A fertility assistance device

Abstract

The present invention relates to a fertility assistance device (1), and applicator (2) adapted to insert a fertility assistance device (1) intravaginally, at or near the cervix (CX) of a mammal, preferably a human. The fertility assistance device (1) comprises a cylindrical receptacle (CR), the cylindrical receptacle (CR) comprising a rim (RI), wherein a surface of said rim (RIM) has one or more protrusions adapted for easy removal after finalized procedure. The cylindrical receptacle (CR) further has a bottom portion (BP) and a sidewall (SW) extending peripherally therefrom, to the rim (RI). The sidewall (SW) comprises one or more folding lines (FL, FL'), the folding lines enabling the cylindrical receptacle (CR) to fold radially inwards, in a predetermined pattern. The applicator (2) comprises an inner tube (IT) adapted to be inserted into an outer tube (OT), the applicator (2) adapted with an insertion mode of operation and a release mode of operation, wherein the applicator (2) is adapted to lock in two said modes of operation by rotation of the two tubes (IT, OT) relative to each other, thus enabling for easy insertion of the fertility assistance device (1) at or near the cervix (CX) of a user.

Description

[0001] A FERTILITY ASSISTANCE DEVICE

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to an intravaginal fertility assistance device, kit of parts and method of increasing the likelihood of conception.

[0004] BACKGROUND OF THE INVENTION

[0005] In recent years, fertility among couples trying to conceive a child has declined. In order to increase the likelihood of conceiving, it is suggested to, post-coitus, retain the sperm close to cervix, by providing a receptacle or cup inserted on the cervix. The receptacle or cup may also be used by solo mothers and LGBTQ+ individuals for insemination without intercourse.

[0006] Such devices are for instance known from WO 2019 / 245368 Al, which discloses an intravaginal conception assistance device for collecting and presenting ejaculate relatively close to a cervix. The device comprises a cup part for collecting the ejaculate present in a vaginal canal and presenting it relatively close to the cervix upon moving through the vaginal canal towards the cervix. According to the disclosure, the cup part is substantially invertible and can be brought from a first, substantially non-inverted state into a second, substantially inverted state in which the cup part has been folded substantially inside out.

[0007] According to the inventors, several problems have been identified with respect to the known prior art. For one, the inverted folding and insertion procedure is difficult and unpleasant. Furthermore, the removal of the cup is both difficult and unpleasant as well. Users may experience inflammation due to difficult removal, caused by e.g. a negative pressure generated during removal and / or scrapes, or scratches at the cervix. Such inflammation may cause a negative environment for the sperm, reducing the chance of successful conception.

[0008] Even further, known devices are not suitable for in vitro delivery of the sperm, but must be performed through injection of the sperm at or near the cervix prior to insertion of the device. Hence, an improved fertility assistance device, kit of parts and method would be advantageous, and in particular a more efficient and / or reliable device would be advantageous.

[0009] OBJECT OF THE INVENTION

[0010] It is a further object of the present invention to provide an alternative to the prior art.

[0011] In particular, it may be seen as an object of the present invention to provide a fertility assistance device, applicator and kit of parts that solves the above mentioned problems of the prior art with insertion and removal.

[0012] SUMMARY OF THE INVENTION

[0013] Thus, the above described object and several other objects are intended to be obtained in a first aspect of the invention by providing a fertility assistance device comprising:

[0014] -a cylindrical receptacle comprising a rim and a bottom portion, with a sidewall extending therebetween, wherein the rim is adapted with protrusions along a surface of said rim, the sidewall extends from the rim and tapers radially inwards, towards the bottom portion; and the sidewall further comprises fold lines which extend between the rim and said bottom portion,

[0015] -a tail, the tail extending from the bottom portion of the receptacle, and wherein the receptacle is adapted for folding the rim and sidewalls radially inwards, in a pre-determined folding pattern, the pattern determined by the fold lines.

[0016] The invention is particularly, but not exclusively, advantageous for obtaining an increased chance of conceiving, by providing sperm at or near the cervix for a prolonged period of time, relative to without the use of said device. The present invention is advantageous for use post-coitus, wherein the sperm has been ejaculated and the device is afterwards inserted to contain said sperm at or near the cervix.

[0017] The present inventios is further advantageous, in that the device is suitable for receiving sperm within the receptacle, after which the fertility assistance device can be inserted at or near the cervix, thus presenting the sperm at or near said cervix and ensure a prolonged interaction by said sperm.

[0018] In the context of the present invention, fertility assistance is to be understood as increasing the chance of conceiving, by prolonging the exposure of sperm to the cervix and hence an egg cell. In a preferred embodiment, the invention is for human use. In other embodiments, the device may be for use with animals, to increase the chance of successful breeding.

[0019] In the context of the present invention, cylindrical receptacle is to be understood as a circular container, adapted to receive and contain sperm, such as a cup or cone.

[0020] In the context of the present invention, protrusions is to be understood as bulges or protuberances along the rim of the receptacle.

[0021] In some embodiments, the protrusions may be in a waved configuration, such as symmetrically distributed along the rim.

[0022] In other embodiments, the protrusions are distributed in an uneven configuration.

[0023] It is to be understood, that the protrusions serve to ensure that the fertility assistance device does not create a negative pressure within the cylindrical receptacle, between the rim and cervix, as this may be unpleasant to the subject, during removal.

[0024] Thus, the present invention is particularly advantageous for providing a comfortable insertion and following removal, for the purpose of increasing chance of conceiving. In the context of the present invention, conceive is to be understood as to become pregnant.

[0025] It is further to be understood, that the cylindrical receptacle and bottom portion of said cylindrical receptacle are suitable for receiving and containing sperm, either by directly injecting or ejaculating sperm into said receptacle or by inserting the receptacle at or near the cervix post-coitus; and wherein the receptacle contains and presents the sperm ejaculated during coitus. It is further to be understood, that the present invention may be used post insemination from e.g. a syringe containing sperm, by either injecting the sperm into the receptacle prior to insertion of the fertility assistance device or by injecting the sperm at or near the cervix and inserting the device post injection.

