JP2019171193A - Device positionable in uterine cavity - Google Patents

Abstract

To provide an intrauterine contraceptive device and a method of delivering and using the same.SOLUTION: The intrauterine contraceptive device includes a wire having a portion capable of forming a three dimensional (3D) structure. The 3D structure is elastically deformable to a partially collapsed configuration via a crush force larger than a force applied thereto by a relaxed uterine cavity. The three dimensional structure is also capable of elastically contracting and expanding in response to contraction and expansion of the uterine cavity.SELECTED DRAWING: Figure 2

Description

  The present invention relates to a device that can be placed in the uterine cavity, and more particularly to an intrauterine device that is configured for contraception or to treat a uterine related disorder, such as menorrhagia.

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

  Copper-added IUDs (eg, paragard) are the most commonly used IUDs. Copper-added IUD forces the uterus and fallopian tube to produce fluids containing leukocytes, copper ions, enzymes, and prostaglandins that are toxic to sperm.

  Hormone-added IUDs (eg Milena or Skyra) release a form of progestin in the hormone. Hormonal addition IUD damages or kills sperm, prevents sperm from moving to the uterus (by making mucus viscous and sticky), and prevents implantation and growth of fertilized eggs (endometrial thickening) Prevent fertilization by preventing). In addition, hormone-added IUD can reduce menstrual bleeding and convulsions.

  Both copper-added IUD and hormone-added IUD are effective for contraception (hormone-added IUD may be slightly more effective than copper-added IUD), both of which have some inherent limitations. Copper-added IUD can increase menstrual bleeding and convulsions, but hormone-added IUD can cause side effects similar to those caused by oral contraceptives such as breast tenderness, mood swings, headache, acne . Hormone-added IUD may also increase the risk of ovarian cysts.

  In addition to the above, both types of IUDs can cause uterine wall perforation and are subject to expulsion. In as many as one in 1,000 women, IUDs usually pierce or perforate the uterine wall during insertion. In the first year, about 2 to 10 IUDs out of 100 are discharged from the uterus into the vagina. If you insert an IUD immediately after giving birth, or if you are a woman who has never been pregnant or a woman under 20 years of age, you are more likely to escape.

  Another limitation of the IUD currently in use is location failure. An IUD that is not in the correct position or moved from an optimal position during use may be less effective in contraception. When pregnant, the presence of IUD increases the risk of miscarriage, especially in the second trimester. Removing IUD early in pregnancy still carries the risk of preterm birth.

  Thus, it would be highly advantageous to have a device that can be implanted in the uterus that does not have the above limitations but can be used for contraception or treatment of uterine related disorders.

  In accordance with one aspect of the present invention, it includes a portion that forms a three-dimensional structure that is elastically deformable into a partially collapsed configuration by a crush force greater than the force applied by the relaxed uterine cavity. An intrauterine contraceptive device comprising a wire is provided, wherein the three-dimensional structure can elastically contract and expand in response to contraction and expansion of the uterine cavity.

According to further features in preferred embodiments of the invention described below, the crushing force is at least 15 g / cm ² and not more than 60 g / cm ² . Preferably, the intrauterine contraceptive device partially collapses a generally spherical three-dimensional structure with a crushing force of about 15 g / cm ² , while any further crushing force further forces the device to about 50-60 g / cm ² . Configured to be almost completely flat with total crushing force.

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

  According to still further features in the described preferred embodiments, the wire of the three-dimensional structure can be elastically linearized by a traction force of 100-150 g against the free end of the wire.

  According to still further features in the described preferred embodiments the three-dimensional structure is formed by at least two loop-like structures that are angled with respect to each other.

  According to still further features in the described preferred embodiments the wire diameter is between 0.4 and 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 the at least two loop-like structures are arranged at an angle of 80-100 ° with respect to each other.

  According to still further features in the described preferred embodiments the at least two loop-like structures are each 12-14 mm in diameter.

  According to still further features in the described preferred embodiments the angle between the at least two loop-like structures narrows when the three-dimensional structure contracts elastically.

  According to still further features in the described preferred embodiments at least one of the at least two loop-like structures is elastically elliptical when the three-dimensional structure is elastically contracted.

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

  According to still further features in the described preferred embodiments the bead diameter is between 1.5 and 6.0 mm.

