(19)
(11)EP 3 490 637 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
20.05.2020 Bulletin 2020/21

(21)Application number: 16825662.6

(22)Date of filing:  21.12.2016
(51)Int. Cl.: 
A61M 5/145  (2006.01)
A61M 5/142  (2006.01)
(86)International application number:
PCT/US2016/068058
(87)International publication number:
WO 2018/026386 (08.02.2018 Gazette  2018/06)

(54)

AUTOMATIC INJECTOR HAVING DOOR BLOCK UNTIL PROPER CARTRIDGE INSERTION

AUTOMATISCHER INJEKTOR MIT TÜRBLOCKIERUNG BIS ZUM EINSETZEN DER KORREKTEN KARTUSCHE

INJECTEUR AUTOMATIQUE À BLOCAGE DE PORTE JUSQU'À L'INSERTION CORRECTE D'UNE CARTOUCHE


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 01.08.2016 US 201662369513 P

(43)Date of publication of application:
05.06.2019 Bulletin 2019/23

(73)Proprietor: West Pharma Services IL, Ltd.
4366411 Ra'anana (IL)

(72)Inventors:
  • BARCHEN, Lior
    90258 Jerusalem (IL)
  • BAR-EL, Yossi
    71947 Beit Arye (IL)

(74)Representative: Petraz, Gilberto Luigi et al
GLP S.r.l.
Viale Europa Unita, 171 33100 Udine
Viale Europa Unita, 171 33100 Udine (IT)


(56)References cited: : 
US-A1- 2011 066 131
US-A1- 2014 188 073
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    FIELD AND BACKGROUND OF THE INVENTION



    [0001] The present invention, in some embodiments thereof, relates to automatic injectors and, more particularly, but not exclusively, to a door block for proper insertion of a cartridge into an automatic injector.

    [0002] U.S. Patent No. 9421323 discloses a doorstop to a drug delivery apparatus that encourages a user of the apparatus to perform the proper usage steps in the proper order. For example, a user may be expected to receive an injector in a transport state, open it to an open state, insert a cartridge, and/or close the cartridge before operation. The doorstop may have an obstructing mode, optionally preventing closing of the door. The cartridge may optionally have a non-obstructing mode allowing closing of the door. Inserting the cartridge may optionally cause a doorstop to move from the obstructing mode to the non-obstructing mode. In the non-obstructing mode the doorstop may optionally prevent removal of the cartridge.

    [0003] Additional background art includes U.S. Patent No. US4689043, U.S. Patent No. US5090877, U.S. Patent No. US5364364, U.S. Patent No. US5445621, U.S. Patent No. US5505709, U.S. Patent No. US5779676, U.S. Patent No. US5830187, U.S. Patent No. US5954697, U.S. Patent No. US6423036, U.S. Patent No. US6599272, U.S. Patent Application Publication No. US2007/0197968, U.S. Patent Application Publication No. US2011/0066131, and International Application Publication No. WO2012032411A2.

    SUMMARY OF THE INVENTION



    [0004] The invention is defined by the appended claims and relates to an automatic injector device according to claim 1 and a method for amplifying a position of a cartridge according to claim 14.

    BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS



    [0005] In the drawings:

    FIG. 1 is a flow chart of inserting cartridge and closing the coupling link, in accordance with some embodiments of the invention;

    FIG. 2 is a state diagram of cartridge insertion, in accordance with some embodiments of the invention;

    FIGs. 3A-3B illustrate a perspective view of a schematic exemplary injector having an exemplary door block mechanism and being loaded with a cartridge, in accordance with some embodiments of the invention, wherein FIG. 3A illustrates an interfering position and FIG. 3B illustrates a non-interfering position;

    FIGs. 3C-3D illustrate a perspective side view of a schematic exemplary door block mechanism and door trajectory, in accordance with some embodiments of the invention, wherein FIG. 3C illustrates an interfering position and FIG. 3D illustrates a non-interfering position;

    FIGs. 3E-3F illustrate a side view of a schematic exemplary cartridge being inserted against a door block mechanism, in accordance with some embodiments of the invention, wherein FIG. 3E illustrates an interfering position and FIG. 3F illustrates a non-interfering position;

    FIGs. 3G-3H illustrate a schematic example for a coupling link, in accordance with some embodiments of the invention, wherein FIG. 3G illustrates a coupling link positioned on an injector door and FIG. 3H illustrates the coupling link after the door is closed;

    FIG. 4A is a perspective view of an unstressed interference element, in accordance with some embodiments of the invention;

    FIG. 4B is an illustration of a door block mechanism, in accordance with some embodiments of the invention;

    FIG. 5 is an exemplary system having a fully inserted cartridge, in accordance with some embodiments of the invention;

    FIG. 6A is a rear view illustration of an example without an inserted cartridge, in accordance with some embodiments of the invention;

    FIG. 6B is a rear view illustration of an example with a not-fully inserted cartridge wherein the interference element interferes with closing the door, in accordance with some embodiments of the invention;

    FIG. 6C is a rear view illustration of an example with a not-fully inserted cartridge wherein the cartridge has pushed the interference element away from the trajectory of the door, but the cartridge itself is preventing closing the door, in accordance with some embodiments of the invention; and

    FIG. 6D is a rear view illustration of an example with a fully inserted cartridge resulting in an interference-free trajectory and a closed door, in accordance with some embodiments of the invention.


    DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION



    [0006] The present invention is defined by the appended claims and in some embodiments thereof, relates to automatic injectors and, more particularly, but not exclusively, to a door block for proper insertion of a cartridge into an automatic injector.

    Overview



    [0007] An aspect of some embodiments of the invention relates to preventing an automatic injector door from locking into a closed position, as long as a cartridge is not inserted into the injector and/or as long as a cartridge is inserted but not properly positioned. In some embodiments, an improper position of the cartridge includes an improper mechanical interface, for example, an improper mechanical coupling of the cartridge to a motor and/or a gear of the injector. Alternatively or additionally, an improper position of the cartridge includes an improper fluid interface, for example, improper positioning of the cartridge with respect to the fluid path, for example, improper coupling of the cartridge with the needle, and/or improper positioning of a cartridge having a needle in the correct needle path of the injector. As used herein, a door comprises a cover which is fixed to the injector housing in one end, and allowed to transition between different states of covering the housing.