[0026] In the context of the present invention, fold lines is to understood as protrusions or grooves provided in the sidewall to ensure a predetermined folding pattern of the receptacle. In some embodiments, the fold lines is provided by a thickening or thinning pattern provided within the sidewall. In some embodiments, the fold lines are symmetrically distributed along a circumference of the receptacle. In other embodiments, the side wall of the receptacle comprises a single fold line or two fold lines, such as two opposing fold lines.

[0027] In the context of the present invention, tail is to be understood as a prolongation of the bottom portion of the cylindrical receptacle. In an advantageous embodiment, the tail thins or reduces in diameter, from the bottom portion towards an end opposite to said bottom portion. It is further to be understood, that the tail is particularly advantageous during removal of the fertility assistance device, as an end of the tail may extend to at or near the vaginal opening of a subject, similar to that of the string of a tampon. Further, when the fertility assistance device is used with an applicator, the tail may be used for pulling the receptacle into said applicator from the proximal end of the applicator, thus ensuring that a user loading the fertility assistance device into said applicator does not need to touch the receptacle unnecessarily. It is further to be understood, that the configuration of the cylindrical receptacle and tail enables for easy insertion and removal, at least when used with an applicator, as the tail provides for a section of the fertility assistance device to touch and apply a pulling force, even if the receptacle contains sperm. Further, the fold lines provides for uniform and predicable folding, to decrease failure or spillage of sperm during inserting; and the protrusions allow for easy removal without the risk of creating a negative pressure preventing the receptacle from release, from the cervix.

[0028] Even further, the protrusions are adapted so as to allow for adherence to the cervix, by a slight negative pressure, whereas a pull force applied to the tail enables the pressure to equalize and thus provide easy removal.

[0029] It is further to be understood, that the fertility assistance device is to be positioned at or near the cervix immediately after coitos and not more than within a few minutes of coitus, such as within 1 to 5 minutes or 1 to 10 minutes; or sperm is positioned within the receptacle prior to the device being inserted intravaginally.

[0030] In some embodiments, the protrusions extend from the rim at a height of between 0.1 to 5 mm, such as between 0.2 to 4 mm, such as between 0.3 to 3 mm, such as between 0.4 to 2 mm. In a preferred embodiment, the protrusions extend from the rim at a height of between 0.5 to 1 mm. It is to be understood, that the protrusions may extend from an inner surface of the rim, an outer surface of the rim or in a distal direction, relative to said rim.

[0031] In a preferred embodiment of the invention, the tail further comprises a holding element at an end opposite the receptacle. This embodiment is particularly advantageous for providing an element to easily hold and pull, for a user using the fertility assistance device. Further, when using the fertility assistance with an applicator, the holding element may be used to lock the fertility assistance device in a biased state, to ensure that the receptacle is folded during insertion.

[0032] In another preferred embodiment of the invention, at least one of the receptacle or tail is made from a flexible polymer, preferably a silicone elastomer. This embodiment is particularly advantageous for providing a comfortable fertility assistance device for the user.

[0033] In yet another preferred embodiment, at least one of the receptacle and tail is made from a biocompatible polymer, preferably a soft polymer such as polysiloxane (PDMS), low density polyethylene (LDPE) or polypropylene (PP).

[0034] In an advantageous embodiment of the invention, the protrusions along the rim are bead-like protrusions. This embodiment is particularly advantageous for providing a rim, which adheres to the cervix during the period of which the sperm is to be presented and contained at the cervix, and which allows for easy removal when a pull force is applied to the tail of the fertility assistance device, as the beads allow for air to pass from outside the receptacle and into the receptacle, thus ensuring equal pressure outside and within said receptacle.

[0035] It is to be understood, that the configuration of the protrusions and the fold lines enables for the rim of the receptacle to release, when a pulling force is applied to the tail of the fertility assistance device.

[0036] In some embodiments, the tail extends from the bottom portion of the receptacle off-centre, to provide an uneven distribution of force to the receptacle, when a pull force is applied to said tail, and hence, allow for the rim of the receptacle to release from the cervix. This embodiment is particularly advantageous for providing a comfortable removal of the fertility assistance device.

[0037] In another advantageous embodiment of the invention, the protrusions extend radially inwards along the rim. This embodiment is particularly advantageous for presenting the protrusions at or near the cervix, as the rim may surround at least a portion of said cervix.

[0038] In yet another advantageous embodiment of the invention, the rim further comprises a lip edge extending along a periphery of said rim. This embodiment is particularly advantageous for providing a seal between the cervix and said rim. It is to be understood, that the rim, protrusions and / or the lip ensures for an adhesion of the receptacle to the cervix, and wherein the receptacle may surround a portion of the cervix; and wherein the protrusions allow for air to pass between an inside and outside of said receptacle at least when a force is applied to the tail of the fertility assistance device, in particular, when the tail is pulled in a direction away from the cervix.

[0039] In a preferred embodiment of the invention, the cylindrical receptacle is formed in one piece.

[0040] In another preferred embodiment, the fertility assistance device is formed in one piece, such as formed or moulded in a biocompatible, soft elastomer. In particular, the fertility assistance device may be formed or moulded in one piece from silicone. This embodiment is particularly advantageous for ensuring, that the tail does not break away from the receptacle, during removal of the fertility assistance device.

[0041] In yet another preferred embodiment of the invention, the protrusions are distributed evenly along the rim of the receptacle. This embodiment is particularly advantageous for ensuring easy and comfortable removal of the fertility assistance device, and further to ensure, that a user can not insert the fertility assistance device at disadvantageous orientation relative to the cervix, as at least the receptacle is circumferentially symmetrical.

[0042] In an advantageous embodiment of the invention, the cylindrical receptacle is shaped as a cup or shaped substantially as a cup. In some embodiments, the receptacle tapers inwards from the rim towards the bottom portion.

[0043] In a second aspect, the invention relates to an applicator for intra vaginal insertion of a fertility assistance device, such as the fertility assistance device according to the first aspect, the applicator comprising:

[0044] -an inner tube slidably arranged within an outer tube, the inner tube adapted with a distal surface extending radially inwards, the applicator adapted for at least two modes of operation: a) an insertion mode, wherein the inner tube is locked in a longitudinal axis, relative to the outer tube, and b) a release mode, wherein, by adjusting a peripheral orientation of the inner tube relative to the outer tube, the inner tube can move in the longitudinal axis, relative to the outer tube, wherein the distal surface of the inner tube can be brought into a plane of, or protrude from, a distal end of the outer tube, when the applicator is in release mode.

