A fertility aid

Abstract

This invention relates to a fertility assistive device (1) and an inserter (2) suitable for insertion of the fertility assistive device (1) into or near the cervix (CX) of the vagina of a mammal (preferably a human). The fertility assistive device (1) includes a cylindrical collector (CR) comprising an edge (RI) having one or more protrusions on its surface, which are adapted for easy removal after a final procedure. The cylindrical collector (CR) also has a base (BP) and sidewalls (SW) extending from the base to the edge (RI). The sidewalls (SW) include one or more crease lines (FL, FL') that allow the cylindrical collector (CR) to fold inward radially according to a predetermined shape. The inserter (2) includes an inner tube (IT) suitable for insertion into an outer tube (OT). The inserter (2) is provided with an insertion operation mode and a release operation mode, wherein the inserter (2) is adapted to be locked in both operation modes by rotating the two tubes (IT, OT) relative to each other, thereby facilitating easy insertion of the fertility aid (1) into or near the user's cervix (CX).

Description

Technical Field

[0001] This invention relates to an intravaginal fertility aid device, a set of components, and a method for increasing the chances of conception. Background Technology

[0002] In recent years, the fertility of couples trying to conceive has declined. To increase the chances of conception, it is recommended to use a collector or cup inserted into the cervix after intercourse to retain semen near the cervix. Additionally, single mothers and the LGBTQ+ community can also use this collector or cup for artificial insemination without intercourse.

[0003] For example, such a device is found in WO 2019 / 245368 A1, which discloses an intravaginal conception aid for collecting semen and placing it relatively close to the cervix. The device includes a cup-shaped component for collecting semen within the vaginal canal and presenting the semen relatively close to the cervix as it moves along the vaginal canal toward the cervix. According to this patent, the cup-shaped component is substantially flippable, capable of transitioning from a first state (substantially unflipped) to a second state (substantially flipped), in which the cup-shaped component is substantially folded from the inside out.

[0004] The inventors discovered several problems with existing technologies. First, the process of folding and inserting is difficult and uncomfortable. Furthermore, removing the cup-shaped device is equally difficult and uncomfortable. Due to the difficulty of removal (e.g., the negative pressure generated during removal, and / or causing cervical abrasions, scratches, etc.), users may experience inflammation. This inflammation may create an unfavorable environment for sperm survival, thereby reducing the chances of successful conception.

[0005] Furthermore, known devices are not suitable for external delivery of semen; instead, semen must be delivered to or near the cervix by injection before insertion of the device.

[0006] Therefore, an improved fertility assist device, kit, and method would be advantageous, especially a more efficient and / or more reliable device.

[0007] Purpose of the invention Another object of the present invention is to provide an alternative to the prior art.

[0008] Specifically, the purpose of this invention can be regarded as providing a fertility assist device, an implant, and a set of components to solve the above-mentioned problems existing in the prior art during the insertion and removal process. Summary of the Invention

[0009] Therefore, a first aspect of the present invention aims to achieve the above-mentioned and several other objectives by providing a fertility assisted device, the device comprising: A cylindrical collector includes an edge and a bottom, with a sidewall extending between the two; wherein the edge has a protrusion along its surface, and the sidewall extends from the edge and tapers radially inward toward the bottom; and the sidewall also includes a crease line extending between the edge and the bottom; A tail rod extends from the bottom of the collector; wherein the collector is adapted to fold its edges and sidewalls inward radially according to a predetermined folding pattern determined by the crease lines.

[0010] Compared to not using the device, the present invention, by delivering semen to or near the cervix for an extended period of time, is particularly beneficial (but not limited to) increasing the chances of conception.

[0011] The present invention is advantageous for use after intercourse, i.e., after ejaculation, by inserting the device to retain the semen at or near the cervix.

[0012] A further advantage of the invention is that the device is adapted to receive semen in the collector, after which the fertility aid can be inserted into or near the cervix, thereby presenting the semen to or near the cervix and ensuring that the sperm can function for an extended period of time.

[0013] In the context of this invention, "assisted reproduction" should be understood as increasing the chances of conception by prolonging the time sperm are exposed to the cervix and subsequently to the egg cell. In a preferred embodiment, the invention is used in humans. In other embodiments, the device can also be used in animals to increase the chances of successful reproduction.

[0014] In the context of this invention, "cylindrical collector" should be understood as a circular container suitable for receiving and containing semen, such as a cup or cone.

[0015] In the context of this invention, "protrusion" should be understood as a bulge or protrusion along the edge of the collector.

[0016] In some embodiments, the protrusions may have a wavy configuration, for example, symmetrically distributed along the edges.

[0017] In other embodiments, the protrusions are distributed in an asymmetrical configuration.

[0018] It should be understood that the protrusion is used to ensure that the fertility assisted device does not create negative pressure inside the cylindrical collector (i.e., between the edge and the cervix), as this would cause discomfort to the user during device removal.

[0019] Therefore, the present invention is advantageous in providing comfortable insertion and subsequent removal, with the aim of increasing the chances of conception.

[0020] In the context of this invention, "conceive" should be understood as pregnancy.

[0021] It should also be understood that the cylindrical collector and its bottom are adapted to receive and contain semen by injecting or ejaculating the semen directly into the collector, or by inserting the collector into or near the cervix after intercourse, wherein the collector contains and presents the semen ejaculated during intercourse. It should also be understood that the invention can be used after artificial insemination by, for example, a syringe containing semen, by injecting the semen into the collector before insertion of the fertility assisted device, or by injecting the semen into or near the cervix and inserting the device after injection.

[0022] In the context of this invention, a "crease line" should be understood as a protrusion or groove provided on the sidewall to ensure that the collector forms a predetermined folded shape. In some embodiments, the crease line is provided by providing a thickened or thinned shape within the sidewall. In some embodiments, the crease lines are symmetrically distributed circumferentially along the collector. In other embodiments, the sidewall of the collector includes a single crease line or two crease lines, such as two opposing crease lines.

