The invention relates to a dose delivery device, wherein a dose can be set by rotating a dose setting member, whereby a push button is elevated from one end of the device, and wherein the set dose can be injected by pressing the push button back to its non-elevated position, thereby axially moving a screw co-operating with the plunger in a cartridge and expelling a medicament out of the cartridge through a needle.
EP 0 327 910 describes a device in which a dose is set by rotating a tubular injection button engaging a threaded screw, thereby causing the injection button to elevate from the end of the injection device. By pressing down the injection button until abutment with a fixed stop the threaded screw is moved a distance corresponding to the movement of the injection button. The screw abuts a plunger in a cartridge and medicine is expelled from the cartridge. This kind of injection device transmits the injection force directly to the plunger of the cartridge but provides no gearing, i.e. the linear movement of the injection button corresponds exactly to the linear movement of the screw.
However, the above described device does not provide a numbered dose dial, and the amount of a set dose must be calculated by adding a one-digit scale with a ten-digit scale. As all parts of the dose setting mechanism conducts only linear movements when a set dose is injected the incremental size of a unit in the dose setting mechanism is very small, and a dose can only be set to and displayed as every second unit.
EP 1 003 581 describes a number of methods to achieve a dose setting providing a gearing between the axial movement of the screw and axial movement of the dose setting member and/or push-button, so that a dose dial with sufficient space for numbers to be added. In one embodiment a dose setting member with printed numbers on the cylindrical surface is engaging a thread in the housing with a higher lead than the lead on a screw. When pressure is added to an injection button the screw is rotationally coupled to the dose setting member and as the screw is rotated in a threaded nut fixed in the housing it is moved forward until the dose setting member abuts a rotational stop.
This device, however, is complicated and contains many layers to provide all the functionality, and this has the consequence that the thread engagement between the dose dial and the housing becomes rather big, and thereby the injection force will be relatively high and the movement of the push-button during injection will be relatively long.
WO 2011/060785 describes a device with a numbered dose dial and with no gearing. A screw is engaged with the housing via a not self-locking thread connection. A ratchet is rotationally coupled to the screw and preventing the screw from rotating backward thereby moving back into the device. A nut which is engaged with the thread of the screw is rotationally locked to a dose setting member during dose setting. The nut also comprises the numbers indicating the amount of a set dose. During the injection sequence the nut is initially released from the dose setting member, then rotationally coupled to the ratchet and the screw and thereafter a continued pressure on the push-button causes the screw, the ratchet and the nut to rotate and to move forward due to the not self-locking thread connection between the screw and the housing.
A disadvantage of this device is that the numbered dose dial are moves during the initial movement of the push-button, which makes it difficult to read the numbers during injection.
It is an objective of the present invention to provide a non-complicated and small injection device comprising a numbered dose dial, and which provides a low injection force and a low push-button movement during injection, and which also provides an easy reading of the set dose and remaining dose during dose setting and injection.
The invention relates to an injection device comprising:
In this way the dose force on the driver is transferred directly to the screw without first being transformed to rotational movement and then back to linear movement with a resulting loss of energy. There is no load on the rotational movement and thereby the energy loss due to the rotation is very low. Furthermore, it is possible to use the mechanism for both a device with and without a gearing.
In an embodiment of the invention a numbered dose dial displaying the amount of set dose is engaged with a fifth thread in the housing having a higher lead than the third and the fourth threads on the driver and the driver is engaging the dose dial via a track allowing axial movement. Hereby it is possible to select a suitable gearing ratio for the device to have the dose force reduced.
In a further embodiment of the invention during injection the screw and the driver are rotationally coupled by means of a connecting tube which is rotationally locked to the screw via the non-circular cross-section of the screw and which is capable of moving axially relative to the screw and which during injection is rotationally coupled to the dose dial. In this way the rotational movements of the screw and the driver can be synchronized by through the dose dial, even though the dose dial has a longer axial movement then the driver.
