Insert with locking portion for intrauterine system

Abstract

An insert (1100, 1300, 1400, 1500) for an intrauterine system (1102, 1336, 1402, 1502) is disclosed, comprising: a handle body (1104, 1306, 1416, 1504), a measuring tube (1110, 1328, 1406, 1510), a plunger (1132, 1202, 1362, 1450, 1532), a flange (1122, 1404, 1522), a finger retainer (1124, 1314, 1446, 1524), and a device (1126, 1526) for reversibly locking the removal wire (1128, 1358, 1414) of the intrauterine system. The proximal end of the measuring tube (1106, 1440, 1506) is movably attached to the distal end of the handle body (1108, 1330, 1454, 1508), provided that the measuring tube is arranged to remain lateral to the cervical canal during insertion. A plunger is movably arranged inside the handle body and the measuring tube. This disclosure also provides a kit including an insert and an intrauterine system.

Description

Technical Field

[0001] This disclosure generally relates to gynecological instruments; and more specifically, to an inserter for an intrauterine system. Furthermore, this disclosure relates to a kit comprising the inserter and an intrauterine system. Background Technology

[0002] Intrauterine systems (IUS) and intrauterine devices (IUDs) are becoming increasingly popular as reversible methods of contraception. Below, the abbreviation IUS is used and encompasses both IUS and IUD. Inserts are typically used to position the IUS inside the uterus.

[0003] Typically, conventional inserts include an insertion cannula that usually needs to pass through the cervical canal to introduce an intrauterine device (IUS) into the subject's uterus. Due to the anatomy of the uterus, insertion of the cannula into the cervical region is often a painful experience for the subject. For example, the diameter of the insertion cannula used for conventional inserts to introduce an IUS into the uterus may be incompatible in size with the cervical os or the entire cervical region (e.g., the cannula may have a large cross-sectional area), resulting in unnecessary pain during IUS insertion.

[0004] Therefore, in light of the foregoing discussion, there is a need to overcome the aforementioned drawbacks associated with conventional inserts. Summary of the Invention

[0005] This disclosure seeks to provide an insert for an intrauterine system (IUS). This disclosure also seeks to provide a kit comprising the insert and the IUS. This disclosure seeks to provide a solution to the existing problem of painful insertion of a cannula of a conventional insert into the cervical region of a subject for introducing the IUS into the uterus.

[0006] One object of this disclosure is to provide a solution that at least partially overcomes the problems encountered in the prior art, and to provide an improved insert that is easier to use and reduces pain compared to existing inserts and provides a relatively more comfortable experience during IUS insertion into the uterus.

[0007] In one aspect, one embodiment of this disclosure provides an insert for the intrauterine system, comprising:

[0008] - Handle body, having a distal end, a proximal end, and a length L defined as the distance between the distal end and the proximal end. h ;

[0009] - A measuring tube having a distal end and a proximal end, the proximal end of which is movably attached to the distal end of the handle body, provided that the measuring tube is arranged to remain outside the cervical canal during insertion;

[0010] - A plunger having a distal end, a proximal end, and a length L defined as the distance between the distal and proximal ends. p The plunger is movably arranged inside the handle body and the measuring tube, wherein the length L p Greater than length L h ;

[0011] - A flange, which is movably arranged to surround the measuring tube;

[0012] - A finger retainer, movably arranged to surround the handle body; and

[0013] - A device for reversibly locking the removal thread of the intrauterine system is arranged on the handle body.

[0014] In another embodiment of this disclosure, a kit is provided that includes an intrauterine system and an insert as described above, wherein the intrauterine system includes:

[0015] - 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;

[0016] - Remove the wire, which is attached to the first end of the frame; and

[0017] -At least one pharmaceutical active agent;

[0018] The frame includes a first locking portion at a first end and a second locking portion at a second end, the first locking portion and the second locking portion being arranged to form a lock, and the removal wire being configured to guide the first locking portion to the second locking portion.

[0019] The embodiments of this disclosure substantially eliminate or at least partially resolve the aforementioned problems in the prior art, and enable the disclosed insert to be conveniently used to position the disclosed IUS into the uterus in a painless or minimally painful manner.

[0020] Other aspects, advantages, features, and objects of this disclosure will become apparent from the accompanying drawings and detailed description of the exemplary embodiments interpreted in conjunction with the appended claims.

[0021] It should be understood that the features of this disclosure can be combined in various combinations without departing from the scope of this disclosure as defined by the appended claims. Attached Figure Description

[0022] The above-described invention and the following detailed description of exemplary embodiments can be better understood when read in conjunction with the accompanying drawings. Exemplary constructions of this disclosure are shown in the drawings for illustrative purposes. However, this disclosure is not limited to the specific methods and means disclosed herein. Furthermore, those skilled in the art will understand that the drawings are not drawn to scale. Wherever possible, identical elements have been indicated by the same numbers.

[0023] Schemes of the present disclosure will now be described by way of example only with reference to the following figures, wherein:

[0024] Figures 1A-1C This is a perspective view of an insert in an assembled and unassembled state, and on an IUS, according to one embodiment of this disclosure;

[0025] Figure 2A A perspective view of an insert piston and plunger subassembly according to one embodiment of the present disclosure is illustrated;

[0026] Figure 2B A cross-sectional view of the piston and plunger subassembly and the piston engagement portion of the insert, according to one embodiment of the present disclosure, is illustrated.

[0027] Figures 3A-3C A schematic diagram of an insert according to one embodiment of the present disclosure is shown, along with an enlarged view depicting the internal structure of different sections of the insert;

[0028] Figures 4A-4I Different views of the insert according to various embodiments of the present disclosure are illustrated, and multiple operational stages for positioning the IUS into the uterus are depicted;

[0029] Figure 5A and Figure 5B Examples of inserts in assembled and unassembled states, respectively, according to another embodiment of this disclosure;

[0030] Figure 6 This is a perspective view of an IUS in a loading configuration according to one embodiment of this disclosure;

[0031] Figure 7 This is an implementation scheme based on the content of this disclosure. Figure 6 A schematic diagram of IUS;

[0032] Figure 8 This is a schematic diagram of an IUS according to another embodiment of this disclosure;

[0033] Figure 9A This is a schematic diagram of an IUS in a loading configuration according to another embodiment of this disclosure;

[0034] Figure 9B Figure 9A is a perspective view of the IUS in a loading configuration according to one embodiment of this disclosure;

[0035] Figure 9C Figure 9A is a cross-sectional view of the IUS in an unfolded state according to one embodiment of the present disclosure;

[0036] Figure 9D These are multiple implementations of the present disclosure that are in the process of being developed. Figure 9A A perspective view of the IUS;

[0037] Figure 10 This is a perspective view of an IUS according to yet another embodiment of this disclosure; and

[0038] Figures 11A-11D It is based on an implementation framework and a schematic diagram of IUS.

[0039] In the accompanying diagram, the numbers are associated with the items identified by the lines linking those numbers to the items. When a number is accompanied by an associated arrow, the number is used to identify the general item that the arrow points to. Detailed Implementation

[0040] The following detailed description illustrates embodiments of this disclosure and ways in which they can be implemented. Although some models for implementing this disclosure have been disclosed, those skilled in the art will recognize that other embodiments for implementing or practicing this disclosure are also possible.

[0041] In one aspect, one embodiment of this disclosure provides an insert for the intrauterine system, comprising:

[0042] - Handle body, having a distal end, a proximal end, and a length L defined as the distance between the distal end and the proximal end. h ;

[0043] - A measuring tube having a distal end and a proximal end, the proximal end of which is movably attached to the distal end of the handle body, provided that the measuring tube is arranged to remain outside the cervical canal during insertion.

[0044] - A plunger having a distal end, a proximal end, and a length L defined as the distance between the distal and proximal ends. p The plunger is movably arranged inside the handle body and the measuring tube, wherein the length L p Greater than length L h ;

[0045] - A flange, which is movably arranged to surround the measuring tube;

[0046] - A finger retainer, movably arranged to surround the handle body; and

[0047] -A device for reversibly locking the removal wire in the intrauterine system is arranged on the handle body.

[0048] In another embodiment of this disclosure, a kit is provided that includes an intrauterine system and an insert as described above, wherein the intrauterine system includes:

[0049] - 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;

[0050] - Remove the wire, which is attached to the first end of the frame; and

[0051] -At least one pharmaceutical active agent;

[0052] The frame includes a first locking portion at a first end and a second locking portion at a second end, the first locking portion and the second locking portion being arranged to form a lock, and the removal wire being configured to guide the first locking portion to the second locking portion.

[0053] Therefore, this disclosure provides the aforementioned insert and kit for the efficient and convenient insertion of an IUS into the uterus. The insert enables the IUS to be inserted into a stable position within the uterus. The insert is easy to use, allowing the IUS to be inserted directly into the cervical canal, rather than inserting any part of the insert into the cervical canal, thus reducing the pain associated with IUS placement into the uterus. Furthermore, the small cross-sectional area of ​​the IUS makes insertion into the uterus virtually painless, or at least less painful than using a conventional IUS and insert. Additionally, multiple parts of the insert are released at specific times during the IUS insertion procedure, providing healthcare professionals with an intuitive and enhanced experience when manipulating the insert during IUS insertion. Therefore, using the aforementioned insert and kit can improve the overall rate of successful IUS insertion without causing any discomfort or only minimal discomfort to the subject.

[0054] In this instruction manual, the proximal end is the end closest to the user (practicing physician) during IUS insertion, and the distal end is the opposite end, furthest from the user.

[0055] The insert includes a handle body having a distal end, a proximal end, and a length L defined as the distance between the distal end and the proximal end. h The handle body is preferably designed for easy one-handed handling of the insert. Furthermore, the handle body is preferably designed to be unbiased, meaning the insert functions equally well when held with either the right or left hand.

