TW202142201A - An inserter for an intrauterine system with a sleeve - Google Patents

Abstract

Disclosed is an inserter (1100, 1400, 1500) for an intrauterine system (1402, 1522), comprising a handle (1102, 1418, 1502), an inner tube (1122, 1300, 1438, 1506), a measurement tube (1110, 1406, 1504), a plunger (1128, 1448, 1540), a flange (1118, 1404, 1530), a tip cover (1116, 1422, 1520), and means (1120, 1420, 1514) for moving the plunger. A proximal end (1112, 1516) of the measurement tube is movably connected to a distal end (1106, 1426, 1510) of the handle. The measurement tube is movably arranged to surround the inner tube. The plunger is movably arranged inside the inner tube and has a proximal end (1130, 1538) and a distal end (1132), and its distal end is configured to cooperate with the intrauterine system. The present disclosure also provides a kit comprising the inserter and the intrauterine system.

Description

Insert for intrauterine system with sheath

The present invention generally relates to a gynecological device; and more specifically, the present invention relates to an insert for an intrauterine system. In addition, the present invention relates to a kit including an insert and an intrauterine system.

Intrauterine system (IUS) and intrauterine device (IUD) are becoming more and more popular as reversible contraceptive methods. In the following, the abbreviation IUS is used and covers IUS’s and IUD’s. Inserts are commonly used to position the IUS in the uterus.

Generally, the conventional insert includes an insertion tube, which usually needs to be passed through the neck tube to introduce the IUS into the uterus of the subject. Inserting an insertion tube into the cervix region is often associated with pain, because traditional inserts include an insertion tube that needs to pass through a relatively narrow neck tube. For example, the diameter of the insertion tube of the conventional insert used to introduce IUS into the uterus may be incompatible in size with the opening of the cervix or the entire cervical area (for example, the tube may have a large cross-sectional area), thereby causing IUS insertion Unnecessary pain during the procedure, because the insertion tube of the traditional insert adds the wall thickness of the insertion tube to the cross-sectional diameter of the IUS, that is, the cross-sectional diameter through the cervix is the diameter of the IUS plus the wall thickness of the insertion tube. Times. Furthermore, the conventional insert may not be suitable for the different configurations and shapes of the IUS.

Therefore, based on the foregoing discussion, there is a need to overcome the aforementioned shortcomings associated with conventional inserts.

The present invention seeks to provide an insert for an intrauterine system (IUS). The present invention also seeks to provide a kit including an insert and an IUS. The present invention seeks to provide a solution to the existing problem of painfully inserting the insertion tube of the conventional insert into the cervical region of the subject to introduce IUS into the uterus.

The purpose of the present invention is to provide a solution that at least partially overcomes the problems encountered in the prior art, and to provide an improved insertion that reduces pain during IUS insertion into the uterus and provides a relatively more comfortable experience compared with existing inserts Things.

In one aspect, an embodiment of the present invention provides an insert for an intrauterine system, which includes -Handle, which has a proximal end, a distal end and an opening; -An inner tube having a proximal end and a distal end, the proximal end of which is connected to the distal end of the handle and the distal end of which is configured to cooperate with the intrauterine system; -A measuring tube having a proximal end and a distal end, the proximal end of which is movably connected to the distal end of the handle, and the measuring tube is movably arranged to surround the inner tube; -A plunger, which is movably disposed inside the inner tube, the plunger has a proximal end and a distal end, and the distal end is configured to cooperate with the intrauterine system; -A flange, which is movably arranged around the measuring tube; -A tip cover, which is configured to surround the distal end of the measuring tube; and -A member for moving the plunger, and the member is arranged in the opening of the handle.

In another aspect, an embodiment of the present invention provides a kit including an insert as described above and an intrauterine system, wherein the intrauterine system includes -A frame having a first end, a second end, and a length Lf defined as the distance between the first end and the second end; -At least one sheath having a first end, a second end, a length Ls defined as the distance between the first end and the second end, and is configured to movably surround a portion of the frame; and -At least one capsule comprising a pharmaceutically active agent, the capsule having a first end, a second end, a length Lc defined as the distance between the first end and the second end, and configured to surround the sheath; in -The length Ls is 5% to 50% of the length Lf; and -The length Lc is 5% to 50% of the length Lf.

The embodiments of the present invention substantially eliminate or at least partially solve the above-mentioned problems in the prior art, and enable the disclosed insert to be conveniently used to position the disclosed IUS in the uterus in a painless or less painful manner.

The additional aspects, advantages, features and purposes of the present invention will become apparent from the drawings and the detailed description of the illustrative embodiments explained in conjunction with the appended claims.

It should be understood that the features of the present invention can be easily combined in various combinations without departing from the scope of the present invention defined by the scope of the attached patent application.

Detailed description of the embodiment The following detailed description illustrates the embodiments of the present invention and the manner in which the embodiments can be implemented. Although some modes for implementing the present invention have been disclosed, those skilled in the art will recognize that other embodiments for implementing or practicing the present invention are also feasible.

In one aspect, an embodiment of the present invention provides an insert for an intrauterine system, which includes -Handle, which has a proximal end, a distal end and an opening; -An inner tube having a proximal end and a distal end, the proximal end of which is connected to the distal end of the handle and the distal end of which is configured to cooperate with the intrauterine system; -A measuring tube having a proximal end and a distal end, the proximal end of which is movably connected to the distal end of the handle, and the measuring tube is movably arranged to surround the inner tube; -A plunger, which is movably disposed inside the inner tube, the plunger has a proximal end and a distal end, and the distal end is configured to cooperate with the intrauterine system; -A flange, which is movably arranged around the measuring tube; -A tip cover, which is configured to surround the distal end of the measuring tube; and -A member for moving the plunger, and the member is arranged in the opening of the handle.

In another aspect, an embodiment of the present invention provides a kit including an insert as described above and an intrauterine system, wherein the intrauterine system includes -A frame having a first end, a second end, and a length Lf defined as the distance between the first end and the second end; -At least one sheath having a first end, a second end, a length Ls defined as the distance between the first end and the second end, and is configured to movably surround a portion of the frame; and -At least one capsule comprising a pharmaceutically active agent, the capsule having a first end, a second end, a length Lc defined as the distance between the first end and the second end, and configured to surround the sheath; in -The length Ls is 5% to 50% of the length Lf; and -The length Lc is 5% to 50% of the length Lf.

Therefore, the present invention provides the above-mentioned insert and the above-mentioned set for effectively and conveniently performing IUS insertion into the uterus. The insert allows the IUS to be inserted into a stable position in the uterus. The insert is easy to use and allows the IUS to directly enter the neck tube instead of inserting any part of the insert into the neck tube. Therefore, the cross-sectional diameter of the passage through the cervix is only determined by the diameter of the capsule with the active drug. There is no increase in size caused by the wall thickness of the insertion tube of the conventional insert. This specific design reduces the pain associated with the placement of the IUS in the uterus. Furthermore, the small cross-sectional area of the IUS makes inserting the IUS into the uterus almost painless or at least less painful than the conventional IUS and inserts. Therefore, the use of the aforementioned inserts and kits can achieve the overall rate of successful IUS insertion without causing any or only minimal discomfort to the subject.

In fact, the insert includes a measuring tube having a proximal end and a distal end, the proximal end of which is movably connected to the distal end of the handle, and the measuring tube is movably arranged to surround the inner tube; The test tube is configured to remain outside the cervical passage during insertion. The insert also includes a tip cap configured to surround the distal end of the measuring tube; if the tip cap is configured to remain outside the cervical passage during insertion.

A further advantage of the insert of the present invention is to minimize the risk of uterine penetration when used properly, because the insert does not include an insertion tube that reaches the uterine cavity.

In this description, the proximal end is the end closest to the user (practitioner) during the insertion of the IUS, and the distal end is the opposite end farthest from the user.

The insert includes a handle with a proximal end, a distal end and an opening. The handle is preferably designed as an insert that is easy to handle with one hand. Furthermore, the handle is preferably designed without any dominant hand preference. In other words, when the handle is held with the right or left hand, the insert also works.

According to an embodiment, the handle is made of a polymer material (such as a medical grade plastic material) and can be used for a single purpose for sanitary purposes. The handle can have various shapes and sizes. The handle is usually a hollow elongated structure, such as tubular, cylindrical, elliptical, oval, cubic or the like. The handle serves as the housing and supporting structure for the various components of the insert. Furthermore, the handle can be designed to match the palm of a medical practitioner.

According to an embodiment, the aforementioned opening of the handle has a longitudinal opening that is substantially the same as the longitudinal axis of the longitudinal axis of the insert. The opening exists between the proximal and distal ends of the handle. It should be understood that the size and shape of the opening of the handle can vary. For example, the shape of the opening can be rounded rectangle, square, circle, ellipse, oval, cubic or the like.

The insert further includes an inner tube having a proximal end and a distal end. The proximal end of the inner tube is connected to the distal end of the handle and the distal end of the inner tube is configured to cooperate with the intrauterine system. The inner tube is a hollow tube. If necessary, the inner tube has a circular cross-section. It should be understood that the cross-sectional shape of the inner tube can vary. For example, the inner tube may have an oval or polygonal shape, as long as the shape substantially corresponds to the circumference of the IUS when loaded into the inner tube of the insert. In an embodiment, the inner tube may not be a closed tube and may have a C-shape, that is, a longitudinal slit (ie, a C-shaped slit) along a portion of its length from the proximal end to the distal end. The inner tube has a diameter similar to the diameter of the largest outer diameter of the IUS. If necessary, the inner tube has a diameter of 2 mm to 3.5 mm, preferably 2.5 mm to 2.9 mm.

Optionally, the distal end of the inner tube includes at least one protrusion on its inner surface. In an example, the inner tube may include three protrusions arranged equidistantly from each other. In the embodiment, the protrusion is in the form of a ring. For example, the protrusion may be guided inward from the inner surface (i.e., inner circumference) of the distal end of the inner tube. The protrusion may extend in a direction perpendicular to the length of the inner tube to form a ring structure on the inner surface of the inner tube. In another embodiment, the protrusion may be a hook. In an example, the wall thickness of the inner tube at the point(s) of the protrusion(s) can be reduced to make the distal end of the inner tube slightly more flexible to cooperate with the IUS. According to an embodiment, the inner tube system is malleable and contains the IUS when the inner tube is loaded into the insert. Optionally, the distal end of the inner tube is configured to cooperate with the aforementioned sheath of the intrauterine system.

