Abstract:
An injection device including a receiving device movable in an insertion movement relative to the injection device, a tensioning element, e.g. a spring, which bears on a part of the injection device, and a coupling element for coupling the receiving device to the spring such that, during an insertion movement of the receiving device the spring is tensioned. In some embodiments, the invention encompasses a method for preparing an injection device for dispensing a substance from an ampoule, wherein a discharging spring of the injection device is tensioned by introduction of the ampoule into the injection device.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of International Patent Application No. PCT/CH2007/000177 filed Apr. 12, 2007, and claims priority to German Application No. DE 10 2006 017 209.4 filed Apr. 12, 2006, the entire contents of both of which are incorporated herein by reference. 
    
    
     BACKGROUND 
     The present invention relates to devices for injecting, dispensing, administering, infusing or delivering a substance, and to methods of making and using such devices. More particularly, it relates to a device for dispensing a substance, e.g. an injection device or an injection pen, which has a spring for administering a measured dose of an injectable product or substance from an ampoule, a double-chamber ampoule, for example. Some embodiments of such a device may be used for self-administering the product or substance. In some embodiments, the device may take the form of a disposable injection device or injector, in others, an automatic injection device or automatic injection pen. 
     U.S. Pat. No. 5,104,380 discloses an injection device wherein the injection needle is fitted on the device manually and the subsequent dispensing of an active substance from the device takes place automatically by a drive. The drive is provided in the form of a spring, which is tensioned by a movement of a dose setting element to set a desired dose to be administered. The spring is blocked or locked in the tensed state until activated. Upon activation, it automatically drives a dispensing mechanism, which drives or moves the active substance through the injection needle. 
     SUMMARY 
     One object of embodiments of the present invention is to provide an injection device and a method of preparing an injection device which simplify handling of such injection devices. 
     Thus, in one embodiment, the present invention comprises an injection device comprising a plunger rod, a container for a substance to be dispensed, wherein the container is able to be inserted in the injection device and, after being inserted, is able to move relative to the injection device, a dispensing spring supported on a part of the injection device, and a coupling element for coupling the container with the dispensing spring so that the spring is tensioned when the container is inserted, the tensioned spring acting on the plunger rod to cause an amount of the substance to be dispensed. 
     In one embodiment, the present invention comprises an injection device including a receiving device movable in an insertion movement relative to the injection device, a tensioning element, e.g. a spring, which bears on a part of the injection device, and a coupling element for coupling the receiving device to the spring such that, during an insertion movement of the receiving device the spring is tensioned. In some embodiments, the invention encompasses a method for preparing an injection device for dispensing a substance from an ampoule, wherein a discharging spring of the injection device is tensioned by introduction of the ampoule into the injection device. 
     In one embodiment, the present invention relates to an injection device with a receiving device for a substance to be dispensed, in particular with an ampoule holder, which is movable relative to the injection device or a part thereof, with a tensioning element, in particular a spring, which can bear on a part of the injection device, and with a coupling element for coupling the receiving device to the spring such that, during an insertion movement of the receiving device into the injection device, the spring can be tensioned. The invention also relates to a method for preparing an injection device for dispensing a substance from an ampoule, wherein a discharging spring of the injection device is tensioned by introduction of the ampoule into the injection device 
     In one embodiment, an injection device in accordance with the present invention comprises a holder device for a substance to be administered, in which the substance to be administered can be either introduced, housed directly or contained, for example in a single-chamber or double-chamber ampoule, in which case the holder device will be designed as an ampoule holder. The holder device can be moved relative to the injection device, e.g., relative to a housing portion of an injection pen. In some embodiments, an element of the injection device serving as the holder or the ampoule holder, for example, can be pushed or screwed into the injection device or into a part of it, for example into the housing of the injection device. If using a known double-chamber ampoule, the substances contained in the double-chamber ampoule can be mixed during the pushing or screwing operation and are thus prepared for administering to a patient. 
     In some embodiments, a tensioning element is disposed on or in the injection device. The tensioning element may be a suitable spring supported at one end against an element in or on the injection device or on its housing, such as a ring or a disc provided for this purpose. In some embodiments, the tensioning element can be tensioned in the direction pointing away from the supported end or surface by a tensioning or coupling element which can be connected to or coupled with the holder device, e.g. the ampoule holder, as an ampoule is introduced and/or the holder device is pushed in or screwed in. 
     In some embodiments, tensioned by introducing an ampoule in accordance with the present invention, the spring may be held in the tensioned state by a coupling element which may be provided in the form of a sliding sleeve or stroke sleeve, until the coupling element, which maintains the spring tension due to a coupling with the ampoule housing, is uncoupled from the ampoule housing by operating a trigger or actuator, thereby enabling the spring to relax. The spring may act on a plunger rod, part of the mechanism that enables an injection or dispensing, directly or via the coupling element, and can push it in the distal direction so that one or more stoppers are pushed into the ampoule by a movement of the plunger rod in the distal direction, thereby forcing or urging a substance out of the ampoule and dispensing it for the injection. 
