EA045214B1 - INTRAUTERINE SYSTEM WITH LOCK PART - Google Patents

Description

Field of technology

The present invention generally relates to long-acting reversible contraceptive systems, and in particular to intrauterine systems. In addition, the present invention relates to kits including an intrauterine system and an insertion device.

State of the art

An intrauterine system (IUD) or intrauterine device (IUD) is usually inserted into the uterus using an insertion device to prevent unwanted pregnancy, plan a family, or treat a medical condition. The following abbreviation is used: IUD, which covers both intrauterine systems and intrauterine devices. Proper functioning of the IUD depends on the configuration of the IUD and the precise placement of the IUD in the uterus.

A regular IUD requires an insertion tube that passes through the cervix during insertion. Indeed, in conventional IUDs available on the market and disclosed in the prior art, a drug (hormone)-containing capsule is located inside the insertion tube during the insertion procedure. As a consequence, the cross-sectional diameter of what must pass through the cervix is equal to the diameter of the capsule and two thicknesses of the inserted tube.

Additionally, when inserting a conventional IUD using an insertion device, there is a risk of penetration of the uterus during insertion. Indeed, if the insertion procedure is performed by an inexperienced doctor or the size of the uterus was incorrectly determined at the probing stage, the insertion device may pierce the wall of the uterus or even perforate it.

It is assumed that the pain and discomfort experienced during the insertion procedure is caused by stretching of the cervical canal. Thus, in light of the above, there is a need to overcome the above-mentioned disadvantages associated with conventional IUDs.

Brief description of the invention

The present invention relates to an intrauterine system (IUD). The present invention also relates to a kit comprising an IUD and an insertion device. The purpose of the present invention is to solve the existing problem of pain and discomfort experienced by a subject during insertion of an IUD. Also, one of the objectives of the present invention is to reduce the diameter of the parts that must pass through the cervical canal during the process of inserting the IUD. Another object of the invention is to provide a new IUD and insertion device that reduces the risk of uterine penetration during insertion.

The purpose of the present invention is to provide a solution that at least partially overcomes the problems encountered in the prior art and provides an improved IUD that is highly flexible, thereby increasing patient acceptability and providing a relatively more comfortable experience during IUD insertion. through the cervical canal and final placement in the uterus, compared to existing systems.

In one aspect, one embodiment of the present invention is an intrauterine system, including a frame having a first end, a second end, and a length L defined as a distance from the first end to the second end;

a removal thread attached to the first end of the frame; and at least one pharmaceutically active agent;

wherein the first end of the frame includes a first lock portion, and the second end of the frame includes a second lock portion, the first lock portion and the second lock portion are configured to form a lock, and the removal thread is configured to guide the first lock portion into the second lock portion.

In another aspect, one embodiment of the present invention is a kit including an intrauterine system and an insertion device, wherein the insertion device includes a handle body having a distal end, a proximal end, and a length Lh defined as the distance between the distal end and the proximal end;

a sizing tube having a distal end and a proximal end, the proximal end thereof being movably attached to a distal end of the handle body, provided that the sizing tube is configured to remain outside the cervical canal during insertion;

a plunger having a distal end, a proximal end, a length Lp, specified as the distance between the distal end and the proximal end, wherein the plunger is movably located inside the handle body and the sizing tube, where the length Lp is greater than the length Lh;

a flange movably located around the dimension tube;

a finger holder movably located around the handle body; and a means for reversibly fixing the intrauterine system removal thread located on the handle body.

Embodiments of the present invention substantially eliminate or at least partially eliminate the above-mentioned problems of the prior art and allow the described IUD to be conveniently used for efficient and convenient insertion into the uterine cavity. Described IUD

- 1 045214 has a small cross-sectional area, which minimizes discomfort and pain during its insertion through the cervix. The described IUD is adapted to various drug loads and doses, which opens up prospects for its use not only as a means of contraception. The disclosed IUD is also suitable for insertion without the need for any part of the insertion device to pass through the cervix having a larger cross-sectional diameter than the capsule, thereby reducing the diameter of what actually passes through the cervix.

The IUD of the present invention can be inserted without the need to retract the drug capsule into the insertion tube. Therefore, the diameter of the object that must pass through the cervical canal during the insertion procedure of the present invention is reduced by two times the wall thickness of the insertion tube of conventional insertion devices. Indeed, for insertion of the present IUD, the insertion device may be such that no part of the insertion device having a cross-sectional diameter greater than the largest diameter of the IUD is inserted into the cervical canal (and therefore into the uterus).

Another advantage of the IUD of the present invention is that the risk of uterine penetration during the insertion procedure is minimized since there is no insertion tube that could penetrate the uterine muscle if inserted too deeply. In addition, the IUD as such cannot penetrate inside, since it immediately begins to form its final shape after passing through the cervical canal.

Additional aspects, advantages, features and objects of the present invention will become apparent from the drawings and detailed description of the illustrative embodiments when taken in conjunction with the appended claims that follow.

It should be noted that the features of the present invention may be combined in various combinations without departing from the scope of the present invention as defined by the appended claims.

Brief description of drawings

The foregoing summary, as well as the following detailed description of illustrative embodiments of the invention, can best be understood when read in conjunction with the accompanying drawings. To illustrate the present invention, exemplary structures of the invention are shown in the drawings. However, the present invention is not limited to the specific methods and tools disclosed herein. Additionally, those skilled in the art will recognize that the drawings are not to scale. Where possible, identical elements are identified by identical numbers.

Embodiments of the present invention will now be described, by way of example only, with reference to the following drawings, in which: FIG. 1 is a perspective view of an IUD in a loaded configuration in accordance with one embodiment of the present invention;

in fig. 2 shows a schematic view of the IUD of FIG. 1 in accordance with one embodiment of the present invention;

in fig. 3 is a schematic view of an IUD in accordance with another embodiment of the present invention;

in fig. 4A is a schematic view of an IUD in a tucked configuration in accordance with another embodiment of the present invention;

in fig. 4B is a perspective view of the IUD of FIG. 4A in a loaded configuration in accordance with one embodiment of the present invention;

in fig. 4C is a cross-sectional view of the IUD of FIG. 4A in an unfolded state in accordance with one embodiment of the present invention;

in fig. 4D is a perspective view of the IUD of FIG. 4A in an unfolded state, in accordance with various embodiments of the present invention;

in fig. 5 is a perspective view of an IUD in accordance with another embodiment of the present invention; and in fig. 6A-6D are schematic illustrations of a frame and IUD in accordance with an embodiment of the invention;

in fig. 7A-7C are perspective views of an assembled and disassembled insertion device, respectively, and a detail view of an IUD, in accordance with an embodiment of the present invention;

in fig. 8A is a perspective view of a piston and plunger assembly of an injection device in accordance with one embodiment of the present invention;

in fig. 8B is a cross-sectional view of a piston and plunger assembly with piston engaging parts of an injection device in accordance with an embodiment of the present invention;

in fig. 9A to 9C are a schematic view of an insertion device with enlarged views showing the internal structure of various portions of the insertion device, in accordance with an embodiment of the present invention;

in fig. 10A-10I are various views of the injection device, depicting various

- 2 045214 operating steps for placing an IUD in the uterus, in accordance with various embodiments of the present invention;

in fig. 11A and 11B show an assembled and disassembled introduction device, respectively, in accordance with another embodiment of the present invention.

In the accompanying drawings, the unemphasized number refers to an element indicated by a line connecting the unemphasized number to the element. When the number is not underlined and is accompanied by a corresponding arrow, the non-underlined number usually identifies the common element that the arrow is pointing to.

Detailed Description of Embodiments

The following detailed description illustrates embodiments of the present invention and methods in which they may be implemented. Although only some embodiments of the present invention have been disclosed, those skilled in the art will understand that other embodiments or practices of the present invention are possible.

In one aspect, one embodiment of the present invention is an intrauterine system, including a frame having a first end, a second end, and a length L defined as a distance from the first end to the second end;

a removal thread attached to the first end of the frame; and at least one pharmaceutically active agent;

wherein the first end of the frame includes a first lock portion and the second end of the frame includes a second lock portion, wherein the first lock portion and the second lock portion are configured to form a lock, wherein the removal thread is configured to guide the first lock portion into the second lock portion.

In another aspect, one embodiment of the present invention is a kit including an intrauterine system and an insertion device, wherein the insertion device includes a handle body having a distal end, a proximal end, and a length Lh defined as the distance between the distal end and the proximal end;

a sizing tube having a distal end and a proximal end, the proximal end thereof being movably attached to a distal end of the handle body, provided that the sizing tube is configured to remain outside the cervical canal during insertion;

a plunger having a distal end, a proximal end, a length Lp, specified as the distance between the distal end and the proximal end, wherein the plunger is movably located inside the handle body and the sizing tube, where the length Lp is greater than the length Lh;

a flange movably located around the dimension tube;

a finger holder movably located around the handle body; and means for reversibly fixing the intrauterine system removal thread located on the handle body.

The present invention relates to the above-mentioned IUD and the above-mentioned kit comprising the IUD and an insertion device, which allows the IUD to be inserted into the uterus effectively and conveniently. The IUD is straightened when inserted into the insertion device (by the manufacturer) and restores its required shape when inserted into the uterine cavity (i.e. in an expanded state) using locking parts. Moreover, when deployed, the deployed IUD takes on a smooth shape, such as a triangular shape, a ring shape, or a round shape. This smooth shape of the IUD not only ensures proper placement of the IUD in the uterus, but also reduces the risk of potential perforation of the uterine lining. Moreover, the frame segments, bend segments, and locking portions of the IUD allow the IUD to achieve the desired continuous, smooth shape when deployed. A definite advantage is that the aforementioned IUD provides an intuitive insertion experience for the healthcare professional. In addition, the above-mentioned insertion device of the kit allows for an increase in the overall success rate of IUD insertion without causing any or only minimal discomfort to the subject. Moreover, the risk of uterine penetration during insertion is minimized because the insertion device does not include an insertion tube that enters the uterine cavity.

