Intrauterine system and its inserter device

Abstract

The present invention relates to a device comprising an intrauterine system, an inserter for the intrauterine system, and packaging for the inserter, wherein the inserter comprises a handle having a first end and a second end, an insertion tube having a first end and a second end, a first operating means for withdrawing the intrauterine system into the insertion tube, and a second operating means for expelling the intrauterine system from the insertion tube, and the packaging comprises a container, a cover arranged to close the container, and means for activating the first operating means of the inserter.

Description

[Technical field]

[0001] The present invention relates to an apparatus comprising an intrauterine system, an inserter therefor and a package thereof. The present invention also relates to a package for an inserter for an intrauterine system. [Background technology]

[0002] Various kinds of inserters have been developed to place intrauterine systems (IUS) with drug-containing cylinders, as well as mechanical, copper-wire-containing intrauterine devices (IUDs). In the following, IUDs and IUSs can be used interchangeably, and it should be understood that when one is mentioned, either one can be used. Simple rod-like inserters have been proposed to insert relatively small or sufficiently flexible intrauterine devices in their original expanded shape using a simple pushing technique. However, the most common inserters are configured to insert the device into the uterus in a deflated state. These inserters usually include an insertion tube with a relatively small diameter, a rounded blunt end that easily passes through the cervical canal and does not damage or injure the fundus on contact, and a plunger inside the insertion tube. Before insertion, the device, whether IUD or IUS, is usually retracted into the insertion tube by a string attached to the device for removing the device from the uterus, or by using an inserter with a special window that fits the device in its expanded shape, and pushing the device into the insertion tube with the plunger. The insertion tube with the retracted device therein is then inserted through the cervical canal into the uterus. Once the device is properly positioned, it is expelled by pushing the plunger towards the uterus or by holding the plunger steady and retracting the insertion tube outward. Once expelled from the insertion tube within the uterine cavity, the device resumes its original expanded shape.

[0003] An example of a common intrauterine contraceptive device has a T-shaped body made of plastic material, which consists of an elongated body portion having a cross member with two wings at one end. When the device is placed, for example, in the uterus and in an expanded configuration, the elongated member and the cross member form a generally T-shaped part. The tips of these wings are preferably hemispherical to facilitate insertion of the device through the cervical canal. The elongated member has a helical or wire-like copper wire or a hormone capsule arranged around the body. The ends of the longitudinal body portions have loops with strings attached, which allow the device to be removed from the uterus after use or whenever necessary.

[0004] The difficult steps illustrated for the general T-instrument case apply equally to intrauterine systems having other types of frames, such as a figure-of-seven or closed continuous frames.

[0005] During the insertion of the T-shaped intrauterine system, it is extremely important that the hemispherical end of the cross member is exactly in the right position relative to the edge of the insertion tube when the device is inserted into the uterus. If the IUS is pulled into the insertion tube by the removal string, as is usually the case with existing devices, it can be understood that it is difficult to stop the IUS in the right position, especially if the relative movement of the insertion tube and the plunger is not limited by any stop member. If the pulling force is too large, the end of the device will easily enter almost completely into the insertion tube. During insertion of the device, the sharp edges of the insertion tube may prevent the device from being inserted through the cervical canal. On the other hand, if the device is not pulled deep enough into the insertion tube, the frame end will protrude outwards due to the relatively wide width of the insertion tube. At the wing stage, the diameter is too large, making the device more difficult to insert. When the device is pulled into the insertion tube, it is important that it is in the right position, i.e. without damaging the loop, the rest of the body part and the string. If the instrument is retracted into the wrong position within the insertion tube, the edges of the insertion tube can damage the loop or body. If continued retraction does not result in the instrument being in the correct position, the string can cut through the loop or body, which can also cause the instrument to become stuck within the insertion tube.

