Inserter and retriever for intrauterine device (IUD) system

Abstract

Inserters and retrievers for an intrauterine device (IUD) system are disclosed. The IUD system may generally include at least one element comprising a magnetic core and a coating exterior to the magnetic core. Delivery and retrieval devices may generally include a catheter having an internal chamber dimensioned to hold the at least one element. Delivery devices may include a plunger slidably disposed within the internal chamber of the catheter, and retrieval devices may include a wand slidably disposed within the internal chamber of the catheter having a magnetic end. Related kits are also disclosed, as well as related methods of providing and facilitating controlled contraception.

Description

[0001] INSERTER AND RETRIEVER FOR INTRAUTERINE DEVICE (IUD) SYSTEM

[0002] CROSS REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application Serial No. 63 / 436,434 titled “INSERTER AND RETRIEVER FOR INTRAUTERINE DEVICE (IUD) SYSTEM” having a filing date of December 30, 2022 and U.S. Provisional Application Serial No. 63 / 541,564 titled “INSERTER AND RETRIEVER FOR INTRAUTERINE DEVICE (IUD) SYSTEM” having a filing date of September 29, 2023, each of which is incorporated herein by reference in its entirety for all purposes.

[0004] FIELD OF TECHNOLOGY

[0005] Aspects and embodiments disclosed herein are directed toward intrauterine device (IUD) systems and methods of providing contraception and / or treatment or prevention of a uterine disease, condition, or symptom thereof. In particular, aspects and embodiments disclosed herein are directed toward IUD systems having a plurality of magnetic IUD elements.

[0006] SUMMARY

[0007] In accordance with one or more aspects, a delivery device for an intrauterine device (IUD) system including at least one element comprising a magnetic core and a coating exterior to the magnetic core is disclosed. The delivery device may comprise a catheter having an internal chamber dimensioned to hold the at least one element, the catheter having an outer diameter (OD) dimensioned to pass through a cervix of a subject and a length dimensioned to deposit the at least one element in a uterus of the subject, and a plunger slidably disposed within the internal chamber of the catheter.

[0008] In some aspects, the catheter may be a 4.0 mm to 5.0 mm OD catheter. The catheter may have a flexibility selected to pass through the cervix of the subject for tenaculum-free insertion.

[0009] In some aspects, the IUD system may include a plurality of elements, the internal chamber being dimensioned to hold the plurality of elements in an axial or generally aligned conformation.

[0010] In some aspects, the catheter may extend from a body having an ergonomic configuration for handheld operation of the delivery device, the body comprising an actuator operably connected to discharge the plunger. The body may comprise a rotatable collar fixed to the catheter. The rotatable collar may comprise tactile detents positioned to indicate incremental rotation of the body to desirable positions.

[0011] In some aspects, the catheter may be dimensioned to deposit the at least one element in the uterus of the subject, the uterus of the subject having an anatomical geometry selected from anteflexed, anteverted, retroflexed, retroverted, midline, and combinations thereof, each independently of a first degree, second degree, or third degree.

[0012] In some aspects, the delivery device may further comprise a stopper positioned along the catheter at a distance selected to contact the cervix of the subject when the delivery device is positioned to deposit the at least one element in the uterus of the subject.

[0013] In some aspects, the internal chamber may comprise divots to position the at least one element in place. An opening of the internal chamber may comprise a crimpled edge to position the at least one element in place. The catheter may be configurable to position the at least one element to protrude from an opening at a distal end of the internal chamber during insertion. A distal end of the catheter may have a cervical dilating tip. The cervical dilating tip may comprise a tapered end and a rounded tip.

[0014] In some aspects, the internal chamber may comprise a lateral opening for release of the at least one element.

[0015] In accordance with one or more aspects, a retrieval device for an intrauterine device (IUD) system including at least one element comprising a magnetic core and a coating exterior to the magnetic core is disclosed. The retrieval device may comprise a catheter having an internal chamber dimensioned to hold the at least one element, the catheter having an outer diameter (OD) dimensioned to pass through a cervix of a subject and a length dimensioned to retrieve the at least one element from a uterus of the subject, and a wand slidably disposed within the internal chamber of the catheter having a magnetic end.

[0016] In some aspects, the IUD system may include a plurality of elements, the internal chamber being dimensioned to hold the plurality of elements in an axial or generally aligned conformation.

[0017] In some aspects, the magnetic end may be dimensioned to de-assemble the plurality of elements from a conformation that resists expulsion from the uterus of the subject into the axial or generally aligned conformation. The magnetic end may be dimensioned to provide a magnetic force between 0.05 Kg (0.5N) and 20 Kg (200 N).

[0018] In accordance with one or more aspects, a kit is disclosed. The kit may comprise an intrauterine device (IUD) system including at least one element comprising a magnetic core and a coating exterior to the magnetic core, a delivery device comprising a catheter having an internal chamber dimensioned to hold the at least one element, the catheter having an outer diameter (OD) dimensioned to pass through a cervix of a subject and a length dimensioned to deposit the at least one element in a uterus of the subject, and a plunger slidably disposed within the internal chamber of the catheter, and instructions to deliver the plurality of elements to the uterus of the subject using the delivery device.

[0019] In some aspects, the kit may further comprise a retrieval device comprising a catheter having an internal chamber dimensioned to hold the at least one element, the catheter having an outer diameter (OD) dimensioned to pass through the cervix of the subject and a length dimensioned to retrieve the at least one element from the uterus of the subject, and a wand slidably disposed within the internal chamber of the catheter having a magnetic end.

[0020] In accordance with one or more aspects, a method of providing controlled contraception or treating or preventing a uterine disease, condition, or symptom thereof in a subject is disclosed. The method may comprise delivering with a delivery device to a uterus of the subject a plurality of elements, each element comprising a magnetic core and a coating exterior to the magnetic core, the magnetic core being dimensioned to assemble the plurality of elements into a conformation that resists expulsion from the uterus of the subject. The delivery device may comprise a catheter having an internal chamber dimensioned to hold the plurality of elements, the catheter having an outer diameter (OD) dimensioned to pass through a cervix of a subject and a length dimensioned to deposit the plurality of elements in the uterus of the subject, and a plunger slidably disposed within the internal chamber of the catheter.

[0021] In some aspects, the method may comprise inserting the catheter through the cervix of the subject with tenaculum-free insertion. The method may comprise delivering the plurality of elements with sounding-free insertion of the delivery device.

[0022] In some aspects, the method may further comprise retrieving with a retrieval device the plurality of elements from the uterus of the subject, the retrieval device comprising a catheter having an internal chamber dimensioned to hold the plurality of elements, the catheter having an outer diameter (OD) dimensioned to pass through the cervix of the subject and a length dimensioned to retrieve the plurality of elements from the uterus of the subject, and a wand slidably disposed within the internal chamber of the catheter having a magnetic end. The method may comprise retrieving the plurality of elements from the uterus of the subject in an axial or generally aligned conformation.

[0023] In accordance with one or more aspects, a method of facilitating controlled contraception or treating or preventing a uterine disease, condition, or symptom thereof in a subject is disclosed. The method may comprise providing a plurality of elements, each element comprising a magnetic core and a coating exterior to the magnetic core, the magnetic core being dimensioned to assemble the plurality of elements into a conformation that resists expulsion from the uterus of a subject, and providing instructions to deliver the plurality of elements to the uterus of the subject with a delivery device comprising a catheter having an internal chamber dimensioned to hold the plurality of elements, the catheter having an outer diameter (OD) dimensioned to pass through a cervix of a subject and a length dimensioned to deposit the plurality of elements in the uterus of the subject, and a plunger slidably disposed within the internal chamber of the catheter.

[0024] In some aspects, the method may comprise providing the delivery device. The method may further comprise providing instructions to retrieve the plurality of elements from the uterus of the subject with a retrieval device comprising a catheter having an internal chamber dimensioned to hold the plurality of elements, the catheter having an outer diameter (OD) dimensioned to pass through the cervix of the subject and a length dimensioned to retrieve the plurality of elements from the uterus of the subject, and a wand slidably disposed within the internal chamber of the catheter having a magnetic end.

[0025] In some aspects, the method may further comprise providing the retrieval device.

[0026] The disclosure contemplates all combinations of any one or more of the foregoing aspects and / or embodiments, as well as combinations with any one or more of the embodiments set forth in the detailed description and any examples.

[0027] BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated in various figures is represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing. In the drawings:

[0029] FIG. 1A is a schematic drawing of a uterine implant element, according to one embodiment;

[0030] FIG. IB is a schematic drawing of three uterine implant elements arranged in a triad conformation, including a sectional and a partial sectional view of the uterine implant elements, according to one embodiment;

[0031] FIG. 1C is a sectional drawing of three uterine implant elements arranged in a triad conformation, showing shell thickness relationships, according to one embodiment; FIG. ID is a sectional drawing of a uterine implant element, showing beveled features, according to one embodiment;

[0032] FIG. IE is a sectional drawing of three uterine implant elements arranged in a triad configuration, showing beveled conjoining relationships, according to one embodiment;

[0033] FIGS. 2A-2C are sectional views of varied uterine implant elements, according to certain embodiments;

[0034] FIG. 3A is a schematic drawing showing magnetic field of three uterine implant elements arranged in a triad configuration, with each element containing a cylindrical magnetic core, according to one embodiment;

[0035] FIG. 3B is a schematic drawing showing magnetic field of three uterine implant elements arranged in a triad configuration, with each element containing a cylindrical magnetic core with beveled edges, according to one embodiment;

[0036] FIG. 3C is a schematic drawing showing overall profile of three uterine implant elements arranged in a triad configuration, according to one embodiment;

[0037] FIG. 3D is a schematic drawing showing overall profile of three uterine implant elements arranged in a triad configuration, having a smaller overall profile than the uterine implant elements of FIG. 3C, according to one embodiment;

[0038] FIG. 4 is a sectional view of a uterine implant element, according to one embodiment;

[0039] FIG. 5 is a chart comparing magnetic force for several magnetic core geometries and assembly configurations, according to certain embodiments;

[0040] FIG. 6 is a schematic drawing of a uterine implant element, according to one embodiment;

[0041] FIG. 7 is a sectional view of a uterine implant element, according to one embodiment;

[0042] FIG. 8 is a sectional drawing of a uterine implant element, showing magnetic flux patterns of an axial charge, according to one embodiment;

[0043] FIG. 9 is a schematic drawing of an IUD system, in accordance with one embodiment;

[0044] FIG. 10 is a partial sectional view of an IUD system, showing magnetic flux patterns, in accordance with one embodiment;

[0045] FIG. 11 is a schematic drawing of a uterine implant element, in accordance with one embodiment;

[0046] FIG. 12A is a schematic drawing of a plurality of contraceptive elements with a partial view of a delivery device, according to one embodiment;

[0047] FIG. 12B is a schematic drawing of a plurality of contraceptive elements with a partial view of a retrieval device, according to one embodiment; FIG. 13 includes several views of an inserter, according to one embodiment;

[0048] FIG. 14 includes several views of a retriever, according to one embodiment;

[0049] FIG. 15 is a schematic drawing of an inserter in use, according to one embodiment;

[0050] FIG. 16 is a schematic drawing of an inserter in use, according to one embodiment;

[0051] FIG. 17 is a schematic drawing of an inserter in use, according to one embodiment;

[0052] FIG. 18 includes a side view (top panel) and a top view (bottom panel) of an inserter, according to one embodiment;

[0053] FIG. 19 includes a side view (top panel) and a top view (bottom panel) of a retriever, according to one embodiment;

[0054] FIG. 20 is an exploded view of an inserter, according to one embodiment;

[0055] FIGS. 21A-21B are cutout views showing internal components of an inserter, according to one embodiment;

[0056] FIGS. 22A-22B are cutout views showing internal components of a retriever, according to one embodiment;

[0057] FIGS. 23A-23B are side views of exemplary retrievers, according to certain embodiments;

[0058] FIGS. 24A-24B include a schematic diagram and a side perspective view of an exemplary magnetic end, according to certain embodiments;

[0059] FIGS. 25A-25B include a schematic diagram and a side perspective view of an exemplary magnetic end, according to one embodiment;

[0060] FIGS. 26A-26D are schematic diagrams of exemplary magnetic ends positioned on a wand within a catheter, according to certain embodiments;

[0061] FIG. 27A includes photographs showing use of a retriever with the magnetic end of FIG. 26B;

[0062] FIG. 27B is a drawing showing the magnetic field of the magnetic end of FIG. 26B;

[0063] FIG. 28 includes photographs showing use of a retriever with the magnetic end of

[0064] FIG. 26D;

[0065] FIG. 29 is a side view of an inserter, according to one embodiment;

[0066] FIGS. 30A-30B include a side view and a partial side view of a retriever, according to one embodiment.

[0067] DETAILED DESCRIPTION

[0068] Contraception may be provided by a variety of methods. One of the safest and most effective methods is the placement of an intrauterine device (IUD) in the uterus of the subject to prevent pregnancy as a result of sexual intercourse. The IUD will generally have a contraceptive effect for the duration of the stay in the uterus. The contraceptive effect may be easily reversed by removing the IUD from the uterus.

[0069] Current IUDs on the market are T-shaped framed devices made of plastic that release a spermicide or a hormonal agent to provide contraception. These conventional IUDs may be very effective, but the T-shaped frame design leads to significant pain upon insertion, perforation of the uterus, expulsion from the uterus, and vaginitis caused by an external retrieval string. Accordingly, there is a need for improved IUDs that provide easier and less painful insertion and removal.

[0070] For insertion, the conventional T-shape IUDs require placement at the top of the uterus (fundus) with a hard, inflexible applicator device and require sounding, a procedure to measure distance from the cervical aperture to the fundal end of the uterus with a device (sound). Sounding adds a significant pain point to the IUD insertion process, as the fundus is particularly sensitive to probing with the sound. The conventional T-shape devices also require the use of a tenaculum for insertion. The tenaculum is a forceps with sharply pointed hooks for moving and / or holding the cervix during insertion of the IUD to allow entry into the uterus. The use of a tenaculum adds another step and significant pain point to the IUD insertion process. Accordingly, there is also a need for improved insertion of IUDs that provide easier and less painful insertion and removal, as well as fewer steps, such as by eliminating sounding and the user of a tenaculum.

[0071] The embodiments described herein provide an intrauterine device (IUD) system, e.g., a frameless IUD system, including one or more uterine implant elements which provide high effectiveness, are easily inserted, easily retrieved, and exhibit a high retention rate, without affecting future fertility. In certain embodiments, the IUD system is free of an external retrieval string. The embodiments described herein also provide an inserter and a retriever for the IUD system which provide insertion and retrieval without the use of a sound and / or without the use of a tenaculum.

[0072] Select Definitions

[0073] As used herein, “anti-fertility agent” means a drug, compound, or biological product having a contraceptive effect on a subject. The anti-fertility agent may be an active agent of a composition. In some embodiments, the anti-fertility agent may be a hormonal agent. In some embodiments, the anti-fertility agent may be a cytotoxic agent, sometimes referred to as a “spermicide”. The anti-fertility agent may also be referred to as a “contraceptive agent” herein.

[0074] As used herein, “hormonal agent” means an anti-fertility agent comprising a hormone or signaling molecule. The hormonal agent may be a naturally occurring hormone, e.g., progesterone. The hormonal agent may be a synthetic hormone, e.g., progestagens such as progestin.

[0075] As used herein, “cytotoxic” agent means a non-hormonal anti-fertility agent that targets sperm cells and / or ova cells. The cytotoxic agent may also be referred to as a spermicide or spermicidal agent. In certain exemplary embodiments, the cytotoxic agent may be copper.