The IUD includes a frame. The frame has a flexible tubular structure designed to adapt to the anatomical structure of the cervical region as well as the uterine cavity. The flexible structure allows the frame to easily bend into a shape and withstand the deformation and stress associated with that shape. For example, the framework may be stretched to a nearly straight line (ie, a straightened configuration) during insertion of the IUD by the aforementioned insertion device (or other suitable insertion device) and is shaped when positioned in the uterine cavity by the locking portions. If necessary, the frame can be triangular, ring-shaped, oval, round, polygonal, or almond-shaped when unfolded.

Optionally, the frame has a substantially circular cross-section and the width W is

- 3 045214 frame diameter. In a preferred design, the frame has a smooth cross-section. In other embodiments, the frame may have an oval or elliptical cross-section to prevent any injury to the uterine cavity. The width W of the frame can be in the range of 1.5-3.5 mm. The width W usually ranges from 1.5, 1.7, 1.9, 2.1, 2.3, 2.5, 2.7, 2.9, 3.1 or 3.3 mm to 1. 7, 1.9, 2.1, 2.3, 2.5, 2.7, 2.9, 3.1, 3.3 or 3.5 mm. A certain advantage is provided by the fact that the smooth round cross-section and small diameter of the frame facilitate frictional and almost painless insertion of the IUD into the cervical canal and uterus, and also minimize the risk of perforation of the uterine fundus. In addition, the frame material provides the necessary elasticity of the IUD during operation. The elasticity of the frame prevents the IUD from being removed from the uterine cavity and movement within the uterine cavity due to uterine contractions, as the flexible frame balances the tension caused by uterine contractions.

If necessary, the frame is made of a material selected from polyethylene, polypropylene, polyetheretherketone and thermoplastic polyurethane. Typically, the frame is made of an inert biocompatible material of an elastomeric composition.

The bend segments, such as the first bend segment and the second bend segment, allow the frame to bend sufficiently to achieve the desired shape. Moreover, the above-mentioned removal thread guides the first lock portion and the second lock portion to engage each other, which in turn provides the desired shape. As used herein, removal thread also refers to thread in the plural. The removal thread is attached by any suitable method, such as a knot or glue.

If necessary, the frame may include at least one diagnostic means for determining the location of the IUD in the uterine cavity without physical intervention. In one example, the at least one diagnostic agent may be an x-ray opaque agent, such as barium sulfate, for example, up to 20% by weight (weight percent) of the polymeric/elastomer scaffold material. In another example, the at least one diagnostic agent may be a ferromagnetic agent or an agent detectable by ultrasound or fluoroscopic imaging of the deployed IUD. Optionally, the at least one diagnostic agent is provided as an inert metal, either coated on at least a portion of the IUD frame, or as a partial metal ring, such as silver, embedded in the IUD.

The frame has a first end, a second end, and a length L, defined as the distance from the first end to the second end. Generally, the term first end refers to the end that is closest to the subject's uterus at the time of insertion of the IUD (also called the distal end), and the term second end refers to the end opposite the first end, that is, the end that is closer to the user, e.g. , to a healthcare professional, while inserting the IUD using the insertion device (also called the proximal end). If required, the length L of the frame ranges from 50 to 110 millimeters (mm) in a straightened configuration (ie, when threaded into the insertion device). The length L can generally be in the range from 50, 60, 70, 80, 90 or 100 mm to 60, 70, 80, 90, 100 or 110 mm. The IUD frame, after deployment in the required position in the uterine cavity, can achieve a given configuration (length x width) in the range from 25 x 23 mm ² to 31 x 28 mm ² , preferably 26 x 25 mm ² . When unfolded, the length usually ranges from 25, 27 or 29 mm to 27, 29 or 31 mm. Likewise, when unfolded, the width typically ranges from 23, 25 or 27 to 24, 26 or 28 mm. In one example, the triangular shaped IUD frame configuration when deployed may be 26.6 x 24.5 mm (length x width). In another example, the triangular shaped IUD frame configuration when deployed may be 26.2 x 24.3 mm ² (length x width).

Moreover, the first end of the frame includes a first lock portion, and the second end of the frame includes a second lock portion, the first lock portion and the second lock portion being arranged to form a lock. The first lock portion and the second lock portion extend as overhangs from the first end and the second end of the frame, respectively. Optionally, the first lock portion and the second lock portion are geometrically mating structures such as, for example, a hook and loop, a pin and loop (or groove), or a clamp and post. It should be noted that the first locking portion and the second locking portion, having geometrically mating structures, come into contact with each other in an expanded state in the uterus to engage with each other. The first locking portion mechanically cooperates with the second locking portion to secure the frame for suitable placement of the IUD in the uterus. During fixation, the first locking part is directly held in a non-displaceable state by the second locking part, resulting in the frame being fixed in the required shape. In the unlocked state, the first lock portion and the second lock portion are in a disengaged state, such as in a straightened configuration at least partially within the insertion device or in a configuration where the IUD is not yet fully inserted (or released) into the uterine cavity. It should be noted that external influences such as uterine contractions do not affect the locking of the frame when the first locking portion is locked on the second locking portion. In one embodiment, the width of the first lock portion and the second lock portion may be greater than the width W

- 4 045214 frames. The width of the first locking portion and the second locking portion may be in the range of 1.5-4 mm. The width of each of the first locking portion and the second locking portion is typically in the range of 1.5, 2, 2.5, 3, or 3.5 mm to 2, 2.5, 3, 3.5, or 4 mm. Notably, the construction material of the first clasp portion and the second clasp portion makes the IUD including the first clasp portion and the second clasp portion highly pliable, and therefore the effective width and largest outer diameter of the IUD is less than 3.7 mm, preferably 2.9 mm.

Optionally, the first locking portion is a pin, and the second locking portion is a loop, wherein the pin is configured to be permanently engaged in the loop. The engagement of the pin with the loop ensures that a significant portion of the pin fits into the loop. In a preferred embodiment, the pin has a circular doorknob-like structure and the hinge has an associated recess or hole-like structure to more effectively engage the pin with the hinge. The engagement of the pin and loop provides the required shape of the frame when deployed inside the uterus.

Optionally, the first locking portion is a hook, and the second locking portion is a loop, wherein the hook is configured to be permanently inserted into the loop. The hook engages with the loop to secure the frame in the desired shape when the IUD is deployed inside the uterus. If necessary, the first locking part and the second locking part are prepared from the same material from which the frame is made. Optionally, the first locking portion is a clamp and the second locking portion is a rod. Geometrically coupled structures of the clamp and rod are fixed to each other in an expanded state inside the uterus.

According to one embodiment of the invention, the second locking portion is designed to completely surround the first locking portion when the locking portions are engaged together. This embodiment, in combination with the injection device discussed below, ensures that the first locking portion does not contact the plunger of the injection device.

Optionally, the frame includes first, second and third frame segments having a width W defined as a dimension perpendicular to the length, wherein the first and second frame segments are connected through a first bending segment, and the second and third frame segments are connected through a second bending segment. The width W of the first, second and third frame segments is substantially equal to the width of the frame. The width W of the first, second and third frame segments can be in the range of 1.5-3.5 mm. The width W usually ranges from 1.5, 1.7, 1.9, 2.1, 2.3, 2.5, 2.7, 2.9, 3.1 or 3.3 mm to 1. 7, 1.9, 2.1, 2.3, 2.5, 2.7, 2.9, 3.1, 3.3 or 3.5 mm. The first bend segment and the second bend segment allow the frame to bend at predetermined distances to allow the frame to achieve a desired triangular shape when deployed in the uterus. Typically, the flex segments are thinner in at least one dimension than the frame segments to allow them to flex effectively during insertion, resulting in the correct shape of the IUD. The curvature segments (like the entire IUD) must, however, withstand the force of pulling the IUD, and this force is typically set to 12 N. Thus, it may be critical to make the curvature segments wider than the frame segments, in a direction perpendicular to the direction in which the curvature segments are thinner frame segments.

According to one embodiment, the first and third frame segments are slightly curved, i.e. are not completely straight. The bending radius can be, for example, 120-155% of the largest dimension of the IUD when it is fixed in the mold. Thus, the radius may be, for example, in the range from 120, 125, 130, 135 or 140% to 130, 135, 140, 145, 150 or 155% of the largest dimension, for example about 45 mm. This helps the IUD rotate correctly during insertion, minimizing patient discomfort and penetration of the uterine wall.

If necessary, the first bend segment is located at a first distance D1 from the first end, and the second bend segment is located at a second distance D2 from the first end, wherein the first distance D1 is in the range of 25-40% of the length L, and the second distance D2 is 55- 80% of the length L. The first distance D1 is usually in the range from 25, 30 or 35% to 30, 35 or 40% of the length L. The first distance D1 can be in the range from 12.5 to 44 mm, preferably from 17. 5 to 28 mm. In one example, the first distance D1 is in the range of 32-34% of the frame length L, i.e. from 16 to 37.4 mm. Likewise, the second distance D2 typically ranges from 55, 60, 65, 70, or 75% to 60, 65, 70, 75, or 80% of the length L. In one example, the first distance D2 may range from 27.5 to 88 mm, preferably from 38.5 to 56 mm. In one example, the second distance D2 is in the range of 65-67% of the frame length L, i.e. from 32.5 to 73.7 mm.

The first bend segment has a first width W1 and the second bend segment has a second width W2, wherein the first width W1 may be in the range of 5-50% of the width W and the second width W2 may be in the range of 5-50% of the width W. In others options, the first width W1 is 20-30% of the width W, and the second width W2 is in the range of 20-30% of the width W. The width W1 is usually in the range of 5, 10, 15, 20, 25, 30, 35, 40 or 45% to 10, 15, 20, 25, 30, 35, 40, 45 or 50% of the width W. In one example, the width W1 may be in the range of 0.1 to 2 mm, and preferably 0.4 up to 1.2 mm. Likewise, the width of W2 usually ranges from 5, 10, 15, 20, 25, 30, 35, 40 or

- 5 045214

45% to 10, 15, 20, 25, 30, 35, 40, 45 or 50% of the width W. For example, the width W2 can be in the range from 0.1 to 2 mm, and preferably from 0.4 to 1. 2 mm. Thus, the first width W1 and the second width W2 may be substantially the same.