In a further embodiment of the invention the driver is coupled to a dose selector during dose setting and decoupled during injection and the driver and the dose selector travels the same distance during dose setting and injection. In this way a very simple device comprising only a few parts can be made and the movement of the push-button will be very low. This also gives the possibility of having the dose setting clicks arranged between the dose selector and the housing.
In an even further embodiment of the invention a clutch is provided between the dose dial and the connecting tube and the clutch couples the dose dial and the connecting tube together during injection. This allows that the push on the push-button can directly couple the connecting tube and the driver together.
In an even further embodiment of the invention a bidirectional ratchet is provided between the dose dial and the connecting tube and the bidirectional ratchet indexes the dose dial on specific rotational positions around the revolution. In this way it is ensured that the number reflecting the set dose is displayed precisely.
In a further embodiment of the invention a unidirectional ratchet is rotationally coupled to the screw but axially movable relative to the screw and the ratchet prevents the screw from moving toward the push-button end. This ensures that the screw will not rotate along with the connecting tube during dose setting.
The objectives of the invention can be obtained by an injection device comprising a threaded screw, which is engaging the internal thread of a driver. The driver also has an external thread of the same lead as the internal thread headed in the same direction and engaging a nut fixed in the housing. The driver is furthermore rotationally connected with a numbered dose dial, which is engaging the housing via a thread with a bigger lead than the threads on the driver and the dose dial. A unidirectional ratchet cooperating with teeth in the nut fixed in the housing is rotationally but not axially connected to the screw, and also a connecting tube is rotationally but not axially connected to the screw. Between the dose dial and the connecting tube, a bidirectional ratchet is arranged.
A dose selector is integrated with the dose dial. When a dose is set by rotating the dose selector the unidirectional ratchet will prevent the screw and the connecting tube from rotating and the bidirectional ratchet between the connecting tube and the dose dial will click and position the dose dial on equally spaced increments around the revolution. The driver is rotated along with the dose dial, but as the lead on the external thread engaging the nut fixed in the housing is smaller than the lead on the dose dial engaging the housing, the driver is caused to move up a smaller distance than the dose dial. As the internal and the external thread on the driver has the same lead the screw will not move up or down when a dose is set. If a set dose is corrected the torque arising from the unidirectional ratchet and the resistance in the cartridge, which together are bigger than the torque arising from the bidirectional ratchet between the connecting tube and the dose dial, prevents the screw from rotating.
When the set dose is injected a push-button, which is axially locked to the connecting tube, but capable of rotating, is pushed down. This pushes the connecting tube into rotational engagement with the dose dial and further push on the push-button causes the dose dial to rotate due to the thread engagement with the housing. Thereby also the connecting tube, the screw, the driver and the unidirectional ratchet will rotate, and the unidirectional ratchet will produce a clicking sound. As both the driver and the screw rotate the screw will move down with the same speed as the driver causing the medicament to be expelled.
To prevent that a dose higher than the remaining content of the cartridge is set the thread on the screw is provided with a stop in the end headed towards the push button. As described above the unidirectional ratchet prevents the screw from rotating during dose setting, and further dose setting will therefore be prevented when the internal thread on the driver abuts the stop on the screw thread.
In another embodiment there is no gearing between the movement of the push-button and the screw and it is the thread engagement between the nut fixed in the housing and the driver that rotates the injection mechanism during injection. A nut assembly comprises a dose dial with numbers and a driver fixed to each other and is engaging the screw in an internal thread and the housing in an external thread. The screw is rotationally locked to a connecting tube and to a unidirectional ratchet. A combined dose selector and push-button is rotationally coupled to the nut assembly during dose setting and they are maintained in engagement by means of a spring located between the connecting tube and the nut assembly. When a dose is set, the dose selector is rotated in increments defined by flexible protrusions on the dose selector cooperating with grooves in the housing. The nut assembly rotates along and this rotation elevates the nut assembly and the dose selector. When a set dose is injected the combined dose selector and push-button is pushed which disengaging it from the dose dial and instead engaging the connecting tube with the nut assembly. Due to the thread engagement between the driver, which is part of the nut assembly, and the thread in the housing further pushing will cause the nut assembly, the connecting tube, the screw and the unidirectional ratchet to rotate and the ratchet will produce a clicking sound.
