HK1240066B - Device positionable in the uterine cavity - Google Patents

Description

Devices that can be placed in the uterine cavity

Technical Field and Background

The present invention relates to devices that are placeable in the uterine cavity, and more particularly to intrauterine devices configured to prevent pregnancy or treat uterine-related conditions such as menorrhagia.

An intrauterine device (IUD) is a small device that is implanted in the uterine cavity and can be used for birth control. There are two general types of contraceptive IUDs, the copper IUD and the hormonal IUD.

The copper IUD (such as Paragard) is the most commonly used IUD. The copper IUD forces the uterus and fallopian tubes to produce fluid containing white blood cells, copper ions, enzymes, and prostaglandins that are toxic to sperm.

Hormonal IUDs (such as Mirena or Skyla) release a form of the hormone progesterone. Hormonal IUDs prevent fertilization by damaging or killing sperm, thereby preventing them from migrating to the uterus (by making the mucus thicker and stickier) and by preventing a fertilized egg from implanting and growing (by preventing the uterine lining from thickening). Hormonal IUDs can also reduce menstrual bleeding and cramping.

Both copper and hormonal IUDs are effective in preventing pregnancy (hormonal IUDs may be slightly more effective than copper IUDs), however both suffer from some inherent limitations. Copper IUDs may increase menstrual bleeding or cramping, while hormonal IUDs may cause side effects similar to those caused by oral contraceptives, such as breast tenderness, mood swings, headaches, and acne. Hormonal IUDs may also increase the risk of ovarian cysts.

In addition to the above, both types of IUDs can cause perforation of the uterine wall and can easily be expelled. About 1 in 1,000 women will have an IUD retained in their body or perforate the uterine wall, usually during insertion. In the first year, about 2 to 10 IUDs out of 100 will be expelled from the uterus into the vagina. Expulsion is more likely when the IUD is inserted immediately after childbirth, in women who are not pregnant, or in women under 20 years of age.

Another limitation of currently used IUDs is malpositioning. An IUD that fails to stay in place or migrates out of its optimal position during use may be less effective in preventing pregnancy. If pregnancy does occur, the presence of the IUD increases the risk of miscarriage, especially during the second trimester. Removing the IUD at the start of pregnancy still carries the risk of preterm birth.

Therefore, it would be highly advantageous to have a uterine implantable device that could be used to prevent pregnancy or treat uterine-related disorders without the limitations described above.

Summary of the Invention

According to one aspect of the present invention, there is provided an intrauterine device comprising a thread including a portion forming a three-dimensional configuration, the portion being elastically deformable into a partially collapsed configuration by a squeezing force greater than the force applied thereto by a relaxed uterine cavity, the three-dimensional configuration being capable of elastically contracting and expanding in response to contraction and expansion of the uterine cavity.

According to further features in preferred embodiments of the invention described below, the squeezing force is at least 15 g/cm ² and no more than 60 g/cm ^2. Preferably, the intrauterine device is configured such that a squeezing force of approximately 15 g/cm ² partially collapses the generally spherical three-dimensional configuration, while any additional squeezing force further collapses the device, collapsing it to an almost completely flattened shape with a total squeezing force of approximately 50-60 g/cm ² .

According to still further features in the described preferred embodiments, the three-dimensional configuration has a diameter of 12-20 mm, preferably 13 mm in diameter.

According to still further features in the described preferred embodiments, the three-dimensionally configured string can be elastically linearized to the free end of the string by a tensile force of 100-150 grams.

According to still further features in the described preferred embodiments, the three-dimensional configuration is formed by at least two annular structures that are angled relative to each other.

According to still further features in the described preferred embodiments, the wire has a diameter of 0.4-0.6 mm.

According to still further features in the described preferred embodiments, the wire is made of Nitinol.

According to still further features in the described preferred embodiments, at least two of the annular structures are positioned at an angle of 80-100 degrees relative to each other.

According to still further features in the described preferred embodiments, each of the at least two annular structures has a diameter of 12-14 mm.

According to still further features in the described preferred embodiments, the angle between the at least two annular structures decreases when the three-dimensional configuration elastically contracts.

According to still further features in the described preferred embodiments, at least one of the at least two annular structures elastically ovalizes when the three-dimensional configuration elastically contracts.

According to still further features in the described preferred embodiments, the device further comprises a bead attached to the wire.

According to still further features in the described preferred embodiments, the beads have a diameter of 1.5-6.0 mm.

According to still further features in the described preferred embodiments, the beads are spaced apart along lines forming the three-dimensional configuration.

