Field of invention

The invention relates to a dose delivery device wherein a dose can be set by rotating a dose setting member, and by which rotation of the dose setting member loads a spring when the dose is set, and by which a push on a push- button releases the applied spring force, driving a piston rod forward which co-operates with a piston in a cartridge and expelling a medicament out of the cartridge through a needle. Description of the related art

EP 327 910 discloses an injection device in which a dose is set by screwing up a tubular injection button along a threaded piston rod, 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 piston rod is moved a distance correspond- ing to the movement of the injection button. The piston rod mates a piston in a cartridge and medicament is expelled from the cartridge. This kind of injection device transmits the injection force directly to the piston of the cartridge but provides no gearing, i.e. the linear movement of the injection button corresponds exactly to the linear movement of the piston rod.

As not only the hydraulic flow through the needle but also the piston in the cartridge and the mechanical elements causes resistance, the dose force in the above kind of injection devices can be rather high. Users having reduced finger strength could therefore profit by a reduced injection force needed to carry out an injection.

EP 1003 581 describes a number of methods to achieve a dose injection device providing a gearing between the axial movement of the piston rod and the dose setting member. In one embodiment a dose setting member is screwed up in a thread i.e. in the housing having a larger pitch then the pitch on the piston rod. When pressure is added to an injection button, the piston rod is being rotational coupled to the dose setting member and as the piston rod is rotated in a nut fixed to the housing, it is moved forward until the dose setting member abuts a fixed stop. This embodiment provides a gearing in movement, but does not reduce the needed injection force very much, as the transmission from linear movement to rotational movement and back from rotational to linear movement eats up most of the obtained force reduction due to friction.

A dose setting device where a gearing providing both a longer injection button movement when injecting and a following lower injection pressure is described in WO 94/13344. This dose setting mechanism comprises a flat rotatable dose setting element engaged with an injection button, a dose administration wheel connected with a piston rod and a coupling ring connected with the dose setting element and injection button. Only when the injection button is pressed, the coupling ring will engage the dose administration wheel and as the gearwheel connection between the dose setting element and the injection button has a larger diameter then the gearwheel connection between the administration wheel and the piston rod, a gearing with a little loss of force due to friction is obtained. However, this development provides a complicated voluminous mechanical solution which demands high precision. EP1568389 describes a pen with a gearing with a very little loss of injection force due to friction. A nut is screwed up along a threaded piston rod. The nut is provided with a gearwheel on the side, which on one side engage the housing and on the other side elevates an injection button. When the injection button is pushed, the nut and the piston rod are moved with a gearing ratio of 2: 1 between the injection button and the piston rod. As none of the parts of the injection mechanism rotates in threads during injection, the loss of force due to friction is very limited.

However, this mechanism is rather complicated, and is not suited for simple, disposable injection pens. For people having small hands or who are psychically impaired, it might not be sufficient to reduce the dose force and it might therefore be necessary to reduce the dose stroke as well.

WO2006045528 describes a pen with a torsional spring operatively connected to a dose setting member. A rotationally mounted scale drum is connected to the spring via a driver, and is adapted to display the dose to be expelled in accordance with the setting of the dose setting member. The rotationally mounted display member is arranged along a helical path and is adapted to be rotated over an angle corresponding to one or more revolutions, so that the endpoints of the angle defines the maximum dose to be set, and the "end of dose" position. When the pushbutton is depressed, the driver rotates the piston rod in a thread in the housing and the piston rod advances towards the needle end expelling the set dose. This has the advantage that the pushbutton only has to be moved a very little distance independent of the set dose, when the set dose is injected. However, the use of a torsional spring introduces some problems in the assembling process. As the torsional spring tends to rotate the dose setting member back to zero position, a mechanism which prevents this must also be provided.

The pen described in WO2008116766 is based on a push spring. A non-rotating piston rod is locked against translation by a thread engagement with a nut, which is locked against rotation, when the pen is in dose setting mode. When setting a dose, a dose tube, which is also engaged with the piston rod by a thread connection, is rotated and due to the engagement with the piston rod it is elevated towards the pushbutton end, and the push spring is thereby loaded. When the dose is to be injected, the push-button is depressed and the nut is thereby set free to rotate due to the torque from the thread engagement with the piston rod. The problem with this configuration is that when an injecting is carried out, the nut rotates in the same direction as the dose tube did, when the dose was set, and therefore it is not possible to rotate a scale drum back to its initial position in a simple mechanical way. This configuration is therefore not suited for mechanical pens comprising a numbered scale drum.

