation of the medicament delivery device  45 , once it has been properly mated with the guide cap  130  on the patch pump system  30 , is not necessary. 
         [0118]    In some implementations, in order to fill the syringe  95 , a special vial cap  41  ( FIG. 13D ) for connecting the medicament delivery system  45  to the medicament vial  99  is needed. At one end, the cap  41  resembles the guide cap  130 , while the other end includes a skirt  42  that is dimensioned to accommodate the syringe  95 . In some variations, the vial cap  41  is hollow having, at the first end, a conical or frusto-conical shape that includes a plurality of raised portion  44  and a plurality of cut-out portions  46  that alternate about the periphery of the cap  130 . Although the vial cap  41  is being described as having a conical or frusto-conical shape, that is done for illustrative purposes only, as the cap  41  could assume any practical shape. The vial cap  41  includes a centrally located opening  43  that passes through the entire cap  41 , for enabling the needle  22  to have access to the septum of the medicament vial  99 . Each of the cut-out portions  46  is dimensioned to receive and to accommodate a corresponding resilient tab  48 . In some variations, one end of each cut-out portion  46  includes a wedge  141  that is structured and arranged to temporarily catch and hold, e.g., along a stop  142 , the locking tabs  49  formed on the end of each of the resilient tabs  48 . 
         [0119]    In operation, the resilient tabs  48  of the adapter key  20   e  are aligned with the cut-out portions  46  of the vial cap  41  before the adapter key  20   e  is urged in an axial direction towards the medicament vial  99 . As the resilient tabs  48  ride along the cut-out portions  46 , the tabs  48  are displaced radially outward, until the resilient tabs  48  reach the end of the wedge  141 , at which point the locking tabs  49  engage or abut the stop  142 . With the locking tabs  49  abutting the stop  142 , the needle  22  will have pierced the septum of the medicament vial  99 , to provide fluid communication between the medicament vial  99  and the syringe  95 . Refraction of the plunger  93  of the syringe  95  creates a suction or negative pressure, drawing a measured amount of the medicament into the syringe  95 . 
         [0120]    The arcuate shutter  14   e  is provided to cover and uncover the septum  16 , which, respectively, interrupts and provides a fluid communication with the reservoir or pump  17 . As shown in  FIG. 13A , the arcuate shutter  14   e  may be configured to include an L-shaped end  132  at one, e.g., a distal, end; a U-shaped, e.g., proximal, end; and an arcuate central portion  131  therebetween. In some variations, the U-shaped end includes a pair of legs  133  separated by an opening  134 . In some implementations, the shutter  14   e  is disposed beneath the user contact side  31  of the patch pump system  30 , such that in an at rest state, the arcuate central portion  131  of the arcuate shutter  14   e  is beneath the filling port  32 , covering the septum  16 . 
         [0121]      FIGS. 15A and 15B  illustrate an embodiment of a method of mating or coupling a medicament delivery system  45  having adapter key  20   e  with the guide cap  130  of a patch pump system  30 , while  FIGS. 16A through 16F  illustrate an embodiment of a method of filling the reservoir  17  of the patch pump system  30 , using the medicament delivery system  45  having adapter key  20   e . In a first step ( FIGS. 15A and 15B ), the adapter key  20   e  is inserted into the guide cap  130  of the patch pump system  30 , such that each of the resilient tabs  48  of the adapter key  20   e  are aligned with a corresponding cut-out portion  137  in the guide cap  130 , as well as with the openings  119  in user contact surface  31  of the patch pump system  30 . As shown in  FIGS. 16A and 16B , when the adapter key  20   e  is first inserted and properly mated in the guide cap  130 , one or more of the resilient tabs  48  is positioned above a corresponding opening  119 , as well as above the L-shaped end  132  of the arcuate shutter  14   e . In this position, the arcuate shutter  14   e  is in a closed position, such that the central portion  131  of the arcuate shutter  14   e  covers the septum  16  of the reservoir  17 . The needle  22  and the covered septum  16  are properly aligned for delivery of the medicament. In a second step ( FIGS. 16C and 16D ), the medicament delivery system  45  may be urged further into the patch pump system  30 , such that each resilient tab  48  passes through a corresponding opening  119  and, at least one of the resilient tabs  48  contacts the L-shaped end  132  of the arcuate shutter  14   e . Further urging of the medicament delivery system  45  displaces the arcuate shutter  14   e  to an open position, aligning the U-shaped opening  134  and the filling port  32  and exposing the septum  16  to the needle  22 . 
         [0122]    With the arcuate shutter  14   e  now open ( FIG. 16C ), the needle  22  can be advanced, e.g., with further urging of the medicament delivery system  45 , to the delivery position in a next step ( FIGS. 16E and 16F ), that pierces the septum  16  and enables delivery of medicament into the reservoir  17  in the patch pump device  30 . Once the reservoir  17  has been filled, the medicament delivery system  45  can be retracted, e.g., by lifting the syringe  95 , to remove and disengage the adapter  20   e  from the guide cap  130  of the patch pump device  30  and to re-close the arcuate shutter  14   e . Advantageously, to prevent additional uses of the adapter  20   e , in some variations, certain features, e.g., the resilient tabs  48 , may be frangible so as to break off after filling has been completed, e.g., by twisting the medicament delivery system  45  to cause the resilient tabs  48  to break against the peripheral surface of openings  119 . 
