Intrauterine system with anchor

Abstract

An intrauterine system (100, 300, 400, 500, 600) is disclosed that includes a frame (102, 302, 402, 502, 602), a removal string (218, 326, 436, 626), and at least one pharmaceutically active agent. The frame has a first end (104, 304, 404, 504, 604), a second end (106, 306, 406, 506, 606), and a length L. 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), the first locking portion and the second locking portion being arranged to form a lock (202, 312, 432). A removal thread is attached to the first end of the frame. The removal thread is configured to guide the first locking portion to the second locking portion. Further disclosed is a kit including the above-mentioned intrauterine system and an insertion tool.

Description

[Technical field]

[0001] The present disclosure relates generally to long-acting reversible contraceptive systems, and more particularly to intrauterine systems. Additionally, the present disclosure relates to kits including the intrauterine systems and insertion devices. [Background technology]

[0002] Intrauterine systems (IUS) or intrauterine devices (IUDs) are typically positioned within the uterus using an inserter to prevent unwanted pregnancy, for family planning or to treat medical conditions. In the following, the abbreviation IUS will be used to encompass both IUS and IUDs. Proper function of the IUS depends on the configuration of the IUS and the correct placement of the IUS within the uterus.

[0003] A conventional IUS requires an insertion tube that passes through the cervix during insertion. In fact, in conventional IUS available on the market and disclosed in the prior art, the drug (hormone)-containing capsule is inside the insertion tube during the insertion procedure. As a result, the cross-sectional diameter that needs to pass through the cervix is ​​the diameter of the capsule, which is twice the wall thickness of the insertion tube.

[0004] Furthermore, during insertion of a conventional IUS with an inserter, there is a risk of uterine penetration during insertion. Indeed, if an inexperienced physician performs the insertion procedure or if the dimensions of the uterus are incorrectly determined in the probe step, the inserter may penetrate or even perforate the uterine wall.

[0005] It is hypothesized that the pain and discomfort associated with the insertion procedure is due to the stretching of the cervical channel. Therefore, in light of the above discussion, there is a need to overcome the aforementioned shortcomings associated with the conventional IUS. Summary of the Invention [Means for solving the problem]

[0006] The present disclosure seeks to provide an intrauterine system (IUS). The present disclosure also seeks to provide a kit including an IUS and an insertion tool. The present disclosure seeks to provide a solution to the existing problem of pain and discomfort experienced by subjects during placement of an IUS. One object of the present invention is also to reduce the diameter of the portion that must pass through the cervical channel during the IUS insertion process. A further object of the present invention is to provide a new IUS and its insertion tool that reduces the risk of uterine penetration during insertion.

[0007] It is an object of the present disclosure to provide a solution that at least partially overcomes the problems encountered in the prior art, provides an improved IUS that is highly flexible to increase patient acceptance, and provides a relatively comfortable experience during insertion of the IUS through the cervical canal and final placement in the uterus compared to existing systems.

[0008] In one aspect, an embodiment of the present disclosure comprises: a frame having a first end, a second end, and a length L defined as the distance from the first end to the second end; a removal string attached to a first end of the frame; at least one pharma- ceutical active agent; An intrauterine system comprising: A first end of the frame includes a first locking portion and a second end of the frame includes a second locking portion, the first locking portion and the second locking portion are arranged to form a lock, and the removal thread is configured to guide the first locking portion to the second locking portion.

[0009] In another aspect, an embodiment of the present disclosure provides a kit including an intrauterine system and an inserter, the inserter comprising: 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 measurement tube having a distal end and a proximal end, the proximal end of the measurement tube being movably attached to the distal end of the handle body, the measurement tube being positioned to remain outside the cervical channel during insertion; A plunger having a distal end, a proximal end, and a length Lp defined as a distance between the distal end and the proximal end, the plunger being movably disposed inside the handle body and the measuring tube, the length Lp being greater than the length Lh; a flange movably disposed so as to surround the measuring tube; A finger holder movably disposed so as to surround the handle body; a means for reversibly locking a removal string of the intrauterine system disposed in the handle body; Equipped with.

[0010] The embodiments of the present disclosure substantially eliminate or at least partially address the aforementioned problems in the prior art, allowing the disclosed IUS to be efficiently and conveniently inserted into the uterine cavity. The disclosed IUS has a small cross-sectional area, which minimizes discomfort and pain during insertion through the cervix. The disclosed IUS is adaptable to various drug loads and doses, paving the way for its use beyond mere contraceptive means. The disclosed IUS is also suitable for insertion without the need for any part of the insertion instrument having a cross-sectional diameter larger than the capsule to pass through the cervix, thus reducing the diameter of what actually passes through the cervix.

[0011] The IUS according to the present invention can be inserted without drawing the drug-filled capsule into the insertion tube. Thus, the diameter of the object that must pass through the cervical channel during the insertion procedure of the present invention is reduced by twice the wall thickness of the insertion tube of the conventional insertion tool. In fact, for the insertion of the IUS of the present invention, the insertion tool can prevent any part of the insertion tool having a cross-sectional diameter larger than the maximum diameter of the IUS from entering the cervical canal (and consequently the uterus).

[0012] A further advantage of the IUS according to the invention is that the risk of uterine penetration during the insertion procedure is minimized since there is no insertion tube that can penetrate the uterine muscle if inserted too deeply, and the IUS itself cannot be penetrated since it immediately begins to form its final shape after passage through the cervical channel.

[0013] Further aspects, advantages, features and objects of the present disclosure will become apparent from the drawings and detailed description of illustrative embodiments taken in conjunction with the appended claims.

[0014] It will be understood that features of the present disclosure can be combined in various combinations without departing from the scope of the present disclosure, which is defined by the appended claims.

[0015] The above summary, as well as the following detailed description of exemplary embodiments, will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the disclosure, exemplary configurations of the disclosure are shown in the drawings. The disclosure is not limited, however, to the particular methods and instrumentalities disclosed herein. Moreover, those skilled in the art will appreciate that the drawings are not to scale. Wherever possible, similar elements are designated with the same reference numerals.

[0016] Embodiments of the present disclosure will now be described, by way of example only, with reference to the following figures: [Brief description of the drawings]

[0017] [Figure 1] FIG. 1 is a perspective view of an IUS in a loaded configuration according to one embodiment of the present disclosure. [Diagram 2] 2 is a schematic diagram of the IUS of FIG. 1 according to one embodiment of the present disclosure. [Diagram 3] 1 is a schematic diagram of an IUS according to another embodiment of the present disclosure. [Figure 4A] 1 is a schematic diagram of an IUS in a loaded configuration according to yet another embodiment of the present disclosure. [Figure 4B]FIG. 4B is a perspective view of the IUS of FIG. 4A in a loaded configuration according to one embodiment of the present disclosure. [Figure 4C] 4B is a cross-sectional view of the IUS of FIG. 4A in a deployed state according to one embodiment of the present disclosure. [Figure 4D] 4B is a perspective view of the IUS of FIG. 4A in a deployed state according to various embodiments of the present disclosure. [Diagram 5] FIG. 1 is a perspective view of an IUS according to yet another embodiment of the present disclosure. [Figure 6A] 1 is a schematic diagram of a frame and an IUS according to one embodiment. [Figure 6B] 1 is another schematic diagram of a frame and an IUS according to one embodiment. [Figure 6C] 1 is yet another schematic diagram of a frame and an IUS according to one embodiment. [Figure 6D] 1 is yet another schematic diagram of a frame and an IUS according to one embodiment. [Figure 7A] FIG. 1 is a perspective view of an assembled insertion tool according to one embodiment of the present disclosure. [Figure 7B] FIG. 1 is a perspective view of an insertion tool in an unassembled state according to one embodiment of the present disclosure. [Figure 7C] FIG. 2 is a perspective view of a detail of an IUS according to one embodiment of the present disclosure. [Figure 8A] FIG. 13 is a perspective view of a piston and plunger subassembly of the insertion tool according to one embodiment of the present disclosure. [Figure 8B] FIG. 13 is a cross-sectional view of a piston and plunger subassembly with an engagement portion of the piston of an insertion tool according to one embodiment of the present disclosure. [Figure 9A] FIG. 1 is a schematic diagram of an insertion tool with an enlarged view showing the internal structure of a section of the insertion tool, according to one embodiment of the present disclosure. [Figure 9B] FIG. 13 is a schematic diagram of an insertion tool with an enlarged view showing the internal structure of another section of the insertion tool, according to one embodiment of the present disclosure. [Figure 9C]FIG. 13 is a schematic diagram of an insertion tool with an enlarged view showing the internal structure of yet another section of the insertion tool, according to one embodiment of the present disclosure. [Figure 10A] 1A-1C are diagrams of an insertion tool illustrating different stages of operation for positioning an IUS within a uterus, according to various embodiments of the present disclosure. [Figure 10B] 11A-11C are diagrams of an insertion tool illustrating different operational stages for positioning an IUS within a uterus, according to various embodiments of the present disclosure. [Figure 10C] 13A-13C are diagrams of an insertion tool illustrating yet another operational stage for positioning an IUS within a uterus, according to various embodiments of the present disclosure. [Figure 10D] 13A-13C are diagrams of an insertion tool illustrating yet another operational stage for positioning an IUS within a uterus, according to various embodiments of the present disclosure. [Figure 10E] 13A-13C are diagrams of an insertion tool illustrating yet another operational stage for positioning an IUS within a uterus, according to various embodiments of the present disclosure. [Figure 10F] 13A-13C are diagrams of an insertion tool illustrating yet another operational stage for positioning an IUS within a uterus, according to various embodiments of the present disclosure. [Figure 10G] 13A-13C are diagrams of an insertion tool illustrating yet another operational stage for positioning an IUS within a uterus, according to various embodiments of the present disclosure. [Figure 10H] 11A-11C are diagrams of an insertion tool illustrating yet another operational stage for positioning an IUS within a uterus, according to various embodiments of the present disclosure. [Figure 10I] 13A-13C are diagrams of an insertion tool illustrating yet another operational stage for positioning an IUS within a uterus, according to various embodiments of the present disclosure. [Figure 11A] FIG. 13 illustrates an assembled insertion tool according to another embodiment of the present disclosure. [Figure 11B] FIG. 13 illustrates an insertion tool in an unassembled state according to another embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] In the accompanying drawings, non-underlined numbers refer to items identified by a line connecting the non-underlined number to the item. Where a number is not underlined and has an associated arrow, the non-underlined number is used to identify the general item to which the arrow is pointing.

[0019] The following detailed description illustrates embodiments of the present disclosure and how they may be practiced. Although several aspects of practicing the present disclosure are disclosed, those skilled in the art will recognize that other embodiments for practicing or proceeding with the present disclosure are possible.