It is an objective of the invention to provide a spring driven injection device comprising few and simple parts, which is not based on a torsional spring and which is suited for mechanically displaying of the set dose.

Brief description of the invention

The invention relates to a spring actuated dose delivery device comprising a housing, a dose setting member, a push button, a piston rod rotationally locked to the housing during dose setting and rotating in a thread in the housing during injection, a driver engaged with the piston rod via a thread, and a compressible spring, wherein a dose can be set by rotating the dose setting member, whereby the com- pressible spring is being compressed, and wherein the set dose can then can be injected by pressing the push button, through which motion the energy in the compressible spring stored when setting the dose will be set free c h a r a c t e r i s e d b y the driver follows a helical path when setting a dose and the same helical path but in the opposite direction when injecting a set dose

This way a compressible spring can be used in a very simple way.

In an embodiment of the invention a first dose member and the driver is rotationally but not axially coupled during both dose setting and injection and wherein the first dose member, during injection, is engaging a second dose member in such a way that they rotate together, the second dose member being rotationally locked to the piston rod. In this way the driver can be rotated by rotating the first dose member, and an axial movement of the hand during dose setting is avoided.

In another embodiment of the invention the engagement between the first dose mem- ber and the second dose member is by means of a two-way ratchet, arranged in such a way, that they can be positioned relative to each other at certain increments equally spaced around the axis of the pen. In this way a separate coupling between the two parts are avoided, if the ratchet is capable of holding the parts together during injection.

In yet another embodiment of the invention the second dose member does not move axial during dose setting or injection and the first dose member and the second dose member are rotationally de-coupled during dose setting. This has the advantage that the dose setting mechanism is unable to influence the piston rod during dose setting.

In yet another embodiment of the invention the second dose member is rotationally coupled to the housing when a dose is set, and decoupled when the dose is injected. This ensures even further that the piston rod does not rotate during dose setting. In yet another embodiment of the invention the dose setting member and the first dose member disengages when a dose is injected. This has the advantage that the dose setting member does not rotate during injection.

In yet another embodiment of the invention the second dose member further com- prises one or more ratchet arms which cooperate with teeth in the housing to produce a clicking sound when the dose is injected. This provides dosing clicks without adding a new item.

In yet another embodiment of the invention one or more ratchet arms are provided on the first dose member and the corresponding click teeth are provided within the hous- ing. This makes it possible to add different characteristic to the teeth and to e.g. make the last click tooth higher and the sound louder.

In yet another embodiment of the invention the first dose member and the second dose member are coupled together by additional sets of teeth a dose is injected. This ensures even further that the first and the second dose member do not rotate relatively when the set dose is injected.

In yet another embodiment of the invention a spring is applied between the dose set- ting member and the push-button, arranged in such a way, that the spring force on the push-button acts towards the needle end and the spring force on the dose setting member acts away from the needle end. This has the advantage that the spring will help a user to inject the set dose and the needed force to inject is reduced. In yet another embodiment of the invention the dose setting member is capable of moving up and down and the dose setting member will remain connected with the first dose member when the dose setting member is pushed towards the needle end and rotated. This allows the user to overrule the force of the spring and thereby rotate the piston rod forward. This embodiment allows the user to overrule the force of the spring without having a dose setting member which rotates during injection.

In yet another embodiment of the invention a scale drum displaying the amount of a set dose follows the driver rotationally and is engaging the housing via a thread in the housing. As the pitch of the thread can be set to anything, this makes it possible to provide a scale drum with large numbers.

In yet another embodiment of the invention a gearing is provided between the pushbutton and the dose setting member, the gearing comprising an additional threaded member with a first thread engaging the push-button and a second thread headed in the opposite direction engaging the dose setting element, and the push-button and the dose setting element being rotationally coupled. In this way an alternative or supplementing way of reducing the dose force needed to carry out an injection is provided.