         [0123]    In still another embodiment, an implementation of a self-contained medicament delivery system  170  is depicted in  FIGS. 17 through 19 . The self-contained medicament delivery system  170  includes a unique adapter key  20   f  that is disposed at an outlet  160  of the system  170  and adapted to mate or couple with the socket on the user contact side  31  of the patch pump system  30 . The adapter key  20   f  and socket, as well as the corresponding shutter  14   f  integrated into the patch pump system  30 , may be of a type discussed hereinabove and, as a result will not be discussed in further detail. 
         [0124]    In some variations, the medicament delivery system  170  ( FIG. 17 ) further includes a housing  171 , an inlet  174 , for receiving a medicament container, e.g., a medicament vial  99 ; an outlet  160  that includes a removable or replaceable adapter key  12   f ; a latch  172 , for selectively coupling the medicament container  99  to a second needle  181 , and a pump actuation button  177 . 
         [0125]    Internally, in some variations, the system  170  includes at least one conduit  180 , e.g., sterile tubing and the like, and a pump, e.g., a peristaltic pump, mechanism  165  for delivering a measured amount of a medicament, e.g., about 0.2 mL of insulin per actuation of the button  177 , into the reservoir  17  of the patch pump system  30 . For example, in some applications, the conduit  180  is arranged in a serpentine configuration having a looped portion. The embodied pump mechanism  165  includes a gear-driven rotor  179  having a plurality of, e.g., three, rollers  189  disposed at the ends of a corresponding plurality of rotor arms, and an elongate rack  178  having a plurality of teeth. As shown in  FIG. 18 , when a user presses down on the pump activation button  177 , e.g., using her thumb or other digit, the rack  178  translates linearly in the same direction as the applied force, causing the rotor  179  to rotate. 
         [0126]    The operation of a peristaltic pump  165  is well known to those skilled in the art; accordingly, it will only be described briefly in the context of the present invention and use. In short, as the rotor  179  of the gear-driven peristaltic pump  165  rotates, a leading (in the direction of rotation) roller  189  pinches off a leading portion of the flexible, fluid-filled conduit  180 . As the leading roller  189  continues to move, a trailing roller  189  pinches off a second, trailing portion of the flexible, fluid-filled conduit  180 , confining or trapping a measured volume of the fluid, e.g., 2 mL, between the leading and trailing rollers  189 . The leading and trailing rollers  189  continue to rotate with a measured volume of fluid trapped between therebetween. Once the leading roller  189  reaches a pre-determined location  166 , it no longer pinches the flexible, conduit  180  and the trailing roller  189  forces the fluid out of the conduit  180  and into the needle  22  and the reservoir  17 . Each pump event initiated by depressing the pump actuation button  177  delivers a pre-determined amount of medicament to the reservoir  17 , e.g., with about 0.2 mL of insulin. 
         [0127]    Needle-carrying fixtures  182   a ,  182   b  are removably attached at either end of the conduit  180 , e.g., to provide an air- and fluid-tight sliding fit with the conduit  180 . A first fixture  182   a  is translatably disposed within the adapter key  20   f  and configured, upon activation of the needle deployment device  173 , to introduce a needle  22  through the filling port  32  and the septum  16  to provide a fluid communication to the reservoir  17  of the patch pump system  30 . A second fixture  182   b  is disposed in the vicinity of the inlet  174  and latch  172  and configured, upon activation of the latch  172 , to urge the septum covering the medicament vial  99  around the needle  181  to provide a fluid communication. More specifically, activation of the latch  172  ( FIG. 19 ) causes the toggle  175  to rotate about a pin  188 , such that a distal tip  186  of the toggle  175  clears a shelf  176  that otherwise retains the distal tip  186 , preventing the medicament vial  99  from moving. Once the distal tip  186  of the toggle  175  clears a shelf  176 , the medicament container  99  is able to slide into contact with a second needle  181 . 
         [0128]    In some embodiments, the filling pump device  170  is shipped attached to the patch pump device  30 , including sterile tubing connecting to the patch pump device  30  at the outlet  160  and to a medicament container  99  at the inlet  174 . A counter can also be included to keep track of the filling amount. For example, in one implementation, the counter may count the number of rotations of the rotor  179  of the gear-driven peristaltic pump  165 , realizing that the volume of medicament contained within the sterile tubing, between the leading and trailing rollers  189  rotates, is substantially constant, e.g., 2 mL. For the illustrated implementation, one rotation of the rotor  179  would deliver three measured quantities of the medicament or 6 mL to the reservoir  17  of the patch pump device  30 . 
         [0129]    The terms and expressions employed herein are used as terms and expressions of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described or portions thereof. In addition, having described certain embodiments of the invention, it will be apparent to those of ordinary skill in the art that other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit and scope of the invention. The features and functions of the various embodiments may be arranged in various combinations and permutations, and all are considered to be within the scope of the disclosed invention. Accordingly, the described embodiments are to be considered in all respects as only illustrative and not restrictive. Furthermore, the configurations, materials, and dimensions described herein are intended as illustrative and in no way limiting. Similarly, although physical explanations have been provided for explanatory purposes, there is no intent to be bound by any particular theory or mechanism, or to limit the claims in accordance therewith.