# Patent

## Title
Cartridge interface assembly

## Abstract

A cartridge interface assembly (80) characterized by a driving plunger (82) including an outer shaft (84), and a driver (86) including an inner shaft (88) movable telescopically with respect to the outer shaft (84), wherein rotation of the driver (86) causes the driving plunger (82) to advance in a direction away from the driver (86), and wherein the cartridge interface assembly (80) is inserted in a cartridge (22) in which a plunger (24) is slidingly disposed, and rotation of the driver (86) causes the driving plunger (82) to advance distally in the cartridge (22) until abutting against the plunger (24).

## Background
CROSS-REFERENCE TO RELATED APPLICATION
This application is a section 371 of International Application No. PCT/US2011/021605, filed Jan. 19, 2011, which was published in the English language on Jul. 28, 2011 under International Publication No. WO 2011/090956 which is a continuation-in-part of U.S. application Ser. No. 12/689,250 filed Jan. 19, 2010, the disclosures of which are incorporated herein by reference.


FIELD OF THE INVENTION
The present invention generally relates to external drug pumps, and particularly to an assembly for pushing a drug from a cartridge, in which the assembly interfaces between an actuator, e.g., a motor, and a pushing device, e.g., a plunger in the cartridge.
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 of the patient and delivers the substance to the patient via a cannula or needle that is inserted into the patient's skin.
PCT Patent Application PCT/IL2008/001312 (published as WO 2009/044401) to Gross and Cabiri (as well as U.S. patent applications Ser. Nos. 12/244666 and 12/244668, the disclosures of which are incorporated herein by reference), describes an external drug pump. In this pump, a cartridge is provided that contains a substance to be administered to a subject. (The terms “drug” and “substance” are used interchangeably throughout the specification and claims, and encompass any material administered to a subject. The term “cartridge” throughout the specification and claims encompasses any container for a drug, such as but not limited to, a cartridge, vial, syringe, bottle, ampoule and many more, and is not limited to any size or shape.)
The cartridge is sealed by a stopper, and has first and second threaded elements (e.g., a screw and a nut) that are threadedly coupled to each other. The distal end of the second threaded element defines a coupling portion that couples the second threaded element to the stopper. The first threaded element is rotatable with respect to the cartridge, and is linearly immobile with respect to the cartridge during rotation of the first threaded element. The first threaded element, rotated by a motor, is configured to linearly advance the stopper and at least the distal end of the second threaded element toward the distal end of the cartridge, without substantially rotating the second threaded element and the stopper.
The following is provided to facilitate understanding of the above described assembly.
Reference is made to FIG. 1, which illustrates the relevant elements of the prior art cartridge assembly of WO 2009/044401 (based on FIG. 4 of that application), wherein a cartridge 22 is inserted into a housing base.
The distal end of cartridge 22 is inserted into a cartridge piercing mechanism 44, which pierces a seal at the distal end of cartridge 22 having a stopper 24 therein (the stopper being an example of a plunger, piston or pushing device; the stopper will also be referred to as a plunger). Cartridge 22 is then lowered into the housing base. Typically, opposing resilient arms 70 support the cartridge upon the housing base. As cartridge 22 is lowered into the housing base, a first cog 52 engages a second cog 54. (First cog 52 is rotated by the motor, not shown here.) In some applications, before insertion of cartridge 22 into the housing, first threaded element 26 protrudes a distance h from the proximal end of the cartridge. The proximal end of the first threaded element (or of second cog 54) comprises a rounded portion 74. Portion 34 of the housing base comprises an angled face 76. As rounded portion 74 slides past the angled face, the first threaded element is pushed the distance h inside the cartridge. As a result, the first and second threaded elements 26 and 28 and the stopper 24 are displaced towards the distal end of the cartridge 22. During operation, the motor (not shown) turns cog 52, which turns cog 54. This linearly advances stopper 24 towards the distal end of the cartridge 22, thereby administering the substance from cartridge 22.
Reference is now made to FIG. 2, which illustrates cartridge 22 with plunger 24 in an initial position before cartridge 22 has been filled. The cartridge is either pre-filled by the manufacturer or filled by the user, such as with a hypodermic needle 15 inserted through a septum 17 in cartridge 22 (FIG. 3) or through a septum 19 in the housing of the drug pump (FIG. 4). As shown in FIG. 3, the plunger 24 moves linearly in the cartridge 22 as the cartridge is filled. Because no two cartridges will be filled with exactly the same amount of substance, such as due to tolerances, different injected volumes, different diameters or other dimensions, different plunger shapes, air bubbles or other factors, there is unfortunately no definitive position of the plunger 24 after cartridge 22 has been filled. This can cause a problem because it is possible that the overall length of the geared and threaded mechanism (which is predefined) that interfaces with plunger 24 may not meet the filled position of plunger 24 (which is unknown), thereby causing a problem to properly push against plunger 24 in order to administer the substance.
SUMMARY OF THE INVENTION
The present invention seeks to provide an improved assembly for pushing a drug from a cartridge, in which the assembly interfaces between an actuator, e.g., a motor, and a pushing device, e.g., a plunger in the cartridge, as is described more in detail hereinbelow. The invention solves the above mentioned problem of the prior art. Although the invention is described with reference to PCT Patent Application WO 2009/044401, nevertheless it is understood that the invention is applicable for many types of motor-driven drug cartridges.
There is thus provided in accordance with an embodiment of the present invention a cartridge interface assembly including a driving plunger including an outer shaft, and a driver including an inner shaft movable telescopically with respect to the outer shaft, wherein rotation of the driver causes the driving plunger to advance in a direction away from the driver, and wherein the cartridge interface assembly is inserted in a cartridge in which a plunger is slidingly disposed, and rotation of the driver causes the driving plunger to advance distally in the cartridge until abutting against the plunger. The driver may include a gear wheel. The inner shaft may mate with an intermediate shaft, and the intermediate shaft may mate with the outer shaft, so that the shafts are movable telescopically with respect to one another.
In accordance with a non-limiting embodiment of the present invention the inner shaft is threadedly received inside a hollow portion of the intermediate shaft, and the intermediate shaft is threadedly received inside a hollow portion of the outer shaft.
There is also provided in accordance with an embodiment of the present invention a method for interfacing between a driver and a plunger slidingly disposed in a cartridge, the method including inserting a cartridge interface assembly in the cartridge, the cartridge interface assembly including a driving plunger including an outer shaft, and a driver including an inner shaft movable telescopically with respect to the outer shaft, and rotating the driver to cause the driving plunger to advance distally in the cartridge until abutting against the plunger.