[0020] In one aspect, an embodiment of the present disclosure comprises: a frame having a first end, a second end, and a length L defined as the distance from the first end to the second end; a removal string attached to a first end of the frame; at least one pharma- ceutical active agent; An intrauterine system comprising: A first end of the frame includes a first locking portion and a second end of the frame includes a second locking portion, the first locking portion and the second locking portion are arranged to form a lock, and the removal thread is configured to guide the first locking portion to the second locking portion.

[0021] In another aspect, an embodiment of the present disclosure provides a kit including an intrauterine system and an inserter, the inserter comprising: 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 measurement tube having a distal end and a proximal end, the proximal end of the measurement tube being movably attached to the distal end of the handle body, the measurement tube being positioned to remain outside the cervical channel during insertion; A plunger having a distal end, a proximal end, and a length Lp defined as a distance between the distal end and the proximal end, the plunger being movably disposed inside the handle body and the measuring tube, the length Lp being greater than the length Lh; a flange movably disposed so as to surround the measuring tube; A finger holder movably disposed so as to surround the handle body; a means for reversibly locking a removal string of the intrauterine system disposed in the handle body; Equipped with.

[0022] The present disclosure provides an IUS as described above and a kit including the IUS as described above and an insertion tool that allows for efficient and convenient insertion of the IUS into the uterus. The IUS straightens out when loaded (by the manufacturer) into the insertion tool, and with the aid of the locking portion, returns to the desired shape when inserted into the uterine cavity (i.e., when in a deployed state). Furthermore, the disclosed IUS achieves a smooth shape, such as a triangular, annular, or rounded shape, in the deployed state. Such a smooth shape of the IUS not only ensures proper fit of the IUS within the uterus, but also reduces the risk of potential perforation of the endometrium. Furthermore, the frame segments, bend segments, and locking portions of the IUS allow the IUS to achieve a desired continuous smooth shape in its deployed state. Beneficially, the aforementioned IUS provides an intuitive insertion experience to the medical professional. Furthermore, the insertion tool of the above-mentioned kit allows for an overall increase in the success rate of insertion of the IUS with no or minimal discomfort to the subject. Furthermore, since the insertion tool does not include an insertion tube that enters the uterine cavity, the risk of uterine penetration during insertion is minimized.

[0023] The IUS comprises a frame. The frame has a flexible tubular structure designed to conform to the anatomical structure of the cervical region as well as the uterine cavity. The flexible structure allows the frame to bend easily into a shape and to withstand the strain and stress associated with that shape. For example, the frame can be stretched into a substantially straight line (i.e., a straight configuration) during insertion of the IUS using the insertion tool described above (or another suitable insertion tool), and achieves a predetermined shape when placed in the uterine cavity with the aid of the locking portion. Optionally, the frame may have a triangular, annular, elliptical, circular, polygonal, or almond shape in the deployed state.

[0024] Optionally, the frame has a predominantly essentially circular cross section, with the width W being the diameter of the frame. The frame preferably has a smooth cross section. Further optionally, the frame may have an oval or elliptical cross section to prevent damage to the uterine cavity. The width W of the frame may be in the range of 1.5-3.5 mm. The width W is typically 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. Beneficially, the smooth circular cross section and the small diameter of the frame facilitate frictionless and nearly painless insertion and removal of the IUS into the cervix and uterus, minimizing the risk of fundal perforation. Additionally, the manufacturing material of the frame provides the necessary elasticity for the IUS during use. The elasticity of the frame prevents expulsion of the IUS from the uterine cavity and displacement within the uterine cavity due to uterine contractions, as the flexible frame counteracts the stresses caused by uterine contractions.

[0025] Optionally, the frame is manufactured from a material selected from polyethylene, polypropylene, polyetheretherketone and thermoplastic polyurethane. Typically, the frame is made of an inert, biocompatible material of an elastomeric composition.

[0026] The bending segments, such as the first bending segment and the second bending segment, allow the frame to bend appropriately to achieve a desired shape. Furthermore, the aforementioned removal thread guides the first locking portion and the second locking portion to lock together, thereby providing a desired shape. In this specification, the removal thread also means a plurality of threads. The removal thread is attached in any suitable manner, such as by knotting or adhesive.

[0027] Optionally, the frame may comprise at least one diagnostic means for positioning the IUS in the uterine cavity without physical intervention. In one example, the at least one diagnostic means may be a radiopaque agent such as barium sulfate, e.g., up to 20 wt-% (weight percent) of the polymeric / elastomeric material of the frame. In another example, the at least one diagnostic means may be a ferromagnetic agent or an agent detectable by ultrasound or fluoroscopic imaging of the IUS in its deployed state. Optionally, the at least one diagnostic means is provided as an inert metal coated on at least a portion of the frame of the IUS, or as a partial metal ring, e.g., made of silver, embedded in the IUS.

[0028] 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. Typically, the term "first end" refers to the end closer to the subject's uterus during insertion of the IUS (also referred to as the distal end), and the term "second end" refers to the end opposite the first end, i.e., closer to a user such as a medical professional during insertion of the IUS with the use of an insertion tool (also referred to as the proximal end). Optionally, the length L of the frame ranges from 50 to 110 millimeters (mm) in a straight configuration (i.e., when loaded into an insertion tool). The length L may typically be from 50, 60, 70, 80, 90, or 100 mm to 60, 70, 80, 90, 100, or 110 mm. The frame of the IUS, once deployed at a desired location in the uterine cavity, can achieve a predetermined configuration (length x width) in the range of 25 x 23 mm to 31 x 28 mm, preferably 26 x 25 mm. In the deployed state, the length is typically 25, 27, or 29 mm to 27, 29, or 31 mm. Similarly, in the deployed state, the width is typically 23, 25, or 27 mm to 24, 26, or 28 mm. In one example, the frame configuration of a triangular IUS in the deployed state may be 26.6 x 24.5 mm (length x width). In another example, the frame configuration of a triangular IUS in the deployed state may be 26.2 x 24.3 mm (length x width).

[0029] Further, the first end of the frame comprises a first locking portion, and the second end of the frame comprises a second locking portion, and the first locking portion and the second locking portion are configured to form a lock. The first locking portion and the second locking portion extend overhangingly from the first end and the second end of the frame, respectively. Optionally, the first locking portion and the second locking portion are geometrically complementary structures, such as, for example, hook and loop, pin and loop (or slot), or clamp and column. It will be understood that the first locking portion and the second locking portion having geometrically complementary structures contact and engage with each other in the deployed state in the uterus. The first locking portion mechanically interacts with the second locking portion to lock the frame to properly position the IUS in the uterus. During locking, the first locking portion is directly and non-displaceably held by the second locking portion, thereby locking the frame in a desired shape. While unlocked, the first and second locking portions reside in a disengaged state, e.g., in a straight configuration at least partially inside the insertion tool, or in a configuration in which the IUS has not yet been fully inserted (or released) into the uterine cavity. It will be appreciated that external influences, such as uterine contractions, do not affect the locking of the frame when the first locking portion is locked to the second locking portion. In one embodiment, the width of the first and second locking portions may be greater than the width W of the frame. The width of the first and second locking portions may be in the range of 1.5 to 4 mm. The width of each of the first and second locking portions is typically from 1.5, 2, 2.5, 3, or 3.5 mm to 2, 2.5, 3, 3.5, or 4 mm. In particular, the materials of manufacture of the first and second anchors render the IUS, including the first and second anchors, highly malleable, such that the effective width and maximum outer diameter of the IUS is less than 3.7 mm, preferably less than 2.9 mm.

[0030] Optionally, the first locking portion is a pin and the second locking portion is a loop, the pin being configured to be permanently inserted into the loop. Engagement of the pin with the loop ensures that a substantial portion of the pin is engaged with the loop. Preferably, the pin has a knob-like structure and the loop has a complementary recess or aperture-like structure for more efficient pin-loop engagement. Engagement of the pin with the loop provides the frame with a desired shape in a deployed state within the uterus.

[0031] Optionally, the first locking portion is a hook and the second locking portion is a loop, and the hook is configured to be permanently inserted into the loop. The hook engages with the loop to lock the frame in a desired shape in a deployed state of the IUS in the uterus. Optionally, the first locking portion and the second locking portion are made from the same material used to make the frame. Optionally, the first locking portion is a clamp and the second locking portion is a column. The geometrically complementary structures of the clamp and the column lock into each other in a deployed state in the uterus.

[0032] According to one embodiment, the second locking portion is designed to completely accommodate the first locking portion when the locking portions are locked together. Such an embodiment ensures that when combined with an insertion tool, as described below, the first locking portion does not come into contact with the insertion tool plunger.

[0033] Optionally, the frame comprises first, second and third frame segments having a width W defined as the dimension perpendicular to the length, the first and second frame segments being connected via a first bend segment and the second and third frame segments being connected via a second bend segment. The width W of the first, second and third frame segments is essentially the same as the width of the frame. The width W of the first, second and third frame segments may be in the range of 1.5 to 3.5 mm. The width W is typically 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 and second bend segments allow the frame to bend a predetermined distance to allow the frame to achieve a desired triangular shape in the deployed state in utero. Typically, the flexion segment is thinner in at least one dimension than the frame segment to allow the frame segment to bend efficiently during insertion so that the IUS obtains its correct shape. However, the flexion segment (as a whole IUS) must withstand a force when the IUS is withdrawn, typically defined as 12 N. Therefore, it may be beneficial to make the flexion segment wider than the frame segment in the direction perpendicular to the direction in which the flexion segment is thinner than the frame segment.

[0034] According to one embodiment, the first and third frame segments are slightly curved, i.e., not completely straight. The radius can be, for example, 120-155% of the maximum dimension of the IUS when the IUS is locked into shape. Thus, the radius can be from 120, 125, 130, 135 or 140% to 130, 135, 140, 145, 150 or 155% of the maximum dimension, for example, about 45 mm. This helps the IUS to rotate correctly during insertion, thus minimizing discomfort to the patient and penetration of the uterine wall.

[0035] Optionally, the first bent segment is disposed at a first distance D1 from the first end, and the second bent segment is disposed at a second distance D2 from the first end, the first distance D1 being 25-40% of the length L, and the second distance D2 being 55-80% of the length L. The first distance D1 is typically from 25, 30 or 35% to 30, 35 or 40% of the length L. The first distance D1 may typically be from 12.5 to 44 mm, preferably from 17.5 to 28 mm. In one example, the first distance D1 is 32-34% of the length L of the frame, i.e., 16-37.4 mm. Similarly, the second distance D2 is typically from 55, 60, 65, 70 or 75% to 60, 65, 70, 75 or 80% of the length L. In one example, the first distance D1 may be 27.5 to 88 mm, preferably 38.5 to 56 mm. In one example, the second distance D2 is 65 to 67% of the length L of the frame, ie, 32.5 to 73.7 mm.

