US20060153693A1 - Administering apparatus comprising a service life timer - Google Patents

Abstract

An administering apparatus having a service life timer is provided that includes a casing with a reservoir for a container for a product to be administered, a conveying member for the product, an adder for recording and adding a change in the state of the apparatus, and an output means connected to the adder that outputs a signal perceivable by the senses in response to recording a change in state of the apparatus.

Description

CROSS-REFERENCE TO RELATED APPLICATION
• This application claims the benefit of German Application No. DE 10 2004 063 648.6, filed on Dec. 31, 2004, the contents of which is incorporated herein by reference in its entirety.
BACKGROUND
• The invention relates to medical devices and methods of using and making such devices. More particularly, it relates to an administering apparatus for administering a fluid product. It is preferably used in an injection apparatus in the form of an injection pen. Injection apparatus and/or infusion apparatus may be used for diabetes therapy, administering growth hormones or osteoporosis preparations. In particular, in cases in which a user self-administers a product or substance, the user has to be able to rely on his/her apparatus operating reliably. In principle, however, this requirement also applies in the out-patient, clinical and veterinary fields, which also represent areas of application for the invention.
• Proposals for increasing service safety of administering apparatuses, in general, tend towards measures for preventing operational errors which can lead to damage to the apparatus. In some cases, when operating errors go undetected, an incorrect dosage may be administered and also be undetected. Providing a user interface that allows a user to set the product dosage to be administered may increase service safety. WO 03/057285 A2 is an example of an injection apparatus that includes a weekday display which is adjusted when setting the dosage. According to this example, when a dosage is to be administered daily, a user may check that he/she has administered the intended dosage.
SUMMARY
• It is an object of the invention to increase the reliability of an administering apparatus, so that when in use, the desired amount of the product is also administered.
• In one embodiment, the present invention comprises an administering apparatus, such as an injection apparatus or an infusion apparatus, having a service life timer. The administering apparatus includes a casing with a reservoir for a container for a product to be administered, a conveying member for the product, an adder for recording and adding a change in the state of the apparatus, and an output coupled to the adder providing a perceptible signal in response to a change in state of the apparatus.
• In one embodiment, the present invention comprises an administering apparatus, such as an injection apparatus or an infusion apparatus, comprising a service life timer, the administering apparatus comprising a casing comprising a reservoir for a container for a product to be administered, a conveying member for the product, an adder for recording and adding a change in the state of the apparatus, wherein the adder is incremented upon administering the product, and an output means coupled to the adder, the output means outputting a signal perceivable by the senses, in accordance with the addition result.
• In accordance with the invention, the apparatus is equipped with a service life timer which provides the user with an indication of when the apparatus has reached its service life, after which it is no longer certain that the apparatus will function reliably. The service life timer includes an adder, preferably a mechanical adder (although any suitable combinational component, whether mechanical, electrical, analog or digital, may be used), for recording and adding a change in the state of the apparatus which results from repeated administration of the product. In this way, changes to the state of the apparatus due to normal wear and tear are tracked. Such changes in state occur when setting a product dosage to be administered and when delivering said dosage. Over the total period of use of the apparatus, these changes in state are constantly repeated, often several times per day, and accumulatively lead to a gradual loss of reliability. The service life timer also includes an output means which is connected to the adder and outputs a signal which can be perceived by the senses, in accordance with the addition result. The display may include an acoustic, tactile, and/or optical display. In one preferred embodiment, the service life timer operates without electrical energy.
• In one exemplary embodiment, as partially or completely emptied containers are exchanged for more completely or completely filled containers, the adder counts the number of container changes. The number of container changes may be regarded as an integral value for the number of deliveries and/or dosage setting processes if the apparatus is equipped with a dosing means. If the number of container changes has reached or exceeded a predetermined critical value, the output means may indicate to the user that the apparatus has reached the end of its service life. The apparatus may also be equipped with a blocking (or locking) means which is coupled to the service life timer such that when the end of the service life is reached, the service life timer automatically places the blocking means in a blocking state preventing product delivery. Such a blocking means preferably operates after a warning indication is signaled by the output means. This allows sufficient time for the user to acquire a new apparatus.
• In another embodiment, the adder only counts the number of container changes as changes in state. Alternatively, the apparatus may additionally count the number of deliveries and/or dosage setting processes and incorporate these in ascertaining the end of the service life. In alternative embodiments, the adder may count the number of deliveries, the number of dosage setting processes, or may counts these two changes in state in combination. Each type of action may be weighted according to the extent it wears on the apparatus. For example, delivery movements may wear more on the apparatus compared to the dosage setting process. When the adder increments for delivery, the increment may be larger compared to the increment corresponding to the dosage setting.
• In another embodiment according to the present invention, the output means, in addition to indicating that an “end of service life” event has occurred, the output means may also indicate the approaching expiration of the service life of the apparatus. For example, ten or twenty container changes before the expiration of the apparatus, the output means may sound a warning signal indicating the apparatus' status. The output means may also include an output structure for an optical display. The expiration of service life indication may be imparted by a colored marking. For example, a color which is characteristic of the non-critical range, for example green, may be displayed up until a critical service life is reached, and then a warning color such as red may be displayed. The colored marking may also include one or more transition regions, for example from green to red. The transition regions may be yellow, or yellow and orange in succession. The output structure may thus be provided with a colored strip which is colored continuously green in a first portion and then abruptly red, may be colored yellow in an adjoining second strip and then transition to red, or may be colored yellow, then orange, and then red. Accordingly, a colored strip may be used which continuously changes in color, or color graduations may form the optical display. In addition, an illuminated display such as a rear illumination may also be provided. The illuminated display may also be equipped with an energy source of its own and thus autonomous from the apparatus.
• In one embodiment, the adder cooperates with an actuator which is actuated in response to the change in device status or device state. For example, an actuator may be formed by an operable triggering element which performs a triggering movement which causes a delivery movement of the conveying member. By being coupled to such an actuator, the delivery processes may be counted. The conveying member also forms a preferred actuator, either as an alternative to the triggering element, or in a coupling with the triggering element which is established directly by the change in device status, or only when the change in device status is recorded. Both the coupling with the triggering element and the coupling with the conveying member enable the delivery processes to be counted. In another alternative, in which the apparatus allows the dosage to be set, a dosing member of the dosing means may form the actuator. In such an embodiment, the dosing movement of the dosing member is recorded. In embodiments in which the triggering element also simultaneously forms a dosing member which is moved when setting the dosage, the dosing movement of the triggering element may be recorded instead of or in addition to the triggering movement.
• In further embodiments, the adder for recording and adding the change in device status is coupled both to the triggering element and the conveying member. In particular, the conveying member or the triggering element can mount to the adder. In such a coupling, relative movements between the triggering element and the conveying member may be recorded. This type of coupling is particularly suitable for counting the container changes if, after a new filled container is inserted, the conveying member assumes a different position relative to the triggering element than after the container is emptied or partially emptied. Mounting the adder using the triggering element is particularly preferably combined with recording the change in state on the basis of a position which the conveying member assumes relative to the triggering element. Alternatively, container changes may also be determined solely on the basis of recording the position of the conveying member relative to the casing of the apparatus or to another structure. In another example, the adder may be coupled to casing parts of the casing such that the separating or connecting processes of the casing parts, to be performed for a container change, are recorded. While the number of separating and connecting processes does not have to exactly match the number of container changes, the number of separating and connecting processes may provide a useful indication.
• In another embodiment, the adder may be formed by a mechanical reducing gear. In addition, the reducing gear may operate pneumatically, hydraulically, or may operate by pneumatic and hydraulic components.
• A recorder for the individual changes in device status, for example, due to each exchange of the container, may form the input or trigger the drive member of the reducing gear. The recorder may thus be a movement recorder, or a contact recorder, which is itself moved by contact with the actuator cited. The movements of such a recorder caused by the changes in device status are reduced by other gear components and transferred to the output means, for example onto a display structure. The recorder may be coupled to a subsequent adding member, such that the changes in device status cause a movement of the adding member. If the recorder is moved by the change in device status, its movements are preferably mechanically transferred onto the adding member. In each case, the adding member is moved on from an initial position, which it assumes before the recorded change in device status, to a new position. The new position is the initial position when recording the next change in device status. In this sense, the changes in device status and consequently the change in the state of the recorder caused by them are transferred into a further movement of the adding member, added and thus counted. The adding member alone may therefore forms a counting member, and the recorder may operate as a switching member.
• The display structure on the device may be fixedly connected to the adding member, or may be formed integrally with the adding member. In preferred embodiments, however, the reducing gear is multi-staged with at least two reducing stages, such that a larger number of changes in state may be counted, with a compact design of the adder. Each of the stages may be formed as an adding stage. Thus, the movement of the adding member may for example be a rotational movement about a rotational axis or, as applicable, a back-and-forth linear movement, the path distance of which—in the case of rotational movement measured at the circumference—is transferred into a shorter path distance of a subsequent gear member. In the case of an optical display, as is preferred in one embodiment, the display structure may form an adding output member of the adder. The adding member forms an adding input member of the multi-staged embodiment of the adder. In the multi-staged embodiment, the adding input member and the adding output member are preferably coupled to each other via one or more intermediate members.
• The adder may be formed as a toothed wheel gear or include a toothed wheel, gear or the like as one stage or as a number of toothed wheel stages in which an input speed is reduced to an output speed.