[0023] In the context of this invention, the "tail rod" should be understood as an extension of the bottom of the cylindrical collector. In advantageous embodiments, the tail rod thins or decreases in diameter from the bottom toward an end opposite to the bottom. It should also be understood that the tail rod is particularly advantageous when removing the fertility aid, as the end of the tail rod can extend to or near the user's vaginal opening, similar to the pull string of a tampon. Furthermore, when the fertility aid is used in conjunction with an inserter, the tail rod can be used to pull the collector into the inserter from its proximal end, thereby ensuring that the user does not need to unnecessarily touch the collector when inserting the fertility aid into the inserter.

[0024] It should also be understood that the cylindrical collector and tail rod configuration allows for easy insertion and removal, at least when used with an inserter, because the tail rod provides a point of access and traction for the fertility aid device, even when the collector is filled with semen. Furthermore, the creases allow for even and predictable folding to reduce the risk of sperm inactivation or leakage during insertion; meanwhile, the protrusions allow for easy removal of the device without creating negative pressure that could prevent the collector from being released from the cervix.

[0025] Furthermore, the protrusion fits the cervix with slight negative pressure, and when a pulling force is applied to the tail rod, the negative pressure is balanced, thus enabling easy removal.

[0026] It should also be understood that the fertility assistive device is placed on or near the cervix immediately after intercourse, and within a few minutes of intercourse, such as within 1 to 5 minutes or 1 to 10 minutes after intercourse; or, the semen has been pre-placed in a collector before the device is inserted into the vagina.

[0027] In some embodiments, the height of the protrusion extending from the edge is between 0.1 mm and 5 mm, for example, between 0.2 mm and 4 mm, or between 0.3 mm and 3 mm, or between 0.4 mm and 2 mm. In a preferred embodiment, the height of the protrusion extending from the edge is between 0.5 mm and 1 mm. It should be understood that the protrusion may extend from the inner surface or outer surface of the edge, or extend distally relative to the edge.

[0028] In a preferred embodiment of the invention, the tail rod further includes a gripping element at its end away from the collector. This embodiment is particularly advantageous for providing a component that is easy to grip and pull on for the user of the fertility assist device. Furthermore, when used with the inserter, the gripping element can be used to lock the fertility assist device in an biased state to ensure that the collector is in a folded state during insertion.

[0029] In another preferred embodiment of the invention, at least one of the collector or tail rod is made of a flexible polymer, preferably a silicone elastomer. This embodiment is particularly advantageous for providing a comfortable fertility assistive device for the user.

[0030] In another preferred embodiment of the invention, at least one of the collector and the tail rod is made of a biocompatible polymer, preferably a soft polymer such as polysiloxane (PDMS), low-density polyethylene (LDPE), or polypropylene (PP).

[0031] In an advantageous embodiment of the invention, the protrusions along the edge are beaded protrusions. This embodiment is particularly advantageous in providing an edge that can conform to the cervix during the period when semen is presented and retained at the cervix, and allows the device to be easily removed when a pulling force is applied to the tail rod of the fertility assist device, because the beaded protrusions allow air to enter from the outside of the collector, thereby ensuring equal pressure inside and outside the collector.

[0032] It should be understood that the configuration of the protrusions and creases allows the edge of the collector to be released when a pulling force is applied to the tail rod of the fertility aid.

[0033] In some embodiments, the tail rod extends eccentrically from the bottom of the collector to provide a non-uniform force distribution to the collector when a pulling force is applied to the tail rod, thereby allowing the edge of the collector to be released from the cervix. This embodiment is particularly advantageous for achieving comfortable removal of assisted reproductive devices.

[0034] In another advantageous embodiment of the invention, the protrusion extends radially inward along its edge. This embodiment is particularly advantageous for presenting the protrusion at or near the cervix, as the edge may surround at least a portion of the cervix.

[0035] In another advantageous embodiment of the invention, the edge further includes a lip extending circumferentially along the edge. This embodiment is particularly advantageous for providing a seal between the cervix and the edge.

[0036] It should be understood that the edges, protrusions, and / or lips ensure the collector's fit to the cervix, wherein the collector may surround a portion of the cervix; and wherein the protrusions allow air to circulate between the inside and outside of the collector, at least when force is applied to the tail rod of the fertility aid, particularly when the tail rod is pulled in a direction away from the cervix.

[0037] In a preferred embodiment of the invention, the cylindrical collector is formed as a single piece.

[0038] In another preferred embodiment, the fertility assist device is formed as a single piece, for example, molded or formed from a biocompatible soft elastomer. In particular, the fertility assist device may be integrally molded or formed from silicone. This embodiment is particularly advantageous in ensuring that the tail rod does not break off from the collector when the fertility assist device is removed.

[0039] In another preferred embodiment of the invention, the protrusions are evenly distributed along the edge of the collector. This embodiment is particularly advantageous for ensuring easy and comfortable removal of the fertility assistive device and also ensures that the user does not insert the fertility assistive device in an unfavorable orientation relative to the cervix, since at least the collector is circumferentially symmetrical.

[0040] In an advantageous embodiment of the invention, the cylindrical collector is cup-shaped or substantially cup-shaped. In some embodiments, the collector tapers inward from the edge toward the bottom.

[0041] In a second aspect, the present invention relates to an inserter for vaginal insertion of a fertility-assisting device, for example for inserting a fertility-assisting device according to the first aspect, the inserter comprising: - An inner tube that can be slidably arranged inside an outer tube, the inner tube having a radially inwardly extending distal end face. The importer is compatible with at least two operating modes: a) Insertion mode, in which the inner tube is locked relative to the outer tube on the vertical axis; and b) Release mode, in which the inner tube can move relative to the outer tube along the longitudinal axis by adjusting the circumferential orientation of the inner tube relative to the outer tube. When the inlet is in release mode, the distal end face of the inner tube can be brought into the distal end plane of the outer tube or protrude from the distal end of the outer tube.

[0042] This embodiment is particularly advantageous for providing an inserter for a fertility assist device or conception aid, wherein the inserter ensures easy and comfortable assistance during insertion.