[0036] The first bent segment has a first width W1 and the second bent segment has a second width W2, where the first width W1 may be 5-50% of the width W and the second width W2 may be 5-50% of the width W. Further optionally, the first width W1 is 20-30% of the width W and the second width W2 is 20-30% of the width W. The width W1 is typically from 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 0.1-2 mm, preferably 0.4-1.2 mm. Similarly, the width W2 is typically from 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. For example, the width W2 may be 0.1 to 2 mm, preferably 0.4 to 1.2 mm. Thus, the first width W1 and the second width W2 may be substantially the same.

[0037] 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 can be 100-150% of W and W2 can be independently 100-150% of W. Indeed, W1 and W2 can be independently selected to be from 100, 105, 110, 115, 120, 125, 130, 135, or 140% to 105, 110, 115, 120, 125, 130, 135, 140, 154, or 150% of W.

[0038] Optionally, the cross section of the frame at the first and second bend segments has an essentially concave shape, and the first width W1 and the second width W2 are the smallest dimensions of the cross section. The concave shape of the cross section of the frame at the first and second bend segments allows bending of the IUS. In one embodiment, the cross section of the frame at the first and second bend segments can have different shapes, as long as the frame can be bent into a desired shape. For example, there may be a notch 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 be bent into a desired shape.

[0039] Optionally, the frame includes a bend point that allows the IUS to be removed. The bend point is a weak portion compared to other portions of the frame. In one embodiment, the bend point is provided in a middle portion of the frame that does not have a stop at its end, such as the middle section of the second frame segment. Alternatively, the bend point may be provided in other portions of the frame as long as it facilitates bending or breaking of the frame of the IUS. In one embodiment, during removal of the IUS from the IUS, when the removal thread is pulled, the IUS is bent at the bend point, thus breaking the circle or triangular shape of the frame, thereby allowing the "folded" frame to be removed through the cervical channel. The bend point should be designed so that the IUS does not bend in the wrong direction during insertion. In another embodiment, when the removal thread is pulled, the IUS breaks at the bend point.

[0040] The IUS comprises a removal thread attached to a first end of the frame. As used herein, the term "removal thread" refers to a thread (i.e., string) that is attached to the IUS at one end and used to remove the IUS at the end of the wearing period (about 3-10 years, preferably 5-7 years). The removal thread is not only used for removal and / or replacement of the IUS at the end of the wearing period, but also to detect (e.g., as an indication) whether the IUS is in the correct position in the uterine cavity after it has been deployed in the uterus. Additionally, the removal thread is typically used to hold the IUS in place relative to the insertion tool when it is in the sales package.

[0041] The removal thread is further configured to guide the first locking portion to the second locking portion. The removal thread guides the first locking portion to contact the second locking portion and further engages the first locking portion with the second locking portion to provide a desired shape for the IUS inside the uterine cavity. In other words, the removal thread guides the first locking portion to the second locking portion so that they engage and lock with each other when the removal thread is pulled. The distortion during pulling the removal thread causes the first locking portion to be immovably inserted into the second locking portion, thereby locking the frame in the desired shape. Optionally, the first end of the frame has an attachment means for coupling the removal thread. The attachment means may include, but are not limited to, for example, openings, perforations, recesses, protrusions, notches, and the like.

[0042] The IUS includes at least one pharmacoactive agent. In one example, the pharmacoactive agent may be a hormone, a drug or drug analog, an active pharmaceutical ingredient, or a health-promoting substance with contraceptive or other healing properties. Such pharmacoactive agents function by either thickening cervical mucus, altering the endometrium to make it unsuitable for egg implantation, stopping ovulation, or acting as a COX1 / COX2 inhibitor. In one example, the pharmacoactive agent may provide and / or enhance protection against various microbial infections, such as bacterial infections, fungal infections, and / or sexually transmitted diseases. The IUS may also include two or more pharmacoactive agents.

[0043] Optionally, the pharma- ceutical active agent is progesterone and its derivatives, estrogen, progestin, levonorgestrel, cyproterone acetate, desogestrel, etonogestrel, lynestrenol, medroxyprogesterone acetate, norethisterone, norethisterone acetate, norgestimate, drospirenone, gestodene, 19-nor-17-hydroxyprogesterone esters, 17a-ethynyltestosterone and its derivatives, 17a-ethynyl-19-nortestosterone and its derivatives. derivatives, ethynodiol diacetate, dydrogesterone, norethynodrel, allylstrenol, medrogestone, norgestrienone, ethisterone and dl-norgestrel; and androgenic steroids, such as danazol and gestrinone; naproxen, ibuprofen, mefenamic acid, flurbiprofen, indomethacin, diclofenac, piroxicam, meloxicam, ketoprofen, gonadotropin releasing hormone agonists, progesterone receptor antagonists, such as Mifepristone (11β-4-dimethylaminophenyl-17β-hydroxy-17α-propynyl-4,9-estradien-3-one); ulipristal acetate, (11β,17β)-17-hydroxy-11-[4-(methylsulfonyl)phenyl]-17-(pentafluoroethyl)-estra-4,9-dien-3-one, 17α-acetoxy-11β-[4-(N,N-dimethylamino)phenyl]-21-methoxy-19-norpregna-4,9-diene-3,20-dione , 17α-acetoxy-11β-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione, 11β-(4-acetylphenyl)-17β-hydroxy-17α-(1,1,2,2,2-pentafluoroethyl)-4,9-estradien-3-one, asoprisnil (benzaldehyde-4-[(11β,17β)-17-methoxy-17-(methoxymethyl)-3-oxoestra-4,9-dien-11-yl)]-1-oxime).

[0044] The hormone agent may be, for example, levonorgestrel, and the COX inhibitor may be indomethacin. It will be understood that the pharmacoactive agent is administered in an appropriate amount, for example, the maximum feasible amount suitable for the subject. Furthermore, the amount of the pharmacoactive agent (i.e., the dosage) will vary depending on the particular pharmacoactive agent, the intended use, the duration of action, the release rate and the duration of treatment, and the age and medical condition of the subject. Furthermore, the pharmacoactive agent typically has a pH level suitable for the uterus. Thus, the IUS not only functions as a long-acting reversible contraceptive method, but may also be used for various other purposes, such as treating medical conditions, uterine bloating, pain, etc., depending on the pharmacoactive agent delivered through the IUS.

[0045] Optionally, at least one pharma- ceutical active agent is disposed within the frame. In one example, the at least one pharma- ceutical active agent is dispersed or dissolved in the material of the frame prior to its manufacture. In one embodiment, the at least one pharma- ceutical active agent is provided in one of the three frame segments, i.e., the first, second, or third frame segments. In another embodiment, the at least one pharma- ceutical active agent is provided in all three frame segments.

[0046] Optionally, the at least one pharma- ceutical active agent is disposed in at least one capsule, and the capsule is disposed to surround the frame at a majority of its length L. Specifically, the at least one capsule is a drug container containing a pharma- ceutical active agent. The at least one capsule disposed to surround the frame can also provide the frame of the IUS with the necessary rigidity at such a portion of the length of the frame. The at least one capsule is disposed to surround at least one of the first frame segment, the second frame segment, or the third frame segment, and the first locking portion, the first bending segment, the second bending segment, and the second locking portion do not include the at least one capsule.

[0047] Optionally, the at least one capsule is disposed to surround the frame along its entire length, excluding the first and second locking portions. The at least one capsule is disposed to surround the first, second, and third frame segments. In such a case, the at least one capsule is sufficiently flexible to bend at the bend segment.

[0048] Optionally, the at least one capsule is made from poly(dimethylsilicone), siloxane-based elastomers, thermoplastic polyurethanes, thermoplastic polyurethane elastomers, ethyl acetate, polyolefin-based elastomers, silicone-containing thermoplastics, polyurethanes, polylactic acid, and polycaprolactone. Further optionally, the at least one capsule is made from a biocompatible polymer matrix. Examples of biocompatible polymer matrices include, but are not limited to, copolymers of dimethylsiloxane and methylvinylsiloxane, polyethylene, polypropylene, polybutadiene, polyisoprene, acrylic acid polymers, ethylene / propylene copolymers, ethylene / ethylacrylate copolymers, poly(methacrylates), polymethylmethacrylate, styrene-butadiene-styrene block copolymers, styrene-isobutylene-styrene copolymers, poly(hydroxyethylmethacrylate), polyethers, polyacrylonitrile, polyethylene glycol, polymethylpentene, polyhydroxyalkanoates, polyorthoesters, hydrophilic polymers (such as hydrophilic hydrogels), crosslinked polyvinyl alcohol, polytetrafluoroethylene, polyvinyl chloride, polyvinyl acetate, neoprene rubber, and butyl rubber.

[0049] 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, in which the pharma- ceutical active agent is dispersed or dissolved. In another example, in a core-membrane system, the at least one capsule may include a pharma- ceutical active agent core and a membrane that encases the pharma- ceutical active agent core. The core may be a hollow tube-like structure assembled on a frame (surrounding the frame for most of its length L) to deliver the pharma- ceutical active agent at a controlled rate in the uterus. The membrane may be a permeable layer composed of an inert material that prevents direct contact between the pharma- ceutical active agent and biological fluids in the uterus. Additionally, the membrane layer may regulate the release rate of the pharma- ceutical active agent by acting as a diffusion layer surrounding the pharma- ceutical active agent core. In one embodiment, the membrane may surround the at least one capsule from all directions, resulting in a closed capsule. In another embodiment, the at least one capsule is not completely surrounded by a membrane. In one embodiment, the membrane is more permeable compared to the pharma- ceutical active agent core, allowing the pharma- ceutical active agent to come into contact with biological fluids.

[0050] Optionally, the cross section of at least one capsule is selected from a circle shape and an oval shape. For example, the capsule can have a circular, circle shape, oval or elliptical cross section, as long as the shape is suitable for insertion into the cervix and uterus. Optionally, the outer diameter of the capsule is within the range of 2 to 3.5 mm, preferably about 2.9 mm. The outer diameter of the capsule is typically 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.

[0051] Optionally, the IUS comprises at least two capsules. In one example, the at least two capsules are arranged at a predetermined distance from each other on the frame. Preferably, when the IUS is inserted into the uterine cavity, the at least two capsules do not contact each other. Optionally, the number of capsules may be three, four, etc., depending on the different types of therapeutic agents to be administered.

[0052] Optionally, the IUS comprises a first capsule arranged to surround a first frame segment, a second capsule arranged to surround a second frame segment, and a third capsule arranged to surround a third frame segment, and the first locking portion, the first bending segment, the second bending segment, and the second locking portion do not include capsules. In this embodiment, the first capsule, the second capsule, and the third capsule can impart sufficient rigidity to the frame during the insertion process and further assist the IUS in achieving the desired continuous smooth shape (i.e., a pre-specified configuration) in its deployed state. The first locking portion, the first bending segment, the second bending segment, and the second locking portion do not have capsules to cause the necessary bending and / or shaping of the IUS frame.

