HK40003188B - An arrangement for an intrauterine system and its inserter - Google Patents

Description

Arrangement for an intrauterine system and inserter therefor

Technical Field

The invention relates to an arrangement (arrangement) comprising an intrauterine system (intrauterine system), an inserter (inserter) therefor and a package therefor. The invention also relates to a package for an inserter for an intrauterine system.

Background

Various types of inserters have been developed for positioning mechanical and copper wire containing intrauterine devices (IUDs) and intrauterine systems having drug containing cylinders (IUS). In the following, the IUD and IUS may be used interchangeably and when referring to one, it will be understood that either of them may be used. Simple rod-like inserters have been proposed for inserting intrauterine devices that are relatively small or sufficiently flexible in their original, expanded shape by using simple push-in techniques. However, the most common inserters are configured for introducing the device into the uterus in a contracted state. These inserters typically include: an insertion tube having a relatively narrow diameter and a rounded, blunt end that will easily pass through the cervical canal and will not damage or injure the fundus (fundus) upon contact therewith; and a plunger inside the insertion tube. Prior to insertion, the device (whether an IUD or an IUS) is usually retracted into the insertion tube by means of a string attached to the device and intended to remove the device from the uterus or by pushing the device into the insertion tube by means of a plunger, where the inserter has a specific window for accommodating the device in an expanded shape. The insertion tube with the device therein is then introduced into the uterus through the cervical canal. When the device is correctly positioned, it is released by pushing the plunger towards the uterus or by holding the plunger steady and by retracting the insertion tube outwards. Once expelled from the insertion tube within the uterine cavity, the device should return to its original expanded shape.

A typical example of an intrauterine device has a T-shaped body made of a plastic material and consisting of an elongated body part having at one end a transverse member comprising two wings, the elongated member and the transverse member forming a substantially T-shaped piece when the device is in an expanded configuration, e.g. positioned in the uterus. The tips of these wings are preferably hemispherical to facilitate introduction of the device through the cervical canal. The elongate member has a copper spiral or copper wire or hormone capsule disposed about the body. The end of the vertical body portion has a loop with one or more strings attached thereto by which the device can be removed from the uterus after use or whenever required.

The challenging steps that will be exemplified with the common T-shaped device are also applicable to intrauterine systems having another type of frame, e.g. a 7-shaped or closed, continuous frame.

For insertion into a T-shaped intrauterine system it is of utmost importance that the hemispherical end of the transverse member is in the exact correct position with respect to the edge of the insertion tube when introducing the device into the uterus. If the IUS is pulled into the insertion tube by means of the removal string, which is often the case with prior devices, it will be appreciated that it will be difficult to stop the IUS in the correct position, especially if the relative movement of the insertion tube and the plunger is not limited by any stop members. Pulling with too much force tends to cause the ends to almost fully enter the insertion tube. During insertion of the device, the sharp edges of the insertion tube may interfere with the introduction of the device through the cervical canal. On the other hand, if the device is not drawn deep enough into the insertion tube, the frame end protrudes outward because of the relatively wide insertion tube. The diameter at the level of the wings remains too wide, which makes the introduction of the device more difficult. When the device is pulled into the insertion tube, it is important that the device is in the correct position, i.e. not damaging the loop, the rest of the body or the string. If the device is pulled into the wrong position within the insertion tube, the edge of the insertion tube may damage the ring or the body. If the pulling continues and the device is not turned to the correct position, the string will eventually cut through the ring or body, which may also cause the device to jam within the insertion tube.

Some known inserters do not actually pull the IUS inside the insertion tube, but rather move the insertion tube towards the proximal end of the inserter to cover the entire IUS. Thus, where the inserter includes a slider, the slider is not moved downwardly (i.e., toward the user) but is moved upwardly (i.e., away from the user) as one could intuitively expect. If such an inserter is used, the slide is initially moved to the wrong direction (towards the user), the IUS is prematurely released and therefore unusable. Indeed, reassembly of the device is not recommended for obvious hygienic reasons. It is therefore an object of the present invention to provide a package for an inserter by which the user does not make such mistakes.