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 a prior art cartridge assembly;
FIG. 2 is a simplified illustration of the prior art cartridge with plunger in an initial position before the cartridge has been filled;
FIG. 3 is a simplified illustration of filling the prior art cartridge with a hypodermic needle inserted through a septum in the cartridge;
FIG. 4 is a simplified illustration of filling the prior art cartridge with a hypodermic needle inserted through a septum in a housing of a drug pump;
FIGS. 5 and 6 are simplified pictorial and sectional illustrations, respectively, of a cartridge interface assembly including a driving plunger, constructed and operative in accordance with an embodiment of the present invention;
FIGS. 7 and 8 are simplified illustrations of the cartridge interface assembly inserted in a cartridge, respectively before and after the driving plunger abuts against the plunger of the cartridge, in accordance with an embodiment of the present invention;
FIGS. 9 and 10 are simplified illustrations of a cartridge interface assembly, constructed and operative in accordance with another embodiment of the present invention, about to be screwed into a plunger of a cartridge, with the driver (gear wheel) moved away from, and abutting against, the body of the cartridge interface assembly, respectively; and
FIGS. 11A and 11B are close-up pictorial illustrations of the cartridge interface assembly of FIGS. 9 and 10, showing a locking assembly, constructed and operative in accordance with an embodiment of the present invention.