[0053] Optionally, the capsules contain different pharmaceutically active agents. Optionally, the first capsule, the second capsule, and the third capsule may have the same or different structures and may contain the same or different pharmaceutically active agents. In one example, the first capsule may contain a first pharmaceutically active agent such as a progestin, the second capsule may contain a second pharmaceutically active agent such as diclofenac, and the third capsule may contain a third pharmaceutically active agent such as levonorgestrel. Further, the release of the pharmaceutically active agents from at least two capsules may occur simultaneously or sequentially depending on the release rate of the pharmaceutically active agent to be achieved and the respective interactions with the intrauterine body fluids.

[0054] Optionally, a first pharma- ceutical active agent is disposed within a capsule, the capsule being disposed to surround the frame over a majority of its length L, and a second pharma- ceutical active agent is disposed within the frame. The capsule affects the release rate of the pharma- ceutical active agent in the uterus. At least one pharma- ceutical active agent dispersed or dissolved in the manufacturing material of the frame has a release rate of the pharma- ceutical active agent that is different from the release rate of the pharma- ceutical active agent disposed within the capsule. It will be understood that the release rate of the pharma- ceutical active agent depends on the permeability of the manufacturing material of the frame and / or the capsule.

[0055] According to one embodiment, the frame is obtained by an injection molding process. One capsule is placed to surround a portion of the frame forming the capsule-frame assembly. However, if there is more than one capsule, the capsules can be placed anywhere on the frame depending on the desired shape of the IUS to be achieved, and at least the first locking portion and the second locking portion do not include a capsule.

[0056] In another exemplary aspect, an embodiment of the present disclosure comprises: a frame having a first end, a second end, and a length L defined as the distance from the first end to the second end; a removal string attached to a first end of the frame; a copper wire disposed around at least a portion of the frame; An intrauterine system comprising: A first end of the frame includes a first locking portion and a second end of the frame includes a second locking portion, the first locking portion and the second locking portion are arranged to form a lock, and the removal thread is configured to guide the first locking portion to the second locking portion.

[0057] According to this embodiment, the copper wire disposed around at least a portion of the frame functions as a contraceptive by preventing fertilization of an egg by sperm. A copper IUS (i.e., an IUS that includes copper) is hormone-free and therefore a good option for women who, for medical reasons, prefer or are recommended to use non-hormonal birth control methods.

[0058] The present disclosure also provides a kit including an intrauterine system and an insertion tool. The IUS of the kit is as described above. According to one embodiment, the IUS is pre-installed (or pre-loaded) in the insertion tool in a sterile distribution package. The distribution package protects the contents of the kit from environmental and mechanical factors. The various embodiments and variations described above for the IUS apply mutatis mutandis to the IUS of the kit.

[0059] Thus, the present disclosure provides a kit for efficient and convenient IUS insertion into the uterus. The insertion tool allows for the insertion of the IUS into a stable position within the uterus. The insertion tool is easy to use and allows for the IUS to be inserted directly into the cervical canal instead of inserting any part of the insertion tool into the cervical canal to reduce pain associated with IUS placement into the cervical canal. Furthermore, due to the small cross-sectional area of ​​the IUS, the insertion of the IUS into the uterus is largely painless, or at least less painful than conventional IUS and insertion tools. Furthermore, various parts of the insertion tool are released at specific times during the IUS insertion process, thereby providing the medical professional with an intuitive and improved experience while manipulating the insertion tool in the IUS insertion process. Thus, the use of the kit may allow for an overall increase in the success rate of IUS insertion with no or minimal discomfort to the subject.

[0060] As used herein, the proximal end is the end closest to the user (physician) during insertion of the IUS, and the distal end is the opposite end furthest from the user.

[0061] The insertion tool comprises 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 handle body is preferably designed to easily handle the insertion tool with one hand. Furthermore, the handle body is preferably designed to avoid any handedness preference. In other words, the insertion tool functions equally when held using the handle body in either the right or left hand.

[0062] According to one embodiment, the handle body is manufactured from a polymeric material (e.g., a medical grade plastic material) and is available for single use for sanitary purposes. The handle body can have various shapes and sizes. The handle body is typically a hollow elongated structure, e.g., tubular, cylindrical, elliptical, oval, rectangular, etc. The handle body serves as a housing and support structure for various components of the insertion tool. Furthermore, the handle body may be designed to fit in the palm of a medical practitioner's hand. In one example, the handle body has a first cover portion and a second cover portion. Each of the first cover portion and the second cover portion can have a geometrically complementary structure for attachment to each other in the assembled state of the insertion tool. According to one embodiment, the length Lh is 70-110 mm. Optionally, the length Lh of the handle body is about 94 mm. The length Lh is typically from 70, 75, 80, 85, 90, 95 or 100 mm to 80, 85, 90, 95, 100, 105 or 110 mm.

[0063] The insertion tool further comprises a measuring tube having a distal end and a proximal end. The proximal end of the measuring tube is movably attached to the distal end of the handle body. The measuring tube is a hollow tubular structure. Optionally, the measuring tube has a circular or oval cross-section.

[0064] Optionally, the proximal portion of the measuring tube is provided with an insertion depth indicator, for example on its outer surface. In one example, the insertion depth indicator can point to a calibration line with a corresponding numerical value marked on the outer surface of the proximal portion of the measuring tube. Such an insertion depth indicator is used to correctly set the aforementioned flange in the correct position on the measuring tube at the start of the IUS insertion process after the insertion length (i.e., the uterine and cervical length) has been measured.

[0065] Optionally, the measuring tube is manufactured from a medical grade polymeric material such as polyethylene, polypropylene, silicone, or metal. Optionally, the measuring tube may be made of polyetheretherketone, thermoplastic polyurethane, thermoplastic polyurethane elastomer, etc. It may include a reinforcing material such as fiberglass.

[0066] The insertion tool further comprises a plunger having a distal end, a proximal end, and a length Lp defined as the distance between the distal end and the proximal end. The plunger is movably disposed inside the handle body and the measuring tube. The length Lp is greater than the length Lh. According to one embodiment, the length Lp is 50-90 mm. The length Lp is typically from 50, 55, 60, 65, 70, 75, or 80 mm to 60, 65, 70, 75, 80, 85, or 90 mm.

[0067] According to one embodiment, the plunger is hollow to allow the removal thread of the intrauterine system described above to pass through the plunger. Thus, the plunger can be a thin hollow tubular structure that allows the removal thread to pass through the plunger. It will be understood that the term "removal thread" as used herein refers to one or more threads (i.e., strings) that are attached to the IUS at one end and used to remove the IUS at the end of the wearing period (which can be, for example, 5 to 7 years). The removal thread is not only used for removal of the IUS, but also to detect whether the IUS is in the correct position in the uterine cavity after it has been deployed in the uterus. In one example, the IUS may be preloaded in an insertion tool in a sales package. In the preloaded state of the IUS, one end of the removal thread remains coupled to the aforementioned first anchor of the IUS, and the other end of the removal thread passes through the plunger.

[0068] According to one embodiment, the distal end of the plunger is configured to cooperate with the second stop. Optionally, a portion of the plunger at the distal end may have a geometrically complementary form to the second stop. Optionally, the plunger is made of a medical grade polymeric material, such as polyethylene, polypropylene, silicone, or metal.

[0069] According to one embodiment, the plunger comprises means for preventing removal of the plunger from inside the handle body. The plunger may comprise these means for preventing removal of the plunger from inside the handle body at the proximal end of the plunger. In one embodiment, the means have a circumference greater than that of the rest of the plunger. Optionally, the means are in the form of a ring or polygonal part that holds the plunger inside the piston and the handle body. The plunger is mounted at its distal end within the piston. In particular, the plunger is locked between engagement parts of the piston. In one example, the engagement parts of the piston may be small protrusions that extend inwardly from geometrically opposite directions from the inner surface of the distal part of the piston.

[0070] The insertion tool further comprises a flange movably arranged around the measuring tube. In one embodiment, an insertion depth indicator on the measuring tube allows the user to set the position of the flange. At the start of the IUS insertion procedure, the flange is manually moved to a designated position on the measuring tube with the help of an insertion depth indicator on the outer surface of the proximal portion of the measuring tube. The designated position refers to the length of the uterine cavity plus the length of the cervical canal previously measured during a uterine gastroscopy. Once set on the measuring tube of the insertion tool, a firm grip of the flange is established against the measuring tube, thereby preventing undesired movement of the flange from its initial set position when the insertion tool is used in the IUS insertion process.

[0071] Optionally, the flange is provided with gripping surfaces on two diametrically opposite sides of the outer part of the flange. In one example, the gripping surfaces have a wavy structure to allow a firm grip with the fingers of one hand and to press the outer part of the flange towards the inner part of the flange in order to adjust the flange to the correct position by sliding the flange on the measuring tube. In such a case, release of the grip sets the flange in place and friction between the flange and the measuring tube allows the flange to stay in place.

[0072] Optionally, the flange has a length Lr. The length Lr is 2-10%, preferably 4-8%, of the length L of the measuring tube of the insertion tool. In one example, Lr may be from 2, 3, 4, 5, 6, 7, or 8 to 4, 5, 6, 7, 8, 9, or 10% of L. Optionally, the flange is made of a polymeric material, such as low density polyethylene, high density polyethylene, polypropylene, thermoplastic polyurethane, thermoplastic polyurethane elastomer, polyetheretherketone, and / or combinations thereof. The flange can have various shapes, for example, rounded rectangular, oval, elliptical, circular, etc.

[0073] The insertion tool may further comprise a tip cover, the tip cover having a distal end and a proximal end, and arranged to retract inside the distal end of the measuring tube when the tip cover is arranged to remain outside the cervical channel during insertion. The distal end of the tip cover has a round-ball structure to prevent the measuring tube from entering the cervical canal of the subject. The proximal end of the tip cover is movably arranged within the inner surface of the measuring tube at the distal end of the measuring tube. During insertion of the IUS, when the insertion tool is pushed towards the subject, the tip cover slides back (i.e., towards the handle body) and engages with the inner surface of the measuring tube. Optionally, the tip cover is movably attached to the outer surface of the measuring tube and slides over the measuring tube.