[0006] In some known inserters, the IUS is not actually drawn into the insertion tube, but rather the insertion tube is moved towards the proximal end of the inserter so as to cover the entire IUS. Thus, if the inserter is provided with a slider, this slider is not moved downwards (i.e. towards the user) as would be intuitively expected, but upwards (i.e. away from the user). If in the case of such an inserter the slider is initially moved in the wrong direction (towards the user), the IUS will be prematurely expelled and therefore unusable. In fact, for obvious hygiene reasons, reassembly of the device is not recommended. It is therefore an object of the present invention to provide a package for an inserter that does not allow the user to make this type of mistake.

[0007] Therefore, some intrauterine systems, for example those with a T-shaped body, cannot be inserted in the patient's uterus in an unfolded state, nor can they be stored for a long time in the inserter with the horizontal arms also inside the tube and ready for insertion. Indeed, if such an intrauterine system is stored for a long time, it cannot properly recover its original intended shape due to the memory effect of the material used for the body, and therefore does not fit properly inside the uterus. Therefore, this kind of intrauterine system is usually stored in a sales package such that all the straight parts of the intrauterine system are stored in the inserter, and the remaining parts of the intrauterine system are retracted into the inserter by the physician just before insertion. This step is considered cumbersome and may lead to the intrauterine system not always being correctly positioned in the insertion tube (insufficient or over-retracted). This may affect the sterility of the insert. Therefore, there is a need to provide a package for the intrauterine system and its inserter that will overcome this problem. Thus, one of the objectives is also to increase the safety of the patient and to improve the ease of use for the physician. Another objective is to provide an arrangement in which the steps that need to be performed by the physician are reduced. Summary of the Invention

[0008] The present specification provides an apparatus comprising an intrauterine system, an inserter for the intrauterine system, and a package for the inserter, an inserter comprising a handle having a first end and a second end, an insertion tube having a first end and a second end, a first operating means for retracting the intrauterine system into the insertion tube, and a second operating means for expelling the intrauterine system from the insertion tube; the package comprises a container, a cover arranged to close the container, and means for actuating a first operating means of the inserter; Regarding the device.

[0009] The present specification also relates to a package for an inserter for an intrauterine system, the package comprising a container, a cover arranged to close the container, and means for activating a first operating means of the inserter to retract the intrauterine system into an insertion tube of the inserter when the inserter is removed from the package. [Brief description of the drawings]

[0010] [Figure 1] 1 illustrates a schematic representation of an inserter according to one embodiment. [Figure 2A] 2 illustrates the operating principle of the inserter of FIG. 1. [Figure 2B] 2 illustrates the operating principle of the inserter of FIG. 1. [Figure 2C] 2 illustrates the operating principle of the inserter of FIG. 1. [Diagram 3] 1 illustrates an apparatus according to one embodiment. [Figure 4] 4 shows an apparatus according to another embodiment. [Figure 5A] 5 illustrates different steps when removing the inserter from the package shown in FIG. 4. [Figure 5B] 5 illustrates different steps when removing the inserter from the package shown in FIG. 4. [Figure 5C] 5 illustrates different steps when removing the inserter from the package shown in FIG. 4. [Figure 5D] 5 illustrates different steps when removing the inserter from the package shown in FIG. 4. [Figure 6] 1 illustrates a locking throttle according to one embodiment. [Figure 7A] 13 shows a locking throttle according to another embodiment. [Figure 7B] 13 shows a locking throttle according to another embodiment. [Figure 7C] 13 shows a locking throttle according to another embodiment. [Figure 7D] 13 shows a locking throttle according to another embodiment. [Figure 8] 1 shows a further embodiment of a locking throttle. [Figure 9A]13 shows another embodiment of a locking throttle. [Figure 9B] 13 shows another embodiment of a locking throttle. [Figure 9C] 13 shows another embodiment of a locking throttle. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The present specification provides an apparatus comprising an intrauterine system, an inserter for the intrauterine system, and a package for the inserter, an inserter comprising a handle having a first end and a second end, an insertion tube having a first end and a second end, a first operating means for retracting the intrauterine system into the insertion tube, and a second operating means for expelling the intrauterine system from the insertion tube; the package comprises a container, a cover arranged to close the container, and a means for actuating a first operating means of the inserter; Regarding the device.