[0056] According to one embodiment, the handle body is made of a polymer material (e.g., medical-grade plastic) and is intended for single use for hygienic purposes. The handle body can have various shapes and sizes. Typically, the handle body is a hollow, elongated structure, such as tubular, cylindrical, elliptical, oval, cubic, or similar structures. The handle body serves as a shell and support structure for multiple components of the insert. Furthermore, the handle body can be designed to conform to the palm of a practicing physician. In one embodiment, the handle body has a first cap and a second cap. Each of the first and second caps can have geometrically complementary structures, thus attaching to each other in the assembled state of the insert. According to one embodiment, the length L... h The length is 70mm-110mm. Optionally, the length L of the handle body is... h It is approximately 94mm. Length L h Typically ranging from 70mm, 75mm, 80mm, 85mm, 90mm, 95mm or 100mm to as high as 80mm, 85mm, 90mm, 95mm, 100mm, 105mm or 110mm.

[0057] The insert also includes 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.

[0058] Optionally, the proximal portion of the measuring tube includes an insertion depth indicator, for example, on its outer surface. In one embodiment, the insertion depth indicator may point to a calibration line marked with a corresponding numerical value on the outer surface of the proximal portion of the measuring tube. This insertion depth indicator is used to correctly position the aforementioned flange on the measuring tube at the beginning of the IUS insertion procedure and after the insertion length (i.e., the length of the uterus and the length of the cervical canal) has been measured.

[0059] Optionally, the measuring tube is made of a medical-grade polymer material (e.g., polyethylene, polypropylene, silicone, etc.) or metal. Alternatively, the measuring tube may be made of polyetheretherketone, thermoplastic polyurethane, thermoplastic polyurethane elastomer, etc. It may include reinforcing materials such as glass fiber.

[0060] The insert also includes a plunger having a distal end, a proximal end, and a length L defined as the distance between the distal end and the proximal end. p The plunger is movably disposed inside the handle body and the measuring tube. Length L p Greater than length L h According to one implementation scheme, the length L p 50mm-90mm. Length L pTypically, the thickness ranges from 50mm, 55mm, 60mm, 65mm, 70mm, 75mm or 80mm to as high as 60mm, 65mm, 70mm, 75mm, 80mm, 85mm or 90mm.

[0061] According to one embodiment, the plunger is hollow, thereby allowing the removal wire of the aforementioned intrauterine system to pass through the plunger. Therefore, the plunger can be a thin, hollow tubular structure that allows the removal wire to pass through it. It will be understood that the term "removal wire" as used herein refers to one or more wires (i.e., cords) attached at one end to the IUS and used to remove the IUS at the end of its wear period (e.g., 5-7 years). Once the IUS is deployed within the uterus, the removal wire is used not only to remove the IUS but also to detect whether the IUS is in the correct position within the uterine cavity. In one embodiment, the IUS may be pre-loaded in the insert within the retail packaging. In the pre-loaded state of the IUS, one end of the removal wire remains attached to the aforementioned first locking portion of the IUS, while the other end of the removal wire passes through the plunger.

[0062] According to one embodiment, the distal end of the plunger is configured to cooperate with a second locking portion. Optionally, a portion of the plunger at the distal end may have a geometrically complementary form to the second locking portion. Optionally, the plunger is made of a medical-grade polymer material (e.g., polyethylene, polypropylene, silicone, etc.) or metal.

[0063] According to one embodiment, the plunger includes means for preventing its removal from the inside of the stem body. These means for preventing removal from the inside of the stem body may be included at the proximal end of the plunger. In one embodiment, the circumference of the means is greater than the circumference of the rest of the plunger. Optionally, the means is in the form of an annular or polygonal portion retaining the plunger inside the piston and the stem body. The plunger is attached to the distal end of the inside of the piston. Specifically, the plunger is locked between the engaging portions of the piston. In one embodiment, the engaging portion of the piston may be a protrusion extending inwardly in geometrically opposing directions from the inner surface of the distal portion of the piston.

[0064] The insert also includes 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 using the insertion depth indicator on the outer surface of the proximal portion of the measuring tube. This designated position is the length of the uterine cavity plus the length of the cervical canal previously measured during uterine probing. Once set on the measuring tube of the insert, the flange establishes a firm grip relative to the measuring tube, thereby preventing unwanted movement of the flange from its initial set position during the IUS insertion procedure.

[0065] Optionally, the flange includes gripping surfaces on two radially opposite sides at the outer edge of the flange. In one embodiment, the gripping surfaces have a wavy structure to allow for a firm grip by the fingers of a single hand and to press the outer edge of the flange toward the inner edge of the flange to adjust the flange into the correct position by sliding the flange on the measuring tube. In this case, releasing the grip sets the flange in place, and friction between the flange and the measuring tube allows the flange to remain in its position.

[0066] Optionally, the flange has a length L r Length L r It is 2%-10% of the length L of the measuring tube of the insert, preferably 4%-8% of the length L of the measuring tube of the insert. In one embodiment, L r The percentage of L can be 2%, 3%, 4%, 5%, 6%, 7%, or 8%, up to a maximum of 4%, 5%, 6%, 7%, 8%, 9%, or 10%. 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 a variety of shapes, such as rounded rectangles, ovals, ellipses, circles, or similar shapes.

[0067] The insert may also include a tip cap having a distal and a proximal end and being arranged to retract inside the distal end of the measuring tube, provided that the tip cap is arranged to remain outside the cervical canal during insertion. The distal end of the tip cap has a rounded bulbous structure to prevent the measuring tube from entering the subject's cervical canal. The proximal end of the tip cap is movably arranged within the inner surface of the measuring tube at the distal end. During IUS insertion, as the insert is pushed toward the subject, the tip cap slides rearward (i.e., toward the handle body) and locks itself onto the inner surface of the measuring tube. Optionally, the tip cap is movably attached to the outer surface of the measuring tube and slides on the measuring tube.

[0068] The insert also includes a finger retainer movably arranged to surround the handle body. The finger retainer serves as a support for a finger (e.g., two fingers), facilitating the pressing of the piston toward the distal end of the handle body during IUS insertion. According to one embodiment, in the assembled state of the insert, only the optional tip cap, flange, and means for reversibly locking the removal wire (e.g., a wire lock) are movable, while the rest of the insert is locked. The rest of the insert is only released at specific times during use (i.e., during the IUS insertion process). For example, the finger retainer is initially locked in the insert. Optionally, the finger retainer includes one or more hooks for locking movement of the finger retainer within the insert. In one embodiment, the finger retainer includes two hooks, such as a first hook and a second hook, which can be locked in corresponding recesses provided in the distal end of the handle body. During the IUS insertion process, once the piston is fully inserted into the handle body, the finger retainer unlocks and moves toward the proximal end of the handle body. Furthermore, after the finger retainer moves to the proximal end of the handle body, the lock that holds the measuring tube relative to the handle body is also released. In one embodiment, one or more clamps may be used to lock the movement of the measuring tube relative to the handle body. The proximal portion of the measuring tube moves inside the handle body until the flange abuts the distal end of the handle body. Thus, multiple portions of the insert are released at specific times during the IUS insertion process, providing a visually intuitive and enhanced experience for healthcare professionals and a comfortable experience for the subject during IUS insertion.

[0069] A finger retainer can be disposed on the proximal end of the handle body. The finger retainer can have one or two annular or semi-annular structures, thereby providing grip for at least two fingers. Alternatively, the finger retainer can be in the form of a circular object extending radially outward from opposite sides of the outer surface of the handle body at the proximal end of the handle body. In such an embodiment, the finger retainer is movably disposed on the handle body. Alternatively, the finger retainer is fixedly disposed on the handle body.

[0070] The insert also includes a means for reversibly locking the removal wire of the intrauterine system, the means being disposed on the handle body. According to one embodiment, the means for reversibly locking the removal wire includes a rotatable knob arranged in a first position to lock the removal wire between the handle and the knob, and arranged in a second position to allow movement of the removal wire relative to the handle body. Optionally, the knob and handle body include corresponding features that allow locking of the removal wire when the knob is in the first position.

[0071] In another embodiment, the means for reversibly locking the removal wire may be a roller-like mechanism on which the removal wire rolls. Rolling of the roller-like mechanism in one direction (e.g., forward) can lock the removal wire, while rolling of the roller-like mechanism in another direction (e.g., opposite direction) can release the removal wire. In one embodiment, the roller-like mechanism may be a pinion arranged in an opening in the handle body and having a corresponding counterpart.

[0072] According to one embodiment, the insert further includes a piston attached to the plunger and arranged for moving the plunger, the piston being movably disposed inside the handle body. The piston is disposed at the proximal end of the handle body. Furthermore, the proximal end of the piston includes a pressing member. For example, the pressing member is provided for the thumb of the user of the insert. When the pressing member of the piston is pushed, the piston enters the interior of the handle body and moves further forward toward the distal end of the handle body. In one embodiment, the pressing member may be integrated into the piston during an injection molding process. Additionally, the plunger is locked between the aforementioned engaging portions of the piston. During insertion of the IUS, as the piston is pushed forward toward the distal end of the handle body, the plunger is pushed into the cervical canal and partially into the uterine cavity.

[0073] According to one embodiment, the piston is hollow, thereby allowing the removal wire of the intrauterine system to pass through the piston. The piston is a hollow tubular structure that allows the removal wire to pass through it. In one embodiment, the IUS may be pre-loaded in the insert in the retail packaging. In the pre-loaded state of the IUS, one end of the removal wire remains coupled to the aforementioned first locking portion of the IUS, while the other end of the removal wire passes through the plunger and piston and protrudes from the handle body to surround the means for reversibly locking the removal wire.

