![]() improved device for adjusting a dosage with a limiting mechanism for a device for administering a pr
专利摘要:
IMPROVED DEVICE FOR ADJUSTING A DOSAGE WITH A LIMITATION MECHANISM FOR A DEVICE FOR THE ADMINISTRATION OF A PRODUCT. Dosing device for an administration device with a limiting mechanism, comprising a first limiting means (50) with a first stopping means (52), a second limiting means (30) with a second stopping means (32) , in which the second limiting means follows movements of the first limiting means during dosing movements with a defined transmission ratio, and in which the first and second stopping means each describe a path curve by their movements in such a way that the two path curves intersect at at least one point or are so close to each other that the stopping means contacts one another in a stopping position, whereby a blocking of the movement of the limiting means in relation to the other during the Dosing movements can be carried out in which the respective path curves described by the first and second stopping means are closed and can preferably be traversed several times by the first stopping means. either by the second means of stop or by both means of (...). 公开号:BR112014028627B1 申请号:R112014028627-2 申请日:2013-05-13 公开日:2021-01-26 发明作者:Jürg Hirschel;Ulrich Moser 申请人:Ypsomed Ag; IPC主号:
专利说明:
SPECIFICATION [001] The invention relates to an improved device for adjusting a dosage in a device for administering a product, for example, an injection syringe for insulin in the form of a pen-shaped syringe for self-administration of insulin, referred to like a pen. The invention also relates to a limiting mechanism that prevents adjustment of a dosage to be administered, past a predetermined value. As an example for the invention, but not restrictive for applications in delivery devices, modalities of such devices are described in published patent application CH 703993 A2, which is incorporated herein in its entirety by reference. [002] In administration devices with product containers, for example, an inserted cartridge containing a product for multiple administrations, it is sometimes desirable to avoid a pre-selected dosage that exceeds the amount of product left in the cartridge. If such a dosage can be preselected, the user would assume that a corresponding dosage can be administered, whereas in fact only a portion is administered. This is undesirable or even dangerous depending on the situation. [003] A means of solving this known problem in the prior art is to count or measure the total as the sum of the dosages administered, with a limit stop preventing further dosage selection, or ejection as soon as the total corresponds to the volume nominally contained in the cartridge . [004] A drive mechanism for drug delivery devices is described in published patent application WO 2004/078226, for example. This drive mechanism contains a housing, a dosing definition sleeve and a two-part piston. In one embodiment, a drive sleeve moves downwards along an inner part of the piston rod when a dose is selected. The distance traveled corresponds to the piston ejection stroke required for dosing. When a subsequent dose is selected, the drive sleeve moves further along the piston rod. The position of the drive sleeve therefore corresponds to the amount of medication still contained in the cartridge. When the drive sleeve reaches the end of the thread on the inside of the piston rod and therefore can no longer rotate, this corresponds to an empty cartridge. [005] Another example is described in published patent application US 6582404, which shows a limitation mechanism for drug delivery devices that prevents definition of a dose that exceeds the amount remaining in the cartridge. The delivery device comprises a dosage setting member which is moved away from a fixed limit stop by rotation with respect to a trigger when defining a dosage. The dose setting member is connected to the actuator in such a way that the former can be turned in one direction without moving the latter. Dosing is administered around the dose setting member and thereby moving the actuator. The rotation actuator causes an ejection movement of the piston rod. The driver is provided with a strip, the length of which corresponds to the amount of medication contained in the cartridge. A track follower, which is connected to the dose setting member, runs in this range. Each time a dosage is selected, the track follower moves more in the track. When the track follower reaches the end of the track, the dosage setting member cannot be rotated further and setting a dosage beyond the value remaining in the cartridge is prevented, [006] Another example of such a device is described in patent EP 055-5 996 and features an injection device for administering liquids such as insulin to body tissues. This injection device contains a dosage setting mechanism having a 1-ring and a 10-ring. A transmission member is provided to selectively couple one ring to the other so that they saw together only in selected sections during dosage definition. The defined dosage is displayed by means of digits on the rings. The injection device further comprises a dosage limiting mechanism, which limits the movement of a guide shaft to the piston movement intended in the cartridge, in which projections in the piston reach the end of the grooves along the guide shaft and prevent a additional movement. The dosage limiting mechanism is provided separately from the dosage setting mechanism. [007] Finally, WO 2006/086983 shows an example of a dosage setting device for self-injection devices having a dosage limiting mechanism having two rotating parts, in which the first part rotates continuously while defining a dosage and the second part it only turns part of the time by a selective coupling device after a defined rotation position has been reached. This has the effect that the second part turns discontinuously over a smaller angle than the first part. The rotation of the second part is then limited by a fixed stop for the housing, which prevents a dosage setting exceeding the remaining amount still present in the cartridge. [008] A disadvantage of dosage setting devices for self-injection devices known from the prior art with a dosage limiting mechanism is that such devices need considerable space and / or coupling mechanisms, which need control and influence negatively the limitation. [009] The problem of the present invention is to create a device for defining a dosage in an injection or infusion device for administering a product having a limiting mechanism that reliably, simply and effectively in space prevents the definition of a dosage being administered beyond a predetermined value and also overcomes other disadvantages known from the prior art. [0010] This problem is solved by the objective with the characteristics of claim 