Optionally, the second end of the sheath of the IUS includes at least one indentation configured to cooperate with at least one protrusion on the inner surface of the distal end of the inner tube. In an example, the at least one indentation may be a flared portion. During the loading of the IUS into the insert, pull the flared part over the protrusion of the inner tube towards the handle. When the member for moving the plunger moves toward the proximal end of the handle in the opening, pull the flared part to load the IUS into the insert. This protrusion further promotes the flared portion of the IUS to remain in place until the plunger fully pushes the IUS out of the inner tube and into the uterus during the IUS insertion procedure.

According to an embodiment, the proximal end of the inner tube is attached to the distal end of the handle. The attachment member is used to attach the proximal end of the inner tube to the distal end of the handle. For example, the attachment member may be an attachment mechanism based on screws and nuts, an attachment mechanism based on pushing member-slots, or other attachment mechanisms known in the art. The inner tube is attached to the distal end of the handle in such a way that the inner tube remains immobile relative to the handle.

The insert further includes a measuring tube having a proximal end and a distal end. The proximal end of the measuring tube is movably connected to the distal end of the handle. The measuring tube is movably arranged to surround the inner tube. The measurement tube is a hollow tubular structure. Specifically, the cross section of the measuring tube is larger than the cross section of the inner tube.

If necessary, the measuring tube has a circular or oval cross-section. The cross-sectional shape of the measuring tube is complementary to the cross-sectional shape of the inner tube. For example, if the inner tube has an oval or elliptical shape, the measuring tube also has a similar shape surrounding the inner tube. In the embodiment, the inner tube and the measuring tube have a C-shape, that is, they do not have a complete circular cross-section but have a longitudinal narrow along their entire length or along a portion of its length (such as along about 90% of its length). Sew. Furthermore, the measuring tube and the inner tube are usually arranged concentrically. If both the measuring tube and the inner tube have slits, the measuring tube can accommodate an inner tube with two slits, and the slits of the measuring tube and the slits of the inner tube face different directions, that is, they do not face each other.

If necessary, the measuring tube is made of medical grade polymer materials (such as polyethylene, polypropylene, silicone and the like) or metal. If necessary, the measuring tube can be made of polyetheretherketone, thermoplastic polyurethane, thermoplastic polyurethane elastomer, glass fiber and the like.

The insert further includes a tip cover configured to surround the distal end of the measuring tube. The tip cap is configured to prevent the measuring tube from entering the neck tube of the subject. According to an embodiment, the tip cover is movably arranged on the distal end of the measuring tube. If necessary, the tip cap is fixedly attached to the distal end of the measuring tube. The cross section of the tip cover is larger than the measuring tube. During the insertion of the IUS, when the insert is pushed toward the subject, the tip cover slides back (ie, toward the handle) and locks itself on the outer surface of the measuring tube.

The insert further includes a flange movably arranged around the measuring tube. In an embodiment, the length of the measuring tube includes a scoring scale thereon to allow the user to set the position of the flange. When starting the IUS insertion program, manually move the flange to the designated position on the measuring tube with the help of the marking of the scoring scale on the outer surface of the measuring tube. The designated position refers to the length of the uterine cavity plus the length of the neck tube previously measured during uterine exploration (in some cases, the designated position may refer to the length of the uterus). Once set on the measuring tube of the insert, a firm grip of the flange is established relative to the measuring tube, thereby preventing unwanted movement of the flange from its initial setting position when the insert is used in the IUS insertion procedure .

Optionally, the flange includes gripping surfaces on two diametrically opposite sides of the outer part of the flange. In an example, the gripping surface has a wavy structure to achieve a firm grip with the fingers of one hand and is used to press the outer part of the flange toward the inner part of the flange to slide the flange on the measuring tube Adjust to the correct position. According to another embodiment, the flange includes a spring lock on its side, and closing the spring lock will ensure that the flange is firmly held in place on the measuring tube.

Optionally, the flange has a length Lr. The length Lr is 2% to 10% of the length L of the measuring tube of the insert, preferably 4% to 8%. In an example, Lr can be 2%, 4%, 6%, 8% to 4%, 6%, 8%, or 10% from L. Optionally, the flange is made of a polymer material, such as low-density polyethylene, high-density polyethylene, polypropylene, thermoplastic polyurethane, thermoplastic polyurethane elastomer, polyether ether ketone, and/or combinations thereof. The flange may have various shapes, such as a rounded rectangle, an oval, an ellipse, a circle, or the like.

The insert further includes a plunger movably disposed inside the inner tube. The plunger has a proximal end and a distal end. The distal end of the plunger is configured to cooperate with the intrauterine system. The plunger is a thin rod-shaped structure. The distal end of the plunger has, for example, a slit in the longitudinal direction to engage with the aforementioned second end of the frame of the IUS. Specifically, the slit at the distal end of the plunger accommodates the joining member provided at the second end of the frame of the IUS. Furthermore, the portion of the plunger at the distal end may be non-tubular and have a curved portion including a slit. If necessary, the plunger is made of medical grade polymer material (such as polyethylene, polypropylene, silicone, and the like) or metal. If necessary, the plunger and inner tube are made of flexible materials to prevent perforation of the uterus.

The insert further includes a member for moving the plunger arranged in the opening of the handle. According to an embodiment, the member for moving the plunger includes a sled movably arranged inside the handle. The member for moving the plunger further includes a slider movably arranged in the opening of the handle together with the sled, wherein the proximal end of the plunger is connected to the sled. In an example, the handle has a first cover portion (e.g., upper side) and a second cover portion (e.g., bottom side). The sliding member is arranged in the opening provided in the first cover part. The movement of the slider toward the proximal end of the handle uses the removal thread to load the IUS into the inner tube of the insert.

It should be understood that the term " remove threads " (as used herein) refers to one or more threads connected to the IUS at one end and used to remove one or more threads of the IUS at the end of the wear cycle (which is about 5 to about 7 years) (I.e. string line). The removal of the thread is not only used to raise and/or replace the IUS at a later time during the wearing cycle, but also to detect whether the IUS is in the correct position in the uterus once the IUS is deployed in the uterus. In an example, the IUS can be pre-loaded in the insert in the sales package. In the preloaded state of the IUS, the removed thread remains coupled to the aforementioned second end of the frame. Therefore, the movement of the slider toward the proximal end of the handle pulls back to remove the thread to facilitate loading of the IUS into the inner tube of the insert. Furthermore, the movement of the slider toward the distal end of the handle further pushes the plunger in the inner tube towards the subject. The plunger then pushes the aforementioned second end of the frame and therefore the specific part of the frame is released from the insert into the uterine cavity.

According to an embodiment, the handle includes at least one first rack arranged inside the handle on the longitudinal side of the opening. The skid includes at least one second rack, and the at least one second rack is configured to be parallel to the at least one first rack. The slider further includes at least one first pinion gear configured to cooperate with the at least one first rack. The slider further includes at least one second pinion gear configured to cooperate with the at least one second rack, wherein the at least one first pinion gear is configured to cooperate with the at least one second pinion gear to translate the slider之Mobile.

According to an embodiment, the insert further includes a third rack arranged inside the handle on the longitudinal side of the opening opposite to the first rack. The skid includes a fourth rack arranged parallel to the second rack. The slider includes a third pinion gear configured to cooperate with a third rack. The slider further includes a fourth pinion gear configured to cooperate with the fourth rack, wherein the third pinion gear is configured to cooperate with the fourth pinion gear to translate the movement of the slider.

The term "rack" refers to a toothed rod or rack which is usually a linear gear rod. The term " pinion gear " refers to a circular gear that meshes with the teeth on the rack, and the rotational movement applied to the pinion causes the movable rack (such as the second and fourth racks of the sled) to move relative to the pinion In order to convert the rotary motion of the pinion gear into linear motion. In other words, when the pinion gear rotates, the movable rack moves in a straight line. The use of racks and pinions allows large movements of various parts without having to make the handle too long. Furthermore, during the loading procedure, by pulling the removal thread toward the proximal end of the handle, the rack and pinion of the handle are configured to engage the removal thread of the IUS.

According to an embodiment, the member for moving the plunger includes at least one rack arranged inside the handle, the rack having a proximal end and a distal end. The member for moving the plunger further includes a pinion gear disposed in the opening of the handle and configured to cooperate with at least one rack, wherein the proximal end of the plunger is connected to the distal end of the rack. In this embodiment, the member for moving the plunger operates in a roller-like mechanism, and the pinion gear can be similar to a roller that can be arranged in the opening of the handle. In an example, the rack may be a movable rack. When the rack is moved to the first position (that is, the rack is close to the proximal end of the handle) by rolling the pinion forward (that is, toward the distal end of the handle), the IUS is loaded into the inner tube of the insert. During the insertion of the IUS, when the rack is moved from the first position to the second position (that is close to the distal end of the handle) by rolling the pinion gear backwards (that is, toward the proximal end of the handle), the frame of the IUS is partially from the insert Release it. The movement of the frame from the first position to the second position pushes the proximal end of the plunger connected to the rack to the distal end of the handle, thereby further releasing part of the frame into the uterine cavity.

The insert preferably includes a member for releasing and removing the thread once the IUS is in the uterus. The member for releasing can be a simple knob that releases the thread when turned. According to another embodiment, the insert further includes a member for cutting and removing threads. The handle includes a thread cutting button. In an example, the thread cutting button can be provided on the second cover part (ie, the bottom side) of the handle. The handle may further include a member (for example, at least one cutting blade) for cutting and removing the thread. In an example, when the thread cutting button is pushed, at least one cutting blade inside the handle cuts and removes the thread. After the IUS is properly positioned in the uterine cavity, the removal thread is released by pushing the thread cutting button, which further pushes at least one cutting blade to cut the removal thread in the handle.

According to an embodiment, a P-shaped IUS (ie, an IUS with a P-shaped frame) is used as an example to describe the procedure of inserting the IUS into the uterus (ie, the operation stage of the aforementioned insert when in use), and the following is described.