In another embodiment, the first width W1 of the first bend segment and the second width W2 of the second bend segment are greater than the width W of the frame segment. For example, W1 may be in the range of 100-150% of W, and W2 may independently be in the range of 100-150% of W. Indeed, W1 and W2 may be independently selected from the range of 100, 105, 110, 115, 120, 125, 130, 135 or 140% to 105, 110, 115, 120, 125, 130, 135, 140, 154 or 150% W.

Optionally, the cross-section of the frame through the first bend segment and through the second bend segment has a substantially concave shape, with the first width W1 and the second width W2 being the smallest cross-sectional dimensions. The concave cross-sectional shape of the frame through the first bend segment and through the second bend segment allows the IUD to bend. In one embodiment, the cross-section of the frame through the first bend segment and through the second bend segment may have a different shape if this allows the frame to bend into the desired shape. For example, a notch may be present on at least one side of each of the first, second, or third bend segments and the second bend segment to allow the frame to bend into a desired shape.

If necessary, the frame includes a bending point that allows the IUD to be removed. The bending point is a weaker part compared to other parts of the frame. In one embodiment, the bending point is provided in the middle part of the frame, which does not have locking parts at its end, for example, in the middle part of the second frame segment. In an alternative design, the bending point may be provided in any other part of the frame if it facilitates bending or tearing of the IUD frame. In one embodiment, during removal of the IUD from the uterus, the tension on the removal suture causes the IUD to bend at the bend and the round or triangular shape of the frame is thereby broken, allowing the folded frame to be removed through the cervical canal. The bending point should be designed so that the intrauterine device does not bend in the wrong direction when inserted. In another embodiment, the IUD breaks at the bend when the removal suture is pulled.

The IUD includes a release thread attached to the first end of the frame. The term removal string as used herein refers to a string (namely a string) attached to the IUD at one end and used to remove the IUD at the end of the wear period (which is approximately 3-10 years, preferably 5-7 years). The removal thread is used not only to remove and/or replace the IUD at a later time during the wearing period, but also to determine (eg, as an indicator) the correct position of the IUD in the uterine cavity after the IUD has been deployed in the uterus. In addition, the release thread is typically used to hold the IUD in place with respect to the insertion device while it is in the product package.

In addition, the removal thread is configured to guide the first lock portion into the second lock portion. The removal thread guides the first locking portion to contact the second locking portion and then to engage the first locking portion with the second locking portion to shape the IUD within the uterine cavity. In an alternative embodiment, the removal thread guides the first lock portion into the second lock portion to engage and lock together as the removal thread is pulled. As a result of the tension when the thread is pulled, the first locking part is motionlessly inserted into the second locking part, thereby fixing the frame in the required shape. Optionally, the first end of the frame has attachment means for engaging the removal thread. Examples of fastening means include, but are not limited to, hole, perforation, recess, projection and recess.

The IUD includes at least one pharmaceutically active agent. In one example, the pharmaceutically active agent may be a hormone, a drug or drug analogue, an active pharmaceutical ingredient, or a health promoting substance having contraceptive or other medicinal properties. Such a pharmaceutically active agent acts either by thickening the cervical mucus, or by changing the endometrium, making it unsuitable for egg implantation, or by stopping ovulation, or by acting as COX1/COX2 inhibitors. In one example, the pharmaceutically active agent can provide and/or enhance protection against various microbial infections, such as bacterial infection, fungal infection and/or sexually transmitted infection. The IUD may also include more than one pharmaceutically active agent.

If necessary, the pharmaceutically active substance is selected from progesterone and its derivatives, estrogen, progestin, levonorgestrel, cyproterone acetate, desogestrel, etonogestrel, linestrenol, medroxyprogesterone acetate, norethisterone, norethisterone acetate, norgestimate, drospirenone, gestodene, 19-nor-17-esters hydroxyprogesterone, 17a-ethynyltestosterone and its derivatives, 17a-ethynyl-19-nortestosterone and its derivatives, ethynodiol diacetate, dydrogesterone, norethinodrel, allylestrenol, meddrogestone, norgestrienon, ethisterone and d1-norgestrel; and androgenic steroids such

- 6 045214 as danazol and gestrinone; naproxen, ibuprofen, mefenamic acid, flurbiprofen, indomethacin, diclofenac, piroxicam, meloxicam, ketoprofen, gonadotropin-releasing hormone agonists, progesterone receptor antagonists such as mifepristone (11b-4-dimethylaminophenyl-17b-hydroxy-17apropynyl-4,9-estradiene -3-on); ulipristal acetate, (11c,17c)-17-hydroxy-11-[4(methylsulfonyl)phenyl]-17-(pentafluoroethyl)estra-4,9-dien-3-one, 17 α-acetoxy-11c-[4 -(%K-dimethylamino)phenyl]-21-methoxy-19-norpregna-4,9-diene-3,20-dione, 17 α-acetoxy-11 in-(4-%K-dimethylaminophenyl)-19-norpregna -4,9-diene-3,20-dione, 11b-(4-acetylphenyl)-17b-hydroxy-17α-(1,1,2,2,2-pentafluoroethyl)-4,9-estradiene-3- he, asoprisnil (benzal dehyde-4-[(11β,17β)-17-methoxy-17-(methoxymethyl)-3oxoestra-4,9-dien-11-yl)]-1-oxime).

For example, levonorgestrel can be used as hormones, and indomethacin can be used as a COX inhibitor. It should be understood that the pharmaceutically active agent is administered in a suitable amount, for example in the maximum possible amount suitable for the subject. Moreover, the amount (ie, dose) of the pharmaceutically active agent varies depending on the specific pharmaceutically active agent, the intended use, time of action, rate of release and period of therapy, as well as the age and health of the subject. In addition, the pharmaceutically active agent typically has a pH level suitable for the uterus. Thus, the IUD not only functions as a long-acting reversible contraceptive method, but can also be used for a variety of other applications such as the treatment of disease, swelling, pain in the uterus, depending on the pharmaceutically active agent delivered through the IUD.

If necessary, at least one pharmaceutically active substance is contained in the frame. In one example, the at least one pharmaceutically active substance is dispersed or dissolved in the scaffold material prior to its manufacture. In one embodiment, the at least one pharmaceutically active substance is located in one of three segments of the framework, i.e. in the first, second or third frame segment. In another embodiment, at least one pharmaceutically active substance is contained in all three segments of the framework.

Optionally, the at least one pharmaceutically active substance is contained in at least one capsule, the capsule being arranged so as to surround the frame along at least part of its length L. In particular, the at least one capsule is a drug container containing a pharmaceutical active substance. At least one capsule located around the framework may also provide the necessary rigidity of the IUD framework in this part of the length of the framework. The at least one capsule is positioned to surround at least one of the first, second, or third frame segments while the first lock portion, the first bend segment, the second bend segment, and the second lock portion remain free from the at least one capsule.

If necessary, at least one capsule is placed around the frame along its entire length, with the exception of the first locking part and the second locking part. At least one capsule is positioned around the first, second and third frame segments. In this case, at least one capsule is flexible enough to bend at the bend points.

Optionally, at least one capsule is prepared from poly(dimethylsilicone), siloxane-based elastomer, thermoplastic polyurethane, thermoplastic polyurethane elastomer, ethyl vinyl acetate, polyolefin-based elastomer, silicone-containing thermoplastic, polyurethane, polylactic acid and polycaprolactone. If necessary, at least one capsule is prepared from a biocompatible polymer matrix. Examples of a biocompatible polymer matrix include, but are not limited to, dimethylsiloxane and methylvinylsiloxane copolymers, polyethylene, polypropylene, polybutadiene, polyisoprene, acrylic acid polymers, ethylene/propylene copolymers, ethylene/ethyl acrylate copolymers, poly(methacrylate), polymethyl methacrylate, styrene butadiene block copolymers. styrene, styrene-isobutylene styrene copolymers, poly(hydroxyethyl methacrylate), polyesters, polyacrylonitriles, polyethylene glycols, polymethylpentene, polyhydroxyalkanoates, polyorthoethers, hydrophilic polymers (e.g. hydrophilic hydrogels), cross-linked polyvinyl alcohol, polytetrafluoroethylene, polyvinyl chloride, polyvinyl acetate, neoprene rubber and butyl rubber.

In one embodiment, the at least one capsule is selected from a matrix system and a core-membrane system. In one example, the matrix system may be a polymer matrix, such as a siloxane-based elastomer, with the pharmaceutically active agent dispersed or dissolved therein. In another example, in a core-membrane system, at least one capsule may include a pharmaceutically active agent core and a membrane surrounding the pharmaceutically active agent core.

The core may be a hollow tube-like structure assembled on a scaffold (surrounding the scaffold for at least part of its length L) to deliver the pharmaceutically active agent at a controlled rate into the uterus. The membrane may be a permeable layer consisting of an inert material that prevents direct contact between the pharmaceutically active agent and the body fluid in the uterus. In addition, the membrane layer can control the release rate of the pharmaceutically active agent by acting as a diffusion layer surrounding the pharmaceutically active agent core. In one embodiment, the membrane may surround at least one capsule on all sides, resulting in a closed capsule. In another embodiment of the invention, the at least one capsule is not completely surrounded by a membrane. In one embodiment, the membrane is more permeable and allows the pharmaceutically active agent to contact biological fluids compared to the pharmaceutically active agent core.

If necessary, the cross-section of at least one capsule is selected from round and oval. For example, the capsule may have a circular, annular, oval or elliptical cross-section, provided that the shape is suitable for insertion into the cervical canal and into the uterus. If necessary, the outer diameter of the capsule is in the range of 2-3.5 mm and preferably about 2.9 mm. The outer diameter of the capsule usually ranges from 2, 2.1, 2.3, 2.5, 2.7, 2.9, 3.1 or 3.3 mm to 2.1, 2.3, 2.5 , 2.7, 2.9, 3.1, 3.3 or 3.5 mm.