     In some embodiments, the coupling element may be integrated in the holder device or ampoule holder, connected to it, mounted on it or secured to it by a releasable connection, such as a retaining or catch element. In some embodiments, the coupling element is not coupled with the ampoule holder until the ampoule holder has been inserted and/or moved. For example, the coupling element may have at least one and, in some preferred embodiments, two or more retaining or catch elements, to permit an operable coupling or connection with or between the ampoule holder and/or the plunger rod. To this end, the retaining or catch elements may be biased radially inwardly and/or outwardly and, in the case of a cylindrical or sleeve-shaped coupling element pushed inwardly, in a direction toward the plunger rod, and/or outwardly in the direction of a housing or housing portion of the injection device. 
     In some embodiments, the one or more retaining or catch elements may have oblique surfaces or part-pieces which are not perpendicular to the longitudinal axis of the injection device or, in other words, which converge in a conical arrangement. A member pushing on the coupling element in the axial direction of the injection device, such as an element connected to a trigger button or setting ring, releases a retaining or catch element holding the coupling element in an axially fixed position from a coupling or catch connection with the housing of the injection device to release the coupling element. The coupling element is moved by the pressure of the spring as it is biased in the distal direction of the injection device when the ampoule is being pushed on. This pushing movement of the coupling element can be transmitted to the plunger rod via a coupling or catch connection. 
     In some embodiments, the coupling element is mounted so that it is prevented from rotating on the plunger rod. For example, the plunger rod may have a non-round profile, e.g. a rectangular or square cross-section, in which case the coupling element may be sleeve shaped and may have a guide region in which the plunger rod is guided as it slides axially so that the coupling element can be moved along the plunger rod in the axial direction. A groove or web may also be provided in or on the plunger rod in the longitudinal direction, in which case a co-operating complementary element may be provided on the coupling element, e.g. a suitable web or a groove. 
     In some preferred embodiments, the ampoule holder is connected to the injection device or a housing thereof by a thread or threads so that the ampoule holder can be screwed into the injection device. The ampoule holder has an external thread, which can be turned in an internal thread of the injection device. Another option would be to push or slide the ampoule holder into the injection device without any relative rotating movement. 
     In some embodiments, a dose setting ring is provided on the injection device to set or select the dose to be dispensed. In some embodiments, the dose setting ring is blocked or locked, i.e. can not be rotated relative to the injection device or can be rotated only to a very limited degree, until an ampoule has been fully inserted. To this end, one or more stops are provided on the dose setting ring, which are able to move unhindered when the ampoule holder is in the inserted state. The stops run or extend at least partially inside a groove, e.g. an annular groove. The groove may be provided in a functional sleeve disposed in the interior of the housing. In the state in which the ampoule holder has not been inserted, the stops lie opposite one or more complementary stops so that their movement is blocked or prevented. The complementary stops may be moved out of the path of movement of the stops of the dose setting ring by inserting the ampoule holder so that the dose setting ring can be freely rotated to set the dose. To this end, the functional sleeve can be pushed relative to the dose setting ring as a whole or the functional sleeve may be split so that only a part of the functional sleeve slides as the ampoule holder is inserted so that complementary stops are moved out of the annular groove. 
     In some embodiments, the trigger button for actuating the dispensing operation is coupled with the dose setting ring so that when setting a dose by using the setting ring, the trigger button is moved out of the housing of the injection device. To this end, a thread-type coupling may be provided between the trigger button and setting ring, so that a trigger button mounted so that it can not rotate and is moved out of the injection device due to a rotation of the setting ring. 
     In one embodiment, the trigger button is prevented from rotating but is mounted so that it can be moved axially on the dose setting ring. Due to the rotating movement of the dose setting ring, the trigger button can be moved axially relative to the dose setting ring along a guide arrangement. A suitable guide arrangement might be provided by mutually adapted oblique surfaces on the trigger button and an element which is prevented from rotating relative to the dose setting ring. The trigger button is recessed so far into the housing or into the dose setting ring that it is inaccessible until it has been activated by inserting the ampoule holder or turning the dose setting ring. 
     When the setting operation has been completed, the trigger button is extended in a position in which it can be activated. Dispensing can be triggered by operating, e.g. pushing or touching, the trigger button. In this respect, the trigger button is moved back to or into a recessed position in which it inaccessible for further operation. In one preferred embodiment, the dose setting ring is also returned to a blocked or locked position once the substance has been dispensed, i.e. when the trigger button has been operated. The injection device is then completely locked to prevent further operation after performing one dispensing operation. It is then not possible to set another dose or operate the trigger button again. The injection device, e.g. pen, is fully locked. 