    [0008] In some embodiments, an automatic injector comprises a door having a latching mechanism. Typically, an injector door is being closed once a cartridge is placed within the injector. A cartridge may be filled and/or pre-filled with a pharmaceutical substance, which may include for example, a drug, and/or placebo, and/or a nutritional supplement or the like. In some embodiments, a cartridge has a distal side being in fluid communication with a needle of the injector, and a proximal side having a plunger for driving the fluid through the fluid path. In order for the injector to work properly, a cartridge needs to have both a correct mechanical interface, permitting proper driving of the plunger, and a correct fluid interface permitting proper fluid communication from the cartridge to the needle and into an injection subject.

    [0009] Optionally, the latching mechanism causes the door to close irrevocably, potentially identifying a used injector and preventing reuse of a disposable injector. In some embodiments, a cartridge which is not inserted properly into the injector interferes with a closing trajectory of the door and prevents its latching. Alternatively or additionally, an amplifier, which is affected by the cartridge position, mechanically interferes with closing the door when the cartridge is positioned improperly. It is a potential advantage to prevent a door from irrevocably closing without an inserted cartridge, for example, when preventing automatic injector devices from closing during transit. It is a potential advantage to prevent a door from irrevocably closing when the cartridge is not properly inserted, because operating the device while the cartridge is not in a proper position might result in fluid which would not be injected or be injected not through the fluid path, for example resulting in leakage. Alternatively or additionally, improper cartridge position may lead to gear malfunction and/or breakage.

    [0010] An aspect of some embodiments of the invention relates to inhibiting operational communication to a cartridge of an automatic injector until the cartridge is sufficiently inserted into the injector device. In some embodiments, operational communication comprises engaging a driving mechanism with the cartridge, for example, by mechanically coupling a gear system to a plunger residing within the cartridge. In some embodiments, a mechanical coupling link is provided, optionally, being coupled to the injector door, for example, on an inner wall of the door.

    [0011] In some embodiments, operational communication is determined by a state of a mechanical coupling link between the driving mechanism of the cartridge and a motor of the injector. For example, a coupling link may be a gear linking between a gear of the motor and a gear of the driving system of the plunger. Optionally, the state of the coupling link is characterized by at least two positions; an engaged position which enables mechanical operable communication between the cartridge and the motor, and a disengaged position in which the motor is disconnected from the driving mechanism of the cartridge. In some embodiments, an improper position of the cartridge prevents the coupling link to enter its engaged position.

    [0012] In some embodiments, an injector comprises a cartridge bay sized and shaped for accommodating the cartridge, and having an opening for inserting the cartridge therethrough. Optionally, an injector door is hingedly connected to one side of the injector base, and is pivotally movable to its closing position resulting in covering the cartridge bay opening. In some embodiments, the door comprises a latching mechanism at the side of the door opposite to the hinge, and for locking with a complementary lock residing in the injector base opposite to the hinged connection with the door. In some embodiments, when the door is pivotally moved over the opening of the cartridge bay it defines a movement trajectory. Optionally, a coupling link residing in the door comprises a movement trajectory which follows the movement trajectory of the door. In some embodiments, a user gets a tactile feeling that the cartridge is misplaced by not being able to properly latch the door to the housing.

    [0013] When the cartridge is improperly inserted into the injector, in some embodiments, the cartridge itself mechanically interferes with an engaged position of the coupling link. Optionally, a protruding edge of the cartridge interferes with a trajectory of positioning the coupling link. In some embodiments, a protruding edge includes a flange, and/or a bevel, and/or a knob, and/or a bulge. Optionally, the protruding edge extends along the entire perimeter of the cartridge, potentially enabling insertion of the cartridge without being sensitive to its rotational orientation.

    [0014] Alternatively or additionally, when the cartridge is improperly positioned, an interference element mechanically interferes with transitioning the coupling link into its engaged position. Alternatively or additionally, an interference element mechanically interferes with the trajectory of closing the injector door. In some embodiments, the interference element is mechanically coupled to a sensor which detects the position of the cartridge. Optionally, the sensor couples an improper position of the cartridge with a presence of the interference element in the trajectory of the door and/or coupling link. Alternatively or additionally, the sensor couples a proper position of the cartridge with removing the interference element from the trajectory of the door and/or coupling link.

    [0015] Optionally, the sensor is elastic. In some embodiments, when the cartridge is not fully inserted, the elastic sensor exerts a force on the cartridge, pushing it away from the cartridge bay, thereby enhancing the improper position of the cartridge. A potential advantage of enhancing the improper position of the cartridge is to prevent a user from operating an injector when the cartridge is positioned within the injector, but not in a proper manner. System failures sometimes occur when a device door is closed prematurely, without noticing the cartridge is not properly positioned. For example, in some cases a user may close the device door before inserting the cartridge fully into the injector. In other cases, the device door may close during transit. Some solutions prevent closing the door until the cartridge has been at least partially inserted, but do not prevent closing the door when the cartridge has been partially, but not fully, inserted.

    [0016] Premature coupling of the driving mechanism with the plunger, may sometimes lead to system failure, potentially resulting in breakage of components of the injector and/or interfering with the injection of the injectable substance to a user of the injector.

    [0017] In some embodiments, a sensor, for example a cartridge contact interface, detects the presence of the cartridge in a location proximal to the cartridge bay. In some embodiments, a sensor positioned at the rim of the opening of the cartridge bay provides mechanical feedback to the positioning of the cartridge with respect to the rim of the cartridge bay. In some embodiments, the sensor is elastic. In some embodiments, the sensor is positioned to be insensitive to the body of the cartridge, but to mechanically contact a distinct cross-section of the cartridge proximal end, for example a protruding edge.