[0043] It should be understood that both the inner tube and the outer tube are hollow structures, so the inner tube is fitted inside the outer tube, and at least the tail rod of the fertility assist device can extend in both the inner tube and the outer tube; preferably, the tail rod extends from the proximal end of the inner tube.

[0044] In the context of this invention, "slidably arranged" should be understood as a type of fit for sliding between mechanical components, which is a common type of fit in mechanical engineering. Specifically, the outer diameter of the inner tube is slightly smaller than the inner diameter of the outer tube, allowing the inner tube to move relative to the outer tube along the longitudinal or longitudinal axis within the outer tube.

[0045] In a preferred embodiment of the invention, the length of the inner tube is greater than the length of the outer tube. This embodiment is particularly advantageous because it ensures that the distal end of the inner tube can reach the plane defined by the distal end of the outer tube, while the user can still operate the proximal end of the inner tube extending from the proximal end of the outer tube.

[0046] "The distal end face of the inner tube can be brought into the plane of the distal end of the outer tube" should be understood as the distal end face of the inner tube being moved to a position very close to the distal end of the outer tube, so that the collector can be deployed.

[0047] "The distal end face of the inner tube can be brought into the plane of the distal end of the outer tube" should be understood as the distal end face of the inner tube being able to be moved to within 2.0 mm of the distal end of the outer tube, preferably within 1.0 mm, more preferably within 0.5 mm, and even more preferably within 0.2 mm.

[0048] Regarding this invention, "proximal end" should be understood as the end closer to the user's hand when operating the inserter, while "distal end" should be understood as the end farther from the connection point or origin (i.e., the user's hand). Therefore, in this invention, when the inserter is inserted, the "distal end" is located at or near the cervix, while the "proximal end" is farther from the cervix, for example, closer to the user's hand operating the inserter. This also applies to assisted reproductive devices, wherein during operation of the assisted reproductive device, the collector faces the cervix in the distal direction, while the tail extends in the proximal direction, i.e., away from the cervix, and may extend out of the vagina.

[0049] It should also be understood that by rotating the inner tube about its longitudinal axis relative to the outer tube, the inner and outer tubes are adapted to engage or interlock in the insertion mode; wherein the distal end face of the inner tube is located proximal to the distal end of the outer tube. This helps ensure that the distal portion of the outer tube is not occupied by the inner tube, thus preparing to receive and enclose the collector of the fertility-assisted device. Furthermore, when the distal end of the outer tube of the inserter is located at or near the cervix, the locking of the inserter can be released by rotating the inner tube relative to the outer tube; subsequently, the inner tube can be moved distally relative to the outer tube, thereby pushing the bottom of the collector with its distal end face, thus delivering the collector to or near the cervix.

[0050] Therefore, when the inserter is in insertion mode, the inner and outer tubes interlock; the distal end of the outer tube is not occupied by the inner tube; and the inner tube extends from the proximal end of the outer tube. When the fertility aid device is inserted into the inserter, the tail rod passes through the inner tube through the distal end of the outer tube; the bottom of the collector abuts against the distal end of the outer tube; wherein, the user applies a pulling force to the tail rod in the proximal direction, causing the collector to fold into a predetermined shape and slide into the outer tube, thereby preparing for the insertion of the fertility aid device into the vagina.

[0051] When the distal end of the outer tube of the collector is positioned at or near the cervix, the inner tube is rotated to release its interlock with the outer tube; subsequently, the inner tube is moved distally relative to the outer tube to push the collector toward the cervix.

[0052] It should be understood that when the text describes "rotating the inner tube," it can actually mean rotating the outer tube. Whether the inner tube rotates relative to the outer tube or the outer tube rotates relative to the inner tube, the same result can be achieved.

[0053] When the fertility assist device is positioned at or near the cervix, the inserter is removed from the vagina. The fertility assist device is now in place to retain semen at or near the cervix for a longer period of time, such as 10 minutes, 20 minutes, 30 minutes, 1 hour, or 2 hours, particularly preferably between 15 minutes and 2 hours, and more preferably between 30 minutes and 1 hour.

[0054] After this extended period of time, the user pulls the tail lever to remove the fertility assistive device.

[0055] It should be understood that the inserter is particularly advantageous when used in conjunction with the fertility assistive device described in the first aspect of the invention, but it is also suitable for the easy insertion of other similar devices to increase the chances of conception. In some embodiments, the inserter can also be used to insert a contraceptive device adapted to cover the cervix during intercourse, thereby preventing sperm from reaching the cervix.

[0056] In a preferred embodiment of the invention, the inner and outer tubes are curved. This embodiment is particularly advantageous because the curved shape better adapts to the anatomy of the insertion site (i.e., the vagina). Furthermore, this curved shape serves as a simple means of ensuring interlocking between the inner and outer tubes, as rotation of the inner tube relative to the outer tube can be interlocked through the misalignment of the two curved curves. This is particularly advantageous when the inserter's material has relatively high friction.

[0057] In the context of this invention, "curved" should be understood as having a slight deviation from a straight line and without sharp angles or edges.

[0058] In a preferred embodiment, the radii of curvature of the inner and outer tubes are between 500 and 2000, for example, between 800 and 1700, or between 1000 and 1500, or between 1010 and 1200, or between 1015 and 1100, or between 1020 and 1050, or between 1025 and 1030. Preferably, the radius of curvature is 1027.

[0059] Regarding other dimensions, the length of the fertility assistive device can be approximately 20 cm, with the outer tube approximately 14 cm long and the inner tube approximately 14.5 cm long. When the inserter handle is included, the total length of the inserter can be between 15 cm and 25 cm, for example, between 16 cm and 20 cm. It should be understood that dimensions may vary depending on the user's anatomy, and the above dimensions may be suitable for some human users.