[0045] This embodiment is particularly advantageous for providing an applicator for a fertility assistance device or conceiving aid, wherein the applicator ensures easy and comfortable assistance during insertion.

[0046] It is to be understood, that the inner and outer tubes are hollow, and thus the inner tube fits within the outer tube, and a least the tail of the fertility assistance device may extend within the inner and outer tube; preferably wherein the tail extends from the proximal end of the inner tube.

[0047] In the context of the present invention, slidably arranged is to be understood as a fit for mechanical parts that slide on one another, which is a common type of fit within mechanical engineering. In particular, an outer diameter of the inner tube is slightly less than an inner diameter of the outer tube, so that the inner tube may move in a longitudinal direction or axis within the outer tube, relative to said outer tube.

[0048] In a preferred embodiment of the invention, the inner tube has a greater length than the outer tube. This embodiment is particularly advantageous to ensure, that the distal surface of the inner tube may reach a plane as defined by the distal end of the outer tube, while a user is still able to operate a proximal end of the inner tube, which extends out of the proximal end of the outer tube.

[0049] That the distal surface of the the inner tube can be brought into the plane of the distal end of the outer tube is to be understood as the distal surface of the inner tube being brought so close to the distal end of the outer tube that the receptacle can be unfolded. That the distal surface of the the inner tube can be brought into the plane of the distal end of the outer tube isto be understood as that the distal surface of the the inner tube can be brought within 2.0 mm, preferably within 1.0 mm, more preferably within 0.5 mm, and even more preferably within 0.2 mm of the distal end of the outer tube.

[0050] With respect to the present invention, proximal is to be understood a near a users hand during operation of the applicator, and distal is to be understood as situated away from the point of attachment or origin, i.e. the hand of the user. Hence, within the present invention, distal is at or near the cervix, when the applicator is inserted, and proximal is away from the cervix, such as near the hand of a user operating the applicator. This further applies to the fertility assistance device, wherein the receptacle is distally oriented towards the cervix and the tail is extending proximally, away from the cervix and possibly extending out from the vagina, during operation of the fertility assistance device.

[0051] It is further to be understood, that the inner and outer tube are adapted to engage or interlock in an insertion mode, by rotating the inner tube around a longitudinal axis, relative to a longitudinal axis of the outer tube; and wherein the distal surface of the inner tube is located proximal to the distal end of the outer tube. This is advantageous to ensure, that a distal portion of the outer tube is not occupied by the inner tube, and ready to receive and surround the receptacle of the fertility assistance device. Further, when the applicator is positioned with the distal end of the outer tube at or near the cervix, the applicator can be unlocked by rotating the inner tube relative to the outer tube; the inner tube can then be moved distally, relative to the outer tube, by which the distal surface of the outer tube pushes on the bottom portion of the receptacle, thereby delivering the receptacle at or near the cervix.

[0052] Thus, when the applicator is arranged in insertion mode, the inner tube is interlocked with the outer tube; the distal end of the outer tube is free from the inner tube; and the inner tube extends from the proximal end of the outer tube. When the fertility assistance device is loaded into the applicator, the tail is led through the distal end of the outer tube, through the inner tube; the bottom portion abuts the distal end of the outer tube; and wherein a pull force applied by a user to the tail, in a proximal direction folds the receptacle in a predetermined pattern in slides the receptacle into the outer tube, thus preparing the fertility assistance device for intravaginal insertion.

[0053] When the distal end of the outer tube of the applicator is positioned at or near the cervix, the inner tube is rotated to release from interlock with the outer tube; the inner tube is moved distally, relative to the outer tube to push the receptacle towards the cervix.

[0054] It is to be understood that when it is stated that the the inner tube is rotated, it may as well be the outer tube that is rotated. Whether you rotate the inner tube relative to the outer tube, or the outer tube relative to the inner tube gives the same result.

[0055] When the fertility assistance device is positioned at or near the cervix, the applicator is removed from the vagina and the fertility assistance device is in place, for containing sperm at or near the cervix for a prolonged period of time, such as 10 minutes, 20 minutes, 30 minutes or 1 hours or two hours, in particular between 15 minutes and 2 hours, preferably between 30 minutes and 1 hour.

[0056] After the prolonged period of time has expired, the user pulls the tail, removing the fertility assistance device.

[0057] It is to be understood, that the applicator is particularly advantageous for use with the fertility assistance device according to the first aspect of the invention, but may be suitable for easy insertion of other, similar devices for the purpose of increasing chance of conceiving. In some embodiments, the applicator may be used for the insertion of a contraception device, adapted to cover the cervix during intercourse and thus, preventing sperm from reaching the cervix.

[0058] In a preferred embodiment of the invention, the inner and outer tubes are curved. This embodiment is particularly advantageous, as the curve may better accommodate the anatomy of which to be inserted into, i.e. the vagina. Further, the curve serves as a simple means of ensuring interlocking between the inner tube and outer tube, as the rotation of the inner tube relative to the outer tube interlock by deviation of the two curves. This is particularly advantageous, when the materials of the applicator has relative friction.

[0059] In the context of the present invention, curved is to be understood as a slight deviation from a straight line, without sharp breaks or angularity.

[0060] In a preferred embodiment, the curve of the inner and outer tube, has a radius of curvature between 500 and 2000, such as between 800 and 1700, such as between 1000 and 1500, such as between 1010 and 1200, such as between 1015 and 1100, such as between 1020 and 1050, such as between 1025 and 1030. Preferably, the radius of curvature is 1027.

[0061] With respect to other dimensions, the fertility assistance device may have a length of approximately 20 cm, the outer tube may have a length of approximately 14 cm and the inner tube may have a length of approximately 14.5 cm. The total length of the applicator may be between 15 cm and 25 cm, such as between 16 and 20 cm, when including an applicator handle. It is to be understood, that dimensions may vary, depending on anatomy of the subject and the above dimensions may suit some human subjects.