A. Flange adjustment: manually move the flange to the designated position on the measuring tube with the help of the marking of the grading scale on the outer surface of the measuring tube. The designated position refers to the length of the uterine cavity plus the length of the neck tube previously measured during the uterine probing. In an example, providing gripping surfaces on two diametrically opposite sides of the flange can be used to press the outer part towards the inner part of the flange. The insert is used under sterile conditions by means of a pair of sterile gloves worn by a user (eg, a health care professional). In another example, the flange has a snap lock that is opened in the initial step (ie in the sales package) and closed by the user by pressing when the flange is in its correct position.

B. Loading stage: Generally, the IUS including the P-shaped frame is pre-loaded into the insert and stored in the sales package in its final shape (ie, P-shaped). According to an embodiment, the IUS is preloaded on the insert in such a way that the aforementioned capsule of the IUS is configured to contact the distal end of the inner tube. In the preloaded state, the capsule is covered by the tip cover of the insert, and the rest of the frame of the IUS is located outside the insert. The member (such as the slider) used to move the plunger moves backward (ie, toward the proximal end of the handle in the opening) to load the IUS into the insert using the removal thread. The backward movement of the member used to move the plunger pulls the removal thread toward the proximal end of the handle. In the loaded state, the frame of about 10 mm remains outside the insert (that is, outside the tip cover of the measuring tube).

C. The first IUS insertion stage: the measuring tube enters the cervix through the vagina. The insert is positioned so that the tip cap reaches the cervix (ie, the external orifice) and a small part of the frame outside the insert enters the neck canal. During the IUS insertion procedure, the measuring tube itself does not enter the neck canal at any operating stage, thereby reducing discomfort during the IUS insertion procedure.

D. Second IUS insertion stage: Gently push the insert towards the subject, which moves the tip cap back (ie, towards the handle), and part of the frame (for example, about 30 mm) is released from the insert in the neck canal . When the tip cover moves backward, the tip cover locks itself on the outer surface of the measuring tube. At this stage, the capsule is still in contact with the inner tube, and only part of the frame of the IUS enters the neck tube. The member used to move the plunger (such as the slider) is still close to the proximal end of the handle in the opening. Gently push the insert towards the subject until the user feels resistance from the insert (usually physical pressure).

E. The third IUS insertion stage: When the tip cap is in firm contact with the uterine neck, the member (such as the slider) used to move the plunger moves forward toward the distal end of the handle in the opening, which moves the insert Plunger. The plunger pushes one end of the frame (i.e. the aforementioned second end) and therefore more of the frame is released from the insert into the uterine cavity.

F. Fourth IUS insertion stage: The insert is pushed toward the patient until the flange abuts the handle. The proximal part of the measuring tube enters the inside of the handle. In this state, the IUS enters its bottom position and the entire IUS is located in the uterine cavity. In other words, the IUS is fully deployed in the uterine cavity and the desired shape is obtained in the uterine cavity (ie, in the P-shaped configuration in this example). When the plunger reaches the distal end of the inner tube, the sac of the IUS is also released from the inner tube of the insert into the uterine cavity.

G. Remove the thread to release or cut and remove the insert: release to remove the thread. In an embodiment, the thread is released and removed by turning or pushing the thread release knob or by pushing the thread cutting button provided on the second cover part (ie, the bottom side) of the handle. When the thread release or cutting button is performed, the member that releases or cuts the thread removal inside the handle (ie, the knob or the cutting blade) releases or cuts the thread removal. If the thread is cut, the insert is positioned so that the thread is cut and removed to leave a visible distance of about 2 cm to 3 cm outside the cervix (ie, about 2 cm outside the external orifice that can be detected by touching and in the vagina) To 3 cm). Next, the insert is pulled out from the subject to indicate that the IUS insertion procedure is completed by the insert.

It should be understood that the IUS insertion procedure is described by taking the P-shaped frame as an example. However, in the case of an S-shaped frame or a hook-shaped frame (almost similar to a question mark without a period), the IUS insertion procedure is similar except for the loading phase. For example, in the case of an S-shaped frame, the IUS is preloaded so that the capsule is located outside the insert and the tip cap is in its retracted state (ie, closer to the handle). During the loading of the IUS into the insert, the tip cap is pulled to the capsule of the IUS (ie its distal (or extended) position), and IUS insertion similar to the P-shaped IUS is performed. In an example, the tip cover can be pulled up manually or automatically. This insert is also suitable for other types of IUS than the IUS described here.

The present invention also provides a kit including an insert and an intrauterine system. The insert of the set is as described above, and the intrauterine system includes -A frame having a first end, a second end, and a length Lf defined as the distance between the first end and the second end; -At least one sheath having a first end, a second end, a length Ls defined as the distance between the first end and the second end, and is configured to movably surround a portion of the frame; and -At least one capsule comprising a pharmaceutically active agent, the capsule having a first end, a second end, a length Lc defined as the distance between the first end and the second end, and configured to surround the sheath; in -The length Ls is 5% to 50% of the length Lf; and -The length Lc is 5% to 50% of the length Lf.

Optionally, the second end of the sheath includes at least one indentation configured to cooperate with at least one protrusion on the inner surface of the distal end of the inner tube. According to another embodiment, the distal end of the inner tube is configured to cooperate with the sheath of the IUS. The above-mentioned various embodiments and variants are applied to the set after being appropriately modified.

Therefore, the present invention provides a kit including an IUS and an insert, which can effectively and conveniently insert the IUS into the uterus. When loaded into the insert, the IUS straightens and returns to its original shape when inserted into the uterine cavity (i.e., in a deployed state). Furthermore, the disclosed IUS obtains a smooth shape in the deployed state, such as an S shape, a C shape, a P shape, a 7 shape or a hook shape. In this connection, in terms of smoothness, it means a shape that does not have any sharp edges. The smooth shape of the IUS not only ensures the proper fit between the IUS and the uterus, but also reduces the risk of potential perforation of the endometrium. In addition, for the current IUS insertion, the insert can be such that any part of the insert having a cross-sectional diameter greater than the maximum diameter of the IUS does not enter the neck canal (and thus the uterus).

A further advantage of the IUS according to the present invention is that the risk of uterine penetration during the insertion procedure is minimized because there is no insertion tube that may penetrate the uterine muscle if inserted too deeply. In addition, the IUS itself cannot penetrate the uterine wall because it begins to form its final shape immediately after passing through the cervical passage.

Furthermore, the aforementioned sheath and the capsule of the IUS give the IUS sufficient hardness during the insertion procedure and further help the IUS to obtain the desired continuous smooth shape in its deployed state. In addition, the disclosed IUS (including the capsule) has a small cross-sectional area (does not need to be covered by any part of the insert), so that the IUS can be comfortably inserted into the cervix region and the uterus, thereby minimizing the inconvenience during the IUS insertion procedure. Necessary pain and discomfort. In addition, the aforementioned set of inserts can increase the overall rate of successful IUS insertion without causing any or only minimal discomfort to the subject.

IUS includes the framework. The frame of the IUS has a first end and a second end. The frame has a length Lf defined as the distance between the first end of the frame and the second point. In the present invention, the term "first end" refers to the end closer to the subject's uterus (also called the distal end) during IUS insertion, and the term "second end" refers to the end opposite to the first end , That is, during the insertion of the IUS by using the aforementioned insert to be closer to the end (also known as the proximal end) of the user (such as a health care professional). The frame has a flexible tubular structure designed to fit the anatomy of the cervix region and the uterine cavity. The flexible structure allows the frame to be easily bent into a shape and can withstand the strain and stress associated with the shape. When pressure is applied to the frame, the frame is easily deformed (for example, the IUS is removed from the insert), and once the pressure is released, the frame can return to its original shape. For example, during the insertion of the IUS using the aforementioned insert, the frame can be stretched to an almost straight line (ie, straightened configuration), and when placed in the uterine cavity (ie, expelled from the insert) to obtain the desired shape (ie, Pre-designated configuration). Therefore, the flexibility of this frame improves the comfort of the user not only during the insertion of the IUS into the neck tube and uterus, but also during the removal of the IUS when needed. The frame may be a hollow structure, or it may be non-hollow.

Generally, the material of the frame is such that the IUS can be temporarily straightened for insertion, and after insertion, it still returns to its original shape. In fact, in the most typical system, the IUS is not placed inside the insert until shortly before the insertion (ie, by the medical practitioner).

If necessary, in the straightened configuration (that is, when loaded into the insert), the length Lf of the frame is in the range from 50 mm to 110 mm. The length Lf can usually be in the range from 50 mm, 60 mm, 70 mm, 80 mm, 90 mm or 100 mm up to 60 mm, 70 mm, 80 mm, 90 mm, 100 mm or 110 mm. Once the IUS frame is deployed in the desired position in the uterine cavity, the pre-designated in the range of 25 mm × 20 mm to 31 mm × 28 mm, preferably 27 mm × 23 mm to 31 mm × 25 mm can be obtained Configuration (length x width). In the deployed state, the length is usually from 25 mm, 27 mm, or 29 mm up to 27 mm, 29 mm, or 31 mm. Similarly, in the deployed state, the width is usually from 20 mm, 22 mm, 24 mm, 26 mm to 22 mm, 24 mm, 26 mm, or 28 mm. In an example, the configuration of the frame of the S-shaped IUS in the deployed state may be 29.5 mm × 23.8 mm (length × width).

If necessary, the frame has a shape selected from an S shape, a P shape, a C shape, a 7 shape, or a hook shape. In the deployed state, the frame returns to the original shape discussed above. In addition, if necessary, in the deployed state, the frame may have a spiral shape or an inverted P shape. If necessary, the frame has a T-shape, that is, a cylindrical contraceptive body with two arms in the deployed state. In this embodiment, the two arms can be made of a very thin material (or metal) so that during the loading of the IUS into the insert, the two arms can be contained inside the aforementioned capsule.

If necessary, the cross-section of the frame can be selected from round and oval. The frame has a smooth cross section and may have, for example, a round, oval or elliptical cross section to prevent any damage in the uterine cavity. The best shape and cross-section of the frame provide suitable springback for IUS when in use. For example, the resilient frame prevents the discharge or displacement of the IUS inside the uterine cavity during uterine contraction, because the flexible frame balances the stress caused by the uterine contraction. Furthermore, the resilience (or elasticity) of the frame depends on the material of the frame.