[0060] In another preferred embodiment of the invention, one of the inner and outer tubes is provided with a protruding locking element (such as a tongue), and the other of the inner and outer tubes is provided with a recessed locking element (such as a groove or slot), the recessed locking element being adapted to receive and engage with the protruding locking element. In some embodiments, one of the inner or outer tubes has a slot or groove extending from a proximal end to a distal end, wherein the protrusion or tongue is received within the slot or groove. In these embodiments, the slot may have a slight shoulder or notch somewhere between the proximal and distal ends to ensure that the inner and outer tubes can interlock at a position where the distal end face of the inner tube is proximal to the distal end of the outer tube, thereby reserving sufficient space for the collector to be inserted into the distal end of the outer tube.

[0061] In another preferred embodiment of the invention, the inserter has a longer length in the insertion mode compared to the release mode. Therefore, when the inserter is ready to be inserted, the portion of the proximal end of the inner tube extending from the proximal end of the outer tube is larger than the extension portion in the release mode, in which the inner tube moves further distally into the outer tube.

[0062] In an advantageous embodiment, the invention further includes an inserter handle fixed to the proximal end of the inner tube, the inserter handle including an opening adapted to provide access from the inserter handle to the inner tube. This embodiment is particularly advantageous for ensuring safe and comfortable operation of the inner tube relative to the outer tube during insertion.

[0063] In another advantageous embodiment of the invention, the proximal end of the outer tube extends outwardly radially to provide an end stop, wherein the end stop prevents the outer tube from being completely swallowed or aspirated into the user's / subject's vagina during insertion of the inserter.

[0064] In another advantageous embodiment of the invention, the infeeder handle further includes a retainer adapted to secure a portion of the fertility aid device. This embodiment is particularly advantageous for locking the tail rod in an offset position, thereby ensuring that the collector does not unfold within the outer tube during insertion.

[0065] In a preferred embodiment, the retainer of the inlet handle is a slot adapted to receive a portion of the tail rod from the side, wherein the slot gradually narrows to apply pressure to the tail rod. It should be understood that the invention may also cover other types of retainers.

[0066] The retainer on the inserter handle is particularly advantageous for keeping the fertility aid in an off-center position during insertion.

[0067] In another preferred embodiment of the invention, the delivery device is made of a biocompatible polymer, such as polyester, medical-grade PVC and polyethylene, PEEK, polycarbonate, Ultem PEI, polysulfone, polypropylene (PP), and polyurethane. It should also be understood that the delivery device may only require limited biocompatibility, i.e., suitable for exposure times of less than 24 hours.

[0068] In an advantageous embodiment of the invention, the distal end of the outer tube includes a protrusion or recess along the inner edge surface.

[0069] In another advantageous embodiment, the protrusions or depressions at the distal end of the outer tube are wavy or beaded.

[0070] The above embodiments are particularly advantageous in ensuring that the fertility assist device does not adhere to the inserter when it is released from the inserter, for example, preventing adhesion caused by the accumulation of negative pressure between the inserter and the fertility assist device.

[0071] In a third aspect, the present invention relates to a set of components for assisted reproduction, comprising: -The fertility assistive device according to the first aspect of the invention; and - According to the second aspect of the invention, the inserter is adapted to be inserted into the vagina by placing a fertility assist device into the inserter, the collector being nested within the distal end of the outer tube, and the tail rod extending from the proximal end of the inner tube.

[0072] In a fourth aspect, the present invention relates to a method for increasing the chances of conception, the method comprising: - Provide a fertility assist device according to the first aspect of the invention; - Provide an importer according to the second aspect of the invention; - The fertility assist device is inserted into the infeeder, the collector is nested at the distal end of the outer tube, and the tail rod extends from the proximal end of the inner tube; - Lock the implant in insertion mode, thus folding the fertility aid; and When the collector is located at or near the cervix: -Unlock the importer; - Bring the distal end face of the inner tube into the plane of the distal end of the outer tube, thereby pushing the collector out of the outer tube through the distal end face and causing the collector to unfold.

[0073] In another alternative embodiment, the method includes: - Provide a fertility assist device according to the first aspect of the invention; - Provide an importer according to the second aspect of the invention; - Lock the importer in insert mode; - The fertility assist device is inserted into the inlet, the collector is nested at the distal end of the outer tube, and the tail rod extends from the proximal end of the inner tube; - A force is applied to the tail rod in the proximal direction, causing the collector to fold within the outer tube; and When the collector is located at or near the cervix: -Unlock the importer; - Bringing the distal end face of the inner tube into the plane of the distal end of the outer tube, thereby pushing the collector out of the outer tube and deploying the collector through the distal end face; and - Remove the importer.

[0074] It should be understood that, according to the method described in the fourth aspect, the following conditions also need to be met: a) This method is applied immediately after intercourse, within 1 to 5 minutes of intercourse; or b) Place the semen into the collector before folding it.

[0075] In a fifth aspect, the present invention relates to the use of any fertility aid device according to the first aspect, an inserter according to the second aspect, or a set of components according to the third aspect in increasing the chances of conception, which is achieved by inserting the fertility aid device into or near the cervix after sexual intercourse, for example, around a portion of the cervix.

[0076] Each of the first, second, third, fourth, and fifth aspects of the invention may be combined with any other aspect. These and other aspects of the invention will be embodied and illustrated in the embodiments described below. Attached Figure Description

[0077] The fertility assistive device, implant, complete set of components, and method of the present invention will now be described in more detail with reference to the accompanying drawings. The drawings illustrate one embodiment of the invention and should not be construed as limiting other possible embodiments falling within the scope of the appended claims.