Thus, some intrauterine systems (e.g. with a T-shaped body) cannot be inserted not only inside the uterus of a patient in their deployed state, but also for a long time inside the inserter in a state where the horizontal arm is also inside the tube ready for insertion. Indeed, if such an intrauterine system is stored for an extended period of time, due to the memory effect of the material used by the body, the intrauterine system may not properly return to its original and intended shape and thus be improperly loaded inside the uterus. Therefore, such intrauterine systems are usually stored in the way they are sold in packages: that is, any straight part of the intrauterine system is stored inside the inserter, while the remaining part of the intrauterine system is withdrawn inside the inserter by the physician immediately before insertion. This step may be considered cumbersome and may result in the intrauterine system not being positioned completely correctly inside the insertion tube (not enough or too much). This may have an impact on the sterility of the implant. Therefore, there is a need to provide a package for an intrauterine system and an inserter therefor that overcomes this problem. It is therefore also an object to increase patient safety and ease of use for the physician. Another object is to provide an arrangement that reduces the steps required to be performed by a physician.

Disclosure of Invention

The present description relates to an arrangement comprising an intrauterine system, an inserter for the intrauterine system and a 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 manipulation device for withdrawing the intrauterine system inside the insertion tube; and a second manipulation device for expelling the intrauterine system from the insertion tube, and

-the package comprises: a container; a lid arranged to close the container; and means for acting on the first handling means of the inserter.

The present description also relates to a package for an inserter for an intrauterine system. The package comprises: a container; a lid arranged to close the container; and means for acting on a first handling means of the inserter for withdrawing the intrauterine system inside the insertion tube of the inserter when removing the inserter from the package.

Drawings

Fig. 1 schematically illustrates an interposer according to one embodiment.

Fig. 2A-2C illustrate the operating principle of the interposer of fig. 1.

Fig. 3 illustrates an arrangement according to one embodiment.

Fig. 4 illustrates an arrangement according to another embodiment.

Fig. 5A-5D illustrate different steps of removing the inserter from the package as illustrated in fig. 4.

FIG. 6 illustrates a locking throttle valve according to one embodiment.

Fig. 7A-7D illustrate a locking throttle valve according to another embodiment.

FIG. 8 illustrates yet another embodiment of a locking throttle.

Fig. 9A-9C illustrate another embodiment of a locking throttle.

Detailed Description

The present description relates to an arrangement comprising an intrauterine system, an inserter for the intrauterine system and a 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 manipulation device for withdrawing the intrauterine system inside the insertion tube; and a second manipulation device for expelling the intrauterine system from the insertion tube, and

-the package comprises: a container; a lid arranged to close the container; and means for acting on the first handling means of the inserter.

Thus, the present description presents an arrangement in which the intrauterine system is automatically loaded into the inserter when the inserter is removed from the packaging. This effect is achieved by a suitably designed package, depending on the configuration of the inserter used. The package has a structure that holds the handle in place but allows for easy removal of the handle by grasping it by hand.

In the present description and claims, the first end generally means the end closer to the uterus during insertion of the intrauterine system, also referred to as the front end. The second end is the end opposite the first end, also referred to as the distal end. The term "removal string" means one or more strings used to remove the system once it has reached the end of its useful time. Thus, there may be one or more such cords, and this term also encompasses cords that are not used for removal but only for locking the device during insertion.

According to one embodiment said means for acting on the first handling means of the inserter comprises a form capable of exerting a force of 10N-30N on the inserter when the inserter is pulled away from the container. In practice, the force exerted by the package on the inserter should be both large enough to pull the IUS inside the inserter, but small enough to avoid damaging the inserter. The required force should also be such that the user first needs to exert only a relatively small force to load the IUD when removing the inserter from the package, and then exert a slightly greater force to remove the inserter from the package without damaging the inserter. The package may also comprise means for releasing the means acting on the first handling means once the IUS is correctly positioned inside the inserter. One embodiment is given below in conjunction with a specific embodiment of the interposer.