DETAILED DESCRIPTION OF EMBODIMENTS
Reference is now made to FIGS. 5 and 6, which illustrate a cartridge interface assembly 80, constructed and operative in accordance with a non-limiting embodiment of the present invention.
Cartridge interface assembly 80 includes a driving plunger 82 at the distal end of an outer shaft 84. A driver 86, such as but not limited to, a gear wheel, includes an inner shaft 88. Inner shaft 88 is received inside a hollow portion of an intermediate shaft 90 and threadedly mates therewith. Intermediate shaft 90 is in turn received inside a hollow portion of outer shaft 84 and threadedly mates therewith. The shafts 84, 88 and 90 are arranged to move telescopically with respect to one another. Outer shaft 84 may further include a proximal O-ring 92. The driving plunger 82 and O-ring 92 are preferably made of an elastomer, such as natural or synthetic rubber. The other parts may be made of plastic or metal.
In an alternative embodiment, the intermediate shaft 90 may be omitted and inner shaft 88 and outer shaft 84 may be arranged to move telescopically with respect to one another. In further alternative embodiments, there may be more than three shafts arranged to move telescopically with respect to one another.
Reference is now made to FIG. 7, which illustrates the cartridge interface assembly 80 inserted in cartridge 22. Driving plunger 82 is initially distanced somewhat from plunger 24 of cartridge 22. Rotation of driver 86 (such as by meshing with a rotating motor not shown) causes inner shaft 88 to rotate, which causes intermediate shaft 90 to rotate and advance linearly towards the distal end of cartridge interface assembly 80, that is, in the direction towards driving plunger 82 as indicated by arrow 91. The distal movement of intermediate shaft 90 in turn causes outer shaft 84 to advance distally together with driving plunger 82. The friction of driving plunger 82 against the inner wall of cartridge 22 is such that it is much easier for driving plunger 82 to move linearly than to rotate, such that the rotation of inner shaft 88 and intermediate shaft 90 cause driving plunger 82 to advance distally in cartridge 22 until driving plunger 82 abuts against plunger 24 as shown in FIG. 8. In an alternative embodiment, driving plunger 82 is allowed to rotate somewhat as it advances linearly until it abuts against plunger 24. In another alternative embodiment, driving plunger 82 does not need to touch the inner wall of cartridge 22 and advances distally in cartridge 22 until it abuts against plunger 24.
Thus, with the present invention, no matter what the final position of plunger 24 is after filling cartridge 22 with the substance to be administered, the driving mechanism for pushing plunger 24 will always properly contact plunger 24 via cartridge interface assembly 80 due to the distance compensating action of cartridge interface assembly 80.
Reference is now made to FIGS. 9 and 10, which illustrate an alternative embodiment of the cartridge interface assembly, with like elements being designated by like numerals. In this embodiment, a cartridge interface assembly 100 can be connected to a plunger 124 by a screw connection. The plunger 124 is formed with a threaded hole 126. The cartridge interface assembly 100 includes a threaded fastener 102 protruding from a distal end thereof, formed with male threads that correspond to the threaded hole 126. The threaded hole 126 and threaded fastener 102 are formed with right-hand (clockwise) threads. Accordingly, the telescoping shafts are formed with left-hand (counterclockwise) threads, so as to be opposite in direction to the threaded connection of the threaded fastener 102 into the threaded hole 126. The telescoping shafts of cartridge interface assembly 100 (such as the telescoping shafts 84, 88 and 90 of the first embodiment, not shown here) are rotated clockwise (as viewed from the distal end of driver 86) during operation in order to advance linearly towards the distal end of the cartridge interface assembly (as described above).
It may be desirable to supply the cartridge interface assembly 100 with the telescoping shafts fully inside a body 103 of the assembly 100 so that the driver 86 (shown in the illustrated embodiment of FIGS. 9 and 10 with a double gear wheel, but the invention is not limited to such a gear wheel) abuts against the proximal end of the body 103 of the cartridge interface assembly 100 as seen in FIG. 10. If the telescoping shafts are not turned tightly into the body to the position of FIG. 10, it may be possible for the shafts to unscrew during transportation and handling before assembly, with the result that the position of FIG. 10, which is the desirable position for assembly with the cartridge plunger, is not maintained. On the other hand, if the driver 86 is tightened too much against the body of assembly 100 in an effort to maintain the closed position of FIG. 10, this can increase the torque necessary for the motor to overcome the tight connection in order to start turning the driver 86, thereby overburdening the motor.
To solve this double problem (possible opening of telescoping shafts or the driver being tightened too much), a locking assembly is provided with the assembly 100 as is now described with reference to FIGS. 11A and 11B.
Driver 86 is formed with a recess 104, bounded by a wall 105 and a first locking tooth 106. The proximal end of the body 103 of the cartridge interface assembly 100 is formed with a second locking tooth 108. In the final position shown in FIGS. 11A and 11B (that of FIG. 10), second locking tooth 108 is received in recess 104. The first and second locking teeth 106 and 108 are formed with slanted walls 110 and 112, respectively. The slanted walls 110 and 112 can glide over each other in the clockwise direction, meaning that the second locking tooth 108 is free to move in and out of recess 104 in the clockwise direction. This permits rotation of driver 86 in the clockwise direction, which is the direction the motor turns driver 86 to advance the telescoping shafts distally. However, the second locking tooth 108 cannot move past wall 105, which means the second locking tooth 108 is cannot move past recess 104 in the counterclockwise direction, thereby preventing driver 86 from being unscrewed away from the proximal end of the body 103.
Thus the locking assembly of the first and second locking teeth 106 and 108 enables easy assembly of the telescoping shaft assembly with the plunger 124, and attains and maintains the final desired position of the driver 86 (i.e., the cartridge gear final position). The locking assembly prevents the telescoping shaft assembly from opening during transportation and handling, and ensures a small opening torque during operation.
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 combination cartridge and cartridge interface assembly comprising:
a rotationally immobile cartridge (22) having an inner cylindrical surface, a first stopper (24) slidingly inserted in the cartridge (22), a distal end and a substance therein for administration to a subject; and
a cartridge interface assembly (80) comprising:
a driving plunger (82) comprising a first shaft (84), the driving plunger (82) having an abutting surface and one or more outer surfaces in contact with the inner cylindrical surface of the cartridge (22);
a driver (86) comprising a gear wheel and a second shaft (88) rotatably fixed to the gear wheel, said second shaft (88) mating with said first shaft (84), so that said shafts are movable telescopically with respect to one another, wherein rotation of said driver (86) causes said driving plunger (82) to linearly advance in a direction away from said driver (86), the arrangement being such that on insertion of the cartridge interface assembly (80) in the rotationally immobile cartridge (22), the one or more outer surfaces of the driving plunger (82) and the inner cylindrical surface of the cartridge (22) have a frictional relationship such that it is easier for the driving plunger (82) to move linearly than rotate within the cartridge, wherein the frictional relationship is the only force impeding rotation of the driving plunger (82) with respect to the cartridge (22) such that rotation of said driver (86) causes said driving plunger (82) to linearly advance only towards the distal end until the abutting surface of the driving plunger (82) abuts against the stopper (24) whereupon the driving plunger (82) urges the stopper (24) towards the distal end for metering substance from the cartridge; and
a locking assembly that permits said driver (86) to rotate in a first rotational direction and blocks rotation of said driver (86) in a second rotational direction opposite to the first rotational direction.