[0078] Figure 1 A three-dimensional diagram of a fertility-assisted device according to an embodiment of the present invention is shown; Figure 2 An exploded view of the injector according to an embodiment of the present invention is shown; Figure 3 A three-dimensional diagram of the assembled importer according to an embodiment of the present invention is shown; Figure 4 A cross-sectional side view of the assembled inlet device according to an embodiment of the present invention is shown; Figure 5 A three-dimensional view of a fertility assistive device in release mode located within an injector, according to an embodiment of the present invention, is shown. Figure 6A shows a three-dimensional view of the fertility assistive device folded inside the injector in insertion mode; Figure 6B shows a top view of a folded fertility assistive device according to an embodiment of the present invention; Figure 7A A three-dimensional diagram showing the insertion of a fertility aid device into the vagina using an inserter is shown; Figure 7B A fertility-assisted device positioned at the cervix according to an embodiment of the present invention is shown; Figure 8 This is a flowchart of the method according to the present invention; Figures 9A and 9B show a three-dimensional view and a partial enlarged view of the assembled implant in release mode according to a preferred embodiment of the present invention; Figure 10 A three-dimensional diagram of a fertility-assisted device according to a preferred embodiment of the present invention is shown; Figure 11This illustrates an embodiment of the invention, showing a device positioned within an injector in release mode. Figure 10 The fertility assistive device shown. Detailed Implementation

[0079] Figure 1 A three-dimensional view of a fertility assistive device 1 according to an embodiment of the present invention is shown. The fertility assistive device 1 includes a cylindrical collector CR and a gripping element HE, with an elongated tail rod TA extending between them. The cylindrical collector CR includes an edge RI and a bottom BP, with a sidewall SW extending between them. The surface of the edge RI is provided with a protrusion PR. The sidewall SW is provided with crease lines FL and FL' extending between the edge RI and the bottom BP.

[0080] Figure 2 An exploded view of an injector 2 according to an embodiment of the present invention is shown. The injector 2 includes an outer tube OT, an inner tube IT, and an injector handle AH. The outer tube OT includes a hollow tube body TB. The outer tube OT is adapted at its distal end DE to accommodate a fertility assist device (such as...). Figure 1 , Figure 5 (As shown in Figure 6A). The tube body TB expands radially outward at its proximal end (i.e., the end opposite to the distal end DE) to form an anatomical end stop ES. The inner tube IT includes a hollow tube body TB'. The tube body TB' extends radially inward at its distal end to form a distal end face DS. This distal end face DS provides a pushing surface for inserting fertility aids (such as...) Figure 5 (As shown in Figure 6A) It extends from the distal end DE of the outer tube OT. The tube body TB' expands radially outward at the proximal end (i.e., the end opposite the distal end face DS) to form the handle edge HR. It should be understood that the inner tube IT is sized to slidably fit within the outer tube OT. Figure 2 Also shown are introducing handles AH and AH', which consist of two half-shells adapted to be joined together around the handle edge HR of the inner tube IT. The introducing handles AH and AH' include an opening AP providing a passage from the interior of the inner tube IT to the interior of the introducing handles AH and AH'. Furthermore, the introducing handle AH is provided with a retainer FI, which is formed as a slot to lock the gripping element of the fertility aid's tail rod (such as...). Figure 1 , Figure 5 (as shown in Figure 6A).

[0081] Figure 3 A three-dimensional view of the assembled inlet 2 in release mode according to an embodiment of the present invention is shown. The inlet 2 includes an outer tube OT and an inner tube IT (slightly visible in...) Figure 2 and Figure 3 (Clearly shown in the image) and the importer handle AH. (As shown in the image) Figure 3As shown, when the injector is in release mode, the distal end face DS of the inner tube protrudes beyond the distal end DE of the outer tube OT, or is flush with the distal end DE of the outer tube OT. The injector handle AH is provided with a retainer FI, which is formed as a slot to lock the gripping element HE of the tail rod TA (e.g., Figure 1 , Figure 5 (as shown in Figure 6A).

[0082] Figure 4 A cross-sectional side view of the assembled inlet in release mode according to an embodiment of the present invention is shown. The inlet 2 includes an inner tube IT positioned within an outer tube OT, wherein the distal end face DS of the inner tube protrudes from the distal end DE of the outer tube OT. The inlet also includes an inlet handle AH surrounding a handle edge HR of the inner tube IT. A retainer FI of the inlet handle AH is visible at the proximal end of the inlet 2. Furthermore, in Figure 4 The end stop ES of the outer tube OT can be seen, which abuts against the introducer handle AH. The dashed line CU represents the curvature of the introducer 2, that is, the portion of the outer tube OT and inner tube IT that deviates from a straight line. It should be understood that the curvatures of the inner tube IT and the outer tube OT are basically the same to achieve a sliding fit. It should also be understood that in order to release the fertility aid 1 from the introducer 2, the tail rod TA must be released from the retainer FI.

[0083] Figure 5 A three-dimensional view of a fertility aid device 1, positioned within an infeeder 2 in release mode, according to an embodiment of the present invention, is shown. In release mode, the cylindrical collector CR is in an extended state and protrudes from the distal end DE of the outer tube OT. The tail rod TA of the fertility aid device 1 extends proximally, passes through the infeeder handle AH, and is fixed in the retainer FI of the infeeder handle. It should be understood that, at this time, semen can be introduced into the cylindrical collector before insertion of the fertility aid device 1.

[0084] Figure 6A shows a three-dimensional view of the fertility aid 1 in a folded state within the infeeder 2, according to an embodiment of the present invention. In the infeeder mode, the cylindrical collector CR is folded and is at least partially surrounded or nested within the distal end DE of the outer tube OT. The outer tube OT and the inner tube IT move relative to each other along the longitudinal or longitudinal axis to extend the length of the infeeder 2, as indicated by the pull arrow PU, which shows that the inner tube IT is moving away from the outer tube OT. The inner tube IT and the outer tube OT are also locked to each other by rotating relative to each other, as indicated by the locking arrow LO. It should be understood that as the length of the infeeder 2 is extended, the cylindrical collector CR is pulled into the distal end DE because the tail rod TA is fixed in the retainer FI of the infeeder handle AH.

[0085] Figure 6B shows a top view of the fertility aid 1 folded as shown in Figure 6A. The cylindrical collector CR is folded at the distal end DE of the outer tube OT. It should be understood that this allows the fertility aid 1 to be easily inserted. It should also be understood that, as Figure 1 The creases shown allow the cylindrical collector to fold into a predetermined shape.

