Patent Application
20060153693
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.
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.
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.
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.
The casing part 4 accommodates a piston rod 15 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 a drive member 5 and a coupler which in a coupled state, i.e. in a coupler engagement, couples the drive member 5 to the piston rod 15. The piston rod 15, together with the piston 3, forms a conveying means. In the coupled state, coupler members 6-10 transfer a drive force exerted on the drive member 5 onto the piston rod 15. No coupler engagement exists in
The drive member 5 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, the drive member 5 is in threaded engagement with coupler input member 6. The coupler input member 6 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. The dosing member 18 surrounds the coupler input member 6 and is connected to the coupler input member 6 such that it is secured against rotating and cannot be moved axially. The piston rod 15 protrudes into the drive member 5 and the coupler input member 6.
The piston rod 15 is provided with an outer thread over its axial length. Via the outer thread, it is in threaded engagement with a coupler output member 9 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 the drive member 5 and the coupler input member 6. A coupler sleeve 8 is connected to the coupler output member 9 such that it is secured against rotating and cannot be moved axially. The coupler sleeve 8 and the coupler output member 9 may be regarded as an integral component with respect to the movements between the drive member 5 and the piston rod 15; however, in order to accommodate an equalizing spring 17, they are embodied in two parts and fixedly connected to each other. The coupler output member 9 and the coupler sleeve 8 are mounted in the casing part 4 such that they may be rotated about the threaded axis R of the coupler output member 9 but cannot be moved axially. In the threaded engagement, the piston rod 15 protrudes through the coupler output member 9 and protrudes into the coupler sleeve 8. The equalizing spring 17 is clamped between a proximal end of the coupler sleeve 8 and a proximal end of the piston rod 15 and acts on the piston rod 15 in the advancing direction V as a pressure spring. The equalizing spring 17 presses onto the piston rod 15 via a disc 15a which is supported such that it may be rotated on the piston rod 15 and forms a flange of a sleeve placed onto the piston rod 15.
The piston rod 15 is linearly guided in and counter to the advancing direction V in a linear guide 4a, such that it cannot be rotated relative to the casing part 1. The drive member 5 is also linearly guided relative to the casing part 4 such that it may be moved in and counter to the advancing direction V, for which purpose the casing part 4 directly forms a linear guide 4b.
The threaded axis of the piston rod 15 forms the main movement axis of the device. It forms a rotational axis R for the rotational drive movement of the coupler input member 6 and, via the coupler intermediate member 7, the coupler output member 9. It forms both threaded axes. It also forms the translational axis for the piston rod 15 and the drive member 5.
The coupler also includes a coupler intermediate member 7 and a coupler restoring member 10 which is formed as a pressure spring and charges the coupler intermediate member 7 with an elasticity force acting counter to the advancing direction V. The restoring member 10 is clamped between the coupler output member 9 and the coupler intermediate member 7.
If no force acting in the advancing direction V is exerted on the drive member 5, the restoring member 10 ensures, via the coupler intermediate member 7, that the coupler engagement is released. This state is shown in
In the decoupled state, the coupler input member 6 is retracted from the coupler sleeve 8 counter to the advancing direction V, such that the coupler input member 6 may be freely rotated relative to the coupler sleeve 8, and therefore the coupler output member 9 fixedly connected to it. The coupler output member 9 is simultaneously connected, such that it cannot be rotated, to the casing part 4 via the coupler sleeve 8, the coupler intermediate member 7 and a decoupling member 11. For this rotationally secure coupling, the coupler intermediate member 7 is provided with engaging elements 7b on an inner area radially facing the coupler sleeve 8, and the coupler sleeve 8 is provided with corresponding engaging elements 8b. For the rotationally secured engagement with the decoupling member 11, the coupler intermediate member 7 is provided with engaging elements 7b on an outer circumferential area, and the decoupling member 11 is provided with radially facing engaging elements 11a on a shell inner area which, in the decoupled state, interlock with each other—like the engaging elements 7b and 8b—in the manner of grooves and springs or toothings parallel to the advancing direction V. The coupler intermediate member 7, in its rotationally secured engagement with the coupler sleeve 8 and its rotationally secured engagement with the decoupling member 11, may be moved axially in and counter to the advancing direction V, wherein the engagement with the decoupling member 11 is released when it moves in the advancing direction V.