    [0018] In some embodiments, the sensor also prevent the cartridge from residing in a location being just outside the cartridge bay, forcing the cartridge to a location being even more remote than the opening, potentially amplifying the improper position by positioning the cartridge in a more noticeable configuration, visually and/or tactile wise. Optionally, the sensor interferes with positioning the protruding edge of the cartridge in a location being laterally to the rim and being outside of the cartridge bay, in the direction of the inserted cartridge. In case of incomplete cartridge insertion, the elastic sensor will pressure the cartridge outward extracting the cartridge from the bay and/or block the door from closing.

    [0019] In some embodiments, a cartridge lock is provided to interlock the cartridge once it is inserted into the correct position. In some embodiments, an elastic door block combined with a cartridge lock (for example, locking the cartridge into position only when fully inserted) prevents door closure until the cartridge is fully inserted. In some embodiments, the configuration gives the user tactile feedback when the cartridge has been properly (fully) inserted, for example a click or a snap. Optionally, the configuration prevents removal of the cartridge after insertion.

    [0020] An aspect of some embodiments of the invention relates to amplifying a position of a cartridge within an injector device. In some embodiments, a position of a cartridge indicates its success to correctly interface with the injector device. Optionally, interface with the injector includes a mechanical interface, such as for example, a plunger driving mechanism. Alternatively or additionally, interface with the injector includes a fluid interface, such as the fluid path from the cartridge, to the needle and eventually to an injection subject.

    [0021] In some embodiments, amplifying includes mechanically coupling an interference element with the position of the cartridge, for example, by contacting a protruding cross-section of the cartridge with the interference element. Optionally, contacting is provided directly. Alternatively or additionally, contacting is provided indirectly, for example through a contact interface. In some embodiments, the interference element comprises a deflected orientation which interferes with a mechanical operation of the injector. For example, the deflected interference element may be positioned along a mechanical trajectory of closing a door of the injector. Alternatively or additionally, the interference element is positioned to prevent a coupling link for mechanically coupling a motor with a driving system of the fluid path.

    [0022] A potential advantage of translating the cartridge position with an operational feature of the injector is that even a small malposition of the cartridge, which may be difficult to notice, is translated into an operational malfunction and/or tactile feedback which is easier to detect. In some embodiments, a malposition of the cartridge includes placing the proximal edge of the cartridge (i.e. the edge having the plunger and being opposite to the distal edge having the needle) in a location being no more than 0.5 mm, and/or no more than 1 mm, and/or no more than 2 mm, and/or no more than 3 mm, and/or no more than 4 mm, and/or no more than 5 mm from the opening of the cartridge bay, in a direction facing away from the cartridge bay.

    DETAILED EMBODIMENTS



    [0023] The invention is defined by the appended claims.

    Exemplary sequence of events



    [0024] Referring now to the drawings, FIG. 1 shows a flowchart of inserting a cartridge and closing an injector door, in accordance with some embodiments of the invention.

    [0025] In some embodiments, an automatic injector is provided to a user without having the injectable matter, which is optionally supplied in a cartridge. In some embodiments, the cartridge is provided with a fluid outlet in its distal end and a plunger for driving the fluid out of the fluid outlet in its proximal end. In some embodiments, the automatic injector comprises a housing having a cartridge bay for accommodating the cartridge and a door for closing a proximal opening of the cartridge bay. Optionally, a door is coupled to a gear for coupling a powering gear of a motor to the driving gear of the plunger.

    [0026] In some embodiments, an injector is supplied in 102 without a cartridge. In some embodiments, the door of the injector is blocked 104 from closing by an interference element. Optionally, an interference element interferes with a trajectory of closing the door as long as a cartridge is not inserted into the device. Potentially, preventing closing of the door without a cartridge eliminates irrevocable closing of the device by mistake, and/or during transit. It may also prevent operating the device without first inserting an injectable substance, such as found in the cartridge.

    [0027] In some embodiments, a cartridge is inserted into the device in 106 but not sufficiently. In some embodiments, a cartridge which is not fully inserted into the device is a cartridge which comprises a proximal edge residing outside of the cartridge bay. For example, a cartridge has a body which has less than 99 %, or less than 98%, or less than 97%, or less than 96%, or less than 95%, or less than 92%, or less than 90%, residing within the cartridge bay.

    [0028] Alternatively or additionally, a cartridge is defined as not fully inserted when the cartridge is not properly coupled to an operational interface of the injector. In some embodiments, an operational interface is a fluid interface. Alternatively or additionally, an operational interface is a mechanical interface. In some embodiments, an injector properly operates by operably communication between a motor, a driving system, a plunger residing in a cartridge and a fluid outlet of the cartridge coupled to a needle. In some embodiments, a cartridge is provided after the operating components are supplied with the injector and it needs to be coupled correctly to the operational path. In some embodiments, an improper position of the cartridge with respect to the cartridge bay indicates an incorrect operable communication.

    [0029] In some embodiments, when the cartridge is not fully inserted in 106, the door is still blocked for closing in 108. Optionally, the door is still blocked by the interference element blocking in 104. Alternatively or additionally, the door is blocked by the cartridge itself. In some embodiments, the cartridge comprises a protruding proximal edge, optionally interfering with closing the door. Optionally, the protruding edge of the cartridge extends along the entire circumference of the cartridge to reduce sensitivity to the insertion orientation of the cartridge. Alternatively, the protruding edge is provided in only a portion of the perimeter of the cartridge, potentially providing information regarding the orientation of the cartridge within the cartridge bay.

    [0030] In some embodiments, a cartridge is fully inserted into the device in 112. In some embodiments, once the cartridge is fully inserted, feedback is provided to the interference element which causes it to inflect away from the trajectory of closing the door. Optionally, the cartridge is locked into place in 114, which, in some embodiments, results in the interference element being locked in its inflected orientation.