[0076] As used herein, “contraception” means the prevention of pregnancy as a consequence of sexual intercourse. Contraception may include barrier methods, preventing ovulation in the female, inactivating or killing sperm, inhibiting or preventing motility of sperm, modulating cervical mucus, and / or preventing the fertilized ovum from implanting in the uterus.

[0077] As used herein, “inert” means non-toxic or non-harmful to surrounding tissues. An inert material may be biocompatible.

[0078] As used herein, a “subject” may include an animal, a mammal, a human, a non-human animal. The term “subject” is intended to include human and non-human animals, for example, mammals, large animals, livestock animals, companion animals, and primates. In certain embodiments, the subject is a mammalian subject, and in particular embodiments, the subject is a human subject. Although applications with humans are clearly foreseen, veterinary applications, for example, with non-human animals, are also envisaged herein. The term “non-human animals” of the disclosure includes all mammals, such as non-human primates, domesticated, laboratory / research, and agriculturally useful animals, for example, horse, sheep, goat, dog, cat, cow, pig, rat; wild carnivores, such as wolf, bear, cheetah, tiger, leopard, lion; ungulates such as wild hogs, boars; or ruminants / pseudo ruminants such as camels, deer, antelope, buffaloes; or large mammals such as elephants; among others. The subject may be biologically equipped to bear offspring. The subject may have a uterus or uterine cavity. The subject may be female. The subject may be of a childbearing age.

[0079] As used herein, “retention rate” means a percentage of IUD systems that remain in uterus of the subject after a selected period of time has elapsed from the date of insertion without voluntary removal. The elapsed period of time can be 24 hours, 48 hours, 72 hours, 7 days, one month, three months, six months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months, 132 months, 144 months, or more.

[0080] As used herein, treatment of a disease or condition refers to reducing the severity or frequency of at least one symptom of that disease or condition, compared to a similar but untreated patient. Treatment can also refer to halting, slowing, or reversing the progression of a disease or condition, compared to a similar but untreated patient. Treatment may comprise addressing the root cause of the disease and / or one or more symptoms.

[0081] Intrauterine Device (IUD) System

[0082] The disclosure provides an intrauterine device (IUD) system. The system may have one or more uterine implant elements, also referred to as intrauterine device elements, “IUD elements” or “elements” herein. The element may be a device for insertion into the uterus of a subject to provide contraceptive effects, inhibit, limit, or reduce side effects of menstrual periods, e.g., discomfort, pain, excessive bleeding, cramps, or inflammation, and / or treat or prevent uterine diseases, conditions, and symptoms thereof, e.g., abnormal uterine bleeding, irregular menstrual cycle, irregular vaginal discharge, endometriosis, adenomyosis, uterine fibroids, polyps, or cysts, polycystic ovary syndrome (PCOS), pelvic inflammatory disease, endometrial hyperplasia, uterine cancer, dysuria, genital tuberculosis, uterine prolapse, bacterial, parasitic, or viral sexually transmitted diseases, discomfort, pain, cramps, or inflammation.

[0083] Exemplary elements are shown in FIGS. 1A-1B. FIG. 1A shows a lateral side view of one uterine implant element 10. FIG. IB shows a lateral side view of several uterine implant elements 10 assembled in a conformation, in which one element is shown in a sectional view and another element is shown in a partial sectional view. The elements may include a magnetic core 11. The magnetic core may be an axially charged magnetic core, with opposing north (N) and south (S) poles at each end.

[0084] The element 10 may comprise one or more layers exterior to the magnetic core 11. The element 10 may comprise a shell 12 exterior to the magnetic core 11. In other embodiments, the element 10 may be substantially free of the shell 12. In one particular embodiment, the element 10 may comprise a coating exterior to the shell 12. In other embodiments, the element 10 may be substantially free of a coating exterior to the shell 12. The one or more layers of the element 10 may be selected based on function or manufacture.

[0085] The contraceptive or therapeutic effect of the elements may be provided by implantation of the elements in the uterus. The contraceptive or therapeutic effect may be provided by the geometry and physical features of the elements and / or arrangement or configuration of elements when placed in the uterus of the subject. In certain embodiments, the elements may be dimensioned to provide contraception. For example, in certain veterinary applications, such as equine mares, the suppression of estrus provided by the presence and / or geometry of the elements may provide contraception. In certain embodiments, the elements may be dimensioned to provide treatment or prevention of a uterine disease, condition, or symptom thereof. A therapeutic effect may be provided in addition to or alternatively to the contraceptive effect.

[0086] In some embodiments, the contraceptive effect of the elements may be provided by an anti-fertility agent. In one particular embodiment, the anti-fertility agent may be provided in a coating exterior to the magnetic core 11. In certain embodiments, the shell 12 may be formed of or comprise the anti-fertility agent. For instance, the anti-fertility agent may be homogeneously or non-homogeneously embedded in the shell 12. In other embodiments, the anti-fertility agent coating may be exterior to the shell 12. Thus, the anti-fertility agent coating may form an outermost layer of the element 10, such as an encasement, wire, sheath, or other structure on an exterior surface of the element 10.

[0087] The coating, e.g., anti-fertility agent coating or other coating, need not cover the complete surface of the element 10, for instance, the coating may cover at least 25%, 25% - 50%, 50% - 75%, or 75% - 100% of the exterior surface of the element 10. In yet other embodiments, the anti-fertility agent coating may form an internal layer of the element 10 (for example, between the core 11 and shell 12 layer) and be released through the shell 12. Exemplary anti-fertility agents include hormonal agents and cytotoxic agents.

[0088] The element may be dimensioned to be ergonomic (compatible with uterine tissues, optionally, maximize effectiveness, efficiency, safety, and comfort when inserted within the uterus of the subject). In some embodiments, the element may be ergonomic by adapting to the uterine shape and environment. The core and / or the shell of the element may be dimensioned to be ergonomic, providing the desired properties of the element. The element, e.g., core and / or shell, may have smooth, oval, or rounded edges. The element, e.g., core and / or shell, may be dimensioned to prohibit, limit, or reduce distortion or perforation of the uterine lining. The element, e.g., core and / or shell, may be dimensioned to reduce the likelihood of side effects associated with insertion, e.g., discomfort, pain, bleeding (e.g., excessive bleeding), cramps, or inflammation. In some embodiments, the element is oval (for example, having a rounded and slightly elongated outline or shape, like that of an egg; elliptical; ellipsoidal configuration). Each element 10 may have a length between about 1 mm to about 100 mm, for example, between about 1 mm to 50 mm, 1 mm to 30 mm, 1 mm to 20 mm, 1 mm to 10 mm, or 5 mm to 10 mm. In exemplary embodiments, for example, for use in humans, the element may have a length of less than 10 mm.

[0089] Each element 10 may have a width of between about 1 mm to about 30 mm, for example, between about 1 mm to 15 mm, 1 mm to 10 mm, or 2 mm to 6 mm. In exemplary embodiments, for example, for use in humans, the element may have a width capable of passing through the human cervix for placement within the uterine cavity. The exemplary element may have a width between 3 mm and 4.5 mm. In some embodiments, the element may have a width capable of passing through a catheter for implantation in the uterine cavity. The exemplary element may have a width of less than 4.5 mm, for example, 3 mm to 4.4 mm, 3 mm to 4.2 mm, or 3 mm to 4.0 mm.

[0090] Each element may have a mass of between 0.1 g to 100 g, for example, 0.1 g to 1.0 g, 0.1 g to 0.5 g, 0.4 g to 0.6 g, 0.6 g to 0.8 g, 0.5 g to 1.0 g, 0.5 g to 50 g, 0.5 g to 10 g, 0.5 g to 5 g, or 1 g to 2 g. In exemplary embodiments, each element may have a mass of about 0.5 g, 0.4 g to 0.6 g, or 0.6 g to 0.8 g. Together, three elements may have a mass of about 1.2 g, 1.5 g, 1.8 g, 2.1 g, or 2.4 g. In particular, exemplary elements having a polymeric shell may have a mass of about 0.1 to 0.3 g. Together, three elements having a polymeric shell may have a mass of about 0.6 g to 0.8 g.

[0091] The elements may be dimensioned to fit the target subject, for example, to pass through a cervix of the target subject and fit within a uterine cavity of the target subject. As disclosed herein, the uterine cavity may refer to the space inside the uterus, within opposed anterior and posterior moist mucous endometrial membranes and myometrial muscles. In certain embodiments, the elements 10 may be dimensioned to fit primates. For primates (e.g., human), the length of the element may be about 1 mm to about 10 mm, for example, about 7 mm to about 8.5 mm, and the width (or diameter) may be about 2 mm to about 6 mm, for example, about 3 mm to about 3.5 mm, about 3.5 mm to about 4 mm, or about 4 mm to about 5 mm.

[0092] The magnetic core 11 of the element 10 may be formed of or comprise a magnetic material. Exemplary magnetic materials include iron (or an ore, alloy, or other material) that has its component atoms so ordered that the material exhibits properties of magnetism, such as attracting other iron-containing objects or aligning itself in an external magnetic field. For example, the core 11 may be formed of or comprise materials that are magnetized (called ferromagnetic or ferrimagnetic). Exemplary magnetic materials include iron, nickel, cobalt, or an alloy thereof. The core may comprise an alloy of rare earth metal (e.g., neodymium, e.g., highly attractive neodymium), and a naturally occurring mineral, such as lodestone. In some embodiments, the elements may be substantially free of nickel.

[0093] The element 10 may comprise an optional shell 12 exterior to the magnetic core 11. The shell 12 may be formed of an inert material. The shell 12 may protect the magnetic core 11 from structural damage, such as, fracturing, cracking, chipping, corrosion, or any other structural damage. For example, neodymium cores may tend to be brittle. Multiple neodymium cores may fracture if impacted together. A shell can protect the neodymium core to prevent fracturing.

[0094] The shell 12 may have an average thickness of 0.1 mm to 1.5 mm, for example, 0.1 mm to 0.15 mm, 0.15 mm to 0.25 mm, 0.25 mm to 0.5 mm, 0.1 mm to 0.5 mm, or 0.5 mm to 1.5 mm. In certain exemplary embodiments, the shell has an average thickness of at least 0.13 mm, for example, between 0.1 mm to 0.5 mm, for example, about 0.25 mm.

[0095] The shell thickness may vary based on core or element geometry. In some embodiments, the shell 12 may have a variable thickness. For instance, the shell 12 may have a body thickness, an edge thickness, and / or an end thickness which may each be independently selected. The body portion of the shell may refer to the shell covering a lateral side of the magnetic core, or side 12a as shown in FIG. 1A. The edge portion of the shell may refer to the shell covering an edge portion of the magnetic core, or side 12b as shown in FIG. 1A. The end side of the shell may refer to the shell covering an end portion of the magnetic core, or side 12c as shown in FIG. 1A. The shell 12 thickness may be defined as the dimension between exterior surfaces of sides 12a, 12b, and 12c, as shown in FIG. 1A, relative to an associated core surface of side I la, 11b, 11c, respectively, as shown in FIG. IB.

[0096] The shell thickness may be selected to enable the plurality of elements to magnetically assemble into a selected conformation, for example, by introducing space between the magnetic core and the ends, edges, and exterior perimeter of the element. In some embodiments, the edge side 12b thickness may be less than the body side 12a thickness. The shell may have an edge side 12b thickness to body side 12a thickness ratio of between 1:1 to 1:5, for example, between 1:1 to 1:2, between 1:2 to 1:3, between 1:3 to 1:4, or between 1:4 to 1:5. In some embodiments, the end side 12c thickness may be greater than the body side 12a thickness. The shell may have an end side 12c thickness to body side 12a thickness ratio of between 10:1 to 1:1, for example, 10:1 to 8:1, 8:1 to 6:1, 6:1 to 4:1, 4:1 to 2:1, or 2:1 to 1:1. In some embodiments, the edge side 12b thickness may be selected to provide a desired overall profile of the uterine implant elements when deployed in the uterine cavity. For instance, diameter of a triad conformation may be selected by controlling edge side 12b thickness of the elements 10.

[0097] The shell may have an edge side 12b thickness (thickness B) of between 0.05 mm to 0.5 mm, for example, 0.05 mm to 0.1 mm, 0.1 mm to 0.15 mm, 0.15 mm to 0.2 mm, 0.2 mm to 0.25 mm, 0.25 mm to 0.3 mm, 0.3 mm to 0.35 mm, 0.35 mm to 0.4 mm, or 0.4 mm to 0.5 mm. The shell may have a body side 12a thickness (thickness A) of 0.1 mm to 1.5 mm, for example, 0.1 mm to 0.15 mm, 0.15 mm to 0.25 mm, 0.25 mm to 0.5 mm, or 0.5 mm to 1.5 mm. The shell may have an end side 12c thickness (thickness C) of between 0.25 mm and 1.5 mm, for example, 0.25 mm to 0.5 mm, 0.5 mm to 1.0 mm, or 1.0 mm to 1.5 mm. In some embodiments, the end portion of the shell may be domed. In such embodiments, the end side 12c thickness may refer to the thickness of the shell at the center of the dome. In other embodiments, the end portion of the shell may be truncated. In such embodiments, the end side 12c thickness may refer to the thickness of the shell at the center of the truncated side.

[0098] FIG. 8 is a sectional view of an element shown with a diagrammatic representation of magnetic flux patterns, indicative of a magnetically charged inner core 11. As shown in the exemplary embodiment of FIG. 8, the magnetic flux is oriented symmetrically about the center of core 11, typical of an axially charged body. The magnetic flux of an axially charged body flows outward from one end, referred to as a north pole of the magnet, toward and back into the opposite end, referred to as a south pole of the magnet, and through the core in a continuous cycle. The magnetic flux generally flows through the axial end surfaces of the magnetic body, including the peripheral edges. Magnetic flux also generally flows uninterrupted through inert materials. Thus, as shown in the exemplary embodiment of FIG. 8, the magnetic flux flows through inert shell 12 on both ends of the axially charged magnetic core 11.

[0099] The elements disclosed herein may have a core comprising a north pole at a first end and a south pole at the opposite end. Typically, north (N) and south (S) poles of magnetically charged bodies will be attracted. A north pole typically repels a north pole. Similarly, a south pole typically repels a south pole. Increasing distance between north and south ends of two opposed magnets will typically reduce the force of magnetic attraction, in a relationship that is generally exponential relative to the increased distance. Conversely, bringing the north and south ends of two opposed magnetically charged bodies closer together (reducing the distance), will typically increase the force of magnetic attraction, in a relationship that is generally exponential relative to the decreased distance. Accordingly, the elements may be designed (for example, have a core and / or shell dimensioned) to have a selected magnetic force between one another when positioned in proximity, encouraging a given number of elements to adopt a desired conformation by magnetic attraction to each other.

[0100] Referring to FIG. 1C, the element may have a core and shell dimensioned to selfassemble three elements into a triad conformation when brought into proximity with each other. As shown in FIG. 1C, the exemplary element 10 has the smallest shell thickness on side 12b (thickness B), intermediate thickness on side 12a (thickness A), and largest thickness on side 12c (thickness C, which refers to the thickness of the shell and a void space). It should be understood that edge side 12b and end side 12c generally refer to the sides on both halves of the element 10, however the thicknesses of each side may be independently selected. In some embodiments, as shown in FIG. 1C, the dimension between an exterior surface of side 12a, 12b, and 12c relative to an associated core surface of side I la, 1 lb, 11c, respectively, may include a void space and the shell thickness, for example, as shown with respect to thickness C of FIG. 1C. Thus, in some embodiments, the element may include a void space, inert filler, or clearance gap, between the magnetic core 11 and the shell 12 to accommodate a toleranced fit between a physical portion of the shell 12 and the encased internal core 11. The shell and void space, inert filler, and / or clearing gap may form a total thickness (providing a dimension between the exterior surface of the shell and the associated core surface) of between 0.05 mm and 1.50 m, for example, 0.05 mm to 0.1 mm, 0.1 mm to 0.25 mm, 0.25 mm to 0.5 mm, 0.5 mm to 1.0 mm, or 1.0 mm to 1.5 mm.