In yet another embodiment of the invention numbers displaying the amount of a set dose is printed on the driver. This makes it possible to have one item less in the device, and to minimize the friction. As the number will be smaller compared to the numbers of a separate scale drum, a magnifier might be needed

The objectives of the invention can be obtained by an injection device comprising a housing and a cartridge containing the medicament to be injected. A linear push spring is adapted to be preloaded between a driver engaged with a piston rod via a thread and a first dose member, the driver and the first dose member being rotation- ally but not longitudinally coupled. The piston rod which is also engaged with the housing via the thread has one or more longitudinally tracks and is rotationally coupled to a second dose member. This second dose member is also axially connected with and rotationally engaged with the first dose member via a bi-directionally ratchet mechanism and to the housing via locking teeth. A numbered scale drum is coupled rotationally to the first dose member and a dose setting member is coupled to the first dose member during dose setting.

When a dose is set, the dose setting member is rotated, which will rotate the first dose member, the driver, the spring and the scale drum. This will cause the driver to elevate towards the end of the pen, and the push spring to be compressed further be- yond the preloaded force. The first dose member will click in the second dose member in the bi-directionally ratchet. The click torque is of a size big enough to hold against the torque which is trying to rotate the dose setting member back to zero position and which arises from the thread engagement between the piston rod and the housing. A pushbutton is abutting the first dose member via a sliding bearing. When the push button is depressed, the first dose member is moved a small distance for- ward disconnecting it from the dose setting member. At the same time the second dose member is disconnected from the housing. As everything now is set free to rotate, the spring will press the driver and the piston rod forward, and due to the thread engagement between the piston rod and the housing, the piston rod, the driver, the first and second dose member and the scale drum will be rotated as the piston rod advances into the cartridge.

The advancement of the piston rod will expel the medicament due to a co-operation with a piston in the cartridge. The first or the second dose member can be arranged to provide a clicking sound against the housing when injecting a set dose. An advantage by using the first dose member is, that it always ends the same place, and it is therefore possible to configure different sounds at certain intervals, e.g. at 0,10,20 units, by changing the height or width of the relevant teeth.

The dose setting member and the first dose member can be configured to be one part or to act as one part, so that the dose setting member will follow the first dose member in any movement. This has the advantage that it allows the user to overrule the force of the spring and rotate the piston rod forward, when the push-button is pressed. This is also an advantage for initial priming of ampoules.

Figures

In the following the invention is described in further details with reference to the drawings, wherein

Figure 1 shows a perspective view of a pen according to the invention

Figure 2 shows an exploded view of the pen according to the invention Figure 3 schematically shows a vertical sectional view of a pen according to the invention ready to set a dose

Figure 4 schematically shows a vertical sectional view of a pen according to the invention where a dose has been set.

Figure 5 schematically shows a vertical sectional view of a pen according to the invention where a dose has been injected and the push-button is still depressed

Figure 6 schematically shows a vertical sectional view of a pen according to the invention where a gear element is provided between the first dose element and the push-button Figure 7 shows an exploded view of a pen according to the invention where a gear element is provided between the first dose element and the push-button

Figure 8 schematically shows a vertical sectional view of a pen according to the invention where the dose setting element can be pressed down to forcedly expel the medicament

Figure 9 shows an exploded view of a pen according to the invention which is capable of producing both a dosing click per unit and another type of click at another interval

Figure 10 schematically shows a vertical sectional view of a pen according to the invention which is capable of producing both a dosing click per unit and another type of click at another interval Figure 11 schematically shows a vertical sectional view of a pen according to the invention where the first and second dose member are rotation- ally connected during injection, ready to set a dose

Figure 12 schematically shows a vertical sectional view of a pen according to the invention where the first and second dose member are rotation- ally connected during injection, where the push-button is depressed

Figure 13 schematically shows a vertical sectional view of a pen according to the invention where the numbers corresponding to the set dose are printed directly on the driver

Figure 14 shows an exploded view of a dose setting mechanism of a pen according to the invention where the numbers corresponding to the set dose are printed directly on the driver

