Technical Field of the Invention

The present invention relates to contraceptive or therapeutical devices to be placed to the vicinity of a uterus.

Background

There are several known methods directed to contraception. These are generally divided into two main groups which can be classified as traditional and modern methods.

The traditional methods include withdrawal, calendar follow-up and lactation which are known to be used since a very long time. General opinion on the traditional methods is that they lack reliability. However, the traditional methods are still widely preferred over the modern methods. Main reasons to this fact are that the traditional methods do not bear economic expenses, that the modern methods can also fail, and that the modern methods have side effects on health.

Intrauterine device usage is an effective method which is included to modern contraceptive methods. Intrauterine devices bear several side effects severely affecting women's life which include pain when placing to the uterus, vaginal discharge, severe bleeding, nausea and menstrual pain. Additionally, intrauterine devices can slip and move away from their intended positions when in use, resulting in pregnancy risk and potentially damage the womb wall. The potential case of womb wall damage can cause pelvic infection due to perforation, which in the future may impede fecundability. Epithelial damage at endometrium can be encountered when placing or using an intrauterine device. Several examples to intrauterine devices for contraceptive or therapeutic uses are disclosed in CN 100571665 A, US 4,246,896 A, AU 498,686 B2, US 5,224,493 A, US 4,004,582 A, US 4,578,076 A, HR P931396 A2, GB 1 588 195 A and ES 2 116 834 Bl. WO 2010/086681 A1 discloses another example of an intrauterine device which extends from the uterus into the vagina; including a protrusion extending into the vagina, in continuous contact with the cervix and even with the ectocervix when in use; and further including a string which even further extends from said protrusion into the vagina. A typical, widely used intrauterine device is equipped with such string for provision of mechanical control. Even in the cases where the above-mentioned severe problems related to intrauterine devices are not encountered, said string can cause discomfort during intercourse. In particular, when in use, extending into the vagina and being in contact with cervix, the protrusion potentially causes discomfort in both parties of the intercourse. The probability of that the device can be completely pushed into the womb at the intercourse, can potentially necessitate a surgical operation for extraction of the device.

Methods based on the use of copper containing and hormone releasing devices are known to be widely used in intrauterine applications. Shortly after the emergence of intrauterine devices which include copper, it is confirmed that copper shows a toxic effect. Individuals having copper allergy or Wilson's disease cannot use intrauterine devices which include copper. Hormone releasing intrauterine device were developed upon anemic patients' complications related to bleeding which can increase to an excessive extent. Properties of widely used current intrauterine devices are similar to those of copper containing ones in terms of their shape and location of placement.

In release-type intrauterine devices, a synthetic hormone is released from the intrauterine device body which is usually T-shaped. Current hormonal intrauterine systems include levonorgestrel (LNG) which comprises synthetic progesterone. The amount of hormone determines the duration of effectiveness. Body of the device is equipped with a silastic (inert silicone elastomer containing) coating which (controlled-) releases hormone in a pre determined daily amount, thus coated with a proportion control device. The effective mechanisms of LNG containing intrauterine devices (abbreviated of LNG-RIA) are based on prevention of the passage of sperms into uterus, provision of thickening in cervical mucus for sperm capacitation, and inhibition of thickening in endometrium layer. Side effects related to the use of LNG-RIA include acne, hair loss, hirsutism, depression, anxiety, headache, breast ache, weight gain and a vaginal bacterial infection.

Unlike the devices to be implanted to different parts of human body e.g. arm, to release hormones to the whole body, intrauterine devices locally releasing hormones with spermicidal effect become prominent. Intrauterine devices are generally produced with a T-shape as in the products with current commercial names Mirena, Liletta, Kyleena, Skyla and T380A, or I-shaped as in the product with current commercial name GyneFix; and placed to uterus. Due to being placed to the uterus, hormone-releasing intrauterine devices can cause health problems such as perforation, excessive bleeding and pain.

The above-mentioned drawbacks cause women to avoid intrauterine devices.

Objects of the Invention

Main object of the present invention is to overcome the drawbacks encountered in the prior art.

Another object of the present invention is to provide an intrauterine device which maintains its position when in use. A further object of the present invention is to provide an intrauterine device with minimized probability of causing health problems. An even further object of the present invention is to provide an intrauterine device with minimized probability of causing discomfort and with minimized probability of failing to maintain its position during sexual intercourse. An even further object of the present invention is provision of an intrauterine device with minimized probability of necessitating surgical intervention for positional correction or removal from the body of a user. An even further object of the present invention is provision of an intrauterine device which maintains its position during daily activities of a user, and which provides an enhanced level of comfort do the user at daily use and during sexual intercourse.