• The recorder and the adding input member may be mounted and coupled to each other such that the recorder may be moved back and forth between two end positions and causes the adding input member to move further when moving in at least one of the two directions. In another embodiment, the coupling is formed as an adjusting engagement which the recorder passes into through its movement with the adding input member. The back-and-forth recording movement of the recorder is preferably converted in the adjusting engagement into a rotational movement of the adding input member. In alternative embodiments, the recorder may instead complete a rotational movement itself during recording and thus roll off on the adding input member, in order to rotate it in this way. Such an adjusting engagement is useful when dosage setting processes are counted by means of the recorder. In one example, the rotational movement of the adding input member may be reduced with respect to its speed in a multi-staged reducing gear, by the adding input member driving an adding intermediate member in another adjusting engagement, such that the adding intermediate member performs only a partial revolution per revolution of the adding input member. The adder may also have multiple recorders, one of which for example performs a rotational recording movement and the other a translational recording movement. The multiple recorders may act on the same adding input member, in succession.
• According to another embodiment of the present invention, an adder device for coupling to an administering apparatus for determining the status of the apparatus is provided that includes an adder casing, a recorder slidably coupled to the casing, an adding input member rotatably coupled to the casing, and an adding output structure coupled to that casing and the adding input member, where the adding output structure outputs a status indicator perceivable by the senses. According to the present embodiment, the recorder slidably shifts in response to a change in the apparatus and engages with the adding input member and rotatably shifts the adding input member from a first position to a second position. The display structure is rotatable in response to the adding input member shifting from the first position to the second position.
• In another embodiment, the recorder includes a restoring member such as a spring for tensing the recorder in an advancing position.
• In another embodiment, the adding output structure includes an annular disk mounted by the adder casing, and is rotatable relative to a portion of the apparatus.
• In yet another embodiment, a recorder is secured against rotating by the adder casing. According to another example of the present invention, the adder casing may further include rotational guide for guiding the adding input member. In some embodiments the adding input member includes a ring with one or more sets of toothings (which also may be referred to as teeth, and which may take the form of any suitable texturing or meshing structures). The sets of toothings may be situated opposite one or more toothings situated on a recorder. In one example, the recorder slides in a recording motion and the toothings of the recorder passes into a toothed engagement with one or more sets of adding input member toothings, where the adding input member is rotatable from a first position to a second position in response to the recorder recording motion.
• According to another embodiment of the present invention, the recorder is slidable in response to an apparatus container change. In another implementation of the present invention, an intermediate member for coupling the adding input member to the adding output structure is included.
• According to some embodiments, the adder is mounted to the administering apparatus, such that the adder casing is connected to a triggering element of the apparatus.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 depicts an injection apparatus according to an embodiment of the present invention, in a perspective view;
• FIG. 2 depicts an injection apparatus according to an embodiment of the present invention with the coupler open, in a longitudinal section;
• FIG. 3 depicts an injection apparatus according to an embodiment of the present invention with the coupler closed;
• FIG. 4 depicts a detail from the injection apparatus ofFIG. 2, an according to an embodiment of the present invention;
• FIG. 5 depicts a detail from the injection apparatus ofFIG. 3, an according to an embodiment of the present invention;
• FIG. 6 depicts an injection apparatus according to an embodiment of the present invention after a dosage has been set;
• FIG. 7 depicts an injection apparatus according to an embodiment of the present invention after a reservoir has been emptied;
• FIG. 8 depicts a decoupling member and a casing part of an injection apparatus according to an embodiment of the present invention;
• FIG. 9 depicts a distal portion of the injection apparatus with the casing parts connected according to an embodiment of the present invention;
• FIG. 10 depicts a distal portion of the injection apparatus while the casing parts are being detached according to an embodiment of the present invention;
• FIG. 11 depicts an injection apparatus of an exemplary embodiment, with the coupler open, in a longitudinal section;
• FIG. 12 depicts an injection apparatus with the coupler closed, in a different longitudinal section according to an embodiment of the present invention;
• FIG. 13 depicts a detail fromFIG. 11 according to an embodiment of the present invention;
• FIG. 14 depicts a detail fromFIG. 12, according to an embodiment of the present invention;
• FIG. 15 depicts an injection apparatus after a dosage has been set, according to an embodiment of the present invention;
• FIG. 16 depicts an injection apparatus after the reservoir has been emptied, according to an embodiment of the present invention;
• FIG. 17 depicts an injection apparatus of the second exemplary embodiment, with the casing parts detached from each other, according to an embodiment of the present invention;
• FIG. 18 depicts a detail fromFIG. 17, according to an embodiment of the present invention;
• FIG. 19 depicts an injection apparatus according to an embodiment of the present invention;
• FIG. 20 depicts a proximal part of the injection apparatus of the third exemplary embodiment, with the coupler open, according to an embodiment of the present invention;
• FIG. 21 depicts the injection apparatus of the third exemplary embodiment, with the coupler closed, according to an embodiment of the present invention;
• FIG. 22 depicts a proximal part of the injection apparatus of the third exemplary embodiment, when correcting the dosage, according to an embodiment of the present invention;
• FIG. 23 depicts a proximal part of the injection apparatus of the third exemplary embodiment, after the reservoir has been emptied, according to an embodiment of the present invention;
• FIG. 24, includingFIGS. 24aand24b, depicts a blocking member and a stopping member of the third exemplary embodiment, according to an embodiment of the present invention;
• FIG. 25 depicts a service life timer, according to an embodiment of the present invention; and
• FIGS. 26-38 depict a module and components of the service life timer, in various views and sections, according to an embodiment of the present invention.
DETAILED DESCRIPTION OF THE DRAWINGS
• With regard to fastening, mounting, attaching or connecting the components of devices of the present invention, unless specifically described as otherwise, conventional fasteners such as screws, rivets, toggles, pins and the like may be used. Other fastening or attachment means appropriate for connecting components include friction fitting, adhesives, welding and soldering, the latter particularly with regard to electrical or processing components or systems of the devices. Any suitable mechanical or power communicating links, linkages or transmission may be used. Any suitable electronic, electrical, communication, computer or processing components may be used, including any suitable electrical components and circuitry, wires, wireless components, sensors, chips, boards, micro-processing or control system components, software, firmware, hardware, etc.
• FIG. 1 shows an injection apparatus of a first exemplary embodiment. The injection apparatus comprises afirst casing part1 and asecond casing part4 which are detachably connected to each other. In the exemplary embodiment, thecasing parts1 and4 are screwed to each other. The injection apparatus is formed as a slim injection pen. Thecasing part1 serves to accommodate acontainer2 filled with a fluid product and in this sense forms a reservoir, and thecasing part4 serves as a bearer for a dosing and drive means, adosing member18 of which may be seen. Thecasing part4 is breached in the region of thedosing member18, such that a user has direct access to thedosing member18. Thedosing member18 is mounted such that it may be rotated about a central longitudinal axis of the apparatus, and formed as a sleeve which is ribbed on its outer circumference so as to be user-fiendly. Adosage display20 may also be seen, which is laterally placed through a breach in the shell of thecasing part4.
• FIG. 2 shows the injection apparatus of the first exemplary embodiment, in a longitudinal section. Thecontainer2 is accommodated in thecasing part1. In thecontainer2, apiston3 is accommodated such that it can be moved in an advancing direction V. Thepiston3 seals thecontainer2, fluid-proof, at its proximal end. Advancing thepiston3 in the advancing direction V displaces and delivers product through an outlet of thecontainer2. The outlet, for example, may include an injection needle protruding into the outlet and fastened to the distal end of thecasing part1 by means of a needle holder. Thecontainer2 is formed in the manner of conventional ampoules. Thecasing part1 directly forms a container holder; in the exemplary embodiment, an ampoule holder. The proximal end of thecasing part1 protrudes into thecasing part4 and is screwed to thecasing part4.
• Thecasing part4 accommodates apiston rod15 and the dosing and drive means which is formed as a dosing and drive mechanism. In a dosing and drive line, the dosing and drive means includes adrive member5 and a coupler which in a coupled state, i.e. in a coupler engagement, couples thedrive member5 to thepiston rod15. Thepiston rod15, together with thepiston3, forms a conveying means. In the coupled state, coupler members6-10 transfer a drive force exerted on thedrive member5 onto thepiston rod15. No coupler engagement exists inFIG. 2, such that thepiston rod15 is decoupled from thedrive member5. In this decoupled state, the user may set the product dosage to be administered, by a dosing movement of thedosing member18; in the exemplary embodiment, a rotational movement.
• Thedrive member5 is sleeve-shaped. On its shell outer area, it comprises a thread about a threaded axis R pointing in the advancing direction V. Via this thread, thedrive member5 is in threaded engagement withcoupler input member6. Thecoupler input member6 is also sleeve-shaped and provided with a corresponding inner thread for the threaded engagement. The thread pitch in the threaded engagement is large enough that self-locking cannot occur. Thedosing member18 surrounds thecoupler input member6 and is connected to thecoupler input member6 such that it is secured against rotating and cannot be moved axially. Thepiston rod15 protrudes into thedrive member5 and thecoupler input member6.
• Thepiston rod15 is provided with an outer thread over its axial length. Via the outer thread, it is in threaded engagement with acoupler output member9 which is provided with a corresponding inner thread. These two threads also exhibit a thread pitch which prevents self-locking in the threaded engagement. In one example, the thread pitch is less than the thread pitch in the threaded engagement between thedrive member5 and thecoupler input member6. Acoupler sleeve8 is connected to thecoupler output member9 such that it is secured against rotating and cannot be moved axially. Thecoupler sleeve8 and thecoupler output member9 may be regarded as an integral component with respect to the movements between thedrive member5 and thepiston rod15; however, in order to accommodate an equalizingspring17, they are embodied in two parts and fixedly connected to each other. Thecoupler output member9 and thecoupler sleeve8 are mounted in thecasing part4 such that they may be rotated about the threaded axis R of thecoupler output member9 but cannot be moved axially. In the threaded engagement, thepiston rod15 protrudes through thecoupler output member9 and protrudes into thecoupler sleeve8. The equalizingspring17 is clamped between a proximal end of thecoupler sleeve8 and a proximal end of thepiston rod15 and acts on thepiston rod15 in the advancing direction V as a pressure spring. The equalizingspring17 presses onto thepiston rod15 via adisc15awhich is supported such that it may be rotated on thepiston rod15 and forms a flange of a sleeve placed onto thepiston rod15.
• Thepiston rod15 is linearly guided in and counter to the advancing direction V in alinear guide4a, such that it cannot be rotated relative to thecasing part1. Thedrive member5 is also linearly guided relative to thecasing part4 such that it may be moved in and counter to the advancing direction V, for which purpose thecasing part4 directly forms a linear guide4b.
• The threaded axis of thepiston rod15 forms the main movement axis of the device. It forms a rotational axis R for the rotational drive movement of thecoupler input member6 and, via the couplerintermediate member7, thecoupler output member9. It forms both threaded axes. It also forms the translational axis for thepiston rod15 and thedrive member5.
