Extractable dose setting knob

[0001] This application claims priority to German Application No. DE 10 2006 002 383.8, filed on Jan. 17, 2006 and German Application No. DE 10 2006 004 563.7, filed on Feb. 1, 2006, the contents of which are incorporated in their entirety by reference herein.

[0002] The present invention related to devices for dispensing, administering, injecting or delivering substances, and to methods of making and using such devices. More particularly, it relates to devices for dispensing a substance, such as injection devices or injection pens, having a dose setting element for administering a set or selected dose of an injectable product. In some embodiments, such injection devices may be used for self-administering a product, may be disposable, and/or may be used with a single or dual chamber ampoule.

[0003] Relatively small, easily portable injection devices, which may be referred to as injection pens, are commonly used as a means of self-administering medicaments. Ease of use, accurate dose metering and reliability of the dose setting are important factors for self-administering medicaments, such as insulin or a hormone.

[0004] Patent specification DE 10 2004 310, owned by the owner of the present application, discloses an injection device with a dose metering element, which effects a forward drive movement relative to the housing of the injection device in a forward drive direction and a dose metering movement opposite the forward drive direction. The dose metering element is coupled with a conveying mechanism so that the forward drive movement causes a conveying movement of the conveying mechanism. The length of a travel distance determining the dose to be dispensed which the dose metering element covers during the forward drive movement is set by the dose metering movement. The housing constitutes a first catch mechanism in a sleeve portion surrounding the dose metering element and a second catch mechanism formed by the dose metering element or a separate, additional dose metering catch body, and a catch engagement of the catch mechanisms can be released by a dose metering movement of the dose metering element or the separate, additional dose metering body without any rotating motion.

[0005] Patent specification U.S. Pat. No. 5,807,346 discloses a measuring instrument for dispensing different doses of a fluid, which has a reservoir for accommodating the fluid, a displaceable toothed rack element axially disposed inside and a pushing element which can be operated by the user. Annular notches are provided on the toothed rack element, and the housing has various axial slots distributed across its periphery. An outwardly projecting pin is provided on the pushing element, which is able to engage in one of the axial slots of the housing, thereby enabling the setting element to be easily extracted by the user.

[0006] Patent specification EP 0 713 403 B1 discloses a syringe with a barrel, which defines or has a cylinder. The cylinder has a nozzle at one end and encloses a plunger able to slide in the longitudinal direction inside the cylinder. The distance by which the plunger is able to move inside the cylinder defines the volume administered by the syringe, and the plunger is drivingly coupled with a slide so that it moves parallel with the plunger. The longitudinal distance by which the plunger is able to slide inside the cylinder is defined by restrictions to the movement caused by a stop surface on the barrel or on the slide co-operating with end stops on the slide or barrel. The syringe can be locked in a state in which the stop surface and the end stops are able to move relative to one another within movement restrictions which can be selected from one or more selectable, pre-defined movement restrictions. Because the stop surface has an insert which can be inserted in an orifice in the barrel or slide so that it projects out from it and can only be removed with great difficulty or by using a special tool, the projecting part of the insert acts as a stop surface. The position of each such orifice relative to the end stops defines one of the pre-selected movement distances.

[0007] An object of the present invention is to provide an injection device which is easier to set while simultaneously reducing the likelihood of incorrect operation.

[0008] In one embodiment, the present invention comprises an injection device for dispensing a dose of a substance, the device comprising a housing, a dispensing element which can be displaced relative to the housing and a locking element which can be coupled with the dispensing element during or after a substance dispensing operation so that after the dispensing element has effected a dispensing operation once, it can no longer be operated to dispense another dose, and a method of locking an injection device after a substance has been dispensed once, whereby a dispensing element operated to dispense the substance is locked or blocked before, during or after dispensing a set dose so that no more substance can be dispensed.

[0009] Based on a first aspect of the present invention, an injection device in accordance with the present invention has a housing device for a substance to be dispensed, in which the substance to be dispensed can either be introduced directly or into which it can be inserted in a container, for example an ampoule, in which case the housing device is designed as an ampoule holder. The housing device can be moved relative to the injection device, whereby an element of the injection device constituting the holder or ampoule holder can be pushed or screwed into it or a part of it, for example into the housing. If using a dual chamber ampoule of a known type, the substances contained in the dual chamber ampoule can be admixed as a result of the pushing or screwing-in operation and, thus, may be made ready for administering to a patient. A dose metering or setting element is also provided, for example a rotating knob or moveable structure, for setting the dose of substance to be administered from the injection device, and the quantity or dose of substance to be administered can be selected or fixed by moving the dose metering or setting element to a certain position. In an initial state, the dose metering element is pushed so far into the injection device that it can not be grasped or held by a user, or can only be grasped and manipulated with great difficulty.