According to still further features in the described preferred embodiments, a portion of the bead is free to slide on the wire.

According to still further features in the described preferred embodiments, the beads are made of copper.

According to still further features in the described preferred embodiments, the beads comprise an active agent.

According to still further features in the described preferred embodiments, the active agent is selected from the group consisting of: a hormone, a tissue ablative agent, a chemical agent, and a pharmaceutical agent.

According to still further features in the described preferred embodiments, the thread is coated with a material capable of releasing the active agent in the uterine cavity.

According to still further features in the described preferred embodiments, the active agent is selected from the group consisting of: a hormone, a tissue ablative agent, a chemical agent, and a pharmaceutical agent.

According to another aspect of the present invention, a system for treating the uterine cavity is provided, comprising: (a) a wire including a portion forming a three-dimensional configuration, the portion being elastically deformable into a partially collapsed configuration by a compressive force greater than the force applied thereto by the relaxed uterine cavity, the three-dimensional configuration being capable of elastically contracting and expanding in response to contraction and expansion of the uterine cavity; and (b) a delivery guide for advancing the wire into the uterine cavity.

According to still further features in the described preferred embodiments, the conveying guide maintains the wire in a linear configuration such that a portion of the wire forms a three-dimensional configuration when ejected from the conveying guide.

According to still further features in the described preferred embodiments, the three-dimensional configuration is formed by the sequence of wire loops as a portion of the wire is pushed out of the delivery guide.

According to still further features in the described preferred embodiments, the system further includes an imaging or illumination unit attachable to the transport guide.

According to yet another aspect of the present invention, there is provided a method of treating a uterine cavity, the method comprising delivering an intrauterine device into the uterine cavity, the device comprising: a thread having a portion forming a three-dimensional configuration, the portion being elastically deformable into a partially collapsed configuration by a compressive force greater than the force applied thereto by the relaxed uterine cavity, the three-dimensional configuration being capable of elastically contracting and expanding in response to contraction and expansion of the uterine cavity.

According to still further features in the described preferred embodiments, the thread comprises an active agent selected from the group consisting of a contraceptive agent, a drug, a tissue ablative agent, a chemical agent, and a pharmaceutical formulation.

The present invention successfully addresses the shortcomings of currently known configurations by providing an IUD that is configured for maximum stability in the uterine cavity with minimal uterine wall irritation (maximum compliance) and user discomfort.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those of ordinary skill in the art to which the present invention belongs. Although methods and materials similar or equivalent to those described herein can be used for the practice or testing of the present invention, suitable methods and materials are described below. In the event of conflict, the patent specification (including definitions) shall prevail. In addition, materials, methods and examples are only illustrative and are not intended to be limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is described herein by way of example only and with reference to the accompanying drawings. With specific and detailed reference now to the drawings, it should be emphasized that the details shown are by way of example only and are intended solely for the purpose of illustrative discussion of preferred embodiments of the invention, and are presented in order to provide what is believed to be the most useful and understandable description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to illustrate structural details of the invention in greater detail than is necessary for a basic understanding of the invention, the description taken in conjunction with the drawings making clear to those skilled in the art how several forms of the invention may be implemented in practice.

In the attached figure:

1a-b illustrate the uterine cavity in a relaxed state (Fig. 1a) and a prior art T-shaped IUD positioned within the relaxed uterine cavity (Fig. 1b).

Figure 2 shows the device in a three-dimensional configuration.

FIG. 3 shows the device of FIG. 2 partially compressed by the force of a relaxed uterine wall.

FIG. 4 shows a configuration of the device of FIG. 2 including copper ion-releasing beads disposed on a thread.

Figure 5 shows a delivery guide that may be used to deliver the present device into the uterine cavity.

Figures 6a-c illustrate the progressive formation of the three-dimensional configuration of the device as it is pushed out of the delivery guide in the uterine cavity.

DETAILED DESCRIPTION

The present invention is an implantable device that can be used to prevent pregnancy or treat uterine-related diseases. Specifically, the present invention relates to an intrauterine device that can release an active agent suitable for preventing pregnancy, release hormones for menopausal treatment, treat intrauterine infections, or treat endometrial and myometrial lesions.

The principles and operation of the present invention may be better understood with reference to the drawings and accompanying descriptions.

Before explaining at least one embodiment of the present invention in detail, it should be understood that the present invention is not limited in its application to the details set forth in the following description or illustrated by the examples. The present invention can have other embodiments or be practiced or carried out in various ways. In addition, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered as limiting.