If necessary, the IUD includes at least two capsules. In one example, at least two capsules are located at a predetermined distance from each other on the frame. In a preferred embodiment, at least two capsules are not in contact with each other after insertion of the IUD into the uterine cavity. If necessary, the number of capsules can be 3, 4, etc., depending on the different types of therapeutic agents to be administered.

Optionally, the IUD includes a first capsule located around the first frame segment, a second capsule located around the second frame segment, and a third capsule located around the third frame segment, wherein the first lock portion, the first bend segment, the second bend segment, and the second lock portion are not contain capsules. In this embodiment, the first capsule, second capsule, and third capsule may provide sufficient rigidity to the frame during the insertion process and further help the IUD achieve a desired continuous smooth shape (ie, desired configuration) when deployed. The first lock portion, the first bend segment, the second bend segment, and the second lock portion do not contain capsules to cause the necessary bends and/or shape of the IUD frame.

If necessary, the capsules contain various pharmaceutically active substances. Optionally, the first capsule, the second capsule and the third capsule may be the same or different in structure, and may contain the same or different pharmaceutically active agents. In one example, the first capsule may include a first pharmaceutically active agent, such as a progestin, the second capsule may include a second pharmaceutically active agent, such as diclofenac, and the third capsule may include a third pharmaceutically active agent, such as levonorgestrel. In addition, the release of the pharmaceutically active agents from the at least two capsules can be accomplished simultaneously or alternately depending on the rate of release of the pharmaceutically active agents to be achieved and their respective interactions with the biological fluid in the uterus.

Optionally, the first pharmaceutically active substance is contained in a capsule, the capsule being positioned so as to surround the frame for at least part of its length L, and the second pharmaceutically active substance is contained in the frame. The capsule affects the rate of release of the pharmaceutically active substance in the uterus. The at least one pharmaceutically active agent dispersed or dissolved in the frame material has a release rate of the pharmaceutically active agent that is different from the release rate of the pharmaceutically active agent located in the capsule. It should be understood that the rate of release of the pharmaceutically active substance depends on the permeability of the frame and/or capsule material.

According to one embodiment, the frame is produced by injection molding. One capsule is located around a part of the frame, forming a capsule-frame assembly. However, in cases where there is more than one capsule, the capsules may be located anywhere in the frame, leaving at least the first locking portion and the second locking portion free of the capsule, depending on the desired shape of the IUD to be achieved.

Another exemplary embodiment of the present invention is an intrauterine system, including a frame having a first end, a second end, and a length L defined as a distance from the first end to the second end;

a removal thread attached to the first end of the frame; and copper wire located around at least a portion of the frame;

wherein the first end of the frame includes a first lock portion and the second end of the frame includes a second lock portion, wherein the first lock portion and the second lock portion are configured to form a lock, wherein the removal thread is configured to guide the first lock portion into the second lock portion.

According to this embodiment, the copper wire located around at least a portion of the frame functions as a contraceptive, preventing the sperm from fertilizing the egg. The copper IUD (i.e., an IUD that includes copper) does not contain hormones and is therefore a good option for women who prefer or are medically recommended for a non-hormonal method of contraception.

The present invention also relates to a kit comprising an intrauterine system and an insertion device. The IUD from the kit is described above. In one embodiment, the IUD is pre-installed (or pre-charged) into the insertion device in a sterile product package. The packaging of the product protects the contents of the set from environmental influences and mechanical factors. Various embodiments and options described above for the IUD apply mutatis mutandis to the IUD of the kit.

Thus, the present invention provides a kit for effectively and conveniently performing the insertion of an IUD into the uterus. The insertion device allows you to install the IUD in a stable position in the uterus. The insertion device is easy to use and, instead of inserting any part of the insertion device into the cervical canal, provides direct insertion of the IUD into the cervical canal to reduce pain associated with insertion of the IUD into the uterus. Moreover, the small cross-sectional area of the IUD makes insertion of the IUD into the uterus virtually painless, or at least less painful than using conventional IUDs and insertion devices. In addition, various parts of the insertion device are released at specific times during insertion of the intrauterine contraceptive, thereby providing an intuitive and improved experience for the healthcare professional when operating the insertion device during insertion of the intrauterine contraceptive. Thus, the use of the above insertion device and kit may allow the overall success rate of IUD insertion to be increased without causing any or only minimal discomfort to the subject.

As used herein, the proximal end is the end that is closest to the user (the physician) during insertion of the IUD, and the distal end is the opposite end that is furthest from the user.

The insertion device includes a handle body having a distal end, a proximal end, and a length Lh defined as the distance between the distal end and the proximal end. The preferred design of the handle body is designed to allow easy movement of the insertion device with one hand. Moreover, the handle body in the preferred embodiment is designed without any preference regarding chirality. In an alternative design, the insertion device operates the same when held by the handle body with either the right or left hand.

According to one embodiment, the body of the handle is made of a polymeric material (for example, medical plastic) and can be used for one-time use for hygienic purposes. The handle body can have different shapes and sizes. The handle body is typically a hollow elongated structure, such as tubular, cylindrical, elliptical, oval, cuboid, or the like. The handle body serves as a housing and support structure for various components of the insertion device. In addition, the handle body may be configured to fit the palm of a healthcare professional. In one example, the handle body has a first extension portion and a second extension portion. Each of the first patch portion and the second patch portion may have a geometrically mating structure for attaching to each other when the insertion device is assembled. According to one embodiment, the length Lh is 70-110 mm. If necessary, the length Lh of the handle body is approximately 94 mm. The length Lh usually ranges from 70, 75, 80, 85, 90, 95 or 100 mm to 80, 85, 90, 95, 100, 105 or 110 mm.

The introduction device further includes a sizing tube having a distal end and a proximal end. The proximal end of the sizing tube is movably attached to the distal end of the handle body. The sizing tube is a hollow tube-like structure. If necessary, the measuring tube has a round or oval cross-section.

If necessary, the proximal part of the measuring tube includes insertion depth indicators, for example, on its outer surface. In one example, the insertion depth indicators may refer to graduation lines with corresponding numerical values marked on the outer surface of the proximal portion of the sizing tube. Such insertion depth indicators are used to correctly position the aforementioned flange in the correct position on the sizing tube at the beginning of the IUD insertion process after measuring the insertion length (ie, the length of the uterus and cervical canal).

If necessary, the sizing tube is made from a medical grade polymer material such as polyethylene, polypropylene, silicone, etc., or metal. If necessary, the sizing tube can be made of polyetheretherketone, thermoplastic polyurethane, thermoplastic polyurethane elastomer and the like. It may include a reinforcing material such as fiberglass.

In addition, the insertion device includes a plunger having a distal end, a proximal end, and a length Lp defined as the distance between the distal and proximal ends. The plunger is movably located inside the handle body and the sizing tube. Lp is longer than Lh. According to one embodiment, the length Lp is in the range of 50-90 mm. Lp length usually ranges from 50, 55, 60, 65, 70, 75 or 80 mm to 60, 65, 70, 75, 80, 85 or 90 mm.

According to one embodiment of the invention, the plunger is hollow, allowing the removal thread of the aforementioned intrauterine system to pass through the plunger. Thus, the plunger may be a thin, hollow tube-like structure that allows the removal thread to pass through the plunger. It should be understood that the term removal string as used herein refers to one or more strings (namely strings) attached to the IUD at one end and used to remove the IUD at the end of the wearing period (which may be, for example, 5-7 years). The removal thread is used not only to remove the IUD, but also to determine the correct position of the IUD in the uterine cavity after it is inserted into the uterus. In one example, the IUD may be pre-loaded into the insertion device in the delivery kit. In the pre-primed state of the IUD, one end of the removal thread remains connected to the above-mentioned first locking part of the IUD, while the other end of the removal thread passes through the plunger.

According to one embodiment of the invention, the distal end of the plunger is configured to interact with the second locking part. If necessary, the plunger portion at the distal end may be shaped to be geometrically mated to the second locking portion. If necessary, the plunger is made of medical grade polymer material such as polyethylene, polypropylene, silicone and the like or metal.

In one embodiment, the plunger includes means to prevent it from being removed from the handle body. The plunger may include this means to prevent it from being removed from the handle body at a proximal end of the plunger. In one embodiment of the invention, the means has a circumference that is larger than the circumference of the remainder of the plunger. If necessary, the means is shaped like a ring or polygonal piece that holds the plunger inside the piston and handle body. The plunger is attached to the distal end inside the piston. More precisely, the plunger is fixed between the engaging parts of the piston. In one example, the piston engaging portions may be small projections projecting inwardly in geometrically opposite directions from the inner surface of the distal portion of the piston.

In addition, the introduction device includes a flange movably located around the sizing tube. In one embodiment, insertion depth indicators on the gauge tube allow the user to set the position of the flange. At the beginning of the IUD insertion procedure, the flange is manually moved to a predetermined position on the sizing tube using insertion depth indicators on the outer surface of the proximal part of the sizing tube. The given position is understood as the length of the uterine cavity plus the length of the cervical canal, previously measured during probing of the uterus. Once installed on the sizing tube of the inserter, the flange is firmly held on the sizing tube, thereby preventing unwanted movement of the flange from its original position when the insertion device is used during insertion of the IUD.

Optionally, the flange includes a gripping surface on two diametrically opposed sides on the outer portion of the flange. In one example, the gripping surface has a wavy structure to provide a secure grip with the fingers of one hand and to press the outside of the flange toward the inside of the flange and position the flange by sliding along the gauge tube. In this case, releasing the grip forces the flange into place, and the friction between the flange and the sizing tube allows the flange to remain in place.

If necessary, the flange has a length of Lr. The length Lr is in the range of 2-10%, preferably 4-8% of the length L of the dimensional tube of the introducing device. In one example, Lr may range from 2, 3, 4, 5, 6, 7, or 8% to 4, 5, 6, 7, 8, 9, or 10% of L. If desired, the flange is prepared from a polymeric material such as such as low density polyethylene, high density polyethylene, polypropylene, thermoplastic polyurethane, thermoplastic polyurethane elastomer, polyetheretherketone and/or a combination thereof. The flange may have various shapes, such as rounded rectangular, oval, elliptical, round or the like.