[0010] For some purposes of the present invention, the housing device for the substance to be administered, for example a screw-in or push-in ampoule container, which can be screwed or pushed into the injection device, is coupled with the setting element so that as the substance housing device is being pushed into the injection device or into a housing or once it has been completely or almost completely pushed in, the setting element is at least partially pushed out of the injection device or a housing so that it can be operated by a user to set a dose. The dose metering or setting element may be provided in the form of a rotatable dose setting knob of a type known per se, for example, which is disposed generally at the proximal or rear end of the injection device and is fixedly connected to a dose metering knob sleeve, for example, which is able to slide axially inside and/or out of the injection device to push the dose metering knob out, thereby releasing it to enable a dose to be set.

[0011] In one preferred embodiment, the dose metering element can be coupled with the injection device so that it can not be rotated in a state in which it is pushed into the injection device and/or, for example, can not be rotated until it has been pushed out to set a dose. The dose metering element may be designed so that when it has been moved to a predetermined, defined position relative to the injection device in which it can be rotated to set the dose, it can be pulled farther out of the injection device to charge the injection device. As the dose metering element is being pulled out farther, it is rotationally locked and/or may also be rotatable for example. In another option, the dose is not set until after the dose metering element has been charged or pulled out of the injection device and the dose metering element is not locked to prevent rotation until it has been pushed back into the injection device to dispense the substance.

[0012] In some embodiments, in the initial state or in the retracted state, the setting element may be retained by static friction or by a catch mechanism in the injection device or in a housing of the injection device. The force of the static friction or the catch mechanism can be overcome by pushing the substance housing device, such as the ampoule holder to push the setting element out of the injection device. A proximal end of the substance housing element or a setting element-extraction element provided on it may come into contact with the setting element or dose metering element or may be connected to or coupled with the dose metering element by one or more other elements, e.g. a guide sleeve, secured relative to the injection device by a releasable catch mechanism or holder, so that a pushing-in or turning movement of the substance housing device causes the setting or dose metering element to be pushed out. A catch element or some other fixing element may also be provided, which holds the dose metering element in the state pushed into the injection device and can be released by the substance housing device directly or by an element coupled with it, to enable the dose metering element to be pushed out.

[0013] In some embodiments, a plunger rod or toothed rack is provided in the injection device so that a proximal stopper or displacement body in the substance housing device or in an ampoule is pushed into the injection device relative to the substance housing region, in other words is pushed into the ampoule, during the operation of pushing in or screwing in the substance housing device or the ampoule. Thus, in the case of a dual chamber ampoule, admixing of the components contained in the dual chamber ampoule is initiated and terminated when the plunger rod or toothed rack has been sufficiently pushed in, so that mixing takes place in a dual chamber ampoule in readiness for administering the substance.

[0014] In some embodiments, the coupling between the substance housing element and setting or dose metering element is designed so that the dose metering element is not pushed out of the injection device until the substance housing element has been completely or almost completely introduced or pushed in to completely or almost completely mix the substances contained in a dual chamber ampoule. For example, the dose metering element may not be coupled with the substance housing element until the last part of the insertion movement, for example the last 6 mm. In some embodiments, only after coupling, for example once the proximal end of the substance housing element has made contact with the dose metering element, is the dose metering element pushed out of the injection device by the remaining insertion path of 6 mm, for example, so that the dose metering element can be gripped by a user and rotated to set the dose, for example, or pushed farther out to prime the pen.

[0015] In some embodiments, a marking is provided on the dose metering element, for example on the circumferential face of the dose metering knob or on a dose metering knob sleeve. The marks or indicia may be printed and serve as an aid for setting a dose and specify dose units, for example. This dose display may be printed or applied to the dose metering element so that it is not visible until the dose metering element has been extracted by pushing the dose metering element so far out, for example, that the dose display can be seen by a user. In some embodiments, the display printed on the dose metering element may be pushed into the region of a viewing window provided in the housing of the injection device, for example, and thus rendered visible.

[0016] In one embodiment of the method of the present invention, i.e., the method of preparing an injection device for dispensing a metered dose of a substance, a metering element is pushed into or positioned in the injection device. The metering element, which can not then be grasped, or can be grasped only with great difficulty, is not pushed out of the device again until a substance housing element, for example an ampoule holder or an ampoule, is being or has been inserted in the injection device. Only then can the setting or dose metering element be gripped by a user and operated.