[0074] The insertion tool further comprises a finger holder movably arranged to surround the handle body. The finger holder can be used as a support for fingers (e.g., two fingers) to conveniently push the piston toward the distal end of the handle body during the IUS insertion process. According to one embodiment, in the assembled state of the insertion tool, only the optional tip cover, the flange, and the means for reversibly locking the removal thread (e.g., thread lock) are movable, and the other parts of the insertion tool are locked. The other parts of the insertion tool are only released at a certain time during use (i.e., during the IUS insertion process). For example, the finger holder is initially locked in the insertion tool. Optionally, the finger holder comprises one or more hooks that lock the movement of the finger holder in the insertion tool. In one embodiment, the finger holder comprises two hooks, such as a first hook and a second hook, that can be locked in corresponding recesses provided in the distal end of the handle body. When the piston is fully entered into the handle body during the IUS insertion process, the finger holder is unlocked and moves toward the proximal end of the handle body. Also, after the finger holder moves to the proximal end of the handle body, the lock that holds the measurement tube in motion relative to the handle body is released. In one example, one or more clamps can be used to lock the movement of the measurement tube relative to the handle body. The proximal portion of the measurement tube moves inside the handle body until the flange abuts the distal end of the handle body. Thus, various portions of the insertion tool are released at specific times during the IUS insertion process, thereby providing an intuitive and improved experience for the medical professional and a comfortable experience for the subject during the IUS insertion process.

[0075] The finger holder may be disposed at a proximal end of the handle body. The finger holder may have one or two ring-like or semi-ring-like structures to provide a grip for at least two fingers. In other words, the finger holder may be in the form of a circle extending outwardly 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 disposed on the handle body. Optionally, the finger holder is fixedly disposed on the handle body.

[0076] The insertion tool further comprises a means for reversibly locking a removal thread of the intrauterine system arranged in the handle body. According to one embodiment, the means for reversibly locking the removal thread comprises a rotatable knob arranged in a first position to lock the removal thread between the handle and the knob and arranged in a second position to allow the removal thread to be moved relative to the handle body. Optionally, the knob and the handle body comprise corresponding configurations that allow locking the removal thread when the knob is in the first position.

[0077] In another embodiment, the means for reversibly locking the removal thread may be a roller-like mechanism around which the removal thread is wound. The removal thread may be locked when the roller-like mechanism rolls in one direction (e.g., forward) and the removal thread may be released when the roller-like mechanism rolls in the other direction (e.g., reverse). In one example, the roller-like mechanism may be a pinion disposed in an opening in the handle body and having a corresponding portion.

[0078] According to one embodiment, the insertion tool further comprises a piston attached to the plunger and arranged to move the plunger, the piston being movably arranged inside the handle body. The piston is arranged at a proximal end of the handle body. Furthermore, the proximal end of the piston comprises a pressing member. The pressing member is provided, for example, on the thumb of a user of the insertion tool. When the pressing member of the piston is pressed, the piston enters the interior of the handle body and advances further toward the distal end of the handle body. In one example, the pressing member may be integrated into the piston during an injection molding process. Also, the plunger locks between the engagement portions of the piston described above. In the IUS insertion process, when the piston is pressed forward toward the distal end of the handle body, the plunger is pushed into the cervical canal and partially into the uterine cavity.

[0079] According to one embodiment, the piston is hollow to allow the removal thread of the intrauterine system to pass through the piston. The piston is a hollow tubular structure that allows the removal thread to pass through. In one example, the IUS may be preloaded into the insertion tool in the sales package. In the preloaded state of the IUS, one end of the removal thread remains connected to the aforementioned first locking part of the IUS, while the other end of the removal thread passes through the plunger and the piston and emerges from the handle body around the means for reversibly locking the removal thread.

[0080] According to one embodiment, the piston comprises a means for preventing removal of the plunger from inside the handle body. The piston may comprise a means for preventing removal from inside the handle body at a distal end of the piston. In one example, the means for preventing removal of the piston from inside the handle body may be at least one protrusion extending from an outer surface of the piston at a distal end of the piston. The at least one protrusion prevents accidental removal of the piston from the handle body. In another example, two protrusions may be attached or disposed on the outer surface of the piston. The two protrusions may extend in two geometrically opposite directions from the outer surface of the piston. Optionally, the means for preventing removal of the piston from inside the handle body may be in the form of a ring that fits the inner diameter of the handle body.

[0081] According to one embodiment, the process of IUS insertion into the uterus (i.e., the operational stages of the insertion tool described above, if used), will be described using an IUS with an anchoring portion as an example, as follows.

[0082] Typically, prior to insertion, the IUS is stored in a sales package at least partially inside the insertion tool (i.e., preloaded in the insertion tool). A removal thread (also a guide thread) is attached to a first end of the frame of the IUS (i.e., the end that first enters the uterus), and the other end of the removal thread is attached to the handle body. According to one embodiment, the IUS is preloaded in the insertion tool such that a small portion of the IUS protrudes from the insertion tool, and the remaining portion of the IUS is surrounded and protected by the tip cover. In one example, about 10 mm of the frame is left outside the insertion tool (i.e., outside the tip cover of the measuring tube) in the preloaded state. The insertion tool is used in aseptic conditions with a pair of sterile gloves worn by the user (e.g., a medical professional). The insertion process then begins with the adjustment of the flanges.

[0083] A) Flange adjustment: The flange is manually moved to a specified position on the measuring tube with the help of an insertion depth indicator on the outer surface of the measuring tube. The specified position refers to the length of the uterine cavity + the length of the cervical canal previously measured during a uterine gastroscopy. In one example, the outer part of the flange can be pressed towards the inner part using gripping surfaces provided on two diametrically opposite sides of the flange.

[0084] After adjustment of the flanges, the steps differ slightly depending on whether the insertion tool has a tip cover or not. Below, both variants are disclosed (step B for devices without tip cover, step B″ for devices with tip cover).

[0085] B) First IUS insertion stage: the measuring tube is passed through the vagina towards the cervix. The inserter is positioned so that the distal end of the measuring tube reaches the cervical opening (i.e. the external orifice) and the first end (i.e. the tip) of the IUS is located inside the cervical opening. At this stage, the piston is in an extended state and the aforementioned pressing member of the piston is away from the proximal end of the handle body.

[0086] B') First IUS insertion stage: The measuring tube is passed through the vagina towards the cervix. The inserter is positioned so that the tip cover reaches the cervical opening (i.e., the external orifice) and the first end (i.e., the tip) of the IUS is located inside the cervical opening. The entire inserter is then gently pushed towards the subject, which causes the tip cover to move backwards (i.e., towards the handle body) and a portion (e.g., about 30 mm) of the frame to be released from the inserter at the cervical canal. As the tip cover moves backwards, it locks itself inside the measuring tube. In other words, the cervical opening prevents the tip cover from moving forward with the inserter, and instead forces the tip cover to enter the inside of the measuring tube and lock onto the inner surface of the distal part of the measuring tube. The inserter is gently pushed towards the subject until resistance from the inserter, typically physical pressure, is felt by the user. The measuring tube itself is not passed through the cervical canal at any stage during the IUS insertion process, thereby reducing discomfort during the IUS insertion process, in which the piston is in an extended state and the aforementioned pushing member of the piston is away from the proximal end of the handle body.

[0087] C) Second IUS insertion stage: While maintaining firm contact of the measuring tube (if a tip cover is used, the contact point of the tip cover, i.e. the tip of the insertion tool) to the cervix, the piston is pressed from its proximal end towards the distal end of the handle body. The finger holder can be used as a support for the fingers (e.g. two fingers) to conveniently press the piston towards the distal end of the handle body. The IUS, under the influence of the removal thread held firmly (when attached to the handle body), leaves the insertion tool and starts to form a loop. The movement of the piston moves the plunger attached to the piston, which in turn pushes the end of the frame (i.e. the second lock mentioned above), thus releasing more of the frame from the insertion tool into the uterine cavity. Before the piston is completely inside the handle body, the piston opens the lock of the finger holder, thus allowing its movement. The movement of the finger holder (while the piston and plunger are not moving) causes the IUS to form its final shape, but does not move further in the uterus. The finger holder also unlocks the plunger and piston, locking the IUS into its final shape after the user manipulates the piston (pushing toward the distal end of the handle body). Thus, the user pushes the piston while holding the finger holder tightly, and the stop in the handle ensures said movement.

[0088] Thus, when the finger holder contacts the proximal end of the handle body (and the movement of the piston within the handle body stops), the IUS is outside the insertion tool and the locking parts (i.e., the first locking part and the second locking part) of the IUS lock. The piston is locked inside the handle body by the finger holder snap hook so that the user cannot pull it back. The locking part of the measuring tube is opened, allowing its movement.

[0089] D) Third IUS insertion phase: The entire insertion tool is pushed towards the patient until the flange contacts the handle body. In this phase, part of the measuring tube travels inside the handle body (i.e. towards the medical professional). This pushes the IUS into the correct position within the uterus. In other words, the IUS moves into fundal position and the entire IUS is accurately positioned within the uterine cavity.

[0090] E) Release of removal thread and removal of insertion instrument: The removal thread is released. The removal thread is released by rotating the means for reversibly locking the removal thread. In one embodiment, the means for reversibly locking the removal thread comprises a rotatable knob, which is rotated from a first position to a second position to allow the removal thread to be moved relative to the handle body and further to allow the removal thread to be released. Optionally, the removal thread is released by pressing a thread cutting button provided on the handle body. When the thread cutting button is pressed, a cutter blade inside the handle body cuts the removal thread. The insertion instrument is positioned such that the removal thread is cut and approximately 2-3 cm is visible outside the cervix (i.e., outside the external orifice and approximately 2-3 cm into the vagina and detectable by touch). The insertion instrument is then withdrawn from the subject indicating completion of the IUS insertion process by the insertion instrument.

[0091] Instead of a piston, different means for moving the plunger may be used in the IUS insertion process as described above, but it should be understood that the use of a piston makes the operation of the insertion instrument much more convenient. For example, the plunger may be moved using a slider disposed on the handle body. Further, in another embodiment, instead of the tip cover moving inside the measurement tube (e.g., in the first IUS insertion stage as described above), the tip cover slides over the distal end of the measurement tube and locks itself onto the outer surface of the measurement tube. In such a case, the tip cover may need to be made of two parts instead of one (i.e., when the tip cover is drawn into the measurement tube, the tip cover is made of one part). Further, additional welding may be required to assemble the two parts of the tip cover onto the measurement tube. The present insertion instrument is also suitable for other types of IUSs other than those described herein.

[0092] Detailed Description of the Drawings Referring to FIG. 1, a perspective view of an IUS 100 in a loaded configuration according to an embodiment of the present disclosure is shown. As shown, the IUS 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 extended when loaded into the insertion instrument before the IUS 100 is inserted into the uterus. The first end 104 of the frame 102 includes a first locking portion 108, and the second end 106 of the frame 102 includes a second locking portion 110. In this embodiment, the first locking portion 108 is a hook and the second locking portion 110 is a loop. Further, the outer diameter 112 (i.e., the maximum outer diameter) of the IUS 100 is shown. The IUS 100 further includes a pharmaceutically active agent disposed within the frame 102.

[0093] 2 shows a schematic diagram of the IUS 100 of FIG. 1 according to one embodiment of the present disclosure. In this embodiment, the frame 102 of the IUS 100 is a triangular shaped frame. A first stop 108 at a first end 104 of the frame 102 and a second stop 110 at a second end 106 of the frame 102 are positioned to form a deployed lock 202 in the uterus.