In the relaxed state, the uterine cavity is merely a narrow slit with essentially no volume ( FIG. 1 a). During uterine contractions, the uterine walls relax and contract relative to each other. When relaxed, the uterine walls exert an inward force of 10 mmHg (approximately 13.5 grams/cm ² ). However, under contraction, the inward force exerted by the uterine walls can rise to as much as 50-60 mmHg (approximately 67-82 grams/cm ² ) and higher (Gestel et al., Human Reproduction Update, Vol. 9, No. 2, 2003, pp. 131-138).

The overall design of the currently used IUD has not changed in decades, dictated by the anatomical spatial limitations of the relaxed uterus. Consequently, the most widely used IUD is configured as a flat, T-shaped device (Figure 1b), which minimizes forced contact between the IUD and the relaxed uterine wall, although its three sharp edges can prick and irritate the contracting wall. Although this design is effective in preventing pregnancy, it can lead to perforation, dislocation, and expulsion because any device stabilizing force provided by the relaxed uterine wall is greatly reduced during uterine contractions.

Furthermore, currently used IUDs are difficult to transport due to their flat T-shaped design and can cause perforation of tissue walls during insertion due to the forward arrow motion upon exiting the insertion device.

To address these issues with flat IUDs, the present inventors described in a previous application (US20110271963) a three-dimensional IUD that is formed from a single wire when delivered into the uterine cavity and is capable of contracting and expanding with the movement of the uterine wall, while assuming a substantially flat configuration when the uterus is in a relaxed state.

Experiments using this breakthrough design demonstrated a reduced incidence of migration and high levels of comfort among test subjects. While this design has been shown to be less susceptible to migration than flat IUDs, improvements have been made to the device to increase its stability in the uterus, particularly during periods of flaccidity.

While reducing the present invention to practice, the inventors unexpectedly discovered that by not completely flattening the relaxed uterine wall but applying a slight counterforce to the uterine wall, the device is less likely to migrate, become dislocated, and be expelled from the uterus. Without wishing to be bound by theory, the inventors suspect that a completely flat device composed of a single (multi-loop) wire is susceptible to 'device creep' caused by movement of the relaxed uterine wall.

To address this issue, the inventors designed a three-dimensional device characterized by specific compression forces and diameter ranges that prevent the device from completely flattening under the forces exerted by the walls of a relaxed uterus, while enabling the device to contract and expand with an active uterus.

As further described in the Examples section below, these features provide the intrauterine device of the present invention, wherein the substantial advantages of the device, particularly with regard to device stability, are described in US20110271963.

Thus, according to one aspect of the present invention, an intrauterine device is provided. As used herein, an "intrauterine device" refers to any device that can be implanted in the uterine cavity, preferably by delivery through the vaginal cavity and cervix. As further described herein, such a device is preferably configured to release an active agent capable of preventing pregnancy (contraception or birth control IUD) or treating uterine disorders, such as menorrhagia or medical or surgical treatment of the endometrium or myometrium for any duration (including minutes, hours, days, weeks, months or years).

The device includes a wire having a portion capable of forming an elastically deformable three-dimensional configuration.

The thread can be composed of a selected elastic material that can be preformed into a three-dimensional configuration and linearized by tension on the ends of the thread. This transition between the three-dimensional configuration and the linear configuration can be repeatedly achieved due to the elasticity of the material and its ability to maintain a three-dimensional shape without any tension on the ends of the thread (e.g., shape memory).

Examples of materials suitable for this purpose include alloys such as stainless steel, nickel-titanium, copper-aluminum-nickel and other copper-containing alloys or polymers such as polyurethanes, polyols, polyethylene terephthalate and acrylates.

The wire may be 50-100 mm long, of which the portion forming the three-dimensional configuration is 50-100% (10-100 mm) of the total length.

The three-dimensional configuration of the present device is formed by two or more sequential rings of lines angled relative to each other. The diameter of the rings can be 12-18 mm and are arranged (in a double ring configuration) so that one ring is located in the plane of the second ring and is angled 60-120 degrees (preferably 80-100 degrees) relative to it (the angle is measured at the line portion that interconnects the rings). Thus, the rings form a ring-in-ring structure that 'captures' a roughly spherical volume of approximately 0.9-3.0 cm ³ (preferably 1-1.5 cm ³ ) with a surface area of 4.5-10.1 cm ² (preferably 6-8 cm ² ). A further description of the three-dimensional configuration of the linear/linearized line and the formation of the rings is provided below.