• The coupler also includes a couplerintermediate member7 and acoupler restoring member10 which is formed as a pressure spring and charges the couplerintermediate member7 with an elasticity force acting counter to the advancing direction V. The restoringmember10 is clamped between thecoupler output member9 and the couplerintermediate member7.
• If no force acting in the advancing direction V is exerted on thedrive member5, the restoringmember10 ensures, via the couplerintermediate member7, that the coupler engagement is released. This state is shown inFIG. 2. Thecoupler input member6 is pressed in the advancing direction V until it abuts against the couplerintermediate member7, and is pressed into a proximal end position by the restoringmember10 via the couplerintermediate member7. By means of the couplerintermediate member7, the restoringmember10 holds thecoupler input member6 in a holding position relative to thecoupler output member9 and thecoupler sleeve8 fastened to it. The restoringmember10 and the couplerintermediate member7 thus form a holding means, acting in a non-positive lock, for thecoupler input member6.
• FIG. 3 shows the injection apparatus in a coupled state. A coupler engagement exists between thecoupler input member6 and thecoupler sleeve8. For the coupler engagement, thecoupler input member6 and thecoupler sleeve8 form engaging elements which, in the coupler engagement, establish a rotationally secured connection between the twomembers6 and8 about the threaded axis R pointing in the advancing direction V. The engaging elements co-operate as grooves and springs or toothings which are formed parallel to the advancing direction V and evenly distributed about the threaded axis R.
• FIGS. 4 and 5 show the region of the coupler engagement in detail.FIG. 4 shows the apparatus in the decoupled state andFIG. 5 shows the apparatus in the coupled state.FIG. 4 thus corresponds toFIG. 2, andFIG. 5 thus corresponds toFIG. 3.
• In the decoupled state, thecoupler input member6 is retracted from thecoupler sleeve8 counter to the advancing direction V, such that thecoupler input member6 may be freely rotated relative to thecoupler sleeve8, and therefore thecoupler output member9 fixedly connected to it. Thecoupler output member9 is simultaneously connected, such that it cannot be rotated, to thecasing part4 via thecoupler sleeve8, the couplerintermediate member7 and adecoupling member11. For this rotationally secure coupling, the couplerintermediate member7 is provided with engaging elements7bon an inner area radially facing thecoupler sleeve8, and thecoupler sleeve8 is provided with corresponding engaging elements8b. For the rotationally secured engagement with thedecoupling member11, the couplerintermediate member7 is provided with engaging elements7bon an outer circumferential area, and thedecoupling member11 is provided with radially facingengaging elements11aon a shell inner area which, in the decoupled state, interlock with each other—like the engaging elements7band8b—in the manner of grooves and springs or toothings parallel to the advancing direction V. The couplerintermediate member7, in its rotationally secured engagement with thecoupler sleeve8 and its rotationally secured engagement with thedecoupling member11, may be moved axially in and counter to the advancing direction V, wherein the engagement with thedecoupling member11 is released when it moves in the advancing direction V.
• If thedrive member5 is operated by exerting a pressure force on a triggeringelement16 in the advancing direction V, thedrive member5 and thecoupler input member6 together complete an axial coupler stroke of length X. In this drive stroke movement or coupler movement, thecoupler input member6 pushes the couplerintermediate member7 in the advancing direction V, against the restoring elasticity force of the restoringmember10. In the course of the stroke movement, theengaging elements6aand8apass into engagement with each other, while the couplerintermediate member7 simultaneously moves relative to thedecoupling member11 until it passes out of the rotationally secured engagement with thedecoupling member11. The couplerintermediate member7 remains in the rotationally secured engagement with thecoupler sleeve8. The coupler movement is limited by a stopper of the triggeringelement16 on thecoupler sleeve8; in the exemplary embodiment, on its proximal facing area.
• FIG. 5 shows the injection apparatus in the coupled state. Theengaging elements6aand8aare axially superimposed, such that the coupler engagement is established as a rotationally secured engagement between thecoupler input member6 and thecoupler sleeve8. The engagement between the couplerintermediate member7 and thedecoupling member11 is not released until the coupler engagement is securely established.
• For setting the dosage, the user rotates thedosing member18, which locks in easily releasable locking positions. Thedosing member18 is connected to thecoupler input member6 such that it is secured against rotating and also cannot be moved axially, such that the latter rotates with it. Thedrive member5 guided linearly in and counter to the advancing direction V at4bis moved, by the dosing movement of thecoupler input member6, in the proximal direction and then protrudes out of thecasing part4. The axial dosing path of thedrive member5 follows from the rotational angle by which thedosing member18 is rotated and the thread pitch in the threaded engagement between thedrive member5 and thecoupler input member6 which abuts against the couplerintermediate member7 in the advancing direction V and against thecasing part4 counter to the advancing direction V.
• FIG. 6 shows the injection apparatus with thecontainer2 still completely filled, after a first dosage has been set. In this state, the user penetrates the skin with the injection needle, for a subcutaneous injection. Once the injection needle has been placed, the user operates thedrive member5 by pressing it in the advancing direction V, into thecasing part4. In the first portion of the drive movement, coupler movement or coupler stroke X, thedrive member5 slaves thecoupler input member6, against the elastic restoring force of the restoringmember10, until the coupler engagement with thecoupler sleeve8 is established and the rotationally secured engagement between the couplerintermediate member7 and thedecoupling member11 is released. As soon as thecoupler sleeve8 and together with it thecoupler output member9 may freely rotate about the common threaded axis R, the coupler stroke X is complete and a delivery stroke follows as the second portion of the drive movement. During the delivery stroke, thedrive member5 is pressed further in the advancing direction V. Since thecoupler input member6 cannot perform any further movement in the advancing direction V once it abuts axially against the couplerintermediate member7, it rotates—in the threaded engagement with thedrive member5 which is guided such that it is secured against rotating—about the common threaded axis R. When rotated in the coupler engagement, thecoupler input member6 slaves thecoupler sleeve8, which slaves thecoupler output member9. Thecoupler sleeve8 is held in thecasing part4, together with thecoupler output member9, such that it cannot be moved axially. The rotational movement of thecoupler output member9 advances thepiston rod15, via the threaded engagement with thepiston rod15 and its rotationally secured linear guide at4a, and thus causes the delivery movement of thepiston rod15 and together with it thepiston3. As soon as theinjection button16 passes into abutting contact against thecoupler sleeve8 in the course of the drive and delivery movement (FIG. 3), the delivery process is complete.
• If the user takes the pressure off the triggeringelement16, then the restoringmember10 moves thecoupler input member6, via the couplerintermediate member7, back to the holding position retracted out of the coupler engagement, as shown inFIGS. 2 and 4. Thecoupler input member6 and together with it thedrive member5, thedosing member18 and thedosage display20, are decoupled from thecoupler output member9 and thus from thepiston rod15 by the retracting movement of thecoupler input member6. On the other hand, thepiston rod15 is again connected to thecasing part4, such that it is secured against rotating, via the returning couplerintermediate member7 anddecoupling member11.
• FIG. 7 shows the injection apparatus at the end of a final delivery which has emptied thecontainer2.
• For exchanging the emptiedcontainer2, thecasing part1 is detached from thecasing part4; in the exemplary embodiment, by a screwing movement. When thecasing parts1 and4 are detached, thedecoupling member11 is automatically moved relative to thecasing part4, counter to the direction of the coupler movement of thecoupler input member6; in the exemplary embodiment, counter to the advancing direction V. Thecasing part4 mounts thedecoupling member11 accordingly. The axial path which thedecoupling member11 thus travels relative to thecasing part4 is as long as the coupler stroke X, such that once thecasing parts1 and4 have been detached, thedecoupling member11 lying axially opposite thecoupler input member6 blocks it, and thecoupler input member6 may no longer be moved in the advancing direction V, at least not into the coupler engagement with thecoupler sleeve8. Blocking thecoupler input member6 in the disengaged position prevents thecoupler output member9 from being able to pass into a rotationally secured connection with thecasing part4 and so prevent thepiston rod15 from being able to be retracted. In other words, it ensures that thepiston rod15 may be retracted into thecasing part4, without being blocked.
• FIG. 8 shows thedecoupling member11 and thefirst casing part1 in a perspective view. Thedecoupling member11 is a sleeve part and comprises, in a distal portion, threeengaging elements12 protruding radially inwards and, in a proximal portion, a fixingelement13 protruding radially outwards.
• FIG. 9 shows thecasing part1 and a connecting portion of thecasing part4, wherein the hiddendecoupling member11 is shown by a broken line. For its decoupling function, thedecoupling member11 is accommodated in the connecting portion of thecasing part4 such that it may be rotated and moved axially. Its relative mobility is determined by an axial guide4eand a circumferential guide4c, along which the fixingelement13 moves in succession when thecasing part1 is detached from thecasing part4. The circumferential guide4cextends at a right angle to the axial guide4e, in the circumferential direction about the screw axis. It is formed as a breach or cavity in thecasing part4.
• Thedecoupling member11 is in a guiding engagement with thecasing part1. For the guiding engagement, oneguiding curve1aper engagingelement12 is formed on a shell outer area of thecasing part1 and guides the engagingelement12 and thus thedecoupling member11 when thecasing parts1 and4 are detached. Another guidingcurve1a, spaced in parallel, guides thedecoupling member11 accordingly, when thecasing parts1 and4 are connected (FIG. 10). In a distal portion, the guidingcurve1aruns obliquely, i.e. at a pitch, with respect to the screw axis of the screw connection between thecasing parts1 and4, such that in the relative movement between thecasing parts1 and4, required for detaching them, the engagingelement12 performs an axial movement of thedecoupling member11 relative to thecasing part4, sliding along the guidingcurve1a, until the fixingelement13 reaches the axial height of the circumferential guide4c. The pitch measures about 45° and is constant. However, the pitch measurement may be selected from the entire range larger than 0° and smaller than 180° and, as applicable, may also be variable, as long as the relative movement required for detaching thecasing parts1 and4—in the exemplary embodiment, a screwing movement—causes a movement of thedecoupling member11 counter to the coupler movement X to be performed by thecoupler input member6 for coupling. A distal portion of the guidingcurve1aruns axially, such that when thecasing parts1 and4 are screwed further apart, the fixingelement13 is moved along the circumferential guide4c. In the course of this relative circumferential movement between thedecoupling member11 and thecasing part4, the fixingelement13 slides over a fixingelement4din the region of the circumferential guide4c. The fixingelement4dis formed as a cam on a strip portion of thecasing part4. The strip portion acts as a spiral spring which is fixedly clamped on both sides and elastically gives when the fixingelement13 moves over the fixingelement4d, in order to then spring back again into its initial position and form a releasable locking engagement for thedecoupling member11. In the locking position, the fixingelement13 abuts the fixingelement4din one circumferential direction and in the other circumferential direction abuts a collar formed in the circumferential guide4cand is thus fixed in both circumferential directions.
• FIG. 10 shows the twocasing parts1 and4 and thedecoupling member11, after its fixingelement13 has been moved behind the fixingelement4dof thecasing part4. Thedecoupling member11 is in the releasable locking engagement with thecasing part4 via the fixingelements4dand13 and in this way is axially fixed on thecasing part4 such that it is secured against rotating. In the locking position shown inFIG. 10, thedecoupling member11 blocks thecoupler input member6 and thus ensures that thedrive member5 and thepiston rod15 are decoupled. As soon as thedecoupling member11 has reached the locking position, its engagingelement12 moves out of the guiding engagement with the guidingcurve1awhen thecasing parts1 and4 are screwed further apart. The guidingcurve1ais shaped accordingly.