     In some embodiments, the invention comprises a method of preparing an injection device for dispensing a substance from an ampoule, whereby a spring contained in the injection device is tensioned by pushing an ampoule or an ampoule holder relative to, e.g. into, the injection device or its housing. An injection takes place due to the fact that the tensed spring is relaxed after a trigger or actuating button has been operated and a force is exerted on a plunger rod which pushes into the ampoule. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1A and 1B  are longitudinal sectional views of an embodiment of an injection device in accordance with the present invention with a dispensing spring, wherein the spring is relaxed before an ampoule is screwed into the device; 
         FIGS. 1C and 1D  are side views, perpendicular to one another, showing the injection device illustrated in  FIGS. 1A and 1B ; 
         FIGS. 2A and 2B  are longitudinal sectional views showing an embodiment of an injection device in accordance with the present invention after an ampoule has been screwed into the device, the dispensing spring being tensed; 
         FIGS. 2C and 2D  are side views, perpendicular to one another, showing the injection device illustrated in  FIGS. 2A and 2B ; 
         FIGS. 3A and 3B  are longitudinal sectional views showing an embodiment of an injection device in accordance with the present invention after a dose has been set by using a setting ring, with the trigger button extracted; and 
         FIGS. 3C and 3D  are side views, perpendicular to one another, showing the injection device illustrated in  FIGS. 3A and 3B ; 
         FIGS. 4A and 4B  are longitudinal sectional views showing an embodiment of an injection device in accordance with the present invention in n end position after pressing in the trigger button and releasing the spring to dispense a dose; 
         FIGS. 4C and 4D  are side views, perpendicular to one another, showing the injection device illustrated in  FIGS. 4A and 4B . 
     
    
    
     DETAILED DESCRIPTION 
     With regard to fastening, mounting, attaching or connecting components of embodiments of the present invention, unless specifically described otherwise, conventional mechanical fasteners and methods may be used. Other appropriate fastening or attachment methods include adhesives, welding and soldering, the latter particularly with regard to the electrical system of the invention, if any. In embodiments with electrical features or components, suitable electrical components and circuitry, wires, wireless components, chips, boards, microprocessors, inputs, outputs, displays, control components, etc. may be used. Generally, unless otherwise indicated, the materials for making embodiments of the invention and/or its components may be selected from appropriate materials such as metal, metallic alloys, ceramics, plastics, etc. 
       FIG. 1A  is a cross-section in the longitudinal direction of an embodiment of an injection device in accordance with the present invention, also illustrated in  FIG. 1C , with an ampoule holder  2  in which an ampoule  3  is inserted, partially screwed into an internal thread  4   a  of the housing  4  of the injection device by using the external thread  2   a  of the ampoule holder  2 . The ampoule  3  is a double-chamber ampoule and has two stoppers  3   a  and  3   b , which close off two substances in the ampoule  3  which have to be mixed and are separated from one another in an initial position. In the axial direction, a plunger rod  1  is locked by a ring  1   b  projecting radially out from the plunger rod  1  to prevent it from moving in the proximal direction. The ring lies against a passage orifice formed by webs  4   b , the passage orifice being smaller than the external diameter of the ring  1   b . A sliding sleeve or stroke sleeve  5  is disposed on the plunger rod  1  so that it is prevented from rotating but is able to slide on the plunger rod  1 . 
       FIG. 1B  is a cross-section illustrating the device shown in  FIG. 1A  in section through a plane illustrated in  FIG. 1D , which is perpendicular to the plane shown in section in  FIG. 1A . The sliding sleeve  5  has catch elements  5   a  biased radially inwardly, which locate in recesses  1   c  of the plunger rod  1  and are thus relaxed in an initial position. A spring  6  is supported against a contact surface  4   b  in the interior of the injection device and is relaxed in the position illustrated in  FIGS. 1A-D . 
     When the ampoule holder  2  is turned into the housing  4 , the rear stopper  3   b  of the ampoule  3  comes into contact with a contact element  1   e  of the plunger rod  1 . When the ampoule holder  2  is turned further relative to the ampoule  3 , the substances contained in the double-chamber ampoule  3  are mixed. 
