Abstract:
A cartridge insertion assembly including apparatus with a pathway formed therein, a cartridge including a cartridge coupling element connectable to an activation mechanism disposed in the apparatus operative to cause a substance contained in the cartridge to be metered out of the cartridge, and a door pivoted to the apparatus that includes a door coupling element arranged with respect to the cartridge such that when the door is in a fully closed position, the door coupling element couples the cartridge coupling element with a coupling element of the activation mechanism.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a continuation of U.S. patent application Ser. No. 13/892,905, filed May 13, 2013 and entitled CARTRIDGE INSERTION ASSEMBLY, which is a continuation of U.S. patent application Ser. No. 13/272,555, filed Oct. 13, 2011 and entitled CARTRIDGE INSERTION ASSEMBLY FOR DRUG DELIVERY SYSTEM and issued as U.S. Pat. No. 8,465,455, which is a continuation of U.S. patent application Ser. No. 12/559,563, filed on Sep. 15, 2009 and entitled “CARTRIDGE INSERTION ASSEMBLY FOR DRUG DELIVERY SYSTEM and issued as U.S. Pat. No. 8,157,769. 
     
    
       [0002]    The contents of all of the above applications are incorporated by reference in their entireties as if fully set forth herein. 
       BACKGROUND OF THE INVENTION 
       [0003]    The present invention generally relates to drug delivery systems, e.g., external drug pumps, and particularly to an assembly for inserting a cartridge, which contains a substance to be administered to a patient, into the drug delivery system. 
         [0004]    External drug pumps are typically used to deliver to patients substances which contain large molecules which cannot be digested when administered orally, such as insulin. Typically, the pump is adhered to the abdomen or chest or other of the patient and delivers the substance to the patient via a cannula that is inserted into the patient subcutaneously, although the invention described below is not limited to needle administration of substances. 
       BRIEF SUMMARY OF THE INVENTION 
       [0005]    The present invention seeks to provide an improved assembly for inserting a cartridge, which contains a substance to be administered to a patient, into a drug pump (or any kind of drug delivery system), as is described more in detail hereinbelow. It is noted that the term “cartridge” encompasses any kind of reservoir or container (disposable or not) for a substance that is to be administered to a patient, such as but not limited to, a vial, ampoule, bottle, pre-filled syringe and the like, and is not limited to any size or shape. 
         [0006]    There is thus provided in accordance with an embodiment of the present invention a cartridge insertion assembly including apparatus with a pathway formed therein, a cartridge insertable into the pathway, the cartridge including a cartridge coupling element connectable to an activation mechanism disposed in the apparatus operative to cause a substance contained in the cartridge to be metered out of the cartridge, and a door pivoted to the apparatus that includes a door coupling element arranged with respect to the cartridge such that when the door is in a fully closed position, the door coupling element couples the cartridge coupling element with a coupling element of the activation mechanism. 
         [0007]    In accordance with an embodiment of the present invention a locking latch is cantilevered from a base of the apparatus, wherein when the cartridge is fully inserted in the apparatus, the locking latch abuts against a rim of the cartridge, thereby locking the cartridge in the pathway. 
         [0008]    In accordance with an embodiment of the present invention when the cartridge is fully inserted in the apparatus, the cartridge abuts against a cartridge stopper disposed in the apparatus. 
         [0009]    In accordance with an embodiment of the present invention the cartridge includes a septum at an end opposite to the cartridge coupling element, and the apparatus includes a hollow needle, wherein when the cartridge is fully inserted in the apparatus, the needle punctures the septum. 
         [0010]    In accordance with an embodiment of the present invention the door includes a closure member on an inside surface thereof, the closure member including one or more inclined ramp members, wherein closing the door causes the ramp members to slide and push against the cartridge coupling element so as to push the cartridge fully into the apparatus. 
         [0011]    In accordance with an embodiment of the present invention the door is formed with one or more ribs, which when the door is fully closed, the ribs are received in one or more corresponding grooves formed in the apparatus. 