[0094] The frame 102 further comprises 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 via a 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 the same as the width of the frame 102. Further, the first bend segment 210 having a first width W1 and the second bend segment 212 having a second width W2 are shown. In this embodiment, the cross section of the frame 102 at the first bend segment 210 and the second bend segment 212 has an essentially concave shape 214. The first width W1 and the second width W2 are the smallest dimensions of the cross section of the frame 102. In this embodiment, the first width W1 is essentially the same as 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., localized thinning) at the first bend segment 210 and the second bend segment 212 compared to other portions of the frame 102 facilitates bending of the frame 102 into a triangular shape. The frame 102 further comprises a bend point 216 that facilitates removal of the IUS 100, if desired.

[0095] The IUS 100 further comprises a removal string 218 attached to the first end 104 of the frame 102. Specifically, the removal string 218 is coupled to an opening 220 in the first holdup 108 at the first end 104 of the frame 102. The removal string 218 is configured to guide the first holdup 108 towards the second holdup 110. Additionally, a length 222 and a width 224 of the frame 102 of the triangular shaped IUS 100 in a deployed state within the uterus are shown.

[0096] 3, a schematic diagram of an IUS 300 is shown, according to another embodiment of the present disclosure. The IUS 300 comprises a frame 302 having a first end 304 and a second end 306. In this embodiment, the frame 302 is a triangular shaped frame. The first end 304 of the frame 302 comprises a first lock 308 and the second end 306 of the frame 302 comprises a second lock 310. The first lock 308 and the second lock 310 are arranged to form a lock 312. The first lock 308 is a hook and the second lock 310 is a loop, with the hook configured to be permanently inserted into the loop.

[0097] The frame 302 further comprises 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 via a first bend segment 320. Similarly, the second frame segment 316 is connected to the third frame segment 318 via a second bend segment 322. In this embodiment, the frame 302 further comprises two bend points 324 that allow for removal of the IUS 300. The area between the two bend points 324 is a weaker portion of the frame 302 compared to other portions of the frame 302.

[0098] The IUS 300 further comprises a removal thread 326 attached to the first end 304 of the frame 302. The removal thread 326 is received in an opening 328 in the first anchor 308. The removal thread 326 is configured to guide the first anchor 308 towards the second anchor 310. The IUS 300 further comprises four capsules, a first capsule 330, a second capsule 332, a third capsule 334 and a fourth capsule 336. The first capsule 330 has a shorter length compared to the other capsules 332, 334 and 336. The capsules 330, 332, 334 and 336 contain the same or different pharma- ceutical active agents.

[0099] 4A shows a schematic diagram of an IUS 400 in a loaded configuration according to yet another embodiment of the present disclosure. As shown, the IUS 400 comprises a frame 402 having a first end 404, a second end 406, and a length L defined as the distance from the first end 404 to the second end 406. The frame 402 is straightened and extended when loaded into an insertion tool (i.e., in the loaded configuration) prior to inserting the IUS 400 into the uterus. The first end 404 of the frame 402 comprises a first stop 408 and the second end 406 of the frame 402 comprises a second stop 410. In this embodiment, the first stop 408 is a pin and the second stop 410 is a loop. The first stop 408 and the second stop 410 have complementary structures to allow the pin to be permanently inserted into the loop. The first anchor 408 of the IUS 400 includes an opening 412 for receiving a removal suture.

[0100] The frame 402 further comprises 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 disposed to surround a first frame segment 422 and a second frame segment 424, respectively. The third capsule 418 and the fourth capsule 420 are disposed to surround a third frame segment 426 of the frame 402. Additionally, a first flex segment 428 and a second flex segment 430 are shown. The first frame segment 422 is connected to the second frame segment 424 via the first flex segment 428, and the second frame segment 424 is connected to the third frame segment 426 via the second flex segment 430.

[0101] 4B illustrates a perspective view of the IUS 400 of FIG. 4A, according to one embodiment of the present disclosure. As shown, the first catch 408 is a pin and the second catch 410 is a loop, i.e., the pin has a geometrically complementary structure such that it substantially engages the loop in a deployed state of the IUS 400 in the uterus.

[0102] FIG. 4C shows a schematic cross-sectional view of the IUS 400 in a deployed state, according to an embodiment of the present disclosure. In the deployed state, the frame 402 of the IUS 400 assumes a triangular shape when the first catch 408 and the second catch 410 engage to form a lock 432. The frame 402 further comprises a bend point 434 that allows the IUS 400 to be removed. In this embodiment, the bend point 434 is located in the middle section of the second bend segment 430 and is a weaker portion compared to other portions of the frame 402. Further shown are a first capsule 414 disposed to surround the first frame segment 422, a second capsule 416 disposed to surround the second frame segment 424, a third capsule 418 disposed to surround a portion of the third frame segment 426, and a fourth capsule 420 disposed to surround another portion of the third frame segment 426 of the frame 402, respectively. The first hook 408 includes an opening 412 for receiving a removal string 436. The removal string 436 guides the first hook 408 against and engages the second hook 410 to impart the desired triangular shape to the frame 402 in the deployed uterus.

[0103] 4D illustrates a perspective view of the IUS 400 of FIG. 4C in a deployed state, according to one embodiment of the present disclosure. As shown, the first and second catches 408, 410 have geometrically complementary structures such that the first catch 408 substantially engages the second catch 410 to form a deployed lock 432 in the uterus.

[0104] FIG. 5 shows a schematic diagram of an IUS 500 according to yet another embodiment of the present disclosure. The IUS 500 comprises a frame 502 having a first end 504 and a second end 506. The first end 504 of the frame 502 comprises a first locking portion 508, and the second end 506 of the frame 502 comprises a second locking portion 510. The first locking portion 508 and the second locking portion 510 have geometrically complementary structures in a clamp and column arrangement such that the first locking portion 508 can be locked to the second locking portion 510. The first locking portion 508 comprises an opening 512 for receiving a removal suture. The frame 502 further comprises a first capsule 514, a second capsule 516, and a third capsule 518 spaced apart to surround a portion of the frame 502. In this embodiment, the frame 502 has a rounded rectangular tubular cross section. In the deployed state in utero, the frame 502 is bent at two bending segments 520 and 522 that are free of the capsules, namely the first capsule 514 , the second capsule 516 , and the third capsule 518 .

[0105] 6A-6D are schematic diagrams of an IUS frame and an IUS according to one embodiment, showing how the IUS is locked into shape. Indeed, FIG. 6A shows a frame 602 of an IUS. The figure also shows a first end 604 of the frame and a second end 606 of the frame. The first end 604 of the frame 602 includes a first stop 608 and the second end 606 of the frame 602 includes a second stop 610. In this embodiment, the first stop 608 is a knob and the second stop 610 is a loop.

[0106] The frame 602 further comprises 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 via a first bend segment 618. The second frame segment 614 and the third frame segment 616 are connected to each other via a second bend segment 620. The widths of the first frame segment 612, the second frame segment 614, and the third frame segment 616 are smaller than the widths of the stops 608 and 610. In this embodiment, the cross-sections of the frame 602 at the first bend segment 618 and the second bend segment 620 have an essentially concave shape. Furthermore, the widths of the bend segments are greater than the widths of the frame segments. The frame 602 further comprises a bend point 622 that facilitates removal of the IUS 600 when necessary.

[0107] FIG. 6B shows the IUS including capsule 624 and removal string 626 in a form that can be stored in a sales package, i.e., before being inserted inside an insertion tool. FIG. 6C and FIG. 6D show the steps of closing and locking the IUS into its shape once it is released into the uterus. FIG. 6B shows how the frame 602 is bent by pulling the removal string 626. 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, the first end 604 is pulled through the second end 606, thus locking the IUS 600 into its shape.

[0108] 7A, a perspective view of an insertion tool 1100 in an assembled state preloaded with an IUS 1102 is shown, according to one embodiment of the present disclosure. The insertion tool 1100 comprises a handle body 1104 having a proximal end 1106 and a distal end 1108. The insertion tool 1100 further comprises a measurement tube 1110 having a proximal end 1112 and a distal end 1114. The proximal end 1112 of the measurement tube 1110 is movably attached to the distal end 1108 of the handle body 1104. The insertion tool 1100 further comprises a tip cover 1116 having a distal end 1118 and a proximal end 1120. The tip cover 1116 is positioned to retract inside the distal end 1114 of the measurement tube 1110. The insertion tool 1100 further comprises a flange 1122 movably disposed around the measurement tube 1110. A finger holder 1124 is movably disposed about the handle body 1104. The insertion tool 1100 further comprises a means 1126 for reversibly locking a removal suture of the IUS 1102. The means 1126 for reversibly locking a removal suture is disposed on the handle body 1104. The insertion tool 1100 further comprises a piston 1130 movably disposed inside the handle body 1104.

[0109] Referring to FIG. 7B, a perspective view of the insertion tool 1100 of FIG. 7A in an unassembled state with an IUS 1102 is shown, according to one embodiment of the present disclosure. The insertion tool 1100 further comprises 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 assembled state of the insertion tool 1100, the plunger 1132 is movably disposed within the handle body 1104 and the measuring tube 1110. Further shown are a first cover portion 1138A and a second cover portion 1138B of the handle body 1104. The handle body 1104 has a length Lh defined as the distance between the distal end 1108 and the proximal end 1106. Note that the length Lp is greater than the length Lh. Further shown are the first and second parts 1140A, 1140B of the measuring tube 1110, the first and second parts 1142A, 1142B of the finger holder 1124, and the first and second parts 1144A, 1144B of the piston 1130. Further shown are the flange tip cover 1116 and the means 1126 for reversibly locking the removal thread of the IUS 1102. In the assembled state of the insertion tool 1100, the tip cover 1116 accommodates the frame 1146 of the IUS 1102 in a straight configuration (i.e., the pre-loaded state of the IUS 1102 in the insertion tool 1100 prior to inserting the IUS 1102 into the uterus). Further shown are the flange 1122, the finger holder 1124, and the means 1126 for reversibly locking the removal thread of the IUS 1102.

[0110] 7C also shows a close-up view of the IUS 1102. The IUS 1102 comprises a frame 1146 having a first end 1148 and a second end 1150, with a length L defined as the distance from the first end 1148 to the second end 1150. The frame 1146 is straightened and extended when loaded into the insertion tool 1100 in an assembled state prior to inserting the IUS 1102 into the uterus. The first end 1148 of the frame 1146 comprises a first locking portion 1152 and the second end 1150 of the frame 1146 comprises a second locking portion 1154. In this embodiment, the first locking portion 1152 is a pin and the second locking portion 1154 is a loop. The first locking portion 1152 and the second locking portion 1154 have complementary structures to allow the pin to be permanently inserted into the loop. A first stop 1152 at a first end 1148 of the frame 1146 includes an opening 1156 for receiving the removal string 1128 .