[0012] Thus, the present specification presents a device in which the intrauterine system is automatically loaded into the inserter when it is removed from the package. This effect is obtained by a properly designed package, depending on the structure of the inserter used. The package has a structure that allows easy removal by grasping it with the hand, while keeping the handle in place.

[0013] In this specification and claims, the first end generally means the end closer to the uterus during insertion of the intrauterine system, also called the anterior end. The second end is the end opposite the first end, also called the distal end. The term removal string means one or more strings used to remove the system when the period of use of the system has ended. Thus, there may be one or more such strings, and the term also includes strings that are not used for removal, but are used only to secure the device during insertion.

[0014] According to one embodiment, the means for activating the first operating means of the inserter are shaped to exert a force of 10-30 N on the inserter as it is pulled away from the container. Indeed, the force exerted by the package on the inserter must be large enough to pull the IUS into the inserter, but small enough not to damage the inserter. The force required should also be such that, when removing the inserter from the package, the user can first load the IUD with a relatively small force and then apply a slightly larger force to remove the inserter from the package without damaging it. The package may also comprise means for releasing the means for activating the first operating means once the IUS is correctly positioned in the inserter. An example is given below in relation to a particular example of an inserter.

[0015] The force required to be applied to the inserter can be from 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, or 29 N to 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 N. The force required can be greater depending on the construction and strength of the inserter. Of course, the force required must be small enough not to damage the inserter.

[0016] According to another embodiment, the means for actuating the first operating means of the inserter is a locking throttle arranged in relation to the container of the package. The locking throttle may comprise two parts that rotate relative to each other. For example, the locking throttle may be arranged in a first open position when the inserter is placed in the package and in a second closed position when stored. Such an arrangement would make the packaging easier. The force applied to the inserter when it is removed from the package creates a frictional force large enough to load the IUS into the insertion tube. Thus, the two parts may each have an opening through the thickness, the openings being arranged slightly offset (eccentric) one with respect to the other.

[0017] The locking throttle may also be made of two halves, between which the insertion tube is placed when packaging. Both halves are then attached to each other, for example by glue, by ultrasonic welding or by a snap-lock part. Again, such a locking throttle may make packaging easier. When such a locking throttle is used, it grips the insertion tube sufficiently to move the insertion tube towards the proximal end of the inserter, thereby indirectly actuating the first operating means of the inserter (to retract the intrauterine system into the insertion tube).

[0018] According to one embodiment, the inserter is configured as follows. the inserter handle having a longitudinal opening at a first end, the opening having a longitudinal axis parallel to the longitudinal axis of the inserter; The first operating means is a movable slider disposed within the longitudinal opening and having a first end and a second end; a fixation means for reversibly fixing the intrauterine system to the second operating means; Equipped with the second operating means being a plunger having a first end and a second end and attached to the slider by the second end; An insertion tube is disposed around the plunger; The inserter further comprises fixing means for reversibly fixing the intrauterine system to the plunger via a removal string of the intrauterine system.

[0019] This type of inserter is explained in more detail below. According to one embodiment, said fixing means are controllable by a slider and / or by the insertion tube.

[0020] According to yet another embodiment, the cover is configured to only partially open. The cover can, for example, comprise a tear line whereby the opened portion of the cover is separated from the remaining portion. The cover can also be made of two different materials, and when the package is opened, the openable portion of the cover is detached from the remaining portion.

[0021] According to one embodiment, the container is made of a plastic material. The cover may also be made of a plastic material. Furthermore, one or both of the container and the cover may be made of a fiber-reinforced plastic material. In fact, the material of the container and / or the cover may be, for example, polyethylene, polypropylene, polyester, polyamide, etc. The reinforcing fibers may be, for example, plastic fibers or glass fibers. In particular, the cover may also be made of a nonwoven material, such as a spunbonded nonwoven material or a flash-spun nonwoven material. One such suitable material is sold under the trade name Tyvek®.