The force required to be exerted on the inserter may be from 10N, 11N, 12N, 13N, 14N, 15N, 16N, 17N, 18N, 19N, 20N, 21N, 22N, 23N, 24N, 25N, 26N, 27N, 28N or 29N up to 11N, 12N, 13N, 14N, 15N, 16N, 17N, 18N, 19N, 20N, 21N, 22N, 23N, 24N, 25N, 26N, 27N, 28N, 29N or 30N. The force required may also be higher depending on the structure and strength of the inserter. The required force naturally needs to be low enough so as not to cause any damage to the inserter.

According to another embodiment said means for acting on the first handling means of the inserter is a locking throttle arranged in connection with 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 the first open position when the inserter is packaged and turned to the second closed position for storage. Such an arrangement will make the packaging operation easier. The force exerted on the inserter when removing the inserter from the package then generates a friction force which is high enough to load the IUS inside the insertion tube. Thus, the two portions may each have one opening through their thickness, and the openings may be arranged slightly off-line (off-center) one with respect to the other.

The locking throttle can also be made of two halves, between which the insertion tube is arranged during packaging. The halves are then attached to each other, for example by gluing, by ultrasonic welding or by snap locking parts. Furthermore, such a locking throttle will make packaging easier. In case such a locking throttle is used, it has a sufficiently tight grip on the insertion tube such that it forces the insertion tube to move towards the proximal end of the inserter, thus acting in an indirect way on the first handling means of the inserter (for withdrawing the intrauterine system inside the insertion tube).

According to one embodiment, the inserter is as follows:

the handle of the inserter has a longitudinal opening at its first end, said opening having a longitudinal axis parallel to the longitudinal axis of the inserter,

-the first manipulating device comprises:

-a movable slide arranged in said longitudinal opening and having a first end and a second end, an

-locking means for reversibly locking the intrauterine system with respect to the plunger,

the second manipulating means is a plunger having a first end and a second end, the plunger being attached to the slide by its second end,

-the insertion tube is arranged around the plunger and;

the inserter further comprises a locking means for reversibly locking the intrauterine system with respect to the plunger via a removal string of the intrauterine system.

This type of interposer is discussed in more detail below. According to one embodiment, said locking means can be controlled by the slider and/or the insertion tube.

According to yet another embodiment, the lid is arranged to be only partially opened. The lid may, for example, include a perforation line where the open portion of the lid is disengaged from the remaining portion. The lid may also be made of two different materials, wherein the openable portion is detached from the rest of the lid when the package is opened.

According to one embodiment, the container is made of a plastic material. The cover may also be made of a plastic material. Further, either or both of the container and the lid may be made of a fibre reinforced plastics material. In practice, the material of the container and/or the lid 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 spunbond nonwoven material or a flash spun nonwoven material. One such suitable material is known under the trade nameAnd (4) selling.

When made of a plastic material, the container may be manufactured in any suitable manner. For example, it may be thermoformed from a sheet of material, or it may be made by injection molding. The container may also comprise several parts. For example, it may consist of a cardboard box and a separate part, called the main packaging, on which the inserter is arranged, made of plastic material. The primary package is disposed within a box. The following discussion of the primary package applies to the container without the use of an added cartridge. The lid may be arranged to close the box and the primary package, or both the primary package and the box may have their own lid.

Thus, the primary package may be formed such that said means for acting on the first handling means of the inserter is an integral part of the primary package, or the primary package may comprise separate means for acting on the first handling means as an insert on the primary package or the container to be arranged. The means for acting on the first handling means may also be arranged around the insertion tube or, if a flange is used, around the flange. For the latter option, the flange needs to be designed such that it is fixed on the insertion tube and needs to be compressed to be able to move it.

One type of inserter that is particularly suitable for use in the present arrangement is as described in WO2010/031900, the contents of WO2010/031900 being incorporated herein by reference.