[0074] According to one embodiment, the piston includes means for preventing its removal from the inside of the stem body. The piston may include the means for preventing its removal from the inside of the stem body at its distal end. In one embodiment, the means for preventing the piston from being removed from the inside of the stem body may be at least one protrusion extending from the outer surface of the piston at its distal end. This at least one protrusion prevents the piston from being accidentally removed from the stem body. In another embodiment, two protrusions may be attached to or disposed on the outer surface of the piston. These two protrusions may extend from the outer surface of the piston in two geometrically opposite directions. Optionally, the means for preventing the piston from being removed from the inside of the stem body may be in the form of a ring conforming to the inner diameter of the stem body.

[0075] According to one implementation, the process of inserting an IUS into the uterus (i.e., the operational phase of the aforementioned insert during use) is described using an example of an IUS having a locking portion, as follows.

[0076] Typically, prior to insertion, the IUS is at least partially located within the insert (i.e., pre-loaded in the insert) and stored in its retail packaging. A removal wire (which is also the guide wire) is attached to the first end of the IUS frame (i.e., the end that first enters the uterus), while the other end of the removal wire is attached to the handle body. According to one embodiment, the IUS is pre-loaded onto the insert in such a way that a small portion of the IUS protrudes from the insert, while the remainder is surrounded and protected by a tip cap. In one embodiment, in the pre-loaded state, approximately 10 mm of the frame remains outside the insert (i.e., outside the tip cap of the measuring tube). The insert is used under aseptic conditions by a user (e.g., a healthcare professional) wearing sterile gloves. The insertion process then begins with adjusting the flange.

[0077] A) Adjusting the flange: Using the insertion depth indicator on the outer surface of the measuring tube, manually move the flange to the designated position on the measuring tube. This designated position is the length of the uterine cavity plus the length of the cervical canal previously measured during uterine probing. In one embodiment, gripping surfaces provided on two radially opposite sides of the flange can be used to press the outer side of the flange toward the inner side of the flange.

[0078] After adjusting the flange, the steps differ slightly depending on whether the insert includes a tip cap. Both variations will be disclosed below (Step B for devices without a tip cap, and Step B' for devices with a tip cap).

[0079] B) First IUS Insertion Stage: The measuring tube is inserted through the vagina toward the cervix. The insert is positioned such that the distal end of the measuring tube reaches the cervical os (i.e., the external opening), and the first end (i.e., the tip) of the IUS is positioned inside the cervical os. During this stage, the piston is in an extended position, with the aforementioned pressing member of the piston away from the proximal end of the handle body.

[0080] B') First IUS Insertion Phase: The measuring tube is passed through the vagina toward the cervix. The insert is positioned such that the tip cap reaches the cervical os (i.e., the external opening), and the first end of the IUS (i.e., the tip) is positioned inside the cervical os. The entire insert is then gently pushed toward the subject, causing the tip cap to move backward (i.e., toward the handle body), and a portion of the frame (e.g., approximately 30 mm) is released from the insert within the cervical canal. As the tip cap moves backward, it locks itself inside the measuring tube. Alternatively, the cervical os prevents the tip cap from moving forward with the insert, instead forcing the tip cap inside the measuring tube and locking itself on the inner surface of the distal portion of the measuring tube. The insert is gently pushed toward the subject until the user feels resistance, typically physical pressure. During the IUS insertion process, the measuring tube itself does not enter the cervical canal at any stage of operation, thus reducing discomfort during the IUS insertion process. At this stage, the piston is extended, with the aforementioned pressing member of the piston away from the proximal end of the handle body.

[0081] C) Second IUS Insertion Stage: While maintaining firm contact between the measuring tube and the cervical port (in the case of a tip cap, the contact portion of the tip cap, i.e., the tip of the insert), the piston is pressed from its proximal end toward the distal end of the handle body. A finger retainer serves as a support for the fingers (e.g., two fingers), facilitating pressing the piston toward the distal end of the handle body. The IUS begins to leave the insert and forms a ring under the effect of the removal wire, which is firmly held (as it is attached to the handle body). The movement of the piston causes the plunger attached to the piston to move, which in turn pushes one end of the frame (i.e., the aforementioned second locking portion), thus releasing more of the frame from the insert into the uterine cavity. Before the piston is fully inside the handle body, the piston unlocks the finger retainer, allowing it to move. The movement of the finger retainer (when the piston and plunger are not moving) causes the IUS to take its final form but does not allow the IUS to move further inside the uterus. The finger retainer also unlocks the plunger and piston, locking the IUS into its final shape after the user applies force to the piston (pushing it towards the distal end of the handle body). Therefore, the user pushes the piston while maintaining a firm grip on the finger retainer, and the locking portion inside the handle ensures this movement.

[0082] Therefore, when the finger retainer meets the proximal end of the handle body (and simultaneously the movement of the piston inside the handle body stops), the IUS is on the outside of the insert, and the locking portion of the IUS (i.e., the first locking portion and the second locking portion) locks. The piston is locked inside the handle body by the snap hook of the finger retainer, so the user cannot pull it back. The locking of the measuring tube is released, allowing its movement.

[0083] D) Third IUS insertion stage: The entire IUS is pushed toward the patient until the flange meets the handle body. During this stage, a portion of the measuring tube moves inside the handle body (i.e., toward the healthcare professional). This pushes the IUS into the correct position within the uterus. In other words, the IUS moves to its base position, and the entire IUS is precisely positioned within the uterine cavity.

[0084] E) Releasing the Removal Thread and Removing the Insert: Releasing the removal thread. The removal thread is released by rotating a device for reversibly locking the removal thread. In one embodiment, the device for reversibly locking the removal thread includes a rotatable knob that rotates from a first position to a second position to allow movement of the removal thread relative to the handle body and further allows release of the removal thread. Alternatively, the removal thread is released by pushing a thread-cutting button provided on the handle body. When the thread-cutting button is pushed, a cutter on the inner side of the handle body cuts the removal thread. The insert is positioned such that the removal thread is cut, leaving approximately 2-3 cm visible on the outer side of the cervix (i.e., on the outer side of the opening and approximately 2-3 cm into the vagina, detectable by touch). The insert is then pulled out of the subject, indicating that the IUS insertion process is complete.

[0085] It will be understood that, as described above, different devices can be used instead of a piston to move the plunger during IUS insertion, although using a piston makes the operation of the insert more convenient. For example, a slider arranged on the handle body can be used to move the plunger. Furthermore, in another embodiment, instead of the tip cap moving inside the measuring tube (e.g., in the first IUS insertion phase described above), the tip cap slides on the distal end of the measuring tube and locks itself onto the outer surface of the measuring tube. In this case, the tip cap may need to be made of two parts rather than one (i.e., the tip cap is made of one part when it retracts inside the measuring tube). Additionally, welding may be required to assemble the two parts of the tip cap to the measuring tube. This insert is also suitable for other types of IUS besides those described herein.

[0086] This disclosure also provides a kit that includes an insert and an intrauterine system (IUS). The insert for this kit is as described above. Several embodiments and variations described above are applicable to this kit with appropriate modifications.

[0087] Therefore, this disclosure provides a kit comprising an IUS and an insert that enables efficient and convenient insertion of the IUS into the uterus. The IUS is straightened when loaded into the insert (by the manufacturer) and recovers its desired shape upon insertion into the uterine cavity (i.e., in the deployed state) thanks to a locking portion. Furthermore, the disclosed IUS achieves a smooth shape, such as triangular, annular, or circular, in the deployed state. This smooth shape of the IUS not only ensures proper fit within the uterus but also reduces the potential risk of endometrial perforation. Additionally, the frame segment, curved segment, and locking portion of the IUS allow it to achieve a desired, continuous, smooth shape in its deployed state. Advantageously, the aforementioned IUS provides healthcare professionals with an intuitive insertion experience. Furthermore, the insert in the aforementioned kit can improve the overall rate of successful IUS insertion without causing any discomfort or only minimal discomfort to the subject. Moreover, since the insert does not include an insertion cannula into the uterine cavity, the risk of uterine perforation during the insertion process is minimized.

[0088] The IUS includes a frame. This frame has a flexible, tubular structure designed to adapt to the anatomy of the cervical region and the uterine cavity. The flexible structure allows the frame to be easily bent into a shape and withstand the strain and pressure associated with that shape. For example, during IUS insertion using the aforementioned insert (or another suitable insert), the frame can be stretched to a near-straight line (i.e., a straightened configuration) and, with the aid of a locking portion, achieve a pre-defined shape when placed within the uterine cavity. Optionally, the frame, in its unfolded state, can be triangular, annular, oval, circular, polygonal, or almond-shaped.

[0089] Optionally, the frame has a substantially circular cross-section, with the width W being the diameter of the frame. The frame preferably has a smooth cross-section. More alternatively, the frame may have an oval or elliptical cross-section to prevent any damage within the uterine cavity. The width W of the frame can range from 1.5 mm to 3.5 mm. Width W is typically from 1.5 mm, 1.7 mm, 1.9 mm, 2.1 mm, 2.3 mm, 2.5 mm, 2.7 mm, 2.9 mm, 3.1 mm, or 3.3 mm to a maximum of 1.7 mm, 1.9 mm, 2.1 mm, 2.3 mm, 2.5 mm, 2.7 mm, 2.9 mm, 3.1 mm, 3.3 mm, or 3.5 mm. Advantageously, the smooth, circular cross-section and small diameter of the frame facilitate frictionless and virtually painless insertion and removal of the IUS from the cervix and uterus, minimizing any risk of uterine base perforation. Furthermore, the material used to manufacture the frame provides the necessary elasticity for the IUS during use. The elasticity of the frame prevents the IUS from being expelled from the uterine cavity and prevents it from shifting within the uterine cavity due to uterine contractions, as the flexible frame balances the pressure caused by uterine contractions.

[0090] Optionally, the frame is made of a material selected from polyethylene, polypropylene, polyetheretherketone, and thermoplastic polyurethane. Typically, the frame is made of an inert, biocompatible material of an elastomeric composition.