[0017] In another embodiment, the present invention relates to an injection device with a housing and a substance dispensing element which can be displaced relative to the housing, so that a movement of the dispensing element, for example a movement pushing the dispensing element into the injection device, forces the substance contained in the injection device out of the injection device, causing it to be dispensed. For the purpose of this embodiment of the invention, at least one fixing element is provided in the injection device, which makes it impossible to dispense another dose when a substance has already been dispensed from the injection device once by the dispensing element. The dispensing element may be coupled with a dose metering or setting element or they may be combined, so that a dose can be set by a rotation of the dispensing element. In some embodiments, this can be accomplished by pulling on the injection device or by pulling out the dispensing element. The substance may then be dispensed by pushing the dispensing element in. In some preferred embodiments, the dispensing element may also be a rotating or dose setting knob of the injection device. Likewise, the dispensing element may also be a housing part of the injection device which can be displaced relative to another element or housing part of the injection device.

[0018] In some embodiments, a locking or catch element, such as a latch cam and/or a groove for example, is provided on the dispensing element which, together with a complementary counter-element, e.g., a matching groove or latch cam of the injection device of or an ampoule, can establish a catch connection, which can not be released or is difficult to release, during or after a dispensing operation, once a set, once-only dose has been dispensed. The locking element or catch element may co-operate with a plunger rod or toothed rack of the injection device, for example, and the counter-element may be provided in the form of a catch element projecting into the dispensing element, for example, and disposed on a flexible arm, for example, such as a latch cam, by which a positive connection is established between the dispensing element and the toothed rack or plunger rod once the substance has been dispensed. This being the case, the dispensing element can no longer be moved relative to the toothed rack or plunger rod. Likewise, the dispensing element may be fixed relative to the injection device or a housing of it, for example by means of catch connection, during or after a dispensing operation, to prevent a further dispensing operation. Another option would be for the dispensing element to move in a specific direction only, for example to move axially and/or in rotation, to apply a locking or blocking action, so that it is no longer possible for substance to be dispensed from the injection device, again due to the locked direction(s) of movement.

[0019] In one embodiment of a method of dispensing a substance from an injection device and/or locking an injection device in accordance with the present invention, a dispensing element for triggering or causing substance to be dispensed is fixed or locked before, during or after a set dose of substance to be dispensed has been dispensed, so that the dispensing element can no longer move in a direction by which further dispensing of a substance from the injection device can be triggered.

[0020] In accordance with some embodiments of present invention, a quantity or dose of a substance to be dispensed, either pre-set or set by a user, can be dispensed only once, whereby any additional dispensing of the substance can be blocked or prevented even if there is still a residual quantity of the substance in the injection device. This may be particularly necessary in the case of dual chamber ampoules containing admixed substances which can deteriorate or degrade in terms of quality over time, possibly posing a health risk. In this case it would not be advisable to administer substance to a patient again.

[0029] FIG. 1A is a plan view in section, showing an embodiment of an injection device in accordance with the present invention. The device comprises an ampoule holder 1 for accommodating a substance, into which a dual chamber ampoule 2 with two stoppers 2a and 2b displaceably disposed in it can be inserted. The ampoule holder 1 can be displaced relative to the housing of the injection device, which is provided in the form of a threaded sleeve 3 in the embodiment illustrated, and can be screwed into the internal thread 3a of the threaded sleeve 3 due to an engagement by the external thread 1a at the proximal end of the ampoule holder 1. Due to an engagement of the annular web 3c provided on the internal face of the threaded sleeve 3 in the circumferentially extending groove 5d (see FIG. 2A) on the external face of a guide sleeve 5, the guide sleeve 5 can be connected to the threaded sleeve 3. The sleeve 5 has inwardly biased catch elements 5a on its distal or forward end which engage in matching grooves or teeth 4a of a toothed rack 4, which is prevented from rotating by axially extending grooves and holds the latter so that it can not move in the proximal direction. However, the toothed rack 4 can be moved in the distal direction relative to the guide sleeve 5, as a result of which the catch elements 5a provided on resilient arms slide out of the grooves or teeth 4a of the toothed rack and snap into a subsequent groove or teeth 4a. In the embodiment illustrated, a dose metering knob is provided at the proximal end and serves as a dispensing and dose metering element 6, which is pushed so far into the housing or into the threaded sleeve 3 that it cannot be practically gripped by a user. In the position of the injection device illustrated in FIG. 1A, which might be referred to a retail position, only the ampoule holder 1 is able to move, e.g., can be screwed into the threaded sleeve 3, to admix the substances contained in the dual chamber ampoule 2. However, it is still not possible to effect a setting operation by the dose setting knob 6.