[0062] In another preferred embodiment of the invention, one of the inner and outer tube is adapted with a protruding locking means, such as a tongue, and the other of the inner and outer tube is adapted with a recessed locking means adapted to receive and engage with the protruding locking means, such as a groove or slit. In some embodiments, one of the inner and outer tube has a slit or groove extending from the proximal end to the distal end, and wherein a not or tongue is received within said slit or groove. In these embodiments, the slit may have a slight shoulder or notch, at a point in between the proximal and distal end, to ensure that the inner and outer tube are enabled to interlock at a position wherein the distal end of the inner tube is positioned proximal to the distal end of the outer tube, ensuring sufficient room for the insertion of the receptacle within the distal end of the outer tube. In yet another preferred embodiment of the invention, the applicator has an extended length in the insertion mode, relative to the release mode. Thus, when the applicator is ready for insertion, the proximal end of the inner tube extends from the proximal end of the outer tube with a greater portion, than when in release mode, wherein the inner tube is moved further distally into the outer tube.

[0063] In an advantageous embodiment, the invention further comprises an applicator handle fixated to a proximal end of the inner tube, the applicator handle comprising an aperture adapted to provide a passage from the applicator handle into 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.

[0064] In another advantageous embodiment of the invention, the proximal end of the outer tube extends radially outwards, to provide an end stop, wherein said end stop prohibits the outer tube from being engrossed or absorbed into the vagina of the user / subject, during insertion of the applicator.

[0065] In yet another advantageous embodiment of the invention, the applicator handle further comprises a fixture adapted for fixating a portion of the fertility assistance device. This embodiment is particularly advantageous for locking the tail in a biased position, thus ensuring that the receptacle does not unfold from within the outer tube, during insertion.

[0066] In a preferred embodiment, the fixture of the applicator handle is a slit adapted to receive a portion of the tail from a side, and wherein said slit progressively narrows to apply a pressure to said tail. It is to be understood, that other types of fixtures may be covered by the invention.

[0067] The fixture of the applicator handle is particularly advantageous for providing the fertility assistance device in a biased position, during insertion of the applicator.

[0068] In another preferred embodiment of the invention the applicator is made from a biocompatible polymer, such as polyester, medical grades of PVC and Polyethylene, PEEK, Polycarbonate, Ultem PEI, Polysulfone, Polypropylene (PP) and Polyurethane. It is further to be understood, that the applicator may only require limited biocompatibility, i.e. suitable for use with less than 24 hour exposure time.

[0069] In an advantageous embodiment of the invention, the distal end of the outer tube comprises protrusions or recesses along an inner rim surface.

[0070] In another advantageous embodiment, the protrusions or recesses at the distal end of the outer tube are wave-shaped or bead-like.

[0071] The above embodiments are particularly advantageous for ensuring, that the fertility assistance device, when released from the applicator, does not adhere to said applicator, such as due to a build-up of negative pressure between the applicator and said fertility assistance device.

[0072] In a third aspect, the invention relates to a kit of parts for fertility assistance comprising:

[0073] -the fertility assistance device according to the first aspect of the invention, and -the applicator, according to the second aspect of the invention, the applicator adapted to insert the fertility assistance device intravaginally by positioning the fertility assistance device into said applicator, the receptacle nesting within a distal end of the outer tube and the tail extending from a proximal end of the inner tube.

[0074] In a fourth aspect, the invention relates to a method of increasing the likelihood of conception, the method comprising:

[0075] -providing the fertility assistance device according to the first aspect of the invention,

[0076] -providing the applicator, according to the second aspect of the invention, -loading the fertility assistance device within the applicator, the receptacle nested at a distal end of the outer tube and the tail extending from a proximal end of the inner tube,

[0077] -locking the applicator in the insertion mode, thereby folding the fertility assistance device, and when the receptacle is at or near cervix; -unlocking the applicator,

[0078] -bringing the distal surface of the inner tube into a plane of the distal end of the outer tube, thus pushing the receptacle from within the outer tube by said distal surface and unfolding the receptacle.

[0079] In an alternative embodiment, the method comprises:

[0080] -providing the fertility assistance device according to the first aspect of the invention,

[0081] -providing the applicator, according to the second aspect of the invention, -locking the applicator in the insertion mode,

[0082] -loading the fertility assistance device within the applicator, the receptacle nested at a distal end of the outer tube and the tail extending from a proximal end of the inner tube,

[0083] -applying a force to the tail, in a proximal direction, thereby folding the receptacle within the outer tube, and when the receptacle is at or near cervix;

[0084] -unlocking the applicator,

[0085] -bringing the distal surface of the inner tube into a plane of the distal end of the outer tube, thus pushing the receptacle from within the outer tube by said distal surface and unfolding the receptacle, and -removing the applicator.

[0086] It is to be understood, that the methods according to the fourth aspect, further requires the following: a) that the method is applied -post coitus, immediately after coitos and not more than 1 - 5 minutes of coitus, or b) sperm is deposited in the receptacle prior to folding said receptacle.

[0087] In a fifth aspect, the invention relates to the use of any of the fertility assistance device according to the first aspect, the applicator according to the second aspect or the kit of parts according to the thirds aspect, for increasing the likelihood of conception by inserting the fertility assistance device at or near, such as around a portion of the cervix post-coitus. The first, second, third, fourth and fifth aspect of the present invention may each be combined with any of the other aspects. These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

[0088] BRIEF DESCRIPTION OF THE FIGURES

[0089] The fertility assistance device, applicator, kit of part and method, according to the invention will now be described in more detail with regard to the accompanying figures. The figures show one way of implementing the present invention and is not to be construed as being limiting to other possible embodiments falling within the scope of the attached claim set.