Summary of the Invention The device proposed with the present invention comprises a uterus-side first distal end for, when in use, being positioned in the uterine cavity of a user; a cervix-side second distal end for, when in use, being positioned in the endocervical canal of the user; and a neck between the first distal end and second distal end for, when in use, being held by the internal os of the user.

Brief Description of the Drawings

The present invention is exemplified with the annexed figures brief explanation of which is herewith provided; the examples are solely representatively depicting ways of application of the present invention, and are as such not intended to limit the scope by exclusion of other ways of application and to delimit the general effects which provide solution to the technical problem.

Fig.l (a) is a representative perspective view, (b) a frontal view and (c) a base view (at an aspect from vagina towards uterus when in use) of an exemplary embodiment of the device according to the present invention.

Fig.2 (a) is a representative perspective view, (b) a frontal view, (c) a side view, and (d) a base view (at an aspect from vagina towards uterus when in use) of an exemplary second embodiment of the device according to the present invention.

Fig.3 is a partial, representational drawing of reproductive organs of a user, showing a uterus, an internal os connecting the uterus to an endocervical canal, and an external os connecting the endocervical canal to a vagina.

Fig.4 shows representational frontal view of a positioning of the embodiment of the device according to the present invention which is shown in Fig.1(a) to Fig.1(c), when in use (neck portion being held by the internal os). Fig.5 shows representational frontal view of a positioning of the embodiment of the device according to the present invention which is shown in Fig.2(a) to Fig.2(c), when in use (neck portion being held by the internal os).

Detailed Description of the Invention

Referring to the drawings, brief description of which being provided above, the present invention is described below in detail. List of reference signs used in the drawings are listed as follows;

1. uterus-side distal end (first end)

2. cervix-side distal end (second end)

3. neck

4. flow path (through hole)

5. outer wall

6. inner wall

7. arm

100. device (intrauterine device)

1000. uterine cavity

1001. endocervical canal

1002. internal os

1005. vagina

A. main axis

A'. Central axis of the endocervical canal

To overcome the shortcomings mentioned in prior art, an intrauterine device (100) (abbreviated as: device, 100) is developed.

The device (100) according to the present invention comprises: - an uterus-side distal first end (1) (first end, 1) for, when in use, being positioned in the uterine cavity (1000) of a user,

- a cervix-side distal second end (2) (second end, 2) for, when in use, being positioned in the endocervical canal (1001) of the user, and

- a neck (3) between the first end (1) and second end (2) for, when in use, being held by the internal os (1002) of the user.

The device (100) according to the present invention can further comprise a flow path (4) (which can also be named as through hole, 4) for provision of fluid communication from the uterine cavity (1000) to the cervix (1003) along a main axis (A), to correspond to a central axis (A') of the endocervical canal (1001) when the device is in use. As a result, fluid flow between the uterus (1000) and vagina (1005) is enabled through the device (100), and the device (100) does not block the endocervical canal (1001).

By means of the above-mentioned technical features, the device (100) is shaped and sized to contact with the internal os (100) wall around the main axis (A), and to be detained inside the internal os (1002) at the neck (3) portion. When in use, the device (100) is able to contact with mucosa at the internal os (1002) and endocervical canal (1001) zones, yet preferably does not extend from the cervix (1003) into the vagina (1005). When in use, the device (100) is subjected to radials force towards the central axis (A of the endocervical canal, due to the tissues around the internal os (1002) and due to the geometry of the internal os (1002). Since the radial distance between the main axis (A) and an outer wall (5) of the device increases in the direction from the neck (3) towards the first end (1) as well as in the direction from the neck (3) towards the second end (2), said force which is continuously exerted by the internal os (1002) when de device (100) is in use, will constitute a resistance preventing the device (100) from moving along the central axis (A') of the endocervical canal. Thus, when in use, the position of the device (100) does not get negatively affected by daily moves of the user.

The device (100) according to the present invention being designed such that it does not extend from the cervix (1003) into the vagina (1005) canal when in use, rules out the possibility of the device (100) to be pushed towards the uterus (1000) during sexual intercourse. Within this context; considering that in a non-pregnant adult woman the length of endocervical canal (1001) (i.e. the distance between the internal os 1002 and external os 1004 along the central axis A' of the endocervical canal) is up to 5 cm; in a preferred embodiment of the device (100) according to the present invention, combined length (D) of the second end (2) and neck (3) portions along the main axis (A) is up to 5 cm. In another preferred embodiment of the device (100) according to the present invention, for use with the same technical effect in the cases where the length of the endocervical canal (1001) is shorter than the above-mentioned value, the combined length (D) of the second end (2) and neck (3) portions along the main axis (A) (i.e. a total distance between the second end 2 and the radial projections of the neck 3 onto the main axis A) is within a range between 1 cm and 4 cm.