[0030] FIG. 1B shows the injection device illustrated in FIG. 1A in the mixing position, after the ampoule holder 1 has been screwed into the threaded sleeve 3. By pushing the ampoule 2 held by the ampoule holder 1 in the proximal direction, the shoulder 4c placed on the front face of the toothed rack 4 can be moved into the ampoule 2, thereby pushing the abutting stopper 2b into the ampoule 2 so that the ampoule 2 can be mixed. Priming may also take place at the same time.

[0031] As illustrated in FIG. 1C, the ampoule holder 1 can be screwed into the threaded sleeve 3 of the injection device as far as a proximal stop surface 1b of the ampoule holder 1 projecting on the radially outer, distal or front face of the guide sleeve 5. As the ampoule holder 1 is screwed in further, the guide sleeve 5 is moved in conjunction with the ampoule holder 1 in the proximal direction relative to the threaded sleeve 3, thereby releasing the catch connection 3c, 5d, until a stop element 5b provided on the external face of the guide sleeve 5 has moved against a complementary stop element 3b on the internal face of the threaded sleeve 3, limiting the screwing movement of the ampoule holder 1 as a result. When the guide sleeve 5 is pushed in the proximal direction, the dose setting knob 6 mounted in the guide sleeve 5 is pushed in the proximal direction out of the injection device so that the dose setting knob 6 can be used to set a dose to be dispensed from the injection device. At the same time, the annular web 3c moves into engagement with the circumferentially extending grooves 5e (priming position) and 5f (end position) of the guide sleeve 5 pushed past the ampoule holder 1 lying against the guide sleeve 5.

[0032] FIG. 1D illustrates the charged injection device, whereby the dose setting knob 6 has been extracted or extends from the injection device until a catch element 4b projecting out from the toothed rack 4 in the proximal direction has latched in a catch orifice 6a provided on the internal face of the dose setting knob 6. Thus, a pressure applied to the dose setting knob 6 enables the toothed rack 4 latched to it to be pushed in the distal direction of the injection device, as illustrated in FIG. 1E, to push the stoppers 2a and 2b disposed in the ampoule 2 in the distal direction as a result and dispense the already admixed medicament out of the ampoule 2. When the dose metering knob 6 is pushed back into the pen or into the threaded sleeve 3, it can no longer be moved, and can no longer be pulled out, as will be explained below. This ensures that the injection device can be used only for a single dispensing operation.

[0033] FIG. 2A is a perspective view, in cross-section, showing the dose setting knob 6 when it is retracted in the initial position, which can be extracted from the injection device by turning or pushing in the ampoule holder 1 by means of the guide sleeve 5, thus releasing it for a user; see FIG. 2B.

[0034] FIG. 3A is a perspective view in cross-section showing a first embodiment of a setting and dispensing mechanism in accordance with the present invention. In the position illustrated, the dose setting knob 6 can be freely rotated to select a dose, and the snapper or catch element 4b of the threaded rod 4 biased radially outwards can run freely around the groove 6p extending circumferentially on the proximally inner face of the dose setting knob 6 so that the dose setting knob 6 is also held. Once a dose has been set, for example using a marking applied to the external circumferential face of the dose setting knob 6, the dose setting knob 6 can be pulled out of the injection device, as illustrated in FIG. 3B, until the catch element 4b of the threaded rod 4 biased radially outwards is guided by a groove 6i on the internal face of the dose setting knob 6 and latches in one of several catch orifices 6a or 6b (with guide grooves 6i or 6j; see FIG. 5B) provided in the interior of the dose setting knob 6. The set dose can be dispensed by pushing the dose setting knob 6 in so that it pushes the threaded rod 4 in the distal direction with it, relative to the guide sleeve 5, due to the positive connection 6a, 4b. When the catch element 4b engages in the groove 6i of the dose setting knob 6, as illustrated in FIG. 3B, the dose setting knob can no longer be freely rotated but is able to slide axially in the groove 6i until it latches in the catch orifice 6a. Once pushed into the pen, the dose setting knob 6 can no longer be moved due to this connection 4b, 6a and because of the catch connection formed by elements 4a, 5a or the like. The catch connection 3c, 5f between the threaded sleeve 3 and guide sleeve 5 is stronger than the catch connection 4a, 5a between the guide sleeve 5 and toothed rack 4, so that a pressure applied to the dose setting knob 6 causes an axial forward movement of the toothed rack 4 relative to the guide sleeve 5.