[0090] FIG. 1 shows a trimetric view of the fertility assistance device, according to an embodiment of the invention;

[0091] FIG. 2 shows an exploded view of the applicator, according to an embodiment of the invention;

[0092] FIG. 3 shows a trimetric view of the assembled applicator, according to an embodiment of the invention;

[0093] FIG. 4 shows a cross-sectional side view of the assembled applicator, according to an embodiment of the invention;

[0094] FIG. 5 shows a trimetric view of the fertility assistance device positioned, in release mode, within the applicator, according to an embodiment of the invention; FIG. 6A shows a trimetric view of the fertility assistance device folded, in insertion mode, within the applicator, and

[0095] FIG. 6B shows a top view of the folded fertility assistance device, according to an embodiment of the invention;

[0096] FIG. 7A shows a trimetric view of the intravaginal insertion of the fertility assistance device by use of the applicator, and

[0097] FIG. 7B shows the fertility assistance device positioned at the cervix, according to an embodiment of the invention;

[0098] FIG. 8 is a flow-chart of a method according to the invention;

[0099] FIG. 9A and FIG. 9B shows a trimetric view and close-up of the assembled applicator in release mode, according to a preferred embodiment of the invention; FIG. 10 shows a trimetric view of the fertility assistance device, according to a preferred embodiment of the invention.

[0100] Fig. 11 shows the fertility assistance device from fig. 10 positioned, in release mode, within the applicator, according to an embodiment of the invention.

[0101] DETAILED DESCRIPTION OF AN EMBODIMENT

[0102] FIG. 1 shows a trimetric view of the fertility assistance device 1, according to an embodiment of the invention. The fertility assistance device 1 comprises a cylindrical receptacle CR and a holding element HE, with an elongate tail TA extending therebetween. The cylindrical receptacle CR comprising a rim RI and a bottom portion BP, with a sidewall SW extending therebetween. The rim RI is adapted with protrusions PR along a surface of said rim RI. The sidewall SW is adapted with fold lines FL, FL' extending between the rim RI and the bottom portion BP.

[0103] FIG. 2 shows an exploded view of the applicator 2, according to an embodiment of the invention. The applicator 2 is comprised of an outer tube OT, an inner tube IT and an applicator handle AH. The outer tube OT is comprised of a hollow tubular body TB. At the distal end DE, the outer tube OT is adapted to receive a fertility assistance device (shown in FIG. 1, 5, and 6A). Proximally, i.e. opposite the distal end DE, the tubular body TB flares radially outwards, to provide an anatomical end stop ES. The inner tube IT is comprised of a hollow tubular body TB'. At the distal end, the tubular body TB' extends radially inwards, to provide a distal surface DS. The distal surface DS provides for a pushing surface, to push the fertility assistance device (shown in Fig. 5 and 6A) from the distal end DE of the outer tube OT. Proximally, i.e. opposite the distal surface DS, the tubular body TB' flares radially outwards to provide a handle rim HR. It is to be understood, that the inner tube IT is dimensioned so as to slidably fit within the outer tube OT. FIG. 2 further shows the applicator handle AH, AH' comprised of two half-shells which are adapted to fit together, around the handle rim HR of the inner tube IT. The applicator handle AH, AH' comprises an aperture AP, providing a passage from within the inner tube IT and into the applicator handle AH, AH'. Further, the applicator handle AH is adapted with a fixture FI, provided as a slit, to lock the holding element of the tail of the fertility assistance device (as shown in FIG. 1, 5 and 6A).

[0104] FIG. 3 shows a trimetric view of the assembled applicator 2, in release mode, according to an embodiment of the invention. The applicator 2 is comprised of an outer tube OT, and inner tube (slightly visible, clearly shown in FIG. 2 and 3) and an applicator handle AH. When the applicator is in release mode, as shown in FIG. 3, the distal surface DS of the inner tube protrudes or is in plane with the distal end DE of the outer tube OT. The applicator handle AH is adapted with a fixture FI, provided as a slit, to lock the holding element HE of the tail TA (as shown in FIG. 1, 5 and 6A).

[0105] FIG. 4 shows a cross-sectional side view of the assembled applicator, in release mode, according to an embodiment of the invention. The applicator 2 is comprised of the inner tube IT positioned within the outer tube OT, and wherein the distal surface DS of the inner tube protrudes from the distal end DE of the outer tube OT. The applicator further comprises an applicator handle AH, which surrounds the handle rim HR of the inner tube IT. The fixture FI of the applicator handle AH can be seen at the proximal end of the applicator 2. Further, in FIG. 4 the ends stop ES of the outer tube OT can be seen, to abut the applicator handle AH. The dotted line CU indicates the curve of the applicator 2, i.e. wherein the outer tube OT and inner tube IT deviates from a straight line. It is to be understood, that the curve of the inner and outer tube IT, OT is substantially identical, to provide for a slidable fit. It is to be understood, that for the fertility assistance device 1 to be released from the applicator 2, the tail TA must be released from the fixture FI.

[0106] FIG. 5 shows a trimetric view of the fertility assistance device 1 positioned, in release mode, within the applicator 2, according to an embodiment of the invention. In release mode, the cylindrical receptacle CR is unfolded, and protrudes from the distal end DE of the outer tube OT. The tail TA of the fertility assistance device 1 extends proximally, through the applicator handle AH, and is fixated in the fixture FI of the applicator handle. It is to be understood that, that at this point, sperm may be introduced into the cylindrical receptacle, prior to insertion of the fertility assistance device 1. FIG. 6A shows a trimetric view of the fertility assistance device 1 folded, in insertion mode, within the applicator 2, according to an embodiment of the invention. In insertion mode, the cylindrical receptacle CR is folded, and at least partly surrounded by, or nested within, the distal end DE of the outer tube OT. The outer tube OT and the inner tube IT are translated away from each other, in a longitudinal direction or axis, to extend the length of the applicator 2, shown by the pull arrow PU, which illustrates that the inner tube IT is translated away from the outer tube OT. The inner tube IT and the outer tube OT, is further interlocked, by rotating one relative to the other, as indicated by the locking arrow LO. It is to be understood, that as the applicator 2 length is extended, the cylindrical receptacle CR is pulled into the distal end DE, as the tail TA is fixated in the fixture FI of the applicator handle AH.

[0107] FIG. 6B shows a top view of the folded fertility assistance device 1, as shown in FIG. 6A. The cylindrical receptacle CR is folded at the distal end DE of the outer tube OT. It is to be understood, that this enables for easy insertion of the fertility assistance device 1. It is further to be understood, that the fold lines, as shown in FIG. 1, enables for a predetermined fold of the cylindrical receptacle.

[0108] FIG. 7A shows a trimetric view of the intravaginal insertion of the fertility assistance device 1 by use of the applicator 2, according to an embodiment of the invention. When the applicator 2 is positioned intravaginally, the inner tube IT is rotated (shown by arrow) relative to the outer tube OT, to release the fertility assistance device 1.