The insertion device may further include an end housing having a distal end and a proximal end and positioned to fit inside the distal end of the sizing tube if the end housing is positioned to remain outside the cervical canal during insertion. The distal end of the end housing has a circular bulb-shaped structure to prevent the sizing tube from entering the subject's cervical canal. The proximal end of the end housing is movably located in the inner surface of the sizing tube at the distal end of the sizing tube. During insertion of the IUD, as the insertion device is advanced toward the subject, the end housing is moved rearward (ie, toward the handle body) and secured to the inner surface of the sizing tube. If necessary, the end casing is movably mounted on the outer surface of the measuring tube and slides along the measuring tube.

The insertion device further includes a finger holder movably located around the handle body. The finger holder can be used to support the fingers (eg, two fingers) to provide comfortable pressure on the piston toward the distal end of the arm housing during the IUD insertion process. According to one embodiment of the invention, in the assembled state of the insertion device, only the optional end casing, flange and means (eg thread lock) for reversibly fixing the removal thread are movable, and other parts of the insertion device are fixed. Other parts of the insertion device are released only at certain times during operation (ie, during the IUD insertion process). For example, the finger holder is initially fixed in the insertion device. If necessary, the finger holder includes one or more hooks that fix the movement of the finger holder in the insertion device. In one embodiment, the finger holder includes two hooks, for example, a first hook and a second hook, which can be fixed in corresponding recesses provided in the distal end of the handle body. During insertion of the IUD, when the piston is fully inserted into the handle body, the finger holder is released from fixation and moves to the proximal end of the handle body. In addition, after the finger holder is moved to the proximal end of the handle body, the lock holding the movement of the sizing tube relative to the handle body is also released. In one example, one or more clamps may be used to block movement of the gauge tube relative to the handle body. The proximal portion of the sizing tube is moved within the handle body until the flange abuts the distal end of the handle body. In this way, various parts of the insertion device are released at specific times during the insertion of the IUD, thereby providing an intuitive and improved experience for the healthcare provider as well as comfort for the subject during insertion of the IUD.

The finger holder may be located at the proximal end of the handle body. The finger holder may have one or two ring-shaped or semi-ring-shaped structures to provide gripping of at least two fingers. In an alternative design, the finger holder can be configured as circles extending outward from diametrically opposed sides of the outer surface of the handle body at its proximal end. In such an embodiment, the finger holder is movably located on the handle body. If necessary, the finger holder is fixedly fixed to the handle body.

In addition, the insertion device includes a means for reversibly fixing the intrauterine system removal thread located on the handle body. According to one embodiment of the invention, the reversible removal thread locking means includes a rotary handle positioned in a first position to lock the removal thread between the handle and the handle, and in a second position to allow the removal thread to move relative to the handle body. If necessary, the handle and handle body are appropriately shaped to allow the removal thread to be blocked when the handle is in the first position.

In another embodiment of the invention, the means for reversibly securing the removal thread may be a roller-like mechanism on which the removal thread is wound. Rotating the roller-like mechanism in one direction (eg, forward) may secure the removal thread, and rotating the roller-like mechanism in another direction (eg, reverse) may release the removal thread. In one example, the roller mechanism may be a gear located in an opening in the handle body and having a corresponding counterpart.

According to one embodiment of the invention, the insertion device further includes a piston attached to the plunger and configured to move the plunger, the piston being movably located within the handle body. The piston is located at the proximal end of the handle body. In addition, the proximal end of the piston includes a pressure element. A pressure element is provided, for example, for the thumb of the user of the insertion device. When the piston push member is pushed, the piston enters the handle body and then moves forward toward the distal end of the handle body. In one example, the pressure element may be integrated into the piston during the injection molding process. In addition, the plunger is fixed between the above-mentioned piston engaging parts. During insertion of the IUD, the plunger is pushed into the cervical canal and partially into the uterine cavity as the piston moves forward towards the distal end of the handle body.

According to one embodiment of the invention, the piston is hollow, allowing the intrauterine system removal thread to pass through the piston. The piston is a hollow tube-like structure that allows the removal thread to pass through it. In one example, the IUD may be pre-loaded into an insertion device in a product package. In the pre-threaded state of the IUD, one end of the removal thread remains connected to the above-mentioned first locking part of the IUD, while the other end of the removal thread passes through the plunger and piston and exits the handle body around the means for reversibly fixing the removal thread.

In accordance with one embodiment, the piston includes means to prevent it from being removed from the handle body. The piston may include means to prevent it from being removed from the handle body at a distal end of the piston. In one example, the means for preventing the piston from being removed from the handle body may be at least one projection from the outer

- 11 045214 piston surface at the distal end of the piston. At least one protrusion prevents accidental removal of the piston from the handle body. In another example, two projections may be attached to or located on the outer surface of the piston. Two projections may extend from the outer surface of the piston in two geometrically opposite directions. If necessary, the means for preventing the piston from being removed from the handle body can be made in the form of a ring, which is compatible in shape with the inner diameter of the handle body.

According to one embodiment, the process of inserting an IUD into the uterus (namely, the stages of operation of the above-mentioned insertion device during use) is described using the example of an IUD having locking parts, and is as follows.

Typically, before insertion, the IUD is at least partially contained in the insertion device (i.e., pre-tucked into the insertion device) and stored in the product packaging. The removal thread (which also acts as a guide protector) is attached to the first end of the IUD frame (that is, the end that first enters the uterus), and the other end of the removal thread is attached to the handle body. In one embodiment, the IUD is pre-threaded into the insertion device such that a small portion of the IUD protrudes from the insertion device and the remainder of the IUD is surrounded and protected by an end housing. In one example, about 10 mm of the frame remains outside the insertion device (ie, outside the end housing of the sizing tube) in a pre-filled state. The insertion device is used under aseptic conditions with a pair of sterile gloves worn by the user (eg, a healthcare professional). The insertion process begins with adjusting the flange.

A) Flange Adjustment: The flange is manually moved to a predetermined position on the gauge tube by means of insertion depth indicators on the outer surface of the gauge tube. The given position is understood as the length of the uterine cavity plus the length of the cervical canal, previously measured during probing of the uterus. In one example, a gripping surface located on two diametrically opposed sides of the flange may be used to force the outer portion toward the inner portion of the flange.

After adjusting the flange, the steps are slightly different depending on whether the insertion device includes an end housing or not. Both options are described below (Stage B for a device without an end casing, Stage B for a device with an end casing).

C) The first stage of IUD insertion: the measuring tube passes through the vagina to the cervix. The insertion device is positioned so that the distal end of the sizing tube reaches the opening of the cervix (ie, the external opening) and the first end (ie, the tip) of the IUD is located inside the opening of the cervix. At this stage, the piston is in an extended state and the aforementioned piston pressing member is positioned away from the proximal end of the handle body.

B') The first stage of IUD insertion: the measuring tube passes through the vagina to the cervix. The insertion device is positioned such that the end housing reaches the cervical opening (ie, the external opening) and the first end (ie, the tip) of the IUD is located inside the cervical opening. The entire insertion device is then gently pushed toward the subject, which causes the end housing to move rearward (ie, toward the handle body) and a portion of the frame (eg, about 30 mm) is released from the insertion device into the cervical canal. When the end housing is moved back, it locks inside the sizing tube. In an alternative design, the cervical opening prevents the end housing from moving forward with the insertion device, but instead causes the end housing to fit inside the sizing tube and lock onto the inner surface of the distal portion of the sizing tube. The insertion device is gently advanced towards the subject until the user feels resistance from the insertion device, usually physical pressure. The measuring tube itself does not pass into the cervical canal at any of the operational stages during the insertion of the intrauterine device, which reduces discomfort during the insertion of the device. At this stage, the piston is in an extended state and the aforementioned piston pressing member is removed from the proximal end of the handle body.

C) Second stage of IUD insertion: maintaining tight contact of the sizing tube (in the case of using an end casing, contact of the end casing, i.e., the tip of the inserting device) with part of the cervix, the piston is pressed in the direction from the proximal end to the distal end of the handle body. To provide comfortable pressure on the piston toward the distal end of the handle body, a finger holder can be used to support the fingers (eg, two fingers). The IUD begins to emerge from the insertion device and form a loop under the action of the removal thread, which is held tightly (as it is attached to the handle body). The movement of the piston moves a plunger attached to the piston, which in turn pushes the end (ie the aforementioned second locking portion) of the framework, and thus more of the framework is released from the insertion device into the uterine cavity. Before the piston is completely inside the handle body, it opens the lock of the finger holder, thereby allowing its movement. Movement of the finger holder (while the piston and plunger do not move) forces the IUD into its final shape, but does not advance the IUD further into the uterus. The finger holder also opens the plunger lock and piston

- 12 045214 nya, after which the user's action on the piston (pushing it towards the distal end of the handle body) closes the IUD into its final shape. Thus, the user presses on the piston while maintaining a firm grip on the finger holder, and the locking parts inside the handle provide the above movements.

Thus, when the finger holder meets the proximal end of the handle body (and also stops the movement of the piston within the handle body), the IUD is located outside the insertion device and the locking portions (ie, the first locking portion and the second locking portion) of the IUD lock. The piston is secured inside the handle body by finger holder snap locks so that the user cannot pull it back. The fixation of the sizing tube is removed, allowing it to move.

D) The third stage of IUD insertion: the entire insertion device is advanced towards the patient until the flange comes into contact with the handle body. At this stage, part of the sizing tube is moved inside the handle body (i.e. towards the healthcare worker). This pushes the IUD into the correct position in the uterus. In other words, the IUD moves to its fundus position and the entire IUD is precisely positioned in the uterine cavity.

E) Release of the removal thread and removal of the insertion device: the removal thread is released. The removal thread is released by turning the removal thread reversible locking means. In one embodiment of the invention, the means for reversibly securing the removal thread includes a rotary handle that is rotated from a first position to a second position to allow movement of the removal thread relative to the handle body and further allow release of the removal thread. If necessary, the removal thread is released by pressing the thread cutting button located on the handle body. When the thread cutting button is pressed, the cutting blade inside the handle body cuts the removal thread. The insertion device is positioned to cut the removal thread so as to leave about 2-3 cm visible outside the cervix (ie, outside the external opening and about 2-3 cm in the vagina so that it can be detected by touch). The insertion device is then removed from the subject, indicating that the insertion device has completed the process of inserting the intrauterine device.