Indeed, an inserter particularly suitable for use in the present description comprises a handle, a plunger (second manipulator) attached to the handle, a slide (first manipulator), an insertion tube surrounding the plunger, the second end of the insertion tube being attached to the slide or means for moving the slide. The inserter further comprises means for reversibly locking the removal string of the intrauterine system in such a way that the IUS remains immobile relative to the plunger during the necessary steps before and during insertion, and again for releasing the string and the IUS after the IUS has been inserted. The inserter also includes an opening in a portion of the handle and a channel within which the insertion tube slides in a longitudinal direction.

Furthermore, the insertion tube may comprise a flange, which may be adjusted such that its distance from the first end of the insertion tube corresponds to the depth of the uterus.

The portion of the handle adjacent the first end thereof has an opening with a first end and a second end, the opening extending in the direction of the plunger. The surfaces of the first end of the slider and the surfaces at the first end of the opening together form a first pair of stop members and the surfaces of the second end of the slider and the surfaces at the second end of the opening together form a second pair of stop members. When inserting the IUS, the slider and the insertion tube may be moved forward until the surfaces contact each other, and moved backward until the surfaces contact each other. The locking device is arranged inside the handle.

The longitudinal opening in the handle may also be very narrow and need not be positioned symmetrically and relative to the longitudinal axis on the handle. This type of inserter is particularly suitable for use with the present package, as the automatic loading prevents the IUD from being accidentally released prior to insertion. Indeed, since loading of the IUD inside the inserter is done by pushing the slider forward, it may be seen as not intuitive by some physicians.

This type of inserter is used as follows. Within the package, the IUS is placed in the first end (i.e. the front end, i.e. the end that enters the uterus) of the inserter such that the elongate member of the device with the drug containing reservoir is inside the insertion tube, wherein the tip of the elongate member abuts the end of the plunger. The means for moving the slider are in a starting or initial position and the removal string inside the inserter is tightened and locked by the locking means.

The package is opened by pulling on a lid of a container closing the package. The lid may be partially or fully open and the shape of the package is such that the handle can be easily grasped and the inserter pulled out of the package. The pull-out position may be a direct pull, or it may require slightly raising the inserter relative to the package and pulling the inserter. Thus, the means for acting on the first manipulating means of the inserter come into action and pull the slide towards the first end of the insertion tube. The slider is moved toward the first end of the insertion tube until the front surface of the slider abuts the front surface of the opening of the handle (at the first end of the opening), thereby stopping the movement of the insertion tube. At this point, the IUS is substantially within the insertion tube and ready for insertion.

The distance the slider and the insertion tube move between these surfaces has been designed to substantially correspond to the length of the IUS assembled for insertion. The first end of the insertion tube is stopped at such a level that: the hemispherical tip of the wings of the IUS remains partially uncovered by the insertion tube while the wings remain together.

The force required to withdraw the inserter from the package is thus greater than the force required to move the slider towards the first end of the insertion tube, but less than the force required to break the inserter (i.e. e.g. the insertion tube will be detached from the handle). Thus, the inserter can be removed from the package when the front surface of the slider has abutted the front surface of the opening of the handle.

The inserter in this configuration is introduced into the uterus until the IUS is in the correct position (this may be shown for example by means of a flange as mentioned above), at a point after the device is released from the insertion tube. While holding the inserter stationary, the insertion tube is retracted toward the handle by moving the slider rearwardly until the distal surface of the slider abuts the open distal surface of the handle (at the second end of the handle). The distance the slider and the insertion tube can be moved can be chosen to clearly indicate the moment when the IUS is fully released from the insertion tube moving towards the handle.

For this embodiment, the package and in particular the container thereof may further comprise specific means for releasing the means acting on the first manipulation means of the inserter. This may mechanically open the means for acting and thus release the inserter, for example when the slider reaches its position abutting the front end of the opening.

In this embodiment, the means for acting on the first actuation means may comprise, for example, a throttle valve forcing the IUS to swing closed and a separate part holding the throttle valve in its position within the package. This embodiment is particularly useful if the package is made of thermoformed plastic sheet material.