If necessary, the frame is made of a material selected from polyethylene, polypropylene, polyetheretherketone, and thermoplastic polyurethane. Generally, the frame is made of elastic material. The frame is made of inert biocompatible materials. If necessary, the frame is made of a material that exhibits a shape memory effect (such as shape memory plastic). In the example, the frame is made of a shape memory material that can have a first shape and a second shape and can change from the first shape to the second shape and has been in the second shape for a short period of time and then changes from the second shape to the first shape. production. Examples of shape memory plastics include (but are not limited to) thermoplastic and thermosetting polymers (such as polyurethane, polyurethane prepolymer), block copolymers (such as polyethylene terephthalate and polyethylene oxide block copolymers, Block copolymers of polystyrene and poly(1,4-butadiene), block copolymers of poly(2-methyl-2-oxazoline) and polytetrahydrofuran) and amorphous polynorbornene. In addition, the frame can be made of fiber reinforced plastic or polymer (such as glass fiber reinforced plastic).

If necessary, the round end portion is disposed at the first end of the frame and the round end portion has a larger diameter than the frame. The first end of the frame is smooth and curved (for example, semi-circular or round tip) to facilitate smooth and frictionless movement of the IUS in and out of the neck canal and uterus, and to avoid any risk of perforation at the bottom of the uterus. In other words, the rounded tip ensures the safety of the bottom area of the uterus. The rounded end portion can also function during the use of the IUS to prevent the capsule from sliding off the frame and to prevent the capsule from sliding off the frame during the removal of the IUS.

According to an embodiment, the frame further includes a member for joining at its second end. The means for joining enables the aforementioned plunger of the insert to cooperate with the frame of the IUS. Examples of members for joining include, but are not limited to, knobs, grooves, notches, indentations, and combinations thereof. Furthermore, the removal thread may preferably be coupled to the attachment member (ie, near the second end of the frame) by a knob or other methods known in the art. It should be understood that the term " remove the thread " (as used herein) refers to the connection to the IUS at one end and is used to remove the IUS at the end of the wear cycle (about 3 years to about 10 years, preferably 5 years to 7 years) One or more threads (ie chord lines). The thread removal is not only used to keep the IUS connected to the insert at a later time during the wearing period to remove and/or replace the IUS, but also to detect whether the IUS is in the correct position in the uterine cavity once the IUS is deployed in the uterus .

Optionally, the frame may include at least one diagnostic component for positioning the IUS in the uterine cavity without physical intervention. In an example, the at least one diagnostic component may be an X-ray opaque agent (such as barium sulfate), such as a polymer/elastomer material of up to 20% by weight (weight percentage) of the frame. In another example, the at least one diagnostic component may be a ferromagnetic agent or an agent that can be detected by ultrasound or fluorescence imaging of IUS in a deployed state. If necessary, the at least one diagnostic component is configured as an inert metal, coated on at least part of the frame of the IUS or configured to be partially embedded in the IUS.

If necessary, the IUS includes at least one sheath having a first end, a second end, a length Ls defined as the distance between the first end and the second end, and is configured to movably enclose a portion of the frame. The at least one sheath is an elongated hollow tubular member or part surrounding a portion of the frame. The at least one sheath acts as a supporting member to strengthen the frame and give it suitable stiffness so that the frame can obtain a desired shape (ie, a pre-designated configuration). The length Ls is substantially smaller than the length Lf and only covers part of the frame. However, the cross-sectional area (or inner diameter) of at least one sheath is larger than the cross-sectional area (ie, outer diameter) of the frame.

The length Ls is 5% to 50% of the length Lf. If necessary, the length Ls is 15% to 30% of the length Lf. The length Ls is usually 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40% or 45% of the length Lf up to 10%, 15%, 20%, 25%, 30%, 35 %, 40%, 45% or 50%. For example, the length Ls can be from 2.5 mm to 55 mm, and preferably 7.5 mm to 33 mm.

If necessary, the at least one sheath is made of polyetheretherketone, high-density polyethylene, ultra-high molecular weight polyethylene, polypropylene, polymethylmethacrylate, polyacrylate, nickel-titanium alloy, copper, silver and titanium become. Mixtures of these materials can also be used. The at least one sheath is usually made of an inert biocompatible material, and has sufficient strength to withstand the physiological and mechanical stress conditions that can prevail in the uterus. Examples of inert biocompatible materials include (but are not limited to) ceramics (e.g. alumina (Al2O3), zirconia (ZrO2), bioglass (e.g. Na2OCaOP2O3-SiO), hydroxyphosphate lime, tricalcium phosphate and the like) , Metals and their alloys (such as titanium, nitinol (alloy of nickel and titanium) and the like), polymers (such as polyvinyl chloride, polystyrene, polytetrafluoroethylene, polyurethane, polyamide, polyether) Ash, polyetherimide, epoxy resin and the like), polymer composite materials and reinforced rubber (such as fiber reinforced rubber, silicone rubber and the like). In addition, it is further advantageous if the sheath is made of a material with only edge friction to ensure that the sheath can easily move on the frame.

The IUS further comprises at least one capsule with a pharmaceutically active agent. The at least one capsule has a first end, a second end, and a length Lc defined as the distance between the first end and the second end. The at least one capsule is configured to surround the sheath. Specifically, the at least one capsule is a drug container including the drug active agent. The at least one sheath disposed on the sheath also provides hardness to IUS.

The length Lc is 5% to 50% of the length Lf. If necessary, the length Lc is 15% to 30% of the length Lf. The length Lc usually ranges from 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40% or 45% of the length Lf up to 10%, 15%, 20%, 25%, 30%, 35 %, 40%, 45% or 50%. If necessary, the cross-section of the capsule is selected from round and oval. For example, the capsule may have a circular, oval, or polygonal shape, as long as the shape is suitable for insertion into the neck tube and uterus. If necessary, the outer diameter of the capsule is in the range of 2 mm to 3.5 mm, and preferably about 2.9 mm. The outer diameter of the capsule is usually 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 up to 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.

If necessary, the length Ls is substantially the same as the length Lc. Specifically, the length Ls of the at least one sheath, the length Lc of the at least one capsule, and the arrangement of the sheath and the capsule on the frame affect the shape of the IUS and the release rate of the pharmaceutically active agent into the uterine cavity. In an embodiment, the length Ls is less than the length Lc. In another embodiment, the length Ls is greater than the length Lc. In an example, if the length Ls is greater than the length Lc, the IUS has higher stiffness. In another example, if the length Ls is shorter than the length Lc, the release rate of the pharmaceutically active agent is affected. The release rate of the pharmaceutically active agent can be controlled (for example, increased) by introducing a plurality of holes in at least one sheath, so as to allow the biological fluid in the uterine cavity to contact the pharmaceutically active agent inside the capsule.

In an embodiment, at least one capsule is selected from a matrix system and a core-membrane system. In an example, the matrix system may be a polymer matrix in which the pharmaceutically active agent is dispersed or dissolved, such as a silicone-based elastomer. In another example, in the core-membrane system, at least one capsule may include a core of the pharmaceutically active agent and a membrane that encloses the core of the pharmaceutically active agent. The core may be a hollow tubular structure assembled on a frame (surrounding a sheath) to deliver the pharmaceutically active agent in the uterus at a controlled rate. The membrane can be a permeable layer made of an inert material that prevents direct contact between the pharmaceutically active agent and the biological fluid in the uterus. In addition, the film layer can adjust the release rate of the pharmaceutically active agent by acting as a diffusion layer surrounding the core of the pharmaceutically active agent. In an embodiment, the membrane may surround the first end and the second end of at least one capsule to cause the capsule to be closed. In another embodiment, at least one of the first and second ends or ends of at least one capsule is open, that is, not surrounded by a membrane. In the examples, the membrane (when present) is more permeable to the pharmaceutically active agent compared to the pharmaceutically active agent core.

If necessary, the at least capsule is made of poly(dimethyl silicone), silicone-based elastomer, thermoplastic polyurethane, thermoplastic polyurethane elastomer, ethyl acetate, polyolefin-based elastomer, thermoplastic-containing polysiloxane, Manufacturing of polyurethane, polylactic acid and polycaprolactone. Combinations and mixtures of these materials can also be used. More optionally, the 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 methylvinylsiloxane, polyethylene, polypropylene, polybutadiene, polyisoprene, Acrylic polymer, ethylene/propylene copolymer, ethylene/ethyl acrylate copolymer, poly(methacrylate), polymethyl methacrylate, styrene-butadiene-styrene block copolymer, styrene- Isobutylene-styrene copolymer, polyhydroxyethyl methacrylate, polyether, polyacrylonitrile, polyethylene glycol, polymethyl methacrylate, polyhydroxyalkanoate, polyorthogonal ester, hydrophilic polymer (Such as hydrophilic hydrogel), cross-linked polyvinyl alcohol, polytetrafluoroethylene, polyvinyl chloride, polyvinyl acetate, neoprene rubber and butyl rubber.

If necessary, the pharmacologically active agent is selected from the group consisting of progesterone and its derivatives, estrogen, progesterone, levonorgestrel, cyproterone acetate, gestosterone, etostilbestrol, ethinyl estradiol, and medroxyprogesterone acetate Ketones, norethindrone, norethindrone acetate, norgestrel, norgestrel, norspirone, gestodene, 19-nor-17-hydroxyprogesterone ester, 17a-ethynyl testosterone and its derivatives Compounds, 17a-ethynyl-19-nortestosterone and its derivatives, ethylene glycol diacetate, gestosterone, oxynorethindrone, allosterone, medroxyprogesterone, norprogesterone, acetylene triene Ketones, ethinylgestrel and dl-norprogesterone; and androgenic steroids, such as danazol and gestrinone; naproxen, ibuprofen, mefenamic acid, flurbiprofen, indomethacin , Diclofenac, piroxicam, meloxicam, ketoprofen, gonadotropin releasing hormone agonists, progesterone receptor antagonists, such as mifepristone (11β-4-dimethylaminophenyl-17β- Hydroxy-17α-propionyl-4,9-estradien-3-one); Ulipristal acetate, (11β,17β)-17-hydroxy-11-[4-(methylsulfonyl)benzene Base]-17-(pentafluoroethyl)-estradiol-4,9-dien-3-one, 17α-acetoxy-11β-[4-(N,N-dimethylamino)benzene Yl)-21-methoxy-19-norgestrel-4,9-diene-3,20-dione, 17α-acetoxy-11β-(4-N,N-dimethylamine Phenyl)-19-norgestrel-4,9-diene-3,20-dione, 11β-(4-acetylphenyl)-17β-hydroxy-17α-(1,1,2 ,2-Pentafluoroethyl)-4,9-estradiene-3-one, isovaleronitrile (benzaldehyde-4-[(11β,17β)-17-methoxy-17-(methoxymethyl Yl)-3-keto-4,9-dien-11-yl)]-1-oxime).