    [0031] In some embodiments, once the cartridge is sufficiently inserted and the interference element is removed from the closing trajectory, the door is unblocked in 116 and can be closed 118. Optionally, the door is coupled 120 to a coupling link which serves as a mechanical connection between the mechanical interface of the injector, for example, connecting between a motor residing within the injector with a driving system of the plunger. In some embodiments, the supplied cartridge is preassembled with the driving system of the plunger and is optionally loaded into the injector with the driving system coupled to its proximal end.

    Exemplary state of events



    [0032] Reference is now made to FIG. 2, showing a state diagram of cartridge insertion followed by closing the injector door, in accordance with some embodiments of the invention. Optionally the system can only go to the next state when the previous state is fully accomplished. Optionally, the system cannot return from one state to a previous state.

    [0033] In some embodiments, an injector is supplied to a user without a cartridge. In some embodiments, the injector is provided with a deflected interference element 202. In some embodiments, the deflected interference element in 202 interferes with closing the device door leading to a blocked door 204. In some embodiments, as long as a cartridge is not inserted, the door remains blocked in 204. In some embodiments, as long as a cartridge is inserted but not fully inserted in 206, the interference element remains deflected in 208 and the door remains blocked in 210.

    [0034] In some embodiments, once a cartridge is fully inserted in 212, it causes the interference element to be in an inflected state in 214. In some embodiments, once the cartridge is fully inserted in 212 it is also locked in place in 216. In some embodiments, the inflected interference element 214 no longer interferes with closing the door, leading to an unblocked door in 218. In some embodiments, an unblocked door 218 is closed 220, and optionally latched in the closed position, optionally irrevocably.

    Exemplary trajectories of operation



    [0035] Reference is now made to FIGs. 3A-3B, illustrating schematic exemplary injector having an amplifier for a cartridge positioned improperly. An aspect of some embodiments of the invention relates to an elastic sensor for enhancing the detection of a position of a cartridge within an automatic injector.

    [0036] In some embodiments, an injector is supplied with housing 301 having a cartridge bay 370 for accommodating cartridge 400. In some embodiments, housing 301 further comprises door 350 for closing the opening 372 of cartridge bay 370. In some embodiments, door 350 is hingedly connected to housing 301 through hinge 354. Optionally, door 350 closes over opening 372 by rotating about a first axis defined by hinge 354, and pivotally moving towards a second axis perpendicular to the first axis, resulting in door trajectory A.

    [0037] In some embodiments, interference element 335 is positioned along the trajectory A, causing a mechanical interference for the movement of door 350 from an open position to a closed position. In some embodiments, an open position of door 350 is characterized by door 350 being unlatched to the housing, and a closed position of door 350 is characterized by door 350 being latched to the housing, optionally through latch 352 and complementary latch 302. For example, latch 352 may comprise a snap element, such as a pin, a dent, a bulge and the like, complementary to a dent, a pin or a bulge in complementary latch 302.

    [0038] In some embodiments, interference element 335 is mechanically coupled to a cartridge contact interface 330. In some embodiments, contact interface 330 is positioned along the cartridge trajectory A of inserting cartridge 400, optionally along cartridge bay. In some embodiments, contact interface 330 intersects with a trajectory of a protruding element, for example, such as flange 405, comprised in cartridge 400. Optionally, the protruding element is provided in the proximal portion of cartridge 400. Alternatively or additionally, the protruding element is provided at the distal portion of cartridge 400, potentially indicative of the positioning of the fluid outlet of the cartridge.

    [0039] In some embodiments, contact interface 330 extends into the trajectory B of cartridge 400 such that it interferes with the protruding element, but does not interfere with the body of the cartridge. Optionally, contact interface 330 is positioned at the rim 374 of opening 372. A potential advantage of placing the contact interface 330 at the rim 374 is its sensing of the cartridge position just outside the cartridge bay 370, which might be a position which due to its proximity to being fully within the cartridge bay, it may go unnoticed that the cartridge is not fully inserted. Alternatively or additionally, contact interface 330 is positioned inside the cartridge bay, optionally in proximity to the fluid path which is positioned at the distal end of the cartridge bay. In some embodiments, a mechanical connection, such as for example a rod, couples contact interface 330 with interference element 335.

    [0040] In some embodiments, as long as the cartridge 400 is not inserted and/or not fully inserted into cartridge bay 370, interference element 335 is deflected into the trajectory A of door 350, as shown for example in FIG. 3A. In some embodiments, the deflected interference element 335 is in an unstressed state. Alternatively, the deflected orientation of the interference element 335 is its stressed state.

    [0041] In some embodiments, once cartridge 400 is fully inserted into cartridge bay 370, protruding edge 405 presses against contact interface 330 and shifts its position. In some embodiments, once contact interface 330 shifts position it causes interference element 335 to inflect away from trajectory A of door 350, such as shown in FIG. 3B. Optionally, contact interface 330 is elastic. In some embodiments, protruding edge 405 presses against an unstressed contact interface 330, causing it to be pushed in the direction of trajectory B, i.e. towards the cartridge bay.

    [0042] Optionally, once cartridge 400 is fully inserted, it is locked into place by cartridge locking mechanism 308, for example, a snap or a latch. In some embodiments, locking mechanism 308 presses cartridge 400 against contact interface 330 and retains its stressed position, optionally retaining the inflected orientation of the interference element 335.

    Exemplary door blocking mechanism



    [0043] Reference is now made to FIGs. 3C-3F, illustrating a door blocking mechanism according to some embodiments of the invention. In some embodiments, door 350 connected at one side at hinge 354, is pivotally rotated along trajectory A into a closed position. The closing movement of door 350 is shown by the outline of moved door 350a.

    [0044] In some embodiments, interference element 335 comprises a deflected orientation in which it interferes with trajectory A. Optionally, interference element 335 comprises protrusion 336, for example a pin, and/or a spike, and/or a rod, and/or a wand. In some embodiments, protrusion 336 further interferes with door 350, or with a feature residing in door 350, such as for example coupling link 360, exemplified in FIGs. 3G-3H.