In the method for determining the length (D) as defined for the device (100) embodiments within the context of the present invention, the reference to the neck (3) corresponds to an alignment at which a minimum width (W3) at the neck (3); said alignment corresponds to where the radial distance of the outer wall (5) to the main axis (A) at the neck (3) portion has its minimum value.

In accordance with the features described above, the device according to the present invention comprises a neck (3) disposed between the first end (1) and second end (2) and which has a width (W3) along a radial direction relative to the main axis (A), said width (W3) being smaller when compared to the widths of said first end (1) and of said second end (1). Here, the concept of width can be defined as a radial distance of the outer wall of the device (100) to the main axis (A). An exemplary embodiment of the device (100) according to the present invention which fits all of the definitions above is representatively shown in Fig.1(a) to Fig.1(c), and another exemplary embodiment which fits all of the definitions above is representatively shown in Fig.2(a) to Fig.2(c).

A width (Wl) value at the first end (1) portion, as well as a width (W2) value at the second end (2) portion can preferably be greater than 1.1 times (1.1 folds), more preferably greater than 1.3 times, of a width (W3) value at the neck (3) portion; even more preferably, they can have a value within a range between 1.4 and 2.5 times of the width (W3) value at the neck (3) portion.

An embodiment of the device according to the present invention can be defined as: a device (100) in which the first end (1) and second end (2) are arranged substantially in the form of respective spheres connected to each other at a neck (3), which corresponds to portions of the first end and second end at which they have relatively small widths in a section perpendicular to the main axis (A). The example in Fig.l (a)-(c) shows representative depictions of a preferred embodiment according to this definition. In said preferred embodiment, the device (100) has a helical structure which includes an elastic material. Thus said preferred embodiment is able to show a resilience behavior such as in bending of a spring when subjected to force components in a direction perpendicular to the main axis (A). Said elastic material can comprise a polymeric material mentioned in the present specification, for example, EVA copolymer. Fig. 1(a) is a representational perspective view of said exemplary preferred embodiment. Fig.l (b) is a representational frontal or side view of the embodiment shown in Fig.l (a), where it is emphasized that a width (W3) at the neck (3) has a value smaller than a width (Wl) at the first end (1) and smaller than a width (W2) at the second end (2). Fig.l (c) is a plan view emphasizing the flow path (which provides a fluid communication through the device (100) between the uterus and vagina when the device (100) is in use) in the embodiment shown in Fig.l (a) and Fig.l (b).

Another exemplary embodiment of the device according to the main context of the present invention which is shown in Fig.2 (a) to Fig.2 (d), comprises a plurality of arms (7) (exemplified over two arms in the drawings) converged (connected/united with each other) on the second end (2). In such embodiment, the device (1000) can comprise a flow path (4) at the second end (2) for provision of fluid communication between the uterus (1000) and vagina (1003). Each pair of arms (7) and their convergence at the second end (2) side, constitutes a one-sided lever (i.e. class-2 lever) in which the second end (2) also serves as a fulcrum. When a force is applied in a direction radial to the main axis (A), first end (1) sides of the arms approach to each other by pivoting around the second end (2). Thus the device (100) shows a high extent of flexibility, facilitating the positioning (emplacing) of the neck (3) portion to the internal os (1002) such that the first end (1) side extends into the uterus (1000). The flow path can be disposed at the second end (2). The first end (1) is formed at the ends of the arms (7) distal to the second end (2). Each of the arms can be arranged in the form of wave which, starting from the second end (2), diverge from the main axis (A), then approach to the main axis (A) thereby forming the neck (3) portion, and then diverge again from the main axis (A) thereby preambling a first end (1) portion, and then conclude the first end (1) portion.

A preferred version of said embodiment which is representatively shown in Fig.2 (a) to Fig.2 (d), a projection of a distance between the second end (2) and a zone of the neck (3) portion which is narrowest radial to the main axis (A), said projection being perpendicular to the main axis (A), can have a length (D) corresponding to a distance between the internal os (1002) and external os (1004) of an ordinary user. Said length (D) can be within a range between 4 cm and 5 cm. As also indicated above, in the method for determining the length (D) for the device (100) embodiments in the present specification, the reference to neck (3) corresponds to an alignment at which the neck (3) has a smallest width (W3); said alignment corresponds to where the radially greatest distance of the outer wall (5) at the neck (3) portion relative to the main axis (A) has the smallest value. When a device (100) having such length (D) between the neck (3) and second end