[0086] Figure 7A A three-dimensional diagram is shown illustrating the insertion of a fertility assistive device 1 into the vagina using an inserter 2 according to an embodiment of the present invention. When the inserter 2 is positioned within the vagina, the inner tube IT rotates relative to the outer tube OT (as indicated by the arrow) to release the fertility assistive device 1.

[0087] Figure 7B A fertility assist device 1, positioned at the cervix CX according to an embodiment of the present invention, is shown. When the fertility assist device 1 is positioned at the cervix CX, the inserter 2 is removed, leaving the tail rod TA in a superficial position for easy removal (not shown).

[0088] Figure 8 This is a flowchart of a method for increasing the chances of conception according to the present invention, the method comprising the following steps: S1 - Provides a fertility assistive device according to the first aspect of the present invention; S2 - Provides an importer according to the second aspect of the invention; S3 - Insert the fertility assist device into the infeeder, wherein the collector is nested at the distal end of the outer tube and the tail rod extends from the proximal end of the inner tube; S4 - Locks the implant in insertion mode, thereby folding the fertility aid; and When the collector is located at or near the cervix: S5 - Unlock the infuser; S6 - Bring the distal end face of the inner tube into the distal end plane of the outer tube, or make it protrude from the distal end of the outer tube, thereby pushing the collector out of the outer tube through the distal end face and unfolding the collector.

[0089] Figures 9A and 9B show a three-dimensional view and a partial enlarged view of the assembled injector 2 in release mode according to a preferred embodiment of the present invention.

[0090] Figure 9A shows the assembled inlet 2 in release mode. The inlet 2 includes an outer tube OT and an inner tube IT (slightly visible in the figure). Figure 2 and Figure 3 (Clearly shown in the image) and the inlet handle AH. The inlet handle AH is provided with a retainer FI, which is formed as a slot to lock the gripping element HE of the tail rod TA (as shown in the image). Figure 1 , Figure 5 Figure 6A and Figure 10(As shown). The distal end DE of the outer tube OT includes multiple protrusions / recesses along its circumference, which are adapted to ensure that the cylindrical collector does not adhere to the inlet 2 during release.

[0091] Figure 9B is a partial enlarged view of the distal end DE of the outer tube OT, which clearly shows the bulge / depression.

[0092] Figure 10 A three-dimensional view of a fertility assist device 1 according to a preferred embodiment of the present invention is shown. The fertility assist device 1 includes a cylindrical collector CR and a gripping element HE, with an elongated tail rod TA extending between them. The gripping element HE is elongated or cylindrical in shape and has a neck between its two ends. It should be understood that the reduced diameter of the central portion allows the user to obtain better grip when releasing the fertility assist device 1 from an inserter (e.g., shown in FIG. 9A). The cylindrical collector CR includes an edge RI and a bottom BP, with a sidewall SW extending between them. The edge RI has a protrusion PR along its surface. The sidewall SW has a plurality of crease lines FL, FL' extending between the edge RI and the bottom BP.

[0093] Figure 11 This illustrates an embodiment of the invention, showing a device positioned within an injector in release mode. Figure 10 The fertility assistive device of the illustrated embodiment. Enlarged partial views of the various parts of the fertility assistive device are shown in circles. The fertility assistive device is positioned in the inlet in the release mode. The gripping element HE is positioned within the handle AH, which can be released from the handle AH. The handle AH is shaped to accommodate the larger gripping element HE. The inner tube IT and outer tube OT are in the release mode. The tail rod TA extends through the interior of the inlet, and the cylindrical collector CR is in the deployed state and ready for release.

[0094] The following is a list of items according to embodiments of the present invention: Project 1. A fertility assistive device, comprising: - A cylindrical collector includes an edge and a bottom, with a sidewall extending between the two; wherein the edge has a protrusion along the surface of the edge, and the sidewall extends from the edge and radially tapers inward toward the bottom; and the sidewall also has a crease line extending between the edge and the bottom; - Tail rod, extending from the bottom of the collector; and The collector is adapted to fold its edges and sidewalls radially inward according to a predetermined folding pattern, which is determined by the fold lines.

[0095] Project 2. The device according to Project 1, wherein the tail rod further includes a gripping element at its end away from the collector.

[0096] Item 3. The apparatus according to Item 1 or 2, wherein at least one of the collector or tail rod is made of a flexible polymer, preferably silicone.

[0097] Project 4. The device according to any one of the preceding projects, wherein at least one of the collector and the tail rod is made of a biocompatible polymer.

[0098] Item 5. The apparatus according to any one of the preceding items, wherein the protrusions along the edge are beaded protrusions.

[0099] Item 6. The device according to any one of the preceding items, wherein the protrusion extends radially inward along the edge.

[0100] Item 7. The device according to any one of the preceding items, wherein the edge further includes a lip extending circumferentially along the edge.

[0101] Item 8. The apparatus according to any one of the preceding items, wherein the collector and the tail rod are formed as a single piece.

[0102] Item 9. The apparatus according to any one of the preceding items, wherein the protrusions are evenly distributed along the edge of the collector.

[0103] Item 10. The apparatus according to any one of the preceding items, wherein the collector is cup-shaped.

[0104] Item 11. An inserter for vaginal insertion of a fertility assisted device, the inserter comprising: - An inner tube that can be slidably arranged inside an outer tube, the inner tube having a radially inwardly extending distal end face. The importer is compatible with at least two operating modes: a) Insertion mode, wherein the inner tube is locked relative to the outer tube on the longitudinal axis; and b) Release mode, in which the inner tube can move relative to the outer tube along the longitudinal axis by adjusting the circumferential orientation of the inner tube relative to the outer tube. When the inlet is in release mode, the distal end face of the inner tube can be brought into the distal end plane of the outer tube or protrude from the distal end of the outer tube.

[0105] Item 12. The infuser as described in Item 11, wherein the inner tube and the outer tube are curved.

[0106] Item 13. The inlet according to Item 11, wherein one of the inner tube and the outer tube is provided with a protruding locking element, such as a tongue, and the other of the inner tube and the outer tube is provided with a recessed locking element, such as a groove or slot, the recessed locking element being adapted to receive and engage with the protruding locking element.