[0091] For example, the bends in the first and second bending sections allow the frame to bend sufficiently to achieve the desired shape. Furthermore, the aforementioned removal wires guide the first and second locking portions to lock together, which in turn provides the desired shape. In this specification, "removal wire" also refers to a plural of wires. The removal wires are attached in any suitable manner, such as by knotting or using glue.

[0092] Optionally, the frame may include at least one diagnostic means for locating the IUS within the uterine cavity without physical intervention. In one embodiment, the at least one diagnostic means may be an X-ray-proof reagent, such as barium sulfate, for example, up to 20 wt% (by weight) of the polymer / elastomer material of the frame. In another embodiment, the at least one diagnostic means may be a ferromagnetic reagent or a reagent detectable by ultrasound or fluorescence imaging of the IUS in its deployed state. Optionally, the at least one diagnostic means may be provided as an inert metal, or coated on at least a portion of the frame of the IUS, or provided as a partial metal ring, such as a metal ring made of silver embedded in the IUS.

[0093] 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 IUS insertion (also called the distal end), while the term "second end" refers to the end opposite the first end, i.e., the end closer to the user (such as a healthcare professional) during IUS insertion using an insert (also called the proximal end). Optionally, the length L of the frame is 50mm-110mm in a straightened configuration (i.e., when loaded into an insert). The length L can typically range from 50mm, 60mm, 70mm, 80mm, 90mm, or 100mm to a maximum of 60mm, 70mm, 80mm, 90mm, 100mm, or 110mm. Once the IUS frame is deployed to the desired position within the uterine cavity, it can achieve a pre-specified configuration (length × width) ranging from 25mm × 23mm to 31mm × 28mm, preferably 26mm × 25mm. In the unfolded state, the length typically ranges from 25mm, 27mm, or 29mm to a maximum of 27mm, 29mm, or 31mm. Similarly, the width in the unfolded state is typically from 23mm, 25mm, or 27mm to a maximum of 24mm, 26mm, or 28mm. In one embodiment, the frame of the triangular IUS in the unfolded state may be configured as 26.6mm × 24.5mm (length × width). In another embodiment, the frame of the triangular IUS in the unfolded state may be configured as 26.2mm × 24.3mm (length × width).

[0094] Furthermore, the first end of the frame includes a first locking portion, and the second end of the frame includes a second locking portion, the first and second locking portions being arranged to form a lock. The first and second locking portions extend from the first and second ends of the frame as overhangs, respectively. Optionally, the first and second locking portions are geometrically complementary structures, such as hooks and rings, pins and rings (or grooves), or clamps and posts. It will be understood that the first and second locking portions, having geometrically complementary structures, contact each other in an unfolded state within the uterus to engage with each other. The first and second locking portions mechanically act against each other to lock the frame, thereby properly placing the IUS into the uterus. When locked, the first and second locking portions are held directly in an immovable manner, thereby locking the frame into the desired shape. When unlocked, the first and second locking portions exist in a separated state, for example, in a straightened configuration at least partially inside the insert or in a configuration when the IUS has not yet been fully inserted (or released) into the uterine cavity. It will be understood that when the first locking portion is locked to the second locking portion, external influences such as uterine contractions will not affect the locking of the frame. In one embodiment, the width of the first locking portion and the second locking portion may be greater than the width W of the frame. The width of the first locking portion and the second locking portion may be in the range of 1.5mm-4mm. The width of each of the first locking portion and the second locking portion is typically from 1.5mm, 2mm, 2.5mm, 3mm, or 3.5mm to a maximum of 2mm, 2.5mm, 3mm, 3.5mm, or 4mm. It is worth noting that the manufacturing material of the first locking portion and the second locking portion gives the IUS including the first locking portion and the second locking portion high ductility, so that the effective width and maximum outer diameter of the IUS are less than 3.7mm, preferably 2.9mm.

[0095] Optionally, the first locking portion is a pin, and the second locking portion is a ring, wherein the pin is arranged to be non-removably inserted into the ring. The engagement of the pin and ring ensures that a majority of the pin is engaged within the ring. Preferably, the pin has a knob-like structure, and the ring has complementary grooves or openings for more efficient pin-ring engagement. The engagement of the pin and ring provides the desired shape for the frame in its deployed state inside the uterus.

[0096] Optionally, the first locking portion is a hook, and the second locking portion is a ring, wherein the hook is arranged to be non-removably inserted into the ring. The hook engages with the ring to lock the frame in the desired shape in the deployed state of the IUS inside the uterus. Optionally, the first and second locking portions are made of the same material used to manufacture the frame. Optionally, the first locking portion is a clamp, and the second locking portion is a post. The geometrically complementary structures of the clamp and the post lock each other in the deployed state inside the uterus.

[0097] According to one embodiment, the second locking portion is designed to completely encompass the first locking portion when the locking portions are locked together. When combined with the insert discussed below, this embodiment ensures that the first locking portion does not contact the plunger of the insert.

[0098] Optionally, the frame includes first, second, and third frame segments having a width W (defined as a dimension perpendicular to the length), the first and second frame segments being connected via a first bending section, and the second and third frame segments being connected via a second bending section. The width W of the first, second, and third frame segments is substantially the same as the width of the frame. The width W of the first, second, and third frame segments can be in the range of 1.5mm to 3.5mm. The width W is typically from 1.5mm, 1.7mm, 1.9mm, 2.1mm, 2.3mm, 2.5mm, 2.7mm, 2.9mm, 3.1mm, or 3.3mm to a maximum of 1.7mm, 1.9mm, 2.1mm, 2.3mm, 2.5mm, 2.7mm, 2.9mm, 3.1mm, 3.3mm, or 3.5mm. The first and second bending sections allow the frame to bend at predetermined distances to achieve a desired triangular shape in its unfolded state within the uterus. Typically, the curved segments are thinner than the frame segments in at least one dimension, allowing them to bend effectively during insertion so that the IUS acquires its correct shape. However, when the IUS is pulled out, the curved segments (as part of the IUS) need to withstand a force, typically limited to 12 N. Therefore, it may be advantageous to make the curved segments wider than the frame segments in a direction perpendicular to the direction in which the curved segments are thinner than the frame segments.

[0099] According to one implementation, the first and third frame segments are slightly curved, meaning they are not perfectly straight. The radius can be, for example, 120%-155% of the maximum size of the IUS when it is locked in shape. Therefore, the radius can be, for example, from 120%, 125%, 130%, 135%, or 140% of the maximum size to up to 130%, 135%, 140%, 145%, 150%, or 155%, for example, approximately 45 mm. This helps the IUS rotate correctly during insertion, thereby minimizing patient discomfort and perforation of the uterine wall.

[0100] Optionally, a first curved section is arranged at a first distance D1 from the first end, and a second curved section is arranged at a second distance D2 from the first end, wherein the first distance D1 is 25%-40% of the length L, and the second distance D2 is 55%-80% of the length L. The first distance D1 is typically from 25%, 30%, or 35% of the length L to a maximum of 30%, 35%, or 40%. The first distance D1 can typically be from 12.5 mm to 44 mm, preferably from 17.5 mm to 28 mm. In one embodiment, the first distance D1 is 32%-34% of the frame length L, i.e., 16 mm to 37.4 mm. Similarly, the second distance D2 is typically from 55%, 60%, 65%, 70%, or 75% of the length L to a maximum of 60%, 65%, 70%, 75%, or 80%. In one embodiment, the first distance D2 can be from 27.5 mm to 88 mm, preferably from 38.5 mm to 56 mm. In another embodiment, the second distance D2 is 65%-67% of the frame length L, i.e., 32.5 mm to 73.7 mm.

[0101] The first curved segment has a first width W1, and the second curved segment has a second width W2. The first width W1 can be 5%-50% of the width W, and the second width W2 can be 5%-50% of the width W. More preferably, 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% of the width W to a maximum of 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, or 50%. In one embodiment, the width W1 can be from 0.1 mm to 2 mm, preferably from 0.4 mm to 1.2 mm. Similarly, the width W2 is typically from 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, or 45% of the width W, up to a maximum of 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, or 50%. For example, the width W2 can be from 0.1 mm to 2 mm, preferably from 0.4 mm to 1.2 mm. Therefore, the first width W1 and the second width W2 can be substantially the same.

[0102] In another embodiment, the first width W1 of the first curved segment and the second width W2 of the second curved segment are both greater than the width W of the frame segment. For example, W1 can be 100%-150% of W, and W2 can independently be 100%-150% of W. In practice, W1 and W2 can be independently selected from W ranging from 100%, 105%, 110%, 115%, 120%, 125%, 130%, 135%, or 140% to as high as 105%, 110%, 115%, 120%, 125%, 130%, 135%, 140%, 145%, or 150%.

[0103] Optionally, the cross-section of the frame at the first and second bending sections has a substantially concave shape, wherein the first width W1 and the second width W2 are the minimum dimensions of the cross-section. The concave shape of the cross-section of the frame at the first and second bending sections allows for bending of the IUS. In one embodiment, the cross-section of the frame at the first and second bending sections can have different shapes, as long as the shape allows the frame to bend into the desired shape. For example, a notch may be present on at least one side of each of the first, second, or third bending section and the second bending section to allow the frame to bend into the desired shape.

[0104] Optionally, the frame includes a bend point that allows the IUS to be removed. This bend point is a weaker section compared to the rest of the frame. In one embodiment, the bend point is located in a middle section of the frame that does not have a locking portion at the ends, such as in the middle of a second frame section. Alternatively, the bend point can be located in any other part of the frame, as long as it facilitates bending or breaking of the IUS frame. In one embodiment, during removal of the IUS from the IUS, the IUS bends at the bend point when the removal wire is pulled, and the circular or triangular shape of the frame collapses, allowing the “folded” frame to be removed through the cervical canal. The bend point should be designed so that the IUS does not bend in the wrong direction during insertion. In another embodiment, the IUS breaks at the bend point when the removal wire is pulled.