A transparent window may be added to the housing to protect the user from touching the dose dial or a magnifier may be added to enlarge the number and make it more readable. A window or a magnifier can also act as a stop for the maximum settable dose by having an inwardly headed protrusion cooperating with the dose dial or with another part of the device.
In another embodiment the dose dial has an outer thread with a lead of e.g., the double of the lead of the screw. A window item which may also comprise a magnifier, and which is axially but not rotationally movable relative to the housing, is engaging the thread of the dose dial. When the dose dial rotates up along the screw, the window item moves down a bigger distance than the dose dial, and in that way more space on the dose dial is provided for numbers. A prolonged hole in the housing allows the window item to move up and down.
Alternatively, the outer thread on the dose dial has a very high lead and engages the internal thread of an enlarging dose dial provided with dose indicative numbers and engaged with an internal thread in the housing. If the lead between the enlarging dose dial and the housing is bigger than the lead between the dose dial and the housing, then more space for the numbers along the axis of the device is provided. If also the high lead thread between the dose dial and the enlarging dose dial is handed in a direction that makes the enlarging dose dial rotate faster than the dose dial, then more rotationally space for the numbers is provided as well. To ease assembly the rotational connection between the dose dial and the enlarging dose dial could be a straight key/groove connection instead of a thread connection, which then would only provide more axial space for the numbers.
The dose delivery device may be designed to be either disposable or reusable and to contain one, two or multiple cartridges at the time. If the dose delivery device is designed to be reusable, the screw must be capable of rotating backward when the cartridge holder is disconnected.
In the following the invention is described in further details with reference to the drawings, wherein
In the following the terms “up” and “down”, “upper” and “lower”, “upward” and “downward” and “left” and “right” refer to the drawings and does not necessarily correspond to a situation of use. The term “axial” is to be construed as parallel with the main axis of the device.
Parts, which are fixed together, are marked with individual part numbers. However, they may also be marked as one part, and functionally features from a first part fixed to a second part are also to be considered as being features of the second part.
It should be understood that the dose selector 41, 134, 234, 334 of the shown embodiments is an element by which a dose can be both set and reset and, in some embodiments, also pushed to inject the set dose. The dose selector can be an individual element, or it can be integrated with the dose dial or other parts. In embodiments where the dose selector is only for setting and resetting the dose a separate push-button 4, 355 for injecting the set dose is provided.
The dose setting and the dose injection mechanisms are highly integrated and the change from dose setting mode to dose injection mode is caused by an initial movement of a push-button 4, 355 or a dose selector 134, 234 before the actual injection starts.
As shown in
The connecting tube 3 has three ratchet arms (best seen on
When a dose is set the dose selector 41 with the integrated dose dial 2 is rotated. Due to the thread engagement 14/42 between the dose dial 2 and the housing 1 the dose selector 41 and the dose dial 2 elevates out of the housing 1 a distance equivalent to the set dose. The driver 5 rotates along with the dose dial 2 due to the key/groove connection 13/24, but due to the thread engagement 22/29 between the driver 5 and the nut 8 fixed in the housing, and because this thread has a lower lead, the driver 5 elevates less than the dose dial 2.