[0022] If the container is made of plastic material, it can be manufactured in any suitable manner. For example, it can be thermoformed from a sheet material or it can be made by injection molding. The container may also comprise several parts. For example, it may comprise a cardboard box and a separate part made of plastic material, called the primary package, in which the insert is placed. This primary package is placed inside the box. If no additional box is used, the following description regarding the primary package applies to the container. A cover may be placed to close both the box and the primary package, or both the primary package and the box may have their own covers.

[0023] Thus, the primary package may be formed such that the means for activating the first operating means of the inserter are an integral part of the primary package, or the primary package may comprise separate means for activating the first operating means as an insert placed in the primary package or in the container. The means for activating the first operating means may also be placed around the insertion tube or around the flange if a flange is used. In the latter case, the flange must be designed to be fixed to the insertion tube and must be compressed to be able to move the insertion tube.

[0024] One type of inserter that is particularly suitable for use in this configuration is as described in WO 2010 / 031900, the contents of which are incorporated herein by reference.

[0025] Indeed, one inserter that is particularly suitable for this application comprises a handle, a plunger (second operating means) attached to the handle, a slider (first operating means) and an insertion tube around the plunger, the second end of which is attached to the slider or a means for moving the slider. The inserter also comprises means for reversibly fixing the removal string of the IUS so that the intrauterine system does not move relative to the plunger before and during the necessary steps during insertion, and for releasing the string and the IUS again after the insertion of the IUS is completed. The inserter further comprises an opening in a portion of the handle and a channel through which the insertion tube slides longitudinally.

[0026] Additionally, the insertion tube may include a flange that can be adjusted in distance from the first end of the insertion tube to correspond to the depth of the uterus.

[0027] The portion of the handle closer to the first end of the insertion tube has an opening with a first end and a second end, the opening extending toward the plunger. A surface of the first end of the slider and a surface of the first end of the opening together form a first pair of stop members, and a surface of the second end of the slider and a surface of the second end of the opening together form a second pair of stop members. When inserting the IUS, the slider and the insertion tube can be moved forward until the pair of surfaces contact each other and backward until the pair of surfaces contact each other. A fixing means is disposed within the handle.

[0028] The longitudinal opening of the handle can also be very narrow and need not be symmetrically disposed on the handle with respect to the longitudinal axis. This type of inserter is particularly suitable for use with the package of the present invention, since automatic loading prevents the IUD from being accidentally expelled prior to insertion. In fact, loading of the IUD into the inserter is accomplished by pushing the slider forward, which may be considered counterintuitive by some physicians.

[0029] This type of inserter is used as follows: In the package, the IUS is placed at the first end (i.e. the front end, i.e. the end entering the uterus) of the inserter, so that the elongate member of the device, with the drug-containing reservoir, is inside the insertion tube with the tip of the elongate member abutting the end of the plunger, the means for moving the slider is in the starting or initial position and the removal string in the inserter is tensioned and fixed by the fixing means.

[0030] The package is opened by pulling the cover that closes the container of the package. The cover can be partially or completely opened and the shape of the package is such that the handle can be easily grasped and the inserter can be pulled out of the package. The pulling can be done directly or by slightly lifting the inserter relative to the package. This results in the actuation of the means for activating the first operating means of the inserter, which pulls the slider towards the first end of the insertion tube. The slider is moved towards the first end of the insertion tube until the front face of the slider abuts (at the first end of the opening) against the front face of the opening in the handle, stopping the movement of the insertion tube. At this point, the IUS is substantially inside the insertion tube and is ready for insertion.