    [0045] In some embodiments, interference element 335 is mechanically coupled to contact interface 330. In some embodiments, contact interface comprises a surface extending into a trajectory B of inserting cartridge 400, as shown in FIG. 3E. In some embodiments, contact interface 330 is positioned at the rim 374 of opening 372 of cartridge bay 370, potentially sensing the position of cartridge 400 with respect to cartridge bay 370.

    [0046] In some embodiments, as long as cartridge bay is not properly fitted with cartridge 400, contact interface 330 extends towards the direction of inserting cartridge 400, causing interference 335 to deflect into door trajectory A, as shown in FIG. 3C. In some embodiments, once a cartridge is properly fitted within cartridge bay 370, such as shown in FIG. 3F, contact interface 330 is pressed distally into the cartridge bay in the direction of insertion of cartridge 400, causing interference 335 to inflect away from trajectory A. FIG. 3D shows an inflected orientation of interference 335 and the non-interfered door trajectory A, but the cartridge 400 is not shown in order to clearly see the mechanism.

    Exemplary gear blocking mechanism



    [0047] Reference is now made to FIGs. 3G-3H, showing blocking mechanism of an exemplary coupling link for a gearing system of an automatic injector, in accordance with some embodiments of the invention.

    [0048] In some embodiments, door 350 is provided with coupling link 360. In some embodiments, coupling link 360 serves as a mechanical coupler between a motor of the injector, for example through powering gear 362, and the cartridge, for example through driving gear 364. In some embodiments, driving gear 364 is mechanically coupled to plunger 304. In some embodiments, operating driving gear 364 drives plunger 304 towards a fluid outlet of cartridge 400, driving fluid from within cartridge 400 and out into the fluid path of the automatic injector.

    [0049] Optionally, coupling link 360 comprises a cogwheel. In some embodiments, the cogwheel comprises cogs which are complementary to the cogs in powering gear 362 and driving gear 364. In some embodiments, coupling link intefaces with powering gear 362 and driving gear 364 only when door 350 is closed. In some embodiments, interference element 335, and optionally protrusion 336, interferes directly with coupling link 360, preventing it to interface with powering gear 362 and driving gear 364 as long as cartridge 400 is not properly positioned.

    Exemplary door blocking elements



    [0050] Reference is now made to FIG. 4A, illustrating a perspective view of an unstressed interference element before cartridge insertion, in accordance with some embodiments of the invention. The interference element protrudes into the path of the door and prevents closing the door.

    [0051] In some embodiments, an automatic injector comprises a housing 301 having a cartridge bay 370 which comprises a cartridge contact interface 330. In some embodiments, contact interface 330 serves as a sensor for detecting the presence and/or position of a cartridge inserted into cartridge bay 370. In some embodiments, contact interface 330 is coupled to interference 335 serving in its deflected orientation as a mechanical block for door 350.

    [0052] In some embodiments, contact interface 330 extends from a rim 374 of cartridge bay 370, optionally ventrally location, being opposite to the closing direction of door 350. A potential advantage of positioning contact interface 330 ventrally, is to save up on the width of the housing containing the contact interface 330 and its coupled interference element 335. However, it is possible that in some embodiments, contact interface is positioned at any other location along the perimeter of rim 374.

    [0053] In some embodiments, a cartridge lock mechanism 308 is provided for locking in the cartridge once it is positioned correctly in cartridge bay 370. Optionally, cartridge lock 308 is positioned along rim 374.

    Exemplary door and gear blocking elements



    [0054] Reference is now made to FIG. 4B, illustrating a door and gear stop mechanism, in accordance with some embodiments of the invention. Shown here is a cartridge not fully inserted and the interference mechanism is in an unstressed state blocking the door.

    [0055] In some embodiments, cartridge 400 is inserted into cartridge bay 370 by first inserting its distal end 404 having the fluid outlet, and lastly inserting its proximal end 402, optionally having flange 405. In some embodiments, once cartridge 400 is inserted sufficiently into cartridge bay 370, flange 405 presses against contact interface 330 and shifts it towards the distal end. In some embodiments, the coupled interference element 335 inflects away from the closing trajectory of door 350 and/or coupling gear 360, enabling to close the injector once the cartridge 400 is correctly placed.

    [0056] Optionally, cartridge 400 is locked in this position even when the door is not closed, through lock 308.

    Exemplary closed configuration



    [0057] Reference is now made to FIG. 5, showing the cartridge fully inserted and the door closed, in a side cross-section of the automatic injector, and in accordance with some embodiments of the invention.

    [0058] In some embodiments, as the cartridge 400 is fully pushed distally into the cartridge bay 370, the poximal flange 405 of the cartridge pushes a contact interface 330 of the door stopper in the distal direction, optionally flexing the door stopper and inflecting the interference element 335 out of the way of the door.

    [0059] In some embodiments, once the cartridge 400 is fully inserted, a cartridge lock mechanism 308 locks the cartridge in place with the door stopper 335 out of the path of the door. Optionally, when the cartridge is locked, a user receives tactile feedback that the cartridge is in place. For example, the feedback may include a click of the lock mechanism and a cessation of proximal force pushing the cartridge out of the bay by the door stop interface, due to the proximal force exerted by the door stop being now held by the locking mechanism.

    Exemplary usage



    [0060] Reference is now made to FIGs. 6A-6D, wherein FIG. 6A, is a rear view illustration of an embodiment without the cartridge 400 inserted, FIGs. 6B-6C are rear view illustrations of embodiments with the cartridge 400 not fully inserted, and FIG. 6D is a rear view illustration of an embodiment having the cartridge 400 fully inserted. In FIG. 6A, the interference element 335 blocks movement of a drive gear 360 connected to the door 350, preventing closure of the door 350.

    [0061] When a cartridge is inserted, but not sufficiently, as shown in FIGs. 6B and 6C, the door 350 cannot close due to mechanical interference. In some embodiments, such as shown in FIG. 6B, when the cartridge is inserted to the extent that it does not mechanically engage with contact interface 330, then interference element 335 is not deflected away from the trajectory of door 350 and the door is inhibited from closing. In some embodiments, when the cartridge is inserted to the extent that it does engage with contact interface 330 and therefore causing the interference element 335 to deflect, if the cartridge is still not fully inserted then the cartridge flange 405 mechanically interferes with the trajectory of closing the door.