  According to still further features in the described preferred embodiments the beads are spaced along the wire forming the three-dimensional structure.

  According to still further features in the described preferred embodiments a portion of the bead slides freely 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 hormones, tissue ablation agents, chemical agents, and pharmaceutical agents.

  According to still further features in the described preferred embodiments the wire 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 hormones, tissue ablation agents, chemical agents, and pharmaceutical agents.

  According to another aspect of the present invention, a system for treating a uterine cavity, (a) elastically deforming into a partially collapsed configuration with a crushing force greater than the force applied by the relaxed uterine cavity. A wire comprising a portion forming a possible three-dimensional structure, wherein the three-dimensional structure can elastically contract and expand in response to contraction and expansion of the uterine cavity; and (b) the wire in the uterine cavity And a delivery guide for advancing to a system is provided.

  According to still further features in the described preferred embodiments the delivery guide maintains the wire in a linear configuration such that the portion of the wire forms a three dimensional structure when advanced from the delivery guide.

  According to still further features in the described preferred embodiments the three dimensional configuration is formed by the sequential looping of the wire as the portion of the wire is advanced from the delivery guide.

  According to still further features in the described preferred embodiments the system further comprises an imaging unit or illumination unit attachable to the delivery guide.

  According to yet another aspect of the present invention, a method of treating a uterine cavity comprising delivering an intrauterine contraceptive device into the uterine cavity, wherein the device is crushed greater than the force exerted by the relaxed uterine cavity. Including a wire that includes a portion that forms a three-dimensional structure that is elastically deformable into a partially collapsed configuration by force, wherein the three-dimensional structure elastically contracts and expands in response to contraction and expansion of the uterine cavity A method that can be extended is provided.

  According to still further features in the described preferred embodiments the wire comprises an active agent selected from the group consisting of a fertility modulating agent, a drug, a tissue ablation agent, a chemical and a pharmaceutical.

  The present invention provides a currently known configuration by providing an intrauterine contraceptive device configured for maximum stability in the uterine cavity and minimal uterine wall stimulation (maximum compliance) and user discomfort. Successfully address the shortcomings.

  Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In the case of a dispute, the patent specification containing the definition will dominate. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

  The present invention will now be described, by way of example only, with reference to the accompanying drawings. DETAILED DESCRIPTION OF THE INVENTION The details presented will now be given by way of example only, with specific reference to the drawings, and for purposes of illustration only, and only for the purpose of illustrating the preferred embodiment of the present invention. It is emphasized that they are presented to provide what is considered to be the most useful and easily understood description of the conceptual aspects of the invention. In this respect, no further attempt is made to show structural details relating to the present invention in more detail than is necessary for a basic understanding of the present invention. It will be clear to those skilled in the art that some forms may actually be implemented.

The uterine cavity is shown relaxed. Fig. 2 shows a prior art T-shaped IUD placed in a relaxed uterine cavity. Figure 3 shows a device of the present invention in a three-dimensional configuration. Figure 3 shows the device of Figure 2 partially compressed by the relaxed uterine wall force. FIG. 3 shows the configuration of the instrument of FIG. 2 including copper ion releasing beads placed on a wire. Fig. 5 shows a delivery guide that can be used to deliver the device of the present invention to the uterine cavity. FIG. 4 shows the stepwise formation of the three-dimensional structure of the device of the present invention as it is pushed out of the delivery guide within the uterine cavity. FIG. 4 shows the stepwise formation of the three-dimensional structure of the device of the present invention as it is pushed out of the delivery guide within the uterine cavity. FIG. 4 shows the stepwise formation of the three-dimensional structure of the device of the present invention as it is pushed out of the delivery guide within the uterine cavity.

  The present invention is an implantable device that can be used for contraception or treatment of uterine related disorders. Specifically, the present invention relates to an intrauterine device capable of releasing an active agent suitable for contraception, hormone release for menopause treatment, treatment of intrauterine infection, or treatment of endometrial and myometrial disorders. .

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

  Before describing in detail at least one embodiment of the present invention, it should be understood that the application of the present invention is not limited to the details set forth in the following description or the details illustrated by the examples. . The invention is capable of other embodiments and of being practiced or carried out in various ways. It should also be understood that the wording and terminology used herein is for illustrative purposes and should not be considered limiting.