1. [0011] Additional advantageous modalities follow from the dependent claims. PRESENTATION OF THE INVENTION [0012] Several indications of directions and positions are made in the present description, which will be briefly explained in this point. "Axial orientation" means an orientation along the longitudinal axis of an delivery device or some other device. "Distai" refers to the end of the delivery device on which the product comes out. Thus, "proximal" refers to the opposite end of the delivery device. "In the distal direction" means seen in the direction of the distal end and "in the proximal direction" means similarly seen in the direction of the proximal end. [0013] The invention relates, for example, to an improved injection device for administering a fluid product. Such an injection device comprises a housing with a container for the product, a transport unit for transporting the product and a dosing device for defining a product dosage to be administered and for displaying the defined product dosage. The housing forms a container for the product, preferably a container for a container filled with the product. This container can be a cartridge, for example. The transport unit comprises a piston rod, which is movable in relation to the housing in a transport direction in order to eject the defined product dosage in a transport stroke corresponding to the defined product dosage. The conveying stroke is a translation movement of the piston rod, preferably a linear pushing movement. In a preferred embodiment, a movable piston of the container constructed as a cartridge is displaced in the transport stroke. The transport unit further comprises a guide element, which guides the translation movement of the piston rod. In a preferred embodiment, the guide element is constructed as a longitudinal guide for the piston rod, fixed in relation to the housing, so that the piston rod can be displaced relative to the guide element, but cannot be rotated. The transport unit further comprises a drive element which is engaged with the piston rod. The drive element in a preferred embodiment is constructed as a threaded nut, the inner thread from which it is brought into engagement with a corresponding outer thread applied to the outer surface of the piston rod. The threaded nut is preferably mounted in the housing rotatingly, but axially fixed. In a possible preferred embodiment, the following results of kinematic arrangement for the transport mechanism of the transport unit: a rotation of the threaded nut axially fixed in relation to the piston rod results in an axial movement of the piston rod, because it cannot rotate in relation to the housing due to the longitudinal guide. In other, equally preferred embodiments, the kinematic arrangement can also be reversed. This is done through a so-called kinematic inversion, in which the threaded nut is rotatively fixed in relation to the housing and the longitudinal guide can rotate in relation to the housing and also mounted mobile. If the longitudinal guide is rotated with this kinematic inversion, then the piston rod bolts due to the screwing of the threaded nut, which is rotatively fixed in relation to the housing in this case. The injection device dosing device comprises a dosing setting member, preferably a dosing sleeve, which is in threaded engagement with the inner part of the housing. A catchable element, which allows the definition of a desired dosage by the user, is mounted on the proximal end of the dosing definition member. When the dose to be administered is increased, the dose setting member is preferably rotated out of the injection device. To deliver the set dose or to reduce a dosage that may have been too high, the dosage setting member can then be screwed back onto the injection device. In another preferred embodiment, there is a non-self-locking threaded connection between the housing and the dosing setting member configured as a dosing sleeve, so that the dosing sleeve can be screwed back into the injection device by exerting axial forces. . [0015] The dosing device further comprises a coupling device, which can operatively connect the dosing device to the transport device. The coupling device is designed in such a way that a dosage to be administered can be adjusted and / or corrected independently of the conveying device and that the dosing device can be selectively coupled operatively to the conveying device during dose administration. , so that a movement of the metering device is transferred completely or proportionally to the conveying device as an ejection movement. For example, only the rotational proportion of a screw movement of a metering sleeve, or, alternatively, only the axial displacement of the same, can be transferred to the transport device. In one embodiment, the coupling device comprises a coupling sleeve with an engaging surface, the coupling surface having engaging elements. The dosing definition member constructed as a dosing sleeve has an anti-coupling surface with counter-engaging elements. The coupling surface and the counter-coupling surface can be brought into engagement with each other through a coupling movement and a relative movement between the coupling and the dosing sleeve can therefore be suppressed. [0016] The dosing device further comprises an ejection button, which is mounted movable on the proximal end of the dosing device. In a preferred embodiment of the dosing definition member such as a dosing sleeve, the ejection button is mounted coaxially with the dosing sleeve at the proximal end thereof. Preferably, the button can rotate in relation to the dosing sleeve and is mounted with a certain axial mobility. In a preferred embodiment, the coupling sleeve is also arranged coaxially with the dosing sleeve, the coupling sleeve preferably being arranged at least in part within the dosing sleeve. In this embodiment, the engaging surface is arranged as an annular flange on the outer surface of the sleeve in the proximal area of the same. In addition, the counter-coupling surface is also arranged inside the dosing sleeve. In a possible embodiment, the coupling elements and the counter-coupling element are oriented axially in relation to the injection device so that, in this case, the coupling movement is an axial movement. For example, the coupling hitch can be created by pressing the eject button. The arrangement of the dosing sleeve, coupling sleeve and ejection button can further comprise a spring, which keeps the coupling surface and the counter-coupling surface in engagement. The dosing sleeve and the coupling sleeve move axially together during a dosing movement, in which a rotation with respect to each other is possible as long as the eject button is not pressed and, therefore, the coupling is not blocked. [0017] In a preferred embodiment, the coupling sleeve is rotationally fixed