If the drive member 5 is operated by exerting a pressure force on a triggering element 16 in the advancing direction V, the drive member 5 and the coupler input member 6 together complete an axial coupler stroke of length X. In this drive stroke movement or coupler movement, the coupler input member 6 pushes the coupler intermediate member 7 in the advancing direction V, against the restoring elasticity force of the restoring member 10. In the course of the stroke movement, the engaging elements 6a and 8a pass into engagement with each other, while the coupler intermediate member 7 simultaneously moves relative to the decoupling member 11 until it passes out of the rotationally secured engagement with the decoupling member 11. The coupler intermediate member 7 remains in the rotationally secured engagement with the coupler sleeve 8. The coupler movement is limited by a stopper of the triggering element 16 on the coupler sleeve 8; in the exemplary embodiment, on its proximal facing area.
For setting the dosage, the user rotates the dosing member 18, which locks in easily releasable locking positions. The dosing member 18 is connected to the coupler input member 6 such that it is secured against rotating and also cannot be moved axially, such that the latter rotates with it. The drive member 5 guided linearly in and counter to the advancing direction V at 4b is moved, by the dosing movement of the coupler input member 6, in the proximal direction and then protrudes out of the casing part 4. The axial dosing path of the drive member 5 follows from the rotational angle by which the dosing member 18 is rotated and the thread pitch in the threaded engagement between the drive member 5 and the coupler input member 6 which abuts against the coupler intermediate member 7 in the advancing direction V and against the casing part 4 counter to the advancing direction V.
If the user takes the pressure off the triggering element 16, then the restoring member 10 moves the coupler input member 6, via the coupler intermediate member 7, back to the holding position retracted out of the coupler engagement, as shown in
For exchanging the emptied container 2, the casing part 1 is detached from the casing part 4; in the exemplary embodiment, by a screwing movement. When the casing parts 1 and 4 are detached, the decoupling member 11 is automatically moved relative to the casing part 4, counter to the direction of the coupler movement of the coupler input member 6; in the exemplary embodiment, counter to the advancing direction V. The casing part 4 mounts the decoupling member 11 accordingly. The axial path which the decoupling member 11 thus travels relative to the casing part 4 is as long as the coupler stroke X, such that once the casing parts 1 and 4 have been detached, the decoupling member 11 lying axially opposite the coupler input member 6 blocks it, and the coupler input member 6 may no longer be moved in the advancing direction V, at least not into the coupler engagement with the coupler sleeve 8. Blocking the coupler input member 6 in the disengaged position prevents the coupler output member 9 from being able to pass into a rotationally secured connection with the casing part 4 and so prevent the piston rod 15 from being able to be retracted. In other words, it ensures that the piston rod 15 may be retracted into the casing part 4, without being blocked.
The decoupling member 11 is in a guiding engagement with the casing part 1. For the guiding engagement, one guiding curve 1a per engaging element 12 is formed on a shell outer area of the casing part 1 and guides the engaging element 12 and thus the decoupling member 11 when the casing parts 1 and 4 are detached. Another guiding curve 1a, spaced in parallel, guides the decoupling member 11 accordingly, when the casing parts 1 and 4 are connected (
When the casing parts 1 and 4 are screwed together again, they are centred with respect to the circumferential direction by means of co-operating centring elements, such that the engaging element 12 of the decoupling member 11 pass into engagement with the guiding curve 1a again. As soon as the guiding engagement has been established, further screwing together automatically moves the decoupling member 11 out of the locking engagement of the fixing elements 4d and 13 until it again assumes the same position relative to the casing part 4 as in
While or before screwing together, the piston rod 15 is simply retracted into the casing part 4, which—due to the released coupler engagement, causes a rotational movement of the coupler output member 9.