In the relaxed state, the uterine cavity is a mere slit with virtually no volume (FIG. 1a). While the uterus is contracting, the uterine walls relax and contract with each other. When relaxed, the uterine wall applies a force of 10 mmHg (about 13.5 g / cm ² ) inward, but under contraction, the force applied by the uterine wall inward is 50-60 mmHg (about 67-82 g / cm ² ) or more. (Gestel et al. Human Reproduction Update, Vol. 9, No. 2 pp. 131-138, 2003).

  The overall design of the IUD currently in use has not changed for decades. This is because the anatomical space of the relaxed uterus is pressed down. As such, the most widely used IUD is configured as a flat T-shaped instrument (FIG. 1b) that minimizes forced contact between the IUD and the relaxed uterine wall. However, the three sharp edges may pierce and stimulate the contracting wall. While such designs are effective in contraception, while the uterus is contracting, the force to stabilize the instrument provided by the relaxed uterine wall is significantly reduced, which can lead to perforation, misplacement, and prolapse. is there.

  In addition, currently utilized IUDs are difficult to deliver due to the flat T-shaped design and advance with an arrow-like movement as they exit the insertion instrument, resulting in perforations in the tissue wall during insertion. is there.

  In order to solve these problems of flat IUDs, we have described a three-dimensional IUD in a previous application (US Patent No. 20110196963), which is delivered during delivery into the uterine cavity. It is formed from a single wire and can be contracted and expanded in accordance with the movement of the uterine wall, assuming a substantially flat configuration when the uterus is in a relaxed state.

  Experiments conducted on this breakthrough design showed that the rate of movement decreased and the comfort level was high in the tested subjects. Although this design has been shown to be less susceptible to movement than a flat IUD, improvements have been sought for the instrument that increase the stability of the instrument in the uterus, especially when relaxed.

  In practicing the present invention, we unexpectedly did not completely flatten by a relaxed uterine wall, but rather a device that applied a slight counter-force to the uterine wall was difficult to move and misplaced. Has been found to be difficult to occur and to be excreted from the uterus. Without being bound by theory, the inventors have found that a completely flattened instrument composed of a single (multiple loop) wire is a “instrument swirl” caused by loose movement of the uterine wall. We think that it is easy to receive.

  To address this problem, we contracted and adjusted the instrument to the moving uterus while preventing the instrument from completely flattening under the force applied by the relaxed uterine wall. A three-dimensional instrument was designed that was characterized by a specific crushing force and diameter range that could be expanded.

  As further described in the Examples section below, these features provide considerable benefits over the device described in US Patent No. 20110196963, particularly with respect to device stability. Bring to the instrument.

  Accordingly, an intrauterine contraceptive device according to one aspect of the present invention is provided. As used herein, “intrauterine contraceptive device” refers to any device that can be implanted into the uterine cavity, preferably via delivery through the vaginal cavity and neck. As described further herein, such a device is preferably used for contraception for any length of time, eg, minutes, hours, days, weeks, months, or years. To release active agents that can be treated (contraceptive IUD or fertility adjusted IUD), or treatment of uterine disorders such as menorrhagia, medical or surgical therapy to the endometrium or myometrium Composed.

  The device of the present invention includes a wire having a portion that can form a resiliently deformable three-dimensional structure.

  The wire can be pre-shaped into a three-dimensional structure and can be composed of an elastic material selected so that it can be straightened by the traction forces on both ends of the wire. Such a transition between a 3D configuration and a linear configuration is repetitive due to the elastic nature of the material and the ability to maintain a 3D shape when there is no traction at the end of the wire (eg, shape memory). Can bring.

  Examples of suitable materials for such purposes include alloys such as stainless steel, nickel-titanium, copper-aluminum-nickel, and other copper-containing alloys, or polymers such as polyurethane, polyol, polyethylene terephthalate, and acrylate. Can be mentioned.

  The wire may have a length of 50 to 100 mm, and the portion forming the three-dimensional structure may be 50 to 100% of the entire length (10 to 100 mm).