Mixtures of these agents can also be used. In an example, the pharmaceutically active agent may be a hormone, a drug or a drug analog, an active drug ingredient, or a health-promoting substance with contraceptive properties. This pharmacologically active agent works by thickening the cervical mucus, changing the endometrium to make it unsuitable for egg implantation, stopping ovulation, or acting as a COX1/COX2 inhibitor. In an example, the pharmaceutically active agent can provide and/or enhance protection against various microbial infections, such as bacterial infections, fungal infections, and/or sexually transmitted infections. As the hormone, for example, levonorgestrel can be used, and as the COX inhibitor, indomethacin can be used. Pharmaceutically active agents can also be effective in treating or preventing diseases such as endometriosis.

It should be understood that the pharmaceutically active agent is administered in a suitable amount, such as in the largest feasible amount suitable for the subject. Furthermore, the amount of the pharmaceutically active agent varies depending on the specific pharmaceutically active agent to be administered, the intended use, the duration of action, the release rate and the treatment period, as well as the age and medical conditions of the subject. In addition, the pharmaceutically active agent usually has a pH level suitable for the uterus. Therefore, IUS not only serves as a long-acting reversible contraceptive method, but can also be used in many other applications, such as the treatment of diseases in the uterus, swelling and pain depending on the pharmacologically active agent supplied through IUS.

If necessary, the IUS includes at least two capsules. In an example, the at least two capsules are placed on the frame at a predetermined distance from each other. One of the at least two capsules may be configured to surround the sheath, and the other capsule may be directly configured to surround the frame, ie without a sheath. If necessary, the capsule without a sheath is arranged at the first end of the frame, and the movement of the capsule can be restricted. Preferably, once the IUS is inserted into the uterine cavity and after insertion, the at least two capsules do not touch each other. In an example, the IUS may include two sheaths. In this example, each of the at least two capsules may surround the corresponding sheath of the two sheaths.

Optionally, at least part of the at least one capsule does not contain a pharmaceutically active agent. In an example, the at least one capsule may include a pharmaceutically active agent distributed in a specific part of the capsule (for example, 20% to 40% of the length Lc), and the remaining part of the at least one capsule may not include a pharmaceutically active agent. In another example, 70% to 95% of the length Lc of the at least one capsule includes the pharmaceutically active agent, and the remaining 5% to 30% of the length Lc may not contain the pharmaceutically active agent. In yet another example, the at least one capsule is completely free of pharmaceutically active agents, thereby merely serving as a structural unit to provide the desired shape to the IUS when inserted into the uterus. In this case, the pharmaceutically active agent can be provided in the framework. In yet another example, if there are two capsules, the first capsule may include the pharmaceutically active agent and the second capsule disposed at the first end of the frame may not include the pharmaceutically active agent. In this case, the second capsule only serves as a structural unit to provide the desired shape to the IUS when inserted into the uterus.

If necessary, the first capsule and the second capsule may be the same or different in structure, and may contain the same or different pharmaceutically active agents. For example, the first capsule may contain a first pharmaceutically active agent (such as progestin), and the second capsule may contain a second pharmaceutically active agent (such as diclofenac sodium). In another example, a third capsule (ie, a capsule without any active ingredients) can be placed between at least two capsules. In addition, the release of the pharmaceutically active agent from the at least two capsules can be performed simultaneously or one after another depending on the release rate of the pharmaceutically active agent to be achieved and its respective interaction with the biological fluid in the uterus.

Optionally, the second end of the at least one sheath includes an enlargement. The enlargement acts as a holding or locking member to hold the at least one capsule and prevent it from sliding off the frame during the insertion procedure and use. The enlargement can further enable proper engagement with the aforementioned inner tube of the insert during the loading of the IUS into the inner tube of the insert and during insertion. The amplification can, for example, resemble a horn or a horn-shaped protrusion extending from the second end of the at least one sheath. The term "horn" (as used herein) refers to a bell-shaped protrusion from the second end of at least one sheath. It should be understood that since at least one sheath is usually made of the same material over its entire length, the enlargement at the second end is also flexible to support and facilitate the assembly of at least one capsule around the sheath and the frame during the IUS insertion procedure And move.

According to an embodiment, various operating stages related to the possible assembly of at least one sheath and at least one capsule on the frame of the IUS are described below. First, the frame is obtained by injection molding process or by extrusion. In the injection molding procedure, the sheath is obtained in an open configuration and has two longitudinal portions (for example, when split along the length of the hollow tube, similar to the two halves of the hollow tube). The sheath is arranged along a part of the longitudinal direction of the frame and is bent along a part of the frame so that the two longitudinal parts of the sheath are joined to each other to obtain a sheath-frame assembly. The joining can be performed, for example, by laser welding or by other methods known in the art. In the extrusion process, the sheath is formed by squeezing a tube and the above-mentioned amplification (such as a horn shape) is selected for formation by subsequent processing. Thereafter, the sheath is cut along its longitudinal direction and positioned on the frame. The sheath can be welded or glued together, but this is not mandatory.

Then, a capsule is configured to surround the sheath-frame assembly forming the capsule-sheath-frame assembly. If necessary, at least one sheath and at least one capsule are arranged close to the second end of the frame. However, in the case of more than one sheath and capsule, the sheath and corresponding capsule can be arranged at any position on the frame depending on the desired shape to be achieved, that is, between the first end of the frame and the second end of the frame .

According to an embodiment, the IUS is pre-installed (or pre-loaded) together with the insert in a sterile sales package, but the most typical one is that the IUS itself is still located outside the insert, and only the removed thread is located inside the insert. The removal of the thread can, for example, be used to retract the frame of the IUS inside the insert (when the capsule mounted on the sheath remains outside the insert). In effect, the frame retracts or retracts inside the insert, and the capsule moves to the end of the frame (its first end). Therefore, the largest diameter through the cervix is the diameter of the capsule.

Schematic description 1A, there is shown a perspective view of an insert 1100 in an assembled state according to an embodiment of the present invention. The insert 1100 includes a handle 1102 having a proximal end 1104, a distal end 1106, and an opening 1108. The insert 1100 further 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 connected to the distal end 1106 of the handle 1102. The tip cover 1116 is configured to surround the distal end 1114 of the measuring tube 1110. The insert 1100 further includes a flange 1118 movably disposed around the measuring tube 1110. The member 1120 for moving the plunger (not shown here) is arranged in the opening 1108 of the handle 1102.

1B, there is shown a perspective view of the insert 1100 of FIG. 1A in an unassembled state according to an embodiment of the present invention. The insert 1100 further includes an inner tube 1122 having a proximal end 1124 and a distal end 1126. The distal end 1126 of the inner tube 1122 is configured to cooperate with the IUS. The insert 1100 further includes a plunger 1128 having a proximal end 1130 and a distal end 1132. In the assembled state of the insert 1100, the plunger 1128 is movably arranged inside the inner tube 1122, and the measuring tube 1110 is movably arranged to surround the inner tube 1122. The handle 1102 has a first cover part 1134A and a second cover part 1134B. The first cover portion 1134A includes an opening 1108.

The insert 1100 further includes a first rack 1136A disposed inside the handle 1102 and a sled 1138 including a second rack 1140A. The insert 1100 further includes a third rack 1136B disposed inside the handle 1102 opposite to the first rack 1136A. The skid 1138 includes a fourth rack 1140B. In addition, the slider 1142 is shown in the figure. In the assembled state of the insert 1100, the slider 1142 includes a first pinion 1144 configured to cooperate with the first rack 1136A, a second pinion 1146 configured to cooperate with the second rack 1140A, and A third pinion 1148 that cooperates with the third rack 1136B and a fourth pinion 1150 that is configured to cooperate with the fourth rack 1140B. The figure further shows the front gear axis 1147. In addition, the first attachment member 1152 and the second attachment member 1154 are shown in the figure. The first attachment member 1152 is used to attach the inner tube 1122 to the handle 1102 and support the measuring tube 1110 so that the measuring tube 1110 can move relative to the handle 1102. The second attachment member 1154 is used to attach the plunger 1128 to the sled 1138.

1C, the figure shows the arrangement of the sled 1138, the plunger 1128, and the inner tube 1122 of the insert according to an embodiment of the present invention. The proximal end 1130 of the plunger 1128 is connected to the sled 1138, and the plunger 1128 is movably disposed inside the inner tube 1122.

1D, the figure shows the configuration of the pry 1138 in the handle of the insert according to the embodiment of the present invention. The sled 1138 is movably arranged inside the second cover portion 1134B of the handle. It is worth noting that the sled 1138 is disposed between the first rack 1136A and the third rack 1136B of the second cover portion 1134B of the handle. The second rack 1140A of the sled 1138 is arranged parallel to the first rack 1136A of the handle. The fourth rack 1140B of the skid 1138 is arranged parallel to the third rack 1136B of the handle.

2A to 2D are different views of an exemplary implementation of a slider 1200 according to an embodiment of the present invention. Referring to FIG. 2A, a schematic top view of the slider 1200 is shown. In this embodiment, the slider 1200 is a rectangle with rounded corners in shape. Referring to FIG. 2B, a schematic bottom view of the slider 1200 is shown. The sliding member 1200 includes a first pinion gear 1202, a second pinion gear 1204, a third pinion gear 1206, and a fourth pinion gear 1208. The first pinion gear 1202 is connected to the third pinion gear 1206 by an axis. The second pinion gear 1204 is connected to the fourth pinion gear 1208 by an axis. The first pinion 1202 and the third pinion 1206 are configured to cooperate with the second pinion 1204 and the fourth pinion 1208 to translate the linear movement of the slider, respectively. 2C, there is shown a perspective view of a slider 1200 with a first pinion 1202 connected to a third pinion 1206. Referring to FIG. 2D, a schematic side view of the slider 1200 is shown, which depicts the configuration of the third pinion gear 1206 relative to the fourth pinion gear 1208.