in relation to the threaded nut, but axially movable. This mode allows axial movement of the coupling sleeve in relation to the threaded nut. If the coupling is blocked by pressing the eject button and the dosing sleeve is screwed onto the injection device, then the coupling sleeve follows this movement. Due to the rotational locking of the threaded nut, the rotation is only transmitted to the threaded nut and, consequently, the piston rod is moved axially. [0018] In order to ensure that the drive element constructed as a threaded nut can only rotate in the direction that results in a movement of the piston rod in the direction of ejection, that is, in the direction that causes an ejection, a so-called blocking Reverse rotation is preferably provided between the housing and the threaded nut. This can be a radially directed or axially directed reverse rotation lock. The reverse rotation lock is preferably constructed by a locking means so that a rotation of the threaded nut contrary to the direction of ejection is completely blocked. For rotation in the ejection direction, the reverse rotation lock preferably has a certain resistance, also known as reluctance, due to a means of friction engagement, which must be overcome in order to cause a movement of the threaded nut. This is advantageous in order to avoid unwanted ejection when correcting an excessively high dosage. Preferably, the rotation resistances of the reverse rotation lock and the coupling are combined with each other. [0019] According to a first aspect, the dosing device according to the invention has a limiting mechanism which contains the following parts: a first limiting means with a first stopping means adapted in such a way that the limiting means follows a movement of the dose setting member during the dosing movement; a second limiting means with a second stopping means adapted in such a way that the second limiting means continuously follows a movement of the first limiting means during the metering movement proportionally with a defined transmission ratio, and during a non-ejection movement suffers any relative movement with respect to the first limiting means. [0020] The first and the second stop means each describe a path curve in such a way by movements that its two path curves intersect at least at one point or become so close that the stop means beats against another, whereby a movement block and the dosing movement can be carried out. Preferably, the stop means moves at an identical speed on path curves of different length, or at different speeds on path curves of equal length, in which closed path curves can be passed through one or both of the stop means, preferably several times, or partially until the stop means hits another one in a limit stop position. [0021] In a preferred embodiment, the first limiting means can preferably be constructed in a section of the inner axial wall of the dosing sleeve as a circumferential set of teeth consisting of teeth and the interstices of teeth. The first stop means is constructed as a wedge that fills a tooth interstice in a part of the wall section and therefore interrupts the circumferential set of teeth. This section is referred to as a stop zone and the section with a set of teeth running freely as a trigger zone. [0022] The second limiting means can be constructed as a sleeve-type stop wheel with axial ends projecting distally and proximally from an axis of rotation, in which the axis of rotation is fixed by means of radius, which can also be constructed as a continuous wall inside the stop wheel. Circumferential set of teeth consisting of teeth and interstices of teeth is built into an outer wall section of the stop wheel. The second stop means is formed in the outer wall section of the stop wheel by a rib extending one of the teeth in the axial direction. The second limiting element or stop wheel is also axially disposed in such a way that its circumferential set of teeth meshes with the circumferential set of teeth of the first limiting means in the area of the driving zone, and the rib is moved in the area of the zone stop. The shaft ends are rotatably received by support points on the coupling sleeve so that the stop wheel, positively connected positively to the set of teeth, can rotate about its own axis parallel to the common axis of rotation of the coupling sleeve. dosage and coupling sleeve. [0023] In a preferred embodiment, the first stop means moves over a circular path curve during a dosing movement, due to the relative movement of the dosing sleeve and the coupling sleeve, and the second stop means moves over a curve path that can be circular. If there is a lack of relative movement of the dosing sleeve and the coupling sleeve during an ejection movement, the stopping means does not move against one another on these curves. Proper selection of dimensions and the gear ratio can have the effect that the stopping medium passes through its path curves several times until, starting from a stopping position, they again contact each other in the stopping position. These distances or this angle of rotation from the stop position to the stop position can be referred to as periods. [0024] This period results mathematically from the lowest common multiple (LCM) of the numerator and denominator of the transmission ratio. Therefore, it appears that the period can advantageously have large values if at least the numerator or denominator is selected as a prime number. Thus, suitably long paths or rotation angles can be dimensioned or limited with high resolution and compact construction at the same time, as the path curves can be traversed several times. For example, by selecting an appropriate starting position within a period, any desired rotation distance that must be traveled until the stop position is reached can be defined. By properly selecting the starting position for the stop wheel, the dosage limitation can be programmed for any desired number of fractions of tooth steps or rotations within a period, with no structural changes in the design being required. In a preferred embodiment, such a distance may correspond to the amount of medication nominally contained in the cartridge. Each time a dosing movement takes place, the stopping medium runs in relation to another one in its path curves and can thus reach its stopping position. In this way, the dosing sleeve can no longer rotate in the direction of increasing the dosage and a dosage setting higher than the remainder still present in the cartridge is prevented. In a preferred embodiment, this is achieved directly due to the fact that, by contacting each other, the stop means prevents further movement of the two stop means in the direction of the stop stop. On the other hand, it is possible to leave the stop position at any time by reversing the movement, in which case the dosing sleeve