The handle may have many shapes and is preferably designed to enable easy manipulation of the inserter even with only one hand. The plunger attached to the handle is advantageously hollow or has a groove or hole extending in the axial direction, allowing the cords to slide freely therein without any risk of them getting stuck between the plunger and the insertion tube. The first end (i.e. the front end of the plunger) is preferably suitably shaped with e.g. notches, indentations, eyelets, funnels or grooves to accommodate the lower end of the intrauterine system and to achieve an optimal and safe positioning of the intrauterine system on the plunger to minimize the possibility of damaging the intrauterine system. Thus, the IUS will not twist as it is being pulled within the insertion tube or during insertion, and will assume a specified constant configuration when released.

The slider mechanism is preferably inside the handle and comprises at least one elongated element which can be moved in the longitudinal direction of the plunger. According to one embodiment, the slider comprises means for moving the slider, which means is preferably part of the slider, and the insertion tube is attached to the means. According to another embodiment, the slider comprises at least two elements, preferably parallel, which are combined at least one point by a cross member. The cross member may form means by which the slider may be moved, such as a knob or switch. The handle may include one or more means for connecting the slider elements and facilitating movement of the slider, such as a support, shoulder, retainer, saddle, groove, or slot. The slider preferably comprises at least one structural element, for example an extension, capable of generating the operations necessary for the locking means to keep the cord fixed during storage or during a preliminary step before insertion or during insertion and/or to release the cord when the slider is moved to the rearward position. In the following description, the term slider is used to designate both the slider itself and the means attached to it for moving it. Thus, the term slider is used for ease of reading.

The locking means is any arrangement that by movement of the slider or the means for moving the slider and the insertion tube triggers that the removal string may be secured to hold the IUS in a stable position and/or to release the string after insertion to release the IUS. The locking means may be, for example, according to what has been described in WO 2010/031900. In particular, the locking device comprises an object which is reversibly prevented and/or allowed movement of the cord and which is attached to the handle vertically or horizontally by being at least partially moved or pivoted (e.g. rotated about an axis or axis) from an original position. The object may have several shapes and may be, 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 of variable size and shape, such as knobs, ribs or switches. When the slider mechanism is moved backwards, at a suitable point, a part or extension of the slider or insertion tube is pressed against at least one extension of the object, sufficiently to change its orientation with respect to the original position to cause release of the cord. Preferably, the object has a slot or pinhole through which the cord extends. The locking device may also comprise at least one counterpart against which the string is pressed by the object and is thus reversibly secured in the locking position. The counterpart has a suitable shape adapted to fit at least a part of the surface of the object. One or more extensions of the object may be used to hold the object and the counterpart in a fixed configuration until the slide is moved backwards to release the IUS. The counterpart preferably has a suitable design for keeping the cord in the correct orientation, such as a slot or a pinhole through which the cord extends. Furthermore, the object and the at least one counterpart preferably have a suitable length and diameter to fit inside the handle.

The intrauterine system used in the present arrangement may be any device or system known in the art. Furthermore, any inserter in which the intrauterine system cannot be stored for an extended period of time within the inserter may be used in conjunction with the present arrangement. In fact, the package is suitable for any type of inserter.

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 further comprise more than one capsule and each capsule may comprise a different therapeutically active agent. A capsule may also include more than one therapeutically active agent. The therapeutically active agent is any agent known and useful such as, for example, a contraceptive or an agent that benefits from local release in the uterus.

The present description also relates to a package for an inserter for an intrauterine system. The package comprises: a container; a lid arranged to close the container; and means for acting on a first handling means of the inserter for withdrawing the intrauterine system inside the insertion tube of the inserter when removing the inserter from the package. Thus, the inserter is as described above and said means for acting on the first handling means of the inserter comprises a form of force capable of applying a force of 10N-30N to the inserter when the inserter is pulled away from the container.

The present description also relates to a method for positioning an intrauterine system in the uterus of a patient, wherein the method uses an arrangement according to the present description. The method comprises the following steps:

-opening the lid of the package,

slightly raising the handle of the inserter in order to be able to grasp it correctly,

-pulling the inserter out of the packaging, during which pulling the intrauterine system is automatically loaded inside the insertion tube,

-introducing an inserter into the uterus of a patient until the intrauterine system is in its correct position,

-releasing the intrauterine system from the inserter,

-removing the inserter from the uterus of the patient.