The screw 7 is prevented from rotating during dose setting by the unidirectional ratchet 6 as the direction of rotation is in the locking direction. As the lead of the internal thread 23 and the external thread 22 on the driver 5 are the same the screw 7 does not move up or down during dose setting. The connecting tube 3 does not rotate either due to the rotational connection with the screw 7, and v-shaped grooves 18 in the bottom of the dose selector 41 (see
When the set dose is injected the push-button 4 is pushed. This will first of all lock the connecting tube 3 rotationally to the integrated dose selector 41 and dose dial 2 as the v-shaped teeth 19 on the connecting tube 3 engage with the v-shaped grooves 18 inside the dose selector 41. Now a continued press on the push-button 4 causes the dose dial 2 to rotate due to the not self-locking thread engagement 14/42 between the dose dial 2 and the housing 1. The connecting tube 3, the screw 7, the driver 5 and the unidirectional ratchet 6 are all rotationally locked to the dose dial 2 during injection and will rotate as well. As the screw 7 during injection is prevented from rotating relative to the driver 5 and as it is prevented from moving up and down relative to the driver 5 due to thread engagement 23/26 with the driver 5, the screw will move the same distance as the driver, and the medicament contained in the cartridge will be expelled. The injection stops when the stopping surfaces 12 (see
To minimize the loss of energy in the system, sliding surfaces 20/21 with a small contact diameter are provided between the push-button 4 and the connecting tube 3.
To prevent that a dose larger than the remaining content of the cartridge can be set, the thread 26 on the screw 7 is provided with a stop in the end pointing towards the push-button 4. As the screw 7 is prevented from rotating in the dose set direction by the unidirectional ratchet 6 further rotation of the dose selector 41 is prevented when the internal thread 23 on the driver 5 abuts the thread stop.
In the following the operations of setting and injecting a dose on the above described device will be described.
On the device showed on
On
On
On
When a dose is set the dose selector 134 is rotated and click protrusions 145 on the outside of the dose selector 134 produce a clicking sound and index the dose selector 134 around the circumference in cooperation with grooves 138 on the inner periphery of the housing 101. This will also rotate the driver 150 and the driver will display the amount of the set dose in a window 111 in the housing 101. The screw 107 is rotationally locked to a unidirectional ratchet 106 with ratchet arms 127 cooperating with teeth 146 inside the housing 101. The screw 107 is prevented from rotating during dose setting as this is the locking direction of the ratchet 106, and during dose correction because of the torque arising from the ratchet 106 and the resistance in the cartridge. The ratchet 106 cannot move axially relative to the housing 101.
To inject the set dose the dose selector 134 is pressed down. This disconnects the dose selector 134 from the dose dial 132 and presses down the connecting tube 133. This will then rotationally connect the connector 133 with the dose dial 132 due to teeth 140 on the connector 133 and teeth 139 (see
In the following the operations of setting and injecting a dose on the above described device without a gearing will be described.
In
In
In
On
Number | Date | Country | Kind |
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PA 2018 00555 | Sep 2018 | DK | national |
Filing Document | Filing Date | Country | Kind |
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PCT/DK2019/000277 | 9/2/2019 | WO |
Publishing Document | Publishing Date | Country | Kind |
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WO2020/048570 | 3/12/2020 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
6221053 | Walters | Apr 2001 | B1 |
20040267207 | Veasey | Dec 2004 | A1 |
20050261634 | Karlsson | Nov 2005 | A1 |
20060206057 | DeRuntz | Sep 2006 | A1 |
20060258988 | Keitel | Nov 2006 | A1 |
20120046643 | Plumptre | Feb 2012 | A1 |
Number | Date | Country |
---|---|---|
1 003 581 | May 2000 | EP |
2 201 972 | Jun 2010 | EP |
2016518230 | Jun 2016 | JP |
0195959 | Dec 2001 | WO |
2011060785 | May 2011 | WO |
2012037938 | Mar 2012 | WO |
2014187811 | Nov 2014 | WO |
Entry |
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International Search Report (Form PCT/ISA/210) for International Patent Application No. PCT/DK2019/000277, issued from the European Patent Office, date of mailing Dec. 4, 2019, 3 pages. |
Number | Date | Country | |
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20210330890 A1 | Oct 2021 | US |