    [0062] In some embodiments, contact interface 330 is elastic, and when the cartridge is not fully inserted, contact interface 330 exerts an opposing force to the insertion of the cartridge, causing the cartridge to stick out of the cartridge bay 370, amplifying the presence of the cartridge in an improper position.

    [0063] Once the cartridge is inserted at FIG. 6D, the locking mechanism 308 blocks rearward (proximal) movement of the rear (proximal) flange 405 of the cartridge 400, locking the cartridge in the fully inserted position. The proximal flange 405 of the cartridge 400 pushes the contact interface 330 forward (distally) so that the drive gear 360 clears the interference element 335 allowing the door to close.

    General



    [0064] As used herein the term "about" refers to ± 25 %. The terms "comprises", "comprising", "includes", "including", "having" and their conjugates mean "including but not limited to".

    [0065] The term "consisting of' means "including and limited to".

    [0066] The term "consisting essentially of' means that the composition, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

    [0067] As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise.


    Claims

    1. An automatic injector device for delivering a pharmaceutical substance from a cartridge (400) having a protruding edge (405), said cartridge positioned in a housing (301) of said device, said housing comprising:

    a cartridge bay (370) having an opening (372) sized to allow passage of said cartridge into said cartridge bay;

    a door (350) to said cartridge bay opening, said door connected to said housing and having an unlatched position and a latched position, said door defining a trajectory between the unlatched position and the latched position;

    an interference element (335) having a deflected and an inflected orientation, said deflected orientation mechanically interferes with said trajectory of said door; and

    a contact interface (330) positioned along said cartridge bay and extending up to said protruding edge, said contact interface mechanically couples said deflected and inflected orientation of the interference element with a sensed contact of said protruding edge, such that when said protruding edge is positioned at said contact interface, said contact interface shifts said interference element into said inflected orientation.


     
    2. The device of claim 1, wherein said door further comprises a coupling link, positioned to mechanically link said cartridge with a motor, when said door is in the latched position.
     
    3. The device of claim 2, wherein said coupling link comprises a gear having cogs complementary to a powering gear of said motor and a driving gear of said cartridge.
     
    4. The device of claim 3, wherein said driving gear is mechanically coupled to a plunger residing within said cartridge.
     
    5. The device of claim 1, wherein said contact interface is positioned at a rim of said opening of said cartridge bay.
     
    6. The device of claim 1, wherein said contact interface is elastic.
     
    7. The device of claim 6, wherein said deflected orientation comprises an unstressed configuration of said interference element and said inflected orientation comprises a stressed configuration of said interference element.
     
    8. The device of claim 6, wherein said contact interface mechanically interferes with a location of said protruding edge of said cartridge residing beyond said rim and outside of said cartridge bay.
     
    9. The device of claim 8, wherein said location comprises a range of about 0.5 mm to about 3 mm beyond said rim and outside of said cartridge bay.
     
    10. The device of claim 1, further comprising a cartridge lock positioned at said rim.
     
    11. The device of claim 10, wherein said cartridge lock comprises a snap mechanism shaped to snap over a proximal edge of said cartridge and mechanically press against said cartridge, when said cartridge is positioned in said cartridge bay and said protruding edge contacts said contacts interface.
     
    12. The device of claim 1, wherein a transition from said unlatched position to said latched position of said door is irrevocable.
     
    13. The device of claim 12, wherein said door is pivotable about a first axis parallel to said cartridge bay and wherein said door is rotatable about a second axis which is perpendicular to the first axis.
     
    14. A method for amplifying a position of a cartridge having a protruding edge in a housing of an automatic injector, said housing having a door for closing the cartridge inserted into a cartridge bay of said housing, comprising:

    mechanically interfering with a trajectory of closing said door through a deflected interference element;

    inserting said cartridge into said cartridge bay of said housing;

    pressing said protruding edge of said cartridge against a contact interface positioned along said cartridge bay, said contact interface mechanically coupled to said deflected interference element;

    shifting the position of said contact interface, thereby inflecting said interference element away from said trajectory of said door; and

    latching said door in a closed position.


     
    15. The method of claim 14, wherein said latching said door in said closed position further comprises positioning a coupling link between a driving system of said cartridge and a motor of said injector.
     
    16. The method of claim 14, wherein said inserting said cartridge further comprises inserting at least 95% of said cartridge before said protruding edge of said cartridge is pressed against said contact interface.
     
    17. The method of claim 16, further comprising pushing said cartridge away from said cartridge bay when less than 95% of said cartridge is inserted.
     
    18. The method of claim 17, wherein said pushing comprises preventing a proximal edge of said cartridge from residing in a range of about 0.5 mm to about 3 mm outside of said cartridge bay.
     
    19. The method of claim 14, further comprising locking a position of said cartridge following said pressing of said protruding edge against said contact interface.
     
    20. The method of claim 19, wherein said locking a position of said cartridge comprises locking said pressing of said protruding edge against said contact interface and locking said interference element in an inflected orientation.
     


    Ansprüche

    1. Automatischer-Injektor-Vorrichtung zum Zuführen einer pharmazeutischen Substanz von einer Kassette (400) aus, die einen vorstehenden Rand (405) hat, wobei die Kassette in einem Gehäuse (301) der Vorrichtung positioniert ist, wobei das Gehäuse aufweist:

    einen Kassetten-Schacht (370) mit einer Öffnung (372), die größenbemessen ist, um das Passieren der Kassette in den Kassettenschacht zu erlauben,

    eine Tür (350) zu der Kassettenschacht-Öffnung, wobei die Tür mit dem Gehäuse verbunden ist und eine Entriegelungsposition und eine Verriegelungsposition hat, wobei die Tür eine Bewegungsbahn zwischen der Entriegelungsposition und der Verriegelungsposition definiert,

    ein Interferier-Element (335), das eine ausgelenkt- und eine eingelenkt-Orientierung hat, wobei die ausgelenkt-Orientierung mechanisch mit der Bewegungsbahn der Tür interferiert, und

    eine Kontaktschnittstelle (330), die entlang des Kassettenschachts positioniert ist und sich bis zu dem vorstehenden Rand hin erstreckt, wobei die Kontaktschnittstelle die ausgelenkt- und eingelenkt-Orientierung des Interferier-Elements mit einem abgetasteten Kontakt des vorstehenden Rands mechanisch kuppelt, sodass, wenn der vorstehende Rand an der Kontaktschnittstelle positioniert ist, die Kontaktschnittstelle das Interferier-Element in die eingelenkt-Orientierung verschiebt.