The dosage display 20 of the first exemplary embodiment is coupled to the drive member 5 via a display coupling member 21 and the coupler input member 6. The display coupling member 21 is connected to the coupler input member 6 such that it is secured against rotating, by being able to move on the coupler input member 6 and relative to it in and counter to the direction of the coupler movement X, forming a ring in the exemplary embodiment. Conversely, the display coupling member 21 may be rotated with respect to the casing part 4 about the rotational axis R, but is held such that it cannot be moved axially relative to the casing part 4. The display coupling member 21 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 the dosage display 20, in order to introduce the dosing movement and also the drive movement into the gear.
FIGS. 11 to 18 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 the drive member 5 and the piston rod 15. However, the drive member 5 and the piston rod 15, 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.
Unlike the first exemplary embodiment, the coupler intermediate member 7′ may be moved axially and is in engagement with the coupler output member 9, such that it is secured against rotating, in any axial position. It is again formed as a sleeve part and mounted on the coupler output member 9 such that it may be slid axially. For this purpose, it penetrates through the coupler sleeve 8′ 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 restoring member 10′, which is the same in its embodiment and installation but reduced with regard to its function, is tensed between the coupler output member 9 and the coupler intermediate member 7′, 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 the coupler input member 6′ is retracted from the coupler intermediate member 7′ counter to the advancing direction V, as shown in
Another modification exists in the dosing member 18′. Unlike the dosing member 18 of the first exemplary embodiment, the dosing member 18′ cannot be moved relative to the casing part 4 in the direction of the coupler movement X; in the exemplary embodiment, the axial direction. Instead, the coupler input member 6′ is again connected to the dosing member 18′ such that it is secured against rotating, but may be moved axially. The rotationally secured engagement between the coupler input member 6′ and the dosing member 18′ exists in the decoupled state of the drive member 5 and the piston rod 15 and is released in the course of the coupler stroke X, namely directly before the rotationally secured connection between the coupler output member 9 and the casing part 4 is released. For this engagement, the coupler input member 6′ and the dosing member 18′ are provided with engaging elements 6b and 18a which are formed on shell areas, radially facing each other, of the two members 6′ and 18′ in the manner of grooves and springs. With respect to the rotationally secured connection between the coupler input member 6′ and the dosing member 18′, reference may also be made to
Another difference with respect to the first exemplary embodiment exists with regard to the holding means. In the second exemplary embodiment, the restoring member 10′ has no effect which separates the coupler members 6′ and 9 from each other. The holding means of the second exemplary embodiment includes a coupler restoring member 14, a supporting structure 6c and the dosing member 18′. The restoring member 14 charges the coupler input member 6′, via the supporting structure 6c, with an elastic restoring force which counteracts the coupler movement X of the coupler input member 6′. In the direction of the coupler movement X, which in the exemplary embodiments coincides with the advancing direction V, the restoring member 14 is supported on the dosing member 18′ which forms a supporting collar for this purpose. The supporting structure 6c is connected to the coupler input member 6′ 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 restoring member 14 is supported. Counter to direction of the coupler movement X, the supporting structure 6c abuts with respect to the casing part 4. The coupler movement X moves the coupler input member 6′, against the elastic restoring force of the restoring member 14, into the coupler engagement with the coupler intermediate member 7′. As in the first exemplary embodiment, the restoring member 14 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, the coupler output member 9 is connected, such that it is secured against rotating, to the casing part 4 via the coupler sleeve 8′, the coupler intermediate member 7′ and the decoupling member 11′. Operating the injection button 16 and consequently performing the coupler stroke X (
In the state shown in
The dosing movement and the drive movement are also introduced into the gear of the dosage display 20′ via the coupler input member 6′ and a display coupling member 22 in the second exemplary embodiment. The display coupling member 22 is also connected to the coupler input member 6′, such that it is secured against rotating, and cannot be moved relative to the casing part 4 in and counter to the direction of the coupler movement X.
FIGS. 19 to 24 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 a drive member 25 formed as a drive spring. The drive member 25 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 the piston rod 15.