[0109] FIG. 7B shows the fertility assistance device 1 positioned at the cervix CX, according to an embodiment of the invention. When the fertility assistance device 1 is in position at the cervix CX, the applicator 2 is removed, leaving the tail TA in a superficial position, for easy removal (not shown).

[0110] FIG. 8 is a flow-chart of a method of increasing the likelihood of conception according to the invention, the method comprising the following steps:

[0111] 51-providing the fertility assistance device according to the first aspect of the invention,

[0112] 52-providing the applicator, according to the second aspect of the invention, 53-loading the fertility assistance device within the applicator, the receptacle nested at a distal end of the outer tube and the tail extending from a proximal end of the inner tube,

[0113] 54-locking the applicator in the insertion mode, thereby folding the fertility assistance device, and when the receptacle is at or near cervix;

[0114] 55-unlocking the applicator,

[0115] 56-bringing the distal surface of the inner tube into a plane of, or protruding from, the distal end of the outer tube, thus pushing the receptacle from within the outer tube by said distal surface and unfolding the receptacle.

[0116] FIG. 9A and FIG. 9B shows a trimetric view and close-up of the assembled applicator 2 in release mode, according to a preferred embodiment of the invention.

[0117] FIG. 9A shows the assembled applicator 2, in release mode, the applicator 2 comprised of an outer tube OT, and inner tube (slightly visible, clearly shown in FIG. 2 and 3) and an applicator handle AH. The applicator handle AH is adapted with a fixture FI, provided as a slit, to lock the holding element HE of the tail TA (as shown in FIG. 1, 5, 6A and 10). The distal end DE of the outer tube OT comprises a plurality of protrusions / recesses along the periphery, adapted to ensure that the cylindrical receptacle does not adhere to the applicator 2, during release.

[0118] FIG. 9B is a close-up / zoom of the distal end DE of the outer tube OT, wherein the protrusions / recesses are clearly visible.

[0119] FIG. 10 shows a trimetric view of the fertility assistance device 1, according to a preferred embodiment of the invention. The fertility assistance device 1 comprises a cylindrical receptacle CR and a holding element HE, with an elongate tail TA extending therebetween. The holding element HE is shaped as an elongate or cylindrical element, with a necking portion in between two ends. It is to be understood, that the reduced diameter at the centre portion provides for an improved grip to a user, when releasing the fertility assistance device 1, from the applicator as shown in e.g. FIG. 9A. The cylindrical receptacle CR comprising a rim RI and a bottom portion BP, with a sidewall SW extending therebetween. The rim RI is adapted with protrusions PR along a surface of said rim RI. The sidewall SW is adapted with a plurality of fold lines FL, FL' extending between the rim RI and the bottom portion BP.

[0120] FIG. 11 shows the fertility assistance device in the embodiment shown in FIG. 10, positioned, in release mode, within the applicator, according to an embodiment of the invention. Close-up views of various parts of the fertility assistance device are shown in the circles. The fercillity assistance device is positioned in the applicator in release mode. The holding element HE is positioned within the handle AH from where it can be realised. The handle AH is formed to accommodate the larger holding element HE. The inner tube IT and the outer tube OT are placed in release mode. The tail TA extends through the interior of the applicatior, and the cylindrical receptacle CR is unfolded and ready for release.

[0121] The following is a list of Items, according to embodiments of the invention:

[0122] Item 1. A fertility assistance device comprising:

[0123] -a cylindrical receptacle comprising a rim and a bottom portion, with a sidewall extending therebetween, wherein the rim is adapted with protrusions along a surface of said rim, the sidewall extends from the rim and tapers radially inwards, towards the bottom portion; and the sidewall further comprises fold lines which extend between the rim and said bottom portion,

[0124] -a tail, the tail extending from the bottom portion of the receptacle, and wherein the receptacle is adapted for folding the rim and sidewalls radially inwards, in a pre-determined folding pattern, the pattern determined by the fold lines.

[0125] Item 2. The device according to Item 1, wherein the tail further comprises a holding element at an end opposite the receptacle. Item 3. The device according to Item 1 or 2, wherein at least one of the receptacle or tail is made from a flexible polymer, preferably silicone.

[0126] Item 4. The device according to any of the preceding Items, wherein at least one of the receptacle and tail is made from a biocompatible polymer.

[0127] Item 5. The device according to any of the preceding Items, wherein the protrusions along the rim are bead-like protrusions.

[0128] Item 6. The device according to any of the preceding Items, wherein the protrusions extend radially inwards along the rim.

[0129] Item 7. The device according to any of the preceding Items, wherein the rim further comprises a lip edge extending along a periphery of said rim.

[0130] Item 8. The device according to any of the preceding Items, wherein the receptacle and tail is formed in one piece.

[0131] Item 9. The device according to any of the preceding Items, wherein the protrusions are distributed evenly along the rim of the receptacle.

[0132] Item 10. The device according to any of the preceding Items, wherein the receptacle is shaped as a cup.

[0133] Item 11. An applicator for intra vaginal insertion of a fertility assistance device, the applicator comprising:

[0134] -an inner tube slidably arranged within an outer tube, the inner tube adapted with a distal surface extending radially inwards, the applicator adapted for at least two modes of operation: a) an insertion mode, wherein the inner tube is locked in a longitudinal axis, relative to the outer tube, and b) a release mode, wherein, by adjusting a peripheral orientation of the inner tube relative to the outer tube, the inner tube can move in the longitudinal axis, relative to the outer tube, wherein the distal surface of the inner tube can be brought into a plane of, or protrude from, a distal end of the outer tube, when the applicator is in release mode.

[0135] Item 12. The applicator according to Item 11, wherein the inner and outer tube are curved.

[0136] Item 13. The applicator according to Item 11, wherein one of the inner and outer tube is adapted with a protruding locking means, such as a tongue, and the other of the inner and outer tube is adapted with a recessed locking means adapted to receive and engage with the protruding locking means, such as a groove or slit.

[0137] Item 14. The applicator according to any of Items 11 to 13, wherein said applicator has an extended length in the insertion mode, relative to the release mode.