[0035] FIG. 4A, together with FIG. 4B, illustrates another embodiment of a setting and dispensing mechanism in accordance with the present invention. FIG. 4A illustrates the position of the dose setting knob 6 as releasably retained by the catch element 4b engaging in the groove 6p so that it can not rotate due to the engagement of one or more guide bars 5c (see FIG. 4B) on the internal face of the guide sleeve 5 in matching grooves or notches 6o radially disposed on the external face of the dose setting knob 6.

[0036] When the dose setting knob 6 is pulled out of the injection device, as illustrated in FIG. 4B, the lock preventing the dose setting knob 6 from rotating is released by pushing the notches 6o away from the guide bars so that the catch element 4b runs through the empty groove 6c of the dose setting knob 6 into the setting groove 6q extending circumferentially round the internal face of the dose setting knob 6. The dose setting knob 6 can then be freely rotated to select a dose. The dose is set, or dose selecting is enabled, by recesses or orifices 6a, 6b, 6m, 6n disposed in the circumferential direction on the internal face of the dose setting knob 6 and catch points axially offset from one another, with co-operating guide grooves 6i to 6l (see FIG. 5B) of differing axial length. When the dose setting knob 6 is pushed in, the catch element 4b moves along the guide groove 6i, 6j, 6k or 6l set by the rotation position of the dose setting knob 6 until it latches at the co-operating catch point 6a, 6b, 6m or 6n. When the dose setting knob 6 is pushed farther in, it drives the toothed rack 4 coupled with it via the catch connection of the catch element 4b. When the dose setting knob 6 has been completely pushed in, the dose setting knob 6 can no longer be moved due to the anti-rotation lock 5c, 6o and the coupling with the toothed rack 4 which can no longer be pulled out in the proximal direction, so that the injection device is locked.

[0037] FIG. 5A is a perspective view showing a section through an embodiment of a dose setting knob 6 which can be used with both of the variants described above and others, on which different catch orifices 6a, 6b are disposed on the internal face in the circumferential direction and offset from one another in the axial direction, offering a latching option in one of the catch orifices 6a 6b for the catch element 4b lying in a different respective axial direction due to a rotated position of the dose setting knob 6. In the embodiment described with reference to FIG. 3, the toothed rack 4 can therefore be pulled out only as far as the rotation position and the orifices 6a, 6b, 6m, 6n of the knob 6 allow, even if the knob 6 is fully extracted. In the embodiment described in connection with FIG. 4, on the other hand, the toothed rack can by pushed in only so far until it latches, predetermined by the rotation position and the orifices 6a, 6b, 6m, 6n of the knob 6.

[0038] FIG. 5B is a diagram showing the internal contour of the dose setting knob 6 and illustrating how different travel paths of the toothed rack 4 can be pre-set depending on the rotation position of the dose setting knob 6 due to grooves 6i to 6l of differing lengths to push in the catch element 4b, thereby enabling different doses to be dispensed. “1st” dose in FIG. 5B denotes the smallest dose and “4th dose” the largest dose which can be dispensed with the second embodiment.

[0039] FIG. 6A illustrates how the setting and dose metering mechanism co-operates with the toothed rack 4 in the embodiment illustrated in FIG. 3, and the cross-sectional view illustrated in FIG. 6A illustrates the maximum stroke or dispensing movement possible with the mechanism, illustrated in the form of the distance between the catch element 4b of the toothed rack 4 and the catch orifice 6a of the dose 4 setting knob 6 denoted by D_max.

[0040] When the dose setting knob 6 is pulled out, as illustrated in FIG. 6B, the catch element 4b latches in the catch orifice 6a and the dose setting knob 6 can no longer be rotated once latching takes place in the extracted position, but can be pushed in as illustrated in FIG. 6C to dispense the dose. In the pushed-in position, the catch lugs 5a of the guide sleeve 5 prevent the toothed rack 4 and, hence, the dose setting knob 6 coupled with the tooth rack 4, from being pulled back out again so that the dose metering knob 6 is secured in the position illustrated in FIG. 6C. In this position, the injection device cannot be operated.

[0041] Instead of a catch system or catch orifice(s), such as described in connection with FIGS. 3 to 6, it would also be possible to provide one or more stops, complementary stops, steps, projecting elements, webs or cams on the dose setting knob 6, for example, as a means of setting or selecting the dose. Likewise, the grooves 6i to 6l may be designed as blind grooves or dead-ends without adjoining orifices.

[0042] 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 invention to the precise forms and steps disclosed. Obvious modifications or variations are possible in light of the above teachings. 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.