[0111] 8A, a perspective view of an insertion tool piston and plunger subassembly 1200 is shown according to one embodiment of the disclosure. The piston and plunger subassembly 1200 shows the placement of a plunger 1202 within a piston 1204. The plunger 1202 includes a means 1206 for preventing its removal from inside the handle body and the piston 1204 of the insertion tool.

[0112] 8B, there is shown a cross-sectional view of a piston and plunger subassembly 1200 of an insertion tool, according to one embodiment of the disclosure. In the piston and plunger subassembly 1200, a plunger 1202 is attached to a piston 1204. Also shown is an enlarged view of a distal portion of the piston and plunger subassembly 1200 to show an engagement portion 1208 of the piston 1204. The plunger 1202 locks between the engagement portions 1208 of the piston 1204.

[0113] 9A, a schematic diagram of an insertion tool 1300 is shown with an enlarged view of a first section 1302 of the insertion tool 1300 to show a piston 1304 movably disposed inside the handle body 1306, according to one embodiment of the present disclosure. The piston 1304 comprises a means 1308 for preventing removal of the piston 1304 from inside the handle body 1306. Additionally, an enlarged view of a second section 1310 of the insertion tool 1300 is shown to show a first hook 1312 of a finger holder 1314 that is locked within a first recess 1316 of the handle body 1306 and that is released during the insertion process when the piston is moved toward the distal end of the handle body for a first portion of its movement.

[0114] 9B, there is shown a schematic diagram of the insertion tool 1300 with a close-up of a fourth section 1324 of the insertion tool 1300 to show the clamp 1326 securing the measurement tube 1328, according to one embodiment of the present disclosure. The clamp 1326 secures the measurement tube 1328 such that the measurement tube 1328 is movably attached inside the distal end 1330 of the handle body 1306. Once the IUS is fully inside the uterus and the locking portions are locked together, the clamp is opened towards the insertion end by a piston.

[0115] 9C, a schematic diagram of the insertion tool 1300 is shown with an enlarged view of a fifth section 1332 of the insertion tool 1300 to illustrate the placement of the tip cover 1334 within the measurement tube 1328. In the fifth section 1332, the IUS 1336 is shown preloaded into the insertion tool 1300 such that a small portion of the frame 1338 of the IUS 1336 protrudes from the insertion tool 1300, with the remainder of the frame 1338 surrounded and protected by the tip cover 1334. Additionally, an enlarged view of the IUS 1336 is shown. The frame 1338 of the IUS 1336 has a first end 1340 and a second end 1342. The frame 1338 is straightened and extended when loaded into the insertion tool 1300 prior to inserting the IUS 1336 into the uterus. The first end 1340 of the frame 1338 includes a first stop 1344 and the second end 1342 of the frame 1338 includes a second stop 1346. In this embodiment, the first stop 1344 is a pin and the second stop 1346 is a loop. The IUS 1336 further includes a pharma- ceutical active agent disposed within the 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 one another via a first bend segment 1354. The second frame segment 1350 and the third frame segment 1352 are connected to one another via a second bend segment 1356. A removal thread 1358 is attached to the opening of the first stop 1344. The fifth section 1332 further shows a distal end 1360 of a plunger 1362 configured to cooperate with the second stop 1346. The plunger 1362 is hollow to allow the removal string 1358 of the IUS 1336 to pass therethrough.

[0116] 10A-10H show different views of the insertion tool 1400 showing various stages of operation for positioning the IUS 1402 in the uterus, according to one embodiment of the present disclosure. Referring to FIG. 10A, the adjustment of the flange 1404 on the measurement tube 1406 of the insertion tool 1400 is shown, according to one embodiment of the present disclosure. The flange 1404 is manually moved to a designated position on the measurement tube 1406 with the help of an insertion depth indicator 1408 on the outer surface of the measurement tube 1406. The designated position refers to the length of the uterine cavity plus the length of the cervical canal previously measured during a uterine gastroscopy. The flange 1404 once set does not move during the insertion process of the IUS 1402. Additionally, a portion of the frame 1412 of the IUS 1402 is shown outside the insertion tool 1400 in a pre-loaded state. Further, in the preloaded state, the removal string 1414 is coupled to one end (i.e., the first end) of the frame 1412 and passes through the insertion tool 1400, with a portion of the removal string 1414 emerging from the handle body 1416 of the insertion tool 1400. The rotatable knob 1418 is disposed in a first position to lock the removal string 1414 between the handle body 1416 and the rotatable knob 1418.

[0117] 10B and 10C show one embodiment of the flange 1404 in more detail. In this embodiment, the flange 1404 includes a snap lock 1410 that is originally in an "open" position, with the snap lock 1410 open and allowing the flange to move easily. Once the flange is in the correct position (on the insertion depth indicator 1408), the snap lock 1410 is closed by pressing the flange, thus bringing the snap lock to the "closed" position.

[0118] 10D illustrates a first insertion stage of the IUS 1402 using the insertion tool 1400, according to one embodiment of the present disclosure. In this stage, the insertion tool 1400 is shown moving from a first state 1424 (left) to a second state 1426 (right). In the first state 1424 (left), the tip cover 1422 is shown in an extended position. The measurement tube 1406 is passed through the vagina 1428 toward the cervix. The insertion tool 1400 is positioned such that the tip cover 1422 reaches the cervical opening and the first end (i.e., tip) of the IUS 1402 is located inside the cervical opening. At this stage, the entire insertion tool 1400 is gently pushed toward the subject, which causes the tip cover 1422 to move backwards inside the handle body 1416.

[0119] In a second state 1426 (right side), the tip cover is retracted inside the handle body 1416, releasing a portion of the frame 1412 from the insertion tool 1400 into the cervical canal 1430 and partially into the uterine cavity 1432. The second state 1426 further shows the distal end 1434 of the tip cover having a rounded spherical configuration to prevent the measuring tube 1406 from entering the cervical canal 1430. At this stage, the pushing member 1436 of the piston 1438 is still separated from the proximal end 1440 of the handle body 1416 (i.e., the piston 1438 is in an extended state).

[0120] 10E, a second insertion stage of the IUS 1402 using the insertion tool 1400 is shown according to one embodiment of the present disclosure. In this stage, in act 1442 (left side), the piston 1438 is pressed from its proximal end against the pressing member 1436 while maintaining firm contact of the distal end 1434 of the tip cover (i.e., the tip of the insertion tool 1400) against the cervix. The finger holder 1446 is used as a support for fingers (e.g., two fingers in this case) to conveniently press the piston 1438 towards the handle body 1416.

[0121] The piston 1438 is pushed from the proximal end until the piston 1438 is completely inside the handle body 1416 and no further movement of the piston 1438 is allowed (i.e., movement of the piston 1438 stops). The IUS 1402 begins to exit the insertion tool 1400, forming a loop within the uterine cavity 1432. Movement of the piston 1438 moves a plunger 1450 attached to the piston 1438, which pushes against the end of the frame, thus releasing more of the frame from the insertion tool 1400 and forming a loop within the uterine cavity 1432.

[0122] In action 1448 (right side), after the piston has fully entered the handle body 1416, the finger holder 1446 is unlocked and moves towards the proximal end of the handle body 1416. At this stage, the IUS 1402 is outside the insertion tool 1400 and the IUS 1402 is at the entrance to the uterine cavity 1432. At this stage, the plunger has also locked itself inside the insertion tool 1400 and cannot move further by pushing the piston.

[0123] 10F illustrates the step where the locking portion of the IUS 1402 locks while the IUS 1402 is at the entrance to the uterine cavity 1432. The measuring tube 1406 is released and can therefore move again.

[0124] 10G, a third insertion stage of the IUS 1402 using the insertion tool 1400 is shown, according to one embodiment of the present disclosure. In this stage, the insertion tool 1400 is pushed towards the patient until the flange 1404 contacts the handle body 1416 (i.e., a portion of the proximal end of the measuring tube 1406 is inside the distal end 1454 of the handle body 1416). During this stage, the IUS 1402 moves to a fundal position and the entire IUS 1402 is accurately positioned within the uterine cavity 1432.

[0125] 10H, there is shown the release of the removal string 1414 using the insertion tool 1400 after the IUS 1402 has been deployed in the uterine cavity, according to one embodiment of the present disclosure. At this stage, the removal string 1414 is released using the rotatable knob 1418. The rotatable knob 1418 is moved from its initial first position to a second position to allow the removal string 1414 to be moved relative to the handle body 1416 and ultimately released.

[0126] 10I, removal of the insertion device 1400 from the subject is shown according to one embodiment of the present disclosure. The insertion device 1400 is withdrawn from the vagina 1428, signifying completion of the insertion process of the IUS 1402 by the insertion device 1400.

[0127] 11A, a schematic diagram of an insertion tool 1500 in an assembled state preloaded with an IUS 1502 is shown according to another embodiment of the present disclosure. The insertion tool 1500 comprises a handle body 1504 having a proximal end 1506 and a distal end 1508. The insertion tool 1500 further comprises a measuring tube 1510 having a proximal end 1512 and a distal end 1514. The proximal end 1512 of the measuring tube 1510 is movably attached to the distal end 1508 of the handle body 1504. The insertion tool 1500 further comprises a flange 1522 movably disposed around the measuring tube 1510. A finger holder 1524 is disposed on the handle body 1504. In this embodiment, the finger holder 1524 is ring-shaped, i.e., in the form of a circle extending outward from diametrically opposed sides of the outer surface of the handle body 1504 at its proximal end 1506. The insertion tool 1500 further comprises a means 1526 for reversibly locking a removal suture of the IUS 1502. The means 1526 for reversibly locking a removal suture is disposed on the handle body 1504. The insertion tool 1500 further comprises a piston 1530 movably disposed inside the handle body 1504.

[0128] 11B, a perspective view of the insertion tool 1500 of FIG. 11A in an unassembled state is shown according to one embodiment of the present disclosure. The insertion tool 1500 further comprises a plunger 1532 having a distal end 1534 and a proximal end 1536. In the assembled state of the insertion tool 1500, the plunger 1532 is movably disposed inside the handle body 1504 and the measuring tube 1510. The handle body 1504 has a first cover portion 1538A and a second cover portion 1538B. Further shown are the first portion 1540A and the second portion 1540B of the measuring tube 1510, and the first portion 1542A and the second portion 1542B of the piston 1530. Further shown are a means 1526 for reversibly locking a removal suture of the IUS 1502, as well as a flange 1550.