• When thecasing parts1 and4 are screwed together again, they are centred with respect to the circumferential direction by means of co-operating centring elements, such that the engagingelement12 of thedecoupling member11 pass into engagement with the guidingcurve1aagain. As soon as the guiding engagement has been established, further screwing together automatically moves thedecoupling member11 out of the locking engagement of the fixingelements4dand13 until it again assumes the same position relative to thecasing part4 as inFIG. 9 and FIGS.2 to7; this corresponds to the operational position of thedecoupling member11.
• While or before screwing together, thepiston rod15 is simply retracted into thecasing part4, which—due to the released coupler engagement, causes a rotational movement of thecoupler output member9.
• Thedosage display20 of the first exemplary embodiment is coupled to thedrive member5 via adisplay coupling member21 and thecoupler input member6. Thedisplay coupling member21 is connected to thecoupler input member6 such that it is secured against rotating, by being able to move on thecoupler input member6 and relative to it in and counter to the direction of the coupler movement X, forming a ring in the exemplary embodiment. Conversely, thedisplay coupling member21 may be rotated with respect to thecasing part4 about the rotational axis R, but is held such that it cannot be moved axially relative to thecasing part4. Thedisplay coupling member21 circumferentially comprises a toothing, which in the exemplary embodiment is formed as a conical toothing, via which it is in toothed engagement with a gear of thedosage display20, in order to introduce the dosing movement and also the drive movement into the gear.
• FIGS.11 to18 show an injection apparatus of a second exemplary embodiment. The injection apparatus of the second exemplary embodiment exhibits some modifications as compared to the apparatus of the first exemplary embodiment with regard to the coupling and decoupling of thedrive member5 and thepiston rod15. However, thedrive member5 and thepiston rod15, and the manner in which they cooperate remains the same. The functionally identical components are provided with the same reference numbers as in the first exemplary embodiment. In order to indicate modifications, the relevant components are provided with the same reference numbers, but apostrophized.
• FIG. 11 shows the injection apparatus in its resting state, in which thedrive member5 is decoupled from thepiston rod15. Thefirst casing part1 is covered by aprotective cap37 which is connected to thecasing part4 and removed for administering the product. Unlike the first exemplary embodiment, the coupler engagement is established and released between the modifiedcoupler input member6′ and the modified couplerintermediate member7′.
• FIG. 12 shows the injection apparatus of the second exemplary embodiment in its coupled state, which is established by charging the triggeringelement16 and therefore thedrive member5 and thecoupler input member6′ with a drive force acting in the advancing direction V. However, as in correspondingFIG. 3 of the first exemplary embodiment previously, no dosage has yet been selected or only a small dosage of a few units for priming. Theprotective cap37 has been replaced by acasing part38 which is placed onto thecasing part4 and snapped onto it. Thecasing part38 mounts aneedle protection39, for example, in the form of a needle protecting sleeve, such that it may be elastically moved counter to the advancing direction V. When the injection needle (not shown) is injected, theneedle protection39 springs counter to the advancing direction V, into thecasing part38; in a reversal of this movement, the needle penetrates through a distal opening of theneedle protection39.
• FIGS. 13 and 14 show the region of the coupler engagement in detail, whereinFIG. 13 stands for the decoupled state andFIG. 14 stands for the coupled state. Unlike the first exemplary embodiment, theengaging elements6aand7cbetween which the coupler engagement is established exhibits an inclination with respect to the advancing direction V. In the exemplary embodiment, theengaging elements6aand7care each formed in the manner of a conical toothed ring encircling the threaded axis of thepiston rod15, wherein thecoupler input member6′ forms itsengaging elements6aon its distal end as inner cones, and the couplerintermediate member7′ forms theengaging elements7con its proximal end as outer cones. The conical engaging areas are congruent to each other and lie directly opposite each other, axially facing, with the clear distance X. Instead of conical, the coupler areas could also be shaped to be congruently convex/concave.
• Unlike the first exemplary embodiment, the couplerintermediate member7′ may be moved axially and is in engagement with thecoupler output member9, such that it is secured against rotating, in any axial position. It is again formed as a sleeve part and mounted on thecoupler output member9 such that it may be slid axially. For this purpose, it penetrates through thecoupler sleeve8′ which is axially slit accordingly, which however is not visible in the figures. The rotationally secured connection is created in a positive lock via engaging elements formed as axially linear toothings. The restoringmember10′, which is the same in its embodiment and installation but reduced with regard to its function, is tensed between thecoupler output member9 and the couplerintermediate member7′, as in the first exemplary embodiment, and charges the latter with an elasticity force, counter to the advancing direction V. In the decoupled state, in which thecoupler input member6′ is retracted from the couplerintermediate member7′ counter to the advancing direction V, as shown inFIG. 13, the restoringmember10′ presses the couplerintermediate member7′ into the rotationally secured engagement with thedecoupling member11′. The corresponding engaging elements are again indicated as7aand11a. Theengaging elements7aand11aare also formed as conical toothed rings. The engagement between the couplerintermediate member7′ and thedecoupling member11′ may alternatively be purely in a frictional lock. In this case, theengaging elements7aand11acomprise mutually facing congruent frictional areas; in the exemplary embodiment, these would be the mutually facing conical areas.
• Another modification exists in thedosing member18′. Unlike thedosing member18 of the first exemplary embodiment, thedosing member18′ cannot be moved relative to thecasing part4 in the direction of the coupler movement X; in the exemplary embodiment, the axial direction. Instead, thecoupler input member6′ is again connected to thedosing member18′ such that it is secured against rotating, but may be moved axially. The rotationally secured engagement between thecoupler input member6′ and thedosing member18′ exists in the decoupled state of thedrive member5 and thepiston rod15 and is released in the course of the coupler stroke X, namely directly before the rotationally secured connection between thecoupler output member9 and thecasing part4 is released. For this engagement, thecoupler input member6′ and thedosing member18′ are provided with engaging elements6band18awhich are formed on shell areas, radially facing each other, of the twomembers6′ and18′ in the manner of grooves and springs. With respect to the rotationally secured connection between thecoupler input member6′ and thedosing member18′, reference may also be made toFIGS. 11 and 12. The rotationally secured connection exists in the decoupled state shown inFIG. 11, and is released in the coupled state shown inFIG. 12.
• Another difference with respect to the first exemplary embodiment exists with regard to the holding means. In the second exemplary embodiment, the restoringmember10′ has no effect which separates thecoupler members6′ and9 from each other. The holding means of the second exemplary embodiment includes acoupler restoring member14, a supporting structure6cand thedosing member18′. The restoringmember14 charges thecoupler input member6′, via the supporting structure6c, with an elastic restoring force which counteracts the coupler movement X of thecoupler input member6′. In the direction of the coupler movement X, which in the exemplary embodiments coincides with the advancing direction V, the restoringmember14 is supported on thedosing member18′ which forms a supporting collar for this purpose. The supporting structure6cis connected to thecoupler input member6′ such that it cannot be moved in or counter to the direction of the coupler movement X. It is formed as a short sleeve with an outer flange on which the restoringmember14 is supported. Counter to direction of the coupler movement X, the supporting structure6cabuts with respect to thecasing part4. The coupler movement X moves thecoupler input member6′, against the elastic restoring force of the restoringmember14, into the coupler engagement with the couplerintermediate member7′. As in the first exemplary embodiment, the restoringmember14 is formed as a pressure spring charged with a pressure force in the direction of the coupler movement X.
• The mode of operation of the modified coupler is the same as the coupler of the first exemplary embodiment. Thus, in the decoupled state, thecoupler output member9 is connected, such that it is secured against rotating, to thecasing part4 via thecoupler sleeve8′, the couplerintermediate member7′ and thedecoupling member11′. Operating theinjection button16 and consequently performing the coupler stroke X (FIG. 11) establishes the coupler engagement, in the second exemplary embodiment between thecoupler input member6′ and the couplerintermediate member7′. In the first phase of the coupler stroke X, theengaging elements6aand7cinterlock with each other, such that thecoupler input member6′ is connected, such that it is secured against rotating, to thecoupler output member9 via the couplerintermediate member7′ and thecoupler sleeve8′. Only once the rotationally secured engagement has been established is the couplerintermediate member7′ moves out of engagement with thedecoupling member11′ by thecoupler input member6′ pressing in the advancing direction V, such that thecoupler output member9 may freely rotate about the threaded axis R formed with thepiston rod15 and the coupler engagement is completely established.
• FIG. 14 shows the injection apparatus in its coupled state, i.e., in the coupler engagement, andFIGS. 15 and 16 correspond generally toFIGS. 6 and 7 of the first exemplary embodiment, such that reference may be made toFIGS. 6 and 7.
• FIG. 17 shows the injection apparatus of the second exemplary embodiment while thereservoir2 is being exchanged. Once thereservoir2 has been emptied, as shown inFIG. 16, thecasing part1 is detached from thecasing part4, which moves thedecoupling member11′ into the decoupling position. This function fully corresponds to that of thedecoupling member11 of the first exemplary embodiment, such that reference may be made to explanations therein and toFIGS. 8-10.
• In the state shown inFIG. 17, thecasing part1 is already accommodating thenew reservoir2. In order to connect thecasing part1 to thecasing part4, thecasing part1 may be moved towards thecasing part4 using thepiston3 which proximally seals thereservoir2. Thepiston rod15 which freely protrudes out of thecasing part4 is moved back by thepressing piston3 in the threaded engagement with thecoupler output member9 which may be freely rotated but is axially fixed. Due to the rotationally securedlinear guide4a, which in the second exemplary embodiment is formed by a coupler receptacle which is inserted into thecasing part4 such that it is secured against rotating, thepiston rod15 completes an axial linear movement when retracted, while thecoupler output member9 freely rotates, together with thecoupler sleeve8′, about the common threaded axis. Instead of moving thepiston rod15 back pressing against thepiston3, thepiston rod15 may also be moved back beforehand by pressing directly on its plunger.
• FIG. 18 shows the coupler region, with thedecoupling member11′ situated in the decoupling position, in detail. The function of thedecoupling member11′ corresponds to that of the first exemplary embodiment, namely blocking thecoupler input member6′ in the retracted axial position.
• The dosing movement and the drive movement are also introduced into the gear of thedosage display20′ via thecoupler input member6′ and adisplay coupling member22 in the second exemplary embodiment. Thedisplay coupling member22 is also connected to thecoupler input member6′, such that it is secured against rotating, and cannot be moved relative to thecasing part4 in and counter to the direction of the coupler movement X.
• FIGS.19 to24 show a third exemplary embodiment of the injection apparatus, in which during administering, the drive force for delivering the product is not applied manually but rather by adrive member25 formed as a drive spring. Thedrive member25 is tensed by setting the dosage to be administered. The spring energy absorbed when setting the dosage is released when the apparatus is triggered and converted into advancing thepiston rod15.
• FIG. 19 shows the injection apparatus of the third exemplary embodiment, complete with the assembled casingpart38 and theneedle protection39 accommodated in it, which may be slid counter to the advancing direction V, against the force of a restoring spring.
• FIGS. 20 and 21 show thecasing part4 with the components of the injection apparatus accommodated in it;FIG. 20 in a resting state comparable to the preceding exemplary embodiments, in which the dosage may be set, andFIG. 21 in the coupler engagement. Where nothing different is said below, reference is made in particular toFIGS. 20 and 21.