[0101] In one exemplary embodiment, as shown in FIG. 1C, three elements 10, each with axially charged magnetic cores 11, are brought near each other. Opposite poles (N / S) attract to self-arrange the elements. By designing the end side 12c to have the greatest thickness and the edge side 12b to have the smallest thickness, the elements 10 will generally favor selfassembly by joining edges 12b of two elements 10 (“bevel to bevel”). Therefore, by selecting the shell thicknesses, the elements 10 may be designed to favor self-assembly into a selected conformation, such as a triad conformation. The shell thicknesses may also be selected or designed to favor self-assembly of the elements 10 into a generally linear conformation, for example, when confined within a catheter for insertion and / or retrieval.

[0102] The shell may be formed of or comprise an inert material. In particular, the shell may be formed of a high coercivity material, for example, a material preventing degradation, e.g., by contact with tissues. The shell may be a polymeric material. The shell may be a non-toxic and physiologically acceptable material, such as Teflon®, silicon, polyethylene, polypropylene, poly ether ether ketone (PEEK), or ethylene vinyl acetate (EVA) elastomers. Other shell materials, such as any shell material available to one of ordinary skill in the art suitable for in uterus use, may be used for the elements disclosed herein.

[0103] In some embodiments, the element 10 may comprise an adhesive layer 15, as shown in FIGS. 2A-2C. The adhesive layer 15 may be positioned between the magnetic core 11 and the shell 12. The shell 12 may prevent oxidative corrosion of the magnetic core 11. The adhesive layer 15 may be provided to improve surface properties of the core 11. The adhesive layer 15 may have a nominal thickness, for example, about or less than 0.1 mm, between 0.1 mm and 0.01 mm, or less than 0.01 mm.

[0104] In the exemplary embodiment of FIG. 2A, the internal magnetic core 11 may be encased within an elliptically shaped shell 12. The coating 13, e.g., anti-fertility agent coating or other coating, may be exterior to the shell 12. In the exemplary embodiment shown in FIG. 2B, the internal magnetic core 11 may be encased within an elliptically shaped shell 12. The anti-fertility agent, if present, may be part of the shell 12 layer. In the exemplary embodiment of FIG. 2C, the magnetic core 11 may be generally elliptical. The magnetic core 11 may be encased within a thin shell 12. As in the embodiment of FIG. 2B, the element 10 of FIG. 2C may also comprise an anti-fertility agent as part of the shell 12.

[0105] In some embodiments, the uterine implant element may be free of an anti-fertility agent. In some embodiments, the uterine implant element may be free of a hormonal antifertility agent. The element may be free of a cytotoxic anti-fertility agent.

[0106] In some embodiments, the element may comprise a coating, e.g., an anti-fertility agent coating. The coating may be an exterior layer 13 of the element 10 (FIG. 2A). The coating may be embedded in the shell 12, for example, as shown in FIGS. 2B-2C. In some embodiments, the anti-fertility agent may be released from the shell 12. In such embodiments, the shell may be formed of an absorbent material, for example having a microstructure, to provide time-controlled release of an anti-fertility agent.

[0107] The coating 13, e.g., anti-fertility agent coating or other coating, may be applied, for example, by an electrostatic spray, electroplating, electroless plating, ion deposition, or other method. The coating 13 may be positioned exterior to the magnetic core 11, for example on an exterior surface of the core 11, on an exterior surface of the adhesive 15, or on an exterior surface of the shell 12. The anti-fertility agent coating 13 or anti-fertility agent embedded within and exuding from the shell 12 may be a slow-release agent and / or an extended-release agent. The anti-fertility agent coating 13 and / or shell 12 may be designed to provide a predetermined release profile of the anti-fertility agent. For example, the coating 13 and / or shell 12 may be designed to provide release of a therapeutic amount of the anti-fertility agent over a period of 12, 18, 24, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 months or more. The anti-fertility agent may be a hormonal agent, a cytotoxic agent, or a combination thereof.

[0108] The anti-fertility agent may be a substantially non-released agent. In other embodiments, the anti-fertility agent may be a slow-release agent. Each element may have 400 mm2or less of the anti-fertility agent, for example, 300 mm2or less, 200 mm2or less, 150 mm2or less, 100 mm2or less, 75 mm2or less, or 50 mm2or less. The IUD system (e.g., as formed of more than one element) may have 500 mm2or less of the anti-fertility agent, for example, 400 mm2or less, 300 mm2or less, 200 mm2or less, 150 mm2or less, 100 mm2or less, or 75 mm2or less. The IUD system (e.g., as formed of more than one element) may have 400 mm2to 500 mm2, 300 mm2to 400 mm2, 200 mm2to 300 mm2, or 100 mm2to 200 mm2of the anti-fertility agent. In certain exemplary embodiments, for example, for use with a human subject, the total active surface area of the anti-fertility agent may typically range between 150 mm2and 400 mm2, for example, 175 mm2and 380 mm2.

[0109] In some embodiments, the element is permeable to release of the anti-fertility agent at a low rate. Upon insertion in the uterus, the element may release a therapeutically effective amount of the anti-fertility agent. The therapeutically effective amount may be a contraceptive and / or fertility suppressing amount. The therapeutically effective amount may be an amount effective to provide treatment or prevent a uterine disease, condition, or symptom thereof. The element may include, for example, embedded in the shell or as an independent layer, a therapeutically effective amount of the anti-fertility agent.

[0110] The anti-fertility agent may be a hormonal agent. Exemplary contraceptive antifertility agents include progesterone or a progestogen, e.g., progestin. The therapeutic amount of the anti-fertility agent in each element may be between 1 mg and 60 mg, e.g., between 1 mg and 3 mg, between 3 mg and 5 mg, between 5 mg and 7 mg, between 7 mg and 10 mg, between 10 mg and 20 mg, between 20 mg and 30 mg, between 30 mg and 40 mg, between 40 mg and 50 mg, or between 50 mg and 60 mg.

[0111] In some embodiments, the element is substantially free of a hormonal agent. For instance, in some embodiments, the element is substantially free of progesterone, or progestogen, e.g., progestin.

[0112] The anti-fertility agent may be a cytotoxic agent. One exemplary cytotoxic agent is copper. One exemplary cytotoxic agent is nonoxynol 9 (N-9).

[0113] The element 10 may contain protrusions, such as rings or ridges 14 (as shown in FIG. 1A), comprising the cytotoxic agent, on an exterior surface of the element 10. The element 10 may contain the cytotoxic agent embedded in the shell 12, which is substantially flush with the surface. The element 10 or shell 12 may contain cytotoxic agent microparticles. At least a portion or the entire outer surface of the element 10 or shell 12 may be or contain the cytotoxic agent.

[0114] In some embodiments, the element 10 may have a smooth or substantially smooth exterior surface (FIG. 11). The smooth or substantially smooth exterior surface may be an anti-fertility agent exterior surface, e.g., a copper surface. In other embodiments, the element 10 may have one or more surface modification 14, as shown in FIG. 1A. One exemplary surface modification is a protrusion, as described above. Another exemplary surface modification is an indentation. Additionally, or alternatively, the element 10 may have a textured surface. The surface modification 14 may be or comprise, for example, shallow grooves, undulations, indentations, protrusions, articulations, texture, rings, ridges or any other three-dimensional feature.

[0115] In certain exemplary embodiments, the protrusion or indentation may be elongated. The surface modification may have a width of between about 0.1 mm and 0.5 mm, for example, between about 0.2 mm and 0.4 mm, or about 0.3 mm. The surface modification 14 may be longitudinal (spanning at least a portion of the length of the body of the element), lateral (spanning at least a portion of the width of the body of the element), or a combination thereof.

[0116] The surface modification may comprise or be formed of the anti-fertility agent. The surface modification may be provided to increase surface area of the anti-fertility agent, for example, to increase dosage of the anti-fertility agent.

[0117] In one exemplary embodiment, the element 10 may have a smooth exterior copper surface (FIG. 11). The shell 12, which may comprise the anti-fertility agent, for example, a copper shell, may be formed by laser welding a plurality of shell portions together. In the exemplary embodiment of FIG. 11, the shell 12 is formed by laser welding a top shell portion to a bottom shell portion. Thus, the element 10 may comprise a laser weld seam 17. The seam 17 may be vertical, horizontal, or any other orientation. In some embodiments, the element 10 may comprise more than one seam 17. The seam 17 may have a thickness selected to be minimal (produce a negligible reduction in surface area of the shell 12).

[0118] In some embodiments only one element 10 is inserted in the uterus of the subject. In other embodiments, more than one element 10 is inserted into the uterus of the subject to form the IUD system. For example, in some embodiments, at least two, three, four, five, six, seven, eight, nine, ten, or more elements 10 may be inserted into the uterus of the subject to form the IUD system. When more than one element 10 is inserted, each element 10 may be smaller (than if only using one), as the multiple elements 10 will self-assemble or arrange themselves into a larger IUD system internally (in uterus) by magnetic force. The north pole of the magnetic core 11 of one element 10 may attract the opposite south pole of the magnetic core 11 of another element 10 to assemble multiple elements 10 together into a larger conformation that resists expulsion from the uterus. Multiple elements 10 may be conformably adjoined, for example, to form a stable conjoined trilobular, circular or coiled conformation. The elements may generally assemble or arrange themselves into a lower energy conformation.

[0119] In some embodiments, one element may form the IUD system. One exemplary element 100 having a total length of at least two, three, or more elements 10 (as previously described, for example, at least 3 mm to 30 mm) may be used to form the IUD system (FIG. 6). The element 100 may have a flexible or semi-flexible body. The element 100 may have a magnetic core having a north pole and a south pole as previously described or a plurality of magnetic cores arranged to position a north pole of a first magnetic core and a south pole of a second magnetic core at opposite ends. The north pole may attract the south pole to assemble the element 100 into a conformation that resists expulsion from the uterus, for example, a circular or coiled conformation.

[0120] In certain embodiments, the single element IUD system as shown in FIG. 6 may be designed to assemble (for example, into the circular or coiled conformation) by spring-loaded mechanism. The element may be substantially non-magnetic or may comprise a single magnet on one end. The spring-loaded mechanism may be provided by spring 19 extending between opposite ends of the element 100.

[0121] Thus, while the disclosure may generally refer to a plurality of elements, it should be understood that a single element having a flexible body being dimensioned similarly, e.g., having a similar width and total length as a plurality of elements, may also be used.

[0122] Thus, the IUD system may include an element having a length of 30 mm or less, for example, 3 mm to 30 mm, comprising a magnetic core and a coating exterior to the magnetic core. The magnetic core may comprise at least one of a north pole and a south pole. In some embodiments, the magnetic core may comprise a north pole opposite a south pole. The magnetic core may be formed of a north pole magnetic core and a south pole magnetic core. The magnetic core may be dimensioned to assemble the element into a conformation that resists expulsion from the uterus of a subject.

[0123] The one or more elements may generally be independent from one another. For example, the one or more elements may be free of any connective threading or filament. However, in some embodiments, if more than one element is utilized in the IUD system, the elements may be threaded to each other with a filament (e.g., a monofilament or tail string) or any other connector. In some embodiments, elements which are threaded or connected to each other may still be free of a tail string. Thus, in some embodiments, threading or other connectors may be utilized only between adjacent elements.

[0124] FIG. 9 shows an exemplary IUD system having three elements 10, joined by two filaments 18a, 18b, each filament 18a, 18b extending between two adjacent elements 10. A first element and a last element are not joined by a filament. The exemplary elements 10 shown in FIG. 9 do not contain a tail string. The first element and the last element may each include a magnetic core that enables the threaded elements to assemble into a conformation that resists expulsion from the uterus. The magnetic core of the first element may be or comprise a north pole, while the magnetic core of the last element may be or comprise a south pole. The central element (or any element positioned between a first and a last element) may be non-magnetic. In other embodiments, the central element or any element positioned between a first and a last element may also comprise a magnetic core. Any combination of magnetic and non-magnetic elements may be used.

[0125] FIG. 10 shows an exemplary IUD system, such as the one shown in FIG. 9, with a diagrammatic representation of magnetic flux patterns. The exemplary IUD system of FIG. 10 includes two magnetic elements 10 at opposite ends of the system with a non-magnetic element 21 positioned between the magnetic elements 10. The magnetic flux of each of the elements 10 of the system of FIG. 10 is oriented symmetrically about the center of each magnetic core 11, as shown in the single axially charged body of FIG. 8. As shown in FIG. 10, an IUD system having two magnetic elements 10 and a non-magnetic element 21 may self-assemble into a triad conformation by magnetic force.

[0126] The connective threading or filament may be flexible to enable the elements to assemble into an axial or generally aligned conformation. The connective threading or filament may have a length selected to allow the elements to assemble into a desired conformation, such as a triad conformation. The threading or filament may be fixed to an exterior surface of the elements. In certain embodiments, the connective threading or filament may be integrally molded, e.g., injection molded, with the shell.

[0127] In some embodiments, the connector may extend from one element as a longer filament or tail string for retrieval of the IUD system. The filament may generally be formed of or coated with an inert material. The filament material may be selected to provide a desired structural stability in the uterine cavity. Exemplary filament materials include nitinol, e.g., nitinol wire, nylon, e.g., nylon sutures, polypropylene, polyethylene, or polyether, such as polyether ether ketone (PEEK), and others. In some embodiments, the elements and / or IUD system may be substantially free of nitinol.

[0128] The magnetic core 11 may be dimensioned to assemble the plurality of elements into a conformation that resists expulsion from a uterus of the subject. The conformation may be the lowest energy conformation for magnetic assembly. In certain exemplary embodiments, the conformation is a triad or triangular conformation.

[0129] Each element 10 having a magnetic core 11 may have at least one of a north pole and a south pole, optionally both a north pole and a south pole at opposite ends. The magnetic core 11 may be an axially charged magnetic core (charged about a central axis of the magnetic core). The plurality of elements 10 may assemble by attracting an end of an alternate element 10 having an opposite charge or pole. Furthermore, the plurality of elements 10 may assemble by repelling an end of an alternate element 10 having a like charge or pole. In one exemplary embodiment, the lower energy conformation (for three elements) is a triad conformation (FIGS. IB, 1C, IE). In other embodiments, the lower energy conformation (for two or more elements) is a raft conformation. In the raft conformation, the plurality of elements 10 align laterally in a parallel array. The conformation may be flexible and / or variable, e.g., conformable to natural movement of surrounding tissues.

[0130] The magnetic core 11 may be, for example, cylindrical, polygonal, e.g., rectangular (e.g., cubed), triangular, pentagonal, hexagonal, or faceted. Thus, the core may have a rounded, circular, oval, polygonal, e.g., rectangular, square, triangular, pentagonal, hexagonal, or faceted cross-section. In certain exemplary embodiments, the magnetic core 11 may have a circular cross section. The circular cross section may be selected to achieve a maximal magnetic force per volume of an element 10, which may be beneficial when providing an element 10 capable of passing through a minimally sized lumen of a cylindrical catheter (of the inserter or retriever). Thus, in certain embodiments, an element 10 having a circular cross section may provide maximal magnetic force while minimizing patient discomfort during insertion or retrieval.

[0131] In some embodiments, the core 11 may be oval or ellipsoidal, for example, having a rounded and elongated outline or shape, like that of an elliptical egg.