[0107] Item 14. An importer according to any one of Items 11 to 13, wherein the importer has a longer length in the insertion mode relative to the release mode.

[0108] Item 15. The infuser according to any one of items 11 to 14 further includes an infuser handle fixed to the proximal end of the inner tube, the infuser handle including an opening adapted to provide a passage from the infuser handle to the inner tube.

[0109] Item 16. The injector according to Item 15, wherein the injector handle further includes a retainer adapted to secure a portion of the fertility assist device.

[0110] Item 17. The delivery device according to any one of items 11 to 16, wherein the delivery device is made of a biocompatible polymer.

[0111] Item 18. A set of components for assisted reproduction, comprising: - A fertility assistive device according to any one of items 1 to 10; and - An inserter according to any one of items 11 to 17, the inserter being adapted to be inserted into the vagina by placing a fertility assist device into the inserter, the collector being nested within the distal end of the outer tube, and the tail rod extending from the proximal end of the inner tube.

[0112] Project 19. A method to increase the chances of conception, comprising: - Provide fertility assistive devices according to any one of items 1 to 10; - Provide an importer according to any one of items 11 to 17; - The fertility assist device is inserted into the infeeder, the collector is nested at the distal end of the outer tube, and the tail rod extends from the proximal end of the inner tube; - Lock the tail rod in the retainer of the inlet handle; - Lock the importer in insert mode, thus causing the collector to fold inside the outer tube; and When the collector is located at or near the cervix: -Unlock the importer; - Bring the distal end face of the inner tube into the distal end plane of the outer tube, thereby pushing the collector out of the outer tube through the distal end face and causing the collector to unfold.

[0113] Item 20. A method to increase the chances of conception, comprising: - Provide fertility assistive devices according to any one of items 1 to 10; - Provide an importer according to any one of items 11 to 17; - The fertility assist device is inserted into the infeeder, the collector is nested at the distal end of the outer tube, and the tail rod extends from the proximal end of the inner tube; - Lock the implant in insertion mode, thus folding the fertility aid; and When the collector is located at or near the cervix: -Unlock the importer; - Bring the distal end face of the inner tube into the distal end plane of the outer tube, thereby pushing the collector out of the outer tube through the distal end face and causing the collector to unfold.

[0114] Item 21. The use of any fertility assistive device according to any one of Items 1 to 10, the injector according to any one of Items 11 to 17, or the kit according to Items 19 or 22 in increasing the chances of conception.

[0115] Item 22. A set of components for assisted reproduction, comprising: - Assisted reproductive devices, including: - A cylindrical collector, comprising an edge and a bottom, with sidewalls extending between them; wherein the edge has protrusions along its surface, and the sidewalls extend from the edge and radially taper inward toward the bottom; and the sidewalls also have creases extending between the edge and the bottom; and - Tail rod, extending from the bottom of the collector; - An inserter for inserting the assisted reproductive device, the inserter comprising: - A curved hollow outer tube, including a proximal end and a distal end, the distal end including a nested portion within the tube for a collector, the nested portion defining an inner diameter; - A curved hollow inner tube, including a proximal end and a distal end; the curvature and diameter of the outer tube are slidably matched with the curvature and diameter of the inner tube. The fertility assist device is adapted to be inserted into the introducing device, the collector is nested within the nested portion of the outer tube, and the tail rod extends from the proximal end of the inner tube.

[0116] In summary, the present invention relates to a fertility assistive device 1 suitable for insertion into or near the cervix CX of a mammal (preferably a human) and an inserter 2. The fertility assistive device 1 includes a cylindrical collector CR, which includes an edge RI, wherein the surface of the edge RI has one or more protrusions adapted for easy removal after a final procedure. The cylindrical collector CR also has a bottom BP and sidewalls SW extending circumferentially from the bottom BP to the edge RI. The sidewalls SW include one or more crease lines FL, FL', which allow the cylindrical collector CR to be folded inwardly radially according to a predetermined shape. The inserter 2 includes an inner tube IT adapted for insertion into an outer tube OT. The inserter 2 is provided with an insertion mode and a release mode, wherein the inserter 2 is adapted to be locked in both modes by rotating the two tubes IT, OT relative to each other, thereby facilitating easy insertion of the fertility assistive device 1 into or near the cervix of the user.

[0117] Although the invention has been described in conjunction with specific embodiments, it should not be construed as being limited in any way to the examples given. The scope of the invention is defined by the appended claims. In the context of the claims, the terms "comprising" or "including" do not exclude other possible elements or steps. Similarly, references to terms such as "a" or "a" should not be construed as excluding a plural. The use of reference numerals in the claims relating to elements shown in the drawings should also not be construed as limiting the scope of the invention. Furthermore, the various features mentioned in different claims can be advantageously combined, and the mention of these features in different claims does not exclude the possibility that such combinations are not feasible or advantageous.

Claims

1. A fertility assistive device (1), the fertility assistive device (1) comprising: - A cylindrical collector (CR) includes an edge (RI) and a bottom (BP), with a sidewall (SW) extending between the edge (RI) and the bottom (BP); wherein the edge has a protrusion (PR) along its surface, the sidewall extends from the edge and radially tapers inward toward the bottom; and the sidewall also has crease lines (FL, FL') extending between the edge and the bottom. - Tail rod (TA), extending from the bottom of the collector; and The collector is adapted to fold its edges and sidewalls radially inward according to a predetermined folding pattern, which is determined by the fold lines.

2. The apparatus according to claim 1, characterized in that, The tail rod also includes a gripping element (HE) at its end away from the collector.

3. The apparatus according to claim 1 or 2, characterized in that, At least one of the collectors or tail rods is made of a flexible polymer, preferably silicone.

4. The apparatus according to any one of the preceding claims, characterized in that, At least one of the collector and the tail rod is made of a biocompatible polymer.

5. The apparatus according to any one of the preceding claims, characterized in that, The protrusions along the edge are bead-shaped protrusions.