[0031] The distance traveled by the slider and insertion tube between the surfaces is designed to approximately correspond to the length of the IUS assembled for insertion. The first end of the insertion tube is stopped at a stage where the hemispherical tips of the wings of the IUS are partially uncovered by the insertion tube, but the wings are still together.

[0032] Thus, the force required to pull the inserter out of the package is greater than the force required to move the slider toward the first end of the insertion tube, but less than the force required to damage the inserter (i.e., for example, the insertion tube becomes detached from the handle). Thus, when the front face of the slider abuts against the front face of the opening in the handle, the inserter can be removed from the package.

[0033] The inserter in this configuration is inserted into the uterus until the IUS is in the correct position (which may be indicated, for example, by means of a flange as described above), after which the device is expelled from the insertion tube. While holding the inserter stationary, the insertion tube is retracted towards the handle by moving the slider rearward until its distal face abuts the distal face of the opening (at the second end) of the handle. The distance that the slider and insertion tube can be moved is selected to clearly indicate the moment when the IUS is fully expelled from the insertion tube moving towards the handle.

[0034] In this embodiment, the package, in particular its container, may also comprise specific means for releasing the means for activating the first operating means of the inserter, for example, when the slider reaches a position against the front end of the opening, the activating means may be mechanically opened, thereby allowing the inserter to be ejected.

[0035] In this embodiment, the means for actuating the first operating means may comprise, for example, a throttle that forces the vanes of the IUS to close and a separate part that holds the throttle in place within the package. This embodiment is particularly useful where the package is made from a thermoformed plastic sheet.

[0036] The handle can have many shapes and is preferably designed to allow easy operation of the inserter even with one hand. The plunger attached to the handle is advantageously hollow or has an axially extending groove or hole, so that the string can slide freely inside the plunger without risk of being pinched between the plunger and the insertion tube. The first or front end of the plunger is preferably suitably shaped, for example with a notch, indentation, eyelet, funnel shape or groove, to fit the lower end of the intrauterine system and to optimally and securely position the intrauterine system on the plunger, minimizing the possibility of damaging the intrauterine system. Thus, the IUS does not twist when being drawn into the insertion tube or during insertion, but assumes a specific and constant configuration when expelled.

[0037] The slider mechanism preferably resides in the handle and comprises at least one elongated element that can be moved in the longitudinal direction of the plunger. According to one embodiment, the slider comprises a means for moving the slider, which is preferably part of the slider, and an insertion tube attached to said means. According to another embodiment, the slider comprises at least two elements, preferably parallel, combined at at least one point by a cross member. The cross member can form a means for moving the slider, for example a knob or a switch. The handle can comprise one or more means for connecting the slider elements and facilitating the movement of the slider, for example a support, a shoulder, a holder, a saddle, a groove or a slot. The slider preferably comprises at least one structural element, for example an extension that can generate the necessary movement of the fastening means to hold the string fixed during storage or during the preparation stage before insertion or during insertion and / or to release the string when the slider is moved to the rear position. In the following description, the term slider is used to refer both to the slider itself and to the means for moving the slider attached to it. Therefore, the term slider is used for convenience of reading.

[0038] The fixing means is any configuration that can fix the removal string to hold the IUS in a stable position and / or release the string to expel the IUS after insertion due to the movement of the slider or the movement of the means for moving the slider and the insertion tube. The fixing means may, for example, conform to those described in WO 2010 / 031900. In particular, the fixing means comprises an object that can at least partially move or pivot from an original position, for example by rotating about an axis or axis, and by being mounted vertically or horizontally with respect to the handle, thereby reversibly preventing and / or allowing the movement of the string. The object can have several shapes, for example round or rod-shaped, wedge-shaped, polygonal, or rectangular with rounded or sharp corners. The surface of the object preferably comprises one or more extensions, for example knobs, ribs or switches, of variable size and shape. When the slider mechanism is moving backwards, at a suitable point, a part or extension of the slider or the insertion tube is pressed against at least one extension of the object, thereby sufficiently changing the orientation of the object relative to its original position to release the string. Preferably, the object has a slot or pinhole through which the string passes. The fixing means may also comprise at least one counterpart against which the string is pressed by the object, so that it is reversibly fixed in a fixed position. The counterpart has a suitable shape adapted to fit at least some parts of the surface of the object. The extension of the object can be used to hold the object and the counterpart in a fixed configuration until the slider is moved backwards to expel the IUS. The counterpart preferably has a suitable design to keep the string in a suitable orientation, e.g. a slot or pinhole through which the string passes. Furthermore, the object and said at least one counterpart preferably have a suitable length and diameter to fit within the handle.