2. The combination according to claim 1, wherein said second shaft (88) is threadedly received inside a hollow portion of said first shaft (84).

3. The combination according to claim 1, wherein said driving plunger (82) is at a distal end of said first shaft (84).

4. A combination cartridge and cartridge interface assembly comprising:
a rotationally immobile cartridge (22) having an inner cylindrical surface, a first stopper (24) slidingly inserted in the cartridge (22), a distal end and a substance therein for administration to a subject: and
a cartridge interface assembly (80) comprising:
a driving plunger (82) comprising a first shaft (84), the driving plunger (82) having an abutting surface and one or more outer surfaces in contact with the inner cylindrical surface of the cartridge (22);

a driver (86) comprising a second shaft (88). said second shaft (88) mating with said first shaft (84), so that said shafts are movable telescopically with respect to one another, wherein rotation of said driver (86) causes said driving plunger (82) to linearly advance in a direction away from said driver (86), the arrangement being such that on insertion of the cartridge interface assembly (80) in the rotationally immobile cartridge (22), the one or more outer surfaces of the driving plunger (82) and the inner cylindrical surface of the cartridge (22) have a frictional relationship such that it is easier for the driving plunger (82) to move linearly than rotate within the cartridge, wherein the frictional relationship is the only force impeding rotation of the driving plunger (82) with respect to the cartridge (22) such that rotation of said driver (86) causes said driving plunger (82) to linearly advance only towards the distal end until the abutting surface of the driving plunger (82) abuts against the stopper (24) whereupon the driving plunger (82) urges the stopper (24) towards the distal end for metering substance from the cartridge, an intermediate shaft (90) being threadedly received inside a hollow portion of said first shaft (84), said second shaft (88) being threadedly received inside a hollow portion of said intermediate shaft (90); and
a locking assembly that permits said driver (86) to rotate in a first rotational direction and blocks rotation of said driver (86) in a second rotational direction opposite to the first rotational direction.