[0138] Item 15. The applicator according to any of Items 11 to 14 further comprising an applicator handle fixated to a proximal end of the inner tube, the applicator handle comprising an aperture adapted to provide a passage from the applicator handle into the inner tube.

[0139] Item 16. The applicator according to Item 15, wherein the applicator handle further comprises a fixture adapted for fixating a portion of the fertility assistance device.

[0140] Item 17. The applicator according to any of Items 11 to 16, wherein said applicator is made from a biocompatible polymer.

[0141] Item 18. A kit of parts for fertility assistance comprising:

[0142] -the fertility assistance device according to any of Items 1 to 10, and

[0143] -the applicator, according to any of Items 11 to 17, the applicator adapted to insert the fertility assistance device intravaginally by positioning the fertility assistance device into said applicator, the receptacle nesting within a distal end of the outer tube and the tail extending from a proximal end of the inner tube. Item 19. A method of increasing the likelihood of conception, the method comprising:

[0144] -providing the fertility assistance device according to any of Items 1 to 10,

[0145] -providing the applicator, according to any of Items 11 to 17,

[0146] -loading the fertility assistance device within the applicator, the receptacle nested at a distal end of the outer tube and the tail extending from a proximal end of the inner tube,

[0147] -locking the tail in the applicator handle fixture,

[0148] -locking the applicator in the insertion mode, thereby folding the receptacle within the outer tube, and when the receptacle is at or near cervix;

[0149] -unlocking the applicator,

[0150] -bringing the distal surface of the inner tube into a plane of the distal end of the outer tube, thus pushing the receptacle from within the outer tube by said distal surface and unfolding the receptacle.

[0151] Item 20. A method of increasing the likelihood of conception, the method comprising:

[0152] -providing the fertility assistance device according to any of Items 1 to 10,

[0153] -providing the applicator, according to any of Items 11 to 17,

[0154] -loading the fertility assistance device within the applicator, the receptacle nested at a distal end of the outer tube and the tail extending from a proximal end of the inner tube,

[0155] -locking the applicator in the insertion mode, thereby folding the fertility assistance device, and when the receptacle is at or near cervix;

[0156] -unlocking the applicator,

[0157] -bringing the distal surface of the inner tube into a plane of the distal end of the outer tube, thus pushing the receptacle from within the outer tube by said distal surface and unfolding the receptacle.

[0158] Item 21. Use of any of the fertility assistance device according to any of Items 1 to 10, the applicator according to any of Items 11 to 17 or the kit of parts according to Item 19 or 22 for increasing the likelihood of conception. Item 22: A kit of parts for fertility assistance comprising:

[0159] -a fertility assistance device comprising:

[0160] -a cylindrical receptacle comprising a rim and a bottom portion, with a sidewall extending therebetween, wherein the rim is adapted with protrusions along a surface of said rim, the sidewall extends from the rim and tapers radially inwards, towards the bottom portion; and the sidewall further comprises fold lines which extend between the rim and said bottom portion, and

[0161] -a tail, the tail extending from the bottom portion of the receptacle, -an applicator to insert the fertility assistance device, the applicator comprising:

[0162] -a curved, hollow outer tube comprising a proximal end and a distal end, the distal end comprising a receptacle nesting portion within said tube, the nesting portion defining an inner diameter,

[0163] -a curved, hollow inner tube comprising a proximal end and a distal end; the curvature and diameter of the outer tube slidably fitting to the curvature and diameter of the inner tube, wherein the fertility assistance device is adapted to be loaded into the applicator, the receptacle nesting in the nesting portion of the outer tube and the tail extending from the proximal end of the inner tube.

[0164] In short, the present invention relates to a fertility assistance device 1, and applicator 2 adapted to insert a fertility assistance device 1 intravaginally, at or near the cervix CX of a mammal, preferably a human. The fertility assistance device 1 comprises a cylindrical receptacle CR, the cylindrical receptacle CR comprising a rim RI, wherein a surface of said rim RIM has one or more protrusions adapted for easy removal after finalized procedure. The cylindrical receptacle CR further has a bottom portion BP and a sidewall SW extending peripherally therefrom, to the rim RI. The sidewall SW comprises one or more folding lines FL, FL', the folding lines enabling the cylindrical receptacle CR to fold radially inwards, in a predetermined pattern. The applicator 2 comprises an inner tube IT adapted to be inserted into an outer tube OT, the applicator 2 adapted with an insertion mode of operation and a release mode of operation, wherein the applicator 2 is adapted to lock in two said modes of operation by rotation of the two tubes IT, OT relative to each other, thus enabling for easy insertion of the fertility assistance device 1 at or near the cervix CX of a user.

[0165] Although the present invention has been described in connection with the specified embodiments, it should not be construed as being in any way limited to the presented examples. The scope of the present invention is set out by the accompanying claim set. In the context of the claims, the terms "comprising" or "comprises" do not exclude other possible elements or steps. Also, the mentioning of references such as "a" or "an" etc. should not be construed as excluding a plurality. The use of reference signs in the claims with respect to elements indicated in the figures shall also not be construed as limiting the scope of the invention. Furthermore, individual features mentioned in different claims, may possibly be advantageously combined, and the mentioning of these features in different claims does not exclude that a combination of features is not possible and advantageous.

Claims

CLAIMS1. A fertility assistance device (1) comprising:-a cylindrical receptacle (CR) comprising a rim (RI) and a bottom portion (BP), with a sidewall (SW) extending therebetween, wherein the rim is adapted with protrusions (PR) along a surface of said rim, the sidewall extends from the rim and tapers radially inwards, towards the bottom portion; and the sidewall further comprises fold lines (FL, FL') which extend between the rim and said bottom portion,-a tail (TA), the tail extending from the bottom portion of the cylindrical receptacle, and wherein the receptacle is adapted for folding the rim and sidewalls radially inwards, in a pre-determined folding pattern, the pattern determined by the fold lines.

2. The device according to claim 1, wherein the tail further comprises a holding element (HE) at an end opposite the receptacle.

3. The device according to claim 1 or 2, wherein at least one of the receptacle or tail is made from a flexible polymer, preferably silicone.

4. The device according to any of the preceding claims, wherein at least one of the receptacle and tail is made from a biocompatible polymer.