As described above, the present device is designed to improve the stability of previous designs. To provide the necessary stability, the inventors have found that a wire diameter of 0.3-1.0 mm combined with an overall device diameter of 12-20 mm results in elastic resistance to the wall forces of a relaxed uterus and slight shape changes of the device under such forces, while enabling the device to contract and expand with the active uterus (and almost completely flatten under strong contractions). Although the present device exerts a counterforce on the relaxed uterine wall, this counterforce does not cause tissue irritation and does not cause any discomfort.

As mentioned above, the device of the present invention may be used as a birth control device or as a device suitable for treating uterine disorders such as menorrhagia or other endometrial or myometrial disorders.

Thus, the device may be configured to release metal ions or hormones (e.g., progesterone, estrogen, foetal hormone, LH and/or FSH), antibiotics, anti-inflammatory drugs, silver nitrate and/or other chemical agents suitable for preventing pregnancy or treating uterine-related diseases and conditions.

The active agent may be released from the thread, a coating disposed thereon, or from structures such as beads disposed on the thread.

For example, in the case of copper, the device may comprise a copper bead having a diameter of 1.5-6.0 mm mounted on a wire. The bead may be composed of pure copper, gold or silver or any other metal having contraceptive activity.

The beads may be threaded onto a wire and free to move on the wire, in which case the beads include a central through hole (0.4-1.1 mm in diameter), and/or they may be fixed to the wire by adhesive or crimping. A configuration of the present device including fixed and free-moving beads is shown in FIG4 , which is described in more detail below.

Copper ions may also be released from a copper-containing coating that is bonded to or formed on the wire by, for example, printing, vapor deposition, spraying, or the like.

Hormones such as estrogen, progesterone, gonadotropins, etc. can be released from hormone-containing beads or from a coating made of a hormone-containing polymer such as silicone or polyvinyl alcohol (PVA).

Ablative agents such as trichloroacetic acid, silver nitrate, cantharidin, vitamin A derivatives, or other chemical tissue disrupting agents can be released from beads or coatings containing the ablative agent. The beads or coatings can contain the agent and an optional carrier material. The beads can be fixedly attached to the wire or slidably mounted on the wire.

Referring now to the drawings, FIG. 1 illustrates one embodiment of the present apparatus, referred to herein as apparatus 10 .

The device 10 includes a wire 12 formed into a three-dimensional configuration 14 from a first loop 16 adjacent to a second loop 18. The ends of the wire 12 (indicated by E) are turned inward in the direction of the volume defined by the loops 16 and 18 of the device 10. Any of the ends E can be connected to a pull cord 57 (Figures 3 and 5) for loading the device 10 into the transfer guide and for removing the device 10 from the body. Such a pull cord can be made of nylon, polypropylene, or polyethylene attached to the wire by adhesive crimping or the like. The function of the pull cord 57 is described below.

The rings 16 and 18 are connected by an abutment section 20 which forms an angle 'A' between the rings 16 and 18; the angle 'A' may be 80-100 degrees.

The overall diameter (D) of the device 10 may be 12-15 mm, preferably 13 mm. The rings 16 and 18 may be substantially equal to a diameter (d) of 12-18 mm, preferably 13 mm. The diameter (wd) of the wire 12 may be 0.4-1.0 mm, preferably 0.6 mm.

As described above, device 10 is configured to partially compress under the force exerted by the walls of the relaxed uterine cavity.

For example, a device 10 having an overall diameter of 13 mm, comprised of two adjacent loops (13 mm diameter) of nitinol wire (0.5 mm diameter) formed into two adjacent loops at a 90-degree angle relative to each other, will partially collapse under a force of 13.6 g/cm ² to form a generally oval shape with a height of 10 mm ( FIG. 3 ). When partially collapsed, the device 10 exerts an elastic reaction force against the wall of the uterine cavity, thereby firmly securing the device 10 in place. Near-flattening of this configuration of the device 10 would require approximately 50-60 g/cm ² .

Collapse of device 10 under such forces is effected by two separate or combined mechanisms, angle A (elastic bending at segment 20) and shape change (circular to elliptical) of each of rings 16 and 18 (elastic bending of the rings).

Collapse along one axis of the device 10 is primarily mediated by segment 20, which can bend under relatively low forces (exerted by the relaxed uterine wall). This collapse enables the device 10 to assume the elliptical configuration described above. Collapse along other axes requires greater forces (uterine contraction) because it requires a change in the shape of the rings 16 and 18 (circular to elliptical) (and further bending of segment 20). Collapse along a combination of axes is also possible and will depend on the orientation of the device 10 in the uterine cavity and the type of contraction.