It should be understood that other means of moving the plunger may be used in place of a plunger during insertion of the IUD as described above, although the use of a plunger makes the insertion device much more convenient to operate. For example, to move the plunger, you can use a slider located on the handle body. Moreover, in another embodiment of the invention, instead of moving the end housing within the sizing tube (eg, during the first step of IUD insertion as described above), the end housing slides over the distal end of the sizing tube and is secured to the outer surface of the sizing tube. In this case, it may be necessary to make the end casing in two parts instead of one (ie, in the case where the end casing extends into the sizing tube, the end casing is made in one piece). Additionally, additional welding may be required to mount the two end housing pieces onto the sizing tube. This insertion device is also suitable for types of IUDs other than those described here.

Detailed description of drawings

In fig. 1 is a perspective view of an IUD 100 in a tucked configuration in accordance with one embodiment of the present invention. As shown, the IUD 100 includes a frame 102 having a first end 104, a second end 106, and a length L, defined as the distance from the first end 104 to the second end 106. The frame 102 is straightened and stretched when threaded into the insertion device before the IUD 100 is inserted into the uterus. The first end 104 of the frame 102 includes a first lock portion 108, and the second end 106 of the frame 102 includes a second lock portion 110. In this embodiment, the first lock portion 108 is a hook and the second lock portion 110 is a loop. Also shown is the outer diameter 112 (i.e., the largest outer diameter) of the IUD 100. The IUD 100 also includes a pharmaceutically active agent located in the frame 102.

In fig. 2 shows a schematic view of the IUD 100 of FIG. 1 in accordance with one embodiment of the present invention. In this embodiment, the frame 102 of the IUD 100 has a triangular shape. The first lock portion 108 at the first end 104 of the frame 102 and the second lock portion 110 at the second end 106 of the frame 102 are arranged to form the lock 202 in an expanded state in the uterus.

The frame 102 further includes a first frame segment 204, a second frame segment 206, and a third frame segment 208. The first frame segment 204 and the second frame segment 206 are connected to each other through the first bend segment 210. The second frame segment 206 and the third frame segment 208 are connected to each other via a second bend segment 212. The width W of the first frame segment 204, the second frame segment 206, and the third frame segment 208 is equal to the width of the frame 102. Also shown is the first bend segment 210 having a first width W1, and the second bend segment 212 having a second width W2. In this embodiment, the cross section of the frame 102 at the first bend segment 210 and at the second bend segment 212 has a substantially concave shape 214. The first width W1 and the second width W2 are the smallest cross-sectional dimensions of the frame 102. In this embodiment, the first width W1 is substantially identical the second width W2, and each of the first width W1 and the second width W2 is about 25% of the width W. The smaller cross-section (i.e., local thinning) on the first bend segment 210 and the second bend segment 212 compared to other parts of the frame 102 facilitate the bending of the frame 102 into a triangular shape. The frame 102 also includes a bending point 216 that facilitates removal of the IUD 100 if necessary.

The IUD 100 also includes a removal thread 218 attached to the first end 104 of the frame 102. Specifically, the removal thread 218 is connected to an opening 220 in the first locking portion 108 at the first end 104 of the frame 102. The removal thread 218 is configured to guide the first locking portion 108 toward a second locking portion 110. The length 222 and width 224 of the frame 102 of the triangular shaped IUD 100 when deployed in the uterus are shown next.

In fig. 3 is a schematic view of an IUD 300 in accordance with another embodiment of the present invention. The IUD 300 includes a frame 302 having a first end 304 and a second end 306. In this embodiment, the frame 302 is triangular in shape. The first end 304 of the frame 302 includes a first lock portion 308, and the second end 306 of the frame 302 includes a second lock portion 310. The first lock portion 308 and the second lock portion 310 are configured to form a lock 312. The first lock portion 308 is a hook and the second lock portion is part 310 is a loop, and the hook is configured to be permanently inserted into the loop.

The frame 302 further includes a first frame segment 314, a second frame segment 316, and a third frame segment 318. The first frame segment 314 is connected to the second frame segment 316 through a first bend segment 320. Likewise, the second frame segment 316 is connected to the third frame segment 318 through a second bendable segment 322. In this embodiment, the frame 302 further includes two bend locations 324 to allow removal of the IUD 300. The area between the two bend locations 324 is the weaker portion of the frame 302 by compared to other parts of the 302 frame.

The IUD 300 also includes a removal thread 326 attached to the first end 304 of the frame 302. The removal thread 326 is inserted into an opening 328 provided in the first locking portion 308. The removal thread 326 is configured to guide the first locking portion 308 into the second locking portion 310. IUD 300 also includes four capsules, a first capsule 330, a second capsule 332, a third capsule 334, and a fourth capsule 336. The first capsule 330 is shorter in length than the other capsules 332, 334, and 336. Capsules 330, 332, 334, and 336 contain the same or different pharmaceutically active substances.

In fig. 4A shows a schematic view of an IUD 400 in a loaded configuration in accordance with another embodiment of the present invention. As shown, the IUD 400 includes a frame 402 having a first end 404 and a second end 406, and a length L is defined as the distance from the first end 404 to the second end 406. The frame 402 straightens and stretches when inserted into the insertion device (i.e., when inserted). configuration) before inserting IUD 400 into the uterus. The first end 404 of the frame 402 includes a first lock portion 408, and the second end 406 of the frame 402 includes a second lock portion 410. In this embodiment, the first lock portion 408 is a pin and the second lock portion 410 is a hinge. The first lock portion 408 and the second lock portion 410 have mating structures to allow the pin to be permanently inserted into the loop. The first locking portion 408 of the IUD 400 includes an opening 412 for receiving the removal thread.

The frame 402 also includes a first capsule 414, a second capsule 416, a third capsule 418, and a fourth capsule 420. The first capsule 414 and the second capsule 416 are positioned to surround the first frame segment 422 and the second frame segment 424, respectively. The third capsule 418 and the fourth capsule 420 are located around the third segment 426 of the frame 402. Next, the first bend segment 428 and the second bend segment 430 are shown. The first frame segment 422 is connected to the second frame segment 424 through the first bend segment 428, and the second frame segment 424 is connected to the third frame segment 426 through the second bend segment 430.

In fig. 4B is a perspective view of the IUD 400 of FIG. 4A in accordance with one embodiment of the present invention. As shown, the first lock portion 408 is a pin and the second lock portion 410 is a loop, i.e. has geometrically conjugated structures such that the pin essentially engages in a loop in the deployed state of the IUD 400 in the uterus.

In fig. 4C is a schematic cross-sectional view of an deployed IUD 400 in accordance with one embodiment of the present invention. When deployed, the frame 402 of the IUD 400 takes on a triangular shape when the first locking portion 408 and the second locking portion 410 engage to form the lock 432. The frame 402 also includes a bend point 434 allowing removal of the IUD 400. In this embodiment, the bend point 434 is located in the middle section of the second frame segment 424 is flexed and is a weaker portion compared to the other portions of the frame 402. Shown below is a first capsule 414 located around the first frame segment 422, a second capsule 416 located around the second frame segment 424, a third capsule 418 located around parts of the third frame segment 426, and a fourth capsule 420 located around another part of the third frame segment 426 of the frame 402, respectively. The first locking portion 408 includes a receiving hole 412

- 14 045214 thread 436 removal. The removal thread 436 guides the first lock portion 408 to contact the second lock portion 410 and further engage the first lock portion 408 with the second lock portion 410 to provide the desired triangular shape of the frame 402 in the uterus in the deployed state.

In fig. 4D is a perspective view of the IUD 400 of FIG. 4C in an unfolded state in accordance with one embodiment of the present invention. As shown, the first lock portion 408 and the second lock portion 410 have geometrically mating structures such that the first lock portion 408 substantially engages the second lock portion 410 and forms a lock 432 when deployed in the uterus.

In fig. 5 is a schematic view of an IUD 500 in accordance with another embodiment of the present invention. The IUD 500 includes a frame 502 having a first end 504 and a second end 506. The first end 504 of the frame 502 includes a first lock portion 508, and the second end 506 of the frame 502 includes a second lock portion 510. The first lock portion 508 and the second lock portion 510 have geometrically mating clip and rod structures such that the first lock portion 508 can be secured to the second lock portion 510. The first lock portion 508 includes an opening 512 for receiving the removal thread. The frame 502 also includes a first capsule 514, a second capsule 516, and a third capsule 518 that are spaced apart from each other and arranged around a portion of the frame 502. In this embodiment, the frame 502 has a rectangular tube-like cross-section with rounded corners. When deployed in the uterus, the frame 502 bends at two bend segments 520 and 522, which are devoid of capsules, i.e. the first capsule 514, the second capsule 516 and the third capsule 518.

In fig. 6A-6D are schematic illustrations of an IUD frame and an IUD in accordance with an embodiment, and also show how the IUD is secured into the mold. Indeed, in FIG. 6A shows an IUD frame 602. The drawing also shows a first frame end 604 and a second frame end 606. The first end 604 of the frame 602 includes a first lock portion 608, and the second end 606 of the frame 602 includes a second lock portion 610. In this embodiment, the first lock portion 608 is a bulge and the second lock portion 610 is a hinge.

Frame 602 also includes a first frame segment 612, a second frame segment 614, and a third frame segment 616. The first frame segment 612 and the second frame segment 614 are connected to each other through the first bend segment 618. The second frame segment 614 and the third frame segment 616 are connected to each other by a second bend segment 620. The width of the first frame segment 612, the second frame segment 614, and the third frame segment 616 is less than the width of the lock portions 608 and 610. In this embodiment, the cross-section of the frame 602 through the first bend segment 618 and through the second bend segment 620 has a substantially concave shape. In addition, the width of the bending segments is greater than the width of the frame segments. The frame 602 further includes a flex point 622 that facilitates removal of the IUD 600 when needed.