• Thedrive member25 is a spiral spring acting as a torsion spring, comprising spring windings which encircle the threaded axis R of the threaded engagement between thecoupler output member9 and thepiston rod15. The spring windings are arranged one over the other, radially with respect to the spring windings; they exhibit a zero pitch with respect to the threaded axis R. An inner end of the spring windings is fastened to thecoupler input member6′, and an outer end is fastened to a supportingstructure26 which is connected to thecasing part4 such that it may be moved in the direction of the coupler movement X but is secured against rotating. On the other hand, the supportingstructure26 is connected to thecoupler input member6′ such that it cannot be moved in and counter to the direction of the coupler movement X. Thecoupler input member6′ may be rotated about the threaded axis R relative to the supportingstructure26. Another supportingstructure6dis connected to thecoupler input member6′ such that it cannot be moved in and counter to the direction of the coupler movement X; in the exemplary embodiment, thecoupler input member6′ and the supportingstructure6dare formed integrally. Thedrive member25 is axially enclosed by the supportingstructures6dand26.
• The functionality of the coupler corresponds to that of the second exemplary embodiment, such that the same reference indicators are used for thecoupler members6′-10′ and thedecoupling member11′. Unlike the coupler of the second exemplary embodiment, however, thecoupler sleeve8′ therein has been omitted. The couplerintermediate member7′ is directly in an engagement with thecoupler output member9 which transfers the rotational drive movement of thecoupler input member6′ onto thecoupler output member9.
• 20″ indicates a dosage display which is coupled to thecoupler input member6′ via adisplay coupling member23 and, like thedisplay coupling members21 and22 of the other exemplary embodiments previously, is connected to thecoupler input member6′, such that it is secured against rotating. Thedisplay coupling member23 cannot be moved in and counter to the direction of the coupler movement X relative to thecasing part4. As in the first and second exemplary embodiment previously, the rotationally secured connection of thedisplay coupling member23 exists both in the decoupled and in the coupled state of the device.
• In order to prevent thecoupler input member6′ for setting the dosage and during storage from the rotational drive movement, and to hold thedrive member25 in its tensed state, a rotational block is formed between thecoupler input member6′ and thecasing part4. In the holding position of thecoupler members6′,7′ and9 shown, the rotational block exists between a first blockingmember24 and asecond blocking member34. The blockingmember24 is connected to thecoupler input member6′, such that it is secured against rotating. The blockingmember34 is connected to thecasing part4, such that it is secured against rotating but may be moved in and counter to the direction of the coupler movement X relative to thecasing part4 and thecoupler input member6′. The facing areas of the blockingmembers24 and34, which contact each other in the blocking engagement, form a ratchet which allows a rotational movement of thecoupler input member6′ which tenses thedrive member25 and prevents a rotational movement in the opposite direction.
• FIG. 24, includingFIGS. 24aand24b, depicts thecoupler input member6′ together with the blockingmember24 mounted on it, such that it is secured against rotating, thedisplay coupling member23 connected to thecoupler input member6′, such that it is secured against rotating, and a connectingpart33 connected to theinput member6′ such that it cannot be moved. Thedisplay coupling member23 forms a units counting ring of thedosage display20″ and is suitably coupled to a tens counting ring in order to display the dosage set. On proximal facing side facing the blockingmember34, the blockingmember24 is provided with blocking teeth24awhich are arranged evenly about the axis R and in the blocking engagement co-operate with counter teeth of the blockingmember34, in order to form the rotational block with respect to the drive movement. For a second function connected with dosing and delivery, a shell outer area of the blockingmember24 is provided with a thread24b, the threaded axis of which coincides with the threaded axis R of thepiston rod15. A stoppingmember27 engages with the thread24b. The stoppingmember27 is guided such that it may be linearly moved parallel to the threaded axis R; in the exemplary embodiment, in an axial groove on the inner shell area of thecasing part4. The blockingmember24 forms arotational stopper24cfor the stoppingmember27, which limits the drive movement of thecoupler input member6′ which advances thepiston rod15. It forms anotherrotational stopper24dfor the stoppingmember27, which determines the maximum dosage which may be delivered and set. Another stoppingmember27 is arranged on the other side of the threaded axis R, opposite the stoppingmember27 which may be seen in the view inFIG. 23, and co-operates in the same way with two otherrotational stoppers24cand24d. The thread24bis double-threaded. The stoppingmembers27 simultaneously abut against the respectively assignedrotational stoppers24cand24d, as may be seen in the cross-sectional representation inFIG. 23 for therotational stoppers24c. Therotational stoppers24cdetermine a zero dosage position and therotational stoppers24ddetermine a maximum dosage position.
• In the third exemplary embodiment, the holding means is formed in a third variant. It includes acoupler restoring member19, as well as thedisplay coupling member23 and the blockingmember24. The restoringmember19 is supported on thecasing part4 via thedisplay coupling member23 in the direction of the coupler movement X and by the blockingmember24 counter to the direction of the coupler movement X. The restoringmember19 presses the blockingmember24 until it abuts against the connectingpart33. Since the connectingpart33 is connected to thecoupler input member6′ such that it cannot be moved in and counter to the direction of the coupler movement X, the restoringmember19 thus exerts an elastic restoring force, acting counter to the direction of the coupler movement X, on thecoupler input member6′ via the blockingmember24 and the connectingpart33, said elastic restoring force holding thecoupler input member6′ in the holding position retracted out of the coupler engagement. It again acts as a pressure spring. The blockingmember24 is a sleeve part comprising an outer shell forming the thread24b, an inner shell serving to mount it on thecoupler input member6′ such that it is secured against rotating, and a base connecting the two shells, on which the blocking teeth24aare formed. The restoringmember19 protrudes into the blockingmember24 which is cup-shaped in this way, and is supported on the base of the blockingmember24.
• The restoringmember19 not only presses the blockingmember24 until it abuts against the connectingpart33, but also until it abuts against thecasing part4. Abutting in this other way prevents the blockingmember24 from being able to be moved counter to the direction of the coupler movement X beyond the holding position assumed inFIG. 20. The blockingmember24 may thus be moved relative to thecoupler input member6′, against the restoring elasticity force of the restoringmember19, in the direction of the coupler movement X. Conversely, thecoupler input member6′ may be moved counter to the direction of the coupler movement X relative to the blockingmember24 abutting against thecasing part4.
• The equalizingspring17, tensed between thepiston rod15 and the connectingpart33, supports the restoringmember19 in its function of holding thecoupler input member6′ in the holding position. In certain embodiments, the equalizingspring17 may replace the restoringmember19 for retracting thecoupler members6′,7′ and9. However, the equalizingspring17 may be weak enough that, at least once it has been partially relaxed, it may no longer hold thecoupler members6′-9 in the holding position, and thus may no longer reliably hold the coupler in the decoupled state.
• A triggeringelement28 is provided for triggering thedrive member25. The triggeringelement28 may be moved translationally relative to thecasing part4 in the direction of the coupler movement X—in the exemplary embodiment, the advancing direction V and/or the distal direction—and rotationally about the rotational axis R of thecoupler input member6′, which in the exemplary embodiment coincides with the threaded axis R of thepiston rod15, and is guided in these two movements by thecasing part4. The translational movement in the distal direction establishes the coupler engagement between thecoupler input member6′ and the couplerintermediate member7′ and releases the rotational block between the blockingmembers24 and34, which triggers thedrive member25, i.e. delivery. The translational movement in the advancing direction V is therefore also referred to as the triggering movement in the following.
• In another function, the triggeringelement28 forms the dosing member of the third exemplary embodiment. Via multiple intermediate members, the rotational movement of the triggeringelement28 relative to thecasing part4 sets the product dosage which may be delivered by the next delivery process. This movement is also referred to as the dosing movement in the following. From the zero dosage position, which is shown inFIG. 20 and determined by the stoppingmembers27 abutting therotational stoppers24cof the blockingmember24 which limit the drive movement of thecoupler input member6′, the dosage may be set by rotating the triggeringelement28 in the direction of the rotational direction arrow indicated, the dosing direction. The rotational dosing movement of the triggeringelement28 is transferred onto thecoupler input member6′ via aninner part29, which is connected to the triggeringelement28 such that it is secured against rotating and shifting or is formed integrally with it, and the connectingpart33. For transferring, theinner part29 and the connectingpart33 are in an engagement with each other, such that they are secured against rotating, and the connectingpart33 is connected to thecoupler input member6′ such that it is secured against rotating. For secured against rotating, theinner part29 and the connectingpart33 are provided with aninner toothing29aand anouter toothing33awhich interlock with each other in the resting state of the apparatus and may be axially shifted with respect to each other.
• The triggeringelement28 is arranged in the proximal end region of thecasing part4 so as to be user-friendly. Its outer sleeve part surrounds thecasing part4. A base of the triggeringelement28 forms a proximal end of the injection apparatus. For setting the dosage, the triggeringelement28 may be operated as a turning button and is ribbed on its outer shell area for this purpose. For triggering, it may be operated as a push button. During the dosing movement, the triggeringelement28 locks with thecasing part4 in discrete positions corresponding to the dosage units.
• A stopper element29bfacing a proximal facing area of the connectingpart33 projects radially inwards from theinner part29. In the resting state of the apparatus, a clear distance remains between the connectingpart33 and the stopper element29b, which is just large enough that the rotational block between theinner part29 and the connectingpart33 is released during the triggering movement of the triggeringelement28, before the stopper element29bterminates the relative movement of the triggeringelement28 relative to the connectingpart33 by abutting contact.
• Thesecond blocking member34 is tensed in the blocking engagement with the blockingmember24 by means of a blockingspring31. For this purpose, the blockingspring31 is supported in the direction of the coupler movement X on the blockingmember34 and counter to the coupler movement X on acasing part30 which is fixedly connected to thecasing part4. Anotherspring32, arranged between theinner part29 and the blockingmember34, tenses the triggeringelement28 relative to the blockingmember34 into a proximal end position. The blockingmember34 is axially guided, such that it is secured against rotating, by thecasing part4. Thecasing part4 forms a distal and a proximal stopper for the mobility of the blockingmember34.
• In the resting state shown inFIG. 20, the user sets the dosage by rotating the triggeringelement28 in the dosing direction. During this rotational dosing movement, the triggeringelement28 slaves the connectingpart33 via therotational block29a,33a, which for its part slaves thecoupler input member6′ which thus completes the same rotational dosing movement as the triggeringelement28. Rotating thecoupler input member6′ tenses thedrive member25. In the engagement with the thread24bof the blockingmember24, the stoppingmember27 migrates from thestopper24cof the thread24bdetermining the zero dosage in the direction of thestopper24ddetermining the maximum dosage (FIG. 24).