The drive member 25 is a spiral spring acting as a torsion spring, comprising spring windings which encircle the threaded axis R of the threaded engagement between the coupler output member 9 and the piston rod 15. 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 the coupler input member 6′, and an outer end is fastened to a supporting structure 26 which is connected to the casing part 4 such that it may be moved in the direction of the coupler movement X but is secured against rotating. On the other hand, the supporting structure 26 is connected to the coupler input member 6′ such that it cannot be moved in and counter to the direction of the coupler movement X. The coupler input member 6′ may be rotated about the threaded axis R relative to the supporting structure 26. Another supporting structure 6d is connected to the coupler input member 6′ such that it cannot be moved in and counter to the direction of the coupler movement X; in the exemplary embodiment, the coupler input member 6′ and the supporting structure 6d are formed integrally. The drive member 25 is axially enclosed by the supporting structures 6d and 26.
The functionality of the coupler corresponds to that of the second exemplary embodiment, such that the same reference indicators are used for the coupler members 6′-10′ and the decoupling member 11′. Unlike the coupler of the second exemplary embodiment, however, the coupler sleeve 8′ therein has been omitted. The coupler intermediate member 7′ is directly in an engagement with the coupler output member 9 which transfers the rotational drive movement of the coupler input member 6′ onto the coupler output member 9.
20″ indicates a dosage display which is coupled to the coupler input member 6′ via a display coupling member 23 and, like the display coupling members 21 and 22 of the other exemplary embodiments previously, is connected to the coupler input member 6′, such that it is secured against rotating. The display coupling member 23 cannot be moved in and counter to the direction of the coupler movement X relative to the casing part 4. As in the first and second exemplary embodiment previously, the rotationally secured connection of the display coupling member 23 exists both in the decoupled and in the coupled state of the device.
In order to prevent the coupler input member 6′ for setting the dosage and during storage from the rotational drive movement, and to hold the drive member 25 in its tensed state, a rotational block is formed between the coupler input member 6′ and the casing part 4. In the holding position of the coupler members 6′, 7′ and 9 shown, the rotational block exists between a first blocking member 24 and a second blocking member 34. The blocking member 24 is connected to the coupler input member 6′, such that it is secured against rotating. The blocking member 34 is connected to the casing part 4, such that it is secured against rotating but may be moved in and counter to the direction of the coupler movement X relative to the casing part 4 and the coupler input member 6′. The facing areas of the blocking members 24 and 34, which contact each other in the blocking engagement, form a ratchet which allows a rotational movement of the coupler input member 6′ which tenses the drive member 25 and prevents a rotational movement in the opposite direction.
In the third exemplary embodiment, the holding means is formed in a third variant. It includes a coupler restoring member 19, as well as the display coupling member 23 and the blocking member 24. The restoring member 19 is supported on the casing part 4 via the display coupling member 23 in the direction of the coupler movement X and by the blocking member 24 counter to the direction of the coupler movement X. The restoring member 19 presses the blocking member 24 until it abuts against the connecting part 33. Since the connecting part 33 is connected to the coupler input member 6′ such that it cannot be moved in and counter to the direction of the coupler movement X, the restoring member 19 thus exerts an elastic restoring force, acting counter to the direction of the coupler movement X, on the coupler input member 6′ via the blocking member 24 and the connecting part 33, said elastic restoring force holding the coupler input member 6′ in the holding position retracted out of the coupler engagement. It again acts as a pressure spring. The blocking member 24 is a sleeve part comprising an outer shell forming the thread 24b, an inner shell serving to mount it on the coupler input member 6′ such that it is secured against rotating, and a base connecting the two shells, on which the blocking teeth 24a are formed. The restoring member 19 protrudes into the blocking member 24 which is cup-shaped in this way, and is supported on the base of the blocking member 24.
The restoring member 19 not only presses the blocking member 24 until it abuts against the connecting part 33, but also until it abuts against the casing part 4. Abutting in this other way prevents the blocking member 24 from being able to be moved counter to the direction of the coupler movement X beyond the holding position assumed in
The equalizing spring 17, tensed between the piston rod 15 and the connecting part 33, supports the restoring member 19 in its function of holding the coupler input member 6′ in the holding position. In certain embodiments, the equalizing spring 17 may replace the restoring member 19 for retracting the coupler members 6′, 7′ and 9. However, the equalizing spring 17 may be weak enough that, at least once it has been partially relaxed, it may no longer hold the coupler members 6′-9 in the holding position, and thus may no longer reliably hold the coupler in the decoupled state.