Detailed description

Fig. 1 shows a pen la according to the invention in an oblique view. Visible is the housing 2a comprising a window 15 where the amount of a set dose can be displayed with numbers following a helical path on the scale drum 18 (numbers not shown), the dose setting member 7a by which a dose is set, the push-button 9a by which a set dose is injected and the cartridge holder 3 comprising a thread 16 for the attachment of a double ended needle. The cartridge holder 3 also contains the medicament filled cartridge 17. The cartridge 17 comprises a piston which cooperates with the piston rod 4 (see fig. 3) of the injection system, to expel a set dose of medicament from the cartridge 17 out through the needle. The cooperation between the different elements of the pen will be described in the following. As shown in figure 3 a piston rod 4 having a thread 27 is engaged with the housing member 14a in a thread 28. A driver 5 is rotationally locked to a first dose member 6a via a key/groove connection and is at the same time engaged with the piston rod 4 via a thread 29. A compressible dosing spring 8 is located between a recess 19 (better seen on fig. 2) on the driver 5 and the first dose member 6a and is pre-tensed to a force large enough to carry out an injection. A second dose member 10a is rotational locked to the piston rod 4 via a key/groove connection and releasable locked to the housing 2a via lock teeth on both parts 20a, 21a during dose setting. Thereby the piston rod 4 is locked both longitudinally due to the thread engagement with the housing member 14a and rotationally through the rotational connection with the second dose member 10a.

When a dose is to be set, the dose setting member 7a which is longitudinally coupled to the housing 2a and rotationally coupled to the first dose member 6a is rotated and due to the rotational connection between the first dose member 6a and the driver 5, the driver 5 is rotated up along the piston rod 4 towards the push-button end. The first dose member 6a is mating an inner recess 30 in the housing which forms a gliding bearing when a dose is set, and which prevents the first dose member from moving in the direction towards the push-button. Consequently the dosing spring 8 will be fur- ther compressed.

To index the first dose member 6a at certain positions around a revolution, the first dose member 6a is engaged with the second dose member 10a via a two-way ratchet 11a which cooperates with grooves equally spaced around a revolution in the second dose member 10a. This ratchet connection must be strong enough to hold the torque produced when the piston rod 4 is pushed in the thread connection with the housing member 14a. This can be seen on fig. 2 and 3.

A scale drum 18 is rotational locked to the first dose member 6a via a key/groove connection and engaged with the housing 2a via a thread. The pitch of the thread can be set to any value which will allow the numbers written on the scale drum to have a sufficient readable size and the pen to have a reasonable size as well. As the first dose member 6a is rotated in one direction when setting a dose and in the other direction when injecting the set dose, the scale drum 18 can be configured to show a dose in every possible situation during dose setting and injection. The scale drum 18 can at the same time form the extreme stops when setting a dose and when injecting the set dose, such that a dose higher than the intended maximum dose and lower than zero cannot be set, and such that the scale drum forms the "end of dose" stop. When a set dose is to be injected, the first dose member 6a is pushed towards the needle end via the push-button 9a which is mating the first dose member 6a through a sliding bearing surface on both parts 22, 23. This pushes the lock teeth 20a on the second dose member 10a out of engagement with the lock teeth 21a on the housing member 14a and the second dose member 10a will be able to rotate (see fig. 3). This will cause the driver 5 to move the piston rod 4 towards the needle end, and at the same time it will cause it to rotate due to the thread engagement between the housing member 14a and the piston rod 4. As both the first dose member 6a, the driver 5, the second dose member 10a, the spring 8 and the piston rod 4 is rotational locked to each other during injection of a set dose, they will all rotate during injection due to the thread engagement between the piston rod 4 and the housing member 14a. The longitudinal movement of the first dose member when it is pushed down via the push-button 9a will also disconnect the lock teeth 24, 25 between the first dose member 6a and the dose setting member 7a, to avoid that the dose setting member 7a will rotate during injection. When the injection has been accomplished, the user re- leases the pressure on the push-button 9a and the spring 8 will move the first dose member 6a towards the push-button end until it abuts the recess 30 in the housing whereafter the first dose member 6a has engaged the dose setting member 7a and the second dose member 10a has engaged the housing 2a. The only loss of energy originating from the mechanical parts of the pen during injection is the small contributions from the small diameter gliding bearings between the first dose member 5 and the push-button 9a and between the piston rod 4 and the piston washer 31, the longitudinal key/groove connections between the first dose mem- ber 6a and the scale drum 18 and between the first dose member 6a and the driver 5, and the tread engagements between the piston rod 4 and the housing member 14a and between the scale drum 18 and the housing 2a. These are all very small.