4 shows a configuration of device 10 that includes beads 22 disposed on string 12. As described above, beads 22 may be fixed to string 12, and/or they may be free to move on string 12. In the configuration shown in FIG4 , beads 24 and 26 are fixed to the ends of string 12, while the middle bead 22 is free to move along string 12.

The securing beads 24 and 16 provide several advantages while allowing the bead 22 (intermediate the beads 24 and 26) to slide freely on the wire 12. The beads 24 and 26 protect (and blunt) the end of the wire 12, thereby minimizing the chance of tissue perforation during delivery and avoiding any sharp edges from irritating or piercing the tissue during use.

Allowing beads 22 (intermediate beads 24 and 26) to slide freely on thread 12 optimizes contact between beads 22 and the uterine wall, thereby maximizing contact between the active agent contained therein and the tissue wall and reducing potential irritation that may be caused by fixed beads during use.

Furthermore, as the device 10 cyclically contracts and expands, beads affixed along the wire 12 may obstruct each other and interfere with the device's expansion or contraction. By allowing the beads 22 to slide along the wire 12, the chance of bead obstruction is reduced. This is particularly important when removing the device 10, as the linearization of the wire may be limited by bead obstruction.

The device 10 can be manufactured by wrapping a wire (e.g., Nitinol) around a mold (e.g., a mandrel) that can hold the wire in the desired form. The mold and the wrapped wire are then heated or chemically treated for a specific period of time to set the wire into the molded shape, and the shaped wire is removed from the mold. The resulting wire structure can then be coated and/or the beads can then be threaded with front and rear beads permanently attached to the wire by welding. Any excess wire protruding beyond the front or rear beads can then be trimmed.

As described above, device 10 is implanted in the uterine cavity to release the active agent therein.

Delivery and implantation of the device 10 in the uterine cavity is preferably performed using a dedicated delivery guide.

FIG. 5 illustrates one configuration of such a transfer guide, referred to herein as guide 50 .

The guide 50 includes a hollow tube 52 having a distal opening 53 and a proximal opening 55 defining a lumen therebetween. The wire 12 with the mounted beads 22 and the attached pull cord 57 is linearized and placed within the lumen of the tube 52. The device 10 can be loaded into the lumen by threading the pull cord 57 through the lumen and pulling it through, thereby linearizing the three-dimensional configuration formed by the wire 12 as it is pulled into the lumen. A typical pulling force required for this linearization can be 100-150 grams.

The guide 50 also includes a plunger 54 having a shaft 58 fitted with a handle 56. The plunger shaft 58 is fitted into the lumen of the tube 52 through the proximal opening 55. The handle 56 is used to advance the shaft 58 within the lumen of the tube 52, thereby advancing the wire 12 with the fitted beads 22 out of the distal opening 53, thereby gradually forming the double-ring three-dimensional configuration of the device.

6a-c illustrate the use of delivery guide 50 to deliver device 10 into the uterine cavity.

The distal opening 53 of the guide 50 can be placed in the uterine cavity by measuring the uterine depth using a hysterometer (sound) before insertion. Depending on the insertion depth of the guide 50, the measured depth from the fundus to the external opening of the cervical canal is marked on the tube 52.

6a-c, a plunger 54 (not shown in FIG6a-c) is then used to push the string 12 and attached beads 22 away from the opening 53, thereby forming a first loop (FIG. 6b) and a sequential second loop (FIG. 6c) of the 3D structure of the device 10 from the linear line. The delivery guide 50 is then removed from the body, leaving the device 10 in the uterus with the proximal end of the attached drawstring 57 positioned at the vaginal cavity.

The delivery guide 50 may also include an attached light source (e.g., an LED or fiber optic light) to illuminate the uterine cavity with white light or a specific wavelength of light (e.g., blue light). The delivery guide may also include a camera for 3D imaging of the uterine cavity rather than using a hysteroscope.

As used herein, the term "about" refers to ±10%.

Additional objects, advantages and novel features of this invention will become apparent to one of ordinary skill in the art upon examination of the following examples, which are not intended to be limiting.

Example

Reference is now made to the following examples, which together with the above descriptions illustrate the invention in a non limiting fashion.

Example 1

A clinical study using an IUD device based on the teachings of US20110271963 began in January 2014. The study included fifty female subjects, including one who had undergone abortion, 39 with menorrhagia, and 44 nulliparous women.