A triggering element 28 is provided for triggering the drive member 25. The triggering element 28 may be moved translationally relative to the casing part 4 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 the coupler input member 6′, which in the exemplary embodiment coincides with the threaded axis R of the piston rod 15, and is guided in these two movements by the casing part 4. The translational movement in the distal direction establishes the coupler engagement between the coupler input member 6′ and the coupler intermediate member 7′ and releases the rotational block between the blocking members 24 and 34, which triggers the drive member 25, 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 triggering element 28 forms the dosing member of the third exemplary embodiment. Via multiple intermediate members, the rotational movement of the triggering element 28 relative to the casing part 4 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 in
The triggering element 28 is arranged in the proximal end region of the casing part 4 so as to be user-friendly. Its outer sleeve part surrounds the casing part 4. A base of the triggering element 28 forms a proximal end of the injection apparatus. For setting the dosage, the triggering element 28 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 triggering element 28 locks with the casing part 4 in discrete positions corresponding to the dosage units.
A stopper element 29b facing a proximal facing area of the connecting part 33 projects radially inwards from the inner part 29. In the resting state of the apparatus, a clear distance remains between the connecting part 33 and the stopper element 29b, which is just large enough that the rotational block between the inner part 29 and the connecting part 33 is released during the triggering movement of the triggering element 28, before the stopper element 29b terminates the relative movement of the triggering element 28 relative to the connecting part 33 by abutting contact.
The second blocking member 34 is tensed in the blocking engagement with the blocking member 24 by means of a blocking spring 31. For this purpose, the blocking spring 31 is supported in the direction of the coupler movement X on the blocking member 34 and counter to the coupler movement X on a casing part 30 which is fixedly connected to the casing part 4. Another spring 32, arranged between the inner part 29 and the blocking member 34, tenses the triggering element 28 relative to the blocking member 34 into a proximal end position. The blocking member 34 is axially guided, such that it is secured against rotating, by the casing part 4. The casing part 4 forms a distal and a proximal stopper for the mobility of the blocking member 34.
In the resting state shown in
The injection apparatus also offers a convenient way of correcting the dosage, as is clear from a comparison of
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 triggering element 28 takes on another function, for which purpose it is coupled to the needle protection 39 (
In a first phase of injecting, the user presses the injection apparatus against the skin, such that the needle protection 39 is moved in the distal direction relative to the casing part 38. However, this first part of the movement of the needle protection 39 does not yet expose the injection needle; rather, its tip remains short of the needle protection 39. In this first phase of the injecting process, the needle protection 39 abuts against a resisting element, such that it cannot be moved further in the distal direction relative to the casing part 38. By continuing to exert pressure on the injection apparatus in the direction of the skin, the user presses the triggering element 28 in the proximal direction. In the course of this first phase of its triggering movement, the triggering element 28 releases an abutting contact between the needle protection 39 and the resisting element, such that the injection apparatus, and together with it the injection needle, is moved relative to the needle protection 39 in the direction of the skin, and the injection needle injects. With respect to the function of the triggering element 28 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, the drive member 25 may be released and the product delivered by pressing further onto the triggering element 28. In the second phase of the triggering movement of the triggering element 28, which follows the injection phase, the triggering element 28 and therefore the inner part 29 is pressed further in the distal direction relative to the connecting part 33, against the pressure of the spring 32, such that the rotational block 29a, 33a is released. The triggering element 28 may rotate idly. As soon as the rotational block 29a, 33a has been released, the stopper element 29b passes into abutting contact with the connecting part 33. In the third phase of the triggering movement which then follows, the triggering element 28 presses the connecting part 33 and therefore the coupler input member 6′ via the stopper element 29b, 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 blocking spring 31, the blocking member 34 follows this movement, until it abuts against the casing part 4. Before the blocking member 34 reaches the abutting position, the coupler input member 6′ passes into the coupler engagement with the coupler intermediate member 7′. The coupler input member 6′ presses the coupler intermediate member 7′ out of the frictional-lock blocking engagement with the decoupling member 11′, against the force of the restoring member 10′. Once the blocking engagement between the conical areas of the two members 7′ and 11′ has been released and the coupler engagement therefore completely established, the blocking member 34 abuts the casing part 4. In the final phase of the triggering movement which then follows, the triggering element 28 presses the blocking member 24 out of the blocking engagement with the blocking member 34 via the connecting part 33.