[0105] The IUS includes a removal thread attached to the first end of a frame. As used herein, the term "removal thread" refers to a thread (i.e., cord) attached to one end of the IUS for removal at the end of the wearing period (approximately 3-10 years, preferably 5-7 years). Once the IUS has unfolded within the uterus, the removal thread is used not only for removal and / or replacement of the IUS later in the wearing period, but also for detecting (e.g., as an indicator) whether the IUS is in the correct position within the uterine cavity. Furthermore, in retail packaging, the removal thread is typically used to hold the IUS in place relative to the insert.

[0106] The removal wire is also configured to guide a first locking portion to a second locking portion. The removal wire guides the first locking portion to contact the second locking portion and further engages the first locking portion with the second locking portion, thereby providing the desired shape to the IUS within the uterine cavity. Alternatively, when the removal wire is pulled, it guides the first locking portion to the second locking portion to engage and lock together. Strain during the pulling of the removal wire causes the first locking portion to be immovably inserted into the second locking portion, thereby locking the frame into the desired shape. Optionally, a first end of the frame has an attachment device for attaching the removal wire. Embodiments of the attachment device include, but are not limited to, openings, perforations, grooves, protrusions, and notches.

[0107] The IUS includes at least one pharmaceutically active agent. In one embodiment, the pharmaceutically active agent may be a hormone, a drug or drug analogue, an active pharmaceutical ingredient, or a health-promoting substance with contraceptive or other therapeutic properties. This pharmaceutically active agent works by thickening cervical mucus, altering the endometrium to make it unsuitable for ovulation, stopping ovulation, or acting as a COX1 / COX2 inhibitor. In one embodiment, the pharmaceutically active agent may provide and / or enhance protection against a variety of microbial infections, such as bacterial infections, fungal infections, and / or sexually transmitted infections. The IUS may also include more than one pharmaceutically active agent.

[0108] Optionally, the pharmaceutically active agent is selected from 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-ethinyltestosterone and its derivatives, 17a-ethinyl-19-nortestosterone and its derivatives, and ethynodiol. The following medications are considered steroids: diacetate, dydrogesterone, norethynodrel, allylestrenol, 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, and progesterone receptor antagonists. Antagonists, such as mifepristone (11β-4-dimethylaminophenyl-17β-hydroxy-17α-propynyl-4,9-Estradiene-3-one (11β-4-dimethylaminophenyl-17β-hydroxy-17α-propinyl-4,9-estradiene-3-one), ulipristale acetate, (11β,17β)-17-hydroxy-11-[4-(methylsulfonyl)phenyl]-17-(pentafluoroethyl)-estra-4,9-dien-3-one, 17α-acetyl-11β-[4-(N,N-dimethylamino)phenyl]-21- Methoxy-19-norpregna-4,9-diene-3,20-dione (17α-acetoxy-11β-[4-(N,N-dimethylamino)phenyl]-21-methoxy-19-norpregna-4,9-diene-3,20-dione), 17α-acetyl-11β-(4-N,N-dimethylaminophenyl) -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-perfluoroethyl)-4,9-estradiene-3-one (11β-(4-acetylphenyl)-17β-hydroxy-17α-(1,1,2,2,2-pentafluoroethyl)-4,9-estradiene-3-one), asoprisnil (benzaldehyde-4-[(11β,17β)-17-methoxy-17- (methoxymethyl)-3-oxoestrone-4,9-dien-11-yl)]-1-oxime)(asoprisnil(benzal dehyde-4-[(11β,17β)-17-methoxy-17-(methoxymethyl)-3-oxoestra-4,9-dien-11-yl)]-1-oxime)).

[0109] For example, levonorgestrel can be used as a hormone, and indomethacin as a COX inhibitor. It will be understood that the active pharmaceutical ingredient (API) is administered in an appropriate amount, such as the maximum feasible amount suitable for the subject. Furthermore, the amount (i.e., dosage) of the API varies depending on the specific API, intended use, duration of action, rate of release, and duration of treatment, as well as the subject's age and medical condition. Additionally, the API typically has a pH suitable for the uterus. Therefore, IUS not only functions as a long-acting, reversible method of contraception but can also be used for a variety of other applications, such as treating uterine conditions, swelling, and pain, depending on the API delivered via IUS.

[0110] Optionally, at least one pharmaceutically active agent is disposed within the frame. In one embodiment, the at least one pharmaceutically active agent is dispersed or dissolved in the frame material prior to frame fabrication. In one embodiment, at least one pharmaceutically active agent is disposed in one of three frame segments (i.e., a first, second, or third frame segment). In another embodiment, at least one pharmaceutically active agent is disposed in all three frame segments.

[0111] Optionally, at least one pharmaceutically active agent is disposed in at least one capsule, which is disposed around the frame over at most a portion of the frame length L. Specifically, at least one capsule is a drug container containing the pharmaceutically active agent. The at least one capsule disposed around the frame can also provide the required rigidity to the frame of the IUS at this portion of the frame length. At least one capsule is disposed around at least one of the first, second, or third frame segments such that the first locking portion, the first curved portion, the second curved portion, and the second locking portion do not contain at least one capsule.

[0112] Optionally, in addition to the first and second locking portions, at least one capsule is arranged to surround the frame along its entire length. At least one capsule is arranged to surround the first, second, and third frame segments. In this case, at least one capsule has sufficient flexibility to bend at the curved sections.

[0113] Optionally, at least one capsule is made of poly(dimethyl silicone), siloxane elastomer, thermoplastic polyurethane, thermoplastic polyurethane elastomer, ethyl vinyl acetate, polyolefin elastomer, silicone-containing thermoplastic, polyurethane, polylactic acid, and polycaprolactone. More preferably, at least one capsule is made of a biocompatible polymer matrix. Examples of biocompatible polymer matrices include, but are not limited to, copolymers of dimethylsiloxane and methylvinylsiloxanes, polyethylene, polypropylene, polybutadiene, polyisoprene, acrylic polymers, ethylene / propylene copolymers, ethylene / ethyl acrylate copolymers, poly(methacrylic acid), polymethyl methacrylate, styrene-butadiene-styrene block copolymers, styrene-isobutylene-styrene copolymers, poly(hydroxyethylmethacrylate), polyether, polyacrylonitrile, polyethylene glycol, polymethylpentene, polyhydroxyalkanoates, polyorthoesters, hydrophilic polymers (such as hydrophilic hydrogels), crosslinked polyvinyl alcohol, polytetrafluoroethylene, polyvinyl chloride, polyvinyl acetate, chloroprene rubber, and butyl rubber.

[0114] In one embodiment, at least one capsule is selected from matrix systems and core-membrane systems. In one embodiment, the matrix system may be a polymer matrix, such as a siloxane elastomer, in which a pharmaceutical active agent is dispersed or dissolved. In another embodiment, in a core-membrane system, at least one capsule may include a pharmaceutical active agent core and a membrane encapsulating the pharmaceutical active agent core. The core may be a hollow tubular structure assembled on a frame (surrounding the frame over at most a portion of the frame length L) to deliver the pharmaceutical active agent at a controlled rate within the uterus. The membrane may be a permeable layer made of an inert material that prevents direct contact between the pharmaceutical active agent and the biofluid within the uterus. Furthermore, the membrane layer can modulate the release rate of the pharmaceutical active agent by acting as a diffusion layer surrounding the pharmaceutical active agent core. In one embodiment, the membrane may surround at least one capsule from all directions to form a closed capsule. In another embodiment, at least one capsule is not completely surrounded by a membrane. In one embodiment, the membrane is more permeable than the pharmaceutical active agent core and allows the pharmaceutical active agent to contact the biofluid.

[0115] Optionally, the cross-section of at least one capsule is selected from circular and oval shapes. For example, the capsule may have a rounded, circular, oval, or elliptical cross-section, provided the shape is suitable for insertion into the cervix and uterus. Optionally, the outer diameter of the capsule is in the range of 2 mm to 3.5 mm, preferably about 2.9 mm. The outer diameter of the capsule is typically from 2 mm, 2.1 mm, 2.3 mm, 2.5 mm, 2.7 mm, 2.9 mm, 3.1 mm, or 3.3 mm to a maximum of 2.1 mm, 2.3 mm, 2.5 mm, 2.7 mm, 2.9 mm, 3.1 mm, 3.3 mm, or 3.5 mm.

[0116] Optionally, the IUS comprises at least two capsules. In one embodiment, at least two capsules are placed on a frame at a predetermined distance from each other. Preferably, once the IUS is inserted into the uterine cavity, at least two capsules will not come into contact with each other. Optionally, the number of capsules can be three, four, etc., depending on the different types of therapeutic agents to be administered.

[0117] Optionally, the IUS includes 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, wherein the first locking portion, the first bending segment, the second bending segment, and the second locking portion do not contain capsules. In this embodiment, the first, second, and third capsules provide sufficient rigidity to the frame during insertion and further help the IUS achieve 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 contain capsules, thereby creating the necessary bending and / or shaping within the frame of the IUS.

[0118] Optionally, the capsules comprise different pharmaceutically active agents. Optionally, the first, second, and third capsules may be structurally identical or different, and may contain the same or different pharmaceutically active agents. In one embodiment, the first capsule may comprise a first pharmaceutically active agent, such as a progestin, the second capsule may comprise a second pharmaceutically active agent, such as diclofenac, and the third capsule may comprise a third pharmaceutically active agent, such as levonorgestrel. Furthermore, the release of pharmaceutically active agents from at least two capsules may occur simultaneously or sequentially, depending on the release rate of the pharmaceutically active agents to be realized and their respective interactions with intrauterine biological fluids.