     
    2. Vorrichtung gemäß Anspruch 1, wobei die Tür ferner aufweist eine Kupplungsverbindung, die positioniert ist, um die Kassette mechanisch mit einem Motor zu verbinden, wenn die Tür in der Verriegelungsposition ist.
     
    3. Vorrichtung gemäß Anspruch 2, wobei die Kupplungsverbindung ein Zahnrad mit Zähnen hat, das komplementär ist zu einem Leistungsantriebszahnrad des Motors und einem Antriebszahnrad der Kassette.
     
    4. Vorrichtung gemäß Anspruch 3, wobei das Antriebszahnrad mit einem Kolben mechanisch gekuppelt ist, der in der Kassette untergebracht ist.
     
    5. Vorrichtung gemäß Anspruch 1, wobei die Kontaktschnittstelle an einem Rand der Öffnung des Kassettenschachts positioniert ist.
     
    6. Vorrichtung gemäß Anspruch 1, wobei die Kontaktschnittstelle elastisch ist.
     
    7. Vorrichtung gemäß Anspruch 6, wobei die ausgelenkt-Orientierung eine unbelastet-Konfiguration des Interferier-Elements aufweist und die eingelenkt-Orientierung eine belastet-Konfiguration des Interferier-Elements aufweist.
     
    8. Vorrichtung gemäß Anspruch 6, wobei die Kontaktschnittstelle mit einer Position des vorstehenden Rands der Kassette mechanisch interferiert, die über den Rand hinaus und außerhalb des Kassettenschachts angesiedelt ist.
     
    9. Vorrichtung gemäß Anspruch 8, wobei die Position einen Bereich von etwa 0,5 mm bis etwa 3 mm über den Rand hinaus und außerhalb des Kassettenschachts umfasst.
     
    10. Vorrichtung gemäß Anspruch 1, ferner aufweisend einen Kassettenriegel der an dem Rand positioniert ist.
     
    11. Vorrichtung gemäß Anspruch 10, wobei der Kassettenriegel aufweist einen Rastmechanismus, der gestaltet ist, um über einen proximalen Rand der Kassette zu rasten und mechanisch gegen die Kassette zu drücken, wenn die Kassette im Kassettenschacht positioniert ist und der vorstehende Rand die Kontaktschnittstelle kontaktiert.
     
    12. Vorrichtung gemäß Anspruch 1, wobei ein Übergang von der Entriegelungsposition zu der Verriegelungsposition der Tür unumkehrbar ist.
     
    13. Vorrichtung gemäß Anspruch 12, wobei die Tür um eine erste Achse parallel zu dem Kassettenschacht schwenkbar ist und wobei die Tür um eine zweite Achse rotierbar ist, welche zu der ersten Achse senkrecht ist.
     
    14. Verfahren zum Verstärken einer Position einer Kassette, die einen vorstehenden Rand hat, in einem Gehäuse eines automatischen Injektors, wobei das Gehäuse eine Tür hat zum Schließen der in einen Kassettenschacht des Gehäuses eingesetzten Kassette, aufweisend:

    mechanisches Interferieren mit einer Schließen-Bewegungsbahn der Tür mittels eines ausgelenkten Interferier-Elements,

    Einsetzen der Kassette in den Kassettenschacht des Gehäuses,

    Pressen des vorstehenden Rands der Kassette gegen eine Kontaktschnittstelle, die entlang des Kassettenschachts positioniert ist, wobei die mechanische Kontaktschnittstelle mit dem ausgelenkten Interferier-Element mechanisch gekuppelt ist,

    Verschieben der Position der Kontaktschnittstelle, dadurch einlenkend des Interferier-Elements weg von der Bewegungsbahn der Tür, und

    Verriegeln der Tür in einer geschlossen-Position.


     
    15. Verfahren gemäß Anspruch 14, wobei das Verriegeln der Tür in der geschlossen-Position ferner aufweist Positionieren einer Kupplungsverbindung zwischen einem Antriebssystem der Kassette und einem Motor des Injektors.
     
    16. Verfahren gemäß Anspruch 14, wobei das Einsetzen der Kassette ferner aufweist Einsetzen von wenigstens 95% der Kassette bevor der vorstehende Rand der Kassette gegen die Kontaktschnittstelle gedrückt wird.
     
    17. Verfahren gemäß Anspruch 16, ferner aufweisend Drücken der Kassette weg vom Kassettenschacht, wenn weniger als 95% der Kassette eingesetzt ist.
     
    18. Verfahren gemäß Anspruch 17, wobei das Drücken aufweist Verhindern, dass ein proximaler Rand der Kassette in einen Bereich von 0,5 mm bis etwa 3 mm außerhalb des Kassettenschachts gelangt.
     
    19. Verfahren gemäß Anspruch 14, ferner aufweisend Verriegeln einer Position der Kassette folgend dem Drücken des vorstehenden Rands gegen die Kontaktschnittstelle.
     
    20. Verfahren gemäß Anspruch 19, wobei das Verriegeln einer Position der Kassette aufweist Verriegeln des Drückens des vorstehenden Rands gegen die Kontaktschnittstelle und Verriegeln des Interferier-Elements in einer eingelenkt-Orientierung.
     