5. A combination cartridge and cartridge interface assembly comprising:
a rotationally immobile cartridge (22) having an inner cylindrical surface, a first stopper (24) slidingly inserted in the cartridge (22), a distal end and a substance therein for administration to a subject; and
a cartridge interface assembly (80) comprising:
a driving plunger (82) comprising a first shaft (84), the driving plunger (82) having an abutting surface and one or more outer surfaces in contact with the inner cylindrical surface of the cartridge (22);
a driver (86) comprising a second shaft (88), said second shaft (88) mating with said first shaft (84), so that said shafts are movable telescopically with respect to one another, wherein rotation of said driver (86) causes said driving plunger (82) to linearly advance in a direction away from said driver (86), the arrangement being such that on insertion of the cartridge interface assembly (80) in the rotationally immobile cartridge (22), the one or more outer surfaces of the driving plunger (82) and the inner cylindrical surface of the cartridge (22) have a frictional relationship such that it is easier for the driving plunger (82) to move linearly than rotate within the cartridge, wherein the frictional relationship is the only force impeding rotation of the driving plunger (82) with respect to the cartridge (22) such that rotation of said driver (86) causes said driving plunger (82) to linearly advance only towards the distal end until the abutting surface of the driving plunger (82) abuts against the stopper (24) whereupon the driving plunger (82) urges the stopper (24) towards the distal end for metering substance from the cartridge, a threaded fastener (102) protrudes from a distal end of said cartridge interface assembly (100) that mates with a threaded hole (1 26) formed in said plunger (1 24); and

a locking assembly that permits said driver (86) to rotate in a first rotational direction and blocks rotation of said driver (86) in a second rotational direction opposite to the first rotational direction.

6. A combination cartridge and cartridge interface assembly comprising:
a rotationally immobile cartridge (22) having an inner cylindrical surface, a first stopper (24) slidingly inserted in the cartridge (22), a distal end and a substance therein for administration to a subject; and
a cartridge interface assembly (80) comprising:
a driving plunger (82) comprising a first shaft (84), the driving plunger (82) having an abutting surface and one or more outer surfaces in contact with the inner cylindrical surface of the cartridge (22);
a driver (86) comprising a second shaft (88), said second shaft (88) mating with said first shaft (84), so that said shafts are movable telescopically with respect to one another, wherein rotation of said driver (86) causes said driving plunger (82) to linearly advance in a direction away from said driver (86), the arrangement being such that on insertion of the cartridge interface assembly (80) in the rotationally immobile cartridge (22), the one or more outer surfaces of the driving plunger (82) and the inner cylindrical surface of the cartridge (22) have a frictional relationship such that it is easier for the driving plunger (82) to move linearly than rotate within the cartridge, wherein the frictional relationship is the only force impeding rotation of the driving plunger (82) with respect to the cartridge (22) such that rotation of said driver (86) causes said driving plunger (82) to linearly advance only towards the distal end until the abutting surface of the driving plunger (82) abuts against the stopper (24) whereupon the driving plunger (82) urges the stopper (24) towards the distal end for metering substance from the cartridge, said driver (86) being formed with a recess (104), bounded by a wall (105) and a first locking tooth (106), and a proximal end of a body (103) of said cartridge interface assembly (80, 100) is formed with a second locking tooth (108), which in a final assembly position, is received in said recess (104), and wherein said first and second locking teeth (106, 108) are formed with slanted walls (110, 112) which can glide over each other in the first rotational direction, but said second locking tooth (108) cannot move past said wall (105) in the second rotational direction.

7. A cartridge interface assembly (100), comprising:
a rotatable driver (86), linkable to a stopper (24), slidingly disposed in a cartridge (22) for advancing said stopper (24) distally in said cartridge for dispensing a substance from said cartridge (22), wherein a locking assembly permits said driver (86) to rotate in a first rotational direction and blocks rotation of said driver (86) in a second rotational direction opposite to the first rotational direction, wherein said driver (86) is formed with a recess (104), bounded by a wall (105) and a first locking tooth (106), and a proximal end of a body (103) of said cartridge interface assembly (100) is formed with a second locking tooth (108), which in a final assembly position, is received in said recess (104), and wherein said first and second locking teeth (106, 108) are formed with slanted walls (110, 112) which can glide over each other in the first rotational direction, but said second locking tooth (108) cannot move past said wall (105) in the second rotational direction.