[0132] The core may be formed of one or more magnetic bodies. In some embodiments, the core may be formed of a single magnetic body having a north pole and a south pole, optionally a north pole on one end and a south pole on an opposite end (FIG. 7). In other embodiments, the core may comprise or be formed of two or more magnetic bodies (FIG. 6), each magnetic body having at least one north pole (1 In) positioned on one end of the element and at least one south pole (I ls) positioned on an opposite end of the element. The two or more magnetic bodies may be positioned such that opposite poles 1 In, 1 Is of the respective magnetic bodies come together to self-assemble the element into a desired conformation. In the exemplary embodiment of FIG. 7, magnetic bodies are positioned on opposite ends of a central axis of the element 100, each magnetic body having an opposing pole 1 In, I ls, respectively, on a far end of the magnetic body, such that poles 1 In, I ls come together to self-assemble the element 100 into a coiled or circular conformation.

[0133] The magnetic core 11 may have generally blunt edges or rounded edges, for example, to form an ellipsoidal structure. In certain embodiments, the magnetic core 11 may have beveled edges 1 lb to induce self-assembly of three devices into a triad conformation. The beveled edges 1 lb may be formed by bevel angle 1 Id, as shown in FIG. 4. The beveled edge 1 lb may additionally facilitate inclusion of a larger or maximally sized magnetic core 11 within an elliptically shaped element 10, which may be used to provide a greater magnetic force per volume of the element. Thus, the dimensions of the magnetic core, e.g., length of sides I la, 11b, 11c and cross-sectional geometry and shell, e.g., thickness of sides 12a, 12b, 12c, (FIGS. 1A-1B) may be selected or designed to induce self-assembly after deployment and maintain a sufficient magnetic force to resist expulsion. In certain embodiments, the dimensions of shell, e.g., thickness of sides 12a, 12b, 12c, may be selected to provide sufficient magnetic force to form a stable IUD system that conforms to the uterine cavity, adapting cyclical changes in response to the natural movement of uterine tissues.

[0134] The edge side 1 lb of the core 11 may be defined as a side of the core 11 that joins the lateral side 1 la to the distal end 11c of the core 11, as shown in the sectional view of FIG. 4. The width of the core 11 may be defined as a dimension extending from the lateral side I la to an opposite lateral side (optionally a diameter of a magnetic core having a circular cross section). The length of the core 11 may be defined as a dimension extending from one distal end 11c to an opposite distal end.

[0135] The core 11 may have an edge side 1 lb on either or both ends. The edge side 1 lb may extend around a perimeter of the core 11, for example, around a circumference of the crosssection of the core 11. In some embodiments, the edge side 1 lb may be beveled. A beveled edge may be defined as an edge that forms an angle between the distal end 11c and the edge side 1 lb. The bevel angle 1 Id may be defined as an angle formed between a center of end 11c (optionally a center of the circular cross sectional area) and edge side 1 lb, as shown in FIG. 4. The bevel angle may be from about 5° - 50°, for example, from about 5°-15°, 15°-30°, 20°-40°, 30°-45°, or 30°-50°. In certain exemplary embodiments, the bevel angle may be about 30°.

[0136] In one exemplary embodiment, as shown in the diagram of FIG. ID, a 30° bevel angle forms a circumferential 60° inclusive angle forming a conical surface about both ends of a magnetic core 11 having a circular cross section. When a magnetic core 11 is encased within an elliptically shaped shell 12 to form element 10, the tapered end side 12c of the elliptical shell 12 will generally follow the conical surface of the magnetic core 11.

[0137] In one exemplary embodiment, when a set of three elements 10, each containing a core 11 with a 30° bevel angle forming a 60° inclusive end angle, are brought together (as shown in FIG. IE), the conical surfaces of each magnet core 11 are typically induced to selfassemble into a magnetically attracted triad conformation or conformal triangular structure (FIG. IE). The edge sides 1 lb of two adjacent cores 11 will typically be separated by the sum of the edge side 12b thicknesses (FIG. 1C). Thus, when the exemplary elements 10 of FIG. IE are introduced into a uterine cavity, the three magnetic elements 10 are induced to form a magnetically conjoined structure effective to resist expulsion from the uterine cavity.

[0138] In some embodiments, the core may be dimensioned to have a lateral side I la length to edge side 11b length ratio of from about 1:1 to 5:1, for example, 1:1 to 2:1, 2:1 to 3:1, 3:1 to 4:1, or 4:1 to 5:1. The core may have a lateral side I la length of 0.5 mm to 10 mm, for example, 0.5 mm to 1 mm, 1 mm to 3 mm, 1 mm to 5 mm, or 5 mm to 10 mm. The core may have an edge side 1 lb length of 0.1 mm to 5 mm, for example, 0.1 mm to 0.5 mm, 0.3 mm to 1.0 mm, 0.5 mm to 1.0 mm, 1.0 mm to 3 mm, or 3 mm to 5 mm. The core may be dimensioned to have a distal end 11c length of about 1 mm to 6 mm, for example, 1 mm to 2 mm, 1 mm to 3 mm, 2 mm to 4 mm, 3 m to 5 mm, or 4 mm to 6 mm.

[0139] The magnetic core 11 may form at least 50% of a volume of the element 10. In some embodiments, the magnetic core may form at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, or at least 99% of the volume of the element.

[0140] The magnetic core 11 may be dimensioned to provide a selected magnetic force of attraction between two elements, for example, between two elements at opposite poles. The magnetic force may be effective to resist expulsion from the uterus of the subject. The magnetic force may be effective to adapt to the natural movement of the uterine tissues. In some embodiments, the core 11 may be dimensioned to provide about 0.1-22 N of magnetic force, for example, about 0.1-5 N, about 0.1-0.5 N, about 0.5-0.75N, about 0.75-1.0 N, about 1.0-1.25 N, about 1.25-1.5 N, about 1.5-2.0 N, about 2.0-3.0 N, about 3.0-4.0 N, or about 4.0- 5.0 N of magnetic force. The dimensionality of the core that may be selected to provide the desired magnetic force includes the length and width (or diameter) of the core, the geometry of the cross-section of the core, and the geometry of the edges of the core, for example, length and / or angle of bevel. Additionally, the material of the core may be selected to provide the desired magnetic force.

[0141] Furthermore, the dimensionality of the shell 12 may be selected to provide the desired magnetic force. For instance, the thickness of the shell may be selected to control distance between two adjacent magnetic cores, for example, two cores at opposite poles, or more than two magnetic cores in an IUD system. In some embodiments, the shell 12 may have a thickness selected to position opposing magnetic cores at 0.25 mm - 1.0 mm from one another, for example, 0.25 mm - 0.5 mm or 0.5 mm - 1.0 mm. In certain exemplary embodiments, the thickness of the shell may be selected to position opposing magnetic cores no more than 0.5 mm from one another.

[0142] Additionally, the dimensionality of the magnetic core may be selected to provide a selected magnetic force of attraction between an element and a retrieval magnet. The magnetic core may be dimensioned to de-assemble to plurality of elements from the conformation that resists expulsion to a conformation that allows retrieval. The conformation that allows retrieval may be, for example, an axial or generally aligned conformation. The magnetic core may be dimensioned to de-assemble into a generally linearly connected conformation, e.g., the axial conformation or a linear train-like conformation, when brought into close proximity with a magnetic retrieval device.

[0143] In certain embodiments, 1-4 elements are used to form the IUD system. The size and number can be dependent on the species (human or non-human mammal). For example, when multiple elements are used, the size of each element may be individually about 2 mm to about 30 mm in length, for example, about 2 mm to about 15 mm in length or about 2 mm to about 10 mm in length, and about 2 mm to about 15 mm in width, for example, about 2 mm to about 10 mm in width or about 2 mm to about 6 mm in width or about 2 mm to about 4 mm in width. The size may be selected to allow the placement of the elements in the uterus at any stage of the menstrual cycle, while still retaining a high retention rate. The retention rate of the IUD system may be at least about 90%, at least about 95%, at least about 99%, or at least about 100% retention rate. The size may be selected to allow insertion of the elements through the cervix of the subject, for example, easier and less painful insertion into the uterus of the subject. In some embodiments, the health, pregnancy / non-pregnancy status, and / or reproductive system dimensionality of the subject may be determined before insertion of the IUD system. For instance, an ultrasound of the uterus may be performed in two dimensions or three dimensions to determine the health, pregnancy / non-pregnancy status, and / or dimensions to accept or reject the subject for use of the IUD system. In general, the minimum precaution may be to establish non-pregnancy of the subject before introducing the IUD system. In some embodiments, the health, pregnancy / non-pregnancy status, and / or dimensionality of the reproductive system of the subject may be determined to aid in the choice of size and / or number of elements to be used. The dimensionality of the reproductive system of the subject may include, for example, anatomical geometry, anatomical dimensions, and / or anatomical positioning (e.g., normal or abnormal positioning of the uterus).

[0144] In accordance with one aspect, the disclosure includes methods of providing controlled contraception to a subject and / or methods of facilitating controlled contraception. The methods may comprise delivering to the uterus of the subject a plurality of uterine implant elements. The plurality of elements may be delivered individually or simultaneously. Individual delivery may include, for example, delivery of a single element by a single actuation of a delivery device. Simultaneous delivery may include, for example, delivery of the plurality of elements by a single actuation of a delivery device.

[0145] In accordance with one aspect, the disclosure includes methods of treating or preventing a uterine disease, condition, or symptom thereof in a subject and / or methods of facilitating treatment or prevention of a uterine disease, condition, or symptom thereof. The methods may comprise delivering to the uterus of the subject a plurality of uterine implant elements. The plurality of elements may be delivered individually or simultaneously. Individual delivery may include, for example, delivery of a single element by a single actuation of a delivery device. Simultaneous delivery may include, for example, delivery of the plurality of elements by a single actuation of a delivery device.

[0146] Inserter / Applicator

[0147] The methods may comprise delivering to a subject a plurality of uterine implant elements using a delivery device (also referred to as an “inserter” or “introducer” or “applicator” herein) dimensioned to allow placement of the plurality of elements in the uterus of the subject. The delivery device may be dimensioned for use with a target subject. For example, the delivery device may be dimensioned for use with a human subject. One exemplary delivery device that may be used is the handler developed by 3Daughters, Inc. (Fort Lauderdale, FL) as described herein. Self or assisted insertion may be performed, for example, insertion conducted by a trained practitioner and / or medical professional.

[0148] The methods may comprise delivering the plurality of elements individually. For instance, the inserter may be dimensioned to deliver the plurality of elements individually. In other embodiments, the methods may comprise delivering the plurality of elements sequentially or simultaneously. For instance, the inserter may be dimensioned to deliver the plurality of elements simultaneously, optionally in a sequential (axial or generally aligned) arrangement.

[0149] The IUD elements 10 disclosed herein may be administered, e.g., delivered, to the uterus of the subject with reduced pain. Subjects may be asked to rate pain score under the numeric rating scale (NRS) after administration of the IUD elements 10. The NRS is a verbal or written determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents extreme pain. In some embodiments, an average or maximum NRS pain score for administration, e.g., delivery, of the IUD elements 10 may be less than 10, e.g., less than 9, less than 8, less than 7, less than 6, less than 5, less than 4, less than 3, less than 2, or less than 1.

[0150] In other embodiments, subjects may be asked to rate pain score under the visual analog scale (VAS) after administration or retrieval of the IUD elements 10. The VAS is a graphic rating scale that may utilize a line or a series of graphical depictions, such as cartoon faces, for the subject to select, indicating degrees of pain level. For a line depiction, a first end of the line may represent no pain, with an opposite end of the line representing extreme pain. Subjects may be asked to indicate pain level by identifying a point on the line. In some embodiments, an average or maximum VAS pain score for administration, e.g., delivery, of the IUD elements 10 may be less than 100% across the line (e.g., less than an extreme end point of the line), for example, less than 80% across the line, less than 75% across the line, less than 60% across the line, less than 50% across the line, less than 40% across the line, less than 25% across the line, or less than 20% across the line.

[0151] For the graphical depiction, five graphics may visually represent increasing pain level from no pain to extreme pain. Subjects may be asked to indicate pain level by identifying a specific graphic that demonstrates their pain level. In some embodiments, an average or maximum VAS pain score for administration, e.g., delivery, of the IUD elements 10 may be less than the graphic used to identify extreme pain (e.g., less than the fifth graphic), less than the fourth graphic, less than the third graphic, or less than the second graphic. The inserter, e.g., applicator, may comprise an insertion catheter 40 dimensioned to pass through the cervix of the subject, for example, having an outer diameter dimensioned to pass through the cervix of the subject. FIG. 12A includes a partial view of an exemplary applicator discharging a plurality of elements 10. The catheter 40 may comprise a chamber 41 for accommodating the one or more elements 10 of the IUD system. The applicator may comprise a plunger 42 for discharging the one or more elements 10 from the chamber 41 into the uterine cavity of the subject. The plunger 42 may be slidably disposed within the chamber 41. Upon being discharged from the chamber 41, the plurality of elements 10 may selfassemble into a desired conformation by way of magnetic attraction.

[0152] In some embodiments, for example, as shown in FIG. 12A, the catheter 40 may be dimensioned to accommodate the elements 10 in an axial array, for example, aligned in series with respect to an axial center of the elements 10. A distal tip of the catheter 40 may be inserted through the cervix and into the uterine cavity, to discharge the elements 10 from the chamber 41 into the uterine cavity by advancement of the plunger 42. The applicator may allow for insertion of the elements 10 without bimanual examination, ultrasound, and / or sounding of the uterus.

[0153] In some embodiments, the inserter may comprise one catheter 40. For instance, the inserter may comprise no more than one catheter 40. In other embodiments, the inserter may comprise more than one catheter 40. For instance, the inserter may comprise first, second, and / or third catheters. One or more catheters may be positioned concentrically or in parallel.

[0154] In some embodiments, the catheter 40 may comprise one or more marker lines identifying length intervals along the catheter 40. The length intervals may be defined from the distal tip of the catheter 40 towards the body 43. The length intervals may be regular intervals marking, for example, inches or centimeters, and optional fractional values. In some embodiments, the marker lines may define up to 10 in, for example, up to 8 in, 7 in, 6 in, or 5 in or 25 cm, for example, up to 22 cm, 20 cm, 18 cm, 16 cm, 14 cm, 12 cm, or 10 cm. The fractional marker lines may define intervals of 0.1, 0.2, 0.25, or 0.5 of each inch or centimeter marked. The marker lines may be utilized by the user or operator to determine how much of the catheter 40 has been inserted through the uterine cavity, e.g., to clear the length of the cervix and / or optionally to avoid contacting the fundus (a pain point) of the patient. In some embodiments, marker lines may enable use of the inserter without a stopper 47.

[0155] The chamber 41 may define an interior channel dimensioned to fit the plunger 42, for example, slidably fit the plunger 42. In some embodiments, the chamber 41 is substantially transparent, to allow visualization of the interior channel. For instance, the chamber 41 may be formed to allow visualization of the movement of the plunger 42 and / or elements 10 within the channel.

[0156] The one or more uterine implant elements 10 may be positioned in the interior channel of the chamber 41 prior to insertion. In some embodiments, each element 10 may be inserted individually. In some embodiments, more than one element 10 (or all elements 10) of the IUD system may be inserted sequentially or simultaneously. Thus, the chamber 41 may have an inner diameter dimensioned to fit the element 10 and plunger 42. The chamber 41 may have an inner diameter of between 1 mm and 20 mm, for example, 1 mm to 2 mm, 2 mm to 3 mm, 3 mm to 3.5 mm, 3.5 mm to 4 mm, 4 mm to 4.5 mm, 4.5 mm, to 5 mm, 5 mm to 10 mm, 10 mm to 15 mm, or 15 mm to 20 mm. In exemplary embodiments, for example, for human application, the chamber 41 may have an inner diameter of about 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, or 4.0 mm.