Referring to FIG. 3, there is shown a perspective view of an exemplary inner tube 1300 according to an embodiment of the present invention. The inner tube 1300 has a proximal end 1302, a distal end 1304, and a C-shaped slit 1306 along almost 90% of the length of the inner tube 1300. In this embodiment, the inner tube 1300 has three protrusions 1308 in the inner surface 1310A of the distal end 1304 of the inner tube 1300. The attachment member 1312 is attached to the outer surface 1310B of the proximal end 1302 of the inner tube 1300. The attachment member 1312 is used to attach the inner tube 1300 to the handle.

4A to 4J show different views of the insert 1400 according to an embodiment of the present invention, which depict various stages of operation for positioning the IUS 1402 in the uterus. 4A, the figure shows the adjustment of the flange 1404 on the measuring tube 1406 of the insert 1400 according to an embodiment of the present invention. With the aid of the marking of the scoring scale 1408 on the outer surface of the measuring tube 1406, the flange 1404 is manually moved at a designated position on the measuring tube 1406. The designated position refers to the length of the uterine cavity plus the length of the neck tube previously measured during uterine probing.

Figures 4B and 4C show details of the flange 1404. The flange is initially in the "open" position, where the snap lock 1410 is in an open state, and the flange can be easily moved. Once the flange is in its correct position (on the scoring scale 1408), the snap lock 1410 is closed by pressing the flange, and therefore the snap lock will be in the "closed" position.

Referring to FIG. 4D, the figure shows the preload state 1412 (on the left side) and the load state 1414 (on the right side) of the IUS 1402 according to an embodiment of the present invention. In the preloaded state 1412, part of the frame 1416 of the IUS 1402 is located outside the insert 1400. In this embodiment, the frame 1416 is a P-shaped frame. In addition, the figure shows the handle 1418, the member 1420 for moving the plunger, the tip cover 1422 of the measuring tube 1406, and the flange 1404 set at the designated position on the measuring tube 1406. The handle 1418 has a proximal end 1424, a distal end 1426, and an opening 1428. In the preloaded state 1412, the member 1420 for moving the plunger is positioned toward the distal end 1426 of the handle 1418.

In the loading state 1414, the member 1420 for moving the plunger has moved backward (ie, toward the proximal end 1424 of the handle 1418 in the opening 1428) to load the IUS 1402 into the insert using the removal thread 1430. The rearward movement of the member 1420 for moving the plunger pulls the removal thread 1430 toward the proximal end 1424 of the handle 1418. In the loading state 1414, a part of the frame 1416 (for example, about 10 mm) remains outside the tip cover 1422 of the measuring tube 1406. The previously set flange 1404 does not move during the insertion procedure of the IUS 1402.

4E, the figure shows the first insertion stage of the IUS 1402 using the insert 1400 according to an embodiment of the present invention. In this stage, the measuring tube 1406 passes through the vagina 1432 and faces the neck of the uterus. As shown in the figure, the insert 1400 is positioned so that the tip cap 1422 reaches the outer aperture 1434 and a small portion of the frame 1416 remaining outside the insert 1400 enters the neck tube 1436.

4F, the figure shows the second insertion stage of the IUS 1402 using the insert 1400 according to an embodiment of the present invention. In this stage, the insert 1400 is gently pushed toward the subject, which causes the tip cover 1422 to move backward (ie, toward the handle 1418), and a portion of the frame 1416 (for example, about 30 mm) is released from the insert 1400 to In the neck tube 1436. When the tip cover 1422 moves backward, the tip cover 1422 is locked on the outer surface of the measuring tube 1406 by itself. At this stage, the member 1420 for moving the plunger is still close to the proximal end 1424 of the handle 1418 in the opening 1428.

Referring to FIG. 4G, the figure shows the third insertion stage of the IUS 1402 using the insert 1400 according to an embodiment of the present invention. At this stage, while maintaining firm contact between the tip cap 1422 and the uterine neck, the member 1420 for moving the plunger moves forward toward the distal end 1426 of the handle 1418 in the opening 1428, which is in the inner tube of the insert 1400 Move the plunger within 1438. The plunger pushes the end (ie, the second end) of the frame 1416 and therefore more of the frame 1416 is released from the inner tube 1438 of the insert 1400 into the uterine cavity 1440.

Referring to FIG. 4H, the figure shows the fourth insertion stage of the IUS 1402 using the insert 1400 according to an embodiment of the present invention. In this stage, the insert 1400 is pushed toward the patient until the flange 1404 abuts the handle 1418 (ie, the portion of the proximal end of the measuring tube 1406 enters the interior of the distal end 1426 of the handle 1418). During this phase, the IUS 1402 moves to its bottom position and the entire IUS 1402 is completely deployed in the uterine cavity 1440 and obtains the desired P-shape in the uterine cavity 1440. At this stage, the IUS 1402 including the capsule 1442 is also released from the inner tube 1438 of the insert 1400 in the uterine cavity 1440. In addition, the figure shows the first end 1444 and the second end 1446 of the frame 1416 of the IUS 1402. In FIG. 4H, an enlarged view of a portion of the insert and a portion of the IUS 1402 is further shown to depict the interaction of the plunger and the engagement member 1450A at the second end 1446 of the frame 1416 of the IUS 1402. The plunger 1448 is movably arranged in the inner tube 1438.

Referring to FIG. 4I, the figure shows the stage of cutting and removing the thread 1430 with the insert 1400 after the IUS 1402 is deployed in the uterine cavity 1440 according to an embodiment of the present invention. In this stage, the thread 1430 is released and removed by pushing the thread cutting button 1452 provided on the second cover portion 1454 (ie, the bottom side) of the handle 1418. The figure further shows an enlarged view of the internal structure of the insert 1400 to depict the cutting mechanism for removing the thread 1430 using the thread cutting button 1452. When the thread cutting button 1452 is pushed, the thread removing member 1456 inside the cutting handle 1418 cuts the removing thread 1430.

Referring to FIG. 4J, there is shown a removal of an insert 1400 from a subject according to an embodiment of the present invention. After cutting and removing the thread 1430, the insert 1400 is pulled out from the vagina 1432 to indicate that the IUS 1402 insertion procedure is completed by the insert 1400. In this case, the removal thread 1430 of about 2 cm to about 3 cm can be seen on the outside of the cervix (ie, outside the external orifice 1434) and about 2 cm to about 3 cm in the vagina 1432. In addition, the figure shows an enlarged cross-sectional view of the IUS 1402 in a deployed state in the uterine cavity. The IUS 1402 includes a sheath 1458 configured to surround a portion of the frame 1416. The sheath 1458 has a first end 1460 and a second end 1462. The second end 1462 of the sheath 1458 includes an indentation 1464 (ie, an enlargement). The IUS 1402 further includes a capsule 1442 configured to surround the sheath 1458. The capsule 1442 has a first end 1466, a second end 1468 and includes a pharmaceutically active agent. The configuration and length of the sheath 1458 and the capsule 1442 promote the frame 1416 to obtain a P shape. Furthermore, the round end portion 1470 is disposed at the first end 1444 of the frame 1416 and the round end portion 1470 has a larger diameter than the frame 1416. In addition, the figure shows the removal thread 1430 attached to the groove 1450B in the member 1450A for engagement at the second end 1446 of the frame 1416.

Referring to FIG. 5A, there is shown a perspective view of an insert 1500 according to another embodiment of the present invention. The insert 1500 includes a handle 1502, a measuring tube 1504, and an inner tube 1506. The handle 1502 has a proximal end 1508, a distal end 1510, and an opening 1512. The member 1514 for moving the plunger is arranged in the opening 1512 of the handle 1502. In this embodiment, the member 1514 for moving the plunger operates in a roller-like mechanism. The measuring tube 1504 has a proximal end 1516 and a distal end 1518. The proximal end 1516 of the measuring tube 1504 is movably connected to the distal end 1510 of the handle 1502. The tip cover 1520 is configured to surround the distal end 1518 of the measuring tube 1504. The measuring tube 1504 is movably configured to surround the inner tube 1506. The figure further shows IUS 1522. The frame 1524 of the IUS 1522 and the part of the capsule 1526 exist outside the insert 1500. In this embodiment, the frame 1522 is an S-shaped frame. In the case of an S-shaped frame, the IUS 1522 is preloaded into the insert 1500 so that the capsule 1526 is located outside the insert 1500 and the tip cap 1520 is in a retracted state (ie, pulled back toward the handle 1502). The distal end 1528 of the inner tube 1506 is configured to cooperate with the IUS 1522. The flange 1530 is movably arranged on the measuring tube 1504.

5B and 5C are schematic top views of an insert 1500 according to an embodiment of the present invention, which depict an exemplary internal structure of the handle 1502 of the IUS 1522 in a preloaded state and an inserted state, respectively. Referring to Figure 5B, there is shown an insert 1500 with a member 1514 for moving the plunger. The member 1514 for moving the plunger includes a rack 1530 arranged inside the handle 1502. The rack 1530 has a proximal end 1532 and a distal end 1534. The member 1514 for moving the plunger further includes a pinion 1536 arranged in the opening of the handle 1502. The pinion 1536 is configured to cooperate with the rack 1530. The proximal end 1538 of the plunger 1540 of the insert 1500 is connected to the distal end 1534 of the rack 1530. The rack 1530 is located in the first position 1542 (ie, when the frame 1530 is close to the proximal end 1508 of the handle 1502). When the rack 1530 moves to the first position 1542 by rolling the pinion 1536, the IUS 1522 is loaded into the inner tube of the insert 1500. Push the tip cover 1520 forward (ie, push away from the handle 1502).

Referring to Figure 5C, there is shown an insert 1500 with a rack 1530 in a second position 1544 (ie, when the rack 1530 is close to the distal end 1510 of the handle 1502). In the inserted state, when the rack 1530 is moved to the second position 1544 by rolling the pinion 1536, the IUS 1522 is partially released from the insert 1500.