rotates in the direction of dosing reduction. [0025] In another preferred embodiment according to a second aspect, such prevention of additional movement of the two limiting means can also be done indirectly by means of a force that appears in the mutual strike of the two stop means against a force of elastic re-establishment and / or through a gear means that brings a first limit stop means in the coupling sleeve for engagement with a second limit stop means in the second limit means. In a preferred embodiment, a radial limit stop can be formed, preferably, integrally, in the second limit stop means, in an outer wall section of the stop wheel. This axial section is called a limit stop zone. The force acting between the two stop means is capable of deforming the axis of rotation and / or the radius half on the stop wheel elastically, whereby the stop wheel is translated or articulated transversely to its axis of rotation. In the process, the second limit stop means comes into operative connection with the first limit stop means, which is applied in the area of the limit stop zone on the coupling sleeve. This operative connection can be configured as a friction fitting or shape fitting, as a counter-radial stop on the coupling sleeve in a preferred embodiment, and prevents further relative rotation of the stop wheel in the direction of increasing the dosage in relation to the coupling sleeve. coupling, which in turn cannot rotate in the direction of increased dosage due to the reverse rotation lock. In another preferred embodiment, the second limit stop means can also be supported on a transverse guide on the mobile stop wheel in the transverse direction and fixed rotationally and axially with respect to the axis of rotation of the stop wheel, and can be maintained in its normal position by means of a spring. This second limit stop means extends axially after the limit stop zone and the stop zone. The second stopping means is applied to the area of the stopping zone in the second stopping means opposite to the radial stopping stop, which can extend beyond the stopping zone. Instead of returning the second limit stop means from its stop position to its normal position by means of a spring means, this can be done in another preferred mode by a gear orientation, which abuts the radial limit stop as a curved surface on the coupling sleeve in the limit stop zone and moves the second limit stop means radially in its transverse guide during return rotation of the stop wheel, in the case where the dosing sleeve rotates in the direction of dosage reduction . [0026] As an additional safety aspect, the axial movement of the piston rod, the transport stroke, can be blocked when the maximum amount of transportable product has been reached. For this purpose, at least one limit stop, which engages with a limit counter stop in the actuation element as soon as the maximum amount of transportable product has been driven out of the injection device, can be arranged at the proximal end of the stem. piston. The limit stop and the limit counter stop can act radially, that is, perpendicular to the longitudinal axis of the injection device, due to the end of the threads. Alternatively, the limit stop and limit counter stop can also act axially, that is, parallel to the longitudinal axis of the injection device. Axial and radial actions can also be combined in advantageous modalities. [0027] Other aspects and arrangements of modalities according to the invention are presented in the descriptions of the Figures. DETAILED DESCRIPTION OF THE DRAWINGS [0028] Several modalities will be explained below with reference to the Figures. A person skilled in the art will recognize that accordingly several changes and modifications can be made to the modalities indicated below without departing from the spirit of the invention or leaving its scope of protection. LIST OF DRAWINGS [0029] Figure 1: exploded view of the individual parts of a first embodiment of an injection device according to the invention. [0030] Figure 2: longitudinal section and a side view of the dosing sleeve in the first modality with a first limiting means. [0031] Figure 3: side view of the coupling sleeve in the first mode. [0032] Figure 4: side view of the second means of limitation in the first modality in the form of a stop wheel. [0033] Figure 5a, b: longitudinal sections of the limiting mechanism in the first mode in a normal position and a stop position. [0034] Figure 6: longitudinal section of the limitation mechanism in the first mode with axial actuation, stop and limit stop zones. [0035] Figure 7: side view of the limitation mechanism in the first modalities and cross sections in areas of axial drive, stop and limit stop in a normal position. [0036] Figure 8: side view of the limiting mechanism in the first modalities and cross sections in axial actuation zones, stop and limit stop in a stop position. [0037] Figure 9a, b: longitudinal sections of the limiting mechanism in a second mode in a normal position and a stop position. [0038] Figure 10: side views and cross sections of the second limiting means in the second embodiment in the form of a stop wheel with a second transversely movable limit stop means and a spring means. [0039] Figure 11: a longitudinal section and a side view of the coupling sleeve in the second embodiment [0040] Figure 12: a cross section and a side view of the coupling sleeve in the second mode with a first means of limit stop. [0041] Figure 13: cross sections of the limiting means in the second mode in axial actuation zones, stop and limit stop in a normal position and a stop position. [0042] Figure 14a, b: longitudinal sections of the limiting mechanism in a third mode in a normal position and a stop position. [0043] Figure 15: front views and cross sections of the second limiting means in the third embodiment, in the form of a stop wheel with a second limiting means guided by means of transversely movable gear. [0044] Figure 16: longitudinal section and side view of the coupling sleeve in the third modality. [0045] Figure 17: longitudinal section and a side view of the coupling sleeve in the third embodiment with a first limiting means. [0046] Figure 18: cross sections of the limitation mechanism in the third modality in the areas of axial thrust, paragerri and limit stop in a normal position and a stop position. [0047] E'igura 19a, b: arrangement of the first to third modalities. [0048] Figure 20 · a, b: arrangement of a fourth modality. [0049] Figure 21a, b: arrangement of a fifth modality. [0050] Figure 22a, b: arrangement of a sixth modality. [0051] Figure 23a, b: arrangement of a seventh modality. [0052] Figures 1-8 show a first modality of the device according to the invention installed in an injection device for the cause of the example. Figure 1 shows an exploded view of the individual parts of