[0157] The plunger 42 may be slidable along the chamber 41 within the catheter 40 to advance elements 10 to an implantable site within the uterine cavity. Conventional T-shaped IUD insertion devices typically include a lumen which is slidable over a central shaft, such that actuation of the device typically retracts the lumen to reveal an IUD. The inserter disclosed herein comprises a catheter 40, e.g., a flexible catheter 40, fixed to a body 43 as an extension of the body 43. The inserter disclosed herein comprises a plunger 42 configured to advance within the chamber 41 of the catheter 40 to deploy the IUD elements 10 from an opening of the chamber 41.

[0158] The catheter 40, e.g., flexible catheter 40, may be 10 mm to 100 mm in length, for example, 10 mm to 80 mm in length, 10 mm to 50 mm in length, or 10 mm to 30 mm in length. The chamber 41, which in some embodiments may be defined in length by the distance between a static (retracted) position of the plunger 42 and the distal end of the catheter 40, may be dimensioned to fit one or more elements 10, for example, all elements 10, for sequential or simultaneous insertion. Thus, the chamber 41 may have a length about or slightly longer than the length of the one or more uterine implant elements 10 when aligned, e.g., axially aligned, or positioned in series within the chamber 41.

[0159] In other embodiments, the chamber 41 may be dimensioned to have a length slightly shorter than the length of the one or more elements 10 when aligned, e.g., axially aligned, or positioned in series within the chamber 41. In such embodiments, the rounded end of the element 10 or leading element 10 may protrude from the chamber 41, effective to serve as a blunt extensive tip of the insertion assembly (inserter loaded with elements 10). Such an embodiment may ease insertion into the cervix, through the cervix, and into the uterus, and

[0160] T1 reduce pain, discomfort, or other side effects of insertion, as well as eliminate steps, such as the use of a tenaculum and sounding.

[0161] The catheter 40 or chamber 41 may be 1 mm to 20 mm in width, for example, 1 mm to 2 mm, 2 mm to 3 mm, 3 mm to 3.5 mm, 3.5 mm to 4 mm, 4 mm to 5 mm, 5 mm to 7 mm, 7 mm to 9 mm, 5 mm to 10 mm, 10 mm to 15 mm, or 15 mm to 20 mm. The chamber 41 may be similar in dimensions to a 4.0 mm - 5.0 mm OD catheter. The chamber 41 may have a width about or slightly wider than a uterine implant element. The plunger 42 may be 10 mm to 100 mm in length (about or slightly longer than the chamber 41) and 0.5 mm to 20 mm in width (narrower or slightly narrower than the chamber 41).

[0162] The applicator may be free of a magnet. For instance, the distal end of the plunger may be free of a magnet or free of a ferromagnetic material. In some embodiments, the distal end of the plunger may comprise or be formed of a non-magnetic material, for example, a polymeric or other non-magnetic material. The plunger 42 may be integrally formed or molded from a polymeric or other non-magnetic material.

[0163] The catheter 40 may be formed or coated or coextruded with an inert material. The catheter 40 may be formed of a polymeric material, e.g., by extrusion. The extrusion material may be sufficiently flexible and pliable to reduce undesirable side effects of insertion, e.g., patient discomfort and pain. In some embodiments, the extrusion material may have sufficient rigidity to enable insertion of the catheter 40 into and through a cervical canal. Exemplary extrusion materials include polyethylene, polyurethane, and fluorinated ethylene propylene (FEP).

[0164] Views of one particular exemplary inserter are shown in FIG. 13. As shown in FIG. 13, on opening in the chamber 41 may have an inward crimpled edge 45 (opening of the chamber has a slightly smaller diameter than chamber) to hold the elements 10 in place before discharge. The crimpled edge 45 may be flexible with applied pressure, for example, may be an expandable opening. Additionally or alternatively, the chamber 41 may have inward formed divots 46 to hold the elements 10 in place within the chamber 41. The opening in the chamber 41 may be positioned at a distal end of the chamber 41, as shown in FIG. 13, or on a lateral or side surface of the chamber 41, as shown in FIGS. 15-17.

[0165] In some embodiments, the catheter 40 may be flexible. The catheter 40 may have a flexibility selected or effective to reach the uterus of the subject, for example, without the need for a tenaculum to stabilize the cervix. The flexibility may be sufficient to avoid perforation of the uterine wall and / or allow adjustment and bendability to adjust positions in the uterus. However, in certain embodiments the flexibility may be limited to avoid spiraling or coiling of the catheter 40 within the uterus or upon insertion through the cervical canal. The catheter 40 may be formed of or comprise a bendable polymer.

[0166] The plunger 42 may be a malleable structure, such as a soft tempered wire or other malleable structure. The malleability of the plunger 42 may enable a user to manually selectively bend the catheter 40 in an orientation or conformation desired for the selfguidance through the cervical canal. The malleability of the plunger 42 may facilitate access to different anatomical geometries of the uterus, for example, a uterus in various degrees of anteflexion or retroflexion.

[0167] The inserter may comprise a body 43, also sometimes referred to as a “handle” herein. The body 43 may have an ergonomic configuration for handheld operation. The body 43 may have one or two grips 57 on lateral sides (FIG. 18). The grips 57 may be formed of a yielding material which is comfortable for single-handed use. The grips 57 may have a structured or ribbed surface for stability and manipulation of the inserter during use with or without surgical gloves. The body 43 may also comprise a finger rest 55 protruding from a bottom side of the body 43 (FIG. 18). During use, the finger rest 55 may assist with stability and manipulation, providing increased control. The finger rest 55 may have a structured or ribbed surface.

[0168] The inserter may comprise a button or actuator 44 located on body 43 for discharging the plunger 42. The button or actuator 44 may be operably connected to the plunger 42. In some embodiments, the button or actuator 44 may be slidable along the body, e.g., in an axial direction, for discharging the plunger 42. The button or actuator 44 may provide tactile feedback, for example, click feedback, to a user or operator upon extension of the plunger 42 within the channel of the catheter, indicating discharge of the elements 10 from the inserter.

[0169] In some embodiments, the button or actuator 44 comprises a locking mechanism at the one or both of the extended or retracted positions of the plunger 42. The locking mechanism may comprise, for example, a notch and a corresponding tab or any other mechanical locking element. The button or actuator 44 may comprise a release mechanism to unlock the locking mechanism. In some embodiments, the release mechanism is actuated upon depression of the button or actuator 44 to disengage corresponding locking mechanism elements, such as disengaging a tab from a corresponding notch. In some embodiments, the button or actuator 44 is free from a locking mechanism.

[0170] In some embodiments, the inserter may comprise a safety tab 51 (FIG. 18). The safety tab 51 may be a removable structure positioned to prevent the button or actuator 44 from moving into the extended plunger 42 position. In embodiments which have a sliding button 44, the safety tab 51 may be positioned within the channel to block the button 44 from sliding into the extended plunger 42 position. The safety tab 51 may be removed by a user before use. In some embodiments, the safety tab 51 may be reversibly removable, to allow repositioning after use. In other embodiments, the safety tab 51 may not be re-positioned, and may be discarded after use.

[0171] In some embodiments, the button or actuator 44 or the plunger 42 may comprise a spring-loaded mechanism. The spring-loaded mechanism may provide resistance against automatic movement of the button or actuator 44 and plunger 42. The spring-loaded mechanism may position the button or actuator 44 in the retracted plunger 42 (backward) position, as shown in the embodiment of FIG. 18. Alternatively, the spring-loaded mechanism may position the button or actuator 44 in the extended plunger 42 (forward) position. In some embodiments, the button or actuator 44 or plunger 42 may be free of any spring-loaded mechanism.

[0172] FIG. 20 is an exploded view of an inserter, according to certain embodiments. The exploded view of FIG. 20 shows plunger 42 and catheter 40. Catheter 40 is held to collar 43a by retainer 56. Body 43 is generally formed of top 43u and bottom 43d body portions snapped together. Collar 43a is partially fitted over body 43 and rotatable with respect to body 43 by rotator 52a and lug 52b. Button 44 is slidable by button catch 54. Spring 59 and spring seat 58 provide a spring-loaded mechanism to position the button 44 in the retracted plunger 42 position.

[0173] FIGS. 21A-21B are cutout views showing the spring-loaded mechanism within body 43. In the embodiment of FIG. 21A, button catch 54 is positioned in the retracted plunger 42 position (backward) and spring 59 is relaxed. In the embodiment of FIG. 21B, button catch 54 is in the extended plunger 42 position (forward) and spring 59 is compressed.

[0174] In some embodiments, the button or actuator 44 may be positioned for single-handed operation of the inserter. For instance, the button or actuator may be operable from a single side of the applicator. In other embodiments, the button or actuator 44 may be positioned for two-handed operation of the inserter. For instance, the button or actuator may be operable by actuation from both sides simultaneously or actuation from either side of the inserter (body 43).

[0175] In some embodiments, the catheter 40 may have a curvature. One exemplary catheter 40 having a curvature is shown in the side view of FIG. 18 (top panel). The curvature may be 5°-15°, 15°-30°, or 30°-45°. In other embodiments, the catheter 40 may have no curvature. One exemplary catheter 40 having no curvature is shown in the side view of FIG. 29. In some embodiments, the body 43 of the inserter is rotatable with respect to the catheter 40, for example, at least 90° or at least 180°, optionally 360°, to change configuration of the directional orientation of the catheter 40, e.g., of the opening or optional curvature of the catheter 40. In embodiments that comprise the button or actuator 44 on a single side of the inserter, the body 43 may be rotatable to provide the catheter 40 in a first orientation defining a first positioning of the lateral opening or a curvature in the direction of the button or actuator 44 and a second orientation defining a second positioning of the lateral opening or the curvature in the direction opposite the button or actuator 44. The rotation may be accompanied with tactile detents, indicating incremental rotation to desirable positions, for example, at 180°, 90°, or 45°. In other embodiments, the body 43 of the inserter may be fixed with respect to the catheter 40.

[0176] In use, the catheter 40 may be rotated after insertion in the uterus to align the opening in the channel 41 laterally within the uterine cavity, rather than parallel with the uterus wall. Such a lateral alignment may enable formation of the elements 10 into a desired conformation after deployment from the inserter. The degree of curvature of the catheter 40, if any curvature is present, may be selected responsive to the desired arc of rotation of the catheter 40 within the uterine cavity. In some embodiments, the catheter 40 may have only a slight curvature (for example, 15° or less, 10° or less, or 5° or less) or no curvature to avoid a large arc of rotation within the uterine cavity.

[0177] The body 43 or handle may comprise a rotatable collar 43a on a distal end of the body 43, proximate the catheter 40. The catheter 40 may be fixed to the rotatable collar 43a, allowing rotation of the body 43 with respect to the catheter 40. The rotatable collar 43a may be separated from the main portion of the body 43 by a circumferential seam which allows independent rotation. The rotatable collar 43a may have a spring insert to provide tactile positional control. Thus, in some embodiments, the rotatable collar 43a may be rotated to one or more preset positions. The preset positions may be spaced at intervals of 45°, 90°, 180° or other angles.

[0178] The rotatable collar 43a may have protruding features, such as a thumb pad 43b or knurling, to facilitate single-handed operation, e.g., single-handed rotation of the body 43. The thumb pad 43b or other ergonomic feature of the body 43 may have a structured or ribbed surface to facilitate grip for stability, control, and manipulation of the inserter. The inserter may allow for insertion of the elements without the use of a tenaculum. Accordingly, the methods may comprise tenaculum-free placement. In particular, the flexibility of the catheter may be selected to allow tenaculum- free placement of the elements. The diameter of the catheter may be selected to allow tenaculum-free placement of the elements. For instance, the diameter of the catheter may be 3.5 mm - 5.0 mm or less (for human application). In some embodiments, the methods may comprise dilating the cervix to allow for tenaculum- free placement of the elements.

[0179] In certain embodiments, the catheter 40 may have a cervical dilating tip extending beyond the chamber 41. For instance, a distal portion of the inserter may have a narrower or narrowing diameter to assist in dilation, or “auto-dilate" the cervix when inserted. The cervical dilating tip may be rounded and / or blunt, to facilitate initial insertion into and through the cervix. In particular, the narrower or narrowing diameter of the cervical dilating tip may facilitate positioning of the catheter into the cervical cavity, in proximity of the fundus and fallopian tubes, without the need for a tenaculum to straighten entry through the cervical canal by grasping and pulling upon the cervix.

[0180] The cervical dilating tip may comprise a tapered end 48 (FIG. 16), for instance, having a smaller diameter transitioning with a taper into the larger diameter of the chamber 41. The smallest diameter of the tapered end 48 may be smaller than a diameter of the element 10. The tapered end 48 may have a smallest diameter of between 0.5 mm to 3.0 mm, for example, 0.5 mm to 1.0 mm, 1.0 mm to 1.5 mm, 1.5 mm to 2.0 mm, 2.3 mm to 2.5 mm, 2.0 mm to 2.5 mm, or 2.5 mm to 3.0 mm. The cervical dilating tip may have a length of between about 1 cm to 2 cm, measured from the distal end of the internal chamber 41 to the distal end of the catheter 40. The cervical dilating tip may comprise a rounded tip 49 (FIG. 16). The rounded tip 49 may have a diameter larger than the smallest diameter of the tapered end 48.

[0181] The tapered end 48 may be flexible. As shown in the schematic diagrams of FIGS. 15-17, in use the tapered end 48 may enable the user to lightly touch upon the fundus of the uterus with minimal subject discomfort to determine maximum insertion depth. Thus, insertion may be performed without sounding to pre-determine depth. The tapered end 48 may also enable insertion without the use of an inherently painful tenaculum. In certain embodiments, the tapered end 48 may enable insertion without the use of a stopper 47.

[0182] The cervical dilating tip may be flexible. The cervical dilating tip may be formed of or comprise a bendable polymer. The cervical dilating tip may include an encased malleable structure 53 (FIG. 18), such as a soft tempered wire or other malleable structure. As shown in FIG. 18, the malleable structure 53 may enable a user to manually selectively bend the tip in an orientation or conformation desired for the self-guidance through the cervical canal. The malleable structure 53 may facilitate access to different anatomical geometries of the uterus, for example, a uterus in various degrees of anteflexion or retroflexion.

[0183] The inserter having a tapered end 48 may have a lateral opening of the chamber 41 (FIGS. 15-17). The chamber 41 may comprise a ramp dimensioned to direct the elements 10 to the lateral opening when pushed from the channel of the catheter. The lateral opening may have a crimpled edge, as previously described. The lateral opening may be elongated to allow angled release of the elements 10 from the internal chamber 41. The lateral opening may be tear drop or keyhole shaped. In some embodiments, the elongated lateral opening may have a narrower opening on the end closest to the tapered end 48 of the catheter 40. The sides of the lateral opening may come together or approach one another when the opening is in a relaxed configuration, closing the lateral opening. The sides of the lateral opening may be expanded when pushing an element 10 through the lateral opening. Bending the tip of the catheter 40 away from the lateral opening (in a direction opposite the lateral opening) may allow the lateral opening to remain closed until the elements 10 are pushed through the opening by the plunger 42.

[0184] In some embodiments, the inserter may be free of a balloon. In some embodiments, the inserter may be free of any expandable or inflatable component. For instance, the inserter may be free of a dilating balloon. In other embodiments, the inserter may comprise a balloon, for example, a dilating balloon. The inserter may comprise one or more expandable or inflatable components.