[0039] The intrauterine system used with the device may be any device or system known in the art. Furthermore, any inserter that does not allow for long-term storage of an intrauterine system may be used in conjunction with the device. Indeed, the packaging is suitable for any type of inserter.

[0040] According to one embodiment, the intrauterine system comprises a T-shaped body and an elastomeric capsule containing a therapeutically active agent. According to another embodiment, the intrauterine system comprises a triangular body and at least one capsule containing a therapeutically active agent. The intrauterine system may also comprise two or more capsules, each of which may contain a different therapeutically active agent. Also, one capsule may contain two or more therapeutically active agents. The therapeutically active agent may be any known and useful agent, such as, for example, a contraceptive agent or an agent effective for local release in the uterus.

[0041] The present specification also relates to a package for an inserter for an intrauterine system, the package comprising a container, a cover arranged to close the container, and means for activating a first operating means of the inserter for drawing the intrauterine system into an insertion tube of the inserter when the inserter is removed from the package. The inserter is thus as described above, and the means for activating the first operating means of the inserter has a shape capable of applying a force of 10 to 30 N to the inserter when the inserter is pulled away from the container.

[0042] The present disclosure also relates to a method for placing an intrauterine system in a patient's uterus using a device according to the present disclosure, the method comprising: opening the cover of the package; lifting the inserter handle slightly so that the handle can be properly grasped; withdrawing the inserter from the package, during which the intrauterine system is automatically loaded into the insertion tube; inserting the inserter into the patient's uterus until the intrauterine system is in the correct position; expelling the intrauterine system from the inserter; removing the insert from the patient's uterus; Equipped with.

[0043] The method advantageously includes the further steps of first observing the uterus using the probe and setting the flange accordingly to indicate the correct depth of insertion.

[0044] When using an inserter as described in more detail herein, the IUS is ejected by retracting the slider toward the handle, pulling the inserter rearward, until the second pair of stop members abut one another. Movement of the slider also releases the locking means, thereby releasing the removal string. The distance the slider or insertion tube travels is selected such that at the moved position the IUS is fully ejected from the insertion tube.

[0045] Detailed Description of the Drawings In the following description, the term slider and corresponding reference numbers are used to refer to both the slider itself and the means attached to it for moving the slider. Thus, the term slider is used for ease of reading.

[0046] Figure 1 shows a general view of an inserter according to one embodiment. The inserter comprises a handle 3, a plunger 2 attached to the handle, a slider 5 and an insertion tube 6 around the plunger, the second end of which is attached to the slider or a means for moving the slider. The inserter also comprises a means for reversibly fixing the string (not shown). The inserter further comprises an opening 8 in a portion of the handle, a channel 9 in which the insertion tube slides longitudinally, and a flange 4.

[0047] The handle 3 has an opening 8 with a first end 8a and a second end 8b, which extends towards the plunger 2. A surface of the first end 5a of the slider 5 and a surface of the first end 8a of the opening 8 together form a first pair of stop members, and a surface of the second end 5b of the slider 5 and a surface of the second end 8b of the opening 8 together form a second pair of stop members. The fixing means are not visible as they are located inside the handle 3.

[0048] 2A, 2B and 2C illustrate the principle of operation of the inserter shown in FIG.