Referring to FIG. 6, there is shown a schematic diagram of an IUS 100 according to an embodiment of the present invention. The IUS 100 includes a frame 102, a sheath 104, and a capsule 106. In this embodiment, the frame 102 is an S-shaped frame. The frame 102 has a first end 108 and a second end 110. Furthermore, the round end portion 114 is disposed at the first end 108 of the frame 102. The round end portion 114 has a larger diameter than the rest of the frame 102. In addition, the second end 110 of the frame 102 includes a member 116 for joining, which facilitates the cooperation of the plunger of the insert with the IUS 100. In addition, the figure shows the removal thread 118 attached to the opening 120 in the member 116 for engagement.

The sheath 104 has a first end (not visible here) and a second end 122. The sheath 104 is configured to movably surround a portion of the frame 102. The second end 122 of the sheath 104 includes an enlarged object 124 having a flared shape. The capsule 106 has a first end 126 and a second end 128. The capsule 106 is configured to surround the sheath 104 and includes a pharmaceutically active agent.

FIG. 7 shows a schematic diagram of the IUS 100 of FIG. 6 in a loaded configuration according to an embodiment of the present invention. As shown in the figure, before inserting the IUS 100 into the uterus, when the insert is loaded, the IUS 100 including the frame 102, the sheath 104, and the capsule 106 is straightened and stretched. In addition, the figure shows the outer diameter 202 of the IUS 100 which substantially corresponds to the outer diameter of the capsule 106 (ie, the maximum diameter of the IUS 100). In this embodiment, the length Lc of the capsule 106 is approximately 25% of the length Lf of the frame 102.

FIG. 8 shows a cross-sectional view of the IUS 100 of FIG. 6 according to an embodiment of the present invention. As shown in the figure, the sheath 104 is configured to movably surround a portion of the frame 102, and the capsule 106 is configured to surround the sheath 104. In addition, the figure shows the length Ls of the sheath 104, the length 304 and the width 306 of the frame 102 when the frame 102 is in an S-shaped configuration in the deployed state in the uterus.

FIG. 9 shows a schematic diagram of the capsule 106 disposed on the sheath 104, wherein the second end of the sheath 104 has an enlarged view 402 of an enlarged object 124. The enlargement 124 has a trumpet shape and acts as a holding member to hold the capsule 106 in a proper position on the frame 102 and prevent it from sliding out of the frame 102 during the IUS insertion procedure.

FIG. 10 shows a schematic diagram of an IUS 500 according to another embodiment of the present invention. The IUS 500 includes a frame 502. In this embodiment, the frame 502 is a 7-shaped frame. As shown in the figure, the IUS 500 includes two capsules 504 and 506. The capsule 504 is disposed on a sheath 508 and the capsule 506 is disposed on another sheath (not visible here). The two capsules 504 and 506 are separated by a predetermined distance in the deployed state in the uterus. The frame 502 includes a round end portion 510 at the first end 512 of the frame 502 and a member 514 for joining at the second end 516 of the frame 502. The member 514 for joining includes an opening 518. As shown in the figure, the frame 502 has a protrusion 520 each close to the first end 522 and the second end 524 of the sheath 508 located on alternate sides of the frame 502. The frame 502 has only one protrusion 520 near the second end of the sheath under the capsule 506. The rounded end portion 510 of the frame 502 prevents the capsule 506 from sliding out of the frame 502 from the first end 512.

Fig. 11 shows a cross-sectional view of the IUS 500 of Fig. 10. Referring to FIG. 11, there is shown a sheath 602 disposed on the frame 502. The sheath 602 has a first end 604 and a second end 606. The sheath 602 is surrounded by the capsule 506 and the sheath 508 is surrounded by the capsule 504. In addition, the figure shows the removal thread 608 coupled to the opening 518 in the member 514 for engagement.

Figure 12 shows a cross-sectional view of an IUS 700 according to another embodiment of the present invention. The IUS 700 includes a frame 702, two sheaths 704 and 706, and two capsules 708 and 710. In this embodiment, the frame 702 is a P-shaped frame (specifically, an open P-shaped frame). As shown in the figure, capsules 708 and 710 are disposed on sheaths 704 and 706, respectively. The capsules 708 and 710 are separated by a predetermined distance in the deployed state in the uterus. The frame 702 includes a round end portion 712 at the first end 714 of the frame 702 and a member 716 for joining at the second end 718 of the frame 702. The member 716 for joining includes an opening 720. As shown in the figure, the frame 702 has a protrusion 722 each close to the first end 724 and the second end 726 of the sheath 706. The rounded end portion 712 of the frame 702 prevents the capsule 710 from sliding off the frame 702 and further facilitates the comfortable insertion of the IUS 700 into the neck tube and uterus. In addition, the first end 728 and the second end 730 of the sheath 704 are shown in the figure. It is worth noting that the frame 702 has no protrusions near the first end 728 and the second end 730 of the sheath 704.

Fig. 13 shows a cross-sectional view of an IUS 800 according to another embodiment of the present invention. The IUS 800 includes a frame 802, three sheaths 804, 806, and 808, and three capsules 810, 812, and 814. In this embodiment, the frame 802 is a P-shaped frame (specifically, a closed P-shaped frame). As shown in the figure, capsules 810, 812, and 814 are disposed on sheaths 804, 806, and 808, respectively. When the frame 802 acquires a P shape in the deployed state in the uterus, the capsules 810, 812, and 814 are separated by a predetermined distance. The frame 802 includes a round end portion 816 at the first end 818 of the frame 802 and a member 820 for joining at the second end 822 of the frame 802. The member for engagement 820 includes an opening 824 for receiving the removal thread 826. As shown in the figure, the frame 802 has a first end 830 each close to the sheath 804, a second end 832 of the sheath 806, and a protrusion 828 of the first end 834 of the sheath 808 on the same side of the frame 802 . The protrusions 828 facilitate the assembly of the sheaths 804, 806, and 808 on the frame 802 and control their movement during insertion and use.

Referring now to FIG. 14, there is shown a cross-sectional view of an IUS 900 according to another embodiment of the present invention. The IUS 900 includes a frame 902 and two capsules 904 and 906. In this embodiment, the frame 902 is a hook-shaped frame. As shown in the figure, the capsules 904 and 906 are directly disposed on different parts of the frame on the frame 902 (ie, the parts 908 and 910, respectively). When the frame 902 acquires a hook shape in the deployed state in the uterus, the capsules 904 and 906 are separated by a predetermined distance. The frame 902 includes an end portion 912 at the first end 914 of the frame 902 and a member 916 for joining at the second end 918 of the frame 902. The member 916 for joining includes an opening 920. As shown in the figure, the frame 902 has a first end 924 and a second end 926 each close to the sheath 904 and a protrusion 922 further close to the first end 928 and the second end 930 of the capsule 906 on the same side of the frame 902 .

FIG. 15 is a schematic diagram of IUS 101 according to an embodiment of the present invention. The IUS 101 includes a frame 103, a sheath (not shown in the figure), and a capsule 105. In this embodiment, the frame 103 is another form of the S-shaped frame. The removal thread 107 is attached to the opening 109.

Referring now to FIGS. 16A and 16B, there are shown various operating stages 1002 to 1014 related to assembling the sheath 1016 and the capsule 1018 on the frame 1020 according to an embodiment of the present invention. Referring to FIG. 16A, at operation 1002, a frame 1020 is obtained by an injection molding process. At operation 1004, the sheath 1016 is also obtained in an open configuration through an injection molding process. In the open configuration, the sheath 1016 has a first end 1022, a second end 1024, and two longitudinal portions 1026A and 1026B. At operation 1006, the two longitudinal portions 1026A and 1026B of the sheath 1016 are longitudinally arranged along the portion 1028 of the frame 1020.

16B, at operation 1008, the longitudinal portions 1026A and 1026B of the sheath 1016 are bent along the portion 1028 of the frame 1020. At operation 1010, a capsule 1018 is obtained. As shown in the figure, the capsule 1018 has a hollow tubular structure. At operation 1012, the longitudinal portions 1026A and 1026B of the sheath 1016 are joined together by laser welding to obtain the sheath-frame assembly 1030. At operation 1014, the capsule 1018 is configured to surround the sheath-frame assembly to form the capsule-sheath-frame assembly 1032.

Modifications to the embodiments of the invention described in the foregoing are possible without departing from the scope of the invention defined by the scope of the appended patent application. The expressions used to describe and claim the present invention (such as "include", "include", "incorporate", "have", and "are") are intended to be interpreted in a non-exclusive manner, that is, items and components that are not explicitly described are allowed Or components. The reference singular should also be interpreted as related to the plural.