         [0012]    In accordance with an embodiment of the present invention the closure member includes a hub, wherein when the door is fully closed, the hub is fixedly received in a snap member. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0013]    The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which: 
           [0014]      FIG. 1  is a simplified illustration of apparatus for administering a substance to a subject, in accordance with an embodiment of the present invention; 
           [0015]      FIG. 2  is a simplified illustration of the apparatus of  FIG. 1 , showing a door of a cartridge insertion assembly in the open position and a cartridge poised for insertion into the apparatus; 
           [0016]      FIG. 3  is a simplified illustration of the cartridge partially inserted into the apparatus; 
           [0017]      FIG. 4  is a simplified illustration of the cartridge partially inserted into the apparatus, showing components of the cartridge insertion assembly; 
           [0018]      FIG. 5  is a simplified illustration of the cartridge fully inserted into the apparatus up to a cartridge stopper of the cartridge insertion assembly, with the door still open; 
           [0019]      FIG. 6  is a simplified illustration of the cartridge fully inserted into the apparatus and locked in place; 
           [0020]      FIG. 7  is a simplified illustration of a locking latch that locks the cartridge in place; 
           [0021]      FIG. 8  is a simplified illustration of the inside of the door of the cartridge insertion assembly; 
           [0022]      FIG. 9  is a simplified illustration of partially closing the door of the cartridge insertion assembly; 
           [0023]      FIG. 10  is a simplified illustration of the door fully closed, but only showing the inner components of the door (e.g., coupling elements) and not the outside surface of the door itself; and 
           [0024]      FIG. 11  is a simplified illustration of the door fully closed, showing a snap that snaps the door to the body of the apparatus. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0025]    Reference is now made to  FIGS. 1 and 2 , which illustrate apparatus  10  for administering a substance (e.g., insulin) to a subject, in accordance with a non-limiting embodiment of the present invention. Typically, apparatus  10  includes a cartridge  12  ( FIG. 2 ) that contains the substance to be administered to a subject.  FIG. 2  illustrates a door  14  of a cartridge insertion assembly in the open position and cartridge  12  poised for insertion into a pathway  15  in apparatus  10 . 
         [0026]    As seen in  FIG. 2 , cartridge  12  includes a cartridge coupling element  16  (e.g., a gear) for coupling (e.g., meshing) with an activation mechanism  18  (seen in  FIG. 4 , which typically includes a motor, a battery and a control unit) that causes the substance contained in cartridge  12  to be metered out of cartridge  12  for eventual administration to the patient. (In some embodiments, cartridge coupling element  16  is assembled to an end of a driving screw.) The way in which the activation mechanism works to meter the substance out of cartridge  12  is not pertinent to this invention. By way of example, the activation mechanism may work as in an external drug pump of the type described in US Patent Applications 20090093792 and 20090093793 or PCT Patent Application PCT/IL2008/001312 (published as WO 2009/044401), the disclosures of which are incorporated herein by reference. However, the invention is not limited to such a drug pump, and may be used for any kind of suitable administration of substances, not just by needle puncture into the patient, but also transdermally (wherein the substance is metered by apparatus  10  to a transdermal patch), by spray (wherein the substance is metered by apparatus  10  to a spray nozzle), micro needles array and others. 
         [0027]    It is noted that although cartridge  12  is typically a one-use item, the electronics, batteries and motor and other elements of the system can be used more than once if desired. 
         [0028]    As seen in  FIG. 3 , in accordance with a non-limiting embodiment of the present invention, door  14  includes a door coupling element  20  (e.g., a gear, but could also be any other coupling element for transmitting rotary motion, such as a friction wheel) for effecting coupling (e.g., meshing) between the cartridge coupling element  16  and a coupling element  22  ( FIG. 2 ) of the activation mechanism  18 , as will be described more in detail below. 