6. The apparatus according to any one of the preceding claims, characterized in that, The protrusion extends radially inward along the edge.

7. The apparatus according to any one of the preceding claims, characterized in that, The edge also includes a lip that extends circumferentially along the edge.

8. The apparatus according to any one of the preceding claims, characterized in that, The collector and the tail rod are formed as a single unit.

9. The apparatus according to any one of the preceding claims, characterized in that, The protrusions are evenly distributed along the edge of the collector.

10. The apparatus according to any one of the preceding claims, characterized in that, The collector is cup-shaped.

11. The apparatus according to any one of claims 2-10, characterized in that, The gripping element is droplet-shaped.

12. The apparatus according to any one of claims 2-10, characterized in that, The gripping element is elongated and has a neck in the middle.

13. An inserter (2) for vaginal insertion of a fertility assistive device (1), the inserter comprising: - An inner tube (IT) is slidably arranged inside an outer tube (OT), the inner tube having a radially inwardly extending distal end face (DS). The importer is compatible with at least two operating modes: a) Insertion mode, wherein the inner tube is locked relative to the outer tube on the longitudinal axis; and b) Release mode, in which the inner tube can move relative to the outer tube along the longitudinal axis by adjusting the circumferential orientation of the inner tube relative to the outer tube. in, When the inlet is in release mode, the distal end face of the inner tube can be brought into the distal end plane of the outer tube or protrude from the distal end (DE) of the outer tube.

14. The importer according to claim 13, characterized in that, The inner tube and the outer tube are curved.

15. The injector according to claim 13 or 14, characterized in that, One of the inner tube and the outer tube is provided with a protruding locking element, such as a tongue, and the other of the inner tube and the outer tube is provided with a recessed locking element, such as a groove or slot, which is adapted to receive and engage with the protruding locking element.

16. The injector according to any one of claims 13-15, characterized in that, The importer has a longer length in insert mode compared to its length in release mode.

17. The injector according to any one of claims 13-16, characterized in that, It also includes an inlet handle (AH) fixed to the proximal end of the inner tube, the inlet handle including an opening (AP) adapted to provide a passage from the inlet handle to the inner tube.

18. The importer according to claim 17, characterized in that, The injector handle also includes a retainer adapted to secure a portion of the fertility assist device.

19. The injector according to any one of claims 13-18, characterized in that, The delivery device is made of a biocompatible polymer.

20. The injector according to any one of claims 13-19, characterized in that, The ability of the distal end face of the inner tube to be brought into the plane of the distal end of the outer tube includes: the distal end face of the inner tube being positioned within 2.0 mm of the distal end of the outer tube, preferably within 1.0 mm, more preferably within 0.5 mm, and even more preferably within 0.2 mm.

21. The injector according to any one of claims 13-20, characterized in that, The distal end of the outer tube includes a protrusion or groove along the inner edge surface.

22. The importer according to claim 21, characterized in that, The protrusions or grooves at the distal end of the outer tube are wavy or beaded.

23. A set of components for assisted reproduction, comprising: - The fertility assistive device (1) according to any one of claims 1 to 12, and - The inserter (2) according to any one of claims 13 to 21 is adapted to insert the fertility assist device into the vagina by positioning the fertility assist device in the inserter, the cylindrical collector (CR) nested in the distal end (DE) of the outer tube, and the tail rod (TA) extending from the proximal end of the inner tube.

24. A method for increasing the chances of conception, the method comprising: - Provide a fertility assistive device (1) according to any one of claims 1 to 12. - Provide an importer (2) according to any one of claims 13 to 21. - The fertility assist device is inserted into the infeeder, the collector (CR) is nested at the distal end (DE) of the outer tube (OT), and the tail rod (TA) extends from the proximal end of the inner tube (IT). - Lock the implant in insertion mode, thereby folding the fertility aid device, and When the collector is located at or near the cervix (CX): -Unlock the importer - Bring the distal end face (DS) of the inner tube into the plane of the distal end of the outer tube, or protrude from the distal end of the outer tube, thereby pushing the collector out of the outer tube through the distal end face and unfolding the collector.

25. The fertility assist device according to any one of claims 1 to 12, the implanter according to any one of claims 13 to 22, or the use of the kit according to claim 23 or 26 in increasing the chances of conception.

26. A set of components for assisted reproduction, comprising: - Assisted reproductive devices, including: - A cylindrical collector, comprising an edge and a bottom, with a sidewall extending between the edge and the bottom, wherein the edge has a protrusion along its surface, and the sidewall extends from the edge and radially tapers inward toward the bottom; and the sidewall also has a crease line extending between the edge and the bottom; and - Tail rod, extending from the bottom of the collector; - An inserter for inserting the assisted reproductive device, the inserter comprising: - A curved hollow outer tube, including a proximal end and a distal end, the distal end including a nested portion within the tube for a collector, the nested portion defining an inner diameter; - A curved hollow inner tube, including a proximal end and a distal end; the curvature and diameter of the outer tube are slidably matched with the curvature and diameter of the inner tube. The fertility assist device is adapted to be inserted into the introducing device, with the collector nested within the nested portion of the outer tube and the tail rod extending from the proximal end of the inner tube.

27. An inserter (2) for vaginal insertion of a fertility assistive device (1) according to any one of claims 1 to 12, the inserter comprising: - An inner tube (IT) is slidably arranged inside an outer tube (OT), the inner tube having a radially inwardly extending distal end face (DS). The importer is compatible with at least two operating modes: c) Insertion mode, in which the inner tube is locked relative to the outer tube on the vertical axis; and d) Release mode, in which the inner tube can move relative to the outer tube along the longitudinal axis by adjusting the circumferential orientation of the inner tube relative to the outer tube. When the inlet is in release mode, the distal end face of the inner tube can be brought into the plane of the distal end of the outer tube or protrude from the distal end (DE) of the outer tube.

28. A fertility-assisted system comprising a fertility-assisted device according to any one of claims 1 to 12 and an inserter according to any one of claims 13 to 22, the fertility-assisted device being adapted to be inserted into the inserter.

Images