[0119] Optionally, a first active pharmaceutical ingredient is disposed within a capsule arranged to surround the frame over at most a portion of the frame's length L, and a second active pharmaceutical ingredient is disposed within the frame. The capsule influences the release rate of the active pharmaceutical ingredient in the uterus. At least one active pharmaceutical ingredient dispersed or dissolved in the manufacturing material of the frame has a different release rate than the active pharmaceutical ingredient disposed within the capsule. It will be understood that the release rate of the active pharmaceutical ingredient depends on the permeability of the manufacturing materials of the frame and / or the capsule.

[0120] According to one embodiment, the frame is obtained via injection molding. A capsule is arranged to surround part of the frame, forming a capsule-frame assembly. However, in the presence of more than one capsule, the capsules can be arranged anywhere on the frame such that at least the first and second locking portions are capsule-free, depending on the desired shape of the IUS to be achieved.

[0121] In another exemplary aspect, one embodiment of this disclosure provides an intrauterine system comprising:

[0122] - 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;

[0123] - Remove the wire, which is attached to the first end of the frame; and

[0124] - Copper wires, arranged to surround at least a portion of the frame;

[0125] The frame includes a first locking portion at a first end and a second locking portion at a second end. The first and second locking portions are arranged to form a lock, and a removal wire is configured to guide the first locking portion to the second locking portion.

[0126] According to this implementation, copper wires arranged to surround at least a portion of the frame provide contraception by preventing sperm from fertilizing the egg. Copper IUS (i.e., copper-containing IUS) are hormone-free, making them a good option for women who prefer or are advised to use non-hormonal contraceptive methods for medical reasons.

[0127] According to one implementation, the IUS is pre-installed (or pre-loaded) in an insert within the aseptic sales package. The sales package protects the contents of the kit from environmental and mechanical factors.

[0128] Detailed description of the attached figures

[0129] refer to Figure 1AThe diagram shows a perspective view of an insert 1100 pre-loaded with an IUS 1102 in an assembled state according to one embodiment of the present disclosure. The insert 1100 includes a handle body 1104 having a proximal end 1106 and a distal end 1108. The insert 1100 also includes a measuring tube 1110 having a proximal end 1112 and a distal end 1114. The proximal end 1112 of the measuring tube 1110 is movably attached to the distal end 1108 of the handle body 1104. The insert 1100 also includes a tip cap 1116 having a distal end 1118 and a proximal end 1120. The tip cap 1116 is arranged to retract inside the distal end 1114 of the measuring tube 1110. The insert 1100 also includes a flange 1122 movably arranged to surround the measuring tube 1110. A finger retainer 1124 is movably arranged to surround the handle body 1104. The insert 1100 also includes a means 1126 for reversibly locking the removal wire of the IUS 1102. The means 1126 for reversibly locking the removal wire is disposed on the handle body 1104. The insert 1100 also includes a piston 1130 movably disposed inside the handle body 1104.

[0130] refer to Figure 1B The illustration shows one embodiment based on this disclosure. Figure 1A A perspective view of the insert 1100 with IUS 1102 in its unassembled state. The insert 1100 also includes a distal end 1134, a proximal end 1136, and a length L defined as the distance between the distal end 1134 and the proximal end 1136. p The plunger 1132. In the assembled state of the insert 1100, the plunger 1132 is movably arranged inside the handle body 1104 and the measuring tube 1110. Further shown are the first cap portion 1138A and the second cap portion 1138B of the handle body 1104. The handle body 1104 has a length L defined as the distance between the distal end 1108 and the proximal end 1106. h It is worth noting that the length L p Greater than length L hFurther, the first portion 1140A and the second portion 1140B of the measuring tube 1110, the first portion 1142A and the second portion 1142B of the finger retainer 1124, and the first portion 1144A and the second portion 1144B of the piston 1130 are shown. Further, the flange tip cap 1116 and the device 1126 for reversibly locking the removal wire of the IUS 1102 are shown. In the assembled state of the insert 1100, the tip cap 1116 accommodates the frame of the IUS 1102 in a straightened configuration (i.e., the IUS 1102 is in a pre-loaded state in the insert 1100 before insertion into the uterus). Further, the flange 1122, the finger retainer 1124, and the device 1126 for reversibly locking the removal wire of the IUS 1102 are shown.

[0131] further, Figure 1C An enlarged view of IUS 1102 is shown. IUS 1102 includes a frame 1146 having a first end 1148, a second end 1150, and a length L defined as the distance from the first end 1148 to the second end 1150. Before IUS 1102 is inserted into the uterus, the frame 1146 is straightened and stretched when loaded into the insert 1100 in an assembled state. The first end 1148 of the frame 1146 includes a first locking portion 1152, and the second end 1150 of the frame 1146 includes a second locking portion 1154. In this embodiment, the first locking portion 1152 is a pin, and the second locking portion 1154 is a ring. The first locking portion 1152 and the second locking portion 1154 have complementary structures to allow the pin to be non-movably inserted into the ring. The first locking portion 1152 at the first end 1148 of the frame 1146 includes an opening 1156 for receiving a removal wire 1128.

[0132] refer to Figure 2A This image shows a perspective view of a piston and plunger subassembly 1200 of an insert according to one embodiment of the present disclosure. In the piston and plunger subassembly 1200, an arrangement of a plunger 1202 within a piston 1204 is shown. The plunger 1202 includes a means 1206 for preventing its removal from the handle body of the insert and the inside of the piston 1204.

[0133] Figure 2B A cross-sectional view of a piston and plunger subassembly 1200 of an insert according to one embodiment of the present disclosure is shown. In the piston and plunger subassembly 1200, a plunger 1202 is attached to a piston 1204. Further shown is an enlarged view of the distal portion of the piston and plunger subassembly 1200 to depict the engaging portion 1208 of the piston 1204. The plunger 1202 locks between the engaging portions 1208 of the piston 1204.

[0134] Figure 3A A schematic diagram of an insert 1300 according to one embodiment of the present disclosure is shown, along with an enlarged view of a first segment 1302 of the insert 1300 to depict a piston 1304 movably disposed inside a handle body 1306. The piston 1304 includes a means 1308 for preventing the piston 1304 from being removed from the inside of the handle body 1306. Further, an enlarged view of a second segment 1310 of the insert 1300 is shown to depict a first hook 1312 of a finger retainer 1314 locked in a first recess 1316 of the handle body 1306, which is opened during the movement of the first portion as the piston moves toward the distal end of the handle body during insertion.

[0135] Figure 3B A schematic diagram of an insert 1300 according to one embodiment of the present disclosure is shown, along with an enlarged view of the fourth segment 1324 of the insert 1300 to depict a clamp 1326 for securing the measuring tube 1328. The clamp 1326 secures the measuring tube 1328 in such a way that the measuring tube 1328 is movably attached to the inside of the distal end 1330 of the handle body 1306. The clamp is opened by a piston at the end of insertion when the IUS is fully inside the uterus and the locking portions are locked together.

[0136] Figure 3CA schematic diagram of the insert 1300 and an enlarged view of the fifth segment 1332 of the insert 1300 are shown to depict the arrangement of the tip cap 1334 inside the measuring tube 1328. In the fifth segment 1332, the IUS 1336 is shown pre-loaded into the insert 1300 in such a manner that a small portion of the frame 1338 of the IUS 1336 protrudes from the insert 1300, while the remainder of the frame 1338 is surrounded and protected by the tip cap 1334. Further, 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. Before the IUS 1336 is inserted into the uterus, the frame 1338 is straightened and stretched when loaded into the insert 1300. The first end 1340 of frame 1338 includes a first locking portion 1344, and the second end 1342 of frame 1338 includes a second locking portion 1346. In this embodiment, the first locking portion 1344 is a pin, and the second locking portion 1346 is a ring. IUS 1336 also includes a pharmaceutically active agent disposed within frame 1338. Frame 1338 also includes a first frame segment 1348, a second frame segment 1350, and a third frame segment 1352. The first frame segment 1348 and the second frame segment 1350 are connected to each other via a first bend 1354. The second frame segment 1350 and the third frame segment 1352 are connected to each other via a second bend 1356. A removal wire 1358 is attached to an opening in the first locking portion 1344. In the fifth segment 1332, the distal end 1360 of a plunger 1362 configured to cooperate with the second locking portion 1346 is further shown. The plunger 1362 is hollow, thus allowing the removal wire 1358 of the IUS 1336 to pass through the plunger 1362.

[0137] Figures 4A-4H Different views of an insert 1400 according to one embodiment of this disclosure are illustrated, depicting various operational stages of positioning the IUS 1402 within the uterus. Reference Figure 4AThe diagram illustrates the adjustment of the flange 1404 on the measuring tube 1406 of the insert 1400 according to one embodiment of the present disclosure. The flange 1404 is manually moved to a designated position on the measuring tube 1406 using an insertion depth indicator 1408 on the outer surface of the measuring tube 1406. The designated position is the length of the uterine cavity plus the length of the cervical canal previously measured during uterine probing. Once set, the flange 1404 does not move during the insertion of the IUS 1402. Further, a portion of the frame 1412 of the IUS 1402 is shown outside the insert 1400 in a pre-loaded state. Additionally, in the pre-loaded state, a removal wire 1414 is attached to one end (i.e., the first end) of the frame 1412, passing through the insert 1400, and a portion of the removal wire 1414 protrudes from the handle body 1416 of the insert 1400. A rotatable knob 1418 is positioned in a first position to lock the removal wire 1414 between the handle body 1416 and the rotatable knob 1418.

[0138] Figure 4B and Figure 4C An embodiment of flange 1404 is shown in more detail. In this embodiment, flange 1404 includes a snap-lock 1410 that is initially in an "open" position, allowing the flange to move easily when the snap-lock 1410 is open. Once the flange is in its correct position (on the insertion depth indicator 1408), the snap-lock 1410 is closed by pressing the flange, thus placing the snap-lock in the "closed" position.