The Second dose member 10a is provided with a one-way ratchet 12a producing a clicking sound against the housing member 14a when the set dose is injected. This will also cause a limited loss of energy.

In the following the sequences of setting and injecting a set dose will be described. Fig. 3 shows a device ready for setting a dose. The scale drum 18 is in zero position and the driver 5 is in its not elevated position. The first dose member 6a is in its upper position engaging the dose setting member 7a and the second dose member 10a is engaging the housing 2a.

In fig. 4 a dose has been set by rotating the dose setting member 7a. This has caused the scale drum 18 to elevate due to the thread connection between the housing 2a and the scale drum 18 and the set dose is therefore displayed in the window 15 in the housing 2a (see fig. 1). As it can be seen, the driver 5 has also moved, but a smaller distance than the distance for the scale drum. The movement of the driver 5 has been compressing the spring 8.

In fig. 5 the set dose has been injected and the push-button 9a is still depressed and the first dose member 6a is still disengaged from the dose setting member 7a and the second dose member 10a is still disengaged from the housing 2a. The scale drum 18 has moved back to its zero position stop ending the injection and the driver 5 has moved back to its not elevated position. It is now clearly, that the piston rod 4 has moved a distance corresponding to the distance moved by the driver 5 and the piston washer 31 and the piston 26 has been pushed forward in the cartridge 17.

Fig. 6 and 7 shows an embodiment of the pen lb according to the invention with a geared push-button 9b. By increasing the axial movement of the push-button 9b, the required dose force can be lowered. This is done by adding a threaded member 32 which is mating the sliding bearing surface 23 on the first dose member 6b. The threaded member 32 is further situated between the push-button 9b and the first dose member 6b and rotates relative to the push-button 9b via a thread engagement 35/36 and relative to the dose setting member 7b via a thread engagement 37/38. The pushbutton 9b is rotationally locked to the dose setting member 7b via a key/groove connection 33/34. If the pitches in the thread connections 35/36 and 37/38 are equal, the push-button 9b will move exactly two times the distance of the movement of the threaded member 32 and the gearing ratio is consequently 2: 1. Any other gearing ra- tio is possible by changing the ratios between the pitches of the thread connections. The loss of energy due to friction can be very low, as only the ratio between the pitches is important, and the pitches therefore can be set very high.

In fig. 8 is shown an embodiment of the pen lc according to the invention which re- duces the dose force in another way. A spring 39 is placed between a recess 46 on the dose setting member 7c and the push-button 9c. The dose setting member 7c is mating the recess 52 in the housing 2a formed by the circular track 48, and the spring 39 will therefore act on the push-button in a direction, that will reduce the dose force and thereby help the user.

This embodiment also provides another advantage as it makes it possible for the user to overrule an unintended stop of injection e.g. by a clogged needle, simply by pressing down the dose setting member 7c in the circular track 48 on the housing 2a instead of pressing the push-button 9c and simply "reset" the dose. As the spring 39 is either blocked against further compression or the dose setting member 7c in another way brings along the push-button 9c, the push-button will also be depressed, and the whole dosing mechanism is set free to rotate. As both the dose setting member 7c and the first dose member 6c are pressed down, they will not disengage, and a forced rotation of the first dose member 6c is thereby possible. This also makes it possible to make an initial priming to loosen the piston 26 in the cartridge 17 before use.

Fig. 9 and 10 shows an embodiment of the pen le according to invention capable of producing an extra click sound for e.g. every 5, 10 or 20 units which is different from the dosing click produced for every unit. This click sound should be configured to make the last click at end of injection, to help the user to determine when an injection is fulfilled. At the same time it allows a user to count the units or at least to follow the injection roughly.

Compared to the embodiment la the teeth 21d for rotationally lock of the second dose member lOd has been moved to the nut 14d, and the two-way ratchet 1 Id for dose setting has been moved to the second dose member lOd which is axial locked to the first dose member 6d (see fig. 9).