100: Intrauterine system (IUS) 101: Intrauterine system (IUS) 102: Frame 103: Frame 104: Sheath 105: Capsule 106: Capsule 107: Remove thread 108: first end 109: Open 110: second end 114: round end part 116: Component 118: Remove thread 120: opening 122: second end 124: Amplification 126: first end 128: second end 202: Outer diameter 304: length 306: width 402: Magnified view 500: Intrauterine system (IUS) 502: Frame 504: Capsule 506: Capsule 508: Sheath 510: round end part 512: first end 514: Components for joining 516: second end 518: open 520: protrusion 522: first end 524: second end 602: Sheath 604: first end 606: second end 608: Remove thread 700: Intrauterine system (IUS) 702: Frame 704: Sheath 706: Sheath 708: Capsule 710: Capsule 712: round end part 714: first end 716: component used for joining 718: second end 720: open 722: protruding part 724: first end 726: second end 728: first end 730: second end 800: Intrauterine system (IUS) 802: Frame 804: Sheath 806: Sheath 808: Sheath 810: Capsule 812: Capsule 814: Capsule 816: round end part 818: first end 820: Components for joining 822: second end 824: open 826: Remove thread 828: protruding part 830: first end 832: second end 834: first end 900: Intrauterine system (IUS) 902: frame 904: Capsule 906: Capsule 908: part 910: part 912: end part 914: first end 916: Components for joining 918: second end 920: open 922: protruding part 924: first end 926: second end 928: first end 930: second end 1002 to 1014: Operational stage 1016: Sheath 1018: Capsule 1020: frame 1022: first end 1024: second end 1026A: Longitudinal part 1026B: Longitudinal part 1028: part 1030: Sheath-frame assembly 1032: Capsule-sheath-frame assembly 1100: Insert 1102: Handle 1104: near end 1106: remote 1108: opening 1110: measuring tube 1112: proximal 1114: remote 1116: Tip cover 1118: Flange 1120: component 1122: inner tube 1124: near end 1126: remote 1128: Plunger 1130: near end 1132: remote 1134A: The first cover part 1134B: The second cover part 1136A: The first rack 1136B: The third rack 1138: sled 1140A: second rack 1140B: The fourth rack 1142: Slide 1144: the first pinion 1146: second pinion 1147: Front gear axis 1148: third pinion 1150: the fourth pinion 1152: first attachment member 1154: second attachment member 1200: Slide 1202: The first pinion 1204: second pinion 1206: third pinion 1208: Fourth Pinion 1300: inner tube 1302: near end 1304: remote 1306: C-shaped slit 1308: prominent 1310A: inner surface 1310B: Outer surface 1312: attachment member 1400: Insert 1402: intrauterine system 1404: flange 1406: measuring tube 1408: Rating Scale 1410: spring lock 1412: preload status 1414: Loading status 1416: frame 1418: handle 1420: component 1422: Tip cap 1424: near end 1426: remote 1428: opening 1430: Remove thread 1432: vagina 1434: External orifice 1436: neck tube 1438: inner tube 1440: Uterine cavity 1442: Capsule 1444: first end 1446: second end 1448: Plunger 1450A: component 1450B: Groove 1452: Thread cutting button 1454: second cover part 1456: component 1458: Sheath 1460: first end 1462: second end 1464: indentation 1466: first end 1468: second end 1470: round end part 1500: Insert 1502: Handle 1504: Measuring tube 1506: inner tube 1508: near end 1510: remote 1512: opening 1514: component 1516: near end 1518: remote 1520: Tip cap 1522: Intrauterine system (IUS) 1524: frame 1526: Capsule 1528: remote 1530: flange 1532: near end 1534: remote 1536: pinion 1538: near end 1540: Plunger 1542: first position 1544: second position Lc: length Lf: length Ls: length

The above [Summary of the Invention] and the following detailed description of the illustrative embodiments can be better understood when read in conjunction with the accompanying drawings. In order to illustrate the present invention, an exemplary structure of the present invention is shown in the drawings. However, the present invention is not limited to the specific methods and tools disclosed herein. Furthermore, those skilled in the art should understand that the diagrams are not drawn to scale. Where possible, similar elements have been indicated by the same numbers. The embodiments of the present invention will now be described by way of example only with reference to the following figures, in which: 1A and 1B are perspective views of the inserter in an assembled state and an unassembled state, respectively, according to an embodiment of the present invention; 1C shows the configuration of the inner tube of the sled, plunger, and inserter according to an embodiment of the present invention; Figure 1D illustrates the configuration of the pry in the handle of the inserter according to an embodiment of the present invention; 2A to 2D show different views of an exemplary implementation of a slider according to an embodiment of the present invention; Figure 3 is a perspective view of an exemplary inner tube according to an embodiment of the present invention; 4A to 4J show different views of the insert depicting the positioning of the IUS in the uterus at various stages of operation according to various embodiments of the present invention; Figure 5A is a perspective view of an inserter according to another embodiment of the present invention; 5B and 5C respectively show schematic top views of an interposer with an IUS in a preloaded state and an inserted state according to an embodiment of the present invention; Figure 6 is a schematic diagram of an intrauterine system (IUS) according to an embodiment of the present invention; FIG. 7 is a schematic diagram of the IUS of FIG. 6 in a loaded configuration according to an embodiment of the present invention; Fig. 8 is a cross-sectional view of the IUS of Fig. 6 according to an embodiment of the present invention; 9 is a schematic diagram of the configuration of the capsule on the sheath with the horn-shaped enlargement according to the embodiment of the present invention; Figure 10 is a schematic diagram of an IUS according to another embodiment of the present invention; Figure 11 is a cross-sectional view of the IUS of Figure 10 according to an embodiment of the present invention; Figure 12 is a cross-sectional view of an IUS according to another embodiment of the present invention; Figure 13 is a cross-sectional view of an IUS according to another embodiment of the present invention; Figure 14 is a schematic diagram of an IUS according to another embodiment of the present invention; FIG. 15 is a schematic diagram of IUS according to another embodiment of the present invention; and FIGS. 16A and 16B jointly illustrate various operating stages related to assembling the sheath and the capsule on the frame of the IUS according to various embodiments of the present invention. In the figure, the ununderlined number is related to the item identified by the line that links the ununderlined number to the item. When the number is not underlined and the associated arrow is attached, the ununderlined number is used to identify the general item pointed to by the arrow.

1100: Insert

1102: Handle

1104: near end

1106: remote

1108: opening

1110: measuring tube

1112: proximal

1114: remote

1116: Tip cover

1118: Flange

1120: component

Claims (14)

An insert (1100, 1400, 1500) for an intrauterine system (1402, 1522), which includes Handle (1102, 1418, 1502), which has a proximal end (1104, 1424, 1508), a distal end (1106, 1426, 1510) and an opening (1108, 1428, 1512); The inner tube (1122, 1300, 1438, 1506), which has a proximal end (1124, 1302) and a distal end (1126, 1304), its proximal end is connected to the distal end of the handle and its distal end is configured to The intrauterine system cooperates; Measuring tube (1110, 1406, 1504), which has a proximal end (1112, 1516) and a distal end (1114, 1518), the proximal end of which is movably connected to the distal end of the handle, and the measuring tube is movable Ground configuration to surround the inner tube; Plunger (1128, 1448, 1540), which is movably arranged in the inner tube, the plunger has a proximal end (1130, 1538) and a distal end (1132), and its distal end is configured to interact with the uterus Internal system collaboration; Flanges (1118, 1404, 1530), which are movably arranged around the measuring tube; Tip cover (1116, 1422, 1520), which is configured to surround the distal end of the measuring tube; and The member (1120, 1420, 1514) is used to move the plunger, and the member is arranged in the opening of the handle. Such as the insert (1100, 1400, 1500) of claim 1, wherein the member (1120, 1420) used to move the plunger includes The skid (1138) is movably arranged inside the handle (1102, 1418); The slider (1142, 1200), which together with the sled is movably arranged in the opening (1108, 1428) of the handle; Wherein, the proximal end (1130) of the plunger (1128, 1448) is connected to the sled. Such as the insert of claim 2 (1100, 1400, 1500), where The handle (1102, 1418) includes at least one first rack (1136A) arranged inside the handle on the longitudinal side of the opening (1108, 1428); The skid (1138) includes at least one second rack (1140A), and the at least one second rack is configured to be parallel to the at least one first rack; and The slider (1142, 1200) includes At least one first pinion (1144, 1202) configured to cooperate with the at least one first rack, At least one second pinion (1146, 1204) configured to cooperate with the at least one second rack, Wherein, the at least one first pinion gear is configured to cooperate with the at least one second pinion gear to translate the movement of the slider. Such as the insert of claim 3 (1100, 1400, 1500), where The insert also includes a third rack (1136B) arranged inside the handle (1102, 1418) on the longitudinal side of the opening (1108, 1428), which is opposite to the first rack (1136A); The skid (1138) includes a fourth rack (1140B) arranged parallel to the second rack (1140A); and The slider (1142, 1200) includes The third pinion (1148, 1206), which is configured to cooperate with the third rack, The fourth pinion (1150, 1208), which is configured to cooperate with the fourth rack, The third pinion gear is configured to cooperate with the fourth pinion gear to translate the movement of the slider. Such as the insert (1100, 1400, 1500) of claim 1, wherein the member (1514) used to move the plunger includes At least one rack (1530), which is arranged inside the handle (1502), the rack has a proximal end (1532) and a distal end (1534), and A pinion (1536), which is disposed in the opening (1512) of the handle and configured to cooperate with the at least one rack, The proximal end (1538) of the plunger (1540) is connected to the distal end of the rack. Such as the insert (1100, 1400, 1500) of claim 1, wherein the member (1120, 1420, 1514) used to move the plunger includes a motor. Such as the insert (1100, 1400, 1500) of any one of claims 1 to 6, wherein the tip cover (1116, 1422, 1520) is movably arranged on the measuring tube (1110, 1406, 1504) On the far end (1114, 1518). Such as the insert (1100, 1400, 1500) of any one of claims 1 to 6, wherein the tip cap is fixedly attached to the distal end (1114, 1518) of the measuring tube (1110, 1406, 1504) superior. Such as the insert (1100, 1400, 1500) of any one of claims 1 to 6, which further includes a member (1456) for cutting the threads to be removed. Such as the insert (1100, 1400, 1500) of any one of claims 1 to 6, wherein the distal end (1126, 1304) of the inner tube (1122, 1300, 1438, 1506) includes its inner surface (1310A) At least one protrusion (1308) on the upper part. For example, the insert (1100, 1400, 1500) of claim 10, wherein the protrusion (1308) is in the form of a ring (1314). A kit, which includes an insert and an intrauterine system (1402, 1522) as claimed in any one of claims 1 to 11, wherein the intrauterine system includes The frame (1416) has a first end (1444), a second end (1446), and a length Lf defined as the distance between the first end and the second end; At least one sheath (1458), which has a first end (1460), a second end (1462), a length Ls defined as the distance between the first end and the second end, and is configured to be movable The part surrounding the frame; and At least one capsule (1442) comprising a pharmaceutically active agent, the at least one capsule having a first end (1466), a second end (1468), and a length Lc defined as the distance between the first end and the second end , And configured to surround the sheath; in The length Ls is 5% to 50% of the length Lf; and The length Lc is 5% to 50% of the length Lf. The set of claim 12, wherein the second end (1462) of the sheath includes the inner surface of the distal end (1126, 1304) of the inner tube (1122, 1300, 1438, 1506) At least one protrusion (1308) on (1310A) cooperates with at least one indentation (1464). Such as the set of claim 12 or 13, wherein the distal end (1126, 1304) of the inner tube (1122, 1300, 1438, 1506) is configured to be compatible with the sheath of the intrauterine system (1402, 1522) (1458) Collaboration.

Images