The method advantageously includes the further step of probing the uterine depth with the probe at its start and setting the flange accordingly to show the correct insertion depth.

When using an inserter as explained in more detail in this specification, the IUS is released by pulling the IUS back, by retracting the slider all the way towards the handle until the second pair of stop members are together. Movement of the slider also releases the locking means and thus the removal string. The distance the slider or the insertion tube is moved may be selected such that at this point the IUS has been completely released from the insertion tube.

Detailed description of the drawings

In the following description, the term slide and corresponding reference numerals are used to designate the slide itself and the means attached to it for moving it. Thus, the term slider is used for ease of reading.

FIG. 1 illustrates a general overview of an interposer, according to one embodiment. The inserter comprises a handle 3, a plunger 2 attached to the handle, a slide 5, an insertion tube 6 surrounding the plunger, the second end of the insertion tube being attached to the slide or means for moving the slide. The inserter also comprises means for reversibly locking the string (not shown). The inserter further comprises an opening 8 in a part of the handle, a channel 9 within which the insertion tube slides in the longitudinal direction, and a flange 4.

The handle 3 has an opening 8, which opening 8 has a first end 8a and a second end 8b, which opening extends in the direction of the plunger 2. The surface of the first end 5a of the slide 5 and the surface at the first end 8a of the opening 8 together form a first pair of stop members and the surface of the second end 5b of the slide 5 and the surface at the second end 8b of the opening 8 together form a second pair of stop members. The locking means is arranged inside the handle 3 and is therefore not visible.

Fig. 2A, 2B and 2C illustrate the operating principle of the inserter shown in fig. 1.

Fig. 2A shows the inserter and T-shaped IUS 1 in one configuration when the inserter and T-shaped IUS 1 are in sterile packaging. The IUS is placed in the first end (i.e. the front end, i.e. the end that enters the uterus) of the inserter such that the elongate member of the device with the reservoir containing the drug is inside the insertion tube 6, wherein the tip of the elongate member abuts the end of the plunger (shown with reference numeral 2 a). The means for moving the slider 5 is in the starting or initial position and the removal string inside the inserter is tightened and locked by locking means (not shown in this figure).

Fig. 2B illustrates a first step of the plug-in procedure. The movement of the insertion tube is stopped by pushing the slider forward to move the insertion tube towards the IUS until the surface 5a abuts the surface 8a of the opening 8 of the handle 3. This step is performed automatically by the present package.

Fig. 2C illustrates a procedure of releasing the IUS. The device in the configuration according to figure 2B is introduced into the uterus until the IUS is in the correct position, after which the device is released 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 of the handle 3.

Fig. 3 illustrates an arrangement according to one embodiment. In this figure, the inserter is shown within its packaging. The package comprises a container 9, a lid 10, a locking throttle 11 and a locking portion 12 for holding the locking throttle 11 in its position. The inserter comprises a handle 13, a slide 14 (as first handling means for withdrawing the intrauterine system inside the insertion tube), an insertion tube 15 and a flange 16. A part of the intrauterine system 17 is also visible below the locking part 12. The lid 10 has been partially opened and the inserter is ready to be removed from the package.

Fig. 4 illustrates an arrangement according to another embodiment. In this embodiment, the cover 18 is divided into two parts and this figure illustrates the moment when the first part has been removed making most of the inserter accessible. At this point, the inserter may be grasped by inserter handle 13 and removed from container 9.

Fig. 5A-5D illustrate different steps of removing the inserter from the package as illustrated in fig. 4. In fig. 5A, the handle 13 of the inserter is slightly raised from the container 9. Fig. 5B to 5D show the package from the other side and illustrate how the intrauterine system is extracted inside the insertion tube 19. In fact, in fig. 5B it can be seen that the intrauterine system has been partially withdrawn inside the insertion tube 19, since the wings 20 of the system have been partially folded towards each other. As can be seen from this figure, the second part of the lid 18 covers the container 9 at this end of the package. In fig. 5C, the wings 20 almost touch each other when the IUS is further withdrawn inside the insertion tube 19. In fig. 5D, the IUS is inside the insertion tube 19 (where only the tip of the wings protrude from the insertion tube) and the inserter has been partly removed from the package.