In fig. 6B shows the IUD in the form in which it can be stored in product packaging, i.e. before it is inserted inside the insertion device, including capsule 624 and removal thread 626. In fig. Figures 6C and 6D show the stages of closure and retention in the form of the IUD once it is released inside the uterus. In fig. 6B shows how the frame 602 is bent by pulling the removal thread 624. In fig. 6C, the first end 604 of the frame 602 is in contact with the second end 606 of the frame, and in FIG. 6D, first end 604 is pulled through second end 606, thereby locking IUD 600 into shape.

In fig. 7A is a perspective view of the insertion device 1100 in an assembled state with the IUD 1102 pre-inserted, in accordance with one embodiment of the present invention. The insertion device 1100 includes a handle body 1104 having a proximal end 1106 and a distal end 1108. The insertion device 1100 further includes a sizing tube 1110 having a proximal end 1112 and a distal end 1114. The proximal end 1112 of the sizing tube 1110 is movably attached to the distal end 1108 of the housing. 1104 handles . The insertion device 1100 further includes an end housing 1116 having a distal end 1118 and a proximal end 1120. The end housing 1116 is disposed to extend within the distal end 1114 of the sizing tube 1110. The introducing device 1100 further includes a flange 1122 movably positioned around the sizing tube 1110. Around the housing 1104 of the handle is movably located finger holder 1124. The insertion device 1100 further includes a means 1126 of reversible fixation of the removal thread of the IUD 1102. The means 1126 of reversible fixation of the removal thread is located on the body 1104 of the handle. The insertion device 1100 further includes a piston 1130 that is movably located within the handle housing 1104.

In fig. 7B is a perspective view of the injection device 1100 of FIG. 7A disassembled with IUD 1102, in accordance with one embodiment of the present invention. The insertion device 1100 further includes a plunger 1132 having a distal end 1134, a proximal end 1136, and a length Lp defined as the distance between the distal end 1134 and the proximal end 1136. In the insertion device 1100 assembly, the plunger 1132 is movably located within the handle body 1104 and the size tube 11 10 Next, a first trim piece 1138A and a second trim piece 1138B are shown.

- 15 045214 housing 1104 handles.

The handle body 1104 has a length Lh, defined as the distance between the distal end 1108 and the proximal end 1106. Notably, the length Lp is greater than the length Lh. Next, a first portion 1140A and a second portion 1140B of sizing tube 1110, a first portion 1142A and a second portion 1142B of finger holder 1124, and a first portion 1144A and second portion 1144B of piston 1130 are shown. Next, a flanged end housing 1116 and reversible thread locking means 1126 for removing the IUD 1102 are shown. In the insertion device 1100 assembly, the end housing 1116 accommodates the frame 1146 of the IUD 1102 in a straightened configuration (ie, in the pre-primed state of the IUD 1102 in the insertion device 1100 prior to insertion of the IUD 1102 into the uterus). Next, a flange 1122, a finger holder 1124, and a reversible fixation means 1126 for the IUD removal thread 1102 are shown.

Next in FIG. 7C shows an enlarged view of IUD 1102. The IUD 1102 includes a frame 1146 having a first end 1148 and a second end 1150, wherein the length L is defined as the distance from the first end 1148 to the second end 1150. The frame 1146 is straightened and stretched when inserted into the insertion device 1100 assembly before inserting the IUD 1102 into the uterus. . The first end 1148 of the frame 1146 includes a first lock portion 1152, and the second end 1150 of the frame 1146 includes a second lock portion 1154. In this embodiment, the first lock portion 1152 is a pin and the second lock portion 1154 is a hinge. The first lock portion 1152 and the second lock portion 1154 have mating structures configured to permanently insert a pin into the loop. The first lock portion 1152 at the first end 1148 of the frame 1146 includes an opening 1156 for receiving the removal thread 1128.

In fig. 8A is a perspective view of a piston and plunger injection device assembly 1200 in accordance with one embodiment of the present invention. The piston and plunger assembly 1200 illustrates the location of the plunger 1202 within the piston 1204. The plunger 1202 includes means 1206 to prevent it from being removed from the handle body and an insertion device piston 1204.

In fig. 8B is a cross-sectional view of a piston and plunger injection device assembly 1200 in accordance with one embodiment of the present invention. In the node 1200 from the piston and plunger Plunger 1202 is attached to the piston 1204. The next type of distal part of the node 1200 is shown from the piston and plunger, which shows the hooking parts of 1208 pistons 1204. Plunger 1202 is fixed between the engaging parts 1208 piston 1204.

In fig. 9A is a schematic view of the insertion device 1300 with an enlarged view of a first portion 1302 of the insertion device 1300 depicting a piston 1304 that is movably located within the handle body 1306, in accordance with one embodiment of the present invention. The piston 1304 includes means 1308 for preventing the piston 1304 from being removed from the handle body 1306 . Next, an enlarged view of the second portion 1310 of the insertion device 1300 is shown to depict the first hook 1312 of the finger holder 1314, which engages the first recess 1316 of the handle body 1306 and which opens during the insertion process as the piston moves towards the distal end of the handle body, during the first part of the movement. .

In fig. 9B shows a schematic view of the insertion device 1300 with an enlarged view of the fourth portion 1324 of the insertion device 1300 to depict the clamps 1326 that secure the sizing tube 1328, in accordance with one embodiment of the present invention. The clamps 1326 secure the sizing tube 1328 such that the sizing tube 1328 is movably coupled within the distal end 1330 of the handle body 1306. The clamps are opened by a piston at the end of insertion when the IUD is completely inside the uterus and the locking parts are locked together.

In fig. 9C shows a schematic view of the insertion device 1300 with an enlarged view of the fifth portion 1332 of the insertion device 1300 depicting the location of the end housing 1334 within the sizing tube 1328. The fifth portion 1332 shows the IUD 1336 pre-threaded into the insertion device 1300 such that a small portion of the IUD frame 1338 1336 protrudes from the insertion device 1300, and the remainder of the frame 1338 is surrounded and protected by an end housing 1334. The following is an enlarged view of the IUD 1336. The frame 1338 of the IUD 1336 has a first end 1340 and a second end 1342. The frame 1338 is straightened and stretched when inserted into the insertion device 1300 before insertion of IUD 1336 into the uterus. The first end 1340 of the frame 1338 includes a first lock portion 1344, and the second end 1342 of the frame 1338 includes a second lock portion 1346. In this embodiment, the first lock portion 1344 is a pin and the second lock portion 1346 is a hinge. The IUD 1336 also includes a pharmaceutically active agent located within a frame 1338. The frame 1338 further includes a first frame segment 1348, a second frame segment 1350, and a third frame segment 1352. The first frame segment 1348 and the second frame segment 1350 are connected to each other through the first bend segment 1354. The second frame segment 1350 and the third frame segment 1352 are connected to each other through the second bend segment 1356. Attached to the hole in the first lock portion 1344 is a removal thread 1358. The fifth segment 1332 also shows the distal end 1360 of the plunger 1362, which is configured to engage with the second locking portion 1346. The plunger 1362 is hollow to allow passage of the IUD removal thread 1358 1336 through the plunger.

- 16 045214

1362.

In fig. 10A-4H show various views of the insertion device 1400 depicting various operational steps for placing the IUD 1402 in the uterus, in accordance with one embodiment of the present invention. With reference to FIG. 10A shows the adjustment of the flange 1404 on the sizing tube 1406 of the injector 1400, in accordance with one embodiment of the present invention. The flange 1404 is manually moved to a predetermined position on the sizing tube 1406 using insertion depth indicators 1408 on the outer surface of the sizing tube 1406. The specified position is the length of the uterine cavity plus the length of the cervical canal previously measured during probing of the uterus. Once installed, the flange 1404 does not move during the insertion process of the IUD 1402. The portion of the frame 1412 of the IUD 1402 that is outside the insertion device 1400 in a pre-inserted state is shown next. Moreover, in the pre-threaded state, the removal thread 1414 is connected to one end (i.e., the first end) of the frame 1412, passes through the insertion device 1400, and a portion of the removal thread 1414 exits the handle body 1416 of the insertion device 1400. To fix the removal thread 1414 between The handle body 1416 and the rotary handle 1418 are located in the first position by the rotary handle 1418.

In fig. 10B and 10C show one embodiment of flange 1404 in more detail. In this embodiment, flange 1404 includes a snap lock 1410 that is initially in an open position such that the flange can be easily moved. Once the flange is in the correct position (at the insertion depth indicators 1408), the snap lock 1410 is closed by pressing the flange and thus the snap lock is in the closed position.

In fig. 10D shows the first step of inserting an IUD 1402 through an insertion device 1400 in accordance with one embodiment of the present invention. At this point, a transition from a first state 1424 (left) to a second state 1426 (right) of the injection device 1400 is shown. In the first state 1424 (left), the end housing 1422 is shown in an extended position. A sizing tube 1406 extends through the vagina 1428 toward the cervix. The insertion device 1400 is positioned such that the end housing 1422 reaches the cervical opening, with the first end (ie, tip) of the IUD 1402 located within the cervical opening. At this point, the entire insertion device 1400 is gently pushed toward the subject, which causes the end housing 1422 to move rearward within the handle body 1416.

In the second state 1426 (right), the end housing is retracted into the handle body 1416, and a portion of the frame 1412 extends from the insertion device 1400 into the cervical canal 1430 and partially into the uterine cavity 1432. Next in the second state 1426, the distal end 1434 of the end housing is shown, which has a circular a bulbous structure to prevent the sizing tube 1406 from entering the cervical canal 1430. At this point, the pressure member 1436 of the piston 1438 is still spaced from the proximal end 1440 of the handle body 1416 (i.e., the piston 1438 is in an extended state).

In fig. 10E shows the second step of inserting an IUD 1402 using an insertion device 1400 in accordance with one embodiment of the present invention. At this point, in process 1442 (left), while maintaining intimate contact of the distal end of the end housing 1434 (i.e., the tip of the insertion device 1400) with a portion of the cervix, the piston 1438 is pressed by the pressure member 1436 from the proximal end of the piston 1438. The finger holder 1446 is used to support the fingers (eg, two fingers in this case) to comfortably press the piston 1438 toward the handle body 1416.