Three-month follow-up data were obtained and analyzed for 29 of the 51 test subjects. Ten expulsion events were reported. No reports of pregnancy, perforation, or dislocation were reported. Of the 29 monitored subjects, 19/29 reported being "very happy" and 9/29 were "somewhat happy."

While the study lacked comparative means and provided limited basis for analysis, it was observed that expulsion issues may exist. To address this, the IUB was modified as described herein to improve the device's performance in the field. Design changes included increasing the frame diameter by 30% from 10 mm to 13 mm and increasing the frame stiffness by increasing the wire diameter by approximately 30% (from 0.335 to 0.432), further reducing ductility, which in turn should facilitate better placement.

Example 2

Multicenter study

A multicenter study was conducted to test the device's expulsion and pregnancy rates, as well as the number of malpositions. The patient population ranged from 15 to 220 years old and included women aged 15 to 42 years who met specific inclusion and exclusion criteria and required long-acting reversible contraception.

Table 1 below summarizes these findings.

Table 1 - Clinical data collected from four studies using this device

Research Group insert discharge Discharge rate pregnancy Pregnancy rate dislocation A 15 0 0 0 0 0 B 50 10 20% 0 0 0 C 220 5 2.2% 1 0.45% 0 D 200 8* 5% 0 0 0 total 485 twenty three 4.7% 1 0.2% 0

*Six of the eight expulsions observed by the same physician were due to a non-recommended insertion technique that appeared to involve withdrawing the tube 1.5 cm prior to device deployment. Corrective action was taken.

Overall data appear to be consistent with or improve upon published adverse event rates. Expulsion rates in Study B were associated with poorer candidate selection (more than half had menorrhagia and dysmenorrhea at baseline) and the use of an unusually aggressive insertion technique. Almost all expulsions occurred in young minors and post-abortion patients.

QOL parameters (ie, satisfaction, lack of pain, and bleeding) appeared to be equivalent to or better than expected for all groups, including study group B. Overall, the results with this device are promising.

It is understood that certain features of the present invention that are described in the context of separate embodiments for clarity may also be provided in combination in a single embodiment. Conversely, different features of the present invention that are described in the context of a single embodiment for brevity may also be provided separately or in any suitable subcombination.

Although the present invention is described in conjunction with specific embodiments of the present invention, it will be apparent that many changes, modifications and variations will be clear to those skilled in the art. Therefore, it is intended to include all such changes, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are incorporated herein by reference in their entirety, to the extent that each independent publication, patent or patent application is specifically and individually indicated to be incorporated herein by reference. In addition, the quoting or identification of any reference in this application should not be construed as admitting that these references can be used as prior art of the present invention.

Claims (12)

1. An intrauterine contraceptive device comprising a thread carrying a plurality of beads, a portion of which is slid freely on the thread, the thread including a portion forming a three-dimensional configuration, the portion being elastically deformable into a partially collapsed configuration by a compressive force greater than that applied thereto by a relaxed uterine cavity, the compressive force being at least 15 g/ ^cm² ; the three-dimensional configuration being elastically contracting and expanding in response to contraction and expansion of the uterine cavity. 2. The device as claimed in claim 1, wherein the diameter of the three-dimensional configuration is 13-20 mm. 3. The apparatus of claim 1, wherein the line of the three-dimensional configuration can be elastically linearized by a tension of 100g-150g at the free end of the line. 4. The device of claim 1, wherein the three-dimensional configuration is formed by at least two annular structures that are angled relative to each other. 5. The device of claim 4, wherein each of the at least two annular structures has a diameter of 12-14 mm. 6. The apparatus of claim 4, wherein when the three-dimensional configuration elastically contracts, the angle between the at least two annular structures decreases; and/or when the three-dimensional configuration elastically contracts, at least one of the at least two annular structures elastically becomes elliptical. 7. The device of claim 1, wherein the diameter of the bead is 1.5-6.0 mm. 8. The apparatus of claim 1, wherein the beads are spaced apart along the lines forming the three-dimensional configuration. 9. The device of claim 1, wherein the bead is made of copper. 10. The apparatus of claim 1, wherein the beads comprise an active agent; the active agent is selected from the group consisting of hormones, tissue ablatives, chemical reagents, and pharmaceutical preparations. 11. The device of claim 1, wherein the thread is coated with a material capable of releasing an active agent into the uterine cavity. 12. The apparatus of claim 11, wherein the active agent is selected from the group consisting of hormones, tissue ablatives, chemical reagents, and pharmaceutical preparations.