The dosing ratchet 12d has been moved from the second dose member lOd to the first dose member 6d and a set of corresponding click teeth 49 has been added in the housing 2d (see fig. 9). One or more of these teeth 50 has another configuration e.g. is higher than the rest of the teeth and will therefore make a different sound. As the first dose member 6d is rotationally locked to the scale drum 18 and the scale drum 18 always ends in the same rotational position, the clicks will always be produces at the same positions relative to the remaining dose. When a dose is set and the first dose member 6d is rotated, the dosing ratchet arm 12d is rotating in an area 51 in the housing 2d without teeth, and it is therefore capable of rotating both ways. The sec- ond dose member lOd is axial connected to the first dose member 6d and is locked against rotation via the teeth 20d/21d on the second dose member and the housing member 14d and an incremental dose setting click is produced by the two-way ratchet l id. When a set dose is injected, the second dose member lOd is moved down and the teeth 20d/21d which are locking the second dose member lOd rotationally to the housing 2d is disengaged and the injection can be carried out. When the first dose member 6d is pressed down, the dosing ratchet 12d is moved down to a lower section of the housing comprising the dosing teeth 49/50, and a clicking sound is produced.

Fig. 11 and 12 shows an embodiment of the pen le according to the invention where the second dose member lOe is better rotationally secured to the first dose member 6e during injection to prevent that unintended relative rotation between the two parts during injection will result in an inaccurate injection. If the embodiment shown in fig. 11 and 12 is combined with the embodiment shown in fig. 8, it is ensured, that the torque needed to restart an unintentionally stopped injection or to carry out an initially priming can be provided manually, by pressing down the dose setting member 7c and rotate in the resetting direction. When a dose is set and the first dose member 6e is rotated, a dose setting click and incrementation is made by the two-way ratchet 1 le in a third dose member 44 which is secured rotationally to the housing via the teeth 20e/21e. The third dose member 44 is also locked rotationally to the second dose member lOe via sets of teeth 42/43. When a set dose is injected, the first dose member 6e and the third dose member 44 is moved down, and the teeth connection to the housing 20e/21e is disconnected, and also the teeth connection 42/43 to the second dose member is disengaged. At the same time, the first dose member 6e is engaging the teeth 42 on the second dose member lOe via corresponding teeth 45 in the first dose member. In this way it is ensured that the first dose member 6e is both set free to rotate to allow the injection, and that it is rotationally secured to the second dose member lOe.

Fig. 13 and 14 shows an embodiment where the scale drum has been left out and where the numbers has been printed on a outer part 55 of the driver 5f instead. This is possible, as the driver 5 f always follows the same helical path due to the engagement with the piston rod 4f and a certain position of the driver 5f therefore corresponds to a certain amount of insulin. Two spokes 54 are connecting the outer part 55 with the driver 5f through two slides 53 in the first dose member 6f, and thereby it is also se- cured, that the driver 5f and the first dose member 6f are rotationally coupled. As can be seen on fig. 14 the first dose member 6f comprises a knob 1 If which cooperates with grooves in the second dose member lOf to provide a tactile and audible feed back when setting a dose and to increment the first dose member 6f at certain positions equally spaced around the centre axis of the pen If. The first dose member 6f and the second dose member lOf move together in axial direction, and as can be seen on fig. 13 the driver 5f is engaging the piston rod 4f via a thread.

On fig. 15 another set-up between the first dose member 6g, the second dose member lOg and the housing 2g can be seen. During dose setting the first dose member 6g and the second dose member lOg are de-coupled and thereby they have no influence on each other. The first dose member 6g is engaging the housing 2g in a two-way ratchet 56/1 lg capable of holding against the torque caused by the spring which tends to rotate the driver 5g and the first dose member 6g due to the thread engagement between the piston rod and the housing member 14g. The second dose member lOg, which does not move axially, is rotationally locked to the piston rod 4g and is engaging the housing 2g with two one-way ratchet arms 12g cooperating with teeth 59 in the housing member 14g. This prevents the piston rod from rotating in one direction, while the resistance in the cartridge prevents it from rotating in the other direction. This is possible because the resulting torque on the piston rod during dose setting is zero. The maximum dose which can be set is reached when the driver 5g hits the end 61 of the guiding slots 60 in the first dose member 6g.

During injection the click connection 56/1 lg between the first dose member and 6g the housing 2g are pushed out of engagement and the teeth 57/58 on first dose member 6g and the second dose member lOg are pushed into engagement, and the dose setting mechanism comprising the first dose member 6g, the second dose member lOg, the driver 5g, the spring and the piston rod is thereby free to rotate due to the thread engagement between the piston rod and the housing member whereby the medicament will be expelled out through the needle.