[0049] Figure 2A shows the inserter and the T-shaped IUS 1 in the configuration when in a sterile package. The IUS is placed at the first end (i.e. the front end, i.e. the end entering the uterus) of the inserter such that the elongated member of the device with the drug-containing reservoir is inside the insertion tube 6 with the tip of the elongated member abutting the end of the plunger (indicated with reference number 2a). The means for moving the slider 5 is in the starting or initial position and the removal string in the inserter is taut and fixed by a fixing means (not shown).

[0050] 2B shows the first step of the insertion procedure: the insertion tube is moved toward the IUS by pushing the slider forward until surface 5a abuts surface 8a of opening 8 in handle 3, thereby stopping the movement of the insertion tube. This step is performed automatically by the package.

[0051] Figure 2C shows the procedure for expelling the IUS. The device in the configuration according to Figure 2B is inserted into the uterus until the IUS is in the correct position, after which it is expelled from the insertion tube. While holding the inserter stationary, the insertion tube is retracted towards the handle by moving the slider 5 backwards until the surface 5b of the slider abuts the surface 8b of the opening 8 in the handle 3.

[0052] Figure 3 shows the device according to one embodiment. In this figure, the inserter is shown in its packaging. The packaging comprises a container 9, a cover 10, a locking throttle 11 and a fastener 12 for holding the locking throttle 11 in place. The inserter comprises a handle 13, a slider 14 (as a first operating means for drawing the intrauterine system into the insertion tube), an insertion tube 15 and a flange 16. A part of the intrauterine system 17 is also visible below the fastener 12. The cover 10 has been partially opened, preparing the inserter for removal from the packaging.

[0053] Figure 4 shows the device according to another embodiment, in which the cover 18 is in two parts and this figure shows the first part removed, giving access to the majority of the inserter, which can then be grasped by the handle 13 and removed from the container 9.

[0054] Figures 5A to 5D show the different steps of removing the inserter from the package shown in Figure 4. In Figure 5A, the handle 13 of the inserter is slightly lifted out of the container 9. Figures 5B to 5D show the package from the other side, showing how the intrauterine system is being retracted into the insertion tube 19. Indeed, in Figure 5B it can be seen that the wings 20 of the intrauterine system are partially folded towards each other, so that the system is already partially retracted into the insertion tube 19. As can be seen from this figure, the second part of the cover 18 covers the container 9 at the uterine system end of the package. In Figure 5C, the IUS has been retracted further into the insertion tube 19, so that the wings 20 are almost in contact with each other. In Figure 5D, the IUS is in the insertion tube 19 (only the tips of the wings protrude from the insertion tube) and the inserter has already been partially removed from the package.

[0055] Figure 6 shows a locking throttle according to one embodiment, which is designed to be turned by hand while the inserter is in the package. The locking throttle comprises two concentric parts, a larger part 21 and a smaller part 22, the larger part 21 extending inside the smaller part 22, as will be seen in more detail below (in relation to a locking throttle of a different embodiment but with the same working principle).

[0056] Figures 7A-7D show another embodiment of a locking throttle for automatic operation. This locking throttle also comprises two parts, a larger part 23 and a smaller part 24. Figures 7B and 7C show the locking throttle from an end view, with Figure 7B in the open position (the interior of the larger part 23 is not visible) and Figure 7C in the closed position (the interior of the larger part 23 is visible in the opening). Figure 7D shows a cross-section of the locking throttle, where it can be seen that the larger part 23 extends into the smaller part 24.

[0057] Figure 8 shows a further embodiment of a locking throttle. The locking throttle is shown in cross section, with a first portion 25 partially disposed within a second portion 26. As can be seen from this view, the central axis 27 of the first portion 25 is parallel to the central axis 28 of the second portion 26, but the axes 27 and 28 are not aligned. The central axis 29 of the locking throttle is also shown and is located between the central axes of the two portions.