The three-dimensional structure of the device of the present invention is formed by two or more continuous loops of wire that are angled with respect to each other. The diameter of the loops can be 12-18 mm, and one loop is arranged in the plane of the second loop and makes an angle of 60-120 °, preferably 80-100 ° with respect to each other (angle Is measured at the portion of the wire that connects the loops together (a two-loop configuration). Therefore, loop, the volume of 4.5～10.1Cm ² (preferably 6~8cm ²⁾ 0.9~3.0cm ³ substantially spherical having a surface area (preferably 1~1.5cm ³⁾ " It forms a loop-in-loop structure that “confines”. Further explanation regarding the formation of loops with three-dimensional structures and linear / linearized wires is given below.

  As explained above, the device of the present invention was designed to improve the stability of the previous design. In order to achieve the required stability, the inventors have found that a 0.3-1.0 mm diameter wire combined with an instrument with a total diameter of 12-20 mm provides an elastic resistance to the relaxed uterine wall force. Make and slightly change the shape of the instrument (and be almost completely flat under severe contraction) while allowing the instrument to contract and expand with the moving uterus under such force ) Was revealed. The device of the present invention applies an opposing force against the relaxed uterine wall, but such an opposing force does not cause irritation to the tissue and does not lead to any discomfort.

  As described above, the device of the present invention can be used as a fertility adjustment device, or as a device suitable for treating uterine disorders such as menorrhagia or other endometrial or myometrial disorders.

Thus, the device of the present invention may comprise metal ions or hormones (eg, progesterone, estrogen, menotropin hormone, LH and / or FSH), antibiotics, anti-inflammatory drugs, silver nitrate, and / or contraceptive or uterine related disorders and It can be configured to release other chemicals suitable for treating the condition.
The active agent can be released from the wire, a coating disposed thereon, or a structure such as a bead disposed on the wire.

  For example, in the case of copper, the device of the present invention may include 1.5 to 6.0 mm diameter copper beads mounted on a wire. Pure copper, gold, silver or any other metal can constitute a bead effective for contraception.

  The beads may be allowed to move freely over the wire through the wire, in which case the beads include a central through-hole (0.4-1.1 mm in diameter) and / or adhesive or crimping May be fixed to the wire. The configuration of the device of the present invention, including fixed beads and freely moving beads, is shown in FIG. 4, which will be described in more detail below.

  Also, for example, copper ions can be released from a copper-containing coating that is adhered by printing, vapor deposition, spray coating, or the like, or formed on a wire.

  Hormones such as estrogen, progesterone, menotopine and the like can be released from hormone-containing beads or coatings made of hormone-containing polymers such as silicone or polyvinyl alcohol (PVA).

  Ablation agents, such as trichloroacetic acid, silver nitrate, cantharidin, vitamin A derivatives or other chemical tissue disrupting agents, can be released from the ablation agent-containing beads or coatings. The bead or coating can include a drug and an optional carrier material. The beads may be fixed to the wire or slidably mounted on the wire.

  Referring now to the drawings, FIG. 2 shows one embodiment of the device of the present invention, referred to herein as device 10.

  The instrument 10 includes a wire 12, which forms a three-dimensional structure 14 with a first loop 16 that is continuous with a second loop 18. Both ends of wire 12 (indicated by E) are turned inward in the direction of the volume defined by loops 16 and 18 of instrument 10. Either end E can be tied to a traction string 57 (FIGS. 3 and 5) for mounting the instrument 10 into the delivery guide and for removing the instrument 10 from the body. Such traction strings can be made from nylon, polypropylene or polyethylene and are attached to the wire 12 through gluing, crimping, and the like. The function of the tow string 57 will be described below.

  Loops 16 and 18 are connected at a continuous segment 20, where an angle “A” is formed between loop 16 and loop 18. The angle “A” can be between 80 and 100 degrees.

  The overall diameter (D) of the instrument 10 can be 12-15 mm, preferably 13 mm. The loops 16 and 18 are substantially equal in diameter (d) of 12-18 mm, preferably 13 mm. The diameter (wd) of the wire 12 can be 0.4 to 1.0 mm, preferably 0.6 mm.

  As described above, the instrument 10 is configured to be partially compressed under the force applied by the wall of the relaxed uterine cavity.