a first embodiment of an injection device according to the invention. Figure 2 shows a longitudinal section and a side view of the dosing sleeve in the first embodiment with the first limiting means. Figure 3 shows side views of the coupling sleeve in the first embodiment. Figure 4 shows side views of the second limiting means in the first modality in the form of a stop wheel. Figure 5 shows longitudinal sections of the limiting mechanism in the first modality in a normal position and a stop position. Figure 6 shows a longitudinal section of the limitation mechanism in the first mode with axial heating zones, stop and limit stop. Figure 7 shows a side view of the limitation mechanism in the first inodality and cross sections. in the axial coupling, stop and stop zones Limit at a normal height. Figure 8 shows a side view of the Limitation mechanism in the first modality and cross sections in the axial drive, stop and limit stop zones in a stop position. [0053] The first modality is conceived as a so-called single-use pen. That is to say, the ejection device is issued to the user fully assembled, that is, with the product to be administered. Before use, the user only needs to expel air from the injection device, also known as primer. The typical course of the injection process can be as follows: the user removes the protective cap 1 from the injection device and attaches an injection needle (not shown) to the needle holder 2a. The dosage can now be adjusted using the rotary knob 11a. For this purpose, the rotary knob 11a is rotated so that the dosing sleeve 50 is screwed out of the injection device. The dosing sleeve 50 is screwed out of the injection device until the desired dosage is displayed in the threaded sleeve window 9. If an excessively high dosage is set inadvertently, the dosage can be corrected by turning the rotary knob in the opposite direction, using the that the dosing sleeve 50 is screwed back into the housing. The dosing device limits the maximum adjustable dosage to a predetermined value. If an attempt is made to screw the dosing sleeve out of the housing beyond this value, a radial limit stop on the dosing sleeve 50 and a limit counter stop for the threaded sleeve 9 prevent further rotation by mutual interaction. [0054] During the dosing and correction movements, the dosing sleeve 50 rotates in relation to the coupling sleeve 40. The coupling sleeve 40 is held fixedly rotatably in a shape socket or friction socket against the housing 5 by one reverse rotation lock (not shown, for example, applied to threaded nut 7 and housing 5), for example, by means of latch and pressure. If the desired dosage has been adjusted, the injection needle can be inserted in the desired position on the user's body. The user then pushes the eject button 14 in the distal axial direction and thus blocks a relative rotation between the coupling sleeve 40 and the dosing sleeve 50. In the event of increased pressure in the distal axial direction, the dosage starts to move back to the housing in a screwing motion. Because of the rotation lock established between the dosing sleeve and the coupling sleeve, the coupling sleeve 40 performs the same movement as the dosing sleeve 50. Because the coupling sleeve 40 is permanently rotatably locked to the stationary axially threaded nut. 7, the rotational movement of the metering sleeve 50 is transmitted to the threaded nut 7. No axial force is transmitted to the threaded nut 7, because the coupling sleeve 40 is mounted axially movable on the threaded nut 7. Thus, the rotating threaded nut 7 produces an axial movement of the threaded rod 8 in the distal direction, in which the latter is guided axially and rotatably locked in the housing 5. The flange 4 acts on the cartridge plug and pushes it, corresponding to the displacement of the threaded rod 8 in the distal direction also, in which the previously defined dosage can be ejected or administered. At the end of administration, when the dosing sleeve has been completely screwed back into the housing, radial stops at the dosing sleeve 50 and the threaded sleeve 9 prevent overcrowding and further ejection of the dosing device. [0055] The limiting device according to the invention ensures that the most recently defined dosage can be completely ejected or injected, [0056] For this purpose, the dosing sleeve 50 has coaxially applied teeth set 51, which can extend axially along the three axial sections, actuation zone A, stop zone B and limit stop zone C. Circumferential tooth set it is formed at least in zone A. A first stop means is formed as a stop wedge 52 in the axial extension of a tooth interstice of the circumferential set of teeth 51 in stop zone B. As described above, the coupling sleeve 40 it is inserted coaxially into the dosing sleeve 50. Preferably, the coupling sleeve 40 has a lateral cutout 41, which extends at least in certain sections through the three sections, drive zone A, stop zone B and limit stop zone C, and into which the stop wheel 30 is inserted. The axis of rotation 36 of the wheel, connected by means of radius 37 to the wheel, is rotatably received at its proximal axis end 34 in the proximal support 42, and at its distal axis end 35 in the distal support 43 of the coupling sleeve 40 At least in an area of the driving zone A, circumferential set of teeth 31 with 17 teeth, for example, which mesh with circumferential set of teeth 51 with 25 teeth, for example, in the dosing sleeve 50, is formed on the wheel stop 30. The transmission formed in this way sets the stop wheel 30 in rotation when the dosing sleeve 50 and the coupling sleeve 40 rotate relative to each other by their common axis L. The axis of rotation 36 of the stop wheel 30 is displaced parallel to this axis L. A second stop means is formed as a stop rib 32 in the axial extension of the tooth in the circumferential set of teeth 31, at least in the stop zone B. In the limit stop zone C, a first stop means li mite is formed in the cutout 41 of the coupling sleeve 40 such as a limit stop acting radially 44, which can be brought into engagement with a second limit stop means constructed as a limit stop acting radially 33 in the limit stop zone C on the stop wheel 30. This coupling takes place by rotating the stop wheel 30 out of its normal position to a stop position against the elastic force of its axis of rotation 36 and / or the elastic force of its radius half 37. The coupling prevents further rotation of the stop wheel 30 in the direction of increasing the dosage. Because a rotation of the coupling sleeve 40 in relation to the housing 5 in the dosing increase direction is blocked by the reverse rotation lock (not shown), the dosing sleeve 50 may also not be additionally rotated in the direction of dosing increase by the interconnection formed by the set of teeth 31 and the set of teeth 51. On the other