[0139] Figure 4D The first insertion phase of the IUS 1402 using the insert 1400 according to one embodiment of this disclosure is shown. In this phase, the transition from a first state 1424 (left) to a second state 1426 (right) of the insert 1400 is shown. In the first state 1424 (left), the tip cap 1422 is shown in the extended position. The measuring tube 1406 extends through the vagina 1428 toward the cervix. The insert 1400 is positioned such that the tip cap 1422 reaches the cervical os, and the first end (i.e., the tip) of the IUS 1402 is positioned inside the cervical os. In this phase, the entire insert 1400 is gently pushed toward the subject, causing the tip cap 1422 to move rearward inside the handle body 1416.

[0140] In the second state 1426 (right), the tip cap retracts inside the handle body 1416, and a portion of the frame 1412 is released from the insert 1400 into the cervical canal 1430 and partially into the uterine cavity 1432. Further shown in the second state 1426 is the distal end 1434 of the tip cap, which has a bulbous structure to prevent the measuring tube 1406 from entering the cervical canal 1430. At this stage, the pressing member 1436 of the piston 1438 remains away from the proximal end 1440 of the handle body 1416 (i.e., the piston 1438 is in the extended state).

[0141] refer to Figure 4E The image shows the second insertion stage of IUS1402 using insert 1400 according to one embodiment of this disclosure. In this stage, at operation 1442 (left side), while maintaining firm contact between the distal end 1434 of the tip cap (i.e., the tip of insert 1400) and the cervical port, the piston 1438 is pressed against the pressing member 1436 from the proximal end. The finger retainer 1446 serves as a support for the fingers (e.g., two fingers in this case) to facilitate pressing the piston 1438 toward the handle body 1416.

[0142] Press the piston 1438 proximally until it is fully inside the handle body 1416 and no further movement of the piston 1438 is permitted (i.e., movement of the piston 1438 ceases). The IUS 1402 begins to disengage from the insert 1400 and forms a ring for entry into the uterine cavity 1432. The movement of the piston 1438 causes the plunger 1450 attached to it to move, which in turn pushes one end of the frame, thus releasing more of the frame from the insert 1400 to form a ring for entry into the uterine cavity 1432.

[0143] At operation 1448 (right side), after the piston is fully inserted into the handle body 1416, the finger retainer 1446 is unlocked and moves towards the proximal end of the handle body 1416. At this stage, IUS 1402 is outside the insert 1400, and IUS 1402 is at the entrance to the uterine cavity 1432. At this stage, the plunger also locks itself inside the insert 1400 and cannot be moved further by pressing the piston.

[0144] Figure 4F The steps for locking the locking portion of IUS 1402 are shown, with IUS 1402 positioned at the entrance of uterine cavity 1432. Measuring tube 1406 is released and can be moved again.

[0145] refer to Figure 4GThe image shows the third insertion stage of an IUS 1402 using insert 1400 according to one embodiment of this disclosure. In this stage, insert 1400 is pushed toward the patient until flange 1404 meets handle body 1416 (i.e., a portion of the proximal end of measuring tube 1406 enters inside the distal end 1454 of handle body 1416). During this stage, IUS 1402 moves to its base position, and the entire IUS 1402 is precisely positioned within uterine cavity 1432.

[0146] refer to Figure 4H The illustration shows, according to one embodiment of this disclosure, the release of the removal wire 1414 using the insert 1400 after the IUS 1402 has been deployed in the uterine cavity. At this stage, the removal wire 1414 is released using a rotatable knob 1418. The rotatable knob 1418 moves from its initial first position to a second position to allow the removal wire 1414 to move relative to the handle body 1416 and ultimately be released.

[0147] refer to Figure 4I The illustration shows the removal of inserter 1400 from a subject according to one embodiment of this disclosure. Inserter 1400 is pulled out of vagina 1428, indicating that insertion of IUS 1402 is complete.

[0148] refer to Figure 5A The diagram illustrates a pre-loaded insert 1500 of an IUS 1502 in an assembled state according to another embodiment of the present disclosure. The insert 1500 includes a handle body 1504 having a proximal end 1506 and a distal end 1508. The insert 1500 also includes 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 insert 1500 also includes a flange 1522 movably arranged around the measuring tube 1510. A finger retainer 1524 is disposed on the handle body 1504. In this embodiment, the finger retainer 1524 is annular in shape, i.e., a circular object extending radially outward from opposite sides of the outer surface of the handle body 1504 at its proximal end 1506. The insert 1500 also includes a means 1526 for reversibly locking the removal wire of the IUS 1502. The means 1526 for reversibly locking the removal wire is disposed on the handle body 1504. The insert 1500 also includes a piston 1530, which is movably disposed inside the handle body 1504.

[0149] refer to Figure 5B The illustration shows one embodiment based on this disclosure. Figure 5AA perspective view of the insert 1500 in its unassembled state. The insert 1500 also includes a plunger 1532 having a distal end 1534 and a proximal end 1536. In the assembled state of the insert 1500, the plunger 1532 is movably arranged inside the handle body 1504 and the measuring tube 1510. The handle body 1504 has a first cap portion 1538A and a second cap portion 1538B. Further shown are a first portion 1540A and a second portion 1540B of the measuring tube 1510, and a first portion 1542A and a second portion 1542B of the piston 1530. Further shown are a device 1526 for reversibly locking the removal wire of the IUS 1502, and a flange 1550.

[0150] Figure 6 A perspective view of an IUS 100 in a loading configuration according to one 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 stretched when loaded into the insert 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 ring. Further, the outer diameter 112 (i.e., the maximum outer diameter) of the IUS 100 is shown. The IUS 100 also includes a pharmaceutically active agent disposed within the frame 102.

[0151] Now for reference Figure 7 The illustration shows one embodiment based on this disclosure. Figure 6 A schematic diagram of the IUS 100. In this embodiment, the frame 102 of the IUS 100 is a triangular frame. A first locking portion 108 at a first end 104 of the frame 102 and a second locking portion 110 at a second end 106 of the frame 102 are arranged to form a lock 202 in the unfolded state in the uterus.

[0152] Frame 102 also includes a first frame segment 204, a second frame segment 206, and a third frame segment 208. The first frame segment 204 and the second frame segment 206 are connected to each other via a first curved segment 210. The second frame segment 206 and the third frame segment 208 are connected to each other via a second curved 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 frame 102. Further, it is shown that the first curved segment 210 has a first width W1, and the second curved segment 212 has a second width W2. In this embodiment, the cross-section of frame 102 at the first curved segment 210 and the second curved segment 212 has a substantially concave shape 214. The first width W1 and the second width W2 are the minimum dimensions of the cross-section of frame 102. In this embodiment, the first width W1 and the second width W2 are substantially the same, and each of the first width W1 and the second width W2 is approximately 25% of the width W. Compared to other parts of the frame 102, the smaller cross-section (i.e., localized thinning) at the first bending segment 210 and the second bending segment 212 facilitates bending the frame 102 into a triangle. The frame 102 also includes bending points 216 that facilitate the removal of the IUS 100 if needed.

[0153] The IUS 100 also includes a removal wire 218 attached to a first end 104 of the frame 102. Specifically, the removal wire 218 is coupled at the first end 104 of the frame 102 to an opening 220 of a first locking portion 108. The removal wire 218 is configured to guide the first locking portion 108 toward a second locking portion 110. Further, the length 222 and width 224 of the frame 102 of the triangular IUS 100 in its unfolded state in the uterus are shown.

[0154] Now for reference Figure 8 The diagram illustrates a schematic of an IUS 300 according to another embodiment of the present disclosure. The IUS 300 includes a frame 302 having a first end 304 and a second end 306. In this embodiment, the frame 302 is a triangular frame. The first end 304 of the frame 302 includes a first locking portion 308, and the second end 306 of the frame 302 includes a second locking portion 310. The first locking portion 308 and the second locking portion 310 are arranged to form a lock 312. The first locking portion 308 is a hook, and the second locking portion 310 is a ring, with the hook arranged to be non-movably inserted into the ring.

[0155] Frame 302 also includes a first frame segment 314, a second frame segment 316, and a third frame segment 318. The first frame segment 314 is connected to the second frame segment 316 via a first bend 320. Similarly, the second frame segment 316 is connected to the third frame segment 318 via a second bend 322. In this embodiment, frame 302 also includes two bends 324 that allow the IUS 300 to be removed. The area between the two bends 324 is a weaker portion of frame 302 compared to the rest of the frame 302.

[0156] The IUS 300 also includes a removal wire 326 attached to a first end 304 of the frame 302. The removal wire 326 is received in an opening 328 disposed in a first locking portion 308. The removal wire 326 is configured to guide the first locking portion 308 toward a second locking portion 310. The IUS 300 also includes four capsules: a first capsule 330, a second capsule 332, a third capsule 334, and a fourth capsule 336. The first capsule 330 is shorter in length than the other capsules 332, 334, and 336. Capsules 330, 332, 334, and 336 contain the same or different pharmaceutical active agents.

[0157] Now for reference Figure 9A This diagram illustrates an IUS 400 in a loading configuration according to another embodiment of the present disclosure. As shown, the IUS 400 includes 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. Before the IUS 400 is inserted into the uterus, the frame 402 is straightened and stretched (i.e., in a loading configuration) when loaded into the insert. The first end 404 of the frame 402 includes a first locking portion 408, and the second end 406 of the frame 402 includes a second locking portion 410. In this embodiment, the first locking portion 408 is a pin, and the second locking portion 410 is a ring. The first locking portion 408 and the second locking portion 410 have complementary structures to allow the pin to be nonmovably inserted into the ring. The first locking portion 408 of the IUS 400 includes an opening 412 for receiving a removal wire.