As soon as the rotational block formed by the blocking members 24 and 34 is released, the rotational drive movement of the coupler input member 6′ is initiated due to the drive force of the drive member 25 and is transferred onto the coupler output member 9 via the coupler engagement. Because it is guided—such that it is secured against rotating—in the linear guide 4a, the piston rod 15 is moved, in the threaded engagement with the coupler output member 9, in the advancing direction V, and product is delivered. This delivery movement is terminated by the stopping member 27 abutting the stopper 24c of the blocking member 24 determining the zero dosage.
When connecting the casing parts 1 and 4, the adapter structure 35 forms a linear guide for the casing part 1. The casing part 1 may be inserted into the adapter structure 35, where a slight frictional lock and correspondingly a sliding guide for the casing part 1 may be present. In certain embodiments, the casing part 1 may not be rotated about the central longitudinal axis of the casing part 4 relative to the adapter structure 35. The engagement, which may be rotationally secured, is established right at the beginning of inserting the casing part 1 into the adapter structure 35. Once the casing part 1 has been inserted until it abuts against the casing part 4, i.e. once the coupler is accommodated at 4a, the casing part 1 is rotated relative to the casing part 4 and slaves the adapter structure 35 during this rotational movement, until the engaging element 12 of the decoupling member 11′ abuts the end of the guiding curve 35a. In certain embodiments, the rotational movement of the casing part 1 is prevented until its axial abutting position. This may provide a rotational block up until the abutting position may be formed between the casing parts 1 and 4.
The movement of the decoupling member 11′ 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, the decoupling member 11′ presses the coupler input member 6′ beyond its holding position assumed in the resting state and blocks it in said decoupling position. In this forced decoupling movement, the coupler input member 6′ slaves the triggering element 28 via the stopper element 29b. Via the latch between the slaving means 29c and 34a, the blocking member 34 is also slaved against the force of the blocking spring 31, and moved out of the blocking engagement. The blocking member 24 may not follow the blocking member 34, since it is abutting against the casing part 4. Detaching the casing parts 1 and 4 thus releases the rotational block by means of the decoupling mechanism which the casing parts 1 and 4 form with the decoupling member 11′ via the adapter structure 35. If the coupler input member 6′ has not yet assumed the zero dosage position, it is now at the latest rotated into the zero dosage position by the drive member 25 and the dosage display 20″ is zeroed. In this respect, because of the coupling between the dosage display 20″ and the coupler input member 6′, for each delivery, the dosage display 20″ 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 the container 2 is no longer contains the complete dosage set, the user may then read this from the dosage display 20″ 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 the container 2 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 the piston rod 15 serves as an indication that the container 2 has been changed. The piston rod 15 forms a first actuator of the service life timer and the triggering element 16 forms a second actuator, which co-operate to switch or further switch the service life timer and in this way count the container changes.
The service life timer includes an adder 50 which is formed as a mechanical gear. An adder casing 51, which mounts the components of the adder 50 such that they may be moved, is connected to the triggering element 16, such that it cannot be moved in and counter to the direction of the triggering movement. In a further example, the adder casing 51 is secured against rotating. In addition, triggering element 16 and display structure 56 may together form output means of the service life timer.
The service life timer is described below with reference to FIGS. 25 to 38.
The adder 50 includes the adder casing 51 and the adder members which it mounts such that they may be moved, namely a recorder 52, the adding input member 54, the adding intermediate member 55, the display structure 56 which simultaneously forms an adding output member, and a recorder restoring member 53 which is formed as a spring member and tenses the recorder 52 in the advancing direction V relative to the adder casing 51, into a resting position. The recorder restoring member 53 acts as a pressure spring which is supported on the recorder 52 in the advancing direction V and on the adder casing 51 counter to the advancing direction V.