• The injection apparatus also offers a convenient way of correcting the dosage, as is clear from a comparison ofFIGS. 20 and 22. If the user has inadvertently set too high a dosage, he/she may correct the dosage by rotating thecoupler input member6′ back. For correcting the dosage, he/she pulls the triggeringelement28 in the proximal direction. This retracting movement of the triggeringelement28 is indicated inFIG. 22 by an arrow, as is the rotational direction for correcting. In the resting state of the apparatus, theinner part29 and the blockingmember34 are in a slaving engagement with respect to a movement in the proximal direction. The corresponding slaving means are indicated as29cand34a. The slaving means29cformed by theinner part29 and the slaving means34aformed by the blockingmember34 grip behind each other and form a latch for the retracting movement of the triggeringelement28. By pulling on the triggeringelement28, the blockingmember34 is thus also moved in the proximal direction, against the force of the blockingspring31, and is thus released from the blocking engagement with the blockingmember24 which abuts against thecasing part4. As soon as the rotational block is released, the user may correct the dosage by means of a reverse rotational movement of the triggeringelement28 and the still extant rotationally secured engagement between theinner part29 and the connectingpart33. As soon as the user releases the triggeringelement28, it snaps back together with the blockingmember34 due to the effect of the blockingspring31 in the distal direction and the blockingmember34 thus snaps back into the blocking engagement with the blockingmember24. During the reverse rotational movement, the user expediently continues to hold the triggeringelement28, which is facilitated by the rotational angular locking positions of the triggeringelement28. However, the user may also let the triggeringelement28 snap back and re-dose as applicable.
• Once the desired dosage has been set, the apparatus is placed onto the skin at the desired administering location, and the injection needle is injected. For injecting the needle, the triggeringelement28 takes on another function, for which purpose it is coupled to the needle protection39 (FIG. 19).
• In a first phase of injecting, the user presses the injection apparatus against the skin, such that theneedle protection39 is moved in the distal direction relative to thecasing part38. However, this first part of the movement of theneedle protection39 does not yet expose the injection needle; rather, its tip remains short of theneedle protection39. In this first phase of the injecting process, theneedle protection39 abuts against a resisting element, such that it cannot be moved further in the distal direction relative to thecasing part38. By continuing to exert pressure on the injection apparatus in the direction of the skin, the user presses the triggeringelement28 in the proximal direction. In the course of this first phase of its triggering movement, the triggeringelement28 releases an abutting contact between theneedle protection39 and the resisting element, such that the injection apparatus, and together with it the injection needle, is moved relative to theneedle protection39 in the direction of the skin, and the injection needle injects. With respect to the function of the triggeringelement28 for injecting the injection needle, reference may be made to the U.S. patent application entitled “Attachment Module for an Injection Device Comprising an Engagement Control for a Needle Covering Element,” owned by the owner of the present application and incorporated by reference herein.
• As soon as the injection needle has been subcutaneously placed, thedrive member25 may be released and the product delivered by pressing further onto the triggeringelement28. In the second phase of the triggering movement of the triggeringelement28, which follows the injection phase, the triggeringelement28 and therefore theinner part29 is pressed further in the distal direction relative to the connectingpart33, against the pressure of thespring32, such that therotational block29a,33ais released. The triggeringelement28 may rotate idly. As soon as therotational block29a,33ahas been released, the stopper element29bpasses into abutting contact with the connectingpart33. In the third phase of the triggering movement which then follows, the triggeringelement28 presses the connectingpart33 and therefore thecoupler input member6′ via the stopper element29b, in the direction of the coupler movement X; in the exemplary embodiment, in the advancing direction V. Due to the effect of the spring force of the blockingspring31, the blockingmember34 follows this movement, until it abuts against thecasing part4. Before the blockingmember34 reaches the abutting position, thecoupler input member6′ passes into the coupler engagement with the couplerintermediate member7′. Thecoupler input member6′ presses the couplerintermediate member7′ out of the frictional-lock blocking engagement with thedecoupling member11′, against the force of the restoringmember10′. Once the blocking engagement between the conical areas of the twomembers7′ and11′ has been released and the coupler engagement therefore completely established, the blockingmember34 abuts thecasing part4. In the final phase of the triggering movement which then follows, the triggeringelement28 presses the blockingmember24 out of the blocking engagement with the blockingmember34 via the connectingpart33.
• As soon as the rotational block formed by the blockingmembers24 and34 is released, the rotational drive movement of thecoupler input member6′ is initiated due to the drive force of thedrive member25 and is transferred onto thecoupler output member9 via the coupler engagement. Because it is guided—such that it is secured against rotating—in thelinear guide4a, thepiston rod15 is moved, in the threaded engagement with thecoupler output member9, in the advancing direction V, and product is delivered. This delivery movement is terminated by the stoppingmember27 abutting thestopper24cof the blockingmember24 determining the zero dosage.
• FIG. 21 shows the injection apparatus when a zero dosage or a small priming dosage is set, in the coupled state after the rotational block has been released, i.e. after the triggeringelement28 has completely performed the triggering movement. If pressure is continuously exerted on the triggeringelement28, the triggering sequence described above progresses automatically from injecting to completely delivering the dosage set.
• FIG. 23 shows the injection apparatus after thecontainer2 has been emptied. Thecasing part1 has already been removed from thecasing part4. Thepiston rod15 assumes its most distal position. Thedecoupling member11′ blocks thecoupler input member6′ in the position retracted from the couplerintermediate member7′. The functionality of thedecoupling member11′ corresponds to that in the other exemplary embodiments. Unlike the two first exemplary embodiments, however, thecasing part1 and thedecoupling member11′ are not directly in a guiding engagement with each other, but rather via anadapter structure35. Theadapter structure35 is a sleeve in thecasing part4 which is fixed in and counter to the direction of the coupler movement X in the connecting portion, but may be rotated about the central longitudinal axis R of thecasing part4. Theadapter structure35 forms a guidingcurve35aeither as a cavity on or a breach in its shell area facing thedecoupling member11′. The guidingcurve35aexhibits the course of a threaded portion. The length measured over the circumference and the pitch of the guidingcurve35ameasured with respect to the central longitudinal axis of thecasing part4 are dimensioned such that thedecoupling member11′ is moved into the decoupling position shown inFIG. 21 by a quarter to a half revolution of theadapter structure35 relative to thedecoupling member11′. For generating the axial movement, thedecoupling member11′ engages via its engagingelement12 with the guidingcurve35a. In this respect, reference is made to the statements regarding the first exemplary embodiment.
• When connecting thecasing parts1 and4, theadapter structure35 forms a linear guide for thecasing part1. Thecasing part1 may be inserted into theadapter structure35, where a slight frictional lock and correspondingly a sliding guide for thecasing part1 may be present. In certain embodiments, thecasing part1 may not be rotated about the central longitudinal axis of thecasing part4 relative to theadapter structure35. The engagement, which may be rotationally secured, is established right at the beginning of inserting thecasing part1 into theadapter structure35. Once thecasing part1 has been inserted until it abuts against thecasing part4, i.e. once the coupler is accommodated at4a, thecasing part1 is rotated relative to thecasing part4 and slaves theadapter structure35 during this rotational movement, until the engagingelement12 of thedecoupling member11′ abuts the end of the guidingcurve35a. In certain embodiments, the rotational movement of thecasing part1 is prevented until its axial abutting position. This may provide a rotational block up until the abutting position may be formed between thecasing parts1 and4.
• The movement of thedecoupling member11′ caused in the guiding engagement exhibits an axial length which is greater than the length X of the complete coupler movement. In its decoupling movement, thedecoupling member11′ presses thecoupler input member6′ beyond its holding position assumed in the resting state and blocks it in said decoupling position. In this forced decoupling movement, thecoupler input member6′ slaves the triggeringelement28 via the stopper element29b. Via the latch between the slaving means29cand34a, the blockingmember34 is also slaved against the force of the blockingspring31, and moved out of the blocking engagement. The blockingmember24 may not follow the blockingmember34, since it is abutting against thecasing part4. Detaching thecasing parts1 and4 thus releases the rotational block by means of the decoupling mechanism which thecasing parts1 and4 form with thedecoupling member11′ via theadapter structure35. If thecoupler input member6′ has not yet assumed the zero dosage position, it is now at the latest rotated into the zero dosage position by thedrive member25 and thedosage display20″ is zeroed. In this respect, because of the coupling between thedosage display20″ and thecoupler input member6′, for each delivery, thedosage display20″ is reset in accordance with the delivered dosage. If the dosage set is not delivered one time, for example because the injection process is aborted or thecontainer2 is no longer contains the complete dosage set, the user may then read this from thedosage display20″ which is only partially reset.
• Service Life Timer
• The injection apparatus of the second exemplary embodiment is equipped with a service life timer. The service life timer counts the number of changes of thecontainer2 and indicates to the user when the end of the service life has been reached. In one exemplary embodiment, when a number of container changes, ascertained or counted by means of the service life timer, have been performed, the service life timer signals to the user that the service life of the injection apparatus has passed. Reference may also be made to a U.S. patent application entitled “Service Life Timer for a Device for Administering a Product in Doses” filed on the same date as the present application, owned by the owner of the present application, and incorporated herein by reference.
• Resetting thepiston rod15 serves as an indication that thecontainer2 has been changed. Thepiston rod15 forms a first actuator of the service life timer and the triggeringelement16 forms a second actuator, which co-operate to switch or further switch the service life timer and in this way count the container changes.
• FIG. 25 shows the proximal end region of the injection apparatus of the second exemplary embodiment, in the state fromFIG. 11. The apparatus assumes this state directly after anothercontainer2 has been inserted and thepiston rod15 correspondingly reset, before the triggeringelement16 is pressed in.
• The service life timer includes anadder50 which is formed as a mechanical gear. Anadder casing51, which mounts the components of theadder50 such that they may be moved, is connected to the triggeringelement16, such that it cannot be moved in and counter to the direction of the triggering movement. In a further example, theadder casing51 is secured against rotating. In addition, triggeringelement16 anddisplay structure56 may together form output means of the service life timer.
• FIG. 26 shows theadder50 and the output means as a separate module, separate from the injection apparatus, in a side view. The module is simply plugged or snapped into thedrive member5 which is open at the proximal end, such that the module is fixedly connected to thedrive member5 and cannot perform any movements relative to thedrive member5 in and counter to the direction of the coupler movement X or any rotational movements about the rotational axis R.
• FIG. 27 shows the module in a view counter to the advancing direction V.FIG. 28 shows the module in the longitudinal section indicated inFIG. 27, andFIGS. 29 and 30 show the cross-sections A-A and B-B indicated inFIG. 26.FIG. 31 shows components of the module without theadder casing51 andFIG. 32 shows components of the module with theadder casing51, each in a perspective view.FIG. 33 shows the components of the module individually, in their assembly positions relative to each other. The output means in particular may be seen inFIG. 34.FIG. 35 individually shows an addinginput member54 of theadder50, andFIG. 36 individually shows an addingintermediate member55 of theadder50, whileFIGS. 37 and 38 show an adjusting engagement formed between these two components, in detail.
• The service life timer is described below with reference to FIGS.25 to38.