         [0029]    Reference is now made to  FIG. 4 , which illustrates the cartridge  12  partially inserted into apparatus  10 , showing components of the cartridge insertion assembly. Cartridge  12  has a septum  24  at an end opposite to cartridge coupling element  16 . The septum  24  is pierced by a hollow needle  26  so that contents of cartridge  12  flow out of cartridge  12  into needle  26  and from needle  26  to an exit port (not shown) for eventual administration to the patient. A cartridge stopper  28 , which may be made of a rigid material (e.g., plastic) or more preferably a resilient material (e.g., an elastomer or silicone), is provided for arresting movement of cartridge  12  during insertion into apparatus  10  and preventing over-insertion of cartridge  12 . Cartridge stopper  28  also prevents the torque, which is generated by the activation mechanism  18  to rotate the driving screw of the cartridge, from rotating cartridge  12 . The cartridge stopper  28  abuts against a shoulder  30  of cartridge  12 .  FIG. 5  shows cartridge  12  fully inserted into apparatus  10  up to cartridge stopper  28  with door  14  still open. 
         [0030]    Reference is now made to  FIGS. 6 and 7 . The cartridge insertion assembly of apparatus  10  includes a locking latch  32  which is cantilevered from a base  33  ( FIG. 7 ) of the apparatus  10 . While inserting cartridge  12  into apparatus  10 , a rim  34  near cartridge coupling element  16  depresses and slides over locking latch  32 . When cartridge  12  is fully inserted into apparatus  10 , rim  34  moves past locking latch  32  and locking latch  32  springs back and abuts against rim  34 , thereby locking cartridge  12  in place. The user cannot remove cartridge  12  from apparatus  10 . 
         [0031]    Reference is now made to  FIG. 8 , which illustrates the inside of door  14 . The door coupling element  20  mentioned above is in the middle of the inside of door  14 . On one side of element  20  is a hinge member  36  that pivotally connects (e.g., by snap fit) into a corresponding socket  38  (seen in  FIG. 10 ) in the body of apparatus  10 . On the other side of element  20  is a closure member  40 , which is formed with a central hub  42  and one or more ramp members  44  (in the illustrated embodiment, two inclined ramp members  44  extend on either side of hub  42 ). Even if the user has not fully inserted cartridge  12  into apparatus  10 , the act of closing door  14  (see  FIG. 9 ) causes the ramp members  44  to slide and swipe against cartridge coupling element  16 . The inclined surfaces of ramp members  44  gently push and wedge cartridge coupling element  16  to seat fully into apparatus  10  so that septum  24  is pierced by hollow needle  26  as described above with reference to  FIGS. 4 and 5 . 
         [0032]    After the cartridge  12  is locked in place, ramp members  44  keep pushing against the driving screw to create priming of the drug pump, wherein contents of the cartridge  12  overflow and pressurize into the needle  26  and drip out therefrom. This priming process reduces the breaking force (the initial force to remove the plunger after a long storage time) and removes air bubbles from the fluid path. 
         [0033]    The inside of door  14  is formed with one or more ribs  46 , which when door  14  is fully closed, are received in one or more corresponding grooves  38  ( FIG. 10 ) formed at the end of the housing of apparatus  10 . Ribs  46  seated in grooves  48  provide resistance to axial pull-out forces that may be acting on cartridge  12  and door  14  during operation of apparatus  10 . 
         [0034]      FIG. 10  illustrates door  14  fully closed. Door coupling element  20  couples between cartridge coupling element  16  of the cartridge and coupling element  22  of the activation mechanism, so that the activation mechanism can now cause the substance contained in the cartridge to be metered out of the cartridge for eventual administration to the patient. 
         [0035]    Reference is now made to  FIG. 11 . When door  14  is fully closed, hub  42  of closure member  40  snaps and is fixedly received in a snap member  50  (curved snap member) so that door  14  is properly secured to the body of apparatus  10 . 
         [0036]    It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of the features described hereinabove as well as modifications and variations thereof which would occur to a person of skill in the art upon reading the foregoing description and which are not in the prior art.