[0185] The inserter may be dimensioned to deposit the elements at a target location or a target tissue in the uterus. The inserter may be dimensioned to deposit the elements in the uterine cavity below the fundus. In some embodiments, the inserter may be dimensioned to deposit the elements in an upper uterine cavity section. In other embodiments, the inserter may be dimensioned to deposit the elements in a lower uterine cavity section, beyond the cervical canal. Recognizing that there may be anatomical variations between the individual intended subjects, the inserter may be dimensioned to deposit the elements at the target location or target tissue of a subject having an average sized uterus and reproductive anatomy or dimensioned to deposit the elements at the target location or a target tissue of at least 90% of subjects, at least 95%, or at least 99% of subjects.

[0186] The inserter may comprise a stopper 47. The stopper 47 may be positioned along the catheter 40 at a distance selected to set or position the stopper 47 just beyond the length of the cervix for administration of the elements into the target location or target tissue of the uterine cavity. The stopper 47 may be positioned at a distance selected to allow the catheter 40 to penetrate beyond the isthmus of uterus and restrict penetration from contacting the fundus of the uterus.

[0187] In particular, the stopper 47 may be positioned along the catheter 40 at a distance selected to set or position the stopper 47 just beyond the length of the cervix of a subject having an average sized reproductive anatomy or a distance selected to set or position the stopper 47 just beyond the length of the cervix of at least 90% of subjects, at least 95%, or at least 99% of subjects. In some embodiments, the stopper 47 may be fixed at the selected position on the catheter 40. In some embodiments, the stopper 47 may be slidable along the catheter 40. A slidable stopper 47 may comprise a positionable interference fit upon the catheter or a locking mechanism to releasably secure the stopper 47 at a desired distance or position along the catheter 40. In some embodiments, the inserter may be free of the stopper 47.

[0188] The inserter may be designed for compatibility with subjects at a variety of developmental stages or age groups. The inserter may be dimensioned for compatibility with subjects at a variety of developmental stages or age groups, for example, adolescent, prepregnancy, post-birth, post-abortion, peri-menopausal, or menopausal subjects. The inserter may be designed for compatibility with subjects having a variety of reproductive system anatomical variations. The inserter may be dimensioned and / or formed of materials that are compatible with a variety of reproductive system anatomical variations. For example, the inserter may be designed for use with a subject having a uterus that is anteflexed, anteverted, retroflexed, retroverted, midline, and combinations thereof, each independently of a first degree, second degree, or third degree.

[0189] Retriever

[0190] The methods may comprise retrieving the plurality of uterine implant elements from the subject using a retrieval device (also referred to as a “retriever” herein) dimensioned to retrieve the plurality of elements from the uterus of the subject. One exemplary retrieval device that may be used is the handler developed by 3Daughters, Inc. (Fort Lauderdale, FL) as described herein. The retrieval device may be dimensioned for use with a target subject. For example, the retrieval device may be dimensioned for use with a human subject. Self or assisted retrieval may be performed.

[0191] The retriever may generally include a magnetic end effective to attract the elements. Upon bringing the magnetic end into close proximity with the elements, the plurality of elements may be induced to de-assemble into an axial or generally aligned conformation that allows retrieval from the uterus of the subject with the retrieval device. The magnetic end may be positioned on a distal end of a wand or elongated structure dimensioned to retrieve the plurality of elements from the uterus of the subject. In one particular embodiment, the retriever may be similar in dimensions and assembly as the inserter. For instance, in some embodiments, the retriever may comprise a catheter dimensioned to retrieve the plurality of elements in sequential, axial, or generally aligned arrangement.

[0192] The methods may comprise retrieving the plurality of elements individually. For instance, the retriever may be dimensioned to retrieve the plurality of elements individually. In other embodiments, the methods may comprise retrieving the plurality of elements sequentially or simultaneously. For instance, the retriever may be dimensioned to retrieve the plurality of elements simultaneously, optionally in a sequential (axial or generally aligned) arrangement. The magnetic end may be operable to draw a plurality of magnetically joined elements in a train or chain-like configuration, optionally through an opening of the catheter into the chamber.

[0193] The IUD elements 10 disclosed herein may be retrieved from the uterus of the subject with reduced pain. Subjects may be asked to rate pain score after retrieval of the IUD elements 10. In some embodiments, an average or maximum NRS pain score for retrieval of the IUD elements 10 may be less than 10, e.g., less than 9, less than 8, less than 7, less than 6, less than 5, less than 4, less than 3, less than 2, or less than 1. In some embodiments, an average or maximum line VAS pain score for retrieval of the IUD elements 10 may be less than 100% across the line, for example, less than 80% across the line, less than 75% across the line, less than 60% across the line, less than 50% across the line, less than 40% across the line, less than 25% across the line, or less than 20% across the line. In some embodiments, an average or maximum graphic VAS pain score for retrieval of the IUD elements 10 may be less than the fifth graphic, less than the fourth graphic, less than the third graphic, or less than the second graphic.

[0194] In certain embodiments, the retriever may comprise a catheter 30 dimensioned to pass through the cervix of the subject. FIG. 12B includes a partial view of an exemplary retriever shown attracting and retrieving a plurality of elements 10. The catheter 30 may comprise a chamber 31 for accommodating the one or more elements 10 of the IUD system. The retriever may comprise a wand 32 for attracting and retrieving the one or more elements 10 from the uterus of the subject into the chamber 31 through an opening in the catheter 30, generally in an opposite direction as the insertion of the elements with the plunger 42, described above. The retriever may allow for retrieval of the elements without bimanual examination, ultrasound, and / or sounding of the uterus.

[0195] In certain embodiments, as shown in FIGS. 23A-23B, the retriever may comprise a wand 32 having a magnetic end 33. In some embodiments, the retriever may be free of the catheter 30. In other embodiments, the wand 32 may be slidably positioned within the chamber 31 of the catheter 30.

[0196] The wand 32 may be dimensioned to retrieve the plurality of elements 10 from the uterus of the subject. In some embodiments, the wand 32 may comprise a support structure or “grip” on one end, opposite the magnetic end 33, for use and handling. The support structure may comprise ridges 61a (FIG. 23 A) or another physical structure to provide tactile control of the wand 32 during use. While the exemplary wand 32 of FIG. 23A does not comprise a body, it should be noted that the wand 32 may comprise or be fixed to a body (for example, as shown in FIG. 19) or another specially molded ergonomic grip 61b (FIG. 23B), even in embodiments in which the retriever is free of the catheter 30. The wand 32 may be malleable, as described in more detail below.

[0197] In some embodiments, the wand 32 may comprise one or more than one supporting rib. Exemplary supporting ribs 32a, 32b are shown in FIGS. 30A-30B. The ribs 32a, 32b may be formed of a circular collar surrounding a body of the wand 32. The ribs 32a, 32b may be dimensioned to maintain a position of the wand 32 within the chamber 31 as the wand 32 is driven to slide up and down the chamber 31. For instance, the ribs 32a, 32b may be dimensioned to maintain the body of the wand 32 in a substantially central position of the chamber 31, e.g., concentric within the chamber 31. In some embodiments, the plunger 42 of the inserter may comprise one or more than one supporting rib.

[0198] As previously described, the plurality of elements 10 may be found in the uterus assembled into a desired conformation by way of magnetic attraction. The wand 32 may attract the magnet of the uterine implant element 10, breaking up the assembled conformation. In some embodiments, the wand 32 may have a magnetic end 33, e.g., an integrally fixed magnetic end 33 upon the distal end of the wand 32. In embodiments in which the retriever comprises a chamber 31, the wand 32 may be slidably disposed within the chamber 31. When the wand 32 is advanced within the chamber 31, the magnetic end 33 may project from the distal end of the chamber 31. In embodiments in which the retriever does not comprise a catheter 30, the magnetic end 33 of the wand 32 may attract the IUD elements 10 upon insertion of the wand 32 into the uterus. In use, the magnetic end 33 may attract an opposite pole of a first uterine implant element 10. Simultaneously, the magnetic end 33 may repel a like pole of another adjacent uterine implant element 10 to break up the conformation, as shown in FIG. 12B. For an exemplary triad conformation, the elements 10 may realign into an axial array (in series or generally aligned with respect to an axial center of the elements 10) and be retrieved into the chamber 31 through an opening by magnetic attraction to the magnetic end and retraction of the wand 32.

[0199] The magnetic end 33 may include a north and a south pole at opposite ends. A first pole may be positioned at a distal end of the magnetic end 33, to attract an opposite pole of a uterine implant element 10. A second pole of the magnetic end 33 may be positioned adjacent the wand 32. The magnetic end 33 may have a length defined from the tip of a first pole to the tip of a second pole. Each pole may have a length defined from a central plane of the magnetic end 33 to a distal end of the magnetic end 33.

[0200] In some embodiments, the magnetic end 33 may be dimensioned to define no more than two poles. For instance, the magnetic end 33 may be dimensioned to avoid the creation of localized poles between the first pole and the second pole. The length, profile, and / or diameter of the magnetic end 33 (optionally the length, profile, and / or diameter of each pole individually) may be selected to provide desired properties, such as to define a desired magnetic field surrounding the magnetic end 33.

[0201] In some embodiments, the magnetic end 33 may be dimensioned to provide a desired magnetic flux. For instance, the length, profile, and / or diameter of the magnetic end 33, optionally of each pole individually, may independently be controlled to provide a desired magnetic flux. In one particular embodiment, the first pole positioned on the distal end may be dimensioned to be as strong as possible while the second pole adjacent the wand 32 may be controlled to be as weak as possible. Pole strength can be controlled by independently selecting length and diameter of the poles. For instance, the first pole may have a diameter and / or length greater than the second pole. Thus, each pole of the magnetic end 33 may have a length and / or diameter selected to provide a desired magnetic flux.

[0202] In some embodiments, the magnetic end 33a may have a mushroom-shaped profile (FIGS. 24A-24B). As shown in FIGS. 24A-24B, the first pole may comprise a dome 332 extending from a central plane. The second pole may comprise a cone 334 extending from the central plane. The second pole may be tapered toward the central plane. The magnetic end 33 may be symmetrical about a center axis. In some embodiments, each of the first pole and the second pole may comprise a dome, a cone, and / or a tapered portion. The magnetic end 33a having a mushroom-shaped profile may be used with a retriever which is free of a catheter (e.g., FIGS. 23A-23B) or a retriever comprising a catheter (e.g., FIG. 19).

[0203] In some embodiments, the magnetic end 33b may have a bulb-shaped profile (FIGS. 25A-35B). As shown in FIGS. 25A-25B, the bulb-shaped magnetic end 33b may be similar to the mushroom-shaped magnetic end 33a, except that the second pole may comprise a dome 338 at a distal end of a tapered portion 337. In the exemplary embodiment of FIGS. 25A- 25B, the first pole comprises a dome 336 and the second pole comprises a dome 338 and a tapered portion 337. In some embodiments, each of the first pole and the second pole may comprise a dome, a cone, and / or a tapered portion. The magnetic end 33b having a bulbshaped profile may be used with a retriever which is free of a catheter (e.g., FIGS. 23A-23B) or a retriever comprising a catheter (e.g., FIG. 19).

[0204] The magnetic end 33 may have a length smaller than the length of a uterine implant element 10. For instance, the magnetic end 33 may have a length 5-30% smaller than a uterine implant element 10, for example, 5-10%, 10-15%, 15-20%, 20-25%, or 25-30%. In certain exemplary embodiments, the magnetic end 33 may have a length between 5-8 mm, for example, 5-5.5 mm, 5.5-6 mm, 6-6.5 mm, 6.5-7 mm, 7-7.5 mm, or 7.5- 8 mm.

[0205] The first pole may have an average diameter greater than the second pole. In some embodiments, the first pole may have an average diameter 1.5x-5x greater than the second pole, for instance, 1.5x-2x, 2x-2.5x, 2.5x-3x, 3x-4x, or 4x-5x greater than an average diameter of the second pole. In certain exemplary embodiments, the first pole may have an average or maximum diameter between 2-5 mm, for example, 2-2.5 mm, 2.5-3 mm, 3-3.5 mm, 3.5-4 mm, 4-4.5 mm, or 4.5-5 mm. In certain exemplary embodiments, the second pole may have an average or maximum diameter of 1.5-3.5 mm, for example, 1.5-2 mm, 2-2.5 mm, 2.5-3 mm, or 3-3.5 mm. The magnetic end 33 may have a maximum diameter as defined by the first pole. In certain exemplary embodiments, the magnetic end may have a minimum diameter between 1-3 mm, for example, 1-1.5 mm, 1.5-2 mm, 2-2.5 mm, or 2.5-3 mm.

[0206] In one particular embodiment, a cup magnet or pot magnet may be used as the magnetic end 33 to shield or eliminate a pole of the magnet, for example, the second pole adjacent the wand 32. A cup magnet would generally have a more limited magnetic field. Thus, in use, the cup magnet would need to be brought into closer proximity to the IUD elements within the uterus for retrieval. However, once connected to the IUD element within the uterus, the magnetic force between the cup magnet and the element would be stronger.

[0207] The magnetic end 33 may be dimensioned to provide a desired variable pulling capacity. In some embodiments, the spacing or arrangement of each pole on the magnetic end 33 may be controlled to provide a desired variable pulling capacity. For instance, each pole of the magnetic end 33 may have a length and / or diameter selected to provide a desired variable pulling capacity. The attractive force between the magnet of the uterine implant element 10 and the magnetic end 33 may have a variable pulling capacity of 1.05 Kg (0.1 N) to 20 Kg (200 N), e.g., up to 0.1 Kg (1 N), 1.0 Kg (10 N), or 10 Kg (100 N).

[0208] The magnetic end 33 may be dimensioned to disassemble the IUD system conformation within the uterus. In some embodiments, the spacing or arrangement of each pole on the magnetic end 33 may be controlled to provide a magnetic flux sufficient to disassemble the IUD system conformation within the uterus. For instance, each pole of the magnetic end 33 may have a length and / or diameter selected to provide a magnetic flux sufficient to disassemble the IUD system conformation within the uterus.

[0209] The magnetic end 33 may comprise or be formed of high grade magnetic, such as, a rare earth type magnet, e.g., highly magnetic neodymium, e.g., N52, N50, or N48. The dimensions and / or magnetic material of the magnetic end 33 may produce equal or greater magnetic force at the external surface than an individual element 10.

[0210] The magnetic end 33 may be coated or plated with a material to prevent oxidative corrosion. Exemplary biomedical grade materials include titanium, e.g., titanium nitride (TiN).

[0211] In other embodiments, the wand 32 may be free of a magnet. The wand 32 may have a ferromagnetic material at a distal end or be formed of a ferromagnetic material at least on the distal end to attract the magnetic IUD elements within the uterus.

[0212] The catheter 30 may be formed or coated or coextruded with an inert material. The catheter 30 may be formed of a polymeric material, e.g., by extrusion. The extrusion material may have sufficient body to enable insertion of the catheter 30 into and through a cervical canal, and yet also be sufficiently flexible and pliable to reduce undesirable side effects of insertion, e.g., patient discomfort and pain. Exemplary extrusion materials include polyethylene, polyurethane, and fluorinated ethylene propylene (FEP).

[0213] The catheter 30 may be formed of or comprise a bendable polymer. The wand 32 may be a malleable structure. The malleability of the wand 32 may enable a user to manually selectively bend the catheter 30 in an orientation or conformation desired for the selfguidance through the cervical canal. The malleability of the wand 32 may facilitate access to different anatomical geometries of the uterus, for example, a uterus in various degrees of anteflexion or retroflexion. In some embodiments, the retriever may comprise one catheter 30. For instance, the retriever may comprise no more than one catheter 30. In other embodiments, the retriever may comprise more than one catheter 30. For instance, the retriever may comprise first, second, and / or third catheters. One or more catheters may be positioned concentrically or in parallel.