5. The device according to any of the preceding claims, wherein the protrusions along the rim are bead-like protrusions.

6. The device according to any of the preceding claims, wherein the protrusions extend radially inwards along the rim.

7. The device according to any of the preceding claims, wherein the rim further comprises a lip edge extending along a periphery of said rim.

8. The device according to any of the preceding claims, wherein the receptacle and tail is formed in one piece.

9. The device according to any of the preceding claims, wherein the protrusions are distributed evenly along the rim of the receptacle.

10. The device according to any of the preceding claims, wherein the receptacle is shaped as a cup.

11. The device according to any of claims 2 to 10, wherein the holding element is shaped like a droplet.

12. The device according to any of claims 2 to 10, wherein the holding element is elongate, with a necking portion at the centre of said holding element.

13. An applicator (2) for intra vaginal insertion of a fertility assistance device (1), the applicator comprising:-an inner tube (IT) slidably arranged within an outer tube (OT), the inner tube adapted with a distal surface (DS) extending radially inwards, the applicator adapted for at least two modes of operation: a) an insertion mode, wherein the inner tube is locked in a longitudinal axis, relative to the outer tube, and b) a release mode, wherein, by adjusting a peripheral orientation of the inner tube relative to the outer tube, the inner tube can move in the longitudinal axis, relative to the outer tube, wherein the distal surface of the inner tube can be brought into a plane of, or protrude from, a distal end (DE) of the outer tube, when the applicator is in release mode.

14. The applicator according to claim 13, wherein the inner and outer tube are curved.

15. The applicator according to claim 13 or 14, wherein one of the inner and outer tube is adapted with a protruding locking means, such as a tongue, and the other of the inner and outer tube is adapted with a recessedlocking means adapted to receive and engage with the protruding locking means, such as a groove or slit.

16. The applicator according to any of claims 13 to 15, wherein said applicator has an extended length in the insertion mode, relative to the length of the applicator when in release mode.

17. The applicator according to any of claims 13 to 16 further comprising an applicator handle (AH) fixated to a proximal end of the inner tube, the applicator handle comprising an aperture (AP) adapted to provide a passage from the applicator handle into the inner tube.

18. The applicator according to claim 17, wherein the applicator handle further comprises a fixture adapted for fixating a portion of the fertility assistance device.

19. The applicator according to any of claims 13 to 18, wherein said applicator is made from a biocompatible polymer.

20. The applicator according to any of claims 13 to 19, wherein that the distal surface of the the inner tube can be brought into the plane of the distal end of the outer tube comprises that the distal surface of the the inner tube is positioned within 2.0 mm, preferably within 1.0 mm, more preferably within 0.5 mm, and even more preferably within 0.2 mm of the distal end of the outer tube.

21. The applicator according to any of claims 13-20, the distal end of the outer tube comprising protrusions or recesses along an inner rim surface.

22. The applicator according to claim 21, wherein the protrusions or recesses at the distal end of the outer tube are wave-shaped or bead-like.

23. A kit of parts for fertility assistance comprising:-the fertility assistance device (1) according to any of claims 1 to 12, and-the applicator (2), according to any of claims 13 to 21, the applicator adapted for insertion of the fertility assistance device intravaginally by positioning the fertility assistance device into said applicator, the cylindrical receptacle (CR) nesting within a distal end (DE) of the outer tube and the tail (TA) extending from a proximal end of the inner tube.

24. A method of increasing the likelihood of conception, the method comprising:-providing the fertility assistance device (1) according to any of claims 1 to 12,-providing the applicator (2), according to any of claims 13 to 21, -loading the fertility assistance device within the applicator, the cylindrical receptacle (CR) nested at a distal end (DE) of the outer tube (OT) and the tail (TA) extending from a proximal end of the inner tube (IT),-locking the applicator in the insertion mode, thereby folding the fertility assistance device, and when the receptacle is at or near cervix (CX);-unlocking the applicator,-bringing the distal surface (DS) of the inner tube into a plane of, or protruding from, the distal end of the outer tube, thus pushing the cylindrical receptacle from within the outer tube by said distal surface and unfolding the receptacle.

25. Use of any of the fertility assistance device according to any of claims 1 to 12, the applicator according to any of claims 13 to 22 or the kit of parts according to claim 23 or 26 for increasing the likelihood of conception.

26. A kit of parts for fertility assistance comprising:-a fertility assistance device comprising:-a cylindrical receptacle comprising a rim and a bottom portion, with a sidewall extending therebetween, wherein the rim is adapted with protrusions along a surface of said rim, the sidewall extends from the rim and tapers radially inwards, towards the bottom portion; and the sidewallfurther comprises fold lines which extend between the rim and said bottom portion, and-a tail, the tail extending from the bottom portion of the receptacle, -an applicator to insert the fertility assistance device, the applicator comprising:-a curved, hollow outer tube comprising a proximal end and a distal end, the distal end comprising a receptacle nesting portion within said tube, the nesting portion defining an inner diameter,-a curved, hollow inner tube comprising a proximal end and a distal end; the curvature and diameter of the outer tube slidably fitting to the curvature and diameter of the inner tube, wherein the fertility assistance device is adapted to be loaded into the applicator, the receptacle nesting in the nesting portion of the outer tube and the tail extending from the proximal end of the inner tube.

27. An applicator (2) for intra vaginal insertion of the fertility assistance device (1) according to any of claims 1 to 12, the applicator comprising:-an inner tube (IT) slidably arranged within an outer tube (OT), the inner tube adapted with a distal surface (DS) extending radially inwards, the applicator adapted for at least two modes of operation: c) an insertion mode, wherein the inner tube is locked in a longitudinal axis, relative to the outer tube, and d) a release mode, wherein, by adjusting a peripheral orientation of the inner tube relative to the outer tube, the inner tube can move in the longitudinal axis, relative to the outer tube, wherein the distal surface of the inner tube can be brought into a plane of, or protrude from, a distal end (DE) of the outer tube, when the applicator is in release mode.

28. A fertility assistance system, the system comprising the fertility assistance device according to any of claims 1 to 12 and the applicator according to any of claims 13 to 22, the fertility assistance device adapted to be inserted into the applicator.

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