# Patent

## Title
Cartridge insertion assembly for drug delivery system

## Abstract

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.

## Background
FIELD OF THE INVENTION
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.
BACKGROUND OF THE INVENTION
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.
SUMMARY OF THE INVENTION
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.
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.
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.
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.
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.
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.
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.
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 DRAWINGS
The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:
FIG. 1 is a simplified illustration of apparatus for administering a substance to a subject, in accordance with an embodiment of the present invention;
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;
FIG. 3 is a simplified illustration of the cartridge partially inserted into the apparatus;
FIG. 4 is a simplified illustration of the cartridge partially inserted into the apparatus, showing components of the cartridge insertion assembly;
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;
FIG. 6 is a simplified illustration of the cartridge fully inserted into the apparatus and locked in place;
FIG. 7 is a simplified illustration of a locking latch that locks the cartridge in place;
FIG. 8 is a simplified illustration of the inside of the door of the cartridge insertion assembly;
FIG. 9 is a simplified illustration of partially closing the door of the cartridge insertion assembly;
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
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 EMBODIMENTS
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.
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 U.S. 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

## Claims

1. A cartridge insertion assembly in a drug delivery device comprising: an apparatus with a pathway formed therein; a cartridge insertable into said pathway, said cartridge comprising a cartridge coupling element connectable to an activation mechanism disposed in said apparatus operative to cause a substance contained in said cartridge to be metered out of said cartridge;
a door pivoted to said apparatus that comprises a door coupling element arranged with respect to said cartridge such that when said door is in a fully closed position, said door coupling element couples said cartridge coupling element with a coupling element of said activation mechanism; and
a locking latch cantilevered from a base of said apparatus, wherein when said cartridge is fully inserted in said apparatus, said locking latch abuts against a rim of said cartridge, thereby locking said cartridge in said pathway, and wherein said door comprises a closure member on an inside surface thereof, said closure member comprising one or more inclined ramp members, wherein closing said door causes said ramp members to slide and push against said cartridge coupling element so as to push said cartridge fully into said apparatus, said closure member further comprising a hub, wherein when said door is fully closed, said hub is fixedly received in a snap member.

2. The cartridge insertion assembly according to claim 1, wherein when said cartridge is fully inserted in said apparatus, said cartridge abuts against a cartridge stopper disposed in said apparatus.

3. The cartridge insertion assembly according to claim 1, wherein said cartridge comprises a septum at an end opposite to said cartridge coupling element, and said apparatus comprises a hollow needle, wherein when said cartridge is fully inserted in said apparatus, said needle punctures said septum.

4. The cartridge insertion assembly according to claim 1, wherein said door is formed with one or more ribs, which when said door is fully closed, said ribs are received in one or more corresponding grooves formed in said apparatus.

5. The cartridge insertion assembly according to claim 1, wherein said coupling elements comprise gears.