For example, an instrument 10 having an overall diameter of 13 mm comprised of Nitinol wire (diameter 0.5 mm) formed in two continuous loops (diameter 13 mm) at an angle of 90 degrees to each other is 13.6 g Partly collapsed with a force of / cm ² to form a substantially oval shape (FIG. 3) with a height of 10 mm. When partially collapsed, the instrument 10 applies an elastic counterforce to the wall of the uterine cavity, thereby securing the instrument 10 in place. With this near flat arrangement of the instrument 10, about 50-60 g / cm ² would be required.

  The collapse of the instrument 10 under such a force can result in a change in angle A (elastically bending at segment 20) and a change in shape in each of loops 16 and 18 (from round to oval) (the loop is It is affected by two separate or combined mechanisms (bend by elasticity).

  The collapse of the instrument 10 along one axis is primarily mediated by the segment 20 which can be bent under relatively little force (issued by the relaxed uterine wall). By crushing in that way, the instrument 10 can assume the elliptical configuration described above. Since a change in shape in loops 16 and 18 (from round to oval) is required (as well as segment 20 bending further), greater force (in the uterus) is needed to collapse along the other axis. Shrinkage) is necessary. It is also possible to collapse the shaft together, depending on the direction of the instrument 10 in the uterine cavity and the type of contraction.

  FIG. 4 shows a configuration of the instrument 10 that includes a bead 22 disposed over the wire 12. As described above, the bead 22 may be secured to the wire 12 and / or the wire 12 may move freely. In the configuration shown in FIG. 4, the beads 24 and 26 are fixed at both ends of the wire 12, but the bead 22 in between moves freely along the wire 12.

  By securing the beads 24 and 16 while allowing the beads 22 (between the beads 24 and 26) to slide freely on the wire 12, several advantages are obtained. Beads 24 and 26 protect (and blunt) both ends of wire 12, minimizing the possibility of puncturing tissue during delivery and eliminating sharp corners from stimulating or puncturing tissue during use. To do.

  By allowing the bead 22 (between the beads 24 and 26) to slide freely on the wire 12, the contact between the bead 22 and the uterine wall is optimized, whereby the active agent contained therein The contact between the tissue wall and the tissue wall is maximized and reduces possible irritation that may be caused by beads that are stationary during use.

  In addition, as the instrument 10 contracts and expands periodically, beads that are secured along the wire 12 can catch each other and prevent the instrument from expanding or contracting. By allowing the beads 22 to slide along the wire 12, the likelihood of the beads being caught is reduced. This is especially important when removing the instrument 10 because the bead catching may prevent the wire from straightening.

  The device 10 can be made by wrapping a wire (eg, nitinol) around a mold (eg, a mandrel) that can maintain the wire in the desired form. The wire wound with the mold is then heated or chemically treated for a specified time to secure the wire in the molded shape, and the shaped wire is removed from the mold. The formed wire structure can then be coated and / or the beads can be passed through the wire with the leading and trailing beads permanently attached to the wire via soldering. Any excess wire that protrudes from the leading or trailing bead can then be cut off.

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

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

  FIG. 5 shows one configuration of such a delivery guide, referred to herein as guide 50.

  The guide 50 includes a hollow tube 52 with a distal opening 53 and a proximal opening 55 and defining a cavity therebetween. The wire 12 having the beads 22 to be installed and the attached pulling string 57 is arranged in a straight line in the lumen of the tube 52. The instrument 10 can be mounted in the lumen by passing the tow string 57 through the lumen and pulling it to straighten the three-dimensional structure formed by the wire 12 when pulled into the lumen. it can. Typical traction forces required for such linearization can be 100-150 g.

  The guide 50 also includes a plunger 54 having a shaft 58 fixed to the handle 56. The plunger shaft 58 is fitted into the lumen of the tube 52 from the proximal opening 55. The handle 56 is used to advance the shaft 58 into the lumen of the tube 52 so that the wire 12 and the fixed bead 22 step through the two-loop three-dimensional structure of the instrument of the present invention from the distal opening 53. Advance while forming.

  FIGS. 6a-6c illustrate delivery of the instrument 10 into the uterine cavity using the delivery guide 50. FIG.

  The distal opening 53 of the guide 50 can be placed in the uterine cavity by measuring the depth of the uterus before insertion using a hysterometer (sound). The measured depth from the bottom of the cervix to the outer uterine ostium is marked on the tube 52 as a reference for the insertion depth of the guide 50.