The display structure 56 is formed as an annular disc which is mounted by the adder casing 51, such that it may be rotated relative to the triggering element 16, in a space remaining free between the adder casing 51 and the triggering element 16. For mounting it such that it may be rotated, a journal projects from the annular disc, through an opening of the adder casing 51, and into a bore of the recorder 52, in which the recorder restoring member 53 is also accommodated. The annular disc of the display structure 56 also forms a hollow wheel for a final stage of the adder 50.
The adder casing 51 mounts the recorder 52 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. The adder casing 51 is provided with a circular cylindrical groove encircling the rotational axis R, in which the adding input member 54 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 adding input member 54 and a circumferential stay on the casing 51, are also conceivable. The adding input member 54 is shaped as a ring and provided on both axial facing sides, circumferentially in each case, with a toothing 54a and 54b of serrated teeth in an even separation. The two toothings 54a and 54b together form a sagittal toothing. The recorder 52 protrudes through the adding input member 54 and into a receptacle of the adder casing 51, and is slide-guided in the receptacle 51, such that it is secured against rotating. The receptacle is open on a longitudinal side, wherein the opening extends on both sides of the adding input member 54 in its guiding groove. Two toothings 52a and 52b of the recorder 52 (
The recording movement is limited in both directions by corresponding stoppers. The stoppers are formed by the adding input member 54, namely in the maximum toothed engagement of the toothings 52a and 54a on the one hand and of the toothings 52b and 54b on the other hand. This results in a switching path for the recorder 52 from one of the two end positions to the other, respectively. In the relaxed state, the recorder restoring member 53 presses the recorder 52 into the toothed engagement with the toothing 54b of the adding input member 54. The switching path is longer than the coupler stroke X.
The adding input member 54 is coupled to the display structure 56 via an adding intermediate member 55 which is shown individually in
The functionality of the output means may be seen in particular from an overview of
The adder 50 reduces the recording movement of the recorder 52 to a slow rotational movement of the display structure 56 corresponding to the recorded change in state and composed of discrete rotational increments. For each individual container change, the recorder 52 performs its back-and-forth recording movement. In the adjusting engagement between its toothings 54a and 54b and the counter toothings 52a and 52b of the recorder 52, the adding input member 54 is rotated further by one tooth per recording movement. In this sense, the recorder 52 and the adding input member 54 form a first counting and reducing stage. A second, next reducing stage is formed by the adding input member 54 and the adding intermediate member 55, namely by means of the adjusting engagement between the engaging structure 54c and the input wheel 55b. In this second adjusting engagement, the adding intermediate member 55 is rotated further by two teeth of its input wheel 55b for each full revolution of the adding input member 54. Lastly, the third and final reducing stage is formed by the output wheel 55c and the display structure 56.
Assuming, merely by way of example, that the adding input member 54 exhibits a number of teeth in the range of 20 to 30, the input wheel 55b exhibits a number of teeth in the range of 6 to 10, and that the output wheel 55c also exhibits a number of teeth in the range of 6 to 10 and the display structure 56 also exhibits a number of teeth in the range of 20 to 30, then the output means 16, 56 will display the state “end of service life” after at least 120 and at most 750 container changes.
When changing the container 2, the piston rod 15 is reset to the proximal position shown in
The adder 50 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, the adder casing 51 merely has to be connected to the triggering element 16 of the first exemplary embodiment in a corresponding way. Similarly, in a third exemplary embodiment, the adder 50 may be inserted in the space remaining free between the stopper element 29b and the base of the triggering element 28 and may be connected to the triggering element 28 such that it cannot be moved in and counter to the advancing direction V. The recorder 52 then protrudes through the stopper element 29b and is held out of engagement with the toothing 54b, against the force of the recorder restoring member 53, by the piston rod 15 situated in the proximal position. The switching path of the recorder 52 is also dimensioned such that the full triggering movement moves the recorder 52 into a sufficient toothed engagement with the toothings 52a and 54a such that the adding input member 54 is rotated at least far enough that the toothings 52b and 54b may then interlock with each other, in order to rotate the adding input member 54 further. The toothings 52b and 54b do not engage until the piston rod 15 has been advanced slightly away from the drive member 25.
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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2004 063 648.6 | Dec 2004 | DE | national |