• Theadder50 includes theadder casing51 and the adder members which it mounts such that they may be moved, namely arecorder52, the addinginput member54, the addingintermediate member55, thedisplay structure56 which simultaneously forms an adding output member, and arecorder restoring member53 which is formed as a spring member and tenses therecorder52 in the advancing direction V relative to theadder casing51, into a resting position. Therecorder restoring member53 acts as a pressure spring which is supported on therecorder52 in the advancing direction V and on theadder casing51 counter to the advancing direction V.
• Thedisplay structure56 is formed as an annular disc which is mounted by theadder casing51, such that it may be rotated relative to the triggeringelement16, in a space remaining free between theadder casing51 and the triggeringelement16. For mounting it such that it may be rotated, a journal projects from the annular disc, through an opening of theadder casing51, and into a bore of therecorder52, in which therecorder restoring member53 is also accommodated. The annular disc of thedisplay structure56 also forms a hollow wheel for a final stage of theadder50.
• Theadder casing51 mounts therecorder52 such that it may be linearly moved back and forth in and counter to the advancing direction V, and guides it such that it is secured against rotating. Theadder casing51 is provided with a circular cylindrical groove encircling the rotational axis R, in which the addinginput member54 is guided such that it may be rotated about the rotational axis R but cannot be moved in and counter to the advancing direction V. Other rotational guides, for example a groove in the addinginput member54 and a circumferential stay on thecasing51, are also conceivable. The addinginput member54 is shaped as a ring and provided on both axial facing sides, circumferentially in each case, with atoothing54aand54bof serrated teeth in an even separation. The twotoothings54aand54btogether form a sagittal toothing. Therecorder52 protrudes through the addinginput member54 and into a receptacle of theadder casing51, and is slide-guided in thereceptacle51, such that it is secured against rotating. The receptacle is open on a longitudinal side, wherein the opening extends on both sides of the addinginput member54 in its guiding groove. Twotoothings52aand52bof the recorder52 (FIGS. 26, 28 and33) protrude out of the opening, such that thetoothings52aand52blie opposite thetoothings54aand54bof the addinginput member54 at the same radial height. Therecorder52 thus forms thecounter toothing52afor thetoothing54aand thecounter toothing52bfor the toothing54b. The counter toothings52aand52bare formed as short tooth segments in the circumferential direction, and in the exemplary embodiment exhibit a width of two teeth. The counter toothings52aand52bare shaped to be congruent to thetoothings54aand54band are offset by half a tooth with respect to each other. In a recording movement of therecorder52, relative to theadder casing51 and thus relative to the addinginput member54 counter to the advancing direction V, thecounter toothing52apasses into toothed engagement with thetoothing54aand thus rotates the addinginput member54 further by half a tooth. In a following reverse movement in the advancing direction V, caused by therecorder restoring member53, thecounter toothing52bpasses into toothed engagement with the toothing54b, such that the addinginput member54 is again rotated further by half a tooth. The forward and reverse movement together forms the recording movement of therecorder52, by which the addinginput member54 is rotated further from an initial rotational angular position to a new rotational angular position. The recording movement corresponds to a change of thecontainer2. In the next container change, the new position of the previous container change is the initial position. The addinginput member54 operates as a first counting member of theadder50.
• The recording movement is limited in both directions by corresponding stoppers. The stoppers are formed by the addinginput member54, namely in the maximum toothed engagement of thetoothings52aand54aon the one hand and of thetoothings52band54bon the other hand. This results in a switching path for therecorder52 from one of the two end positions to the other, respectively. In the relaxed state, therecorder restoring member53 presses therecorder52 into the toothed engagement with the toothing54bof the addinginput member54. The switching path is longer than the coupler stroke X.
• The addinginput member54 is coupled to thedisplay structure56 via an addingintermediate member55 which is shown individually inFIG. 36 and may in particular also be seen inFIGS. 28, 31,33,37 and38. The addingintermediate member55 is formed by ashaft55aand twospur wheels55band55c—in the exemplary embodiment, toothed wheels—which are placed rotationally rigid on theshaft55a. The spur wheel55bis an input wheel and thespur wheel55can output wheel of the addingintermediate member55. The input wheel55bco-operates with the addinginput member54. Theoutput wheel55crolls off on a shell inner face of thedisplay structure56 which thus forms a hollow wheel for theoutput wheel55c. The engagement between theoutput wheel55cand thedisplay structure56 is also formed as a toothed engagement (FIGS. 29 and 31). The inner toothing of thedisplay structure56 does extend over almost the entire circumference of the shell inner area, but is not formed circumferentially but is rather interrupted by a radially raised region.
• FIG. 35 shows the addinginput member54 in a perspective view, in particular onto its shell inner area. It forms an engagingstructure54cfor the input wheel55bon the shell inner area. Measured over the entire circumference of the shell inner area, the engagingstructure54cis very short; in the exemplary embodiment, it exhibits a width, measured in the circumferential direction, of one separation of the toothing of the input wheel55b, such that one full revolution of the addinginput member54 rotates the input wheel55band therefore the entire addingintermediate member55 further by one tooth separation.
• FIGS. 37 and 38 show the adjusting engagement formed between the addinginput member54 and the addingintermediate member55 by the engagingstructure54cand the input wheel55b, in detail. With respect to this adjusting engagement, reference is additionally made toFIGS. 35 and 36. The input wheel55bexhibits an even number of teeth comprising first teeth of equal length and second teeth of equal length, which however are axially shorter than the first teeth. The first teeth and second teeth are alternately distributed over the circumference. All the teeth of the input wheel55bare identical in profile and co-operate in the same way with the engagingstructure54c. With respect to the addinginput member54, it may also be noted that it comprises two circularaxial portions54dand54ehaving different diameters. In the adjusting engagement, the axially shorter teeth of the input wheel55baxially cover only theaxial portion54dhaving the greater diameter, while the longer teeth of the input wheel55balso extend into theaxial portion54ehaving the smaller diameter. The engagingstructure54cis shaped such that the longer teeth may mesh with the engagingstructure54cin the adjusting engagement, though only in the adjusting engagement. The smaller-diameteraxial portion54e, which adjoins the engagingstructure54con both sides in the circumferential direction, prevents the addingintermediate member55 from being able to rotate idly once it has passed through the engagingstructure54c, by blocking the longer teeth of the input wheel55bwith theaxial portion54ehaving the smaller diameter.
• The functionality of the output means may be seen in particular from an overview ofFIGS. 28, 31 and34. The proximal facing area of thedisplay structure56 is provided with a colored marking in the form of a colored ring or colored annular portion, and the triggeringelement16 comprises a window16aaxially flush with the colored marking, through which the colored marking may be read. The colored marking is colored green over a significant part of its arc length, yellow in an adjoining part and red in a short end part. In the course of the service life, the user thus sees the green part through the window, towards the end of the service life classified as reliable he/she sees the yellow part, and at the end of the service life the red part of the colored marking appears in the window16a.
• Theadder50 reduces the recording movement of therecorder52 to a slow rotational movement of thedisplay structure56 corresponding to the recorded change in state and composed of discrete rotational increments. For each individual container change, therecorder52 performs its back-and-forth recording movement. In the adjusting engagement between itstoothings54aand54band the counter toothings52aand52bof therecorder52, the addinginput member54 is rotated further by one tooth per recording movement. In this sense, therecorder52 and the addinginput member54 form a first counting and reducing stage. A second, next reducing stage is formed by the addinginput member54 and the addingintermediate member55, namely by means of the adjusting engagement between the engagingstructure54cand the input wheel55b. In this second adjusting engagement, the addingintermediate member55 is rotated further by two teeth of its input wheel55bfor each full revolution of the addinginput member54. Lastly, the third and final reducing stage is formed by theoutput wheel55cand thedisplay structure56.
• Assuming, merely by way of example, that the addinginput member54 exhibits a number of teeth in the range of 20 to 30, the input wheel55bexhibits a number of teeth in the range of 6 to 10, and that theoutput wheel55calso exhibits a number of teeth in the range of 6 to 10 and thedisplay structure56 also exhibits a number of teeth in the range of 20 to 30, then the output means16,56 will display the state “end of service life” after at least 120 and at most 750 container changes.
• When changing thecontainer2, thepiston rod15 is reset to the proximal position shown inFIG. 25, either manually before connecting thecasing parts1 and4 or by thepiston3 pressing against thepiston rod15, while connecting thecasing parts1 and4. At the end of the resetting movement, it contacts therecorder52 and presses it slightly into theadder casing51, via itsdisc15aand against therecorder restoring member53. This first part of the recording movement should disengage therecorder52 from the toothing54b, in order to prevent the service life timer from counting when the triggeringelement16 is merely pressed. For priming the apparatus, which should be performed after each container change, a priming dosage of a few dosage units, for example one to three units, should then be set and the triggeringelement16 operated such that thepiston rod15 performs a short priming stroke corresponding to the priming dosage. In the triggering movement of the triggeringelement16 and the subsequent delivery movement of thepiston rod15, therecorder52 is initially moved by the coupler stroke X relative to the addinginput member54, into the toothed engagement with thetoothing54aand rotates the addinginput member54 further by half a tooth. The subsequent priming stroke of thepiston rod15 moves therecorder52 back by the priming stroke. When the triggeringelement16 is relaxed, it moves even further back relative to the addinginput member54, by the coupler stroke X, and into engagement with the toothing54b, such that the addinginput member54 is rotated further by another half a tooth and the container change is counted. In one variant, therecorder52 is moved into engagement with thetoothing52aby abutting against thepiston rod15 situated in the proximal position. In this variant, solely the container change, without the triggering movement, alone rotates the addinginput member54 further, at least far enough that when therecorder52 is relaxed, itstoothing52bpasses into engagement with the toothing54b. However, therecorder52 should not yet pass into a maximum engagement with thetoothing52adue to the contact with thereset piston rod15, in order not to block the coupler movement X after a priming dosage has been set. In this variant, thetoothings52aand54aare embodied correspondingly long in the advancing direction V.
• Theadder50 may be provided in the injection apparatus of the first exemplary embodiment in the same way as has been explained on the basis of the second exemplary embodiment. For this purpose, theadder casing51 merely has to be connected to the triggeringelement16 of the first exemplary embodiment in a corresponding way. Similarly, in a third exemplary embodiment, theadder50 may be inserted in the space remaining free between the stopper element29band the base of the triggeringelement28 and may be connected to the triggeringelement28 such that it cannot be moved in and counter to the advancing direction V. Therecorder52 then protrudes through the stopper element29band is held out of engagement with the toothing54b, against the force of therecorder restoring member53, by thepiston rod15 situated in the proximal position. The switching path of therecorder52 is also dimensioned such that the full triggering movement moves therecorder52 into a sufficient toothed engagement with thetoothings52aand54asuch that the addinginput member54 is rotated at least far enough that thetoothings52band54bmay then interlock with each other, in order to rotate the addinginput member54 further. Thetoothings52band54bdo not engage until thepiston rod15 has been advanced slightly away from thedrive member25.
• 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 or steps disclosed. The embodiments were chosen and described to provide the best illustration of the invention and its practical application, 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.