hand, the coupling and its locking due to the restoring force of the rotation axis are released as soon as the stop rib 32 detaches from the stop wedge 52 during a rotation of the stop wheel 30 in the dose reduction direction and the rotated stop wheel can move back to its normal position. The stop wheel 30 is only turned when the stop rib 32 hits the stop wedge 52. With 25 teeth for tooth set 51 and 17 teeth for tooth set 31, for example, and with a maximum starting position selected, this occurs after 25 * 17 = 425 tooth steps, which corresponds to a period. The stop wheel 30 rotates 25 times and the dosing sleeve 50 turns 17 times in this example until the stop rib 32 hits the stop wedge 52 and the resulting transverse force brings the first and second limit stop means for engagement, as as already described. Through an appropriate selection of the starting position of the stop wheel 30, the dosage limitation can be programmed to any desired number and fractions of tooth steps or rotations within the period, without structural changes having to be made in the design. For example, a tooth step can correspond to an IU insulin unit and the stop wheel can be initially inserted at the point corresponding to 125 tooth steps in each period, so that limitation occurs after a total of 300 IU pre- selected or ejected. [0057] Figures 9-13 show a second embodiment of the device according to the invention installed as an example in an injection device similar to that of Figure 1. Figures 9a and b show longitudinal sections of the limiting mechanism of the second embodiment in one normal position and in a stop position. Figure 10 shows side views and the cross sections of the second limiting means in the second embodiment in the form of a stop wheel with a second means of traverse limiting stop and spring return. Figure 11 shows a side view and a longitudinal section of the coupling sleeve in the second embodiment. Figure 12 shows a side view and a cross section of the coupling sleeve in the second embodiment with a first limit stop means. Figure 13 shows cross sections of the limiting mechanism in the second modality in the axial drive, stop and limit stop zones in a normal position and a stop position. [0058] The application and function of the second modality correspond to the first modality with the exception of the following modifications made for the sake of example. The stop wheel 30 is designed with a rigid axis of rotation 36, the wheel and axle preferably being solidly integrated, and is received rotatably at the proximal axis end 34 in the proximal support 42 and at its distal axis end 35 in the support distal 43 from the coupling sleeve 40. In the area of the stop zone B and the limit stop zone C, a transverse orientation groove with inserted slide 38 is provided on the rotation axis 36 or on the stop wheel 30. In the slide 38 or on the axis of rotation 36, an interior space is opened in the area of the stop zone, in which a spring means 39, preferably a compression spring in the form of a helical spring, is engaged. This spring means maintains the control of the slider 38 in its normal transverse position. In this position, the stop rib 32 on one side of the slider 38 can engage with a set of teeth 51 optionally formed in the area of the stop zone, while the stop rib 32 does not hit the stop wedge 52. If so, the slider is displaced transversely with respect to the axis of rotation against the elastic force of the spring means 39 to a stop position. The limit stop 33 formed on the side face of the slider 38 opposite the stop rib 32, as a second limit stop means, is thus brought into engagement with the limit stop 44 applied as a first limit stop means for the sleeve. coupling 40. The coupling prevents further rotation of the stop wheel 30 in the direction of increasing the dosage. On the other hand, this engagement is released by the restoring force of the spring means 39 as soon as the stop rib 32 detaches from the stop wedge 52 during a rotation of the stop wheel 30 in the dose reduction direction and the slide 38 can move back in its normal position due to the force of the spring means 39. [0059] Figures 14-18 show a third embodiment of the device according to the invention installed as an example in an injection device similar to that of Figure 1. Figures 14a and b show longitudinal sections of the limiting mechanism of the third embodiment in one normal position and in a stop position. Figure 15 shows a front view of the second limiting means in the third embodiment in the form of a stop wheel with a second transversely movable limit stop means and gear means return. Figure 16 shows a side view and a longitudinal section of the coupling sleeve in the third embodiment. Figure 17 shows a side view and a cross section of the coupling sleeve in the third embodiment with a first limiting means and a gear cam. Figure 18 shows cross sections of the limitation mechanism in the third modality in the axial drive, stop and limit stop zones in a normal position and a stop position. [0060] The application and function of the third modality correspond to the first modality with the exception of the following modifications made for the sake of example. The stop wheel 30 is designed with a rigid axis of rotation 36, the wheel and axle preferably being solidly integrated, and is received rotatably at the proximal axis end 34 in the proximal support 42 and at its distal axis end 35 in the support distal 43 from the coupling sleeve 40. In the area of the stop zone B and the limit stop zone C, a transverse orientation groove with inserted slide 38 retracted in its normal transverse position is provided on the axis of rotation 36 or on the stop wheel 30. In this normal position, the stop rib 32 on one side of the slider 38 can engage with the set of teeth 51 optionally formed in the area of the stop zone, while the stop rib 32 does not hit the stop wedge 52. If it is in this case, the slider 38 is moved transversely with respect to the axis of rotation against the sliding and static frictional forces defined in its stop position. The limit stop 33 formed on the side face of the slider 38 opposite the stop rib 32, as a second limit stop means, is thus brought into engagement with the limit stop 44 positioned as a first limit stop means on the coupling sleeve 40. The engagement prevents further rotation of the stop wheel 30 in the direction of increasing the dosage. On the other hand, this coupling is released in the event of a rotation of the stop wheel 30 in the direction of dosing reduction. Then the stop rib 32 again detaches from the stop wedge 52, and the slider 38 is moved back to its normal position based on the transmission type interaction of the limit stop 33, on a side face of the slider 38 opposite from the rib stop 32, and the gear cam 45 on the coupling sleeve 40. [0061] It