[0158] Frame 402 also includes a first capsule 414, a second capsule 416, a third capsule 418, and a fourth capsule 420. The first capsule 414 and the second capsule 416 are arranged to surround the first frame segment 422 and the second frame segment 424, respectively. The third capsule 418 and the fourth capsule 420 are arranged to surround the third frame segment 426 of frame 402. Further shown are a first curved segment 428 and a second curved segment 430. The first frame segment 422 is connected to the second frame segment 424 via the first curved segment 428, and the second frame segment 424 is connected to the third frame segment 426 via the second curved segment 430.

[0159] Now for reference Figure 9B The illustration shows one embodiment based on this disclosure. Figure 9A A perspective view of the IUS 400. As shown, the first locking portion 408 is a pin and the second locking portion 410 is a ring, i.e., having a geometrically complementary structure such that, in the deployed state of the IUS 400 in the uterus, the pin is substantially engaged in the ring.

[0160] Now for reference Figure 9C The diagram shows a schematic cross-sectional view of an IUS 400 in an deployed state according to one embodiment of the present disclosure. In the deployed state, the frame 402 of the IUS 400 achieves a triangular shape when the first locking portion 408 and the second locking portion 410 engage to form a lock 432. The frame 402 also includes a bend 434 that allows the IUS 400 to be removed. In this embodiment, the bend 434 is located in the middle section of the second bend segment 424 and is a weaker portion compared to the other portions of the frame 402. Further shown are a first capsule 414 arranged to surround the first frame segment 422, a second capsule 416 arranged to surround the second frame segment 424, a third capsule 418 arranged to surround a portion of the third frame segment 426, and a fourth capsule 420 arranged to surround another portion of the third frame segment 426 of the frame 402. The first locking portion 408 includes an opening 412 for receiving a removal wire 436. The removal wire 436 guides the first locking portion 408 into contact with the second locking portion 410, and further engages the first locking portion 408 with the second locking portion 410, thereby providing the desired triangular shape for the frame 402 in its unfolded state in the uterus.

[0161] Now for reference Figure 9D The illustration shows one embodiment based on this disclosure. Figure 9C A perspective view of the IUS 400 in its deployed state. As shown, the first locking portion 408 and the second locking portion 410 have geometrically complementary structures such that the first locking portion 408 substantially engages with the second locking portion 410, and forms a lock 432 in the deployed state within the uterus.

[0162] Figure 10A schematic diagram of an IUS 500 according to another embodiment of the present disclosure is shown. The IUS 500 includes a frame 502 having a first end 504 and a second end 506. The first end 504 of the frame 502 includes a first locking portion 508, and the second end 506 of the frame 502 includes a second locking portion 510. The first locking portion 508 and the second locking portion 510 have geometrically complementary structures as an arrangement of clamps and posts to allow the first locking portion 508 to be locked to the second locking portion 510. The first locking portion 508 includes an opening 512 for receiving a removal wire. The frame 502 also includes a first capsule 514, a second capsule 516, and a third capsule 518, which are spaced apart and arranged to surround a portion of the frame 502. In this embodiment, the frame 502 has a tubular cross-section with rounded rectangular corners. In its deployed state in the uterus, the frame 502 bends at two curved sections 520 and 522 without capsules (i.e., the first capsule 514, the second capsule 516, and the third capsule 518).

[0163] Figures 11A-11D This is a framework and schematic diagram of an IUS according to one implementation scheme, showing how the IUS is locked and shaped. In fact, Figure 11A The figure shows the frame 602 of the IUS. The figure also shows a first end 604 and a second end 606 of the frame. The first end 604 of the frame 602 includes a first locking portion 608, and the second end 606 of the frame 602 includes a second locking portion 610. In this embodiment, the first locking portion 608 is a knob, and the second locking portion 610 is a ring.

[0164] Frame 602 also includes a first frame segment 612, a second frame segment 614, and a third frame segment 616. The first frame segment 612 and the second frame segment 614 are connected to each other 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 locking portions 608 and 610. In this embodiment, the cross-section of frame 602 at the first bend segment 618 and the second bend segment 620 has a substantially concave shape. Furthermore, the width of the bend segment is greater than the width of the frame segment. Frame 602 also includes a bend point 622 for easy removal of IUS 600 when needed.

[0165] Figure 11B The IUS is shown in a form that can be stored in a sales package, namely, before insertion into the inside of the insert, including a capsule 624 and a removal filament 626. Figure 11C and Figure 11D The steps of closing and locking the IUS once it is released inside the uterus are illustrated. Figure 11BThis illustrates how frame 602 bends by pulling the removal wire 624. Figure 11C In the middle, the first end 604 of frame 602 contacts the second end 606 of frame 602, while Figure 11D In the middle, the first end 604 has been pulled past the second end 606, thereby locking the IUS 600 into shape.

[0166] Modifications may be made to embodiments of the present disclosure described above without departing from the scope of the disclosure as defined by the appended claims. Expressions used to describe and claim this disclosure (such as "comprising," "including," "incorporating," "having," and "is") are intended to be interpreted in a non-exclusive manner, allowing for the presence of items, parts, or elements not explicitly described. Singular references should also be interpreted as relating to the plural.

Claims

1. An insert (1100, 1300, 1400, 1500) for use in an intrauterine system (1102, 1336, 1402, 1502), comprising: - Handle body (1104, 1306, 1416, 1504), having a distal end (1108, 1330, 1454, 1508), a proximal end (1106, 1440, 1506), and a length L defined as the distance between the distal end and the proximal end. h ; - A measuring 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, provided that the measuring tube is arranged to remain outside the cervical canal during insertion; - A plunger (1132, 1202, 1362, 1450, 1532) having a distal end (1134, 1360, 1534), a proximal end (1136, 1536), and a length L defined as the distance between the distal and proximal ends. p The plunger is movably disposed inside the handle body and the measuring tube, wherein the length L p Greater than length L h ; - Flanges (1122, 1404, 1522) are movably arranged to surround the measuring tube; - Finger retainers (1124, 1314, 1446, 1524) are movably arranged to surround the handle body; and - Devices (1126, 1526) for reversibly locking the removal wires (1128, 1358, 1414) of the intrauterine system are arranged on the handle body.

2. The inserts (1100, 1300, 1400, 1500) according to claim 1, wherein the plungers (1132, 1202, 1362, 1450, 1532) are hollow to allow the removal wires (1128, 1358, 1414) of the intrauterine system (1102, 1336, 1402, 1502) to pass through the plungers.

3. The insert (1100, 1300, 1400, 1500) according to any one of the preceding claims, wherein the plunger (1132, 1202, 1362, 1450, 1532) includes a means (1206) for preventing its removal from the inside of the handle body (1104, 1306, 1416, 1504).

4. The insert (1100, 1300, 1400, 1500) according to claim 1 further includes a piston (1130, 1204, 1304, 1438, 1530) attached to the plunger (1132, 1202, 1362, 1450, 1532) and arranged to move the plunger, the piston being movably arranged inside the handle body (1104, 1306, 1416, 1504).

5. The insert (1100, 1300, 1400, 1500) according to claim 4, wherein the piston (1130, 1204, 1304, 1438, 1530) is hollow, thereby allowing the removal wire (1128, 1358, 1414) of the intrauterine system (1102, 1336, 1402, 1502) to pass through the piston.

6. The insert (1100, 1300, 1400, 1500) according to claim 4 or 5, wherein the piston (1130, 1204, 1304, 1438, 1530) includes a means (1308) for preventing its removal from the inside of the handle body (1104, 1306, 1416, 1504).

7. The insert (1100, 1300, 1400, 1500) according to claim 1, wherein the means (1126, 1526) for reversibly locking the removal wire (1128, 1358, 1414) includes a rotatable knob (1418) arranged to lock the removal wire between the handle body (1104, 1306, 1416, 1504) and the knob in a first position (1420), and arranged to allow the removal wire to move relative to the handle body in a second position (1454).

8. The insert (1100, 1300, 1400, 1500) according to claim 7, wherein the knob (1418) and the handle body (1104, 1306, 1416, 1504) include corresponding forms that allow the removal wire (1128, 1358, 1414) to be locked when the knob is in a first position (1420).

9. The insert (1100, 1300, 1400, 1500) according to claim 1 further includes a tip cap (1116, 1334, 1422, 1516) having a distal end (1118, 1434, 1518) and a proximal end (1120, 1520), the tip cap being arranged to retract inside the distal end of the measuring tube, provided that the tip cap is arranged to remain outside the cervical canal during insertion.

10. The insert (1100, 1300, 1400, 1500) according to claim 1, wherein the length L h The diameter is 70mm-110mm.

11. The insert (1100, 1300, 1400, 1500) according to claim 1, wherein the length L p The thickness ranges from 50mm to 90mm.

12. The insert (1100, 1300, 1400, 1500) according to claim 1, wherein the proximal portion of the measuring tube (1110, 1328, 1406, 1510) includes an insertion depth indicator (1408).

13. A kit comprising an insert (1100, 1300, 1400, 1500) according to any one of claims 1-12 and an intrauterine system (1102, 1336, 1402, 1502), wherein the intrauterine system comprises: - A frame (1146, 1338, 1412, 1544) having a first end (1148, 1340, 1546), a second end (1150, 1342, 1548), and a length L defined as the distance from the first end to the second end; - Remove the wires (1128, 1358, 1414) that were attached to the first end of the frame; and - At least one pharmaceutically active agent; The first end of the frame includes a first locking portion (1152, 1344, 1550), and the second end of the frame includes a second locking portion (1154, 1346, 1552). The first locking portion and the second locking portion are arranged to form a lock, and the removal wire is configured to guide the first locking portion to the second locking portion.

14. The kit of claim 13, wherein the distal ends (1134, 1360, 1534) of the plungers (1132, 1132, 1360, 1534) are configured to cooperate with the second locking portion (1154, 1346, 1552).

Images