    Revendications

    1. Dispositif d'injection automatique pour délivrer une substance pharmaceutique à partir d'une cartouche (400) ayant un bord faisant saillie (405), ladite cartouche étant positionnée dans un logement (301) dudit dispositif, ledit logement comprenant :

    un compartiment de cartouche (370) présentant une ouverture (372) calibrée pour permettre le passage de ladite cartouche dans ledit compartiment de cartouche ;

    une porte (350) vers ladite ouverture de compartiment de cartouche, ladite porte étant reliée audit logement et ayant une position déverrouillée et une position verrouillée, ladite porte définissant une trajectoire entre la position déverrouillée et la position verrouillée ;

    un élément d'interférence (335) ayant une orientation déviée et infléchie, ladite orientation déviée interférant mécaniquement avec ladite trajectoire de ladite porte ; et

    une interface de contact (330) positionnée le long dudit compartiment de cartouche et s'étendant jusqu'au dit bord faisant saillie, ladite interface de contact couplant mécaniquement ladite orientation déviée et infléchie de l'élément d'interférence avec un contact détecté dudit bord faisant saillie, de telle sorte que lorsque ledit bord faisant saillie est positionné au niveau de ladite interface de contact, ladite interface de contact décale ledit élément d'interférence dans ladite orientation infléchie.


     
    2. Dispositif selon la revendication 1, dans lequel ladite porte comprend en outre une liaison de couplage, positionnée pour relier mécaniquement ladite cartouche avec un moteur, lorsque ladite porte est dans la position verrouillée.
     
    3. Dispositif selon la revendication 2, dans lequel ladite liaison de couplage comprend un engrenage ayant des pignons complémentaires à un engrenage d'alimentation dudit moteur et un engrenage d'entraînement de ladite cartouche.
     
    4. Dispositif selon la revendication 3, dans lequel ledit engrenage d'entraînement est couplé mécaniquement à un piston résidant à l'intérieur de ladite cartouche.
     
    5. Dispositif selon la revendication 1, dans lequel ladite interface de contact est positionnée au niveau d'un rebord de ladite ouverture dudit compartiment de cartouche.
     
    6. Dispositif selon la revendication 1, dans lequel ladite interface de contact est élastique.
     
    7. Dispositif selon la revendication 6, dans lequel ladite orientation déviée comprend une configuration non contrainte dudit élément d'interférence et ladite orientation infléchie comprend une configuration contrainte dudit élément d'interférence.
     
    8. Dispositif selon la revendication 6, dans lequel ladite interface de contact interfère mécaniquement avec un emplacement dudit bord faisant saillie de ladite cartouche résidant au-delà dudit rebord et à l'extérieur dudit compartiment de cartouche.
     
    9. Dispositif selon la revendication 8, dans lequel ledit emplacement comprend une étendue d'environ 0,5 mm à environ 3 mm au-delà dudit rebord et à l'extérieur dudit compartiment de cartouche.
     
    10. Dispositif selon la revendication 1, comprenant en outre un verrou de cartouche positionné au niveau dudit rebord.
     
    11. Dispositif selon la revendication 10, dans lequel ledit verrou de cartouche comprend un mécanisme d'encliquetage conçu pour s'encliqueter sur un bord proximal de ladite cartouche et presser mécaniquement contre ladite cartouche, lorsque ladite cartouche est positionnée dans ledit compartiment de cartouche et ledit bord faisant saillie vient en contact avec ladite interface de contact.
     
    12. Dispositif selon la revendication 1, dans lequel une transition de ladite position déverrouillée à ladite position verrouillée de ladite porte est irrévocable.
     
    13. Dispositif selon la revendication 12, dans lequel ladite porte peut pivoter autour d'un premier axe parallèle audit compartiment de cartouche et dans lequel ladite porte peut tourner autour d'un second axe qui est perpendiculaire au premier axe.
     
    14. Méthode pour amplifier une position d'une cartouche ayant un bord faisant saillie dans un logement d'un dispositif d'injection automatique, ledit logement ayant une porte pour fermer la cartouche insérée dans un compartiment de cartouche dudit logement, comprenant les étapes consistant à :

    interférer mécaniquement avec une trajectoire de fermeture de ladite porte à travers un élément d'interférence dévié ;

    insérer ladite cartouche dans ledit compartiment de cartouche dudit logement ;

    presser ledit bord faisant saillie de ladite cartouche contre une interface de contact positionnée le long dudit compartiment de cartouche, ladite interface de contact étant couplée mécaniquement audit élément d'interférence dévié ;

    décaler la position de ladite interface de contact, en infléchissant ainsi ledit élément d'interférence à l'écart de ladite trajectoire de ladite porte ; et

    verrouiller ladite porte dans une position fermée.


     
    15. Méthode selon la revendication 14, dans laquelle ledit verrouillage de ladite porte dans ladite position fermée comprend en outre le positionnement d'une liaison de couplage entre un système d'entraînement de ladite cartouche et un moteur dudit dispositif d'injection.
     
    16. Méthode selon la revendication 14, dans laquelle ladite insertion de ladite cartouche comprend en outre l'insertion d'au moins 95 % de ladite cartouche avant que ledit bord faisant saillie de ladite cartouche soit pressé contre ladite interface de contact.
     
    17. Méthode selon la revendication 16, comprenant en outre une poussée de ladite cartouche loin dudit compartiment de cartouche lors d'une insertion de moins de 95 % de ladite cartouche.
     
    18. Méthode selon la revendication 17, dans laquelle ladite poussée comprend l'étape consistant à empêcher un bord proximal de ladite cartouche de résider dans une étendue d'environ 0,5 mm à environ 3 mm à l'extérieur dudit compartiment de cartouche.
     
    19. Méthode selon la revendication 14, comprenant en outre le verrouillage d'une position de ladite cartouche après ladite pression dudit bord faisant saillie contre ladite interface de contact.
     
    20. Méthode selon la revendication 19, dans laquelle ledit verrouillage d'une position de ladite cartouche comprend le verrouillage de ladite pression dudit bord faisant saillie contre ladite interface de contact et le verrouillage dudit élément d'interférence dans une orientation infléchie.
     




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    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description