is understood that the dosage limitation in all the modalities according to the invention also works if the first and second limit stop means in the previous modalities are omitted and the blocking of the rotation movement happens only by tapping the first and second stopping means. [0062] An additional locking mechanism can also be provided in all embodiments. When the last possible quantity of product to be administered has been ejected, that is, when cartridge 3 has been completely emptied, the transport device blocks additional ejection rotation of the dosing sleeve 50. In this case, the end 8a of the thread on the threaded rod 8 hits against the inner thread ribs of the threaded nut 7 and prevents any further axial movement of the threaded rod 8 in relation to the threaded nut 7. Since the threaded rod 8 is rotationally locked in relation to the housing, no common rotation of the threaded nut 7 and the threaded rod 8 is possible. Therefore, the dosing sleeve 50 is prevented from screwing further, as long as the rotational lock between the coupling 40 and the dosing sleeve 50 is maintained. If a higher dosage has been set than the amount of product remaining, then the remaining unadministered amount can be read through the window in the dosing sleeve 50 in the locked state. This remaining amount would then have to be injected into another administration process with a backup injection device. This drawback is generally avoided, however, by the limiting device according to the invention and the injection device shown as an example. That is, the thread end 8a of the threaded rod 8 contacts the inner thread ribs of the threaded nut 7 as soon as the dosing sleeve 50 has reached and exhibited the remaining amount "0" and the cartridge is nominally empty. [0063] In general, the previously presented embodiments of the invention can be seen as representing an arrangement as shown in Figures 19a and 19b. The stopping means 300, 500, in this case, moves at the same speed, operatively connected in a shape fit to another, in circular paths 01, 02 of different sizes, the axis of the smaller circle 01 is inside the circle greater 02, [0064] Representatives of an arrangement as shown in Figures 20a and 20b can be considered a fourth modality. At least one of the two stopping means 300, 500 moves here in a closed non-circular path Ul, as can be done, for example, by a traction chain or a toothed belt, or, in general, by a positively actuated closed belt or traction medium. Such a traction means can advantageously be at least partially folded and / or inverted and / or located in a compartment in order to save space. [0065] Representatives of an arrangement as shown in Figures 21a and 21b can be considered as a fifth modality. The stopping means 300, 500, in this case, moves at the same speed, positively connected to each other, in circular paths Ul, U2, of different sizes, the axis of the smaller circle Ul is outside the larger circle U2. [0066] Representatives of an arrangement as shown in Figures 22a and 22b can be considered a sixth modality. The stop means 300, 500 here move at different speeds, operatively connected positively by means of a transmission gear unit, in two closed paths of different sizes or of equal sizes Ul, U2, as can be done, for example, by traction chains or toothed belts or generally by positively steered closed belts or means of traction. Such a traction means can advantageously be at least partially folded and / or inverted and / or located in a compartment in order to save space. [0067] Representatives of an arrangement as shown in Figures 23a and 23b can be considered a seventh modality. In this case, the stopping means 300, 500 moves in L rotating guide means, with different speeds operatively connected positively by means of a transmission gear unit; shown only schematically in the Figure, in two circular paths of different sizes or of equal sizes Ul, U2, the axis of one circle Ul is outside the axis of the other circle U2. LIST OF REFERENCE NUMBERS - 1 Protective cap 2 Cartridge holder 2a Needle holder 3 Cartridge A Flange 5 Housing 6 Housing insert 7 Threaded nut 8 Threaded rod 8a Thread wound 8g Thread 9 Threaded sleeve 11a Rotary button 13 Click spring dosing 14 ejection button 30 Stop wheel, second stop 31 Set of drive teeth 32 Stop rib, second stop stop 33 Limit counter stop, second stop stop 34 Proximal shaft end 35 Distal shaft end 36 Axis of rotation 37 Half radius 38 Slider in cross guide 39 Spring means 300 Second stop means 40 Coupling, coupling sleeve 41 Cutout 42 Proximal support 43 Distal support 44 Limit stop, first limit stop means 45 Gear meat 50 Dosing sleeve, first stop means 51 Set of teeth 52 Stop wedge, first stop stop 500 First stop stop UI First path curve, path runs r 53 second path curve, circular path
权利要求:
Claims (16) [0001] 1. Dosing device for an administration device with a limiting mechanism, comprising: a first limiting means (50) with a first stopping means (500); a second limiting means (30) with a second stopping means (300); wherein the second limiting means (30) follows movements of the first limiting means (50) during dosing movements with a defined transmission ratio; wherein the second limiting means (30) does not move relative to the first limiting means (50) during administration processes; and in which the first stopping means (500) and the second stopping means (300) each describe a path curve (U1, U2) by their movements in such a way that the two path curves (U1, U2) intersect at at least one point or so close to each other that the stopping means (300, 500) contacts another one in a stopping position, whereby a blocking of the movement of the limiting means (30, 50) in relation to each other during dosing movements can be carried out; characterized by the fact that: the respective path curves (U1, U2) described by the first and second stopping means (300, 500) are closed and can preferably be traversed several times by the first stopping means (500), by the second stop means (300) or by both stop means (300, 500) until the stop means (300, 500) contact one another in the stop position. [0002] Dosing device according to claim 1, further comprising a sleeve-type dosing member with an inner wall, an outer wall and a longitudinal axis; characterized by the fact that: the first limiting means (50) is constructed as a set of teeth (51) with teeth and teeth interstices, and the first stopping means (500) is formed by a wedge (52) that fills by the least one part of an interstice of teeth. [0003] Dosing device according to claim 1 or 2, characterized in that the second limiting means (30) is a stop wheel with a longitudinal axis. [0004] Dosing device according to claim 3, characterized in that the dosing member surrounds the stop wheel (30) at least in part or is adjacent to it. [0005] Dosing device according to