[0129] Modifications to the embodiments of the disclosure described above are possible without departing from the scope of the disclosure, which is defined by the appended claims. Words such as "including," "comprising," "incorporating," "have," "is," and the like, used to describe and claim the disclosure, are intended to be interpreted in a non-exclusive manner, i.e., allowing for the presence of items, components, or elements not expressly described. References to the singular should also be interpreted as relating to the plural. [Explanation of symbols]

[0130] 100 Intrauterine System 102 Frames 104 First end 106 Second End 108 First locking portion 110 Second locking portion 112 Outer diameter 202 Rock 204 First Frame Segment 206 Second Frame Segment 208 Third Frame Segment 210 First bending segment 212 Second bending segment 214 Concave shape 216 Bending point 218 Removal thread 220 Opening 222 Length 224 Width 300 Intrauterine system 302 Frame 304 First end 306 Second end 308 First locking part 310 Second locking part 312 Lock 314 First frame segment 316 Second frame segment 318 Third frame segment 320 First bending segment 322 Second bending segment 324 Bending point 326 Removal thread 328 Opening 330 Capsule 332 Capsule 334 Capsule 336 Capsule 400 Intrauterine system 402 Frame 404 First end 406 Second end 408 First locking part 410 Second locking part 412 Opening 414 Capsule 416 Capsule 418 Capsule 420 Capsule 422 First frame segment 424 Second frame segment 426 Third frame segment 428 First bending segment 430 Second bending segment 432 Rock 434 Bend Point 436 Removal thread 500 Intrauterine System 502 frames 504 First End 506 Second End 508 First locking part 510 Second locking portion 512 Opening 514 Capsules 516 Capsules 518 Capsules 520 First Bending Segment 522 Second Bending Segment 600 Intrauterine System 602 Frames 604 First end 606 Second End 608 First locking part 610 Second locking portion 612 First Frame Segment 614 Second Frame Segment 616 Third Frame Segment 618 First Bending Segment 620 Second Bending Segment 622 Bend Point 624 Capsules 626 Removal thread 1100 Insertion tool 1102 IUS 1104 Handle body 1106 Proximal end 1108 Distal end 1110 Measuring tube 1112 Proximal end 1114 Distal end 1116 Tip cover 1118 Distal end 1120 Proximal end 1122 Flange 1124 Finger Holder 1126 means 1128 Removal thread 1130 Piston 1132 Plunger 1134 Distal end 1136 Proximal end 1138A First Cover Part 1138B Second cover part 1140A First Part 1140B Second part 1142A First Part 1142B Second part 1144A First Part 1144B Second part 1146 Frames 1148 First end 1150 Second end 1152 First locking part 1154 Second locking part 1156 Opening 1200 Piston and Plunger Subassembly 1202 Plunger 1204 Piston 1206 means 1208 Engagement part 1300 Insertion Tool 1302 First Section 1304 Piston 1306 Handle body 1308 means 1310 Second Section 1312 First Hook 1314 Finger Holder 1316 First recess 1324 Fourth Section 1326 Clamp 1328 Measuring tube 1330 Distal end 1332 Fifth Section 1334 Tip cover 1336 IUS 1338 Frames 1340 First end 1342 Second End 1344 First locking part 1346 Second locking part 1348 First Frame Segment 1350 Second Frame Segment 1352 Third Frame Segment 1354 First Bending Segment 1356 Second Bending Segment 1358 Removal thread 1360 Distal end 1362 Plunger 1400 Insertion Tool 1402 IUS 1404 Flange 1406 Measuring tube 1408 Indicator 1410 Snap Lock 1412 Frames 1414 Removal thread 1416 Handle body 1418 Rotatable Knob 1422 Tip cover 1424 First State 1426 Second State 1428 Vagina 1430 Cervix 1432 Uterine cavity 1434 Distal end 1436 Pressing member 1438 Piston 1440 Proximal end 1442 operation 1446 Finger Holder 1448 operation 1450 Plunger 1454 Distal end 1500 Insertion Tool 1502 IUS 1504 Handle body 1506 Proximal end 1508 Distal end 1510 Measuring tube 1512 Proximal end 1514 Distal end 1522 Flange 1524 Finger Holder 1526 means 1530 Piston 1532 Plunger 1534 Distal end 1536 Proximal end 1538A First Cover Part 1538B Second cover part 1540A First Part 1540B Second Part 1542A First Part 1542B Second Part 1550 flange

Claims

1. 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 a length L defined as the distance from said first end to said second end; a removal string (218, 326, 436, 626) attached to the first end of the frame; at least one pharma- ceutical active agent; An intrauterine system (100, 300, 400, 500, 600) comprising: an intrauterine system (100, 300, 400, 500, 600), wherein the first end of the frame comprises a first fastening portion (108, 308, 408, 508, 608) and the second end of the frame comprises a second fastening portion (110, 310, 410, 510, 610), the first fastening portion and the second fastening portion are arranged to form a lock (202, 312, 432), and the removal string is configured to guide the first fastening portion to the second fastening portion.

2. 2. The intrauterine system (100, 300, 400, 500, 600) of claim 1, wherein the at least one pharma- ceutical active agent is disposed within at least one capsule (330, 332, 334, 336, 414, 416, 418, 420, 514, 516, 518, 624), the capsule being positioned to surround the frame (102, 302, 402, 502, 602) over a majority of its length L.

3. The frame (102, 302, 402, 502, 602) a first frame segment (204, 314, 422, 612), a second frame segment (206, 316, 424, 614), and a third frame segment (208, 318, 426, 616) having a width W defined as a dimension perpendicular to said length, said first and second frame segments being connected via a first bent segment (210, 320, 428, 520, 618), and said second and third frame segments being connected via a second bent segment (212, 322, 430, 522, 620); Equipped with the first bent segment has a first width W1 and the second bent segment has a second width W2; The intrauterine system (100, 300, 400, 500, 600) of claim 1 or 2, wherein the first width W1 is 5-50% of the width W and the second width W2 is 5-50% of the width W.

4. The frame (102, 302, 402, 502, 602) a first frame segment (204, 314, 422, 612), a second frame segment (206, 316, 424, 614), and a third frame segment (208, 318, 426, 616) having a width W defined as a dimension perpendicular to said length, said first and second frame segments being connected via a first bent segment (210, 320, 428, 520, 618), and said second and third frame segments being connected via a second bent segment (212, 322, 430, 522, 620); Equipped with the first bent segment has a first width W1 and the second bent segment has a second width W2; The intrauterine system (100, 300, 400, 500, 600) of claim 1 or 2, wherein the first width W1 is 5-50% of the width W and the second width W2 is 100-150% of the width W.

5. 5. The intrauterine system (100, 300, 400, 500, 600) of claim 3 or 4, wherein the cross-section of the frame (102, 302, 402, 502, 602) at the first curved segment (210, 320, 428, 520, 618) and the second curved segment (212, 322, 430, 522, 620) has an essentially concave shape (214), and the first width W1 and the second width W2 are the smallest dimensions of the cross-section.

6. 6. The intrauterine system (100, 300, 400, 500, 600) of claim 1, wherein the first fastening portion (108, 308, 408, 508, 608) is a pin and the second fastening portion (110, 310, 410, 510, 610) is a loop, and the pin is configured to be permanently inserted into the loop.

7. 6. An intrauterine system (100, 300, 400, 500, 600) according to any one of claims 1 to 5, wherein the first fastening portion (108, 308, 408, 508, 608) is a hook and the second fastening portion (110, 310, 410, 510, 610) is a loop, and the hook is configured to be permanently inserted into the loop.

8. 8. The intrauterine system (100, 300, 400, 500, 600) of any one of claims 1 to 7, wherein the pharma- ceutical active agent is selected from progesterone, estrogen, progestin, levonorgestrel, indomethacin, diclofenac, piroxicam, meloxicam and ketoprofen.

9. 9. The intrauterine system (100, 300, 400, 500, 600) of any one of claims 1 to 8, wherein the frame (102, 302, 402, 502, 602) includes a bending point (216, 324, 434, 622) that allows removal of the intrauterine system.

10. 10. An intrauterine system (100, 300, 400, 500, 600) according to any one of claims 2 to 9, comprising at least two capsules (330, 332, 334, 336, 414, 416, 418, 420, 514, 516, 518, 624).

11. The intrauterine system (100, 300, 400, 500, 600) of claim 10, wherein the capsules (330, 332, 334, 336, 414, 416, 418, 420, 514, 516, 518, 624) contain different pharma- ceutical active agents.

12. 3. The intrauterine system (100, 300, 400, 500, 600) of claim 2, wherein the at least one capsule (330, 332, 334, 336, 414, 416, 418, 420, 514, 516, 518, 624) is arranged to surround the frame (102, 302, 402, 502, 602) along its entire length, except for the first fastening portion (108, 308, 408, 508, 608) and the second fastening portion (110, 310, 410, 510, 610).

13. A first capsule (330, 414, 514) arranged to surround the first frame segment (314, 422), a second capsule (334, 416, 518) arranged to surround the second frame segment (316, 424), and a third capsule (418) arranged to surround the third frame segment (426), and the first locking portion (108, 308, 408, 508, 608), the first bending portion (108, 308, 408, 508, 608), and the first frame segment (314, 422) are arranged to surround the first frame segment (314, 422). The intrauterine system (100, 300, 400, 500, 600) of any one of claims 3 to 5, wherein the curved segment (210, 320, 428, 520, 618), the second curved segment (212, 322, 430, 522, 620), and the second anchoring portion (110, 310, 410, 510, 610) do not include a capsule (330, 332, 334, 336, 414, 416, 418, 420, 514, 516, 518, 624).

14. The intrauterine system (100, 300, 400, 500, 600) of claim 1 , wherein the at least one pharma- ceutical active agent is disposed within the frame (102, 302, 402, 502, 602).

15. A kit comprising an intrauterine system (100, 300, 400, 500, 600) according to any one of claims 1 to 14 and an insertion tool (1100, 1300, 1400, 1500), said insertion tool comprising: a handle body (1104, 1306, 1416, 1504) having a distal end (1108, 1330, 1454, 1508), a proximal end (1106, 1440, 1506), and a length Lh defined as the distance between said distal end and said proximal end; a measurement tube (1110, 1328, 1406, 1510) having a distal end (1114, 1514) and a proximal end (1112, 1512), the proximal end of which is movably attached to the distal end of the handle body, the measurement tube (1110, 1328, 1406, 1510) being arranged to remain outside the cervical channel during insertion; A plunger (1132, 1202, 1362, 1450, 1532) having a distal end (1134, 1360, 1534), a proximal end (1136, 1536), and a length Lp defined as a distance between the distal end and the proximal end, the plunger being movably disposed inside the handle body and the measuring tube, and the length Lp being greater than the length Lh; A flange (1122, 1404, 1522) movably arranged to surround the measuring tube; A finger holder (1124, 1314, 1446, 1524) movably arranged to surround the handle body; a means (1126, 1526) for reversibly locking a removal string (1128, 1358, 1414) of the intrauterine system disposed on the handle body; A kit comprising:

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