The piston 1438 is pressed from the proximal end until the piston 1438 is completely inside the handle housing 1416 and further movement of the piston 1438 is no longer possible (ie, the movement of the piston 1438 stops). The IUD 1402 begins to exit the insertion device 1400 and form a loop in the uterine cavity 1432. The movement of the piston 1438 moves the plunger 1450 attached to the piston 1438, which in turn pushes the end of the frame, and thus more frame is released from the insertion device 1400 to form a loop in the uterine cavity 1432.

In process 1448 (right), after the piston is fully seated in the handle body 1416, the finger holder 1446 is released from locking and moves to the proximal end of the handle body 1416. At this stage, the IUD 1402 is outside the insertion device 1400, but the IUD 1402 is at the entrance to the uterine cavity 1432. At this point, the plunger is also fixed within the injection device 1400 and cannot be moved further by pressing on the piston.

In fig. 10F shows the step in which the locking portions of the IUD 1402 are engaged while the IUD 1402 is positioned at the entrance to the uterine cavity 1432. The sizing tube 1406 is released and can thus move again.

In fig. 10G shows the third step of inserting an IUD 1402 using an insertion device 1400 in accordance with one embodiment of the present invention. At this point, the insertion device 1400 is advanced toward the patient until the flange 1404 engages the handle body

-

Claims (14)

1416 (ie, a portion of the proximal end 1406 of the sizing tube will fit inside the distal end 1454 of the handle body 1416). At this stage, IUD 1402 moves to its fundal position, and the entire The 1402 IUD is precisely positioned in the 1432 uterine cavity. In fig. 10H illustrates the release of the removal thread 1414 by the insertion device 1400 following deployment of the IUD 1402 into the uterine cavity, in accordance with one embodiment of the present invention. At this point, the removal thread 1414 is released by the rotary handle 1418. The rotary handle 1418 is moved to a second position from its original first position to allow the removal thread 1414 to move relative to the handle body 1416 and finally release it. In fig. 10I illustrates removal of the insertion device 1400 from a subject in accordance with one embodiment of the present invention. The insertion device 1400 is removed from the vagina 1428, indicating that insertion device 1400 has completed insertion of the IUD 1402. In fig. 11A is a schematic view of an insertion device assembly 1500 preloaded with an IUD 1502, in accordance with another embodiment of the present invention. The insertion device 1500 includes a handle body 1504 having a proximal end 1506 and a distal end 1508. The insertion device 1500 also includes a sizing tube 1510 having a proximal end 1512 and a distal end 1514. The proximal end 1512 of the sizing tube 1510 is movably attached to the distal end 1508 of the housing. 1504 handles . The insertion device 1500 further includes a flange 1522 movably positioned around the sizing tube 1510. A finger holder 1524 is located on the handle body 1504. In this embodiment, the finger holder 1524 is ring-shaped, that is, in the form of circles extending outward from diametrically opposite sides of the outer surface of the body 1504 handles at its proximal end 1506. The insertion device 1500 further includes a means 1526 of reversible fixation of the removal thread of the IUD 1502. The means 1526 of reversible fixation of the removal thread is located on the body 1504 of the handle. The insertion device 1500 also includes a piston 1530 that is movably located within the handle housing 1504. In fig. 11B is a perspective view of the injection device 1500 of FIG. 11A is exploded in accordance with one embodiment of the present invention. The insertion device 1500 further includes a plunger 1532 having a distal end 1534 and a proximal end 1536. In the insertion device 1500 assembly, the plunger 1532 is movably located within a handle body 1504 and a size tube 1510. The handle body 1504 has a first attachment portion 1538A and a second attachment portion 15 38V. Next, a first portion 1540A and a second portion 1540B of the sizing tube 1510 are shown, as well as a first portion 1542A and a second portion 1542B of the piston 1530. The IUD removal thread reversible locking means 1526 1526, as well as a flange 1550, are further shown. Modifications to the above-described embodiments of the present invention are possible without deviating from the scope of the present invention as defined by the appended claims. Expressions such as including, comprising, including, having, is, used to describe and claim the present invention are intended to be construed in a non-exclusive manner, that is, to admit the presence of elements, components or elements not expressly described. A reference to the singular shall also be construed to refer to the plural. CLAIM 1. Intrauterine system (100, 300, 400, 500, 600), including a frame (102, 302, 402, 502, 602) having a first end (104, 304, 404, 504, 604), a second end (106, 306, 406, 506, 606) and length L, specified as the distance from the first end to the second end; a removal thread (218, 326, 436, 626) attached to the first end of the frame; and at least one pharmaceutically active agent; wherein the first end of the frame includes a first locking portion (108, 308, 408, 508, 608), and the second end of the frame includes a second locking portion (110, 310, 410, 510, 610), wherein the first locking portion and the second locking portion are made with the possibility of forming a lock (202, 312, 432), and the removal thread is configured to guide the first lock portion into the second lock portion, wherein at least one pharmaceutically active agent is located in at least one capsule (330, 332, 334, 336 , 414, 416, 418, 420, 514, 516, 518, 624), with the capsule located around the frame (102, 302, 402, 502, 602) for most of its length L. 2. Intrauterine system (100, 300, 400, 500, 600) according to claim 1, in which the frame (102, 302, 402, 502, 602) includes a first segment (204, 314, 422, 612) of the frame, a second segment (206, 316, 424, 614) frame and a third frame segment (208, 318, 426, 616) having a width W defined as a dimension perpendicular to the length, the first and second frame segments being connected through the first segment (210, 320, 426, 520, 618) bend, and the second and third frame segments are connected through the second segment (212, 322, - 18 045214 428, 522, 620) bending; wherein the first bend segment has a first width W1, and the second bend segment has a second width W2, and the first width W1 is in the range of 5-50% of the width W and the second width W2 is in the range of 5-50% of the width W. 3. Intrauterine system (100, 300, 400, 500, 600) according to claim 1, in which the frame (102, 302, 402, 502, 602) includes a first segment (204, 314, 422, 612) of the frame, a second segment (206, 316, 424, 614) frame and a third frame segment (208, 318, 426, 616) having a width W defined as a dimension perpendicular to the length, the first and second frame segments being connected through the first segment (210, 320, 426, 520, 618) bend, and the second and third frame segments are connected through a second bend segment (212, 322, 428, 522, 620); wherein the first bend segment has a first width W1, and the second bend segment has a second width W2 and the first width W1 is in the range of 5-50% of the width W and the second width W2 is in the range of 100-150% of the width W. 4. Intrauterine system (100, 300, 400, 500, 600) according to claim 2 or 3, in which the cross-section of the frame (102, 302, 402, 502, 602) through the first segment (210, 320, 426, 520, 618) bend and through the second bend segment (212, 322, 428, 522, 620) have a substantially concave shape (214), where the first width W1 and the second width W2 are the smallest cross-sectional dimensions. 5. The intrauterine system (100, 300, 400, 500, 600) according to any of the previous paragraphs, in which the first locking part (108, 308, 408, 508, 608) is a pin, and the second locking part (110, 310, 410, 510, 610) is a loop, with the pin located so that it can be permanently inserted into the loop. 6. Intrauterine system (100, 300, 400, 500, 600) according to any one of claims 1 to 4, in which the first locking part (108, 308, 408, 508, 608) is a hook, and the second locking part (110 , 310, 410, 510, 610) is a loop, with the hook located so that it can be permanently inserted into the loop. 7. The intrauterine system (100, 300, 400, 500, 600) according to any of the previous claims, wherein the pharmaceutically active agent is selected from progesterone, estrogen, progestin, levonorgestrel, indomethacin, diclofenac, piroxicam, meloxicam and ketoprofen. 8. The intrauterine system (100, 300, 400, 500, 600) according to any of the previous paragraphs, in which the frame (102, 302, 402, 502, 602) includes a bending point (216, 324, 434, 622) that allows extraction intrauterine system. 9. Intrauterine system (100, 300, 400, 500, 600) according to any one of claims 1-8, including at least two capsules (330, 332, 334, 336, 414, 416, 418, 420, 514, 516 , 518, 624). 10. Intrauterine system (100, 300, 400, 500, 600) according to claim 9, in which the capsules (330, 332, 334, 336, 414, 416, 418, 420, 514, 516, 518, 624) include various pharmaceutically active agents. 11. Intrauterine system (100, 300, 400, 500, 600) according to any one of claims 1-10, in which at least one capsule (330, 332, 334, 336, 414, 416, 418, 420, 514, 516, 518, 624) is located around the frame (102, 302, 402, 502, 602) along its entire length with the exception of the first locking part (108, 308, 408, 508, 308) and the second locking part (110, 310, 410 , 510, 610). 12. Intrauterine system (100, 300, 400, 500, 600) according to any one of claims 2-11, including a first capsule (330, 414, 514) located around the first segment (314, 422) of the frame, a second capsule (334 , 416, 518) located around the second frame segment (316, 424), and a third capsule (418) located around the third frame segment (426); wherein the first locking part (108, 308, 408, 408, 508, 608), the first bending segment (210, 320, 428, 520, 618), the second bending segment (212, 322, 430, 522, 620) and the second the locking part (110, 310, 410, 510, 610) is not connected to the capsules (330, 332, 334, 336, 414, 416, 418, 420, 514, 516, 518, 624). 13. Intrauterine system (100, 300, 400, 500, 600) according to claim 1, wherein at least one pharmaceutically active agent is located in the frame (102, 302, 402, 502, 602). 14. A set for placing an intrauterine system, including an intrauterine system (100, 300, 400, 500, 600) according to any one of claims 1-13 and an insertion device (1100, 1300, 1400, 1500), wherein the insertion device includes a housing (1104 , 1306, 1416, 1504) handles having a distal end (1108, 1330, 1454, 1508), a proximal end (1106, 1440, 1506) and a length L _h , specified as the distance between the distal end and the proximal end; a sizing tube (1110, 1328, 1406, 1510) having a distal end (1114, 1514) and a proximal end (1112, 1512), the proximal end thereof being movably attached to the distal end of the handle body, the sizing tube being disposed to remain outside channel -