claim 4, characterized in that the longitudinal axes of the stop wheel (30) and the dosing member are arranged parallel to one another. [0006] Dosing device according to any one of claims 3 to 5, wherein the stop wheel (30) has an outer surface that has a proximal end and a distal end; characterized by the fact that: the outer surface can be axially subdivided into at least two regions, in which the set of teeth (31) in addition to the set of teeth (51) on the dosing member is applied in a first of at least two regions , in which a stop rib (32) is formed in the second of at least two regions, and where the dosing movement can be blocked by interaction of the wedge (52) and the stop rib (32). [0007] Dosing device according to any one of claims 1 to 6, characterized in that the first stopping means (500) and the second stopping means (300) move at the same speed in path curves of different length (U1, U2), or at different speeds on path curves of equal length (U1, U2). [0008] 8. Dosing device according to claim 2, characterized in that the first stop means (500) moves in its circular path curve (U2) whereby the second stop element or stop wheel (30) it is axially arranged in such a way that its circumferential set of teeth (31) engages with the set of circumferential teeth (51) of the first limiting means and, due to the relative movement of the dosing member and a coupling sleeve (40), the second stopping means (300) moves on its path curve (U1). [0009] Dosing device according to claim 8, characterized by the fact that the stop wheel (30) is received rotatably by support points on the coupling sleeve (40). [0010] Dosing device according to any one of claims 1 to 9, characterized in that at least one of the numerator or denominator of the transmission ratio is a prime number. [0011] Dosing device according to any one of claims 8 to 10, characterized in that the prevention of further movement of the first limiting means (50) and the second limiting means (30) is done indirectly by means of a force that appears at the mutual strike of the first stopping means (500) and the second stopping means (300) against an elastic restoring force and / or through a gear means that brings a first limit stopping means (44) in the coupling sleeve (40) for engaging with a second limit stop means (33) in the second limit means (30). [0012] 12. Dosing device according to claim 11, characterized in that the force between the first stopping means (500) and the second stopping means (300) is capable of deforming the axis of rotation (30) and / or the radius means (37) in the second limitation means (30), which is the stop wheel, resiliently, whereby the second limitation means (30) is translated or articulated transversely to its axis of rotation. [0013] 13. Dosing device according to claim 11, characterized by the fact that the second limit stop means (33) is movably supported in the transverse direction and fixed rotationally and axially in relation to the axis of rotation of the stop wheel (30), in which the second limit stop means (33) is supported on a transverse guide on the stop wheel (30) and is fixed in its nominal position by a spring means (39). [0014] 14. Dosing device according to claim 11, characterized in that the return of the second limit stop means (33) from its stop position to its nominal position is effected by a gear orientation (45) , which abuts the radial limit stop (44) as a curved surface on the coupling sleeve (40) in a limit stop zone and moves the second limit stop means (33) radially in its transverse guide during the return rotation of the control wheel stop (30), in which case the dosing sleeve rotates in the direction of dosing reduction. [0015] 15. Injection device characterized by the fact that it comprises a housing (5) with a container (2) for the product, a transport device for transporting the product, the transport device comprising a piston rod (8), which is movable with respect to the housing (5) in a transport direction in order to eject the defined product dosage in a transport stroke corresponding to the defined product dosage, and the dosage device defined in any one of claims 1 to 14, for define a product dosage to be administered and to display the defined product dosage. [0016] 16. Injection device according to claim 15, characterized in that the metering device further comprises a coupling device (40) which can operatively connect the metering device to the transport device, wherein the metering device coupling (40) is designed in such a way that a dosage to be administered can be set and / or corrected independently from the transport device and that the dosing device can be selectively operatively coupled to the transport device during administration of the dosage.
类似技术:
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同族专利:
公开号 | 公开日 DK3251712T3|2019-04-15| MX2014013844A|2015-05-15| ES2548848T3|2015-10-21| JP5976202B2|2016-08-23| US20200306454A1|2020-10-01| ES2548848T5|2019-03-15| EP3251712B1|2019-01-09| EP2979715A1|2016-02-03| RU2627622C2|2017-08-09| US20150073355A1|2015-03-12| US11058822B2|2021-07-13| JP2016209619A|2016-12-15| PL2814547T3|2015-11-30| CN107029320A|2017-08-11| US11103646B2|2021-08-31| IN2014DN09538A|2015-07-17| JP6431507B2|2018-11-28| CA2870369A1|2013-11-21| MX346637B|2017-03-27| DK2814547T3|2015-10-12| EP2814547B2|2018-10-03| DK2979715T3|2017-10-16| US20190321558A1|2019-10-24| EP2979715B1|2017-07-12| WO2013170392A1|2013-11-21| EP2814547B1|2015-07-08| CN107029320B|2020-03-17| US10518035B2|2019-12-31| AU2013262370A1|2014-12-18| JP2015516242A|2015-06-11| DK2814547T4|2019-01-21| EP2814547A1|2014-12-24| CH706567A2|2013-11-29| PL2814547T5|2019-02-28| RU2014150784A|2016-07-10| CA2870369C|2019-01-08| EP3251712A1|2017-12-06| US9750887B2|2017-09-05| CN104394916A|2015-03-04| BR112014028627A2|2017-06-27| US20170361024A1|2017-12-21| CN104394916B|2016-12-07| AU2013262370B2|2017-04-27|
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法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]| 2019-12-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]| 2020-12-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]| 2020-12-22| B25A| Requested transfer of rights approved|Owner name: YPSOMED AG (CH) | 2021-01-26| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 13/05/2013, OBSERVADAS AS CONDICOES LEGAIS. |
优先权:
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申请号 | 申请日 | 专利标题 US201261647851P| true| 2012-05-16|2012-05-16| US61/647,851|2012-05-16| CH695/12|2012-05-16| CH00695/12A|CH706567A2|2012-05-16|2012-05-16|Improved device to set a dose a limiting mechanism for an apparatus for administering a product.| PCT/CH2013/000081|WO2013170392A1|2012-05-16|2013-05-13|Improved device for adjusting a dosage with a limiting mechanism for a device for administering a product| 相关专利
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