[0214] In some embodiments, the catheter 30 may comprise one or more marker lines identifying length intervals along the catheter 30. The length intervals may be defined from the distal tip of the catheter 30 towards the body 35. The length intervals may be regular intervals marking, for example, inches or centimeters, and optional fractional values. In some embodiments, the marker lines may define up to 10 in, for example, up to 8 in, 7 in, 6 in, or 5 in or 25 cm, for example, up to 22 cm, 20 cm, 18 cm, 16 cm, 14 cm, 12 cm, or 10 cm. The fractional marker lines may define intervals of 0.1, 0.2, 0.25, or 0.5 of each inch or centimeter marked. The marker lines may be utilized by the user or operator to determine how much of the catheter 30 has been inserted through the cervical canal and into the uterine cavity, optionally to avoid contacting the fundus of the patient. In some embodiments, marker lines may enable use of the retriever without a stopper.

[0215] The chamber 31 may define an interior channel dimensioned to fit the wand 32, for example, slidably fit the wand 32. In some embodiments, the chamber 31 is substantially transparent, to allow visualization of the interior channel. For instance, the chamber 31 may be formed to allow visualization of the movement of the wand 42 and / or elements 10 within the channel.

[0216] The one or more uterine implant elements 10 may be retrieved to the interior channel of the chamber 31 through an opening. In some embodiments, each element 10 may be retrieved individually. In some embodiments, more than one element 10 (or all elements 10) of the IUD system may be retrieved sequentially or simultaneously. Thus, the chamber 31 may have an inner diameter dimensioned to fit the element 10 and wand 32. The chamber 31 may have an inner diameter of between 1 mm and 20 mm, for example, 1 mm to 2 mm, 2 mm to 3 mm, 3 mm to 3.5 mm, 3.5 mm to 4 mm, 4 mm to 4.5 mm, 4.5 mm, to 5 mm, 5 mm to 10 mm, 10 mm to 15 mm, or 15 mm to 20 mm. In exemplary embodiments, for example, for human application, the chamber 31 may have an inner diameter of about 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, or 4.0 mm.

[0217] The catheter 30 may be 10 mm to 100 mm in length, for example, 10 mm to 80 mm in length, 10 mm to 50 mm in length, or 10 mm to 30 mm in length. The chamber 31, defined in length by the distance between the distal end of the wand 32 in a static (retracted) position and the distal end of the catheter 30, may be dimensioned to fit one or more elements 10, for example, all elements 10, for sequential or simultaneous retrieval. Thus, the chamber 31 may have a length about or slightly longer than the length of the one or more uterine implant elements 10 when aligned, e.g., axially aligned, or positioned in series within the chamber 31. In other embodiments, the chamber 31 may be dimensioned to have a length slightly shorter than the length of the one or more elements 10 when aligned, e.g., axially aligned, or positioned in series within the chamber 31.

[0218] The wand 32 may have a length (in an advanced position) that is slightly longer than the chamber 31. In such embodiments, the rounded end of the wand 32 (for example, the magnetic end 33) may protrude from the chamber 31, effective to serve as a slightly extending tip during insertion of the retriever. The dimensions, e.g., length, diameter, and / or spacing and arrangement of opposite poles, on the magnetic end 33 may be selected to provide a desired magnetic flux or variable pulling capacity when the magnetic end 33 is positioned to protrude from the chamber 31. Such an embodiment may ease insertion of the retriever into the cervix, through the cervix, and into the uterus, and reduce pain, discomfort, or other side effects of insertion of the retriever.

[0219] The catheter 30 or chamber 31 may be 1 mm to 20 mm in width, for example, 1 mm to 2 mm, 2 mm to 3 mm, 3 mm to 3.5 mm, 3.5 mm to 4 mm, 4 mm to 5 mm, 5 mm to 7 mm, 7 mm to 9 mm, 5 mm to 10 mm, 10 mm to 15 mm, or 15 mm to 20 mm. The chamber 31 may be similar in dimensions to a 4.0 mm - 5.0 mm OD catheter. The chamber 31 may have a width about or slightly wider than a uterine implant element. The wand 32 may be 10 mm to 100 mm in length (about or slightly longer than the chamber 31) and 0.5 mm to 20 mm in width (narrower or slightly narrower than the chamber 31).

[0220] An exemplary embodiment of the retriever is shown in the several views of FIG. 14. The retriever may comprise a body 35. The body 35 may have an ergonomic configuration for handheld operation. The body 35 may be the same or similar as the body 43 of the inserter (described above). For example, the retriever may comprise a button or actuator 34 located on body 35 for discharging the wand 32. The button or actuator 34 may provide tactile feedback, for example, click feedback, to a user or operator upon retraction of the wand 32 within the channel, indicating retrieval of the elements 10.

[0221] In some embodiments, the button or actuator 34 comprises a locking mechanism at one or both of the extended or retracted positions of the wand 32. The locking mechanism may comprise, for example, a notch and a corresponding tab or any other mechanical locking element. The button or actuator 34 may comprise a release mechanism to unlock the locking mechanism. In some embodiments, the release mechanism is actuated upon depression of the button or actuator 34 to disengage the corresponding locking mechanism elements, such as disengaging a tab from a corresponding notch. In some embodiments, the button or actuator 34 is free from a locking mechanism.

[0222] In some embodiments, the button or actuator 34 or the wand 32 may comprise a spring-loaded mechanism. The spring-loaded mechanism may provide resistance against automatic movement of the button or actuator 34 and wand 32. The spring-loaded mechanism may position the button or actuator 34 in the extended wand 32 (forward) position, as shown in the embodiment of FIG. 19. In some embodiments, the retriever may comprise a safety tab (similar to safety tab 51, FIG. 18) positioned to prevent the button or actuator 34 from moving into the retracted wand 32 position. Alternatively, the spring-loaded mechanism may position the button or actuator 34 in the retracted wand 32 (backward) position. In some embodiments, the button or actuator 34 or wand 32 may be free of any spring-loaded mechanism.

[0223] Spring 69 within body 35 is shown in FIGS. 22A-22B. FIGS. 22A-22B are cutout views showing the spring-loaded mechanism. In the embodiment of FIG. 22A, button catch 64 is positioned in the extended wand 32 position (forward) and spring 69 is relaxed. In the embodiment of FIG. 22B, button catch 64 is in the retracted wand 32 position (forward) and spring 59 is compressed.

[0224] The body 35 may comprise a rotatable collar 63a, optionally including a thumb pad 63b (FIG. 19), as previously described with respect to the inserter (43a, 43b FIG. 13). The thumb pad 63b or other ergonomic feature of the body 35 may have a structured or ribbed surface to facilitate grip for stability, control, and positioning of the retriever. The catheter 30 may be fixed to the rotatable collar 63a, allowing rotation of the body 35 with respect to the catheter 30. The rotatable collar 63a may have a spring insert to provide tactile positional control. The rotatable collar 63a may be rotated to one or more preset positions. The preset positions may be spaced at intervals of 45°, 90°, 180° or other angles.

[0225] The retriever may comprise a stopper, as previously described with respect to the inserter (47, FIG. 13). The stopper may be positioned along the catheter at a distance selected to set or position the stopper just beyond the length of for retrieval of the elements from the target location or target tissue of the uterine cavity. In some embodiments, the retriever may be free of a stopper.

[0226] The body 35 may have one or two grips 67 on lateral sides (FIG. 19), similar to grips 57 described with respect to the inserter. The body 35 may also comprise a finger rest 65 protruding from a bottom side of the body 35 (FIG. 19), similar to finger rest 55 previously described with respect to the inserter.

[0227] The chamber 31 may have a curvature. For example, the chamber 31 may be similar to the curvature of catheter 40 shown in the side view of FIG. 18 (top panel). The curvature may be 5°-15°, 15°-30°, or 30°-45°. In other embodiments, the chamber 31 may have no curvature. For example, the chamber 31 may be similar to the catheter 40 shown in the side view of FIG. 29.

[0228] In some embodiments, the body 35 of the retriever is rotatable with respect to the chamber 31, for example, at least 90° or at least 180°, or up to 360°, to change configuration of the directional orientation of the opening or optional curvature of the chamber 31. In embodiments that comprise the button or actuator 34 on a single side of the retriever, the body 35 may be rotatable to provide the chamber 31 in a first orientation defining a curvature in the direction of the button or actuator 34 and a second orientation defining the curvature in the direction opposite the button or actuator 34. The rotation may be accompanied with tactile detents, indicating incremental rotation to desirable positions, for example, at 180°, 90°, or 45°. In other embodiments, the body 35 may be fixed with respect to the chamber 31.

[0229] In use, the chamber 31 may be rotated after insertion in the uterus to position the opening for retrieval of the elements 10. The degree of curvature of the chamber 31, if any curvature is present, may be selected responsive to the desired arc of rotation of the chamber 31 within the uterine cavity. In some embodiments, the chamber 31 may have only a slight curvature (for example, 15° or less, 10° or less, or 5° or less) or no curvature to avoid a large arc of rotation within the uterine cavity.

[0230] The retriever may allow for retrieval of the elements without the use of a tenaculum. Accordingly, the methods may comprise tenaculum-free retrieval. In particular, the flexibility of the chamber may be selected to allow tenaculum- free retrieval of the elements. The diameter of the chamber may be selected to allow tenaculum-free retrieval of the elements. For instance, the diameter of the chamber may be 3.5 mm - 5.0 mm or less (for human application). In some embodiments, the methods may comprise dilating the cervix to allow for tenaculum-free retrieval of the elements.

[0231] In some embodiments, the retriever may be free of a balloon. In some embodiments, the retriever may be free of any expandable or inflatable component. For instance, the retriever may be free of a dilating balloon. In other embodiments, the retriever may comprise a balloon, for example, a dilating balloon. The retriever may comprise one or more expandable or inflatable components. The retriever may be dimensioned to retrieve the elements from a target location or target tissue of the uterus. In some embodiments, the retriever may be dimensioned to retrieve the elements from an upper uterine section. In other embodiments, the retriever may be dimensioned to retrieve the elements from a lower uterine section, beyond the cervical canal. Recognizing that there may be anatomical variations between the individual intended subjects, the retriever may be dimensioned to retrieve the elements from the target location or target tissue of a subject having an average sized uterus and reproductive anatomy or dimensioned to retrieve the elements from the target location or target tissue of at least 90% of subjects, at least 95%, or at least 99% of subjects.

[0232] The retriever may be designed for compatibility with subjects at a variety of developmental stages or age groups. The retriever may be dimensioned for compatibility with subjects at a variety of developmental stages or age groups, for example, adolescent, prepregnancy, post-birth, post-abortion, peri-menopausal, or menopausal subjects. The retriever may be designed for compatibility with subjects having a variety of reproductive system anatomical variations. The retriever may be dimensioned and / or formed of materials that are compatible with a variety of reproductive system anatomical variations. For example, the retriever may be designed for use with a subject having a uterus that is anteflexed, anteverted, retroflexed, retroverted, midline, and combinations thereof, each independently of a first degree, second degree, or third degree.

[0233] Detection Sensor

[0234] The methods may comprise scanning the subject for detection of the IUD system after insertion or retrieval. Detection of the elements may be performed by ultrasound or using a detection sensor. Exemplary detection sensors include a magnetic field detector, Gauss meter, or metal detectors.

[0235] The detection sensor may provide contactless detection. The detection sensor may indicate detection of the device with a visual and / or auditory alarm and / or by transmitting a notification to a computer or mobile device. The detection sensor may be equipped to detect the device from a distance of 2 inches or more, for example, from at least 2 inches, 4 inches, 6 inches, 8 inches, or 10 inches to 1 ft. Examples

[0236] The function and advantages of these and other embodiments can be better understood from the following examples. These examples are intended to be illustrative in nature and are not considered to be limiting the scope of the invention.

[0237] Example 1 : Magnetic Force as a Function of Magnetic Core Geometry

[0238] Digital simulation studies were performed to evaluate the relative effectiveness of alternative magnetic core geometries to assemble into varied configurations. Magnetic force is a function of magnetic material, core geometry, size, and assembly configuration. Three magnetic core geometries were tested, including: a cylindrical core (1), a core with beveled edges having a circular cross-section (2), and a solid ellipsoidal magnet element (without a shell).

[0239] Each configuration was evaluated for magnetic force when assembled into: a triad configuration, a laterally arrayed configuration (magnets aligned side to side), and an axially arrayed configuration (magnets aligned end to end). It should be noted that configurations (1) and (2) were sized to fit within an ellipsoidal shell sized as (3), i.e., a maximal size to be delivered through a particular sized catheter lumen. The data are shown in the table of FIG. 5.

[0240] As shown in FIG. 5, the elliptical magnet (3) had the greatest magnetic force in each of the three configurations but had a higher tendency to stay assembled in a series configuration (when inserted in the uterus of a subject). The cylindrical core (1) prefers to assemble into a triad conformation, as the magnetic forces in that conformation are stronger than in a lateral or axially arrayed configuration. The core with beveled edges (2) also prefers to assemble into the triad conformation and exhibits much stronger magnetic forces holding the elements together, which is preferred. The cylindrical core (1) had the weakest magnetic force in each of the configurations.

[0241] FIGS. 3 A and 3B show shaded plot diagrams, prepared to visualize the relative attractive forces of: a cylindrical core (1) (FIG. 3 A), as compared to a larger diameter core having a circular cross section and beveled ends (2) (FIG 3B). Both core geometries are the same length. Both core geometries have the same diameter at each end. The cylindrical core

[0242] (1) has the weakest magnetic force in each of the configurations. The core with beveled ends

[0243] (2) exhibited a significantly stronger attractive force in a triad configuration (3.6X) than the cylindrical core (1). Shaded plot gradations, ranging from red (strongest) > yellow > green > cyan > blue (weakest) indicate a relative range of magnitude for attractive force. The red shading (1.0) is barely present in the cylindrical core (1) diagram (FIG. 3A). FIGS. 3C and 3D show overall geometry of three elements 10 arranged in a triad configuration. The exemplary elements 10 of FIGS. 3C and 3D have cylindrical magnetic cores 11 with beveled edges. The elements 10 of FIG. 3C have a smaller edge thickness 12b (thickness B) than the elements 10 of FIG. 3D. As shown in FIGS. 3C-3D, by reducing edge thickness 12b from 0.36 mm (FIG. 3C) to 0.2 mm (FIG. 3D), the diameter of the overall triad configuration can be reduced from 10.63 mm (FIG. 3C) to 10.07 mm (FIG. 3D). Accordingly, the elements 10 having a smaller edge thickness 12b self-arrange into a triad configuration having a smaller overall profile and a stronger magnetic attraction between elements 10.

[0244] Example 2: Magnetic End. Design

[0245] Magnetic ends with different properties (length, profile, and diameter) were tested for the ability to capture three exemplary uterine implant elements from a triad confirmation and pull the elements into a catheter. The tested designs are shown in the schematic diagrams of FIGS. 26A-26D.

[0246] The first tested magnet is shown in the diagram of FIG. 26A. The magnet (R) was a cylindrical magnet having a length of 3 mm and a diameter of 3 mm. The R magnet was able to successfully capture the three uterine implant elements. Successful capture of the three uterine implant elements was defined as the ability to pull the three elements into a catheter of the retriever.

[0247] The second tested magnet is shown in the diagram of FIG. 26B. The magnet (R0) was a mushroom- shaped magnet having a north pole diameter of 3.68 mm, south pole diameter of 2.58 mm, and length of 7.80 mm. The R0 magnet was not able to capture the three uterine implant elements, as shown in the photographs of FIG. 27A. It is hypothesized that the R0 magnet was unable to capture the elements due to a localized pole created around the stepdown diameter of the magnetic end (FIG. 27B).