       FIG. 2A , and  FIGS. 2C and 2D , illustrates the injection device shown in  FIG. 1A  after screwing the ampoule holder  2  into the housing  4 . The sliding sleeve  5 , which is coupled with the ampoule holder  2  by retaining elements  5   b  biased radially outwardly, was pushed in the proximal (rearward) direction of the injection device due to the screwing-in movement of the ampoule holder  2 . It therefore causes the spring  6  to be tensioned between the contact surfaces  4   b  and  5   c . In some embodiments, the spring is in contact with the proximal surface  5   c  of the sliding sleeve  5  during the ampoule screwing-in movement, or part of it, and is compressed by the sliding sleeve  5  and thus tensioned. The locating elements  5   a  of the sliding sleeve  5  biased radially inwardly are pulled out of the recesses  1   c  of the plunger rod  1  and locate in or move into the rear recesses  1   d  of the plunger rod  1  in the position illustrated in  FIG. 2B . 
     Before the ampoule holder  2  is screwed in, the dose setting ring is not able to rotate relative to the housing  4 . To this end, the dose setting ring has stops, which are provided on flexible arms disposed in the circumferential direction. The stops move opposite an annular groove disposed in a functional sleeve. During a dose setting movement, the stops are pushed into the annular groove due to a movement of the flexible arms because teeth are provided opposite to the arms, along which the arms are moved, generating an audible clicking noise. As the flexible arms run across the teeth, they are pushed into the annular groove by each tooth. The functional sleeve is prevented from rotating relative to the housing and is of a two-part design, which two parts are able to slide telescopically relative to one another. When the parts of the functional sleeve are in the state extracted from one another, complementary stops move so that they lie inside the annular groove and sit opposite the stops on the dose setting ring, blocking or locking the dose setting ring to prevent it from rotating. When the parts of the functional sleeve are in the state in which they are axially pushed together, the complementary stops move so that they lie outside the track of the annular groove so that the dose setting ring can be rotated. The parts of the functional sleeve are pushed together by screwing in the ampoule holder  2 . The dose setting ring can therefore not be rotated until the ampoule holder  2  has been inserted. 
       FIG. 3A , and  FIGS. 3C and 3D , illustrates the injection device illustrated in  2 A after the setting ring  9  has been rotated to set or select a dose and the trigger button  7  has been extracted or extended from the injection device by a guiding action due to the setting movement of the setting ring  9 . To this end, a proximally extending projection with an oblique surface is provided on a proximal end face of the functional sleeve. A distally (forwardly) extending projection with an oblique surface is provided on a distal end face of the trigger button, which complements the surface of the functional sleeve. As the dose setting ring is turned, the trigger button is driven with it and rotated relative to the functional sleeve, and the oblique surfaces slide off one another and thus push the trigger button axially relative to the functional sleeve and the dose setting ring. The trigger button is transferred from a recessed state into an operable state as a result. 
     When the trigger button is pushed into the injection device, the functional sleeve acts on the sliding element  5  and releases the spring. This being the case, the functional sleeve therefore acts as a releasing element  8 . 
     Grooves of differing axial lengths  11  and  12  are provided on the internal face of the trigger button  7 , as illustrated by the grooves  7   a  and  7   b  in  FIG. 3B , which fix the maximum possible axial movement of the plunger rod  1 . The rod  1  has a lug  1   a  at its proximal end, which moves against a stop  7   c  or  7   d  bounding the respective grooves  7   a ,  7   b  once the plunger rod  1  biased by the spring  6  has been released, thereby fixing the maximum possible dose which can be dispensed. 
     When the trigger button  7  is pushed into the injection device as illustrated in  FIG. 4A , and  FIGS. 4C and 4D , the retaining element  5   b  biased radially outwardly holding the sliding sleeve  5  on the proximal end of the ampoule holder  2 , by which the releasing element  8  co-operating with the button  7  pushes against an oblique surface  5   c  of the retaining element  5   b  and thus pushes it radially inwardly, is released from its engagement with the ampoule holder  2  so that the sliding sleeve  5  is no longer locked relative to the injection device in the axial direction. The spring  6  pushing on the sliding sleeve  5  pushes the sliding sleeve  5  in the distal (forward) direction. Since the sliding sleeve  5  drives the plunger rod  1  with it by the catch elements  5   a  biased radially inwardly and locating in the recesses  1   d  of the plunger rod  1 , the plunger rod  1  is pushed into the ampoule  3  and thus pushes on the rear stopper  3   b , thereby causing the mixed substance contained in the ampoule  3  to be dispensed. 
     In the position illustrated in  FIG. 4B , after the dose has been dispensed from the ampoule  3 , the trigger button  7  is held in the injection device by the lug  1   a  of the plunger rod  1  and can no longer be pulled out, so that the injection device can no longer be used for another injection. 
     Embodiments of the present invention, including preferred embodiments, have been presented for the purpose of illustration and description. They are not intended to be exhaustive or to limit the present invention to the precise forms and steps disclosed. The embodiments were chosen and described to provide the best illustration of the principles of the invention and the practical application thereof, and to enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth they are fairly, legally, and equitably entitled.