Claims (41)

1. An administering apparatus comprising a service life timer, said apparatus comprising:

a casing comprising a reservoir for a container for a product to be administered;

a conveying member for the product;

an adder for recording and adding a change in the state of the apparatus, wherein said adder is incremented upon administering said product; and

an output means coupled to the adder, said output means outputting a signal perceivable by the senses, in accordance with the addition result.

2. The administering apparatus according toclaim 1, wherein said adder records and adds the number of at least one of the following changes in state:

change of the container;

deliveries of the product; and

settings of a dosage to be administered.

3. The administering apparatus according toclaim 1, wherein said service life timer comprises at least one actuator, wherein said adder records a movement or position the at least one actuator performs or assumes in the change in state to be recorded.

4. The administering apparatus according toclaim 3, wherein said at least one actuator comprises an operable triggering element, said triggering element performing a triggering movement which causes a delivery movement of the conveying member, and wherein said adder records the triggering movement of the triggering element.

5. The administering apparatus according toclaim 3, wherein said conveying member forms the at least one actuator, wherein said adder records a resetting position assumed after a resetting movement has been performed, or a delivery movement of the conveying member, or the resetting position and the delivery movement of the conveying member.

6. The administering apparatus according toclaim 3, wherein one of said at least one actuator comprises an operable triggering element and another of said at least one actuator comprises a conveying member, wherein said adder records the triggering movement of the triggering element and the resetting position and delivery movement of the conveying member.

7. The administering apparatus according to3, wherein said at least one actuator comprises an operable triggering element, wherein when a product dosage is set, said operable triggering element performs a dosing movement, and wherein said adder records the dosing movement of the triggering element.

8. The administering apparatus accordingclaim 3, wherein one of said at least one actuator comprises an operable triggering element and another of said at least one actuator comprises a conveying member, and wherein said adder records the resetting position of the conveying member and the dosing movement of the triggering element.

9. The administering apparatus according toclaim 3, wherein said adder comprises a recorder and an adding input member, and wherein said at least one actuator couples the recorder to the adding input member during the change in state, such that the adding input member is moved by the recorder from an initial position to a new position.

10. The administering apparatus according toclaim 1, comprising an injection apparatus or an infusion apparatus, wherein said adder comprises a reducing gear comprising a recorder, said reducing gear transferring movements of the recorder in response to changes in state onto a display structure of the output means.

11. The administering apparatus according toclaim 10, wherein said reducing gear comprises a multi-staged reducing gear having at least two reducing stages, wherein said reducing gear or at least one of said reducing stages comprises a toothed wheel gear.

12. The administering apparatus according toclaim 10, wherein said recorder is moved in a recording movement upon each recording of the changes in state, said movement comprising a back-and-forth recording movement, and wherein said reducing gear comprises an adding input member for rotational movement about a rotational axis (R), said recording movement of the recorder being converted into a rotational movement of the adding input member in a first gear stage.

13. The administering apparatus according toclaim 12, wherein said reducing gear converts the rotational movement of the adding input member to a movement of the display structure in at least one other gear stage.

14. The administering apparatus according toclaim 1, comprising an injection apparatus or an infusion apparatus, wherein said adder comprises a recorder for recording individual changes in state, said recorder performing a recording movement in each change in state.

15. The administering apparatus accordingclaim 14, wherein said recorder comprises a contact recorder movable by means of an actuator of the apparatus by contact with the actuator, wherein the position of the actuator is altered in the change in state.

16. The administering apparatus according toclaim 14, wherein said recorder is moved in a first direction and then in a second direction counter to the first direction upon each recording of the change in state.

17. The administering apparatus according toclaim 14, wherein said adder comprises a recorder restoring member, wherein in each recording of the changes in state, said recorder is moved in a first direction and moved back by the recorder restoring member.

18. The administering apparatus according toclaim 17, wherein said recorder restoring member counteracts the movement in the first direction with an elastic restoring force.

19. The administering apparatus according toclaim 1, wherein said adder comprises an adding input member, said adder moving from an initial position to a new position upon each recording of the individual changes in state, wherein said new position respectively becomes the initial position for the next recording.

20. The administering apparatus according toclaim 19, wherein said recorder moves the adding input member further in an adjusting engagement upon each recording movement.

21. The administering apparatus according toclaim 20, wherein said recorder and said adding input member each comprise at least one toothing in the adjusting engagement with each other, or which pass into the adjusting engagement in the recording movement.

22. The administering apparatus according toclaim 1, wherein said adder comprises a recorder for recording individual changes in state and an adding input member, said adding input member being coupled to the recorder, wherein upon each recording of the individual changes in state, said adding input member moves further from an initial position assumed before each recording to a new position, wherein said new position respectively becomes the initial position for the next recording.

23. The administering apparatus according toclaim 22, wherein said adding input member comprises a first toothing and a second toothing, said adding input member being moved further in an adjusting engagement which the toothings alternately pass into per recording, with one counter toothing each, wherein the toothings passing into the adjusting engagement with each other exhibit an offset with respect to each other before the adjusting engagement is established, such that in the adjusting engagement, the toothings slide off on each other in pairs, forming sliding areas.

24. The administering apparatus according toclaim 23, wherein said recorder forms the counter toothings, said counter toothings facing opposite each other with respect to the direction of the recording movement.

25. The administering apparatus according toclaim 1, wherein said adding input member is rotationally movable further about a rotational axis (R), and wherein toothings are formed about the rotational axis (R).

26. The administering apparatus according toclaim 1, wherein said adding input member comprises an engaging structure, said engaging structure extending over a portion of the adding input member in the direction of the movement of the adding input member, wherein said engaging structure passes into an adjusting engagement with an adding intermediate member or a display structure of the output means, in which the adding intermediate member or the display structure is moved further from an initial position to a new position, once multiple changes in state have been recorded.

27. The administering apparatus according toclaim 1, wherein said adder comprises an adding intermediate member comprising an input wheel, said input wheel passing into the adjusting engagement of the engaging structure.

28. The administering apparatus according toclaim 27, wherein said adding intermediate member comprises an output wheel, said output wheel being rotary-driven by the input wheel and drives onto a mobile display structure of the output means.

29. The administering apparatus according toclaim 1, wherein said output means comprises a mobile display structure, said mobile display structure being coupled to the adding input member, such that the movement of the adding input member causes a movement of the display structure.

30. The administering apparatus according toclaim 29, wherein said adder forms an inner gear with a hollow wheel formed by the display structure and an inner wheel rolling off internally on the hollow wheel upon the adder reaching a final stage.

31. An adder device for coupling to an administering apparatus for determining the status of the apparatus comprising:

an adder casing;

a recorder slidably coupled to said casing;

an adding input member rotatably coupled to said casing; and

an adding output structure coupled to said casing and said adding input member, said adding output structure outputting a status indicator perceivable by the senses; wherein

said recorder slidably shifts in response to a change in the apparatus, said recorder engaging with said adding input member and rotatably shifting said adding input member from a first position to a second position, said display structure rotatable in response to said adding input member shifting from said first position to said second position.

32. The adder device according toclaim 31, wherein said recorder comprises a restoring member for tensing said recorder in an advancing position.

33. The adder device according toclaim 31, wherein said adding output structure comprises an annular disk mounted by the adder casing, said adder disk rotatable relative to a portion of said apparatus.

34. The adder device according toclaim 31, wherein said recorder is secured against rotating by said adder casing.

35. The adder device according toclaim 31, wherein said adder casing further comprises a rotational guide for guiding said adding input member.

36. The adder device according toclaim 31, wherein said adding input member comprises a ring with one or more sets of toothings.

37. The adder device according toclaim 36, wherein said recorder comprises one or more toothings situated opposite said one or more sets of adding input member toothings.

38. The adder device according toclaim 37, wherein said recorder slides in a recording motion and the one or more toothings of said recorder passes into a toothed engagement with said one or more sets of adding input member toothings, said adding input member rotating from said first position to said second position in response to said recorder recording motion.

39. The adder device according toclaim 31, wherein said recorder is slidable in response to an apparatus container change.

40. The adder device according toclaim 31, further comprising an adding intermediate member for coupling said adding input member to said adding output structure.

41. The adder device according toclaim 31, wherein said adder is mounted to said apparatus, such that said adder casing is connected to a triggering element of said apparatus.

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