  Next, as shown in FIGS. 6a-6c, the plunger 54 (not shown in FIGS. 6a-6c) is used to advance the wire 12 and associated beads 22 from the distal opening 53, thereby increasing linearity. From the wire, a first loop (FIG. 6b) and a continuous second loop (FIG. 6c) of the 3D structure of the instrument 10 are formed. The delivery guide 50 is then removed from the body, leaving the instrument 10 and attached traction cord 57 in the uterus, and its proximal end is positioned in the vaginal canal.

  Delivery guide 50 can also include an attached light source (eg, LED or fiber optic light) to illuminate the uterine cavity with white light or a special wavelength of light (eg, blue light). The delivery guide can also include a camera for imaging the uterine cavity in 3D instead of using a hysteroscope.

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

  Additional features, advantages, and novel features of the present invention will become apparent to those skilled in the art upon examination of the following examples. The examples are not intended to be limiting.

  Reference is now made to the following examples. The examples, along with the above description, illustrate the invention in a non-limiting manner.

Example 1
A clinical study using an IUD device based on the teachings of US Pat. No. 20110196963 began in January 2014. The study included 50 female subjects, 1 postpartum subject, 39 men with severe menstruation, and 44 women who had never given birth.

  Three-month follow-up data from 29 of 51 test subjects were obtained and analyzed. Ten cases of escape were reported. There were no reports of pregnancy, perforation or poor positioning. Of the 29 monitored subjects, 19/29 reported “very satisfied” and 9/29 reported “somewhat satisfied”.

  There was no comparative arm in the study, and it was observed that there was a potential escape problem, although there were limitations in providing a basis for analysis. To address this problem, the IUD has been modified as described herein to improve the performance of the instrument in situ. For design changes, increase the frame diameter from 10 mm to 13 mm by 30%, increase the wire diameter from 0.335 to 0.432 by about 30% to increase the rigidity of the frame, and further reduce the malleability. It included encouraging better placement.

Example 2
Multicenter study A multicenter study was conducted to verify the escape rate and pregnancy rate as well as the number of occurrences of poor positioning of the device of the present invention. The number of patients varied from 15 to 220 and included women aged 15 to 42 years who required contraception to meet certain inclusion and exclusion criteria and to return to their original working state for a long time.
Table 1 below summarizes the results.

  Overall data appears to meet or improve published adverse event rates. For the escape rate in Study Group B, the selection of candidates was insufficient (more than half were suffering from menorrhagia and dysmenorrhea at the baseline) and abnormally invasive insertion was adopted. Is related to Almost all escapes were associated with young inexperienced and postpartum patients.

  QOL parameters, ie satisfaction, lack of pain and bleeding appear to be as good or better than expected in all groups, including Study Group B. Overall, the results of the device of the present invention are promising.

  It will be understood that certain features of the invention described in the context of separate embodiments for clarity may also be provided in combination in a single embodiment. Conversely, various features of the invention described in the context of a single embodiment for the sake of brevity can be provided separately or in any appropriate subcombination.

  While the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents, patents, patents, patents, patent applications, and patent applications referred to herein, as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. And patent applications are incorporated herein by reference in their entirety. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

Claims (6)

An intrauterine contraceptive device (10) comprising a wire (12) comprising a part forming a three-dimensional structure (14) composed of at least two loops perpendicular to each other, said three-dimensional structure (14) Has a crushing force of at least 15 g / cm ² so that the three-dimensional structure (14) elastically deforms into a partially collapsed configuration under the force applied by the relaxed uterine cavity; The intrauterine contraceptive device, wherein the three-dimensional structure (14) can elastically contract and expand in response to contraction and expansion of the uterine cavity.   The instrument according to claim 1, wherein the three-dimensional structure (14) has a diameter of 13 to 20 mm.   The instrument according to claim 1, wherein the diameter of the wire (12) is between 0.4 and 0.6 mm.   The instrument of claim 1, wherein the wire (12) is made of Nitinol.   The device of claim 1, wherein the wire (12) is coated with a material capable of releasing an active agent in the uterine cavity.   6. The device of claim 5, wherein the active agent is selected from the group consisting of hormones, tissue ablation agents, chemicals, and pharmaceuticals.