[0248] The third tested magnet is shown in the diagram of FIG. 26C. The magnet (QI 1) was a bulb-shaped magnet having a north pole diameter of 3.0 mm, a south pole diameter of 2.1 mm, and a length of 6.75 mm. Specifically, the magnet QI 1 had a length from the tapered portion to the end of the north pole of 3.0 mm. The gradual tapering of the bulb- shaped magnetic end was designed to avoid the localized pole created around the step-down diameter of the magnetic end. While the magnet QI 1 was able to capture the three uterine implant elements with a higher success rate than the magnet R0, the magnet QI 1 was not as consistent at capturing the three uterine implant elements as desired. The fourth tested magnet is shown in the diagram of FIG. 26D. The magnet (Q12) was a bulb-shaped magnet having a north pole diameter of 3.0 mm, a south pole diameter of 2.1 mm, and a length of 5.75 mm. Specifically, the magnet Q12 had a length from the tapered portion to the end of the north pole of 2.0 mm. Thus, the overall length of the magnetic end was reduced by 1.0 mm, but specifically the length from the tapered portion to the end of the north pole was reduced by 1.0 mm. The magnet Q12 was able to successfully capture the three uterine implant elements, as shown in the photographs of FIG. 28.

[0249] Accordingly, the dimensions of the magnet may be selected to successfully capture uterine implant elements from a triad conformation.

[0250] However, it is noted that the magnet dimensions from this example were selected to successfully capture the tested uterine implant elements. It is believed that the dimensions of a magnet capable of capturing uterine implant elements may vary with varying uterine implant element dimensions.

[0251] Example 3: Prophetic Example of a Method, of Providing Contraception

[0252] A frameless IUD system as disclosed herein will be used to provide contraception to a subject. In particular, three uterine implant elements which make up the IUD system will be delivered to the uterus of a subject with an accompanying handler (developed by 3Daughters, Inc., Fort Lauderdale, FL) to provide contraception. The uterine implant elements will have a magnetic core dimensioned to assemble into a conformation that adapts to the uterine environment and resists expulsion. In this example, the uterine implant elements will have a magnetic core dimensioned to adopt a stable triad conformation in the uterus of the subject.

[0253] The uterine implant elements will have the following dimensions: a length of less than 10 mm, for example, between 2.0 mm and 10 mm and a width of between 2.0 mm and 6.0 mm, for example, dimensioned to fit within a 4.0 mm - 5.0 mm OD catheter; the magnetic core of the uterine implant element will have a rounded cross- sectional area and beveled edges; and an anti-fertility agent coating forming a shell protectively encasing the magnetic core will have a varied thickness.

[0254] The element will generally be ellipsoidal in shape, as provided by the shell. The shell will be dimensioned to enable the three elements to self-assemble into the stable triad configuration upon administration and de-assemble into an axially arrayed (aligned) configuration for retrieval. Traditional contraceptive devices with a frame (plastic (polyethylene)) T-shaped design cause painful insertions, incidences of perforation of the uterus, expulsion from the uterus, and include required strings for removal from the uterus.

[0255] The frameless IUD system disclosed herein will include a plurality of uterine implant elements that conform and adapt to the uterine environment, provide an easier insertion process (with fewer steps, reducing or eliminating pain points), have smooth exterior dimensions, and are structurally independent from each other. Accordingly, the frameless IUD system disclosed herein will provide contraception to a subject with reduced insertion pain, reduced (or eliminated) risk of expulsion (adapting to the uterine environment), reduced (or eliminated) risk of uterine perforation, and without requiring strings for removal.

[0256] Example 4: Prophetic Example of Insertion of a Plurality of Elements

[0257] An applicator as disclosed herein will be used to insert a frameless IUD system into the uterus of a subject to provide contraception. In particular, three uterine implant elements which make up the IUD system will be delivered to the uterus of a subject with the applicator. One exemplary applicator is the handler developed by 3Daughters, Inc. (Fort Lauderdale, FL). In this example, the applicator will have a catheter including an internal chamber, a plunger slidably disposed within the internal chamber, and a flexible dilating tip at a distal end of the catheter. The applicator will have a body fixed to the catheter with an actuator operably connected to the plunger.

[0258] The inserter will be removed from sterile packaging having the frameless IUD system within the internal chamber. FIG. 18 is a schematic diagram of the applicator. A safety tab preventing extension of the plunger will be removed. The safety tab may be discarded. The plunger within the internal chamber is designed to provide structure and support to provide a curvature as desired. The dilating tip is designed for smooth entry from the cervix into the uterus and will be bent to provide a curvature needed to adapt the inserter to different uterine positions. The body will be rotated via a rotatable collar to position the curvature of the catheter in a desired direction to enter the uterine cavity.

[0259] The catheter will be inserted into the uterine cavity of the subject through the cervical canal just passed the internal os or until the dilating tip gently touches the fundus. The user will slide the actuator button fully forward to discharge the frameless IUD system within the uterine cavity. The user will then remove the applicator from the subject.

[0260] FIGS. 15-17 are schematic diagrams showing insertion of the applicator through the cervix into the uterine cavity of the subject. The tapered end of the dilating tip will allow insertion without a tenaculum or sounding of the uterus. The flexibility of the catheter and ability to adopt the desired curvature to varying uterine positions will allow insertion of the catheter without the use of a tenaculum. A stopper (FIG. 15) may be set or used to assess cervical length and deploy the IUD elements just beyond the internal os of the cervix into the uterus. Alternatively, a stopper need not be used (FIGS. 16-18).

[0261] By allowing insertion of the catheter and IUD without sounding and without the use of a tenaculum, the applicator disclosed herein will provide delivery of an IUD system with a reduced number of steps and significantly reduced pain for the subject.

[0262] Example 5: Prophetic Example of Retrieval of a Plurality of Elements

[0263] A retriever as disclosed herein will be used to retrieve a frameless IUD system from the uterus of a subject. In particular, three uterine implant elements which make up the IUD system will be retrieved from the uterus of a subject with the retriever. One exemplary retriever is the handler developed by 3Daughters, Inc. (Fort Lauderdale, FL). In this example, the retriever will have a catheter including an internal chamber, a wand slidably disposed within the internal chamber having a magnetic end, and a body fixed to the catheter with an actuator operably connected to the wand.

[0264] FIG. 14 is a schematic diagram showing retrieval of the three magnetic IUD elements. While placed in the uterus of the subject, the magnetic elements will be positioned in a stable conformation that resists expulsion from the uterus by magnetic attraction to one another, such as a triad conformation, as shown in FIG. IE. The retriever will be removed from sterile packaging. The healthcare provider may elect to visualize the position of the magnetic elements in the uterine cavity using ultrasound. The wand within the internal chamber will be bent to provide a curvature as desired. The body will be rotated via a rotatable collar to position the curvature of the catheter of the retriever in a desired direction.

[0265] The catheter of the retriever will be inserted into the uterine cavity of the subject through the cervical canal until tactile feedback indicates that the magnetic elements have attached to the magnetic end. The magnetic end of the wand will be advanced within the internal chamber to attract an opposite pole of a first element and repel a like pole of an adjacent element, breaking up the triad conformation into an axial or generally aligned conformation. The user will slide the actuator button fully backward to bring the frameless IUD system magnetic elements within the internal chamber. The user will then remove the retriever from the subject. The flexibility of the catheter and ability to adopt the desired curvature may facilitate insertion of the retriever.

[0266] Thus, by using magnetic attraction the retriever disclosed herein will provide easy retrieval of an IUD system from the uterus with significantly reduced pain for the subject.

[0267] The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. As used herein, the term “plurality” refers to two or more items or components. The terms “comprising,” “including,” “carrying,” “having,” “containing,” and “involving,” whether in the written description or the claims and the like, are open-ended terms, i.e., to mean “including but not limited to.” Thus, the use of such terms is meant to encompass the items listed thereafter, and equivalents thereof, as well as additional items. Only the transitional phrases “consisting of’ and “consisting essentially of,” are closed or semi-closed transitional phrases, respectively, with respect to the claims. Use of ordinal terms such as “first,” “second,” “third,” and the like in the claims to modify a claim element does not by itself connote any priority, precedence, or order of one claim element over another or the temporal order in which acts of a method are performed, but are used merely as labels to distinguish one claim element having a certain name from another element having a same name (but for use of the ordinal term) to distinguish the claim elements.

[0268] Having thus described several aspects of at least one embodiment, it is to be appreciated various alterations, modifications, and improvements will readily occur to those skilled in the art. Any feature described in any embodiment may be included in or substituted for any feature of any other embodiment. Such alterations, modifications, and improvements are intended to be part of this disclosure and are intended to be within the scope of the invention. Accordingly, the foregoing description and drawings are by way of example only.

[0269] Those skilled in the art should appreciate that the parameters and configurations described herein are exemplary and that actual parameters and / or configurations will depend on the specific application in which the disclosed methods and materials are used. Those skilled in the art should also recognize or be able to ascertain, using no more than routine experimentation, equivalents to the specific embodiments disclosed.

[0270] What is claimed is:

Claims

CLAIMS1. A delivery device for an intrauterine device (IUD) system including at least one element comprising a magnetic core and a coating exterior to the magnetic core, the delivery device comprising: a catheter having an internal chamber dimensioned to hold the at least one element, the catheter having an outer diameter (OD) dimensioned to pass through a cervix of a subject and a length dimensioned to deposit the at least one element in a uterus of the subject; and a plunger slidably disposed within the internal chamber of the catheter.

2. The delivery device of claim 1, wherein the catheter is a 4.0 mm to 5.0 mm OD catheter.

3. The delivery device of claim 1, wherein the catheter has a flexibility selected to pass through the cervix of the subject for tenaculum-free insertion.

4. The delivery device of claim 1, wherein the IUD system includes a plurality of elements, the internal chamber being dimensioned to hold the plurality of elements in an axial or generally aligned conformation.

5. The delivery device of claim 1, wherein the catheter extends from a body having an ergonomic configuration for handheld operation of the delivery device, the body comprising an actuator operably connected to discharge the plunger.

6. The delivery device of claim 5, wherein the body comprises a rotatable collar fixed to the catheter.

7. The delivery device of claim 6, wherein the rotatable collar comprises tactile detents positioned to indicate incremental rotation of the body to desirable positions.

8. The delivery device of claim 1, wherein the catheter is dimensioned to deposit the at least one element in the uterus of the subject, the uterus of the subject having an anatomical geometry selected from anteflexed, anteverted, retroflexed, retroverted, midline, and combinations thereof, each independently of a first degree, second degree, or third degree.

9. The delivery device of claim 1, further comprising a stopper positioned along the catheter at a distance selected to contact the cervix of the subject when the delivery device is positioned to deposit the at least one element in the uterus of the subject.

10. The delivery device of claim 1, wherein the internal chamber comprises divots to position the at least one element in place.

11. The delivery device of claim 1, wherein an opening of the internal chamber comprises a crimpled edge to position the at least one element in place.

12. The delivery device of claim 1, wherein the catheter is configurable to position the at least one element to protrude from an opening at a distal end of the internal chamber during insertion.

13. The delivery device of claim 1, wherein a distal end of the catheter has a cervical dilating tip.

14. The delivery device of claim 13, wherein the cervical dilating tip comprises a tapered end and a rounded tip.

15. The delivery device of claim 14, wherein the internal chamber comprises a lateral opening for release of the at least one element.

16. A retrieval device for an intrauterine device (IUD) system including at least one element comprising a magnetic core and a coating exterior to the magnetic core, the retrieval device comprising: a catheter having an internal chamber dimensioned to hold the at least one element, the catheter having an outer diameter (OD) dimensioned to pass through a cervix of a subject and a length dimensioned to retrieve the at least one element from a uterus of the subject; and a wand slidably disposed within the internal chamber of the catheter having a magnetic end.

17. The retrieval device of claim 16, wherein the IUD system includes a plurality of elements, the internal chamber being dimensioned to hold the plurality of elements in an axial or generally aligned conformation.

18. The retrieval device of claim 17, wherein the magnetic end is dimensioned to de-assemble the plurality of elements from a conformation that resists expulsion from the uterus of the subject into the axial or generally aligned conformation.

19. The retrieval device of claim 16, wherein the magnetic end is dimensioned to provide a magnetic force between 0.05 Kg (0.5N) and 20 Kg (200 N).

20. A kit comprising: an intrauterine device (IUD) system including at least one element comprising a magnetic core and a coating exterior to the magnetic core; a delivery device comprising a catheter having an internal chamber dimensioned to hold the at least one element, the catheter having an outer diameter (OD) dimensioned to pass through a cervix of a subject and a length dimensioned to deposit the at least one element in a uterus of the subject, and a plunger slidably disposed within the internal chamber of the catheter; and instructions to deliver the plurality of elements to the uterus of the subject using the delivery device.

21. The kit of claim 20, further comprising a retrieval device comprising a catheter having an internal chamber dimensioned to hold the at least one element, the catheter having an outer diameter (OD) dimensioned to pass through the cervix of the subject and a length dimensioned to retrieve the at least one element from the uterus of the subject, and a wand slidably disposed within the internal chamber of the catheter having a magnetic end.

22. A method of providing controlled contraception or treating or preventing a uterine disease, condition, or symptom thereof in a subject, comprising: delivering with a delivery device to a uterus of the subject a plurality of elements, each element comprising a magnetic core and a coating exterior to the magnetic core, the magnetic core being dimensioned to assemble the plurality of elements into a conformation that resists expulsion from the uterus of the subject,the delivery device comprising a catheter having an internal chamber dimensioned to hold the plurality of elements, the catheter having an outer diameter (OD) dimensioned to pass through a cervix of a subject and a length dimensioned to deposit the plurality of elements in the uterus of the subject, and a plunger slidably disposed within the internal chamber of the catheter.

23. The method of claim 22, comprising inserting the catheter through the cervix of the subject with tenaculum-free insertion.

24. The method of claim 22, comprising delivering the plurality of elements with sounding- free insertion of the delivery device.

25. The method of claim 22, further comprising retrieving with a retrieval device the plurality of elements from the uterus of the subject, the retrieval device comprising a catheter having an internal chamber dimensioned to hold the plurality of elements, the catheter having an outer diameter (OD) dimensioned to pass through the cervix of the subject and a length dimensioned to retrieve the plurality of elements from the uterus of the subject, and a wand slidably disposed within the internal chamber of the catheter having a magnetic end.

26. The method of claim 25, comprising retrieving the plurality of elements from the uterus of the subject in an axial or generally aligned conformation.

27. A method of facilitating controlled contraception or treating or preventing a uterine disease, condition, or symptom thereof in a subject, comprising: providing a plurality of elements, each element comprising a magnetic core and a coating exterior to the magnetic core, the magnetic core being dimensioned to assemble the plurality of elements into a conformation that resists expulsion from the uterus of a subject; and providing instructions to deliver the plurality of elements to the uterus of the subject with a delivery device comprising a catheter having an internal chamber dimensioned to hold the plurality of elements, the catheter having an outer diameter (OD) dimensioned to pass through a cervix of a subject and a length dimensioned to deposit the plurality of elements in the uterus of the subject, and a plunger slidably disposed within the internal chamber of the catheter.

28. The method of claim 27, comprising providing the delivery device.

29. The method of claim 27, further comprising providing instructions to retrieve the plurality of elements from the uterus of the subject with a retrieval device comprising a catheter having an internal chamber dimensioned to hold the plurality of elements, the catheter having an outer diameter (OD) dimensioned to pass through the cervix of the subject and a length dimensioned to retrieve the plurality of elements from the uterus of the subject, and a wand slidably disposed within the internal chamber of the catheter having a magnetic end.

30. The method of claim 29, further comprising providing the retrieval device.

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