[0058] Figures 9A-9C show another embodiment of the locking throttle. In this embodiment, the locking throttle comprises two parts 30a, 30b, which are attached to each other about a pivot axis, as can be seen in Figure 9A, where the locking throttle is in the open position. One part 30a comprises two projections 31, 32, the other part 30b comprises corresponding openings 33, 34. The projection 32 can be designed to guide the locking throttle to a closed position, and the projection 31, together with the opening 33 of the other part 30b of the locking throttle, can be designed to lock the locking throttle.

[0059] Figure 9B shows the locking throttle in a substantially closed state, i.e., portions 30a and 30b are substantially in contact with one another. The tip of projection 31 is visible through opening 35 (as shown in Figure 9C), and portions 30a and 30b define an opening 36 through the locking throttle. [Explanation of symbols]

[0060] 2 Plunger 2a End of plunger 3 Handle 4 Flanges 5 Slider 5a Surface, first end 5b Surface, second end 6 Insertion tube 8 Openings 8a Surface, first end 8b Surface, second end 9 Channel, vessel 10. Cover 11 Fixed throttle 12 Fixed part 13 Handle 14 Slider 15 Insertion tube 16 Flange 17 Intrauterine System 18 Cover 19 Insertion tube 20 Feather 21 Greater Part 22 Smaller Parts 23 Greater part 24 Smaller Parts 25 First Part 26 Second Part 27 Center axis 28 Center axis 29 Center axis 30a part 30b part 31 Protrusion 32 Protrusion 33 Opening 34 Opening 35 Opening 36 Opening

Claims

1. A device comprising an intrauterine system (1, 17), an inserter for said intrauterine system and a package for said inserter, The inserter comprises: a handle (3, 13) having a first end and a second end; an insertion tube (6, 15, 19) having a first end and a second end; a first operating means (5, 14) for drawing the intrauterine system into the insertion tube (6, 15, 19); and a second operating means for expelling the intra-uterine system from the insertion tube (6, 15, 19), The package comprises a container (9), a cover arranged to close the container, and a locking throttle (11) for locking the inserter to the container, In the apparatus, the inserter handle (3, 13) has a longitudinal opening at the first end, the opening having a longitudinal axis parallel to the longitudinal axis of the inserter; the first operating means comprises a movable slider (5, 14) arranged in the longitudinal opening and having a first end and a second end; a fastening means is arranged inside the handle (3, 13) of the inserter for reversibly fastening the intrauterine system (1, 17) to the second operating means via a removal string of the intrauterine system, a plunger (2) having a first end and a second end and attached to the handle (3, 13) by said second end; The insertion tube (6, 15, 19) is disposed around the plunger (2); 13. The device according to claim 12, wherein the locking throttle (11) of the package is configured to retract the intra-uterine system into the insertion tube (6, 15, 19) when the inserter is removed from the package.

2. 2. The device according to claim 1, wherein the locking throttle (11) of the package has a shape capable of exerting a force of 10 to 30 N on the inserter when the inserter is pulled away from the container (9).

3. 3. The device according to claim 1 or 2, wherein the fixed throttle (11) of the package is a fixed throttle (11) arranged in relation to the container of the package.

4. 2. Apparatus according to claim 1, wherein said fixing means is controllable by said movable slider (5, 14).

5. 2. The device according to claim 1, wherein the fixing means is controllable by the insertion tube (6, 15, 19).

6. 6. Apparatus according to any one of the preceding claims, wherein the cover (10, 18) is adapted to be only partially open.

7. 7. Apparatus according to any one of the preceding claims, wherein the container (9) is made of a plastic material.

8. 8. Apparatus according to any one of the preceding claims, wherein the cover (10, 18) is made of a plastic material.

9. 9. The device according to claim 8, wherein the cover (10, 18) is made of a fiber-reinforced plastic material.

10. 10. The device according to any one of claims 1 to 9, wherein the intrauterine system (1, 17) comprises a T-shaped body and an elastomeric capsule containing a therapeutically active agent.

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