FIG. 6 illustrates a locking throttle valve according to one embodiment. In this embodiment, the locking throttle is designed to be turned by hand during packaging of the inserter. The locking throttle comprises two concentric parts, a larger part 21 and a smaller part 22, whereas the larger part 21 extends inside the smaller part 22, as can be seen in more detail below (in connection with a locking throttle according to another embodiment but using the same working principle).

Fig. 7A-7D illustrate a locking throttle valve according to another embodiment for automated processing. The locking throttle also comprises two parts-a larger part 23 and a smaller part 24. Fig. 7B and 7C illustrate the locking throttle as seen from its end, fig. 7B in its open position (where the inside of the larger portion 23 is not visible) and fig. 7C in its closed position (where the inside of the larger portion 23 is visible in the opening). Fig. 7D shows a cross section of the locking throttle, wherein it can be seen that the larger part 23 extends inside the smaller part 24.

FIG. 8 shows yet another embodiment of a locking throttle. The locking throttle is shown in a cross-sectional view, wherein the first portion 25 is partially arranged inside the second portion 26. As can be seen, 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 illustrated and positioned between the central axes of the two parts.

Fig. 9A-9C illustrate another embodiment of a locking throttle. In this embodiment, the locking throttle comprises two portions 30a and 30b attached to each other about a pivot axis, as seen in fig. 9A, with the locking throttle in the open position. One part 30a comprises two projections 31 and 32 and the other part 30b comprises corresponding openings 33 and 34. The projection 32 may be designed to guide the closing of the locking throttle and the projection 31 with its opening 33 in the other part 30b of the locking throttle may be designed to lock the throttle.

Fig. 9B shows the locking throttle valve almost closed, i.e. the portions 30a and 30B almost contact each other. The tip of the tab 31 will be visible in the opening 35 (as illustrated in fig. 9C), and the portions 30a and 30b will define an opening 36 through the locking throttle.

Claims (11)

1. An arrangement comprising an intrauterine system, an inserter for the intrauterine system and a package 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 handling device for withdrawing the intrauterine system inside the insertion tube; and a second manipulation device for expelling the intrauterine system from the insertion tube, and

-the package comprises: a container; a lid arranged to close the container; and means for acting on the first manipulating means of the inserter;

it is characterized in that

-the handle (3,

-the first manipulating device comprises:

-a movable slide (5

-locking means for reversibly locking the intrauterine system with respect to the plunger (2),

the second handling means is a plunger (2) having a first end and a second end, the plunger being attached by its second end to the slide (5,

-the insertion tube (6

The inserter further comprises locking means for reversibly locking the intrauterine system (1.

2. An arrangement according to claim 1, characterised in that the locking throttle (11) comprises a form capable of exerting a force of 10N-30N on the inserter when the inserter is pulled away from the container (9).

3. An arrangement according to claim 1, characterized in that the means for acting on the first operating means of the inserter is a locking throttle (11) arranged in connection with the container of the package.

4. An arrangement according to claim 2, characterized in that the means for acting on the first operating means of the inserter is a locking throttle (11) arranged in connection with the container of the package.

5. An arrangement according to claim 1, characterised in that the locking means can be controlled by the slide (5.

6. An arrangement according to claim 1, characterised in that the locking means are controllable by the insertion tube (6.

7. An arrangement according to any one of the preceding claims, characterised in that the cover (10.

8. An arrangement according to any of claims 1-6, characterized in that the container (9) is made of plastic material.

9. An arrangement according to any one of claims 1-6, characterised in that the cover (10.

10. An arrangement according to claim 9, characterised in that the cover (10.

11. An arrangement according to any of claims 1-6, characterized in that the intrauterine system (1.