(2) is placed into the genitals of a user, the flow path (4) can be caught with a tool (e.g. a hook) aimed through the vagina (1005) and the external os (1004). Furthermore, such device (100) is inherently visible from an aspect through the vagina (1005) and the external os (1004), thereby facilitating said catching. By means of such facilitated act of catching, the device (100) can be easily removed by medical staff, by extracting from the genitals of a respective user. In addition to this advantage of said embodiment, it is made sure that the device (100) is sized such that it substantially cannot extend into the vagina (1005) when in use. Thereby it is safeguarded that the device cannot be pushed through the vagina (1005) towards the uterus (1000) during a sexual intercourse. Thus the neck

(3) portion cannot leave its position aligned to the internal orifice (1002) without consent/intention of a user (and/or without control of the medical staff). Such embodiment can be manufactured from a biodegradable material (thereby eliminating any requirement of removal by medical professionals); or alternatively, the device can be man ufactu red from a non-biodegradable material, and at the end of its expected life, it can be easily removed from the user's genitals by medical professionals.

This embodiment of the device (100) can be equipped with a drug. When in use, the first end (1) of the device (100) extends into the uterus (1000), on the other hand, the second end (2) can extend towards the vicinity of the cervix (1003). The drug can include e.g. a contraceptive hormone. Alternatively, or furthermore, the drug can include a spermicide, and in this case, along the central axis (A of the endocervical canal, the spermicidal effect can be started at a zone relatively distant to the uterus (1000); thereby further enhancing the contraceptive activity of the device (100). Said drug can be provided at a coating layer formed on the outer wall (5); more preferably said drug can be provided at a coating layer which constitutes the outer wall (5). Said coating layer can comprise a matrix for provision of a controlled release of the drug (e.g. at a predetermined daily amount/dosage); for instance, the coating layer can include a polymer matrix which is known for being suitable for such purpose (e.g. a semi-permeable membrane comprising EVA copolymer).

A preferred embodiment of the device (100) according to the present invention is arranged to be suitable for releasing one or more pharmaceutical substances to the endocervical canal (1001) and in particular, to the internal os (1002) zone. The drug mentioned along the present specification can include one or more substances selected from contraceptive hormones, anti-cancer drugs and spermicides.

Within this context, in a preferred embodiment of the device (100), one or more of (preferably, the body of the device constituted by the first end (1), second end (2) and neck (3)) can be formed from a permeable material for provision of drug to the mucosa at the endocervical canal when in use (i.e. from a material allowing permeation of the drug), and comprises said drug. The permeable materials which fit to this definition include polymeric materials such as ethylene vinyl acetate (EVA) copolymer or other polymeric materials known to be used in formation of permeable matrices for controlled/gradual drug release, and said materials can be used individually or in combinations their combinations. Also within this context, or furthermore, the device (100) according to the present invention, for instance an outer wall (5) thereof, can be equipped with a coating suitable for a gradual release of said drug. Said coating can include a semi-permeable membrane which is arranged for releasing the drug in a pre-determined daily amount. EVA is an example to the coating materials which fit to such definition, yet, other materials which also fit to this definition are known in the technical field related to the controlled or gradual drug release, and these materials can be also used individually or in combinations thereof.

The device (100) can be partially or entirely manufactured from one or more materials used in 3D printers or in additive manufacturing; EVA is an example to such materials, yet, also other material options are known to fit to this definition in the technical field related to manufacturing with 3 dimensional printers, and these can be used individually as well as in combinations thereof. Hence, it is possible to manufacture the device (100) in a factory which makes production using 3D printers, with high capacities and low cost.

In a preferred embodiment, the device (100) can comprise a biodegradable material. In such embodiment, it is possible that a device can be pushed into the uterus upon expiry of its lifetime which corresponds to cease of the drug release, and a new device can be placed, without negatively affecting the health of the user. In such case, the device, lifetime of which is expired, will gradually disappear by biodegradation without negatively affecting the health of the user, or leaves the uterus and body of the user when turned into small pieces upon degradation.

With the device (100) according to the present invention, in which the above-mentioned shortcomings of the prior art are overcome, uterine health complications are prevented and potentially, the target group of is broadened when compared to those interested in known intrauterine devices.

The device (100) according to the present invention solves the problems encountered in the prior art, and the proposed intrauterine device embodiments bear one or more of the following features: - maintaining its position during use,

- having a minimized probability of causing health complications,

- having a minimized probability of causing discomfort or getting dislocated during sexual intercourse, - having a minimized probability of necessitating surgical intervention for correcting the position, or for removal from the body of the user,

- maintaining its position during daily activities, provision of an enhanced comfort level during daily use and sexual intercourse,

- being easy to produce and enabling to keep the production costs low.